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
Claim Status
Claims 1-22 and 24 are pending. Claim 23 has been canceled. Claim 24 has been amended. Claims 1-22 and 24 are being examined in this application.
Claim Objections
Claim 24 is objected to because of the following informalities: The claim should be amended to recite “A method of treatment………..said method comprising administering a therapeutically effective amount of the compound according to claim 1 to a patient in need thereof”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
The rejection of claims 23-24 under 35 USC 101 is withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 112
The rejection of claims 23-24 under 35 USC 112(b) is withdrawn in view of the amendments to the claims.
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.
This rejection is maintained.
Claim 24 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of a subject suffering from the claimed diseases, does not reasonably provide enablement for the prevention of a subject suffering from the claimed diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The MPEP states:
“There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.”
(A) The breadth of the claims; and (B) The nature of the invention;
The claim is drawn to a method of treatment………..said method comprising administering a therapeutically effective amount of the compound according to claim 1 to a patient in need thereof.
The specification teaches that the term “treatment” covers both preventative (prophylactic) treatment (page 15, 1st para).
(C) The state of the prior art;
Antushevich et al. (Clinica chimica acta 483: 241-248 (2018)) teach apelin’s role in neurological disorders, hypertension disorders, metabolic disorders, respiratory disorders, gastrointestinal disorders, inflammatory markers, hepatic disorders, kidney disorders, and cancer.
However, Antushevich et al. do not teach the usage of apelin in preventing any of the diseases claimed.
Wysocka et al. (Cancer. Front. Physiol. 9: 557 (2018)) teach apelin’s role in cardiovascular disease, obesity, and cancer.
However, like Antushevich et al., Wysocka et al. do not teach the usage of apelin in preventing any of the diseases claimed.
(D) The level of one of ordinary skill;
The skill of those skilled in the art is high.
(E) The level of predictability in the art;
The unpredictability of preventing the claimed diseases is very high because of the large number of factors that play into a given subject developing a given listed disorder.
(F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The specification demonstrates the agonism effects of various compounds on human Apelin receptors.
However, the specification does not provide any examples with respect to the use of the claimed compound to prevent any of the diseases claimed.
The MPEP (2164.02) states that " The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).” The MPEP further states that
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“Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”
Given the number of disease states listed, a tremendous amount of experimentation would be required to determine if apelin agonist treatment would provide meaningful prophylaxis in each given case.
Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the invention as claimed.
Response to Arguments
Applicant’s arguments filed on 6/16/2026 have been fully considered but they are not persuasive.
Applicant argues that claim 24 does not recite prevention of a disease and has been amended to be more clearly directed to methods of treatment.
Applicant’s arguments are not persuasive because, as discussed above, the specification teaches that the term “treatment” covers both preventative (prophylactic) treatment (page 15, 1st para).
Therefore, the claim encompasses the prevention of the claimed diseases.
For the reasons stated above the rejection is maintained.
Allowable Subject Matter
Claims 1-22 are allowed.
Conclusion
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 SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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