DETAILED ACTION
This Action is in response to the communication filed on 12/1/2025.
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 .
Status of the Claims
The amendments filed 6/13/2025 and 12/01/2025 have been entered.
Claims 1-22 are pending.
Claim 1-12, 20 have been previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/19/2024.
Applicant’s election without traverse of species (i): binding pair of SEQ ID NO: 1 and SEQ ID NO:2, in the reply filed on 12/1/2025 is acknowledged.
Claims 13-19, 21, 22 are addressed herein as they read on the elected subject matter.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located in new claim 21 and 22 which recited SEQ ID NOs: 1-18 but the Sequence listing only includes the nucleotide sequences SEQ ID NOs: 1-8.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Claim Objections
Claims 21 and 22 are objected to because of the following reasons: claims 21-22 recite 18 different nucleotide sequences identified as SEQ ID NOs: 1-18. However, the sequence listing only includes nucleotide sequences identified as SEQ ID NOs: 1-8. That is, the Sequence listing does not include SEQ ID NOs: 9-18. Since SEQ ID NOs: 9-18 are not included in the Sequence listing: (a) the application is not in sequence compliance (see above), and (b) the claims explicitly reciting SEQ ID NOs: 9-18 cannot be fully searched. Accordingly, claims 21-22 are objected to because they cannot be fully searched and examined as SEQ ID NOs: 9-18 cannot be fully and properly searched (i.e. a search of the nucleotide databases cannot be performed for SEQ ID NOs that are not present in the Sequence Listing). It is noted that SEQ ID NOs: 1-8 as provided in the Sequence Listing have been fully searched and no prior art was identified for SEQ ID NOs: 1-8 (i.e., the nucleotide sequences identified in the SEQUENCE LISTING as SEQ ID NOs: 1-8, not the sequences identified as SEQ ID NOs: 1-8 in claims 21-22). It is noted that the objection can be overcome by placing the application in compliance with the sequence rules (see above for further guidance). It is noted that should the application become compliant with sequence rules, a new search would be required for SEQ ID NOs: 9-18. Since claim 21-22 cannot be fully searched, however the claims have been searched and examined to the extent possible (i.e., SEQ ID NOs: 1-8 have been searched. The sequences that cannot be searched (i.e., SEQ ID NO: 9-18) have been withdrawn from further consideration. Claims 13-19 are subject to full search and examination.
Appropriate correction is required.
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 21- 22 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.
Claims 21 and 22 both explicitly recite: “5' tgctcctg 3' (SEQ ID NO:1) and 5' caggagca3' (SEQIDNO:2), 5' gcctgacg 3' (SEQ ID NO:3) and 5'cgtcaggc 3' (SEQ ID NO:4),5' ctgcctgacg 3' (SEQ ID NO:5) and 5'cgtcaggcag 3' (SEQ ID NO:6),5' gactgcctgacg 3' (SEQ ID NO:7) and 5'cgtcaggcagtc 3' (SEQ ID NO:8),5' tgctcctgt 3' (SEQ ID NO:9) and 5' acaggagca3' (SEQ ID NO:10),5' gtgcgtct 3' (SEQ ID NO:11) and 5' agacgcac 3' (SEQ IDNO:12), 5' gttggtgt 3' (SEQ ID NO:13) and 5' acaccaac 3' (SEQ ID NO:14),5' caacacaccaac 3' (SEQ ID NO:15) and 5' gttggtgtgttg 3' (SEQ ID NO:16), and5' acacaccaac 3' (SEQ ID NO:17) and 5' gttggtgtgt 3' (SEQ ID NO:18).” However, the sequence listing defines SEQ ID NO: 1 as ctgcctgacg, SEQ ID NO: 2 as cgtcaggcag, SEQ ID NO: 3 as gactgcctgacg, SEQ ID NO: 4 as cgtcaggcagtc, SEQ ID NO: 5 as caacacaccaac, SEQ ID NO: 6 as gttggtgtgttg, SEQ ID NO: 7 as acacaccaac, and SEQ ID NO: 8 as gttggtgtgt. The sequence listing does not include SEQ ID NOs: 9-18. It is noted that the nucleotide sequences recited in claims 21-22 that are identified as SEQ ID NOs: 1-8 do not match the nucleotide sequences listed in the Sequence Listing as SEQ ID NOs: 1-8. Since the sequences do not match it is unclear which specific nucleotide sequences applicant wishes to claim. It is noted that a search of the sequence databases using SEQ ID NOs: 1-8 listed in the sequence listing has been performed and prior art has not been identified for these specific sequences. However, a search for SEQ ID NOs: 9-18 could not be performed as the sequence listing does not include SEQ ID NOs: 9-18.
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.
Claims 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suresh et al. (The Journal Physical Chemistry B (2013) pp. 5397-5792, vol. 117, issue 18).
It is noted that claim 13 has been amended since the non-final office action, specifically by an amendment filed on 06/13/2025. Amended claim 13 now includes the new limitation “wherein the binding pair is obtainable by a method according to claim 1.” Claim 13 is drawn to a composition comprising binding pair of nucleic acid oligonucleotides. The new limitation merely indicates how the binding pair may be obtained (by the method of claim 1). However, the new limitation does not impart any new structural requirement to the claimed binding pair. Furthermore, the new limitation can be considered as a product-by-process limitation. Applicant is respectfully reminded that MPEP § 2113 (Product-By-Process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps) states,
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).”
Regarding claims 13-15, Suresh teaches analysis of fully modified locked nucleic acid (β-D-LNA and α-L-LNA) duplexes in comparison to pure DNA and RNA duplexes (see title). Suresh teaches that two fully modified LNA duplexes (β-LNA and α-LNA) having a nonamer (9-mer) sequence were produced and subject to molecular dynamic (MD) simulations (e.g., see p.5557 last paragraph of column 1). Suresh teaches that MD simulation was performed using the CHARMM36 all atom nucleic acid force field with ethe NAMD program which encompassed steps including immersion of the systems in a pre-equilibrated water box, and teaches that the modified TIP3P water model was used to model an explicit solvent environment (see p. 5557, paragraph bridging columns 1-2). Thus, Suresh teaches a liquid composition comprising an aqueous solvent and a binding pair, the binding pair comprising a first single-stranded (ss-) locked nucleic acid (LNA) oligonucleotide and a second ss-LNA oligonucleotide, wherein each of the first ss-LNA oligonucleotide and the second ss-LNA oligonucleotide consists of 8 to 15 LNA monomers, each LNA monomer comprising a nucleobase, the nucleobases of the LNA monomers forming a first nucleobase sequence of the first ss-LNA oligonucleotide and a second nucleobase sequence of the second ss-LNA oligonucleotide, and wherein the first ss-LNA oligonucleotide and the second ss-LNA oligonucleotide form an antiparallel duplex of 9 consecutive Watson-Crick base pairs. Although Suresh does not explicitly teach that the antiparallel duplex base pairs at a temperature from 20°C to 40°C, the fully modified LNA oligonucleotides taught by Suresh meet the structural limitations required by the claims thus they would necessarily have the same traits as the claimed ss-LNA oligonucleotides including forming an antiparallel duplex at a temperature of 20°C to 40°C. The limitation with respect to how the binding pair can be obtained is considered a product-by-process limitation and is addressed above.
Regarding claims 16-17, Suresh teaches that the ss-LNA oligonucleotides comprise adenine, uracil, guanine, and cytosine nucleobases (see p. 5557, last paragraph of column 1), which are nucleobases selected from the group of nucleobases listed in claim 16, and include two or three different nucleobases as required by claim 17.
Regarding claim 18, Suresh teaches the sequence of ss oligonucleotides is C[T/U]GA[T/U]A[T/U]GC which a 9-mer sequence that has a total of 4 G/C residues, which is a G+C content lower than 75% as 4/9=44% (see p. 5557, last paragraph of column 1).
Therefore, the instant claims are anticipated by Suresh.
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.
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Suresh et al. (The Journal Physical Chemistry B (2013) pp. 5397-5792, vol. 117, issue 18) in view of Eichart et al. (Nucleic Acids Research (2010) pp. 6729-6736, vol. 38, no. 19, of record – IDS citation).
Suresh, as discussed above, teaches analysis of fully modified locked nucleic acid (β-D-LNA and α-L-LNA) duplexes in comparison to pure DNA and RNA duplexes. Furthermore, Suresh states:
“There are no studies concerning the structural and energetic properties of fully substituted α-LNA duplexes. As mentioned above, an X-ray crystal structure of a full β-LNA duplex has been published recently.41 In the present paper, an attempt is made to investigate the structural, dynamic, and energetic properties of fully modified LNA duplexes (α-LNA and β-LNA) and how they compare to the corresponding pure DNA and RNA duplexes using MD simulations.” (see page 5557, first column).
It is noted that reference 41 cited by Suresh is Eichart et al. (Nucleic Acids Research (2010) of record – IDS citation) which, as explained by Suresh, teaches identifying an X-ray crystal structure of a full β-LNA duplex.
Suresh does not teach each cytosine is replaced by 5-methylcytosine (m5C), as required by claim 19.
Eichart teaches determination of an X-ray crystal structure of a full β-LNA duplex that is a 7mer helix derived from the Escherichia coli tRNA and constructed “to contain exclusively LNA building blocks by maintaining the base sequence of the RNA except the U to T and C to m5C exchange in standard LNA synthesis.” (See p. 670 under “Materials and Methods”). Accordingly, Eichart teaches -ray crystal structure of fully LNA modified duplex wherein each nucleobase is an LNA base and each cytosine is 5-methylcytosine.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the date that the instantly claimed invention was filed to modify the LNA duplexes of Suresh such that each cytosine is replaced with 5-methylcytosine, with a reasonable expectation of success.
It is noted that KSR forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396).
The combination of prior art cited above satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 USPQ2d 1385 (2007):
“Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.”
In this case, at least rationales (B), (C), (E), and/or (G) apply.
Nevertheless, since Suresh teaches that an X-ray crystal structure of a full β-LNA duplex has been published recently, explicitly citing Eichart, and considering that Suresh is building on the work of Eichart, as indicated by Suresh’s explicit reference to Eichart, as indicated above, there would have been motivation to modify the LNA duplex used by Suresh such that each cytosine is replaced with 5-methylcytosine, for instance, at least have consistency with the prior art. Furthermore, the fact that a fully LNA modified duplex was made and the X-ray crystal structure of the duplex was successfully determined (as reported by Eichart), provides a reasonable expectation of success for replacing each cytosine with 5-methylcytosine in Suresh’s LNA duplex.
Therefore, the instant claim is unpatentable over the cited prior art.
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 13-19, and new claims 21, 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, 15-18 of copending Application No. 17/544,110 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are drawn to a liquid composition comprising an aqueous solvent and a binding pair comprising a first and second ss-LNA oligonucleotide that consist of 8 to 15 LNA monomers that form an antiparallel duplex at a temperature from 20°C to 40°C.
Claim 13 of the ‘110 application is drawn to a pair of separate complementary ss- oligonucleotides, each ss-oligonucleotide consisting of LNA monomers, the separate ss-oligonucleotides in aqueous solution being capable of forming with each other and antiparallel duplex in the absence of denaturing conditions prior to duplex formation or during duplex formation. Claim 15 provides specific ss-oligonucleotide sequences which pair, including SEQ ID NO: 9 and SEQ ID NO: 10 each of which consists of 9 LNA bases, and claim 18 is drawn to a method of forming antiparallel all -LNA duplex the method comprising the steps of (a) providing separately the first and the second member of a pair of single-stranded all- LNA oligonucleotides of claim 13, wherein each single-stranded all-LNA oligonucleotide is separately dissolved in aqueous solution in the absence of a denaturant and kept at a temperature from 0 0C to 40 °C; (b) contacting the single-stranded all-LNA oligonucleotides of the pair with each other at a temperature from 0 0C to 40 0C in the absence of a denaturant; thereby forming the antiparallel all-LNA duplex.
Regarding instant claim 19 which requires each cytosine is replaced by a 5-methylcytosine, although the claims of the co-pending application do not explicitly require that each cytosine is replaced by a 5-methylcytosine, using the specification of the co-pending application as a dictionary to define specific embodiments encompassed by the claimed invention, it is clear that the specification of the co-pending application indicates that each cytosine can be replaced by a 5-methylcytosine (e.g., see paragraph [0157] of the published application (US20220195497A1)).
Regarding new claims 21-22 encompass binding pairs including the paired sequences SEQ ID NO: 5 and SEQ ID NO: 6. Claims 15 of the ‘110 application indicates that the binding pair can be a pair including a sequence identified as SEQ ID NO: 23 and SEQ ID NO: 17. It is noted that instant SEQ ID NO: 5 is identical to SEQ ID NO: 17 of the ‘110 application and instant SEQ ID NO: 6 is identical to SEQ ID NO: 23 of the ‘110 application.
Therefore, the instant claims are an obvious variation of the invention claimed in co-pending U.S. application 17/544,110, and a nonstatutory double patenting rejection is appropriate.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 06/13/2025 have been fully considered but they are not persuasive.
Regarding the rejection of claims under 35 USC 102 and 35 USC 103, Applicant argues that the oligonucleotides taught by Suresh would meet the structural limitations of the claims including forming a duplex at temperature of 20 to 40 degrees C, and that claim 13 has been further amended to recite that the binding pair is obtainable by the method of claim 1.
In response, as indicated in the rejection, the binding pair taught by the prior art meets the structural limitations required by the claims, therefore the would necessarily have the same functional characteristics as well, including forming a duplex at 20-40 degrees C. Furthermore, MPEP 2112.01 II (Composition claims – If the composition is physically the same , it must have the same properties), which states:
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
It is noted that MPEP 2112.01 also indicates that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. In the instant case, there is no evidence showing the prior art product do not necessarily possess the characteristics of the claimed products. This should not be construed as an invitation for providing evidence. Applicant is reminded of the timely submission of evidence as stated in MPEP 716.01.
For these reasons and reasons made of record, the rejection is maintained.
With respect to the non-statutory double patenting rejection of claims, it is noted that applicant present no traversal of the rejection. Since the rejection has not been traversed, the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637