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 following species: a synthetic luciferase (claim 3); glutamate (claim 4); SEQ ID NO:8 (claims 10-11); and SEQ ID NO:4 (claims 12, 15, 16), in the reply filed on 13 November 2025 is acknowledged.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1-13 are examined upon their merits.
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 Application No. 63/102,004, filed on 11 January 2022.
Claims 1-13 have an earliest effective US filing date of 11 January 2022.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Specifically, paragraph [0007] cites a reference but no IDS has been submitted. Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Specifically, paragraph [0027] of the specification contains an embedded hyperlink that may be remedied by spelling out “world wide web dot ncbi.nlm…”. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 is directed to a nucleotide sequence, which fails to limit the bioluminescent protein indicator of the parent claim, Claim 1. Depending claim 12 does not further limit the subject matter of the claim upon which it depends, and does not include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-10 and 12-13 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.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. Claim 1 recites “a first portion of a bioluminescent peptide…wherein the bioluminescent protein indicator luminesces upon the ligand binding to the binding peptide” and a “a second domain comprising a binding peptide which binds a ligand” wherein “the second domain binds to …[the instantly elected] glutamate” Claim 4. These are essential elements are claimed by what they do rather than what they are materially; Claim 6 recites, “a sequence comprising at least 85% sequence identity to an Igx leader sequence”; Claim 8 recites, “the transmembrane domain comprises a sequence comprising at least 85% sequence identity to PDGFRP”; Claim 10 recites, “at least 85% sequence homology to the sequence… [of the instantly-elected] SEQ ID NO: 8”; and Claim 12 recites, “at least 85% sequence identity … [of the instantly-elected] SEQ ID NO: 4”. The specification provides no description of what 15% of these proteins can be altered such that the invention maintains the functional requirements of the claims. These claims do not require the domains or sequence identities possess any particular structure or distinguishing feature such that a person having ordinary skill in the art could at once envision those domains or sequences that are encompassed. Therefore the claims are drawn to a genera of domains or sequences.
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 (see MPEP 2163(II)(3)(a)( i)(A), reduction to drawings MPEP 2163(II)(3)(a) (i)(B), 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 MPEP 2163(II)(3)(a) (i)(C). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
In the instant case, the only factor present in the claim is a recitation of requisite activity (fluorescing upon binding; binding; etc.). There is not even identification of any particular portion of a structure that must be conserved for the claimed activities.
Regarding the first domain comprising a first portion of a bioluminescent peptide…wherein the bioluminescent protein indicator luminesces upon the ligand binding to the binding peptide” the specification teaches only three full-length luciferase molecules: luciferase from Gaussia princeps, luciferase from Renilla reniformis, or a synthetic luciferase. There is no written description of any “portion” of these molecules that maintains the functional requirements of the claim. Thus, the claims encompass a genus of “portions”, and the instant specification fails to adequately describe that genus in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s) had possession of the claimed invention.
Regarding the 85% identities encompassed by the claims, the specification fails to provide a representative number of species that are up to 15% altered such that a person having ordinary skill in the art would at once envision those altered sequences that still maintain the functional requirements of the instant claims. The specification teaches only a leader domain comprising Igκ; a full-length SEQ ID NO: 8; and a full-length SEQ ID NO:4. Claim 11 is explicitly left out of this rejection because it teaches the indicator of SEQ ID NO: 8. Thus, the specification fails to provide adequate description for the genus of molecules encompassed by the claims. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, or representative number of species, the specification does not provide adequate written description of the claimed genus.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see page 1115).
Claims 1-10 and 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a bioluminescent indicator comprising a bioluminescent indicator comprising the instantly-elected SEQ ID NO: 8, does not reasonably provide enablement for any other bioluminescent indicator encompassed by the broad scope of the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
With respect to claim breadth, the standard under 35 U.S.C. §112, first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. In addition, when analyzing the scope of enablement, the claims are analyzed with respect to the teachings of the specification and are to be “given their broadest reasonable interpretation consistent with the specification.” See MPEP 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
As such, the broadest reasonable interpretation of the invention is that it comprises any portion of a first domain wherein the bioluminescent protein indicator luminesces upon the ligand binding to the binding peptide, and a second domain comprising a binding peptide which binds any ligand; and, a third domain comprising a second portion of the bioluminescent peptide. A skilled artisan would not know how to use the method with a reasonable expectation of success based solely on what is disclosed in the specification.
What is enabled by the disclosure is narrow in comparison to the breadth of what is encompassed by the claims: The specification discloses a bioluminescent indicator consisting of the instantly-elected SEQ ID NO: 8, which binds glutamate. The claims, however, broadly encompass any tri-domain molecule that luminesces upon a ligand binding to the binding peptide. The claims encompass a molecule comprising a sequence comprising at least 85% sequence identity to an Igx leader sequence; a transmembrane domain comprising a sequence at least 85% sequence identity to PDGFRP; and , a sequence 85% homologous to SEQ ID NO: 8. There is no guidance or direction within the disclosure as filed as to what 15% of the residues within each of these sequences can be substituted/deleted/modified while still maintaining the function of the bioluminescent indicator. Therefore, the specification does not provide enabling support for how to make the invention commensurate in scope with what is claimed.
The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. The instant specification is not enabling because one cannot follow the guidance presented therein, or within the art at the time of filing, and make the claimed method without first making a substantial inventive contribution. Given that the nature of the invention, a person having ordinary skill in the art would have to make multiple proteins comprising sequences in which 15% of the residues are substituted/deleted/modified and demonstrate that these constructs maintain the ability to luminesces upon ligand binding. The amount of experimentation required for enabling guidance, commensurate in scope with the breadth of the claim invention, goes beyond what is considered ‘routine’ within the art, and constitutes undue further experimentation in order to make the invention with a reasonable expectation of success. Therefore, Claims 1-10 and 12-13 are rejected under 35 U.S.C. 112, first paragraph, for failing to meet the enablement requirement.
Conclusion
Claim 11 is objected to as being dependent upon a rejected base claim, but in so far as it reads upon the elected SEQ ID NO:8, would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
No claim is allowed.
Correspondence
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