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 with traverse of Group I (claims 1-10) in the reply filed on March 5, 2026 is acknowledged. The traversal is on the grounds that there is not a serious search burden because the claimed method is specifically tied to and relies on the claimed antibody-DNA conjugate. This is not found persuasive because the claimed antibody-DNA conjugate can also be a therapeutically useful product. Thus, the searches for a therapeutically useful antibody-DNA conjugate would be different from a diagnostic tool comprising the claimed antibody-DNA conjugate. Thus, there is a serious search burden due to the differences in the scope of the claims.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 5, 2026. Therefore, claims 1-10 are under examination.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete.
Required response - Applicant must:
• 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.
It is noted that the Sequence Listing Incorporation by Reference paragraph lists the size of the XML file as 72 KB. However, the size should be listed as 72,807 bytes.
Specification
The disclosure is objected to because of the following informalities:
All acronyms throughout the specification should be written out fully followed by the acronym in parentheses at the first occurrence of each acronym.
Appropriate correction is required.
Claim Objections
Claims 1, 7-8, and 10 are objected to because of the following informalities:
At claim 1, lines 2-3, “configured to bind” should be changed to “capable of binding.”
At claim 1, lines 4-5, “configured to bind” should be changed to “capable of binding.”
At claim 7, line 3, “close” should be changed to “closed.”
At claim 8, line 4, “and” should be inserted before “marker proteins of acquired diseases.”
At claim 10, line 2, “AZ biomarkers” should be changed to “Alzheimer’s biomarkers.”
Appropriate correction is required.
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 1-8 and 10 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 inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. 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.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
A written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name," of the claimed subject matter sufficient to distinguish it from other materials. Fiers v. Revel, 984 F.2d at 1171,25 USPQA2d, 1601; In re Smyth, 480 F.2d 1376,1383, 178 USPQ 279,284 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is an unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
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 a sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that, for a generic claim, the genus can be adequately described in the disclosure presents a sufficient number of representative species that encompass the genus. 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. See MPEP § 2163. Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad genus. 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. 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: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial Structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and v. Correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art.
A "representative number of species" means that the species, which are adequately described, are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. This disclosure of only one or a few species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 115; Noelle v. Lederman, 355 F.3d, 1343, 1350, 69 USPO2d 1508, 1514 (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). In addition, it has been well known that minor structural differences even among structurally related compounds can result in substantially different biology, expression, and activities. The instant claims require an antibody-DNA conjugate comprising a first antibody-DNA conjugate, which can bind to a target protein and a second antibody-DNA conjugate, which can also bind to the target protein, with a first oligo linked to a first antibody and a second oligo linked to a second antibody. The rejected claims thus comprise a genus of antibody-DNA conjugates that are each capable of binding to a target protein, which may be any protein. The specification and claims further recite that the target protein can be any marker proteins of pathogens, marker proteins of infectious diseases, marker proteins of genetic diseases, and marker proteins of acquired diseases. Claim 10 further recites that the target protein can be an Alzheimer’s (AZ) biomarker or a cancer biomarker.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof. The specification provides data regarding the detection of only a few proteins/biomarkers. Specifically, Applicants provide data for several proteins, including SARS-Cov2, troponin I (TnI), troponin T (TnT), Tau, Tau 181, CEA (carcinoembryonic antigen), CA199, PSA, and CA153 (see Tables 4 and 6).
However, it is impossible for one to extrapolate from the limited specific proteins and/or the generic recitation of broad classes of biomarkers that would be detectable using the claimed antibody-DNA conjugate. The prior art does not appear to offset the deficiencies of the instant specification. The prior art teaches that, while biomarkers give a “dynamic and incredible way to deal with understanding the range of neurological illness” (Priyanaka et al. 10(4) World Journal of Pharmaceutical Research 408-417 (2021)) (abstract). Priyanaka further discloses types of biomarkers being biomarkers of exposure (used in risk prediction) and biomarkers of disease, which are used in screening, diagnosis and monitoring disease progression (paragraph bridging pages 409 and 410). Priyanaka provides a discussion of a wide variety of biomarkers, from environmental exposure effect modifies, genetic susceptibility, intermediate biomarkers, and biomarkers of disease (pages 411-413). Priyanaka, however, also discloses that inconstancy and changeability can be significant concerns (paragraph bridging pages 413 and 414). Priyanaka further discloses that the assessment of biomarker legitimacy is unpredictable (page 414, first full paragraph).
In addition, the prior art discloses that prognostication tools have limited accuracy and variable levels of validation (Hui, 22(4) Cancer Control 489-497 (2015)) (abstract). Hui further discloses prognostic factors differ in early stage and advanced stage cancer (Table 1). And, while Hui nots that prognostic tools (i.e., biomarkers) can facilitate clinical decision-making, there is uncertainty in survival prediction (abstract).
Chen et al. (2(2) International Journal of Pathology and Clinical Research 1-6 (2016)) disclose that pathway-based analyses show promise for fining true tumor biomarkers, but fail to explain why the onset of cancer can still be partially due to “bad luck” (abstract). Chen further discloses that determination of molecular explanations for apparently random epigenomic occurrences will assists researchers in finding biomarkers (page 4, column 2, final paragraph).
Thus, the variation in the diseases, their etiologies, and biomarkers associated with the diseases, are complex and are not extrapolatable to all pathogenic, infectious, genetic, and acquired diseases, including Alzheimer’s and cancer.
Therefore, the description of the limited sources of target proteins/biomarkers is not sufficient to support the genus of such target proteins or biomarkers. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See Vas-Cath at page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is now is claimed." (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed antibody-DNA conjugates that can bind to any target protein, which may be a myriad of pathogen marker proteins, infectious disease marker proteins, genetic disease marker proteins, acquired disease marker proteins (claim 8) or Alzheimer’s marker proteins or cancer marker proteins (claim 10). Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential antibody-DNA conjugate. The compound itself is required. See Fiers v. Revel, 25USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18USPQ2d 1016. Therefore, the skilled artisan would have reasonably concluded applicants were not in possession of the claimed invention for claims 1-8 and 10.
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.
Claim 10 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 10 recites that the target protein to which the antibodies bind is Troponin I, AZ biomarkers, and cancer biomarkers. However, claim 10 depends from claim 9, which recites that the target protein is a nucleocapsid protein of SARS-Cov2 virus. Because claim 10 recites target proteins that are not associated with SARS-Cov2 virus, the claim does not further limit claim 9. It is suggested that claim 10 depend from claim 8 instead.
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.
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 1-2, 5, 8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ebai et al. (63(9) Clinical Chemistry 1497-1505 (2017)).
Regarding claim 1, Ebai discloses oligonucleotide-conjugated antibodies (page 1497, column 1, second paragraph). Ebai discloses pairs of antibody-oligo conjugates, each of the antibodies capable of binding to a target protein (Figure 1). Ebai discloses that proximity ligation assays (PLAs) use pairs of antibody-conjugated DNA oligonucleotides (page 1498, column 1, third paragraph).
Regarding claim 2, Ebai discloses that the PLA probes were prepared by covalently conjugating oligonucleotides to antibodies (paragraph bridging pages 1498 and 1499).
Regarding claim 5, Ebai discloses that the antibody-DNA conjugates bind to different sites on the target protein (Figure 1A).
Regarding claims 8 and 10, Ebai discloses that the antibody-DNA oligo conjugates can be used to detect proteins from tumors (i.e., biomarkers of acquired diseases, cancer) (page 1498, column 2, Patient Samples).
Ebai discloses each and every limitation of claims 1-2, 5, 8, and 10, and therefore Ebai anticipates claims 1-2, 5, 8, and 10.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ebai, as applied to claims 1-2, 5, 8, and 10 above, and in view of Wiener et al. (10 Scientific Reports 1457, 1-11 (2020)).
Ebai discloses antibody-DNA oligo conjugate sets, as discussed above.
Ebai fails to disclose or suggest the length of the DNA oligo.
Regarding claim 4, Wiener discloses single- and double-oligonucleotide antibody conjugates for protein analysis (abstract) Wiener discloses evaluation of a variety of conjugate characteristics, including oligonucleotide length (abstract). Wiener discloses that the length of the antibody-DNA oligo conjugates can vary (page 7, final two paragraphs). Wiener discloses that the length of the oligonucleotides can range from 32 nucleotides to 64 nucleotides (page 7, final two paragraphs). Wiener discloses that unstructured oligonucleotides with a length of 32 nucleotides showed a higher conjugation level (page 10, second full paragraph).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to use the length of Wiener’s 32 nucleotide oligo in the antibody-DNA oligo conjugates of Ebai because using such a length will provide for a higher level of conjugate yield, which can then be used in protein analysis as disclosed by both Ebai and Wiener. One of ordinary skill in the art would have been motivated to create the antibody-DNA oligo conjugates of Ebai using the oligonucleotide length in order to increase the yield of conjugates.
Claims 3, 6-7, and 9 is rejected under 35 U.S.C. 103 as being unpatentable Ebai, as applied to claims 1-2, 5, 8, and 10 above, and in view of Liu et al. (12 Chemical Science 9022-9030 (2021)).
Ebai discloses antibody-DNA oligo conjugate sets, as discussed above.
Ebai fails to disclose or suggest the conjugates can be used to detect SARS-Cov2 virus nucleocapsid protein.
Regarding claim 3, Liu discloses a system that employs a pair of antibody-DNA conjugates that can be used to detect the N protein (i.e., nucleocapsid protein) of SARS-Cov2 (Figure 4). Liu discloses that the antibody conjugates bind to different portions of the N protein (Figure 4). Liu discloses a connector nucleotide that, when bound to the N protein, provides attachment between the 3’ and 5’ portions of the oligonucleotide of the conjugate (paragraph bridging pages 9026 and 9027 and Figure 4). Liu discloses that, if no binding occurs (i.e., no N protein present), the oligonucleotide portions do not bind with the connector (Figure 4).
Regarding claim 6, Liu discloses that the connector provide for joining of the 3’ and 5’ ends of the oligonucleotide portion of the antibody-DNA oligo conjugate (paragraph bridging pages 9026 and 9027, page 9028, column 1, first and second full paragraphs and Figure 4).
Regarding claim 7, Liu discloses that, upon binding the connector binds to the 3’ and 5’ ends of the DNA oligo portion of the conjugate, forming a closed circle (Figure 4).
Regarding claim 9, Liu discloses methods of improving diagnostic technologies of SARS-Cov2 (abstract). Liu discloses the use of an antibody-DNA oligo conjugate set for the detection of the N protein of SARS-CoV2 (paragraph bridging pages 9026 and 9027, page 9028, column 1, first and second full paragraphs and Figure 4).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Ebai’s antibody-DNA oligo conjugates using the connector of Liu to form a closed loop by attaching the connector via 3’ and 5’ ends to the oligo portion of the antibody-DNA oligo conjugates because this provides a method where the antibodies bind to separate portions of the SARS-Cov2 N protein, which can then be detected using amplification methods. One of ordinary skill in the art would have been motivated to combine Ebai’s antibody-DNA oligo conjugates with those of Liu in order to detect the nucleocapsid protein of SARS-Cov2, enabling a sensitive detection method of SARS-Cov2. One of ordinary skill in the art would also have had a predictable and reasonable expectation of success in combining Ebai’s and Liu’s antibody-DNA oligo conjugates because each of the conjugates comprise the same or equivalent (i.e., use of the connector) structures.
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 9-14 of copending Application No. 18/915,618 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘618 application and the instant application claim an antibody-DNA conjugate for detection of target proteins.
Regarding claim 1, the ‘618 application claims an antibody-antigen capture set that comprises a first antibody-DNA conjugate configured to bind to a target protein, with a first DNA oligo linked to the first antibody and a second antibody-DNA conjugate configured to bind to the target protein and a second DNA oligo linked to the second antibody (claim 1).
Regarding claim 2, the ‘618 application claims that the first DNA oligo is covalently linked to the first antibody and the second DNA oligo is covalently linked to the second antibody (claim 9).
Regarding claim 3, the ‘618 application claims that the first DNA oligo is covalently linked to the first antibody on its 3’ end and the second DNA oligo is covalently linked to the second antibody on its 5’ end (claim 10).
Regarding claim 4, the ‘618 application claims that the first and second DNA oligos have a length between 20 and 300 nucleotide bases (claim 11).
Regarding claim 5, the ‘618 application claims that the first antibody binds to a first binding site of the target protein and the second antibody binds to a second binding site of the target protein (claim 2).
Regarding claim 6, the ‘618 application claims that the first antibody and second antibody each binds to the target protein, the 5’ end of the first DNA oligo and the 3’ end of the second DNA oligo attaches to each other (claim 12).
Regarding claim 7, the ‘618 application claims that the first antibody and second antibody, the first DNA oligo and second DNA oligo, and the target protein form a closed loop structure (claim 13).
Regarding claim 8, the ‘618 application claims that the target protein is selected from the group consisting of marker proteins of pathogens, marker proteins of infectious diseases; marker proteins of genetic diseases, marker proteins of acquired diseases (claim 14).
While the ‘618 application does not specifically claim that the target protein is a nucleocapsid protein of SARS-Cov2 virus, Troponin I, Alzheimer’s biomarkers or cancer biomarkers, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the ‘618 antibody-DNA conjugate could be used to detect SARS-Cov2 virus, Troponin I, Alzheimer’s biomarkers or cancer biomarkers because these conditions are a known subset of pathogen markers, infectious disease markers, genetic disease markers, or acquired disease markers. As such, one of ordinary skill in the art would have had a predictable and reasonable expectation of success in detecting any of SARS-Cov2 virus, Troponin I, Alzheimer’s biomarkers or cancer biomarkers because these conditions are a known subset of pathogen markers, infectious disease markers, genetic disease markers, or acquired disease markers. Therefore the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chang et al. (910 Analytica Chimica Acta 12-24 (2016) disclose immunoassay for the detection of biomolecules (abstract). Chang et al. disclose that this assay employs the use of antibody-DNA oligo conjugates (abstract). Although Chang et al. do disclose antibody-DNA oligo conjugates, Chang et al. do not disclose the use of conjugate sets that bind to separate portions of the same biomolecule.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636
Prosecution Insights