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 filed 03/27/2024 is a National Stage entry of PCT/KR2022/014521 , International Filing Date: 09/28/2022 claims foreign priority to 10-2021-0130818, filed 10/01/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/27/2024, 06/12/2025 and 04/06/2026 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 1/13/2025 is pending. Claims 1-16 are pending and under examination.
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 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 or activity of cells’ in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests ‘wherein the peptide promotes proliferation or activity’.
Claim 5, Examiner recommends correcting ‘the formation’, ‘the activity’ and substitute with ‘formation’, ‘activity’ to avoid the antecedent basis rejection for ‘the’.
Claim 7, for the reasons set forth above, Examiner recommends removing ‘the’ in the limitation ‘the activation’.
Claim 11, Examiner recommends removing ‘the’ in the limitation ‘the expression’.
Claims 6, 8,10, 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 6, the instant claim recites, induces one or more phosphorylation. It is unclear what the phrase is referring to -if the phrase is referring to one or more than one phosphorylation or if the Applicant is referring to phosphorylation of one or more proteins, encompassed in the Markush group. Examiner suggests amending the claim to ‘A peptide for preventing hair loss…’. Appropriate correction is required.
Regarding claim 8, the instant claim recites, promotes one or more expressions. It is unclear what the phrase is referring to -if the phrase is referring to one or more than one expression for LEF-1, c-Myc and cyclin D1 or if the Applicant is referring to expression of one or more genes, encompassed in the Markush group. Appropriate correction is required.
Regarding claim 10, the instant claim recites, promotes one or more expressions. It is unclear what the phrase is referring to -if the phrase is referring to one or more than one expression of Ha3-II, Keratin-14 and Keratin-19 or if the Applicant is referring to expression of one or more genes, encompassed in the Markush group. Appropriate correction is required.
Regarding claim 14, the claim recites ‘improving hair loss’, which is a contrasting phrase to qualify ‘preventing hair loss.’ Examiner suggests to correct the phrase to reflect the intended use of the claimed composition.
Claims 15 and 16, which depend from claim 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as these claims incorporate by dependency the indefiniteness of claim 14.
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 (claim 1, 5, 6, 7, 8, 9, 10, 11, 12), promoting hair growth (claim 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, 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.
Claim 1 is directed to a peptide comprising SEQ ID NO: 1 having the activity of preventing hair loss or promoting hair growth.
Claim 3 is directed to a composition for preventing hair loss or promoting hair growth.
Claim 12 is directed to a composition for preventing or treating hair loss.
Claim 14 is directed to a composition for preventing or improving hair loss.
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 (claim 1, 5, 6, 7, 8, 9, 10, 11, 12), promoting hair growth (claim 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16) or treatment. The specification discloses ‘treating’ to encompass ‘administering a therapeutically effective amount of peptide to a subject’ [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.
See in re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The eight Wands
factors are applied to claims 1,3-16 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 - 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 [46]. Accordingly, claims 1,3-16 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/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 of Enablement Analysis 35 USC § 112(a)
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 1,3-16, 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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-16 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Stephanie Baud et al., hereinafter Baud (Stephanie Baud et al., Elastin peptides in aging and pathological conditions, BioMol Concepts 2013; 4(1): 65–76) as evidenced by Gyros Protein Technologies (PurePep Blog, Nov 4, 2020).
Regarding claim 1, Baud teaches elastin derived peptide GGVPG (i.e. SEQ ID NO: 1) (page 68, last paragraph, line 5). Regarding the claim limitation ‘having the activity…growth’, absent evidence to the contrary, it is presumed that the peptide in Baud, retains the activity as claimed. In this case, the
limitation at issue, is the natural result of the peptide, explicitly disclosed by the prior art " Id. at 1195-96, 112 USPQ2d at 1952. But see, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (see MPEP §2112 .IV). Additionally, it is noted "the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 2, the claim limitation ‘promotes the....formation’ is interpreted by the Examiner as unappreciated property. Applicant is reminded that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Regarding claim 3, Examiner interprets ‘for preventing….growth’ as intended use. As the teachings in Baud of the peptide, is 100 % identical to the claimed SEQ ID NO: 1, it would be capable of the same intended use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children's Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (see MPEP § 2111. 02 (II)). As previously noted, 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). (See MPEP § 2112.01 (I)).
Regarding claim 4, Examiner interprets ‘for preventing…growth’ as intended use. Regarding 0.01 µM to 100 µM, Baud teaches that elastin peptides are raised using synthetic peptides derived from the known sequence or using hydrolyzed elastin (see page 72, Highlights, line 6). As evidenced by Gyros Protein Technologies, peptides can be synthesized providing 24 % overall yield-97 % yield (i.e. 0.01 µM to 100 µM).
Regarding claim 5, Examiner interprets ‘for preventing….claim 3’ as intended use. Regarding the claim limitation ‘induces the formation…matrix cells’, the rejection has been noted above in claim 1.
Regarding claim 6, Examiner interprets ‘for....claim 3’ as intended use. Regarding ‘induces…cells’, the rejection has been noted above in claim 1.
Regarding claim 7, Examiner interprets ‘for....claim 3’ as intended use. Regarding ‘induces…cells’, the rejection has been noted above in claim 1.
Regarding claim 8, Examiner interprets ‘for....claim 3’ as intended use. Regarding ‘promotes…cells’, the rejection has been noted above in claim 1.
Regarding claim 9, Examiner interprets ‘for....claim 3’ as intended use. Regarding ‘inhibits…cells’, the rejection has been noted above in claim 1.
Regarding claim 10, Examiner interprets ‘for....claim 3’ as intended use. Regarding ‘promotes…cells’, the rejection has been noted above in claim 1.
Regarding claim 11, Examiner interprets ‘for....claim 3’ as intended use. Regarding ‘promotes…cells’, the rejection has been noted above in claim 1.
Regarding claim 12, Examiner interprets ‘for....loss’ as intended use. The teachings in Baud have been set forth above.
Regarding claim 13, Examiner interprets ‘for....claim 12’ as intended use. The rejection used in claim 1, applies to the limitation ‘external skin preparation’.
Regarding claim 14, Examiner interprets ‘for....loss’ as intended use.
Regarding claim 15, Examiner interprets ‘for....claim 14’ as intended use. Regarding ‘wherein…preparation’, the rejection has been noted above in claim 1.
Regarding claim 16, Examiner interprets ‘for....claim 14’ as intended use. Regarding ‘wherein…spray’, the rejection has been noted above in claim 1.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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