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 .
Election/Restrictions
Claim 6-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/06/2026.
Priority
The examiner notes that claims 1-15 contain subject matter not supported by the provisional application 63/073,723. Specifically there is no support for wherein the pinene is in a concentration of greater than 80% by weight of the liquid substance. Therefore the priority date of the instant application is 9/02/2021.
Response to Amendment
The examiner notes that the claims have been amended on 1/06/2026. In claim 1, it appears applicant removed step e., however this was not crossed out. Claim 2 is not original as noted and has also been amended.
As per MPEP 714: (2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of "currently amended," and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of "currently amended," or "withdrawn" if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as "withdrawn— currently amended."
Claim Objections
The claims are objected to because of the following informalities:
Claim 1, line 6 recites “the actuator chamber”. This should read “an actuator chamber”.
Claim 1, line 7 recites “the actuator”. This should read “an actuator”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 52 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 52 recites that pinene reduces the viral load in the nasopharynx. There is no discussion of viral load in the original disclosure and how it relates to viral replication. While there is discussion of reduced viral replication, this is not enough to support the reduction of a viral load in the nasopharynx. For example, if viral replication is reduced a slight amount the viral load can still be increased.
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.
Claim(s) 1-3 and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong (WO 2011/026198 A1) in view of Eyal (WO 2021/191886 A1) in view of Geser et al. (US 2003/0226907 A1) in view of Nasal Sprays.
Regarding claim 1, Wong discloses:
A method of atomization, using an atomizer device (1), for therapeutic treatment (page 1, paragraph 2) comprising:
a. filling a reservoir bottle (2) of an atomizer with a substance (a material as set forth on page 4, line 3);
b. connecting the reservoir bottle (2) to the actuator chamber (30) with a feed tube (12), the feed tube (12) being attached to the actuator (13), a nasal spray tip (14) being attached to the actuator chamber (see figure 3),
c. inserting the nasal spray tip in a nostril (page 8, 2nd full paragraph);
d. applying manual force the actuator, the actuator causing the material to produce aerosol, the aerosol traveling through the nostril (page 12, first paragraph).
While Wong does not explicitly disclose wherein the material in the reservoir is a liquid, Wong indicates it is known to dispense liquid via a nasal spray system (page 2, 3rd full paragraph). Further Wong does not explicitly disclose the method is of pinene atomization for the treatment of respiratory viruses, the liquid substance being comprised of pinene and an excipient and being suitable for atomization, wherein the pinene is in a concentration of greater than 80% by weight of the liquid substance.
However, Eyal teaches a method for treating a respiratory virus [00015]-[00016] [00035] via nasal spray of a liquid substance [00026]. The liquid substance [0026] is comprised of a pinene being suitable for atomization ([00066] alpha and beta pinene) and a suitable excipient [00104] [00108]. The examiner notes that the combination with Eyal teaches the material in the reservoir to be liquid.
While Eyal teaches that at least three terpenes and/or terpenoids have a concentration of greater than 80% by weight of the liquid substance (from 0.01-99.99%: [00101]) and that the terpenes include alpha and beta pinene [0066] the concentration of each of the at least three terpenes is not explicitly disclosed. However, a finite number of identified, predictable potential solutions are available in order for each of the at least three terpenes to achieve 0.01-99.99% active ingredient by weight and of those, there are several in which alpha and beta pinene have a concentration of greater than 80% by weight of the liquid substance. For example, 50% alpha pinene, 40% beta pinene and 5% of cineol (from [0066]), which would result in 90% concentration by weight of pinene. Based on the teachings of Eyal, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success and therefore is obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Further it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong such that the material in the reservoir is a liquid and further that the method is of pinene atomization for the treatment of respiratory viruses, the liquid substance being comprised of pinene and an excipient and being suitable for atomization, wherein the pinene is in a concentration of greater than 80% by weight of the liquid substance as taught by Eyal for the benefit of providing an antiviral agent [0066] to the user.
Wong does not explicitly disclose the nasal spray tip being attached to a protective cap; the protective cap that is removed prior to inserting the nasal spray tip into the nasal cavity.
However, Geser teaches it is known for a nasal spray tip (65; [0003]) being attached to a protective cap (66); the protective cap that is removed prior to inserting the nasal spray tip into the nasal cavity (as discussed in [0105], the cap 66 is removeable and opening 65 is closed off by cap 66 and thus the cap must be removed prior to being placed in the nostril as the medicament would not be able to enter the nostril with cap 66 on mouthpiece 65).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wong to include the nasal spray tip being attached to a protective cap; the protective cap that is removed prior to inserting the nasal spray tip into the nasal cavity as taught by Geser for the benefit of preventing contamination of the mouthpiece 65 when not in use.
Wong does not explicitly disclose inhaling while applying manual force the actuator.
However, Nasal Sprays discloses inhaling while applying manual force the actuator (step 5 in both pressurized canister instructions and pump bottle instructions).
Therefore, it would have been obvious to have modified Wong wherein the method includes inhaling while applying manual force the actuator as taught by Nasal Sprays as this is the proper way to use a nasal spray (see title of Nasal Sprays: How to use them correctly).
Regarding claim 2, Wong as modified further discloses wherein the liquid substance also comprises cineole (Eyal: [0066]; see also rejection of claim 1 above).
Regarding claim 3, Wong as modified currently does not explicitly disclose wherein the liquid substance also comprises additional therapeutic compounds.
However, Eyal further teaches it is known for the liquid substance to include additional therapeutic compounds [0024]-[0025] [00104].
Therefore it would have been obvious to one of ordinary skill in the art to have modified Wong such that the liquid substance also comprises additional therapeutic compounds to induce a relaxing effect or to provide antibacterial/antifungal properties.
Regarding claim 52, Wong as modified further discloses wherein the pinene disrupts the nucleocapsid protein binding and reduces the viral load in the nasopharynx. The examiner points to [0001] and further to [0019] of applicant’s disclosure wherein the pinene is both alpha and beta pinene. Wong as modified also delivers alpha and beta pinene to the nose. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Therefore, it is the examiner’s position that the prior art inherently also possesses the claimed property of disrupting the nucleocapsid protein binding and reducing the viral load in the nasopharynx.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong (WO 2011/026198 A1) in view of Eyal (WO 2021/191886 A1) in view of Geser et al. (US 2003/0226907 A1) in view of Nasal Sprays, in further view of Himalaya Terpenes Pvt. Ltd
Regarding claims 4-5, Wong as modified discloses the claimed invention substantially as claimed but does not explicitly disclose wherein the purity of the pinene in the liquid substance is greater than 85% or wherein the purity of the pinene in the liquid substance is between 90% and 100%.
However Himalaya Terpenes Pvt. Ltd teaches it is known for the purity of the pinene in the liquid substance is greater than 85% (page 1 under typical properties purity min is 90% and page 2, Alpha pinene purity 80-95%) or wherein the purity of the pinene in the liquid substance is between 90% and 100% (page 1 under typical properties purity min is 90% and page 2, Alpha pinene purity 80-95%).
Therefore, it would have been obvious to one having ordinary skill in the art to have modified Wong such that the purity of the pinene in the liquid substance is greater than 85% or wherein the purity of the pinene in the liquid substance is between 90% and 100% as taught by Himalaya Terpenes Pvt. Ltd for the benefit of ensuring a pure substance is delivered to the patient’s nose.
Conclusion
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785