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
The present application claims status as a 371 (National Stage) of PCT/KR2021/020229 filed 12/29/2021, and claims priority under 119(a)-(d) to Korean Application No. KR10-2021-0130423 filed on 09/30/2021.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Korean Application No. KR10-2021-0130423, which papers have been placed of record in the file. Please note that the Korean application is in a foreign language and thus cannot be verified.
Claim Status
Claims 1-11 were filed on 03/29/2024.
Information Disclosure Statement
The IDS(s) filed on 03/24/2024, 03/14/2025, 06/26/2025, 04/06/2026 and 04/22/2026 have been considered by the Examiner.
However, per 37 CFR 1.98, when applicants cite a foreign language reference, whether Non-Patent Literature (NPL) or Foreign Patent (FP); Applicants are required to submit (1) an English language abstract, (2) English translation/equivalent reference, or (3) a statement of relevance in a transmittal letter. In the instant case, NPLs filed on 06/26/2025, 04/06/2026 and 04/22/2026 have not been considered because the NPLs are in a foreign language (i.e., Japanese and Chinese) and an English translation/equivalent reference nor a statement of relevance in a transmittal letter have not been submitted.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because the "Sequence Listing" part of the disclosure submitted as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) is not the same as the CRF of the "Sequence Listing" as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Required response - Applicant must provide:
A replacement "Sequence Listing" as described above in items 1) c) or d) in accordance with 37 CFR 1.825(b)(1)(ii) or (iii); as well as
An amendment specifically directing its entry into the application as required by 37 CFR 1.825(b)(2)(ii);
A statement that identified the locations of any deletions, replacements or additions to the “Sequence Listing” as required by 37 CFR 1.825(b)(3);
A statement that the "Sequence Listing" added by amendment includes no new matter as required by 37 CFR 1.825(b)(5);
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4); and
A statement that the content of the previously-filed CRF is identical to the "Sequence Listing" part of the disclosure added by amendment as required by 37 CFR 1.825(b)(7), where provided under item 1) c) or d) (note that where a "Sequence Listing" part of the disclosure is provided under item 1) a) or b), the text file will also serve as the CRF, and the statement of identity is not required);
OR
A CRF as required by 37 CFR 1.821(e)(1) or 1.821(e)(2); and
A statement that the content of the CRF is identical to the "Sequence Listing" part of the disclosure previously submitted as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Specification
The disclosure is objected to because of the following informalities: the specification filed on 03/29/2024, makes reference to SEQ ID NO: 1 (i.e., KRRRKRK) and the Sequence Listing in Computer Readable Form filed on 03/29/2024, lists SEQ ID NO: 1 as LYSARGARGARGLYSARGLYS. Since conflicting information pertaining to the sequence represented by SEQ ID NO: 1 has been presented, it is difficult to determine which amino acid sequence version is accurate.
Appropriate correction is required.
Claim Interpretation
For purposes of applying prior art, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation set forth below, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
The scope of “a peptide comprising”, is interpreted as open-ended requiring 100% identity to SEQ ID NO: 1 (i.e., KRRRKRK) with any N-/C-terminal additions. Per MPEP 2111.03(I), the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. As such, a peptide that comprises SEQ ID NO: 1 (i.e., KRRRKRK) would meet the claim limitation.
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.
1. Claims 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 is drawn to “[a] peptide comprising an amino acid sequence of SEQ ID NO: 1”. The instant specification, at pg. 19, para[0093], Table 1, makes reference to the amino acid sequence KRRRKRK represented by SEQ ID NO: 1. Conversely, the Sequence Listing in Computer Readable Form filed on 03/29/2024, at pg. 3 of 6, lists SEQ ID NO: 1 as LYSARGARGARGLYSARGLYS. Therefore, an ordinary skilled artisan would not be able to ascertain the metes and bounds of the claimed peptide comprising an amino acid sequence of SEQ ID NO: 1, because it has not been clearly established, whether the amino acid sequence represented by sequence identity number 1 corresponds to KRRRKRK or to LYSARGARGARGLYSARGLYS. In order to advance prosecution, SEQ ID NO: 1 as recited in instant claim 1, will be interpreted as KRRRKRK. Claims 2-11 are also indefinite because of their dependency upon a rejected claim under 35 U.S.C 112(b).
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.
2. Claims 2-11 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.
MPEP 2163.II.A.3.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the 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”.
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Nature of the Invention:
Claims 2-11 are broadly directed to a composition comprising the peptide of claim 1 that comprises an amino acid sequence of SEQ ID NO: 1. The included dependent claims, while further limiting the composition, largely do not further limit the breadth of the claimed peptide, which therefore does not suffice as sufficient breadth limitation.
Applicants only reduced to practice one peptide comprising an amino acid sequence of SEQ ID NO: 1 (i.e., KRRRKRK). However, a representative number of peptides comprising the amino acid sequence of SEQ ID NO: 1 that exhibit the claim functions (i.e., skin aging inhibition or skin regeneration), have not been reduced to practice. Therefore, any peptide comprising KRRRKRK, would exhibit the function of skin aging inhibition and/or skin regeneration activity.
Since the claims require a peptide comprising an amino acid sequence of SEQ ID NO: 1 (i.e., KRRRKRK), the Specification must sufficiently demonstrate possession of a representative number of peptides comprising KRRRKRK, that exhibit the desired function/activity, that results from the relationship, or correlation between structure and function, sufficient to allow one of skill in the art to identify possession of the full scope of the invention.
Conclusion regarding possession:
Applicant does not have sufficient breadth of disclosure, namely a representative number of species and/or with the structure: function relationship (SEQ ID NO: 1) necessary to effectively demonstrate possession of the invention, for the exceptionally large genus of peptides comprising an amino acid sequence of SEQ ID NO: 1, as recited in instant claim 1.
The species described are insufficient to serve as representative of the entire genus. The nature of experimentation necessary to identify the peptides comprising SEQ ID NO: 1 with the desired function would be unusually high and the motivation to test all peptides would therefore be very low. Taking into consideration the factors outlined above, including the nature of the invention, the state of the art, the guidance provided by the Specification, it is concluded that the specification does not demonstrate sufficient written description to indicate possession of the invention as recited in the claims.
Reduction to practice of a single peptide comprising an amino acid sequence of SEQ ID NO: 1, is not sufficient representation of the entire genus of peptides that comprise KRRRKRK. Applicants are in possession of a single peptide comprising an amino acid sequence of SEQ ID NO: 1.
3. Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for skin aging inhibition and skin regeneration, does not reasonably provide enablement for preventing photoaging. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
To address whether sufficient evidence supports the determination that the disclosure does not satisfy the enablement requirement and whether undue experimentation might be needed, the below factors are considered:
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The breadth of the claims: The claim encompasses where preventing includes 100% prevention of photoaging. Additionally, the breadth of the claim exacerbates the complex nature of the subject matter to which the present claim is directed, because photoaging results from DNA changes to the skin cells by UV radiation.
The nature of the invention: The invention pertains to using a peptide comprising SEQ ID NO: 1, and compositions comprising the peptide to inhibit skin aging and/or induce skin regeneration.
The state of the prior art: The art teaches that photoaging is the premature aging of your skin due to ongoing exposure to ultraviolet A (UVA) and ultraviolet B (UVB) radiation. UV radiation causes changes to the DNA in the cells of tour skin, which can lead to premature skin aging (photoaging) and skin cancer (see Cleveland Clinic, “Sun-Damaged Skin (Photoaging)” retrieved on 06/16/2026 from https://my.clevelandclinic.org/health/diseases/5240-sun-damage-protecting-yourself, last updated on 10/28/2022, herein after “Cleveland Clinic”). Cleveland Clinic adds that once UV radiation changes your skin cells’ DNA, the DNA damage can’t be reversed. However, this doesn’t mean that you can’t change the appearance of your skin. You can treat, reduce and/or repair the effects of sun-damaged skin. Treatments can remove spots and other skin discolorations, reduce wrinkles and fine lines, smooth out skin, stimulate new skin and collagen production - steps that improve the look, tone and quality of your skin (see Cleveland Clinic, pg. 1, last paragraph). The art also teaches that peptides are reshaping modern dermatology by acting as potent biological messengers that influence virtually every aspect of skin vitality (see Dermakor, Blog, “Penetrable Peptides in Dermal Sciences: The Next Era of Effective Regeneration”, retrieved from https://www.imcas.com/en/blog/article/1208/penetrable-peptides-in-dermal-sciences-the-next-era-of-effective-regeneration, on 06/16/2026, first available online on April 7th, 2026, herein after “Dermakor”). Dermakor adds that cell penetrating peptides elevate the potential of peptides and other actives by enabling them to cross cell membranes and reach the cytosol, where key regulatory processes occur. Unlike conventional topical ingredients that primarily act near the skin surface, CPPs fundamentally shift how functional actives interact with the skin. They enter cells through both energy dependent and direct translocation mechanisms, dramatically amplifying the effects of peptides, antioxidants, growth factor mimetics, anti-inflammatory agents. Their non disruptive uptake, safety, biocompatibility, and flexibility across covalent, noncovalent, and micelle-based formats make CPPs an essential platform in advanced cosmetic formulation (see Dermakor, pg. 1, second paragraph).
The level of one of ordinary skill: Practitioners in this art (medical clinicians, pharmacists, doctors and/or pharmaceutical chemists) would presumably be highly skilled in the art for the prevention photoaging.
The level of predictability in the art: The instant claimed invention is highly unpredictable. If one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains (i.e., preventing photoaging), then there is a lack of predictability in the art. Moreover, it is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The court has indicated that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. (See In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970)). This is because it is not obvious from the disclosure of one species, what other species will work. In the instant case, Applicants do not demonstrate that photoaging can be prevented with a composition comprising an amino acid sequence of SEQ ID NO: 1.
The amount of direction provided by the inventor: The specification does not enable any person skilled in the art to which it pertains to use the invention commensurate in scope with the claims. There is a lack of adequate guidance from the specification with regard to the actual prevention photoaging as recited in the claims. Applicants fail to provide the guidance and information required to ascertain whether the claimed administration of composition comprising SEQ ID NO: 1, prevents DNA changes caused by UV radiation to skin cells without resorting to undue experimentation. Applicants' limited disclosure is noted but is not sufficient to justify claiming preventing photoaging, as claimed.
The existence of working examples: The specification does not articulate the use of a peptide comprising SEQ ID NO: 1, in photoaging prevention. Instead, the working examples pertain to the secretion of proteins of extracellular matrix components (i.e., collagen and hyaluronic acid) (see instant specification, pg. 21, para[00104]); Increase in Expression of genes (SIRT1 and AQP3) related to skin barrier function (see instant specification, pg. 22, para[00111]); confirmation of effect of inhibiting active oxygen species increased by UV rays (see instant specification, pg. 23, para[00118]); confirmation of increase in expression of extracellular matrix components genes inhibited by ultraviolet rays (see instant specification, pg. 25, para[00127]); confirmation of inhibition of Expression of MMP-1 and Activity of MMP-2 Increased by UV rays (see instant specification, pg. 26, para[00134]); and confirmation of inhibition of Expression of MMP-1 increased by heat treatment (see instant specification, pg. 28, para[00142]). However the working examples lack evidence of 100% prevention of photoaging.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: Due to the breadth of the claim, preventing photoaging by administering the claimed composition comprising a peptide comprising SEQ ID NO: 1 would require substantive experimentation, given that Applicants have only reduced to practice one peptide, and that one peptide is not a representative number of the claimed genus.
After applying the Wands factors and analysis to claim 11, in view of the applicant' s entire disclosure, and considering the In re Wright, In re Fisher and Genentech decisions discussed above, it is concluded that the practice of the invention as claimed in claim 11 would not be enabled by the written disclosure for a pharmaceutical composition comprising the peptide of claim 1 as an active ingredient. Therefore, claim 11 is rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to prevent photoaging.
Applicants can overcome the instant rejection by amending independent claim 11 to recite “inhibiting or delaying” instead of preventing photoaging.
Claim Rejections - 35 USC § 102
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.
4. Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by US 2021/0206811 A1 Pub. Date: Jul. 8, 2021 (herein after “DiMaio”).
Regarding claim 1, DiMaio discloses a peptide with the amino acid sequence IPWVIHTHDYSGDFYLHPSLRKRRRKRKYL represented by SEQ. ID NO: 389 (see pg. 15, Table 1, 5th entry). The peptide comprise residues KRRRKRK (i.e., instant SEQ ID NO: 1) from residues 23 to 29.
Regarding claim 2, MPEP 2112.01 (II) states: "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
DiMaio’s peptide (i.e., SEQ ID NO: 389), which is 100% identical to instant SEQ ID NO: 1 from position 23 to 29 reads on the instantly claimed peptide comprising the amino acid sequence represented by SEQ ID NO: 1. Therefore DiMaio’s peptide necessarily possesses the claimed skin aging inhibition activity or skin regeneration activity, because a chemical composition and its properties are inseparable. Thereby, the instantly claimed properties and/or functions are necessarily present in DiMaio’s peptide.
Regarding claims 3-11, MPEP 2112.01 states that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not inherently possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Accordingly, the claimed functional properties of the compositions as recited in instant claims 3-11 would necessarily read upon the prior art, because as previously discussed DiMaio’s SEQ ID NO: 389 anticipates the instantly claimed peptide comprising the amino acid sequence represented by SEQ ID NO: 1. Therefore, the claimed properties/functions of the compositions would have been obvious to one skilled in the art.
With respect to the intended use of each of the compositions (i.e., claims 3,9 and 11), the Examiner would like to remind Applicants that the preambles recite pharmaceutical compositions, and while the use of a descriptive clause, i.e. “for skin aging inhibition”, “for skin regeneration”, “for preventing or treating”, when referring to the contemplated use (i.e. “intended use”) of a claimed compound is proper, it is not a limitation and thus of no significance in determining the patentability thereof over the prior art, please refer to In re Thomas (CCPA 1949) 178 F2d 412, 84 USPQ 132.
Accordingly, claims 1-11 are anticipated by the DiMaio’s disclosure of SEQ ID NO: 389.
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.
5. Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/697,403 claim set filed on 03/29/2024 (PG Pub US 20240409584A1) in view of US 2021/0206811 A1 Pub. Date: Jul. 8, 2021 (herein after “DiMaio”), and Vedadghavami et al. Nano Today. 2020 October; 34:100898, pp. 1-52 (herein after “Vedadghavami”).
Regarding instant claims 1-11, Copending Application ‘403 claims:
1. A peptide comprising an amino acid sequence of SEQ ID NO: 1.
2. The peptide of claim 1, wherein the peptide has skin aging inhibition activity or skin regeneration activity.
3. A composition for skin aging inhibition or skin regeneration, the composition comprising the peptide of claim 1 as an active ingredient.
4. The composition of claim 3, wherein the composition improves resistance to damage to cells caused by aging or an external stimulus.
5. The composition of claim 4, wherein the external stimulus is ultraviolet rays or infrared rays.
6. The composition of claim 4, wherein the cells are skin fibroblasts or keratinocytes.
7. The composition of claim 3, wherein the composition i) increases expression or secretion of collagen, fibronectin, or elastin, and ii) increases expression of SIRT1 or AQP3.
8. The composition of claim 3, wherein the composition i) inhibits production of reactive oxygen species (ROS) caused by ultraviolet rays, ii) increases expression of collagen, fibronectin, or elastin decreased by ultraviolet rays, and iii) inhibits expression of MMP-1 or activity of MMP-2 and MMP-9 increased by ultraviolet rays.
9. A cosmetic composition for skin aging inhibition or skin regeneration, the cosmetic composition comprising the peptide of claim 1 as an active ingredient.
10. The cosmetic composition of claim 9, wherein the skin aging inhibition or the skin regeneration is prevention or reduction of skin wrinkles, skin elasticity improvement, skin barrier strengthening, prevention of pigmentation, or amelioration of skin photoaging.
11. A pharmaceutical composition for preventing or treating photoaging, the pharmaceutical composition comprising the peptide of claim 1 as an active ingredient.
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because in Copending App ‘403, SEQ ID NO: 1 is represented by DSSPLRSPSYAS (see specification, filed 03/29/2024, pg. 22, para[00103], Table 1).
As such the difference between Copending App ‘403 claims 1-11 and instant claims 1-11 is instant SEQ ID NO: 1 (i.e., KRRRKRK).
Since DiMaio discloses the amino acid sequence IPWVIHTHDYSGDFYLHPSLRKRRRKRKYL represented by SEQ ID NO: 389 (see DiMaio, pg. 15, Table 1, 5th entry); which reads on the instantly claimed peptide; an ordinary skilled artisan would have been motivated to arrive at the claimed invention by substituting DSSPLRSPSYAS (i.e., SEQ ID NO: 1) in Copending App ‘403 with DiMaio’s SEQ ID NO: 389.
One of ordinary skill in the art would have been motivated to do so drug delivery using cationic peptides and proteins was known (see Vedadghavami, pg. 1, Title). Vedadghavami adds that CPPs have sparked considerable interest due to their ability to penetrate through the skin stratum corneum (SC), which is the first barrier for transdermal drug delivery (see pg. 18, last full paragraph). The cationic charge from arginine and lysine residues in CPPs or CPP-drug conjugates enhances their binding to negatively charged cell membrane and ECM components like heparin sulfate, phospholipids and keratin (pI = 4.0–6.5) in the SC barrier [191–193] (see Vedadghavami and literature reviewed at pg. 18, last full paragraph). This creates an electrical potential gradient generating inward pointing electric fields providing a driving force that plays a significant role in the translocation and penetration of CPPs into different layers of the skin [194] (see pg. 18, last full paragraph).
An ordinary skilled artisan would have been motivated with reasonable expectation of success to make the substitution because it was known that cationic cell penetrating peptides rich in arginine and lysine residues are able to penetrate through the skin stratum corneum, thus it would have been obvious to make the substitution.
Although the claims at issue are not identical, they are not patentably distinct from each other because under an obviousness rationale, an ordinary skilled artisan would have been motivated to substitute DSSPLRSPSYAS for DiMaio’s SEQ ID NO: 389.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6. Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/697,386 claim set filed on 03/29/2024 (PG Pub US 20240407993A1) in view of US 2021/0206811 A1 Pub. Date: Jul. 8, 2021 (herein after “DiMaio”), and Vedadghavami et al. Nano Today. 2020 October; 34:100898, pp. 1-52 (herein after “Vedadghavami”).
Regarding instant claims 1-11, Copending Application ‘386 claims:
1. A peptide comprising an amino acid sequence of SEQ ID NO: 1.
2. The peptide of claim 1, wherein the peptide has skin aging inhibition activity or skin regeneration activity.
3. A composition for skin aging inhibition or skin regeneration, the composition comprising the peptide of claim 1 as an active ingredient.
4. The composition of claim 3, wherein the composition improves resistance to damage to cells caused by aging or an external stimulus.
5. The composition of claim 4, wherein the external stimulus is ultraviolet rays or infrared rays.
6. The composition of claim 4, wherein the cells are skin fibroblasts or keratinocytes.
7. The composition of claim 3, wherein the composition i) increases expression or secretion of collagen, fibronectin, elastin, or hyaluronic acid, and ii) increases expression of SIRT1 or AQP3.
8. The composition of claim 3, wherein the composition i) inhibits production of reactive oxygen species (ROS) caused by ultraviolet rays, ii) increases expression of collagen, fibronectin, or elastin decreased by ultraviolet rays, and iii) inhibits expression of MMP-1 increased by ultraviolet rays.
9. A cosmetic composition for skin aging inhibition or skin regeneration, the cosmetic composition comprising the peptide of claim 1 as an active ingredient.
10. The cosmetic composition of claim 9, wherein the skin aging inhibition or the skin regeneration is prevention or reduction of skin wrinkles, skin elasticity improvement, skin barrier strengthening, prevention of pigmentation, or amelioration of skin photoaging.
11. A pharmaceutical composition for preventing or treating photoaging, the pharmaceutical composition comprising the peptide of claim 1 as an active ingredient.
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because in Copending App ‘386, SEQ ID NO: 1 is represented by LCACCLHNCNECQ (see specification, filed 03/29/2024, pg. 23, para[00110], Table 1).
As such the difference between Copending App ‘386 claims 1-11 and instant claims 1-11 is instant SEQ ID NO: 1 (i.e., KRRRKRK).
Since DiMaio discloses the amino acid sequence IPWVIHTHDYSGDFYLHPSLRKRRRKRKYL represented by SEQ ID NO: 389 (see DiMaio, pg. 15, Table 1, 5th entry); which reads on the instantly claimed peptide; an ordinary skilled artisan would have been motivated to arrive at the claimed invention by substituting LCACCLHNCNECQ (i.e., SEQ ID NO: 1) in Copending App ‘386 with DiMaio’s SEQ ID NO: 389.
One of ordinary skill in the art would have been motivated to do so drug delivery using cationic peptides and proteins was known (see Vedadghavami, pg. 1, Title). Vedadghavami adds that CPPs have sparked considerable interest due to their ability to penetrate through the skin stratum corneum (SC), which is the first barrier for transdermal drug delivery (see pg. 18, last full paragraph). The cationic charge from arginine and lysine residues in CPPs or CPP-drug conjugates enhances their binding to negatively charged cell membrane and ECM components like heparin sulfate, phospholipids and keratin (pI = 4.0–6.5) in the SC barrier [191–193] (see Vedadghavami and literature reviewed at pg. 18, last full paragraph). This creates an electrical potential gradient generating inward pointing electric fields providing a driving force that plays a significant role in the translocation and penetration of CPPs into different layers of the skin [194] (see pg. 18, last full paragraph).
An ordinary skilled artisan would have been motivated with reasonable expectation of success to make the substitution because it was known that cationic cell penetrating peptides rich in arginine and lysine residues are able to penetrate through the skin stratum corneum, thus it would have been obvious to make the substitution.
Although the claims at issue are not identical, they are not patentably distinct from each other because under an obviousness rationale, an ordinary skilled artisan would have been motivated to substitute LCACCLHNCNECQ for DiMaio’s SEQ ID NO: 389.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7. Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/697,270 claim set filed on 10/28/2024 (PG Pub US20250064707A1) in view of US 2021/0206811 A1 Pub. Date: Jul. 8, 2021 (herein after “DiMaio”), and Vedadghavami et al. Nano Today. 2020 October; 34:100898, pp. 1-52 (herein after “Vedadghavami”).
Regarding instant claims 1-11, Copending Application ‘270 claims:
[Claim 1.] A peptide comprising an amino acid sequence of SEQ ID NO: 1.
[Claim 2.] The peptide of claim 1, wherein the peptide has skin aging inhibition activity or skin regeneration activity.
[Claim 3.1 A composition for skin aging inhibition or skin regeneration, the composition comprising the peptide of claim 1 as an active ingredient.
[Claim 4.] The composition of claim 3, wherein the composition improves resistance to damage to cells caused by aging or an external stimulus.
[Claim 5.1 The composition of claim 4, wherein the external stimulus is ultraviolet rays or infrared rays.
[Claim 6.1 The composition of claim 4, wherein the cells are skin fibroblasts or keratinocytes.
[Claim 7.] The composition of claim 3, wherein the composition i) increases expression or secretion of collagen, fibronectin, or elastin, and ii) increases expression of SIRT1 or AQP3.
[Claim 8.1 The composition of claim 3, wherein the composition i) inhibits production of reactive oxygen species (ROS) caused by ultraviolet rays, ii) increases expression of SIRTl or AQP3 decreased by ultraviolet rays, and iii) inhibits expression of Cleaved PART-1 or Cleaved Caspase-3 increased by ultraviolet rays.
[Claim 9.1 A cosmetic composition for skin aging inhibition or skin regeneration, the cosmetic composition comprising the peptide of claim 1 as an active ingredient.
[Claim 10.] The cosmetic composition of claim 9, wherein the skin aging inhibition or the skin regeneration is prevention or reduction of skin wrinkles, skin elasticity improvement, skin barrier strengthening, prevention of pigmentation, or amelioration of skin photoaging.
[Claim 11.] A pharmaceutical composition for preventing or treating photoaging, the pharmaceutical composition comprising the peptide of claim 1 as an active ingredient.
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because in Copending App ‘270, SEQ ID NO: 1 is represented by EYIPNRVCRR (see specification, filed 03/29/2024, pg. 21, para[00105], Table 1).
As such the difference between Copending App ‘270 claims 1-11 and instant claims 1-11 is instant SEQ ID NO: 1 (i.e., KRRRKRK).
Since DiMaio discloses the amino acid sequence IPWVIHTHDYSGDFYLHPSLRKRRRKRKYL represented by SEQ ID NO: 389 (see DiMaio, pg. 15, Table 1, 5th entry); which reads on the instantly claimed peptide; an ordinary skilled artisan would have been motivated to arrive at the claimed invention by substituting EYIPNRVCRR (i.e., SEQ ID NO: 1) in Copending App ‘270 with DiMaio’s SEQ ID NO: 389.
One of ordinary skill in the art would have been motivated to do so drug delivery using cationic peptides and proteins was known (see Vedadghavami, pg. 1, Title). Vedadghavami adds that CPPs have sparked considerable interest due to their ability to penetrate through the skin stratum corneum (SC), which is the first barrier for transdermal drug delivery (see pg. 18, last full paragraph). The cationic charge from arginine and lysine residues in CPPs or CPP-drug conjugates enhances their binding to negatively charged cell membrane and ECM components like heparin sulfate, phospholipids and keratin (pI = 4.0–6.5) in the SC barrier [191–193] (see Vedadghavami and literature reviewed at pg. 18, last full paragraph). This creates an electrical potential gradient generating inward pointing electric fields providing a driving force that plays a significant role in the translocation and penetration of CPPs into different layers of the skin [194] (see pg. 18, last full paragraph).
An ordinary skilled artisan would have been motivated with reasonable expectation of success to make the substitution because it was known that cationic cell penetrating peptides rich in arginine and lysine residues are able to penetrate through the skin stratum corneum, thus it would have been obvious to make the substitution.
Although the claims at issue are not identical, they are not patentably distinct from each other because under an obviousness rationale, an ordinary skilled artisan would have been motivated to substitute EYIPNRVCRR for DiMaio’s SEQ ID NO: 389.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/697,397 claim set filed on 12/10/2024 (PG Pub US20250197447A1) in view of US 2021/0206811 A1 Pub. Date: Jul. 8, 2021 (herein after “DiMaio”), and Vedadghavami et al. Nano Today. 2020 October; 34:100898, pp. 1-52 (herein after “Vedadghavami”).
Regarding instant claims 1-11, Copending Application ‘397 claims:
[Claim 1.] A peptide comprising an amino acid sequence of SEQ ID NO: 1.
[Claim 2.] The peptide of claim 1, wherein the peptide has skin aging inhibition activity or skin regeneration activity.
[Claim 3.] A composition for skin aging inhibition or skin regeneration, the composition comprising the peptide of claim 1 as an active ingredient.
[Claim 4.] The composition of claim 3, wherein the composition improves resistance to damage to cells caused by an external stimulus.
[Claim 5.1 The composition of claim 3, wherein the external stimulus is ultraviolet rays or infrared rays.
[Claim 6.1 The composition of claim 4, wherein the cells are skin fibroblasts.
[Claim 7.] The composition of claim 3, wherein the composition inhibits production of reactive oxygen species (ROS) caused by ultraviolet rays.
[Claim 8.] The composition of claim 3, wherein the composition increases expression of collagen, fibronectin, or elastin in damaged cells.
[Claim 9.] The composition of claim 3, wherein the composition inhibits expression or activity of MMP-1 or MMP-2.
[Claim 10.] A cosmetic composition for skin aging inhibition or skin regeneration, the cosmetic composition comprising the peptide of claim 1 as an active ingredient.
[Claim 11.] The cosmetic composition of claim 10, wherein the skin aging inhibition or the skin regeneration is prevention or reduction of skin wrinkles, skin elasticity improvement, skin barrier strengthening, prevention of pigmentation, or amelioration of skin photoaging.
[Claim 12.] A pharmaceutical composition for preventing or treating photoaging, the pharmaceutical composition comprising the peptide of claim 1 as an active ingredient.
Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). This is pertinent because in Copending App ‘397, SEQ ID NO: 1 is represented by LKKNGSCKRGPRTHYGQK (see specification, filed 12/10/2024, pg. 22, para[0098], Table 1).
As such the difference between Copending App ‘397 claims 1-11 and instant claims 1-11 is instant SEQ ID NO: 1 (i.e., KRRRKRK).
Since DiMaio discloses the amino acid sequence IPWVIHTHDYSGDFYLHPSLRKRRRKRKYL represented by SEQ ID NO: 389 (see DiMaio, pg. 15, Table 1, 5th entry); which reads on the instantly claimed peptide; an ordinary skilled artisan would have been motivated to arrive at the claimed invention by substituting LKKNGSCKRGPRTHYGQK (i.e., SEQ ID NO: 1) in Copending App ‘397 with DiMaio’s SEQ ID NO: 389.
One of ordinary skill in the art would have been motivated to do so drug delivery using cationic peptides and proteins was known (see Vedadghavami, pg. 1, Title). Vedadghavami adds that CPPs have sparked considerable interest due to their ability to penetrate through the skin stratum corneum (SC), which is the first barrier for transdermal drug delivery (see pg. 18, last full paragraph). The cationic charge from arginine and lysine residues in CPPs or CPP-drug conjugates enhances their binding to negatively charged cell membrane and ECM components like heparin sulfate, phospholipids and keratin (pI = 4.0–6.5) in the SC barrier [191–193] (see Vedadghavami and literature reviewed at pg. 18, last full paragraph). This creates an electrical potential gradient generating inward pointing electric fields providing a driving force that plays a significant role in the translocation and penetration of CPPs into different layers of the skin [194] (see pg. 18, last full paragraph).
An ordinary skilled artisan would have been motivated with reasonable expectation of success to make the substitution because it was known that cationic cell penetrating peptides rich in arginine and lysine residues are able to penetrate through the skin stratum corneum, thus it would have been obvious to make the substitution.
Although the claims at issue are not identical, they are not patentably distinct from each other because under an obviousness rationale, an ordinary skilled artisan would have been motivated to substitute LKKNGSCKRGPRTHYGQK for DiMaio’s SEQ ID NO: 389.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLAUDIA E ESPINOSA whose telephone number is (703)756-4550. The examiner can normally be reached Monday-Friday 9:30-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CLAUDIA ESPINOSA/ Patent Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654
Prosecution Insights