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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 24 April 2026 has been entered.
Claim Status
Claims 1, 3-5, 7 and 9-16 are currently pending. Claims 21-24 and 26-27 were canceled in the Office action mailed on 22 April 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 24 April 2026 has been considered by the examiner.
Claim Objections
Claim 10 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 7. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Both claims 7 and 10 ultimately depend from claim 1.
Claim 7 also depends from claim 4 (which depends from claim 1). Claim 4 limits the AMD to wet AMD. Claim 7 then recites “wherein the wet AMD is AMD having the following characteristics:
Active CNV under the macular fovea secondary to wet AMD occurs in an affected eye; and/or
Central subfield thickness is ≥250µm through optical coherence tomography (OCT) scanning.
Claim 10 depends from claim 1 and recites “wherein the individual suffers from wet AMD with the following characteristics:
Active CNV under the macular fovea secondary to wet AMD occurs in an affected eye; and/or
Central subfield thickness is ≥250µm through optical coherence tomography (OCT) scanning.
Therefore, claim 10 is substantially duplicative of claim 7 despite minor variations in the wording as all of the limitations which are found in claim 7 are also present in claim 10.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the following effects:
(4) onset of geographic atrophy in the individual is lagged; and/or
(5) onset of geographic atrophy in the individual is slowed.
However, the metes and bounds of “lagged” and “slowed” are unclear because onset lagging and onset slowing appear to be of the same scope and essentially the same thing. A review of the specification does not reveal a definition for what would be considered “lagged” versus “slowed” and in the absence of such, the two effects appear to be the same thing. Therefore, the claim is indefinite because the metes and bounds of “lagged” and “slowed” are unclear since they are recited as two different effects which should be materially distinct.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11-16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 14-16 depend from claim 1 which administers the fusion protein to the individual at a dose ranging from 4 mg to 8 mg per eye. Claims 14-16 all recite “administering to the individual the fusion protein at a dose of about 0.01-10 mg/eye”, which is a broadening limitation. Therefore, claims 14-16 fail to further limit the subject matter of the claim upon which they depend as well as failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 3-5, 7, 9-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-63 of copending Application No. 19/510,794 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the two applications are directed to a method of treating the same condition (age-related macular degeneration) by administration of the same compound (fusion protein having the amino acid sequence of SEQ ID NO:1 wherein the sequences are identical between the two applications) with the same dose (the instant application administers 4-8 mg per eye and ‘794 administers 1-8mg per eye). The instant claims and the claims of ‘794 each recite characteristics of the subject population (such as active CNV, central subfield thickness, etc.; see instant claims 7 and 10 and ‘794 claims 8-11) as well as treatment outcomes (see instant claims 11-13 and ‘794 claims 51-63). Therefore, the claims of the instant application and those of ‘794 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Z Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christine J Saoud/Primary Examiner, Art Unit 1645
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