3Notice 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 .
DETAILED ACTION
Claims 1-4 and 6-7 are pending and are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/02/2024 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims benefit of U.S. Provisional Application No. 62/030981 filed on 07/30/2014 and application 62/012,268 filed on 06/13/2014.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-4 and 6-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Ronchi et al. (US 2020/0206186, priority date of 7/17/2017) in view of Busetti et al. (US2017/0258864, referenced in IDS dated 8/2/04)
Instant claims are drawn to a method of treating and/or preventing ocular affections in a subject in need thereof, said method comprising orally administering to said subject compositions comprising a quercetin solid dispersion, a phospholipid, and a water very soluble carrier, said water very soluble carrier having a complete solubility at a temperature comprised between 15- 25 °C of 1 g of said carrier in a water volume of 1 mL or less; or in a water freely soluble carrier, said water freely soluble carrier having a complete solubility at a temperature comprised between 15-25 °C of 1 g of said carrier in a water volume comprised between 1 and 10
Ronchi et al. discloses a powder solid dispersion comprising quercetin, phospholipids and a carrier very soluble to freely soluble in water, wherein the quercetin to phospholipids weight ratio ranges from 5:1 to 1:1 (abstract, claim 1 and para [0028-0029]). They disclose wherein the phospholipids are selected from the group consisting of lecithin from soy, sunflower or egg, phosphatidyl choline, phosphatidyl serine, phosphatidyl ethanolamine, or their mixtures, wherein the acyl groups, which are the same or different, are mostly derived from palmitic, stearic, oleic, linoleic, linolenic acids (claim 2 and para [0020] ). They further disclose wherein the carrier is selected from the group consisting of mono- and di-saccharides; soluble oligo- and poly-saccharides selected from a group consisting of sucrose, fructose or maltodextrins (claims 6-7 and para [0027]). They also disclose that the has been surprisingly found that powder solid dispersions comprising, preferably consisting of, quercetin, phospholipids and a carrier very soluble to freely soluble in water are characterized by an improved solubility and oral bioavailability of quercetin in humans [0018]. They disclose that their powder solid dispersion of the invention is easy to incorporate in conventional solid dosage forms, like tablets and capsules, but also in ready-to-use or extemporary liquid formulations and examples of the dosage forms of the formulations of the invention include coated or uncoated tablets, chewable tablets, capsules, soft gelatin capsules, hard gelatin capsules, caplets, lozenges, chewable lozenges, extemporary and ready-to-use liquid formulation and combinations thereof [0051] and [0054].
With regards to the limitation in instant claim 1 , the limitation wherein the water very soluble carrier having a complete solubility at a temperature comprised between 15- 25 °C of 1 g of said carrier in a water volume of 1 mL or less; or in a water freely soluble carrier, said water freely soluble carrier having a complete solubility at a temperature comprised between 15-25 °C of 1 g of said carrier in a water volume comprised between 1 and 10 mL, while Ronchi et al. does not specifically teach this, They teach the same mono, di, oligo or polysaccharides instantly claimed as their water soluble carriers and absence of evidence to the contrary, the carriers taught by Ronchi et al. will inherently possess the functional property instantly claimed.
Ronchi et al . fails to disclose the instantly claimed method of treating and/or preventing ocular affections in a subject with their composition.
However, Busetti et al. discloses an oral solid dosage form of quercetin for the treatment and/or prevention of allergic conjunctivitis (abstract, claim 16)..They disclose that quercetin, which belongs to the flavanol class, represents the aglyconic part of several glycosides and it is considered a natural antihistamine capable to block the recruitment, the activation and the degranulation of mast cells and advantageously, quercetin does not cause the common side effects of slackness and drowsiness caused by other antihistamines [0003]. They disclose that their composition is administered along with other antiallergic drugs and their composition of the invention allows to reduce the administered amounts of said other drugs thus limiting the side effects of the latter such as, for example, drowsiness, incoordination, vision alteration and digestive disorders of the anticholinergic type. [0017-0019].
As such it would have been prima facia obvious to a person of ordinary skill in the art to arrive at the instant claims motivated and guided by the combined teachings of Ronchi et al. and Busetti et al. Ronchi et al. explicitly discloses the instantly claimed composition which is a solid dispersion of quercetin with phospholipids and water soluble carrier which is a mono/ poly or oligosaccharide. While Ronchi et al. do not teach the utility of their formulation in treating and/or preventing ocular affections in a subject, ,Busetti et al. disclose that Quercetin has anti0histamine activity and are useful in the treatment of allergic conjunctivitis (ocular infections). It would have been obvious to a person of ordinary skill in the art to utilize the formulation of Ronchi et al. in the method of Busetti et al for treatment of allergic conjunctivitis. An ordinarily skilled artisan would be motivated from the teachings of Ronchi et al., that their inventive composition is characterized by an improved solubility and oral bioavailability of quercetin in humans and is easy to incorporate in conventional dosage forms. As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in treating ocular disease such as allergic conjunctivitis with the composition taught by Ronchi et al. thus rendering the instant claims obvious.
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 double patenting rejection is appropriate where the claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 1-4 and 6-9 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-19 of US patent 11,331,298 (‘298). In view of Busetti et al. (US2017/0258864)
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claimed invention of ‘298read on the instant claimed invention.
Instant claims are drawn to a method of treating and/or preventing ocular affections in a subject in need thereof, said method comprising orally administering to said subject compositions comprising a quercetin solid dispersion, a phospholipid, and a water very soluble carrier, said water very soluble carrier having a complete solubility at a temperature comprised between 15- 25 °C of 1 g of said carrier in a water volume of 1 mL or less; or in a water freely soluble carrier, said water freely soluble carrier having a complete solubility at a temperature comprised between 15-25 °C of 1 g of said carrier in a water volume comprised between 1 and 10
The patent ‘298 claims are drawn to a powder solid dispersion comprising quercetin, phospholipids and a carrier very soluble to freely soluble in water, wherein the quercetin to phospholipids weight ratio ranges from 5:1 to 1:1, and wherein the quercetin to carrier weight ratio ranges from 1:5 to 5:1.
Patent ‘298 does not teach the method of treating or preventing ocular disease with their composition.
However, Busetti et al. discloses an oral solid dosage form of quercetin for the treatment and/or prevention of allergic conjunctivitis (abstract, claim 16)..They disclose that quercetin, which belongs to the flavanol class, represents the aglyconic part of several glycosides and it is considered a natural antihistamine capable to block the recruitment, the activation and the degranulation of mast cells and advantageously, quercetin does not cause the common side effects of slackness and drowsiness caused by other antihistamines [0003]. They disclose that their composition is administered along with other antiallergic drugs and their composition of the invention allows to reduce the administered amounts of said other drugs thus limiting the side effects of the latter such as, for example, drowsiness, incoordination, vision alteration and digestive disorders of the anticholinergic type. [0017-0019].
As such it would have been prima facia obvious to a person of ordinary skill in the art to arrive at the instant claims motivated and guided by the combined teachings of ‘298. and Busetti et al. ‘298explicitly discloses the instantly claimed composition which is a solid dispersion of quercetin with phospholipids and water soluble carrier which is a mono/ poly or oligosaccharide. While ‘298 do not teach the utility of their formulation in treating and/or preventing ocular affections in a subject, Busetti et al. disclose that Quercetin has antihistamine activity and are useful in the treatment of allergic conjunctivitis (ocular infections). It would have been obvious to a person of ordinary skill in the art to utilize the formulation of ‘298. in the method of Busetti et al for treatment of allergic conjunctivitis and arrive at the instant claims.
Conclusion
Claims 1-4 and 6-7 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/ Primary Examiner, Art Unit 1691
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