DETAILED ACTION
Preliminary Amendment filed on 12/02/2024 is acknowledged. Claims 1-37 are cancelled. Claims 38-57 are pending in the application and are considered on merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 38-52, drawn to an integrated device for distinguishing multiple fluorophores from an array of optical sources over time, classified in B82Y20/00.
II. Claim 53-57, drawn to a method of distinguishing multiple fluorophores from an array of optical sources over time, classified in C12Q1/6825.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus as claimed can be used to practice another and materially different process.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention; and
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Yingying Zhou on 09/10/2025 a provisional election was made without traverse to prosecute the invention of group I, claim 38-52. Affirmation of this election must be made by applicant in replying to this Office action. Claim 53-57 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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.
Claim 38-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of U.S. Patent No. 9,410,891. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the currently patented claims expressly recite the same subject matter, it would have been obvious to one of ordinary skill in the art at the time the invention was made to employ both device and methods, as recited in both sets of claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 47 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 47 recites “wherein the device is configured to use charge binning to improve the SNR of fluorophore lifetime signatures”. Charge binning, a technique used in image sensors, can improve the signal-to-noise ratio (SNR) by combining the electrical signals from multiple adjacent pixels. Claim 47 depends on claim 38.
Claim 38 recites “a detector having a single pixel”. Thus, claim 47 expands limitation of claim 38 from “single pixel” to multiple adjacent pixels. Thus, Claim 47 fail to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 38, 41-46 and 49-52 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Rae et al. (Sensors, 2009) (Rae).
Regarding claim 38, Rae discloses an integrated device for distinguishing multiple fluorophores from an array of optical sources over time (abstract), the device comprising:
an array of elements, each element comprising:
a top layer comprising an optical source that emits two or more fluorescent
signals, each fluorescent signal having a different rate of signal decay (Fig. 2, page 9265, par 1);
a middle layer (optical filter) (Fig. 2, page 9261, par 1); and
a bottom layer comprising a detector having a single pixel (By processing raw SPAD data locally within each pixel) (Fig. 2, page 9264, par 1);
wherein the middle layer transfers light from the top layer to a bottom layer (Fig. 2, page 9261, par 1);
wherein the pixel is configured to measure photonic emission lifetime of each of the two or more different fluorescent signals to distinguish the identity of each of the fluorescent signals (page 9265, par 1).
Regarding claim 41, the phrase “wherein the two or more fluorescent signals are from distinctly labeled nucleotides” describes an intended use of the device. Rae’s device is capable to detect fluorescent signals from distinctly labeled nucleotides. Thus, Rae meets the claim.
Regarding claim 42, the phrase “wherein the distinct fluorescent labels comprise four distinctly labeled nucleotides” describes an intended use of the device. Rae’s device is capable to detect the distinct fluorescent labels comprising four distinctly labeled nucleotides. Thus, Rae meets the claim.
Regarding claim 43, Rae discloses that the integrated device further comprising at least one illumination waveguide (sapphine) that provides excitation light to the optical source (Fig. 2).
Regarding claim 44, Rae discloses that wherein the middle layer comprises a filter (page 9261, par 1).
Regarding claim 45, Rae discloses that wherein the middle layer comprises a lens (page 9271, par 2).
Regarding claim 46, Rae discloses that wherein the pixel is a CMOS pixel configured to determine different species of chemical tags by means of processing high speed lifetime decay signatures (Fig. 2, page 9264, par 1).
Regarding claim 49, the phrase “wherein the device is configured to detect kinetics of nucleotide incorporation” describes an intended use of the device. Rae’s device is capable to detect kinetics of nucleotide incorporation. Thus, Rae meets the claim.
Regarding claim 50, the phrase” wherein the device is configured to detect a binding reaction” describes an intended use of the device. Rae’s device is capable to detect a binding reaction. Thus, Rae meets the claim.
Regarding claim 51, the phrase” wherein the device is configured to detect a hybridization reaction” describes an intended use of the device. Rae’s device is capable to detect a hybridization reaction. Thus, Rae meets the claim.
Regarding claim 52, the phrase” wherein the device is configured to perform an antibody assay” describes an intended use of the device. Rae’s device is capable to perform an antibody assay. Thus, Rae meets the claim.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 39-40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rae et al. (Sensors, 2009) (Rae).
Regarding claim 39, Rae discloses that wherein the optical source comprises an aperture (Fig. 3). It would have been obvious to one of ordinary skill in the art to optimize the size of the aperture by routine experimentation.
Regarding claim 40, Rae discloses that wherein the nanoscale aperture defines an optical confinement structure (Fig. 3).
Claim 47 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rae et al. (Sensors, 2009) (Rae) in view of Guidash (EP 2323409).
Regarding claim 47, Rae does not specifically disclose that wherein the device is configured to use charge binning to improve the SNR of fluorophore lifetime signatures.
However, Guidash discloses using charge binning to improve the SNR of image sensor (par [0001] [0012]). It would have been obvious to one of ordinary skill in the art to use charge binning to improve the SNR of fluorophore lifetime signatures as taught by Guidash. The result is predictable.
Claim 48 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rae et al. (Sensors, 2009) (Rae) in view of Lundquist et al. (US 2008/0212960) (Lundquist).
Regarding claim 48, Rae does not specifically disclose that wherein the device further comprises a fluidic conduit configured to provide reagents across the array of reaction cells. However, Lundquist discloses a fluidic conduit configured to provide reagents across the array of reaction cells (par [0057] [0058]). It would have been obvious to one of ordinary skill in the art to include a fluidic conduit configured to provide reagents across the array of reaction cells, in order to monitor reaction in real time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./Primary Examiner, Art Unit 1797