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 .
Status of Claims
Claims 1-26 are cancelled. Claims 27-45 are added. Claims -----27-30 and 36-45 are currently pending and under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The claims have an earliest effective filing date of 08/06/2019, corresponding to application 62/883,499.
Information Disclosure Statement
The Information Disclosure Statements filed on 05/24/2022 and 01/17/2025 have been considered.
Election/Restrictions
Claims 31-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/03/2026.
Claim Objections
Part (c) of claim 29 recites “then patients,” and then the claim recites patient treatment plans based upon disease activity. The recitation of “then patients” in Part (c) of claim 29 is confusing, and Applicant is encouraged to replace “then patients” with “wherein.”
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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) 27-28, 36-41, and 43 are rejected under 35 U.S.C. 102a1 as being anticipated by Al-Khersan (Al-Khersan et al, Expert Opinion On Pharmacotherapy, 2019, Vol 20, 1879-1891; published July 12th, 2019).
Al-Khersan et al teach the use of faricimab in treatment-naïve nAMD. Al-Khersan further teach faricimab can be used at an interval of 1.5mg every 4 weeks, 6mg every 4, 8, 12, or 16 weeks (Al-Khersan et al, pg.1885, Section 6.4 Faricimab). Al- Khersan meets the limitations of claims 27-28, 39-41, and 43.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 29-30, 42, and 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Khersan (Al-Khersan et al, Expert Opinion On Pharmacotherapy, 2019, Vol 20, 1879-1891; published July 12th, 2019).
Al-Khersan et al teach the use of faricimab in treatment-naïve nAMD. Al-Khersan further teach faricimab can be used at a dose of 1.5mg every 4 weeks, 6mg every 4, 8, 12, or 16 weeks (Al-Khersan et al, pg.1885, Section 6.4 Faricimab). Additionally, Al-Khersan et al teach disease activity is assessed at 24 weeks using BCVA, OCT, and clinical examination (Al-Khersan et al, pg.1885, Section 6.4 Faricimab). Al-Khersan et al taught that after assessment the patient treatments can change (Al-Khersan et al, pg.1885, Section 6.4 Faricimab).
Regarding claims 29-30 and 42, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
With respect to the order of steps, it is noted that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930); Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959)). See MPEP §2144.04 IV C. - the claimed order of steps is an obvious variant of the steps of the cited prior art.
Regarding claim 44, Al-Khersan et al teach that nAMD patients are treated with anit-VEGF (Al-Khersan et al, Abstract). Al-Khersan et al does not teach that the patients treated with faricimab were previously treated with anti-VEGF. However, one of ordinary skill in the art would be motivated with a reasonable expectation of success to treat patients with faricimab who were previously treated with anti-VEGF because faricimab is a bispecific antibody against VEGF and ANG2 because anti-VEGF and anti-ANG2 have both previously been used in nAMD and two medicaments are usually more effective than one.
Regarding claim 45, it is noted that the wherein clause does not further limit the claim as a person of ordinary skill would recognize that a computer software program could be used in the development of a treatment method.
Therefore, claims 29-30, 42, and 44-45 were prima facie obvious at the time of effective filing.
Conclusion
No claim is allowed.
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/J.K.D./Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642