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 . 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 Sept, 2025 has been entered.
Election/Restrictions
Applicant’s elected treatment with aflibercept without traverse in the reply filed on 11 Feb, 2020.
Claims Status
Claims 1, 4, and 24 are pending.
Claim 1 has been amended.
Claim 24 is new.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 4, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Heier et al (Opthalmol (2012) 119 p2537-2548, called Heier2 in this rejection) in view of Heier et al (Opthalmol. (2011) 118(6) p1098-1106).
Heier2 describes treatment of wet AMD with aflibercept (VEGF trap-eye) compared to a second VEGF blocking antibody (abstract). Three groups were treated every 4 weeks (with different dosages), a fourth group was treated every 4 weeks for three weeks, then moved to every 8 weeks (p2540, 1st column, 3d paragraph). Participants had CNV lesions comprising at least 50% of the total lesion size (p2540, 1st column, 2nd paragraph) as determined by fluorescein angiography (p2540, 1st column, 2nd paragraph). No group proved statistically inferior to the comparison antibody (p2541, 2nd column, 2nd paragraph).
The difference between this reference and the instant claims is that the clinical trial described in this reference excludes the patients claimed by applicants.
Heier et al discuss the treatment of neovascular age related macular degeneration (AMD) with VEGF Trap-Eye (abstract), is the same aflibercept as was used by Heier2. Two groups were treated with 0.5 or 2 mg, depending on group, every 4 weeks for 12 weeks, then as needed, while another 3 groups were treated with different amounts depending on group every 12 weeks, followed by as needed (fig 2, p1100, 1st column, top of page). Patients were >50 yrs old with subfoveal CNV secondary to wet AMD and lesions of less than 5400 µm in diameter (p1100, 1st column, 1st paragraph), with exclusion of subretinal hemorrhage of greater than 50% of the lesion size and excluding the fovea, and other exclusions, none of which involved the area of CNV (p1100, 1st column, 2nd paragraph). Changes in the size of the CNV and lesion were measured using fluorescence angiography (p1100, 2nd column, 5th paragraph), indicating that classification into classic, minimally classic, and occult lesions was made before therapy – otherwise, there would be no baseline to compare changes to. Note that these lesions were active CNV lesions, which shrank during therapy (p1102, 1st column, 2nd paragraph) while improving visual acuity (p1102, 1st column, 3d paragraph, continues to 2nd column).
Heier et al shows that a patient population that includes patients with areas of active CNV less than 50% of the total lesion size will benefit from treatment with aflibercept. Therefore, it would be obvious to treat the patients of Heier2 excluded due to smaller CNV lesions, to obtain the benefits of the therapy for those patients. As Heier et al teaches that a group containing these patients benefits from the therapy, an artisan in this field would attempt this expansion of the treatment group of Heier2 with a reasonable expectation of success.
The combination of Heier2 and Heier et al render obvious identifying and selecting patients with an active CNV lesion size less than 50% of the total lesion size, using fluorescein angiography and treating with afilbercept. Thus, the combination of references renders obvious claim 1.
Both references discuss multiple groups with treatment given every 4 weeks for at least three treatments, rendering obvious claim 4.
Treatment was every 4 weeks for 3 weeks, followed by every 8 weeks, rendering obvious claim 24
response to applicant’s arguments
Applicants argue that fluorescein angiography is precise, and claim unexpected results of being effective in the claimed group.
Applicant's arguments filed 12 Sept, 2025 have been fully considered but they are not persuasive.
Applicants argue that fluorescein angiography is precise, making the 50% limitation exact. This is in answer to an argument from the board stating that uncertainty tends to suggest obviousness. However, applicants have provided no evidence that fluorescein angiography is precise. Indeed, the reference relied upon by the board to show uncertainty, Zayit-Soudry et al, is discussing fluorescein angiography (title).
Applicants argue that it is unexpected that the claimed therapy works. It is not clear why this would be unexpected; as of applicant’s priority date, this is the method recommended for patients with wet AMD (Heier et al, p1104, 1st column, 3d paragraph, for example), regardless of active CMV lesion size.
New Rejections
Claim Rejections - 35 USC § 102
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, 4, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heier et al (Opthalmol (2012) 119 p2537-2548, previously cited) in view of Zayit-Soudry et al (Retina (2007) 27 p798-803).
Heier2 describes treatment of wet AMD with aflibercept (VEGF trap-eye) compared to a second VEGF blocking antibody (abstract). Three groups were treated every 4 weeks (with different dosages), a fourth group was treated every 4 weeks for three weeks, then moved to every 8 weeks (p2540, 1st column, 3d paragraph). Participants had CNV lesions comprising at least 50% of the total lesion size (p2540, 1st column, 2nd paragraph) as determined by fluorescein angiography (p2540, 1st column, 2nd paragraph). No group proved statistically inferior to the comparison antibody (p2541, 2nd column, 2nd paragraph).
While this reference excludes patients with CNV lesions less than 50% of the total lesion size, as evidenced by Zayit-Soudry et al, there is considerable disagreement in interpreting fluorescein angiography to determine CNV size (abstract), meaning that the ranges of Heier et al overlap with that of applicants. When a prior art range overlaps with or touches a claimed range, it anticipates (MPEP 2131.03(II)).
Heier et al treats patients with an active CNV lesion size that is, by some measures, less than 50% of the total lesion size, as determined by fluorescein angiography, using intravitreal injection of aflibercept, anticipating claim 1.
The reference treats some patients every 4 weeks for three times, followed by every other month, anticipating claims 4 and 24.
Double Patenting
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, 4, and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, and 6 of copending Application No. 19/327,664 (reference application) in view of Heier et al (Opthalmol. (2011) 118(6) p1098-1106).
Competing claims 1 and 2 describe a method of treating age related macular degeneration where the CNV is less than 50% of the total lesion size using an anti-VEGF treatment. Competing claims 3 and 4 describe a Markush group of dosing schedules, which overlap with those claimed by applicants. Competing claim 6 specifies that the treatment is selected from an Markush group that includes aflibercept.
The difference between the competing claims and the examined claims is that the competing claims do not specify fluorescein angiography to determine lesion size, and does not specify intravitreal injections.
Heier et al describes treatment of wet age related macular degeneration with an anti-VEGF therapy (abstract). Fluorescein angiography was used to determine lesion size (p1101, 2nd column, 2nd paragraph, continues to p1102). Material was administered intravitreally (p1099, 2nd column, 3d paragraph).
Therefore, it would be obvious to use fluorescein angiography to determine lesion size and intravitreal administration of the therapy as a substitution of one known element (the unspecified measurement and administration techinique of the competing claims) for another (the angiography and administration route of Heier et al) yielding expected results. As these are common in this field, an artisan in this field would have a reasonable expectation of success with these techniques.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658