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 .
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.
Election/Restrictions
Applicant's election with traverse in the reply filed on 10 March 2026, is acknowledged. The traversal is on the ground(s) that there is no search burden. While the Examiner does not agree with this traversal, he nevertheless is withdrawing the Election of Species Requirement.
All claims have been examined on the merits.
Current Status of 18/289,719
This Office Action is responsive to the amended claims of 6 November 2023.
Claims 1-10 have been examined on the merits.
Priority
The effective filing date is 13 May 2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6 November 2023, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 2 is objected to as it contains: “encompassing the following components” or “consisting of the following components”. The “encompassing” and the “consisting of” are to different scopes of claimed subject matter. Kindly strike one of “encompassing…” or “consisting of …” to render moot this objection.
Claims 3-5 and 10 are similarly objected to as these claims refer back to claim 2 but do not remedy the rationale underpinning the basis for rejecting claim 2.
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.
Claim 5 is 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.
The word “including” is disclosed within claim 5. This renders the metes and bounds of claim 5 undefined (hence rendering claim 5 indefinite under 35 USC 112(b)). The artisan is not certain if the limitations following “including” are required limitations or merely exemplary limitations. Please revise claim 5 by striking “including” to render moot this rejection.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
NANJING (WO 2019/174623 A1, WIPO-English language machine translation provided by US Patent Office).
This prior art rejection is based on the WIPO-English-language machine-translation (provided) and the Written Opinion for PCT/CN2022/092583.
The prior art reference NANJING teaches a pharmaceutical formulation comprising 0.5%-90% of the instant claim 1 compound, including in monomethanesulfonate salt form (as active pharmaceutical ingredient), and pharmaceutically acceptable excipients, and discloses that said formulation/composition can be processed into an oral capsule form (description, page 1, background art, and page 4, also, see paragraphs 2-4). This anticipates instant claim 1.
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 1-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over:
NANJING (WO 2019/174623 A1, WIPO-English language machine translation provided by US Patent Office),
in view of:
ANSEL (Ansel, Howard, et al. “Pharmaceutical Dosage Forms and Drug Delivery Systems.” 7th ed. Lippincott. (1999)).
This prior art rejection is based on the WIPO-English-language machine-translation (provided) and the Written Opinion for PCT/CN2022/092583.
The instant claims 1-7 and 10 are drawn to pharmaceutical formulations comprising a well-known API and well-known fillers, disintegrants, and lubricants, as well as methods of making thereof.
Determining the scope and contents of the prior art:
NANJING teaches the limitations of instant claim 1, supra.
Furthermore, the prior art reference NANJING teaches “mannitol” as the “filler”; “starch” as the “disintegrant”; and “talc” as the “lubricant” (para [0032]).
Moreover, the prior art reference ANSEL teaches that physicians (and pharmacists/medicinal chemists) routinely change (optimize) the dosing of active pharmaceutical ingredients to meet the particular requirements of the patient (i.e., they routinely change the dosing to match the patient’s body mass index) (see page 48).
Ascertaining the differences between the prior art and the claims at issue:
While NANJING teaches “mannitol” as the “filler”; “starch” as the “disintegrant”; and “talc” as the “lubricant” (para [0032]), NANJING is silent as to their percentage concentrations.
While the prior art reference ANSEL teaches that physicians (and pharmacists/medicinal chemists) routinely change (optimize) the dosing of active pharmaceutical ingredients to meet the particular requirements of the patient (i.e., they routinely change the dosing to match the patient’s body mass index) (see page 48), the ANSEL reference is silent as to the active pharmaceutical ingredient of the instant claims 1-7.
Resolving the level of ordinary skill in the pertinent art:
The artisan is knowledgeable in formulating pharmaceutical formulations comprising active pharmaceutical ingredient, filler, disintegrants, and lubricants. The artisan also is knowledgeable in admixing these ingredients into various percentage concentrations to routinely optimize the therapeutic efficacy of the pharmaceutical formulation thus formed.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
The artisan would find prima facie obvious the fillers, disintegrants, and lubricants of instant claims 5-7 and the concentrations of instant claims 2-7 given the teachings of NANJING.
The fillers, disintegrants, and lubricants of instant claims 5-7 are common (hence obvious variants) in the pharmaceutical arts. Moreover, the concentrations of “mannitol” as the “filler”; “starch” as the “disintegrant”; and “talc” as the “lubricant” (NANJING-para [0032]) of instant claims 2-4 plus the concentrations of the common fillers, disintegrants, and lubricants of instant claims 5-7 are interpreted as variables that the artisan would routinely optimize to maximize therapeutic efficacy of the active pharmaceutical ingredient that the Written Opinion for PCT/CN2022/092583 says the reference NANJING teaches (NANJING-description, page 1, background art, and page 4, also, see paragraphs 2-4). So, too, are the method(s) of making thereof (instant claim 10), as there are only so many ways to mix the ingredients taught by NANJING plus obvious variations thereof and routinely optimize their concentrations (this teaches instant claim 10).
Moreover, the reference ANSEL teaches that physicians (and pharmacists/medicinal chemists) routinely change (optimize) the dosing of active pharmaceutical ingredients and other ingredients to meet the particular requirements of the patient (i.e., they routinely change the dosing to match the patient’s body mass index) (see page 48). The ANSEL reference thus implies that concentrations of active pharmaceutical ingredients and fillers, disintegrants, and lubricants are routinely optimized (to maximize therapeutic efficacy). This is especially true since neither the claims nor the Specification define how these percentages / concentrations are critical.
“Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). See MPEP 2144.05(II)(A).
Thus, this teaches instant claims 1-7 and 10.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over:
ZHU (WO 2018/050108 A1, WIPO-English language machine translation provided by US Patent Office),
in view of:
ANSEL (Ansel, Howard, et al. “Pharmaceutical Dosage Forms and Drug Delivery Systems.” 7th ed. Lippincott. (1999)).
The instant claims 8-9 are drawn to pharmaceutical formulations comprising a well-known API and well-known fillers, disintegrants, and lubricants.
Determining the scope and contents of the prior art:
ZHU teaches the active pharmaceutical ingredient (API)
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of limitations of instant claims 8-9, supra (see Example 1 of para [0040]). ZHU also teaches “pharmaceutically acceptable salts thereof” (para [0012]).
Furthermore, the prior art reference ZHU teaches “mannitol” as the “filler”; “starch” as the “disintegrant”; and “talc” as the “lubricant” (para [0032]). Thus, ZHU does teach “filler”, “disintegrant”, and “lubricant”.
Moreover, the prior art reference ANSEL teaches that physicians (and pharmacists/medicinal chemists) routinely change (optimize) the dosing of active pharmaceutical ingredients to meet the particular requirements of the patient (i.e., they routinely change the dosing to match the patient’s body mass index) (see page 48).
Ascertaining the differences between the prior art and the claims at issue:
While ZHU teaches “mannitol” as the “filler”; “starch” as the “disintegrant”; and “talc” as the “lubricant” (para [0032]), ZHU is silent as to their percentage concentrations.
While the prior art reference ANSEL teaches that physicians (and pharmacists/medicinal chemists) routinely change (optimize) the dosing of active pharmaceutical ingredients to meet the particular requirements of the patient (i.e., they routinely change the dosing to match the patient’s body mass index) (see page 48), the ANSEL reference is silent as to the active pharmaceutical ingredient of the instant claims 1-7.
Resolving the level of ordinary skill in the pertinent art:
The artisan is knowledgeable in formulating pharmaceutical formulations comprising active pharmaceutical ingredient, filler, disintegrants, and lubricants. The artisan also is knowledgeable in admixing these ingredients into various percentage concentrations to routinely optimize the therapeutic efficacy of the pharmaceutical formulation thus formed.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
The artisan would find prima facie obvious the specific fillers, disintegrants, and lubricants of instant claims 8-9 and the concentrations thereof given the teachings of ZHU.
The fillers, disintegrants, and lubricants of instant claims 8-9 are common (hence obvious variants) in the pharmaceutical arts. Moreover, the concentrations of the common fillers, disintegrants, and lubricants of instant claims 8-9 are interpreted as variables that the artisan would routinely optimize to maximize therapeutic efficacy of the active pharmaceutical ingredient that ZHU teaches (ZHU para [0040]).
Moreover, the reference ANSEL teaches that physicians (and pharmacists/medicinal chemists) routinely change (optimize) the dosing of active pharmaceutical ingredients and other ingredients to meet the particular requirements of the patient (i.e., they routinely change the dosing to match the patient’s body mass index) (see page 48). The ANSEL reference thus implies that concentrations of active pharmaceutical ingredients and fillers, disintegrants, and lubricants are routinely optimized (to maximize therapeutic efficacy). This is especially true since neither the claims nor the Specification define how these percentages / concentrations are critical.
“Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). See MPEP 2144.05(II)(A).
Thus, this teaches instant claims 8-9.
Conclusion
No claims are presently allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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