CTNF 17/813,889 CTNF 89126 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-42-04 AIA 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/2/2026 has been entered. Claims 7, 11-15 and new claims 16-21 are under consideration in the instant Office Action. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 7, 11-15 and new claims 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kim US2016/0032259 (IDS 9/7/2022, #3) in view of Davis-Smyth et al., US8,273,353 (6/13/2025 PTO-892) Kim teaches using VEGF-Grab to treat eye diseases and disorders (see paragraphs 5, 8-9) as in instant claim 7 and new claim 16. Kim teaches an isolated nucleic acid sequence encoding VEGF-Grab (see paragraph 11). Kim teaches that VEGF-Grab is a soluble decoy receptor fusion protein which neutralize VEGF-A, VEGF-B and PIGF and is comprised of the D2 and D3 immunoglobulin (Ig)-like domains of VEGFR1 fused to a IgG1 Fc (see paragraphs 9, 182-183 and Figure 1A) as in instant claims 7 and 11-15. Kim teaches administering the VEGF-Grab via intravitreal administration (see paragraphs 8 and 177) as in instant claim 7. Kim teaches that ocular diseases for treatment include choroidal neovascularization, retinal neovascularization, retinal vein occlusion and age related macular degeneration (see paragraphs 5, 9, 77, 79, 83, 90, 94) as in instant claims 7, and 12-14 and new claim 16. Kim teaches SEQ ID NO: 6 (a VEGF-Grab, pages 38-39) that encompasses instant SEQ ID NOs: 3, 16-17 with minor differences wherein SEQ ID NO:16 at position 46 is threonine while Kim’s teaches tyrosine and alanine in instant SEQ ID NO: 17 at position 151 rather than arginine as taught by Kim. Kim teaches that the VEGF-Grab has improved pharmacokinetic profile and is stronger and more durable anti-angiogenic compared to the VEGF-trap (aka aflibercept; see paragraph 9). Kim teaches using a diode laser to treat CNV and administering aflibercept and VEGF-Grab with specific doses (see paragraphs 31-33, 177-178 and 195) as now required in new claims 17-21. These minor differences are not shown to be critical and the prior art already teaches the required SEQ ID NOs: 16-17 as SEQ ID NO:51 and 49 in Davis-Smyth’s teaching (see pages 50-51). Davis-Smyth also teaches the 24-34 amino acids of SEQ ID NO: 3 in Davis-Smyth’s SEQ ID NO: 7 (see column 4, lines 39-41) as required in instant claim 7. As in stated in MPEP §2144.06, substituting one equivalent element for another known for the same purpose renders an invention obvious and an “express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout , 675 F.2d 297, 213 USPQ 532 (CCPA 1982)." Moreover, this section of the MPEP teaches "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven , 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). Accordingly, the cumulative reference teachings render obvious the claimed composition. Further, while Kim and Davis-Smyth are silent on the multiple characteristic described in instant claims 8-15, it is clear that the same product would have the same characteristics as the instantly claimed VEGF-Grab composition since there is no evidence to the contrary. Note that rejections are appropriate when the prior art discloses a method (or product) that appears to be identical except that the art is silent as to an inherent property; see MPEP § 2112(III). In such situations, the burden is on applicant to provide evidence that the prior art product (or method) is not the same or an obvious variant; see MPEP § 2112(V). Finally, the specific doses and regimes as set forth in new claims 17-21 are determined through routine optimization with a reasonable expectation of success since both Kim and Davis-Smyth teach using these composition to treat a vascular endothelial growth factor related disease condition in an eye of a subject . Response to Arguments 07-37 AIA Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive. As already acknowledged in the instant rejection above, Kim’s sequences are not the same and have minor differences in comparison to the instant SEQ I DNOs: 16 and 17. Applicant argues that these differences teach way from the instant claimed invention since Kim teaches “that such decoy receptors should be mutated to eliminate "positively charged residues at the VEGFR1 D3 region, in particular, b 1- b 2 loop and/or b 3- b 4 loop. Kim, [0072]. Accordingly, Kim teaches that the preferred VEGF-Grab (VEGF-GRAB3) has three mutations (R135S, K138T, and R172N) for glycosylation sites that eliminate positive residues. Kim, [0183]; see also [0007] (teaching that "[g]lycosylation [l] ... provides a negative charge and increases solubility, thus diminishing non-specific binding to the ECM" and [2] grants resistance to proteolysis and extended serum half-life, enhancing a protein's PK profile"). All three of these genetically engineered modifications differ from the claimed sequence.” It is pointed out that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories , 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also > Upsher-Smith Labs. v. Pamlab, LLC , 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). Kim is depended upon to show that the construct is well-known in the prior art and can be manipulated in many forms and still retrain its function. These functions can be manipulated and still retain its vital function. The Davis-Smyth reference clearly show that the unmodified sequences as in the instant claims are well-known. The prior art clearly sets forth that the components are well-known and disclosed in the prior art and would be obvious to try because there components are easily interchangeable and the combination has a predictable results. The fact that the point mutations produce certain effects that applicant does not think effective does not detract from the reasonable obvious to try and produce a specific product with well recognized results . Absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. “Good science and useful contributions do not necessarily result in patentability.” PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007). Whether the construct of Kim to be more efficacious than in the one produced by the combination of Kim and Davis-Smyth references is not determinative as to the propriety of the obviousness of the claimed invention. That is because “ the question is whether there is something in the prior art as a whole to suggest the desirability, and thus the obviousness, of making the combination, not whether there is something in the prior art as a whole to suggest that the combination is the most desirable combination available .” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (citation omitted). An "obvious to try" rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. " [A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 35 U.S.C. 103." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). The teachings of Kim and Davis-Smyth demonstrate that the ordinary artisan was aware of the criteria to determine peptide efficacy in the treatment of VEGF related diseases. Thus, it would be conventional and within the skill of one in the art to identify the claimed peptide and its efficacy in the treatment of treatment of VEGF related diseases. Finally, Applicant argues that the Davis-Smyth reference teaches away from instant claims since they teach away from the D1 removal as required in the instant claims. Applicant argues that the instant application demonstrates that the claimed V23 construct was more effective at inhibiting choroidal neovascularization (CNV) than the V123 constructs. This is not found persuasive because the instant claims are not the V23 construct and actually still read on the V123 construct since the claim language of “N is an N-terminal peptide comprising amino acid residues 27-34 of SEO ID NO:1.” only requires that the 27-34 amino acids of SEQ ID NO: 3 be present but can encompass the larger or entire sequence of SEQ ID NO: 3. And it is also pointed out that Kim teaches SEQ ID NO: 6 (a VEGF-Grab, pages 38-39) that encompasses instant SEQ ID NOs: 3, 16-17 and so does Davis-Smyth. Therefore, the prior art has clearly envisioned the same fusion proteins of anti-VEGF agents and there is sufficient guidance in the prior art to produce the claimed product to be used as a therapeutic treatment of VEGF related disease of the eye. Therefore the claims are obvious over the prior art of record, and the rejection is maintained. Conclusion No claims are allowed. Advisory Information Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURORA M. FONTAINHAS whose telephone number is 571-272-2952. The examiner can normally be reached on Monday - Friday (8AM - 4PM). Examiner interviews are available via telephone, in-person, 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, Jeffrey Stucker can be reached on (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. /AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675 Application/Control Number: 17/813,889 Page 2 Art Unit: 1675 Application/Control Number: 17/813,889 Page 3 Art Unit: 1675 Application/Control Number: 17/813,889 Page 4 Art Unit: 1675 Application/Control Number: 17/813,889 Page 5 Art Unit: 1675 Application/Control Number: 17/813,889 Page 6 Art Unit: 1675 Application/Control Number: 17/813,889 Page 7 Art Unit: 1675 Application/Control Number: 17/813,889 Page 8 Art Unit: 1675 Application/Control Number: 17/813,889 Page 9 Art Unit: 1675
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