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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 3/23/2023 wherein claim 7 was amended. In addition, the Examiner acknowledges receipt of the substitute specification filed 3/23/2023.
Note(s): Claims 1-20 are pending.
Priority
This application is a CON of PCT/US21/39021 filed 6/25/2021 and PCT/US21/39021 claims benefit to PRO 63/044,493 filed 6/26/2020.
Note(s): The earliest effective filing date is 6/26/2020 as the pending application is fully supported in the provisional application.
Claim Interpretation
Independent claim 1 is directed to a cyclic peptide compound having Formula (I):
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wherein Y1, X3, X8, X13, and Y2 are defined therein.
Claim 8 is directed to a method of prevention and/or treating stroke or related conditions and diseases using the compound of independent claim 1.
Information Disclosure Statement
The information disclosure statement filed 1/16/2023; 7/17/2024; and 8/21/2025 were considered.
Written Description Rejection
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 8-16 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.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection. The instant application does not sufficiently describe the invention as it involves prevention of stroke and related conditions and diseases. The pending application does not provide evidence that by administering the cyclic peptide of Formula (I):
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that conditions and related conditions and diseases such as inflammatory diseases, neurodegenerative diseases, central nervous system injury, central nervous system diseases, peripheral nerve injury, peripheral nerve disease, brain inflammatory diseases/condition, sepsis, colitis, cerebral hemorrhaging, intracerebral hemorrhaging, subarachnoid hemorrhage, cerebral ischemia, brain trauma, spinal cord injury, multiple sclerosis, Parkinson’s disease, and Alzheimer’s disease are prevented. Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms as set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
112 Second Paragraph Rejections
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 8, 13-16, and 20 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.
Claims 8 and 13-16: Claim 8 is ambiguous because of the phrase ‘related conditions and diseases’ (lines 1-2). In particular, it is unclear what related conditions and diseases the claim is referencing. Since claims 13-16 depend upon claim 8 for clarity, those claims are also vague and indefinite.
Claim 14: The claim recites the limitation "said plurality of times" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation ‘mammal’, and the claim also recites ‘primate’ and ‘human’ which are the narrower statements of the range/limitations. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 20: The claim is ambiguous because of the phrase ‘suitable for administration by injection to cause slow release of said cyclic peptide compound or as a spray’. According to MPEP 2173.05(p), a single claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product (cyclic peptide compound), the claim limitation is not directed to the product, but rather to actions involving the product (e.g., administration of the freeze dried powder or liquid form of the compound to result in slow release of the cyclic peptide compound or spray) which creates confusion as to when direct infringement occurs. Specifically, it is unclear whether infringement occurs when one has a product or when the administration of the compound occurs.
Allowable Claims
Claims 1-7 and 17-19 are allowable over the prior art of record.
Comments/Notes
For clarity of the claimed invention, the following changes are respectfully suggested to be consistent with other variables appearing in the application and/or further clarify the invention:
claim 1, line 1, delete ‘the general’;
claim 1, line 10, delete ‘the symbol’;
claim 1, line 16, replace ‘may be’ with ‘is’;
(4) claim 2, lines 1-7, 9, 11, 13, 15, 17, and 19-21, delete the dash marks (-) at the beginning of each line.
(5) claim 14, line 1, replace ‘include’ with ‘is selected from’;
(6) claim 19, line 2, replace ‘comprises’ with ‘is selected from’; and
(7) claim 20, line 2, replace ‘formulated as’ with ‘selected from’.
It should be duly noted that no prior art is cited in the pending invention. In particular, the claims are distinguished over the prior art of record because the prior art neither anticipates nor renders obvious the specific cyclic peptide compound and uses thereof. The closest prior art is Vitek et al (US Patent No. 8,034,762) which contains an overlapping inventor. The pending invention requires 13 amino acid residues in the cyclic peptide sequence along with Y1 and Y2, respectively (if present) on the ends on the peptide.
Vitek et al disclose a similar compound to that of the claimed invention. Specifically, Vitek et al disclose the peptide Ac-ASHLRKL-Aib-KRLL-NH2 wherein Ac is acetyl (column 10, line 18). The peptide in Vitek et al differs from that of the pending invention in the following manner: (1) Vitek et al do not disclose that the peptide is a cyclic peptide, but is a linear structure; (2) the third amino acid defined as X3 in the pending invention does not list histidine as on of the options. However, a skilled artisan could very well argue conservation substitution of histidine with lysine. But, more importantly, (3) the Vitek et al peptide lacks an amino acid residue at position X13 as required in the pending invention. There is no motivation to incorporate a thirteenth amino acid residue at the specific location listed in the pending invention.
Conclusion
Claims 1-7 and 17-19 are allowable over the prior art of record. Claims 8-16 and 20 are rejected.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
December 14, 2025