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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 7/6/2026 wherein claims 1, 2, 13-15, 23, and 24 were amended; claims 17 and 22 were canceled; and claim 27 was added.
Note(s): Claims 1-16, 18-21, and 23-27 are pending.
Priority
This application is a CIP of PCT/US2020/065523 filed 12/17/2020 and PCT/US2020/065523 is a CIP of 16/719,703 (now US Patent No. 11,147,855) filed 12/18/2019.
Note(s): The earliest effective filing date is 12/18/2019 because Serial No. 16/719,703 fully supports the pending invention.
Claim Interpretation
Independent claim 1 is directed to a drug delivery system comprising: a prostaglandin as set forth therein, a CNTF compound, a FAS or FASL inhibitor, and a biodegradable polymer.
Claim 16 is directed to a method of treating a glaucoma or ocular hypertension.
Applicant’s Election
Once again, Applicant's election without traverse of Group I (pending claims 1-15 and 23-27) filed 12/17/2025 is acknowledged. The restriction requirement was deemed proper and made FINAL.
Applicant elected the species wherein the prostaglandin is bimatoprost acid; the CNTF compound is a CNTF peptide in general, not a specific peptide as requested in the restriction requirement; the FAS/FASL inhibitor is a peptide comprising YLGA (SEQ ID NO: 5); and the sustained released component is a polymer. Claims 1, 2, 4, 7, 13-15, and 23-27 read on the elected species.
Applicant’s elected species was searched and no prior art was found to reject the claims. The search was expanded and prior art was found to render obvious the drug delivery system of independent claim 1 as set forth below.
Withdrawn Claims
Claims 3, 5, 6, 8-12, 16, and 18-21 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention/species.
Information Disclosure Statement
The information disclosure statement filed 7/6/2026 was considered.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 7/6/2026 to the rejection of claims 1, 2, 4, 13-15, and 23-26 made by the Examiner under 35 USC 103, 112, and/or double patenting have been fully considered and deemed persuasive-in-part for the reasons set forth below.
Double Patenting Rejections
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.
I. Claims 1, 2, 4, 13-15, and 23-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/274,423 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to compositions comprising a prostaglandin (e.g., bimatoprost acid and salts thereof), a CNTF compound (e.g., Peptide 21), a sustained delivery component (a hydrogel), and optionally, comprising a FAS/FASL inhibitor (e.g., MET 4-8). The claims differ in that of the pending invention are generally directed to a prostaglandin, a CNTF compound, and a sustained delivery component whereas the copending application is directed to a composition having a specific prostaglandin (bimatoprost acid), a specific CNTF compound (Peptide 21), and a specific delivery component (hydrogel). Thus, the skilled artisan would recognize that the pending invention encompasses the copending claims. Hence, the inventions disclose overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
APPLICANT’S ASSERTIONS
In summary, Applicant has requested that the rejection be held in abeyance until allowable subject matter comes forth.
EXAMINER’S RESPONSE
Applicant’s argument was considered. The rejection is still deemed proper and the double patenting rejection is MAINTAINED.
II. The claims were previous rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,147,855.
APPLICANT’S ASSERTIONS
In summary, it is asserted that the rejection should be withdrawn because the parent application was subjected to a restriction between the drug delivery system and method of treating glaucoma or ocular hypertension.
EXAMINER’S RESPONSE
Applicant’s response was considered and is deemed appropriate. However, it should be noted that the pending application contains both product (drug delivery system) and method claims that read on the very same treatments (glaucoma and ocular hypertension) that are US Patent No. 11,147,855 using the same components. While the rejection is WITHDRAWN, the double patenting rejection will be re-instated when the product and method claims are rejoined.
Written Description Rejection
The 112 first paragraph (written description) rejection is WITHDRAWN because Applicant amended the claims to overcome the rejection.
112 Second Paragraph Rejections
The 112 second paragraph rejections are WITHDRAWN because Applicant amended the claims to overcome the rejections.
103 Rejection
It is duly noted that Applicant amended the claims on 7/6/2026 to insert an additional component (a FAS or FASL inhibitor) and incorporating specific prostaglandins into the claim. Thus, the 103 rejection below was modified to accommodate the incorporation of the additional component.
NEW GROUNDS OF REJECTION
112 Second Paragraph Rejection
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 27 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 27: The claim is ambiguous because it is unclear how one would determine/know whether the biodegradable polymer is one that allows the prostaglandin and CNTF compound to remain in a human being’s body for longer than the time that it would take for the prostaglandin and CNTF compound to be metabolized or passed out of the body.
Claim 27: The claim is ambiguous because according to MPEP 2173.05(p), a single claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product (delivery system), the claim limitation is not directed to the product itself, but rather to actions involving the product which creates confusion as to when direct infringement occurs. Specifically, it is unclear whether infringement occurs when one has a delivery system or when the biodegradable polymer functions such that it allows the prostaglandin and CNTF compound to remain in the body for longer than the time that it would take for the prostaglandin and CNTF compound to be metabolized or passed out the body.
103 Rejection
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.
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.
Claims 1, 2, 4, 13-15, and 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Sambhara et al (Therapeutic Advances in Chronic Disease, 2014, Vol. 5, Nol, 1, pages 30-43) in view of Cao et al (Drug Discovery Today, August 2019, Vol. 24, No. 8, pages 1694-1700) and in further view of Krishnan et al (Journal of Neuroinflammation, September 2019, Vol. 16, No. 184, pages 1-15).
Independent claim 1 is directed to a drug delivery system comprising: a prostaglandin (bimatoprost, bimatoprost acid, travoprost, travoprost acid, latanoprost, latanoprost acid, latanoprostene, tafluprost acid, or a combination thereof), a CNTF compound, and a FAS or FASL inhibitor in combination with a biodegradable polymer.
Claim 2 is directed to the drug delivery system of claim 1 wherein the CNTF compound is a CNTF peptide.
Claim 4 is directed to the drug delivery system wherein the prostaglandin is bimatoprost acid or a salt thereof.
Claim 13 is directed to the drug delivery system of claim 1 wherein the prostaglandin is not covalently bonded or covalently linked to the CNTF compound or the FAS or FASL inhibitor.
Claim 14 is directed to the drug delivery system of claim 1 wherein the prostaglandin is covalently bonded or covalently liked to the CNTF compound or the FAS or FASL inhibitor.
Sambhara et al is directed to glaucoma management and available drug treatments. The drug treatment includes the use of prostaglandins (see entire document, especially, abstract). In particular, Sambhara et al disclose that prostaglandin substances enhance the uveoscleral outflow due to relaxation of the ciliary muscle and remodeling of extracellular matrix tissue within the ciliary body. Possible prostaglandins that may be used include latanoprost, bimatroprost, travoprost, and tafluprost (page 31, Table 1; page 34, left column, first paragraph; page 34, left and right columns, bridging paragraph). Prostaglandin substances are administered as topical eye drops (page 34, left column, first paragraph).
While Sambhara et al do not specifically state that they incorporated a CNTF compound in combination with their prostaglandins, such modification would have been obvious prior to Applicant’s effective filing date for the following reasons: (1) based on the teaching of Sambhara et al regarding relaxation of the ciliary muscle and remodeling of extracellular matrix tissue within the ciliary body leading to increased aqueous outflow, a skilled artisan would be motivated to incorporate a ciliary enhancing agent (e.g., CNTF, ciliary neurotrophic factor). (2) On page 40 (left column, third complete paragraph), it is disclosed that neuroprotective agents, specifically ciliary neurotrophic factor (CNTF), when deprived and/ or dysfunction of CNTF is present glaucoma resulted, but supplementation of CNTF is a possible neuroprotector. Thus, the skilled artisan would be motivated to incorporate CNTF into the composition.
Cao et al is directed to advance in intraocular sustained release drug delivery. The document discloses that topical eye drop administration and intravitreal injections are the current standard for ocular drug delivery. The drug delivery of Cao et al results in sustained drug delivery of therapeutics (page 1694, abstract; page 1695, right column, third complete paragraph). Various sustained delivery components are disclosed in Cao et al. A preferred embodiment of sustained delivery components includes biodegradable polymers. Cao et al disclose that possible biodegradable polymers that may be utilized include PLGA, PCL, crosslinked PEG, POE, and polyanhydrides (page 1695, left and right columns, bridging paragraph; page 1697, Table 2; page 1698, Table 3).
Cao et al disclose that in one of their studies, their investigation treatment , NT-501 ECT, provided intravitreal sustained release of soluble ciliary neurotrophic factor (CNTF) factor. In addition, Cao et al disclose that NT-501 is now being utilized in clinical studies for the treatment of glaucoma (page 1697, left column, first complete paragraph). Thus, it would be obvious to a skilled artisan prior to the effective date of Applicant’s invention to incorporate a CNTF in the treatment of a glaucoma. Furthermore, since Sambhara et al is also directed to treatment of glaucoma and also suggests that one should incorporate a CNTF substance, based on the combined teachings of Sambhara et al and Cao et al and the fact that both references are in the same field of endeavor, motivation is present to combine the reference teachings. In addition, based on MPEP 2144.06, Section I, that is directed to art recognized equivalences for the same purpose, it is prima facie obvious to combine two substances/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. Hence, combining prostaglandin with a CNTF substance and a biodegradable polymer is rendered obvious by the combined prior art teachings.
Sambhara et al fail to disclose a FAS or FASL inhibitor. However, Krishnan et al is made of record for its teachings of a small peptide antagonists of the FAS receptor which inhibits neuroinflammation and prevents axon degeneration and retinal ganglion cell death in glaucoma subjects (see entire document, especially, abstract; page 2, right column, first complete paragraph). The small peptide inhibitor of Fas that Krishnan et al focused on was Met (e.g., Met 12) (pages 2-3, bridging paragraph).
Since Krishnan et al disclose that it is well known in the art to use a FAS receptor peptide inhibitor to provide neuroprotection for eye treatment (glaucoma) and all three documents (Sambhara et al, Cao et al, and Krishnan et al) are directed to compositions useful for treating eyes, the references may be considered to be within the same field of endeavor. Hence, the reference teachings are combinable. Furthermore, based on MPEP 2144.06, it is prima facie obvious combine ingredients which are taught in the prior art to be useful for the same purpose in order to form a new compositions to be used for the very same purpose (treatment of the eyes/glaucoma) as the idea of combining the ingredients flows logically from their having been individual taught in the prior art. As a result, a drug delivery system comprising a prostaglandin, a CNTF compound, and a FAS inhibitor is rendered obvious by the cited prior art and the limitations of claims 1, 2, 4, 13, and 14 are met.
Claim 15 is directed to the drug delivery system of claim 1 wherein the prostaglandin, the CNTF compound, the FAS or FASL inhibitor, or a combination thereof is covalently bonded or linked to the polymer.
Claim 23 is directed to the drug delivery system of claim 1 wherein the CNTF compound is covalently bonded or covalently linked to the FAS or FASL inhibitor.
Claim 24 is directed to the drug delivery system of claim 1 wherein the CNTF compound and the FAS or FASL inhibitor are covalently bonded or covalently linked to the polymer.
Claim 25 is directed to the drug delivery system of claim 14 wherein the covalent bonding is by direct covalent bonding and the covalent linking is via a linking group.
Claim 26 is directed to the drug delivery system of claim 15, wherein the covalent bonding is by direct covalent boding and the covalent linking is via a linking group.
Claim 27 is directed to the drug delivery system of claim 1 wherein the biodegradable polymer allows the prostaglandin and CNTF compound to remain in a human beings body for longer that the time that it would take for the prostaglandin and CNTF compound to be metabolized or passed out the body.
In regard to claims 15 and 23-27 which involves the linking of the components and characteristics of the biodegradable polymer, according to MPEP 2112.01, Section II, it would have been obvious to a skilled artisan that if the compositions are physically the same, then the properties/characteristics would be the same. In particular, since products of identical chemical compositions cannot have mutually exclusive properties, it is recognized that chemical composition and its properties are inseparable. Thus, the bonding as well as the biodegradable polymer allowing the prostaglandin and CNTF compounds to remain in the body for a longer period than for the prostaglandin and CNTF compound to be metabolized or passed out the body would be the same for both Applicant and the prior art’s composition. Hence, the limitations of claims 15 and 23-27 are rendered obvious.
Claim Objection
Claim 7 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Note(s): Claim 7 is only objected to as it relates to Applicant’s specific elected species.
Comments/Notes
The full scope of Group I (pending claims 1-15 and 23-27) was not searched.
Sambhara et al (Therapeutic Advances in Chronic Disease, 2014, Vol. 5, Nol, 1, pages 30-43) and Cao et al (Drug Discovery Today, August 2019, Vol. 24, No. 8, pages 1694-1700) were previously mailed to Applicant.
Conclusion
Claims 1, 2, 4, 13-15, and 23-27 are rejected; claims 3, 5, 6, 8-12, 16, and 18-21 are withdrawn; and claim 7 is objected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
September 17, 2026
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