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 12/17/2025 wherein claims 1, 5, and 13-15 were amended; claims 17 and 22 were canceled; and claims 23-26 were added. In addition, the Examiner acknowledges the amendment filed 4/10/2023.
Note(s): Claims 1-16, 18-21, and 23-26 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, a CNTF compound, and a sustained delivery component.
Claim 16 is directed to a method of treating a glaucoma or ocular hypertension.
Applicant’s Election
Applicant's election without traverse of Group I (pending claims 1-15) filed 12/17/2025 is acknowledged. Hence, the restriction requirement is still deemed proper and is therefore 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 23-26 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Withdrawn Claims
Claims 3, 5-12, 16, and 18-21 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention/species.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 statements filed 7/12/2022; 7/25/2024; and 5/19/2025 were considered.
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.
Claims 1, 2, 4, 13-15, and 23-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,147,855. 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, bimatoprost amide, and salts thereof), a CNTF compound (e.g., Peptide 6, DGGL, or Peptide 21), a sustained delivery component, and optionally, comprising a FAS/FASL inhibitor (e.g., YLGA and 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 patented invention is directed to using the composition in a particular amount for treating glaucoma or ocular hypertension. Thus, the skilled artisan would recognize that the pending invention encompasses the patented claims. Hence, the inventions disclose overlapping subject matter.
Claims 1, 2, 4, 13-15, and 23-26 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.
Written Description Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4, 13-15, and 23-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection.
The pending application does not sufficiently describe the invention (1) as it relates to sustained delivery components that are compatible with a prostaglandin and CNTF compound system optionally containing FAS/FASL inhibitor. (2) In addition, the pending application does not sufficiently describe drug delivery systems comprising prostaglandin delivery systems other than those comprising bimatoprost, bimatoprost acid, travoprost, travoprost acid, latanoprost, latanoprost acid, latanoprostene, tafluprost, and tafluprost. Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms as set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
112 Second Paragraph Rejections
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.
Claims 1, 2, 4, 13-15, and 23-26 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.
Claims 1, 2, 4, 13-15, and 23-26: The phrase “sustained delivery component” in line 3 is a relative phrase which renders the claim indefinite. The phrase “sustained delivery component” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In particular, the sustained delivery component allows a substance to be present in the body for what they believe to be a designated time period. How one defines a ‘sustained period of time’ will vary from person to person.
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 and 4 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).
Independent claim 1 is directed to a drug delivery system comprising: a prostaglandin, a CNTF compound, and a sustained delivery component.
Claim 4 is directed to the drug delivery system wherein the prostaglandin is bimatoprost acid or a salt thereof.
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, tafluprost, and uoprostone (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. Those components include PVA, EVA, silicone, PLGA, polyimide, acetyl triethyl citate, and hydrogels (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.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 the prostaglandin with a CNTF substance and a sustained delivery component is rendered obvious by the combined prior art teachings.
Comments/Notes
The full scope of Group I was not searched.
Conclusion
Claims 1, 2, 4, 13-15, and 23-26 are rejected. Claims 3, 5-12, 16, and 18-21 are withdrawn.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. Hartley can be reached at (571)272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
March 28, 2026
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