“DOLLY THE SHEEP” PATENT-ELIGIBILITY:
WHY THE SUPREME COURT HAS A SHARP EYE
ON THE FEDERAL CIRCUIT
*
Harold C. Wegner**
In the “Dolly the Sheep Case”, more formally In re Roslin Institute
(Edinburgh), __ F.3d __ (Fed. Cir. May 8, 2014)(Dyk, J.),1 the Federal Circuit
presents a snapshot view of a Court in difficulty and precisely why the Supreme
Court gives so much attention to the appellate tribunal tasked with crafting a
uniform body of patent case law.
The “Dolly the Sheep” case shows that the Court had a very easy way to
affirm denial of product claims to the patent applicant based upon garden variety
anticipation that is free from any doubt; yet, the Court chose to go into the realm of
patent-eligibility under 35 USC § 101 which is sure to keep the spotlight of
attention on this Court – including attention from the Supreme Court. Even worse,
however, an unnecessary and incorrect characterization of the case law is
perpetuated. The current court could take a page from the 1970’s when the CCPA
refrained from unnecessarily raising red flags and better stayed under the Supreme
Court radar screen.
This paper represents the personal views of the writer and does not
necessarily reflect the views of any colleague, organization or client thereof.
*
**
Partner, Foley & Lardner LLP.
An excerpt of the opinion is found in In re Roslin Institute (Edinburgh), The
“Dolly the Sheep” Patent Application (red bordered, pink appendix).
1
“Dolly the Sheep” Patent-Eligibility
Claims to the Clone, “Dolly the Sheep”
The key claim in question is to a live sheep (or other barnyard animal),
provided it has been cloned. The claim is not to a cloning method, but to the live
animal, per se. There is no limitation to the main claim other than that the sheep
has been cloned:
“A live-born clone of a pre-existing, non-embryonic, donor mammal wherein the
mammal is selected from cattle sheep, pigs, and goats.”
The Patent Office quite properly denied patentability on the basis of
anticipation as the claim covered any barnyard animal from the named Markush
group without any distinguishing characteristic.
The author of the opinion in Roslin Institute was quite well aware of the fact
that the claims to “Dolly the Sheep” and other barnyard animals were anticipated
by the prior art under 35 USC § 102 and that it was of no moment to patentability
how the animals were created: “In determining validity of a product-by-process
claim, the focus is on the product and not the process of making it.” Greenliant
Sys., Inc. v. Xicor LLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012)(Dyk, J.)(citation
omitted).2
Even if the claims defined an animal with bare novelty, the cloned
animal would be expected to share common properties and thus, the
The law of product-by-product-by-process patentability is explained in a
second appendix, Product-by-Process Patentability under Thorpe (green
bordered, buff attachment, an excerpt from In re Thorpe, 777 F.2d 695, 697-98
(Fed. Cir. 1985)(Newman, J.))
2
2
“Dolly the Sheep” Patent-Eligibility
invention as a whole would be obvious under 35 USC § 103: The burden in
such a case of prima facie obviousness is in any event upon the patent
applicant under the Papesch line of case law:
“[I]f an examiner considers that he has found prior art close enough to the claimed
invention to give one skilled in the relevant chemical art the motivation to make
close relatives … of the prior art compound(s), then there arises what has been
called a presumption of obviousness or a prima facie case of obviousness. In re
Henze, 181 F.2d 196 (CCPA 1950); In re Hass, 141 F.2d 122, 127, 130 (CCPA
1944). The burden then shifts to the applicant, who then can present arguments
and/or data to show that what appears to be obvious, is not in fact that, when the
invention is looked at as a whole. In re Papesch, 315 F.2d 381 (CCPA 1963).”
In re Dillon, 919 F.2d 688, 696 (Fed. Cir. 1990)(en banc)(Lourie, J.)
What’s Wrong with the Roslin Institute Opinion: Part (I)
Roslin Institute is hardly unique in terms of exploring areas of the law totally
unnecessary to reach the correct holding. Here, it should have been a simple
matter to produce a one or two paragraph opinion affirming the Patent Office
denial of the Roslin Institute claims based upon anticipation under 35 USC § 102.
But, the panel refrained from touching anticipation as basis for affirmance
but instead created it own analysis on the patenting of animals under patenteligibility under 35 USC § 101.
To be sure, in recent cases the Supreme Court has said that patent-eligibility
under 35 USC § 101 should be considered even before patentability. Yet, to
simply follow guidance in the face of facts that deserve summary treatment and
3
“Dolly the Sheep” Patent-Eligibility
reach the same outcome minimizes the role of the Federal Circuit in its task of
creating a uniform body of patent law.
What’s Wrong with the Roslin Institute Opinion: Part (II)
The Court also took the opportunity to provide a scholarly analysis of
Supreme Court case law. Without citation to any authority and thus presumably
the panel’s own scholarship, the panel stated that:
[T]he Court's opinion[ ] in Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S.
127 (1948), made clear that naturally occurring organisms are not patentable.
In Funk Bros., the Supreme Court considered a patent that claimed a mixture of
naturally occurring strains of bacteria that helped leguminous plants extract
nitrogen from the air and fix it in soil. 333 U.S. at 128-29. The Court concluded
that this mixture of bacteria strains was not patent eligible because the patentee did
not alter the bacteria in any way. Id. at 132 ("[T]here is no invention here unless
the discovery that certain strains of the several species of these bacteria are noninhibitive and may thus be safely mixed is invention. But we cannot so hold
without allowing a patent to issue on one of the ancient secrets of nature now
disclosed."). Critically, in Funk Bros., the Court explained:
“[w]e do not have presented the question whether the methods of selecting and
testing the non-inhibitive strains are patentable. We have here only product claims.
[The patentee] does not create a state of inhibition or of non-inhibition in the
bacteria. Their qualities are the work of nature. Those qualities are of course not
patentable. For patents cannot issue for the discovery of the phenomena of nature.
The qualities of these bacteria, like the heat of the sun, electricity, or the qualities
of metals, are part of the storehouse of knowledge of all men. They are
manifestations of laws of nature, free to all men and reserved exclusively to none.”
4
“Dolly the Sheep” Patent-Eligibility
Id. at 130 (citation omitted). Thus, while the method of selecting the strains of
bacteria might have been patent eligible, the natural organism itself—the mixture
of bacteria—was unpatentable because its "qualities are the work of nature"
unaltered by the hand of man. Id.
Unfortunately, the scholarship does not comport with the reality of the case
law. Funk v. Kalo is explained by Professor Shine Tu.3
If the Supreme Court is to be criticized for faulty analysis of its own case
law, blame must be shared by others who provide the same faulty analysis.4
What’s Wrong with the Roslin Institute Opinion: Part (III)
Issuing an opinion on the patent-eligibility of a mammal is highly
controversial, no matter what the outcome. Why, precisely, did the Court find it
necessary to reach this issue in the face of a black and white case of unpatentability
for anticipation?
There were opportunities in the early 1970’s when the predecessor CCPA
had the opportunity to reach the issue but wisely refrained from doing so. Instead
Standard of “Invention” (green bordered, turquoise attachment, an excerpt
from Shine Tu, Funk Brothers – an Exercise in Obviousness, 80 UMKC L. Rev.
637, 637-38 (2012))
3
To be sure, the panel cites to Chakrabarty and characterization of Funk v
Kalo in that case. But, the statements in Chakrabarty represent dictum
unnecessary to the holding of patent-eligibility in that case.
4
5
“Dolly the Sheep” Patent-Eligibility
of dealing with patent-eligibility of mammals or even chickens the Court gingerly
dealt with microorganisms. American courts of that era were reluctant to deal
with patent-eligibility of anything in the animal kingdom above a microorganism.5
The issue of patenting a barnyard animal as in Roslin Institute was raised
forty years ago in In re Merat, 519 F.2d 1390 (CCPA 1975)(Rich, J.), where
instead of sheep claim 2 was a product by process claim to a heavy meat chicken.
Written in independent form, claim 2 reads:
“[The product obtained by the controlled] process for production of normal
chickens from dwarf hens and normal cocks which includes passing through a
dwarf breed and a heavy breed into which an nr sex-linked recessive dwarfism
gene has been introduced, comprising crossing females of a cooking breed of
poultry having good growth and fattening characteristics with cocks of small size
which carry the nr gene, causing the animals obtained by this first crossing to
reproduce with one another retaining all the subjects of small size which carry the
nr gene so as to constitute a basic breed, and coupling the dwarf hens of this breed
with any desired breed of normal heavy meat cocks, thereby obtaining, as an
industrial product, a chick to be raised as a cooking chicken of normal heavy meat
size.”
The Court in Merat wisely took the cautious approach of denying claim 2
on a basis other than lack of Section 101 patent-eligibility.
See In re Bergy, 563
F.2d 1031, 1035 (CCPA 1977)(Rich, J.)(discussing Merat), vacated and
In contrast, the German Supreme Court, the Bundesgerichtshof, had no
trouble addressing the patent-eligibility of “red doves” and “baker’s yeast”.
Rote Taube (“Red Dove”)(BGH 1969), 1 IIC 136 (1970); Bäckerhefe (“Baker’s
Yeast”), 6 IIC 382 (1975); see also Wegner, Patenting Nature’s Secrets –
Microorganisms, 7 IIC 235 (1976); Wegner, Patent Protection for Novel
Microorganisms Useful for the Preparation of Known Products, 5 Int'l Rev.
Indus. Prop. & Copyright L. 285 (1974)
5
6
“Dolly the Sheep” Patent-Eligibility
superseded by new decision, 596 F.2d 952 (CCPA 1979)(Rich, J.), aff’d sub nom
Diamond v. Chakrabarty, 447 U.S. 303 (1980).
Conclusion
The “Dolly the Sheep” case is not an isolated example of the Federal Circuit
forging ahead with the creation of case law where none was needed at the time.
Creating unnecessary controversy through opinions reaching out into areas
unnecessary for the holding that result in fractured panels represent a root cause for
the greater attention focused on the Federal Circuit today, and for the increased
watchfulness of the Supreme Court. Judicial restraint has gone out the window at
Madison Place.
7
In re Roslin Institute (Edinburgh)*
The “Dolly the Sheep” Patent Application
__ F.3d __ (Fed. Cir. May 8, 2014)
“Dolly the Sheep” and other Cloned Barnyard Animals
Claim 155: “A live-born clone of a pre-existing, non-embryonic, donor mammal,
wherein the mammal is selected from cattle, sheep, pigs, and goats.”
Before DYK, MOORE and WALLACH, Circuit Judges
DYK, Circuit Judge.
…[Assignee-Appellant] Roslin Institute of Edinburgh, Scotland … appeals from a
final decision of the Patent Trial and Appeal Board (Board) [denying claims of its
Campbell et al. application]. The Board held that [its pending] claims 155-159
and 164 [ ]were unpatentable subject matter under 35 U.S.C. § 101. The Board also
rejected [Appellant]'s claims as anticipated and obvious under 35 U.S.C. §§ 102
and 103. We affirm the Board's rejection of the claims under § 101.
Background
[Campbell et al.] produced the first mammal ever cloned from an adult somatic
cell: Dolly the Sheep. A clone is an identical genetic copy of a cell, cell part, or
organism. * * * The cloning method * * * constituted a breakthrough in scientific
discovery. * * *
The resulting cloned animal is an exact genetic replica of the adult mammal from
which the somatic cell nucleus was taken. * * *
This version of the Federal Circuit opinion has been edited by Harold C. Wegner.
Internal record and parallel citations have been omitted. HCW May 13, 2014
*
In re Roslin Institute (Edinburgh)
page 2
Campbell [et al.] obtained a patent on the somatic method of cloning mammals,
which has been assigned to [Appellant[,U.S. Patent No. 7,514,258]. The [ ] patent
is not before us…. Instead, the dispute here concerns the Patent and Trademark
Office's (PTO) rejection of [the Campbell et al. * * * claims [of which] Claims 155
and 164 are representative:
“155. A live-born clone of a pre-existing, non-embryonic, donor mammal, wherein
the mammal is selected from cattle, sheep, pigs, and goats.
“164. The clone of any of claims 155-159, wherein the donor mammal is nonfoetal.”
PTO Rejections for Lack of Patent-Eligibility (§ 101),
Anticipation (§ 102) and Obviousness (§ 103)
* * * [The claims were rejected as] directed to non-statutory subject matter under
35 U.S.C. § 101 as well as anticipated and obvious under §§ 102 and 103. * * *
[T]he Board affirmed the examiner's rejection of all of [the Campbell et al.] claims.
[In addition to affirmance of the rejection under §101, [the Board also affirmed the
examiner's finding that [the Campbell et al.] claimed subject matter was
anticipated by and obvious in light of the relevant prior art under 35 U.S.C. §§ 102
and 103. Specifically, the Board explained that "'[w]here . . . the claimed and prior
art products are identical or substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an applicant to prove that the
prior art products do not necessarily or inherently possess the characteristics of his
claimed product.'" (quoting In re Best, 562 F.2d 1252, 1255 (CCPA 1977)) [ ].
The Board then held that the claimed clones were anticipated and obvious because
they were indistinguishable from clones produced through prior art cloning
methods….
In re Roslin Institute (Edinburgh)
page 3
***
Affirmance Keyed to Lack of Patent-Eligibility (§ 101)
Even before the Supreme Court's recent decision in Association for Molecular
Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), the Court's opinions in
[Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)]and Funk Bros. Seed Co. v.
Kalo Inoculant Co., 333 U.S. 127 (1948), made clear that naturally occurring
organisms are not patentable.
Funk v. Kalo: Patent-Eligibility vs. §103 Patentability (“Invention”)
In Funk Bros., the Supreme Court considered a patent that claimed a mixture of
naturally occurring strains of bacteria that helped leguminous plants extract
nitrogen from the air and fix it in soil. 333 U.S. at 128-29. The Court concluded
that this mixture of bacteria strains was not patent eligible because the patentee did
not alter the bacteria in any way. Id. at 132 ("[T]here is no invention here unless
the discovery that certain strains of the several species of these bacteria are noninhibitive and may thus be safely mixed is invention. But we cannot so hold
without allowing a patent to issue on one of the ancient secrets of nature now
disclosed."). Critically, in Funk Bros., the Court explained:
In re Roslin Institute (Edinburgh)
page 4
“[w]e do not have presented the question whether the methods of selecting and
testing the non-inhibitive strains are patentable. We have here only product claims.
[The patentee] does not create a state of inhibition or of non-inhibition in the
bacteria. Their qualities are the work of nature. Those qualities are of course not
patentable. For patents cannot issue for the discovery of the phenomena of nature.
The qualities of these bacteria, like the heat of the sun, electricity, or the qualities
of metals, are part of the storehouse of knowledge of all men. They are
manifestations of laws of nature, free to all men and reserved exclusively to none.”
Id. at 130 (citation omitted). Thus, while the method of selecting the strains of
bacteria might have been patent eligible, the natural organism itself—the mixture
of bacteria—was unpatentable because its "qualities are the work of nature"
unaltered by the hand of man. Id.
Chakrabarty Dictum
In Chakrabarty, the Court clarified the scope of Funk. The patent at issue in
Chakrabarty claimed a genetically engineered bacterium that was capable of
breaking down various components of crude oil. 447 U.S. at 305. The patent
applicant created this non-naturally occurring bacterium by adding four plasmids
to a specific strain of bacteria. Id. at 305 n.1. Overturning the Board's rejections,
the Court held that the modified bacterium was patentable because it was "new"
with "markedly different characteristics from any found in nature and one having
the potential for significant utility." Id. at 310 (emphasis added). As the Court
explained, the patentee's "discovery is not nature's handiwork, but his own." Id.
Accordingly, discoveries that possess "markedly different characteristics from any
found in nature," id., are eligible for patent protection. In contrast, any existing
organism or newly discovered plant found in the wild is not patentable. Id. at 309;
see also In re Beineke, 690 F.3d 1344, 1352 (Fed. Cir. 2012), cert. denied, 133 S.
Ct. 1243 (2013) (holding that a newly discovered type of plant is not eligible for
plant patent protection, in part, because such a plant was not "in any way the result
of [the patent applicant's] creative efforts or indeed anyone's creative efforts.").
In re Roslin Institute (Edinburgh)
page 5
More recently, in Myriad, the Court held that claims on two naturally occurring,
isolated genes * * * which can be examined to determine whether a person may
develop breast cancer, were invalid under § 101. 133 S. Ct. at 2112-13, 2117-18.
The Supreme Court concluded that the [ ] genes themselves were unpatentable
products of nature.
The claims fail to define novelty for all members of the genus
While [Appellant] does not dispute that the donor sheep whose genetic material
was used to create Dolly could not be patented, [Appellant] contends that copies
(clones) are eligible for protection because they are "the product of human
ingenuity" and "not nature's handiwork, but [their] own." [Appellant] argues that
such copies are either compositions of matter or manufactures within the scope of
§ 101. However, Dolly herself is an exact genetic replica of another sheep and does
not possess "markedly different characteristics from any [farm animals] found in
nature." Chakrabarty, 447 U.S. at 310; see Reply [Brief] (stating that "the clones
are genetic copies"). Dolly's genetic identity to her donor parent renders her
unpatentable.
In Myriad, the Court concluded that "isolated," naturally occurring DNA strands
are not eligible for patent protection. 133 S. Ct. at 2111. Here, as in Myriad,
[Appellant] "did not create or alter any of the genetic information" of its claimed
clones, "[n]or did [[Appellant]] create or alter the genetic structure of [the] DNA"
used to make its clones. Myriad, 133 S. Ct. at 2116. Instead, [Appellant]'s chief
innovation was the preservation of the donor DNA such that the clone is an exact
copy of the mammal from which the somatic cell was taken. Such a copy is not
eligible for patent protection.
In re Roslin Institute (Edinburgh)
page 6
Looking to the Law far beyond Patentability
Related areas of Supreme Court patent case law reinforce this conclusion. For
example, Supreme Court decisions regarding the preemptive force of federal patent
law confirm that individuals are free to copy any unpatentable article, such as a
live farm animal, so long as they do not infringe a patented method of copying.
Sears Roebuck & Co. v. Stiffel Co. clarified that a state may not "prohibit the
copying of [an] article itself or award damages for such copying" when that article
is ineligible for patent protection. 376 U.S. 225, 232-33 (1964) (citing G. Ricordi
& Co. v. Haendler, 194 F.2d 914, 916 (2d Cir. 1952)). In Sears, the question was
whether the defendant, Sears Roebuck & Co., could be held liable under state law
for copying a lamp design whose patent protection had expired. Id. at 225-26. The
Court explained that "when the patent expires the monopoly created by it expires,
too, and the right to make the article—including the right to make it in precisely
the shape it carried when patented—passes to the public." Id. at 230 (citing Kellogg
Co. v. Nat'l Biscuit Co., 305 U.S. 111, 120-22 (1938) and Singer Mfg. Co. v. June
Mfg. Co., 163 U.S. 169, 185 (1896)). The Court further clarified that "[a]n
unpatentable article, like an article on which the patent has expired, is in the public
domain and may be made and sold by whoever chooses to do so." Id. at 231; see
also Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 109 S. Ct. 971,
103 L. Ed. 2d 118 (1989). [Appellant]'s claimed clones are exact genetic copies of
patent ineligible subject matter.2 Accordingly, they are not eligible for patent
protection.
In re Roslin Institute (Edinburgh)
page 7
Novelty Urged keyed to Unclaimed Features
II
However, [Appellant] argues that its claimed clones are patent eligible because
they are distinguishable from the donor mammals used to create them. First,
[Appellant] contends that "environmental factors" lead to phenotypic differences
that distinguish its clones from their donor mammals. A phenotype refers to all the
observable characteristics of an organism, such as shape, size, color, and behavior,
that result from the interaction of the organism's genotype with its environment. A
mammal's phenotype can change constantly throughout the life of that organism
not only due to environmental changes, but also the physiological and
morphological changes associated with aging.
[Appellant] argues that environmental factors lead to phenotypic differences
between its clones and their donor mammals that render their claimed subject
matter patentable. However, these differences are unclaimed. Indeed, the word
"cloned" in the pending claims connotes genetic identity, and the claims say
nothing about a phenotypic difference between the claimed subject matter and the
donor mammals. Moreover, [Appellant] acknowledges that any phenotypic
differences came about or were produced "quite independently of any effort of the
patentee." Funk Bros., 333 U.S. at 131; see id. at 130 ("Their qualities are the work
of nature. Those qualities are of course not patentable. For patents cannot issue for
the discovery of the phenomena of nature."); Chakrabarty, 447 U.S. at 310 ("Here,
by contrast, the patentee has produced a new bacterium with markedly different
characteristics from any found in nature and one having the potential for
significant utility. His discovery is not nature's handiwork, but his own;
accordingly it is patentable subject matter under § 101."). Contrary to [Appellant]'s
arguments, these phenotypic differences do not confer eligibility on their claimed
subject matter. Any phenotypic differences between [Appellant]'s donor mammals
and its claimed clones are the result of "environmental factors," uninfluenced by
[Appellant]'s efforts.
In re Roslin Institute (Edinburgh)
page 8
Second, [Appellant] urges that its clones are distinguishable from their original
donor mammals * * * But any difference in mitochondrial DNA between the donor
and cloned mammals is, too, unclaimed. * * *
There is nothing in the claims, or even in the specification, that suggests that the
clones are distinct in any relevant way from the donor animals of which they are
copies. The clones are defined in terms of the identity of their nuclear DNA to that
of the donor mammals. To be clear, having the same nuclear DNA as the donor
mammal may not necessarily result in patent ineligibility in every case. Here,
however, the claims do not describe clones that have markedly different
characteristics from the donor animals of which they are copies.
Finally, [Appellant] argues that its clones are patent eligible because they are timedelayed versions of their donor mammals, and therefore different from their
original mammals. But this distinction cannot confer patentability. As the Board
noted, "[t]he difficulty with the time-delayed characteristic is that it is true of any
copy of an original." Thus, we affirm the Board's finding that [Appellant]'s clones
are unpatentable subject matter under § 101.
Professor Shine Tu on the Funk v. Kalo
Standard of “Invention”*
[In the first 2011 Myriad opinion**], gene patents have been called into question.
Interestingly, in Myriad, both the district court and the Federal Circuit cite to Funk
Brothers Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948),] as a
case that delineates the boundaries of patentable subject matter. Id. at 1359
("Applying the judicially created exception to the otherwise broad demarcation of
statutory subject matter in section 101 can be difficult . . . . Funk Brothers and
Chakrabarty do not stake out the exact bounds of patentable subject matter.
Instead, each applies a flexible test to the specific question presented in order to
determine whether the claimed invention falls within one of the judicial exceptions
to patentability."). In fact, since 1948, Funk [v. Kalo] has been cited for the
proposition that certain types of natural products do not fall within the scope of
patent protection. [Funk Bros., 333 U.S. at 130-31 ]
This is an excerpt from Shine Tu, Funk Brothers – an Exercise in Obviousness,
80 UMKC L. Rev. 637, 637-38 (2012) (footnotes integrated into text in brackets)(centered,
bracketed headlines added by the editor, HCW).
*
The article refers to Association for Molecular Pathology v. Myriad Genetics, 653
F.3d 1329 (Fed. Cir. 2011). Subsequent tot his article there was a second opinion, Ass'n for
Molecular Pathology v. U.S. Patent and Trademark Office, 689 F.3d 1303 (Fed. Cir. 2012),
which resulted from a remand from the Supreme Court in the 2011 Federal Circuit
decision, 132 S. Ct. 1794 (2012). The Supreme Court issued its merits decision a year later,
Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).
**
Professor Shine Tu on the Funk v. Kalo Standard of “Invention”
page 2
[Leading Academics Cite Funk v. Kalo as Focused on Patent-Eligibility]
Moreover, many casebooks use Funk [v. Kalo] in one form or another to teach the
boundaries of subject matter patentability. [See Edmund W. Kitch & Harvey S.
Perlman, Intellectual Property and Unfair Competition 821 (5th ed. 1998); William
H. Francis, Robert C. Collins, James D. Stevens, Andrew M. Grove & Matthew J.
Schmidt, Cases and Materials on Patent Law Including Trade Secrets, Copyrights,
Trademarks 532 (6th ed. 2007); Robert P. Merges & John F. Duffy, Patent Law
and Policy: Cases and Materials 160 nn.2-3 (5th ed. 2011) (also noting that 1952
Patent Act may undermine the Funk [v. Kalo] holding).] However, this article
argues that Funk [v. Kalo] is erroneously relied upon by judges and juries alike to
determine the limits of patentable subject matter, and that in reality, Funk [v. Kalo]
is a case that outlines the obviousness standard.
[Funk v. Kalo, a Standard for Obviousness Determination]
… Funk [v. Kalo] is, in actuality, a case that outlines an obviousness standard. As
an initial matter, one only needs to look to the historical background in which Funk
[v. Kalo] sits to understand this maxim. Funk [v. Kalo] was decided before the
codification of the 1952 Patent Act and, in fact, simply defines the current
obviousness standard later codified in 35 U.S.C. § 103(a). Accordingly, Funk
[v. Kalo] should not be cited as a case against the patentability of genes under nonpatentable subject matter (35 U.S.C. § 101). Interestingly, the analysis that the
Funk [v. Kalo] Court uses is, at its core, an obviousness analysis. … [T]he novelty
and obviousness standards are better tools that can limit and define the boundaries
of patentability for gene patents.
Product-by-Process Patentability under In re Thorpe*
NEWMAN, Circuit Judge.
Product-by-process claims are not specifically discussed in the patent statute. The
practice and governing law have developed in response to the need to enable an
applicant to claim an otherwise patentable product that resists definition by other
than the process by which it is made. For this reason, even though product-byprocess claims are limited by and defined by the process, determination of
patentability is based on the product itself. In re Brown, 459 F.2d 531, 535 (CCPA
1972); In re Pilkington, 411 F.2d 1345, 1348 (CCPA 1969); Buono v. Yankee Maid
Dress Corp., 77 F.2d 274, 279 (2d Cir. 1935).
This is an excerpt from In re Thorpe, 777 F.2d 695, 697-98 (Fed. Cir.
1985)(Newman, J.). Thorpe is the leading Federal Circuit case standing for the
proposition that patentability or validity of a claim to a product-by-process
depends upon the novelty and nonobviousness of the product and not the
method for making the product: A “product-by-process patent [is] properly
denied where end result was indistinguishable from prior art.” Bonito Boats v.
Thunder Craft Boats, 489 U.S. 141, 158 n.* (1989)(citing Thorpe, 777 F. 2d at
697). See also Greenliant Sys., Inc. v. Xicor LLC, 692 F.3d 1261, 1268 (Fed. Cir.
2012)(Dyk, J.)(“‘In determining validity of a product-by-process claim, the
focus is on the product and not the process of making it.’ Amgen Inc. v. F.
Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed. Cir. 2009). ‘That is because
of the . . . long-standing rule that an old product is not patentable even if it is
made by a new process.’ Id. at 1370; see also SmithKline Beecham Corp. v.
Apotex Corp., 439 F.3d 1312, 1317 (Fed. Cir. 2006) (‘It has long been
established that one cannot avoid anticipation by an earlier product
disclosure by claiming . . . the product as produced by a particular process.’);
Thorpe, 777 F.2d at 697 (‘If the product in a product-by-process claim is the
same as or obvious from a product of the prior art, the claim is unpatentable
even though the prior product was made by a different process.’).”) Edited by
Harold C. Wegner.
*
Product-by-Process Patentability under In re Thorpe*
page 2
The patentability of a product does not depend on its method of production. In re
Pilkington, 411 F.2d 1345, 1348 (CCPA 1969). If the product in a product-byprocess claim is the same as or obvious from a product of the prior art, the claim is
unpatentable even though the prior product was made by a different process. In re
Marosi, 710 F.2d 799, 803 (Fed. Cir. 1983); Johnson & Johnson v. W.L. Gore, 436
F. Supp. 704, 726 (D.Del. 1977); see also In re Fessmann, 489 F.2d 742.
Thorpe does not assert that the product of his process is different from the product
of the prior art. Rather, Thorpe argues that the PTO has the burden of showing that
the product of his process is the same as the product of the prior art. The burden
of presenting a prima facie case of unpatentability resides with the PTO, as
discussed in In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984).
The examiner asserted that Thorpe's product made using zinc oxide and benzoic
acid is prima facie the same as the prior art product made using zinc dibenzoate.
The PTO referred to Thorpe's documents of record as showing that Thorpe also
believed that zinc dibenzoate is formed, and took Thorpe's statement that his
resin's properties are "about equal" to the known resin as an acknowledgment of
similarity. Thorpe invokes the principle that an applicant's own disclosures cannot
be used to support a rejection of the claims, "absent some admission that matter
disclosed in the specification is in the prior art". In re Wertheim, 541 F.2d 257, 269
(CCPA 1976), and cases cited therein. However, Thorpe's purported "admissions"
are of a different sort than those dealt with in Wertheim.
***
Thorpe argues that even if the performance of a compound is comparable to that
of the prior art, this fact does not necessarily imply that the structures are identical.
We agree. We also agree that on the entirety of the record the PTO had correctly
adduced a prima facie case, and that the burden had shifted to Thorpe, "to prove
that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product." In re Fitzgerald, 619 F.2d 67, 70 (CCPA
1980); In re Best, 562 F.2d 1252, 1255 (CCPA 1977). This Thorpe did not do. We
conclude that the Board correctly affirmed the examiner's rejection of [the claims].