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 .
Election/Restrictions
Applicant’s election without traverse of Group I and the species of mucor, M. hiemalis, SE ID NO:1 and residues 335-362 in the reply filed on 23 June 2026 is acknowledged.
Claims 124-133 read upon the election.
Claims 134-143 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims the benefit of US Provisional 63/385,147 filed on 28 November 2022.
Claims 124-133 have an earliest effective US filing date of 28 November 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/13/2025, before the mailing of a first Office action on the merits, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Specification
The title of the invention “Universal Sensing System” is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
A title along the lines of “An FAD dependent glucose dehydrogenase (FAD-GDH) enzyme and method of detecting an analyte comprising said enzyme”, is suggested.
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 124-133 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 124 is indefinite because it recites a product and process in the same claim. MPEP 2173.05(p)(II) states: “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112, second paragraph.” See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). In Katz, a claim directed to “A system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. In re Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.2d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); < Ex parteLyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph). The case law applies to the instant claim(s) which are directed to an enzyme but it further recites, “that is inhibited by contact with an inhibitor and is de-inhibited in the presence of an analyte that binds to said inhibitor.” Thus, because it recites the product and apparatus and the method steps of using the product, the claim is indefinite under 35 U.S.C. 112, second paragraph. This affects the scope of all depending claims.
Claim 124 is further indefinite wherein it recites the enzyme comprises an epitope-grafted allosteric site. It is unclear whether or not this is an engineered site or an intrinsic site within the enzyme because the elected site, residues 335-362, is naturally-occurring. Further, Claim 124 recites this allosteric site, “is inhibited by contact with an inhibitor and is de-inhibited in the presence of an analyte that binds to said inhibitor.” It is unclear whether or not assessing inhibition and de-inhibition are required for infringement because methodology is implicit but this is a product claim and therefore there are no active method steps. Absent method steps, it is unclear how this recitation further limits the structural/material scope of the parent claim; rather the enzyme is claimed by what it does rather than what it is. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim” (emphasis added). Since the claims fail to meet all (3) criteria set forth in MPEP 2173.05(g), then Claim 124 is rejected.
Similarly, Claims 125 and 126 recites the enzyme is a “glucose-metabolizing enzyme” again, it is unclear how this structurally/materially limits the product enzyme of the claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 124-133 are rejected under 35 U.S.C. 101 because the enzyme of the claims is directed to a product of nature, without significantly more.
MPEP 2106.04(c) states: The markedly different characteristics analysis should be applied to the entire product. The claims are drawn to, “an enzyme comprising an epitope-grafted allosteric site that is inhibited by contact with an inhibitor and is de-inhibited in the presence of an analyte that binds to said inhibitor.” Applicant has elected the Mucor hiemalis enzyme of SEQ ID NO:1, and Applicant has indicated the epitope-grafted allosteric site comprises residues 335-362.
This site and SEQ ID NO:1 is >99% identical to a novel enzyme that is also SEQ ID NO: 1 within WO 2013065623 (see alignment below). The ‘623 prior art teaches isolating the DNA (SEQ ID NO:2 of the reference) that encodes for the protein of SEQ ID NO: 1. Paragraph [0122] of the reference states: “In order to amplify the FGDH gene (SEQ ID NO: 2) derived from Mucor hiemalis revealed in Example 13, PCR was performed under the conditions recommended using DNA polymerase KOD-Plus (manufactured by Toyobo Co. Ltd.) using the cDNA prepared in Example 13 as a template. A primer (SEQ ID NO: 13, 14) to which a restriction enzyme site was added was used as the primer. The PCR product amplified by the PCR was operated according to the protocol using cloning kit Target Clone-Plus (manufactured by Toyobo Co. Ltd.) to transform Escherichia coli DH5α strain competent cells (manufactured by Toyobo Co. Ltd.) to obtain the transformant.” Example 13 of the reference discloses Extraction of chromosomal DNA from Mucor hiemalis NBRC 6754. The prior art reference teaches: “The FGDH of the present invention has excellent substrate specificity. In particular, FGDH of the present invention has significantly lower reactivity to at least D-xylose, based on reactivity to D-glucose. More specifically, FGDH of the present invention preferably has a reactivity with D-xylose of 1.2% or less when the reactivity to D-glucose at the same concentration is 100%” (paragraph [0027]). At paragraph [0032] the reference states: “The FGDH of the present invention having excellent substrate specificity as described above is preferable as an enzyme for accurately measuring the amount of glucose in a sample. That is, according to the FGDH of the present invention, it is possible to accurately measure the amount of D-glucose of interest even when impurities such as maltose, D-galactose, and D-xylose are present in the sample. Therefore, the FGDH of the present invention is suitable for applications in which the presence of such impurities is expected or concerned in a sample (typically, the measurement of the amount of glucose in blood), can be applied to various applications including the use, and has high versatility.” Paragraph [0087] details how the enzyme of the reference is used as a sensor for glucose.
There appears to be no marked difference, in either structure or glucose sensing function, between the flavin-bound glucose dehydrogenase (FGDH) enzyme protein produced from chromosomal DNA (cDNA) of Mucor hiemalis NBRC 6754 and the flavin adenine dinucleotide dependent glucose dehydrogenase (FAD-GDH) enzyme of the present invention.
Since the product invention is not markedly different than the naturally-occurring counterpart, the flavin adenine dinucleotide dependent glucose dehydrogenase (FAD-GDH) enzyme of Mucor hiemalis NBRC 6754, then the claims are rejected because the invention is directed to a nature-based product.
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Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 124-133 are rejected under 35 U.S.C. 102(a)(1), or in the alternative under 102(a)(2), as being anticipated by WO 2013065623 published 10 May 2013 (referred to hereafter as the ‘623 publication), which has an effective US filing date of 29 October 2012, (citations refer to English equivalent US 20140287478).
Regarding Claim 124, the ‘623 publication discloses a flavin adenine dinucleotide-dependent glucose dehydrogenase (hereinafter also referred to as "FADGDH") (see paragraph [0004]; “enzyme” of the claim). The prior art inventors “develop a novel glucose dehydrogenase that is more suitable for use in SMBG, and found that the use of an enzyme that has excellent substrate specificity, high affinity for D-glucose, and excellent stability enables shortening the measurement time while accurately measuring blood glucose levels with a small amount of enzyme. Accordingly, an object of this invention is to provide a novel glucose dehydrogenase having, excellent substrate specificity, high affinity for a substrate, excellent thermal stability, and the like” (paragraph [0018]). Specifically, the prior art teaches (a) a polypeptide having an amino acid sequence of SEQ ID NO: 1 [0022]; but also encompasses a polypeptide having the amino acid sequence of SEQ ID NO: 1 in which one or several amino acid residues are substituted, deleted, inserted, added, and/or inverted, and having glucose dehydrogenase activity [0023].
Regarding Claim 125, the prior art teaches the enzyme of the reference has high affinity for D-glucose, is unaffected by other sugars, such as maltose and xylose, and therefore shows excellent substrate specificity [0018].
Regarding Claim 126, the prior art discloses the enzyme of the reference is an FAD dependent glucose dehydrogenase (FAD-GDH) enzyme (“flavin adenine dinucleotide-dependent glucose dehydrogenase” of the reference; see paragraph [0004]).
Regarding Claims 127 and 128, the enzyme of the prior art teaches the FAD-GDH enzyme is from the instantly-elected genus Mucor FAD-GDH, “Derived from a microorganism of the genus Mucor” (reference claim 20) and specifically “ Mucor hiemalis f. silvaticus NBRC6754” (reference claim 15) as required by instant claim 128.
Regarding Claim 129, as stated above, SEQ ID NO: 1 of the reference is 99.19% identical to SEQ ID NO: 1 of the instant claims, which is within the “at least 70% identical thereto” recited by the instant claim. As one can see from the alignment below, there are only two amino acids, at residues 211 and 365, that differ from the instantly-elected SEQ ID NO:1 of the claimed invention. Further the prior art discloses polypeptides in which one or several amino acid residues are substituted, deleted, inserted, added, and/or inverted, and having glucose dehydrogenase activity [0023].
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Regarding claims 130-133, Applicant has elected the allosteric site of residues 335-362 of SEQ ID NO: 1 of the claims. From the alignment above, one can see that those residues are identical between the enzyme of the prior art reference and the claimed enzyme. Therefore, since this region is 100% identical, absent evidence to the contrary, this structural identity teaches the epitope-grafted sequence comprises an epitope sequence corresponding to an analyte of instant claim 131; wherein said analyte is a protein (instant claim 132); and, comprises from 3-30 amino acids (instant claim 133).
Therefore, the enzyme invention of the instant claims fails to distinguish over the enzyme disclosed in the prior art reference, and the claims are rejected.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/Examiner, Art Unit 1675
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