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 .
Priority
This application is a CON of PCT/US2021/052966 filed 09/30/2021. PCT/US2021/052966 has PRO 63/091,791 filed 10/14/2020. PCT/US2021/052966 has PRO 63/091,799 filed 10/14/2020. PCT/US2021/052966 has PRO 63/085,857 filed 09/30/2020 and PCT/US2021/052966 has PRO 63/085,829 filed 09/30/2020.
Information Disclosure Statement
The information disclosure statements submitted on 08/04/2023, 01/23/2024 and 10/22/2025 have been considered by the examiner.
Election/Restrictions
Claims 24-25, 27-28, 31 are withdrawn from further consideration pursuant to 37 CFR
1.142(b) based on the elected species, there being no allowable generic or linking claim. Applicant’s election of the species of SEQ ID NO: 16 and active ingredients retinoid or vitamin A compound in the reply filed on 01/22/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP 818.01 (a))
Claim Status
Claims 1-2, 4, 7-11, 13, 24-25, 27-28, 31-32, 34, 38, 40, 48, and 57-59 are pending. Claims 3, 5-6, 12, 14-23, 26, 29-30, 33, 35-37, 39, 41-47, 49-56 are canceled. Claims 24-25, 27-28, and 31 are withdrawn.
Claims 1-2, 4, 7-11, 13, 32, 34, 38, 40, 48, and 57-59 are being examined on the merits in this office action.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Please see paragraph [0075, 0194, 0218, 0236, 0343, 0411, 0423] of the instant specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 does not depend on any claim. The claim is therefore indefinite because the metes and bounds are not known. For examination purposes, claim 4 is interpreted as depending on claim 1.
Claim Rejections - 35 USC § 112
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, 4, 7-11, 13, 32, 34, 38, 40, 48, and 57-59 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 MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQe2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 48 USPQ2d
1398’.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606: In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus... ."}.
Regents of the University of California v. Ell Lily & Co. 43 USPQ2d 1398",
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representatives, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618. For written description, the analysis considers (a) actual reduction to practice, (b) disclosure of drawing or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties, functional characteristics when coupled with known or disclosed and (d) Representative number of examples.
(a) actual reduction to practice, (b) disclosure of drawing or structural chemical formulas
The instant claims recites “A composition comprising:(a) a non-naturally occurring recombinant polypeptide selected from the group consisting of a human collagen or a truncate thereof, a jellyfish collagen or a truncate thereof, and an elastin or truncate thereof”, wherein “the non-naturally occurring recombinant polypeptide comprises an amino acid sequence truncated at the C-terminal end, the N- terminal end, internally truncated, or truncated at both the C-terminal end and the N-terminal end, relative to a naturally occurring collagen or elastin”, wherein “wherein the non-naturally occurring recombinant polypeptide is 50 to 900 amino acids in length, 50 to 800 amino acids in length, 50 to 700 amino acids in length, 50 to 600 amino acids in length, 50 to 500 amino acids in length, 50 to 400 amino acids in length, 50 to 300 amino acids in length, 50 to 200 amino acids in length, or 50 to 100 amino acids in length”, and wherein “the non-naturally occurring recombinant polypeptide is or comprises a polypeptide having an N-terminal truncation of 50 to 650 amino acids and a C-terminal truncation of 50 to 250 amino acids relative to a naturally occurring human collagen or a naturally occurring jellyfish collagen”. Examiner notes that the elected sequence is SEQ ID NO: 16 which has 187 amino acids. The claims recite that the composition comprises or consists SEQ ID NO: 16. Examiner notes that SEQ ID NO: 16 is a segment of the human collagen Type 21 alpha 1 which has 957 amino acids. Examiner notes that the claims do not provide ample written description for the compounds since the claims do not have a single structural feature. Further, the specification does not clearly define or provide examples of the numerous variation of the compounds being claimed i.e. truncation of the 957 amino acid polypeptide.
(c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties, functional characteristics when coupled with known or disclosed
The specification does not clearly define or provide examples of the numerous variation of the compounds being claimed i.e. truncation of the 957 amino acid polypeptide, encompassing truncation at N terminus, C terminus, or internal truncation. Examiner notes that the claims recite that the polypeptide may have N-terminal truncation of 50-650 amino acids and C-terminal truncation of 50 to 250 amino acids. The claims recite that the polypeptide may one or both truncation at the C and N-terminal. At most, the human collagen Type 21 alpha 1 of 957 amino acids can have about 900 amino acids truncated, leaving only 57 amino acids. Examiner notes that the polypeptide may also comprise an internal truncation. Examiner notes that it is unclear what part of the polypeptide has the recited function and it is unclear if the truncation occurs on the whole collagen polypeptide or on the elected SEQ ID NO: 16. The claims recite that the recombinant polypeptide may have 50 to 900 amino acids in length. If the truncation occurs on SEQ ID NO: 16, which has a total of 187 amino acids, then a truncation of 650 amino acids is impossible since the polypeptide has a total of 187 amino acids. The claims includes possible variations that are limitless and given that there is no disclosed correlation between function and structure of the sequence, written description is lacking. Examiner notes that even though the claims recite a functional characteristic of “effective to restore and improve the appearance”, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds disclosed in the examples in the specification. It is also unclear what part of the polypeptide would have the recited function of improving or restore the appearance of the subject. Thus, the claims and the specification fail to provide written description for the broad genus.
(d) Representative number of examples
The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad.
Although the specification provides specific amino acid sequences that had the effect of restoring and improving the appearance of a subject, the specification lacks sufficient variety of species to reflect this variance in the genus. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”). For these reasons, the claimed invention lacks written description.
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 1-2, 4, 7-11, 13, 32, 34, 38, 40, 48, and 57-59 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. Claim 1 recites a composition that comprises a naturally occurring peptide/protein fragment, which is not markedly different from its naturally occurring peptide/protein, which is not markedly different from its naturally occurring counterpart because it conveys the same amino acid sequences as the natural human collagen type 21 alpha 1. Further, the elected SEQ ID NO: 16 is not markedly different from its naturally occurring counterpart because it conveys the same amino acid sequences at the residues 559-745 of the natural collagen type 21 alpha 1 (See UniProt ID A0A158RFW1_HUMAN). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons. This judicial exception is not integrated into a practical application because the peptide being claimed is naturally occurring. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because for the following reasons.
The rationale for this determination is explained below and is based on the analysis presented in the USPTO's "2014 Interim Eligibility Guidance" as set forth on December 16, 2014, Revised Guidance set forth on May 2016, and 2019 Revised patent Subject Matter Eligibility Guidance set forth on January 7, 2019. Please see MPEP 2106.
Step 1 : Is the claim to a process, machine, manufacture or composition of matter? The instant claims are directed to a statutory patent-eligible subject matter category, a composition of matter.
Step 2a Prong 1 : Is the claim directed to a law of nature, a natural phenomenon (Product of nature), or an abstract idea? The claims are directed to a natural phenomenon, specifically a natural-based product limitation.
Step 2a Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? This judicial exception is not integrated into a practical application because the polypeptides being claimed are naturally occurring.
Further, as evidenced by UniProt ID A0A158RFW1_HUMAN, the instant SEQ ID NO: 16 is a fragment of the naturally occurring protein isolated from Homo sapiens.
Myriad clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., "isolated") in the claims does not automatically confer eligibility. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not "depend simply on the draftsman' s art").
Examiner notes that composition is known to comprises other components such as active ingredients and carriers. The instant claims recite that the composition requires active ingredients such as grape seed extract, tea extract, which are naturally occurring. Further, the claims recite that the composition carriers and the specification discloses that the carriers include water which is also naturally occurring.
Step 2b: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims, as a whole, do not recite any additional elements that amount to significantly more than the judicial exception. Specifically, the claims do not include any elements in addition to the natural product.
In sum, when the relevant steps are analyzed, they weigh against a significant difference. Accordingly, claims 1-2, 4, 7-11, 13, 32, 34, 38, 40, 48, and 57-59 does not qualify as eligible subject matter.
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.
Claims 1, 4, 7-11, 13, 32, 34, 38, 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ouzounov et al. (WO2019068018A2 – hereinafter “Ouzounov”).
Regarding claim 1, Ouzounov teaches a composition comprising 0.005% and 30% w/w non-naturally occurring collagen [0012] and that the composition comprises other cosmetic ingredients [0075] or other ingredients such as sorbic acid, Germaben II, rosemary extract, and EDTA [0076], that the composition is a topical compositions used for decreasing skin damage or promoting the repair of damaged skin [0013], wherein the collagen is recombinantly prepared [0053]. Examiner notes that Germaben II is a known active ingredients used in cosmetic formulations; rosemary extract is also an active ingredient. The disclosure anticipate claim 1.
Regarding claim 4, Ouzounov teaches that the non-naturally occurring collagen is jellyfish (Hydrozoan) collagen, human collagen, that the non-naturally occurring collagen is a full-length or a truncated collagen, that the collagen is truncated by an internal truncation of between 50 amino acids and 500 amino acids, and that the truncation is at the C-terminal end or the N-terminal end of the collagen polypeptide [0010, 0056-0057, 0068].
Regarding claim 7, Ouzounov teaches the non-naturally occurring collagen is jellyfish (Hydrozoan) collagen, human collagen [0010].
Regarding claim 8, Ouzounov teaches that the non-naturally occurring collagen of SEQ ID NO: 16 [0010], which has 211 amino acids which reads on or falls within the recited amino acid ranges thus anticipating the claim.
Regarding claim 9, Ouzounov teaches that the non-naturally occurring collagen is jellyfish (Hydrozoan) collagen, human collagen, that the non-naturally occurring collagen is a full-length or a truncated collagen, that the collagen is truncated by an internal truncation of between 50 amino acids and 650 amino acids or between 50 amino acids and 250 amino acids, and that the truncation is at the C-terminal end or the N-terminal end of the collagen polypeptide [0010, 0068].
Regarding claim 10, Ouzounov teaches wherein the human collagen is human collagen Type 21 [0274, 0277, 0278].
Regarding claims 11 and 13, Ouzounov teaches that the non-naturally occurring collagen of SEQ ID NO: 16 [0010], which comprises the instant SEQ ID NO: 16.
Regarding claim 32, Ouzounov teaches a composition comprising 0.005% and 30% w/w non-naturally occurring collagen [0012] and that the composition comprises other cosmetic ingredients [0075] or other ingredients carriers such as sorbic acid, and EDTA [0076], that the composition is a topical compositions used for decreasing skin damage or promoting the repair of damaged skin [0013].
Regarding claim 34, Ouzounov teaches compositions comprising non-naturally occurring collagen are in one aspect topical compositions for applying to skin [0013-0017] or hair [0075].
Regarding claim 38, Ouzounov teaches a composition comprising 0.005% and 30% w/w non-naturally occurring collagen [0012], wherein the collagen is recombinantly prepared [0053].
Regarding claim 48, Ouzounov teaches that the compositions that comprise the between non-naturally occurring collagen are personal care products such as masks, skin cleaners such as soap, cleansing creams, cleansing lotions, cleansing milks, cleansing pads, facial washes, hair shampoo, hair conditioner and body shampoos [0075].
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.
Claims 2, 40, and 57-59 are rejected under 35 U.S.C. 103 as being unpatentable over Ouzounov et al. (WO2019068018A2 – hereinafter “Ouzounov”) as applied to claim 1 above, and further in view of Chang et al. (WO2015020982A2 – hereinafter “Chang”).
The teachings of Ouzounov are disclosed above and incorporated herein by reference.
Examiner notes that Ouzounov teaches the instant composition comprising collagen and other active ingredients, but does not teach the active ingredient is the elected retinol or vitamin A as recited in claim 2.
However, it is known in the art to combine collagen and retinol in a cosmetic composition for topical or dermal injection as taught by Chang et al.
Chang teaches a composition comprising vitamins combined with hyaluronic acid, and collagen [0035, 0057-0059], wherein the vitamins include one or more retinols [0008, 0084, 00527], such as retinoic acid [00175, 00430]. Chang teaches that the composition is formulated for topical use and/or dermal injection [0009, 0042, 0049-0050], and that such composition can be for use as dermal fillers [00142] and used for reducing fine lines and making wrinkles and facial fine lines appear softer and/or less prominent [0049-0050, 0059-0060, 00147, 00171, 00187] and for wound healing [00183, 00318]. Chang teaches that the composition helped with improved skin quality, health and appearance (Abstract). Chang teaches that there is a need to include vitamins in the composition for intradermal and also topical use that serve for aesthetic enhancement purpose and that the composition may improve skin elasticity, luminosity, skin regeneration, metabolism, smoothness and/or softness of skin (i.e., making the skin feel smoother and softer following treatment); the overall appearance of skin; evening out skin tone and texture; clarity and/or radiance of skin; making the skin look younger; and reducing fine lines and making wrinkles and facial fine lines appear softer and/or less prominent [0049].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Ouzounov and include vitamins such as retinol as taught by since Chang teaches that the composition comprising collagen and retinol was used for intradermal and also topical use that serve for aesthetic enhancement purpose [0049]. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in including retinol as one of the active ingredients since Chang specifically teaches that the composition comprises collagen and retinols and specifically teaches that the retinol is retinoic acid and teaches that the composition may improve skin elasticity, luminosity, skin regeneration, metabolism, smoothness and/or softness of skin [0049].
Regarding claim 2, Chang teaches a composition comprising vitamins combined with hyaluronic acid, and collagen [0035, 0057-0059], wherein the vitamins include one or more retinols [0008, 0084, 00527], such as retinoic acid [00175, 00430]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Ouzounov and include vitamins such as retinol as taught by since Chang teaches that the composition comprising collagen and retinol was used for intradermal and also topical use that serve for aesthetic enhancement purpose [0049].
Regarding claim 40, Chang teaches a composition comprising vitamins combined with hyaluronic acid, and collagen [0035, 0057-0059], wherein the vitamins include one or more retinols [0008, 0084, 00527], such as retinoic acid [00175, 00430]. Chang teaches that the additional agents can be added to the composition in an amount of from about 0.01% and about 2% [0021]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Ouzounov and include vitamins such as retinol in the taught amounts as taught by since Chang teaches that the composition comprising collagen and retinol was used for intradermal and also topical use that serve for aesthetic enhancement purpose [0049].
Regarding claims 57-59, Chang teaches that the composition is formulated for topical use and/or dermal injection [0009, 0042, 0049-0050], and that such composition for use as dermal fillers [00142] and used for reducing fine lines and making wrinkles and facial fine lines appear softer and/or less prominent [0049-0050, 0059-0060, 00147, 00171, 00187] and for wound healing [00183, 00318]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Ouzounov and administer it as taught by Chang since Chang teaches that such a composition can be formulated for topical use and/or dermal injection for use in reducing fine lines and making wrinkles and facial fine lines appear softer and/or less prominent.
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 1-2, 4, 8-9, 11, 13, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9, 17-18, 23-25 of U.S. Patent No. US11174300B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite a composition comprising the non-naturally occurring polypeptide of claim 1, wherein the composition is a product formulated for consumption by an individual (claim 17, 23), wherein the composition further comprising at least one of a carbohydrate, a lipid, a supplemental mineral, a supplemental vitamin, an excipient, a buffering agent, a flavoring agent, a sweetener, or a coloring agent (claim 24), the composition for improving the appearance of the skin, the hair, and/or the nails of a subject, and/or improving bone, muscle, and/or joint health in the subject (claim 25).
The instant claims recite a composition comprising:(a) a non-naturally occurring recombinant polypeptide selected from the group consisting of a human collagen or a truncate thereof, a jellyfish collagen or a truncate thereof, and an elastin or truncate thereof; and(b) one or more active ingredient, wherein the non-naturally occurring recombinant polypeptide and the one or more active ingredient are present in the composition in amounts effective to restore or improve the appearance of a subject (claim 1). The claims of the patent anticipate the instant claims.
Regarding claim 2, the claims of the patent recite wherein the composition further comprising at least one of a carbohydrate, a lipid, a supplemental mineral, a supplemental vitamin, an excipient, a buffering agent, a flavoring agent, a sweetener, or a coloring agent (claim 24).
Regarding claims 4, 9, 11, 13, the claims of the patent recite non-naturally occurring polypeptide comprising an amino acid sequence having at least 80% sequence identity to a truncate of SEQ ID NO: 31, wherein the truncate of SEQ ID NO: 31 has an N-terminal truncation of 50 amino acids to 650 amino acids, a C-terminal truncation of 50 amino acids to 250 amino acids, or both the N-terminal truncation and the C-terminal truncation, relative to SEQ ID NO: 31 (claims 1-6).
Regarding claim 8, the claims of the patent recite wherein the non-naturally occurring polypeptide is 50 amino acids to 250 amino acids in length (claim 9).
Regarding claim 38, the claims of the patent recite wherein the non-naturally occurring polypeptide is an ingredient present in the product in a concentration of at least 0.1% w/w (claim 18).
Claims 1-2, 4, 10, 32 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-11 of U.S. Patent No. US11180541B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite a composition comprising the non-naturally occurring polypeptide comprising from 0.005% to 30% w/w, comprising the amino acid sequence of a collagen with an internal truncation of from 50 amino acids to 300 amino acids, wherein the collagen is selected from the group consisting of jellyfish collagen, human type 21 collagen (Claim 1, 8), wherein the composition is a topical composition, and wherein the topical composition further comprises at least one additional ingredient selected from the group consisting of: a topical carrier, a preservative, and both (claim 9), wherein the preservative includes sorbic acid (claim 11).
The instant claims recite a composition comprising:(a) a non-naturally occurring recombinant polypeptide selected from the group consisting of a human collagen or a truncate thereof, a jellyfish collagen or a truncate thereof, and an elastin or truncate thereof; and(b) one or more active ingredient, wherein the non-naturally occurring recombinant polypeptide and the one or more active ingredient are present in the composition in amounts effective to restore or improve the appearance of a subject (claim 1). The claims of the patent anticipate the instant claims.
Regarding claim 2, the claims of the patent recite wherein the composition is a topical composition, and wherein the topical composition further comprises at least one additional ingredient selected from the group consisting of: a topical carrier, a preservative, and both (claim 9), wherein the preservative includes sorbic acid (claim 11).
Regarding claims 4, the claims of the patent recite a composition comprising the non-naturally occurring polypeptide comprising from 0.005% to 30% w/w, comprising the amino acid sequence of a collagen with an internal truncation of from 50 amino acids to 300 amino acids (claims 1-5, 8).
Regarding claim 10, the claims of the patent recite wherein the non-naturally occurring polypeptide is collagen is selected from the group consisting of jellyfish collagen, human type 21 collagen (Claim 1, 8).
Regarding claim 32, the claims of the patent recite wherein the topical composition further comprises at least one additional ingredient selected from the group consisting of: a topical carrier, a preservative, and both (claim 9).
Regarding claim 38, the claims of the patent recite a composition comprising the non-naturally occurring polypeptide comprising from 0.005% to 30% w/w, comprising the amino acid sequence of a collagen with an internal truncation of from 50 amino acids to 300 amino acids (claims 1-5, 8).
Claims 1-2, 4, 8-9, 32, 34, 38, and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 9-10, 30, 33, 35, 37, 39, 40, 42, 44, 46, 48, 58 of copending Application No. 18/420,585. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application recite a cosmetic formulation comprising: a polypeptide comprising or consisting of an amino acid sequence having at least 80% sequence identity to SEQ ID NO: 32, or a polypeptide comprising or consisting of an amino acid sequence having at least 80% sequence identity to a truncate of SEQ ID NO: 32, wherein the cosmetic formulation is selected from the group consisting of[[:]] a cream, a gel, a gel cream, an oil, an ointment, a serum, a foam, a lotion, a paste, a balm, a solution, a suspension, and a powder (claim 1), wherein the formulation further comprises one or more additional ingredients selected from the group consisting of: levulinic acid, polyglyceryl-3 methylglucose distearate, glyceryl undecylenate, Simmondsia chinensis (Jojoba) seed oil, polyacrylate cross-polymer, squalane, sodium hyaluronate, acrylic acid polymers (carbomers), pentylene glycol, sodium lauryl sulfoacetate, sodium oleoyl sarcosinate, sodium oleate, Ricinus communis (castor) seed oil, Copernicia cerifera (Carnauba) wax, Candelilla wax, Theobroma cacao (Cocoa) Seed Butter, isononyl isononanoate, ozokerite, isopropyl titanium triisostearate, polyhydroxystearic acid, iron oxide, titanium dioxide, sodium levulinate, and hydroxypropyl guar (claim 3).
The instant claims recite a composition comprising: (a) a non-naturally occurring recombinant polypeptide selected from the group consisting of a human collagen or a truncate thereof, a jellyfish collagen or a truncate thereof, and an elastin or truncate thereof; and(b) one or more active ingredient, wherein the non-naturally occurring recombinant polypeptide and the one or more active ingredient are present in the composition in amounts effective to restore or improve the appearance of a subject (claim 1). The claims of the copending application anticipate the instant claims.
Regarding claims 2, 32, the copending claims recite wherein the formulation further comprises one or more additional ingredients selected from the group consisting of: levulinic acid, polyglyceryl-3 methylglucose distearate, glyceryl undecylenate, Simmondsia chinensis (Jojoba) seed oil, polyacrylate cross-polymer, squalane, sodium hyaluronate, acrylic acid polymers (carbomers), pentylene glycol, sodium lauryl sulfoacetate, sodium oleoyl sarcosinate, sodium oleate, Ricinus communis (castor) seed oil, Copernicia cerifera (Carnauba) wax, Candelilla wax, Theobroma cacao (Cocoa) Seed Butter, isononyl isononanoate, ozokerite, isopropyl titanium triisostearate, polyhydroxystearic acid, iron oxide, titanium dioxide, sodium levulinate, and hydroxypropyl guar (claim 3).
Regarding claims 4, 8-9, the copending claims recite wherein the truncate of SEQ ID NO: 32 comprises an N-terminal truncation, a C-terminal truncation, or both, relative to SEQ ID NO: 32, wherein the N-terminal truncation is an N-terminal truncation of 50 amino acids to 750 amino acids relative to SEQ ID NO: 32; and/or wherein the C-terminal truncation is a C-terminal truncation of 50 amino acids to 600 amino acids relative to SEQ ID NO: 32 (claims 1, 4, 9-10)
Regarding claims 34, 48, the copending claims recite a personal care product comprising the cosmetic formulation wherein the personal care product is selected from the group consisting of: a mask, a skin cleaners, a cleansing cream, a cleansing lotion, a facial lotion, a body lotion, a shower gel, an antiperspirant, a deodorant, a shave cream, a depilatory, a face oil, a lip oil, a body oil, a facial cleanser, a cleansing milk, a cleansing pad, a facial wash, a facial cream, a body cream, a facial moisturizer, a body moisturizer, a facial serum, a facial mask, a body mask, a facial toner, a facial mist, an eye cream, an eye serum, an exfoliator formula, a lip balm, a lipstick, a hair shampoo, a hair conditioner, a body shampoo, a hair serum, a scalp serum, a hair mist, a hair spray, a foundation, a tinted multifunctional cream, an eye shadow, a concealer, a mascara, and/or any combination thereof (claims 37, 39, 40, 42, 44, 46, 48, 58).
Regarding claims 38, the copending claims recite wherein the polypeptide is present in the cosmetic formulation at an amount of 0.001% to 30% w/w (claim 30).
Claims 1-2, 4, 7-11, 13, 32, 34, 38, and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49, 55-56, 58-62, 64-75 of copending Application No. 17/491,228. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application recite a composition comprising about 0.001% to about 30% w/w of a non- naturally occurring polypeptide comprising the amino acid sequence of SEQ ID NO: 16 (claim 49, 55), wherein the composition is formulated for topical application (claim 56), the composition further comprising a topical carrier (claim 61), or one or more additional ingredients selected from the group consisting of water, oil, glycereth-8 esters, glycerin, coconut alkanes, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, pentylene glycol, disodium ethylenediaminetraacetic acid (EDTA), caprylyl glycol, chlorophenesin, and phenoxyethanol (claim 62), the method of providing a benefit to the skin (claims 64-72).
The instant claims recite a composition comprising: (a) a non-naturally occurring recombinant polypeptide selected from the group consisting of a human collagen or a truncate thereof, a jellyfish collagen or a truncate thereof, and an elastin or truncate thereof; and(b) one or more active ingredient, wherein the non-naturally occurring recombinant polypeptide and the one or more active ingredient are present in the composition in amounts effective to restore or improve the appearance of a subject (claim 1). The claims of the copending application anticipate the instant claims.
Regarding claims 2, the copending claims recite the composition further comprising a topical carrier (claim 61), or one or more additional ingredients selected from the group consisting of water, oil, glycereth-8 esters, glycerin, coconut alkanes, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, pentylene glycol, disodium ethylenediaminetraacetic acid (EDTA), caprylyl glycol, chlorophenesin, and phenoxyethanol (claim 62). Examiner notes that pentylene glycol has antibacterial properties.
Regarding claims 4, 7-11, 13, the copending claims recite non-naturally occurring polypeptide produced in a microbial host cell, the non-naturally occurring polypeptide comprising an amino acid sequence having at least about 80% sequence identity to a truncate of SEQ ID NO: 31, wherein: i) the truncate of SEQ ID NO: 31 has a truncation at both the N-terminal end and the C- terminal end, ii) the truncate of SEQ ID NO: 31 has a total truncation of 500 amino acids to 770 amino acids, iii) the non-naturally occurring polypeptide comprises the amino acid sequence of SEQ ID NO: 16 (claim 49).
Regarding claim 32, the copending claims recite the composition further comprising a topical carrier (claim 61).
Regarding claim 34, the copending claims recite wherein the composition is a personal care product for application to skin or hair (claim 58).
Regarding claim 38, the copending claims recite composition comprising about 0.001% to about 30% w/w of a non- naturally occurring polypeptide (claim 55).
Regarding claim 48, the copending claims recite wherein the personal care product is selected from the group consisting of: a facial cream, a facial lotion, a facial serum, a facial mask, a facial toner, a boy cream, a body moisturizer, an eye cream, an eye treatment, a lip balm, a lipstick, a hair shampoo, a hair conditioner, a hair serum, a scalp serum, a hair mist, and a hair spray (claim 59).
Claims 1-2, 4, 7-11, 13, 32, 34, and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-28, 34-35, 40-45 of copending Application No. 18/750,919. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application recite a composition comprising from about 0.005% to about 30% w/w of the recombinant polypeptide of claim 26 (claim 40), wherein recombinant human type 21 alpha 1 collagen polypeptide comprising: an N-terminal and/or a C-terminal truncation (claim 26), wherein the composition comprises a topical carrier and/or a preservative (claim 42).
The instant claims recite a composition comprising: (a) a non-naturally occurring recombinant polypeptide selected from the group consisting of a human collagen or a truncate thereof, a jellyfish collagen or a truncate thereof, and an elastin or truncate thereof; and(b) one or more active ingredient, wherein the non-naturally occurring recombinant polypeptide and the one or more active ingredient are present in the composition in amounts effective to restore or improve the appearance of a subject (claim 1). The claims of the copending application anticipate the instant claims.
Regarding claim 2, the copending claims recite wherein the composition comprises a topical carrier and/or a preservative (claim 42).
Regarding claims 4, 7-10, the copending claims recite a recombinant human type 21 alpha 1 collagen polypeptide comprising: an N-terminal and/or a C-terminal truncation (claim 26), wherein the recombinant polypeptide comprises an N-terminal truncation that is between 1 and 85 amino acids relative to full-length human type 21 alpha 1 collagen (claim 27), wherein the recombinant polypeptide comprises an N-terminal truncation that is between 1 and 212 amino acids relative to full-length human type 21 alpha 1 collagen (claim 28).
Regarding claims 11, 13, the copending claims recite wherein the recombinant polypeptide comprises at least 95% amino acid sequence identity to full length SEQ ID NO: 76 (claims 34-35). The sequence is identical to instant SEQ ID NO: 16.
Regarding claim 32, the copending claims recite wherein the composition comprises a topical carrier and/or a preservative (claim 42).
Regarding claim 34, the copending claims recite wherein the composition is formulated for topical application (claim 41), for treating the skin (claims 43-45).
Regarding claim 38, the copending claims recite composition comprising from about 0.005% to about 30% w/w of the recombinant polypeptide (claim 40)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/MERCY H SABILA/Examiner, Art Unit 1654