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, 22, 23, 25-27 are cancelled. Claim 33 is new. Claims 16-21, 24, and 28-33 are pending and under examination.
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Rejections Withdrawn
The rejection under USC 101 is withdrawn per applicant’s amendments and arguments.
The rejection under USC 112(a) is withdrawn per applicant’s arguments.
The rejection under USC 102(a)(1) over Fong is withdrawn per applicant’s amendment to claim 21 and cancellation of other claims that were in the rejection.
The rejection under USC 103 over Fong alone is withdrawn per applicant’s amendments and arguments.
New Rejections – As Necessitated by Amendments
Claim 16 was amended to introduce “A composition comprising at least one isolated glycosylated bacterioruberin”.
Claim 21 was amended into a dependent claim (dependent on claim 16) rather than being an independent claim as it was previously written.
Claim 24 is now amended to be dependent on claim 16 rather than on claim 21.
Claim 33 is a new claim, which is dependent on claim 16.
These amendments changed how these claims and any claims dependent thereon would be interpreted.
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 16-21, 24, 28 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 16-19, 24, and 33 recite the limitation "the glycosylated bacterioruberin" (2nd and 8th line of claim 16, claims 17-19) or “a mixture of glycosylated bacterioruberins comprising” (claims 24 and 33) in the claims where the initial recitation in claim 16 (line 1) is after applicant’s amendment is “at least one isolated glycosylated bacterioruberin”. It is unclear if these later recitations are meant to refer back to “the at least one glycosylated bacterioruberin” that was introduced and if so which “at least one” is being referred to. Additionally in claims 24 and 34, “a mixture of glycosylated bacterioruberins comprising” is an open group where the group mentioned in claim 1 is closed with “is….or…” Markush format. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend claims 16 (2nd and 8th line), and 17-19 to read “the at least one glycosylated bacterioruberin” and may amend claims 23-33 to read “a mixture of the at least one glycosylated bacterioruberin, wherein the at least one glycosylated bacterioruberin is…..or…” or “a mixture of at least two of the at least one glycosylated bacterioruberin, wherein the at least one glycosylated bacterioruberin is….or….”.
Claims 20-21, and 28 are rejected as being dependent on indefinite claims without repairing the issues in the claim on which they depend.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 24 (amended) and 33 (new) are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 24 and 33 provide for a mixture of glycosylated bacterioruberins comprising…” where claim 16, on which claims 24 and 33 depend, provides for a closed Markush group of glycosylated bacterioruberins. Thus, claims 24 and 33 would reopen glycosylated bacterioruberin to having potentially more items than in claim 16 as use of “comprising” for a group leaves the group open to other elements while “is ….or….” Markush structure closes the group to other elements. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Applicant may refer to the items in the groups in claims 24 and 33 with closed language such as “is” or “consisting of”. For example, claim 24 could be “…consisting of monoglycosylated bacterioruberins and diglycosylated bacterioruberins….”.
Maintained Rejections – Modified As Necessitated by Amendment
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 16-21, 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).
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 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 amended claim 16 and claim 29. First, claim 29 to a method does not carry the same compositional limitations of claim 16. Claim 29 only requires that the composition administered in the method have at least one glycosylated bacterioruberin and one or more pharmaceutically or cosmetically acceptable excipients without having a non-glycosylated form of bacterioruberin. Claim 16 provides for an extensive group of glycosylated bacterioruberins having a purity at least 70% by weight and further having excipients and being formulated for cosmetic topicals or food supplements. Thorel provides for use of a composition “with extract of A agilis that is preferably rich in carotenoids” while Fong provides for “A agilis isolated glycosylated bacterioruberin where A agilis is of the micrococcus family”. Fong also provides that bacterioruberins are carotenoids of A agilis. Thus, Thorel provides for using purified carotenoids of A agilis in cosmetic, pharmaceutical or dietary compositions with Fong providing methods to isolate carotenoid compounds (the glycosylated bacterioruberins) from A agilis. One of ordinary skill in the art before the time of filing would seek to use the purified bacterioruberins noted in Fong, with some not having non-glycosylated bacterioruberins, as they represent a purified carotenoid of A Agilis with the reasonable expectation of having carotenoid activity in their formulations and methods when using teachings of Thorel. In the rejection under USC 103, it is the combination of the references that provides the teachings of the claim limitations.
Applicant argues that one would not be able to assess the purity of the bacterioruberins in Fong, and thus, it’s teachings could not apply to the purity values provided in the claims. The compositions as a whole allow the glycosylated bacterioruberin to be diluted into a composition with other components. The claim utilizes “comprising” as a transition phrase for the composition and allows for other components to be present. In addition, see MPEP 2144.04 VII “Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product nonobvious” and “Factors to be considered in determining whether a purified form of an old product is obvious over the prior art include whether the claimed chemical compound or composition has the same utility as closely related materials in the prior art, and whether the prior art suggests the particular form or structure of the claimed material or suitable methods of obtaining that form or structure”. In the case of Fong, Fong recognizes the compounds by name, recognized as carotenoids, and provides for techniques used to isolate/extract the glycosylated bacterioruberin compounds (e.g. HPLC and gradient elution in Material and Methods). Thus, there is a reasonable expectation of success of obtaining such compounds in purer form, where purer forms of carotenoids are desired.
Additionally, in regards to applicant’s argument that Fong does not seem to recognize a separation of the different forms of glycosylated bacterioruberins as seen on page 753, the claims themselves allow for combinations of glycosylated bacterioruberins to be the “at least one glycosylated bacterioruberin.” Thus, the purity does not require a single type of glycosylated bacterioruberin. HPLC fractions 4 and 5 in table 1 of Fong are shown to have all glycosylated bacterioruberins.
Applicant argues that the Strand reference in a filed IDS indicates that glycosylated bacterioruberins only represent 21% of all the total carotenoids in A Agilis. However, as stated above, Fong does provide separating these compounds in fractions as well as these compounds being carotenoids. Thus, it would be obvious to further purify such compounds by known methods to make compositions as provided in teachings of Thorel in view of Fong.
Applicant argues that Thorel cannot remedy deficiencies of Fong even though it teaches pure forms of carotenoids and teaches that carotenoids may be glycosylated. As responded to earlier arguments above, Fong still provides teachings that would make the glycosylated bacterioruberins obvious and in combination with Thorel, these would be seen as pure forms that can be used for Thorel’s carotenoid containing compositions for pharmaceutical, nutritional/dietary, and cosmetic use.
Applicant argues that Thorel does not provide additional guidance that would be able to provide a composition that can protect against UV induced oxidative stress. Thorel teaches application to protect against free radicals, and thus, is capable of protecting against various forms of oxidative stress. It was also provided that “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).” Thus, there is a reasonable expectation of success in using a composition provided by the teachings of Thorel and Fong and using that to protect against conditions with free radical oxygen radicals (ROS). This flows from teachings of the prior art.
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). 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 16-21, 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.
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 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