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
The amendments and arguments filed 13 January 2026 are acknowledged and have been fully considered. Claims 34, 40-41, 54, and 77-82 are currently pending. Claims 34, 40-41, and 54 are amended; claims 1-33, 35-39, 42-53, and 55-76 are cancelled; no claims are withdrawn; claims 77-82 are new.
Claims 34, 40-41, 54, and 77-82 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. In particular, the objection to the specification is withdrawn in view of Applicant’s amendment to the specification. Additionally, the rejection of claims under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendments to the claims. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 41 and 82 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 41 recites the limitation "the macromolecule" in lines 4 and 6. Claim 82 recites the limitation “the macromolecule” in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the macromolecule” is interpreted as SPL7013.
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.
Claim 34, 41, 54, and 77-82 are rejected under 35 U.S.C. 103 as being unpatentable over Grogan et al. (US 8,568,753; of record) as evidenced by Panzade et al. (Research J. Pharm. and Tech., 2010, Vol. 3, 672-675).
Claim 34 is drawn to a nasal spray composition for reducing the likelihood of, or treating a Coronavirus (CoV) infection in an individual, comprising:
an effective amount of SPL7013;
from 0.01% w/w to 1% w/w of a polyacrylic acid polymer; and
a pharmaceutically acceptable carrier.
Claims 77-78 are drawn to the composition of claim 34, wherein the polyacrylic acid polymer is a crosslinked polyacrylic acid, wherein the crosslinked polyacrylic acid is crosslinked with an allyl ether of pentaerythritol.
Claim 79 is drawn to the composition of claim 34, wherein the composition comprises the polyacrylic acid polymer in an amount of from 0.01% to 0.1% w/w.
Claim 80 is drawn to the composition of claim 34, wherein the composition comprises the polyacrylic acid polymer in an amount of from 0.05% to 0.1% w/w.
Claim 81 is drawn to the composition of claim 34, wherein the composition comprises the polyacrylic acid polymer in an amount of 0.5% w/w.
Claim 82 is drawn to the composition of claim 34, wherein the composition comprises a w/w ratio of about 1:20 to 1:10 of the polyacrylic acid polymer to the macromolecule.
Grogan et al. teach microbiocidal compositions comprising a dendrimer (Abstract), including Example 1 (Table 1 in col. 19), comprising SPL7013 ;4.4% w/w Carbopol 971P, as calculated by examiner; purified water, glycerin, and propylene glycol (i.e., a pharmaceutically acceptable carrier).
And as evidenced by Panzade et al., Carbopol 971P is a cross-linked acrylic acid-based polymer (Introduction) crosslinked by allyl pentaerythritol (Carbopol manufacturing and grading).
As such, Grogan et al. teach a composition comprising an effective amount of SPL7013; a polyacrylic acid polymer; and a pharmaceutically acceptable carrier, wherein the polyacrylic acid polymer is a crosslinked polyacrylic acid crosslinked with an allyl ether of pentaerythritol.
The composition of Grogan et al. differs from the instantly claimed composition in the following ways:
Grogan et al. do not teach the composition comprising between 0.01% w/w and 1% w/w of the polyacrylic acid polymer;
Grogan et al. do not teach a w/w ratio of about 1:20 to 1:10 of the polyacrylic acid polymer to the macromolecule; and
Grogan et al. do not teach the composition as a nasal spray for treating a CoV infection.
Yet, as to 1 and 2: Grogan et al. further teach “the microbiocidal composition may be provided in the form of a solution, suspension, lotion, film, jelly, foam, gel, cream, and the like” (Col. 12 line 66 – col. 13 line 1), indicating that a wide range of viscosities are suitable for the antimicrobial composition.
And, as discussed by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454)): “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the concentration of the polyacrylic acid polymer is clearly result-effective variables, determining the viscosity of the composition. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal concentration of the polyacrylic acid polymer in order to best achieve the desired results.
Further, optimizing the amount of the polyacrylic acid polymer in the composition would necessarily result in optimizing the ratio of polyacrylic acid polymer to SPL7013.
And, as to 3: The recitation of “a nasal spray composition for reducing the likelihood of, or treating a Coronavirus (CoV) infection in an individual” is a recitation of intended use of the composition and does not impose further structural limitation on the composition (See MPEP 2111.02(II)). As Grogan et al. teaches all of the structural limitations of claim 34, it reads on the claim.
Based on all of the foregoing, claims 34 and 77-82 are rejected as prima facie obvious.
Claim 41 is drawn to the composition of claim 34, wherein the composition comprises a pH of 3.5 to 7.5.
Grogan et al. further teach the composition having a pH of 4.5 (Col. 19 lines 47-48).
As such, claim 41 is rejected as prima facie obvious.
Claim 54 is drawn to the composition of claim 34, wherein the composition inactivates more than 90% of SARS-CoV2 or a subtype or variant thereof.
As discussed in MPEP 2112.01, “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.
In the instant case, inactivation of SARS-CoV2 or a subtype or variant thereof is a property inherent to compositions comprising SPL7013 as evidenced by the instant specification (Fig. 2; Example 13 on pgs. 105-106).
As Grogan et al. teach all of the limitations of claim 34, the inactivation of SARS-CoV2 or a subtype or variant thereof is necessarily present.
As such, claim 54 is rejected as prima facie obvious.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Grogan et al. as applied to claims 34, 41, 54, and 77-82 above, and further in view of Fairley et al. (Us 2015/0238557; of record) and Lulla et al. (US 9,901,585; of record).
The teachings of Grogan et al. have been set forth above.
Claim 40 is drawn to the composition of claim 34, more specifically Applicant’s elected species of composition, comprising:
a rheology modifier comprising hydroxypropyl methyl-cellulose and microcrystalline cellulose/carboxy methyl cellulose;
a preservative comprising methyl paraben, propyl paraben, and benzalkonium chloride;
an excipient comprising glycerine, propylene glycol, and ethylenediamine tetraacetic acid; and
a pH modifier comprising sodium hydroxide.
Grogan et al. further teach in Table 1 the composition comprising
–
methyl paraben and propyl paraben;
glycerin, propylene glycol, edetate disodium dihydrate (a.k.a. ethylenediamine tetraacetic acid); and
sodium hydroxide (i.e., a pH modifier).
The composition of Grogan et al. differs from the instantly claimed composition in the following ways:
the composition of Grogan et al. does not comprise hydroxypropyl methyl-cellulose and microcrystalline cellulose/carboxy methyl cellulose; and
the composition of Grogan et al. does not comprise benzalkonium chloride.
Yet, as to 1: Grogan et al. further teach the composition additionally comprising viscosity modifying agents as is well known in the art (Col. 13 lines 1-15).
Fairley et al. also teach compositions comprising dendrimers (Abstract) including SPL7013 (Par. [0122]). Fairley et al. further teach the composition including gelling agents/viscosity modifying agents including hydroxypropyl methylcellulose and polymers of acrylic acid (e.g., Carbopol) (Par. [0131]).
Lulla et al. teach thickening agents for pharmaceutical compositions including microcrystalline cellulose and carboxymethyl cellulose (Col. 4 lines 3-20).
And, as discussed in MPEP 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In the instant case, Carbopol 971, hydroxypropyl methylcellulose, and microcrystalline cellulose/carboxy methyl cellulose are all taught in the prior art to be useful as thickening agents in pharmaceutical gels. As such, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Grogan et al. to include hydroxypropyl methylcellulose and microcrystalline cellulose/carboxy methyl cellulose. It would have been obvious to combine the known thickening agents in order to form a composition of SPL7013 having an appropriate viscosity, with a reasonable expectation of success.
And, as to 2: Fairley et al. further teach the dendrimer composition comprising preservatives including benzalkonium chloride, methyl paraben, and propyl paraben (Par. [0130]).
And, as discussed in MPEP 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In the instant case, benzalkonium chloride, methyl paraben, and propyl paraben are all taught in the prior art to be useful preservatives in dendrimer composition. As such, it would have been prima facie obvious to a person having ordinary skill in the art to have modified the composition of Grogan et al. to include benzalkonium chloride. It would have been obvious to combine the known preservatives to obtain a suitably preserved SPL7013 composition, with a reasonable expectation of success.
Based on all of the foregoing, claim 40 is rejected as prima facie obvious.
Response to Arguments
Applicant's arguments filed 13 January 2026 have been fully considered but they are not persuasive.
Applicant argues on pgs. 10-11 of the remarks that the concentration of polyacrylic acid polymer from 0.01% w/w to 1% w/w is critical for optimal nasal administration, and there is no teaching present in Grogan et al. that would lead one of ordinary skill in the art to modify Grogan et al. to arrive at the instantly claimed invention.
This argument is not persuasive. As discussed by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454)): “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, Grogan et al. teach that a variety of different viscosities are appropriate for the SPL7013 composition (Col. 12 line 66 – col. 13 line 1). Further, one of ordinary skill in the art would understand that modifying the concentration of the polyacrylic acid polymer in the composition would directly affect the viscosity of the composition, allowing the ordinarily skilled artisan to obtain a composition having the desired viscosity.
Absent physical evidence establishing the criticality of the range by comparing a sufficient number of tests both inside and outside the claimed range (See MPEP716.02(D)(II)), the optimization of the amount of polyacrylic acid polymer in the composition is considered to be routine, and well within the ability of one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Hoerner whose telephone number is (571)270-0259. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm eastern.
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, Bethany Barham can be reached at (571)272-6175. 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.
/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
Prosecution Insights