DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 11/19/2025, is acknowledged.
Claims 1-4, 7, 9-11, 16, 20-22, 32-34, 38, 51 are pending in this action. Claims 28, 30, 31, 35 have been cancelled. Claims 5-6, 8, 12-15, 17-19, 23-27, 29, 36-37, 39-50 have been cancelled previously. Claims 1-4, 9-11, 1, 20-21, 32-34, 38 have been amended. New claim 51 has been added. No new matter was added. Claims 1-4, 7, 9-11, 16, 20-22, 32-34, 38, 51 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Any rejection or objection not reiterated in this action is withdrawn.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 continuation of PCT/US2023/20721, filed May 2, 2023, which claims benefit of provisional U.S. Application No. 63/337,994, filed May 3, 2022, and U.S. Application No. 63/337,995, filed May 3, 2022.
Information Disclosure Statement
The information disclosure statement, filed 11/19/2025, 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).
Further, US Patent Document number 19/236,809 should be corrected to 2025/0381148. Furthermore, the information disclosure statement does not include Certificate Statement and Privacy Act Statement (MPEP 609).
Claim Objections
Claims 1, 10, 20, 21, 34 are objected to because of the following informalities:
Newly amended claim 1 comprises the typographic error “the organic API wherein” that needs to be corrected to “the organic API, wherein”.
Newly amended claim 1 comprises in step (b) the typographic error “an organic API” that needs to be corrected to “the organic API” (see step (a)) or clarified. Similar is applied to claim 34 (dependent on claim 32).
Claim 10 comprises the typographic error “thickness of 1-10 nM” that needs to be corrected to “thickness of 1-10 nm” or clarified.
Newly amended claim 20 comprises acronym “ALD”. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym is used alone thereafter if needed. Similar is applied to claim 21.
Appropriate correction is required.
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 2, 4, 9, 38 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 2 (dependent on claim 1) recites the limitation “the particles have an aspect ratio of between 5 and 50, including the endpoints” that is not reasonably clear. To this point, it is noted that independent claim 1 does not define/identify the role/use of “endpoints". Therefore, it is unclear how claim 2 narrows the claim upon which it depends. Therefore, the metes and bounds of the claim are not clear. This limitation was interpreted as best understood as “the particles have an aspect ratio of from 5 to 50”. Similar is applied to claim 38 (dependent on claim 32). Clarification is required.
Claim 4 recites the limitation “the particles have a D50 of from 0.1 µm to 100 µm on a volume average basis” that is unclear and indefinite. As stated previously, where a claimed value (i.e., particle size/diameter) varies with its method of measurement and several alternative methods of measurement are available (see Wikipedia), 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). It is well known in the field that there is no a comprehensive standard for particle size measurements, and different methods of particle size analysis yield different estimates of particle size for the same sample (see Wikipedia and references cited wherein; “Interpretation of Particle Size Reported by Different Analytical Techniques” on labmanager.com; “Comparison of particle characterization methods” on microtrac.com), i.e., experimental estimates of particle sizes depend on methods of measurements used to obtain it. Without knowing these parameters, the metes and bounds of the claimed subject matter are not reasonably clear. Clarification is required.
In response to applicant’s argument that “differing particle size results obtained using various instruments are all equally correct, but each simply may be expressing its correct results in different terms”, it is noted that the main purpose of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent; and to provide a clear measure of what the applicant regards as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability. MPEP 2173. Clarification is required.
Claim 9 (dependent on claims 1, 7) recites the limitation "the particles have an average of at least 2 branches" that is unclear. In the present case, it is unclear what “average” should be calculated/estimated. Clarification is required.
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 1-4, 7, 9-11, 16, 20-22, 32-34, 38, 51 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., US 2021/0378971A1 (pub. date 12/09/2021; cited in IDS; hereinafter referred to as Wang), in view of Azad et al., "Impact of Critical Material Attributes (CMAs)-Particle Shape on Miniature Pharmaceutical Unit Operations," AAPS PharmSciTech, April 2021, 22(3):1-11 (cited in IDS; hereinafter refer to as Azad), Johansson et al., US 2021/0169815 (pub. date 06/10/2021; hereinafter referred to as Johansson).
Wang teaches a method of preparing pharmaceutical compositions comprising metal oxide-coated particles comprising an organic active pharmaceutical ingredient (API) enclosed by one or more metal oxide coating made by atomic layer disposition (Abstract; 0077). To this point, Wang teaches that said method comprises (Claims 1, 22, 31; Para. 0005, 0012, 0136 as applied to claims 1, 3, 32, 34): (a) providing uncoated particles of an amorphous solid dispersion core comprising an organic API; (b) performing atomic layer deposition to apply one or more metal oxide layers to the uncoated particles comprising the organic API thereby preparing metal oxide-coated particles comprising the organic API enclosed by the one or more metal oxide layers; (c) processing the coated particles to prepare a pharmaceutical composition, e.g., combining coated particles with pharmaceutically acceptable excipients.
Wang teaches the use of uncoated particles having a D50 of 0.1-200 μm on a volume average basis (Claims 4, 40; Para. 0006 as applied to claims 4).
Wang teaches the use of such coating materials as metal oxide, e.g., zinc oxide, aluminum oxide, silicon oxide and titanium oxide (Claim 18; Para. 0012 as applied to claims 1, 32).
Wang teaches that the metal oxide layer(s) thickness can be in the range of from 0.1 nm to 100 nm (Para. 0007, 0028, 0076, 0126, 0132 as applied to claims 10, 33).
Wang teaches that performing atomic layer deposition includes following steps (Para. 0007-0012 as applied to claims 16, 20-22): (b1) loading the uncoated particles comprising the API into a reactor; (b2) applying a vaporous or gaseous metal precursor to the particles in the reactor; (b3) performing one or more pump-purge cycles of the reactor using inert gas; (b4) applying a vaporous or gaseous oxidant to the particles in the reactor; and (b5) performing one or more pump-purge cycles of the reactor using inert gas; wherein steps (b2)-(b5) are performed at least two times
Wang teaches that said method provides coated particles that have improved flowability and compressibility compared to otherwise identical uncoated particles (Para. 0076, 0156).
Wang does not teach uncoated and/or coated particles having an aspect ratio of greater than 5 (claims 1, 32, 38, 51).
Azad teaches that active pharmaceutical ingredients (APIs) often crystallize as particles with high aspect ratio, e.g., as needle-shaped particles or elongated plates; wherein needle-shaped crystals are typified by aspect ratios in the range of (1:1:100-1000); and wherein the needle-shaped crystals having aspect ratios of (1:1:≥10) may still be “troublesome” during processing operations, e.g., flowability tends to be minimized (Abstract; Pages 1, 2, 6, 10; Figure 3).
Johansson teaches a process for the preparation of composition in the form of a plurality of particles having a weight-, number-, and/or volume-based mean diameter of from 10 nm to 700 μm, wherein said particles comprise: (a) solid cores comprising a biologically active agent; and (b) two or more coating layers provided by atomic layer deposition technique (Claim 15; Abstract; Para. 0009, 0022, 0036-0047, 0055). Johansson teaches that said particles may be spherical with an aspect ratio of smaller than 20, or can be of any shape, e.g., irregular shaped (e.g. ‘raisin’-shaped), needle-shaped, or cuboid-shaped that may be coated (Para. 0057-0058). Johansson teaches that the total thickness of the coating can be in the range of from 0.5 nm to 2 µm (Para. 0076-0079), and one can use such coating material as metal and metalloids, e.g., such as aluminum oxide, zinc oxide, silicon, titanium, magnesium, iron, gallium, zirconium, niobium, hafnium, tantalum, lanthanum (Claim 13; Para. 0088, 0091-0093). Johansson further teaches that said coated particles can be further formulated together with one or more pharmaceutically-acceptable excipients, including adjuvants, diluents or carriers for use in the medicinal or veterinary fields, and can be prepared as tablets, capsules, pills, etc. (Para. 0106-0113).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try/apply the method as taught by Wang for coating API particles having aspect ratio of more than 5 to be used/included into pharmaceutical compositions. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach would allow to use API particles that are irregular shaped, needle-shaped, cuboid-shaped to be incorporated into pharmaceutical compositions (Johansson), and also can be used for controlling flowability and compressibility of compositions comprising said coated particles (Azad). Regarding the particle surface area, it is noted that the cited prior art discloses/teaches particles having dimensions as instantly claimed. Therefore, it is expected that said property, i.e., surface area, would also be provided. Claims 7, 9, 20-22 are rejected as being dependent on rejected base claim.
Response to Arguments
Applicant's arguments, filed 11/19/2025, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner’s comments are set forth next.
In response to applicant’s argument that the instant invention allows improving flowability as compared to particles without coating, it is noted that the fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Applicant is advised to clarify the claim language, the scope of the claims 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. See 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.
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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.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615