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 .
The same original claims 1-26 are pending and examined on the merits here as in the parent (U.S. Application No. 17481490 (now U.S. Patent No. 11,980,654. As originally filed there, the instant claims are drawn to three (3) methods of using, in part, peptide SEQ ID NOS: 1, 3, and 7 (the issued subject matter; an obviousness double patenting rejection added below alongside the same rejections applied in the parent over the same original claims).
Claim Observation/Format
While one of ordinary skill in the art will recognize the acronym MYDGF (as to what it is referring to here as opposed to the 5mer peptide “Met Tyr Asp Gly Phe” which also bears the same acronym by single amino acid identification), following traditional practice, applicant is asked to simply identify such by its full name followed by the acronym in parenthesis in each independent claim as the initial identifier:
--Myeloid Derived Growth Factor (MYDGF)--.
Claim Rejections - 35 USC § 101 – Subject Matter Eligibility; Naturally Occurring Product
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 25-26 (the instant product claims) are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) naturally occurring human myeloid-derived growth factor (“hMYDGF”) which applicant sets forth as instantly SEQ ID NO: 1, see specification page 1:
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As the only element claimed in claim 25-26 is e.g. water, also a naturally occurring molecule the composition comprises only naturally occurring elements.
The prior art of record expressly teach hMYDGF in composition (e.g. with water), thereby recognizing such as naturally occurring:
Wang et al. (MYDGF promotes Cardiomyocyte proliferation and Neonatal Heart regeneration. Theranostics, 2020,10:9100-9112; see abstract, page 9109, right column, last para);
Korf-Klingebiel (Myeloid derived growth factor (C19 or F10) mediates cardiac repair following myocardial infarction. Nat.Med., 2015,21:140-149; see abstract, page 148, left column, last para – page 4, para 2; page 143, left hand column);
Zhao et al. (Production of bioactive recombinant human myeloid-derived growth factor in Escherichia coli and its mechanism on vascular endothelial cell proliferation. J.CellMol.Med., 2020,24,1189-1199; see page 1190, left column; para 2, abstract, fig. 8); or
Bortnov et al. (Solution structure of human myeloid-derived growth factor suggests a conserved functioni n the endoplasmic reticulum. Nature Communications, 2019,10:5612; see abstract, page 2, left column; fig. 4; Bortnov being one of the instant inventors named).
; just as applicant set forth at the outset of the specification:
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This judicial exception is not integrated into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Thus, claims 25-26 are rejected as being directed to a judicial exception without significantly more.
Claim Rejections - 35 USC § 102 - Anticipation
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by any of:
Wang et al. (MYDGF promotes Cardiomyocyte proliferation and Neonatal Heart regeneration. Theranostics, 2020,10:9100-9112; see abstract, page 9109, right column, last para);
Korf-Klingebiel (Myeloid derived growth factor (C19 or F10) mediates cardiac repair following myocardial infarction. Nat.Med., 2015,21:140-149; see abstract, page 148, left column, last para – page 4, para 2; page 143, left hand column);
Zhao et al. (Production of bioactive recombinant human myeloid-derived growth factor in Escherichia coli and its mechanism on vascular endothelial cell proliferation. J.CellMol.Med., 2020,24,1189-1199; see page 1190, left column; para 2, abstract, fig. 8); or
Bortnov et al. (Solution structure of human myeloid-derived growth factor suggests a conserved functioni n the endoplasmic reticulum. Nature Communications, 2019,10:5612; see abstract, page 2, left column; fig. 4; Bortnov being one of the instant inventors named).
Regarding claims 1-24, Wang, Korf-Klingebiel, and Zhao (see sections noted above) each teach the use of MYDGF in the treatment of cardiac tissue which would naturally inhibit neutrophil recruitment (instant claim 1), naturally reduce inflammation thereof via treatment (instant claim 9) and promote wound healing of the cardiac tissue (instant claim 17), thereby rendering such anticipated. Additionally, Bortnov (see sections noted above) teaches the relationship of MYDGF to the signaling pathway of MAPK/STAT3 which is directly tied to inflammation and thereby renders anticipated the inhibition of inflammation, at a minimum (instant claim 9). All of the other claims depending to these claims 1, 9, and 17 are equally rendering anticipated as merely identifying subject taught for treatment (e.g. vertebrate, mammalian, human).
Regarding claims 25-26, each of the four (4) references above expressly teach (see abstract in each) MYDGF (e.g. inferred to be human, instant SEQ ID NO: 1) and compositions comprising the same. Thus, the products of claims 25-26 are anticipated.
Claim Rejections - 35 USC § 103 - Obviousness
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
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 Claimed Invention: Claims 25-26 are products drawn to naturally occurring MYDGF peptide; while the following three (3) method of use claims are drawn to using such to for across the broad strokes of: claim 1 - inhibiting neutrophil recruitment to any damaged tissue; claim 9 – inhibiting any inflammation; and claim 17 – promoting any type of wound healing.
It is noted that this may apply literally anywhere as the state of the art as aware that MYDGF is abundant literally anywhere throughout the tissue and cells of the body (as noted in the instant Background):
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Claim(s) 1-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
Wang et al. (MYDGF promotes Cardiomyocyte proliferation and Neonatal Heart regeneration. Theranostics, 2020,10:9100-9112; see abstract, page 9109, right column, last para), alone or in view of any one of:
Korf-Klingebiel (Myeloid derived growth factor (C19 or F10) mediates cardiac repair following myocardial infarction. Nat. Med., 2015,21:140-149; see abstract, page 148, left column, last para – page 4, para 2; page 143, left hand column); and/or
Zhao et al. (Production of bioactive recombinant human myeloid-derived growth factor in Escherichia coli and its mechanism on vascular endothelial cell proliferation. J.Cell Mol.Med., 2020,24,1189-1199; see page 1190, left column; para 2, abstract, fig. 8); and/or
Bortnov et al. (Solution structure of human myeloid-derived growth factor suggests a conserved function in the endoplasmic reticulum. Nature Communications, 2019,10:5612; see page 2, left column; fig. 4; Bortnov being one of the instant inventors named).
Regarding claims 1-24, Wang, Korf-Klingebiel, and Zhao (see sections noted above) each teach the use of MYDGF in the treatment of cardiac tissue which would naturally inhibit neutrophil recruitment (instant claim 1), naturally reduce inflammation thereof via treatment (instant claim 9) and promote wound healing of the cardiac tissue (instant claim 17), thereby rendering such obvious at a minimum. Additionally, Bortnov (see sections noted above) teaches the relationship of MYDGF to the signaling pathway of MAPK/STAT3 which is directly tied to inflammation and thereby renders obvious the inhibition of inflammation, at a minimum (instant claim 9). All of the other claims depending to these claims 1, 9, and 17 are equally rendering obvious as merely identifying subject taught for treatment (e.g. vertebrate, mammalian, human).
Regarding claims 25-26, each of the four (4) references above expressly teach (see abstract in each) MYDGF (e.g. inferred to be human, instant SEQ ID NO: 1) and compositions comprising the same. Thus, the products of claims 25-26 are equally rendered prima facie obvious to arrive at.
Claim Rejections - 35 USC § 112 – Written Description, Lack of Possession
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 1-26 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. Namely, applicant claims ANY myeloid-derived growth factor (“MYDGF”) bearing a biologically active fragment thereof, an analogous sequence thereof; including e.g. at least 60% identity to instant human (SEQ ID NO: 1), mouse (SEQ ID NO: 3) and zebrafish (SEQ ID NO: 7). However, the latter three naturally occurring examples are the only MYDGF’s found described or sequenced in the instant application. Thus, absent further evidence which is not currently of record that the state of the art knew what these other fragments and analogous sequence structures were – which was not uncovered by the examiner in a review of the prior art nor amongst all the IDS references submitted herewith - applicant was in ‘not’ possession at the time of filing of the instantly claimed: ANY myeloid-derived growth factor (“MYDGF”) bearing a biologically active fragment thereof, an analogous sequence thereof; including e.g. at least 60% identity to instant human (SEQ ID NO: 1), mouse (SEQ ID NO: 3) and zebrafish (SEQ ID NO: 7).
Double Patenting (U.S. Patent No. 11,980,644, Parent)
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 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,980,654. Although the claims at issue are not identical, they are not patentably distinct from each other because the same original claims filed there are filed here, bearing the same three (3) methods of use, bearing the three (3) peptide SEQ ID NOS: 1, 3, and 7 employed therein that ultimately issued in ‘654. As such, while the originally filed claims contain broader scope, the species issued in ‘654 read hereon and render such prima facie obvious.
Conclusion
This is a continuation of applicant's earlier Application No. 17/481,490. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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