DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/19/2026 has been entered.
Claims 1-8, 10 and 21-23 remain pending and under prosecution.
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 .
Information Disclosure Statement
Applicant has not submitted an IDS. Applicant is reminded of the duty to disclose all known prior art resulting from all prior art searches.
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on 10/31/2022 is acknowledged.
Claims 11-20 have been cancelled by applicant.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No elements are interpreted under 112(f).
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.
Claim(s) 1-8, 10, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Moein et al (US Pub No. 20120323098) in view of Stafford (US Pub No. 20110191044),
Hayter et al (US Pub No. 20180153454), and Roe (US Pub No. 20050251064).
In regard to Claims 1 and 21, Moein et al disclose a multianalyte sensor assembly for implantation within a subject, comprising:
a multianalyte sensor 500 with a first side and a second side, best seen in Figure 6,
a first conductor 507 on a first side (0106) and a second conductor 502 on a second side being separated by an insulator 501 – flexible dielectric substrate 501, best seen in Figure 6 (0106),
an aperture being formed through the first conductor, the second conductor, and the insulator, best seen in Figure 27 and shown by the arrow below,
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503
621
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the multianalyte sensor is configured to measure real-time concentrations, i.e. continuous monitoring, of at least glucose and another analyte, i.e. lactate, oxygen, ketones (0057).
However, Moein et al do not expressly disclose:
a case top being mated with a case bottom to define an interior that contains a conformal material and a rigid circuit board, the interior further containing the multianalyte sensor being positioned between the rigid circuit board and the conformal material
formation of the aperture through the first conductor, the second conductor, and the insulator generates conductive slag that couples the first conductor to the second conductor.
1) Stafford teach that it is well-known in the art to provide an analogous multianalyte sensor 710 (0054) with a case top 604 being mated with a case bottom 602 to define an interior, best seen in Figure 7A-B,
that contains a conformal material 210 (seal formed from flexible polymer), best seen in Figure 4 (0099-0101), and
a rigid circuit board – PCB 708 (0112),
the interior further containing the multianalyte sensor 710 being positioned between the rigid circuit board and the conformal material – analyte sensor is positioned between PCB 708 and the seal that protects the interconnect between the analyte sensor and the body electronics that include the PCB, best seen in Figure 4 and 7A-B – “When analyte sensor 402 is into contact with on body electronics 110, elongate member 204 can be compressed or collapsed and seal 210 forms a protective barrier around the connection from harmful elements (e.g., dust, liquid, dirt) between the on body electronics and sensor. In one embodiment, seal 210 is formed from a flexible polymer” (0099).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Moein et al such that there is a case top being mated with a case bottom to define an interior that contains a conformal material and a rigid circuit board, the interior further containing the multianalyte sensor being positioned between the rigid circuit board and the conformal material as taught by Stafford to effective couple the multianalyte sensor structure to the electronics of the sensor that are contained within the case.
2) Hayter et al teach that it is well-known in the art to provide an analogous multianalyte sensor (0266) comprising an aperture 1703 that formed such that conductive slag – conductive ink from the laser drilled hole – couples a first conductor 1704 and a second conductor 1702 separated by insulator 1701 to effectively form a thermocouple, best seen in Figure 16 (0191-0192). Forming a thermocouple effectively enables temperature compensation for the multianalyte sensor (abst).
Roe et al teach that it is well-known in the art to provide an analogous analyte sensor 52, e.g. glucose (0002), that has a layered construction, best seen in Figure 1 and 4-6, and wherein aperture 38 is formed through every single layer to effectively define “a registration opening 42 that is designed to position and secure the integrated sampling device 30 to the bodily fluid sampling device” (0015). The bodily fluid sampling device referred to by Roe et al is similar to that used in Moein et al. In other words, aperture 38 that is formed through every single layer is effectively used to position and secure the analyte sensor of Roe et al during use with the bodily fluid sampling device.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Moein et al such that formation of the aperture generates conductive slag that couples the first conductor to the second conductor as taught by Hayter et al to effectively form a thermocouple in the multianalyte sensor to enable temperature compensation during use, wherein the aperture is formed through the first conductor, the second conductor, and the insulator as suggested by Roe et al, to effectively provide a registration opening that can be used to position and secure the analyte sensor during use with the bodily fluid sampling device.
2. Moein et al disclose the insulator 501 is a central insulator, best seen in Figure 6, having a first side and second side, the first conductor 507 being coupled to the first side and the second conductor 502 being coupled to the second side, best seen in Figure 6 (0106).
3. Moein et al disclose the sensor of claim 2, wherein the first conductor 507 includes a first portion (left) and a second portion (right), best seen in Figure 6.
4. Moein et al disclose the sensor of claim 3, wherein the second conductor 502 includes a first area (left) and a second area (right), best seen in Figure 6.
5. Moein et al disclose the sensor of claim 4, further comprising: a bottom insulator 508 (dielectric layer) being coupled to the first conductor 507, the bottom insulator having at least one bottom opening, best seen in Figure 6 (0107). It is noted that the term “bottom” is relative and is defined as the top in Figure 6.
6. Moein et al disclose the sensor of claim 5, further comprising: a top insulator 503 being coupled to the second conductor 502, the top insulator having at least one top opening, best seen in Figure 9 (0103-0104). It is noted that the term “top” is relative and is defined as the bottom in Figure 6.
7. Moein et al disclose the sensor of claim 6, wherein the bottom opening defines a bottom contact pad and the top opening defines a top contact pad, best seen in Figure 6 and 9.
8. Moein et al as disclose the sensor of claim 7, wherein the aperture (Figure 27) is thus formed between the bottom contact pad and the top contact pad, best seen in Figure 6 and 27.
10, 23. Hayter et al teach aperture 1703 comprising a supplemental short circuit within the aperture, the supplemental short circuit being an electrically conductive material 1704, best seen in Figure 16, per the modification above (0187-0192 of Hayter et al).
22. Moein et al in combination with Hayter et al disclose the electrical coupling of the first conductor to the second conductor (through the aperture) enables electrical connection to be made to the multianalyte sensor from a single side, i.e. to form the thermocouple, see paragraph 0187-0192 of Hayter et al.
Response to Arguments
Applicant’s arguments with respect to Moein et al and Hayter et al have been fully considered but are not persuasive. Applicant contends that Moein et al does not disclose the aperture through the second conductor, defined as element 502. It is agreed that Moein et al does not disclose an aperture through said second conductor; however, it is noted that is actually in line with the structure of the analyte sensor of instant invention. Figure 2 of the instant disclosure show first conductor 202-1 and second conductor 206-1 disposed on opposite sides of insulator 204 – none of which have an aperture (0026-0027). Rather, the aperture recited is intentionally formed to provide the permanent electrical short between the first conductor 202-1 and the second conductor 206-1 with slag when formed by a laser as shown in Figure 3A-B. This is taught by the combination of Hayter et al and Roe et al, above.
Regarding Hayter et al, applicant contends that no second conductor is provided. This is false because Hayter et al clearly teach second conductor 1702, as previously cited in paragraph 0191-0192 above and shown in Figure 16 – “As shown in FIG. 16, a conductive ink layer 1704 is disposed on the opposite side of the sensor substrate 1701 as the layer of gold 1702. The through-hole 1703 is filled with the conductive ink such that the conductive ink layer 1703 and layer of gold 1703 are connected and a thermocouple junction formed” (typos seem present in the citation but Figure 16 clearly label first conductor 1704 and second conductor 1702). Thus, Hayter et al clearly teach using a laser to form an aperture through an insulator 1701 with a first conductor 1704 separated from a second conductor 1702 generates and deposits slag that creates an electrical short circuit between the first conductor and second conductor, as clearly shown in Figure 16 by Hayter et al. Roe et al is thus set forth to show forming an aperture through all the layers of the analyte sensor, such as the layers of Moein et al.
Additionally, it is noted that Rice et al (US Pub No. 20130213147) which has been previously presented, teach that it is well-known in the art for a sensor to have an aperture 59, 38 formed through first conductor 68 and second conductor 66 separated by insulator 67, best seen in Figure 12-13. Therefore, the rejection using Moein et al and Hayter et al is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong Q NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached on 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791