DETAILED ACTION
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.
Claim 3 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 3 requires that an electrolyte is disposed between the membrane and the electrode. However, independent claim 1 states that the membrane is positioned on the electrode. These limitations appear to contradict each other, as an intervening electrolyte would seemingly cause the membrane to no longer be positioned on the electrode but rather on the electrolyte. The specification and Figures do not appear to provide any additional guidance, as this feature is not shown in the Figures and paragraph [0091] simply states “an electrolyte can be disposed between the membrane 404 and the electrode 406 for ion-sensitive field-effect transistor (ISFET) applications”.
Applicant argues that the limitation “a membrane positioned on the electrode” contemplates configurations in which the membrane is indirectly offset from the electrode with the electrolyte disposed therebetween. This would make more sense if the words “above” or “over” were used instead of “on”. The word “on” means “physically in contact with and supported by”. This is what is shown in all the examples depicted in the Figures – i.e., the membrane 214, 404, 706 is directly on and physically touching the electrode 215, 206, 708.
Because the language of claim 3 contradicts the language of independent claim 1, claim 3 is indefinite.
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 1-5, 9-14, 17, 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/362,751 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of copending Application No. 18/362,751 include limitations drawn to:
A biosensor structure comprising:
a well structure comprising a first well and a second well, wherein a geometry of the well structure impacts where a solution dispensed into the well structure is located, wherein the well structure comprises a surface including at least one of a nanostructure or a microstructure thereon to decrease adhesion of the solution, wherein the first well is disposed within the second well such that the first well and the second well extend to different depths relative to a surface of the substrate, wherein the second well has a greater diameter than the first well, and wherein the first well and the second well each comprise a respective tapered sidewall;
an electrode configured to sense an analyte in the solution, the electrode disposed at a bottom of the well structure; and
a membrane positioned on the electrode and on at least part of a bottom surface of the well structure.
A biosensor structure comprising:
a well structure comprising a first well and a second well, wherein the first well and the second well are stepped concentric wells, wherein the well structure comprises asurface including at least one of a nanostructure or a microstructure thereon to decrease adhesion of the solution, wherein the first well is disposed within the second well such that the first well and the second well extend to different depths relative to a surface of the substrate, wherein the second well has a greater diameter than the first well, and wherein the first well and the second well each comprise a respective tapered sidewall;
an electrode configured to sense an analyte in a solution in the well structure; and
a membrane positioned on the electrode.
A biosensor structure comprising:
a well structure comprising a first well, a second well, and a pillar disposed between the first well and the second well, wherein the well structure comprises a surface including at least one of a nanostructure or a microstructure thereon to decrease adhesion of the solution, wherein the first well is disposed within the second well such that the first well and the second well extend to different depths relative to a surface of the substrate, wherein the second well has a greater diameter than the first well, and wherein the first well and the second well each comprise a respective tapered sidewall;
an electrode configured to sense an analyte in a solution in the well structure; and
a membrane positioned on the electrode,
wherein the first well and the second well are concentric, and wherein the second well surrounds the first well in plan view.
Claim 1 of copending Application No. 18/362,751 includes limitations drawn to a well structure, a membrane, an electrode and a textured feature. Claims 2 and 3 define that the textured feature is a microstructure or a nanostructure. Claims 11 and 12 indicate that the well structure is a multi-well structure with stepped concentric wells. Claim 13 states that the sidewalls of the well structure are tapered. Claims 14 and 15 require that a pillar is disposed between the first well and the second well and that the second well has a different diameter than the first well.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 1, 2, 4, 5, 9-14, 17, 19 and 20 are allowable over the prior art, but remain rejected according to the double patenting rejection above.
Applicant’s arguments and remarks filed 02 March 2026 are sufficient to overcome the prior art rejections. The previously cited references do not disclose, in the claimed environment, a biosensor structure comprising a first and second well, a surface including a microstructure or nanostructure to decrease adhesion of a solution, tapered sidewalls, and a membrane positioned on an electrode. Applicant has described how even those these features may be independently known in isolation, there appears to be no reason or suggestion for combining them to arrive at the claimed biosensor structure.
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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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799