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 .
The claim sets filed January 25, 2024 and May 1, 2024 are acknowledged. Claims 1-4, 9, 10, 12-15, and 21-22 are pending in the application. Claims 5-8, 11, and 16-20 have been cancelled. Claims 12-15 are withdrawn from consideration (see below).
Election/Restrictions
Applicant’s election of Group I, claims 1-4, 9, 10, and 21-22 in the reply filed on March 31, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 2-4 and 9-10 are objected to because of the following informalities:
In claim 2 at line 1, it is suggest to correct the uppercase C in “Claim” to the lowercase form “claim” after of and before 1.
In claim 3 at line 1, it is suggest to correct the uppercase C in “Claim” to the lowercase form “claim” after “of” and before “1”.
In claim 3 at line 9, it is recommended to amend the uppercase V in “Vitamin” to the lowercase form “vitamin” before “B12”
In claim 4 at line 1, it is suggest to correct the uppercase C in “Claim” to the lowercase form “claim” after “of” and before “1”.
In claim 4 at line 3, it is recommended to insert a hyphen “-“ between “milli” and “Anson”.
In claim 4 at the end of line 3, it is recommended to correct the uppercase U in “Unit” to the lowercase form “unit” after “Anson”.
In claim 4 at line 4, it is suggested to insert “a” after “having” and before “particle”.
In claim 9 at line 1, it is suggest to correct the uppercase C in “Claim” to the lowercase form “claim” after “of” and before “1”.
In claim 10 at line 1, it is suggest to correct the uppercase C in “Claim” to the lowercase form “claim” after “of” and before “1”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 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.
Claim 9 recites “the food or beverage” at lines 5-7, and this claim depends upon claim 1. However, this recitation lacks antecedent basis as there is no prior recitation of a beverage in claims 1 or 9. Therefore, the scope of claim 9 is indefinite.
For the purpose of the examination, the recitation of “the food or beverage” at lines 5-7 of claim 9 (emphasis added) is interpreted as “the food”
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 4, 9, 10, 21, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dai-Nippon GB 1432039 (hereinafter “Dai-Nippon”).
With respect to claim 1 and the recitation of a food comprising a food component comprising cells of at least one bacterium, said cells comprising a crude protein concentration of at least 60wt% of a total dry weight of said cells and a nucleic acid concentration of less than about 5wt% of a total dry weight of said cells, wherein at least 50% of a total number of said cells are dead cells, wherein the food is selected from the group consisting of a baked item, an item of confectionery and an energy bar, Dai-Nippon teaches foodstuff, such as bakery and saccharide or sugar alcohol containing products, comprising a food component which contains microorganism cells such as bacterial cells. The living cells are treated by chemical autolysis and mechanical treatment to rupture the cells, and these treatments are understood in the art to result in the death of the cells. The cells are also purified to removed nucleic acids. In the examples, the treated cells comprises 62.7% crude proteins, 0.6% nucleic acid, and 96% rupture ratio (example 1) and 62.3% crude protein, 1.2% nucleic acids, and 93% rupture ratio (example 2) (P1, L10-19 and 71-79; P2, L4-22 and 47-49; P3, L12-21 and 110-115; P5, L45-56 and 71-86; and P6, L33-43, 51-56, and 80-97).
With respect to claim 2, Dai-Nippon is relied upon for the teaching of the food of claim 1.
Regarding the recitation of wherein said at least one bacterium is an anaerobic bacterium in claim 2., Dai-Nippon teaches bacteria such as Corynebacterium, Lactobacillus bulgaricus, and Bacillus subtilis may be used (P2, L4-18 and 23-30).
With respect to claim 4, Dai-Nippon is relied upon for the teaching of the food of claim 1.
Regarding the recitation of wherein said food component is characterized by at least one selected from the group consisting of the listed components in claim 4, Dai-Nippon teaches the bacteria is naturally occurring, and the lipids have been removed from the cellular component. The pH of the component is 9 in the example. Additionally, the reference is silent with respect to the presence of casein (P2, L4-22; P3, L12-21; P5, L58-59; P6, L33-44, 51-56, and 80-97).
With respect to claim 9, Dai-Nippon is relied upon for the teaching of the food of claim 1.
Regarding the recitation of further comprising at least one selected from the group consisting of the listed components in claim 9, Dai-Nippon teaches the foodstuff comprises flavoring and amino acids (P5, L62-70).
With respect to claim 10, Dai-Nippon is relied upon for the teaching of the food of claim 1.
Regarding the recitation of characterized by at least one selected from the group consisting of the listed components in claim 10, Dai-Nippon teaches the food comprises dispersed particles of the bacteria (P1, L71-79; P2, L4-22; P5, L42-56 and 71-86).
With respect to claim 21, Dai-Nippon is relied upon for the teaching of the food of claim 1.
Regarding the recitation of wherein said baked item is selected from the group consisting of a cake, a cupcake, a muffin, a biscuit, a bread, a bread roll, and a pitta bread in claim 21, Dai-Nippon teaches the bakery products such as cakes, bread, or biscuits (P5, L73-74).
With respect to claim 22, Dai-Nippon is relied upon for the teaching of the food of claim 1.
Regarding the recitation of wherein said item of confectionery is selected from the group consisting of a sweet, a toffee and a chocolate in claim 22, Dai-Nippon teaches saccharide or sugar alcohol containing products (a sweet) (P5, L45-56 &75-86).
Claim Rejections - 35 USC § 102/103
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.
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 3 and 4 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Dai-Nippon GB 1432039 (hereinafter “Dai-Nippon”) as applied to claim 1 above.
With respect to claim 3, Dai-Nippon is relied upon for the teaching of the food of claim 1.
Regarding the recitation of said cells comprising at least one selected from the group consisting of the listed components in claim 3, it is noted that the claim language relates to characteristics of the cells of the food component in the claimed food. Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102." In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims.
The cells would naturally display the claimed characteristics since Dai-Nippon teaches cells that are identical to the claimed cells as addressed above in claim 1, and Dai-Nippon teaches the cells provide proteins, other intracellular substances, and cell contents which is interpreted to include amino acids, minerals, vitamins, cell wall/cell membrane (peptidoglycan), and other substances (P1, L18-19 & 80-82;P1, L98-P2, L2). As set forth in MPEP §2112.01, "where...the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 59 CCPA 1036, 459 F.2d 531,173 USPQ 685 (1972)." In re Best, Bolton and Shaw 195 USPQ 430 (CCPA 1977).
Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include at least one of the claimed components in the cells with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Dai-Nippon teaches the cells may be supplemented if desired with amino acids, such as methionine (essential animo acid), and other nutrients (P5, L62-65 and 75-76), the quantities of the amino acids and nutrients added is a matter of choice and does not provide a patentable feature over the prior art, and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II).
With respect to claim 4, Dai-Nippon is relied upon for the teaching of the food of claim 1.
Regarding the claim language of wherein said food component is characterized by having protease activity of about 1 milli-Anson unit in claim 4, it is noted that the claim language relates to a characteristic of the food component in the claimed food. Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102." In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims.
Absent any clear and convincing evidence to the contrary, the food component would naturally display the claimed protease activity since Dai-Nippon teaches a food component that is identical to the claimed food component as addressed above in claim 1, and Dai-Nippon teaches the enzymatic lysis of the cells of the microorganisms which contain protein is extremely low (P1, L38-40). As set forth in MPEP §2112.01, "where...the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 59 CCPA 1036, 459 F.2d 531,173 USPQ 685 (1972)." In re Best, Bolton and Shaw 195 USPQ 430 (CCPA 1977).
Claim Rejections - 35 USC § 103
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Dai-Nippon GB 1432039 (hereinafter “Dai-Nippon”) as applied to claim 1 above.
With respect to claim 4, Dai-Nippon is relied upon for the teaching of the food of claim 1.
Regarding the claim language of wherein said food component is characterized by being in the form of a powder having a particle size of from about 1 to about 150 microns in claim 4, Dai-Nippon teaches the food component is in the form of a powder (P5, L75-80). While Dai-Nippon does not expressly disclose the particle size of the powder, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the particle size of the powder through routine optimization with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Dai-Nippon teaches grinding the granules to a powder and incorporating the powder in foodstuffs (P5, L75-80), the particle size of the powder does not provide a patentable feature over the prior art, and such a modification would have involved a mere change in the size (or dimension) of a component. There would have been a reasonable expectation of success. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).
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 1-4, 9-10, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,918,019. Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of U.S. Patent No 11,918,019 (claims 1 and 5) and the instant application (claim 1) relate to food comprising a food component comprising cells of at least one bacterium, and the cells in the claims of U.S. Patent No 11,918,019 and the instant application comprise identical concentrations of crude protein, nucleic acid, and dead cells. Although U.S. Patent No 11,918,019 does not expressly disclose the food is a baked item, an item of confectionery, or an energy bar, it would have been obvious to one of ordinary skill in the art, given the teachings of U.S. Patent No 11,918,019, to arrive at a baked item, an item of confectionery, or an energy bar as the food since claim 5 of U.S. Patent No 11,918,019 is not limited to the particular food and encompasses all foodstuffs and U.S. Patent No 11,918,019 teaches the food is a baked item, an item of confectionery, or an energy bar (C11, L61-C12, L2). Additionally, claims 2-4 and 6-7 of U.S. Patent No 11,918,019 are identical to claims 2-4 and 9-10 of the instant application.
Claims 1, 9-10, and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 11, 14, 16, and 18 of copending Application No. 18/651,720 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of Reference Application No. 18/651,720 and claim 1 of the instant application relate to food comprising comprising cells of at least one bacterium, and the cells in claim 1 of Reference Application No. 18/651,720 and claim 1 of the instant application comprise identical concentrations of crude protein, nucleic acid, and dead cells. Although claim 1 of Reference Application No. 18/651,720 does not expressly disclose the food is a baked item, an item of confectionery, or an energy bar, it would have been obvious to one of ordinary skill in the art, given the teachings of Reference Application No. 18/651,720, to arrive at a baked item, an item of confectionery, or an energy bar as the food since claim 1 of Reference Application No. 18/651,720 is not limited to the particular food and encompasses all foodstuffs and Reference Application No. 18/651,720 teaches foods such as a breakfast cereal, cracker, pancake, or pretzel in claim 2 (baked item) as well as icing such as chocolate ganache or candy in claims 2, 11, and 14 (an item of confectionery). With respect to claims 9-10 of the instant application, the claims of Reference Application No. 18/651,720 teach the food comprises flavorant (claim 18), fruit (claims 2 and 16), whey protein, soy protein, or pea protein (plant protein, claim 18), oil (claim 18), or whipped cream (foam, claim 4).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYNESHA L. MCCLAIN whose telephone number is (571)270-1153. The examiner can normally be reached Monday-Friday 10 AM - 6:30 PM ET.
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, Emily Le can be reached at 571-272-0903. 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.
/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
Prosecution Insights