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 National Stage application of International Application No. PCT/KR2022/014523, filed September 28, 2022, which claims priority to and the benefit of Korean Patent Application No. 10-2021-0130815 filed in the Korean Intellectual Property Office on October 1, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/26/2024, 06/12/2025 and 04/14/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
The claim listing filed 8/30/2024 is pending. Claims 1-16 are pending and under examination.
Sequence Interpretation
Regarding claim 1, the scope of the peptide comprising an amino acid sequence is being interpreted as open-ended requiring 100% identity to SEQ ID NO: 1, with any N-/C-terminal additions.
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.
Claims 2, 5, 7, 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 2 recites the limitation “the proliferation”. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction, e.g.., “wherein the peptide promotes proliferation” is recommended.
Claim 5 recites “the formation of hair by promoting the activity”. There is insufficient antecedent basis for this limitation in the claim. It is recommended correcting “the formation”, “the activity” and substitute with “formation” and “activity”.
Claim 7 recites “induces the activation”. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction, e.g.., “induces activation” is recommended.
Claim 11 recites “promotes the expression”. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction, e.g.., “promotes expression” is recommended.
Claims 6, 8,10, and 14-16 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 6 recites “induces one or more phosphorylation”. It is unclear what the phrase is referring to; if the phrase is (i) referring to one or more than one phosphorylation or (ii) referring to phosphorylation of one or more proteins, encompassed in the Markush group.
It is suggested amending the claim to ‘A peptide for preventing hair loss…’. Appropriate correction is required.
Claim 8 recites “promotes one or more expressions”. It is unclear what the phrase is referring to; if the phrase is (i) referring to one or more than one expression for LEF-1, c-Myc and cyclin D1 or (ii) referring to expression of one or more genes, encompassed in the Markush group. Appropriate correction is required.
Claim 10 recites “promotes one or more expressions”. It is unclear what the phrase is referring to; if the phrase is (i) referring to one or more than one expression of Keratin-14 and Keratin-19 or (ii) referring to expression of one or more genes, encompassed in the Markush group. Appropriate correction is required.
Claim 14 recite “improving hair loss”, which is a contrasting phrase to qualify ‘preventing hair loss.’ It is suggested to correct the phrase to reflect the intended use of the claimed composition.
Further, by virtue of their dependency on claim 14, claims 15 and 16 are also rejected for this same reasoning. 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, 3-16 are 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 cell proliferation of HHFDPC (Fig 1), increased p-Akt and p-ERK levels (Fig 2), and Keratin levels by RT-PCR (Fig 6), i.e. promotes the proliferation or activity of cells related to hair formation (claim 2), does not reasonably provide enablement for preventing hair loss (claims 1 and 5-12), promoting hair growth (claims 3-12 and 14-16) or treatment. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. This is a scope of enablement rejection.
While the instant specification is enabling for, proliferation or activity of cells related to hair formation (claim 2), does not reasonably provide enablement for preventing hair loss (claims 1 and 5-12), promoting hair growth (claims 3-12 and 14-16) or treatment. The specification discloses ‘treating’ to encompass ‘administering a therapeutically effective amount of peptide to a subject’ (see [64]). However, the specification is not enabling for administration of a therapeutically effective amount of peptide to a subject population, for the treatment of hair loss.
As stated in § MPEP 2164.01(a), “there are many factors to consider when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any experimentation is ‘undue’. These factors include, but are not limited to:
(1) The breadth of the claims; (2) The nature of the invention; (3) The state of the prior art; (4) The level of skill in the art; (5) The level of predictability in the art; (6) The amount of direction provided by the inventor; (7) The presence or absence of working examples; (8) The quantity of experimentation needed to make or use the invention based on the disclosure.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. The eight Wands factors are applied to claims 1 and 3-16 as follows:
The breadth of the claims and the nature of the invention
Claims 1-16 are directed to a peptide composition of SEQ ID NO: 1 and the function of the peptide in in vitro assays disclosing cell proliferation of HHFDPC (Fig 1), increased p-Akt and p-ERK levels (Fig 2), and Keratin levels by RT-PCR (Fig 6). The specification does not provide evidence for treating, prevention or promoting hair growth in a subject. As used herein, the term “prevention” means reducing the risk of developing a disease or disorder, and it refers to all actions that suppress or delay the onset of a disease by keeping it from progressing the development of one or more clinical symptoms of the disease in subjects who are easily exposed to or susceptible to the disease but do not yet have the disease or not show symptoms of the disease (see [43]). This would include an array of disorders as disclosed in the specification, i.e., non-cicatrical alopecia or cicatrical alopecia depending on whether the hair follicle is destroyed, for example, hereditary androgenetic alopecia, alopecia areata, tinea capitis due to fungal infection, telogen alopecia, trichotillomania, hair loss due to hair growth disorder disease or lupus, folliculitis decalvans, lichen planus pilaris, hair loss due to burns and/or trauma (see [46]). Accordingly, claims 1 and 3-16 are unduly broad with respect to treating, or preventing hair loss.
The State of the Prior Art
It is noted that there is no prior art that teaches SEQ ID NO: 1 in the treatment of
subject with hair loss, or for promoting hair growth or preventing hair loss in a subject.
The Level of Skill in the Art
Practitioners in this art (dermatologists/cosmetologists/pharmacologists) would presumably be highly skilled in the art for generating compositions with the treatment properties as claimed.
The Level of Predictability in the Art
It is noted that the therapeutic and/or cosmetic art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). This is because it is not obvious from the disclosure, of a specific method of treatment of subject and alleviation of symptoms. In the instant case, the specification provides gene expression data and proliferation data in cell lines. The specification does not demonstrate a subject suffering from a hair loss disorder, and treatment with an effective amount. Without any experimentation demonstrating the claimed function of the peptide, the level of unpredictability remains high. Therefore, it is unpredictable that the composition will function as claimed.
The amount of Direction Provided by the Inventor and The Presence or Absence of
Working Examples
The instant specification does not provide adequate guidance with regard to the method of treatment, prevention and promoting hair growth. Applicant’s limited disclosure is noted but is not sufficient to justify claiming the composition broadly. Absent a reasonable a priori expectation of success for using the peptide of SEQ ID NO: 1, one skilled in the art would have to extensively test the peptide, determine an effective dose on a subject suffering hair loss, ascertain amelioration of symptoms, hair growth endpoints, etc. Since each prospective embodiment, and indeed future embodiments as the art progresses, would have to be empirically tested, and those which initially failed tested further, an undue amount of experimentation would be required to practice the invention as it is claimed in its current scope, because the specification provides inadequate guidance to do otherwise. The amount of direction or guidance presented in the specification is very limited. As discussed in “[t]he Level of Predictability in the Art” section supra, the specification teaches working examples with cells and gene expression data.
There is no prior art that teaches SEQ ID NO: 1 in the treatment or prevention of hair loss in a subject. Also, as noted in the “Breadth of the Claims and Nature of Invention” section, the specification does not provide evidence that a subject suffering hair loss is administered a
therapeutically effective amount or the amelioration of symptoms.
As such, the examples used in the specification are not indicative broadly of a method of
treatment or prevention, with the desired result of amelioration of symptoms. It is further noted that Applicant provides no data, examples, figures, etc. demonstrating a subject with hair loss and an effective amount for treatment. In the absence of such information, a person of ordinary skill in the art would reasonably require undue quantity of experimentation.
Conclusion
MPEP § 2164.01(a), 4th paragraph states that “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510,1513 (Fed. Cir. 1993).
After applying the Wands factors and analysis to claims 1 and 3-16, in view of the Applicant’s entire disclosure, it is concluded that the practice of the invention as claimed in claims 1-16 would not be enabled by the written disclosure for treatment of hair loss. Therefore claims 1-16 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to treat a subject as claimed using the peptide.
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural product) without significantly more.
Claim 1 is drawn to a peptide having, comprising an amino acid sequence of SEQ ID NO: 1. Please refer to the “Sequence Interpretation” section above for the scope of claim 1. Briefly, the scope of the peptide requires 100% identity to an amino acid sequence represented by SEQ ID NO: 1 (i.e., KLQEHLDM), but the peptide can be part of a larger sequence with any N- and/or C-terminal additions.
Claims 3-16 are directed to compositions that comprise the claimed peptide as recited in instant claim 1. Thus, the claimed invention is directed to a product or composition of matter, which is one of the statutory categories of invention.
The NCBI Reference Sequence: WP_130606980.1 reference (cited in IDS filed March 26, 2024) (source Jiang et. al., published August 28, 2019) discloses a 465 length amino acid sequence isolated from Cohnella abietis where residues 72-79 (see highlighted portion in the whole sequence below) are 100% identical to instant SEQ ID NO: 1 (See tyrosine-type recombinase/integrase [Cohnella abietis] - Protein - NCBI accessed on 08/18/2026) thereby constituting a peptide comprising an amino acid sequence of SEQ ID NO: 1 as claimed in instant claim 1.
Thus, claims 3-16 encompass a naturally occurring peptide which is not markedly different from its naturally occurring counterpart because it conveys the same genetic information. Therefore, the claimed invention is directed to a judicial exception.
These judicial exceptions are not integrated into a practical application because claims 1-16 fail to recite a practical application of the peptide and composition. It is further noted, that the claims drawn to a composition (i.e., claims 3-11), pharmaceutical composition (i.e., claims 12-13), and cosmetic composition (i.e., claims 14-16) do not include any elements in addition to the natural product (i.e., KLQEHLDM). Although the compositions are intended to “prevent hair loss or promote hair growth”, such recitation is merely indicating how the claimed invention might be used. Thus, the intended use of the judicial exception does not add a meaningful limitation to the claimed invention, as it is at such high level of generality that it fails to integrate the natural product into a practical application. Thereby, claims 3-11 are nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the structure of the claimed peptide and compositions comprising the claimed peptide, do not require a modification that is significantly more than the naturally occurring products in order to result in markedly different peptide and markedly different compositions.
Accordingly, it is the Examiner’s position that the claimed peptide and compositions are directed to a “product of nature” exception without significantly more because it does not exhibit markedly different characteristics from the naturally occurring counterparts in the natural state.
Further, by virtue of their dependency, claim 2 is also rejected for this same reasoning.
Thus, claims 1-16 encompass patent ineligible 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 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCBI Reference Sequence: WP_130606980.1(cited in IDS filed March 26, 2024) (source Jiang et. al., published August 28, 2019).Claim 1 recites a peptide having the activity of preventing hair loss or promoting hair growth, comprising an amino acid sequence of SEQ ID NO: 1., and dependent claims 2, 3, 12, 14 recite comprising the peptide (i.e., SEQ ID NO: 1).
NCBI Reference Sequence: WP_130606980.1 was aligned with the instantly claimed amino acid sequence SEQ ID NO: 1, and the query match resulted as 100%. Shown below the instantly claimed amino acid sequence highlighted within the sequence of origin ("Cohnella abietis"):
PNG
media_image1.png
184
590
media_image1.png
Greyscale
Regarding the claimed activity, MPEP 2112.01(II) states: “"Products of identical chemical composition can not 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. Id.” The recited activity is necessarily present.
Consequently, claims 1-3, 12, and 14 is anticipated by NCBI Reference Sequence: WP_130606980.1 and rejected.
Further, by virtue of their dependency on claims 4-11, 13, 15 and 16 are also rejected for this same reasoning.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KOYELI BANERJEE whose telephone number is (571)272-5751. The examiner can normally be reached Monday-Friday 8-4PM.
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, Melissa Fisher can be reached at (571) 270-7430. 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.
/KOYELI BANERJEE/ Examiner, Art Unit 1658
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights