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 .
DETAILED ACTION
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 01 Jul 2026 has been entered.
Claims 1-4, 7, 8, 12-18, and 20 remain pending in the application.
Claim 1 is amended.
Claims 5, 6, 9-11, 19, 21, and 22 are cancelled.
Claims 12-14 and 20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. It is noted that claims 12-14 are withdrawn as they require non-elected species.
Claims 1-4, 7, 8, and 15-18 are under consideration to the extent of the elected species. The species under current examination are menthol as the signaling agent and zanamivir as the biologically active agent.
Objections Withdrawn
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 01 Jul 2026 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections pursuant to 35 U.S.C. 112(b) and 112(d) set forth in the Non-Final Office Action mailed 01 Jul 2026 are hereby withdrawn in light of applicant’s amendment of the claims.
Objections/Rejections Maintained – modified form
Specification
The disclosure is additionally objected to because it contains an embedded hyperlink and/or other form of browser-executable code at page 18 (www.nasalize.com) and page 2 (www.phytomedcentral.org).
Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
In the reply filed 01 Jul 2026 applicant noted that the specification has been amended to overcome the objections. The examiner notes, however, that the amendment did not change the form of “www.phytomedcentral.org” and the “www.nasaleze.com” retains the prefix “www.” References to websites should not contain any prefix.
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.
The rejection below was made previously, and the art is applied again in the rejection below with modifications to address the claim amendments.
Claims 1-4, 7, 8, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over James et al. (US 2010/0297269, published 25 Nov 2010) in view of Suzuki et al. (US 4,294,829, published 13 Oct 1981) and Malhotra et al. (US 2015/0034087, published 05 Feb 2015).
James teaches dry powder compositions for administration to the nasal tract comprising cellulose and in particular hydroxypropylmethylcellulose (HPMC) and one or more therapeutic agents ([0001]). James teaches the therapeutic agent may be any active substance for nasal administration to a patient ([0027]) and additionally teaches the inclusion of a flavouring or signaling agent such as menthol ([0040]). James teaches blending of powder ingredients to mix the components ([0053], [0058]), rendering obvious the “homogenised powder” as in claim 1. Thus, James renders obvious dry homogenized powder compositions consisting of HPMC, menthol and a therapeutic agent as in claim 1 as well as the use as a nasally administered medicament of claim 17.
Regarding the amount of signalling agent in claims 1 and 7, James teaches that the signaling agent may be present at various percentages including up to 10, 5, 2, 1 and 0.5% by total weight of the composition ([0048]), rendering obvious the 0.25% to 10% w/w of claim 7 and 0.25 to 2% w/w of claim 1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Regarding claim 15, James teaches the sustained release of the active agent ([0024], [0025]). Regarding claim 16, James teaches the therapeutic agent may have a systemic effect ([0026], claim 3). Regarding the 90-99.75% of HPMC in claim 1, James additionally teaches that the HPMC may be at various concentrations such as at least 50% and preferably at least 60, 70, 80, 90, 95, 97 or 99% by weight of the composition ([0046]), rendering obvious the claimed amount of HPMC. James further teaches that the therapeutic agent to the powdered HPMC may be at various ratios such as between 0.1:9.9 and 1.9:8.1 ([0047]). The combination of the percent HPMC and ratio of therapeutic agent to HPMC renders obvious the amount of active agent as in claims 1 and 8. For example, a ratio of therapeutic agent to HPMC between 0.1:9.9 and 1.9:8.1 and 90% HPMC, as taught by James, would render the agent between 0.9% and 17.1% which overlaps with and renders obvious the claimed amount of active agent in claims 1 and 8. Regarding the limitation of claim 1 that the composition does not contain any other additive or molecular component, the examiner notes that James does not require any components in addition to the HPMC and therapeutic agent, thus rendering it obvious to not include further components beyond the claimed HPMC, signalling agent, and biologically active agent.
James does not teach that particle size of the powder as in instant claims 1-4 or the biologically active agent zanamivir (the species under examination). These deficiencies are made up for in the teachings of Suzuki and Malhotra.
Suzuki teaches a powdery pharmaceutical composition for application to the mucosa of the nasal cavity (col 1 lines 7-9). Suzuki teaches the composition comprises cellulose (col 2 lines 52-54) such as hydroxypropylmethyl cellulose (col 3 line 26). Suzuki teaches that the powdery composition adheres to the nasal mucosa to which it has been administered, stays for an extended period of time, swells and continues to release the active drug and thus is excellent in regard to slow releasing of the active drug (col 1 lines 56-61). Suzuki teaches that the contact of the drug in the powder depends greatly upon the particle size of the powder and if the particle size is reduced that the proportion of powder that adheres to the nasal mucosa decreases and powder is able to reach the lungs and dissipate out of the nostrils (col 1 line 65 – col 2 line 3). Suzuki teaches that at least about 90% by weight of the particles have an effective particle diameter between about 20 and about 250 microns (col 5 lines 17-20) and preferably between about 20 to about 150 microns (col 5 lines 40-42). Suzuki teaches that if more than about 10% of the particles have a diameter less than about 20 microns that the proportion of particles which reach the lungs or dissipate out of the nostrils increases whereas if more than about 10% of the particles have a diameter greater than about 250 microns that the particles are liable to depart from the mucosa before absorption of moisture even when adhered to the nasal mucosa and that these particles are not ideal for spraying into the nasal cavity (col 5 lines 28-39).
Malhotra teaches zanamivir is a therapeutic drug for treating of illness due to influenza A and B virus in adults and pediatric patients ([0007], [0008]) and teaches that zanamivir may be administered in nasal sprays/drops and dry powder inhalers ([0054]) and may be encapsulated in hydroxypropyl methylcellulose ([0059]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed a dry powdered composition of HPMC, a signaling agent of menthol and an active of zanamivir, and to have the particle sizes between 20 and 250 microns and preferably between 20 and 150 microns. Powdered compositions comprising HPMC, menthol and therapeutic agents are known from James and are used for sustained release of the active agent, and, as known from Suzuki, the particle size of powdered nasal compositions is a critical parameter in determining the effective drug release from the composition to the nasal mucosa. Particles less than 20 microns will reach the lungs and dissipate out the nostrils and particles greater than 250 microns are liable to leave the nasal mucosa before absorbing moisture, as taught by Suzuki. Thus, it would have been obvious to have formed the powdered particles of James between 20 and 250 microns and preferably between 20 and 150 microns for optimal drug release performance and one would have a reasonable expectation of success as such particle sizes for HPMC powdered drug compositions are known from the teachings of Suzuki. It is noted Suzuki does not describe the measurement method of laser diffraction as recited in claim 1, but the laser diffraction measurement does not distinguish the instant particles from the particles obvious to form from the teachings of James and Suzuki where overlapping particle size ranges are taught. Regarding the inclusion of zanamivir, the compositions of James include therapeutic agents which may be any active substance for nasal administration to a patient, as taught by James and zanamivir is a known therapeutic drug that may be used in nasal and dry powder compositions including HPMC. Thus it would have been obvious to use zanamivir as a therapeutic agent in the compositions of James as it is a therapeutic drug known for use in powdered formulations with HPMC and for inhalation/nasal delivery. Thus the inclusion of zanamivir merely represents the inclusion of a therapeutic element known in the prior art for its intended purpose as a therapeutic agent. There would have been a reasonable expectation of success as zanamivir is known for use in powdered formulations for inhalation/nasal delivery similar to those of James.
Regarding claim 18 and the limitation that the composition is for use in treating covid-19 disease, the examiner notes that this limitation is directed to an intended use of the composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the claims are drawn to a composition consisting of a dry homogenized powder of HPMC, a signaling agent and a biologically active agent with a particle size between 20 and 500 microns, which is met by the teachings of James, Suzuki and Malhotra.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 01 Jul 2026 have been fully considered but they are not persuasive. Applicant states that the prior art does not teach a three-component closed system and that the prior art teaches formulation that may include additional ingredients without motivation to eliminate such components entirely (page 10 of remarks). Applicant argues that James does not teach a formulation “that must contain only those components and must exclude all other additives or molecular components” (page 11 of remarks). Applicant argues that the rejection does not explain why one would have arrived that the claimed closed formulation (page 12 of remarks). Applicant argues that the percentages of components provide a claimed invention that “is not simply a sub-range selected from James. It is a restricted formulation space defined by both quantitative requirements and compositional exclusion” (pages 12-13 of remarks). Applicant argues that the teachings of Suzuki and Malhotra do not cure the deficiency of James not teaching the closed composition.
The examiner does not find this persuasive. The examiner notes that James teaches an invention comprising HPMC and one or more therapeutic agents ([0001]). Thus, outside of HPMC and a therapeutic agent, no other component is required by James. The example compositions taught by James provide further evidence of this point. Example 1 contains HPMC and the therapeutic Allicin, Example 2 contains HPMC, the therapeutic Echinacea and the signalling agent menthol, and Example 3 contains HPMC, the therapeutic Ginseng, and the signalling agent Lavender ([0056-0062]). Thus, while James may not explicitly state “the composition does not contain any other additive or molecular component” as is claimed, this feature is nonetheless obvious over the teachings of James. It is not necessary for the art to have the limitation expressed in the same language of the claim for it to be obvious. Based on the teachings of James, Suzuki and Malhotra, as described above, it is obvious to form a composition with only the ingredients of HPMC, menthol and zanamivir in amounts that overlap with and thus render obvious the claimed amounts. The art does not require additional components beyond these and thus meets the limitation of a closed composition.
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 1-4, 7, 8, 11, 15-18, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. US 8,202,550 in view of James et al. (US 2010/0297269, published 25 Nov 2010), Suzuki et al. (US 4,294,829, published 13 Oct 1981) and Malhotra et al. (US 2015/0034087, published 05 Feb 2015).
Claim 1 of the ‘550 patent recites a dry powder intranasal compositions comprising HPMC with a viscosity of 10-20 Pas, one or more therapeutic agent and a signaling agent. Claim 3 recites a systemic effect upon administration and claim 4 recites a sustained release of the therapeutic agent. Claim 10 recites that the signaling agent comprises up to 0.25% of the composition. The claims do not require additional components beyond the HPMC, therapeutic agent, and signaling agent.
The ‘550 patent does not recite that the amount of HPMC, signaling agent is menthol, the percent of the active agent of instant claim 8, the particles sizes of claims 1-4 and the active zanamivir. These deficiencies are made up for in the teachings of James, Suzuki and Malhotra.
The teachings of James, Suzuki and Malhotra are described supra.
It would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have the HPMC from at least 90%, used menthol as the signaling agent, have the active agent from 0.8% to 15.2% and the particle size of the power between 20 and 250 microns and preferably between 20 and 150 microns and to use zanamivir as the therapeutic agent. Compositions similar to the powdered composition of the ‘550 patent comprising HPMC a signaling agent and a therapeutic agent are taught by James and menthol is an alternative signaling agent for such compositions, as taught by James, rendering it an obvious signaling agent for the ‘550 patent composition. Additionally, James teaches that the HPMC may be at various concentrations in the composition such as at least 50% and preferably at least 60, 70, 80, 90, 95, 97 or 99% by weight of the composition and teaches that the therapeutic agent to the powdered HPMC may be at various ratios such as between 0.1:9.9 and 1.9:8.1. These ranges render obvious amounts of HPMC and active agent that overlap with and render obvious the claimed ranges. For example, a ratio of therapeutic agent to HPMC between 0.1:9.9 and 1.9:8.1 and 90% HPMC, as taught by James, would render the agent between 0.9% and 17.1%. One of ordinary skill would have a reasonable expectation of success from this amount as the compositions of James and the ‘550 patent are similar and they are taught as suitable by James. The particle size of nasal powders is known to be an important factor in the drug delivery, as taught by Suzuki. Particles below 20 microns are more easily taken into the lungs and dissipated and particles over 250 microns may not be wetted properly before they are lost from the mucosa. Thus, one of ordinary skill would have a reasonable expectation of success in having the particles between 20-250 microns and preferably between 20 and 150 microns for the reasons given above. The inclusion of zanamivir as the therapeutic agent would have been obvious as it is known from Malhotra as a therapeutic used in dry powder inhalation formulations with HPMC, and its inclusion merely represents the use of a known prior art element for its known use.
Response to Arguments
Applicant's arguments filed 01 Jul 2026 have been fully considered but they are not persuasive. Applicant argues that instant claims are distinct from the reference claims for the same reasons provided against the 103 rejection above, namely that instantly claim 1 requires a closed composition of specifically recited components. The examiner does not find this persuasive for similar reasons given above. Namely, the inclusion of the specific compounds and their amounts is obvious from the prior art and the reference claims do not require components in addition to HPMC, signaling agent, and a therapeutic agent.
New Grounds of Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7, 8, 15 and 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 and claim 8 depend from claim 1.
Claim 7 recites the “signalling agent makes up from 0.25% w/w to ≤10% w/w of the total weight of the composition.” Claim 1, however, recites that the signalling agent is from 0.25 to 2% w/w which is less than the range in claim 7. Claim 7 thus fails to limit claim 1 and instead broadens the claimed range.
Claim 8 recites the “biologically active agents makes up from 8% w/w to 9.75% w/w of the composition.” Claim 1, however, already recites “8 to 9.75% w/w of one or more biologically active agents” and thus claim 8 has the same limitation as claim 1 and fails to further limit. Claims 15 and 16 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 8.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.C.M./Examiner, Art Unit 1619 /ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
