DETAILED ACTION
Notice of 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 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.
Withdrawal of Objections and Rejections
Applicant's response, filed 01/02/2026, has been fully considered.
In view of the amendment and remarks from 01/02/2026, the objection to claims and the rejection of the following claims are withdrawn:
claim 6 under 35 USC § 101.
claim 6 under 35 U.S.C. § 103
Newly recited claim 7 is not rejected under 35 USC § 101 because depends on claim 1 and claim 1 introduces elements that are unconventional under step 2B. The following rejections and/or objections are either maintained or newly applied for claims 1-5 and 7. They constitute the complete set applied to the instant application. Herein, "the previous Office action" refers to the Non-Final Rejection of 10/01/2025.
Status of the Claims
Claims 1-5 and 7 are pending.
Claim 6 is cancelled.
Claim 3 is objected to.
Claims 1-5 and 7 are rejected.
Priority
This US Application 17/571,774 (01/10/2022) claims priority from Application No. 63/135,335 (01/08/2021) as reflected in the filing receipt mailed on 06/25/2025. The claims to the benefit of priority are acknowledged. However, the provisional application does not provide support for the new limitations of claims 1 and 7, similarly issues described below in 35 USC 112(a) rejection. Therefore, the effective filing date of claims 1-5 and 7 is 01/10/2022.
Claim objections
Claim 3 is objected to because of the following informality: the term “dNTPs” lacks definition as to what the term means. Appropriate correction is required.
Response to applicant's remarks in regard to Claim objections
The Remarks of 01/02/2026 have been fully considered but are not persuasive for the reasons below:
There are no remarks addressing the objection above directly. It appears that pg. 1 para. 2 represents the only Applicant remarks specific to "dNTPs."
Applicant respectfully submits the term "dNTPs" is standard in PCR practice and is known to refer to deoxynucleoside triphosphates. The Specification identifies polymerase, nucleotides, and PCR reagents (Spec. ,i [0017]). Functional language tied to clearly recited structure is proper (MPEP 2173.05(g)). The amendments clarify apparatus components and remove any ambiguity in scope. Applicant respectfully submits that the claims, as amended, are definite
Examiner disagrees because there is no description in claims for the recited "dNTPs" and the disclosure [0017] does not clarify the issue. [0007] discloses "dNTPs" but also does not describe the term so the term is unclear and up for interpretation.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-5 and 7 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. Any newly recited portions are necessitated by claim amendment.
Claim 1 recites "(b) a rotation assembly comprising: (i) a central spindle mechanically engaging the central spindle opening of the microarray chip, and(ii) a motor configured to rotate the chip around its central axis during hybridization and washing; (c) a stationary optical read head radially aligned with the annular microarray region and configured to detect fluorescence while the chip rotates; and (d) a wash manifold positioned at a fixed angular position relative to the rotation assembly and configured to deliver wash buffer onto microarray region during continuous rotation; wherein the apparatus performs hybridization, washing, and fluorescence reading sequentially without removal of the microarray chip from the rotation assembly" which lacks written description under 35 U.S.C. 112(a).
The instant specification [0024] provides support for a "microarray chip manufactured by immobilizing probe sequences on a long, thin, flat polymer surface that is then curved and fused to form a ring structure; wherein the ring structure affords many physical benefits … the first part of the process is hybridization of genetic material to probes on the microarray surface and the ring microarray is advantageous in its annular shape." However, there is not support within the specification, nor has Applicant provided such support, for "(b) a rotation assembly comprising: (i) a central spindle mechanically engaging the central spindle opening of the microarray chip, and(ii) a motor configured to rotate the chip around its central axis during hybridization and washing."
The instant specification [0025] provides support for "the ring structure affords many physical benefits. For example, the first part of the process is hybridization of genetic material to probes on the microarray surface. The ring microarray is advantageous in its annular shape." However, there is not support within the specification, nor has Applicant provided such support, for "(c) a stationary optical read head radially aligned with the annular microarray region and configured to detect fluorescence while the chip rotates."
The instant specification [0028] provides support for "the entire procedure of hybridization, washing, and reading can be automated simply, with a slow circular motion of the ring and positioning of the heating system in the center of the ring and fluorescence scanner at the top of it." However, there is not support within the specification, nor has Applicant provided such support, for "(d) a wash manifold positioned at a fixed angular position relative to the rotation assembly and configured to deliver wash buffer onto microarray region during continuous rotation; wherein the apparatus performs hybridization, washing, and fluorescence reading sequentially without removal of the microarray chip from the rotation assembly."
Claim 7 recites "(b) perform background subtraction;(c) apply radial-correction normalization accounting for rotation-induced optical path variation; and(d) compute probe-specific hybridization values using calibration curves generated for the annular microarray geometry; wherein the computer module is limited to processing fluorescence signals generated by the apparatus and does not operate on external or generalized datasets" which lacks written description under 35 U.S.C. 112(a). In this case, there is not support within the specification, nor has Applicant provided such support, for the recited steps in claim 7.
The written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. See MPEP 2163.
Claim Rejections - 35 USC § 112(b)
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.
Claim 7 is rejected under 35 U.S.C. 112(b)as being indefinite for failing to particularly point out and distinctly claim the subject matter the invention. Dependent claims are rejected similarly, unless otherwise noted below. Any newly recited portions are necessitated by claim amendment. The following issues cause the respective claims to be rejected under 112(b) as indefinite:
In claim 7, the recited " the annular microarray geometry" requires but lacks antecedent basis, rendering their claims indefinite because there is no previous recitations of the term.
No prior art has been applied to the following claims
Claims 1-5 and 7 are free of the analogous art at least because close art, e.g. Peytavi, Li, Shanmugakani, and Teodoro as cited on the 10/01/2025 Form PTO-892, either individually or in obvious combination, does not teach the recited combination of "(b) a rotation assembly comprising: (i) a central spindle mechanically engaging the central spindle opening of the microarray chip, and(ii) a motor configured to rotate the chip around its central axis during hybridization and washing; (c) a stationary optical read head radially aligned with the annular microarray region and configured to detect fluorescence while the chip rotates; and (d) a wash manifold positioned at a fixed angular position relative to the rotation assembly and configured to deliver wash buffer onto microarray region during continuous rotation; wherein the apparatus performs hybridization, washing, and fluorescence reading sequentially without removal of the microarray chip from the rotation assembly."
Conclusion
No claims are allowed.
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 FRANCINI A FONSECA LOPEZ whose telephone number is (571)270-0899. The examiner can normally be reached Monday - Friday 8AM - 5PM ET.
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/F.F.L./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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