Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-21 are pending.
Priority
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A certified copy of the foreign priority document in English is in parent application 14428530.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 7/24/24, 10/17/24, 3/20/25 and 8/21/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 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, 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 Lehtonen et al. is that Lehtonen et al. do not expressly teach a pharmaceutical dosage form comprising individual nanoparticles or microparticles comprising a core of an organic active pharmaceutical substance, a coating layer as claimed and a pharmaceutically acceptable carrier or excipient that is a solid tablet or capsule, liquid or semi-solid dosage form. This deficiency in Lehtonen et al. is cured by the teachings of 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 pharmaceutical preparation of Lehtonen et al. to have individual nanoparticles or microparticles as claimed 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 Lehtonen et al. teach, for example, converting solid granules into the coated solid pharmaceutical preparation (Page 4, lines 22-27), where “granules” includes all sizes of granules known to the pharmaceutical artisan. 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 coat microparticles/microgranules with a core of an organic active pharmaceutical substance with a metal oxide coating layer of 5-15 nm thickness with a reasonable expectation of success to produce a composition that consist of the organic active pharmaceutical substance and a coating layer. Additionally, it is obvious in view of the combined reference for the ordinary artisan that desires a tablet dosage form made from the individual nanoparticles/microparticles to combine them with the typical excipients/carriers for a tablet and use a conventional tablet press to produce a tablet with a reasonable expectation of success. Accordingly, the ordinary artisan would make a composition wherein the nanoparticles or microparticles consist of an organic active pharmaceutical substance, one or more pharmaceutically acceptable excipients, and a coating layer as claimed. It is the Examiner’s position that modification to a liquid dosage form, 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 those 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11672764 having the same inventors and assignee. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent anticipates the claims by disclosing:
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Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11986559 having the same inventors and assignee. Although the claims at issue are not identical, they are not patentably distinct from each other because the method patent of the patent produces the claimed composition comprising individual nanoparticles or microparticles comprising a core with a metal oxide coating layer of 5-15 nm as shown below:
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Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10603284 having the same inventors and assignee. Although the claims at issue are not identical, they are not patentably distinct from each other because the method patent of the patent employs individual nanoparticles or microparticles comprising a core with a metal oxide coating layer and combining the coated nanoparticles or microparticles of an active pharmaceutical substance with one or more excipients and compressing into a dosage form (Claims 1 and 13) such as a tablet (Claim 8), which is an oral dosage form, where the coating layer comprises titanium oxide and aluminum oxide (Claims 2-4, 9-12) and the pharmaceutical substance is an organic biomolecule (Claim 14) or small molecule such as a sugar (Claims 7 and 15), which would be water soluble, and is made by alternating layer deposition by atomic layer deposition (Claims 1 and 12). Thus, the patent teaches a pharmaceutical composition wherein the nanoparticles or microparticles consist of an organic active pharmaceutical substance, one or more pharmaceutically acceptable excipients, and a coating layer.
The patent does not expressly teach a coating layer of 5-15 nm thickness. However, the thickness of the coating layer is dependent upon the number of atomic layer deposition cycles and thus a variable that can be optimized by the ordinary artisan to control the release of the active substance. Therefore, a coating layer of 5-15 nm thickness appears obvious over the patented subject matter.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Moldt et al. (WO2007112747) teaches: “In some embodiments, these combinations may be formulated into tablets, particles, beads, granules, microtablets, microparticles, microbeads, or microgranules, or placed into capsules, prior to administration. Non-limiting examples include particles, beads, granules, microparticles, microbeads, and microgranules, each in a microencapsulated form, or optionally compressed into larger aggregates or tablets. Other non-limiting examples include tablets, particles, beads, granules, and microtablets, each in a coated form.” (Page 2, lines 11-17; see also claims 19-20). Thus, micro sized beads and granules are obvious over beads and granules in the pharmaceutical art.
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