DETAILED ACTION
Notice of Pre-AIA or AIA Status and New Examiner
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Please note that the examiner for this application has changed. Please address future correspondence to Robert T. Crow (Art Unit 1683) whose telephone number is (571) 272-1113.
Election/Restrictions
3. Applicant’s election of Group II in the reply filed on 17 August 2026 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)).
Claims 1-16 are therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 17 August 2026.
Claims 17-24 are under prosecution.
Specification
4. The substitute specification filed 14 August 2024 has been entered.
5. The use of trade names or marks used in commerce (including but not necessarily limited to Supelco), has been noted in this application. Any trade names or marks should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Information Disclosure Statement
6. The Information Disclosure Statement filed 12 November 2024 is acknowledged and has been considered.
It is noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Interpretation
7. The claims are drawn to a “system.” The specification recites a “system” wherein the “system” is defined in terms of structural limitations. In addition, the claims recite structural limitations of the “system.” Thus, the “system” is interpreted to encompass any collection of reagents and parts used together that are not necessarily part of a completely integrated single unitary device. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
8. It is noted that the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Therefore, the various uses recited in the claims (e.g., identifying a target nucleic acid) fail to define additional structural elements of the claimed system. Thus, any prior art teaching the structural elements of the claim, either anticipates, or renders obvious, the claims. See MPEP § 2114.
Claim Rejections - 35 USC § 103
9. 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.
10. 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.
11. Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Warthoe et al. (U.S. Patent Application Publication No. US 2004/0072208 A1, published 15 April 2004).
Regarding claim 17, Warthoe et al. teach a system (Abstract) comprising a surface capable as functioning as a transducer, in the form of a piezoelectric layer (paragraph 0063) having a probe nucleic acid bound thereto (paragraph 0030). The probe is attached at the 5’ end and is extended by a polymerase from the ‘3 end (paragraph 0056). Thus, Warthoe et al. teach all of the claimed limitations.
Regarding claims 18-19, the system of claim 17 is discussed above. Warthoe et al. teach the sensor comprises a piezoelectric sensor (i.e., claim 18) comprising a quartz crystal as well as gold or aluminum (i.e., clam 19; paragraph 0063-0064).
12. Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Warthoe et al. (U.S. Patent Application Publication No. US 2004/0072208 A1, published 15 April 2004) as applied to claim 17 above, and further in combination with Lazar (U.S. Patent Application Publication No. US 2003/015828 A1, published 18 September 2003).
Regarding claims 20-22, the system of claim 17 is discussed above on Section 11.
Warthoe et al. teach the known techniques discussed above, including formation of a double-stranded hybrid nucleic acid (i.e., the product of polymerase extension; paragraph 0030), as well as labels utilizing antibodies (paragraph 0005) and that the systems have the added advantage of allowing detection of a wide variety of biological based assays (Abstract), Warthoe et al. do not teach the instantly claimed probe.
However, Lazar teaches molecular probes that specifically bind a double-stranded target nucleic acid (i.e., claim 20), in the form of an antibody that binds double-stranded nucleic acids (i.e., claim 21; paragraph 0024). Lazar also teaches the molecular probe is attached to a mass element (i.e., a label; paragraph 0042), in the form of a nanocrystal (i.e., claim 22; paragraph 0036), and the added advantage of providing signal amplification (Abstract). Thus, Lazar teaches the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of the cited prior art to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantages of allowing detection of a wide variety of biological based assays as explicitly taught by Warthoe et al. (Abstract) with signal amplification as explicitly taught by Lazar (Abstract). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in reliable detection of nucleic acid assays.
13. Claims 20 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Warthoe et al. (U.S. Patent Application Publication No. US 2004/0072208 A1, published 15 April 2004) as applied to claim 17 above, and further in combination with Blanche et al. (U.S. Patent Application Publication No. US 2003/0165876 A1, published 4 September 2003).
Regarding claims 20 and 22-24, the system of claim 17 is discussed above on Section 11.
Warthoe et al. teach the known techniques discussed above, including formation of a double-stranded hybrid nucleic acid (i.e., the product of polymerase extension; paragraph 0030), as well as sandwich assays (paragraph 0086), which bind a second probe the target nucleic acid and that the systems have the added advantage of allowing detection of a wide variety of biological based assays (Abstract), Warthoe et al. do not teach the instantly claimed probe.
However, Blanche et al. teach detection of double-stranded nucleic acids using a probe, in the form of a third strand that forms a triple helix by binding the double-stranded nucleic acid (i.e., claim 20; paragraph 0045). Blanche et al. further teach the third strand is a nucleic acid(i.e., oligonucleotide; claims 23-24) and comprises a mass element (i.e., label), in the form of a bead (i.e., clams 22 and 24; paragraphs 0046-0047), and that the probes have the added advantage of not requiring modification of the target double-stranded nucleic acid (i.e., DNA; paragraph 0045; see also paragraph 0044). Thus, Blanche et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of the cited prior art to arrive at the instantly claimed systems with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in systems having the added advantages of allowing detection of a wide variety of biological based assays as explicitly taught by Warthoe et al. (Abstract) and not requiring modification of the target double-stranded nucleic acid as explicitly taught by Blanche et al. (paragraph 0045; see also paragraph 0044). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in reliable detection of nucleic acid assays.
Conclusion
14. No claim is allowed.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights