DETAILED ACTION
Note: 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 3-11 and 21-24 are pending and currently under consideration for patentability under 37 CFR 1.104
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy (CN201711052948.1 filed on October 31, 2017) has been received.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior-filed application (abandoned application 16/130638 filed on September 13, 2018) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 18 July 2024, 11 December 2024, 12 May 2025, 31 July 2025, 21 October 2025, and 4 February 2026 have been considered by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 3-11 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Bentsen et al. (US PG Pub. No. 2009/0124875) (hereinafter “Bentsen”).
Bentsen was cited in applicant’s IDS filed on July 18, 2024.
With respect to claim 21, Bentsen teaches an implantable medical device (abstract “implantable creatine sensors”) comprising: a chemical sensor configured to detect an ion concentration in a bodily fluid (par.0008 “The chemical sensor can be configured to detect creatine concentration in a bodily fluid”), the chemical sensor (creatine sensor 320 in Fig. 4) comprising: a sensing element (matrix 324 encapsulating plurality of beads 322 as depicted in Fig. 4, and described in par.0072), the sensing element comprising a barrier layer forming a top wall, a bottom wall, and opposed side walls of the sensing element (matrix 324 fully encapsulates beads 322, of which matrix 324 has a top, bottom, and side portions, of which are in relation to rigid surrounding layers, as described in par.0072 and further depicted in Fig. 4; Note: the instant application similarly discloses/depicts a matrix that fully encapsulates sensing beads; see instant application par.49 “sensing element 202 can include… an ion permeable polymeric matrix material… can form a top 205, bottom 210, and opposed sides 206 and 208”, of which surround indicator beads as depicted in instant application’s Fig. 2),
Although Bentsen’s embodiment, as depicted in Fig. 4, does not expressly teach the barrier layer comprises a hydrogel, further modification to incorporate hydrogel as the material for the barrier layer would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons. First, Bentsen expressly discloses, in the cited embodiment as depicted in Fig. 4, that pH sensing beads 322 are surrounded by a matrix 324 (par.0072). Bentsen also discloses in other embodiments that pH indicators can be created in a three-dimensional hydrogel matrix (par.0052); and that the pH sensing beads can be suspended and fixed in a hydrogel matrix (par.0117). Therefore, PHOSITA would have had predictable success modifying Bentsen’s embodiment, as depicted in Fig. 4, such that the pH sensing beads 322 are suspended and fixed in a hydrogel matrix as this would be a simple substitution, further preventing conglomerating of the pH sensing beads, as suggested by Bentsen’s other embodiments (see par.0117).
With respect to claim 3, Bentsen teaches the structural reinforcing element comprising polyester, polyurethane, polyethylene, polypropylene, nylon, sintered titanium, deep reactive-ion etched silicon, sintered stainless steel, sintered silica, liquid crystal, glass, borosilicate glass, or mixtures or derivatives thereof (par.0068).
With respect to claim 4, Bentsen teaches the structural reinforcing element selected from the group comprising a woven material, a non-woven material, electrospun material, and randomly woven material (par.0068).
With respect to claim 5, Bentsen teaches the chemical sensor further comprising one or more intramural struts spanning a distance between the top wall and the bottom wall of the outer barrier layer (378 in Fig. 6; 410 in Fig. 7; par.0074, 0077).
With respect to claim 6, Bentsen teaches the one or more intramural struts comprising polyester, polyurethane, polyethylene, polypropylene, nylon, sintered titanium, deep reactive-ion etched silicon, sintered stainless steel, sintered silica, liquid crystal, glass, borosilicate glass, or mixtures or derivatives thereof (par.0068).
With respect to claim 7, Bentsen teaches the outer barrier layer comprising polyHEMA, agarose, alginates, polyvinyl alcohol, polyacrylate, collagen, PEG, gelatin, or mixtures or derivatives thereof (par.0064).
With respect to claim 8, Bentsen teaches further comprising an optical excitation assembly configured to illuminate the sensing element; and an optical detection assembly configured to receive light from the sensing element (206 and 208 in Fig. 2; 306 and 308 in Fig. 3).
With respect to claim 9, Bentsen does not explicitly teach the chemical sensor having a diameter that is greater than 1.0 mm. Although Bentsen does not explicitly teach the chemical sensor having a diameter that is greater than 1.0 mm, this would have been obvious to PHOSITA when the invention was filed since changes in size would only require routine skill in the art (see MPEP 2104.04 (IV)); and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 10, Bentsen teaches the chemical sensor configured to detect an ion selected from the group comprising of potassium, sodium, chloride, calcium, magnesium, lithium, or hydronium (par.0045).
With respect to claim 11, Bentsen teaches the structural reinforcing element comprising the shape of a rectangular column, a cylinder, a conical shape, a frustoconical shape, a pyramid, a frustopyramidal shape (112 in Fig. 2 shows conical shape).
With respect to claim 22, Bentsen does not explicitly teach the structural reinforcing element exhibiting rigidity at least 100% greater than the material of the outer barrier layer. However, further modification of Bentsen’s structural reinforcing element 332/334 to have rigidity at least 100% greater than material of outer barrier layer 324 would have been prima facie obvious to PHOSITA when the invention was filed for the following reasons. First, Bentsen discloses equivalent material for structural reinforcing element 332/334 as claimed in dependent claim 4 (par.0068); and discloses, in other embodiments, utilizing hydrogel for the outer barrier layer (par.0117). Moreover, PHOSITA would have had predictable success modifying Bentsen such that the structural reinforcing element exhibiting rigidity at least 100% greater than the material of the outer barrier layer since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 23, Bentsen teaches the structural reinforcing element defining a plurality of apertures therein (par.0065 “Creatine can diffuse through the overcoat layer… material that is permeable”, of which permeable material suggests openings/apertures when taking into consideration broadest reasonable interpretation).
With respect to claim 24, Bentsen teaches the sensing element comprising a plurality of indicator beads disposed within the interior volume (pH sensing beads 322 in Fig. 4).
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791