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 .
Status of Claims
Claims 1-23 and 51- 222 are canceled. Claims 24-50 are pending.
Election/Restrictions
Applicant’s election of Group II, claims 35-41, in the reply filed on 15 September 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 24-34 and 42-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 15 September 2025.
Claims 35-41 are presented for examination herein.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 35-41 are rejected under 35 U.S.C. 103 as being unpatentable over STENZLER (WO 2015/138406 A1, publication date of 17 September 2015) in view of WRAGHT (US 2018/0214432 A1, publication date of 02 August 2018).
Stenzler is primarily directed towards a liquid nitric oxide releasing solution comprised of at least one nitric oxide releasing compound (abstract).
Regarding claim 35, Stenzler discloses a liquid nitric oxide releasing solution that provides delivery of an effective amount of the gaseous NO (page 5, fourth paragraph). Stenzler discloses that delivery to at least a portion of the upper respiratory tract (page 5, last paragraph). Stenzler discloses that the nitric oxide releasing solution includes at least one nitric oxide releasing compound (page 11, third paragraph). Stenzler discloses that the nitric oxide releasing solution may be administered to the subject in a spray (page 15, last paragraph). Stenzler discloses treatment of including respiratory disease caused by a bacterial, fungal or viral infection (page 17, first paragraph). Stenzler discloses administration via the nasal cavity of the subject (page 17, first paragraph).
Stenzler does not specifically teach an average droplet volume which contains treatment within the upper respiratory tract. The deficiency is made up for by the teachings of Wright.
Wraight is primarily directed towards a pharmaceutical composition that is administered by intranasal application (abstract).
Regarding claims 35-36 and 39, Wraight teaches administration by including nasal administration (paragraph [0033]). Wraight teaches administration to the nasal cavity using a metered dose nasal spray (paragraph [0162]). Wraight teaches that in a spray form the droplet size distribution Dv(50) is about 150 to about 300 µm when tested at a firing distance of about 20 mm to about 50 mm (paragraph [0167]). Wraight teaches that the droplet size distribution Dv(90) of a spray form is about 380 μm to about 650 μm (paragraph [0168]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat a respiratory infection caused by including bacterial, fungal or viral infection (e.g., infection of a pathogen) by administering a liquid nitric oxide releasing solution, by a metered dose nasal spray that administers to the nasal cavity (e.g., upper respiratory tract); wherein the metered dose nasal spray provides a spray form of the liquid nitric oxide releasing solution that has a droplet size distribution Dv(50) is about 150 to about 300 µm when tested at a firing distance of about 20 mm to about 50 mm; and wherein the metered dose nasal spray provides a spray form of the liquid nitric oxide releasing solution that has a droplet size distribution Dv(90) of a spray form is about 380 μm to about 650 μm. The person of ordinary skill in the art would have been motivated to make those modifications in order to provide administration via the nasal cavity, which is an included desired area of administration disclosed in Stenzler, by using s metered dose nasal spray taught by Wraight that provides administration to the nasal cavity; and reasonably would have expected success because Stenzler discloses that the nitric oxide releasing solution may be administered to the subject in a spray (page 15, last paragraph). Stenzler discloses administration via the nasal cavity of the subject (page 17, first paragraph). Wraight teaches administration by including nasal administration (paragraph [0033]). Wraight teaches administration to the nasal cavity using a metered dose nasal spray (paragraph [0162]). Wraight teaches that in a spray form the droplet size distribution Dv(50) is about 150 to about 300 µm when tested at a firing distance of about 20 mm to about 50 mm (paragraph [0167]). Wraight teaches that the droplet size distribution Dv(90) of a spray form is about 380 μm to about 650 μm (paragraph [0168]).
Regarding claims 37-39 and 41, Wraight teaches administration to the nasal cavity using a metered dose nasal spray (paragraph [0162]). Wraight teaches that in a spray form the droplet size distribution Dv(50) is about 150 to about 300 µm when tested at a firing distance of about 20 mm to about 50 mm (paragraph [0167]). Wraight teaches that the droplet size distribution Dv(90) of a spray form is about 380 μm to about 650 μm (paragraph [0168]). As evidenced by the instant specification, metered dose nasal spray pump used for administration to the nose, has a % Volume of < 10 µm and < 5 µm that ranges from less than .147 % to 0% (paragraph [00303] and Tables 4-1 to 4-6). The metered dose nasal spray pump taught by Wraight is substantially the same as the metered dose nasal spray pump disclosed in the instant specification, thus, the metered dose nasal spray pump taught by Wraight, that provides a droplet size distribution Dv(50) is about 150 to about 300 µm when tested at a firing distance of about 20 mm to about 50 mm and provides a spray form that has a droplet size distribution Dv(90) of a spray form is about 380 μm to about 650 μm, when used to administer the liquid nitric oxide releasing solution of Stenzler would necessarily have the same characteristics, e.g., a % Volume of < 10 µm and < 5 µm that ranges from less than .147 % to 0%, 10th percentile by volume of spray of greater than 100 µm, droplet size distribution of about 0.5 to about 2.0. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
Thus, the claimed invention as a whole is clearly prima facie obvious over the teachings of the prior art.
Conclusion and Correspondence
No claims are found allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P NGUYEN whose telephone number is (571)270-5877. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/John P Nguyen/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600