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 .
DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I, SEQ ID NO: 1 and diabetic retinopathy in the reply filed on 7/20/2026 is acknowledged. The traversal is on the ground(s) that “[t]he essence of the present invention lies in inhibiting angiogenesis using a peptide that binds to both a vascular endothelial growth factor (VEGF) receptor and a platelet-derived growth factor (PDGF) receptor. The disease itself is not a distinguishing technical feature of the invention, but merely a target to which the angiogenesis-inhibitory effect is applied. Indeed, the present specification discloses various angiogenesis-related diseases, including cancer, diabetic retinopathy, retinopathy of prematurity, neovascular glaucoma, psoriasis, and rheumatoid arthritis. However, the specification does not disclose different mechanisms of action or different peptides for the respective diseases. Rather, it consistently teaches the common inventive concept that inhibition of angiogenesis through dual binding to the VEGF receptor and the PDGF receptor results in therapeutic effects across various angiogenesis-related diseases”. This is not found persuasive because the claims are drawn to various diseases having different etiologies. Searching all these diseases would be a burden on the Office.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/20/2026.
Status of the Claims
Claims 1-2, 5 and 9-10 are pending in this application.
Claims 9-10 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 1-2 and 5 are presently under consideration as being drawn to the elected species/invention.
Improper Markush
Claims 1-2 and 5 are rejected on the judicially created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F. 2d 716, 721-22 (CCPA 1980) and Ex parte Hazumi, 3 USPQ 2d 1059, 1060 (BPAI 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The diseases claimed do not share a common patient population, common organs, and common end points. For example, diabetic retinopathy and osteoarthritis are different class of diseases and disorders, involving different organs and patient populations.
This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR 41.31 (a)(1) (emphasis provided).
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 1-2 and 5 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.
The claims are drawn to a method of inhibiting angiogenesis and ameliorating, or treating an angiogenesis-related disease, comprising administering a composition comprising a peptide binding to a vascular endothelial growth factor (VEGF) receptor and a platelet-derived growth factor (PDGF) receptor as an active ingredient to a subject in need thereof.
When referring to the peptide, the specification does not provide any structural attributes.
Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“A definition by function alone “does not suffice” to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is”).”
Here, the specification fails to describe which sequences correlate with the required activity (i.e. inhibiting angiogenesis and ameliorating, or treating an angiogenesis-related disease).
The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad.
Based on the teachings of the specification, the peptide can potentially be any peptide.
However, the specification fails to provide a representative number of examples for the claimed peptide.
The specification teaches only 3 peptides (i.e. SEQ ID NOs: 1, 9 and 15).
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Therefore, since the specification fails to identify any relevant structural characteristics that can be attributed to the claimed function and activity, the claimed invention lacks written description.
Claims 1-2 and 5 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 the treatment of diabetic retinopathy with SEQ ID NO: 1, does not reasonably provide enablement for: 1) the treatment of every possible angiogenesis-related disease with a peptide binding to a VEGF receptor and a PDGF receptor; and 2) the treatment of every possible angiogenesis-related disease with any of SEQ ID NOs: 1, 9 and 15. 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 MPEP states:
“There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.”
(A) The breadth of the claims; and (B) The nature of the invention;
The claims are drawn to a method of inhibiting angiogenesis and ameliorating, or treating an angiogenesis-related disease, comprising administering a composition comprising a peptide binding to a vascular endothelial growth factor (VEGF) receptor and a platelet-derived growth factor (PDGF) receptor as an active ingredient to a subject in need thereof.
(C) The state of the prior art;
The state of the prior art does not indicate that peptides binding to a VEGF receptor and a PDGF receptor can treat every possible angiogenesis-related disease.
Furthermore, there are many angiogenesis-related diseases that cannot be treated.
For instance, Costello et al. (Pancreat Disord Ther; Suppl 4; doi:10.4172/2165-7092.S4-002) teaches that pancreatic cancer is an untreatable cancer (abstract).
(D) The level of one of ordinary skill;
The skill of those skilled in the art is high.
(E) The level of predictability in the art;
Considering that not all angiogenesis-related diseases can be treated, the unpredictability of treatment of every angiogenesis-related disease with the claimed peptide is very high.
(F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The specification does not provide any examples with respect to the treatment of any disease, other than diabetic retinopathy with SEQ ID NO: 1.
The MPEP (2164.02) states that " The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).” The MPEP further states that
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“Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”
In the instant application, the specification does not provide any guidance to allow for the treatment of each and every angiogenesis-related disease with the claimed peptide.
Working examples are necessary since the art has indicated unpredictability of treatment of such diseases is very high.
Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the invention as claimed.
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 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (US 2018/0153961).
Kim et al. teach a method of inhibiting angiogenesis or treating a cancer or an ischemic disease comprising administering a composition comprising an effective amount of a KAI1 polypeptide or a gene encoding the same to a subject in need thereof (claim 21), wherein the KAI1 polypeptide consists of amino acids of SEQ ID NO: 1 or 2 (claim 23).
It is noted that SEQ ID NO: 1 comprises instant SEQ ID NOs: 1, 9 and 15.
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.
Claims 1-2 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10517925. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same method.
‘925 teaches a method of treating a cancer comprising administering a composition comprising an effective amount of a KAI1 (Kang AI 1) polypeptide consisting of the amino acid sequence as set forth in SEQ ID NO: 1 or 2 to a subject in need thereof, wherein the cancer is selected from the group consisting of colon cancer, pancreatic cancer, colorectal cancer, prostate cancer, kidney cancer, melanoma, bone metastasis of prostate cancer, ovarian cancer, and blood cancer (claim 1).
It is noted that SEQ ID NO: 1 comprises instant SEQ ID NOs: 1, 9 and 15.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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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.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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