DETAILED ACTION
Claims 1-10 are currently pending and under examination.
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 .
Election/Restrictions
Applicant’s election without traverse of one PHA copolymer is present and
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in the reply filed on 04/10/2026 is acknowledged.
No claims are withdrawn as a result of the species election.
The elected species of PHA copolymer has been found free of the art. Examiner has selected the next species to search of wherein R1 is C8 alkyl-COOH and R2 is the elected alkyl group.
Priority
The instant application is a national stage entry of PCT/EP2022/087122, filed 12/20/2022, which claims priority to FR2114049, filed 12/20/2021.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 06/05/2024 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Claim Objections
There are many types of bullet points (dash, **, ***) and alphabetical/numerical lists scattered throughout the document without general use of indentations, in some cases possibly leading to indefinite interpretations. The Applicant should attempt to clean up the claim set for the sake of legibility to ensure appropriate examination and claim scope representations. See MPEP 608.01(m). Appropriate correction is required.
Claim Rejections - 35 USC § 112 (a)
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.
Claims 1-2 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.
Claims 1-2 recites “solvates.” The specification does not describe the different manners or extent of derivatization employed to arrive at the claimed substances. Merely stating “solvates thereof” in the claims and specification without additional guidance does not allow for an interpretation of what modified compounds are represented by this phrase. Furthermore, Vippagunta (Advanced Drug Delivery Reviews, 2001) demonstrates the unpredictability of solvate formation (pg 15, paragraph 1). The Examiner suggests replacing “solvates” with specific components or removing the term.
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 1-10 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.
Regarding claim 1, the phrase "such as", “preferably”, “particularly”, “preferentially” and “may comprise” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 1 contains the phrase “preferably” and “such as” in multiple instances making the meets and bounds claim unclear as to what is required by the instant claim. Claims 2-10 are further rejected for not curing the ambiguity of claim 1.
Claim 1 recites the limitation "the anionic parts". There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear how anionic parts comprise one or more cationic counterions M+, wherein selections of A- include groups which do not have an anionic part, such as C(O)OH. Claims 2-10 are further rejected for not curing the ambiguity of claim 1.
Claim 1 recites the limitation "the cationic parts". There is insufficient antecedent basis for this limitation in the claim. Claims 2-10 are further rejected for not curing the ambiguity of claim 1.
Claim 1 contains the limitation “it being possible for” and “it being understood that” which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. Claims 2-10 are further rejected for not curing the ambiguity of claim 1.
Claims 1-9, the limitation of “which uses a composition comprising a) one or more PHA copolymers a) which comprises..”, wherein the use of a) consecutively leads to confusion. Claim 10 is further rejected for not curing the ambiguity of claims 1-9.
Claim 1 is rejected as being a method of use claim, which does not contain an active step, thus leading to unclear metes and bounds. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). The instant case contains “which uses at least one compristion”, which does not clearly convey method of use steps.
Regarding claim 2, the phrase “preferably” and “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 2 contains the phrase “preferably” and “such as” making the meets and bounds claim unclear as to what is required by the instant claim.
Regarding claim 3, the phrase “preferably” and “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 3 contains the phrase “preferably” and “such as” making the meets and bounds claim unclear as to what is required by the instant claim.
Regarding claim 4, the limitation of “notably” is unclear whether the limitations following the term are required by the instant claim or not, thus leading to unclear metes and bounds.
Regarding claim 4, the limitation of “(preferably one)” is unclear whether the limitations following the term are required by the instant claim or not, thus leading to unclear metes and bounds. The use of the term preferably and the use of parenthesis make it unclear if the limitations following are required or optional in the instant claim.
Regarding claim 4, the phrase “preferably”, “more preferentially”, “such as” and “more particularly” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 4 contains the phrase “preferably” making the meets and bounds claim unclear as to what is required by the instant claim.
Regarding claim 5, the phrase “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 5 contains the phrase “preferably” making the meets and bounds claim unclear as to what is required by the instant claim.
Regarding claim 5, the limitation of “(preferably one)” is unclear whether the limitations following the term are required by the instant claim or not, thus leading to unclear metes and bounds. The use of the term preferably and the use of parenthesis make it unclear if the limitations following are required or optional in the instant claim.
Regarding claim 6, 8-9, the phrase “preferably”, “more preferentially”, “such as”, “in particular”, “preferentially” and “more particularly” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 6 contains the phrase “preferably” making the meets and bounds claim unclear as to what is required by the instant claim.
Regarding claim 6, the limitation of “as defined in Claim 4” leads to unclear metes and bounds of the claim 6. The claim is indefinite as claim 6 is defined by limitations in claim 4, however is not dependent on claim 4, therefore leading to unclear scope of the claim and unclear metes and bounds.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/178899.
Regarding claim 1, the limitation of a method for treating keratin material which uses at least one composition comprising a) one or more PHA copolymers a) comprising at least two different repeating polymer units chosen from units (a) and (B) in which polymer units (A) and (B) R1 represents saturated or unsaturated, linear or branched, non-cyclic hydrocarbon-based chain comprising from 3 to 30 carbon atoms, said hydrocarbon chain being substituted with one or more groups chosen from anionic groups A-, cationic groups C+ and mixtures thereof wherein A- groups include C(O)OH, optionally water is met by the ‘899 publication teaching cosmetic compristion comprising a biodegradable polyester comprising from 0.1 by weight to 30% by weight of at least one polyhydroxyalkanoate (PHA) in the form of particles (abstract). The PHA is preferably a polymer having a repeat formulated -O-CHR1-(CH2)n-CO- (I) wherein R1 is selected from C1-C12 alkyls optionally substituted with at least one group selected from COOH, wherein N is 1-6 (page 6, lines 20-33). The PHAs can be either homopolymers or copolymers that may consist of different repeating units of formula (I) (page 7, lines 5-15). Particularly preferred repeating units of formula I include poly(3-hydroxyoctanoate-co-3-hydroxyundecen-10-enoate) (page 7, lines 15-30). Surfactants are not required in the compositions (“may also comprise”, page 11, lines 10-15, claim 1). The base formulation may possibly additionally comprise an aqueous phase (page 10, lines 20-25).
Regarding claims 2-6, the limitation of a composition comprising a) one or more PHA copolymers a) which comprise repeating units chosen from formula I, in which R1 and R2 are defined in claim 1, m and n are integer greater than or equal to 1 and wherein R1 is a hydrocarbon based chain which is either substituted with one or more groups chosen from A- and C+ is met by the ‘899 publication teaching cosmetic compristion comprising a biodegradable polyester comprising from 0.1 by weight to 30% by weight of at least one polyhydroxyalkanoate (PHA) in the form of particles (abstract). The PHA is preferably a polymer having a repeat formulated -O-CHR1-(CH2)n-CO- (I) wherein R1 is selected from C1-C12 alkyls optionally substituted with at least one group selected from COOH, wherein N is 1-6 (page 6, lines 20-33). The PHAs can be either homopolymers or copolymers that may consist of different repeating units of formula (I) (page 7, lines 5-15).
Regarding claim 8, the limitation of wherein R2 is chosen form linear o ranched C3-C20 alkyl is met by the ‘899 publication teaching The PHA is preferably a polymer having a repeat formulated -O-CHR1-(CH2)n-CO- (I) wherein R1 is selected from C1-C12 alkyls optionally substituted with at least one group selected from COOH, wherein N is 1-6 (page 6, lines 20-33). The PHAs can be either homopolymers or copolymers that may consist of different repeating units of formula (I) (page 7, lines 5-15).
Regarding claim 10, the limitation of wherein the PHA copolymer are present in a content ranging from 0.1 to 65% by weight relative to the total weight of the composition is met by the ‘899 publication teaching cosmetic compristion comprising a biodegradable polyester comprising from 0.1 by weight to 30% by weight of at least one polyhydroxyalkanoate (PHA) in the form of particles (abstract).
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example, a PHA copolymer comprising a monomer comprising an AKYL-COOH group and a monomer comprising an Alkyl group in a cosmetic composition) from within the prior art disclosure of the ‘899 publication, to arrive at the instantly claimed cosmetic composition “yielding no more than one would have expected from such an arrangement”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of copending Application No. 18/723,263 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘263 application teaches the elected PHA copolymer (Compound I) used for treatment of keratin in overlapping ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of copending Application No. 18/723,248 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘248 application teaches the elected PHA copolymer (Compound I) used for treatment of keratin in overlapping ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-44 of copending Application No. 18/723,216 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘216 application teaches the elected PHA copolymer (Compound I) used for treatment of keratin in overlapping ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of copending Application No. 18/723,188 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘188 application teaches the elected PHA copolymer (Compound I) used for treatment of keratin in overlapping ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 18/707,648 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘648 application teaches the elected PHA copolymer (Compound I) used for treatment of keratin in overlapping ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 18/707,260 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘260 application teaches the elected PHA copolymer (Compound I) used for treatment of keratin in overlapping ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/706,914 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘914 application teaches the elected PHA copolymer (Compound I) used for treatment of keratin in overlapping ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
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