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 Application
Claims 1-20 are pending in this application.
No claim amendments have been submitted.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on November 5, 2024 is acknowledged. A signed copy is attached to this office action.
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.
Claims 1-20 are 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.
Regarding claims 1 and 11, component (a) recites “at least about” however, after a review of the specification, the Examiner was unable to locate support for said limitation. The specification discloses “from 0.05% to less than 0.5%” in paragraph 0011. The Examiner was unable to locate support for the recitation recited in the instant claim. An amendment to the specification would not constitute new matter since the recitation is in the originally filed claims. However, there does not appear to be priority for the recited range.
Additionally regarding claim 1, 11, and 16, component (a) recites “at least about 0.05%” or “at least 0.1%” however, there is no upper amount recited in the instant claim. Applicant’s attention is directed to MPEP 2163.05 III, which discloses “with respect to changing numerical range limitations, the analysis must take into account which ranges one skilled in the art would consider inherently supported by the discussion in the original disclosure. In the decision in In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), the ranges described in the original specification included a range of "25%- 60%" and specific examples of "36%" and "50%." A corresponding new claim limitation to "at least 35%" did not meet the description requirement because the phrase "at least" had no upper limit and caused the claim to read literally on embodiments outside the "25% to 60%" range, however a limitation to "between 35% and 60%" did meet the description requirement”. In this case, the instant specification discloses “from 0.05% to less than 0.5%” in paragraph 0011.
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.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (US 2011/0135702) in view of Cilly et al. (WO 94/10272).
Hoffman discloses a cleaning medium or formulation that contains a sporicidal compositions (abstract).
The compositions comprises 0.01-75 % w/w of an antimicrobial agent, which can be mixed with water to generate a solution with a pH of 3.5 to 9.5 (paragraph 0017).
Examples of antimicrobial agents include hypochlorite’s and hypochlorous acid (paragraph 0018).
The composition further includes about 8, 10, or 12% w/w of a surfactant (paragraph 0017). The surfactant can be anionic, cationic, nonionic, or amphoteric, and combinations thereof (paragraph 0018).
As noted above, the antimicrobial agent can be mixed with water to generate a solution with a pH of 3.5 to 9.5. Hoffman additionally discloses, when dissolved in an aqueous solvent, the active ingredients range from 0.1 to 95% w/w, including all ingredients, therefore, 5-99.9% of the solution would be water (paragraph 0017).
The recitation of wherein the sanitizing or disinfecting composition exhibits at least a 3 long reduction in at least one of M.Bovis or C diff populations within 10 minutes is regarded a necessary result of application of the composition.
Regarding claims 2-3, as noted above, the final pH of the composition is 3.5-9.5, which reads on about 10-12.5 and 11-12.5 recited in the instant claims.
Regarding claim 4, Hoffman discloses sodium lauryl sulfate can be added (paragraph 0018). It is noted that sodium lauryl sulfate is an anionic surfactant.
Regarding claim 5, Table 1 discloses lauryl amine oxide.
Regarding claims 6-7, as noted above, hypochlorite is disclosed.
Regarding claims 9-10, as noted above, the recitation of wherein the sanitizing or disinfecting composition exhibits at least a 3 long reduction in at least one of M.Bovis or C diff populations within 6 minutes is regarded a necessary result of application of the composition.
Regarding claim 11, as noted above, the compositions comprises 0.01-75 % w/w of an antimicrobial agent, which can be mixed with water to generate a solution with a pH of 3.5 to 9.5 (paragraph 0017).
Examples of antimicrobial agents include hypochlorite’s and hypochlorous acid (paragraph 0018).
The composition further includes about 8, 10, or 12% w/w of a surfactant (paragraph 0017). The surfactant can be anionic, cationic, nonionic, or amphoteric, and combinations thereof (paragraph 0018).
As noted above, the antimicrobial agent can be mixed with water to generate a solution with a pH of 3.5 to 9.5. Hoffman additionally discloses, when dissolved in an aqueous solvent, the active ingredients range from 0.1 to 95% w/w, including all ingredients, therefore, 5-99.9% of the solution would be water (paragraph 0017).
Ethylenediamine tetra acetic acid (EDTA) is a known chelator (claim 9).
The final pH of the composition is 3.5-9.5, which reads on about 10-12.5 recited in the instant claims.
the recitation of wherein the sanitizing or disinfecting composition exhibits at least a 3 long reduction in at least one of TB microbes or C diff populations within 7 minutes is regarded a necessary result of application of the composition.
Regarding claim 12, as noted above, Table 1 discloses lauryl amine oxide.
Regarding claim 13, as noted above, Hoffman discloses sodium lauryl sulfate can be added (paragraph 0018). It is noted that sodium lauryl sulfate is an anionic surfactant.
Regarding claim 16, as noted above, as noted above, the compositions comprises 0.01-75 % w/w of an antimicrobial agent, which can be mixed with water to generate a solution with a pH of 3.5 to 9.5 (paragraph 0017).
Examples of antimicrobial agents include hypochlorite’s and hypochlorous acid (paragraph 0018).
The composition further includes about 8, 10, or 12% w/w of a surfactant (paragraph 0017). The surfactant can be anionic, cationic, nonionic, or amphoteric, and combinations thereof (paragraph 0018).
As noted above, the antimicrobial agent can be mixed with water to generate a solution with a pH of 3.5 to 9.5. Hoffman additionally discloses, when dissolved in an aqueous solvent, the active ingredients range from 0.1 to 95% w/w, including all ingredients, therefore, 5-99.9% of the solution would be water (paragraph 0017).
Ethylenediamine tetra acetic acid (EDTA) is a known chelator (claim 9).
The final pH of the composition is 3.5-9.5, which reads on about 10-12.5 recited in the instant claims.
The recitation of:
wherein the composition has a loss of no more than 25% of hypochlorite after 12 months at 70 ˚F; and
wherein the sanitizing or disinfecting composition exhibits at least a 3 long reduction in C diff populations within 6 minutes;
are regarded a necessary result of application of the composition.
Regarding claim 17, as noted above, Table 1 discloses lauryl amine oxide.
Regarding claim 18, as noted above, the recitation of wherein the sanitizing or disinfecting composition exhibits at least a 3 long reduction in at least one of TB microbes within 7 minutes is regarded a necessary result of application of the composition.
Regarding claim 19, as noted above, Hoffman discloses sodium lauryl sulfate can be added (paragraph 0018). It is noted that sodium lauryl sulfate is an anionic surfactant.
Hoffman does not disclose the use of a silicate or the viscosity of the formulation.
Cilly discloses bleach containing hard surface cleaners (abstract).
The compositions of Cilly comprise from about 1% to about 2% of a hypochlorite bleach and from about 0% to about 5% by weight of a bleach stable, long chain surfactant selected from the group consisting of long chain amine oxides, long chair paraffin sulfonates, and long chain alkyl sulfates (page 5).
The compositions additionally comprise about 85% to about 95% of a fluid carrier, preferably water (page 9-10).
Sodium silicate can optionally be added at levels of 0.04% to 0.5% (Example 5).
Example IV discloses a formulation with a viscosity of 100 cps. The formulations comprise thickeners, therefore, a formulation without thickeners, such as those thought by Hoffman would be presumed to have a viscosity of less an 100 cps.
Regarding claim 8, Cilly discloses hypochlorite can be sodium hypochlorite (Example 1).
Regarding claims 14 and 20, as noted above, sodium silicate can optionally be added at levels of 0.04% to 0.5% (Example 5).
Regarding claim 15, all examples disclose the use of a perfume.
It would have been obvious to one of ordinary skill in the art to have added a silicate to the composition of Hoffman as discussed by Cilly since it is generally considered to be prime facie obvious to combine compounds each of which is taught by the prior art to be useful for the same purpose in order to form a composition that is to be used for an identical purpose. The motivation for combining them flows from their having been used individually in the prior art, and from them being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the combination of conventional components of bleach hypochlorite cleaning formulations. It therefore follows that the instant claims define prime facie obvious subject matter. Cf. In re Kerhoven, 626 F.2d 848, 205 USPQ 1069 (CCPA 1980).
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,986,841. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims require the presence of a cationic surfactant. However, its presence is not excluded from the instant claims due to comprising terminology. Additionally, based on the definition of the R value, as determined by the Examiner above, the calculation of R includes cationic surfactants possibly being present. Therefore, it would have been obvious to one of ordinary skill in the art to have included cationic surfactants in the formulation of the instant claims.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,737,465. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite an R value for the total surfactant concentration, whereas the instant claims only require a single surfactant.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,082,586. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite an R value for the total surfactant concentration, whereas the instant claims only require a single surfactant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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