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 .
DETAILED ACTION
Claims 1-22 are pending in the current application.
Claims 8-22 are withdrawn from consideration (see discussion, below).
Claims 1-7 are examined in the current application.
Election/Restrictions
Applicant’s election without traverse of claims 1-7 in the reply filed on February 23rd 2026 is acknowledged.
Claims 8-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 23rd 2026.
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.
Claim 1 is rejected under 35 U.S.C. 112(a), because the specification, while being enabling for a first taste receptor with the polypeptide sequence set forth in SEQ ID No: 2, a second taste receptor comprising a first subunit with the polypeptide sequence set forth in SEQ ID No: 1, and a second subunit with the polypeptide sequences set forth in SEQ ID No: 3, or SEQ ID No: 4, does not reasonably provide enablement for a first taste receptor having a polypeptide sequence which has at least 90% identity to SEQ ID No:2, a second taste receptor comprising a first subunit having a polypeptide sequence which has at least 90% identity to SEQ ID No: 1, and a second subunit having polypeptide sequences which have at least 90% identity to SEQ ID No. 3, or SEQ ID No. 4. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with this claim.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
the quantity of experimentation necessary,
the amount of direction or guidance provided,
the presence or absence of working examples,
the nature of the invention,
the state of the prior art,
the relative skill of those in the art,
the predictability of the art, and
the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108,427 F.2d 833,839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, state and predictability of the art, and relative skill level
The invention relates to a method of identifying compounds that produce or enhance umami taste by measuring the response of two taste receptors to test compositions in comparison to positive and negative controls. The relative skill of those in the art is of one with an advance degree.
The breadth of the claims
Since the instant specification provides no limiting amount of taste receptors, subunits or proteins that meet the amino acid sequences having at least 90% identity to SEQ ID No. 1, SEQ ID No. 2, SEQ ID No. 3, or SEQ ID No. 4, the taste receptors and taste receptors subunits meeting such polypeptide sequence range requirements, will be interpreted expansively. The claim is thus very broad insofar as it suggests that any protein meeting such amino acid sequence range requirements, will be activated and display a response in the presence of an umami taste compound.
The amount of direction or guidance provided and the presence or absence of working examples
While the specification provides guidance and examples of taste receptors and taste receptor subunits with the polypeptide SEQ ID Nos1, 2, 3, or 4, the specification provides no direction or guidance for practicing the claimed invention in its "full scope". No reasonably specific guidance is provided concerning taste receptors with the polypeptide sequence having at least 90% identity to SEQ ID Nos 1, 2, 3, or 4.
The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that every possible protein with a polypeptide sequence that lies within the claimed polypeptide sequence range recited in claim 1 could have umami detecting capabilities as recited in claim 1. Accordingly, the instant claims do not comply with the enablement requirement of §112(a), since to practice the claimed invention in its "full scope" a person of ordinary skill in the art would have to engage in undue experimentation, with no reasonable expectation of success.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Adler et al. (USPatPub. 2017/0219567) in view of Wieland (USPatPub. 2012/0276563 A1).
Regarding claims 1-7: Adler discloses T1R G protein-coupled taste receptors and their subunits (T1R1/T1R3 (umami taste) and T1R2/T1R3 (sweet taste)) and methods of identifying potential taste modulating compounds, i.e., natural flavoring compositions, or synthetic (e.g., glutamate) (see Adler abstract, paragraphs [0073], [0084], [0085] and [0168]). Adler discloses identifying the potential taste modulators, by introducing the potential taste modulators to the taste receptors and measuring their activity, comparing the results to base activity without the modulators (negative control), and to activity when known modulator are used (positive control) (see Adler paragraphs [0167]-[0171]).
As to the polypeptide SEQ IDs recited in claim 1: Adler fails to disclose the polypeptide sequences represented by the SEQ ID Nos recited in claim 1; However, Wieland discloses amino acid SEQ ID 1-4 are known taste receptor to be used to test their activators (i.e., modulators) (see Wieland SEQ 2, 4, 6 and 8). Therefore it would have been obvious to a skilled artisan to use amino acid SEQ. 1-4 recited in claim 1, to assess potential taste receptor modulators, and thus arrive at the claimed limitations.
In the alternative, given the fact Adler is examining the same flavor tones and taste receptors contemplated by Applicant, it is examiner’s opinion the claimed polypeptide sequences embodied by the SEQ ID Nos. recited in claim 1, are inherently present in Adler. As set forth in MPEP §2112.01, "where...the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 59 CCPA 1036, 459 F.2d 531,173 USPQ 685 (1972)." In re Best, Bolton and Shaw 195 USPQ 430 (CCPA 1977).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASSAF ZILBERING whose telephone number is (571)270-3029. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached on (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASSAF ZILBERING/Examiner, Art Unit 1792
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