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 .
Priority
The present application is a National Stage entry of International application PCT/JP2022/008180 filed 02/28/2022, which claims the benefit of Foreign application JP2021-069452, JP2021-207663 filed 04/16/2021, 12/22/2021, respectively. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, although it is noted that no English translation was provided.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 10/02/2024, in the matter of Application N° 18/287,154. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1-9 are pending.
Claims 1-9 are presented for examination and rejected as set forth below.
Specification
The disclosure is objected to because of the following informalities: The Specification has variable resolution of the drawn chemical structures (e.g., [Chem. 7] appears highly resolved; however, [Chem. 8] appears pixelated). To avoid future publication delays by the publication team, the Examiner recommends downloading the pdf of the Specification from the USPTO website, and replacing any chemical structures that appear pixelated I comparison to [Chem. 7].
Appropriate correction is required.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
Claims 1 and 3 pictorially show general formula (2) of claim 1 and general formula (3) of claim 2 are objected to for having poor resolution (i.e., compared to the good resolution of the formula (1) image of instant claim 1).
Appropriate correction is required.
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.
Claims 1, 3, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kuroda (US20060024264A1 cited on the IDS filed 10/16/2023), and in further view of Chen (US20110223259A1).
Applicant’s independent claim 1 is directed to a method for inactivating a coronavirus and/or inhibiting coronavirus growth, by administering an anticoronaviral agent comprising polymers, with at least one or more of the below formula units (i.e., formula (1) or formula (2)). The claims additionally include formula (3) in claim 3. Note, when claims 1 and 3 recite polymers that is comprising at least one type of structural unit, that allows for additional structural units that could be optionally integrated into the instant polymer formulas.
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Finally, the Examiner notes that Applicant does not provide Hildebrand solubility parameters for specific monomer units, but references a book on a method of calculation: “the value calculated by the method described on pages 147-154 of "POLYMER ENGINEERING AND SCIENCE" (1974, Vol. 14, No. 2) can be used as reference”, whereby a defined calculation method demonstrates that the solubility parameters for each monomer are inherent to the specific monomer structure [0056].
Kuroda teaches use of the copolymers as antimicrobial agents in pharmaceutical and non-pharmaceutical applications. Furthermore, Kuroda teaches the obviousness of applying the disclosed compositions to inhibit and/or kill a non-limited number of viruses [0194], and in the form of films, cosmetics, lotions, etc. [0016-0018].
Regarding claims 1, 3, and 9: Kuroda teaches P-DMA (i.e., tertiary amines) and P-Q (i.e., cationic quaternary amines), whereby the structures are recopied below to compare with the instant structures (and the thiol found in the image is a residual chain transfer agent; see Kuroda – claim 1). P-DMA and P-Q bear tertiary and quaternary amines that are demonstrated to have antimicrobial activity (at more than 0.01 wt% because for the antimicrobial assays, each polymer was dissolved in DMSO (5 mg/mL [0246]) against E. Coli (i.e., that depend on degree of polymerization (DP), per Table 7, Examples 1 and 3, [0262]), whereby the copolymers were tested also against viruses [0266], providing motivation for selection of these species according to their use. Thus, the amine-containing monomeric units of P-DMA and P-Q map to instant General Formula 1 and/or 2 of instant claim 1 (i.e., R1, R2, R3 = H or Me), and the ester-containing monomeric unit maps to instant General Formula 3 of instant claim 3 (i.e., instant X = the divalent linking group is ‘oxygen’; R9 = hydrocarbon group of 2 or more is ‘ethyl’; (i.e., R1, R2, R3 = H or Me).
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Note the comprising language of the claims allow for “residual chain transfer agent”, whereby a similar “residual chain transfer agent” is expected based on the method of copolymer production in the Specification (pg 23-24). Further note the structures of the literature as compared to General formula (6) [0040] and General formula (7) [0059], as found in the Specification (as shown below).
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Regarding claims 7: Kuroda teaches the amino unit to have a value of 0.1-0.9 (10-90%) and the ester unit to have a value of 0.9-0.1 (i.e., 90-10 %) (Kuroda – claim 1), which makes obvious the instant amounts of claims 7 (e.g., the instant amino unit is 30% or more and the instant additional unit is 1% or more). Note that with regard to the numerical range, note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)).
In summary, Kuroda teaches a method of administering compositions comprising polymers (including cationic polymers) for treatment of respiratory viruses, and makes obvious monomeric amount variations of that general polymer formula. Also, Kuroda teaches a non-limiting pool of viral infections that benefit from the disclosed copolymers, including examples of several respiratory infections [0194]. However, Kuroda does not teach a method that treats coronavirus (claim 1).
Chen teaches compositions containing cationic polymers (e.g., in certain embodiments, the cationic polysaccharide chitosan [0028]) (abstract) that are used in a method for treatment of coronavirus (Chen – claim 14) by topical application [0123] and/or in article forms [0124]. Chen also teaches coronavirus as an upper respiratory tract infection [0014-0015] that can ameliorate infection by targeting the virus (Chen - claim 14-15).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kuroda to inhibit/kill viruses, by targeting coronavirus, as specified by Chen, because Kuroda teaches targeting of viruses generally (through a non-limiting list of virus targets, including respiratory viruses), and Chen describes coronavirus as a upper respiratory tract virus infection, whereby it’s desirable to avoid human infection [0014-0015] that benefits from compositions comprising cationic polymers including cationic polysaccharides (abstract, [0028]).
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kuroda (US20060024264A1 cited on the IDS filed 10/16/2023) and Chen (US20110223259A1), as applied to claims 1, 3, 7, and 9, and in further view of Ylitalo (US20060034899A1), and
As discussed above, Kuroda and Chen teach a method for administering and effective amount of a composition comprising a polymer to treat coronavirus. Kuroda teaches the amino unit to have a value of 0.1-0.9 (10-90%) and the ester unit to have a value of 0.9-0.1 (i.e., 90-10 %) (Kuroda – claim 1), making obvious monomeric amount variations of that general polymer formula (i.e., see instant amounts in claim 6 and 8) . Furthermore, Kuroda teaches the importance of solubility for polymer activity by concluding that precipitation of the copolymer out of solution leads to decreased anti-microbial activity, as seen by MIC leveling off [0245, 0248, 0251]. For example, Kuroda teaches lower molecular weight polymers are more soluble, and increasing amounts of the butyl (i.e., the alkyl group) decreases solubility. Furthermore, Kuroda demonstrates favorable results for lower molecular weight copolymers and having smaller hydrophobic groups [0257] (e.g., SH30; Figure 7B, C-1 series that is based on methyl methacrylate [0253]).
However, they are silent on the specific Hildebrand solubility parameter values (instant claims 2, 4-6, and 8).
Ylitalo teaches polymers that have defined Hildebrand parameters (i.e., reasonably pertinent to the instant claim set that recites polymers of defined Hildebrand solubility parameters, and therefore considered analogous art), including various methacrylates that range from 16-20 MPA1/2 (pg 2, Table 1). Therefore, the Hildebrand solubility parameter instant ranges (see instant claims 2, 4-5, and 8), including the narrowest instant range of 12-23 (instant claim 8) are obvious, because the compositions of Kuroda contain copolymers that incorporate acrylate and methacrylate subunits in proportions (i.e., the ester unit has a value of 0.9-0.1 (i.e., 90-10 %) (Kuroda – claim 1), whereby the instant Hildebrand solubilities would be expected for copolymers of instant claim 1, that also incorporate (i.e., instant claim 1 contains open-ended “comprising” language) the same or similar monomeric unit amounts (e.g., the instant monomeric units of claim 3). Although the Hildebrand solubility parameter for the tertiary amine/quaternary ammonium monomeric subunit (i.e., similar to formula (1) and (2) of instant claim 1) could not be found in the search of the literature, a PHOSITA would expect the Hildebrand values for polymers composed of these types of monomers to approximate to instant range similar to the structurally related acrylates of Ylitalo’s Table 1, and therefore the copolymers of Kuroda would have Hildebrand values in similar ranges.
Furthermore, with regard to the specific calculation of the Hildebrand solubility parameters of specific monomeric units or copolymers, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. “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). Finally, Kuroda teaches polymeric structural units that read on the instant polymer scope, and thus, the instant Hildebrand solubility parameters would be expected because the Prior Art uses the same structural units (i.e., a composition and its properties are inseparable and Ylitalo teaches that it is the contributing effects of the monomeric structure within a polymer that leads to the estimated/calculated solubility parameter [0015]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kuroda’s compositions to specify the Hildebrand solubility parameters, as taught by Ylitalo, because Ylitalo teaches typical ranges of methacrylate polymers, which are used by Kuroda for application to kill/inhibit various viruses, and furthermore, Kuroda teaches the importance of solubility for polymer activity by concluding that precipitation of the copolymer out of solution leads to decreased anti-microbial activity, as seen by MIC leveling off [0245, 0248, 0251].
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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/R.P./Examiner, Art Unit 1614 7/13/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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