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 .
Election/Restrictions
Applicant’s election of Group IV, claims 219-221 and 231-245, in the reply filed on 17 August 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 240 is objected to because of the following informalities: the term “the” should be added before the term “group” in line 2 of claim 240. 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 220, 221, 232-235, 237-239, and 241-245 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.
Regarding claim 220, the claim recites elements that are structurally similar. It is unclear what the structural difference is between: (1) a hole and a pore; and (2) a groove and a depression.
Regarding claim 221, it is unclear what further limitation the claim provides to claim 219 as a “therapeutic agent-containing polymer composition” comprises a polymer and a therapeutic agent.
Regarding claim 232, the phrase “the plurality of sensing spots” lacks proper antecedent basis. For this examination, the phrase is being interpreted as “a plurality of sensing spots”. Further regarding claim 232, it is unclear how one drug-loading structure would comprise two slots. For this examination, claim 232 is being interpreted such that the sensor comprises two drug-loading structures (slots) symmetrically arranged along a plurality of sensing spots.
Regarding claim 233, the phrase “the plurality of sensing spots” lacks proper antecedent basis. For this examination, the phrase is being interpreted as “a plurality of sensing spots”. Further regarding claim 233, it is unclear how one drug-loading structure would comprise a plurality of holes. For this examination, claim 233 is being interpreted such that the sensor comprises a plurality of drug-loading structures, the drug-loading structures comprising a plurality of holes arranged around a plurality of sensing spots.
Regarding claim 237, it is unclear to what copolymer “a derivative thereof” is referring. For this examination, the phrase “a derivative thereof” is considered to refer to any of the copolymers recited in the claim.
Regarding claim 239, the phrase “can include” renders the claim indefinite in that it is unclear if the claimed polymer does or does not include 1-50 mer% of styrene units.
Regarding claim 241, the phrase “the anti-inflammatory agent” lacks proper antecedent basis. It is also unclear to which anti-inflammatory agent the phrase “derivative thereof” and the phrase “a salt form thereof” is referring.
Regarding claim 244, it is unclear what further limitation the claim provides as claim 219 already requires the analyte sensor to be subcutaneous by virtue of having an “in vivo portion configured to reside below a skin surface”.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
Claims 219-221, 234, 235, 241, 242, 244, and 245 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Somasuntharam et al.’993 (US Pub No. 2021/0076993).
Regarding claim 219, Figures 7A and 7B of Somasuntharam et al.’993 disclose an analyte sensor (see ABSTRACT), the sensor comprising: an in vivo portion configured to reside below a skin surface of a subject and in contact with interstitial fluid of the subject (sections [0004], [0006], [0023-0024]); wherein the in vivo portion comprises a non-sensing region and an active sensing region (section [0031], and see Figures 7B-11 and 7B-12), wherein the non-sensing region comprises a drug-loading structure filled with a therapeutic agent-containing polymer composition (reservoir or port of sections [0007], [0031], and therapeutic agent-containing polymer composition of the ABSTRACT, and section [0009]: “In some embodiments of the invention, the amperometric analyte sensor is formed to comprise at least one reservoir in which the polymeric material comprising the immunosuppressant agent is disposed.”).
Regarding claim 220, the drug-loading structure comprises a reservoir or port (sections [0007], [0031]). A reservoir or port comprises a hole, and can also be considered a groove or depression that holds the drug.
Regarding claim 221, the therapeutic agent-containing polymer composition comprises a polymer and a therapeutic agent (ABSTRACT, and section [0009]: “In some embodiments of the invention, the amperometric analyte sensor is formed to comprise at least one reservoir in which the polymeric material comprising the immunosuppressant agent is disposed.”).
Regarding claim 234, the claim does not require the drug-loading structure to comprise a slot. When read in combination with claim 220, claim 234 requires the drug-loading structure to comprise at least one selected from (1) a slot in a shape of an oval, a shape of a polygon, or an irregular shape, (2) a hole, (3) a pore, (4) a groove, and (5) a depression. As Somasuntharam et al.’993 teaches a hole/groove/depression, it need not teach the shape of the non-selected slot.
Regarding claim 235, Figure 7B-11 shows that the ports are in the shape of a regular polygon (a quadrilateral).
Regarding claims 241 and 242, the therapeutic agent is dexamethasone (sections [0006], [0030], [0043]).
Regarding claim 244, by virtue of the analyte sensor being implantable, it is a subcutaneous sensor. Furthermore, section [0025] discloses that the analyte sensor is a subcutaneous sensor.
Regarding claim 245, the analyte sensor is configured to detect glucose (see ABSTRACT, and section [0025]).
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.
Claims 231-233 and 243 are rejected under 35 U.S.C. 103 as being unpatentable over Somasuntharam et al.’993, as applied to claims 219 and 242.
Regarding claim 231, Somasuntharam et al.’993 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the non-sensing region surrounding the active sensing region. It is noted that Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the particularly claimed arrangement of the non-sensing region relative to the active sensing region. As rearranging the non-sensing region to surround the active sensing region would not modify the operation of the analyte sensor of Somasuntharam et al.’993, the location of the non-sensing region relative to the active sensing region is held to be an obvious matter of design choice (MPEP 2144.04 VI. C.).
Regarding claim 232, Somasuntharam et al.’993 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the drug-loading structure comprising two slots symmetrically arranged along a plurality of sensing spots. Somasuntharam et al.’993 discloses two ports (seen in Figure 7B-11), but fails to explicitly disclose that the ports are slots (i.e., narrow depressions/apertures). According to MPEP 2144.04 IV. B., however, changes in shape of a claimed element is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed element was significant. As Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the shape of the drug-loading structures, one of ordinary skill in the art would have found it a matter of obvious design choice to configure the ports of Somasuntharam et al.’993 as slots. It is further noted that Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the particularly claimed arrangement of the drug-loading structure around sensing spots. As rearranging the drug-loading structures to be symmetrically arranged along the sensing spots would not modify the operation of the analyte sensor of Somasuntharam et al.’993, the location of the drug-loading structures relative to the sensing spots is held to be an obvious matter of design choice (MPEP 2144.04 VI. C.).
Regarding claim 233, Somasuntharam et al.’993 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the plurality of holes (the holes that make up the ports of Somasuntharam et al.’993) being symmetrically arranged around the sensing spots. It is noted that Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the particularly claimed arrangement of the drug-loading structures around sensing spots. As rearranging the drug-loading structures to be symmetrically arranged around the sensing spots would not modify the operation of the analyte sensor of Somasuntharam et al.’993, the location of the drug-loading structures relative to the sensing spots is held to be an obvious matter of design choice (MPEP 2144.04 VI. C.).
Regarding claim 243, Somasuntharam et al.’993 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the therapeutic agent being in a range of 0.01 wt% - 50 wt% based on a total weight of the therapeutic agent-containing polymer composition. It is noted that Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the particular weight% of the therapeutic agent in the therapeutic agent-containing polymer composition. As such, it would have been within the skill of the art, through routine optimization, to have determined the optimum weight% of the therapeutic agent in the therapeutic agent-containing polymer composition. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, it is noted that section [0035] of Somasuntharam et al.’993 discloses a therapeutic agent in the range of 0.01 wt% - 50 wt% based on a total weight of the therapeutic agent-containing polymer composition.
Claims 236-240 are rejected under 35 U.S.C. 103 as being unpatentable over Somasuntharam et al.’993, as applied to claim 219, in view of Van Antwerp’699 (US Pub No. 2003/0031699).
Regarding claims 236 and 237, Somasuntharam et al.’993 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the therapeutic agent-containing polymer composition comprising a polymer matrix comprising a copolymer. Van Antwerp’699 teaches a therapeutic agent-containing polymer composition comprising a polymer matrix and a therapeutic agent, wherein the polymer matrix comprises a polyurethane-based copolymer (sections [0037-0039]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have substituted the therapeutic agent-containing polymer composition of Van Antwerp’699 for the therapeutic agent-containing polymer composition of Somasuntharam et al.’993, as it would merely be the simple substitution of one known therapeutic agent-containing polymer composition for another to obtain predictable results.
Regarding claims 238 and 239, the claims do not positively recite that the polymer matrix comprises the polyvinylpyridine-based copolymer. As the claims provide a further limitation for a non-selected/unrequired item from the list recited in claim 237, Somasuntharam et al.’993 in view of Van Antwerp’699 reads on the claims.
Regarding claim 240, Somasuntharam et al.’993 discloses that the therapeutic agent is an anti-inflammatory agent (sections [0006], [0030], [0043-0044]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wolfe et al.’735 (US Pub No. 2011/0230735) teaches coating or filling an aperture of an in vivo portion of a subcutaneous glucose sensor with a therapeutic agent-containing polymer composition that comprises a polymer matrix and a therapeutic agent (section [0145]).
Figure 7K of Simpson et al.’496 (US Pub No. 2010/0286496) discloses a subcutaneous glucose analyte sensor comprising: an in vivo portion configured to reside below a skin surface of a subject and in contact with interstitial fluid of the subject; wherein the in vivo portion comprises a non-sensing region and an active sensing region. Simpson et al.’496 could be modified in view of Somasuntharam et al.’993 such that its non-sensing region comprises a drug-loading structure filled with a therapeutic agent-containing polymer composition. Simpson et al.’496 could also be modified in view of Wolfe et al.’735 such that its non-sensing region comprises a drug-loading structure filled with a therapeutic agent-containing polymer composition. Finally, Simpson et al.’496 could be modified in view of Garai et al.’175 (US Pub No. 2023/0113175) such that its non-sensing region comprises a drug-loading structure filled with a therapeutic agent-containing polymer composition.
Donoghue et al.’744 (US Pub No. 2005/0113744) teaches an implantable sensor comprising an in vivo portion that comprises a non-sensing region. The non-sensing region comprises a drug-loading structure filled with a therapeutic agent (see Figure 3, drug-loading structures 310a-310c, and section [0051]).
Van Antwerp’699 teaches that conventional therapeutics or bioactive agents used on/in implanted sensors include anticoagulant agents, antibiotic agents, and/or antiviral agents (section [0043]).
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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