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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Effective filing date is 02/18/2021.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 08/17/2023. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Current Status of 18/546,919
This Office Action is in response to the amended claims of 08/17/2023.
Claims 1 is original; and claims 2-21 are currently amended.
Claims 1-21 are examined in this office action.
Claim Objections
Claim 2 is objected to for in appropriate use of comma as shown below:
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Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-11 and 15-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martin (WO-03011027-A1) with evidentiary reference of Wigginton et. al. (Environ. Sci. Technol. 2016, 50, 10, 5077–5085)
Martin discloses a disinfectant composition comprising of, a 0.005% to 45% m/v solution of glutaraldehyde (within the range of claims 4-6 and 9-11, thus anticipating claims 4-6 and 9-11); an alcohol ethoxylate non-ionic surfactant; sodium acetate trihydrate; and pH modifier (Martin, page 2) anticipating claim 1.
Martin discloses composition can be used in water-treatment plant (examiner interpret this as closed volume) (table on page 9) thus anticipating claim 2. Martin further discloses composition is sprayed (spraying indicates aerosolized from of the solution) on surface (page 5 paragraph [2], and (table on page 9) (thus anticipating claim 3 and 7-8.
The evidentiary reference of Wigginton et.al. discloses non-enveloped (claims 18-21) and enveloped viruses (claims 15-17) are present in waste water (abstract), thus composition disclosed in Martin is reducing virus load of both enveloped and non-enveloped viruses in water-treatment plant (page 9), thus anticipating claims 15-21.
Claims 1, 16-17, and 19-21 are directed to the ability of the composition to “inactivate virus by at least 4-log1010 reduction” in different times, examiner interpret this as inherent properties of the composition. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01(I). Thus Claims 1, 16-17, and 19-21 are anticipated.
Claims 1, 16-17, and 19-21 are directed to the ability of the composition to “inactivate virus by at least 4-log1010 reduction “examiner interpret this as inherent properties of the composition. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01(I). Thus Claims 1, 16-17, and 19-21 are anticipated.
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.
Claim(s) 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over
Martin (WO-03011027-A1) with evidentiary reference of Wigginton et. al. (Environ. Sci. Technol. 2016, 50, 10, 5077–5085)
In view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Martin ((WO-03011027-A1) with evidentiary reference of Wigginton et. al. (Environ. Sci. Technol. 2016, 50, 10, 5077–5085) teaches claims 1-11 and 15-21 (see 102 rejection above).
Anisel et.al. teaches dosages (examiner interpret this as concentration) of pharmaceuticals are routinely optimized (Anisel et.al. page 50).
2. Ascertaining the differences between the prior art and the claims at issue.
Martin does not teach concentration glutaraldehyde in the aerosol droplet of the composition of claim 1 when sprayed. Martin further does not teach the dilution of composition of claim 1 with water.
Anisel et.al does not teaches concentration of glutaraldehyde in aerosol droplets or dilution of the concentration of the composition with water.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing different concentration of disinfectant.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 12-14 are drawn to dilution of composition of claim 1 with water. A person skilled in the art would be motivated to dilute the composition with water since the composition of claim 8 is in water. Therefore, it would be expected dilution with water would achieve the desired concentration of claims 12-14. Thus, teaching claims 12-14.
Claims 4-6 and 9-14 are directed to concentration of glutaraldehyde in droplet and in solution. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, Anisel et.al. teaches dosages (examiner interpret this as concentration) of pharmaceuticals are routinely optimized (Anisel et.al. page 50). Generally, concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The 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.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
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 1-21 rejected on the ground of obvious type nonstatutory double patenting as being obvious over claims 1-9, 11-16 and 20 of U.S. Patent No. 8,729,135
In view of
Wigginton et. al. (Environ. Sci. Technol. 2016, 50, 10, 5077–5085)
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
Instant claims of 08/17/2023 was used to make this rejections.
1. Determining the scope and contents of the prior art.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-9 and 11-16 discloses an aqueous composition comprising glutaraldehyde, an alcohol ethoxylate non-ionic surfactant, a pH modifier and a buffer comprising at least sodium acetate trihydrate same as instant claim 1. The specification of the reference claims disclose method of disinfecting various surfaces including waste water treatment (which examiner is interpreting at enclosed volume or partially enclosed volume, using BRI) (column 5, line 20-45) same as instant claims 2. The specification of the reference discloses spraying composition (spraying indicates aerosolized from of the solution) on surface (column 3, lines 30-35, and column 5, line 20-45) teaching claim 3 and 7-8.
The evidentiary reference of Wigginton et.al. discloses non-enveloped (claims 18-21) and enveloped viruses (claims 15-17) are present in waste water (abstract), thus composition disclosed in Martin is reducing virus load of both enveloped and non-enveloped viruses in water-treatment plant (page 9), thus anticipating claims 15-21.
Anisel et.al. teaches dosages (examiner interpret this as concentration) of pharmaceuticals are routinely optimized (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Reference claims does not teach concentration glutaraldehyde in the aerosol droplet of the composition of claim 1 when sprayed.
Wigginton et.al. does not teach disinfecting virus with composition of claim 1.
Anisel et.al does not teaches concentration of glutaraldehyde in aerosol droplets or dilution of the concentration of the composition with water.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing different concentration of disinfectant.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Regarding instant claims 1-8, a person skilled in the art would be motivated to develop a method of in-activating virus load with the composition of reference claims 1-9 and 11-16 since the specification of the reference claims teaches a method of disinfecting surface and waste water treatment plants (column 3, lines 30-35, and column 5, line 20-45) thus teaching instant claims 1-8.
Regarding instant claims 15-21 a person skilled in the art would be motivated develop a method of inactivating both enveloped and non-enveloped viruses with composition of claim 1. Since the reference specification teaches disinfection of waste water column 3, lines 30-35, and column 5, line 20-45) with the composition and according to Wigginton et.al waste water contains both non-enveloped and enveloped viruses(Wigginton abstract), thus teaching instant claims 15-21.
Claims 12-14 are drawn to dilution of composition of claim1 with water. A person skilled in the art would be motivated to dilute the composition with water since the composition of claim 8 is in water. Therefore, it would be expected dilution with water would achieve the desired concentration of claims 12-14. Thus, teaching claims 12-14.
Claims 1, 16-17, and 19-21 are directed to the ability of the composition to “inactivate virus by at least 4-log1010 reduction” in different times, examiner interpret this as inherent properties of the composition. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01(I). Thus teaching Claims 1, 16-17, and 19-21.
Claims 4-6 and 9-14 are directed to concentration of glutaraldehyde in droplet and in solution. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, Anisel et.al. teaches dosages (examiner interpret this as concentration) of pharmaceuticals are routinely optimized (Anisel et.al. page 50). Generally, concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The 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.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Claims 1-2, 7 and 15-21 rejected on the ground of obvious type nonstatutory double patenting as being obvious over claims 1-15 of U.S. Patent No. 8,252,844 In view of
Wigginton et. al. (Environ. Sci. Technol. 2016, 50, 10, 5077–5085)
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
Instant claims of 08/17/2023 was used to make this rejections.
1. Determining the scope and contents of the prior art.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-15 discloses an aqueous composition comprising glutaraldehyde, an alcohol ethoxylate non-ionic surfactant, a pH modifier and a buffer comprising at least sodium acetate trihydrate same as instant claim 1. The specifications of the reference claims disclose method of disinfecting (column 5, lines 10-15).
The evidentiary reference of Wigginton et.al. discloses non-enveloped (claims 18-21) and enveloped viruses (claims 15-17) are present in waste water (abstract), thus composition disclosed in Martin is reducing virus load of both enveloped and non-enveloped viruses in water-treatment plant (page 9), thus teaching claims 15-21.
2. Ascertaining the differences between the prior art and the claims at issue.
Reference claims does not teach concentration glutaraldehyde in the aerosol droplet of the composition of claim 1 when sprayed.
Wigginton et.al. does not teach disinfecting virus with composition of claim 1.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing different concentration of disinfectant.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Regarding 1-2 and 7 a person skilled in the art would be motivated to develop a method of in-activating virus load with the composition of reference claims 1-15 since the specification of the reference claims teaches a method of disinfecting surface (column 5, lines 10-15) (examiner interpret surface as both enclosed and partially enclosed volume) thus instant claims 1-2 and 7.
Regarding instant claims 15-21 a person skilled in the art would be motivated develop a method of inactivating both enveloped and non-enveloped viruses with composition of claim 1. A person skilled in the art would be expected to disinfect waste water with the composition of claim 1 to disinfect both non-enveloped and enveloped viruses in waste water(Wigginton abstract), thus teaching instant claims 15-21.
Claims 1, 16-17, and 19-21 are directed to the ability of the composition to “inactivate virus by at least 4-log1010 reduction” in different times, examiner interpret this as inherent properties of the composition. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01(I). Thus Claims 1, 16-17, and 19-21 are anticipated.
Conclusion
No Claims are allowable as written.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625