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/US2021/072389, filed
12 November 2021. Acknowledgment is made of Applicant’s claim for benefit under 35 USC 119(e) to US Provisional Application No. 63/112738, filed 12 November 2020.
Status of the Claims
Applicant’s preliminary submission filed 16 January 2024 has been entered. Claims 1, 6-17, and 20-27 are pending. Claims 1, 6-7, 9-11, 13-14, 16-17, and 22-25 have been amended, while claims 2-5 and 18-19 have been cancelled without prejudice or disclaimer and claims 26-27 have been newly added. Prosecution on the merits commences for claims 1, 6-17, and 20-27.
Specification
The substitute Specification filed 11 May 2023 is acknowledged and entered into the application file.
Claim Interpretation
Instant claim 25 is directed to a cultured adipose tissue that is produced without perfusion. This is a product-by-process limitation. Product-by-process limitations are considered only in so far as the method of production affects the structure of the final product. In the instant case, there is no evidence that the lack of perfusion within a production method imparts any particular structure or significance to the adipose tissue. Thus, the claim will be interpreted as if adipose tissue derived from any source or production method fulfills the recited claim limitation. See MPEP § 2113.
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 15 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 15: The instant claim recites the limitation "the 3D mold" in Lines 1-2. There is insufficient antecedent basis for this limitation in the claim, as there is no prior recitation of a 3D mold within the instant claim or parent claims 8 and 14. See MPEP § 2173.05(e).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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 –
(a)(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.
(a)(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.
Claims 1, 6, 8-13, 16-17, and 26 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Elfenbein et al (WO 2020/123876 A1), with a publication date of 18 June 2020.
Elfenbein et al disclose systems and methods for producing food products, including cultured food products that are processed to provide a desired shape, texture, and consistency (Abstract).
As such, Elfenbein et al disclose a method of producing cultured adipose tissue for human consumption, the method comprising: a) obtaining a population of mesenchymal stem cells; b) culturing the population of mesenchymal stem cells in a maintenance medium within a stirred suspension tank bioreactor; c) inducing differentiation in the population of mesenchymal stem cells to form adipocytes, wherein the maintenance medium is changed to a differentiation medium within the bioreactor; and d) harvesting and processing the adipocytes to form cultured adipose tissue for human consumption (Paragraphs [011]-[012], [021]-[022], [027], [0132], [0157]-[0159], [0176], [0244], [0271]; Figures 2, 4B, 20-21).
Elfenbein et al further disclose that the processing of the cultured adipose tissue involves the combination of the tissue with a binder, including sodium alginate, as well as the shaping of the final cultured tissue into slices or other defined shapes (Paragraphs [0175], [0186], [0244]).
Accordingly, Elfenbein et al anticipate the claims as follows:
Regarding claims 1, 6, 8-10, and 26: Elfenbein et al disclose a method of producing cultured adipose tissue for human consumption, the method comprising: a) obtaining a population of mesenchymal stem cells; b) culturing the population of mesenchymal stem cells (claims 9-10, 26) in a maintenance medium within a stirred suspension tank bioreactor (claim 6); c) inducing differentiation in the population of mesenchymal stem cells to form adipocytes, wherein the maintenance medium is changed to a differentiation medium within the bioreactor; and d) harvesting and processing the adipocytes to form cultured adipose tissue for human consumption. This therefore reads on the methods of instant claims 1 and 8.
Regarding claims 11-13: Following the discussion of claim 8, Elfenbein et al further disclose that the processing of the cultured adipose tissue involves the combination of the tissue with a binder, including sodium alginate (claims 12-13). This therefore reads on the method of instant claim 11.
Regarding claim 16: Following the discussion of claim 8, Elfenbein et al further disclose that the cultured adipose tissue has a size on the macroscale (Paragraph [081]; Figures 3, 27). Furthermore, as the method of Elfenbein et al comprises the same steps as recited in instant claim 8, the produced cultured adipose tissue will inherently be on the macroscale. See MPEP § 2112. This therefore reads on the method of the instant claim.
Regarding claim 17: Following the discussion of claim 8, Elfenbein et al further disclose that the processing of the cultured adipose tissue involves the shaping of the final cultured tissue into slices or other defined shapes. This therefore reads on the method of the instant claim.
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, 6-13, 16-17, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Elfenbein et al (WO 2020/123876 A1) in view of Fish et al (Trends Food Sci Technol, 2020, of record on IDS filed 16 October 2023).
The discussion of Elfenbein et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Elfenbein et al anticipate claims 1, 6, 8-13, 16-17, and 26. Fish et al is considered prior art under 35 USC 102(a)(1).
Regarding claim 7: As aforementioned in the discussion of claim 1, Elfenbein et al disclose the use of a stirred suspension tank bioreactor in the production of cultured adipose tissue.
Elfenbein et al do not disclose the use of a hollow fiber bioreactor, as required by instant claim 7.
Fish et al, however, disclose that cultured adipose tissue is generated with stirred suspension tank bioreactors and hollow fiber bioreactors (Pages 12-13; Figure 3).
Therefore, it would have been prima facie obvious to have substituted the stirred suspension tank bioreactor of Elfenbein et al with the hollow fiber bioreactor of Fish et al, as doing so would have been a simple substitution of one know adipose tissue-producing bioreactor for another. See MPEP § 2143(I)(B). One of ordinary skill before the effective filing date of the invention would have recognized that the two bioreactors are functionally comparable, as they both allow for the generation of cultured adipose tissue, and would have thereby been able to substitute the bioreactors with predictable results.
Consequently, Elfenbein et al as modified by Fish et al render obvious a method of producing cultured adipose tissue, wherein the mesenchymal stem cells are cultured and differentiated into adipocytes within a hollow fiber bioreactor. This therefore renders obvious the method of the instant claim.
Claims 1, 6, 8-17, and 20-26 are rejected under 35 U.S.C. 103 as being unpatentable over Elfenbein et al (WO 2020/123876 A1) in view of Buchert et al (Annu Rev Food Sci Technol, 2010, of record on IDS filed 16 October 2023).
The discussion of Elfenbein et al regarding claim 8 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Elfenbein et al anticipate claims 1, 6, 8-13, 16-17, and 26. Buchert et al is considered prior art under 35 USC 102(a)(1).
Regarding claims 14-15 and 20-21: Following the discussion of claim 8, Elfenbein et al further disclose that the harvested adipocytes can be processed with transglutaminase (Paragraphs [052], [0208], [0244]).
Elfenbein et al further disclose that the cultured adipose tissue can be combined with generated muscle tissue to form cultured fish meat that has a macroscopic 3D shape (Paragraphs [014], [036], [081], [0103], [0174], [0186], [0219]; Figures 3, 27).
Elfenbein et al do not disclose that the adipocytes are cross-linked with transglutaminase, as required by instant claims 14-15 and 20-21.
Buchert et al, however, disclose that transglutaminase has been found to crosslink meat and fish proteins (Pages 115-116).
Therefore, it would have been prima facie obvious to have modified the method of Elfenbein et al such that the harvested and processed adipocytes are crosslinked with transglutaminase, as suggested in Buchert et al. One of ordinary skill in the art would have been motivated to crosslink the adipocytes within the final cultured fish meat product, as doing so would provide texture to the final cultured fish meat product (Buchert et al: Pages 125-126), and would have had a reasonable expectation of success given that the disclosures of Elfenbein et al and Buchert et al are both concerned with the generation of cultured fish meat. See MPEP § 2143(I)(G).
Consequently, Elfenbein et al as modified by Buchert et al render obvious a method of producing cultured adipose tissue, wherein the harvested and processed adipocytes are cross-linked with transglutaminase (claims 15, 21). This therefore renders obvious the method of instant claim 14 and cultured adipose tissue of instant claim 20, as the final cultured adipose tissue has a macroscopic 3D shape.
Regarding claims 22-24: Following the discussion of claim 20, Elfenbein et al further disclose that the cultured adipose tissue is an edible food product (claim 22) that can be combined with generated muscle tissue (claims 23-24) to form cultured fish meat (Paragraphs [014], [036], [0103], [0174], [0219]). This therefore reads on the methods of the instant claims.
Regarding claim 25: The instant claim comprises product-by-process language. The effect of the product-by-process language is discussed above – see Claim Interpretation – and is incorporated herein in its entirety.
Accordingly, Elfenbein et al as modified by Buchert et al disclose a cultured adipose tissue comprising adipose cells cross-linked together with transglutaminase. This therefore renders obvious the cultured adipose tissue of the instant claim for the same reasons as discussed in the rejection of claim 20. It is also of note that Elfenbein et al do not teach the perfusion of the differentiated adipocytes within their disclosure.
Claims 1, 6, 8-13, 16-17, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Elfenbein et al (WO 2020/123876 A1) in view of Forgacs et al (US 2019/0376026 A1).
The discussion of Elfenbein et al regarding claim 8 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Elfenbein et al anticipate claims 1, 6, 8-13, 16-17, and 26. Forgacs et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claim 27: Following the discussion of claim 8, Elfenbein et al further disclose that the processing of the cultured adipose tissue involves the shaping of the cultured tissue into slices or other defined shapes (Paragraph [0186]).
Elfenbein et al do not disclose that the harvested adipose cells are aggregated within a 3D mold, as required by instant claim 27.
Forgacs et al, however, disclose methods for making cultured meats, wherein a cultured cell product – which can include adipose cells – is placed into a mold to produce a desired shape (Abstract; Paragraphs [0013], [0018], [0021], [0023]-[0025], [0044], [0064], [0129]).
Therefore, it would have been prima facie obvious to have modified the method of Elfenbein et al such that the adipose cells are aggregated within a 3D mold, as detailed in Forgacs et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to aggregate the adipose cells within a 3D mold, as it allows for the final adipose tissue product to be in a defined shape, and would have had a reasonable expectation of success given that the disclosures of both Elfenbein et al and Forgacs et al are concerned with the generation of cultured adipose tissue and final meat products comprising the cultured adipose tissue thereof. See MPEP § 2143(I)(G).
Consequently, Elfenbein et al as modified by Forgacs et al render obvious a method of producing cultured adipose tissue, wherein the adipose cells are aggregated within a 3D mold. This therefore renders obvious the method of the instant claim.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 20 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 37 of copending Application No. 18/294,033 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. The claims are identical. This is a statutory double patenting rejection.
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, 6-17, and 21-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 14, 16, 18, 20-21, 34, 38, and 46 of copending Application No. 18/294,033 (reference application) in view of Elfenbein et al (WO 2020/123876 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims either anticipate or render obvious the instant claims. In the case wherein the copending claims render obvious the instant claims, 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 1 is directed to a method for producing cultured adipose tissue, comprising:
growing adipogenic precursor cells in a first culture media; differentiating the adipogenic precursor cells to adipose cells in a second culture media;
harvesting the adipose cells; and
aggregating the harvested adipose cells to provide the cultured adipose tissue, wherein the first culture media and the second culture media may be the same culture media or different culture medias.
Copending claim 2 further limits copending claim 1, wherein growing the adipogenic precursor cells in the first culture media comprises seeding the adipogenic precursor cells into a bioreactor containing the first culture media, and allowing the adipogenic precursor cells to proliferate in the bioreactor. With that, copending claim 3 further limits copending claim 2, wherein differentiating the adipogenic precursor cells to adipose cells comprises changing the first culture media to the second culture media in the bioreactor.
Therefore, copending claim 1 anticipates instant claim 8, while copending claims 1-3 render obvious instant claim 1.
Each of the following limitations can be further incorporated into the method anticipated by copending claim 1, the cultured adipose tissue anticipated by copending claim 37 (see above), and method rendered obvious by copending claims 1-3:
Copending claim 6 teaches the limitations recited in instant claims 6-7.
Copending claim 14 teaches the limitations recited in instant claims 9-10, and 26.
Copending claims 16 and 34 teach the limitations recited in instant claims 11, 16-17, and 27.
Copending claim 18 teaches the limitations recited in instant claims 12-13.
Copending claim 20 teaches the limitation recited in instant claim 14.
Copending claim 21 teaches the limitation recited in instant claim 15.
Copending claim 38 teaches the limitation recited in instant claim 21.
Copending claim 46 teaches the limitation recited in instant claim 25.
Elfenbein et al teach the limitations recited in instant claim 22-24.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633