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 .
Status of the Claims
Claims 1-2, 10, 15, 17-22, 24, 26, 33, and 35 are pending. Claims 56, 69, 84, 94, 97, 100 are withdrawn as being part of the unelected invention group. Claims 3-9, 11-14, 16, 23, 25, 27-32, 34, 36-55, 57-68, 70-83, 85-93, 95-96, 98-99, 101-102 are cancelled.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/EP2021/059465, filed on April 12, 2021. This application also claims the benefits of foreign priority to GB2019821.4, filed on December 15, 2020 and GB2005356.7, filed on April 10, 2020.
Election/Restrictions
As a reminder, Applicant elected, without traverse, Group I which corresponds to claims 1-2, 10, 15, 17-22, 24, 26, 33, and 35. Applicant also elected the following species without traverse:
N,N,N-trimethylglycine as the quaternary ammonium compound (in Formula 1: R1=methyl, R2=methyl, R3=methyl, R4=OH, R5=carbonyl oxygen), and
trifluoroacetamide as the halogenated organic compound (in Formula 2: R8=CF3, A2=O, R9=H, R10=H). Claims 1-2, 10, 15, 17-22, 24, 26, 33 and 35 read on the elected species.
The elected species being used in a method of inactivating a virus was not found in the prior art and, thus, the search was expanded.
Specification - Abstract
The abstract of the disclosure is objected to because it can be more informative. An example of an amended abstract is provided below:
The present invention relates to a method of inactivating a virus by contacting the virus with a composition comprising N,N,N-trimethylglycine and trifluoroacetamide. Also described are procedures for inactivating viruses in biological samples and on non-biological surfaces. Further disclosures on a composition and kit for inactivating a virus and a method for detecting an analyte in a sample are provided as well.
Appropriate correction is required.
Specification - Disclosure
The specification is objected to because of the following informalities:
The specification omits the “Example 39” label (proceeds from Example 38 directly to Example 40) and includes two examples that are both labeled “Example 44.”
Examiner advises Applicant to amend the specification accordingly to provide sequential numbering of the examples.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections – Improper Markush Grouping
Claims 1-2, 10, 15, 17-22, 24, 26, 33, and 35 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) the species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the Specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons:
The variable is defined as seen below:
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wherein R9 and R10 are each independently selected from substituents as defined in claim 1, item (i). Depicted above are two general structures of a halogenated organic compound of Formula (2) as recited in claim 1. However, these two structures exhibit no discernible structural similarity.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR41.31 (a) (1).
Claims 2, 10, 15, 17-22, 24, 26, 33, and 35, which are dependent on claim 1, are also rejected for further requiring and/or reciting the improper Markush grouping as stated above.
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, 2, 10, 15, 17-22, 24, 26, 33, and 35 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. According to MPEP § 2163:
“Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ Such correlations may be established ‘by the inventor as described in the specification,’ or they may be ‘known in the art at the time of the filing date.’ See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014).
Claim 1 is a generic claim and is directed towards a method of inactivating a virus, comprising contacting the virus with a composition comprising: (i) a quaternary ammonium compound and (ii) a halogenated organic compound with each compound embracing multiple structural alternatives. However, the specification provides written description support for only one species of claim 1: a method of inactivating a virus, comprising contacting the virus with a composition comprising N,N,N-trimethylglycine (i.e., betaine) and trifluoroacetamide. Examples 5, 6, and 41-44 of the instant specification only disclose a mixture of betaine + trifluoro-acetamide exhibiting virucidal activity. No disclosure on the virucidal activity of mixtures comprising other quaternary ammonium compounds and halogenated organic compounds, as recited in claim 1, is provided. Also not disclosed is a reasonable structure-virucidal activity correlation that can help adequately reflect the structural diversity of the claimed genus.
Therefore, claim 1 fails to comply with the written description requirement. Claims 2, 10, 15, 17-22, 24, 26, 33, and 35, which are dependent on claim 1, are also rejected for further requiring and/or reciting the limitations of claim 1 that lack adequate support in the specification.
Examples 5, 6, and 41-44 of the instant specification only disclose a mixture of betaine + trifluoroacetamide + optionally a solvent exhibiting virucidal activity wherein the solvent is PEG 200 (examples 5 and 43), water (examples 6 and 42), and/or ethanol (examples 41 and 42). Therefore, there is no adequate disclosure of a betaine + trifluoroacetamide + solvent mixture, wherein the solvent is not PEG 200, water, and/or ethanol, that can inactivate a virus.
Accordingly, claims 2, 10, and 15 further fail to comply with the written description requirement.
Claim 17 recites: “The method according to claim 2, wherein the solvent is present in an amount of 50 to 98% by volume based on the volume of the composition.”
However, example 41 of the instant specification discloses a composition comprising 95% by weight of the deep eutectic solvent betaine: trifluoroacetamide (1:2 mol:mol) and 5% ethanol with virucidal activity. In example 42, a composition comprising 85% by weight of the deep eutectic solvent betaine: trifluoroacetamide (1:2 mol:mol), 10% water by weight, and 5% ethanol by weight was disclosed to have virucidal activity. In both examples 41 and 42, the weight (and, therefore, volume) of betaine + trifluoroacetamide was greater than the weight (and, therefore, volume) of the solvent. There is no disclosure of a composition of betaine + trifluoroacetamide + solvent exhibiting virucidal activity, wherein the solvent is present in an amount of 50 to 98% by volume based on the volume of the composition.
Accordingly, claim 17 further fails to comply with the written description requirement.
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 1-2, 10, 15, 17-22, 24, 26, 33, and 35 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 the following limitations:
“substituted C1 to C3 alkyl group bearing one or more substituents selected from hydroxyl and halide groups”
“R8 is a substituted C1 to C12 alkyl group bearing one or more substituents selected from fluoro, chloro, bromo, and iodo”
“substituted C1 to C12 alkyl group bearing one or more substituents selected from fluoro, chloro, bromo, iodo, and hydroxyl.”
The specification does not define the term “alkyl.” Therefore, the alkyl groups can be a linear alkyl group that is substituted with alkyl groups to form branched alkyl groups. However, the claim only states that the alkyl groups can be substituted with hydroxyl and/or halide groups. The claim does not state that the alkyl group can be substituted with alkyl groups. Claim 1 also recites unsubstituted alkyl groups. However, as stated above, branched alkyl groups are linear alkyl groups substituted with alkyl groups.
Accordingly, the metes and bounds of the claimed invention cannot be ascertained and claim 1 is rendered indefinite.
Claims 2, 10, 15, 17-22, 24, 26, 33, and 35, which are dependent on claim 1, are also rejected for further requiring and/or reciting the indefinite limitation of claim 1.
Note on 35 USC § 102 and § 103 Rejections
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.
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 1-2, 10, 15, 20, 21, 24, 26, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over:
Goldsborough, A. S. et al. (Goldsborough) (WO2014131906A1; published September 4, 2014)
Zhang et al. (Zhang) (Zhang, M. et al. Betaine Inhibits Hepatitis B Virus with an Advantage of Decreasing Resistance to Lamivudine and Interferon α. J. Agric. Food Chem. 2016, 64, 4068-4077.)
Goldsborough discloses an invention related to the stabilization of biomolecules in biological samples using deep eutectic solvents (DES) (abstract). The DES mixtures can also be used to stabilize viruses in biological samples such as sputum, a swab, plasma, serum, buffy coat and/or blood for subsequent viral diagnostic analysis (pg. 10, 4th paragraph). A specific example of a DES mixture disclosed by Goldsborough is an aqueous dilution of choline chloride: trifluoroacetamide (1:2 mol:mol) with a final concentration of 90% which exhibits strong anti-microbial activity (pg. 72, Example 34). Other examples of DES mixtures, as disclosed by Goldsborough in Table 6 (pg. 54-57), include a mixture comprising choline chloride, trifluoroacetamide, and ethylene glycol (pg. 55, entry no. 12) as well as a mixture comprising betaine (i.e., N,N,N-trimethylglycine; see pg. 20, 1st paragraph, 3rd line) and trifluoroacetamide (pg. 57, Table 6, entry no. 84; betaine: trifluoroacetamide ratio disclosed in Goldsborough is 1:2 mol:mol). Choline chloride has the following structure:
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and is a compound of Formula 1 as recited in instant claim 1 (wherein, R1 = R2 = R3 = methyl, R4 = OH, R5 = H). Trifluoroacetamide is a compound of Formula 2 as recited in instant claim 1 (wherein, R8 = CF3, A2 = O, R9 = R10 = H).
Goldsborough does not disclose the antivirucidal activity of betaine. Zhang is relied upon for this disclosure.
Zhang discloses that betaine (i.e., N,N,N-trimethylglycine) showed anti-hepatitis-B-virus activity both in vitro and in vivo (pg. 4075, left col., last two lines).
Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to evaluate the betaine: trifluoroacetamide (1:2 mol:mol) mixture (as disclosed in Goldsborough: pg. 57, Table 6, entry no. 84) for virus disinfection in a biological sample (such as sputum, a swab, plasma, serum, buffy coat and/or blood for subsequent viral diagnostic analysis), given betaine’s documented antiviral properties. Betaine is also a compound of Formula 1 as recited in instant claim 1 (wherein, R1 = R2 = R3 = methyl, R4 = OH, R5 = carbonyl oxygen) (reads on instant claims 1, 20, 21, 24, 26, 33, and 35).
As stated above Goldsborough discloses DES mixtures comprising of choline chloride, trifluoroacetamide, and a co-solvent such as ethylene glycol (pg. 55, entry no. 12). It would have been obvious for POSITA to replace the choline chloride in the DES mixture disclosed by Goldsborough with betaine since prior art has shown betaine exhibits antiviral activity. It would have also been obvious to try replacing ethylene glycol with other glycols as substituting/optimizing solvents is a routine and “obvious-to-try” parameter in the art (reads on instant claims 1, 2, 10, 15, 26, 33, and 35). According to MPEP §2145:
“An ‘obvious to try’ rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. ‘[A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.’ KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007).”
One of ordinary skill in the art would have been motivated to evaluate the DES mixtures as discussed above for virucidal activity as there is a need for compositions which can inactivate a pathogen, such as a virus, while at the same time stabilizing biomolecules present in the pathogen to allow for the subsequent detection of the pathogen.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624