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 .
Status of Claims
Claims 1-10 are pending and under examination. The claim set is in the submission from 6/4/2026.
Priority
This application is a continuation of 16/875,424 filed on 5/15/2020, which claims priority from US provisional application 62/848,835 filed on 5/16/2019.
Objections and Rejections Withdrawn
The objections over claim 10 are withdrawn per applicant’s amendments.
The rejections under USC 112(b) and 112(d) are withdrawn per applicant’s amendments and arguments.
The rejection under USC 103 over Chatterjee US20200352492 is withdrawn as applicant has made a statement of ownership in the response.
The rejection under USC 103 over Chatterjee US 20200268291 is withdrawn as applicant has made a statement of ownership in the response.
The rejection under USC 103 over Colvin and Carter is withdrawn per applicant’s arguments, however, as Suri provides using metal chelators in a structure in the similar way to applicant’s claims, the rejection over Colvin, Carter and Suri is being maintained for the reasoning set forth in the prior rejection.
The rejection under double patenting over US Patent 11963761 is withdrawn per applicant’s filing of a terminal disclaimer which has been approved.
The rejection under double patenting over US Patent 12419551 is withdrawn per applicant’s arguments about the analyte indicator not having the chelating moiety.
Maintained Rejections
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Colvin US 20120238842; Carter et al (Chemical Reviews, 2014, volume 114, pages 4564-4601) and Suri US 20110236989 (cited previously).
Colvin teaches “An implantable device with in vivo functionality, where the functionality of the device is negatively affected by ROS typically associated with inflammation reaction as well as chronic foreign body response as a result of tissue injury, is at least partially surrounded by a protective material, structure, and/or a coating that prevents damage to the device from any inflammation reactions” (abstract). Colvin teaches “The protective material, structure, and/or coating thereby prevents ROS from degrading the in vivo functionality of the implantable device” (abstract). Colvin teaches “The sensor may also include fluorescent indicator monomers distributed throughout and co-polymerized with the porous sensor graft material that generate signal indicative of the level of fluorescence in the indicator graft. The sensor may also include a radiation source (e.g. an LED), and a photosensitive detector element” (paragraph 55). Colvin teaches “The sensor may also include fluorescent indicator monomers distributed throughout and co-polymerized with the porous sensor graft material that generate signal indicative of the level of fluorescence in the indicator graft. The sensor may also include a radiation source (e.g. an LED), and a photosensitive detector element” (paragraph 55). Colvin teaches “the porous sensor graft may be protected whether it is located in a specific region of a sensor body or completely covering a sensor body” (paragraph 97). Figure 4 shows the sensor and figure 1 shows some analyte indicator molecules. Colvin teaches structural encasings for the implantable devices (paragraph 83). These encasings would be housings. Colvin teaches the sensor body having an outer surface and a radiation source in said sensor body (paragraph 56). Colvin teaches the layer being in the form of a coating sputter deposited on at least part of the device (paragraph 73). Colvin teaches the co-polymerization fabrication of the indicator monomers with the porous sensor graft material (paragraph 96). Colvin teaches sensing of glucose levels (claim 3 of Colvin). Colvin teaches “More particularly, the invention relates to (but is not limited to) electro-optical-based sensing devices for detecting the presence or concentration of an analyte in a medium which are characterized by being totally self-contained and of an extraordinarily compact size which permits the device to be implanted in humans for in situ detection of various analytes” (paragraph 3). Colvin teaches detecting of an analyte and an implantable device (paragraphs 12-13). Thus, Colvin is in general to detection of analytes while also providing for an outer surface with analyte indicators.
Colvin does not teach the chelator with the indicator on the outer surface or with the indicator being in a copolymer with the chelator as part of it.
Carter teaches fluorescent sensors for measuring metal ions in living systems (title and abstract). Carter teaches a general feature of fluorescence sensors for metals is a metal chelating or binding moiety and at least one fluorophore capable of absorbing and emitting light (section 2 on page 4566). Carter teaches a platform with fluorophore, linker and chelator which can be individually modified to alter PET (photoinduced electron transfer) within the probe (bottom of 2nd column on page 4567 and top of 1st column on page 4568, also section 2.3.1). Carter teaches “Molecular probes are comprised of small-molecule fluorophores coupled to a metal chelating unit. They may be entirely chemical in nature or comprised of peptide or nucleic acid components” (section 2.3.1). Carter teaches attaching a DPA chelating group to various positions of the benzoic acid moiety of a fluorophore (2nd column of page 4577). Carter teaches using BAPTA (bis(o-aminophenoxy)-ethane-N,N,N′,N′-tetraacetic acid) as a chelator (1st column of page 4578). Carter teaches EGTA (2nd column of page 4591).
Carter teaches a platform with fluorophore, linker and chelator which can be individually modified to alter PET (photoinduced electron transfer) within the probe (bottom of 2nd column on page 4567 and top of 1st column on page 4568, also section 2.3.1).
Colvin and Carter do not teach the indicator chemically attached or copolymerized to chelating agent or other monomers as stated in claims 5-7.
Suri teaches analyte sensors (abstract). Suri provides for hydrogel with hydrophilic monomers, crosslinking monomers and sensing moieties with sensing moieties bound by pendant groups (paragraph 85). Suri provides for HEMA, PEGMA (polyethylene glycol methacrylate), PEGDMA, methacrylic acid, ethylene dimethacrylate and other monomers and crosslinkers for hydrogels (paragraph 87). Suri provides for dye moieties (paragraph 87). Suri teaches controlling destruction by iron ions by chelation (paragraphs 48 and 60). Suri teaches attaching a polymerizable group to a chelating agent/monomer (paragraph 60). Suri teaches fluorescence indicator system polymerized in a hydrogel (paragraph 110).
One of ordinary skill in the art before the time of filing would have been able to fabricate a sensor for measuring an analyte within a living animal (implantable sensor) by teachings of Colvin where analyte indicator comprises chelating moieties linked with a linker in teachings of Carter and in the form of a hydrogel (by Colvin) are applied on the outer surface of the sensor device housing/encasement. Although Carter does not provide that chelator reduces deterioration of analyte indicator (an intended function of the fabrication), Carter teaches the linking of chelator to fluorophore (indicator), and thus, has this structure of applicant’s claims and would be capable of reducing deterioration of analyte indicator that it is linked to. Carter teaches chelators of applicant’s claims as well and Colvin provides for using a hydrogel form on the outer surface of the sensor encasement in an embodiment. Therefore, there was a reasonable expectation of success in fabricating a sensor with the analyte indicator comprising chelator applied on the outer surface of the sensor’s encasement/housing.
One of ordinary skill in the art at the time of instant filing would have included an indictor like a dye moiety onto a hydrogel polymeric matrix motivated by Colvin and Carter by the teachings of Suri that provide for attaching dye moieties. There was a reasonable expectation of success of one attaching a indicator/dye moiety to a biocompatible copolymer also having chelating agent of a hydrogel taught by Colvin and Carter to obtain a sensor having a hydrogel coating/outer layer that has such a copolymer compound with indicator moiety. Carter motivates modifying the fluorophor, linker and chelator to alter PET within the probe, and thus, provides one of ordinary skill in the art a reason to routinely optimize these items as are taught by the prior art to obtain desired PET.
Response to Arguments Over the Rejection Under USC 103
Applicant argues that there is no motivation to modify Colvin’s device with teachings of Carter. Both Colvin and Carter teach items for sensors of analytes in a body (see MPEP 2144.06) while Carter motivates that addition of metal chelators linked with fluorophore can modify PET (dictates off or on of fluorescence). Note that Colvin recognizes a material to be applied to the sensor body that contains the fluorophore.
“Colvin teaches “The sensor may also include fluorescent indicator monomers distributed throughout and co-polymerized with the porous sensor graft material that generate signal indicative of the level of fluorescence in the indicator graft. The sensor may also include a radiation source (e.g. an LED), and a photosensitive detector element” (paragraph 55). Colvin teaches “the porous sensor graft may be protected whether it is located in a specific region of a sensor body or completely covering a sensor body” (paragraph 97). Figure 4 shows the sensor and figure 1 shows some analyte indicator molecules. Colvin teaches structural encasings for the implantable devices (paragraph 83). These encasings would be housings. Colvin teaches the sensor body having an outer surface and a radiation source in said sensor body (paragraph 56). Colvin teaches the layer being in the form of a coating sputter deposited on at least part of the device (paragraph 73).”
Thus, there is a reasoning to combined fluorphore compounds with metal chelating moieties for sensor devices. In addition, Suri, a reference to an analyte sensor that provides for the configuration of metal chelating moieties bound to analyte indicator, provides in its teachings that “controlling destruction by iron ions by chelation (paragraphs 48 and 60)”. Thus, the prior art in combination to motivate the claimed method of making an analyte sensor does also recognize this purpose of being able to protect against degradation through the teachings of Suri, which had been indicated. There would be a reason to improve both the ability to modify PET (Carter) as well as to decrease degradation (Suri) using metal chelating moieties by the teachings of the prior art.
Applicant argues that modifying Carter by teachings of Colvin would render Carter’s invention inoperable for its use. Although it is true that Carter’s product is different on its own right, in this rejection under USC 103, the method sensor of applying fluorophore provided by Colvin is being modified using Carter’s and Suri’s teachings to include a metal chelating moiety linked with the fluorphore. Furthermore, one of ordinary skill in the art would be motivated to utilize modified fluorophores of the prior art in other fluorophore containing sensors where they can offer the ability to control PET for fluorescence. Additionally, Suri noted the ability of such a combination of analyte indicator and metal chelator to have the ability to limit degradation by iron (a metal) and its utility in sensor devices. Thus, there was a reasonable expectation of success in using the fluorphore-metal chelating moiety combinations of the prior art on the outer portion of the sensor in Colvin to modify the fluorescent signal in a desired manner and to improve stability.
Applicant argues that Carter provides its molecular probes to act as independent units and that metal chelating moieties in Carter are needed for the interaction of indicator with the metal. It remains that Carter teaches a fluorophore, linker and metal chelator. However, the presence of the metal chelator in Carter still operates to chelate metals that are present, which as Suri indicates such chelation of a metal aids in reducing degradation by a metal (iron). There is no evidence to show that Carter’s combinations also having metal chelating groups could not reduce degradation/deterioration of an analyte indicator by a metal in addition to their other purpose(s).
Applicant lastly argues that Suri fails to remedy deficiencies of Colvin and Carter. As Colvin, Carter and Suri still motivate the claimed invention as provided above, Suri’s use in the rejection under USC 103 for its teachings is still appropriate. It is in the combined teachings of the references that teach the claims and the applying step comes from teachings of Colvin.
Applicant should consider the breadth of the claims in relation to analyte indicator (genus that does not only include fluorophores, but many types) and metal chelating moieties (genus) as well as it allowing various structures in which analyte indicator can be combined with a metal chelating moiety. Applicant should consider their own results/findings that might be attributed to particular types of analyte indicators as well as the structures of analyte indicator compounds comprising metal chelating moieties that were used.
Non-Statutory 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 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15, 18-23, and 25 of U.S. Patent No. 12279862. Although the claims at issue are not identical, they are not patentably distinct from each other because as each claim set provides for applying an analyte indicator and compounds capable of binding/sequestering (chelating) metal ions in the form of hydrogel to the outer surface of the analyte sensor. The claims of ‘862 do not have the reacting step or chemically attaching step of metal chelating moieties to analyte indicator in words, but ‘862 provides for incorporating into a polymer (claim 25 of ‘862), which involves reacting/polymerizing monomers/chemically attaching moieties to form ABCD.
Response to Arguments
Applicant argues that the claims of ‘862 do not provide the analyte indicator comprising the metal chelating moiety, however claims of ‘862 provide that the analyte indicator molecules may bind to degradative species including metals, which would make them metal chelators. Thus, the claims of ‘862 provide for analyte indicators with metal chelating/binding groups with its claims, even if it does not use the word “chelating/chelator” specifically. Although ‘862 does not provide for whether this metal binding would reduce deterioration of the analyte indicator, this is a function of the metal chelating group through sequestration of the degradative metal(s). Therefore, this rejection is maintained as applicant has not filed a terminal disclaimer including this patent.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached on (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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