DETAILED ACTION
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 .
Priority
The instant application is a national stage entry under 35 USC 371 of PCT/US2022/019615, filed
09 March 2022. Acknowledgment is made of Applicant’s claim for benefit under 35 USC 119(e) to US Provisional Application No. 63314191, filed 25 February 2022, US Provisional Application No. 63314171, filed 25 February 2022, US Provisional Application No. 63300577, filed 18 January 2022, US Provisional Application No. 63279617, filed 15 November 2021, US Provisional Application No. 63279644, filed 15 November 2021, US Provisional Application No. 63279642, filed 15 November 2021, US Provisional Application No. 63279631, filed 15 November 2021, US Provisional Application No. 63164387, filed 22 March 2021, US Provisional Application No. 63164397, filed 22 March 2021, and US Provisional Application No. 63159403, filed 10 March 2021.
However, support for the limitations recited in independent claim 1 as written – namely, the culturing of non-human cells in platelet-rich lysate to produce a tissue mass of at least 10 g – is first found in US Provisional Application No. 63279631, filed 15 November 2021. Therefore, the effective filing date of the instant invention is 15 November 2021.
Election/Restrictions
Upon reconsideration, the restriction requirement set forth on 11 December 2025 was improper and is hereby WITHDRAWN.
A new restriction requirement for the claims submitted 10 June 2026 is set forth below, which requires Applicant to select a single inventive embodiment from the posed groups.
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Group I, claims 1, 60-61, 63-67, and 79-81, drawn to a method, comprising: lysing non-human blood plasma to produce a platelet-rich lysate; and mixing the platelet-rich lysate and non-human cells; and culturing the non-human cells in the platelet-rich lysate to produce a tissue mass of at least 10 g.
Group II, claims 68-72 and 82-85, drawn to a method, comprising: withdrawing a first blood draw from a non-human animal; causing at least a portion of the first blood draw to be formed into a first cultivated meat product; after at least 4 weeks after withdrawing the first blood draw, withdrawing a second blood draw from the non-human animal in a quantity that is not harmful to animal; and causing at least a portion of the second blood draw to be formed into a second cultivated meat product.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because the groups do not share the same or corresponding technical feature. More specifically, the technical feature of Group I is a tissue mass of at least 10 g made by culturing non-human cells in a non-human platelet-rich lysate, while the technical feature of Group II is cultivated meat products formed from non-animal human blood.
It is of note that a tissue mass is not necessarily a cultivated meat product, as the cultivated meat products are required to be edible. See, for example, Page 6 of the instant Specification.
Therefore, unity of invention is lacking a priori.
Applicant is advised that the reply to this requirement to be complete must include (i) an
election of a species or invention to be examined even though the requirement may be traversed (37
CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a
right to petition, the election must be made with traverse. If the reply does not distinctly and specifically
point out supposed errors in the restriction requirement, the election shall be treated as an election
without traverse. Traversal must be presented at the time of election in order to be considered timely.
Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144.
If claims are added after the election, applicant must indicate which of these claims are readable on the
elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR
1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify
such evidence now of record showing the inventions to be obvious variants or clearly admit on the
record that this is the case. Where such evidence or admission is provided by applicant, if the examiner
finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a
rejection under 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Tani Chen on 22 June 2026, a provisional election was made with traverse to prosecute the invention of Group I, a method, comprising: lysing non-human blood plasma to produce a platelet-rich lysate; and mixing the platelet-rich lysate and non-human cells; and culturing the non-human cells in the platelet-rich lysate to produce a tissue mass of at least 10 g. Affirmation of this election must be made by Applicant in replying to this Office action.
Applicant’s original traversal in the Remarks filed 10 June 2026 asserted that the search and examination of all claims would not create an undue burden. In response, the Examiner respectfully submits that chapter 800 of the MPEP – with which Applicant is ultimately relying on – is limited to a discussion of the subject of restriction and double patenting under Title 35 of the United States Code and Title 37 of the Code of Federal Regulations as it relates to national applications filed under 35 U.S.C. 111(a). The discussion of unity of invention under the Patent Cooperation Treaty Articles and Rules as it is applied as an International Searching Authority, International Preliminary Examining Authority, and in applications entering the National Stage under 35 U.S.C. 371 as a Designated or Elected Office in the U.S. Patent and Trademark Office is covered in MPEP § 1850 and is dictated by PCT Rules 13.1 and 13.2. See MPEP § 801. Burden is not a consideration in a finding of lack of inventive unity; rather, according to MPEP § 1850, the only consideration is whether the inventions share a special technical feature.
Consequently, claims 68-72 and 82-85 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim. Prosecution on the merits commences for claims 1, 60-61, 63-67, and 79-81.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Specification
The preliminary amendments to the Specification filed 08 September 2023 are acknowledged and entered into the application file.
Claim Objections
Claim 63 is objected to because of the following informalities:
Regarding claim 63: The instant claim is objected to for reciting “[t]he method of claim 1, comprising…”, instead of “[t]he method of claim 1, further comprising…”, since additional method steps are required.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 61 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 61: The instant claim recites the limitation "the non-human red blood cells" in Line 1. There is insufficient antecedent basis for this limitation in the claim, as there is no prior recitation of non-human red blood cells within the instant claim or parent claim 1. See MPEP § 2173.05(e).
For the sake of compact prosecution, the instant claim will be interpreted as requiring the non-human blood plasma and non-human cells to be from the same animal species.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 60-61, 63-67, and 79-81 are rejected under 35 U.S.C. 103 as being unpatentable over Chin et al (WO 2021/111219 A1) in view of Gooris et al (US 2019/0321408 A1) and Faram et al (US 2023/0151330 A1).
Chin et al is considered prior art under 35 USC 102(a)(2), with an effective filing date of 02 December 2019. Gooris et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2). Faram et al is considered prior art under 35 USC 102(a)(2), with an effective filing date of 10 June 2020.
Regarding claim 1: Chin et al disclose a method of generating cultured meat products, wherein non-human animal cells are co-cultured with bioengineered cells that secrete growth factors and cytokines, thus replacing replace fetal bovine serum within culture (Paragraphs [0004], [0022], [0040], [0045]-[0046]). It is of note that the bioengineered cells are not present in the final cultured meat product (Paragraph [0040]).
Chin et al further disclose animal cell lysates that are active ingredients in food products, wherein the animal cell lysates are formed by lysing the animal cells via sonication (Paragraphs [0018], [0023], [0050], [0056], [0065], [0075]).
Chin et al do not disclose that the non-human animal cells are cultured in non-human animal platelet-rich lysate, nor that the final cultured meat product is at least 10 g, as required by instant claim 1.
Gooris et al, however, disclose the lysing of non-human animal blood plasma via sonication to produce non-human animal platelet-rich lysate that comprises growth factors and cytokines (Paragraphs [0019]-[0030], [0039]-[0043], [0045], [0055]). Gooris et al further disclose that the non-human animal platelet-rich lysate serves as an alternative to fetal bovine serum in culture (Paragraphs [0010], [0017], [0034], [0060]).
Therefore, it would have been prima facie obvious to have substituted the non-human animal bioengineered cell secretome of Chin et al with the non-human animal platelet-rich lysate of Gooris et al, as doing so would have been a simple substitution of one fetal bovine serum (FBS) alternative for another. See MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the invention would have recognized that the non-human animal bioengineered cell secretome and non-human animal platelet-rich lysate are functionally comparable, as they both allow for essential growth factors and cytokines to be in culture with the non-human animal cells without requiring the actual cell itself to be incorporated into the final cultured meat product, and thereby would have been able to substitute the FBS alternatives with predictable results.
The combination of Chin et al and Gooris et al fail to teach that the final cultured meat product is at least 10 g, as required by instant claim 1.
Faram et al, however, disclose the generation of cultured meat products via the culture of non-human animal cells within a bioreactor in a culture medium comprising growth factors, wherein the final cultured meat product is at least 50 grams (Paragraphs [0003], [0014], [0017], [0051], [0057]-[0058], [0073], [0106]-[0129]).
Therefore, it would have been prima facie obvious to have modified the method of Chin et al in view of Gooris et al such that the final cultured meat product is at least 50 grams, as detailed in Faram et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to produce a final cultured meat product that has enough mass to serve as a food product (Faram et al: Paragraph [0129]), and would have had a reasonable expectation of success given that the disclosures of Chin et al and Faram et al are concerned with the generation of cultured meat products from non-human animal cells within a bioreactor. See MPEP § 2143(I)(G).
Consequently, Chin et al as modified by Gooris et al and Faram et al render obvious a method comprising the lysing of non-human animal blood plasma to produce a non-human animal platelet-rich lysate, which is then mixed and cultured with non-human animal cells to generate a final cultured meat product of at least 50 grams. This therefore renders obvious the method of the instant claim.
Regarding claim 60: As aforementioned in the discussion of claim 1, Chin et al disclose that animal cell lysates are active ingredients in food products (Paragraphs [0018], [0023], [0050], [0056], [0065], [0075]).
Faram et al further disclose that the cultured meat product comprises at least 2% by mass of a scaffold, wherein the scaffold comprises growth factors (Paragraphs [0027], [0092]-[0093], [0099]).
Although Faram et al disclose that the scaffold comprising growth factors is at least 2% by mass of the final cultured meat product, the combination of Chin et al, Gooris et al, and Faram et al fail to teach that the non-human animal platelet-rich lysate is comprised within the cultured meat product at a concentration of at least 0.1%, as required by instant claim 60.
Therefore, it would have been prima facie obvious to have modified the method of Chin et al in view of Gooris et al and Faram et al such that the non-human animal platelet-rich lysate is comprised within the cultured meat product at a concentration of at least 0.1% . One of ordinary skill in the art would have been motivated to generate a final cultured meat product having a non-human animal platelet-rich lysate concentration of at least 0.1%, as it would have been a matter of routine optimization in determining a concentration of non-human animal platelet-rich lysate components – which include growth factors – attached to the scaffold that ensures the final cultured meat product is properly grown and palatable (Faram et al: Paragraphs [0097], [0099], [0102]), especially since the non-human animal cell lysate is an active ingredient in the cultured meat product. See MPEP § 2144.05(II). Furthermore, the ordinary artisan would have had a reasonable expectation of success given that the disclosures of both Chin et al and Faram et al involve the culturing of non-human animal cells with growth factors in a bioreactor to produce a final cultured meat product. See MPEP § 2143(I)(G).
Consequently, Chin et al as modified by Gooris et al and Faram et al render obvious a method wherein the non-human animal platelet-rich lysate is comprised within the cultured meat product at a concentration of at least 0.1%. This therefore renders obvious the method of the instant claim.
Regarding claims 61 and 80-81: Following the discussion of claim 1, Chin et al further disclose that the non-human animal cells and the bioengineered cells from which the secretome is derived are both cow cells (claim 81) (Paragraphs [0036], [0040]). As the ordinary artisan would have recognized that the non-human animal platelet-rich lysate is an alternative to the bioengineered cell secretome, and that the bovine bioengineered cells read on a bovine plasma sample from which a bovine platelet-rich lysate is derived (claims 60, 80), this therefore renders obvious the method of the instant claims for the same reasons as discussed in the rejection of instant claim 1.
Regarding claims 63-64: Following the discussion of claim 1, Gooris et al further disclose that the platelets are derived from an animal blood sample that has been subjected to apheresis (claims 63-64) (Paragraphs [0007], [0034], [0039]-[0043], [0055]). This therefore renders obvious the method of the instant claims for the same reasons as discussed in the rejection of instant claim 1.
Regarding claim 65: Following the discussion of claim 1, Faram et al further disclose that the final cultured meat product comprises myoblasts (Paragraphs [0054], [0058]-[0060], [0082]). This therefore renders obvious the method of the instant claim for the same reasons as discussed in the rejection of instant claim 1.
Regarding claims 66-67: Following the discussion of claim 1, Faram et al further disclose that the non-human animal cells are cultured with hydrogel microcarriers and scaffolds, such that the final cultured meat product comprises the hydrogel (claim 67) microcarriers and scaffolds (claim 66) (Paragraphs [0092]-[0093], [0095]-[0097]). This therefore renders obvious the method of the instant claims for the same reasons as discussed in the rejection of instant claim 1.
Regarding claim 79: Following the discussion of claim 1, Chin et al further disclose that the non-human animal cells are cultured in a bioreactor (Paragraphs [0004], [0030]-[0031], [0038], [0040], [0044]-[0045]; Figures 5-6). This therefore reads on the method of the instant claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 60-61, 63-67, and 79-81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 120 and 122-123 of copending Application No. 18/280998 in view of Gooris et al (US 2019/0321408 A1), Chin et al (WO 2021/111219 A1), and Faram et al (US 2023/0151330 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims. More specifically, the copending claims are not identical because no single copending claim discloses all of the limitations of any of the instant claims; however, each of the limitations of the instant claims are disclosed by separate copending claims, or rendered obvious by the accompanying prior art. The fact that each of the elements were claimed in the copending application, just not in a single claim, still renders obvious the instant invention because each of the features, though separately claimed, can be physically combined into a single embodiment.
Copending claim 120 is directed to a method comprising: culturing non-human cells on microcarriers comprising fibrin to produce cultured cells; and mixing the cultured cells and a fat replica comprising a fat emulsion and non-human blood plasma and/or a lysate of non-human red blood cells to produce a tissue mass of at least 10 g.
Copending claim 120 does not disclose that the non-human blood plasma is lysed to produce a platelet-rich lysate, as required by instant claim 1.
Gooris et al, however, disclose that non-human blood plasma comprises platelets that, when lysed, release a myriad of bioactive agents with important physiological functions – including growth factors that enhance cell proliferation and tissue regeneration (Paragraphs [0002], [0010]-[0011], [0019]-[0029], [0034]). Gooris et al further disclose that the platelet-rich lysate is used in the culture, growth and/or expansion of adipose tissue-derived stem cells (Paragraph [0011]).
Therefore, it would have been prima facie obvious to have modified the method of copending claim 120 such that the non-human blood plasma is lysed such that the cultured cells are cultured with a fat replica comprising a fat emulsion and a platelet-rich lysate, as detailed in Gooris et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to include the platelet-rich lysate within the fat replica, as it allows for the expansion of adipose tissue-derived cells, and would have had a reasonable expectation of success given that the copending claim teaches the incorporation of a cell lysate into the fat replica. See MPEP § 2143(I)(G).
Consequently, the method of copending claim 120 as modified by Gooris et al renders obvious the method of instant claims 1 and 66.
With that, instant claims 60-61, 63-65, 67, and 79-81 are known from the copending application or prior art and can be further incorporated into the method rendered obvious by copending claim 120 in view of Gooris et al:
Copending claims 122-123 teach the limitations recited in instant claims 60 and 65.
Chin et al teach the limitations recited in instant claims 61 and 79-81.
Gooris et al teach the limitations recited in instant claims 63-64.
Faram et al teach the limitations recited in instant claim 67.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 60-61, 63-67, and 79-81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 132, 134, 140, 144, 146, 148, and 150 of copending Application No. 18/281033 in view of Faram et al (US 2023/0151330 A1), Chin et al (WO 2021/111219 A1), and Gooris et al (US 2019/0321408 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims. More specifically, the copending claims are not identical because no single copending claim discloses all of the limitations of any of the instant claims; however, each of the limitations of the instant claims are disclosed by separate copending claims, or rendered obvious by the accompanying prior art. The fact that each of the elements were claimed in the copending application, just not in a single claim, still renders obvious the instant invention because each of the features, though separately claimed, can be physically combined into a single embodiment.
Copending claim 132 is directed to a method of raising non-human cells for cell-based products in culture comprising: exposing a plurality of non-human animal cells in a bioreactor to a cell culture media comprising a platelet lysate arising from a non-human animal, wherein the platelet lysate is present at 2% to 20% by weight of the cell culture media.
Likewise, copending claim 140 is directed to a method comprising: adding cell culture media comprising a platelet lysate arising from a non-human animal to a bioreactor, wherein the platelet lysate is present at 2% to 20% by weight of the cell culture media; adding non-human animal cells to the bioreactor; and growing a cell-based meat product from the non-human animal cells in the bioreactor.
Neither copending claim 132 or 140 disclose that the culture of the platelet lysate and non-human animal cells results in a tissue mass of at least 10 g, as required by instant claim 1.
Faram et al, however, disclose the generation of cultured meat products via the culture of non-human animal cells within a bioreactor in a culture medium comprising growth factors, wherein the final cultured meat product is at least 50 grams (Paragraphs [0003], [0014], [0017], [0051], [0057]-[0058], [0073], [0106]-[0129]).
Therefore, it would have been prima facie obvious to have modified the method of copending claims 132 or 140 such that the culture of the platelet lysate and non-human animal cells results in a final cultured meat product of at least 50 grams, as detailed in Faram et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to produce a final cultured meat product that has enough mass to serve as a food product (Faram et al: Paragraph [0129]), and would have had a reasonable expectation of success given that the methods of the copending claims allow for the generation of cell-based products from non-human animal cells within a bioreactor. See MPEP § 2143(I)(G).
Consequently, the method of copending claims 132 or 140 as modified by Faram et al renders obvious the method of instant claims 1 and 79.
With that, instant claims 60-61, 63-67, and 80-81 are known from the copending application or prior art and can be further incorporated into the method rendered obvious by copending claim 132 or 140 in view of Faram et al:
Copending claims 134, 144, 146, 148, and 150 teach the limitations recited in instant claims 61, 66, and 81.
Chin et al teach the limitations recited in instant claims 60 (in part) and 80.
Gooris et al teach the limitations recited in instant claims 63-64.
Faram et al teach the limitations recited in instant claims 60 (in part), 65, and 67.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA G WESTON/Examiner, Art Unit 1633
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