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 Objections
Claim 1 objected to because of the following informalities: typographical error: “mouse” piece. Appropriate correction is required. (also typographical error in claim 11)
Claims 5-6, 8-14, and 16-36 are objected to because of the following informalities: dependency of claims. Examiner makes suggestions to dependency; appropriate correction is required.
Claim 5 depend from claim 4
Claim 6 depend from claim 5
Claim 16 depend from claim 15
Claim 17 depend from claim 15
Claim 18 depend from claim 15
Claim 19 depend from claim 18
Claim 20 depend from claim 19
Claim 21 depend from claim 18
Claim 22 depend from claim 15
Claims 23-26, 29-36, dependency unclear
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-26, 29-36 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-36 of copending Application No. 17/803,705 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 1-7, 15-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Djupesland et al. (US 2008/0289629) (“Djupesland”).
Djupesland discloses: a device and method for treating a subject for local or systemic nasal injury, disorder or disease or CNS injury, disorder or disease, who is in need of treatment comprising (Fig. 2e):
(a) a mouth piece 19 for blowing a breath into said device by a subject;
(b) a nose guard 17 for propelling the drug substance in the nasal cavity of the subject;
(c) a flexible convoluted middle section sandwiched between said mouth piece and noseguard (see Fig. 2e); and
(d) a dual wall drug dispensing system 53 comprised of a first hollow means into which the drug substance is loaded that generates a first airflow, and a second hollow means that surrounds the first hollow means, so that, when a subject blows air through said mouthpiece and into said device, said first hollow means and said second hollow means in parallel provide a dual airflow comprised of (i) a first airflow expelled from said first hollow means carrying the drug substance, and (ii) a second airflow expelled from the second hollow means to create airflow pressure that surrounds the first expelled airflow, so that the first expelled airflow forms and travels initially in a vertical, somewhat tight and narrow or confined, concentrated plume that drives the concentrated drug substance to the targeted olfactory region for direct diffusion into the brain for the effective treatment. (see Fig. 2e, [0051-0054])
the drug substance is deposited into the superior nasal cavity. (see Fig. 2e, [0051-0054])
the drug substance is distributed into mucosa innervated by the trigeminal nerve. (see Fig. 2e, [0051-0054], [0004])
the CNS injury is brain injury; the brain injury is traumatic brain injury ("TBI") or concussion. [0004]
the TBI is mild TBI, moderate TBI or severe TBI
Claim Rejections - 35 USC § 103
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 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.
Claims 8-14, 22-26, 29-36 are rejected under 35 U.S.C. 103 as being unpatentable over Djupesland in view of Lichty et al. (US 2014/0248367) (“Lichty”).
Djupesland discloses the invention as substantially claimed but does not directly disclose the delivery of ent-19- norprogesterone. Lichty, in the analogous art, teaches the breath-powered nasal delivery of ent-19- norprogesterone to treat traumatic or ischemic CNS injury such as TBI or stroke [0124,0132]. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to deliver ent-19- norprogesterone as a commonly used substance to treat a CNS injury.
Conclusion
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/DEANNA K HALL/Primary Examiner, Art Unit 3783