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 .
Claims 1-14 are pending in the application. Preliminary amendment filed 13 November 2023.
Priority
This application is a 371 of PCT/IB2022/054202 filed 05/06/2022. This application claims foreign priority to ITALY IT102021000011852 filed 05/10/2021, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
The parent application ITALY IT102021000011852 to which priority is claimed is seen to provide adequate support under 35 U.S.C. 112 for claims 1-14 of this application.
Claim Objections
Claim 10 is objected to because of the following informalities: Claim 10 depends from claim 1 and also recites any one of claims 1 to 9. In view of the amendments to claims 3-9, claim 10 is examined as dependent from claim 1. Appropriate correction is required.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figures 1a, 1b and 2 are fuzzy. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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.
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.
Claim(s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Harkins et al (WO 2020/106746 A1; cited in IDS filed 11/13/2023) in view of Ottobelli et al (Ophthalmologica, 2013, 229, 219-226; cited in IDS filed 11/13/2023) and further in view of Williams et al (Science, 2017, 355, 756-760; cited in IDS filed 11/13/2023) and Pujari et al (World Journal of Pharmaceutical Research, 2019, 8(13), 768-783).
The invention of Harkins is drawn to a formulation comprising water as a liquid carrier, with citicoline and another ingredient which can be nicotinamide (page 3, lines 29-30; page 4, lines 29-33; limitations of claim 1). The formulation can have sucrose fructose and citric acid as components. Harkins teaches inclusion of additives (page 4, line 1 and line 18; page 9, lines 1-15; limitation of claims 5 and 7). Hydration improving substances like sodium and potassium salts can be included (page 3, lines 33-34). Acidulants like lactic acid can be included (page 12, line 21). Since sodium ions and lactic acid can be included it would be obvious to also include sodium lactate as a component as in claim 5. Since the composition of Harkins has the claimed ingredients, it should have the bioavailability as in claim 8. Harkins teaches that its formulation has a pH in the range of 2.5-9.5 (page 4, lines 3-5; as in claim 9). Harkins teaches a method of making its composition by dissolving and mixing the active ingredients in water (see Examples 1-5 at page 11; method of claim 14). The instant composition can also be prepared in the same manner.
Even though Harkins does not teach the amounts and ratios of the ingredients as in claims 2-4, and 6, one of ordinary skill in the art can adjust the amounts and ratios using the teachings of Harkins as a starting point (page 5, lines 3-10 and Examples 1-5).
It is well established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33 (CCPA 1937). In re Russell, 439 F.2d 1228, 169 USPQ 426 (CCPA 1971).
The density as in claim 10 can also be adjusted to be in the claimed range.
Harkins does not teach the method as in claims 11-12 and the frequency of administration as in claim 13.
Ottobelli et al teaches that patients diagnosed with glaucoma received oral solutions of citicoline for 2 years. As a result, it was found that supplementation with citicoline might significantly slow down glaucomatous rates of progression (Abstract; page 224-Discussion; method of claims 11 and 12). All the patients were given oral solution of citicoline, one vial containing 500mg of citicoline per day (page 221, left col., first para; as in claim 13).
Williams et al taches that oral administration of nicotinamide (aka vitamin B3) was protective as an intervention in glaucoma prone mice (Abstract; page 758, Fig. 2; page 759, left col., last para.; as in claims 11-12).
In view of the teachings of Ottobelli and Williams it would be obvious to one of ordinary skill in the art to administer a composition comprising an oral aqueous solution of citicoline and nicotinamide in a method of treating a subject having a neurodegenerative pathology, wherein the pathology is glaucoma as in claims 11-12. Since Ottobelli teaches administration of an oral solution of citicoline one a day, it is obvious to administer an oral composition comprising bot citicoline and nicotinamide once a day as in claim 13.
Pujari et al, drawn to composition comprising an active agent for treating patients with glaucoma an ocular hypertension, teaches the use of potassium sorbate as a preservative (page 771, part 2.5; ingredient recited in claim 5). Even though Pujari teaches the use of potassium sorbate in an ophthalmic solution, the artisan would find it obvious to include it as a component in an oral composition comprising citicoline and nicotinamide as in claim 5.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, both citicoline and nicotinamide compositions are known in eh art to be used individually for treating glaucoma. In addition, Harkins teaches that its composition comprising citicoline for treating neurodegenerative pathologies (page 6, lines 24-31). Thus, it is obvious to arrive at the claimed composition, make it via the claimed method and also use in a method treating a neurodegenerative pathology including glaucoma as instantly claimed.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art.
It is obvious to combine individual compositions taught to have the same utility to form a new composition for the very same purpose. In re Kerkhoven, 626 F. 2d 846, 205 USPQ 1069 (CCPA 1980).
The artisan would use the method of preparing the claimed composition as in claim 14 since Harkins teaches the same steps for making it and the method is simple.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-14 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 5-7, 9 and 21 of U.S. Patent No. 10,576,039 (‘039), and as being unpatentable over claims 1-4, 7-9 and 11 of U.S. Patent No. 8,822,429 (‘429) in view of in view of Williams et al (Science, 2017, 355, 756-760; cited in IDS filed 11/13/2023) and further in view of Ottobelli et al (Ophthalmologica, 2013, 229, 219-226; cited in IDS filed 11/13/2023) and Harkins et al (WO 2020/106746 A1; cited in IDS filed 11/13/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim 1 is drawn to an aqueous solution comprising citicoline and nicotinamide. Dependent claims 2-10 recite limitations drawn to concentration and ratios of the ingredients, additional ingredients, and their amounts, excipients and/or additives, bioavailability, pH, and density. Claim 11 is drawn to a method of treating a subject having a neurodegenerative pathology using the composition of claim 1, and dependent claims 12-13 are drawn to the pathology being glaucoma and administration of the composition once per day. Claim 14 is drawn to a method of preparing the composition of claim 1.
Claim 1 of ‘039 is drawn to a composition comprising liposomes that include citicoline or salts thereof. Dependent claims 5-7, and 9 of ‘039 recite limitations drawn to the percentage of citicoline, composition in the form of a solution, pH between 7 and 7.4, and further comprising one or more active agents for topical treatment of glaucoma. Claim 21 is drawn to a method of treating glaucoma in a subject via topical administration of the composition of claim 1.
Claim 1 of ‘429 is drawn to a method of treating glaucoma in a patient by topically administering an ophthalmic composition comprising citicoline. Dependent claims 2-4, 7-9 and 11 recite limitations drawn to diluents and/or excipients, concentration of citicoline, unit dose, inclusion of one or more active principles for treating glaucoma, composition in the form of solution.
The claims of ‘039 and ‘429 differ from the instant claims in that the instant claims are drawn to an aqueous composition comprising citicoline and nicotinamide.
Williams et al taches that oral administration of nicotinamide (aka vitamin B3) was protective as an intervention in glaucoma prone mice (Abstract; page 758, Fig. 2; page 759, left col., last para.).
Ottobelli et al teaches that patients diagnosed with glaucoma received oral solutions of citicoline for 2 years. As a result, it was found that supplementation with citicoline might significantly slow down glaucomatous rates of progression (Abstract; page 224-Discussion; method of claims 11 and 12). All the patients were given oral solution of citicoline, one vial containing 500mg of citicoline per day (page 221, left col., first para).
The teachings of Harkins as set forth above suggests aqueous compositions comprising citicoline and nicotinamide and a method of making it as in instant claim 14.
In view of the teachings of the cited patents and the secondary references it would have been obvious to one of ordinary skill in the art before the filing date of the instant invention to arrive at the composition as instantly claimed, make it using the steps recited in c instant claim 14 and use it in a method of treating a neurodegenerative pathology including glaucoma.
In the instant case ‘039 and ‘429 teach liquid compositions comprising citicoline. Although the claims of '039 and ‘429 employ only citicoline as the active principle, one of ordinary skill in the art would readily recognize that the composition taught by '039 and ‘429 could be modified to include nicotinamide also as an active agent and used in the instant method of treatment with a reasonable expectation of success. The use of known members of classes of agents in compositions and method of use taught in the prior art is not seen to render the instantly claimed composition and method of its use unobvious over the art.
It is obvious to combine individual compositions taught to have the same utility to form a new composition for the very same purpose. In re Kerkhoven, 626 F. 2d 846, 205 USPQ 1069 (CCPA 1980).
The artisan would use the method of preparing the claimed composition as in claim 14 since Harkins teaches the same steps for making it and the method is simple.
Conclusion
Pending claims 1-14 are rejected
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693