DETAILED ACTION
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 40, 42, 43, 45, 46, 50, 52 and 84-89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,618,876.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of U.S. Pat. No. 11,618,876 include limitations drawn to
A method comprising:
(a) providing a system comprising a cartridge engaged with an instrument,
(i) wherein the cartridge comprises:
(1) a preprocessing chamber comprising a stator comprising grinding teeth; and a plunger comprising a shaft and a head comprising grinding teeth and a circumference which provides a side gap between the plunger head and a wall of the preprocessing chamber between about 25 microns and 400 microns, wherein the prepossessing chamber comprises a tissue or cell sample; and
(2) a plurality of cartridge ports, wherein the cartridge ports are in fluid communication with the preprocessing chamber;
(ii) wherein the instrument comprises:
(1) a cartridge interface comprising a plurality of fluid ports engaged with the cartridge ports;
(2) a fluidics subsystem comprising one or more pumps and fluid lines communicating with the fluid ports in the cartridge interface; and
(3) an actuator that moves the plunger along a Z axis of the plunger and rotates the plunger; and
(b) disrupting a tissue sample in the preprocessing chamber by using the actuator to move the plunger along the Z-axis and to rotate the plunger within the preprocessing chamber to grind the tissue sample between the grinding teeth and the grinding stator, to produce a suspension of biological material; and
(c) using the fluidic subsystem to move the suspension of biological material around and above the head through the side gap between the head and the wall of preprocessing chamber, and out of the preprocessing chamber through a port in the preprocessing chamber.
Independent claim 1 of U.S. Pat. No. 11,618,876 contains all of the limitations set forth in claim 1 of this application, except for the recitation “using the fluidic subsystem to move the suspension of biological material around and above the head through the side gap between the head and the wall of preprocessing chamber, and out of the preprocessing chamber through a port in the preprocessing chamber”. However, these limitations can be found in dependent claim 25, which define a side gap and a port for moving fluid away from the preprocessing chamber. Dependent claim 17 expressly requires that the suspension is pushed around and above the plunger head and then through the side wall port above the head.
Claims 40, 42, 43, 45, 46, 50, 52 and 84-89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-28 and 37-42 of U.S. Patent No. 11,926,815.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of U.S. Pat. No. 11,926,815 include limitations drawn to
A method comprising:
(a) providing a system comprising a cartridge engaged with an instrument,
(i) wherein the cartridge comprises:
(1) a preprocessing chamber comprising a stator comprising grinding teeth; and a plunger comprising a shaft and a head comprising grinding teeth and a circumference which provides a side gap between the plunger head and a wall of the preprocessing chamber between about 25 microns and 400 microns, wherein the prepossessing chamber comprises a tissue or cell sample; and
(2) a plurality of cartridge ports, wherein the cartridge ports are in fluid communication with the preprocessing chamber;
(ii) wherein the instrument comprises:
(1) a cartridge interface comprising a plurality of fluid ports engaged with the cartridge ports;
(2) a fluidics subsystem comprising one or more pumps and fluid lines communicating with the fluid ports in the cartridge interface; and
(3) an actuator that moves the plunger along a Z axis of the plunger and rotates the plunger; and
(b) disrupting a tissue sample in the preprocessing chamber by using the actuator to move the plunger along the Z-axis and to rotate the plunger within the preprocessing chamber to grind the tissue sample between the grinding teeth and the grinding stator, to produce a suspension of biological material; and
(c) using the fluidic subsystem to move the suspension of biological material around and above the head through the side gap between the head and the wall of preprocessing chamber, and out of the preprocessing chamber through a port in the preprocessing chamber.
Independent claim 1 of U.S. Pat. No. 11,926,815 contains all of the limitations set forth in claim 1 of this application, except for the recitation “using the fluidic subsystem to move the suspension of biological material around and above the head through the side gap between the head and the wall of preprocessing chamber, and out of the preprocessing chamber through a port in the preprocessing chamber”. However, these limitations can be found in dependent claims 9, 10, 14, 15 and 8, which define a side gap and a port for moving fluid away from the preprocessing chamber. Dependent claim 20 expressly requires that the suspension is pushed around and above the plunger head and then through the side wall port.
Allowable Subject Matter
Claims 40, 42, 43, 45, 46, 50, 52 and 84-89 are allowable over the prior art, but remain rejected according to the double patenting rejections above.
With respect to independent claim 40, Holl is believed to be the closest prior art for the reasons expressed in previous office actions. Holl, however, fails to teach the claimed gap distance between the plunger head and the wall of the preprocessing chamber, or that the fluidic subsystem is configured to remove and collect fluid that has passed through the side gap into a space above the head. Any modification to Holl to arrive at the claimed invention would require a substantial redesign of the Holl preprocessing chamber outlet and seal. Although Kreuwel shows a preprocessing chamber where exposed intracellular analytes pass above the plunger head, Kreuwel does not teach a corresponding fluidic subsystem configured to transport analytes through a port. Applicant’s remarks filed 02 February 2026 are persuasive.
Response to Arguments
The terminal disclaimers filed 11 June 2026 were improper, and therefore the double patenting rejections remain. The terminal disclaimers identify a party who is not the Applicant. The Applicant cited on the TD must be cited exactly as it is cited on the ADS. Please resubmit the TD. A new fee is not required.
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Conclusion
THIS ACTION IS MADE FINAL. 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 NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (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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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
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