Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claim 2 is cancelled.
Claims 1 and 3-21 are pending. Applicant’s amendment has necessitated a new ground of rejection. Accordingly, this Action is FINAL.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 3/6/26 and 7/9/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Terminal Disclaimer
The terminal disclaimer filed on 7/9/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patents 11672764, 11986559 and 10603284 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn rejections
Applicant's Declaration under 37 CFR 1.132, amendments and arguments filed 7/9/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 1-21 were rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lehtonen et al. (WO2012116814; published September 07, 2012 on the IDS filed 7/24/24 foreign document #72) and Venkatesh (US20060078614). Applicant’s amendments and arguments are persuasive.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weimer et al. (US20120201860; of record) and Lehtonen et al. (WO2012116814; published September 07, 2012 on the IDS filed 7/24/24 foreign document #72) and Venkatesh (US20060078614).
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Applicant claims:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical formulation research scientist, as is the case here, then one can assume comfortably that such an educated artisan will have hands on experience with coating equipment and process parameter control and draw conventional ideas from pharmaceutical coating technology with a deep understanding of coating types, polymer chemistry, coating formulation components, granulation methods and particle engineering— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 4, 7, 12, 14-15 and 17, Weimer et al. teach a pharmaceutical substrate having a coating produced by using atomic layer deposition where the coating is 0.5 to 50 nm thick (Claims 1-15 and 18), which overlaps the claimed range of 5-15 nm thick, and administration of the pharmaceutical coated substrate to an organism (Claim 19). Weimer et al. teach aluminum oxide films [0103] but also suggest metal oxides (Claim 21) such as zinc and titanium oxides (Claim 11; [0071]). Thus, the core consists of an active pharmaceutical substance with a metal oxide coating. Weimer et al. teach that: “the substrate is a particle having a number average particle size of no greater than 500 microns, more preferably no greater than 100 microns, still more preferably no greater than 1 micron and even more preferably no greater than 100 nanometers.” [0027]. Thus, nanoparticles and microparticles are taught by Weimer et al. and a composition of those nanoparticle and microparticles consists of a coating layer on a core consisting of a active pharmaceutical substance. Weimer et al. teach conformal coatings [0078, 0091].
Regarding claims 3 and 13, Weimer et al. teach that all reagents are applied in the vapor phase and when multiple reactants are used, the reagents are applied sequentially [0021], hence alternating surface reactions of at least a first and second gaseous precursor.
Regarding claims 1, 4, 6, 7, 12, 14, 15 and 17, Lehtonen et al. teach a coated solid pharmaceutical preparation comprising at least one active ingredient with a coating thickness of about 0.1 to about 100 nm and more preferably from about 0.5 to about 35 nm (Claim 1) and most preferably from about 1 and 10 nm (Page 4, lines 17-21), which overlaps the claimed ranges of 1-100 nm and 5-15 nm thick, where the preparation is, for example, a granule (Claim 2) and the coating has been applied by atomic layer deposition with one or more atomic layers (Claims 3-4) wherein the coating comprises one or more metal oxides (Claims 5-9) and wherein the metal oxides are selected from aluminum oxide, zinc oxide, silicon dioxide and titanium dioxide. Lehtonen et al. teach medicaments (Page 4, lines 9-16) as well as compositions consisting of the water soluble vitamin C and the coating layer(Page 11, lines 12-17), which reads on an organic active pharmaceutical substance. Since the metal oxide coating goes over the organic active pharmaceutical substance core, then individual granules consisting of an organic active pharmaceutical substance and a metal oxide coating layer are produced by Lehtonen et al.
Regarding claims 3 and 13, Lehtonen et al. teach application to the core with alternating surface reactions of at least a first and a second gaseous precursor (Claims 12-14).
Regarding claims 9 and 11, the solid coated granule pharmaceutical preparation of Lehtonen et al. is implicitly an oral dosage form.
Regarding claims 8-11 and 18-21 Venkatesh teaches microparticles of granules, beads or pellets comprising an active, rapidly dispersing microgranules and optional pharmaceutically acceptable excipients (Abstract; [0015, 0053, 0059]) that can be in the form of a tablet (Claims 1-3, 7-16) and easy to swallow suspension (Abstract) with an average size of not more than about 400 µm [0002] or about 100-400 µm [0008, 0062]. Venkatesh teach microgranules of one or more active pharmaceutical ingredients [0024, 0053]. Venkatesh teach pharmaceutically acceptable excipients typically used in ODT formulations ([0015]; claim 2). Venkatesh also teaches compressing the blend of microparticles into tablets using conventional tablet press [0038-0039].
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Weimer et al. is that Weimer et al. do not expressly teach an organic active pharmaceutical substance or a water soluble organic active pharmaceutical substance, with a pharmaceutically acceptable carrier or excipient that is a solid tablet or capsule, liquid or semi-solid dosage form. This deficiency in Weimer et al. is cured by the teachings of Lehtonen et al. and Venkatesh.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the coated pharmaceutical substrate of Weimer et al. with a pharmaceutically acceptable carrier and excipients, as suggested by Venkatesh, and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because Weimer et al. teach administering the coated pharmaceutical substrate to an organism. The ordinary artisan would look to Lehtonen et al. for guidance on how to formulate such ALD coated particles as pharmaceutical dosage forms. Lehtonen et al. teach, for example, converting solid granules into the coated solid pharmaceutical preparation (Page 4, lines 22-27) and “Pharmaceutical preparation above and below is taken to mean a term for various technical administration forms as are known for the administration of medicaments to humans or animals.” (Page 4, lines 8-16). It is known in the art through Venkatesh to make tablets out of microparticles and microgranules with typical excipients/carrier materials and conventional tablet press. In view of the combined references, it is then obvious to formulate the coated pharmaceutical substrate of Weimer et al. with carriers/excipients into, for example, at least an oral dosage form tablet, as suggested by Lehtonen et al. and Venkatesh, for administration to an organism with a reasonable expectation of success. Thus, a composition where the core consists of the organic active pharmaceutical substance and a coating layer with one or more pharmaceutically acceptable excipients is obvious over the combined references. Organic pharmaceutical active substances include both water soluble and water insoluble substances. Selection of a water-soluble organic pharmaceutical active is at the discretion of the ordinary artisan. It is the Examiner’s position that modification to a conventional liquid dosage form, conventional parenteral dosage form or semi-solid dosage form is an obvious variation for the ordinary pharmaceutical artisan. Especially with Lehtonen et al. teaching that the pharmaceutical preparation means a term for various technical administration forms as are known for the administration of medicaments to humans (Page 4, lines 8-10) and the claimed dosage forms are conventional dosage forms.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s Declaration and arguments filed 7/9/26 have been carefully considered but are not persuasive.
First of all, the Declaration by Miaojun Wang is directed to a different Application number: 18199625. Secondly, the Declaration is not directed to the rejections of record but rather over Wang and Kim. The Declarant states that agglomeration is a problem and the contact point between particles will not be exposed to the coating precursors resulting in pin-holes. However, all coating possibilities are claimed including those with pin holes. For at least these reasons, the Declaration is insufficient to overcome the rejection.
Second of all, Applicant’s arguments are directed to a withdrawn rejection. Accordingly, those arguments are moot. Please note that the test for obviousness 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 4I3, 425 (CCPA I98I) (MPEP 2145(III)). All that is required to show obviousness is that the applicant "make his claimed invention merely by applying knowledge clearly present in the prior art. Section 103 requires us to presume full knowledge by the inventor of the prior art in the field of his endeavor." In re Winslow, 365 F.2d 1017, 1020, 53 C.C.P.A. 1574, 1578 (1966). Application of Sheckler, 438 F.2d 999, 1001 (C.C.P.A. 1971). Thus, does Applicant make their claimed invention merely by applying knowledge clearly present in the prior art. At this time, the claims remain rejected.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
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