DETAILED ACTION
Notice of Pre-AIA or AIA Status ad 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.
Continued Examination Under 37 CFR 1.114
3. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 25 August 2025 has been entered.
Amendments and Status of the Claims
4. This action is in response to papers filed 25 August 2025 in which claims 49 and 54 were amended, claim 53 was canceled, and no new claims were added. All of the amendments have been thoroughly reviewed and entered.
All previous rejections not reiterated below are withdrawn in view of the amendments.
The previous rejections under the judicially created doctrine of obviousness-type double patenting are maintained in view of the prior art rejections presented below.
Applicant’s arguments have been thoroughly reviewed and are addressed following the rejections.
Claims 49-52, 54-56, and 60-62 are under prosecution.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 49-52, 54-56, and 60-62 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.
This is a new matter rejection.
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application:
Claim 49 (upon which claims 50-52, 54-56, and 60-62 depend) recites each of the following:
A “copy” of the analyte. A review of both the instant specification and parent Application No. 15/101,524 (hereafter the “‘348 Patent”) yields no teaching of a “copy” of anything.
A bead which “comprises” a large protein of composite material. While both the originally filed specification and the ‘348 Patent teach beads that “are” a large protein or composite material, they do not teach beads that “comprise” these species, and thus encompass beads including more that the cited limitations.
“Collecting” the bound analyte-captured reporter. A review of both the instant specification and the 348 Patent yields no teaching of “collecting” anything.
It is also noted that claim 56 are recites use of a magnetic bead to “collect” the reporter.
A “sensing element.” A review of both the instant specification and the 348 Patent yields no teaching of a “sensing element.”
Claim 52 recites a reporter which “comprises a plurality of particles,” which encompasses a single (i.e., large) reporter bead that is made up of multiple (i.e., smaller) beads. A review of both the instant specification and the ‘348 Patent yields no teaching of this type of reporter bead.
7. 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.
8. Claims 49-52, 54-56, and 60-62 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 49 (upon which claims 50-52, 54-56, and 60-62 depend) is indefinite in each of the following:
I. The recitations “said analyte” and “the analyte,” each of which lacks antecedent basis in the previous recitation of “at least one copy of an analyte.”
It is noted that “the analyte” is also recited in each of claims 50-51, 60, and 61.
II. The term “large” in claim 49 is a relative term which renders the claim indefinite. The term “large” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
III. The recitation “the bound analyte,” which lacks antecedent basis because there is no previous recitation of a “bound analyte.”
IV. The recitation “the reporter,” which lacks antecedent basis in the previous recitation of a “reporter bead.”
It is noted that this limitation is also found in each of claims 52 and 60-62.
V. The recitation “the collected bound analyte,” which lacks antecedent basis because there is not previous recitation of a “collected bound analyte,” nor does the recitation match the previous recitation of a “bound analyte-captured reporter.”
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 49-52, 54-56, and 60-62 are rejected under 35 U.S.C. 103 as being unpatentable over Bambad et al. (U.S. Patent Application Publication No. Us 2011/0053788 A1, published 3 March 2011) in combination with Briman et al. (U.S. Patent Application Publication No. US 2007/0259359 A1, published 8 November 2007) and/or Miles et al. (U.S. Patent Application Publication No. US 2002/0072054 A1, published 13 June 2002) and, as applied to claim 52, as alternatively evidenced by the online dictionary at merriam-webster.com ([retrieved on 2026-05-15]; retrieved from the Internet: <URL: www.merriam-webster.com/dictionary/colloid>).
Regarding claim 49, Bambad et al. teach methods for detecting an analyte, in the form of a DNA molecule in a sample (paragraph 0025), comprising binding at least one copy (i.e., molecule) of nucleic acid analyte 20 from the sample to a probe (i.e., binding ligand 10) bound to a bead (i.e., transport particle/TP 5; Figure 1B and paragraph 0014). Bambad et al. also teach the particle comprises proteins or composite materials (i.e., co-polymers; paragraph 0186), including large proteins (paragraph 0195).
It is also noted that the courts have held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” (Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). See MPEP 2144.04, IVA.
The courts have further stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
In addition, the courts have found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed “large” protein is either not patentably distinct or merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
Bambad et al. further teach the nucleic acid probe and nucleic acid target bind via complementary base-pairing (i.e., hybridization; paragraph 0287), and that a reporter bead (i.e., reporter particle/RP 30) having an extender moiety 50 that binds to target analyte 20 (Figure 1B and paragraph 0014) via complementary base paring (i.e., hybridization; paragraph 0352). The bound analyte-captured reporter is collected on (i.e., transported to; paragraph 0013) a sensing element of a capacitive sensor, (i.e., electrode; paragraph 0303) via magnetic transport (paragraph 0020). Bambad et al. also teach the electrodes are planar (paragraph 0040), as well as measuring the capacitance at the sensing element (paragraph 0303), and that the methods have the added advantage of allowing quantitation of the amount of target sequence of the analyte (paragraph 0181). Thus, Bambad et al. teach the known techniques discussed above.
Bambad et al. also teach melting nucleic acids (paragraph 0031 and 0288), and that the amount of signal corresponding to the bound analyte-captured reporter is compared to the amount of capture probe on the sensing surface (i.e., electrode) (paragraph 0181). Thus, Bambad et al. clearly teach the detection is based on the difference between the bound complex (i.e., having the reporter bead present) and when the reporter bead is not present.
Bambad et al. do not teach the measurement of the bound analyte-captured reporter is compared to the release of the reporter.
However, Briman et al. teach methods of detecting analytes, wherein a denaturation step is performed using heat in order to release reporter molecules, followed by detection of the target (i.e., as opposed to the reporters; paragraph 0201). Briman et al. also teach detection of capacitance (paragraph 0046) and detection of the signal before and after denaturization, and that the methods have the added advantage of detecting the denaturization status directly (paragraph 0202). Thus, Briman et al. teach the know techniques discussed above.
In addition, Miles et al. teach methods wherein reporter (i.e., labeled) probes are released and changes in electrical signals are detected (Abstract and paragraph 0019), and that the methods have the added advantage of being less expensive than optical detection methods (paragraph 0020). Thus, Miles et al. teach the known techniques discussed above.
With respect to the order of steps, it is noted that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930); Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959)). See MPEP §2144.04 IV C. Thus, any claimed order of the steps (e.g., detection after releasing the reporters) is an obvious variant of the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
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 Bambad et al. with Briman et al. and/or Miles et al. to arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantages of:
Allowing quantitation of the amount of target sequence of the analyte as explicitly taught by Bambad et al. (paragraph 0181);
Allowing detection of the denaturization states directly as explicitly taught by Briman et al. (paragraph 0202); and/or
Being less expensive then optical detection methods as explicitly taught by Miles et al. (paragraph 0020).
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 techniques useful for detection of analytes.
Regarding claim 50, the method of claim 49 is discussed above. Bambad et al. teach the analyte is DNA (paragraph 0025), as do Briman et al. (paragraph 0020) and Miles et al (Abstract).
Regarding claim 51, the method of claim 49 is discussed above. Bambad et al. teach the analyte is indicative of a microbiological entity (i.e., pathogenic bacteria; paragraph 0034).
Regarding claim 52, the method of claim 49 is discussed above. Bambad et al. teach the reporter comprises n reporter compositions, wherein n is at least 1 (paragraph 0014 and Figure 1B). Thus, where n=2, there are two (i.e., a plurality) of particles in the reporter.
Alternatively, Bambad et al. teach colloidal gold reporter particles (paragraph 0037). The online dictionary at merriam-webster.com defined colloids as substances consisting of particles. Thus, the colloidal gold particle of Bambad et al. comprises a plurality of gold particles.
Regarding claim 54, the method of claim 49 is discussed above. Bambad et al. teach peptide nucleic acids (paragraph 0031); thus it would have been obvious to have peptide nucleic acid probes.
Regarding claim 55, the method of claim 49 is discussed above. Bambad et al. teach the bead (i.e., first particle) is magnetic (paragraph 0284). Briman et al. also teach magnetic beads with probes immobilized thereon (paragraph 0052).
Regarding claim 56, the method of claim 55 is discussed above. Bambad et al. teach the magnetic bead is used to collect (i.e., transport) the complex (i.e., bound analyte-capture reporter) to the sensing surface (i.e., electrode; paragraph 0020).
It is reiterated that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results. Thus, any claimed order of magnetic collection is an obvious variant of the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 60, the method of claim 49 is discussed above.
It is noted that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments (see MPEP § 2123). Thus, the teaching of Bambad et al. that the detection may be performed without removal of unhybridized probes (paragraph 0350) encompasses the alternate embodiment wherein the detection is performed with removal of unhybridized probes.
Alternatively, it is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph).
Specifically, Bambad et al. al teach washing to remove non-specifically bound probes (paragraphs 0134 and 0322), which also results in removal of unbound reporters. Briman et al. also teach washing to remove unbound species (paragraphs 0180, 0186 and 0212).
It is reiterated that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results. Thus, any claimed order of removal is an obvious variant of the washing step of cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 61, the method of claim 55 is discussed above. Bambad et al. teach the bead (i.e., the magnetic transporter particle) is larger than the reporter (i.e., colloidal) particle (paragraph 0187).
Regarding claim 62, the method of claim 55 is discussed above. Bambad et al. teach the bead (i.e., transport particle/TP 5) and the reporter bead (i.e., reporter particle 30) bind to different portions of analyte 20 (Figure 1B and paragraph 0014).
Double Patenting
12. 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.
13. Claims 49-52, 54-55, and 60-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. US 10,738,348 B2 in combination with Bambad et al. (U.S. Patent Application Publication No. Us 2011/0053788 A1, published 3 March 2011) and, as applied to claim 52, as alternatively evidenced by the online dictionary at merriam-webster.com ([retrieved on 2026-05-15]; retrieved from the Internet: <URL: www.merriam-webster.com/dictionary/colloid>).
Both sets of claims are drawn to first (i.e., magnetic) beads and transportation thereof, second (i.e., reporter) beads that are removed via melting (i.e., heating), detecting capacitance, peptide nucleic acids, microbiological entities, separating beads, smaller reporter beads, etc. Any additional limitations of the ‘348 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘348 claims do not require DNA or plural reporter particles.
However, these limitations, along with the rationale for combining, are discussed above.
Response to Arguments
14. Applicant's arguments filed 25 August 2025 (hereafter the “Remarks”) have been fully considered but they are not persuasive for the reasons discussed below.
A. Pages 4-7 of the Remarks refer to the previous rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, which are withdrawn.
B. Applicant parges on pages 7-8 that Bambad et al. do not teach releasing the reporter prior to detection and allegedly teaches away from this.
However, as noted in the rejections above Bambad et al. teach the amount of signal corresponding to the bound analyte-captured reporter is compared to the amount of capture probe on the sensing surface (i.e., electrode) (paragraph 0181). Thus, Bambad et al. clearly teach the detection is based on the difference between the bound complex (i.e., having the reporter bead present) and when the reporter bead is not present.
With respect to teaching aways, it is noted that Applicant’s citation of Figure 1C (which appears to refer to, but does not cite, paragraph 0014 of Bambad et al.) is prefaced with a note that the figures “depict a variety of different embodiments of the invention.” Thus, Figure 1C is not limiting.
In addition, as noted in MPEP 2123 II, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments (In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971); In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)).
Further, as noted in MPEP 2131.05, a reference is no less anticipatory if, after disclosing the invention, the reference then disparages it (Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998)). The prior art was held to anticipate the claims even though it taught away from the claimed invention.
Thus, even if the allegation that Bambad et al. teach away from the claimed invention (which the examiner disagrees with), the claims are still obvious in view of the cited prior art.
D. Applicant alleges on page 8 of the Remarks that the use of a capacitance sensor would result in strong background signal, and would detect non-specific analytes and unbound reporters.
Applicant presents no evidence to support this assertion. It is reiterated that Applicant cannot merely rely upon counsel’s arguments in place of evidence in the record. Thus, the argument is unconvincing.
In addition, as noted above, the teaching of Bambad et al. that the detection may be performed without removal of unhybridized probes (paragraph 0350) encompasses the alternate embodiment wherein the detection is performed with removal of unhybridized probes.
It is further reiterated that Bambad et al. al teach washing to remove non-specifically bound probes (paragraphs 0134 and 0322), which also results in removal of unbound reporters. Briman et al. also teach washing to remove unbound species (paragraphs 0180, 0186 and 0212).
It is also reiterated that Bambad et al. explicitly each detection of capacitance (paragraph 0303).
E. Applicant’s remaining arguments on pages 8-10 of the Remarks have been considered but are moot because the new ground of rejection does not rely on the references discussed therein.
F. Applicant argues on page 10 of the Remarks that the double patenting rejections are overcome with the amendments, However, the claims remain rejected under non-statutory obviousness type double patenting for the reasons discussed above.
Conclusion
15. No claim is allowed.
16. 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.
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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.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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