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 . 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.
Election/Restrictions
Applicant elected group I (formulations) and a formulation comprising marine collagen peptides, l-glutamine, l-cystine, l-selenomethionine, and boron citrate with traverse in the reply filed on 23 April, 2026. The traversal was found unpersuasive, and the election/restriction requirement made final in the office action of 7 May, 2026.
Claims Status
Claims 1-20 are pending.
Claims 1-20 have been amended.
Claims 4-7 and 13-20 have been withdrawn due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claim(s) 1-3 and 8-12 under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al (J. Food Comp. Anal. (1994) 7(1-2) 59-82) with evidentiary support from Han et al (Biol. Trace Elem. Res. (2012) 148 p61-68), Zotte et al, (Poultry Sci. (2020) 99 p1797-1803), Sanden et al (Foods (2021) 10 548), and Deb-Choudhury et al (Agric. Food. Chem. (2014) 62 p8187-8196) is hereby withdrawn due to amendment.
The provisional rejection of claims 1-3 and 8-11 on the ground of nonstatutory double patenting as being unpatentable over claims 10, 12, 13, 15, and 16 of copending Application No. 18/370,931 is hereby withdrawn due to amendment.
The provisional rejection of claims 1, 3, and 10-12 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/839,218(US 20250228808) (reference application) in view of Furuzawa-Carballeda et al (WO 2022035306 (Feb, 2022) is hereby withdrawn due to amendment.
The provisional rejection of claims 1, 3, and 8-12 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/839,225 (US 20250152537) (reference application) in view of Jang et al (Mol. Med. Rep. (2016) 14 p5489-5494) is hereby withdrawn due to amendment.
The provisional rejection of claims 1-3 and 8-11 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-10 of copending Application No. 18/370,922 is hereby withdrawn due to amendment.
The provisional rejection of claims 1, 3, and 10-12 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of copending Application No. 18/002,880 (US 20230233498) (reference application) in view of Furuzawa-Carballeda et al (WO 2022035306 (Feb, 2022) is hereby withdrawn due to amendment.
The rejection of claims 1-3 and 8-12 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-10 of copending Application No. 18/370,941 (US 20240108696) is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 8-12 are rejected under 35 U.S.C. 101 because they read on a judicial exception, a natural phenomenon.
The Supreme Court has given a 2 part test for eligibility under this statute:
1) Does the claim read on a process, machine, manufacture, or composition of matter?
2a) If the first test is passed, does a judicial exception apply?
2b) If a judicial exception applies, is there something beyond the judicial exception?
Applying the test:
1) The claims are drawn to a formulation, which is a composition of matter.
2a) A chicken breast contains collagen (Sanden et al Foods (2021) 10 548, abstract); as a collagen, it is presumed to meet the amino acid limitations of the claims. Note that fragments of a naturally occurring sequence also read on this statute, so collagen peptides is not patent eligible over the protein they came from. Chicken breast comprises glutamine and cysteine (Zotte et al, Poultry Sci. (2020) 99 p1797-1803, table 3, p1800, 1st column, bottom of page). Tanticharoenkiat et al (J. Food Sci. (1988) 53(5) p1294-1295) show that chicken breast comprises selenium (abstract). And Anderson et al (J. Food Comp. Anal. (1994) 7(1-2) 59-82) shows that chicken breast comprises boron (table 2, starts on p64). Alternatively, selenocysteine is a naturally occurring amino acid (Stadtman, EcoSal Plus (2013), abstract). It should be noted that various hormones are naturally occurring drugs. Absent a showing of a significant difference, the form of the formulation (powder in this case) and the amounts of the material do not change the analysis
2b) There is no evidence of record that mixing the components of the invention gives any effects other than what is expected from the effects of the individual components, nor having a slightly larger amount of collagen compared to other ingredients, or powdering the formulation.. As the invention can be made entirely of naturally occurring elements, with no evidence of anything beyond the natural components, the claims lack patent eligibility.
response to applicant’s arguments
Applicant argues that the newly added limitations of a powder formulation and amounts of a collagen source are significantly different, so render the claims non-patent eligible.
Applicant's arguments filed 6 Aug, 2026 have been fully considered but they are not persuasive.
Applicant has provided no evidence that a powder formulation has significantly different properties than a non-powder formulation, nor that having a collagen source larger by weight than other ingredients will provide any benefit beyond that expected from mixing the ingredients.
Claim Rejections - 35 USC § 112(b)
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.
first rejection
Claims 1-3 and 8-12 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.
Claim 1, and claims dependent on it, requires various material “source.” Applicant has not defined this language. It is unclear if it means something that can be made into the material by a human, the material itself, or some other interpretation. Note that applicant has stated that a collagen source can be proteins other than collagen (p15, line 23-25), further confusing the issue.
response to applicant’s arguments
Applicant argues that a person of skill in the art would understand a source as a physiologically acceptable material that delivers the ingredient.
Applicant's arguments filed 6 Aug, 2026 have been fully considered but they are not persuasive.
Applicant proposes a definition of a source, but this is not consistent with the disclosure. As noted in the rejection, applicant has stated that proteins other than collagen can be a collagen source; this is not consistent with the proposed definition of something that provides an ingredient.
second rejection
Claim 3 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 3 allows for additional “active ingredients.” Applicant has not defined what an active ingredient is. Note that all materials will have an effect on a biological system if enough is given (the dose makes the poison). This makes it unclear what this term encompasses. Applicant did not appear to think boron citrate was an active ingredient (based on their election of species), yet boron has well known anti-oxidant activity (Khaliq et al, Biol. Trace Elem. Res. (Sept 2017), cited by applicant, abstract), and can reasonably be considered an active ingredient.
response to applicant’s arguments
Applicant states that the claim has been amended to overcome this rejection.
Applicant's arguments filed 6 Aug, 2026 have been fully considered but they are not persuasive.
Applicant has amended the claim to require an additional active ingredient. Unfortunately, this does not make clear what an active ingredient is.
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.
Claim(s) 1-3 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sinha-Hikim et al (J. Gerontol. A Med. Sci. (2013) 68(7) p749-759), in view of Kumar et al (LWT- Food Sci. Technol. (2019) 109 p450-456), and Brown et al (US 20180008573), with evidentiary support from the Codeage page for marine collagen peptides powder (downloaded April, 2026).
Sinha-Hikim et al discuss a cystine formulation as an anti-oxidant in the context of aged individuals (title). This formulation comprises L glutamine (39.9% by weight), L cystine (19.9% by weight), and selenomethionine (0.3%) (p750, 1st column, 1st paragraph). Middle aged mice were fed standard mouse feed fortified with this mixture at 0.3% by weight (p750, 1st column, 2nd paragraph). This fortification attenuated atrophy of the gastrocnemius muscles compared to untreated mice; the treated mice had muscles the size of young mice (p751, 2nd column, 1st paragraph), an effect found even at the microscopic level (p751, 2nd column, 2nd paragraph). This worked via suppression of oxidative stress, inhibition of apoptosis, and suppression of lipogenesis (p758, 1st column, 2nd paragraph).
The difference between this reference and the examined claims and applicant’s elected species is that the reference does not discuss a collagen source or a boron source.
Kumar et al discusses marine collagen peptides (title). These compounds are antioxidants, anti-arthritic, help alleviate age related memory loss, and help prevent age related bone loss (p450, 1st column, 2nd paragraph, continued to 2nd column, 1st paragraph). Note that, while the reference does not describe the form of the peptides, they replace flour in the recipe in an amount between 2.5 and 10% of the total formulation (p451, 1st column, 5th paragraph), which requires a powder formulation. This reference shows that marine collagen peptides have many effects that would be beneficial to an aging patient.
Brown et al discusses compositions to reduce oxidative damage (title). Examples of the embodiments of their invention were tested for anti-aging activity in C. elegans (paragraph 149). These include a mineral antioxidant, which could be boron citrate (paragraph 117), applicant’s elected species. Note that at least one example is given using that compound, at a concentration of 0.3% by weight (0.75/summation of all ingredients) (table 3A, p11). This reference renders obvious boron citrate as an ingredient in an anti-aging anti-oxidant mix.
Therefore, it would be obvious to add the marine collagen peptides of Kumar et al to the supplements of Sinha-Hikim et al, to provide antioxidant and anti-arthritic effects, help alleviate age related memory loss, and help prevent age related bone loss, as described by Kumar et al. As both these references discuss anti-aging formulations with anti-oxidant activity, an artisan in this field would attempt this modification with a reasonable expectation of success.
Furthermore, it would be obvious to add the boron citrate of Brown et al to the supplements, as an additional anti-oxidant with anti-aging effects. The MPEP states that “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . .the idea of combining them flows logically from their having been individually taught in the prior art" (MPEP 2144.06).
Sinha-Hikim et al and Kumar et al render obvious a formulation comprising marine collagen peptides, L-glutamine, cystine, and selenomethionine, which can be added to food. As evidenced by the Codeage sales page, marine collagen peptides have 1836 mg Gly per 9g total (1836/9000=20.4%), 594 mg hydroxyproline per 9g (594/9000=6.6%), and 1170 mg Pro per 9g (1171/9000=13%), meeting the amino acid limitations of claim 1 if we assume by mole percentages. Kumar et al strongly suggests a powder formulation. Note that the amount of collagen used by Kumar et al in the final formulation is much higher than any of the other ingredients in any of the final formulations. Thus, the combination of references renders obvious claims 1 and 8-12.
Brown et al render obvious adding boron citrate, an antioxidant (i.e. an active ingredient), rendering obvious claims 2 and 3.
response to applicant’s arguments
Applicants argue that the rejection misses the newly added limitation of the amount of a collagen source.
Applicant's arguments filed 6 Aug, 2026 have been fully considered but they are not persuasive.
The rejection has been modified to take this amendment into account.
New Rejections
Claim Rejections - 35 USC § 112(b)
The legal basis for rejections under this statue was given above, and will not be repeated here.
Claims 1-3 and 8-12 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.
Claim 1, and claims dependent on it, has been amended to require that the collagen source is present in larger amounts than any other single component. The issue is what is considered a component. For example, Stadtman (Annu. Rev. Biochemistry (1996) 65 p83-100) describes selenoprotein P, with 10 selenocysteine residues in a 42 kDa polypeptide. It is unclear if the component for the weight calculation is the 10 seleocysteine residues or the weight of the entire polypeptide. Or, another example, Gates (Science (1959) 130 (3367) p120) describes clays comprising boron (abstract). Is the proper weight for the calculation the amount of boron salts, the amount of elemental boron, or the amount of clay with boron? This is complicated by ingredients that provide more than one compound of the claims.
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.
first rejection
Claims 1-3 and 8-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 12, 13, 15, and 16 of copending Application No. 18/370,931 (US 20240108695) (reference application) in view of Izutsu (in “Therapeutic Proteins (2005) ISBN 1-58829-390-4, p287-292).
Competing claim 10 describes a method using a composition comprising a collagen source, a glutamate source, a cysteine source, a selenium source, and a boron source. Note that the percentage of collagen comprises a range that includes more than 50% by weight. Competing claims 12 and 13 describe specific collagen sources, similar to examined claims 8 and 9. Competing claims 15 and 16 describe specific glutamine sources and cysteine sources respectively, similar to claims 10 and 11.
The difference between the competing claims and the examined claims is that the competing claims do not describe a powder formulation.
Izutsu discusses stabilization of polypeptide formulations (title). Lyophilization (a powder formulation) is the default option for long term stability of polypeptides (p289, section 3.2 “formulation design”).
Therefore, it would be obvious to use a lyophilized formulation of the composition of the competing claims, for long term stability of the formulation. As this is a default formulation, an artisan in this field would attempt this formulation with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
second rejection
Claims 1, 3, and 10-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/839,218(US 20250228808) (reference application) in view of Furuzawa-Carballeda et al (WO 2022035306 (Feb, 2022) and Izutsu (in “Therapeutic Proteins (2005) ISBN 1-58829-390-4, p287-292). Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate the examined claims. Note that Furusawa-Carballeda et al is in Spanish. A machine language translation has been attached to the office action, and all references to locations in the reference refer to the machine translation unless otherwise noted.
Competing claim 1 describes a method of treatment of coronavirus, comprising administering a composition comprising l-Glu, l-cystine, coenzyme Q10 (a therapeutic agent), and selenomethionine.
The difference between the competing claims and the examined claims is that the competing claims do not describe a collagen source, nor does it discuss a powder formulation..
Furusawa Carballeda et al discuss treating a coronavirus with collagen-polyvinylpyrrolidone (title). This reduces the levels of pro-inflammatory cytokines (2nd page, 3d paragraph).
Izutsu discusses stabilization of polypeptide formulations (title). Lyophilization (a powder formulation) is the default option for long term stability of polypeptides (p289, section 3.2 “formulation design”).
Therefore, it would be obvious to add the collagen-polyvinylpyrrolidone of Furusawa Carballeda et al to the formulation of the competing claims, to reduce the levels of pro-inflammatory cytokines in the patients. As this formulation is used to treat the same disorder as the competing claims, an artisan in this field would attempt this modification with a reasonable expectation of success. Note that, while the reference does not specify the amount used, differences in concentration are not considered a patentable distinction (MPEP 2144.05(II)).
Furthermore, it would be obvious to use a lyophilized formulation of the composition of the competing claims, for long term stability of the formulation. As this is a default formulation, an artisan in this field would attempt this formulation with a reasonable expectation of success.
third rejection
Claims 1, 3, and 8-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/839,225 (US 20250152537) (reference application) in view of Jang et al (Mol. Med. Rep. (2016) 14 p5489-5494) and Izutsu (in “Therapeutic Proteins (2005) ISBN 1-58829-390-4, p287-292). Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate the examined claims.
Competing claim 1 describes a method of treatment of HIV, comprising administering a composition comprising l-Glu, l-cystine, coenzyme Q10 (a therapeutic agent), and selenomethionine.
The difference between the competing claims and the examined claims is that the competing claims do not discuss a collagen source or a powder formulation.
Jang et al discusses a hydroxyproline comprising collagen peptide to treat HIV by inhibiting infection (title). This was made by making gelatin of Alaska pollack skins, hydrolyzing the gelatin with pronase E, and purification of the peptide (p5489, 2nd column, 4th paragraph, continues to p5490, 1st column, 1st paragraph). The peptide has the sequence Gly-Pro-Hyp-Gly-Pro-Hyp-Gly-Pro-Hyp-Gly (fig 1, p5491, top of page).
Izutsu discusses stabilization of polypeptide formulations (title). Lyophilization (a powder formulation) is the default option for long term stability of polypeptides (p289, section 3.2 “formulation design”).
Therefore, it would be obvious to include the collagen peptide of Jang et al in the formulation of the competing claims, to inhibit infection by the virus. As this is used to treat the same disorder as the competing claims, an artisan in this field would attempt this modification with a reasonable expectation of success. Note that, while the reference does not discuss
Furthermore, it would be obvious to use a lyophilized formulation of the composition of the competing claims, for long term stability of the formulation. As this is a default formulation, an artisan in this field would attempt this formulation with a reasonable expectation of success.
fourth rejection
Claims 1-3 and 8-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-10 of copending Application No. 18/370,922 (US 20240115666) (reference application) in view of Izutsu (in “Therapeutic Proteins (2005) ISBN 1-58829-390-4, p287-292).
Competing claim 1 describes a method using a composition comprising a collagen source, a glutamate source, a cysteine source, a selenium source, and a boron source. Note that the collagen source includes amounts that are greater than those permitted for any other component. Competing claim 6 describes specific collagen sources similarly to examined claims 8 and 9. Competing claims 7 and 8 describe specific glutamine sources and cysteine sources respectively similarly to examined claims 9 and 10. Competing claim 9 describes selenium sources overlapping with examined claim 11. Competing claim 10 specifies additional therapeutics.
The difference between the competing claims and the examined claims is that the competing claims do not discuss a powder formulation.
Izutsu discusses stabilization of polypeptide formulations (title). Lyophilization (a powder formulation) is the default option for long term stability of polypeptides (p289, section 3.2 “formulation design”).
Therefore, it would be obvious to use a lyophilized formulation of the composition of the competing claims, for long term stability of the formulation. As this is a default formulation, an artisan in this field would attempt this formulation with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
fifth rejection
Claims 1, 3, and 10-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of copending Application No. 18/002,880 US 20230233498) (reference application) in view of Furuzawa-Carballeda et al (WO 2022035306 (Feb, 2022) and Izutsu (in “Therapeutic Proteins (2005) ISBN 1-58829-390-4, p287-292). Note that Furusawa-Carballeda et al is in Spanish. A machine language translation has been attached to the office action, and all references to locations in the reference refer to the machine translation unless otherwise noted.
Competing claim 1 describes a method of treatment of coronavirus, comprising administering a composition comprising a glutathione precursor and a selenium compound. Competing claim 3 specifies that the glutathione precursor comprises l-cystine and a glutamate source, while competing claims 4 and 5 specify the glutamate source to include glutamine or glutamic acid and the selenium source to include one of a Markush group that includes selenomethionine and selenite.
The difference between the competing claims and the examined claims is that the competing claims do not describe a collagen source or a powder formulation.
Furusawa Carballeda et al discuss treating a coronavirus with collagen-polyvinylpyrrolidone (title). This reduces the levels of pro-inflammatory cytokines (2nd page, 3d paragraph).
Izutsu discusses stabilization of polypeptide formulations (title). Lyophilization (a powder formulation) is the default option for long term stability of polypeptides (p289, section 3.2 “formulation design”).
Therefore, it would be obvious to add the collagen-polyvinylpyrrolidone of Furusawa Carballeda et al to the formulation of the competing claims, to reduce the levels of pro-inflammatory cytokines in the patients. As this formulation is used to treat the same disorder as the competing claims, an artisan in this field would attempt this modification with a reasonable expectation of success.
Furthermore, it would be obvious to use a lyophilized formulation of the composition of the competing claims, for long term stability of the formulation. As this is a default formulation, an artisan in this field would attempt this formulation with a reasonable expectation of success.
sixth rejection
Claims 1-3 and 8-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-10 of copending Application No. 18/370,941 (US 20240108696) (reference application) in view of Izutsu (in “Therapeutic Proteins (2005) ISBN 1-58829-390-4, p287-292).
Competing claim 1 describes a method using a composition comprising a collagen source, a glutamate source, a cysteine source, a selenium source, and a boron source. Competing claim 5 lists amounts, with the collagen source comprising a range that is larger than the ranges of the other sources. Competing claim 6 describes specific collagen sources, similar to examined claims 8 and 9. Competing claims 7 and 8 describe specific glutamine sources and cysteine sources respectively, similar to claims 10 and 11. Competing claim 9 describes specific selenium sources, similar to examined claim 12. Competing claim 10 describes additional therapeutics, similar to examined claim 2.
The difference between the competing claims and the examined claims is that the competing claims do not discuss a powder formulation.
Izutsu discusses stabilization of polypeptide formulations (title). Lyophilization (a powder formulation) is the default option for long term stability of polypeptides (p289, section 3.2 “formulation design”).
Therefore, it would be obvious to use a lyophilized formulation of the composition of the competing claims, for long term stability of the formulation. As this is a default formulation, an artisan in this field would attempt this formulation with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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