The Grace Period Restoration Act: A Misguided Missile Harold C. Wegner The academic community has had great difficulty adapting its patent procedures to first-to-file that was introduced nearly four (4) years ago as part of the Leahy Smith America Invents Act of 2011. The community would do well to turn to counterpart institutions in Germany, Japan and elsewhere that operate quite well under first-to-file. Before saying that the “sky is falling” because it has to adapt to new realities and crying out for a legislative return to the past, it would be better to first see how the rest of the world operates, quite nicely, with first-to-file. The Grace Period Restoration Act represents a signal achievement in stone age thinking. Just as America has joined the twenty-first century with first-to-file the academic community seeks to restore a significant portion of the grace period it lost as part of the Leahy Smith America Invents Act of 2011 – now nearly four (4) years ago. The legislation is boldly retroactive to be effective as if part of this four (4) year old legislation. The legislation, if enacted into law, would expand the definition of novelty under 35 USC § 102 to roughly 1200 words, an unreadable mass of verbiage that the sponsors couldn’t figure out, particularly as the legislation does not accomplish its task. (In contrast the European Patent Convention definition of novelty runs to about 200 words; the text is found as an appendix to this paper.) Wegner, The Grace Period Restoration Act: A Misguided Missile Doing Violence to the Tegernsee Initiative The United States has moved ever closer under the leadership of Under Secretary David Kappos and Acting Under Secretary Teresa Stanek Rea toward more and better cooperation with overseas patent offices, notably in the Tegernsee and other initiatives. The United States is a prime beneficiary of the Tegernsee progress because patent simplification and cooperation result in “patent worksharing” that will lessen the load of American patent examiners and enhance patent quality. If the Grace Period Restoration Act comes into being, this will have a dramatic, negative impact on the direction of Tegernsee. “[P]ractical, mainstream steps to * * * put government back in its proper role.” Senator Vitter, as a cosponsor of this legislation, precisely how does this legislation fit within your definition of being something that is “practical” or “mainstream”?* “About David”, downloaded April 15, 2015, http://www.vitter.senate.gov/aboutdavid (“Senator Vitter * * * [is] focused on taking practical, mainstream steps to * * * put government back in its proper role.”). * 2 Wegner, The Grace Period Restoration Act: A Misguided Missile The Text of the Bill is Unreadable and not Understandable The Grace Period Restoration Act goes nowhere close to achieving the goals of the sponsors. The legislation, for example, removes an inventor’s publication as prior art where the inventor makes a “disclosure” of an invention “in a printed publication”. See 35 USC § 102(b)(3)(B)(ii)( “A disclosure [within one year before filing] by any person shall not be prior art to a claimed invention under [§ 102](a) * * * if … before [such] disclosure … the claimed invention is publicly disclosed in a printed publication by [the inventor] in a manner that satisfies the relevant section 112(a) requirements.”). A first question is what happens where the there is, for example, an oral disclosure at a conference so that the invention was “otherwise available to the public”? Or, what happens with commercialization efforts by an academic institution that creates a technical “on sale” issue, prior art events within the scope of § 102(a) but outside the wording of 35 USC § 102(b)(3)(B)(ii) of the Grace Period Restoration Act. See 35 USC § 102(a)(1)(“A person shall be entitled to a patent unless…the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention[.]”)(emphasis added). For example, at the (hypothetical) Waldorf Astoria Conference open to the public on January 3, 2015, and attended by a large audience of those skilled in the art, Professor Littleman gives a lecture on his new invention of the hyperactivity compound, trans-scrotylase. Excited, Professor Smallballs during the question and answer period proposes the cis-isomer as an alternative, cis-scrotylase. Thereafter, Professor Littleman files on his invention to trans-scrotylase and obtains a patent 3 Wegner, The Grace Period Restoration Act: A Misguided Missile For example, in a Post Grant Review, the patent is challenged as anticipated by Professor Smallballs’ oral disclosure of the different compound, cis-scroytlase. The cis-scrotylase is prior art as having been “otherwise available to the public” yet it may not qualify as a “printed publication” and thus is not excluded as prior art. Also, consider the situation where Professor Littleman’s university employer proposes trans-scrotylase to a company in a manner to trigger an “on sale” bar. After the company discusses trans-scrotylase the company publishes its own invention of cis-scrotylase prior to Professor Littleman’s patent filing date. The “on sale” event is outside the safeguard of 35 USC § 102(b)(3)(B)(ii). The Text does not Cover a Third Party’s Different Invention The grace period does not exclude a third party’s disclosure of a different yet obvious invention, a situation that occurs everyday. The issue is considered in detail in Wegner, PATENT DRAFTING, A MANAGEMENT GUIDE, §§ 60 et seq. (attached). In this context, another at first blush relevant provision is 35 USC § 102(b)(3)(E) that states that “[a] disclosure described in [35 USC § 102(b)](1)(A) * * * shall not be prior art to a claimed invention under this paragraph.” But, the referenced paragraph does not exclude as prior art a different invention than that claimed by the applicant. Thus, cis-scrotylase is not excluded as prior art because 35 USC § 102(b)(1)(A) only removes as prior art “[a] disclosure * * * of a claimed invention [which] shall not be prior art to the claimed invention under [35 USC § 102](a)(1) * * *.” USC § 102(b)(1)(A)(emphasis added). 4 Wegner, The Grace Period Restoration Act: A Misguided Missile Appendix: European Patent Convention Article 54, Novelty (1) An invention shall be considered to be new if it does not form part of the state of the art. (2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application. (3) Additionally, the content of European patent applications as filed, the dates of filing of which are prior to the date referred to in paragraph 2 and which were published on or after that date, shall be considered as comprised in the state of the art. (3) Paragraphs 2 and 3 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art. (4) Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.” 5 Grace Period Restoration Act New 35 USC § 102 (New Text Shown in Box) 35 U.S.C. 102 Conditions for patentability; novelty. (a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless— (1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or (2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. (b) EXCEPTIONS.— (1) DISCLOSURES MADE 1 YEAR OR LESS BEFORE THE EFFECTIVE FILING DATE OF THE CLAIMED INVENTION.—A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if— (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. (2) DISCLOSURES APPEARING IN APPLICATIONS AND PATENTS.—A disclosure shall not be prior art to a claimed invention under subsection (a)(2) if— (A) the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor; (B) the subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (C) the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Grace Period Restoration Act New 35 USC § 102 (New Text Shown in Box) (3) DISCLOSURES BY ANY PERSON AFTER PUBLIC DISCLOSURE OF A CLAIMED INVENTION BY AN INVENTOR. – (A) DEFINITIONS.—In this paragraph – “(i) the term ‘covered person’, with respect to a claimed invention, means – “(I) the inventor; “(II) a joint inventor; or (III) another who obtained the claimed invention directly or indirectly from the inventor or a joint inventor; and (ii) the term ‘relevant section 112(a) requirements’ means the requirements for a specification under section 112(a) other than the requirement to set forth the best mode of carrying out the invention. (B) PUBLIC DISCLOSURE. – A disclosure by any person shall not be prior art to a claimed invention under subsection (a) or section 103 if – “(i) the disclosure is made under section (a)(1) or effectively filed under subsection (a)(2) 1 year or less before the effective filing date of the claimed invention; and “(ii) before the disclosure described in clause (i) is made or filed, and 1 year or less before the effective filing of the claimed invention, the claimed invention is publicly disclosed in a printed publication by a covered person in a manner that satisfies the relevant section 112(a) requirements. (C) DETERMINATION THAT PUBLIC DISCLOSURE WOULD HAVE SATISFIED SPECIFICATION REQUIREMENTS. – In determining under subparagraph (b) whether a claimed invention was publicly disclosed in a printed publication by a covered person in a manner that satisfied the relevant section 112(a) requirements – Grace Period Restoration Act New 35 USC § 102 (New Text Shown in Box) (i) only the state of the art known on or before the date of the disclosure may be considered; and (ii) satisfaction of the relevant section 112(a) requirements may be – (I) established by 1 or more public disclosures in printed publications made by a covered person during the period of 1 year or less between – (aa) the disclosure by the covered person described in subparagraph (B)(ii); and (bb) the effective filing date of the claimed invention; and “(II) supported by statements under declaration or oath relating to the existence and content of the public disclosure or disclosures in printed publications described in subclause (I). (D) PRESUMPTION OF VALIDITY. – An applicant for a patent shall present to the Patent and Trademark Office, before the Patent and Trademark Office issues a notice of allowance of the application for patent, each disclosure under subparagraph (C)(ii)(I) and any statement under subparagraph (C)(ii)(II) in order for the section 112(a) support provided by each disclosure or statement under subparagraph (C)(ii) to be taken into account under the section 282(a) presumption of validity of an issued patent. “(E) CERTAIN DISCLOSURES NOT PRIOR ART. – A disclosure described in paragraph (1)(A), (2)(A), or 2(C) shall not be prior art to a claimed invention under this paragraph[:] [*] 35 USC § 102(b)(1)(A) DISCLOSURES MADE 1 YEAR OR LESS BEFORE THE EFFECTIVE FILING DATE OF THE CLAIMED INVENTION.—A disclosure [within one year] before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if … the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor *** Grace Period Restoration Act New 35 USC § 102 (New Text Shown in Box) 35 USC § 102(b) (2)(A) DISCLOSURES APPEARING IN APPLICATIONS AND PATENTS.—A disclosure shall not be prior art to a claimed invention under subsection (a)(2) if …the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor[.][*] *** 35 USC § 102(b) (2)(C) DISCLOSURES APPEARING IN APPLICATIONS AND PATENTS.—A disclosure shall not be prior art to a claimed invention under subsection (a)(2) if …the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. [*] “(F) PROCEDURES. – The Patent and Trademark Office may establish procedures to carry out this paragraph.” [*] Italicized text added for convenience from other portions of Section 102. (c) COMMON OWNERSHIP UNDER JOINT RESEARCH AGREEMENTS.—Subject matter disclosed and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person in applying the provisions of subsection (b)(2)(C) if— (1) the subject matter disclosed was developed and the claimed invention was made by, or on behalf of, 1 or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention; (2) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and (3) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement. Grace Period Restoration Act New 35 USC § 102 (New Text Shown in Box) (d) PATENTS AND PUBLISHED APPLICATIONS EFFECTIVE AS PRIOR ART.—For purposes of determining whether a patent or application for patent is prior art to a claimed invention under subsection (a)(2), such patent or application shall be considered to have been effectively filed, with respect to any subject matter described in the patent or application— (1) if paragraph (2) does not apply, as of the actual filing date of the patent or the application for patent; or (2) if the patent or application for patent is entitled to claim a right of priority under section 119, 365(a), or 365(b) or to claim the benefit of an earlier filing date under section 120, 121, or 365(c), based upon 1 or more prior filed applications for patent, as of the filing date of the earliest such application that describes the subject matter. PATENT DRAFTING A Corporate Management Guide for Original Patent Application Draftsmanship under the New Law HAROLD C. WEGNER © MMXV Harold C. Wegner Wegner, Patent Drafting, A Corporate Management Guide [2016] § 60 An Extremely Narrow Grace Period The new grace period is not anything like the American grace period that has been a central feature of patent law up until the dawn of the Leahy Smith America Invents Act. The new grace period only applies in the case of the inventor’s own prior work or prior commonly owned work or work published by a third party that is derived from an inventor. Undoubtedly the most severe challenge as to the grace period is the official view of the Patent Office that a third party’s disclosure of a variation of derived subject matter is prior art without any grace period. This one glitch in the grace period makes it difficult if not impossible to prospectively rely upon the grace period. § 61. Improvement Inventorship during the Grace Period Consider the following fact pattern that happens every day in the world of science: [1] A scientific conference is held at Cold Spring Harbor where Professor Alpha makes a presentation on his new Alpha-Scrotonoyl Chloride acid inhibitor. [2] Excited about this development, Professor Beta in the Question and Answer period proposes a Beta-Scrotonoyl Chloride acid inhibitor that he suggests would make a better alternative to Professor Alpha’s invention because of the well known interchangability of Alpha and Beta Scrotonoyl derivatives and the known fact that in many cases the Beta form is superior. [3] Professor Beta immediately publishes an e-mail to the relevant members of the 93 Wegner, Patent Drafting, A Corporate Management Guide [2016] scientific community proposing his Beta-Scrotonoyl Chloride acid inhibitor while acknowledging the pioneer work of Professor Alpha with his Alpha-Scrotonoyl Chloride acid inhibitor. [4] Shortly thereafter, Professor Alpha files a patent application to his AlphaScrotonoyl Chloride acid inhibitor. Professor Beta’s disclosure of his Beta-Scrotonoyl Chloride acid inhibitor is a disclosure of his invention and it is not a “disclosure *** of a claimed invention” of Professor Alpha. § 62. Grace Period Only for a “Disclosure *** of a Claimed Invention” A grace period is established under 35 USC § 102(b)(1)(B): “A disclosure *** of a claimed invention shall not be prior art to the claimed invention under [35 USC § 102(a)(1)] if *** the subject matter disclosed had, before such disclosure, been publicly disclosed by *** another who obtained the subject matter disclosed *** from the inventor ***.” (emphasis added). Rewritten to integrate 35 USC § 102(a)(1) into the grace period the provision reads as follows (with § 102(a)(1) integrated into the text in brackets): “A disclosure *** of a claimed invention shall not be prior art to the claimed invention [as having been patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention] if *** the subject matter disclosed had, before such disclosure, been publicly disclosed by *** another who obtained the subject matter disclosed *** from the inventor ***.” (emphasis added). Thus, the wording of the statute makes clear that the grace period applies only to “[a] disclosure *** of a claimed invention”, where such “subject matter 94 Wegner, Patent Drafting, A Corporate Management Guide [2016] disclosed” was derived from the inventor. The wording of the statute is unequivocal and says nothing about a grace period applying to a disclosure of a different invention, but only disclosure of the “claimed invention”. (There is a parallel grace period in 35 USC § 102(b)(2)(B) which, however, raises the identical issue as for 35 USC § 102(b)(1)(B).) The initial Patent Office interpretation of the grace period excludes a third party’s derived disclosure obtained from the true inventor seeking reliance on the grace period if the third party’s derived disclosure is not to the “same” subject matter: Thus, the grace period does not apply under the Patent Office interpretation if the derived disclosure also includes “mere insubstantial changes, or only trivial or obvious variations”. As more fully stated in the Federal Register: “The [grace period] exception in 35 U.S.C. 102(b)(1)(B) applies if the ‘‘subject matter’ disclosed [in the prior art disclosure] had, before such [prior art] disclosure, been publicly disclosed by the inventor or a joint inventor * * * .’ [35 U.S.C. 102(b)(1)(B)]. Thus, the exception [ ] requires that the subject matter in the prior disclosure being relied upon [as prior art] under 35 U.S.C. 102(a) be the same ‘subject matter’ as the subject matter publicly disclosed by the inventor before such prior art disclosure for the exception [ ] to apply. Even if the only differences between the subject matter in the prior art disclosure that is relied upon under 35 U.S.C. 102(a) and the subject matter publicly disclosed by the inventor before such prior art disclosure are mere insubstantial changes, or only trivial or obvious variations, the exception [ ] does not apply.” Examination Guidelines for Implementing the First-Inventor-to-File Provisions of the Leahy-Smith America Invents Act (Request for Comments), 77 FR 43759, 43767 (July 26, 2012)(emphasis added). 95 Wegner, Patent Drafting, A Corporate Management Guide [2016] Thus, the Patent Office has interpreted the grace period to exclude a third party’s prior disclosure of a different invention. Thus, if a third party modifies subject matter disclosed by the inventor, the grace period does not save the applicant from the third party’s disclosure of the modified subject matter. § 63 Armitage Case Against a Broad Grace Period The case for denying a grace period effect is explained by Robert A. Armitage*: ___________________ * This section is retitled by the editor but is otherwise a verbatim reproduction (beyond the introduction) of the substantive portion of a letter captioned Eli Lilly and Company [ ] Supplemental Comments to the United States Patent and Trademark Office [ ] Notice of Proposed Examination Guidelines Entitled: Examination Guidelines for Implementing the First-Inventor-to-File Provisions of the Leahy-Smith America Invents Act”, a supplemental submission to the Request for Comments on the Examination Guidelines for Implementing the First-Inventor-to-File Provisions of the LeahySmith America Invents Act, 77 Fed. Reg. 43759-43773 (July 26, 2012), on behalf of Eli Lilly and Company by its Senior Vice President and General Counsel, Robert A. Armitage, to the Honorable David J. Kappos, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, October 22, 2012, October 22, 2012. Mr. Armitage is undoubtedly the single most significant industry figure leading to the enactment of the Leahy Smith America Invents Act dating back to his participation in almost all of the expert sessions off the WIPO Committee of Experts on Patent Harmonization that met in Geneva over the period 1985-1990, and has been continuously involved in all patent reform efforts since that time, including the entire gestation of the bills leading up to the Leahy Smith America Invents Act. 96 Wegner, Patent Drafting, A Corporate Management Guide [2016] [This paper] addresses the issue of whether the provisions in subparagraph (B) of §102(b)(1) and §102(b)(2), when addressing the “subject matter disclosed” by (or at the behest of) the inventor, is to be construed as the statute was written or should be construed far more broadly. The broad construction would augment the literal language of the statute to encompass a non-statutory “fudge factor.” In construing the statute to include such a non-statutory “fudge factor,” an inventor would be given leeway, for the purpose of evading the prior art effect with respect to a subsequent patent filing, of not only the “subject matter disclosed” by the inventor in an earlier publication (what the statute dictates is the scope of the provision), but also any and all obvious variants of such subject matter, e.g., any additional, non-disclosed embodiments that would represent merely nonsubstantial changes from the subject matter disclosed. [Our] view is that the statute should be applied as written by Congress. If construed to encompass a non-statutory “fudge factor,” the provision would reach nonsensical results. Such a construction would mean that an inventor could more readily avoid prior art by merely publishing on subject matter instead of making a prompt patent filing. Congress could never have intended that an inventor who proceeds to promptly seeking a patent should be disadvantaged relative to an inventor who merely published on limited subject matter and then belatedly seeks a broader patent, only after the public disclosure of the independent work of others. In hopes of preventing such absurd prospects in the implementation of the AIA by the Office, [our] detailed comments follow. 1. Following a “Fudge Factor” Approach Is Unnecessary to Assure the AIA “Grace Period” Functions Fully and Fairly to Bar the Inventor’s Own Work as Prior Art and Meets the Limited Objective of Congress to Protect Publishing Inventors Against Intervening Public Disclosures Representing the Independent Work of Others 97 Wegner, Patent Drafting, A Corporate Management Guide [2016] The fudge-factor proponents rely heavily on AIA legislative history for construing the subparagraph (B) provisions, to the exclusion of simply applying the statutory provisions as written. However, the legislative history that is most frequently cited by fudge-factor proponents clearly relates – and was intended to relate – exclusively to the subparagraph (A) provisions of §§102(b)(1) and (2). Unlike the subparagraph (B) provisions, the subparagraph (A) provisions are the ones that deal with the inventor’s “grace period.” The subparagraph (B) provisions are different and distinct from the “grace period” provisions – they provide an added layer of protection for inventors. The “grace period” by itself serves one and only one function. It allows an inventor to have its own work disregarded as prior art. For example, when an inventor’s own work is directly disclosed by the inventor (or the inventor’s work is disclosed by someone else) in an earlier (pre-patent filing) publication, then the subject matter disclosed directly (or indirectly) by the inventor is entirely disregarded as prior art. Thus, as a technical matter, the subparagraph (B) provisions of §102(b) have nothing whatsoever to do with the “grace period.” Instead, the subparagraph (B) provisions provide an additional “prior art” protection based upon the independent work of others, rather – than is the case with “grace period” protection – the work of the inventor itself. Properly viewed, therefore, the “grace period” under the AIA operates in exactly the same manner as it applies under pre-AIA patent law. The “grace period” – both under the AIA and the pre-AIA law – provides 100% protection against the inventor having its own work used against it, irrespective of who discloses such work or how it comes to be disclosed during the “grace period” in the pre-filing disclosure. While both pre-AIA and the AIA statute have what could be regarded as a perfect “grace period,” the statutory version in the AIA, if anything, is superior to pre-AIA law. The new law quite explicitly deals with “indirect” disclosures that, even if made by others, must be attributable back to the inventor because they are the inventor’s own work. The AIA makes explicit what was merely implicit in preAIA law. 98 Wegner, Patent Drafting, A Corporate Management Guide [2016] Thus, “grace period” – either pre-AIA law or under the AIA itself – provides 0% protection from public disclosures arising from independently created work of others. That said, both the AIA and pre-AIA law have provisions in which such public disclosures of others’ independent work can be disregarded as prior art. However, the statutory schemes under the AIA and pre-AIA law are vastly different. What the new subparagraph (B) provisions provide in terms of an ability to disregard independent work of others as prior art serves as a replacement for what 35 U.S.C. §102(g) (and related “invention date” provisions of pre-AIA law) provided. In a nutshell, both the subparagraph (B) provisions and pre-AIA “invention date” provisions provide a vehicle by which the pre-filing public disclosures, representing work developed by others, can be disregarded as prior art. Viewed in this manner, any contentions from the fudge-factor proponents that the “grace period” under the AIA would be gutted appears by applying the subparagraph (B) provisions as written in the new statute appear to be doubly flawed. First, under both the AIA and pre-AIA versions of §102, the “grace period” provisions function identically – they operate identically and have identical effect. Second, both AIA law and pre-AIA law limit the ability of an inventor to avoid an intervening public disclosure of someone else’s independent work. Thus, contentions of “grace period” gutting simply ignore the first point and, as to the second point, disregard the impact of §102(g) prior art (prior-invention “prior art”) that must be considered whenever there is an intervening public disclosure based upon the independent work of others. Indeed, the pre-AIA law does not go nearly as far in protecting inventors against independent work of others as prior art as some fudge-factor proponents urge that the subparagraph (B) provisions should go to remove such work of others as prior art! Indeed, in key respects applying the subparagraph (B) provisions as written and as manifestly intended by Congress would in many circumstances provide inventors with more useful and effective protection from invalidating prior art compared to current law. The manner in which the AIA operates in this respect is more fully set out below. 99 Wegner, Patent Drafting, A Corporate Management Guide [2016] Hence, rather than gutting the “grace period,” the AIA, applying the statute as written, maintains, if not enhances, the “grace period,” and – under many fact situations – otherwise improves the prospects for obtaining a valid patent compared to current law. 2. Compared to pre-AIA §102(g) Law, the New §102 Provisions – Applied as Written – Provide Fair and Often Superior Protection for Inventors Pre-AIA §102(g) limits the ability of inventors to secure a valid patent in every situation where subparagraph (B) would apply under the AIA. Section 102(g) applies both where there are disclosures of independent work of others that are identical to subject matter an inventor has earlier published and to the situation where there are obvious variations of the inventor’s earlier-published subject matter. Under pre-AIA patent law, such types of intervening disclosures of independent work of others typically portend patent disaster given the operation of pre-AIA §102(g)’s prior invention “prior art” provisions. Under pre-AIA 35 U.S.C. §102(g), inventors faced a potentially mortal risk to patentability if the intervening public disclosure was on either the same subject matter as the earlier publication of the “grace period” inventor or directed to an obvious variation of that earlier-published subject matter. A pre-AIA inventor cannot secure a valid patent in the situation where there is either type of intervening disclosure (same or obvious variation) absent being able to antedate the U.S. invention date for the other person’s independent work – not just the date of publication. This is the first-to-invent principle at work. Thus, even if someone publicly discloses its independently developed subject matter that is only a trivial or insubstantial variation of the inventor’s earlierpublished work, such a public disclosure (since it is of subject matter “not abandoned, suppressed or concealed) constitutes prior art as of its U.S. invention date. In such a situation, the date of invention may well be prior to the invention date of the earlier-publishing inventor given that the respective public disclosures must have taken place within a matter of months from one another in order for this scenario to arise. 100 Wegner, Patent Drafting, A Corporate Management Guide [2016] However, in the vast majority of circumstances, the earlier-publishing inventor remains in a state of “patentability limbo.” Its underlying U.S. invention date is unable to be discerned from the intervening public disclosure itself. Therefore, the inventor cannot be certain its patent will prove valid or can ever be successfully enforced. As a result of the pre-AIA’s prior invention “prior art” provisions, there was no subparagraph (B)-type protection of the breadth that fudge-factor proponents urge for implementing the AIA in the pre-AIA patent law. The profound difficulty that §102(g) imposes on inventors in the factual situation where subparagraph (B) would apply under the AIA arises whether an intervening public disclosure was of the same or an obvious variant of the subject matter that the earlier-publishing inventor had disclosed. Hence, applying subparagraph (B) provisions as drafted and intended by Congress does not deprive inventors of any categorical protection against patent-invalidating prior art that pre-AIA law guaranteed. In addition to ending the “patentability limbo,” the AIA version of §102, by eliminating §102(g) prior art in its entirety, avoids completely the risk inventors face with “interloping” – the possibility that a rival seeing an inventor’s publication will be spurred into a patent filing during the “grace period” interval of the earlier-publishing inventor. When a rival is spurred into such a patent filing under pre-AIA law, the result is that the spurred patent filer can readily gain the status of both first to file and presumptive first to invent. The earlier-publishing inventor who thereafter seeks a patent has (statistically at least) little prospect of securing a patent once beaten to the USPTO by the spurred patent filer. Again, applying the subparagraph (B) provisions as drafted and intended by Congress provides an affirmative and complete protection against interlopers. Those who would condemn the USPTO’s proposed implementation of the AIA, are simply ignoring the difficulties inventor’s face under pre-AIA law and the inherent advantages inventor’s enjoy under the AIA framework to reach an entirely erroneous conclusion that the AIA operates unfairly for inventors and does not go far enough in eliminating independent work of rival inventors as prior art. 101 Wegner, Patent Drafting, A Corporate Management Guide [2016] Indeed, by eliminating the dilemma of the “patentability limbo” and the prospect of “interloping,” the inventor protection from the disclosures of independent work of others under the AIA is, on balance, more secure for any earlier-publishing inventor than less secure. Those in the patent bar who are concerned with the limited reach of the subparagraph (B) provisions appear to be wholly disregarding how the pre-AIA §102(g) provisions operated to, at best, cast patentability of the earlier-publishing inventor’s invention into doubt and subjected the earlierpublishing inventor to interloping. [We] would submit, when this comparison between pre-AIA §102 and the subparagraph (B) provisions (applied as written and intended by Congress) is made, it becomes clear that early-publishing inventors should have greater validity concerns under the pre-AIA law than will exist under the AIA provisions in §102, including the limited reach of the subparagraph (B) provisions. Most importantly, in the situation where subparagraph (B) was intended to apply – the publication of independent work of a rival inventor is encompassed by the earlier-publishing inventor’s disclosure – the patentability protection under subparagraph (B) is categorical and complete, which is a far superior outcome to the “patentability limbo” inflicted by pre-AIA §102(g). 3. Congress Could Not Rationally Have Intended to Eliminate Independent Work of Others As Prior Art with Respect to Subject Matter That an EarlierPublishing Inventor Never Disclosed With the improvement in the patentability prospects for inventors who publish before filing for a patent (occasioned by ending “patentability limbo” and the demise of the incentive for spurred patent filings given pre-AIA §102(g)), there is not one shred of evidence that Congress intended to go beyond this improvement in the law for earlier-publishing inventors by wiping out completely and categorically intervening disclosures of independent work of others as prior art where they include obvious variants of the earlier-publishing inventor’s disclosure. It makes no policy sense to expand this exception from prior art beyond the subject matter disclosed, specifically to expand the exemption to disregard any further disclosure of obvious variations of the earlier-publishing inventor’s disclosure. 102 Wegner, Patent Drafting, A Corporate Management Guide [2016] One principle that ought to apply in this situation is that an inventor who did not publish, but instead sought a patent on the same subject matter, should not be placed in an inferior position to an inventor who published, but only later sought a patent. There is no indication that such an unprecedented outcome could ever have been congressional intent. For an inventor who promptly sought a patent in lieu of being an earlier-publishing inventor who only belatedly decided to seek a patent after review intervening publications of the independent work of others, the subparagraph (B) provisions do not apply. Thus, any attempt by an inventor who promptly sought a patent to later expand its original patent filing to encompass obvious variations of the disclosure in the early patent filing would produce an effective filing date for any such new or modified claims so late in time that would render that any intervening publication of the independent work of a rival inventor prior art. That prior art impact would destroy the patentability of any claim drafted more broadly than the subject matter disclosed in the earlier patent filing. In other words, there would be no added insulation against a prior art publication that consisted of any of the “obvious variations” of what was in the earlier patent filing. The earlier-filing inventor could not secure a patent except for claims supported in the original patent. Under proposals for introducing a “fudge factor” into the “subject matter disclosed” edict, for the earlier-publishing inventor who only belatedly sought a patent, that same prior art dissolves in its entirety and the publishing inventor’s belated patent filing with the broad claims can be rendered validly patentable. Indeed, the early-publishing inventor can secure a valid patent on all the obvious variations from the intervening disclosures of the independent work of others. 103 Wegner, Patent Drafting, A Corporate Management Guide [2016] This absurd result can happen because by publishing, in lieu of the original patent filing, the fudge-factor construction of subparagraph (B) would allow the intervening publication – including any merely obvious embodiments therein relative to the inventor’s earlier publication – to be removed as prior art. Hence, what fudge-factor proponents are arguing is such a sweepingly broad construction of the subparagraph (B) provisions that, among the worst things any inventor might do in devising a patent strategy in a situation where there was concern over intervening work of others being published, would be to actually file for a patent. With the “fudge factor” imposed on the subparagraph (B) exceptions, undertaking a very limited publication and then waiting to determine what subsequent disclosures might build on that original disclosure would be a perfect patent strategy. All such later developments in the art could be swept up in the inventor’s subsequent patent filing, with the inventor’s very early, very limited publication being the ticket to removing all this intervening prior art. The earlier publishing inventor, unlike an earlier patent-filing inventor would thereby be positioned to secure a valid patent on both the subject matter of its original patent filing and the obvious variations, something an earlier-filing, but not earlier-publishing inventor could not do. The intent of the AIA was not to create a “publication strategy” in lieu of or in addition to a “patent-filing” strategy to best protect an invention. Hence, introducing the “fudge factor” is both unnecessary and undesirable if the objective is a fully effective “grace period.” Thus, Congress, which under pre-AIA law never created such a sweeping and categorical exception from prior art as the fudge-factor proponents now seek, certainly could not have intended that the AIA should now do so. 104 Wegner, Patent Drafting, A Corporate Management Guide [2016] Conclusion The fudge-factor proponents’ position is premised on a conclusion that the inventor’s “grace period” would be gutted absent an expansive and unjustifiable construction of the subparagraph (B) provisions. This contention ignores that the “grace period” protections under the AIA and pre-AIA law are substantively identical and provide complete and categorical protection for an earlier-publishing inventor. It also ignores that the protection being sought by introducing a “fudge factor” against the earlier disclosures of the independent work of others is vastly more sweeping and categorical than exists under pre-AIA law. Indeed, applying the subparagraph (B) provisions as written and as intended would in fact provide superior protection compared to the pre-AIA law, which typically results in “patentability limbo” when confronted with a pre-filing public disclosure of the independent work of a rival inventor. § 64 Academic Research Opposition to the Law The U.S. Patent and Trademark Office on December 8, 2010, formally launched its “24 month provisional application” program. In a nutshell, the new program involves various paperwork and the sequential filing of (a) a provisional application; (b) a pro forma regular application at 12 months from the earlier date including at least one claim; (c) publication of the application at 18 months from the earliest date; and (d) filing of regular claims and other various delayed fees at 24 months from the priority date. An excellent analysis is provided by Courtenay Brinckerhoff, USPTO Launches Extended Missing Parts Pilot Program, PharmaPatents Blog (December 10, 2010), http://www.pharmapatentsblog.com/uspto-launches-extended-missingparts-pilotprogram/?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3 105 Wegner, Patent Drafting, A Corporate Management Guide [2016] A+Pharmapatents+%28PharmaPatents%29. * * * ___________ * This section is an abridgement of a paper originally titled as The 24 Month “Provisional” Application (January 12, 2012). The “24 month provisional application” program refers to the Pilot Program for Extended Time Period To Reply to a Notice To File Missing Parts of Nonprovisional Application, signed by David J. Kappos, Under Secretary of Commerce, November 19, 2010, 75 Federal Register 76401 (Dec. 8, 2010). The original notification was published as Request for Comments on Proposed Change To Missing Parts Practice, David J. Kappos, Under Secretary of Commerce, March 29, 2010, 75 Federal Register 16750 (Apr. 2, 2010). No hearing was scheduled, id., but a period for the public to submit written testimony was announced that expired June 1, 2010, id. The testimony is available from the PTO website, Comments on Proposed Change to Missing Parts Practice, http://www.uspto.gov/patents/law/comments/extendedmissingparts.jsp. Apart from changes in headings and deletion of material, the other changes from the January 12, 2012, text hace been that footnotes have either been integrated into the text or deleted. §64[a] 24 Month Deferral of “Real” Patent Requirements (1) The PTO Proposal to Permit Deferral of Patent Drafting The Under Secretary explains that independent inventors have used the provisional application for commercialization purposes, i.e., “—to test the marketplace, attempt to gain financial backing, secure licensing agreements, and to further their product development.” David J. Kappos, Providing Inventors More Time and Options, U.S. Patent and Trademark Office publication “inventorseye” (November 2010), http://www.uspto.gov/inventors/independent/eye/201011/cover.jsp (herein: “inventorseye”). But, the one year period is judged insufficient for such commercialization efforts: “[O]ne year is just not sufficient time to find financial help, evaluate a product’s worth in the marketplace or to completely develop the invention for commercialization.” Id. 4 David J. Kappos, Providing Inventors More Time and Options, U.S. Patent and Trademark Office publication “inventorseye” (November 2010), 106 Wegner, Patent Drafting, A Corporate Management Guide [2016] http://www.uspto.gov/inventors/independent/eye/201011/cover.jsp (herein: “inventorseye”). In the initial Federal Register publication of the proposal, the Patent Office touts the advantages: “A … benefit is added flexibility for applicants who may otherwise be forced to expend resources completing nonprovisional applications that may prove unnecessary given an additional year of commercialization efforts. Providing a longer time period … would give applicants more time to ascertain the value of their inventions, thereby helping applicants to decide whether to incur the additional costs associated with pursuing patent rights.” Request for Comments on Proposed Change To Missing Parts Practice, 75 Fed. Reg. 16750, 16751 (April 2, 2010), http://edocket.access.gpo.gov/2010/20107520.htm. . The PTO itself explains that applicants will be able to use the interval of pendency of the provisional up until the filing of the regular application for commercialization efforts: [Another] benefit is better targeting of applicant resources to commercialization efforts at critical time periods, which efforts can ultimately result in creation of jobs as well as new products and services.” Id. *** [W]ith the 24 month “provisional”, the applicant would simply file a provisional application with “at least one claim, and drawings, when necessary, to understand the invention”, then commence commercialization efforts and then at 24 months from the priority date, bring in the services of a patent attorney to draft a set of claims to cover the invention. 107 Wegner, Patent Drafting, A Corporate Management Guide [2016] (2) Support from the Independent Inventor Community In terms of the numbers of supporters providing testimony, heavy support has been found from amongst independent inventors many of whom apparently see the provisional application as somehow having different disclosure requirements to support claims than the regular (nonprovisional) application. The gist of thinking is that an inventor can file a provisional application disclosing the rough drawings and laboratory notebook details of an invention even without a formal claim, and then proceed to commercialization efforts. If the commercialization efforts are successful, then the inventor hires a patent attorney to write a “normal” patent application meeting all the strict requirements of the patent law. The idea is that only if the commercialization efforts in the one year pendency of the provisional application are successful, then and only then will the applicant invest the serious money needed for a professional patent application being drafted and prosecuted. Obviously, if the premises of this scenario are true, then a 24 month provisional application pendency is manna from patent heaven: One more year of commercial experimentation is provided before the regular application must be filed. 108 Wegner, Patent Drafting, A Corporate Management Guide [2016] (3) The New Railhead Reality The cornerstone that undergirds the 24 month provisional is that the disclosure requirements for provisional and regular applications are different, but the disclosure requirements are identical in terms of whether a later claim in a later application is entitled to priority based upon the earlier application. It doesn’t matter whether the earlier application is a provisional, a foreign priority application or a regular application, each application to be basis for support for a priority claim must have a full disclosure of the invention that is later claimed that meets the identical standard of 35 USC § 112, ¶ 1. There is zero point zero point of leniency for priority based upon a provisional vis a vis a regular application. Thus, for priority to be granted in a regular application keyed to the earlier application – provisional, regular or foreign – the original application must have a disclosure to support the later application under identical standards. The Under Secretary’s proposal implies that the first time that the disclosure requirements should be met are at the time that the non-provisional application is filed claiming priority based upon the provisional application: “The non-provisional application disclosure requirements would have to be met in order [for the non-provisional application] to receive a filing date…. That means “[T]he non-provisional application …would have to have a written description that clearly describes the invention so that someone with ordinary skill in the same technology can make and use the invention. It would also have to contain at least one claim, and drawings, when necessary, to understand the invention.” David J. Kappos, Inventorseye, supra, emphasis added. 109 Wegner, Patent Drafting, A Corporate Management Guide [2016] To be sure, it is essential that the non-provisional application have a disclosure that permits a worker skilled in the art to make and use the invention, but if that level of detail of disclosure is lacking in the provisional application, then priority based upon the provisional application is denied under 35 USC § 120. Even if there is “at least one claim” and a disclosure “to understand the invention”, this is also not enough to permit priority for a generic or subgeneric claim that reads upon even a working example in the provisional application. To have commercialization efforts ongoing for 24 months – or even 12 months – before a regular application is filed that meets the enabling disclosure requirements of 35 USC § 112, ¶ 1, is fatally flawed as explained in the New Railhead case. New Railhead Mfg. v. Vermeer Mfg., 298 F.3d 1290 (Fed. Cir. 2002)(Michel, J.). As explained by Chief Judge Rader, “[c]laims enjoy the earlier filing date only if the provisional application provided adequate written description under 35 U.S.C. § 112, ¶ 1.” Trading Techs. Int'l, Inc. v. eSpeed, Inc., 595 F.3d 1340 (Fed. Cir. 2010)(Rader, J.)(quoting New Railhead, 298 F.3d at 1294). In other words, claim limitations that would be added for the first time 24 months after filing without support in the provisional application as filed would not be entitled to priority. Where a claim is presented after the priority filing, the applicant must show “that he or she ‘had invented each feature that is included as a claim limitation[.]’” Cordis Corp. v. Boston Sci. Corp., 561 F.3d 1319, 1332 (Fed. Cir. 2009)(Dyk, J.)(quoting New Railhead, 298 F.3d at 1295)(emphasis added). 110 Wegner, Patent Drafting, A Corporate Management Guide [2016] Even if the provisional application has a specific disclosure of a specific embodiment to fully teach how to make and use that embodiment, in the chemical and biotechnology arts in particular it is also important to have a series of generic and subgeneric claims based upon that embodiment. But, if the provisional application only has a disclosure of that embodiment, it is too late – 24 months later – to present generic and subgeneric claims: Under the Ruscetta line of cases, if a generic claim and corresponding generic disclosure are presented after the priority date where the priority application only discloses species, the generic claim is not entitled to priority based upon the species. In re Ruscetta, 255 F.2d 687 (CCPA 1958). The argument is sometimes made that because the parent application discloses a species a counterpart application or other disclosure of the species after the priority date cannot be patent-defeating because priority is given to the earlier case for the species. But, the claim to the genus does not have priority so that the intervening disclosure of the species creates a statutory bar under 35 USC § 102(b). Thus, “the description of a single embodiment of broadly claimed subject matter constitutes a description of the [broadly claimed] invention for anticipation purposes whereas the same information in a specification might not alone be enough to provide a description of that invention for purposes of adequate disclosure.” In re Lukach, 442 F.2d 967, 970 (CCPA 1971)(citations omitted). 111 Wegner, Patent Drafting, A Corporate Management Guide [2016] Under the 24 month de facto provisional application scheme the patent attorney enters the scene at 24 months and then amends the application to meet disclosure requirements including adding new claims and supporting disclosure. But, this would in any event involve new matter within the meaning of 35 USC § 132. Therefore, this plan would not work without the use of a continuation-in-part to add the new disclosure. And, of course, to the extent that the invention has been commercialized more than one year before the continuation-in-part date the previously unsupported claims would be barred under 35 USC § 102(b). 64[b] Academic Technology Offices, the Driving Force Based upon information from the very highest level of the PTO, it is understood that the genesis of the movement for a 24 month provisional is the university community where the pendency of the provisional application has been used as a de facto extension of time to make a decision whether to spend the real money of professional patent drafting and prosecution. A. The Strong Support of Research-based Universities The driving force behind the “24 month provisional” has been the powerful lobby of research universities which see the change in practice to be of importance to provide additional time to decide whether to invest in the expensive services of patent counsel to pursue patent protection for innovations developed within their university systems. 112 Wegner, Patent Drafting, A Corporate Management Guide [2016] Apart from testimony of individual inventors, the only strong support for the 24 month provisional came from the community of research-focused universities that have heavy pressures to file patent applications. The premise of the university community is that a provisional application can be filed with a simple disclosure, often drafted by the inventor himself, and that the 12 month provisional priority period can be used for commercialization efforts. If successful at the end of the 12 months, then the great expense of bringing in outside patent counsel can begin. The university community premise continues that if there is a 24 month period, this provides precious additional time before the decision to pursue meaningful patent protection must be made. Perhaps the most outspoken support for the 24 month provisional comes from the University of California: “[The University of California] is comprised of ten research-intensive campuses, and is involved in the management of three national laboratories, each of which files patent applications on discoveries made in their laboratories. Strong and predictable patent protection can provide an incentive for industry partners to invest the effort and resources in developing a university invention into a useable product. 113 Wegner, Patent Drafting, A Corporate Management Guide [2016] “Many university inventions, however, are very early stage, requiring additional research, time and resources before a company is interested in pursuing any of the myriad ways a technology can benefit the public. Until such time, the university must either tap into its limited resources to seek patent protection on promising, but early stage, inventions, or let the opportunity pass by. Any strategies that can help to limit or delay prosecution costs or provide greater flexibility in seeking patent protection for early stage, high-risk university inventions would be welcomed. Therefore, [the University of California] supports the proposed change to the missing parts practice. …” Testimony of William T. Tucker, Executive Director Innovation Alliances and Services of the University of California, available at the PTO website, Comments on Proposed Change to Missing Parts Practice, supra. The federal lobbying arm of 182 major research-intensive universities strongly underscores support for the proposal to give 24 months of commercialization activities before entering the expensive regular stage of patent procurement: “The Council on Governmental Relations (COGR) is an association of 182 U.S. research-intensive universities, affiliated hospitals and research institutes… We strongly support the effective 12 months extension of the existing 12-month provisional application period….. The ability to file provisional patent applications has been highly beneficial to the university community, particularly given the early stage nature of technologies typical of university inventions. The ability to have additional time to assess market viability and find commercial partners for further development would be of particular benefit to universities, and also consistent with the Administration’s current emphasis on enhancing the commercialization of university research. The added flexibility provided by extending the response period for a missing parts notice would not only give university applicants more time to assess commercial value but also allow better targeting of resources for this purpose, as stated in the Notice. University patent budgets are under great strain, and we fully support measures such as proposed that may lead to greater efficiencies.” Testimony of Anthony DeCrappeo, Council on Governmental Relations (COGR) , available at the PTO website, Comments on Proposed Change to Missing Parts Practice, supra. 114 Wegner, Patent Drafting, A Corporate Management Guide [2016] Perhaps the oldest, successful major university research office has voiced its support as well; subject to Patent Term Adjustment concerns, Wisconsin supports the initiative: “As a successful university technology transfer organization, WARF appreciates that one of the goals of the proposed changes to the Missing Parts Practice is to enable applicants to spend up to an additional 12 months exploring the commercial viability of their technologies. Certainly it would be helpful, in some cases, to be able to delay paying approximately 80 % of the filing fees for up to a year (without costly monthly extension fees) to facilitate a more detailed economic analysis….” WARF recognizes that the proposal is not for a true 24 month provisional. Rather, WARF proposes what would require a statutory change: “In fact, it would be better if the rule changes instituted a true 2-year provisional application process. While applicants would still need to act within 12 months for purposes of international filings, the opportunity to wait an additional year before filing a U.S. non-provisional application would be extremely valuable for applicants, as the additional time could advance the developmental stage of inventions appearing in the application (thereby advancing the value of the full disclosure and its public benefit), and ultimately improve the quality of both the applications and the resulting patents.” Testimony of Carl E. Gulbrandsen, Managing Director, Wisconsin Alumni Research Foundation, available at the PTO website, Comments on Proposed Change to Missing Parts Practice, supra. *** Texas A&M voices strong support for the 24 month provisional: “[The Texas A&M University System (‘System’)] generally supports the proposal…. Commercialization, and thus effective development and public utilization of System innovations, is effected through the System’s Office of Technology Commercialization (“OTC”).… 115 Wegner, Patent Drafting, A Corporate Management Guide [2016] “Over the last 5 years, the OTC has filed approximately twice the number of provisional applications as it has U.S. utility applications. Generally, the higher number of provisionals is … due to decisions to abandon the provisional applications. Thus, the experience of the OTC is generally consistent with the recent experience of the USPTO wherein only 50% of provisional applications are subsequently relied upon for priority in nonprovisional applications. “Given a relatively high cost to the System for patent prosecution, decisions to pursue patent protection on a given technology are largely driven by the potential to secure a licensee. Any expansion of time available for determining the licensable potential of a given technology would be a benefit to university commercialization efforts and would be expected to reduce the numbers of applications that must be dropped for want of a licensee. … “[T]he proposed rule would permit university applicants two years of commercialization efforts for a (current) total filing fee cost of $275 if the application is ultimately abandoned prior to the expiration of the two year term. Although filing fees are a relatively minor percentage of the total cost of preparing and filing a patent application, the deferral of fee payments during early commercialization efforts is certainly a benefit of the proposal. “The System is generally supportive of extended pendency periods for provisional applications. While believing that the proposed change could be accomplished in a more straightforward fashion by a change to the patent statute, the proposed rule change would be expected to confer a benefit to university commercialization efforts and is generally supported.” Testimony of Dr. Marilyn M Huston, Ph.D., J.D., Managing Counsel, Business Law and IP, Office of General Counsel, Texas A&M University System, available at the PTO website, Comments on Proposed Change to Missing Parts Practice, supra. 116 Wegner, Patent Drafting, A Corporate Management Guide [2016] B. How Research Organizations Would Use of the 24 Month Provisional Academic research institution administrators have used the provisional patent application as part of a triage process to determine which invention disclosures to fund for full patent treatment: Since the 1990’s, the provisional application system has been used by major research institutions as a triage mechanism to determine which of the many thousands of inventions should be commercialized, selected from the invention report of the dozens or scores or hundreds of their faculty, graduate students and other researchers. Particularly for research organizations where in house commercialization of technology is a secondary concern (if at all), the purpose of the commercialization is to find licensees or other partners to take over the technology in exchange for remuneration, often in the form of running royalties based upon successful ultimate commercialization. It can be seen that of the thousands of inventions that are reported one or two or at most a handful are commercially successful. If all of the inventions were given equal treatment and subject to an expensive patenting procedure involving outside counsel, it can also be seen that the administrative costs of running a technology management program could easily outrun the royalty income for the handful of successful commercial inventions. 117 Wegner, Patent Drafting, A Corporate Management Guide [2016] As a way of performing triage to make sure that commercially successful candidates will be the focus of patenting expenses, some research institutions provide for a relatively pro forma acceptance of inventions with the prompt filing of a provisional application that is based upon the researcher’s own draftsmanship without the aid of a professional outside patent attorney. This provisional application has a relatively de minimis filing fee and the expense of drafting the provisional application is borne by the researcher-inventor who provides a draft of the technical experiments and drawings of his early experiments. In the pharmaceutical, chemical and biotechnology areas, typically a single new compound or bio-molecule will be the subject of the provisional application, including detailed laboratory records of that compound or bio-molecule, but will lack the generic “Markush” definitions for generic protection essential for a commercial exploitation. Upon filing the provisional application, the researcher-inventor alone or with the aid of the technology management team will make intensive efforts to seek funding for commercialization. Efforts at commercialization will include sharing information with private industry, field tests and other experimentation that often involve activities that may qualify as prior art under 35 USC § 102(b). In the current world of email communications, this will often involve electronic correspondence that may be distributed to a group of workers in the art which is without secrecy restrictions. Or, there may be an explanation of the technology at a technical society meeting where abstracts are distributed which explain the invention. Such emails and abstracts may be prior art under 35 USC § 102(b). 118 Wegner, Patent Drafting, A Corporate Management Guide [2016] At about nine or ten months after the provisional application is filed, to the extent that the commercialization efforts have been successful or appear on the verge of success, research managers may decide that the provisional application should be converted to a regular (nonprovisional) application. Now, the great expense of the patenting process begins in two directions. First, domestically, it becomes time-critical to bring in an outside patent counsel to convert the provisional into a full blown, regular application. The crafting of generic coverage with a proper “Markush” definition is vitally important. Without full generic protection the inventor may be limited to the specific embodiments of the provisional application. These embodiments may be at best prototypes, while further research will show other and better commercial candidates within the same family of compounds or bio-molecules. If the regular application is limited to the provisional application-disclosed prototype embodiments, this will often make any regular patent application completely worthless for commercial developments: Competitors will be free to seek the better molecules without worry of infringement of the narrow scope of protection of the provisional application-disclosed embodiments. Second, internationally, an application must be on file “worldwide” within 12 months from the date of the provisional application filing in order to secure overseas patent rights. A “worldwide” coverage today often means the filing of a Patent Cooperation Treaty application at 12 months from the provisional filing date which will then safeguard global rights for 30 months keyed to the priority date, at which time massive foreign filing costs will start to accrue on a “national” basis. 119 Wegner, Patent Drafting, A Corporate Management Guide [2016] About the Author concluded a more than twenty year relationship with the George Washington University Law School where he had been Director of the Intellectual Property Law Program and Professor of Law. Professor Wegner operates as an independent consultant following his retirement from Foley & Lardner LLP following twenty years with the firm. HAROLD C. WEGNER is an Expert Patent Consultant following his retirement from Foley & Lardner LLP where he had practiced for twenty years. contact info: Harold C. Wegner Expert Patent Consultant 8805 Tamiami Trail North-PMB-150 Naples, Florida 34108 [email protected] Prof. Wegner is available to cooperate with corporate and law firm colleagues on matters involving patent drafting and procurement strategies, appellate matters, opinions and expert testimony. Prof. Wegner also provides continuing education services tailored to individual organizational needs. Professor Wegner is a former Patent Examiner who recently 534
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