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 .
Applicant’s response (amendments, arguments, filing of the Terminal Disclaimer) are acknowledged and have overcome the following rejections: 35 USC 101, 102, 103, and the obviousness double patenting rejection.
Claims 1-24, following amendment, are pending and examined on the merits. The 35 USC 112(a) (written description/possession) rejection is maintained for the reasons of record and a new 35 USC 112(b) (indefiniteness) rejection is necessitated by amendment.
Terminal Disclaimer(s) – Filed/Approved;
Traversing the Previous Obviousness Double Patenting Rejection
The terminal disclaimer filed on 12/1/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,980,654 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Scope Interpretation/Observation/Format
As carried out in the parent, and to avoid any misinterpretation of the claims scope (e.g. that a biologically active fragment is still contemplated by said scope; e.g. “an amino acid sequence” of any of peptide SEQ ID NOS: 3,5,7), applicant asked in the next response to amend the three (3) independent claims to incorporate the same Markush group language preceding the former as was carried out by examiner’s amendment to avoid any such misinterpretation in the issued parent U.S. Patent No. 11,980,654, see e.g. claim 1 therein by example (“peptide selected from the group consisting of . . .”):
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Claim Rejections - 35 USC § 112 – Written Description, Lack of Possession;
Maintained, Modified, Necessitated by Amendment
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.
Claims 1-24, following the amendments, remain rejected (modified after amendments) 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. Namely, applicant claims after amendment the myeloid-derived growth factor (“MYDGF”) peptides selected from the group consisting of SEQ ID NOS: 3, 5, 7 OR any peptide of 95%-99% identity thereto.
However, the former three naturally occurring examples are the only MYDGF’s found described or sequenced in the instant application to the instant human (SEQ ID NO: 1), mouse (SEQ ID NO: 3) and zebrafish (SEQ ID NO: 7).
Applicant provides no support or guidance to PHOSITA as to where and with what amino acid substitutions may be carried out within any of the three (3) supported peptides across the various species and still retain function (structure + function).
Thus, absent further evidence which is not currently of record that the state of the art knew what substituted analogues will function as intended – which was not uncovered by the examiner in a review of the prior art nor amongst all the IDS references submitted herewith - applicant was ‘not’ in possession at the time of filing of that instantly claimed by amendment: any substituted peptide of 95-99% identity to the only fully supported peptides: SEQ ID NOS: 3, 5, and 7 of the myeloid-derived growth factor (“MYDGF”) class.
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, there is no such guidance as to peptide position or amino acid to be substituted therein, and still permit the intended function.
Applicant has provided nothing towards these factors.
In the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus – substituting any of these three (3) amino acids anywhere (95%-99% identity).
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).
With the exception of the fully described peptides SEQ ID NOS: 3, 5, and 7, the skilled artisan cannot envision the detailed chemical structure of the encompassed variants, 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.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovinesequence.
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, New, Necessitated by Amendment
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 5 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.
In claim 5, line 2 retains the same original phrase “at least” as added by amendment in claim 4, for which one or the other need be deleted to leave only one such phrase (as in the other independent claims) as the grammatical oversight renders the claim indefinite.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MAURY A AUDET/Primary Examiner, Art Unit 1654
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