DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4-6, 11, 12, 14, 16-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ambikanandan (IN 2011MU01237 A).
Ambikanandan discloses a dry-powder inhalable pharmaceutical composition comprising 10-30% w/w/ sildenafil citrate (Examples A and C-F). The composition further contains 10-80% w/w phospholipid DPPC or poly(lactic acid), and 10-80% w/w lactose, mannitol, glycine, r leucine. Examples A and C disclose a method for preparing the composition by dissolving the components in solvents, mixing the two for co spray-drying. The dry powder composition obtained in Example E ha a particles size of 50nm to 10 µm (Table 8).
Claims 1, 4 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shahin et al (J of Controlled release, 2019, 275-286, v133).
Shahin et al discloses a dry-powder inhalable pharmaceutical composition prepared via spray drying (Tables 1 and 3) where the composition contains 6-8% w/w sildenafil citrate and hyaluronic acid or leucine (pg 128, ¶ 1). The dry-powder particles are spherical and have a particle size in the range of 2-10 µm (Section 3.2.4, ¶ 1).
Claims 1, 4, 9 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ghasemiam et al (Pharm Dev and Tech, 2015, 961-971, v21, no 8).
Ghasemiam et al discloses a dry-powder inhalable pharmaceutical composition comprising sildenafil citrate and PKGA and PVA, with sugars and leucine (pg 2, Preparation of SC loaded PLGA nanoparticles, Table 1, and Table 2). The dry powder has a solid, spherical shape and the majority have a particle size in the range of instant claim 12 (Fig 5 and Table 1-2).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over Ambikanandan (IN 2011MU01237 A).
The reference is discussed above, but does not disclose the specific mass fraction of instant claims 3, 7-8, 10, or 15. The also do not disclose the specific particle sized, preparation conditions of claim 19 and 21-25.
Where amounts are disclosed generally in the reference, it would have been obvious to one of ordinary skill in the art to optimize the content of each component in order to provide the optimal pharmacokinetic properties for the dry inhalation powder. In doing so, the properties disclosed would be optimized, such as particle size and mass weight of each component.
In formulating the dry spray method, it would be obvious to optimize parameters well known for such a process, such as temperatures and spray rates.
Claims 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over Shahin et al (J of Controlled release, 2019, 275-286, v133).
The reference is discussed above, but does not disclose the specific mass fraction of instant claims 3, 7-8, 10, or 15. The also do not disclose the specific particle sized, preparation conditions of claim 19 and 21-25.
Where amounts are disclosed generally in the reference, it would have been obvious to one of ordinary skill in the art to optimize the content of each component in order to provide the optimal pharmacokinetic properties for the dry inhalation powder. In doing so, the properties disclosed would be optimized, such as particle size and mass weight of each component.
In formulating the dry spray method, it would be obvious to optimize parameters well known for such a process, such as temperatures and spray rates.
Claims 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over by Ghasemiam et al (Pharm Dev and Tech, 2015, 961-971, v21, no 8).
The reference is discussed above, but does not disclose the specific mass fraction of instant claims 3, 7-8, 10, or 15. The also do not disclose the specific particle sized, preparation conditions of claim 19 and 21-25.
Where amounts are disclosed generally in the reference, it would have been obvious to one of ordinary skill in the art to optimize the content of each component in order to provide the optimal pharmacokinetic properties for the dry inhalation powder. In doing so, the properties disclosed would be optimized, such as particle size and mass weight of each component.
In formulating the dry spray method, it would be obvious to optimize parameters well known for such a process, such as temperatures and spray rates.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
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