DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/5/2025 has been entered.
Claims 1-3, 8, 10-15, 19-20 are pending.
Election/Restrictions
Newly submitted claims 19-20 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 19 is directed to a functionalized waterborne polyurethane dispersion. Claim 20 is directed to a method of preparing a waterborne polyurethane dispersion. The original claims filed were directed to a method of inactivating a virus on a substrate.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 19 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 1-3, 8, 10-15 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 1 recites in part …the pH modifier is used to at least partially counteract the pH change caused by the addition of silver nitrate and other silver salts… However, it would not be clear if claim 1 requires addition of silver nitrate and other silver salts. Specifically, silver nitrate is not mentioned previously in claim 1, and it would not be clear what step of the method of inactivating a virus on a substrate comprises adding silver nitrate and other silver salts.
Claims 2-3, 8, 10-15 are subsumed by this rejection because of their dependence.
Claim 1 recites the limitation "the coating" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction and/or clarification is required.
Claim Rejections - 35 USC § 103
Claims 1-3, 8, 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Tate et al. (WO 2018/208177) in view of Wei et al. (US 2022/0056194).
Regarding claim 1: Tate is directed to a method comprising the steps of:
(a) applying a liquid composition to the substate in an amount sufficient to inactivate the virus, the liquid composition comprising a polymer bonded to silver nanoparticles (p. 7 Tate) and
(b) curing or crosslinking the polymer to form a coating on the surface of the substrate,
wherein the polymer is selected from polyurethane polymer, and acrylic polymer, and a polyol (p. 5:9-14 p. 11:3-6 Tate).
A specific method is disclosed in Example 13 utilizing an isocyanate hardener to crosslink the resin system and form the Ag nanoparticle urethane composite resin coating (p. 11 Tate).
Tate doesn’t mention a polyurethane dispersed in water or a pH modifier.
Wei is directed to a waterborne polyurethane that comprises a pH regulator or triethylamine ([0037] Wei). One skilled in the art would have been motivated to have selected the waterborne polyurethane of Wei as the polyurethane of choice in Tate since it is self-crosslinking and does not require other resins and crosslinkers when applied (Wei). Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to have selected the polyurethane of Wei as the polyurethane of choice in Tate.
The resin leach rate is less than 1 ppb/cm3/day (p. 5 Tate). It follows the composition would have a leach rate of less than 100 ppb/g/day since it is two orders of magnitude larger, and the density of the composition is similar to the density of the resin.
Tate doesn’t specifically mention a method of inactivating a virus on a substrate, nor a size of the bonded silver nanoparticles having a particular size of 5.2 nm (2.2 nm) with a particle distribution of between 2 nm and 15 nm, and are bonded to carbamate functional groups of the polyurethane polymer.
However, case law holds that 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). MPEP 2112.01(I). In the present case, silver nitrate is added to a waterborne polyurethane and mixed in Example 1. Example 1 of Tate utilizes a self-crosslinking emulsion polymer and AgNO3 at a Ag concentration of between 0.01-1% (p. 19:20-30). This is identical to Example 1 of the present invention and therefore is a method of inactivating a virus on a substrate and also in an amount sufficient to inactivate the virus.
Hence, Tate in combination with Wei suggests a method of inactivating a virus on a substrate, nor a size of the bonded silver nanoparticles having a particular size of 5.2 nm (2.2 nm) with a particle distribution of between 2 nm and 15 nm, and are bonded to carbamate functional groups of the polyurethane polymer. Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
Regarding claim 2: While Tate/Wei doesn’t specifically mention the Ag nanoparticles (AgNP) inactivate the viruses of claim 2, case law holds that a product and its properties are inseparable. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963). In the present case, both Tate and the present invention utilize Ag nanoparticles, and hence would be expected to inactivate the same viruses. Further, per Jeremiah et al., AgNP are effective against antiviral SARS-COV-2 (equivalent to human coronavirus) as well as human pathogenic viruses such as influenza virus, norovirus (Section 1. Introduction Jeremiah).
Regarding claim 3: The polymer is bonded to silver nanoparticles by functional groups of the polymer (p. 7:5-7 Tate). Example 13 comprises adding polyurethane polymer. Selection of a waterborne polyurethane results in a polyurethane polymer in water.
Regarding claim 8: The coating comprises at least 0.05 wt% Ag0 (p. 8:15-21 Tate).
Regarding claim 10: The leach rate is less than 1 ppb per cm2 per day (ppb/cm2/day). While not directly comparable to the claimed parts per billion per gram of set composite per day (ppg/g/day), Tate teaches the low leach rate is attributable to the strong association between AgNP and functional groups of the polymer backbone which form as a result of reducing silver ions by functional groups of the polymer. This is the same reasoning given in the present specification for the claimed low leach rate.
Case law holds that 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). MPEP 2112.01(I).
Hence, a primary case of anticipation of a coating that achieves an leach rate within the scope of claim 10. Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant's position; and (2) it would be the Office's position that the application contains inadequate disclosure, since one skilled in the art would not understand how to obtain the claimed properties with only the claimed reactants, claimed amounts, and substantially similar process of making.
one (p. 7:3-7 Tate).
Regarding claim 11: Tate doesn’t mention the coating achieves an average percent reduction in viral titer by at least 20% according to the JIS Z 2801 test protocol.
However, the coating produced in Tate/Wei is substantially identical to the coating produced in the instant invention.
Case law holds that 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). MPEP 2112.01(I).
Hence, a primary case of anticipation of a coating that achieves an average percent reduction in H1N1 viral titer by at least 20% according to JIS Z 2801 is provided by Tate. Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant's position; and (2) it would be the Office's position that the application contains inadequate disclosure, since one skilled in the art would not understand how to obtain the claimed properties with only the claimed reactants, claimed amounts, and substantially similar process of making.
Regarding claim 12: Tate doesn’t mention the coating achieves an average percent reduction in H1N1 viral titre by at least 20% according to the JIS Z 2801 test protocol.
However, the coating produced in Tate/Wei is substantially identical to the coating produced in the instant invention. Case law holds that 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). MPEP 2112.01(I).
In the present case, Example 1 of Tate utilizes a self-crosslinking emulsion polymer and AgNO3 at a Ag concentration of between 0.01-1% (p. 19:20-30). This is identical to Example 1 of the present invention.
Hence, a primary case of anticipation of a coating that achieves an average percent reduction in H1N1 viral titre by at least 20% according to JIS Z 2801 is provided by Tate. Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant's position; and (2) it would be the Office's position that the application contains inadequate disclosure, since one skilled in the art would not understand how to obtain the claimed properties with only the claimed reactants, claimed amounts, and substantially similar process of making.
Regarding claim 13: Tate doesn’t mention the coating achieves an average percent reduction in human coronavirus viral titre by at least 50% according to the JIS Z 2801 test protocol.
However, the coating produced in Tate/Wei is substantially identical to the coating produced in the instant invention. Case law holds that 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). MPEP 2112.01(I).
In the present case, Example 1 of Tate utilizes a self-crosslinking emulsion polymer and AgNO3 at a Ag concentration of between 0.01-1% (p. 19:20-30). This is identical to Example 1 of the present invention.
Hence, a primary case of anticipation of a coating that achieves an average percent reduction in human coronavirus viral titre by at least 50% according to JIS Z 2801 is provided by Tate. Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant's position; and (2) it would be the Office's position that the application contains inadequate disclosure, since one skilled in the art would not understand how to obtain the claimed properties with only the claimed reactants, claimed amounts, and substantially similar process of making.
Regarding claim 14: Tate doesn’t mention the coating achieves an average percent reduction in feline calicvirus viral titre by at least 40% according to the JIS Z 2801 test protocol.
However, the coating produced in Tate/Wei is substantially identical to the coating produced in the instant invention. Case law holds that 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). MPEP 2112.01(I).
In the present case, Example 1 of Tate utilizes a self-crosslinking emulsion polymer and AgNO3 at a Ag concentration of between 0.01-1% (p. 19:20-30). This is identical to Example 1 of the present invention.
Hence, a primary case of anticipation of a coating that achieves an average percent reduction in feline calicvirus viral titre by at least 40% according to JIS Z 2801 is provided by Tate. Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant's position; and (2) it would be the Office's position that the application contains inadequate disclosure, since one skilled in the art would not understand how to obtain the claimed properties with only the claimed reactants, claimed amounts, and substantially similar process of making.
Regarding claim 15: Tate doesn’t mention the coating achieves an average percent reduction in viral titre by at least 90% according to the JIS Z 2801 test protocol.
However, the coating produced in Tate/Wei is substantially identical to the coating produced in the instant invention. Case law holds that 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). MPEP 2112.01(I).
In the present case, Example 1 of Tate utilizes a self-crosslinking emulsion polymer and AgNO3 at a Ag concentration of between 0.01-1% (p. 19:20-30). This is identical to Example 1 of the present invention.
Hence, a primary case of anticipation of a coating that achieves an average percent reduction in viral titre by at least 90% according to JIS Z 2801 is provided by Tate. Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant's position; and (2) it would be the Office's position that the application contains inadequate disclosure, since one skilled in the art would not understand how to obtain the claimed properties with only the claimed reactants, claimed amounts, and substantially similar process of making.
Response to Arguments
Applicant's arguments filed 6/5/2025 herein “Remarks” have been fully considered but they are not persuasive.
Applicant argues (p. 6 Remarks) the present claims have been amended to recite inter alia applying a waterborne polyurethane dispersion comprising a pH modifier. Moreover, the silver nanoparticle have specific particle size. Applicant has surprisingly discovered the functionalized polyurethane polymer can be produced by direct reduction of the silver ions by a polyurethane polymer of by AgNPs bonding to functional groups of the polyurethane. None of which is disclosed by the cited references. Applicant has surprisingly discovered the antiviral activity against every strain of virus in Example 7.
The rejection has been recast above over Wei, wherein Wei discloses a waterborne dispersion comprising a pH adjuster. Further, Example 13 utilizes a polyurethane polymer, and therefore comprises the reduction by urethane groups. Tate specifically teaches “silver nanoparticles and a polymer where the silver nanoparticles are formed by reduction of silver ions by the functional groups of the polymer” (abstract Tate). No specific functional groups are recited in the claims. Finally, Tate teaches the liquid composition comprising a polymer bonded to silver nanoparticles (p. 7 Tate)
Applicant argues (p. 7 Remarks) the process of Tate is conceptually different to the functionalization in Tate. Waterborne dispersions in an aqueous environment including disturbances can cause the dispersion to agglomerate and fall out of suspension.
The rejection above has been recast above over Wei. Wei is directed to a waterborne dispersion including a pH adjuster, and therefore one skilled in the art would not expect it to agglomerate from the aqueous solution.
Applicants have surprisingly discovered the functionalized polyurethane polymer can be produced by direct reduction of polyurethan polymer.
The burden of showing unexpected results rests on the person who asserts them by establishing that the difference between the claimed invention and the closest prior art was an unexpected difference. See In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). Further, the showing of unexpected results must be commensurate in scope with the claims. See In re Peterson, 315 F.3d 1325, 1330-31 (Fed. Cir. 2003). In the present case, no amounts are recited, and therefore for this reason along the claims are not considered commensurate in scope with the showing of unexpected results.
Applicant argues (p. 7-8 Remarks) Schubert fails to disclose the claimed pH modifier.
The rejection including Schubert has been withdrawn. The rejection above has been recast above over Wei.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT T BUTCHER whose telephone number is (571)270-3514. The examiner can normally be reached Telework M-F 9-5 Pacific Time Zone.
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, Lanee Reuther can be reached at (571) 270-7026. 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.
/ROBERT T BUTCHER/Primary Examiner, Art Unit 1764