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 Objections
Claims 7-9 is objected to because of the following informalities: “topography characterized by” in line 1 should be “topography is characterized by”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “and inflammatory” in line 1 should be “an inflammatory”. Appropriate correction is required.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-2, 10-12 and 15 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-4 of prior U.S. Patent No. 12,042,284. This is a statutory double patenting rejection.
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 4-9, 13 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,042,284. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 4-9, 13 and 14 disclose the same structure as claims 1-4 of the patent.
Application
US 12,042,284
4
Claim 1 discloses the same structure recited in claim 4 which would give the result of a decrease in MIP-1α polypeptide expression of at least 10%.
5
Claim 1 discloses the same structure recited in claim 5 which would inhibit macrophage adherence to the surface by at least 10%.
6, 13
Claims 1 and 4 recite a polyamide
7-9
Claim 1 recites the same structure
14
Claim 1 discloses the same structure recited in claim 14 which would inhibit macrophage adherence to the surface by at least 10% and would give the result of a decrease in MIP-1α polypeptide expression of at least 10%.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,042,284 in view of Pesantez et al. US 2014/0163346. ‘284 does not disclose the electrode structure but Pesantez teaches a similar medical device that teaches a base layer (106) a working electrode, a reference electrode and counter electrode disposed on the base layer ([FIG2][¶17,43]) an analyte sensing layer disposed over the working electrode wherein the analyte sensing layer comprises glucose oxidase ([FIG2][¶45] sensing layer 110) and an analyte modulating layer dispose over the analytes sensing layer, wherein the analyte modulating layer modulates the diffusion of glucose there through ([¶45] modulating layer 112). Therefore it would have been one of ordinary skill in the art prior to the time of filing to combine the teachings of Pesantez with Ross as it would allow for sensing with the microneedle array ([¶39]).
the base layer ([¶43]); an analyte sensing layer disposed over the working electrode, wherein the analyte sensing layer comprises glucose oxidase ([¶44]); and an analyte modulating layer disposed over the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of glucose there through ([¶44]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross US 2017/0157380 in view of Pesantez et al. US 2014/0163346.
Regarding claims 1, 6 and 15, Ross discloses a medical device comprising a surfaced adapted to contact an in vivo environment, the surface comprising a polymer composition having the following characteristics: 5
a surface hydrophobicity of between 75˚ and 90˚ ([¶115] 80 degrees. The angle is dependent on the topography);
a surface topography characterized by:
grooves having an average peak-to-valley height of between 0.3 µm and 5 µm ([¶85,91-92,98-101]);
wells having an average peak-to-valley height of between 1 µm and 2 µm ([¶85,91-92,98-101]); or
grids having an average peak-to-valley height of between 2 µm and 4 µm ([¶85,91-92,98-101] the various topographies have grooves, wells and grids that are within the ranges recited and micro and nanostructure pillars);
Pesantez teaches a medical device comprising a surface adapted to contact an in vivo environment ([FIG2]) and a polyimide layer and a carbon-to-oxygen ratio greater than 5 to 1 ([¶36,55] Polyimide inherently has a carbon-to-oxygen ratio greater than 5 to 1).
Therefore it would have been one of ordinary skill in the art prior to the time of filing to combine the teachings of Pesantez with Ross as it is just the simple substitution of one known biocompatible layer for another.
Ross as modified teaches when exposed to the surface comprising the 5polymer composition, RAW264.7 macrophages are influenced in a manner that inhibits their differentiation into an inflammatory (M1) phenotype, and/or influenced in a manner that facilitates their differentiation into an anti-inflammatory (M2) phenotype (as this is a function of the surface topography and base material, since the combination as modified discloses the appropriate topography and composition it discloses the macrophage behavior).
Regarding claims 2, Pesantez teaches a glucose sensor that uses a microneedle array ([¶39]).
Regarding claim 3, Pesantez teaches the glucose sensor comprises:
a base layer ([FIG2] base layer 106) a base layer ([¶45] substrate 130); a working electrode, a reference electrode, and a counter electrode disposed on
a working electrode ([¶17,43]), a reference electrode ([¶17,43]) and a counter electrode ([¶17,43]) disposed on the base layer ([FIG2])
an analyte sensing layer disposed over the working electrode wherein the analyte sensing layer comprises glucose oxidase ([FIG2][¶45] sensing layer 110)
an analyte modulating layer dispose over the analytes sensing layer, wherein the analyte modulating layer modulates the diffusion of glucose there through ([¶45] modulating layer 112). the base layer ([¶43]); an analyte sensing layer disposed over the working electrode, wherein the analyte sensing layer comprises glucose oxidase ([¶44]); and an analyte modulating layer disposed over the analyte sensing layer, wherein the analyte modulating layer modulates the diffusion of glucose there through ([¶44]).
Regarding claim 4 and 7-9, Ross discloses a surface topography characterized by:
grooves having an average peak-to-valley height of between 0.3 µm and 5 µm ([¶85,91-92,98-101]);
wells having an average peak-to-valley height of between 1 µm and 2 µm ([¶85,91-92,98-101]); or
grids having an average peak-to-valley height of between 2 µm and 4 µm ([¶85,91-92,98-101] the various topographies have grooves, wells and grids that are within the ranges recited and micro and nanostructure pillars);
Ross as modified teaches when exposed to the surface comprising the 5polymer composition, RAW264.7 macrophages exhibit a decrease in MIP-1α polypeptide expression of at least 10% as compared to an equivalent polymer surface not having the same surface topography (as this is a function of the surface topography and base material, since the combination as modified discloses the appropriate topography and composition it discloses the macrophage behavior).
Regarding claim 5, Ross discloses a surface topography characterized by:
grooves having an average peak-to-valley height of between 0.3 µm and 5 µm ([¶85,91-92,98-101]);
wells having an average peak-to-valley height of between 1 µm and 2 µm ([¶85,91-92,98-101]); or
grids having an average peak-to-valley height of between 2 µm and 4 µm ([¶85,91-92,98-101] the various topographies have grooves, wells and grids that are within the ranges recited and micro and nanostructure pillars);
Ross as modified teaches when exposed to the surface comprising the 5polymer composition, RAW264.7 macrophages adherence to the surface is inhibited by at least 10% as compared to an equivalent polymer surface not having the surface topography (as this is a function of the surface topography and base material, since the combination as modified discloses the appropriate topography and composition it discloses the macrophage behavior).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Luu et al. “Micro- and Nanopatterned Topographical Cues for Regulating Macrophage Cell Shape and Phenotype” relating to a fully implantable device.
Neacsu et al. “Reduced inflammatory activity of RAW 264.7 macrophages on titania nanotube modified Ti surface” relating to another fully implantable device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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