The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Formal Matters
Claims 1-15, 21, 22, 23, 25-27 are cancelled. Claims 16-20, 24, and 28-33 are pending and under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/01/2026 has been entered.
Priority
This application is a national stage entry of PCT/EP2021/086269 filed on 12/16/2021 claims priority from French application FR2013389 filed on 12/16/2020.
Rejections Withdrawn
The rejection under USC 112(b) over claims 16-19, 24, 28 and 33 is withdrawn per applicant’s amendments to the claims.
The rejections under USC 112(d) over claims 24 and 33 is withdrawn per applicant’s amendments to the claims.
As these rejections are withdrawn, applicant’s arguments toward these rejections are moot.
Claim Objection
Claims 24 and 33 are objected to for using the plural “bacterioruberins” in the phrase “at least one glycosylated bacterioruberins” when it should be “at least one glycosylated bacterioruberin” to be grammatically correct. The use of “at least one bacterioruberin” is also more consistent with recitations in claim 16. Appropriate correction is required.
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.
Claims 24 and 33 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.
Claims 24 and 33 are indefinite because it appears to limit the composition to a mixture of the at least one glycosylated bacterioruberin via the language “the composition is a mixture of the at least one glycosylated bacterioruberin…” while claim 16, on which claim 24 depends has “A composition comprising” that has at least one glycosylated bacterioruberin along with one or more pharmaceutically acceptable excipients. If applicant means to close the composition to the mixture of at least one glycosylated bacterioruberin via “is a mixture”, then they would be closing the composition form having the one or more excipients. Later in the claim, applicant, recites “wherein the mixture comprises….”, which would now indicate the mixture is open. Thus, it is unclear if the composition is now a closed or open mixture. This also confuses the recitation of “with respect to the total weight of the mixture of the at least one glycosylated bacterioruberin” because if the mixture can contain/comprise other items besides the at least one glycosylated bacterioruberin then the total weight will be different than if it the weight percents are just based on the total weight of the at least one glycosylated bacterioruberin as in the claim. For the purpose of compact prosecution the examiner will still consider this claim as though the mixture can be open so that it would still include the one or more excipients. Applicant may consider this rewording of the claim 24- “The composition of claim 16, wherein the composition comprises a mixture of the at least one glycosylated bacterioruberin, wherein the at least one glycosylated bacterioruberin is monoglycosylated bacterioruberin and diglosylated bacterioruberin, and wherein the mixture comprises 20 to 80% by weight of monoglycosylated bacterioruberin and 20 to 80% by weight of diglycosylated bacterioruberin with respect to the total weight of the at least one glycosylated bacterioruberin.” For claim 33, applicant may consider “The composition of claim 16, wherein the composition comprises a mixture of the at least one glycosylated bacterioruberin, wherein the at least one glycosylated bacterioruberin is monoglycosylated bacterioruberin and/or diglosylated bacterioruberin.”
Maintained With Added Evidentiary Reference For Clarification
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.
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 16-20, 24, and 28-33 are rejected under 35 U.S.C. 103 as being unpatentable over Thorel US 20160113864 and Fong et al (Appl Microbiol Biotechnol, 2001, volume 56, pages 750-756) as evidenced by Sajjad et al (Extremophiles, June 2020, volume 24, pages 447-473).
Thorel teaches cosmetic, pharmaceutical or dietary compositions with extract of A agilis that is preferably rich in carotenoids (abstract and paragraph 34). Thorel teaches “the invention relies on the detection of the protection of proteins against free oxygen radicals (ROS) and radiation of light (UV and visible) by such an extract, to fight against the alteration of cells, particularly that of the skin, caused by external aggressions” and protecting proteins (paragraph 2 and claims 9-13 of Thorel). Thorel teaches isomers or glycosylated of the carotenoids and that the carotenoids can represent more than 90% of the extract (paragraph 18). Thorel teaches a protocol to isolate and purify the carotenoids (paragraph 24). Thorel teaches excipients (paragraphs 35-36 and 40). Thorel teaches topical or oral administration and forms of lotions, creams, gels or others (paragraphs 35 and 40-42). Thorel teaches 0.0001 to 0.01 wt% of the extract added to a cream composition (paragraphs 172-174). Thorel teaches protection against free-radicals (claim 12 of Thorel).
Thorel does not teach the different glycosylated bacterioruberins (a form of glycosylated carotenoid) or mixtures thereof, although it broadly encompasses glycosylated carotenoids that are extracted. Thorel does not teach an amount of the glycosylated bacterioruberin.
Fong teaches A agilis isolated glycosylated bacterioruberin where A agilis is of the micrococcus family (abstract, materials and methods (pigment isolation and separation) and table 1). Fong teaches HPLC fraction 4 which has bacterioruberin monoglycoside and bacterioruberin diglycoside (table 1, identification of carotenoids). Table 1 also provides for fraction 2 with bacterioruberin diglycoside and fraction 3 with bacterioruberin monoglycoside. Fong teaches HPLC fraction 5 which has bacterioruberin monoglycoside and bacterioruberin tetraglycoside (table 1). The figure 6 legend provides for solvents that include H2O, and EtOAc. Such ingredients can be considered excipients. The discussion provides that red color comes from the range of C-50 carotenoid pigments (bacterioruberin) (page 755). The discussion of Fong provides that altering the conditions of bacteria can alter the components including the production of carotenoids (pages 755-756).
Sajjad evidences that there is an accumulation of C-50 carotenoid (bacterioruberin and its glycosylated derivatives) in Arthrobacter Agilis (Carotenoid section of Sajjad). Thus, Sajjad makes evident that A Agilis has glycosylated derivatives of bacterioruberin as being carotenoid.
One of ordinary skill in the art before the time of filing would have looked to teachings of Fong for the forms of glycosylated carotenoids from A agilis (bacterioruberin) for products including topicals and methods of Thorel as Thorel recognizes such A agilis carotenoid compounds as having beneficial antioxidant effects to treat oxidative stress and protect proteins and cells against oxidative stress. There would be a reasonable expectation of success in using glycosylated carotenoids/bacterioruberin in Fong as carotenoids in Thorel and achieving compositions and methods with antioxidant ability.
Response to Applicant’s Arguments over the Rejection under USC 103 over Thorel and Fong
Applicant argues that Thorel and Fong do not suggest composition of claim 16 as Thorel only provides for carotenoid forms that may be glycosylated without providing guidance on isolating glycosylated bacterioruberins with Thorel’s teachings only referring to Fong for their identification. Thus, applicant feels that Thorel, which teaches carotenoids from A agilis and their glycosylated forms, does not reasonably provide the glycosylated bacterioruberins. In this rejection under USC 103, it is a combination of the references that teaches applicant’s claims. Both Thorel and Fong provide for extracted compounds from A agilis including glycosylated/glycoside forms. Sajjad is now further included to evidence that glycosylated bacterioruberin is indeed a carotenoid compound, which are accumulated in A agilis. Fong provides the methods and teachings to allow isolating glycosylated bacterioruberins along with the types of bacterioruberins. Fong’s HPLC fraction 4 has bacterioruberin monoglycoside and bacterioruberin diglycoside. Thus, such compounds are known in the prior art teachings of Fong and would be useful for products of Thorel as being carotenoids from A agilis, which Thorel sees as beneficial. Additionally, although the purity of the at least one glycosylated bacterioruberin is at least 80% by weight in the claim, the composition being claimed uses “comprising” as the transition phrase, which allows the presence of other agents including other bacterioruberin compounds. In this way the composition as a whole can still contain the items presented in the prior art.
Applicant argues that there is no distinction between non-glycosylated or glycosylated forms of the carotenoids in teachings of Thorel, and thus, there is not a reason to isolate the glycosylated forms. Applicant also argues that Fong appears to recognize a difficulty in separating and that other components would be present. In regards to Thorel, it provides the option of glycosylated forms of carotenoids. Alternative embodiments are prior art (see MPEP 2123). Thorel still recognizes them as being carotenoids for its uses. In regards to Fong, it does provide for a fraction with mono- and diglycosylated bacterioruberins. Thus, Fong does recognize having these forms in combination with these glycosylated bacterioruberins being found in applicant’s claims. Although the mono- and di- forms of bacterioruberins were not separated from each other in Fong’s fraction, it represents a fraction with two of the components as in applicant’s claim. As mentioned above in this response to arguments, the claim is to a composition with “comprises” as the transition phrase, and therefore, is not closed from having other items in the prior art, which include other bacterioruberins or other items from an A agilis extract.
Applicant argues there is unexpected results of having a diglycosylated bacterioruberins or a combination of mono- and diglycosylated bacterioruberins in a composition to protect against UV-B-induced protein carbonylation compared with other tested carotenes. The prior art via Fong teaches a combination of mono- and diglycosylated bacterioruberins. Claim 16 is a composition and not toward a method of protecting a subject from UV-B induced protein carbonylation by administering to a subject in need thereof. Method claims 29-32 are also not specific to this use. Further such a method claim would need the particular item or combination seen as providing what applicant considers to be the unexpected benefit likely in some effective amount.
As the rejections over claims 16 and 29 are maintained for reasons above, the rejection over dependent claims, which are also taught by the references, is also maintained.
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 16-17, 19, 20, 28, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 6, 10, 11 and 12 of U.S. Patent No. US 10406097 in view of Thorel US 20160113864 and Fong et al (Appl Microbiol Biotechnol, 2001, volume 56, pages 750-756) as evidenced by Sajjad et al (Extremophiles, June 2020, volume 24, pages 447-473). The claims of ‘097 provide for a cosmetic, pharmaceutical or dietary composition comprising an extract rich in carotenoids of the bacteria Arthrobacter agilis. These are extracts where glycosylated bacterioruberin, a carotenoid, are found. Claims of ‘097 also provide for additives like antioxidants and forms of lotion, cream, spray, solutions, capsules or tablets. Claims of ‘097 provide for 0.0001 to 0.01% by dry weight of the composition.
‘097 does not indicate the glycosylated bacterioruberins, although the extract of A agilis allows for the presence of them.
Thorel teaches cosmetic, pharmaceutical or dietary compositions with extract of A agilis that is preferably rich in carotenoids (abstract and paragraph 34). Thorel teaches “the invention relies on the detection of the protection of proteins against free oxygen radicals (ROS) and radiation of light (UV and visible) by such an extract, to fight against the alteration of cells, particularly that of the skin, caused by external aggressions” and protecting proteins (paragraph 2 and claims 9-13 of Thorel). Thorel teaches isomers or glycosylated of the carotenoids and that the carotenoids can represent more than 90% of the extract (paragraph 18). Thorel teaches a protocol to isolate and purify the carotenoids (paragraph 24). Thorel teaches excipients (paragraphs 35-36 and 40). Thorel teaches topical or oral administration and forms of lotions, creams, gels or others (paragraphs 35 and 40-42). Thorel teaches 0.0001 to 0.01 wt% of the extract added to a cream composition (paragraphs 172-174). Thorel teaches protection against free-radicals (claim 12 of Thorel).
Thorel does not teach the different glycosylated bacterioruberins (a form of glycosylated carotenoid) or mixtures thereof, although it broadly encompasses glycosylated carotenoids that are extracted. Thorel does not teach an amount of the glycosylated bacterioruberin.
Fong teaches A agilis isolated glycosylated bacterioruberin where A agilis is of the micrococcus family (abstract, materials and methods (pigment isolation and separation) and table 1). Fong teaches HPLC fraction 4 which has bacterioruberin monoglycoside and bacterioruberin diglycoside (table 1, identification of carotenoids). Table 1 also provides for fraction 2 with bacterioruberin diglycoside and fraction 3 with bacterioruberin monoglycoside. Fong teaches HPLC fraction 5 which has bacterioruberin monoglycoside and bacterioruberin tetraglycoside (table 1). The figure 6 legend provides for solvents that include H2O, and EtOAc. Such ingredients can be considered excipients. The discussion provides that red color comes from the range of C-50 carotenoid pigments (bacterioruberin) (page 755). The discussion of Fong provides that altering the conditions of bacteria can alter the components including the production of carotenoids (pages 755-756).
One of ordinary skill in the art before the time of filing would have looked to teachings of Fong for the forms of glycosylated carotenoids from A agilis (bacterioruberin) for products including topicals of Thorel and ‘097 as Thorel recognizes such A agilis carotenoid compounds as having beneficial antioxidant effects to treat oxidative stress and protect proteins and cells against oxidative stress. There would be a reasonable expectation of success in using glycosylated carotenoids/bacterioruberin in Fong as carotenoids in Thorel and achieving compositions with antioxidant ability.
Claims 16-20, 24 and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-18 and 24-28 of copending Application No. 18/257,440 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for the glycosylated bacterioruberins and allow for singular and mixtures thereof. ‘440 provides forms that could be food supplement and pharmaceutical such as tablet or capsule. ‘440 claim 28 provides for altering the amount of glycosylated bacterioruberins from 1 mg to 1 g, and thus, seeks to adjust amounts accordingly. Therefore, the claims of ‘440 obviate isolated glycosylated bacterioruberins and combinations thereof as well as composition forms of applicant’s claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments over Double Patenting
In regards to the rejection over US Patent 10406097 in view of Thorel and Fong, as the applicant has amended the claims, the examiner has reconsidered this rejection on a claim against claim basis (in non-statutory double patenting claims would be considered against claims of the US Patent whereas in a prior art rejection, the full reference is used for its teachings). The examiner has removed some claims from this rejection, but the breadth of certain claims of applicant still allows overlap. Claim 33 was added as it was a new claim and uses “comprising” for what is in the mixture, which leaves it open to many compounds along with the glycosylated bacterioruberins. Applicant argues that the rejection should not apply based on arguments made against the rejection over Thorel and Fong. As the rejection under USC 103 was maintained over Thorel and Fong, this is not convincing.
In regards to the claims of copending 18/257,440, the claims continue to substantially overlap in scope. There is no particular argument made against this rejection other than the applicant disagrees and they feel the claims are patentably distinct. This is not convincing as it does not provide particular points on how the claims are patentably distinct.
As no terminal disclaimers have been filed, the rejections are maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached on (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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