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 1-20 filed 21 September 2023 are pending in the application.
Priority
This application is a continuation-in-part of 16232601 filed 12/26/2018, now US Patent No. 11,801,310, which claims the benefit of 62610509 filed 12/26/2017. This application claims foreign priority to EPO EP 18215590.3 filed 12/21/2018, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the parent application 16232601.
Claim Rejections - 35 USC § 103
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.
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 pre-AIA 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Loftsson et al (US 2007/0020336) in view of Park et al (US 2003/0031715) and Han et al (US 4,559,343).
Loftsson teaches the preparation of a composition comprising a poorly soluble drug and a cyclodextrin suspended in an aqueous phase. The suspension may be in the form of an eye drop (abstract, Tables and paragraphs 0064-0071; limitation of claims 1, 7, 13-regarding cyclodextrin; and limitation of claim 20-eye drop; water-solvent as in claim 13). Suitable cyclodextrins include a-, b- and g-cyclodextrins, including derivatives like hydroxypropylcyclodextrin, wherein the cyclodextrin is present in the suspension up to about 40% w/v (paragraph 0083; limitation of claims 2-3, 10-11and 16-17). The reference further teaches the addition of a water-soluble polymer, such as hydroxypropyl methylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose, polyvinylpyrrolidone, wherein the polymer is present up to about 5% w/v (paragraph 0084; as in claims 1, 7 and 13, and claims 4, 12 and 18). The reference further suggests that the product may be a binary, ternary or quaternary complex with the addition of other agents, including salts, in an amount up to about 5% used to enhance the solubilization of the drug (paragraphs 0079, 0085, and 0086).
Loftsson does not teach caffeine as a stabilizer and the amounts by weight as in claims 1, 7 and 13, and does not teach the limitations of claims 5-6, 8-9, 14-15 and 19.
Park, drawn to increasing water solubility of poorly soluble drugs, teaches that the purine derivative, caffeine, is useful in complexation solubilization, categorizing it along with cyclodextrins (paragraphs 0009-0016 and 0029; water-soluble stabilizer as in claims 1, 7 and 13).
Han teaches that xanthine derivatives, such as caffeine, decrease the stinging associated with anti-inflammatory ocular agents (col 2, lines 3-24 and examples).
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, cyclodextrins and its derivatives, water-soluble polymers and a water-soluble stabilizer like caffeine are known in the art to be used for making compositions comprising poorly water-soluble substances. Thus, it is obvious to make compositions comprising cyclodextrins and its derivatives, water-soluble polymers and a water-soluble stabilizer like caffeine as in claim 1 and dependents thereof, and the compositions as in claims 7-20 for improving the solubility of poorly water-soluble substances like tyrosine kinase inhibitors as in the instant claims and those in claims 5-6, 8-9, 14-15, and also make the compositions as in claims 19 and 20 with a reasonable expectation of success.
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.
The artisan would be motivated to modify the composition of Loftsson because the art establishes that the addition of caffeine would have at least two advantages regarding increased solubility of the drug and decreased irritation in the administration of it. In the absence of unexpected results, it would be within the scope of the artisan to optimize the amounts of the components in the composition by weight through routine experimentation based on the ranges taught in the art.
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 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,801,310 (‘310) in view of Park et al (US 2003/0031715) and Han et al (US 4,559,343). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim 1 is drawn to a composition comprising specific percentage range by weight of cyclodextrin and/or derivative thereof, at least one water-soluble polymer and at least one water-soluble stabilizer wherein the stabilizer is caffeine, with dependent claims thereof drawn to specific cyclodextrins, water-soluble polymer and poorly water-soluble substances. Independent claims 7 and 13 are drawn to formulations comprising a tyrosine kinase inhibitor and specific percentage range by weight of cyclodextrin and/or derivative thereof, at least one water-soluble polymer and at least one water-soluble stabilizer wherein the stabilizer is caffeine. The dependent claims thereof are drawn to types of tyrosine kinase inhibitors, specific cyclodextrins, water-soluble polymers, and types of liquid formulations.
Claim 1 of ‘310 is drawn to a composition comprising specific percentage range by weight of cyclodextrin and/or derivative thereof, at least one water-soluble polymer and at least one water-soluble stabilizer wherein the stabilizer comprises adenine or guanine. Dependent claims 2-5 recite limitations drawn to specific cyclodextrins, and water-soluble polymers. There is overlap in the percentage range of the components and the cyclodextrins and water-soluble polymers are the same.
The teachings of Park and Han are set forth above.
Claims 1-5 of ‘301 differ from the instant claims in that the instant claims include a tyrosine kinase inhibitor as poorly water-soluble substance and caffeine as the water-soluble stabilizer. However, it would have been obvious to one of ordinary skill in the art before the filing date of the instant invention that the composition of ‘301 can be used for improving the solubility of poorly soluble substances like the tyrosine kinase inhibitors using caffeine as the water-soluble stabilizer with a reasonable expectation of success in view of Park and Han.
In the instant case ‘301 teaches a composition comprising cyclodextrin and/or derivatives, water-soluble polymer and water-soluble stabilizer applicant claims. The composition of ‘301 is for improving the solubility of poorly soluble substances. Although the claims of '301 use adenine and guanine as the water-soluble stabilizer, one of ordinary skill in the art would readily recognize that the scheme taught by '301 could be modified to use caffeine as the water-soluble stabilizer, and also improve the solubility of tyrosine kinase inhibitor with a reasonable expectation of success in view of Park and Han since caffeine is structurally close to adenine and guanine, and the composition of ‘301 is for improving solubility of a poorly water-soluble substance. The use of known members of classes of components in compositions taught in the prior art is not seen to render the instantly claimed composition unobvious over the art. Once the general scheme has been shown to be old, the burden is on the applicant to present reason or authority for believing that replacing the adenine and guanine with caffeine as the stabilizer and using tyrosine kinase inhibitor as the poorly water-soluble substance as claimed would alter the nature of the product or the composition non-obvious. Park and Han provide the motivation for using caffeine as the stabilizer.
Conclusion
Pending claims 1-20 are rejected
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693