DETAILED ACTION
Notice of Pre-AIA or 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 .
Claim Rejections - 35 USC § 112
Note that dependent claims will have the deficiencies of base and intervening claims.
Claims 1-17 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention.
Independent claim 1 includes the following limitation “. . . . , wherein the first portion is separated from the second portion by a polydimethylsiloxane (PDMS) microfluidic system. [underlining by the Examiner]” Independent claim 12 includes a similar limitation, “. . . ., wherein the first region is separated from the second region by a PDMS microfluidic system.” No support has been found in parent application 17/193454 for these limitations. As best understood by the Examiner, the first portion and the second portion of claim 1 and the first region and second region of claim 12 are actually part of a polydimethylsiloxane (PDMS) microfluidic system. There is only support for the following limitations -- . . . . , wherein the first portion is separated from the second portion by a wall of a polydimethylsiloxane (PDMS) microfluidic system… -- and -- “. . . ., wherein the first region is separated from the second region by a wall of a PDMS microfluidic system. -- See paragraphs [0051] and [0052] of the originally filed specification of parent application 17/193454 and Figure 4, noting especially “the wall structure 70w1 of the PDMS microfluidic system 70…”, “first portion 58a” and “second portion 58b”. As such, instant application 18/776286 should be reclassified as a continuation-in-part of application 17/193454. See MPEP 201.08 (“A continuation-in-part is an application filed during the lifetime of a prior-filed nonprovisional application, international application designating the United States, or international design application designating the United States repeating some substantial portion or all of the prior-filed application and adding matter not disclosed in the prior-filed application. [italicizing by the Examiner]”
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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12090477 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 5 (via claim 1, from which it ultimately depends) of U.S. Patent No. 12090477 B2 explicitly meets all of the limitations of claim 1 of the instant application, except for the claim 1 limitation “. . . . , wherein the first portion is separated from the second portion by a polydimethylsiloxane (PDMS) microfluidic system….”, which is implied by claim 5 of U.S. Patent No. 12090477 B2. Claim 5 of U.S. Patent No. 12090477 B2 requires, “wherein the first analyte solution is provided to the sensor through a first channel of a polydimethylsiloxane microfluidic system, and the second analyte solution is provided to the sensor through a second channel of the PDMS microfluidic system.” As the first channel of the claim 5 PDMS microfluidic system, or at least the sensor portion thereof, may be construed as first portion of claim 1 of the instant application, and the second channel of claim 5 PDMS microfluidic system, or at least the sensor portion thereof, may be construed as second portion of claim 1 of the instant application, the claim 1 limitation “. . . . , wherein the first portion is separated from the second portion by a polydimethylsiloxane (PDMS) microfluidic system….”, may be said to be implied. Note, regarding the rejection of claims 1-17 under 35 U.S.C. 112(a) (new matter), above, that fluidic channels of a PDMS microfluidic system, will inherently have PDMS walls.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 2 together of U.S. Patent No. 12090477 B2. Claim 1, from which claim 2 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 2 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12090477 B2. Claim 1, from which
claim 3 depends, has been addressed above. Claim 5 of U.S. Patent No. 12090477 B2 includes the additional limitation of claim 3 of the instant application through claim 3 of U.S. Patent No. 12090477 B2, from which it depends.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 4 together of U.S. Patent No. 12090477 B2. Claim 3, from which claim 4 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 4 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 4 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 7 together of U.S. Patent No. 12090477 B2. Claim 1, from which claim 5 depends, has been addressed above. . Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 5 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 8 together of U.S. Patent No. 12090477 B2. Claim 5, from which claim 6 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 8 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 6 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 9 together of U.S. Patent No. 12090477 B2. Claim 1, from which claim 7 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 9 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 7 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12090477 B2. Claim 3, from which
claim 5 depends, has been addressed above. Claim 5 of U.S. Patent No. 12090477 B2 includes the additional limitation of claim 8.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 10 together of U.S. Patent No. 12090477 B2. Claim 1, from which claim 9 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 10 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 9 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 6 together of U.S. Patent No. 12090477 B2. Claim 3, from which claim 10 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 6 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 10 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 11 together of U.S. Patent No. 12090477 B2. Claim 1, from which claim 11 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 11 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 11 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 and 5 of U.S. Patent No. 12090477 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 12 of U.S. Patent No. 12090477 B2 explicitly meets all of the limitations of claim 12 of the instant application, except for the claim 12 limitation “. . . . , wherein the first region is separated from the second region by a PDMS microfluidic system…”, which is implied by claim 5 of U.S. Patent No. 12090477 B2. Claim 5 of U.S. Patent No. 12090477 B2 requires, “wherein the first analyte solution is provided to the sensor through a first channel of a polydimethylsiloxane microfluidic system, and the second analyte solution is provided to the sensor through a second channel of the PDMS microfluidic system.” As the first channel of the claim 5 PDMS microfluidic system, or at least the sensor portion thereof, may be construed as first region of claim 12 of the instant application, and the second channel of claim 5 PDMS microfluidic system, or at least the sensor portion thereof, may be construed as second region of claim 12 of the instant application, the claim 12 limitation “. . . . , wherein the first region is separated from the second region by a PDMS microfluidic system…”, may be said to be implied. Note: (1) as the scope of claim 1 of U.S. Patent No. 12090477 B2, from which claim 5 depends, substantially overlaps the scope of claim 12 of U.S. Patent No. 12090477 B2, one of ordinary skill in the art would assume that features in claims depending from claim, such as those of claim 5 of U.S. Patent No. 12090477 B2, could readily be applied to the method of claim 12 of U.S. Patent No. 12090477 B2, and (2) regarding the rejection of claims 1-17 under 35 U.S.C. 112(a) (new matter), above, that fluidic channels of a PDMS microfluidic system will inherently have PDMS walls.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 13 together of U.S. Patent No. 12090477 B2. Claim 12, from which claim 13 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 13 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 13 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 14 together of U.S. Patent No. 12090477 B2. Claim 13, from which claim 14 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 14 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 14 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 15 together of U.S. Patent No. 12090477 B2. Claim 13, from which claim 15 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 15 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 15 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 16 together of U.S. Patent No. 12090477 B2. Claim 13, from which claim 16 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 16 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 16 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 17 together of U.S. Patent No. 12090477 B2. Claim 13, from which claim 17 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 17 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 17 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
16. Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 12090477 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because
claim 18 of U.S. Patent No. 12090477 B2 explicitly meets all of the limitations of
claim 18 of the instant application, except for the claim 18 limitation “. . . . , wherein the first region is separated from the second region; . . . .”, which is implied because
PNG
media_image1.png
386
540
media_image1.png
Greyscale
See Becton, Dickinson & Co. v. Tyco Healthcare Group, LP, Nos. 09-1053, -1111 (Fed. Cir. July 29, 2010).
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 12090477 B2. Claim 18, from which claim 19 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 19 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 19 of the instant application.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 12090477 B2. Claim 18, from which claim 20 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 20 of U.S. Patent No. 12090477 B2 meets the additional limitation of claim 20 of the instant application.
Relevant Prior Art
The claims in the instant application are very similar in scope to those allowed in parent application 17/193454. During prosecution of that application the closest prior art applied in the rejections under 35 U.S.C. 102(a)(1) was an EPO machine-generated English language translation of Ohtake et al. WO 2005/090961 A1 (“Ohtake”), the closest prior art applied in the rejections under 35 U.S.C. 102(a)(2) was Chang et al.
US 2019/0369044 A1 (“Chang”), and the closest prior art applied in the rejections under
35 U.S.C. 103 was Chang. See, for example, the non-final Office Action mailed on November 15, 2023. Ohtake differs from independent claims 1, 12, and 18 of application 18/776286 at least because of the limitations “. . . ., wherein the first portion is separated from the second portion by a polydimethylsiloxane (PDMS) microfluidic system….” In claim 1, “. . . ., wherein the first region is separated from the second region by a PDMS microfluidic system…” in claim 12, and “. . . ., wherein the first region is separated from the second region; and a separating structure surrounding a first region of the sensor…” in claim 18. Chang differs from independent claims 1, 12, and 18 of application 18/776286 at least because of the limitations the combination of limitations in independent claims 1 and 12 each require the step of “disposing a second analyte solution on the sensor and measuring a second electrical signal associated with the second analyte solution…” and the combination of limitations in independent claim 18 requires “a second analyte solution on the second region of the sensor; . . . .” See Allowable Subject Matter on pages 2-3 of the Notice of Allowance in application 17/193454, which was mailed on May 22, 2024.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER STEPHAN NOGUEROLA whose telephone number is (571)272-1343. The examiner can normally be reached on Monday - Friday 9:00AM-5:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached on 571 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795