DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 28 and 38 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 claim(s) contains 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 28 and 38 recite “the first working electrode is disposed upon a first surface of a substrate and a second working electrode is disposed upon an opposing surface of the substrate”. There is no support for such a feature in the original disclosure. While the specifications show that one or more electrodes may be disposed on opposing sides of the substrate ([0066] of the printed publication) and that the device may have more than one working electrode ([0072]), in the configuration where it situated on opposite sides of the substrate, it also states that these electrodes are working, reference, and a counter electrode, respectively, and not multiple working electrodes.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing ot and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 21 and 31 recite that the membrane comprises “up to about 1% by weight of a modified polysiloxane”. The claim fails to identify the basis on which the weight percentage is calculated (i.e. by weight of what?)
Claims 21 and 31 recite that the first portion of an analyte sensor is configured to be positioned above a user’s skin, while also reciting that this first portion comprises the sensing layer and membrane which should be part of the second portion. For purposes of interpretation, it will be understood that it’s the second portion (which is configured to be positioned through the suer’s skin) that comprises the recited sensing layer and membrane. Applicant is advised that should this interpretation be incorrect, the claims would lack written description support.
Claims 27 and 37 recite “a polymer having at least one nitrogen-containing heterocycle such as a pyridine or an imidazole”. Use of “such as” renders it unclear whether pyridine and imidazole are required elements or merely non-limiting examples. Deletion of the exemplary language or amending to “wherein the nitrogen-containing heterocycle is a pyridine or an imidazole” is advised.
Claims 29 and 37 recite “a flux limiting membrane covering the sensing layer.” As claims 21 and 31 already recite “a membrane disposed over at least a portion of the sensing layer”, it is unclear whether the flux limiting membrane refers to this membrane, or a distinct, additional membrane.
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,053,282. Although the claims at issue are not identical, they are not patentably distinct from each other because it is largely a broader recitation of the recited claims.
Claim Rejections - 35 USC § 103
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.
Claims 21-27, 29-37, and 39-40 are is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ouyang (US 2008/0179187) in view of Haubennestel (US 2002/0143087).
As to claims 21 and 31, Ouyang teaches an analyte sensor and the corresponding method of its use, comprising: a first portion configured to be positioned above a user's skin (Fig. 5 – portion of sensor above surface of skin); a second portion configured to be transcutaneously positioned through the user's skin and in contact with the user's bodily fluid to detect an analyte in the bodily fluid in vivo (Fig. 5 – portion under surface of skin; [0032]); a sensing layer disposed on a first working electrode ([0067]), the sensing layer comprising a polymeric electron transfer agent to transfer electrons between the analyte and the first working electrode ([0049]; [0066] – low potential polymeric osmium complex mediator), and a membrane disposed over at least a portion of the sensing layer ([0067] – overlaying the sensing layer is an interfacing membrane). Ouyang additionally teaches collecting data from the sensor, transmitting to a display unit, and displaying an indication of the level of the analyte ([0015]).
Ouyang fails to expressly teach that the membrane comprises “up to about 1% by weight of a modified polysiloxane.” Haubennestel teaches the addition of a modified polysiloxane to a polymer coating formulation ([0003]) with the amounts that are usually 0.1 to 2% by weight ([0005]). Haubennestel teaches that these additions reduce the problems with respect to a lack of smoothness on surfaces ([0002]). Similarly, Ouyang also teaches the importance of uniformity in the thickness of membranes ([0005]). Accordingly, it would have been obvious to modify Ouyang with Haubennestel as it rectifies a problem that is specifically identified by both parties.
As to claims 22 and 32, Haubennestel teaches the modified polysiloxane is a modified polydimethylsiloxane ([0003]).
As to claims 23 and 33, Ouyang teaches the sensing layer comprises an analyte responsive enzyme ([0050]).
As to claims 24 and 34, Ouyang teaches the sensing layer comprises a glucose responsive enzyme ([0012]).
As to claims 25 and 35, Ouyang teaches the polymeric electron transfer agent comprises a transition metal compound or complex ([0042]).
As to claims 26 and 36, Ouyang teaches the polymeric electron transfer agent comprises a ruthenium-containing complex or an osmium-containing complex ([0042]).
As to claims 27 and 37, Ouyang teaches the polymeric electron transfer agent comprises one or more ligands covalently bound to a polymer having at least one nitrogen- containing heterocycle such as a pyridine or an imidazole ([0035], [0066] - Ouyang incorporates by reference USP #6,134,461 which teaches that the electron transfer agents are ligands in col. 20 lines 19-30).
As to claims 29 and 39, Ouyang teaches a flux limiting membrane covering the sensing layer ([0014]; claims 1 and 10).
As to claims 30 and 40, Ouyang teaches a sensor control unit with factory- determined calibration measurements input or stored therein such that no user calibration or recalibration of the analyte sensor is required during use ([0080], [0083]).
Claims 28 and 38 are is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ouyang (US 2008/0179187) and Haubennestel (US 2002/0143087), and further in view of Hoss et al. (US 2007/0203407).
As to claims 28 and 38, the above combination fails to expressly teach that the first working electrode is disposed upon a first surface of a substrate and a second working electrode is disposed upon an opposing surface of the substrate.
Hoss teaches such a limitation, as it discloses a transcutaneous two-sided analyte sensor in which electrodes are disposed on opposing first and second sides of a substrate ([0041]), and further teaches that a second working electrode can be disposed on either side of the substrate ([0051]). It would have been obvious to modify the above combination with Hoss to utilize multiple working electrodes as Hoss teaches that multiple working electrodes may improve and/or facilitate sensor calibration and accuracy of measured data ([0040]) while allowing placement on opposing sides of the substrate to minimize the size of the resulting device, reducing user discomfort.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 9/15/26
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