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 .
Claim Status
Claims 1-18 are pending under examination.
Priority
The instant application claims priority to KR10-2022-0171257, filed 12/09/2022. The priority date of 12/09/2022 is acknowledged although it is noted that no translation has been made of record.
Information Disclosure Statement
The IDS filed on 11/21/2023 is under consideration.
Specification
The use of the terms Witepsol and Tween61 (Pg 18, second paragraph), MiniBEST (Pg 28, first paragraph), and Tecan Infinite M200 Multiplate Reader (Pg 30, first paragraph), which are trades name or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
Claim 1 recites “one or more green tea peptides containing an amino acid sequence selected from the group consisting of SEQ ID NO: 1-7” (emphasis added). This claim is being interpreted as a peptide or protein encompassing or containing the entirety of one of SEQ ID NO: 1-7 meets the limitation of the claim. Conversely, smaller fragments encompassed by SEQ ID NO: 1-7 (i.e., dipeptides) are being interpreted as not meeting the limitations of the claim.
Further, fatigue, as recited in claim 1, is being interpreted as inclusive of both mental and physical fatigue, based upon the instant specification (see Pg 2, 4th paragraph).
Moreover, the limitation “improving, alleviating, recovering, or eliminating” will simply be referred to as “treating” throughout the Office Action.
Claims 8-15 each recite functional limitations that are endowed by the structural elements of claim 1; thus, claims 8-15 are being interpreted as being met by the structural limitations of claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-8, 10, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites that the green tea peptide composition is obtained by fermenting a green tea protein with vegetable lactic acid bacterium (emphasis added). The limitation “a green tea protein” renders the scope of the claim indefinite as is it unclear whether said green tea protein is the same as SEQ ID NO: 1-7 recited in claim 1 or is a different green tea protein. Further, by virtue of their dependency on claim 2, claims 3-7 are also hereby rejected for this same reasoning. For purposes of examination, the claim is being interpreted as a green tea protein is the same as at least one of SEQ ID NO: 1-7.
Additionally, claim 7 recites the limitation “thermal water.” There are multiple ways to interpret this claim. The first is that the water is derived from a thermal hot spring. The second is that the water has a high temperature. Thus, the claim is indefinite because it can be interpreted in multiple ways. For purposes of examination, the claim is being interpreted as the water has a high temperature.
Claim 8 recites that the green tea peptide composition inhibits production of a fatigue substance in a muscle cell. The limitation “a fatigue substance” renders the scope of the claim indefinite as it is unclear what exactly the green tea peptide composition should inhibit the production of, and whether this includes only direct inhibition or also includes indirect inhibition. Further, by virtue of its dependency on claim 8, claim 10 is also hereby rejected for this same reasoning. For purposes of examination, a fatigue substance is being interpreted as being limited to lactic acid, such as is recited in claim 9.
Claim 17 recites the green tea peptide composition is administered in an amount of 1-400mg/kg/day. The limitation “400mg/kg/day” renders the scope of the claim indefinite as it is unclear whether the amount of “per kg” refers to kg of the bodyweight of the subject in need thereof or some other mass. For purposes of examination, the claim is being interpreted as 400mg/kg/day, wherein kg is the bodyweight of the subject in need thereof.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
First rejection – new matter
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant specification provides support for a method of preventing or treating physical fatigue. However, a method of preventing or treating fatigue broadly, where fatigue is inclusive of both mental and physical fatigue, is not supported by the instant application as originally filed.
Further, by virtue of their dependency on claim 1, claims 2-17 are also hereby rejected for this same reasoning.
This is a new matter rejection.
Second rejection – scope of enablement
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating physical fatigue, does not reasonably provide enablement for preventing physical fatigue. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
1) Nature of the invention, 5) breadth of the claims, and 7) the presence or absence
of working examples: The claims are drawn to a method of preventing or treating fatigue comprising administering to a subject in need thereof an effective amount of a green tea peptide composition comprising one or more of SEQ ID NO: 1-7. Practicing a method of prevention requires administration of said composition prior to fatigue setting in, whereas treating requires administration of said composition to a subject already exhibiting muscle fatigue.
The instant specification teaches that the green tea peptide composition exhibits anti-
fatigue efficacy by inhibiting the production of fatigue substances, increasing ATP production, and promoting fat oxidation within muscle cells (Pg 3, final paragraph).
Applicant’s demonstrate the instant peptides can limit lactate or lactic acid; Experimental Example 1 of the instant specification demonstrates that pretreatment of muscle cells with SEQ ID NO: 1-7 in vitro results in a decrease in lactate concentration relative to CoCl2 treatment alone (used to encourage muscle cells to produce ATP without going through oxidative phosphorylation) as well as a corresponding decrease in lactate dehydrogenase activity (LDHA activity), which produces lactate (Pg 27, 3rd paragraph; Figures 3A and 3B). However, although there is an observable and statistically significant reduction in both LDHA activity and lactat4e concentration, lactate still accumulates in muscle cells. Thus, Applicants have not demonstrated the that the recited composition comprising SEQ ID NO: 1-7 is capable of preventing fatigue as measured by lactate accumulation.
2) State of the prior art and 4) predictability or unpredictability of the art: The prior at
teaches that lactic acid is a biomarker for muscle fatigue that accumulates in muscle cells after ATP is depleted due to intense exercise (Wan et al. Muscle fatigue: general understanding and treatment. Exp Mol Med. 2017 Oct 6;49(10):e384.; see Pg 5, “ATP metabolism biomarkers,” first paragraph). Additionally, the prior art teaches several products for the treatment of muscle fatigue (Wan et al., Pg 6-7, “Potential treatment for muscle fatigue”) but no therapeutics for the prevention of muscle fatigue.
Based on the information provided in the instant specification as well as the teachings of the prior art, one skilled in the art would predict that administration of a composition comprising one or more of SEQ ID NO: 1-7 would not prevent fatigue in a subject in need thereof.
3) The relative skill of those in the art: The relative skill of those in the art is high.
6) The amount of direction or guidance presented: At the time of filing, the prior art
offered no examples wherein a therapeutic substance can be administered to prevent physical fatigue, and only one example is offered in the instant specification.
8) The quantity of experimentation necessary: As only a few working examples are
disclosed in the instant specification, reasonable guidance with respect to preventing physical fatigue through administration of a composition comprising at least one of SEQ ID NO: 1-7 was limited. Consequently, one skilled in the art would be burdened with undue experimentation to determine the precise parameters and conditions necessary to effectively prevent fatigue by practicing the steps of the instant method claims. Thus, in view of the Wands factors, as discussed above, Applicants fail to provide information sufficient to practice the claimed invention for the prevention of physical fatigue.
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, 8-16, and 18 are rejected under 35 U.S.C. 101 because it is directed to a judicial exception.
The Supreme Court has given a three-part test for patent eligibility (see flowchart of MPEP 2106(III)):
Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the claims pass the first test, are the claims drawn to a judicial exception (a law of nature, a natural phenomenon (product of nature), or an abstract idea)?
2b) If a judicial exception applies, do the claims recite additional elements that amount to significantly more than the judicial exception?
Applying the three-part test:
Regarding 1), the claims are drawn to a process, specifically a method of preventing or treating fatigue through administration of a green tea peptide composition comprising at least one or more of SEQ ID NO: 1-7.
Regarding 2a), the process described above reads on a naturally-occurring phenomenon, consuming matcha when physically fatigued. As demonstrated by Pacific Crest Coffee Co (PCCC), matcha is generated from Camellia sinensis tea leaves that are picked, steamed, and dried prior to de-stemming and ground into a powder; said powder is subsequently whisked directly into hot water to make, for example, a matcha latte (PCCC, “What is Matcha? Benefits, History, and How It’s Made,” 2025, accessed from https://pacificcrestcoffee.com/blogs/news/what-is-matcha-a-complete-guide-to-the-japanese-green-tea-superfood on 6/17/2026). Consumption of the matcha drink, or other food product comprising matcha, thus reads on administering the SEQ ID NO: 1-7; thus, the claims read on a naturally-occurring process. Additionally, fermented matcha can also be consumed (Hadjipateras, Fermented Matcha Explained: Gut Health Meets Green Tea, 2025, accessed from https://matcha.com/blogs/news/fermented-matcha-explained-gut-health-meets-green-tea on 6/17/2026).
Regarding 2b), there is nothing significantly more recited in claims that would distinguish them from the above described naturally-occurring process; in particular, claims 8-16 merely recite properties of SEQ ID NO: 1-7 endowed by their structure. As such, it does not contain elements added to the judicial exception sufficient to render the claim significantly more than the exception.
In sum, the claim is drawn to patent ineligible subject matter and is rejected here.
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(s) 1, 8-16, and 18 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Alamdari et al. (WO 2016201449 A1, published 12/15/2016), as evidenced by UniProt (ID A0A7J7HMX4, A0A7J7H2J8, and A0A4S4DAA0; see PTO-892 for full citations), BLAST (see PTO-892 for full citations), and Cernava et al. (The tea leaf microbiome shows specific responses to chemical pesticides and biocontrol applications. 2019. The Science of the Total Environment. Vol. 667, Pg. 33-40.).
Alamdari teaches compositions for improving exercise performance and/or recovery (Abstract). Alamdari teaches some problems or issues associated with exercise include: (1) muscle acid building up, ensuing muscle fatigue, and decline in exercise performance and power output; (2) reduced energy production by mitochondria and energy producing pathways (e.g., carbohydrate and fat oxidation and regulation); (3) increased muscle inflammation and damage, reduced adaptation to exercise, and increase in muscle recovery time; (4) reduced perception of energy, and increased perception of fatigue; (5) dehydration, reduced hydration status, and compromised exercise performance, and (6) jitters, nervousness, anxiety, the inability to sleep, or gastrointestinal distress from typical pre-exercise or energy drinks and powders (Pg 1, lines 19-27).
Alamdari teaches compositions that can comprise green tea extract (Pg 2, lines 22-28). Said compositions can be administered to subject in need thereof to improve exercise performance and/or recovery. The administration can be before exercise (prevention) or after (treatment; Pg 7, line 33 – Pg 8, line 6).
SEQ ID NO: 1-7 are all derived from natural proteins found in green tea, as evidenced by UniProt and BLAST; note that SEQ ID NO: 5 reads on Alphaproteobacteria bacterium, which is part of the tea leaf microbiome according to Cernava (see Pg 35, right column, last paragraph). Thus, Alamdari effectively teaches administration of a composition comprising green tea peptides SEQ ID NO: 1-7 to prevent and treat fatigue, thereby anticipating claim 1.
Based upon the Claim Interpretation section above, wherein the limitations of claims 8-15 are being interpreted as being met by the structural elements recited in claim 1, claims 8-15 are also anticipated by Alamdari.
Alamdari further teaches the composition may comprise or consist of green tea extract from 2.67-4% (Pg 14, line 30; Pg 17, lines 9-12) or 1.68% to about 2.11% (Pg 18, lines 17-20) by weight or volume. Thus, claim 16 is anticipated.
As Alamdari teaches administering said compositions as a means to prevent or treat fatigue in response to exercise, the compositions read on a health functional food composition, thereby anticipating claim 18.
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.
Claim(s) 1-3, 8-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Alamdari et al. (WO 2016201449 A1, published 12/15/2016), as evidenced by UniProt (ID A0A7J7HMX4, A0A7J7H2J8, and A0A4S4DAA0; see PTO-892 for full citations), BLAST (see PTO-892 for full citations), and Cernava et al. (The tea leaf microbiome shows specific responses to chemical pesticides and biocontrol applications. 2019. The Science of the Total Environment. Vol. 667, Pg. 33-40.), in view of Hu et al. (Modulation effects of microorganisms on tea in fermentation. Front Nutr. 2022 Aug 2;9:931790.).
The teachings of Alamdari have been set forth above. Alamdari does not teach a method wherein the green tea peptide composition is obtained by fermenting a green tea protein with vegetable lactic acid bacterium.
Hu teaches the impacts of microorganisms and fermentation on tea (Title, Abstract). In particular, Hu teaches that the fermentation of results special sensory characteristic such as bright tea infusion, unique aroma, and a sweet and smooth taste with low levels of bitterness and astringency (Pg 1, final paragraph). Hu further teaches that tea fermentation also results in additional health benefits, including, in some cases, protection against hypertension and cardiovascular diseases (Pg 2, left column, first paragraph).
In summary, Alamdari teaches administering a composition comprising a green tea extract comprising the instant SEQ ID NO: 1-7 to prevent or treat physical fatigue, while Hu teaches the benefits of fermenting tea. Based on these teachings, regarding claim 2, it would be prima facie obvious to ferment the green tea extract taught by Alamdari. One would be motivated to do so in order to take advantage of the benefits of the fermentation process taught by Alamdari. One would have a reasonable expectation of success as Alamdari teaches that tea fermentation is widespread and common.
Regarding claim 3, Alamdari teaches green tea extracts can be fermented by Lactiplantibacillus plantarum 299V (Pg 4, right column, second paragraph).
Claim(s) 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Alamdari et al. (WO 2016201449 A1, published 12/15/2016), as evidenced by UniProt (ID A0A7J7HMX4, A0A7J7H2J8, and A0A4S4DAA0; see PTO-892 for full citations), BLAST (see PTO-892 for full citations), and Cernava et al. (The tea leaf microbiome shows specific responses to chemical pesticides and biocontrol applications. 2019. The Science of the Total Environment. Vol. 667, Pg. 33-40.), and Hu et al. (Modulation effects of microorganisms on tea in fermentation. Front Nutr. 2022 Aug 2;9:931790.), as applied to claims 1-3, 8-16, and 18 above, and further in view of Cho et al. (WO 2015142098 A1, published 9/24/2015; rejection based on English translation).
The teachings of Alamdari and Hu have been set forth above. Alamdari and Hu do not teach a method wherein the green tea protein is obtained from a residue of a primary extract obtained by extracting a green tea with anhydrous or hydrous C1-C6 lower alcohol.
Cho teaches compositions comprising fermented tea extracts as active ingredients that can be used for treating subjects in need thereof (Abstract). The tea can include green tea (Pg 9, 3rd paragraph). Cho teaches methods of post-fermentation extraction may be performed via a tea hydrothermal (thermal water) or spirit (ethanol) extraction (Pg 4, 8th paragraph); Cho also teaches post-fermentation extraction with lower C1-C6 alcohol (Pg 8, 4th paragraph).
In summary, Alamdari and Hu teach a method for preventing or treating fatigue comprising administering a green tea peptide composition comprising one or more of SEQ ID NO: 1-7, wherein the green tea peptide composition is obtained by fermentation. Cho teaches methods for extracting green tea extracts after fermentation. Based on these teaches, regarding claim 4, it would be prima facie obvious to use the post-fermentation extraction method of Cho to extract the fermented green tea peptides used in the method of preventing and treating fatigue taught by Alamdari and Hu. One skilled in the art would be motivated to do so because one would recognize that extraction of the relevant compounds would further concentrate them while removing any impurities. One would have a reasonable expectation of success given that Cho taught that said extraction method could be used with green tea leaves.
Regarding claims 5 and 6, Cho teaches that the ethanol extraction can use 30-70% (v/v) ethanol (Pg 4, 10th paragraph).
Regarding claim 7, Cho teaches a further step comprising filtering and extracting the extract after the (initial) extraction step (Pg 10, 2nd paragraph). As stated above, Cho also teaches the extraction method can be done with thermal water (Pg 4, 8th paragraph).
Regarding claim 17, Cho teaches administering the green tea peptide composition in an amount of 100-500mg/kg/day (Pg 12, 3rd paragraph from bottom).
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 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-17 of copending Application No. 18/515,599 (reference application; claim set filed 5/18/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites the same active steps and peptides (SEQ ID NO: 1-7) as the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Second rejection
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-15 of copending Application No. 18/536,404 (reference application; claim set filed 3/27/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites the same active steps and peptides (SEQ ID NO: 1-7) as the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Third rejection
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/618,666 (reference application; claim set filed 3/27/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application recites the same active steps and peptides (SEQ ID NO: 1-7) as the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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