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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 April 2026 has been entered.
Status of the Claims
Applicant’s submission filed 01 April 2026 have been entered. Claims 1-17 are pending. Claims 1, 8, 13, and 16 have been amended. Therefore, prosecution on the merits continues for claims 1-17. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 8 and 16-17 under 35 USC 112(b)
Applicant’s amendments to each of instant claims 8 and 16 clarify the claim scope, thus obviating the rejections of record.
Therefore, the rejections are withdrawn.
RE: Rejection of claims 1-7 and 12 under 35 USC 103 over Rowat et al in view of Hong et al
Applicant’s amendments to independent claim 1 requiring the multilayer cell sheet to be free of a nanofiber scaffold and free of an exogenous ECM substrate, such that the coated cell sheets are stacked in multiple layers without a support for cell growth, present new limitations that have not previously been considered. Thus, Applicant’s amendments obviate the rejection of record.
Therefore, the rejection is withdrawn.
However, Applicant’s remarks are addressed in so far as they are applicable to the new 35 USC 103 rejection over Marga et al in view of Hong et al:
Applicant has traversed the rejection, asserting in Pages 6-7 of the Remarks filed 01 April 2026 that Hong et al teach that the polymer layer based on the extracellular matrix protein can provide an artificial extracellular matrix to the cell, stabilize the cell, and promote cell proliferation. In response, the Examiner respectfully submits that, while Hong et al do teach that the polymer layers can be comprised of extracellular matrix associated proteins – including positively charged collagen and elastin, and negatively charged tannic acid and alginic acid – the layering of two polymers does not necessarily constitute an exogenous extracellular matrix substrate that serves as a scaffold to support cell growth. Instead, Hong et al disclose that the polymeric layers can be coated onto already proliferated cells, and that the polymer layer may be a flat, non-fibrous structure. See, for example, Paragraphs [0035], [0041], [0043]-[0047], [0060] of Hong et al. Therefore, the flat, polymeric nanofilm of Hong et al comprised of layered collagen and alginic acid is not necessarily an exogenous ECM substrate that supports the growth of the stacked cell sheets.
RE: Rejection of claims 1-8, 12-14, and 16 under 35 USC 103 over Rowat et al in view of Hong et al and Sahraee et al
Applicant’s amendments to independent claims 1 and 13 requiring the multilayer cell sheet to
be free of a nanofiber scaffold and free of an exogenous ECM substrate, such that the coated cell sheets are stacked in multiple layers without a support for cell growth, present new limitations that have not previously been considered. Thus, Applicant’s amendments obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-8 and 12-16 under 35 USC 103 over Rowat et al in view of Hong et al, Sahraee et al, and Schmatz et al
Applicant’s amendments to independent claims 1 and 13 requiring the multilayer cell sheet to be free of a nanofiber scaffold and free of an exogenous ECM substrate, such that the coated cell sheets are stacked in multiple layers without a support for cell growth, present new limitations that have not previously been considered. Thus, Applicant’s amendments obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-8, 12-14, and 16-17 under 35 USC 103 over Rowat et al in view of Hong et al, Sahraee et al, and Nešić et al
Applicant’s amendments to independent claims 1 and 13 requiring the multilayer cell sheet to be free of a nanofiber scaffold and free of an exogenous ECM substrate, such that the coated cell sheets are stacked in multiple layers without a support for cell growth, present new limitations that have not previously been considered. Thus, Applicant’s amendments obviate the rejection of record.
Therefore, the rejection is withdrawn.
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 amendments to independent claim 1 requiring the multilayer cell sheet to be free of
a nanofiber scaffold and free of an exogenous ECM substrate, such that the coated cell sheets are stacked in multiple layers without a support for cell growth, present new limitations that have not previously been considered. Thus, Applicant’s amendments obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Provisional rejection of claims 1-17 on the grounds of nonstatutory double patenting over claims 1-8 and 10-12 of copending Application 18/006447 in view of Rowat et al, Sahraee et al, Schmatz et al, and Nešić et al
Applicant’s amendments to independent claims 1 and 13 requiring the multilayer cell sheet to be free of a nanofiber scaffold and free of an exogenous ECM substrate, such that the coated cell sheets are stacked in multiple layers without a support for cell growth, present new limitations that have not previously been considered. Thus, Applicant’s amendments obviate the rejection of record.
Therefore, the rejection is withdrawn.
It is of note that Applicant has not traversed the rejection, asserting in Page 5 of the Remarks filed 01 April 2026 that no response is required since it is a provisional rejection.
New 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.
Claim 9 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 9: The instant claim recites the limitation "the culturing of the coated cells" in Line 1.There is insufficient antecedent basis for this limitation in the claim, as there is no prior recitation of culturing coated cells within the instant claim or parent claim 1. Instead, parent claim 1 only recites the culturing of cell usable for producing cultured meat. Therefore, the metes and bounds of the claim cannot be determined, rendering the scope of the claim indefinite. See MPEP § 2173.05(e).
Furthermore, the instant claim also recites the limitation "the coated cells" in Lines 1 and 2.There is insufficient antecedent basis for this limitation in the claim, as there is no prior recitation of “coated cells” within the instant claim or parent claim 1. Instead, parent claim 1 only recites the “coated cell sheets”. Therefore, the metes and bounds of the claim cannot be determined, rendering the scope of the claim indefinite. See MPEP § 2173.05(e).
Appropriate correction is required.
For purposes of compact prosecution, the instant claim will be interpreted as if the multilayer cell sheet is stimulated by an ultrasonic wave, an electric current, an electromagnetic field, a magnetic field, or a combination thereof.
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 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Marga et al (US 2015/0079238 A1) in view of Hong et al (KR 2017/0100693 A, as translated by Global Dossier, of record).
Marga et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2). 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: Marga et al disclose methods of forming and using edible microcarriers, wherein the edible microcarriers are comprised within engineered meat (Abstract).
As such, Marga et al disclose a method of producing engineered meat, wherein the method comprises culturing smooth muscle cells and adipocytes with the edible microcarriers such that an aggregated layer of the cultured cells and edible microcarriers is formed (Paragraphs [0020], [0050]-[0057], [0069], [0072]-[0077]). Marga et al further disclose that the formed cell-microcarrier aggregate layers can be planar and stacked on top of one another to form an engineered meat product (Paragraphs [0050], [0056]-[0057]).
Marga et al do not disclose that the planar cell-microcarrier aggregate layer is coated by a nanofilm prior to stacking, 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 elastin and the negative charge polymer solution is comprised of alginic acid – or alginate (Paragraphs [0037]-[0043], [0072]-[0073]).
Hong et al further disclose that stem cells can be differentiated into adipocytes or muscle cells (Paragraph [0004]).
Hong et al further disclose that the polymeric layers can be coated onto already proliferated cells, and that the polymeric layer may be a flat, non-fibrous structure (Paragraphs [0035], [0041], [0043]-[0047], [0060]).
Therefore, it would have been prima facie obvious to have modified the method of Marga et al such that the planar cell-microcarrier aggregate layers 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 cell-microcarrier aggregates in the nanofilm, as the flat, non-fibrous polymeric layers would provide a structure that aids in the stacking of the planar cell-microcarrier aggregate layers (Marga et al: Paragraphs [0055]-[0057]). In addition, the ordinary artisan would have had a reasonable expectation of success since the disclosures of both Marga et al and Hong et al are concerned with manipulation of cells in suspension and creation of planar cell sheets (Marga et al: Paragraph [0053]; Hong et al: Paragraphs [0044]-[0047] , so the method of Marga et al would thereby require minimal adaptation to incorporate the nanofilm of Hong et al. See MPEP § 2143(I)(G).
Consequently, Marga et al as modified by Hong et al render obvious a method of producing engineered meat, wherein planar aggregate sheets of edible microcarriers, smooth muscle cells, and adipocytes (claim 2) are coated in a nanofilm comprised of repeated layers (claim 4) of elastin (claim 5) – a positively charged polymer – and alginate (claim 6) – a negatively charged polymer – and are then stacked to form the engineered meat. As the elastin 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.
Regarding claim 11: Following the discussion of claim 1, Marga et al further disclose that the edible microcarriers comprise a fat and a colorant (Paragraphs [0019], [0027], [0053], [0062] , [0066]-[0067]). This therefore reads on the method of the instant claim.
Claims 1-8, 11-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Marga et al (US 2015/0079238 A1) 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 Marga 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. Marga et al as modified by Hong et al render obvious claims 1-7 and 11-12. 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, Marga et al as modified by Hong et al render obvious a method of producing engineered meat, wherein cell sheets of adipocytes, smooth muscle cells, and edible microcarriers are stacked to form the engineered meat.
The combination of Marga et al and Hong et al fail to teach the addition of a protective layer to the surface of the engineered 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 have modified the combined method of Marga et al and Hong et al such that the engineered 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 Marga et al allows for the incorporation of plant-derived polysaccharides into the engineered meat product (Paragraph [0015]). See MPEP § 2143(I)(G).
Consequently, Marga et al as modified by Hong et al and Sahraee et al render obvious a method of producing engineered meat, wherein the engineered 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, Marga et al as modified by Hong et al and Sahraee et al render obvious a method of producing engineered meat, the method comprising culturing aggregate sheets of adipocytes, smooth muscle cells, and edible microcarriers, coating the aggregate sheets in a porous nanofilm comprised of repeated layers of elastin – a positively charged polymer – and alginate – a negatively charged polymer (claim 14), stacking the coated aggregate sheets to form the engineered meat, and then layering a protective starch and citric acid barrier over the engineered meat to combat oxidative degradation. Marga et al further disclose that the aggregate sheets of adipocytes, smooth muscle cells, and edible microcarriers can be cultured on a substrate (Paragraphs [0055]-[0056], [0080]).
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 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Marga et al (US 2015/0079238 A1) 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 Marga 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 Marga 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. Marga et al as modified by Hong et al render obvious claims 1-7 and 11-12. Marga et al as modified by Hong et al and Sahraee et al render obvious claims 1-8, 11-14, 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, Marga et al as modified by Hong et al and Sahraee et al render obvious a cell culture platform comprising a substrate, a porous nanofilm comprised of stacked elastin and alginate, and a protective layer comprising starch and citric acid.
The combination of Marga 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 polymeric structures, with the resulting structure having antioxidant activity (Pages 2, 5, 7).
Therefore, it would have been prima facie obvious to have modified the combined cell culture platform of Marga 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. See MPEP § 2143(I)(G).
Consequently, Marga et al as modified by Hong et al, Sahraee et al, and Schmatz et al render obvious a cell culture platform for producing engineered 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, 11-14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Marga et al (US 2015/0079238 A1) 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 Marga 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 Marga 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. Marga et al as modified by Hong et al render obvious claims 1-7 and 11-12. Marga et al as modified by Hong et al and Sahraee et al render obvious claims 1-8, 11-14, 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, Marga et al as modified by Hong et al and Sahraee et al render obvious a cell culture platform comprising a substrate, a porous nanofilm comprised of stacked elastin and alginate, and a protective layer comprising starch and citric acid.
The combination of Marga 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 have substituted the starch protective layer of the combined cell culture platform of Marga 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, Marga et al as modified by Hong et al, Sahraee et al, and Nešić et al render obvious a cell culture platform for producing engineered meat, wherein the engineered 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 Marga et al (US 2015/0079238 A1) 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 Marga 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. Marga et al as modified by Hong et al render obvious claims 1-7 and 11-12. 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, Marga et al as modified by Hong et al render obvious a method of producing engineered meat, wherein cell sheets of adipocytes, smooth muscle cells, and edible microcarriers are coated in a nanofilm and stacked to form the engineered meat.
The combination of Marga et al and Hong et al fail to teach the stimulation of the nanofilm-coated aggregate cell sheets, as required by instant claim 9.
Forgacs et al, however, disclose the generation of engineered meat, wherein smooth myocytes – which are smooth muscle cells – 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 [0011], [0018], [0051], [0071]).
Therefore, it would have been prima facie obvious to have modified the combined method of Marga et al and Hong et al such that the nanofilm-coated aggregate cell sheets 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 smooth muscle cells 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 Marga et al and Forgacs et al are both concerned with the culturing of smooth muscle cells for the generation of engineered meat. See MPEP § 2143(I)(G).
Consequently, Marga et al as modified by Hong et al and Forgacs et al render obvious a method of generating engineered meat, wherein the nanofilm-coated aggregate cell sheets 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, Marga et al as modified by Hong et al render obvious a method of producing engineered meat, wherein cell sheets of adipocytes, smooth muscle cells, and edible microcarriers are coated in a nanofilm and stacked to form the engineered meat.
The combination of Marga et al and Hong et al fail to teach the contacting of the nanofilm-coated aggregate cell sheets 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 Marga et al and Hong et al such that the nanofilm-coated aggregate cell sheets 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 Marga et al and Forgacs et al (Paragraphs [0076]-[0077]) are both concerned with the culturing of smooth muscle cells for the generation of engineered meat. See MPEP § 2143(I)(G).
Consequently, Marga et al as modified by Hong et al and Forgacs et al render obvious a method of generating engineered meat, wherein the nanofilm-coated aggregate cell sheets are contacted with growth factors. 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 Marga et al (US 2015/0079238 A1), 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 muscle tissue, the method comprising the steps of:
coating surfaces of cells with alternate stacking a positively charged material and a negatively charged material;
forming a multilayer nanofilm by using one or two or more selected from the group consisting of electrostatic attraction, van der Waals force, hydrophobic bonding and hydrogen bonding, between the positively charged material and the negatively charged material;
forming a porous multilayer nanofilm by crosslinking through covalent bond with a crosslinking agent between the layers of nanofilm;
culturing the cells in the porous multilayer nanofilm; and
performing differentiation of the cultured cells,
wherein the muscle tissue is formed from the differentiated cells and the porous multilayer nanofilm 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.
Marga et al, however, disclose a method of producing engineered meat, wherein the method comprises culturing smooth muscle cells and adipocytes with edible microcarriers such that an aggregated layer of the cultured cells and edible microcarriers is formed (Paragraphs [0020], [0050]-[0057], [0069], [0072]-[0077]). Marga et al further disclose that the formed cell-microcarrier aggregate layers can be planar and stacked on top of one another to form an engineered meat product (Paragraphs [0050], [0056]-[0057]). It is of note that Marga et al do not disclose that the stacked cell-microcarrier aggregate layers comprise a nanofiber scaffold or exogenous ECM substrate.
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 Marga 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 Marga et al. See MPEP § 2143(I)(G).
Consequently, copending claim 1 as modified by Marga et al render obvious instant claims 1, 3-4, and 10.
With that, instant claims 2, 5-9, and 11-17 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 Marga et al:
Copending claims 2, 6-8, and 10-12 teach the limitations recited in instant claims 2, 5-7, 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
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.
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/ALYSSA G WESTON/Examiner, Art Unit 1633
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