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 .
This office action is in response to the amendments filed on February 19, 2026 and the grant of a petition to revive an abandoned application.
Claims 1, 6, 8-12, 14-23, and 42-55 are currently under examination.
Any rejection or objection not reiterated below is hereby withdrawn.
Withdrawal of Rejections
The rejection of claims 14-16 under 35 U.S.C. 101 because the claimed invention is directed to abstract idea is withdrawn based on the amendment to the claims and the remarks filed on February 19, 2026.
The rejection of claims 21 and 23 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn based on the amendment to the claims and the remarks filed on February 19, 2026.
The rejection of claims 1-23 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn based on the amendment to the claims and the remarks filed on February 19, 2026.
The rejection of claim(s) 1-23 under 35 U.S.C. 103 as being unpatentable over Travis et al. (U.S. Patent 9,547,014 B2) and Travis et al. (U.S. Patent 11,549,953 B2) is withdrawn based on the amendment to the claims and the remarks filed on February 19, 2026.
Claim Objections
Claims 6, 8, 9, 10, 11, 12, 14-23, 42, and 44-53 are objected to because of the following informalities: it appears all the dependent claims are missing a comma after the number of the claim from which it depends. For example, in claim 8. The assay of claim 1, where the… In claim 18 the status identifier is missing a right parenthesis. Appropriate correction is required.
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, 6, 8-12, 14-23, 42, and 43-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,306,187 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are of overlapping scope. The issued patent claims are drawn to a coupled enzyme reaction point of care assay system that would use the components of the pending application components in the assay system. Both sets of claims are drawn to coupled enzyme reaction assays. The assays use overlapping components to measure overlapping enzymes. In addition, applicants’ disclosure describes “wells” broadly in paragraph [0029]; [0029] For the remainder of this specification, the terms “well” or “zone” may both be used to describe any volume where a tethered enzyme technology (TET) related assay reaction occurs. These include but are not limited to a well in an IVD assay multi-well strip or plate, or a zone on a filter paper, sheet material, or other volume in a PoC or IVD assay device. The manner of using fluid holding reservoirs was not unobvious based on the breadth of “wells” in both applications. Therefore, it would have been obvious to the person having ordinary skill in the art to run the coupled enzyme reaction as currently claimed, because the co-pending application disclosed an obvious coupled enzyme reaction assay using similar components to identify overlapping enzymes (see claims 1-30). The issued patent claims are drawn to a coupled enzyme reaction point of care assay system that would use the components of the pending application components in the assay system.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 17-20, and 47 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea (a mental analysis step) without significantly more. The claim(s) recite(s) a determination based on a percentage difference based on the difference in signal generated and a comparison of a signal. This judicial exception is not integrated into a practical application because the formula calculation is an abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no particular means of obtaining the differential threshold as claimed. The claims do not recite an affirmative diagnostic threshold in the claims for determining the activity of the enzyme. The steps appear to encompass mental steps for performance of the claimed steps.
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 1, 8-12, 14-23, 42, and 43-55 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.
In claim 1, it is unclear as to the structure of the second enzyme in relation to the first tethered nanobot. Is the second enzyme tethered to the first tethered enzyme nanoparticle?
In claim 1, under the 2nd indentation for the description of the second layer introduction, it is unclear if it is into or onto the first layer. Is it on top of the first layer?
It is unclear how the fourth indentation of claim 1 where there is discussion of frozen wells and then freeze-dried wells does not result in the mixing of the first and second layer? If the freeze-dried step is after the freezing step, then the two layers will be mixed upon freeze-drying. Clarification is requested.
Claims 14 and 15, ultimately depends from claim 1, and there is no reference to a luminescent signal in a negative control well in claim 1. Clarification is requested.
Claim 1 does not disclose how the quantification of the luminescence signal occurs. Clarification is requested.
In claim 14, how is the difference in signal analyzed? Clarification is requested.
In claim 15, how is the relative value of the first enzyme analyzed? Clarification is requested.
In claim 16, how is the comparison of measured activity analyzed? Clarification is requested.
In claims 17 and 19, how are the percentage determined for the relative activity? Clarification is requested.
In claim 18, how does the measured activity compared? Clarification is requested.
In claim 46, what is used for the calculation of the neuron specific enolase enzyme activity? How is the slope of the luminescence calculated and what is used to compare the positive control well?
In claim 47, what is a preset threshold? Clarification is requested.
In claim 49, how is the difference in luminescence done? Clarification is requested.
It is unclear how in claims 54 and 55 where there is discussion of frozen wells and then freeze-dried wells does not result in the mixing of the first and second layer? If the freeze-dried step is after the freezing step, then the two layers will be mixed upon freeze-drying. Clarification is requested.
Any claim dependent on a rejected claim is rejected for failing to cure the indefiniteness.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANAND U DESAI whose telephone number is (571)272-0947. The examiner can normally be reached 9:00-5:30 EST.
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/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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