DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission, filed 07/20/2026, has been entered.
Status of Application
Receipt of the amendments to the specification and claims as well as applicant arguments/remarks, filed 07/20/2026, is acknowledged. Amendments to the specification have been entered.
Claims 1-2, 4-19 are pending in this action. Claim 3 has been cancelled previously. Claims 1, 7-9, 15 have been amended. Claims 1-2, 4-19 are currently under consideration.
Any rejection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
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 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.
Priority
This application is a 371 of PCT/CN2021/119473, filed September 19, 2021, which claims benefit of foreign priority to CN202011014255.5, September 23, 2020. Receipt of the English translation of the priority application CN202011014255.5, filed 07/27/2026, is acknowledged.
Information Disclosure Statement
The information disclosure statement, filed 07/21/2026, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
Claim Rejections - 35 USC § 112(b)
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 4, 11, 12 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 pre-AIA the applicant regards as the invention.
Claims 4, 11, 12 (dependent on claim 1) recite the limitations “crushed into a particle size of 170 μm or less” (claim 4), “crushed into a particle size of 160 μm or less” (claim 11), “crushed into a particle size of 150 μm or less” (claim 12) that is unclear. To this point, it is noted that newly amended claim 1 discloses ”crushing a bulk drug pimavanserin into a particle size of 178 μm or less, wherein the particle size is a D90 size which is particle cumulative distribution of 90% measured by passing a sample of the crushed bulk drug pimavanserin through an 80-mesh sieve”, i.e., through the opening of 178 μm. To this point, it is noted that where a claimed value (i.e., particle size) varies with its method of measurement and several alternative methods of measurement are available, the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). Therefore, the particle size recited in claim 4, 11, 12 are not clearly delineated. Clarification is required.
Claim Rejections - 35 USC § 103- MAINTAINED
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.
Claims 1-2, 4-19 are rejected under 35 U.S.C. 103 as being unpatentable over Tejwani et al., US 2019/0216791 (herein after referred to as Tejwani), in view of Li et al., CN 109498582 A (hereinafter referred to as Li), and Chen et al., US 2021/0069190A
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(hereinafter referred to as Chen).
Tejwani teaches capsules containing compositions containing pimavanserin (i.e., a small molecule shown on the right) or pharmaceutically acceptable salts thereof in crystalline form, e.g., pimavanserin tartrate, and processes for manufacturing said capsules (Abstract; Para. 0002, 0039, 0051, 0082 as applied to claims, 1, 2). Tejwani teaches that said processes may include: (i) granulating pimavanserin for providing a particle size distribution (D90) of 60-450 μm, e.g., less than 100 μm; (ii) mixing with excipients/diluents, e.g., microcrystalline cellulose, and a lubricant, e.g., magnesium stearate; (iii) granulating the mixture; and (iv) filling into capsules (Para. 0055-0068, 0082, 0084; Figs.4-5 as applied to claims 1-2, 4-5, 11-13).
Tejwani teaches that said compositions may include granulated pimavanserin tartrate without binder, dried, and thereafter blended with less than 60 wt% of microcrystalline cellulose and about 1 wt% of magnesium stearate (Para. 0085); or said compositions may include granulated pimavanserin (5, 10, 20 or 34 mg) and 20-94 wt% of microcrystalline cellulose, and 0.1-3 wt% of magnesium stearate (Para. 0088 as applied to claim 6).
Tejwani does not specifically teach crushing the bulk pimavanserin into particles size of 178 µm or less (claim 1) and also does not teach the use of a mixer, e.g., hopper mixer (claims 7, 8) and/or controlling granulation pressure (claims 9, 16-19).
Li teaches a solid oral compositions/tablets comprising pimavanserin and preparation method thereof (Title; Abstract), wherein said solid oral pharmaceutical compositions may include 17 g of pimavanserin, 105 g of microcrystalline cellulose, 2.5 g of magnesium stearate, and other additives per 1000 tablets (Para. 0015; Example 1). To this point, Li teaches that the preparation process includes: (i) sieving pimavanserin through a 100-mesh sieve (i.e., 149 µm) for use; (ii) weighing prescribed amounts of raw materials and excipients, and (iii) uniformly mixing same in a small three-position mixer (Para. 0016). Given that the inner diameter of sieve pores of the 100-mesh sieve is about 149 µm, it is expected that particle size of pimavanserin after passing through the 100-mesh sieve should be 149 µm or less.
Chen teaches oral pharmaceutical compositions that can be tablets and/or capsules and comprising a small molecule that acts as an active ingredient, and at least one pharmaceutically acceptable excipient, and preparation method thereof (Title; Abstract; Para. 0005-0007, 0028). To this point, Chen teaches that said compositions may include (i) 1-60 wt% of active ingredient; (ii) 20-80 wt% of a filler, e.g., microcrystalline cellulose (Para. 0014-0018); (iii) 0.1 to 10 wt% of a lubricant, e.g., magnesium stearate (Para. 0010-0012, 0021-0022). Chen specifically teaches the mixing of intragranular material in a hopper mixer and controlling speed and mixing time before dry granulation, and further compressing said mixtures into tablets under controlled pressure (Examples 1, 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as taught by Tejwani and substitute the pimavanserin granulation step by crushing the bulk/crystalline pimavanserin and sieving pimavanserin through a 100-mesh sieve (i.e., 149 µm sieve) as taught by Li. One would do so with expectation of beneficial results, because Li teaches that said approach can be used for providing compositions that can rapidly disintegrate in the oral cavity, without affection by water, improving Parkinson disease compliance, avoiding the economic loss caused by patient medicine abandoning. It also would have been obvious to use a hopper mixer and control speed and mixing time before dry granulation, and further compressing said mixtures into tablets under controlled pressure as taught by Chen, because the cited prior art teaches that said approach/parameters can be used for providing tablets and/or granules with controllable/desired release rate of the active agent.
With regard to the relative concentrations as instantly claimed (claims 6, 14), it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where 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.
Response to Arguments
Applicant's arguments, filed 07/20/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New rejections and/or arguments have been added to the record to clarify position of the examiner and/or to address newly introduced amendments. Additional examiner comments are set forth next.
In response to applicant's arguments against the references individually, it is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggests the combination to achieve the same advantage or result discovered by applicant. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Further, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In the present case,
All cited references are reasonably drawn to the same field of endeavor that is preparation of tablets/capsules comprising a small molecule as an active ingredient and a pharmaceutically acceptable excipient(s).
Tejwani teaches a process for manufacturing compositions containing pimavanserin or pimavanserin tartrate, wherein said process includes: (i) granulating pimavanserin for providing a controllable/specific particle size distribution, e.g., (D90) of less than 100 μm; (ii) mixing with excipients/diluents/lubricants, e.g., microcrystalline cellulose, magnesium stearate; (iii) granulating the mixture; and (iv) filling into capsules.
Li teaches solid oral compositions comprising pimavanserin and preparation thereof, wherein said compositions may include pimavanserin, microcrystalline cellulose, magnesium stearate, and wherein the preparation process includes (i) sieving pimavanserin through a 100-mesh sieve (i.e., 149 µm); (ii) weighing prescribed amounts of raw materials and excipients, and (iii) uniformly mixing components in a small three-position mixer.
Chen teaches oral pharmaceutical tablets/capsules comprising a small molecule as an active ingredient, a filler/microcrystalline cellulose, a lubricant/magnesium stearate, and specifically teaches (i) mixing of intragranular material in a hopper mixer; (ii) controlling speed and mixing time before dry granulation, and (iii) compressing said mixtures into tablets under controlled pressure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as taught by Tejwani and substitute the pimavanserin granulation step (i) by crushing the bulk/crystalline pimavanserin into particles with controllable particle size as taught by Li, and (ii) to use a hopper mixer, to control speed, mixing time and a pressure as taught by Chen. One would do so with expectation of beneficial results, because cited prior art teaches that said approach can be used for providing compositions that can rapidly disintegrate in the oral cavity (Li), and said preparation parameters can be used for providing compositions/granules with controllable/desired release rate of the active agent (Chen). To this point, it is noted that the Supreme Court decided (KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)) that:
the obviousness analysis needs not seek out precise teachings directed to the subject matter of the challenged claim and can take into account the inferences and creative steps that one of ordinary skill in the art would employ.
the obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents.
it is error to look only the problem the patentee was trying to solve. Any need or problem known in the field of endeavor at the time of invention and addressed by the prior art can provide a reason for combining the elements in the manner claimed.
it is error to assume that one of ordinary skill in the art in attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem. Common sense teaches that familiar items may have obvious uses beyond their primary purposes, and in many cases one of ordinary skill in the art will be able to fit the teachings of multiple patents together like pieces of a puzzle (one of ordinary skill in the art is not automaton).
it is error to assume that a patent claim cannot be proved obvious merely by showing that the combination of elements was “obvious to try”.
Therefore, it is the examiner’s position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed, because every element of the invention has been collectively taught by the combined teachings of the references. Applicant is advised to clarify the claim language/scope; the method steps and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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