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
The preliminary amendment filed 07/29/2024, amended claims 1-3, 5-10, cancelled claim 4, and added claims 11-16.
Claims 1-3 and 5-16 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of DDAC (dodecyl dimethyl ammonium chloride) as the quaternary ammonium salt-type surfactant; dodecyl alcohol as the aliphatic alcohol with 8 or more and 16 or less carbons; and lauryldimethylamine oxide as the specific surfactant other than component A, in the reply filed on 07/09/2026, is acknowledged.
Claims 1-3 and 5-16 are examined on the merits herein.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The abstract of the disclosure is objected to because it is two paragraphs long. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-2, 11, and 14-16 are objected to because of the following informalities:
-In claim 1, in the definition of “(B),” the phrase “8 or more and 16 or less” should be replaced with - -greater than or equal to 8 and less than or equal to 16- -
-In claim 1, in the definition of R1a and the definition of R5a, the phrase “8 or more and 18 or less” should be replaced with - -greater than or equal to 8 and less than or equal to 18- -
-In claim 1, in the definition of R2a, the phrase “1 or more and 3 or less” should be replaced with - -greater than or equal to 1 and less than or equal to 3- -
-In claim 1, in the definition of R3a and R4a, and the definition of R6a and R7a, the phrases “1 or more and 3 or less” should be replaced with - -greater than or equal to 1 and less than or equal to 3- -
-In claim 11, in the definition of R1a and the definition of R2a, the phrase “8 or more and 14 or less” should be replaced with - -greater than or equal to 8 and less than or equal to 14- -
-In claim 11, in the definition of R3a and R4a and the definition of R6a and R7a, the phrase “1 or more and 3 or less” should be replaced with - -greater than or equal to 1 and less than or equal to 3- -
-In claim 11, in the definition of R5a, the phrase “10 or more and 14 or less” should be replaced with - -greater than or equal to 10 and less than or equal to 14- -
-In claim 16, line 3, the phrase “8 or more and 14 or less” should be replaced with - -greater than or equal to 8 and less than or equal to 14- -
-In claim 16, line 4, the phrase “1 or more and 5 or less” should be replaced with - -greater than or equal to 1 and less than or equal to 5- -
-In claim 16, line 6, the phrase “3 mol or more and 15 mol or less” should be replaced with - -greater than or equal to 3 mol and less than or equal to 15 mol- -
-In claim 16, line 10, the phrase “10 or more and 14 or less” should be replaced with - -greater than or equal to 10 and less than or equal to 14- -
-In claim 16, line 12, the phrase “1 or more and 5 or less” should be replaced with - -greater than or equal to 1 and less than or equal to 5- -
-In claim 16, line 15, the phrase “10 or more and 14 or less” should be replaced with - -greater than or equal to 10 and less than or equal to 14- -
-In claim 16, line 16-17, the phrase “10 or more and 14 or less” should be replaced with - -greater than or equal to 10 and less than or equal to 14- -
-In claims 1-2, and 14-15, the parenthetic recitations reciting “(hereinafter referred to as component. . .),” should be deleted, as these recitations are superfluous.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 11 and 16 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.
-In claim 11, R1a, R2a, and R5a are defined as “an alkyl group.” However, in claim 2, from which the definitions of R1a, R2a, and R5a depend, these groups are defined as “an aliphatic hydrocarbon group.” As such, it is not clear if “an alkyl group” in claim 11 is a synonym for “an aliphatic hydrocarbon,” or if the phrase “an alkyl group” imparts some type of limitation to “an aliphatic hydrocarbon.”
In view of compact prosecution, for the purpose of applying prior art, “an alkyl group” and “an aliphatic hydrocarbon” are interpreted as synonyms.
-In claim 16, formula (c3), it is not clear what the arrow starting at N and pointing to O means. It is not clear if the arrow is a mistake and should be a straight line representing a covalent bond, or if the arrow is depicting a bond other than a covalent bond, or if the arrow is imparting some sort of property to N or O.
Further of note regarding claim 16, since q and p are 0, “D” and “E” can be deleted from the structure of (c3) for a clearer and more accurate structural depiction of (c3), and the definitions of “D” and “E” can be deleted from the claim.
In view of compact prosecution, for the purpose of applying prior art, the arrow is interpreted as a covalent bond.
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 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.
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 1-3, 5-8, 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0291151 to Tucker (published 2009, PTO-892), as evidenced by Ataman Chemicals (Tripropylene Glycol Methyl Ether, PTO-892).
Tucker teaches an aqueous decontamination formulation comprising 0.1-1.5wt% dodecyltrimethylammonium chloride (quaternary ammonium salt-type surfactant), 0-0.3wt.% 1-dodecanol, 0-0.6 wt.% tripropylene glycol methyl ether, and water (pg. 5, claims 1, 4; Examples 1-4, pgs. 3-4).
Tucker teaches these compositions as useful for the inactivation of viruses, such as avian influenza, an enveloped virus ([0056]).
Tucker teaches its formulations as maintaining sufficient contact time between the formulation and the agents on both vertical and horizontal surfaces ([0019], [0022], [0023]).
Regarding claim 1, Tucker differs from that of instant claim 1 in that it does not explicitly teach bringing the liquid into contact with a surface of interest to treat an enveloped virus.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the decontamination formulation of Tucker for inactivating avian influenza, an enveloped virus, by bringing the composition in contact with a contaminated surface, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Tucker teaches its formulations for inactivating avian influenza, and
-Tucker teaches bringing its formulations into contact with affected surfaces.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at an effective method of inactivating avian influenza on surfaces.
Regarding claim 2, dodecyltrimethylammonium chloride meets the limitations of instant formula (a1) when R1a is an aliphatic hydrocarbon group with 12 carbons, R2a-R4a are alkyl groups with 1 carbon, and X is Cl-.
Regarding claim 3, Tucker teaches that dodecyltrimethylammonium chloride can be substituted with dideceyldimethylammonium chloride ([0057]-[0058]). As such, an ordinary skilled artisan would have been motivated to substitute dodecyltrimethylammonium chloride with didecyldimethylammonium chloride, to predictably arrive at a formulation that inactivates avian flu; substituting equivalents known for the same purpose is prima facie obvious, see MPEP 2144.06.
Regarding claim 5, Tucker teaches dodecanol (i.e., dodecyl alcohol).
Regarding claims 6-7 and 12-13, Tucker teaches its formulations as comprising 0.1-1.8wt% dodecyltrimethylammonium chloride and 0-0.3wt% dodecanol, or 1-11g dodecyltrimethylammonium chloride and 0-2g dodecanol. While Tucker does not exemplify a formulation having a ratio of (B)/(A) of greater than or equal to ¼ to less than or equal to 10/1, or a content of (A) as greater than or equal to 5ppm or less than or equal to 3000ppm or a content of (B) as 1ppm or more, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select such a ratio and ppms, to arrive at instant claims 6-7 and 12-13. One of ordinary skill in the art would have been motivated to make such selections with a reasonable expectation of success, because:
-Tucker teaches that the individual components in its formulations can comprise a range of grams and percent weight,
-Tucker teaches its formulations for use against a variety of agents, such as chemical and biological warfare agents ([0042]) and toxic chemicals and biological compounds ([0056]), and
- "[W]here 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," MPEP 2144.05(II)
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Thus, an ordinary skilled artisan would have been motivated to make such selections, to predictably arrive at a formulation optimized to inactivate avian influenza.
Regarding claim 8, Tucker teaches avian influenza.
Regarding claim 11, dideceyldimethylammonium chloride meets the limitations of instant formula (a1) when R1a and R2a are an aliphatic hydrocarbon group with 10 carbons, R2a-R4a are an alkyl group with 1 carbon, and X is Cl-.
Regarding claim 14, Tucker teaches tripropylene glycol methyl ether. As evidenced by Ataman Chemicals, tripropylene glycol methyl ether is a surfactant (pgs. 6, 8).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tucker (published 2009, PTO-892) as applied to claims 1-3, 5-8, 11-14 above, and further in view of Missouri Department of Agriculture (Cleaning and Disinfection Standard Operating Guide No. 004, published 2008, PTO-892).
Tucker is applied as discussed above and incorporated herein.
Regarding claims 9-10, Tucker does not teach contacting the surface of a livestock animal or livestock breeding equipment with its formulation.
Missouri Department of Agriculture teaches guidance about establishment, operation, and maintenance of cleaning and disinfection areas during a foreign animal disease outbreak (pg. 2), wherein avian influenza is taught as such a disease (pg. 5, Table 1; pg. A-1, Table 1).
Missouri Department of Agriculture teaches the most common form of cleaning and disinfection comprises dry clean (remove gross contamination, solids), wet wash, rinse, dry, and disinfect with a disinfectant. Disinfectant contact time should be observed carefully and address the time a surface remains wet with the disinfectant (pgs. 12-13, 2.2.3).
Missouri Department of Agriculture specifically teaches procedures for the cleaning and disinfection of livestock equipment (pg. 17, “Vehicle and Heavy Equipment Cleaning and Disinfection”; pgs. 20-21, “Portable Equipment Cleaning and Disinfection”).
Missouri Department of Agriculture teaches soaps and detergents as commonly used to clean the surfaces of contaminated equipment or clothing because these agents destroy the envelop of enveloped viruses (pg. A-3-A-4).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the formulations of Tucker for application to livestock breeding equipment, to arrive at instant claims 9-10. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Tucker teaches its formulations for application to surfaces to inactivate avian influenza, and
-Missouri Department of Agriculture disinfecting all livestock equipment with a disinfectant during a livestock avian flu outbreak to prevent the additional spread of the outbreak by destroying the envelop of the enveloped virus (pg. 2, 1.0).
Thus, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a method that prevents the additional spread of the avian flu by inactivating the virus.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tucker (published 2009, PTO-892) as applied to claims 1-3, 5-8, 11-14 above, and further in view of US 2016/0174550 to Daigle (published 2016, PTO-892).
Tucker is applied as discussed above and incorporated herein.
Regarding claims 15-16, Tucker does not teach C2, C3, or C4.
Daigle teaches aqueous disinfectant formulations for the treatment of avian influenza (abstract, [0006]-[0008]).
Daigle teaches that the ability of a disinfectant solution to make complete and even contact with the surface to be treated is of great importance and teaches that this can be generally achieved by the addition of a surfactant to the formulation ([0010]).
Daigle teaches lauramine oxide (lauryldimethylamine oxide, instant (C3), #20 of Daigle in Tables 2 and 3) and lauryl glucoside (instant (C2), #51 of Daigle in Tables 2 and 3), as such surfactants (pg. 7, [0082], Table 2; pgs. 8-9, [0085], Table 3; pg. 11, claims 16-17).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective fling date of the instantly claimed invention, to added lauramine oxide or lauryl glucoside to the formulation of Tucker, to arrive at instant claims 15-16. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-both Tucker and Daigle are directed toward disinfectant formulations for the inactivation of avian influenza,
-Daigle teaches surfactants, such as lauramine oxide and lauryl glucoside, as imparting the ability to make complete and even contact with the surface to be treated, to disinfectant formulations.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a formulation that is optimized or enhanced to make complete and even contact with the infected surface to be treated, and hence increasing the potential to inactivate the avian influenza virus.
Regarding claim 16, lauryl glucoside is (C2) with an alkyl group of 12 carbons and a degree of condensation of 1, and lauramine oxide is (C3), wherein R2c and R3c are methyl groups, and R1c is an alkyl group with 12 carbons.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 1-3 and 5-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 (preliminary amendment claim set of 07/23/2024) of copending Application No. 18/832,230 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, ‘230 claims a viral or bacterial inactivation agent composition comprising a quaternary ammonium salt type surfactant, an aliphatic alcohol with greater than or equal to 8 and less than or equal to 24 carbons, and water, and specifically claims inactivating an enveloped virus or a gram-negative bacterium (claims 1, 6, 9). ‘230 claims a method of inactivating a virus or bacterium by bringing the composition into contact with a surface of interest (claim 8).
Regarding claims 2, 3 and 11, ‘230 claims instant (a1) and (a2), which encompasses a didecyldimethylammonium salt (claim 2, 12).
Regarding claim 5, ‘230 claims (b1), which encompasses a dodecyl and tetradecyl alcohol (claims 4, 13-14).
Regarding claims 6 and 12, ‘230 claims ratios of B to A within the instantly claimed ratios (claims 5, 15).
Regarding claim 7, ‘230 claims ppms within the instantly claimed ranges (claim 6).
Regarding claim 8, while ‘230 does not claim a content of component (B) as 1 ppm or more, "[W]here 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,” MPEP 2144.05(II). The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 9-10, ‘230 claims application to a hard surface and to a livestock animal or livestock breeding equipment (claims 10-11).
Regarding claims 14-15, ‘230 claims an additional surfactant (C), selected from a nonionic surfactant, a semipolar surfactant, and an amphoteric surfactant.
Regarding claim 8, ‘230 teaches “virus” as an influenza virus ([0066]-[0067]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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/LAUREN WELLS/Examiner, Art Unit 1622
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