DETAILED ACTION
Claim Objections
Claim 12 is objected to because of the following informalities: “gluteraldehyde" in line 2 is misspelled and should be corrected to “glutaraldehyde”. Appropriate correction is required.
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.
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 out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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 1 and 18 recite that the hydrophilic polymer comprises “poly-N-vinylpyrrolidone …, copolymers thereof, and mixtures thereof”. This is a conjunctive connection in which the claim requires the hydrophilic polymer to comprise EVERY recited species. For purposes of examination, it will be understood that the applicant intends to use a choice connection using the word “or” instead, such that it would be formatted as “X, Y, or Z”.
Claims 1 and 18 also recite acetates as a member of a list of hydrophilic polymers. Acetates themselves are a type of ester formed from acetic acid and are not polymers themselves. While there are acetate-containing polymers (such as the polyvinyl acetate) that is also recited, it is unclear what the metes and bounds of the claim is with respect to acetates as it is unclear whether it is intended to broadly recite any acetates, which would not be a hydrophilic polymer, or only hydrophilic polymers that happen to contain acetates, in which case the inclusion of polyvinyl acetate is redundant.
Claim 8 recites a base polymer selected from a group which includes carbonates. Carbonates describes a type of chemical rather than a polymer. For purposes of interpretation, it will be understood as “polycarbonates” instead.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,737,250. Although the claims at issue are not identical, they are not patentably distinct from each other because they are generally a broader recitation of the claims in the above patent. For example, claim 1 in the instant application is equivalent to claim 3 in the ‘250 patent minus the analyte being glucose and certain limitations of the sensing membrane.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,413,227. Although the claims at issue are not identical, they are not patentably distinct from each other because they are generally a broader recitation of the claims in the above patent. For example, claim 1 in the instant application is equivalent to claim 4 in the ‘227 patent minus certain limitations of the sensing membrane.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,998,329. Although the claims at issue are not identical, they are not patentably distinct from each other because they are generally a broader recitation of the claims in the above patent. For example, claim 1 in the instant application is equivalent to claim 4 in the ‘227 patent minus certain limitations of the sensing membrane.
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 1-3, 5-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Boock (US 2009/0247856).
As to claim 1, Boock teaches a device for measurement of a concentration of an analyte, the device comprising: a sensor configured to generate a signal indicative of the concentration of the analyte ([0139]); and a sensing membrane (32) located over the sensor, the sensing membrane comprising an enzyme domain (42) comprising an enzyme ([0202]) and a base polymer ([0203] – polyurethane). Boock further teaches that the catalyst (enzyme) can be impregnated or immobilized into the bioprotective or diffusion resistance domain such that a separate enzyme domain is not required ([0203]) and that both the bioprotective layer and the resistance domain may comprise a combination of base polymer such as polyurethane and one or more hydrophilic polymers including at least polyethylene oxide and polyvinyl acetate ([0177],[0199]). Accordingly, it would have been obvious to modify the various embodiments of Boock to obtain an enzyme domain comprising an enzyme, a base polymer, and a hydrophilic polymer, as it teaches that such a combination is possible.
As to claim 2, Boock teaches the hydrophilic polymer comprises from about 5 wt.% to about 30 wt.% of the enzyme domain ([0177] – between 5-50%).
As to claim 3, Boock teaches the hydrophilic polymer comprises from about 10 wt.% to about 25 wt.% of the enzyme domain ([0177]).
As to claim 5, Boock teaches the hydrophilic polymer comprises poly-N-vinylpyrrolidone (PVP) ([0176])
As to claims 6 and 7, Boock teaches the enzyme is glucose oxidase ([0202]).
As to claims 8-10, Boock teaches the base polymer comprises polyurethane copolymers ([0151]).
As to claim 11, Boock teaches a cross-linking agent to induce cross-linking between polymer molecules ([0192]).
As to claim 12, Boock teaches at least one of the cross-linking agents recited ([0192]).
As to claim 13, Boock teaches the cross-linking agent comprises about 0.1 to 15 wt.% of the total dry weight ([0192]).
As to claim 14, Boock teaches the thickness of the enzyme domain is from about 0.05-100 microns ([0204]).
As to claim 15, Boock teaches the sensor comprises an electrode (38).
As to claim 16, Boock teaches the sensing membrane further comprises a resistance domain (44).
As to claim 17, Boock teaches an interference domain located more proximal to the sensor than the enzyme domain, wherein the interference domain comprises at least about 25% silicone by weight ([0016]).
As to claim 18, Boock teaches all of the recited limitations (see rejection for claim 12 above) along with continuous in vivo glucose measurements ([0133]).
As to claims 19 and 20, Boock teaches in vivo glucose measurements ([0133]).
Claim 4 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Boock (US 2009/0247856) in view of Yang et al. (“Zwitterionic poly(carboxybetaine) hydrogels for glucose biosensors in complex media”).
As to claim 4, Boock does not teach that the enzyme domain comprises a betaine. Yang teaches the incorporation of carboxybetaine-based zwitterionic materials into glucose-oxidase based biosensor matrices to preserve enzyme activity (p2455). It would have been obvious to modify Boock with Yang and incorporate a betaine within the enzyme domain to increase the accuracy of the device.
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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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 8/4/26
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