DETAILED ACTION
The present Office Action is responsive to the Amendment received on October 16, 2025.
Information Disclosure Statement
The IDS received on January 30, 2025 and May 21, 2025 are proper and are being considered by the Examiner. The two IDS were received with the fee under 37 CFR 1.17(p).
Preliminary Remark
All rejections not reiterated herein are withdrawn in view of the Amendment received on October 16, 2025.
Claim 1 is canceled.
Claims 22-41 are new.
Election/Restrictions
Newly submitted claims 30-41 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claims are directed to a method. The previously prosecuted claim(s) were directed to a product.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 30-41 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added 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.
Claim Rejections - 35 USC § 102
The rejection of claim 1 under 35 U.S.C. 102(e) as being anticipated by Yoder et al., (US 2006/0094108, published May 4, 2006, priority September 15, 2005), made in the Office Action mailed on December 19, 2024 is withdrawn in view of the Amendment received on October 16, 2025 by way of its cancellation.
Double Patenting
The rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claims 1-52 of U.S. Patent No. 9,040,288 (herein, “the ‘288 patent”), made in the Office Action mailed on December 19, 2024 is withdrawn in view of the Amendment received on October 16, 2025 by way of its cancellation.
The rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 7,998,708 (herein, “the ‘708 patent”), made in the Office Action mailed on December 19, 2024 is withdrawn in view of the Amendment received on October 16, 2025 by way of its cancellation.
The rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 8,323,900 (herein, “the ‘900 patent”), made in the Office Action mailed on December 19, 2024 is withdrawn in view of the Amendment received on October 16, 2025 by way of its cancellation.
The rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 9,080,207, made in the Office Action mailed on December 19, 2024 is withdrawn in view of the Amendment received on October 16, 2025 by way of its cancellation.
Rejection – New Grounds, Necessitated by Amendment
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 22-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1-52 of U.S. Patent No. 9,040,288 (herein, “the ‘288 patent”) in view of Jovanovich et al. (WO 2005/075081 A1, published August 2005).
In addition, claims 22-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 7,998,708 (herein, “the ‘708 patent”); claims 1-22 of U.S. Patent No. 8,323,900 (herein, “the ‘900 patent”); and claims 1-22 of U.S. Patent No. 9,080,207 over Jovanovich et al. (WO 2005/075081 A1, published August 2005).
For the sake of reducing the redundant rejections, the rejection is detailed over the ‘288 patent below. However, the same rationale applies for the above-cited patents.
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With regard to instant claim 22, the ‘288 patent also claims an apparatus comprising:
a multi-lane microfluidic cartridge, each lane comprising an amplification region within which amplification of polymerase is carried out (see claim 1, “bay configured to receive an insertable multi-lane microfluidic cartridge comprising a plurality of PCR reaction zones … each lane comprising one of the plurality of PCR reaction zones”);
an instrument, the instrument comprising:
a drawer comprising an area configured to receive the multi-lane microfluidic cartridge (receiving bay is recited in claim 1 as receiving the multi-lane microfluidic cartridge and therefore, considered a “drawer”), wherein the drawer comprises:
an area configured to receive multi-lane microfluidic cartridge (see claim 1, “bay configured to receive an insertable multi-lane microfluidic cartridge”);
a plurality of separately controllable heat sources configured to deliver localized heat to selected regions of the multi-lane microfluidic cartridge at specific times (see claim 1, “plurality of heater sets fixed in position in the receiving bay, each heater set configured to thermally couple to one of the plurality of PCR reaction zones in the multi-lane cartridge, each heater set comprising a plurality of heat sources … independently control the temperature of the plurality of heat sources in each heater set to cyclically heat one of the plurality of PCR reaction zones in a series of a heating phases”); and
electrical connectors configured to transmit electrical signals to the plurality of separately controllable heat sources during analysis (see claim 10, “at least two contact heat sources are configured to be in direct physical contact with the multi-lane microfluidic cartridge when the multi-lane microfluidic cartridge is inserted into the receiving bay”);
a detector comprising a fluorescence detection module, wherein the detector is configured to detect the presence of one of more polynucleotides in samples (see claim 1, “a detector configured to detect the presence of one or more amplified polynucleotides on the multi-lane microfluidic device”, also claim 5, “optical detector comprises a light source configured to emit light in an absorption band of a fluorescent dye, and wherein the optical detector further comprises a light detector configured to detect light in an emission band of the fluorescent dye”);
a display, wherein the display is configured to present information to a user and accept input from the user in responsive to various display prompts (see claim 35, “apparatus … further comprising at least one output device coupled to the processor, the at least one output device being selected from the group consisting of: a visual display, a printer, and a speaker”); and
one or more processors configured to control various processing operations to be performed on the samples introduced into the multi-lane microfluidic cartridge (see claim 7, “processor is programmable to operate the detector”),
-) wherein the instrument is configured to control the plurality of separately controllable heat sources to direct heat to the individual sample lanes separately, in all simultaneously, or in groups simultaneously to perform amplification of polynucleotides within the amplification region of each lane of the multi-lane microfluidic cartridge (see claim 1, “each heater configured to thermally couple to one of the plurality of PCR reaction zones in the multi-lane cartridge, each heater set comprising a plurality of heat source”, they are separately controllable and therefore capable of operating separately, in groups or in all); and
-) wherein the instrument is configured to analyze the products of amplification of each lane of the multi-lane microfluidic cartridge separately, in all simultaneously, or in groups simultaneously and transmitting results of the analysis of the sample processed in the multi-lane microfluidic cartridge to the display (the detector is capable of detecting the presence of one or more amplified polynucleotides on the multi-lane microfluidic cartridge that comprises multi-lane PCR zones; see claim 32, “comprising a communication interface coupled to the processor, the communication interface being selected from the group … a wireless network connection, and a wired network connection”).
With regard to instant claim 25, the detector is configured to detect the fluorescence produced from the multi-lane microfluidic cartridge during use (see above), and the location of such detector as being over the cartridge would have been an obvious placement.
With regard to claim 26, the location of the heaters is claimed as being in contact with the multi-lane cartridge and therefore, it would have been an obvious placement of such heaters to heat the cartridge from below as conventionally done in the art such as thermocyclers.
With regard to claim 27, the display is touch-screen (see claim 30).
With regard claim 28, while the display is not explicitly claimed as being in “color,” color displays have been widely available and routinely adopted in the molecular diagnostic devices for the purpose of displaying output data in graphic form and therefore, would have been an obvious application.
With regard to claim 29, the instrument is configured to apply pressure to the multi-lane microfluidic cartridge (see claim 22, “one or more force members configured to apply force to at least a portion of the multi-lane microfluidic cartridge”).
Claims of the ‘288 patent do not explicitly claim that the instrument comprises a “frame” (claim 22, in-part), or that the detector is positioned on rails to facilitate placement of the multi-lane microfluidic cartridge in the “drawer” (claim 23), or that the detector is positioned on rails to facilitate alignment of optics (claim 24).
However, the claimed features of the instant claims would have been a prima facie obvious application (at the time the invention was made) of conventionally known means to predictably place the microfluidic device into the instrument of the ‘288 patent for the purpose of aligning the device for analysis and detection utilizing means that have been known in the art, be it by registration means, or by rails, or by any mechanical means that loads the microfluidic device. Such a knowledge to predictably place the microfluidic device into an analysis instrument is also explicitly demonstrated by the claims of the ‘288 patent in claim where in claim 2, the apparatus of the ‘288 patent is claimed as comprising “a registration member that is complementary to the multi-lane microfluidic cartridge, whereby the receiving bay receives the multi-lane microfluidic cartridge in a single orientation.”
As well, Jovanovich et al. also evidence such a knowledge, wherein the artisans employ rail linear guides that allow aligned movement across a desired axis (“microchips might be movable in X and/or Y axes … fixtures are, in turn, mounted on rail linear guides 760 that define an x-axis …”, section [0191]).
Therefore, one of ordinary skill in the art would have been motivated to apply any such means to predictable place the microfluidic device and orient the necessary elements, such as the detector utilizing conventional means.
As to an instrument having a “frame”, it is understood that any mechanical device requires a sort of frame from which to build the necessary structures and therefore, would have been an inherent element of the instrument in the ‘288 patent.
Therefore, the invention as claimed is deemed prima facie obvious over the claims of the ‘288 patent.
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.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
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/YOUNG J KIM/Primary Examiner
Art Unit 1637 February 4, 2026
/YJK/