DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/30/2024 and 02/17/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
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 2, 5-6 and 8 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.
Regarding claims 2, 5 and 8, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the broadest reasonably interpretation is given and therefore the limitation(s) following the phrase “preferably” are not given patentable weight.
Claim 6 contains the trademark/trade name "soluplus". Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4 and 8-10 are rejected under 35 U.S.C. 102((a)(1)/(a)(2)) as being anticipated by WO2019241504A1 to Liu et al.
Example 18 at pp. 67-68 is drawn to
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Which is a composition comprising a compound of instant formula I or a salt thereof (Pazopanib mono lauryl sulfate), a polymeric carrier (Polyoxyl 35 Castor Oil), and an organic solvent (Glyceryl monocaprylate). The active drug is equivalent to that of claim 3 and the volume ratio of the organic solvent to the pazopanib pharmaceutical composition lies within that of claim 4. The compositions are useful for treating cancer (a tumor of claim 8) (p. 1, line 12). Given the use of liquid carriers, the composition can be considered an encapsulated liquid dosage form. Accordingly, claims 1, 3-4 and 8-10 are anticipated.
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 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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over WO2019241504A1 to Liu et al.
Example 18 at pp. 67-68 is drawn to
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Which is a composition comprising a compound of instant formula I or a salt thereof (Pazopanib mono lauryl sulfate), a polymeric carrier (Polyoxyl 35 Castor Oil), and an organic solvent (Glyceryl monocaprylate).
Liu et al. does not teach an anticipatory composition wherein the pH is 3.0 – 4.5, the composition comprises a sweetener or the components and amounts thereof of claim 6 or the specific preparation method of claim 7.
With respect to the pH limitation, Liu et al. teaches the use of pH adjusting agents at p. 24, lines 20-25. Liu et al. teaches that the solubility of the class of drugs is pH dependent and that the solubility decreases with increasing pH (pp. 28-29, lines 12-2). While a pH of 3.0 – 4.5 is not specifically taught, it is clear that pH is a result-effective variable and a lower pH is preferable. Accordingly, it would have been routine to optimize the pH and arrive at a pH value of 3.0 – 4.5. Flavoring agents such as sweeteners are taught at p. 28 lines 8-12 and it accordingly would have been obvious to include a sweetener in the composition in order to improve palatability for oral administration. The formulas of claim 6 such as Formula 10 are drawn to specific amounts of specific components. With respect to soluplus, addition of another solubilizing agent is merely combining of known equivalents to achieve an expected result. Similarly, ethanol, propylene glycol, glycerol and water are merely the substitution/combination of known equivalents for a solvent which is taught by Liu et al. The specific amounts of each component in claims 3-6 are achievable under routine optimization. With respect to claim 7, the method for preparation merely applies routine mixing of anticipated and/or obvious components. In summary, the components and amounts thereof claimed are suggested by the prior art and there is no evidence of unexpected results commensurate in scope with any of the claims sufficient to support a conclusion of nonobviousness in view of such. Accordingly, claims 1-10 are obvious.
Conclusion
Claims 1-10 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/ Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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