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 27 August 2026 has been entered. Claims 1, 3-15, 18-19, and 21-27 are pending. Claims 1, 3-15, 18-19 have been amended, while claims 2, 16-17, and 20 have been cancelled without prejudice or disclaimer and claims 21-27 have been newly added. Therefore, prosecution on the merits continues for claims 1, 3-15, 18-19, and 21-27. 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: Objection to claims 1, 6, and 11-12
Applicant’s amendments to each of instant claims 1, 6, and 12 correct the minor informalities of record. However, Applicant’s amendments to instant claim 11 only address the informality regarding the comma and fail to address the informality regarding “Ca+2”.
Therefore, the objections are withdrawn for claims 1, 6, and 12 and maintained for claim 11.
RE: Rejection of claims 3, 12-13, 15, and 19 under 35 USC 112(b)
Applicant’s amendments to each of instant claims 3, 12-13, 15, and 19 obviate the rejections of record.
Therefore, the rejections are withdrawn.
RE: Rejection of claims 1-4 and 18
Applicant’s amendments to independent claim 1 requiring the limitation previously presented in now cancelled claim 20 obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-2, 4-14, and 18 under 35 USC 102 over Garcia et al
The cancellation of instant claim 2 renders the rejection of record moot for that claim. For the remaining claims, Applicant’s amendments to independent claim 1 requiring the limitation previously presented in now cancelled claim 20 obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-4, 12-13, and 15-18 under 35 USC 102 over Glusac et al
The cancellation of instant claims 2 and 16-17 renders the rejection of record moot for those claims. For the remaining claims, Applicant’s amendments to independent claim 1 requiring the limitation previously presented in now cancelled claim 20 obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-2, 4, 12-13, and 15-20 under 35 USC 102 over Marga et al
The cancellation of instant claims 2, 16-17, and 20 renders the rejection of record moot for those claims. For the remaining claims, Applicant’s amendments to independent claim 1 requiring the plant protein to be a legume plant protein extract obviate the rejection of record regarding the composite.
However, Applicant has not substantially amended the method of independent claim 19.
Therefore, the rejection is maintained for claim 19 and withdrawn for all other claims.
RE: Provisional rejection of claims 1-18 and 20 on the grounds of nonstatutory double patenting over claims 1 and 5 of copending Application No. 17/602866 in view of Garcia et al, Glusac et al, and Marga et al
Applicant’s amendments to independent claim 1 requiring the composite to comprise cells of an edible animal origin adhered to a surface of a plurality of edible microparticles, wherein at least a portion of said edible microparticles comprises a legume plant protein extract obviate the provisional rejection of record.
Therefore, the provisional rejection is withdrawn.
New/Maintained Grounds of Rejection
Claim Objections
Claims 11 and 22-24 are objected to because of the following informalities:
Regarding claim 11: The instant claim is objected to for reciting “Ca+2” instead of “Ca2+” in reference to calcium in Line 4.
Appropriate correction is required.
Regarding claim 22: The instant claim is objected to for reciting “electopraying” instead of “electrospraying” in Line 2.
Appropriate correction is required.
Regarding claim 23: The instant claim is objected to for failing to recite a comma between “claim 22” and “wherein”.
The instant claim is also objected to for reciting “water-miscible” in Line 2 whereas parent claim 22 recites it as “water miscible”. A consistent recitation of the term needs to be selected.
Appropriate correction is required.
Regarding claim 24: The instant claim is objected to for reciting a miscellaneous semicolon between Lines 2 and 4.
Appropriate correction is required.
Claim Interpretation
Under the broadest reasonable interpretation of each claim, all of the “optional” limitations are
not required. This includes the “optional” limitations recited in instant claims 11, 19, and 26.
Instant claims 12-13 and 27 are directed to a product, which utilizes product-by-process language. The limitations of the process of production are considered only in so far as the process of production imparts distinct structural or chemical characteristics or properties to the claimed product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e. is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP § 2113.
Claims 9, 12-13, and 27 define the legume plant protein extract as being crosslinked by using an organic acid or an enzyme. In the instant case, the method of crosslinking does not impart a structural distinction to the legume plant protein extract, other than requiring the legume plant protein extract to be crosslinked. Therefore, the claims will be interpreted as if a legume plant protein extract crosslinked by any method or agent fulfills the limitations detailed in the instant claims.
The transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. See MPEP § 2111.03(III).
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.
Claim 19 remains rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Marga et al (WO 2015/038988 A1, of record on IDS filed 04 March 2024).
Marga et al disclose edible microspheres that are utilized to grow smooth muscle cells, wherein the smooth muscle cells are adhered to the edible microspheres in order to make engineered meat (Abstract; Paragraphs [00013]-[00015], [00017], [00020], [00041], [00049], [00052], [00068]).
As such, Marga et al disclose that the edible microspheres are comprised of edible plant-derived polysaccharides cross-linked with edible plant protein extract (Abstract; Paragraphs [00015]-[00019], [00037], [00041]-[00042]).
Marga et al further disclose methods of making the microspheres, wherein a composition comprising the edible plant-derived polysaccharides and edible plant protein extract is particulated, such that the microspheres support the proliferation of cultured cells (Abstract; Paragraphs [0004], [00010], [00012]-[00016], [00021]-[00026], [00045]-[00047]; Figure 1).
Accordingly, Marga et al anticipate the instant claim as follows:
Regarding claim 19: Marga et al disclose a method of making plant protein-derived microspheres, wherein a composition comprising edible plant-derived polysaccharides and edible plant protein extract is particulated, such that the microspheres support the proliferation of cultured cells. This therefore reads on the method of the instant claim.
Claims 1, 3, 12-13, 19, 21, 24, and 27 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Mullen et al (US 2020/0392461 A1).
Mullen et al disclose food products made in vitro from avian fibroblast cells and methods of their production (Abstract).
As such, Mullen et al disclose edible microcarriers comprised of chickpea protein isolate, wherein the edible microcarriers allow for the adherence, culture, and proliferation of avian fibroblast cells (Paragraphs [0012], [0073], [0100], [0117]-[0118]).
Mullen et al further disclose that the chickpea protein isolate is crosslinked with transglutaminase (Paragraphs [0040]-[0041], [0047], [0088], [0094], [0102]).
Accordingly, Mullen et al anticipate the claims as follows:
Regarding claims 1, 3, 19, 21, and 24: Mullen et al disclose edible microcarriers comprised of chickpea protein isolate (claims 3, 21), wherein the edible microcarriers allow for the adherence, culture, and proliferation of avian fibroblast cells. This therefore reads on the composite of instant claim 1 and methods of instant claims 19 and 24.
Regarding claims 12-13 and 27: The instant claims are product-by-process limitations further describing the method steps by which the plant protein is cross-linked. See Claim Interpretation above, the content of which is incorporated herein in its entirety.
Mullen et al disclose that the chickpea protein isolate is cross-linked with transglutaminase (claim 27). Accordingly, the recited crosslinking agent does not change the resulting cross-linked plant protein, per se. Therefore, instant claims 12-13 are rejected for the same reason as instant claim 27.
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, 3-4, 12-13, 15, 18-19, 21, 24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Mullen et al (US 2020/0392461 A1) in view of Glusac et al (Food Chemistry, 2020, of record on IDS filed 04 March 2024).
The discussion of Mullen et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety herein. Mullen et al anticipate instant claims 1, 3, 12-13, 19, 21, 24, and 27. Glusac et al is considered prior art under 35 USC 102(a)(1).
Regarding claims 4 and 15: Following the discussion of claim 1, Mullen et al further disclose that the chickpea protein isolate is crosslinked with transglutaminase (Paragraphs [0040]-[0041], [0047], [0088], [0094], [0102]).
Mullen et al do not disclose that the chickpea protein isolate microcarriers are essentially spherical, as required by instant claim 4.
Glusac et al, however, disclose essentially spherical microparticles consisting essentially of transglutaminase cross-linked chickpea protein extract (Abstract; Pages 2-5; Figures 2, 3). Glusac et al further disclose that the microparticles can assist in the creation of plant based foods (Page 8).
Therefore, it would have been prima facie obvious to have substituted the chickpea protein isolate microcarriers of Mullen et al with the chickpea protein extract microparticles of Glusac et al, as doing so would have been a simple substitution of one chickpea protein microparticle 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 chickpea protein microparticles are functionally comparable, as they are both crosslinked with transglutaminase and can be comprised within in vitro food products, and thereby would have been able to substitute the chickpea protein microparticles with predictable results.
Consequently, Mullen et al as modified by Glusac et al render obvious an in vitro food product that comprises essentially spherical (claim 4) microparticles consisting essentially of transglutaminase cross-linked chickpea protein isolate (claim 15). This therefore renders obvious the composite of the instant claims.
Regarding claim 18: Following the discussion of claim 1, Glusac et al further disclose that the microparticles have an average size of about 100 μm (Page 4; Figures 2, 3). This therefore renders obvious the composite of the instant claim for the same reasons as discussed in the rejection of claim 4. See MPEP § 2131.03.
Claims 1, 3-14, 18-19, 21, 24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Mullen et al (US 2020/0392461 A1) in view of Garcia et al (US 2023/0338298 A1, of record).
The discussion of Mullen et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety herein. Mullen et al anticipate instant claims 1, 3, 12-13, 19, 21, 24, and 27. Garcia et al is considered prior art under 35 USC 102(a)(2), with an effective filing date of 09 September 2020.
Regarding claims 5-7, 10-11, and 14: Following the discussion of claim 1, Mullen et al further disclose embodiments of the invention wherein the protein isolate is a lentil protein isolate (Paragraphs [0012], [0073], [0096]).
Mullen et al further disclose that the lentil protein isolate is crosslinked with transglutaminase (Paragraphs [0040]-[0041], [0047], [0088], [0094], [0102]).
Mullen et al do not disclose that the lentil protein isolate microcarriers comprise an oleogel core, as required by instant claim 5.
Garcia et al disclose plant-based microcapsules for the efficient encapsulation and retention of water-soluble ingredients, as well as the efficient co-encapsulation of water-soluble and water-insoluble ingredients (Abstract).
As such, Garcia et al disclose a microcapsule comprising a hydrophilic phase comprising a water-soluble ingredient, a lipophilic phase, and a plant-based protein hydrogel shell (Paragraphs [0005], [0026], [0028], [0033]-[0034], [0037]-[0049]). Garcia et al further disclose that the hydrophilic phase further comprises a rheology modifier, which is a cross-linked dextrin polymer (Paragraph [0046]). Garcia et al further disclose that the lipophilic phase comprises a vegetable oil and glycerol monostearate (Paragraphs [0047]-[0048], [0151]-[0155]). Garcia et al further disclose that the plant-based protein hydrogel shell is comprised of a concentrated legume protein – including lentil protein – and is cross-linked via transglutaminase (Paragraphs [0058], [0060], [0064], [0067], [0074]-[0075], [0096], [0098]).
Garcia et al further disclose that the microcapsules can be comprised within synthetic food products (Paragraphs [0023]-[0024], [0041], [0094], [0104], [0125], [0137], [0193]-[0195], [0249]).
Therefore, it would have been prima facie obvious to have substituted the lentil protein isolate microcarriers of Mullen et al with the concentrated lentil protein microcapsules of Garcia et al, as doing so would have been a simple substitution of one lentil protein microparticle 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 lentil protein microparticles are functionally comparable, as they are both crosslinked with transglutaminase and can be comprised within in vitro food products, and thereby would have been able to substitute the lentil protein microparticles with predictable results.
Consequently, Mullen et al as modified by Garcia et al render obvious an in vitro food product that comprises microcapsules comprising a cross-linked dextrin polymer (claims 10-11), a vegetable oil with glycerol monostearate (claims 5-7), and a cross-linked legume protein hydrogel shell (claim 14).
Regarding claims 4, 8, and 18: Following the discussion of claims 1 and 6, Garcia et al further disclose that the microcapsules are essentially spherical (claim 4) having an average size of 50-600 μm (claim 18), with the lentil protein shell having a thickness of 20 μm (claim 8) (Paragraphs [0128]-[0130], [0246]; Figures 2-3). This therefore renders obvious the composite of the instant claims for the same reasons as discussed in the rejection of claim 5. See MPEP § 2131.03.
Regarding claim 9: Following the discussion of claim 6, Garcia et al further disclose that the plant-based protein is cross-linked with transglutaminase (Paragraphs [0058], [0060], [0064], [0067], [0074]-[0075], [0096], [0098]). This therefore renders obvious the composite of the instant claims for the same reasons as discussed in the rejection of claim 6.
Claims 1, 3, 12-13, 19, 21-24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Mullen et al (US 2020/0392461 A1) in view of Reddy et al (Materials, 2021).
The discussion of Mullen et al regarding claims 19 and 21 can be observed above and is relied upon herein, the content of which is incorporated in its entirety herein. Mullen et al anticipate instant claims 1, 3, 12-13, 19, 21, 24, and 27. Reddy et al is considered prior art under 35 USC 102(a)(1), with a publication date of 28 June 2021.
Regarding claims 22-23: As aforementioned in the discussion of claim 21, Mullen et al disclose a method of making chickpea protein-derived microcarriers, wherein chickpea protein isolate is particulated, such that the microcarriers support the proliferation of cultured avian fibroblasts.
Mullen et al do not disclose that the chickpea protein-derived microcarriers are particulated via electrospraying, as required by instant claim 22.
Reddy et al, however, disclose methods of producing nanoparticles from plant proteins, including legume proteins (Abstract; Pages 2, 31). As such, Reddy et al disclose particulating the plant proteins via electrospraying, wherein the plant protein is comprised within an aqueous alcohol solution and electrosprayed into an alcohol solvent (Pages 3, 21-22, 33).
Reddy et al further disclose that the plant protein nanoparticles can be comprised within various food products to increase the stability, rheological properties, and shelf-life of the food product without adversely affecting its nutritional value, texture, or functionality (Pages 35).
Therefore, it would have been prima facie obvious to have modified the method of Mullen et al such that the chickpea protein isolate is particulated via electrospraying, as suggested in Reddy et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to utilize a known technique for particulating plant proteins, and would have had a reasonable expectation of success given that the disclosures of Mullen et al and Reddy et al are both concerned with the use of plant protein particles within food products. See MPEP § 2143(I)(G).
Consequently, Mullen et al as modified by Reddy et al render obvious a method of producing edible particles, wherein an aqueous alcohol solution (claim 23) comprising the chickpea protein isolate is particulated via electrospraying into an alcohol solvent. This therefore renders obvious the method of instant claim 22.
Claims 1, 3, 12-13, 19, 21, and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Mullen et al (US 2020/0392461 A1) in view of Savir et al (US 2020/0100525 A1).
The discussion of Mullen et al regarding claim 1 can be observed above and is relied upon herein, the content of which is incorporated in its entirety herein. Mullen et al anticipate instant claims 1, 3, 12-13, 19, 21, 24, and 27. Savir et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claims 25-26: As aforementioned in the discussion of claim 1, Mullen et al disclose in vitro food products comprising chickpea protein isolate microcarriers and avian fibroblast cells.
Mullen et al do not disclose that the chickpea protein-derived microcarriers comprise adhered cells that are terminally differentiated or stem cells, as required by instant claims 25-26.
Savir et al, however, disclose methods of producing hybrid foodstuff (Abstract). As such, Savir et al disclose synthetic chicken meat products comprising mesenchymal stem cells, erythrocytes, and fibroblasts (Paragraphs [0018]-[0019], [0031]-[0032], [0055], [0070], [0152]-[0154], [0160]-[0162], [0178], [0280]-[0281], [0322], [0376]).
Savir et al further disclose embodiments wherein the synthetic chicken meat products comprise chickpea protein (Paragraph [0376]).
Therefore, it would have been prima facie obvious to have modified the in vitro food product of Mullen et al such that it further comprises mesenchymal stem cells and erythrocytes, as detailed in Savir et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to include cells that confer an in vitro meat product with a grilled meat taste and color (Savir et al: Paragraph [0070]), and would have had a reasonable expectation of success given that the disclosures of Mullen et al and Savir et al are both concerned with the generation of an in vitro chicken product. See MPEP § 2143(I)(G).
Consequently, Mullen et al as modified by Savir et al render obvious an in vitro chicken product comprising mesenchymal stem cells (claim 26) and erythrocytes. As erythrocytes are terminally differentiated cells, this therefore renders obvious the composite of instant claim 25.
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).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
