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/Restriction
Applicant’s election of the species of Ir-9049 and label 9643 in the reply filed on 11/03/2025 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)).
Claim Status
The amendment of 11/03/2025 has been entered. Claims 1, 20, 22, 24, 26-27, 30, 32, 34-39, 45-48, 51, and 59-61 are pending in this US patent application. Claims 34-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/03/2025.
Claims 1, 20, 22, 24, 26-27, 30, 32, 45-48, 51, and 59-61 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statements filed in this application on 02/12/2024 and 06/14/2024 have been received and considered.
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, 20, 22, 24, 26-27, 30, 32, 45-48, 51, and 59-61 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.
The MPEP states that the purpose of the written description requirement is to ensure that the invention had possession, as of the filing date of the application, of the specific subject matter later claimed by him or her. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention.’ Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F. 2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F. 3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient” (MPEP § 2163).
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus (MPEP § 2163). Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
These factors are discussed below:
(1) Level of skill or knowledge in the art:
The level of skill in the art is high.
(2) Partial structure:
Claim 1 recites a bioluminescent protein, which encompasses all proteins having at least 70% sequence identity with SEQ ID NO.: 1 or a circularly permuted variant thereof, along with all structurally-complementary components, of presumably any length and level of complementarity, of a bioluminescent complex with at least 70% sequence identity to SEQ ID NO.: 2.
(3) Physical and/or chemical properties:
The protein must be bioluminescent according to claim 1, but it can vary in up to 30% of the residues of SEQ ID NO.: 1 or in the structurally-complementary components of SEQ ID NO.: 2. The instant disclosure provides no discussion of which residues are important or necessary for the bioluminescence of the protein.
(4) Functional characteristics alone or coupled with a known or disclosed correlation between structure and function:
Claim 1 recites that the bioluminescent protein catalyzes emission of a first wavelength of light from a coelenterazine luminophore upon interaction therewith. As such, claim 1 encompasses all proteins having at least 70% sequence identity with SEQ ID NO.: 1 or a circularly permuted variant thereof, along with all structurally-complementary components, of presumably any length and level of complementarity, of a bioluminescent complex with at least 70% sequence identity to SEQ ID NO.: 2 that also are capable of the function of catalyzing emission of light from a coelenterazine luminophore.
(5) Method of making the claimed invention:
The instant specification provides no structural information regarding the bioluminescent protein and which portions of the protein are structurally necessary for the recited enzymatic function. The proteins of SEQ ID NO.: 1 and SEQ ID NO.: 2 are the only species discussed in the instant disclosure to perform the recited function within the significantly broader genus recited in the instant claims.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F. 2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outline [goals] appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s) had possession of the entire scope of the claimed invention at the time the application was filed.
Therefore, claims 1, 20, 22, 24, 26-27, 30, 32, 45-48, 51, and 59-61 are rejected under 35 U.S.C. 112, first paragraph, as failing to meet the written description requirement.
Election/Restrictions
Claim 1 is free of the prior art with the elected species of photocatalyst and activatable label. The closest art to claim 1 in light of Applicant’s elected species is found in the teachings of Lindberg, as discussed below. However, Lindberg does not teach or suggest the specific photocatalyst and activatable label elected by Applicant. As such, the Examiner has selected another species of photocatalyst and of activatable label for examination at this time. The Examiner’s selected species of photocatalyst is Ru(bpy)2phen, and the Examiner’s selected species of activatable label is PNA-PyRho. In light of the Examiner’s selections, claims 22, 24, 26-27, 30, 32, 34-39, 47-48, 51, and 60 are withdrawn from consideration at this time.
Claims 1, 20, 45-46, and 61 are currently under examination and were examined on their merits.
Claim Rejections - 35 USC § 102
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.
Claims 1, 20, 45-46, and 61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lindberg et al., Nature Communications 9(1): 3539 (2018; cited on the IDS filed 02/12/2024).
Lindberg teaches Nanoluc luciferase fused to a self-labeling protein and then labeled with a linker comprising Ru(bpy)2phen, methotrexate, and a nucleic acid (see entire document, including page 3, left column, paragraph 2). This luciferase construct was mixed with furimazine and a nucleic acid conjugated to rhodamine (PNA-PyRho), resulting in the release of rhodamine (page 8, right column, paragraph 2; reads on claims 1, 20, 45-46, and 61; the Examiner notes that Nanoluc is equivalent to instant SEQ ID NO.: 1, as stated in the instant specification on page 15, line 18).
Therefore, claims 1, 20, 45-46, and 61 are anticipated by Lindberg and are rejected under 35 U.S.C. 102(a)(1).
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 1, 20, 45-46, and 61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, 8, 12, 14, 17-18, 20-33, 35-39, 41-48, 50, 52-59, 61, and 63-71 of copending Application No. 18/613432 in view of Lindberg et al., Nature Communications 9(1): 3539 (2018). The cited claims of ‘432 recite all of the limitations of the instant claims with the exception of the activatable label of instant claim 1. However, the inclusion of an activatable label with a system comprising the rest of the elements of the system recited in instant claim 1 is taught in Lindberg, as discussed above. As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘432 in view of Lindberg and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 03/03/2026