Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 23 October 2025.
CLAIMS UNDER EXAMINATION
Claims 5-8 and 10-18 have been examined on their merits.
PRIORITY
Provisional Application 62/360495 filed on 11 July 2016 is acknowledged.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 5-8 and 10-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more as evidenced by Sandig et al. (US2012288916A1) and Foster et al. (5672485).
Question 1: Are the claims directed to a process, machine manufacture or composition of matter? Yes, claim 5 is directed to a composition of matter.
Question 2A: Are the claims directed to a product of nature, a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)?
Prong 1. Yes, claim 5 is directed to a nature-based product limitation. The limitation in the claims that sets forth a nature based product is: a spontaneously immortalized chicken fibroblast.
The closest naturally occurring counterpart are chicken fibroblasts immortalized by a spontaneous event.
The specification defines the phrase “spontaneously immortalized fibroblast” as a fibroblast cell which is capable of undergoing unlimited cell division, and preferably also cell expansion, without being subjected to man-induced mutation e.g., genetic manipulation, causing the immortalization. Therefore the claimed fibroblasts read on a naturally occurring product. Sandig discloses a spontaneously immortalized cell line developed by continuous passaging of chicken embryonic fibroblasts ([0021]). As evidenced by Sandig, immortalization by this approach is caused by spontaneous mutations in multiple oncogenes or tumor suppressor genes ([0021]). Therefore a spontaneously immortalized chicken fibroblasts occurs naturally.
The claim has been amended to recite a composition comprising an isolated population of said cells. Isolation of said cells does not result in something different than naturally occurring cells.
The claim recites the cells are capable of surviving culture collapse under adherent culturing conditions. The specification discloses “culture collapse” refers to a cell culture in which the majority of the cells have undergone senescence (i.e., stop cell division) or cell apoptosis/necrosis ([0442]). Foster et al. (cited in the rejections below), discloses a cell line (a composition) comprising spontaneously immortalized chicken fibroblasts. The immortalized cells are isolated chicken embryonic fibroblasts grown in adherent culture. In the method taught by Foster, the majority of cells are dead or dying at passage 11 (column 7, lines 61-62). Therefore the cells isolated by Foster are capable of surviving culture collapse. Culture collapse is a characteristic of the claimed cells that does not recite in something markedly different than the recited judicial exception.
The claim recites the fibroblasts are capable of generating a cultured edible meat. This is an intended use of the claimed fibroblasts. The limitation does not result in something significantly more than naturally occurring immortalized chicken fibroblasts.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? No. The claims are directed to a product (i.e. a composition) and not a method of administration to a subject.
Question 2B: Do the claims recite any additional elements that amount to significantly more than the judicial exception?
(a) Are there any additional elements recited in the claim beyond the exception identified above? Yes.
(b) Do the additional elements, taken individually and as a combination result in significantly more?
Claims 6-7 recite characteristics of the cells. As evidenced by Foster et al. spontaneously immortalized chicken fibroblasts have undergone greater than 400 population doublings and greater than 160 passages (column 3, lines 30-40).
Regarding claim 8: A non-genetically modified fibroblast is a judicial exception.
Claim 10: The claim recites culturing on tissue culture treated plastic. The claims are directed to a product, and not a process of culturing. The claim does not recite something significantly more than the recited judicial exception.
Regarding claims 11-14 recite a product by process limitation for making the cells. As set forth above, the claimed product is indistinguishable from spontaneously immortalized chicken fibroblasts. Therefore the claim limitations do not recite something markedly different than the judicial exception.
Regarding claims 15-16: The base claim recites the fibroblasts are capable of generating an edible meat. The claims are not directed to an edible meat. Therefore the claim limitations do not add something significantly more to the recited judicial exception.
Regarding claims 17-18: As evidenced by Foster, spontaneously immortalized fibroblasts double ever 22-24 hours (column 4, lines 36-37). Therefore the doubling times not add something significantly more to the recited judicial exception.
Therefore, claims 5-8 and 10-18 are not eligible subject matter under 35 USC 101.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 23 October 2025 are acknowledged. The Applicant argues amended claim 5 is directed to a “non-naturally occurring population of fibroblasts created through purposeful human intervention”. The Applicant argues “no evidence has been cited demonstrating that routinely passaging avian embryo fibroblasts until culture collapse, followed by isolation of spontaneous survivors capable of unlimited propagation, was a well-understood or conventional technique”.
In response: While the arguments state claim 5 is directed to a non-naturally occurring population of fibroblasts created through purposeful human intervention, the Applicant’s specification states “spontaneously immortalized fibroblast” have not been subjected to man-induced mutation e.g., genetic manipulation, causing the immortalization. Therefore the claimed fibroblasts read on a naturally occurring product.
The claims are directed to a product, and not a method comprising passaging until collapse and isolation of spontaneous survivors.
The specification discloses “culture collapse” refers to a cell culture in which the majority of the cells have undergone senescence (i.e., stop cell division) or cell apoptosis/necrosis ([0442]). Foster et al. (cited in the rejections below), teaches a method of producing spontaneously immortalized chicken fibroblasts. Foster teaches the majority of cells are dead or dying at passage 11 (column 7, lines 61-62). It is noted Foster teaches the cells are removed from the plate using trypsin (column 7, lines 41-44). Therefore the cells are adherent. Therefore the spontaneously immortalized chicken fibroblasts isolated by Foster are capable of surviving culture collapse under adherent culturing conditions. The claims are not directed to a culture edible meat. Absent evidence the contrary, the cells disclosed by Foster are capable of generating cultured edible meat. Therefore the argument is not persuasive.
The Applicant argues the claimed fibroblasts improve the underlying technological field by enabling scalable production of cultured edible meat from an immortal, non-genetically modified avian cell source.
In response: Claim 5 recites the claimed fibroblasts are capable of generating a cultured edible meat. This limitation does not add significantly more to the recited judicial exception. Therefore the argument is not persuasive.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 17-18 recite a doubling time of about 16 to about 20 hours. Neither the claims nor the specification disclose the values encompassed by the term “about”. Therefore it includes times above and below the claimed range. While the specification provides support for spontaneously immortalized chicken embryonic fibroblast cell line having a doubling time of 18±2 hours ([0316] [0643]), it does not provide support for all possible values encompassed by the term “about”.
An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or
nonobviousness.
Claims 5-8 and 10-18 are rejected under 35 U.S.C. 102 (a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious Foster et al. (previously cited; Immortalized Cell Lines For Virus Growth. Patent Number 5672485 1997).
Claim 5 recites a composition comprising an isolated population of spontaneously immortalized chicken fibroblast.
Foster teaches a spontaneously immortalized cell line from primary chicken embryonic fibroblasts (Abstract; column 2, lines 64-66). A cell line is interpreted to be a composition comprising an isolated population of cells.
Foster teaches a spontaneously immortalized cell line from primary chicken embryonic fibroblasts. Embryonic tissue (hence, containing embryonic cells) is cultured in serum (column 7, lines 35-36). After 24 hours of incubation, the resulting cultures produce radiating fibroblasts (column 7, lines 39-41). The art teaches the cells are removed from the plate using trypsin (column 7, lines 41-44). Therefore the cells are adherent. Foster teaches the majority of cells are dead or dying at passage 11 (column 7, lines 61-62). Therefore the art teaches passaging for at least 10-12 passages using serum containing medium. Foster isolates a small population of healthy fibroblasts (column 7, line 62-64). The art teaches said cells “are currently at passage 160” (column 8, lines 8-9). The specification discloses “culture collapse” refers to a cell culture in which the majority of the cells have undergone senescence (i.e., stop cell division) or cell apoptosis/necrosis ([0442]). Therefore the cells isolated by Foster are capable of surviving culture collapse. Because Foster teaches the claimed cells, they are inherently capable of generating cultured edible meat.
The specification discloses the claimed cells are generated by
(a) culturing avian embryo cells in the presence of a serum-containing medium under adherent culture conditions to thereby obtain chicken embryonic fibroblasts,
(b) passaging the avian embryonic fibroblasts for at least 10-12 passages in the serum-containing medium under the adherent conditions until culture collapse and (c) isolating at least one colony which survived the culture collapse in the serum-containing medium for at least additional 20 passages ([0061 of PG Pub).
Thus, the same method using the same cell would yield the claimed characteristics.
Alternatively, the claimed spontaneously immortalized fibroblasts would have been obvious. Foster teaches the steps as recited above. Therefore the method taught by Foster and as claimed by applicant would be expected to result in the number of senescent and/or death of at least 90% of avian embryonic fibroblasts. Any slight variation rendered by the process is considered obvious absent evidence to the contrary.
The Examiner concludes the burden has been shifted to the applicant to show an unobvious difference between the claimed product and the prior art product.
Therefore, the spontaneously immortalized fibroblast of Foster et al. would have been anticipated or obvious over the cells of the instant application.
The following is noted from MPEP 2113 II:
II. ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS FOUND AND A PRIOR ART REJECTION IS MADE, THE BURDEN SHIFTS TO THE APPLICANT TO SHOW AN NONOBVIOUS DIFFERENCE
"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983) (The claims were directed to a zeolite manufactured by mixing together various inorganic materials in solution and heating the resultant gel to form a crystalline metal silicate essentially free of alkali metal. The prior art described a process of making a zeolite which, after ion exchange to remove alkali metal, appeared to be "essentially free of alkali metal." The court upheld the rejection because the applicant had not come forward with any evidence that the prior art was not "essentially free of alkali metal" and therefore a different and nonobvious product.).
See also Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989) (The prior art disclosed human nerve growth factor (b-NGF) isolated from human placental tissue. The claim was directed to b-NGF produced through genetic engineering techniques. The factor produced seemed to be substantially the same whether isolated from tissue or produced through genetic engineering. While the applicant questioned the purity of the prior art factor, no concrete evidence of an nonobvious difference was presented. The Board stated that the dispositive issue is whether the claimed factor exhibits any unexpected properties compared with the factor disclosed by the prior art. The Board further stated that the applicant should have made some comparison between the two factors to establish unexpected properties since the materials appeared to be identical or only slightly different.)
Therefore claim 5 is rejected.
Foster teaches the cells have undergone greater than 400 population doublings and greater than 160 passages (column 3, lines 30-40). Therefore claims 6-7 are included in this rejection.
Foster teaches the cells do not contain viral protein (column 3, lines 55-56). The art does not disclose genetic modification. Therefore claim 8 is included in this rejection.
Regarding claim 10: the base claim recites the claimed cells are “capable of surviving culturing collapse under adherent culturing conditions”. Claim 10 recites the condition is culture on treated plastic. Because the claimed cells are anticipated, or in the alternative, rendered obvious, they would be expected to be capable of surviving the claimed conditions. Therefore claim 10 is included in this rejection.
Claims 11-14 are also directed to a product by process limitation. See MPEP 2113.
Foster teaches growing primary chicken embryonic fibroblasts in culture; passaging the fibroblasts in culture until they begin cell senescence; identifying loci of non-senescence cells; and growing the non-senescent cells for greater than 30 passages (column 3, lines 14-21). The cells have undergone greater than 160 passages (column 4, lines 30-32). The cells have undergone greater than 400 population doublings and greater than 160 passages (column 3, lines 30-40). The recited limitations do not distinguish the claimed product from the immortalized fibroblasts taught by Foster. Therefore claims 11-14 are included in this rejection.
Regarding claims 15-16: The base claim recites the claimed fibroblasts are capable of generating cultured edible meat. Because the claimed cells are rendered obvious, they would be capable of forming the cultured meat recited in claims 15-16.
Regarding claims 17-18: Because the claimed cells are anticipated, or in the alternative, rendered obvious, they would be expected to have the claimed doubling time. Therefore claims 17-18 are included in this rejection
Therefore the Applicant’s Invention is rejected as claimed.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 23 October 2025 are acknowledged. The Applicant argues Foster does not teach all of the limitations recited in claim 5. The Applicant argues Foster does not teach or suggest the claimed cells may be capable of generating a culture edible meat.
In response: The claims are not directed to a method of making cultured edible meat. The claims are directed to a product. Foster teaches an isolated population of spontaneously immortalized chicken fibroblasts. The art teaches the cells are adherent. The art teaches the cells are able to survive culture collapse. Because Foster teaches the product, it would be capable of generating a cultured edible meat. Therefore the arguments are not persuasive.
CONCLUSION
No Claims Are Allowed
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653