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 .
Claim Status
Claims 3-9 and 11-19 are pending and under current examination.
Applicants' amendments and remarks filed 12/31/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 02/05/2026 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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 3-9 and 11-19 rejected under 35 U.S.C. 103 as being obvious over Hu et al. (United States Patent 8940723) in view of Mcgeechan et al. (WO2017/222965)..
Hu et al. teaches topical compositions for the skin or mouth which comprise 4-methyl-8-phenoxy-1-(2-phenylethyl)-2,3-dihydro-1H-pyrrolo[3,2-c]quinoline or pharmaceutically acceptable salt or solvate and chlorhexidine, see column 18, lines 56-60, claims 1-5 and entire document. The chlorhexidine can be present from 0.01-5% by weight, see column 18, lines 5-8. The 4-methyl-8-phenoxy-1-(2-phenylethyl)-2,3-dihydro-1H-pyrrolo[3,2-c]quinoline or pharmaceutically acceptable salt or solvate can be present from 0.1-10% by weight. The formulation can contain water as the vehicle, see column 18, lines 45-56. Thus, the concentration of the 4-methyl-8-phenoxy-1-(2-phenylethyl)-2,3-dihydro-1H-pyrrolo[3,2-c]quinoline can be 0.5-95% w/v and the concentration of chlorhexidine can be from 0.01-5% w/v. The ranges for the 4-methyl-8-phenoxy-1-(2-phenylethyl)-2,3-dihydro-1H-pyrrolo[3,2-c]quinoline and chlorhexidine or their pharmaceutical acceptable salts or solvates renders obvious the instantly claimed ranges. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). The carrier includes water, see column 18, line 65 and column 27, lines 1-17. The composition is useful in treating infections and exhibits antimicrobial activity, thus is capable of being a disinfectant, see columns 11-12. The active ingredients can be combined to a single formulation, see column 17, lines 28-30 and claim 22. Hu et al. further teach that the composition can comprise a spray form (consumer product), see column 18, line 59 and claim 22 and entire document. Hu et al. teach that the formulation treats microbial infection on an oral surface, see column 12, line 61.
Hu et al. does not teach from 0.001-2% w/v of a dialkyldimethylammonium ammonium chloride wherein the alkyl has 9 or more carbon atoms or from 0.001-1% w/v (instant claims 3 and 8-9) or that the composition has virucidal and sporicidal activity.
Mcgeechan et al. teach synergistic antimicrobial combinations containing quaternary ammonium biocide, see abstract and claim 1. The quaternary ammonium biocide is combined with a second biocide including chlorhexidine or its salts thereof, see claims 1 and 3. The quaternary ammonium compound comprises dimethyl dialkyl ammonium compounds having 8-12 carbons in each of the alkyl groups including dimethyl didecyl ammonium chloride (didecyldimethylammonium chloride), see paragraphs [0025] [0026]. The combination of biocides results in synergism against a variety of microorganisms, see paragraph [0030] and entire document. The composition provides synergism against viruses and fungi and bacteria and spores, see claims 1, 9 and 10. The dimethyl didecyl ammonium chloride can be present from 2-12% by weight but can be diluted wherein the first and second biocide constitute from 0.01% by weight to about 5% by weight wherein the ratio of the first and second biocide can be from 1:5 to 5:1, see paragraphs [0051]-[0053]. Thus, Mcgeechan suggests that in one embodiment both first and second biocide can be present at 0.01% by weight. Since the solvent can be water (paragraph [0078], then a 0.1% w/w of DDAV is 0.1g DDAC per 100g solution. Thus, a 0.1g of DDAC in 100mL is equivalent to 0.1% w/v. The composition can be useful in personal care or hygiene products, see paragraph [0014].
It would have been prima facie obvious to combine the chlorhexidine containing formulation of Hu et al. with didecyldimethylammonium chloride DDAC.
One of ordinary skill in the art would have been motivated to do so because Mcgeechan teaches that a first quaternary ammonium biocide inclusive of DDAC with a second biocide inclusive of chlorhexidine can impart synergism against microorganisms including viruses and bacteria, see claims 1 and 9 and paragraphs [0026]-[0028].
There would have been a reasonable expectation of success because both Hu et al. and Mcgeechan teach products which are useful in killing or inhibiting the growth of microorganisms for personal care products.
Although Hu et al. in view of Mcgeechan does not expressly teach the antibacterial activity as measured by BS EN 11500, sporicidal activity as measured as BSD EN 17126 and the virucidal activity as measured by BS EN 14476, the composition of Hu in view of Mcgeechan is synergistic against a variety of microorganisms including bacteria, viruses and spores. Since the composition of Hu in view of Mcgeechan teaches the composition of claim 3 for the treatment of viruses, bacteria and spores, the composition would necessarily be capable of having activity against Picornavirus, Poxvirus and/or Coronavirus. A chemical composition and its properties are inseparable. Furthermore, from MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). The product of the modified Hu would necessarily have antiviral activity against the claimed microbes because the modified Coates teaches their sporicidal and antiviral properties.
Regarding the ratio of the 4-methyl-8-phenoxy-1-(2-phenylethyl)-2,3-dihydro-1H-pyrrolo[3,2-c]quinoline or pharmaceutically acceptable salt or solvate thereof and chlorhexidine or the salt and/or solvate thereof being from 0.05:1 to about 0.5:1, Hu teaches that the chlorhexidine can be present from 0.01-5% by weight, see column 18, lines 5-8. The 4-methyl-8-phenoxy-1-(2-phenylethyl)-2,3-dihydro-1H-pyrrolo[3,2-c]quinoline or pharmaceutically acceptable salt or solvate can be present from 0.1-10% by weight. These amounts overlap and render obvious the ratios claimed (e.g. 0.5:1). 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
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 3-9 and 11-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 5-22 of U.S. Patent No. 8940723 in view of Mcgeechan et al. (WO2017/222965).
Claims 3-9 and 11-19 are directed to an invention not patentably distinct from claims 1-22 of commonly assigned U.S. Patent No. 8940723. Specifically, both the instant claims and that of Patent ‘723 are directed to compositions which contain a combination of 4-methyl-8-phenoxy-1-(2-phenylethyl)-2,3-dihydro-1H-pyrrolo[3,2-c]quinoline or a pharmaceutically acceptable derivative thereof and chlorhexidine. The instant claims and that of Patent ‘723 are directed to products which treat microbial infections.
The claims of Patent ‘723 do not claim an amount for chlorhexidine or the 4-methyl-8-phenoxy-1-(2-phenylethyl)-2,3-dihydro-1H-pyrrolo[3,2-c]quinoline or weight ratio. However, a suitable concentration of the 4-methyl-8-phenoxy-1-(2-phenylethyl)-2,3-dihydro-1H-pyrrolo[3,2-c]quinoline is from 0.5-95% by weight with a suitable concentration of chlorhexidine from 0.01-5% by weight, see column 17 at lines 62-67 to column 18 at lines 5-8. The formulation can contain water as the vehicle, see column 18, lines 45-56 thus the concentration of the 4-methyl-8-phenoxy-1-(2-phenylethyl)-2,3-dihydro-1H-pyrrolo[3,2-c]quinoline can be 0.5-95% w/v and the concentration of chlorhexidine can be from 0.01-5% w/v. These amounts of chlorhexidine and quinoline overlap the instantly claimed amounts and ratios rendering obvious their inclusion in overlapping ranges.
The difference between the instant claims and that of Patent ‘723 is that the instant claims also contain from 0.001-2% w/v of a dialkyldimethyl ammonium chloride wherein the alkyl has 9 or more carbon atoms or from 0.001-1% w/v(instant claims 3 and 8-9) or that the composition has virucidal and sporicidal activity.
Mcgeechan et al. teach synergistic antimicrobial combinations containing quaternary ammonium biocide, see abstract and claim 1. The quaternary ammonium biocide is combined with a second biocide including chlorhexidine or its salts thereof, see claims 1 and 3. The quaternary ammonium compound comprises dimethyl dialkyl ammonium compounds having 8-12 carbons in each of the alkyl groups including dimethyl didecyl ammonium chloride (didecyldimethylammonium chloride DDAC), see paragraphs [0025] [0026]. The combination of biocides results in synergism against a variety of microorganisms, see paragraph [0030] and entire document. The composition provides synergism against viruses and fungi and bacteria and spores, see claims 1, 9 and 10. The dimethyl didecyl ammonium chloride can be present from 2-12% by weight but can be diluted wherein the first and second biocide constitute from 0.01% by weight to about 5% by weight wherein the ratio of the first and second biocide can be from 1:5 to 5:1, see paragraphs [0051]-[0053]. Thus, Mcgeechan suggests that in one embodiment both first and second biocide can be present at 0.01% by weight. Since the solvent can be water (paragraph [0078], then a 0.1% w/w of DDAV is 0.1g DDAC per 100g solution. Thus, a 0.1g of DDAC in 100mL is equivalent to 0.1% w/v. The composition can be useful in personal care or hygiene products, see paragraph [0014].
It would have obvious to combine the chlorhexidine containing formulation of Patent ‘723 with didecyldimethylammonium chloride DDAC.
One of ordinary skill in the art would have been motivated to do so because Mcgeechan teaches that a first quaternary ammonium biocide inclusive of DDAC with a second biocide inclusive of chlorhexidine can impart synergism against microorganisms including viruses and bacteria, see claims 1 and 9 and paragraphs [0026]-[0028].
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 8940723 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Remarks
Applicants argue that Mcgeechan does not provide synergy data for DDAC. The only synergism data relates to dodecyl dimethyl ammonium carbonate/bicarbonate. Therefore, if a person of ordinary skill in the art were to add a compound from Mcgeechan to the solution of Coates they would add carbonate/bicarbonate since these are the only compounds in Mcgeechan shown to do synergism. Applicants further argue that DDAC could not be added to the mouthwash of Coates oral solution due to it being harmful when swallowed.
Applicants remarks are considered persuasive with regards to Coates and Mcgeechan given the art recognized toxicity of DDAC there would be not motivation to combine for an oral formulation of Coates. Accordingly, the rejection with Coates is withdrawn.
With regards to Hu and Mcgeechan, Applicants argue that Mcgeechan does not provide synergy data for DDAC. The only synergism data relates to dodecyl dimethyl ammonium carbonate/bicarbonate. Therefore, if a person of ordinary skill in the art were to add a compound from Mcgeechan to the solution of Coates they would add carbonate/bicarbonate since these are the only compounds in Mcgeechan shown to do synergism. Applicants argue that the examples of the present Application provide disinfectants with virucidal and antibacterial activity with emollient properties.
Examiner notes that although Hu et al. in view of Mcgeechan does not expressly teach the antibacterial activity as measured by BS EN 11500, sporicidal activity as measured as BSD EN 17126 and the virucidal activity as measured by BS EN 14476, the composition of Hu in view of Mcgeechan is synergistic against a variety of microorganisms including bacteria, viruses and spores. Since the composition of Hu in view of Mcgeechan teaches the composition of claim 3 for the treatment of viruses, bacteria and spores, the composition would necessarily be capable of having activity against Picornavirus, Poxvirus and/or Coronavirus. A chemical composition and its properties are inseparable. Furthermore, the composition of Mcgeechan which includes dialkyldimethyl ammonium chloride provides synergism against viruses and fungi and bacteria and spores, see claims 1, 9 and 10.Examiner respectfully submits that while the carbonate/bicarbonate is exemplified as the first biocide, Mcgeechan clearly teaches that the first biocide can be a quaternary ammonium halide in another embodiment of which is inclusive of the dimethyl dialkyl amomum chloride. (paragraphs [0021]-[0026]). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). From the teachings of Mcgeechan the first biocide acts synergistically with the second (claim 1). The quaternary ammonium cation is not limited to the carbonate/bicarbonates exemplified. Furthermore, even if one of ordinary skill in the art were to include a carbonate/bicarbonate quat with the DDAC, the instant claims are not limited to DDAC in view of the disinfectant comprising claim language.
Applicants argue that Hu discloses synergism between HT61 and chlorhexidine however the HT61 of the instant claims acts as an emollient with antimicrobial activity stemming primarily from DDAC and chlorhexidine. Applicants argue that the examples of the present Application provide disinfectants with virucidal antibacterial activity with emollient properties.
Examiner brings to applicant's attention that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Here, the synergism is taught by Hu between HT62 and chlorhexidine and it is not necessary that the prior art reference teach the same reasons for combining the HT61 with chlorhexidine.
Applicants argue that the weight ratio claimed of HT61 to chlorhexidine would not have been tenable because Hu’s examples indicate that optimal synergistic activity is achieved when it is greater or equal to that of chlorhexidine. A person of ordinary skill in the art would not have been motivated to provide a weight ratio of HT61 to chlorhexidine as claimed.
Examiner respectfully submits that while the chlorhexidine being greater to HT61 may be preferred, Hu suggests that in alternative embodiments that the HT61 is greater than the chlorhexidine because the HT61 is added in amounts from 0.1-10% by weigh and the chlorhexidine is inclusive of from 0.01-5%. The chlorhexidine can be added at 5% and the HT61 at 0.1% since the ranges are inclusive of all amounts within. This ratio is about 0.02 however, the ranges taught by Hu are inclusive of 0.5% HT61 and 5% chlorhexidine which is a ratio of 0.05. Examiner notes that the ranges taught by Hu overlap the weight ranges and ratio of the instant claims.
Conclusion
Currently, no claims are allowed and all claims are rejected.
Applicant’s arguments/remarks are considered unpersuasive . 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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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