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
This Office Action is a response to Applicant’s Amendment and Remarks filed November 20, 2025.
Claims 10, 11 and 15 have been canceled. New claim 26 is acknowledged. Claims 1, 6, 12 and 16 have been amended.
Claims 1-9, 12, 13, 16, 18, 19, 21, 22, 24 and 26 are pending in the instant application.
Claims 1-9, 12, 13, 16, 18, 19, 21, 22, 24 and 26 have been examined on the merits as detailed below:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
In the previous Office Action mailed August 20, 2025, claims 1-13, 15, 16, 18, 19, 21, 22 and 24 were rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20170130231 (hereinafter, “Chae”) as evidenced by Zammit et al. (Int J Gen Med. 2010 Oct 20:3:335-343) or Schapira DV (Cancer 1994; 74:632-639). This rejection is moot against claim 10, 11 and 15 in view of Applicant’s Amendment filed November 20, 2025 to cancel these claims. This rejection is maintained against the remaining claims for the reasons of record set forth in the previous Office Action mailed August 20, 2025. NOTE: New claim 26 is drawn to subject matter within the scope of the rejected claims and, if present, would have been rejected in the prior Office Action. Therefore, the instant rejection applies to new claim 26 as well.
Response to Arguments
In response to this rejection, Applicants traverse and argue that while Chae describes a method for treating or preventing respiratory diseases by administering an Amphiregulin-specific SAMiRNA construct, Chae does not disclose or suggest using that method for the treatment or prevention of obesity. Applicants argue that a person of ordinary skill in the art would find no motivation or reasonable expectation of success to use a respiratory disease therapeutic as an anti-obesity agent since therapeutic agents for respiratory diseases would not be inherently equivalent to anti-obesity agents.
Applicant’s traversal and argument has been fully considered by the Examiner but is not found persuasive because as discussed in the previous Office Action mailed August 20, 2025, Chae teach the same amphiregulin-specific double-stranded oligonucleotide of the claimed invention. Without language of “treating obesity in a subject in need thereof” in the present claims, the Examiner maintains that the method for treating or preventing respiratory diseases by administering the Amphiregulin-specific SAMiRNA construct of Chae would inherently prevent obesity in the subject with respiratory disease. Applicants do not provide any evidence to the contrary, only arguments. Arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.
Chae teach an amphiregulin-specific double stranded oligonucleotide of SEQ ID NO: 107 (see paragraph [0039] in Table on page 6), which is a siRNA and identical to SEQ ID NO: 12 of the present invention. Applicant is reminded that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Thus, administration of the amphiregulin-specific double stranded oligonucleotide of SEQ ID NO: 107 of Chae, which is identical to instant SEQ ID NO: 12 of the present invention, will at least inherently prevent obesity in the subject with respiratory disease, absent some evidence to the contrary. The Examiner has provided sound basis in fact and technical reasoning that reasonably supports the determination that the allegedly inherent characteristic necessarily flows from what has been specifically disclosed within the prior art and has shifted the burden to Applicant to provide evidence, not Attorney arguments to the contrary.
Further, it is important to note that the instant Specification serves as evidence of record establishing this inherency. Failure of those skilled in the art to contemporaneously recognize an inherent property (i.e. a biological mechanism of action) of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999). See also Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993).
The Patent Office does not have the facilities and resources to provide the factual evidence needed in order to determine properties between the instantly claimed method for preventing obesity and the method of preventing or treating respiratory diseases taught by the prior art. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed method and associated method steps are different from the method and associated methods steps taught by the prior art, thereby establishing patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ2d 1922(PTO Bd.Pat. App. & Int. 1989). In the present case, Applicants provide no proof, only statements and arguments of counsel which are not considered evidence.
Regarding new claim 26, Chae teach the Amphiregulin-specific SAMiRNA constructs of their invention comprise hydrophilic compounds comprising hexaethylene glycol and/or hydrophobic compounds comprising C24.
Turning to the facts, the presumption of obviousness applies here, and none of the means for rebutting it has been shown. In view of the foregoing, when all the evidence is considered, the totality of the rebuttal evidence of non-obviousness fails to outweigh the evidence of obviousness made of record. Thus, it is maintained that the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
In the previous Office Action mailed August 20, 2025, claims 1-13, 15, 16, 18, 19, 21, 22 and 24 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-29 of U.S. Patent No. 10,208,309 as evidenced by Zammit et al. (Int J Gen Med. 2010 Oct 20:3:335-343) or Schapira DV (Cancer 1994; 74:632-639). This rejection is moot against claim 10, 11 and 15 in view of Applicant’s Amendment filed November 20, 2025 to cancel these claims. This rejection is maintained against the remaining claims for the reasons of record set forth in the previous Office Action mailed August 20, 2025. NOTE: New claim 26 is drawn to subject matter within the scope of the rejected claims and, if present, would have been rejected in the prior Office Action. Therefore, the instant rejection applies to new claim 26 as well.
Response to Arguments
Applicants do not argue or traverse this particular rejection, therefore, it is maintained. A terminal disclaimer disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 10,208,309 is required or some other appropriate action.
Regarding new claim 26, U.S. Patent No. 10,208,309 teach the siRNAs of their claimed invention comprise a sense strand and an antisense strand and also comprise hydrophilic compounds comprising hexaethylene glycol and/or hydrophobic compounds comprising C24.
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In the previous Office Action mailed August 20, 2025, claims 1-13, 15, 16, 18, 19, 21, 22 and 24 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 and 17 of U.S. Patent No. 12,037,589 as evidenced by Zammit et al. (Int J Gen Med. 2010 Oct 20:3:335-343) or Schapira DV (Cancer 1994; 74:632-639). This rejection is moot against claim 10, 11 and 15 in view of Applicant’s Amendment filed November 20, 2025 to cancel these claims. This rejection is maintained against the remaining claims for the reasons of record set forth in the previous Office Action mailed August 20, 2025. NOTE: New claim 26 is drawn to subject matter within the scope of the rejected claims and, if present, would have been rejected in the prior Office Action. Therefore, the instant rejection applies to new claim 26 as well.
Response to Arguments
In response to this rejection, Applicants traverse and argue that U.S. Patent No. 12,037,589 is directed to preventing and treating fibrosis-related diseases and respiratory diseases and contains no mention or suggestion of obesity.
Applicant’s traversal and argument has been fully considered by the Examiner but is not found persuasive because as discussed in the previous Office Action mailed August 20, 2025, U.S. Patent No. 12,037,589 teach the same amphiregulin-specific double-stranded oligonucleotide of the claimed invention. Without language of “treating obesity in a subject in need thereof” in the present claims, the Examiner maintains that the pharmaceutical composition comprising the compound having a structure of Formula (3) or (4) and having a sequence of SEQ ID NO: 10, 11, or 12 of U.S. Patent No. 12,037,589 would at least inherently prevent obesity when administered to the subject with respiratory disease, absent evidence to the contrary. The Examiner has provided sound basis in fact and technical reasoning that reasonably supports the determination that the allegedly inherent characteristic necessarily flows from what has been specifically disclosed within the prior art and has shifted the burden to Applicant to provide evidence, to the contrary. Applicants do not provide any evidence to the contrary, only arguments. Arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
U.S. Patent No. 12,037,589 teach the same amphiregulin-specific double-stranded oligonucleotide of the claimed invention. Applicant is reminded that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Thus, administration of the amphiregulin-specific double-stranded oligonucleotide of U.S. Patent No. 12,037,589, will inherently prevent obesity in the subject with respiratory disease, absent some evidence, not Attorney arguments to the contrary.
The pharmaceutical composition comprising the compound having a structure of Formula (3) or (4) and having a sequence of SEQ ID NO: 10, 11, or 12 used to prevent and treat fibrosis-related diseases and respiratory diseases of U.S. Patent No. 12,037,589 embraces, encompasses and overlaps in scope with the amphiregulin-specific double-stranded oligonucleotide used to prevent obesity of the present invention.
The Examiner maintains that a terminal disclaimer disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12,037,589 is required or some other appropriate action.
Regarding new claim 26, U.S. Patent No. 12,037,589 teach the compounds having a structure of Formula (3) or (4) and having a sequence of SEQ ID NO: 10, 11, or 12 of their claimed invention comprise hydrophilic compounds comprising hexaethylene glycol and/or hydrophobic compounds comprising C24. See claim 1, for example.
THIS ACTION IS MADE FINAL. 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 Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/Primary Examiner, Art Unit 1635