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 .
Claims 1-10 are pending and examined on the merits.
Allowable Subject Matter
Instantly claimed peptide SEQ ID NO: 1 (VLMGDPSVWWTY), a CD80 protein binding cell uptake enhancing peptide, was not found to be reasonably taught or suggested by the prior art of record. The closest representative prior art of record (Mayilraj et al. "Genome sequencing of Amycolatopsis regifaucium." Submitted (NOV-2016) to the EMBL/GenBank/DDBJ databases; https://www.ddbj.nig.ac.jp/index-e.html) is deemed that of bearing a 75.7% sequence identity thereto, with 9/12 amino acid matches and 1 mismatch across that peptide span:
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Were the remaining issues addressed, the claimed invention would be in condition for allowance.
Claim Rejections - 35 USC § 112(a)(i)/(pre-AIA ) – Written Description
The following is a quotation 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.
Claim 3 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing/identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In this case, claim 4 is directed to any connection – without any definition thereto – relevant to the peptide being “connected to” [any] surface of [any] drug carrier (the full breadth claimed) while the only recitation appears to mix “connected to” with “cross-linked” interchangeably while the latter is really a species of the former; see instant PGPUB 20250302986 (Wang et al.) para 28: “The first peptide in LD-4-7 is connected to the surface of liposome-coated Doxorubicin via polyethylene glycol; the second peptide in LD-4-9 is cross-linked to the surface of liposome-coated Doxorubicin via polyethylene glycol”. Thus, is it unclear if the definition and scope is to be limited to only “cross-linking” or something more and if the latter, what other connections are contemplated. There is a lack of definition as to “connected to” and a lack of further description to better guide PHOSITA as to what the intended scope is as to “connected to”. In the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus as presently claimed. See by contrast instant claim 9, directed where the “connected to” is via linker (and standard linking thereby; e.g. via PEG as in claim 10).
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111; clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry,whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed chemical structure of how the peptide is necessarily to be “connected to” [any] surface of [any] drug carrier (the full breadth claimed) as the only recitation thereto is found in instant PGPUB 20250302986 (Wang et al.) para 28: “The first peptide in LD-4-7 is connected to the surface of liposome-coated Doxorubicin via polyethylene glycol; the second peptide in LD-4-9 is cross-linked to the surface of liposome-coated Doxorubicin via polyethylene glycol” and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Therefore, the full breadth of the claims are not presently deemed to have been in Applicant’s ‘possession’ and found to meet the written description provision of 35 U.S.C. §112.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
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.
Claim 4 is 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.
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 4 recites the broad recitation “nanoparticles”, and the claim also recites “solid lipid nanoparticles” which is the narrower statement of the range/limitation. The claim(s) are 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 Objections
Claims 1-10 are objected to because of the following informalities:
Claims 1-10 are objected (see e.g. claims 1-3 and 9 and the remaining claims objected to as equally containing by dependency thereto), as the term “novel” is not deemed to add any further limitation to the claimed peptide and may be deleted without prejudice as superfluous.
In claim 9, line 1, after the term “is”, the term --a-- should be inserted for grammatical clarity.
Appropriate correction is required.
Claim Interpretation – Peptide SEQ ID NO: 1 Scope
In claims 1-10, the scope of the peptide claimed (see claim 1 and all remaining claims dependent thereto) is interpreted to be directed to the closed ‘consisting of’ transition phrase based on the phrase [the] “amino acid sequence is” [as shown in] SEQ ID NO: 1, absent evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
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