Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
2. Applicant's election without traverse of Group II, claims 18-24, 26-31, 33-34 and 36-37, in the reply filed on 24 March 2026 is acknowledged. Applicant’s election ranibizumab as the species of anti-VEGF agent is also acknowledged. Claims 1, 4-5, 7-8, 10-11, 14, 16-17 and 38-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 24 March 2026.
3. The restriction requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, and/or Claims
4. The Response to the Restriction Requirement filed 24 March 2026 has been entered in full. Claims 1, 4-5, 7-8, 10-11, 14, 16-17 and 38-39 have been withdrawn as discussed supra. Therefore, claims 1, 4-5, 7-8, 10-11, 14, 16-24, 26-31, 33-34 and 36-39 are pending, and claims 18-24, 26-31, 33-34 and 36-37 the subject of this Office Action.
Information Disclosure Statement
5. The information disclosure statements (IDS) submitted on 01 November 2022 and 29 April 2025 have been considered by the Examiner.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 23, 26 and 36-37 are 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.
8. Claim 23 recites the limitation "the organic nanoparticles" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 18, from which claim 23 depends, recites “the nanoparticles are organic, inorganic, or a combination thereof”. Amending the claim to recite, for example, “wherein the nanoparticles are organic and comprise”, would be remedial.
9. Claim 23 is rejected as being indefinite for reciting “wherein the organic nanoparticles comprise at least one of paclitaxel-loaded polymeric micelles, liposomal doxorubicin, or paclitaxel-loaded human serum albumin nanoaggregate”. Since claim 18, from which claim 23 depends, merely recites a method of treating abnormal or excessive angiogenesis, it isn’t clear if the nanoparticles comprising these chemotherapeutic agents are utilized are intended to be utilized for every condition associated with abnormal or excessive angiogenesis, or only in situations where the abnormal or excessive angiogenesis is associated with cancer.
10. Claim 26 recites the limitation "the porphyrin/cholic acid hybrid polymer" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 18, from which claim 26 does not recite a “porphyrin/cholic acid hybrid polymer.”
11. Claim 36 is rejected as being indefinite because from the wording of the claim, it isn’t clear if only one of the recited conditions is required, one or more of the conditions are required, or if all the conditions recited in the claim are required. Therefor the metes and bounds of the claim cannot be determined.
12. Claim 37 is rejected as being indefinite because it is replete with grammatical and idiomatic errors. For example, it isn’t clear what is meant by the recitation of “wherein the area containing abnormal or excessive angiogenesis comprises at least one eye, eyelid and orbital lesions selected from”, since the limitations which follow are not limited to “eye, eyelid and orbital tears”. Accordingly, the metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 102
13. 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.
14. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
15. Claim(s) 18, 20-21, 27-30, 33-34 and 37 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Rudolph et al. (US 2018/0207233; published 26 July 2018).
16. Rudolf et al. teach that age-related macular degeneration (AMD) is a disease or disorder that has a variety of underlying factors, including inflammation and neovascularization in the retina and subretinal space (See pg. 5 [0082]). Rudolf et al. further teach that inflammatory responses upregulate the expression of VEGF and other pro-angiogenic factors that can cause abnormal angiogenesis (See pg. 20 [0203]). Rudolf et al. also teach methods of treating ARMD, comprising administering a nanoparticle comprising an anti-VEGF agent and an anti-inflammatory steroid via intravitreal injection, and can be administered with an NSAID, including bromfenac (See pg. 28 [0263], pg. 40 [0340]),. Rudolf et al. also teaches that the anti-VEGFR agent can be an anti-VEGF antibody (See pg. 22 [0222]), including wherein the anti-VEGF antibody is ranibizumab (See pg. 14 [0134]), and wherein the anti-inflammatory steroid is prednisolone or triamcinolone (See pg. 20 [205]). Rudolf et al. al. also disclose dosage of the anti-VEGF antibody includes 1.25 mg (See pg. 25 [0245]). Thus the Rudolf et al. reference meets all the limitations of claims 18, 20-21, 27-30 and 33-34.
Claim Rejections - 35 USC § 103
17. 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.
18. 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.
19. 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.
20. Considering objective evidence present in the application indicating obviousness or nonobviousness.
21. Claim 31 is obvious over Rudolf et al. as applied to claims 18, 20-21, 27-30 and 33-34 above.
22. While Rudolf et al. does not disclose wherein the triamcinolone is administered at a dose of 12 mg, it is routine experimentation to optimize dosages and dosage schedules.
23. “[W]here 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). Notably, it is not inventive to claim a particular dosage and/or administration schedule when the “discovery” of optimum dosage values or workable ranges via routine experimentation within the context of a known process represents an activity well-known to those of ordinarily skill in the art. Note in this regard that it is a well settled principal that “[d]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). See also Merck & Co. vv. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). See MPEP § 2144.05 part II. Furthermore, 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 the product not of innovation but of ordinary skill and common sense (see KSA International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQe2d 1385 (2007)). To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960) (MPEP 716.02(q)). Accordingly, the invention, taken as a whole, is prima facie obvious over the teachings of the prior art.
24. Claim(s) 22-24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudolph et al. (US 2018/0207233; published 26 July 2018) 18, 20-21, 27-30 and 33-34, and further in view of Li et al. (Nat. Commun. 5:4712, published 2015) and Huynh et al (WIREs Nanomed. Nanobiotechnol. 5:250-265, published 2013).
25. The teachings of Rudolf et al. are summarized above. Rudolf et al does not disclose wherein the nanoparticles are porphysome nanovesicles, semiconductor quantum dots, super paramagnetic iron oxide, or a combination of porphyrin-based organic nanoparticles and the porphyrin/cholic acid hybrid polymers.
26. However, such nanoparticles were known in the art at the time the invention was made, as disclosed by Li et al. and Huynh et al., including those comprising paclitaxel or doxorubicin.
27. It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the nanoparticles as taught by either Li et al. or Huynh et al. in a method for treating abnormal or excessive angiogenesis. The motivation to do so is disclosed by Rudolf et al, which discloses that nanoparticles provide a sustained release of the therapeutics. The expectation of success is high since Rudolf et al. also teach methods of treating ARMD, comprising administering a nanoparticle comprising an anti-VEGF agent and an anti-inflammatory steroid, and multiple nanoparticles that have been successfully utilized as therapeutics, as taught by Li et al. and Huynh et al.
28. Thus, the claims 22-24 and 26 are prima facie obvious over the combined teachings of the prior art.
29. Claim(s) 36 is obvious over Rudolf et al. as applied to claims 18, 20-21, 27-30 and 33-34 above.
30. The teachings of Rudolf et al. are summarized above. Rudolf et al does not disclose wherein the area containing abnormal or excessive angiogenesis comprises pyogenic granuloma, infantile hemangioma, hemangioma of infancy, congenital hemangioma, tufted hemangioma, spindle cell hemangioma, epithelioid hemangioma, kaposiform hemangioendothelioma, retiform hemangioendothelioma, papillary intralymphatic angioendothelioma, dabska tumor, composite hemangioendothelioma, Kaposi sarcoma, angiosarcoma, Epithelioid hemangioendothelioma, capillary malformation, lymphatic malformation, venous malformation, arteriovenous malformation, arteriovenous fistula, capillary-lymphatic malformation, capillary-arteriovenous malformation, capillary- lymphatic-arteriovenous malformation, capillary-venous-arteriovenous malformation, capillary-lymphatic-venous-arteriovenous malformation. However, it would have been obvious at the time the invention was filed to treat abnormal or excessive angiogenesis in an area, including the conditions recited in the claims which are all known to be characterized by abnormal angiogenesis, utilizing the method taught by Rudolf et al. The motivation to do so is disclosed by Rudolf et al. who discloses that that inflammatory responses upregulate the expression of VEGF and other pro-angiogenic factors that can cause abnormal angiogenesis, and disclose methods of treating ARMD, a condition associated with abnormal angiogenesis, comprising administering a nanoparticle comprising an anti-VEGF agent and an anti-inflammatory steroid, and additionally an NSAID. The expectation of success is high since methods of inhibiting abnormal angiogenesis with an anti-VEGF antibody are well known in the art, as evidenced by Rudolf et al.
Summary
31. No claim is allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jon M. Lockard whose telephone number is (571) 272-2717. The examiner can normally be reached on Monday through Friday, 8:00 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached on (571) 272-2911. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JON M LOCKARD/Examiner, Art Unit 1647 June 13, 2026
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