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 .
Election/Restrictions
Applicant’s election of Group I, presently claims 1-6 and 15-19 in the reply filed on 7/15/2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 7-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/15/2026.
Claims 1-6 and 15-19 are under consideration on the merits.
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 1-6 and 15-19 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.
See MPEP § 2163 for a review of the written description requirement. The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117 and M.P.E.P. § 2163.02.
M.P.E.P. §2163 (II)(A)(3)(a) ii) further recites, “The written description requirement for a claimed genus 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”. When there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Finally, 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. 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.", the latter of which may be established by the inventor as described in the specification or the state of the art at the time of filing.
Independent claim 1 is directed towards a recombinant protein, comprising (a) lactate dehydrogenase (LDH); and (b) a minimal c-type cytochrome peptide. Both the lactate dehydrogenase and the minimal c-type cytochrome peptide are generic, as the claim does not recite any particular amino acid sequence and so is inclusive of any amino acid sequence capable of meeting the claimed function. Claims 2-6 and 15-19 either depend from or incorporate the limitations of claim 1.
In this case, Applicant has not disclosed a representative number of species and has not disclosed any reasonable requisite structure-function correlation to adequately describe the genus of recombinant protein(s) comprising (a) a generic lactate dehydrogenase (LDH); and (b) a generic minimal c-type cytochrome peptide of claim 1. “Lactate dehydrogenase” has at least four plain meanings in this art based upon the assigned Enzyme Classification (EC) numbers, all of which are encompassed by the broadest reasonable interpretation of the claim and are mutually exclusive: 1) L-lactate dehydrogenase (EC 1.1.1.27), 2) D-lactate dehydrogenase (EC 1.1.1.28), 3) L-lactate dehydrogenase (cytochrome) (EC 1.1.2.3), and 4) D-lactate dehydrogenase (cytochrome) (EC 1.1.2.4) (all appended as References U-X). In addition to the lactate dehydrogenases varying by L/(S) or D/(R) isomers of lactate as a reactant, the cytochrome lactate dehydrogenases require Fe(III)-cytochrome c as a reactant and further reduce Fe(III)-cytochrome c to Fe(II)-cytochrome c whereas the non-cytochrome lactate dehydrogenases reduce NAD+ to NADH. Furthermore, L-lactate dehydrogenase (EC 1.1.1.27) in animals exists as a tetramer and has five isoenzyme variants depending on the combination of M-type and H-type peptide chains as taught by Drent et al. (Eur Respir J. (1996), 9, 1736-1742; Reference U2) (page 1736, the first paragraph under “Biochemistry and Physiology of LDH” and ”page 1737, left column, paragraph starting “The enzyme is composed of …”). While “minimal c-type cytochrome peptide” (e.g. minimal cytochrome domain or MCD) appears to be terminology unique to the instant Application and Applicant’s related patent applications, the narrower embodiment of MCR-2 is disclosed as obtained from MamP protein which originates from a magnetotactic bacteria magnetoovoid bacterium MO-127. See Siponen et al. (Nature (2013), 502, 681-684 plus appended Methods and Extended Data; Reference V2) (Figure 1). Neither “lactate dehydrogenase” and/or “minimal c-type cytochrome peptide” have been defined or redefined in the specification to otherwise narrow the scope of the claim (see M.P.E.P. § 2111.01(IV)).
The specification only discloses two species of the generic recombinant protein set forth in claim 1: 1) the recombinant protein consisting of MCR-2 fused to the N-terminus of Saccharomyces cerevisiae L-lactate dehydrogenase (cytochrome) encoded by SEQ ID NO: 42 (i.e. LDH-CytB-CytC), or 2) the recombinant protein consisting of MCR-2 fused to the N-terminus of Saccharomyces cerevisiae L-lactate dehydrogenase (cytochrome) lacking a CytB domain encoded by SEQ ID NO: 41 (i.e. LDH-CytC) ([0361]-0362] for polynucleotide sequences and Example 4 in its entirety). There is no disclosure of any other species of lactate dehydrogenase or any other species of minimal c-type cytochrome peptide, nor is there any technical discussion that might support extrapolating the limited showing LDH-CytB-CytC and/or LDH-CytC to any representative species of the other enzyme classes of lactate dehydrogenases (i.e. L- and D-lactate dehydrogenase and D-lactate dehydrogenase (cytochrome)) or any other representative species of minimal c-type cytochrome peptide. There is no disclosure of any structure-function correlation that would support the broadest reasonable interpretation of the scope of claim 1 directed towards mutant or catalytically-active fragments of any species of lactate dehydrogenase, fusion of MCR-2 anywhere else on the disclosed L-lactate dehydrogenase (cytochrome), or a recombinant protein comprising other polypeptide elements that would otherwise predictably preserve the functional properties of the disclosed enzyme such as enzyme kinetics, porphyrin-binding, and lactate oxidation properties to an electrode set forth in Example 4.
Given the lack of applicable prior art and limited showing of the disclosure, this art must be held as unpredictable because a person of ordinary skill in the art could not predict the operability of any other species than the two disclosed species above. See M.P.E.P. § 2163 (II)(A)(3)(ii): "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).
Because the specification is also directed towards parallel embodiments of a recombinant protein comprising flavin-adenine dinucleotide glucose dehydrogenase fused to a minimal c-type cytochrome peptide (FAD-GDH-MCD) and the specification doesn’t clearly distinguish between the separate embodiments when reciting either polypeptide or polynucleotide sequences (e.g. [082]-[084], [096]-[099], [0147]-[0151], etc.), those elements of the disclosure cannot be considered sufficient for descriptive support of the claimed genus of recombinant proteins at this time because the identity of the sequences is unknown (e.g. which unspecified sequences are directed towards FDH-GDH vs LDH).
As such, the disclosure only adequately describes the narrower embodiment of claim 1 of: 1) the recombinant protein consisting of MCR-2 fused to the N-terminus of L-lactate dehydrogenase (cytochrome) encoded by SEQ ID NO: 42 (i.e. LDH-CytB-CytC), or 2) the recombinant protein consisting of MCR-2 fused to L-lactate dehydrogenase (cytochrome) lacking a CytB domain encoded by SEQ ID NO: 41 (i.e. LDH-CytB-CytC). None of claims 15-19 narrow the scope of the generic recombinant protein of claim 1 and so lack adequate written description for the reasons given above.
Claims 2 and 3 are directed towards functional properties of the enzyme of claim 1. Claim 4 recites S. cerevisiae LDH. Claim 5 further comprises a linker. Claim 6 further requires porphyrin-binding to a metal. However, these dependent claims lack adequate written description for the same reasons given above. The functional properties of claims 2 and 3 are only reasonably correlated to the limited showing of LDH-CytB-CytC and LDH-CytC. Claim 4 remains generic to the catalytic activity phenotype of LDH and minimal c-type cytochrome peptide. Claim 5 is generic, and the disclosure does not teach any representative number of species of linker or any particular structure-function correlation. While the properties of claim 6 would necessarily limit claim 1 to the cytochrome-type lactate dehydrogenases, claim 6 remains generic to the minimal c-type cytochrome peptide and fusion attachment site.
For the reasons given above, claims 1-6 and 15-19 are found to lack descriptive support and fail to comply with the written description requirement.
Conclusion
No claims are allowed. No claims are free of the art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Koder et al. (US 2012/0034671; Reference A), Plesch et al. (US 2009/0300794; Reference B), Ostermeier (US 2009/0005266; Reference C), and Durilat et al. (CLIN.CHEM. 22/11, 1802-1805 (1976); Reference W2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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