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 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.
Response to Restriction/Election
Applicants’ election of the following in response to restriction requirement is acknowledged:
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Since Applicants did not traverse the restriction/election requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). Accordingly, the restriction requirement is deemed proper and is made FINAL.
Applicants preserve their right to file a divisional on the non-elected subject matter.
Status of the claims
Claims 1-14 are examined on merits in this office action.
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 1-14 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-14 are directed to a sensor for measuring an analyte wherein the sensor comprises a co-polymer comprising a first monomer and a second monomer having functional units represented by formula (1) and formula (2). As claimed, the first monomer is represented by formula (1)
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and the second monomer is represented by formula (2)
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, wherein each of the formula (1) and formula (2) encompasses inordinately a large number of structurally and functionally divergent structures. In formula (1), A1 represents structurally divergent compounds, as for example, a hydrocarbon, which includes various distinct structures of compounds having hydrogen and carbon, including various cyclic structures, fused cyclic hydrocarbons, and linear hydrocarbons of various structures. R1 as claimed encompasses a hydrocarbon, an oxyacyl group, a phenylene group wherein each may have different types of substitutions groups and X can be distinct types of functional groups including N-hydroxysuccinimide, maleimide, carboxyl group, CHO groups, benzotriazole ester or aryl ester, hydrazine, alkoxyamine, hydroxyamine, imidazole, pyridine, acyl azide,acyl halide, alkyl halide, acid anhydride, aldehyde, ketone, alkyl sulfonate, maleimide, epoxide, aziridine, isocyanate, isothiocyanate, imidoester, and sulfonyl halide. Thus, in permutation and combination of the divergent structures, each of the formula represents an enormous number of distinct structure and in permutation and combination of the divergent structures represented by each of the above formula (1) and formula (2), the co-polymer represents an inordinately a large number of distinct copolymer structures, for which the specification does not have a representative description and disclosure to support the various distinct types of species of copolymer structures represented by the genus of copolymer comprising formula (1) and formula (2). Moreover, claim 3 recites that the polymer further comprises a third binding site having same functional group, thus providing more complexity to the copolymer.
However, throughout the specification, the backbone of the monomer units are very limited to methacrylate and acrylate based copolymer having pendant NH2 group for covalent binding to protein and quaternary amine group for electrostatic interaction, wherein the specification is very limited to only two specific structures of monomer units
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and
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for first monomer (first binding site) and
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and
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for second monomer (second binding site) that binds to protein by electrostatic interaction.
A written description of a chemical genus “requires a precise definition, such as by structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit reflected on Eli Lilly in Ariad while explaining how to sufficiently describe of a genus of compounds:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or
structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
A "representative number of species" must typify the entire claimed genus and account for variation between the species of the genus.
[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated. Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004).
MPEP § 2163 further states that, for a claimed genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus:
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that “only describe[d] one type of structurally similar antibodies” that “are not representative of the full variety or scope of the genus.”). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
Emphasis added.
Therefore, by disclosing limited number of species of monomer units
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and
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for first monomer (first binding site) and monomer units
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and
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for second monomer (second binding site) that binds to protein by electrostatic interaction, the specification does not describe or disclosed representative number of species of monomer units for the co-polymers of the reagent layer of the sensor for measuring an analyte, as encompassed by the broad genus of polymer encompassed by the genus of first monomer of formula (1) and the second monomer of formula (2).
Disclosure of only two species of monomer units for formula (1) and two species for formula (2), cannot be considered as a disclosure of a “representative number of species” for the large number of different types of monomers represented by the genus of formula 1) and formula (2). The specification, then, is considered devoid of sufficiently detailed, relevant, identifying characteristics demonstrating that Applicant was in possession of the entirety of the genus now claimed, i.e., additional complete or partial structures, other physical and/or chemical properties, functional characteristics coupled with a known or disclosed correlation between function and structure, or some combination thereof demonstrating possession of the entirety of the claimed genus.
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, 3, 4 and 5, are rejected under 35 U.S.C. 102 as being anticipated by Ishihara et al (JP 2006321829).
In regards to claims 1 and 5, Ishihara teaches a sensor for detection of enzyme, the sensor comprising a polymer having (see description, Technical Field and abstract) having the structure
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, wherein the monomer unit
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reads on the first binding site (formula 1) of instant claim 1 and the monomer unit
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having phosphorylcholine like group having quaternary amine group, reads on the second binding site of formula 2 of instant claim 1. In the above formula, Ishihara teaches that Y can be p-nitrophenyl group or N-hydoxysuccinimide (which is capable of covalent bonding to protein) (claim 1). Ishihara teaches that the copolymer is bonded to an amino group of each of the above enzymes by a urethane bond, thus disclosing the first binding site covalently bonded to a protein.
Regarding claims 3 and 4, as disclosed above, the structural unit
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comprises m number, thus multiple units of the unit when m is 2 or more, would satisfy the limitation of claim 3 and 4.
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 of this title, 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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ishihara et al (JP 2006321829).
Ishihara has been described for claims 1 and 3-5 above, disclosing sensor layer comprising a polymer .
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wherein the polymer is covalenty bound to enzymes through group Y.
Ishihara teaches that the enzyme is Glucose oxidase (throughout the specification) but however, does not disclose oxidoreductase enzyme.
Ishihara however, is directed to enzyme sensors and also teaches that various enzymes can be immobilized.
Therefore, since the basic concept of covalently immobilizing glucose oxidase to the polymer has been taught and since Ishihara teaches that various enzymes can be immobilized, it would be obvious to one of ordinary skilled in the art to easily envisage immobilizing various known enzymes for detection of various analytes interacting with enzymes with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAFIQUL HAQ whose telephone number is (571)272-6103. The examiner can normally be reached on Mon-Fri 8-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. Emch can be reached on 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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