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 .
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
2. 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 - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because Figure 13 shows a DNA sequence.
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, 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.
Specification
3. The disclosure is objected to because of the following informalities:
a.) In paragraph [0001] of the specification, the status of the parent application should be updated.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 1-15 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 1 is vague because the body of the claim is inconsistent with the preamble. The preamble is directed to detection an analyte but the last line of the claim is only directed to obtaining an absorption spectrum of the biosensor. Examiner suggests adding –to detect the analyte-- to the end of the last line of the claim.
Double Patenting
6. 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.
7. Claims 1, 4-13, and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,808,763. Although the claims at issue are not identical, they are not patentably distinct from each other because patent ‘763 claims a biosensor for detecting an analyte which can be used in a method to detect an analyte and a method for making the biosensor which anticipates the instant method of making a biosensor.
Patent ‘763 claims:
1. A plasmon-resonance biosensor comprising:
a plurality of precious metal nanorods, the precious metal nanorods having a long dimension greater than a narrow dimension by a factor of at least 1.5 and a maximum dimension less than one half micron;
the nanorods organized in rows;
the nanorods in the rows are oriented with the long dimension approximately parallel to the rows;
the precious metal nanorods are conjugated with a biological probe material capable of binding to an analyte, the biological probe material, is a protein-nucleic acid (PNA) or a complimentary DNA.
2. The plasmon-resonance biosensor of claim 1 wherein the precious metal nanorods comprise gold.
3. The plasmon-resonance biosensor of claim 2 wherein the biological probe material is a PNA configured to bind to a tumor-specific DNA.
4. The plasmon-resonance biosensor of claim 1 wherein the precious metal nanorods are disposed in a plurality of patches on a substrate, with at least a first patch conjugated with a first biological probe material and a second patch on the same substrate conjugated with a second biological probe material.
5. A test system comprising the plasmon-resonance biosensor of claim 4 and an optical absorption spectrometer configured to scan the plurality of patches of precious metal nanorods.
6. The plasmon-resonance biosensor of claim 4 further comprising a sensor-array reading system configured to expose the plasmon resonance biosensor first to a neutral solution not bearing analyte, and record pre-exposure spectra from each patch, to then expose the plasmon resonance biosensor to sera that may or may not contain analyte and obtain post-exposure spectra from each patch, and to compare the post-exposure spectra from each patch to the pre-exposure spectra from each patch.
7. The plasmon-resonance biosensor of claim 1 where the biological probe material is PNA.
8. The plasmon-resonance biosensor of claim 1 formed on a glass substrate.
9. A method of making a plasmon-resonance biosensor comprising:
conjugating precious metal nanorods, the nanorods having a long dimension greater than a narrow dimension by a factor of at least 1.5 and the long dimension less than one half micron, with a biological probe material capable of binding to an analyte;
forming a plurality of microfluidic chambers, each chamber having volume less than 0.025 microliter, over a substrate;
injecting an aqueous suspension of the conjugated precious metal nanorods into the microfluidic chambers;
organizing the conjugated precious metal nanorods in rows of conjugated precious metal nanorods; and
aligning a long dimension of the conjugated precious metal nanorods along the rows of conjugated precious metal nanorods;
wherein the plasmon-resonance biosensor is configured to be read by obtaining an optical absorption spectrum upon exposure to the analyte.
10. The method of claim 9 wherein: the step of forming a plurality of microfluidic chambers is performed by mating a stamp to a nanowrinkled substrate, the nanowrinkled substrate having nanowrinkles with depth less than 300 nanometers, and pitch less than 500 nanometers; the organizing the conjugated precious metal nanorods in rows and aligning the long dimension of the conjugated precious metal nanorods along the rows is performed by gravitational settling of the conjugated precious metal nanorods into the nanowrinkles.
11. The method of claim 10 wherein the nanowrinkles are aligned with a direction of flow in the microfluidic chambers of the aqueous suspension of the conjugated nanoparticles.
12. The method of claim 10 further comprising: removing the stamp and transferring the rows of conjugated precious metal nanorods from the nanowrinkled substrate onto a glass substrate.
13. The method of claim 9, wherein the biological probe material comprises a protein-nucleic acid (PNA) compound.
14. The method of claim 13 wherein the PNA is configured to bind to deoxyribose nucleic acid (DNA) strands released by a particular tumor type.
15. The method of claim 14 wherein the particular tumor type is a pancreatic cancer.
16. The method of claim 13 wherein the precious metal nanorods comprise gold nanorods.
17. The method of claim 9, wherein the biological probe material comprises a strand of DNA complimentary to an analyte DNA.
18. The method of claim 17 wherein the biological probe material is configured to bind to deoxyribose nucleic acid (DNA) strands released by a particular tumor type.
19. The method of claim 18 wherein the particular tumor type is a pancreatic cancer.
Patent ‘763 differs from the instant invention in failing to claim a method for detecting an analyte using the biosensor.
However, the biosensor of patent ‘763 has a biological probe material for binding and detecting an analyte. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the biosensor of patent ‘763 in a method to detect an analyte in a sample that is contacted to the biosensor because that is the function of the biosensor of patent ‘763. Claim 5 of patent ‘763 includes an optical absorption spectrometer to scan for binding of analyte to the biological probe material on the biosensor.
With respect to claims 12, 13, and 15, the biosensor of patent ‘763 is for the detection of analytes in general. It would be obvious to one of ordinary skill in the art to modify the sensor of patent ‘763 to detect the analytes recited in instant claims 12, 13, and 15 because the choice of probe material is dictated by the analyte that is to be detected. One would use the appropriate probe material in the sensor of patent ‘763 to detect the desired analyte.
8. Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,808,763 in view of Chung et al (WO 2016/133899 A1).
See above for the claims of US Patent ‘763.
Patent ‘763 differs from the instant invention in failing to teach antibodies as the biological probe material on the nanorods.
Chung et al disclose a LSPR biosensor for performing immunoassays that comprises precious metal nanorods that support antibodies as a biological probe material (page 3).
It would be obvious to one of ordinary skill in the art to modify the sensor of patent ‘763 with antibodies as the biological probe material on the nanorods, as taught by Chung et al because the choice of probe material is dictated by the analyte that is to be detected. One would use the appropriate probe material in the sensor of patent ‘763 to detect the desired analyte.
Allowable Subject Matter
9. Claims 1-20 are free of the prior art of record. The closest prior art is the LSPR biosensor disclosed in Chung et al (WO 2016/133899 A1) which comprised an array of nanorods that support antibodies or nucleic acids as biological probe materials. However, Chung et al fails to discloses the row arrangement of the nanorods as recited in the instant claims.
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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, Bao-Thuy Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
9/16/2026
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