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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/08/2026, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 07/08/2026, is acknowledged.
Claims 1-4, 7, 9-11, 16, 20-22, 32-34, 38, 51 are pending in this action. Claims 5-6, 8, 12-15, 17-19, 23-31, 35-37, 39-50 have been cancelled previously. Claims 1-2, 4, 9-10, 20, 32, 34, 38 have been amended. 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Any rejection or objection not reiterated in this action is withdrawn.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 statements, filed 03/06/2026 and 07/08/2026, are acknowledged and have 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 statements do not include Certificate Statement and Privacy Act Statement (MPEP 609).
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 1-4, 7, 9-11, 16, 20-22, 32-34, 38, 51 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 discloses a preparation of compositions comprising “separate individual zinc oxide coated particles” that is not reasonably clear. In the present case, it is noted that the instant claim discloses a preparation of pharmaceutical compositions comprising zinc oxide coated particles in combination with one or more pharmaceutical acceptable excipients. Therefore, it is unclear from what compounds/constituents said coated particles should be separated. Similar is applied to claims 32, 34. Clarification is required.
Claim 1 recites the limitation “aspect ratio of greater than 5” that is not reasonably clear, because the recited numerical limitation is not clearly delineated. Can this aspect ratio be 100? Similar is applied to claims 7 and 9 regarding the limitations “at least one branch” and/or “at least 2 branches”, to claim 11 regarding the limitation “surface area that is greater than 4 m2/g”, as well as to claims 32, 51. Clarification is required.
Claims 2-4, 10, 16, 20-22, 33, 38 are rejected as being dependent on rejected independent claims 1 and 32 and failing to cure the defect.
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 1-4, 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 claim 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 (Claims 13, 14; 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.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2015/0250731 A1 (cited in IDS), US 2024/0226018 A1 – teaches pharmaceutical formulations comprising individual pharmaceutical particles, wherein each individual particle comprises an active pharmaceutical agent and is coated by atomic layer deposition (ALD) method with ZnO (e.g., Para. 0007, 0026 in US 2015/0250731 A1).
RS 63496 B1 – teaches a preparation of pharmaceutical formulations comprising pharmaceutical nanoparticles, wherein said nanoparticles comprise an active pharmaceutical agent, can be spherical, or irregular, or needle-shaped, or cube-shaped (Para. 0040), and wherein said nanoparticles are coated by ALD method with ZnO layer, e.g., having a thickness of 0.1-5000 nm (Claims 1, 8, 11; Para. 0049-0060).
WO 2021/111098 (cited in IDS) – teaches organic drug particles coated with metal oxides, e.g., zinc oxide, prepared by using the ALD method in several cycles, wherein said drug particles might have an aspect ratio of less than 20, or can be irregular shaped (e.g. ‘raisin’-shaped), needle-shaped, or cuboid shaped particles, and wherein the thickness of the coating is controlled by the number of ALD cycles and can be from 0.5 nm to 2 micrometer (Claim 18; Disclosure of the Invention).
US 2023/0157968 A1 – teaches drug particles coated with zinc oxide prepared by using the ALD method in several cycles, wherein said drug particles might have an aspect ratio of less than 20, or can be irregular shaped (e.g. ‘raisin’-shaped), needle-shaped, or cuboid shaped particles, and wherein the thickness of the coating is controlled by the number of ALD cycles and can be from 0.5 nm to 2 µm (Claims 1-2, 7-9, 15; Abstract; Para. 0018, 0028-0030, 0046-0049).
Response to Arguments
Applicant's arguments and the Declaration under 37 CFR 1.132, filed 07/08/2026, 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 arguments against the references individually, it should be 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 pharmaceutical compositions comprising particles of active pharmaceutical ingredients.
Wang teaches preparation of zinc oxide coated drug particles by ALD method to be used in preparation of powder for pharmaceutical compositions and also teaches that said approach can be used for providing/controlling/improving powder flowability and compressibility compared to otherwise identical powder with uncoated particles.
Azad and/or Johansson teach the use of such pharmaceutical ingredients as particles with high aspect ratio, e.g., as needle-shaped particles, or elongated plates, or irregular shaped (e.g., ‘raisin’-shaped) particles, or cuboid-shaped particles (Azad, Johansson) that can be coated with zinc oxide (Johansson).
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 preparation of pharmaceutical compositions comprising API particles that are irregular shaped, needle-shaped, cuboid-shaped, e.g., API particles having aspect ratio of more than 5 as taught by Johansson and Azad. One would do so with expectation of beneficial results, because Wang teaches the method that provides coated particles that have improved flowability and compressibility compared to otherwise identical uncoated particles. To this point, it should be 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”.
Applicant is advised to clarify the claimed 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.
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
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615
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