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 .
Claim Status
Claims 1-9 are pending. Claims 8-9 are new.
Priority
The instant application is the 371 national stage entry of PCT/KR2021/020016, filed 12/28/2021, which claims priority to KR10-2021-0188875, filed 12/27/2021. The priority date of 12/27/2021 is acknowledged although it is noted that no translation has been made of record.
Information Disclosure Statement
The IDS field on 6/26/2024, 11/18/2025, and 6/8/2026 are under consideration. Any strikethrough is owed to lack of an English translation or description of relevancy in English.
Claim Interpretation
Claim 1 recites a peptide consisting of an amino acid sequence of SEQ ID NO: 1. The claim is being interpreted as limited to a peptide with the exact sequence “IHGTYKELLDTVTAP” and nothing more or less.
Claim 4 recites functional characteristics of the peptide consisting of an amino acid sequence of SEQ ID NO: 1 rather than structural limitations. As such, the claim is being interpreted based upon the structural limitation (a peptide consisting of an amino acid sequence of SEQ ID NO: 1), where the functional limitation is a property endowed by the structure.
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.
Claim 8 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 treating a subset of skin conditions, does not reasonably provide enablement for treating skin conditions broadly. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
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. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
1) Nature of the invention and 5) breadth of the claims: The claim is drawn to a method
of improving a skin condition of a subject comprising administering SEQ ID NO: 1 to the subject. The instant specification notes that “improve skin condition” may comprehensively refer to the process or effect of treating, reducing, or alleviating skin damage, etc., caused by endogenous or exogenous factors of the skin, such as for example, improvement of wrinkles, improvement of skin wound recovery, strengthening of skin barrier, or inhibition of skin aging, but is not limited thereto (instant Pg 3, final paragraph). The issue is whether other known skin conditions not contemplated in the instant application could be treated via administration of SEQ ID NO: 1.
2) State of the prior art and 4) predictability or unpredictability of the art: SEQ ID NO: 1 is
a fragment derived from pigment epithelium-derived factor (PEDF). At the time of filing, the art recognized that some skin conditions were associated with reductions in PEDF expression, and, thus, could likely be treated to some extent with administration of PEDF. For instance, Dong et al. teaches condyloma acuminatum lesions (genital warts) biopsied from patients demonstrate significantly lower PEDF protein and mRNA levels as compared to healthy controls (Abstract; Pg 368, left column, “Results,”; Table 2; Downregulation of pigment epithelium-derived factor in condyloma acuminatum. Journal of International Medical Research Volume 41, Issue 2, April 2013, Pages 365-370). Another study conducted by Zhang et al. noted that expression of PEDF is decreased in malignant melanoma cells relative to melanocytes (Abstract; Figures 2-3; Tables 1-2; Expression of pigment epithelium-derived factor in human melanocytes and malignant melanoma cells and tissues. Dermato-Endocrinology 1:2, 109-113; March/April 2009.). In these instances, it is reasonable to suspect that administration of SEQ ID NO: 1 may help to alleviate these skin conditions.
However, not all skin conditions exhibit reductions in PEDF expression. For instance, Liakouli teaches PEDF expression is increased in biopsies from patients with cutaneous systemic sclerosis (scleroderma), an autoimmune connective tissue disease characterized by accumulation of ECM proteins as well as widespread vasculopathy, as compared to healthy donors (see Pg 433-434, left column, “PEDF expression is increased in SSc patients biopsies compared with healthy donors”; Figure 1; Liakouli et al., Ann Rheum Dis 2018;77:431–440.); moreover, increased expression and secretion of PEDF from dermal fibroblasts plays a direct role in the impairment of angiogenesis (Pg 435-437, right column, “SSc fibroblasts suppress angiogenesis in a PEDF-dependent manner; Figure 2; Pg 438, “Discussion,” first paragraph). In this instance, one would expect that further administration of SEQ ID NO: 1 would likely exacerbate systemic sclerosis rather than alleviate it.
Based on these prior art teachings, one skilled in the art would reasonably predict that administering SEQ ID NO: 1 would effectively improve some but not all skin conditions.
3) The relative skill of those in the art: The relative skill of those in the art is high.
6) The amount of direction or guidance presented: At the time of filing, no direction or
guidance was presented in either the prior art or the instant specification that would enable one to administer SEQ ID NO: 1 to improve skin conditions as broadly as claimed.
7) The presence or absence of working examples: The instant specification teaches
administration of SEQ ID NO: 1 encourages fibroblast and keratinocyte proliferation, inhibits their apoptosis after exposure to UV rays, and reduces reactive oxygen species in vitro; and increases transcription of genes related to wrinkles, elasticity, and the skin barrier (Examples 2-6). However, these working examples primarily pertain to improvements in skin aging.
8) The quantity of experimentation necessary: As described above, the instant
specification discloses a few examples of treating skin aging conditions, but no examples of improving other skin conditions. In light of these teachings and the prior art, one skilled in the art would be burdened with undue experimentation to determine the precise parameters and conditions necessary to effectively improve all skin conditions by administering SEQ ID NO: 1.
Thus, in view of the Wands factors, Applicants fail to provide information sufficient to practice the claimed invention for the treatment of all skin conditions through administration of SEQ ID NO: 1.
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 and 4-9 are rejected under 35 U.S.C. 101 because they are directed to a judicial exception.
The Supreme Court has given a three-part test for patent eligibility (see flowchart of MPEP 2106(III)):
Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the claims pass the first test, are the claims drawn to a judicial exception (a law of nature, a natural phenomenon (product of nature), or an abstract idea)?
2b) If a judicial exception applies, do the claims recite additional elements that amount to significantly more than the judicial exception?
Applying the three-part test to the instant claims:
Regarding 1), claims 1 and 4-7 are drawn to a peptide, which is a composition of matter. Claims 8 and 9 are drawn to a method of administering said peptide.
Regarding 2a), the peptide of claims 1 and 4-7 is a product of nature. The claims are drawn to a peptide, as well as a composition thereof, consisting of an amino acid sequence of SEQ ID NO: 1. SEQ ID NO: 1 reads on pigment epithelium-derived factor (PEDF, also known as serpin family F member 1 or SERPINF1) from different species/organisms, such as:
A0ABQ9VME9_SAGOE
I3L4Z0_HUMAN
A0A2J8SNZ1_PONAB
Others not listed here
While some of these proteins may be longer than the limit imposed by the claims, in Ass’n for Molecular Pathology v Myriad Genetics, the Supreme Court stated that fragments of a biopolymer still trigger this statute. Thus, the fact that these sequences are longer than those claimed does not make the rejection invalid, unless the fragment is significantly different from the full-length polypeptide.
Additionally, the method of using said peptide as recited in claims 8 and 9 reads on a natural phenomenon. Chen teaches that PEDF levels are high in normal skin but quite low in early wounds; after the inflammatory stage of wound healing, PEDF levels return to normal during tissue remodeling to encourage skin repair (Production and function of pigment epithelium-derived factor in isolated skin keratinocytes. Exp Dermatol. 2014 Jun;23(6):436-8.). Thus, the naturally-occurring increase in PEDF levels as a response to wound healing reads on the methods recited in claims 8 and 9.
Regarding 2b), regarding claims 1 and 4-7, there is nothing significantly more recited in the claims that would distinguish the fragment claimed from the above described naturally-occurring peptides; in particular, claim 4 merely recites properties of SEQ ID NO: 1 endowed by its structure, and claims 5-7 recite intended uses for a composition comprising SEQ ID NO: 1. Further, as described above, method claims 8 and 9 read on the naturally-occurring wound healing process. Consequently, the claims do not contain elements added to the judicial exception to render the claims significantly more than the exception.
In sum, the claims are drawn to patent ineligible subject matter and are rejected here.
Conclusion
No claim is allowed; claims 1 and 4-9 are rejected, and claims 2-3 are objected to for depending on a rejected claim.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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