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 .
Election/Restrictions
Applicant’s election without traverse of Group IV, claims 22 and 26-27, in the reply filed on 5/1/2026 is acknowledged.
Claim 1-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 21 and 25 are further withdrawn as being directed to a non-elected method species. Election was made without traverse in the reply filed on 5/1/2026.
In response to species election, applicant elected the peptide sequence of SEQ ID NO: 39 and a disease of diabetic ulcer for the treatment.
Claim Status
Claims 1-15, 21-22, and 25-27 are pending.
Claims 16-20 and 23-24 are cancelled.
Claims 1-15, 21, and 25 are withdrawn as being directed to a non-elected invention, the election having been made on 5/1/2026.
Claims 22 and 26-27 have been examined.
Priority
This application is a 371 of PCT/KR2022/004581 filed on 03/31/2022 and claims KOREA, REPUBLIC OF 10-2021-0045245 filed on 04/07/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/06/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 22 and 26-27 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 promoting blood vessel formation under a condition of cytokine-free Matrigel (SPEC, Example 1-3, p25, line 5-12), improving glycolysis in cultured NIH3T3 fibroblast cells (SPEC, Example 2-2, p25 last para to p26, line 1-5), and diabetic skin wound healing (SPEC, Example 2-4, p26, line 6-25 to p29, line 1-6), does not reasonably provide enablement for the full scope of treating any angiogenesis related diseases comprising psoriasis, angina, pulmonary hypertension, age-related macular degeneration (listed in claim 26) or neonatal hypoxia (listed in claim 27). 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 or use the invention commensurate in scope with these claims.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) as shown follows.
(A) The breadth of the claims is much broader than the metes and bounds supported by the enabled examples and other disclosure in the specification of record.
(B) The nature of the invention is the use of a fragment of Lin28 protein, inherently comprising a cell-penetrating domain and zinc finger domain, to treat diabetic skin wound healing or cell culture assays. The peptide may further comprising a 6-His tag for purification purposes.
(C) The state of the prior art. Seo et al. (KR20150124910 A, the ‘910 application) show Lin28 derivative peptides (e.g., SEQ ID NO: 5) is a cell-penetrating peptide (p17). Seo et al. teach Lin28 derivative peptide (e.g., SEQ ID NO: 5) able to treat cerebral infarction (English translation p27, para 2) and stroke (English translation p32, [0041]). However, the ‘910 application did not teach or suggest Lin28 derivative peptides able to treat any angiogenesis related diseases such as psoriasis, angina, pulmonary hypertension, diabetic vascular heart disease, or heart failure listed in claims 26-27.
(D) The level of one of ordinary skill does not recognize the peptide formula of SEQ ID NO: 1 (claim 2) able to treat any angiogenesis related diseases as claimed according to examiner’s prior art search such as the ‘910 application.
(E) The level of predictability in the art is low because treatment of angiogenesis is involved in many different types of diseases and in various tissues. Furthermore, a patient’s response to treatment is unpredictable.
(F) The amount of direction provided by the inventor is very limited because the disclosure of promoting blood vessel formation under a condition of cytokine-free Matrigel (SPEC, Example 1-3, p25, line 5-12), improving glycolysis in cultured NIH3T3 fibroblast cells (SPEC, Example 2-2, p25 last para to p26, line 1-5), and diabetic skin wound healing (SPEC, Example 2-4, p26, line 6-25 to p29, line 1-6) does not reasonably provide enablement for the full scope of treating any angiogenesis related diseases.
(G) The existence of working examples are enabling for promoting blood vessel formation under cytokine-free Matrigel (SPEC, Example 1-3, p25, line 5-12), improving glycolysis in NIH3T3 fibroblast cells (SPEC, Example 2-2, p25 last para to p26, line 1-5), and diabetic skin wound healing (SPEC, Example 2-4, p26, line 6-25 to p29, line 1-6). Thus, the limited disclosure does not reasonably provide enablement for treating the full-scope of angiogenesis related diseases, such as psoriasis, angina, pulmonary hypertension, age-related macular degeneration (listed in claim 26) or neonatal hypoxia (listed in claim 27).
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure is unknown because treatment of angiogenesis is involved in many different types of diseases and tissues. Furthermore, a patient’s response to treatment is unpredictable; thus, the quantity of experimentation needed to make or use the invention is unknown.
Because applicant fails to satisfy the Wands factor analysis, claims 22 and 26-27 are rejected under 112(a) for lack of full-scope enablement.
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.
Claims 22 and 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seo et al. (KR20150124910 A, the ‘910 application, English translation attached).
Claim 22 is drawn to a method for treating angiogenesis-dependent diseases comprising
administering an effective amount of the cell-penetrating peptide of claim 1 to a subject suffering from an angiogenesis dependent disease.
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Seo et al. teach administer of a composition comprising a cell-permeating peptide (Lin-pep) derived from a Lin28 protein including SEQ ID NOs: 5 to 12 [0001, English translation p2; 0024, English translation p20]. Seo et al. teach route of administering the composition including oral administration and parenteral administration [0046, English translation p36]. Seo et al. show a Lin28 derivative cell-penetrating peptide of SEQ ID NO: 5 comprising the underlined zinc finger domain SEQ ID NO: 1. Seo et al. teach the treated diseases comprising myocardial infarction [English translation p25, para 2] and stroke [English translation p32, 0041]. Seo et al. further teach a single hourly effective dose of the protein can be selected in the range of 0.0000001 mg to 1000 mg per kg of the patient's body weight [English translation p37, last two para], reading on claims 22 and 26-27.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 22 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (KR20150124910 A) as applied to claims 22 and 26-27 and further in view of Lipsky (Clinical Infectious Diseases 2004; 39:S104–14).
Claims 22 and 26-27 is drawn to administering a Lin28 derivative peptide to treat the elected disease species of diabetic ulcer.
Seo et al. (KR20150124910 A) teach administration an effective amount of a Lin28 derivative peptide (SEQ ID NO: 5) to treat skin ulcers [English translation p26, para 2].
Seo et al. did not explicitly teach administration of the a Lin28 derivative peptide to treat a diabetic ulcer.
Lipsky teaches “Foot infections in diabetic patients usually begin in a skin ulceration” known in the art (S104, col 1). Because Seo et al. teach beneficially administering an amount of a Lin28 derivative peptide (SEQ ID NO: 5) effective to treat skin ulcers [English translation p26, para 2], one of ordinary skill in the art would have found it obvious to administer Seo’s peptide to treat Lipsky’s patients with diabetic skin ulcer, further reading on the elected disease species in claims 22 and 26-27.
One of ordinary skill in the art before the effective filing date of this inventio would have found it obvious to combine Seo’s method and composition with Lipsky’s teaching diabetic skin ulcer because (a) Seo et al. teach administration an effective amount of a Lin28 derivative peptide (SEQ ID NO: 5) to treat skin ulcers [English translation p26, para 2] and (b) Lipsky teaches “Foot infections in diabetic patients usually begin in a skin ulceration” known in the art (S104, col 1). The combination would have reasonable expectation of success because both references teach skin ulcer.
Examiner Note:
The examiner did not find a prior art teaching the elected peptide species of SEQ ID NO: 39 (HHHHHHRRPKGKSMQKRRSKGDRCYNCGGLDHHAKECKL). The closest prior art reference of Seo et al. (KR20150124910 A) teaches a method of administering cell-penetrating peptide of SEQ ID NO: 5 (comprising the zinc finger motif of SEQ ID NO: 1) to treat myocardial infarction [English translation p25, para 2] and stroke [English translation p32, 0041].
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
18-June-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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