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 .
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.
Information Disclosure Statement
The information disclosure statement dated 7/14/2026 has been considered and made of record.
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 1-22 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.
With respect to claim 1, recitation of “an outer emission orifice” and “an inner emission orifice” is considered indefinite because the location of these orifices and/or structural cooperation of these orifices with respect to the reaction well emission orifice is unclear. It is suggested that claim 1 be drafted in the following manner to clarify this issue:
Claim 1. A limited well thermal cycling device for preparation of a biological sample for amplification and detection of an analyte, the limited well thermal cycling device comprising:
a heating block configured for preparation of the biological sample and amplification of the analyte, the heating block comprising
a sample well having a flat bottom configured for receiving and preparing the biological sample for amplification and detection, the sample well extending from a top of a heating block base;
a reaction well having a flat bottom configured for receiving and amplifying an analyte of the prepared biological sample for detection, the reaction well extending from the top of the heating block base, wherein
the reaction well has an excitation orifice, an emission orifice, and a cooling orifice, where the excitation orifice and emission orifice are in 90 degree alignment in a horizontal plane from the center of the excitation orifice and the center of the emission orifice; and
heating block alignment holes for removable attachment of an optical block to the heating block base, the heating block alignment holes on the top of the heating block base;
the optical block configured for detecting the analyte of the amplified and prepared biological sample, wherein the optical block is attached via removable attachment to the heating block, the optical block comprising
an inner excitation orifice and an outer excitation orifice, the inner excitation orifice having a smaller diameter than the outer excitation orifice where the inner and outer excitation orifice are in continuing alignment through a central portion of the optical block, wherein a center of the inner and outer excitation orifice is in linear alignment with a center of the reaction well excitation orifice;
an inner emission orifice and an outer emission orifice, the inner emission orifice having a smaller diameter than the outer emission orifice where the inner and outer emission orifice are in continuing alignment through a central portion of the optical block, wherein a center of the inner and outer emission orifice is in linear alignment with a center of the reaction well emission orifice;
an LED board having an LED, the LED board in removable attachment with the optical block where the LED is received by the outer excitation orifice;
a photodiode board having a photodiode, the photodiode board in removable attachment with the optical block where the photodiode is received by the outer emission orifice;
an excitation filter, the excitation filter received by a ledge of the outer excitation orifice, the ledge formed by the continuing alignment between the inner and outer excitation orifice;
an emission filter, the emission filter received by a ledge of the outer emission orifice, the ledge formed by the continuing alignment between the inner emission orifice and the outer emission orifice; and
a heating element in heating communication with the heating block to provide heat transfer to the sample well and reaction well.
Claim 11 is indefinite for the following reasons:
i) Recitation of “a first outer emission orifice”; “a first inner emission orifice”; “a second outer emission orifice”; and “a second inner emission orifice” is considered indefinite because the location of these orifices and/or structural cooperation of these orifices with respect to the reaction well emission orifices of the first and second reaction wells is unclear; and
ii) The two separate paragraphs referencing “heating block alignment holes” is confusing. It would appear that there are only one set of heating block alignment holes.
It is suggested that claim 11 be drafted in the following manner to clarify these issues:
Claim 11. A limited well thermal cycling device for preparation of a biological sample for amplification and detection of an analyte, the limited well thermal cycling device comprising:
a heating block configured for preparation of the biological sample and amplification of the analyte, the heating block comprising
a sample well having a flat bottom configured for receiving and preparing the biological sample for amplification and detection, the sample well extending from a top of a heating block base;
a first reaction well having a flat bottom configured for receiving and amplifying a first analyte of the prepared biological sample for detection, the first reaction well extending from the top of the heating block base, wherein
the first reaction well has a first excitation orifice, a first emission orifice, and a first cooling orifice, where the first excitation orifice and first emission orifice are in 90 degree alignment in a horizontal plane from the center of the first excitation orifice excitation orifice and the center of the first emission orifice; and
a second reaction well having a flat bottom configured for receiving and amplifying a second analyte of the prepared biological sample for detection, the second reaction well extending from the top of the heating block base, wherein
the second reaction well has a second excitation orifice, a second emission orifice, and a second cooling orifice, where the second excitation orifice and second emission orifice are in 90 degree alignment in a horizontal plane from the center of the second excitation orifice and the center of the second emission orifice; and
heating block alignment holes for removable attachment of an optical block to the heating block base, the heating block alignment holes on the top of the heating block base;
the optical block configured for detecting the first and second analytes of the amplified and prepared biological sample, wherein the optical block is attached via removable attachment to the heating block, the optical block comprising
a first inner excitation orifice and a first outer excitation orifice, the first inner excitation orifice having a smaller diameter than the first outer excitation orifice where the first inner and outer excitation orifice are in continuing alignment through a central portion of the optical block, wherein a center of the first inner and outer excitation orifice is in linear alignment with a center of the first reaction well excitation orifice;
a second inner excitation orifice and a second outer excitation orifice, the second inner excitation orifice having a smaller diameter than the second outer excitation orifice where the second inner and outer excitation orifice are in continuing alignment through the central portion of the optical block, wherein a center of the second inner and outer excitation orifice is in linear alignment with a center of the second reaction well excitation orifice;
a first inner emission orifice and a first outer emission orifice, the first inner emission orifice having a smaller diameter than the first outer emission orifice where the first inner and outer emission orifice are in continuing alignment through a central portion of the optical block, wherein a center of the first inner and outer emission orifice is in linear alignment with a center of the first reaction well emission orifice;
a second inner emission orifice and a second outer emission orifice, the second inner emission orifice having a smaller diameter than the second outer emission orifice where the second inner and outer emission orifice are in continuing alignment through the central portion of the optical block, wherein a center of the second inner and outer emission orifice is in linear alignment with a center of the second reaction well emission orifice;
an LED board having a first and a second LED, the LED board in removable attachment with the optical block where the first LED is received by the first outer excitation orifice and the second LED is received by the second outer excitation orifice;
a photodiode board having a first and a second photodiode, the photodiode board in removable attachment with the optical block where the first photodiode is received by the first outer emission orifice and the second photodiode is received by the second outer emission orifice;
a first excitation filter, the first excitation filter received by a ledge of the first outer excitation orifice, the ledge formed by the continuing alignment between the first inner and first outer excitation orifice;
a second excitation filter, the second excitation filter received by a ledge of the second outer excitation orifice, the ledge formed by the continuing alignment between the second inner and second outer excitation orifice;
a first emission filter, the first emission filter received by a ledge of the first outer emission orifice, the ledge formed by the continuing alignment between the first inner and first outer emission orifice;
a second emission filter, the second emission filter received by a ledge of the second outer emission orifice, the ledge formed by the continuing alignment between the second inner emission orifice and the second outer emission orifice; and
a heating element in heating communication with the heating block to provide heat transfer to the sample well and first and second reaction wells.
In claim 21, recitation of “an optical block” is considered to be indefinite because it is not clear from the current claim language whether or not the “optical block” is a positively recited element of the claimed device. Currently, the claim recites “heating block alignment holes for removable attachment of an optical block”; however, while the claim further describes the optical block in detail, the claim is devoid of any language that implies that the optical block is a positively recited element of the claimed “A limited well thermal cycling device”. As result, it is not clear if the optical block is considered to be a positively recited element of the claimed device. Clarification and/or correction is requested.
With respect to claim 22, recitation of “an outer emission orifice” and “an inner emission orifice” is considered indefinite because the location of these orifices and/or structural cooperation of these orifices with respect to the reaction well emission orifice is unclear. It is suggested that claim 22 be drafted in the following manner to clarify this issue:
Claim 22. A limited well thermal cycling device for preparation of a biological sample for amplification and detection of an analyte, the limited well thermal cycling device comprising:
a heating block configured for preparation of the biological sample and amplification of the analyte, the heating block comprising
a sample well having a tapered bottom configured for receiving and preparing the biological sample for amplification and detection, the sample well extending from a top of a heating block base;
a reaction well having a tapered bottom configured for receiving and amplifying an analyte of the prepared biological sample for detection, the reaction well extending from the top of the heating block base, wherein
the reaction well has an excitation orifice, an emission orifice, and a cooling orifice, where the excitation orifice and emission orifice are in 90 degree alignment in a horizontal plane from the center of the excitation orifice and the center of the emission orifice; and
heating block alignment holes for removable attachment of an optical block to the heating block base, the heating block alignment holes on the top of the heating block base;
the optical block configured for detecting the analyte of the amplified and prepared biological sample, wherein the optical block is attached via removable attachment to the heating block, the optical block comprising
an inner excitation orifice and an outer excitation orifice, the inner excitation orifice having a smaller diameter than the outer excitation orifice where the inner and outer excitation orifice are in continuing alignment through a central portion of the optical block, wherein a center of the inner and outer excitation orifice is in linear alignment with a center of the reaction well excitation orifice;
an inner emission orifice and an outer emission orifice, the inner emission orifice having a smaller diameter than the outer emission orifice where the inner and outer emission orifice are in continuing alignment through a central portion of the optical block, wherein a center of the inner and outer emission orifice is in linear alignment with a center of the reaction well emission orifice;
an LED board having an LED, the LED board in removable attachment with the optical block where the LED is received by the outer excitation orifice;
a photodiode board having a photodiode, the photodiode board in removable attachment with the optical block where the photodiode is received by the outer emission orifice;
an excitation filter, the excitation filter received by a ledge of the outer excitation orifice, the ledge formed by the continuing alignment between the inner and outer excitation orifice;
an emission filter, the emission filter received by a ledge of the outer emission orifice, the ledge formed by the continuing alignment between the inner emission orifice and the outer emission orifice; and
a heating element in heating communication with the heating block to provide heat transfer to the sample well and reaction well.
Claims 2-10, 12-18 and 20 are considered indefinite because they depend from indefinite claims and fail to cure the deficiencies of the claims from which they depend.
Response to Arguments
Rejections under 35 USC 112(b)
With respect to the recited “optical block”, the rejections of claims 1, 11 and 22 have been withdrawn in view of the amendments to these claims. However, the rejection of claim 21 has been maintained since it does not include the same amendments that were made to claims 1, 11 and 22.
With respect to the antecedent basis issues in claims 1, 11, 19 and 22, these rejections have been withdrawn in view of the amendments made to the claims. However, new rejections have been made regarding the indefiniteness of the newly recited amendments. Suggestions have been made to overcome these rejections as indicated previously in this office action.
Rejections under 35 USC 103
The 35 USC 103 rejections of claims 1-22 have been withdrawn in view of the amendments to claims 1, 11, 21 and 22 and related comments on pages 2-5 of Applicants’ response dated 7/14/2026.
Allowable Subject Matter
Claims 1-22 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 1, 11, 21 and 22 and any claims dependent therefrom would be allowable because the prior art of record fails to teach or fairly suggest, a limited well thermal cycling device, in the claimed environment or scope of claim, wherein the reaction well has an excitation orifice, an emission orifice, and a cooling orifice, where the excitation orifice and emission orifice are in 90 degree alignment in a horizontal plane from the center of the excitation orifice and the center of the emission orifice; and
heating block alignment holes for removable attachment of an optical block to the heating block base, the heating block alignment holes on the top of the heating block base;
the optical block configured for detecting the analyte of the amplified and prepared biological sample, wherein the optical block is attached via removable attachment to the heating block. The combination of the prior art references of Oommen et al. (US 2017/0115222) and Courtney (US 2015/0233828) fail to teach or fairly suggest the devices encompassed by claims 1, 11, 21 or 22 for the reasons articulated by Applicants on pages 2-5 of the response dated 7/14/2026.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB
Prosecution Insights