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 .
Status of the Claims
Applicant’s submission filed 08 December 2025 have been entered. Claims 1-17 are pending. Claims 8 and 13 have been amended, while claims 16-17 have been newly added. Support for the new claims is found in Paragraphs [0074]-[0075] of the instant Specification. Therefore, prosecution on the merits continues for claims 1-17.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claim 8 under 35 USC 112(b)
Applicant has amended the instant claim such that the protective layer is formed on a surface of the multilayer cell sheet. However, Applicant’s amendments fail to clarify how the protective layer is formed and what it is comprised of in such a way that the ordinary artisan would readily understand. It is of note that the amendment sufficiently clarifies which structures are encompassed by the protective layer.
Therefore, the rejection is maintained.
RE: Rejection of claims 1-7 and 12 under 35 USC 103 over Rowat et al in view of Hong et al
Applicant's arguments filed 08 December 2025 have been fully considered but they are not persuasive.
Applicant has traversed the rejection, asserting in Pages 6-7 of the Remarks filed 08 December 2025 that the instantly claimed invention involves the generation of single cell sheets without the need of an ECM scaffold, which are then stacked to form a multilayer cell sheet. In response, the Examiner respectfully submits that the instant claims utilize the “comprising” transitional phrase, and therefore allow for the inclusion of additional and unrecited components within the prior art. See MPEP § 2111.03(I). In other words, the instant claims as written do not preclude the use of ECM scaffolds within the invention as described by the prior art. It is also of note that the nanofilm formed on the surface of the cell sheets is comprised of materials that are found within an ECM scaffold – such as collagen, elastin, laminin, and fibronectin – wherein the nanofilm coating is necessary to properly form the cultured meat via the stacking of the single cell sheets. See Paragraph [0119] of the instant Specification.
Applicant has further traversed the rejection, asserting in Page 7 of the Remarks filed 08 December 2025 that that the combination of Rowat et al and Hong et al fail to teach the generation of a single cell sheet, as required in the instantly claimed invention. More specifically, Applicant asserts that Rowat et al instead disclose a seeded cell scaffold, while Hong et al disclose a cell pellet from suspension. In response, the Examiner respectfully submits that – as iterated in the rejection of record – Rowat et al disclose sheets of aligned nanofiber scaffolds, wherein the single sheets are stacked to form a multilayer cell sheet. See Paragraphs [0022], [0086] of Rowat et al. Hong et al is a secondary reference relied upon to disclose the use of a nanofilm coatings on cells, wherein the polymeric layers promote cell proliferation while concomitantly providing support via an artificial extracellular matrix scaffold. Therefore, the instant claims are rendered obvious when the cited references are considered together as a whole rather than individually. Applicant has failed to articulate why the use of Hong et al’s coatings in the method of Rowat et al would not be successful, as asserted in the rejection.
Therefore, the rejection is maintained.
RE: Rejection of claims 1-8 and 12-14 under 35 USC 103 over Rowat et al in view of Hong et al and Sahraee et al
Applicant's arguments filed 08 December 2025 have been fully considered but they are not persuasive.
Applicant has traversed the rejection, citing the same assertions presented within Pages 6-7 of the Remarks filed 08 December 2025 in regards to the rejection over Rowat et al in view of Hong et al. In response, the Examiner respectfully directs Applicant to the discussion of the 35 USC 103 rejection over Rowat et al in view of Hong et al.
Therefore, the rejection is maintained and amended to encompass the claims as written.
RE: Rejection of claims 1-8 and 12-15 under 35 USC 103 over Rowat et al in view of Hong et al, Sahraee et al, and Schmatz et al
Applicant's arguments filed 08 December 2025 have been fully considered but they are not persuasive.
Applicant has traversed the rejection, citing the same assertions presented within Pages 6-7 of the Remarks filed 08 December 2025 in regards to the rejection over Rowat et al in view of Hong et al. In response, the Examiner respectfully directs Applicant to the discussion of the 35 USC 103 rejection over Rowat et al in view of Hong et al.
Therefore, the rejection is maintained and amended to encompass the claims as written.
RE: Rejection of claims 1-7 and 9-12 under 35 USC 103 over Rowat et al in view of Hong et al and Forgacs et al
Applicant's arguments filed 08 December 2025 have been fully considered but they are not persuasive.
Applicant has traversed the rejection, citing the same assertions presented within Pages 6-7 of the Remarks filed 08 December 2025 in regards to the rejection over Rowat et al in view of Hong et al. In response, the Examiner respectfully directs Applicant to the discussion of the 35 USC 103 rejection over Rowat et al in view of Hong et al.
Therefore, the rejection is maintained.
RE: Provisional rejection of claims 1-15 over claims 1-8 and 10-12 of copending Application No. 18/006,447 in view of Rowat et al, Sahraee et al, and Schmatz et al
Applicant has not traversed the rejection, asserting in Page 5 of the Remarks filed 08 December 2025 that no response is required since it is a provisional rejection.
Therefore, the rejection is maintained and modified to encompass the claims as written.
New/Maintained Grounds of Rejection
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.
Claims 8 and 16-17 are 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 8: The instant claim requires the formation of “a protective layer” on a surface
of the multilayer cell sheet. The scope of the claim is indefinite, as it is unclear how the protective layer is formed and what it is comprised of. Therefore, the metes and bounds of the claim cannot be determined, as it is unclear what exactly the method step requires.
Appropriate correction is required.
It is of note that claims 16-17 are not included in this rejection because they sufficiently clarify the scope of parent claim 8.
Regarding claims 16-17: New claim 16 requires the protective layer of claim 8 to be “formed by coating a sugar compound”. The scope of the claim is indefinite, as it is unclear if there is a sugar compound present on the surface of the multilayer cell sheet that is coated by the protective layer, or if the protective coating itself is comprised of a sugar compound. Therefore, the metes and bounds of the claim cannot be determined, thus rendering the claim indefinite.
Instant claim 17 is dependent upon parent claim 16 and does not correct the deficiencies of the parent claim, thus rendering it indefinite as well.
Appropriate correction is required.
For the sake of compact prosecution, the instant claims will be interpreted as if the protective layer is a coating comprised of a sugar compound.
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 1-7 and 12 remain rejected under 35 U.S.C. 103 as being unpatentable over Rowat et al (WO 2020/219755 A1, of record) in view of Hong et al (KR 2017/0100693 A, as translated by Global Dossier, of record).
Rowat et al is considered prior art under 35 USC 102(a)(2), with an effective filing date of 23 April 2019. Hong et al is considered prior art under 35 USC 102(a)(1), with a publication date – 05 September 2017 – that is greater than one year before the effective filing date of the instant invention – 22 July 2020.
Regarding claims 1-6 and 12: Rowat et al disclose a cultured meat or food product with more desirable flavor and texture, as well as methods and compositions for producing the same (Abstract).
As such, Rowat et al disclose that the methods for producing the cultured meat involve the growing of myocytes and adipocytes on different nanofiber scaffolds, wherein the nanofiber scaffolds are comprised of either chitosan, fibrinogen, elastin, collagen, gelatin, alginate, or cellulose (Paragraphs [0011]-[0013], [0061], [0064], [0069], [0091]). Rowat et al further disclose that sheets of aligned nanofiber scaffolds can be used to stack layers of muscle cells (Paragraphs [0022], [0086]).
Rowat et al do not disclose that the cells are coated by the nanofiber scaffold to form a nanofilm, as required by instant claim 1.
Hong et al, however, disclose coating stem cells with two or more polymeric layers by repeatedly stacking a positive charge polymer solution and a negative charge polymer solution on the surface of the stem cells to allow for the polymers to bond via electrostatic attraction, wherein the positive charge polymer solution is comprised of collagen and the negative charge polymer solution is comprised of alginic acid – or alginate (Paragraphs [0037]-[0043], [0066], [0072]-[0073], [0080], [0107]; Figure 4)
Hong et al further disclose that stem cells can be differentiated into adipocytes or muscle cells (Paragraph [0004]).
Therefore, it would have been prima facie obvious to have modified the method of Rowat et al such that the adipocytes and myocytes are coated with a layered polymeric nanofilm, as detailed in Hong et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to coat the cells in the nanofilm, as the polymeric layers promote cell proliferation while providing support via an artificial extracellular matrix scaffold (Hong et al: Paragraph [0136]). In addition, the ordinary artisan would have had a reasonable expectation of success since the disclosures of both Rowat et al and Hong et al are concerned with contacting cell sheets with polymeric layers, so the method of Rowat et al would thereby require minimal adaptation to incorporate the nanofilm of Hong et al. See MPEP § 2143(I)(G).
Consequently, Rowat et al as modified by Hong et al render obvious a method of producing cultured meat, wherein cell sheets of adipocytes (claim 2) and myocytes are coated in a nanofilm comprised of repeated layers (claim 4) of collagen (claim 5) – a positively charged polymer – and alginate (claim 6) – a negatively charged polymer – and are then stacked to form the cultured meat. As the collagen and alginate bond via electrostatic attraction (claim 3), this therefore renders obvious the method of instant claim 1 and generated cultured meat of instant claim 12.
Regarding claim 7: Following the discussion of claim 1, Hong et al further disclose that the thickness of the nanofilm is between 50 nm to 80 nm, or 100 nm (Paragraphs [0058], [0103], [0122]). This therefore renders obvious the method of the instant claim for the same reasons as discussed in the rejection of instant claim 1. See MPEP § 2131.03.
Claims 1-8, 12-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Rowat et al (WO 2020/219755 A1, of record) in view of Hong et al (KR 2017/0100693 A, as translated by Global Dossier, of record), and further in view of Sahraee et al (Food Bioscience, 2019, of record).
The discussion of Rowat et al in view of Hong et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Rowat et al as modified by Hong et al render obvious claims 1-7 and 12. Sahraee et al is considered prior art under 35 USC 102(a)(1).
Regarding claims 8 and 16: As aforementioned in the discussion of claim 1, Rowat et al as modified by Hong et al render obvious a method of producing cultured meat, wherein cell sheets of adipocytes and myocytes are stacked to form the cultured meat.
The combination of Rowat et al and Hong et al fail to teach the addition of a protective layer to the surface of the cultured meat, as required by instant claim 8.
Sahraee et al, however, disclose edible coatings and films that prevent the oxidative deterioration of food (Abstract). As such, Sahraee et al disclose that chitosan or starch films with citric acid allow for the protective storage of meat (Page 3, Column 1; Pages 5-6). It is of note that a starch is inherently a polysaccharide, or sugar compound (Page 3, Column 1; Table 1).
Therefore, it would have been prima facie obvious to modify the combined method of Rowat et al and Hong et al such that the cultured meat is coated in a film comprising starch and citric acid to protect the meat from oxidative degradation, as detailed in Sahraee et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to preserve the coloring and integrity of the meat via the antioxidant and antibacterial effects of the film (Sahraee et al: Pages 5-6), and would have had a reasonable expectation of success since the disclosure of Rowat et al allows for the incorporation of starch into the cultured meat product (Paragraph [0078]). See MPEP § 2143(I)(G).
Consequently, Rowat et al as modified by Hong et al and Sahraee et al render obvious a method of producing cultured meat, wherein the cultured meat product is coated in a protective film comprising starch and citric acid (claim 8). As a starch is inherently a sugar compound (claim 16), this therefore renders obvious the method of the instant claims.
Regarding claims 13-14: As aforementioned in the discussion of claim 8, Rowat et al as modified by Hong et al and Sahraee et al render obvious a method of producing cultured meat, the method comprising culturing sheets of adipocytes and myocytes nanofiber scaffolds – or substrates, coating the cell sheets in a porous nanofilm comprised of repeated layers of collagen – a positively charged polymer – and alginate – a negatively charged polymer (claim 14), stacking the coated cell sheets to form the cultured meat, and then layering a protective starch and citric acid barrier over the cultured meat to combat oxidative degradation. As the taught method lends itself to a culture platform comprising all of these components, this therefore renders obvious the cell culture platform of instant claim 13 for the same reasons as discussed in the rejection of instant claims 1 and 8.
Claims 1-8 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Rowat et al (WO 2020/219755 A1, of record) in view of Hong et al (KR 2017/0100693 A, as translated by Global Dossier, of record) and Sahraee et al (Food Bioscience, 2019, of record), and further in view of Schmatz et al (Food and Packaging Shelf Life, 2019, of record).
The discussion of Rowat et al in view of Hong et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. In addition, the discussion of Rowat et al in view of Hong et al and Sahraee et al regarding claim 13 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Rowat et al as modified by Hong et al render obvious claims 1-7 and 12. Rowat et al as modified by Hong et al and Sahraee et al render obvious claims 1-8, 12-14, and 16. Schmatz et al is considered prior art under 35 USC 102(a)(1).
Regarding claim 15: As aforementioned in the discussion of claim 13, Rowat et al as modified by Hong et al and Sahraee et al render obvious a cell culture platform comprising a nanofiber substrate, a porous nanofilm comprised of stacked collagen and alginate, and a protective layer comprising starch and citric acid.
The combination of Rowat et al, Hong et al, and Sahraee et al fail to teach the inclusion of C-phycocyanin within the porous nanofilm, as required by claim 15.
Schmatz et al, however, disclose that C-phycocyanin is incorporated into biodegradable and non-toxic nanofiber structures, with the resulting structure having antioxidant activity (Pages 2, 5, 7).
Therefore, it would have been prima facie obvious to modify the combined cell culture platform of Rowat et al, Hong et al, and Sahraee et al such that C-phycocyanin is incorporated into the nanofilm, as detailed in Schmatz et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to add C-phycocyanin to the nanofilm, as it prevents the deterioration of the coated cells (Schmatz et al: Page 7), and would have had a reasonable expectation of success since the nanofibers within the coating of Hong et al and of Schmatz et al are both biodegradable, as is evidenced by Rowat et al (Paragraphs [0011], [0061]). See MPEP § 2143(I)(G).
Consequently, Rowat et al as modified by Hong et al, Sahraee et al, and Schmatz et al render obvious a cell culture platform for producing cultured meat, wherein C-phycocyanin is incorporated into the porous nanofilm. This therefore renders obvious the cell culture platform of the instant claim.
Claims 1-8, 12-14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Rowat et al (WO 2020/219755 A1, of record) in view of Hong et al (KR 2017/0100693 A, as translated by Global Dossier, of record) and Sahraee et al (Food Bioscience, 2019, of record), and further in view of Nešić et al (Molecules, 2019).
The discussion of Rowat et al in view of Hong et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. In addition, the discussion of Rowat et al in view of Hong et al and Sahraee et al regarding claims 8 and 16 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Rowat et al as modified by Hong et al render obvious claims 1-7 and 12. Rowat et al as modified by Hong et al and Sahraee et al render obvious claims 1-8, 12-14, and 16. Nešić et al is considered prior art under 35 USC 102(a)(1).
Regarding claim 17: As aforementioned in the discussion of claim 16, Rowat et al as modified by Hong et al and Sahraee et al render obvious a cell culture platform comprising a nanofiber substrate, a porous nanofilm comprised of stacked collagen and alginate, and a protective layer comprising starch and citric acid.
The combination of Rowat et al, Hong et al, and Sahraee et al fail to teach that the protective layer comprises agarose, as required by claim 17.
Nešić et al, however, disclose the use of polysaccharides – including starch and agarose – as protective films in the packaging of meats (Pages 12-13, 20).
Therefore, it would have been prima facie obvious to substitute the starch protective layer of the combined cell culture platform of Rowat et al, Hong et al, and Sahraee et al with the agarose protective layer of Nešić et al, as doing so would have been a simple substitution of one polysaccharide protective layer 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 two protective layers are functionally comparable, as both serve as an antimicrobial film for meats (Nešić et al: Pages 13, 20), and thereby would have been able to substitute the two polysaccharide protective layers with predictable results.
Consequently, Rowat et al as modified by Hong et al, Sahraee et al, and Nešić et al render obvious a cell culture platform for producing cultured meat, wherein the cultured meat product is coated in a protective film comprising agarose. This therefore renders obvious the cell culture platform of the instant claim.
Claims 1-7 and 9-12 remain rejected under 35 U.S.C. 103 as being unpatentable over Rowat et al (WO 2020/219755 A1, of record) in view of Hong et al (KR 2017/0100693 A, as translated by Global Dossier, of record), and further in view of Forgacs et al (US 2013/0029008 A1, of record).
The discussion of Rowat et al in view of Hong et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Rowat et al as modified by Hong et al render obvious claims 1-7 and 12. Forgacs et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claim 9: As aforementioned in the discussion of claim 1, Rowat et al as modified by Hong et al render obvious a method of producing cultured meat, wherein cell sheets of adipocytes and
myocytes are coated in a nanofilm and stacked to form the cultured meat.
The combination of Rowat et al and Hong et al fail to teach the stimulation of the coated cells, as required by instant claim 9.
Forgacs et al, however, disclose the generation of engineered meat, wherein myocytes comprised within the engineered layers of the meat are subject to electric stimulation to facilitate the formation of physiological arrangement of muscle cells (Abstract; Paragraphs [0018], [0071]).
Therefore, it would have been prima facie obvious to have modified the combined method of Rowat et al and Hong et al such that the coated cells are subject to electrical stimulation, as taught by Forgacs et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to exercise the myocytes to allow for the generation of more physiologically-relevant cultured meat (Forgacs et al: Paragraphs [0018], [0071]), and would have had a reasonable expectation of success since the disclosures of Rowat et al and Forgacs et al are both concerned with the culturing of myocytes for the generation of cultured meat. See MPEP § 2143(I)(G).
Consequently, Rowat et al as modified by Hong et al and Forgacs et al render obvious a method of generating cultured meat, wherein the coated cells are stimulated with an electric current. This therefore renders obvious the method of the instant claim.
Regarding claim 10: As aforementioned in the discussion of claim 1, Rowat et al as modified by Hong et al render obvious a method of producing cultured meat, wherein cell sheets of adipocytes and
myocytes are coated in a nanofilm and stacked to form the cultured meat.
The combination of Rowat et al and Hong et al fail to teach the contacting of the coated cells with a growth factor, as required by instant claim 10.
Forgacs et al, however, disclose the generation of engineered meat, wherein the engineered meat further comprises growth factors (Abstract; Paragraphs [0059], [0073], [0103]).
Therefore, it would have been prima facie obvious to have modified the combined method of Rowat et al and Hong et al such that the coated cells are contacted with cell growth factors, as taught by Forgacs et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to enhance the proliferation and adhesion of the cells (Forgacs et al: Paragraph [0103]), and would have had a reasonable expectation of success since the disclosures of Rowat et al and Forgacs et al (Paragraphs [0076]-[0077]) are both concerned with the culturing of myocytes for the generation of cultured meat. See MPEP § 2143(I)(G).
Consequently, Rowat et al as modified by Hong et al and Forgacs et al render obvious a method of generating cultured meat, wherein the coated cells are contacted with growth factors. This therefore renders obvious the method of the instant claim.
Regarding claim 11: Following the discussion of claim 1, Rowat et al further disclose that cultured meat further comprises at least one source of fat (Paragraphs [0078]-[0081]).
The combination of Rowat et al and Hong et al fail to teach that the addition of a colorant to the cultured meat, as required by instant claim 11.
Forgacs et al, however, disclose the generation of engineered meat, wherein the engineered meat further comprises one or more colorants and fat (Abstract; Paragraphs [0011], [0072]).
Therefore, it would have been prima facie obvious to have modified the combined method of Rowat et al and Hong et al such that the a colorant and source of fat is added to the cultured meat, as taught by Forgacs et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to enhance the commercial appeal of the engineered meat (Forgacs et al: Paragraph [0072]), and would have had a reasonable expectation of success since the disclosures of Rowat et al and Forgacs et al (Paragraphs [0076]-[0077]) are both concerned with the culturing of myocytes for the generation of cultured meat. See MPEP § 2143(I)(G).
Consequently, Rowat et al as modified by Hong et al and Forgacs et al render obvious a method of generating cultured meat, wherein a source of fat and colorant are added to the cultured meat. This therefore renders obvious 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 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 10-12 of copending Application No. 18/006,447 in view of Rowat et al (WO 2020/219755 A1, of record), Sahraee et al (Food Bioscience, 2019, of record), Schmatz et al (Food and Packaging Shelf Life, 2019, of record), and Nešić et al (Molecules, 2019).
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 1 is directed to a method for forming a nanofilm layer, the method comprising the steps of:
coating surfaces of cells;
forming crosslinking in the nanofilm layer;
culturing the coated cells; and
performing differentiation of the cultured cells,
wherein allowing muscle tissue to be is formed from the differentiated cells and the nanofilm layer comprises a cell growth factor.
Copending claim 1 fails to teach that the coated cells are cell sheets, which are then stacked to form a multilayer cell sheet.
Rowat et al, however, disclose methods for producing the cultured meat that involve the growing of myocytes and adipocytes on different nanofiber scaffolds, wherein the nanofiber scaffolds are comprised of either chitosan, fibrinogen, elastin, collagen, gelatin, alginate, or cellulose (Paragraphs [0011]-[0013], [0061], [0064], [0069], [0091]). Rowat et al further disclose that sheets of aligned nanofiber scaffolds can be used to stack layers of muscle cells (Paragraphs [0022], [0086]).
Therefore, it would have been prima facie obvious to have modified the method of copending claim 1 such that the coated cells are arranged in cell sheets and stacked to form multilayered cell sheets, which ultimately allow for the generation of cultured meat, as detailed in Rowat et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to stack the coated cell sheets, as it allows for the three-dimensional formation of cultured meat, and would have had a reasonable expectation of success based on the disclosure of Rowat et al. See MPEP § 2143(I)(G).
Consequently, copending claim 1 as modified by Rowat et al render obvious instant claims 1 and 10.
With that, instant claims 2-9 and 11-15 are known from the copending claims or prior art and can be further incorporated into the method rendered obvious by copending claim 1 as modified by Rowat et al:
Copending claims 2-4, 6-8, and 10-12 teach the limitations recited in instant claims 2-7, 9, and 11-12.
Sahraee et al, Schmatz et al, and Nešić et al further teach or render obvious the limitations recited in instant claims 8 and 13-17.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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