DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 12/08/2025, is acknowledged.
Amendments to the specification have not been entered, because they are not fully responsive to the prior Office action. First, it is noted that newly amended specification includes information about the method as used in PCT/US2004/001234 (see Pages 8-10). Said application, however, has not been incorporated by reference in its entirety into the instant application as originally filed. Therefore, newly introduced information constitutes new matter. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. Second, it is noted that newly amended disclosure contains an embedded hyperlink and/or other form of browser-executable code (see Page 14) that cannot be included. MPEP 608.01. Therefore, the amendments have not been entered.
Claims 1-2, 4-19 are pending in this action. Claim 3 has been cancelled. Claims 1, 4-10 have been amended. New claims 11-19 have been added. No new matter was added. Claims 1-2, 4-19 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn.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. As stated previously, no English translations of the certified copies of both priority application(s) have been received. Failure to provide a certified translation may result in no benefit being accorded for the non-English application. 37 CFR 41.154(b) and 41.202(e).
Specification
As stated previously, the specification is objected to because of the following informalities:
The use of the trademarks/trade names has been noted in this application (Pages 1, 6, 12, 14). Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
The specification comprises references on foreign applications and publications (Pages 1-3, 8, 12). First, it is noted that publications must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. Second, it is noted that the incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The specification comprises acronyms without proper definition e.g., VF, RSD (Pages 1, 10, 13-14). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
The data shown in the specification are not clear, e.g. “dissolution (%) of 105.68” (i.e., >100%; Pages 12, 13). Clarification is required.
Information Disclosure Statement
The information disclosure statement, filed 01/06/2026, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
The information disclosure statement fails to comply with 37 CFR 1.98(b)(5), which requires that each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. MPEP 609.05(a). In the present case, examiner has considered all references filed by the applicant to expedite the prosecution. However, the applicant is informed that the references filed in an improper format (lined through) should be resubmitted in a proper format to be printed in the patent. MPEP 1302.12. Regarding electronic document(s) retrieved from an online source, it is noted that the format for the citation of an electronic document should be similar to the format used for paper documents of the same type, with the addition of the information in the locations (internet, database, etc.) indicated. MPEP 707.05(e).
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 1-2, 4-19 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.
Newly amended claim 1 recites the limitation, ”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 the crushed bulk drug pimavanserin through an 80-mesh sieve” that is not reasonably clear. To this point, it is noted that the instant claim discloses “particle cumulative distribution of 90% measured by passing the crushed bulk drug pimavanserin through an 80-mesh sieve”, i.e., passing through the opening 178 μm. It is unclear how 10% of particles can have a diameter of more than 178 μm. Similar is applied to new claims 4, 11, 12 (dependent on claim 1) regarding 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), given that claim 1 discloses the use of 80-sieve (i.e., opening 178 μm). Clarification is required.
Claims 7, 8 (dependent on claim 1) disclose the use of apparatus, e.g., a hopper mixer. As stated previously, the claims that recite "an input means" and require a user to use the input means are indefinite, because it is unclear whether infringement occurs when one creates a system/device/apparatus that allows the user to use the input means, or whether infringement occurs when the user actually uses the input means. Such claims are not sufficiently precise to provide competitors with an accurate determination of the ‘metes and bounds’ of protection involved and are ambiguous. MPEP 2173. Clarification is required.
Claim 9 (dependent on claim 1) recited the limitation “the granulation pressure is about 1-100 bar”. Said independent claim, however, does not include or identify the role/use of “a granulation pressure". Therefore, there is insufficient antecedent basis for this limitation in the claim. Clarification is required.
Claims 2, 5-6, 10, 13-19 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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.
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 (hereinafter referred to as Chen).
PNG
media_image1.png
118
252
media_image1.png
Greyscale
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: sieving pimavanserin through a 100-mesh sieve (i.e., 149 µm) for use; weighing prescribed amounts of raw materials and excipients, and 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/formulations 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, avoid 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 12/08/2025, 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. Applicant is advised to clarify the claim language and/or scope 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615