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 .
Status of Claims
Applicant's arguments, filed 12/22/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/22/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1, 2, 8, and 12.
Applicants have introduced new claims 14 and 15.
Applicants have left claims 3-7, 9-11, and 13 as originally filed/previously presented.
Claims 1-15 are the current claims hereby under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation - 35 USC § 112(f) - Maintained
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1: The claim limitation “a connecting element electrically connecting the second contact pad with each of the at least two individual electrically conductive surfaces” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “element” coupled with functional language “electrically connecting the second contact pad with each of the at least two individual electrically conductive surfaces” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “element”.
Claim 13: The claim limitation “applying a connecting element in a manner that the connecting element electrically connects the second contact pad of the analyte sensor with each of the at least two individual electrically conductive surfaces of the second contact area of the circuit carrier” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “element” coupled with functional language “electrically connects the second contact pad of the analyte sensor with each of the at least two individual electrically conductive surfaces of the second contact area of the circuit carrier” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “element”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“The connecting element may be selected from a connecting element which comprises at least one of an electrically conductive rubber; an electrically conductive foam; an elastomeric connector …”, or equivalents thereof, as described in para. [0035] of the disclosure filed on 04/26/2023; and
“The connecting element may be selected from a connecting element which comprises at least one of an electrically conductive rubber; an electrically conductive foam; an elastomeric connector …”, or equivalents thereof, as described in para. [0035] of the disclosure filed on 04/26/2023.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112 - Withdrawn
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.
Response to Arguments
Applicant’s arguments, see page 5 of Remarks, filed 12/22/2025, with respect to the 112(b) rejection of claims 8 and 12-13 have been fully considered and are persuasive. Applicants have amended the claims, rendering the rejections moot. The 112(b) rejection of claims 8 and 12-13 has been withdrawn.
Claim Rejections - 35 USC § 102 - Maintained and Newly Applied Necessitated by Applicant’s Amendments
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 –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 and 9-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Antonio et al. (US 20170290546 A1) (previously cited), hereinafter referred to as Antonio.
The claims are generally directed towards an analyte system, comprising an analyte sensor having a first contact pad, a second contact pad, and an electrically insulating cover which covers surfaces of the analyte sensor apart from the first contact pad and the second contact pad; a circuit carrier having a first contact area, and a second contact area, wherein the second contact area comprises at least two individual electrically conductive surfaces and at least one electrically insulating surface between the at least two individual electrically conductive surfaces that jointly constitute the second contact area; and a connecting element electrically connecting the second contact pad with each of the at least two individual electrically conductive surfaces.
Regarding claim 1, Antonio discloses an analyte system (Abstract, “sensing device for sensing an analyte”), comprising
an analyte sensor (Fig. 5, element 12A, element 12B, para. [0085]) having
a first contact pad (Fig. 6, element 121B, para. [0085], para. [0087], “lower sensor has its contact pads facing down …”), a second contact pad (Fig. 6, element 121A, para. [0085], para. [0087], “upper sensor has its contact pads facing up …”), and an electrically insulating cover which covers surfaces of the analyte sensor apart from the first contact pad and the second contact pad (para. [0083], “insulative sheet material … contact pads, which are exposed through the insulative sheet material …”, para. [0102], “sensors may comprise two strips of insulative sheet material …”);
a circuit carrier (Fig. 6, element 320, para. [0084-0085]) having a first contact area (Fig. 7A, element 322, para. [0087], “lower sensor has its contact pads facing down … sensor contact pads interact with the PCBA contact pads …” - the first contact area being the sensor pads that interact with the lower sensor contact pads), and a second contact area (Fig. 7A, element 322, para. [0087], “upper sensor has its contact pads facing up …”, para. [0088], “sensor elastomeric connector electrically connects the upper sensor contact pads to the PCBA sensor pads …” - the second contact area being the sensor pads that interact with the upper sensor contact pads),
wherein the second contact area comprises at least two individual electrically conductive surfaces (Fig. 7A, 7B, - in an illustrated embodiment, the second contact area comprises three individually electrically conductive surfaces) and at least one electrically insulating surface between the at least two individual electrically conductive surfaces that jointly constitute the second contact area (para. [0083], “insulative sheet material … contact pads, which are exposed through the insulative sheet material …”, para. [0102], “sensors may comprise two strips of insulative sheet material …” - the lower sensor 12B comprises an insulative sheet material that extends between elements 322 connected to elements 121A; para. [0097], “elastomeric connector includes integral insulation layers” - additionally, insulation layers are provided); and
a connecting element (Fig. 7B, element 350, para. [0088]) electrically connecting the second contact pad with each of the at least two individual electrically conductive surfaces (para. [0088], “sensor elastomeric connector electrically connects the upper sensor contact pads to the PCBA sensor pads”).
Regarding claim 2, Antonio discloses the analyte sensor system according to claim 1, wherein the at least two individual electrically conductive surfaces of the second contact area are electrically connected with each other outside the surfaces of the second contact area (para, [0084], “PCBA is adapted to receive electrical signals from the sensor though electrical contacts on the PCBA …”, para. [0085], “sensor electrodes interact with contact pads on the PCBA …”, para. [0087], “PCBA sensor pads, which may be etched or deposited onto the PCBA such that the sensors will be electrically connected to the PCBA …” - the contact pads are electrically connected together through the PCBA).
Regarding claim 3, Antonio discloses the analyte sensor system according to claim 1, wherein the first contact pad is located on a first side of the analyte sensor, and wherein the second contact pad is located on a second side of the analyte sensor (Fig. 6, para. [0085], para. [0087], “upper sensor has its contact pads facing up … lower sensor has its contact pads facing down …”).
Regarding claim 4, Antonio discloses the analyte sensor system according to claim 1, wherein the first contact pad and the second contact pad are located on opposing side of the analyte sensor (Fig. 6, para. [0085], “one double-sided sensor”, para. [0087], “upper sensor has its contact pads facing up … lower sensor has its contact pads facing down …”).
Regarding claim 5, Antonio discloses the analyte sensor system according to claim 1, wherein the first contact pad faces the first contact area of the circuit carrier (Fig. 6, element 121B, para. [0085], para. [0087], “lower sensor has its contact pads facing down …”), and wherein the second contact pad faces away from the second contact area of the circuit carrier (Fig. 6, element 121A, para. [0085], para. [0087], “upper sensor has its contact pads facing up …”).
Regarding claim 6, Antonio discloses the analyte sensor system according to claim 1, wherein the first contact pad directly connects the first contact area of the circuit carrier (Fig. 6, element 121B, element 322, para. [0087], “lower sensor has its contact pads facing down … sensor contact pads interact with the PCBA contact pads through direct touch connection”).
Regarding claim 7, Antonio discloses the analyte sensor system according to claim 1, wherein the at least one of the first contact pad, the second contact pad, the first contact area, and the second contact area comprises a layer of an electrically conductive material (para. [0083], “conductive contact pads …”, para. [0102], “surface elongate conductive elements leading from the distal end to the contacts …”).
Regarding claim 9, Antonio discloses the analyte sensor system according to claim 1, wherein the connecting element comprises at least one of an electrically conductive rubber; an electrically conductive foam; an elastomeric connector (Fig. 7B, element 350, para. [0086], “sensor elastomeric connector/elastomeric pad”).
Regarding claim 10, Antonio discloses the analyte sensor system according to claim 1, wherein the circuit carrier is or comprises a printed circuit board (Fig. 5, element 350, para. [0084], “printed circuit board assembly …”).
Regarding claim 11, Antonio discloses the analyte sensor system according to claim 1, wherein the analyte sensor is a partially implantable analyte sensor for continuously monitoring an analyte (Fig. 2, element 12, Fig. 5, element 12A/12B, para. [0086], “needle to aid in insertion of the sensor into a user’s body …”, para. [0127-0128]).
Regarding claim 12, Antonio discloses a method for producing an analyte sensor system (Abstract) according to claim 1, the method comprising the steps of:
a) providing a circuit carrier (Fig. 6, element 320, para. [0084-0085]) having a first contact area (Fig. 7A, element 322, para. [0087], “lower sensor has its contact pads facing down … sensor contact pads interact with the PCBA contact pads …” - the first contact area being the sensor pads that interact with the lower sensor contact pads) and a second contact area (Fig. 7A, element 322, para. [0087], “upper sensor has its contact pads facing up …”, para. [0088], “sensor elastomeric connector electrically connects the upper sensor contact pads to the PCBA sensor pads …” - the second contact area being the sensor pads that interact with the upper sensor contact pads), wherein the second contact area comprises at least two individual electrically conductive surfaces (Fig. 7A, 7B, - in an illustrated embodiment, the second contact area comprises three individually electrically conductive surfaces) and at least one electrically insulating surface between the at least two individual electrically conductive surfaces that jointly constitute the second contact area (para. [0083], “insulative sheet material … contact pads, which are exposed through the insulative sheet material …”, para. [0102], “sensors may comprise two strips of insulative sheet material …” - the lower sensor 12B comprises an insulative sheet material that extends between elements 322 connected to elements 121A; para. [0097], “elastomeric connector includes integral insulation layers” - additionally, insulation layers are provided);
b) arranging an analyte sensor (Fig. 5, element 12A, element 12B, para. [0085-0086]) having a first contact pad (Fig. 6, element 121B, para. [0085], para. [0087], “lower sensor has its contact pads facing down …”) and a second contact pad (Fig. 6, element 121A, para. [0085], para. [0087], “upper sensor has its contact pads facing up …”);
c) applying a connecting element in a manner that the connecting element electrically connects the second contact pad of the analyte sensor with each of the at least two individual electrically conductive surfaces of the second contact area of the circuit carrier (Fig. 7B, element 350, para. [0088], “sensor elastomeric connector electrically connects the upper sensor contact pads to the PCBA sensor pads”); and
d) providing an electrically insulating cover covering surfaces of the analyte sensor apart from the first contact pad and the second contact pad (para. [0083], “insulative sheet material … contact pads, which are exposed through the insulative sheet material …”, para. [0102], “sensors may comprise two strips of insulative sheet material …”).
Regarding claim 13, Antonio discloses the method according to claim 12, wherein step b) further comprises arranging the analyte sensor in a manner that the first contact pad directly connects the first contact area of the circuit carrier (Fig. 6, element 121B, element 322, para. [0087], “lower sensor has its contact pads facing down … sensor contact pads interact with the PCBA contact pads through direct touch connection”).
Regarding claim 14, Antonio discloses the method according to claim 13, wherein step b) further comprises generating a compressive force between the first contact pad and the first contact area by applying an additional electrically non-conductive elastic element (para. [0086], “sensors 12A, 12B may be held in place … sealed using sensor gaskets …”, para. [0090], “sensor gaskets form face seals between the upper housing, lower housing, and the sensors …”, para. [0100]).
Regarding claim 15, Antonio discloses the analyte sensor system according to claim 1, further comprising an additional electrically non-conductive elastic element for generating a compressive force between two facing surfaces of the first contact pad and the first contact area (para. [0086], “sensors 12A, 12B may be held in place … sealed using sensor gaskets …”, para. [0090], “sensor gaskets form face seals between the upper housing, lower housing, and the sensors …”, para. [0100]).
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive.
Applicants have argued on pages 5-6 of Remarks, filed 12/22/2025, that “Antonio is silent as to the at least two of the limitations of claim 1 … “an electrically insulating cover which covers surfaces of the analyte sensor apart from the first contact pad and the second contact pad” … Antonio is silent as to this claim requirement. In addition, Antonio is silent as to the following limitation regarding the second contact area …”.
The Examiner respectfully disagrees. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
As reiterated in the rejection above, Antonio discloses the two limitations argued by the Applicants.
Claim Rejections - 35 USC § 103 - Maintained
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Antonio et al. (US 20170290546 A1) (previously cited), hereinafter referred to as Antonio, in view of Kasielke et al. (US 20170181651 A1) (previously cited), hereinafter referred to as Kasielke.
Regarding claim 8, Antonio discloses the analyte sensor system according to claim 7.
However, Antonio does not explicitly disclose wherein the electrically conductive material is selected from at least one of gold or an electrically conductive carbon material.
Kasielke teaches an analogous sensor system to produce a signal indicative of a condition of a patient (Abstract). Kasielke teaches an analyte sensor comprises a first contact pad and a second contact pad (Fig. 1A, elements 22A, 22B, para. [0045-0046]), and a circuit carrier having a first contact area and a second contact area (Fig. 1A, elements 34A, 34B, para. [0047]). Kasielke further teaches at least one of the first contact pad, the second contact pad, the first contact area, and the second contact area comprise a conductive material that is selected from at least one of fold or an electrically conductive carbon material (para. [0046]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the conductive material disclosed by Antonio to explicitly be gold or an electrically conductive carbon material, as taught by Kasielke. Kasielke teaches known examples of conductive materials for use in etching contact pads for analyte sensors includes carbon and metals or alloys (para. [0046]). One of ordinary skill in the art would recognize using carbon and metals or alloys would yield the predictable results of an analyte sensor with a conductive surface to electrically connect with a circuit carrier.
Response to Arguments
Applicant’s arguments did not directly address the rejection of claim 8 over Antonio in view of Kasielke, therefore the Examiner cannot find a reason to withdraw the rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791