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 .
Receipt is acknowledged of Applicant’s Request for Continued Examination and Argument filed on 03/02/2026; and IDS filed on 12/17/2025 and 05/27/2026.
Claims 1-3, 6-16, 19-21 are pending in the instant application.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/02/2026 has been entered.
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, 6-16, 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/042,892 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-application recites a pigment epithelium-derived factor (PEDF) for use in a method for the treatment and/or prevention of dry macular degeneration in a subject, preferably dry age-related macular degeneration, wherein the method comprises administering PEDF and VEGF to the subject, wherein the PEDF and the VEGF are administered to the subject concurrently or sequentially (see claim 1), wherein PEDF induces growth of choriocapillaris (see claim 5), wherein the PEDF and the anti-VEGF therapy are administered to the subject concurrently or sequentially (see claim 8).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102/103
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 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) 1-3, 6-16, 19-21 is/are rejected under 35 U.S.C. 102((a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over FONSECA et al (Combined Treatment. July 2017).
FONSECA teaches the prior art had known of using anti-VEGF is the gold standard therapy for aged-related macular degeneration (“AMD”; see under 1. Introduction), wherein combining anti-VEGF drugs with other active agents to achieve synergistic action (see under 1. Introduction) and other promising forms of combined therapy (see 4.3), such as PEDF (see 4.3.3). Additional disclosures include: anti-VEGF drugs, such as intravitreal ranibizumab (see under 4.2.3) and bevacizumab (see under 4.2.5).
Although the reference is silent about the “inhibiting labyrinth capillary formation, inducing growth of choriocapillaris, tightening choriocapillaris, inhibiting extracellular matrix formation, protecting choriocapillaris, and/or guiding vessel development”, “wherein PEDF inhibits the growth and/or formation of geographic atrophy in wet and/or dry AMD”, etc., it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Additionally, these limitations appear to be the PEDF mechanism of actions. Thus, the reference teaches, either expressly or impliedly, each and every limitation of the instant claims.
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) 1-3, 6-16, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over PECHAN et al (Gene Therapies for Neovascular Age-Related Macular Degeneration. Cold Spring Harb Perspect Med 2015;5:a017335 pg. 1-10) in view of TOMBRAN et al (US 6,451,763) and AVERY et al (Intravitreal Bevacizumab (Avastin) for Neovascular Age-Related Macular Degeneration. Ophthalmology 2006;113:363–372).
PECHAN teaches the prior art had known of treating wet age-related macular degeneration (see title and abstract) comprised of: intravitreal injection administration of PEDF (see pg. 5, 2nd col).
PECHAN does not teach using an anti-vascular endothelial growth factor (anti-VEGF), such as bevacizumab.
TOMBRAN teaches a method of treating ocular diseases (see abstract), such as macular degeneration and other inherited and age-related pathologies of retinal cells (see col. 3, line 30-35) comprised of: administering retinal pigmented epithelium derived neurotrophic factor (PEDF; see abstract). Additional disclosures include: PEDF is administered, alone or in conjunction with other clinical procedures (see col. 18, line 50-52). PEDF is administered by intravitreal (see col. 18, line 52-53).
AVERY teaches the prior art had known of using bevacizumab for treating age-related macular degeneration (see title). Additional disclosures include: intravitreal administration (see title) using anti-VEGF, such as Luncentis (ranibizumab) to treat wet age-related macular degeneration (see pg. 372, reference #32).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using an anti-vascular endothelial growth factor (anti-VEGF), such as bevacizumab. The person of ordinary skill in the art would have been motivated to make those modifications, because it would have additive affect in treating age-related macular generation, and reasonably would have expected success because both references dealt in the same field of endeavor, such as treating macular degeneration.
Although the references are silent about the “inhibiting labyrinth capillary formation, inducing growth of choriocapillaris, tightening choriocapillaris, inhibiting extracellular matrix formation, protecting choriocapillaris, and/or guiding vessel development”, “wherein PEDF inhibits the growth and/or formation of geographic atrophy in wet and/or dry AMD”, etc., it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Additionally, these limitations appear to be the PEDF mechanism of actions. Thus, the reference teaches, either expressly or impliedly, each and every limitation of the instant claims.
Response to Arguments
Applicant argues that the '892 application is related to the combined use of PEDF and VEGF rather than the combined use of PEDF and an anti-VEGF therapy. In other words, the combination of therapeutically active agents is quite different in both applications, and thus, not obvious. In the alternative, where the Final Action does not indicate that the claims are otherwise allowable, Applicant respectfully requests that the double patenting rejection be held in abeyance, if not withdrawn in view of the foregoing.
The Examiner finds this argument unpersuasive, because the patent recites wherein the PEDF and the anti-VEGF therapy are administered to the subject concurrently or sequentially (see claim 8).
Applicant argues that Fonseca makes it very clear that not each and any combined treatment provides better visual results ("that some combination therapies for wet macular degeneration produced better visual results" (I81 paragraph, emphasis added)) or more effective and cost-effective treatment ("[i]n some other studies, it has been shown that some combinations are comparatively effective and cost-effective, with considerable less treatments needed than in monotherapy studies" (2nd paragraph, emphasis added)). Fonseca further refers to a synergistic action of corticoids, whereby such synergistic action arises from corticoids acing on "various levels of the inflammatory process and angiogenesis regulation" and also refers to PDGF-B inhibition which inhibition is said to facilitate the action of anti-VEGF therapies by "inducing pericyte stripping, thereby allowing anatomical regression of the neovascular membrane". Furthermore, photodynamic therapy as discussed in section 3.5 of Fonseca acts by "damaging newly formed blood vessels" (2nd paragraph), whereby such damaging is achieved through cellular damage and death meditated by free radicals (generated by photodynamic therapy). Fonseca is important as the teaching thereof is to "induce" PEDF rather than to administer PEDF. It will be acknowledged by a person of ordinary skill in the art that "inducing" PEDF means that PEDF will be generated, as a protein, locally, typically at the site within the eye where PEDF's antiangiogenic effect shall become effective. This can be achieved, for example, by gene therapy. Alternatively, some activator might be used for activating the PEDF gene so as to translate from the PEDF gene the PEDF protein. This passage of Fonseca, however, is silent as to the details of the induction of PEDF. In any case, the agent inducing PEDF is evidently an agent different from PEDF which is to be administered to the subject according to the method of claim 1. In contrast to such induction of PEDF as taught by Fonseca, the method of pending claim 1 makes use of PEDF, as a protein, which is administered to the subject. regarding the delivery of PEDF, section 4.3.3 of Fonseca refers to a phase I clinical trial of intravitreal administration of an IE4-deleted adenoviral vector expressing human PEDF (AdPEDF .11). It is important to note that this phase I study used such adenoviral vector as a monotherapy, i.e. not in combination with any anti-VEGF agent.
The Examiner finds this argument unpersuasive, because FONSECA explicitly teaches administration of an IE4-deleted adenoviral vector expressing human pigment epithelium-derived factor (see 4.3.3) and as discussed in the rejection, FONSECA teaches the prior art had known of using anti-VEGF is the gold standard therapy for aged-related macular degeneration (“AMD”; see under 1. Introduction), wherein combining anti-VEGF drugs with other active agents to achieve synergistic action (see under 1. Introduction) and other promising forms of combined therapy (see 4.3), such as PEDF (see 4.3.3).
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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