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
In response to the restriction requirement dated 2nd March 2026, Applicant elects, without
traverse: PS1259 (SEQ ID NO: 605). Applicant's election in the reply filed on 3 August 2026 is acknowledged.
Claims 80, 85-86, 113-114, 191-205 are pending. Claims 80, 85-86, 113-114, 193-194, 198-203 and 205, read on the elected species and are hereby examined on the merits. Claims 191-192, 195-197 and 204 are withdrawn from further consideration pursuant to 37 CFR l.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Priority
This application filed 08/03/2023 Claims Priority from Provisional Application 63395328, filed 08/04/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/03/2026 and 05/03/2024 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 85 is objected to because of the following informalities: Examiner requests Applicant to assign specific SEQ ID NOs, not included in parenthesis. Appropriate correction is required.
Claim 198 is objected to because of the following informalities: Examiner requests Applicant to assign specific SEQ ID NOs, not included in parenthesis. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: ‘configured to’ in claim 86 (iii) and (iv); ‘configured to’ in claim 114 (i) and (ii).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 80, 85, 198, 199, 193, 194 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 80 is directed to ‘at least 80 % identical to SEQ ID NO: 3, wherein’ comprising substitutions at recited amino acid positions. It is unclear if the claim is directed to a sequence that is 80 % identical to SEQ ID NO: 3 wherein the recited amino acid substitutions are part of the variability in sequence or if the claim is directed to a sequence that is 80 % identical to SEQ ID NO: 3, and in addition, comprises one or more of the recited amino acid substitutions. As such, two possible interpretations are drawn from the claim. For prior art purposes, Examiner interprets the claim to be directed to 80 % identity to SEQ ID NO: 3, and additionally, at least one or more of the recited substitutions.
Claim 85 is 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 85, which is dependent on claim 80, requires a 90 % sequence identity to the recited SEQ ID Nos: 604-606, 660-663, 792-833, 836-1025. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 85 recites the broad recitation of ‘amino acid binding protein of claim 80’, which requires 80 % sequence identity to SEQ ID NO: 3; and the claim also recites ‘90 % identical’ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For prior art purposes, Examiner interprets the instant claim to be directed to a sequence that is 90 % identical to any one of the recited sequences, i.e., SEQ ID NOs 604-606, 660-663, 792-833, 836-1025.
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.
Claims 85 and 194 are 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.
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Claim 85 which is dependent on claim 80, is directed to at least 80 % identity to SEQ ID NO: 3 and at least 90 % identity to the recited sequences. As a representative example (shown below), SEQ ID NO: 916 in the instant claim, has a query match of 63.7 % with SEQ ID NO: 3, which is well below the sequence identity threshold that is required of the sequences in claim 85.
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.
Claim 194 is dependent on claim 193 and is directed to a substitution at position H78. The sequence in claim 193 does not contain H78. 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.
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 86, 113, 200-202, 114, 203, 205 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.
Claim 86 is directed to a protein comprising a structure of Formula (III). In the instant claim, all regions (i.e. α, β, loop) comprise variables -such as peptide sequence, length, composition, functional groups, side chain extensions, N/C-terminal additions, etc.
Claim 113 is directed to a protein comprising a structure of Formula (III-A). In the instant claim, all regions (i.e. α, β) comprise variables -such as peptide sequence, length, composition, functional groups, side chain extensions, N/C-terminal additions, etc.
Claim 114 is directed to a protein comprising a structure of Formula (III-B). In the instant claim, all regions (i.e. α, β, loop) comprise variables -as noted above
Embodiments of the specification reduce to practice ‘structural equivalents’ to Formula (III) (III-A) (III-B) corresponding to specific sequences i.e. SEQ ID NOs: 604-606, 660-663, 792-833 and 836-1025 (see page 38). Applicant, does not reduce to practice all possible sequences or proteins, with a representative peptide structure of Formula (III), Formula (III-A) or Formula (III-B). The written description requirement for “a structure” may be satisfied through sufficient description of a representative number of species of peptide, by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that the Applicant was in possession of the claimed genus of peptides. A “representative number of species” means that the species that are adequately described are representative of the entire genus. See MPEP 2163.
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For example, the PDB database as shown above, lists at least 49, 132 structures comprising mixed alpha/beta proteins. The sequences described in the specification are not representative of the full variation of peptides or proteins comprising the claimed structures represented by Formula (III), (III-A) or (III-B). As such, a skilled artisan is unable to predict all the sequences of peptides that would collectively present a core structure sufficient to encompass the recited Formulas. Thus, the specification fails to satisfy the written description requirement of 35 USC 112 (a) with respect to claim 86, 113 and 114. A claim directed to SEQ ID NOs: 604-606, 660-663, 792-833 and 836-1025 would be fully supported by the disclosure.
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 80, 85-86, 113-114, 193-194, 198-199, 200-203 and 205 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon (natural product) without significantly more.
Regarding claim 80, the claim(s) recite(s) the judicial exception ‘amino acid binding protein…SEQ ID NO: 3’. This judicial exception is not integrated into a practical application because the claims are drafted such that there is no difference in substance from the sequence claim, to that of a naturally occurring protein N-terminal glutamine amidohydrolase in Brienomyrus brachyistius and naturally occurring N-terminal glutamine amidohydrolase-like in Scleropages formosus. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
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See the following analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is directed to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or
abstract idea?
Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon? Yes,
the claim recites an amino acid sequence. Under the broadest reasonable interpretation, the claimed sequence comprising at least 80 % identical to SEQ ID NO: 3, is the sequence of the N-terminal glutamine amidohydrolase protein and the N-terminal glutamine amidohydrolase-like protein that is naturally occurring in Brienomyrus brachyistius and Scleropages formosus respectively.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions
into a practical application. The claim is directed only to the amino acid sequence and to the function
incorporated by the sequence.
Regarding claim 85, the claim(s) recite(s) the judicial exception ‘at least 90 % identical…836-1025)’. This judicial exception is not integrated into a practical application because the claims are drafted such that there is no difference in substance from the sequence claim, to that of a naturally occurring protein N-terminal glutamine amidohydrolase in Homo sapiens. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
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See the following analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is directed to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or abstract idea?
Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon? Yes,
the claim recites an amino acid sequence. Under the broadest reasonable interpretation, the claimed sequence comprising at least 90 % identical (i.e. SEQ ID NO: 916- 929), is the sequence of the N-terminal glutamine amidohydrolase protein that is naturally occurring in Homo sapiens.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions
into a practical application. The claim is directed only to the amino acid sequence and to the function
incorporated by the sequence.
Regarding claims 86, 113 and 114, the claim(s) recite(s) the judicial exception of a structure of Formula or structural equivalent. Embodiments of the specification disclose ‘structural equivalents’ to Formula (III) (III-A) (III-B) corresponding to specific sequences i.e. SEQ ID NOs: 604-606, 660-663, 792-833 and 836-1025 (see page 38).
This judicial exception is not integrated into a practical application because the claims are drafted such that there is no difference in substance, from the structure represented by the Formula, to that of a naturally occurring protein N-terminal glutamine amidohydrolase in Homo sapiens. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
See the following analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is directed to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or
abstract idea?
Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon? Yes,
the claim recites a structural Formula. Under the broadest reasonable interpretation, the claimed sequence comprising at least 90 % identical (i.e. SEQ ID NO: 916- 929), is the sequence of the N-terminal glutamine amidohydrolase protein that is naturally occurring in Homo sapiens.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a
practical application? No, the additional elements in the claim do not integrate the judicial exceptions
into a practical application. The claim is directed only to the structure and to the function
incorporated by the structure.
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) 80 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Jose A. Alves-Gomes hereinafter Gomes (Jose A. Alves-Gomes, The Journal of Experimental Biology 202, 1167–1183 (1999)) as evidenced by Sequence ID: XP_048850104.1.
Regarding claim 80, Gomes teaches Brienomyrus species, specifically, Breinomyrus brachyistius (see Table 1, page 1169) evidenced by the sequence for protein N-terminal glutamine amidohydrolase (see below). Examiner interprets a protein having at least 80 % identity to SEQ ID NO: 3 and in addition, one or more amino acid substitutions as noted in the rejection under 35 U.S.C. 112(b). Accordingly, 146 amino acids that are identical to the 200 amino acid SEQ ID NO: 3 (i.e. 160/200 to meet 80 % identity, and the additional 14 substitutions recited in the claim, totaling 146/200; i.e. 73 %), will read on the claim. Amino acid substitutions at positions S39 and N120, meet the limitations of the claim. See alignment below.
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Claim(s) 80 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Yetty Natalia et al., hereinafter Natalia (Yetty Natalia et al., Aquaculture 233 (2004) 305–320) as evidenced by Sequence ID: KPP58210.1.
Natalia teaches Scleropages formosus, (see Abstract) as evidenced by the sequence for protein N-terminal glutamine amidohydrolase-like (see below). Claim interpretation has been noted above. Amino acid substitutions at C23 and C25, meet the limitation of the claim.
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Claim(s) 85, 86, 113, 114 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Mi Seul Park et al., hereinafter Park (Mi Seul Park et al., Plos one 9 (2014) 1-8) as evidenced by Sequence ID: NP_060494.1.
Regarding claim 85, Park teaches N-terminal glutamine amidohydrolase evidenced by Sequence ID: NP_060494.1. In the interest of compact prosecution, search has been expanded to include the genus. As noted in the rejection under 35 U.S.C 112(b), the claim is interpreted as directed to a sequence at least 90 % identical to the recited sequences. SEQ ID NOs: 916-929 in the instant claim, are >90 % identical to Sequence ID: NP_060494.1. A representative example is shown below.
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Regarding claim 86, embodiments of the specification disclose ‘structural equivalents’ to Formula (III) (III-A) (III-B) corresponding to specific sequences i.e. SEQ ID NOs: 604-606, 660-663, 792-833 and 836-1025 (see page 38). As noted in the rejection above, SEQ ID NOs: 916-929 are >90 % identical to Sequence ID: NP_060494.1. Regarding claim limitation ‘wherein the binding pocket….acid’, Applicant is reminded that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art' s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Regarding claim 113, the rejection has been noted above.
Regarding claim 114, the rejection has been noted above under the rejection for claim 86.
Claim Rejections - 35 USC § 103
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 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, 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 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.
Claim(s) 80 and 199 are rejected under 35 U.S.C. 103 as being unpatentable over Yetty Natalia et al., hereinafter Natalia (Yetty Natalia et al., Aquaculture 233 (2004) 305–320) as evidenced by Sequence ID: KPP58210.1 in view of Georgeta Crivat et al., hereinafter Crivat (Georgeta Crivat et al., Trends Biotechnol. 2012 January ; 30(1): 8–16).
The teachings of Natalia have been set forth above.
Additionally, regarding claim 199, Crivat teaches that watching biological molecules provide clues to their function and regulation, and that some of the most powerful methods is labelling proteins for imaging, using fluorescent tags (see Abstract).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sequence of Sequence ID: KPP58210.1 with a luminescent label. One motivated to do so would have a reasonable expectation of success as fluorophores provide clues to function and regulation of proteins. Thus, one would have recognized that applying the teaching of Natalia, to the method of Crivat, would have yielded predictable results and improved the biological suitability of the protein (See MPEP § 2143 l(A)(D)).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 80, 85-86, 113-114, 193-194, 198-203 and 205 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33, 37,39, 43-47, 67, 70-72, 76-77, 79, 83, 95 of copending Application No. 19264736 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 80, 85-86, 113-114, 193-194, 198, 200-203 and 205 read on the elected species, i.e. SEQ ID NO: 605.
Regarding claims 80, 85-86, 113-114, 193-194, 198, 200-203 and 205, SEQ ID NO: 605 is a 100 % sequence match to SEQ ID NO: 1 in the reference application ‘736. See below.
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Claims 80 and 199 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33, 37,39, 43-47, 67, 70-72, 76-77, 79, 83, 95 of copending Application No. 19264736 (reference application) in view of Georgeta Crivat et al., hereinafter Crivat (Georgeta Crivat et al., Trends Biotechnol. 2012 January ; 30(1): 8–16).
Regarding claim 199, the teachings of reference application ‘736 have been set forth above.
Reference application ‘736 does not teach luminescent labels.
Crivat teaches that watching biological molecules provide clues to their function and regulation, and that some of the most powerful methods is labelling proteins for imaging, using fluorescent tags (see Abstract).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sequence of the reference application ‘736 with a luminescent label. One motivated to do so would have a reasonable expectation of success as fluorophores provide clues to function and regulation of proteins. Thus, one would have recognized that applying the teaching of reference application ‘736, to the method of Crivat, would have yielded predictable results and improved the biological suitability of the protein (See MPEP § 2143 l(A)(D)).
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights