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 without traverse of Group I, Claims 1 – 19 and 48 in the reply filed on 07 JANUARY 2026 is acknowledged. The amendments associated with the response to election are entered.
Claims 20 – 47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected embodiments, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07 JANUARY 2026.
Information Disclosure Statement
It is noted that the Information Disclosure Statement (IDS) submissions (see attachments) are extremely long, citing over 450 references for consideration. The Examiner has considered the references submitted as part of the Information Disclosure Statements, but has found the majority have no relevance to patentability. Applicants are encouraged to provide a concise explanation of the information if Applicants are aware of document(s) or a section of a document that is highly relevant to patentability. See MPEP 609.04(a)(III) and MPEP 2004.13:
Although a concise explanation of the relevance of the information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff ’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Moreover, an IDS should comply with 37 CFR 1.56 (b) which states that "information is material to patentability which is not cumulative to information already of record or being made of record in the application …" [emphasis added]. The cited references, in addition to being extensive in volume, also appear to be largely cumulative, therefore, based upon the large number of references cited, the references have been considered in a cumulative manner. The Examiner further notes that numerous cited references appear to have little or no relevance at all to the claimed invention. For example, many of the references are directed toward dictionary definitions of words that are not used in the instant claims, such as “periphery”, which are not relevant to the claimed invention.
Further, references are noted in the specification at paragraph [0310], [0313], and [0332]. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The use of the term “Bluetooth”, which is a trade name or a mark used in commerce, has been noted in this application in paragraphs [0011], [0094], [0095], and [0315], . The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Overall, the lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 10 objected to because of the following informalities: the term “Bluetooth” is recited without a proper symbol indicating use in commerce such as ™, SM , or ® , as it is a trade name or a mark used in commerce. Appropriate correction is required.
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.
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:
“sensor control device” to “house” the analyte sensor in Claims 12 and 48.
The claim limitation is interpreted according to paragraph [0165] “The sensor control device 5002 may be similar in some respects to the sensor control device 102” and Figures 14A and 14B of Applicant’s specification. The “sensor control device” appears to be a moveable structure with an attached sensor in Applicant’s Figures 14A and 14B to “control” where the sensor is relative to the body.
“plurality of electronic components” to “transmit” the analyte sensor in Claim 2
The claim limitation is interpreted according to paragraph [0087] “embodiments of sensor control devices are disclosed and these devices can have one or more sensors… transmitters… that can perform any and all method steps or facilitate the execution of any and all method steps”; [0096] “communication circuitry 168 (which can be implemented as a transmitter, receiver, transceiver, passive circuit, or otherwise according to the communication protocol)”; and Figure 2B and 2C.
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
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 2 - 3 and 17 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.
Claim 2 recites the term “the plurality of electronic components are further configured to transmit the generated signals”. It is unclear it the intent is that all of the electronic components are capable of performing a “transmit” function, or if it is only part of the group. For the purposes of examination, the term “the plurality of electronic components are further configured to transmit the generated signals” is deemed to claim “a transmitter component of the plurality of electronic components is further configured to transmit the generated signals”. Claim 3 is similarly rejected due to its dependence on Claim 2.
Claim 3 recites the term “a display device”. It is unclear if the display device is intended to be the same or different than the “display screen” previously recited in claim 2 from which this claim depends. Looking to the specification, It appears that “display screen” refers at [00314] to a screen on a device, which could be on a mobile phone, watch, or “any other computing device.” There is also a “screen 112”, which is possible referring to a monitor. For the purposes of examination, the term “a display device” is deemed to claim “a monitor”.
The term “gradient mix of materials comprises approximately 10% fiberglass” in claim 17 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the claim are unclear, as it cannot be ascertained how close of a value to 10% satisfies “approximately 10%”. For the purposes of examination, the term “gradient mix of materials comprises approximately 10% fiberglass” is deemed to claim “gradient mix of materials comprises 10% fiberglass.”
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1- 3, 5 – 6, 8, 10 – 11, 13 – 14, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halac et. al., (United States Patent Application Publication US 2021/0307657 A1), hereinafter Halac.
Regarding Claim 1, Halac discloses A system for measurement of an analyte level ([Abstract]), comprising:
an analyte sensor (Overall Figure 2, used to sense an analyte; [0169] “an analyte sensor attached to a sensor carrier”)(Examiner notes that these structures together are collectively used as an analyte sensor”) having an in vivo portion ([0207] “ in vivo portion of the sensor 138”) configured to be positioned in contact with an interstitial fluid of a user ([0212] “….through the interstitial fluid surrounding the sensor 138”) and an ex vivo portion ([0207] “ex vivo portion of the sensor 138”), the analyte sensor having a first substrate (Fig 52B; [0296] “elongate substrate 4800”; Fig 51A and 51B)
at least one working electrode ([0212] “the working electrode 211 a”) located on the in vivo portion ([0211] “the two electrodes 211 a and 212 a…affixed to a distal in vivo portion…”),
a reference electrode (Fig 3D, “reference electrode 212 a.”; [0212]) located on the in vivo portion ([0209] “…in vivo portion of the sensor 138…forms an electrode 212 a.”); and
a plurality of electronic components mounted on the ex vivo portion (Fig 53A; [0297] “portion 4802 may form a standalone processing circuit for sensor 138 (e.g., an implementation of sensor electronics 112.)“; [0173] “sensor electronics 112…electronic circuitry associated with measuring and processing data generated by the analyte sensor 138.”; [0184]; [0187] “sensor electronics 112 may comprise an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222.”; Fig 2, “ASIC 205”)
wherein the at least one working electrode is configured to sense an analyte level ([0212] “The magnitude of this current…on the working electrode 211 a is a measure of analyte concentration…”), and at least one of the plurality of electronic components (Fig 2, “ASIC 205”) is configured to receive generated signals associated with the analyte level ([0184] “sensor electronics 112 may include electronics components that are configured to process sensor information, such as sensor data…
e.g., via a processor module.”; Fig 2, “processor module 214”; [[0185] “processor module 214 may be integral to sensor electronics 112”)(Examiner notes that the processor module is the first component to receive the sensor data for processing.)
Regarding Claim 2, Halac discloses as described above, The system of claim 1. For the remainder of Claim 2, Halac discloses wherein the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) are further configured to transmit the generated signals associated with the analyte level to a remote device having a display screen ([0187] “The ASIC 205…include…telemetry module 232 for transmitting data from the sensor electronics 112 to one or more devices, such as devices 114, 116, 118, and/or 120”; Fig 1, “display devices 114, 116, 118, and/or 120”; [0175]; [0178] “display device…configured to display…graphical representation of the sensor data including current and historic sensor data output by sensor system 100”; [0205])
Regarding Claim 3, Halac discloses as described above, The system of claim 2. For the remainder of Claim 3, Halac discloses wherein the remote device includes a display device (Fig 1, “display devices 114, 116, 118, and/or 120”; [0171] – [0172]), a mobile phone (Fig 1, “display device 118”), or a wrist-mounted device (Fig 1, “display device 114”; [0177] “key fob-like display device 114 may comprise a wrist watch”)
Regarding Claim 5, Halac discloses as described above, The system of claim 1. For the remainder of Claim 5, Halac discloses wherein the first substrate (Fig 52B; [0296] “elongate substrate 4800”; Fig 51A and 51B) is a flexible monolithic unit ([0293] “printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate”; Fig 51A)
Regarding Claim 6, Halac discloses as described above, The system of claim 1. For the remainder of Claim 6, Halac discloses wherein the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) include one or more processors (Fig 2; [0185] “processor module 214…”) and a battery ([0194] “a source of power, such as a battery 234.”)
Regarding Claim 8, Halac discloses as described above, The system of claim 1. For the remainder of Claim 8, Halac discloses wherein the at least one working electrode ([0212] “the working electrode 211 a”) is configured to sense at least one of lactate ([0212]; [0135] “’analyte’ as used herein…the analyte for measurement…lactate”; [0180]), glucose ([0212]; [0180] “…description herein…glucose as the analyte being measured”), and ketone ([0212]; [0180] “…description herein…glucose as the analyte being measured…other analytes may be used…ketone bodies”).
Regarding Claim 10, Halac discloses as described above, The system of claim 1. For the remainder of Claim 2, Halac discloses wherein the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) includes at least a Wi-Fi antenna ([0336] “…wireless technologies…WiFi”), NFC antenna ([0336] “…wireless technologies…NFC”), Bluetooth antenna (Fig 2; [0190] “A variety of wireless radio technologies that can be implemented in the telemetry module 232 include Bluetooth”), BTLE antenna ([0190] “…Bluetooth Low-Energy”), or GPS antenna.
Regarding Claim 11, Halac discloses as described above, The system of claim 1. For the remainder of Claim 11, Halac discloses wherein the first substrate (Fig 52B; [0296] “elongate substrate 4800”; Fig 51A and 51B) is one of polyamide or polyethylene terephthalate ([0293] “Flexible portion of the substrate may be manufactured from a material such as…polyester”)
Regarding Claim 13, Halac discloses as described above, The system of claim 1. For the remainder of Claim 13, Halac discloses wherein the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) are electrically coupled to the at least one working electrode and the reference electrode ([0211] “Electrodes 211 a, 212 a could be electrically connected to their respective contacts 211 b, 212 b a circuit traces on the planar substrate.”; [0171] “analyte sensor 138 may be physically connected to sensor electronics 112…”).
Regarding Claim 14, Halac discloses as described above, The system of claim 1. For the remainder of Claim 14, Halac discloses wherein the ex vivo portion (Fig 51A and 51B, Fig 52 A; [0293] “ an elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate, from which multiple sensor carriers 402 can be singulated.”)(Examiner notes that the sensor carrier 402 is an ex vivo portion.) comprises a first layer ([0293] “elongate substrate 4800”).
Regarding Claim 18, Halac discloses as described above, The system of claim 14. For the remainder of Claim 18, Halac discloses wherein the ex vivo portion comprises a second layer ([0204] “adhesive patch 126”; [0248] “Wearable assembly 600 may include sensor electronics and an adhesive patch (not shown).”; [0297] “Following testing and/or calibration operations, flexible portion 4802 may be folded around…for installation into on-skin sensor assembly 600.”)
Claims 15 – 16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halac as evidenced by Shapiro of Vinatronic Inc, “PCB FR4: Which Material is Right for Your Project?”, hereinafter Vinatronic Inc.
Regarding Claim 15, Halac discloses as described above, The system of claim 14. For the remainder of Claim 15, Halac discloses wherein the first layer comprises a gradient mix of materials ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”, ”Rigid portion of the substrate may be manufactured from a material such as FR4, FR5, FR6…”)(Examiner notes that FR4 is a circuit board material that is a mix of fiberglass and epoxy resin, as evidenced by Vinatronic Inc [Page 3, “What is FR4?” Section] “FR4 is the NEMA (National Electrical Manufacturers Association) designation for Flame-Retardant fiberglass reinforced epoxy material.”)
Regarding Claim 16, Halac discloses as described above, The system of claim 15. For the remainder of Claim 16, Halac discloses wherein the gradient mix of materials comprises fiberglass ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”, ”Rigid portion of the substrate may be manufactured from a material such as FR4, FR5, FR6…”)(Examiner notes that FR4 is a circuit board material that is a mix of fiberglass and epoxy resin, as evidenced by Vinatronic Inc [Page 3, “What is FR4?” Section] “FR4 is the NEMA (National Electrical Manufacturers Association) designation for Flame-Retardant fiberglass reinforced epoxy material.”)
Regarding Claim 19, Halac discloses as described above, The system of claim 18. For the remainder of Claim 19, Halac discloses wherein each of the first layer ([0293] “elongate substrate 4800”) and the second layer ([0204] “adhesive patch 126”; [0248]; [0297]) comprise a gradient mix of materials ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”,”Rigid portion of the substrate may be manufactured from a material such as FR4, FR5, FR6…”; [0204] “adhesive 126 can be a pressure sensitive adhesive (e.g. acrylic, rubber based, or other suitable type) bonded to a carrier substrate (e.g., spun lace polyester, polyurethane film, or other suitable type)(Examiner notes that FR4 is a circuit board material that is a mix of fiberglass and epoxy resin, as evidenced by Vinatronic Inc [Page 3, “What is FR4?” Section] “FR4 is the NEMA (National Electrical Manufacturers Association) designation for Flame-Retardant fiberglass reinforced epoxy material.”)
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Happy Holden, “Happy’s Tech Talk #3: Photonic Soldering”, hereinafter Happy.
Regarding Claim 4, Halac discloses as described above, The system of claim 1. For the remainder of Claim 4, Halac discloses wherein the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) are mounted to the ex vivo portion using soldering ([0296] “sensors can be permanently connected…solder...or other suitable methods) to the sensor carriers 402.”)(Examiner notes that the “sensor carriers 402” are ex vivo.)
Halac does not disclose using photonic soldering.
Happy teaches how photonic soldering is used in printed electronics. Specifically for Claim 4, Happy teaches using photonic soldering ([Page 1, Paragraph 2 and 3] “curing and annealing of printed inks with flash tubes…”, “Inks cured to the temperature at which they become conductive using IR ovens requires substrates that can withstand these temperatures, like polyimides, ceramics, and epoxy fiberglass.”; Figure 1: “After: High-conductive printed electronic pattern with superior performance and throughput not possible by other methods”; Figure 2).
Happy provides a motivation to combine regarding advantages in manufacturability at [Page 3, Paragraph 1] with “This process was developed as part of enhancing the manufacturability of flexible hybrid electronics (FHE) by sintering metal particle-based inks into conductive traces.”, [Page 2, Paragraph 4] “Light-generated (ER) heating, as in laser soldering, can also be performed by flash tubes, but with the advantage of soldering components not in the line-of-sight”, and the list of advantages at [Page 4, Bottom, “Summary” Section”] – [Page 5, Top, “Summary” Section] A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that photonic soldering would be useful for integrating electronics into a printed circuit board, particularly if that board is of a material such as FR-4 (such as the substrate material taught by Halac).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the FR-4 material combination flexible and rigid printed circuit board substrate disclosed by Halac with photonic soldering electronic components onto printed circuit board substrate taught by Happy, creating a single analyte measurement system with photonic soldered electronics, increasing the ease of manufacturability for the associated materials and geometry.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Zoss et. al., (United States Patent Application Publication US 2022/0255637 A1), hereinafter Zoss.
Regarding Claim 7, Halac discloses as described above, The system of claim 6. For the remainder of Claim 7, Halac discloses the battery ([0194] “a source of power, such as a battery 234.”).
Halac does not disclose wherein the battery includes a printed battery.
Zoss teaches a physiological parameter monitoring system with sensor electronics on a printed circuit board, including a printed battery. Specifically for Claim 7, Zoss teaches wherein the battery includes a printed battery ([0121] “ battery 216′ may comprise an even smaller, lower-profile battery that is printed onto PCB 480.”).
Zoss provides a motivation to combine at [0121] with “…an even smaller, lower-profile battery that is printed onto PCB 480.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that having a lower profile battery printed on the PCB would be useful for miniaturizing a device for user comfort, or for generally fitting more electronic components into a circuit board space.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the battery powering an analyte sensor on a printed circuit board substrate disclosed in Halac with the low-profile printed battery for an analyte sensor taught by Zoss, creating a single analyte device powered by a low-profile printed battery on a PCB, to enhance miniaturization efforts for the comfort and conveniences of the device’s users.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Srinivasan et. al., (United States Patent Application Publication US 2019/0008425 A1), hereinafter Srinivasan.
Regarding Claim 9, Halac discloses as described above, The system of claim 1. For the remainder of Claim 9, Halac discloses wherein the analyte sensor further comprises a substrate (Fig 52B; [0296] “elongate substrate 4800”; Fig 51A and 51B) and at least one antenna (Fig 2; [0190] “A variety of wireless radio technologies that can be implemented in the telemetry module 232 include Bluetooth”; [0321] “…one or more antennas…”)
Halac does not specifically disclose a second substrate.
Srinivasan teaches a percutaneous electrode-based analyte sensor with an in vivo portion and ex vivo portion, including a wired connection to a secondary circuit board with an antenna. Specifically for Claim 9, Srinivasan teaches wherein the analyte sensor further comprises a second substrate ([0110] “printed circuit board 108”; Fig 3)(Examiner notes that a first substrate for Srinivasan would be [0101] “a base substrate layer 402 to support the sensor 400.”, a substrate with electronics.) having at least one antenna (Fig 3, “printed circuit board 108…antenna 112”)
Srinivasan provides a motivation to combine at [0107] “the sensor systems disclosed herein can communicate with other medical devices/systems via a wired or wireless connection.” and Figure 3. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that a second substrate could be used with a wired connection between the structures to have electronics such as the antennae placed at a distance outside the body, creating versatility in the arrangement of parts.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the antenna “telemetry module 232” of the analyte sensor electronics on the PCB substrate disclosed in Halac with Srinivasan’s taught second circuit board substrate with an antenna on a wired connection a distance outside of the body, creating a single analyte sensing apparatus with multiple substrates with electronics for design flexibility in arrangement of device parts relative to a patient.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Donnay et. al,. (United States Patent Application Publication US 2011/0319729 A1), hereinafter Donnay.
Regarding Claim 12, Halac discloses as described above, The system of claim 1. For the remainder of Claim 12, Halac discloses a sensor control device housing the analyte sensor (Fig 53A; [0297] “installation on on-skin sensor assembly 600.”)(Examiner notes that the sensor assembly is used to control where the “analyte sensor 138” is placed on the body, and it houses it in position at its distal end.);
an applicator for delivery of the analyte sensor (Fig 53A and Fig 53B; [0297] “installation on on-skin sensor assembly 600…envelope portion 4804”)(Examiner notes that the “envelope portion 4804” is used to deliver the analyte sensor 138 through the gap 180.) including: and a sensor carrier (Fig 53A and B; Fig 52A and B; “sensor carrier 402”),
Halac does not disclose a housing, configured to secure the sensor control device within an interior of the applicator; and an applicator cap removably coupled to the housing to seal the interior of the applicator.
Donnay teaches an apparatus for insertion of an analyte sensor in the skin of a subject including a housing. Specifically for Claim 12, Donnay teaches a sensor control device housing the analyte sensor (Fig 150, “sensor hub 4022”; [0272])(Examiner notes the 112f interpretation above of sensor control device as a moveable structure with an attached sensor, as shown in Applicant’s Figures 14A and 14B to “control” where the sensor is relative to the body.) and
an applicator ([0273] “Inserter 3700”; Fig 150 – Fig 156) for delivery of the analyte sensor ([0273] “Inserter 3700”; Fig 150 – Fig 156; [0273] “…the sharp carrier 3716 is advanced distally…advancing the sensor hub”)(Examiner notes that the analyte sensor on the sensor hub is delivered distally when the sensor hub is advanced.) including:
a housing (Fig. 150, “housing 3702”) including a sensor carrier (Fig 150; [0273] “sensor hub 4022 is supported by the sharp carrier 3716, with the sharp 324 extending distally in a surrounding position about the sensor…”) configured to secure the sensor control device (Fig 150; “sensor hub 4022”) within an interior of the applicator (Fig 150; [0273] “sensor hub 4022 is supported by the sharp carrier 3716, with the sharp 324 extending distally in a surrounding position about the sensor…”, shown in the interior of “housing 3702” of “inserter 3700”); and
an applicator cap (Fig. 150, “cap 3704”) removably coupled to the housing to seal the interior of the applicator (Fig. 150, Fig 151, “cap 3704”; [0273] “…cap 3704 attached to the housing 3702”, “…cap 3704 is removed”).
Halac is open to combine with a housing as disclosed at [0302] with “Substrate 404 may be sized and shaped (or may include structural features) that form anchoring features for substrate 404 relative to manufacturing stations and/or a housing of a wearable device.” Donnay provides a motivation to combine at [02500] with “Inserter 3700 generally includes, e.g., a housing 3702…sheath 3708…, and a removable distal cap 3704…for maintaining a sterile environment for the medical device and sharp housed therein.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that Halac’s disclosed substrate 404 could be attached to the interior of a structure such as that taught by Donnay, which would be useful for keeping the sensor sterile within a capped structure prior to use.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the analyte sensor on a substrate with anchoring features compatible with a housing disclosed in Halac with the inserter applicator structure housing for an analyte sensor taught by Donnay, creating a single analyte sensor system with interior sensors stored and deployed from a sterile housing environment.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Halac as evidenced by Vinatronic Inc., in view of Yuhas et. al., (United States Patent 5,350,621), hereinafter Yuhas, further in view of Brister et. al., (United States Patent Application Publication US 2006/0020187 A1), hereinafter Brister.
Regarding Claim 17, Halac discloses as described above, The system of claim 15. For the remainder of Claim 17, Halac discloses wherein the gradient mix of materials comprises fiberglass ([0293] “elongate substrate 4800 formed using printed circuit board technology from either a rigid, flexible, or a combination rigid/flexible substrate.”,”Rigid portion of the substrate may be manufactured from a material such as FR4, FR5, FR6…”)(Examiner notes that FR4 is a circuit board material that is a mix of fiberglass and epoxy resin, as evidenced by Vinatronic Inc [Page 3, “What is FR4?” Section] “FR4 is the NEMA (National Electrical Manufacturers Association) designation for Flame-Retardant fiberglass reinforced epoxy material.”)
Halac does not specifically disclose comprises 10% fiberglass, and the in vivo portion comprises PET.
Yuhas teaches FR4 laminated boards used in electronic circuitry. Specifically for Claim 17, Yuhas teaches comprises 10% fiberglass ([Col 2, Lines 52 – 54] “Generally speaking, the resin content in commercial laminates is…from about 30% to about 80% by weight of the cloth”, “…in one example…the amount of resin is…about 50% to 57% for a brominated epoxy resin commonly designates at FR-4”)(Examiner notes that these ranges comprise at least 10% fiberglass.)
A person with ordinary skill in the art would recognize that modifying the ratio of fiberglass: epoxy in a material such as FR4 for circuit board electronics would be a design choice for the manufacturability of the material, where Yuhas teaches that it generally accepted that there is a range of ratios for the resin/fiberglass content in commercial laminates. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. MPEP 2144.07.
Brister teaches a transcutaneous sensor assembly with porous material on a distal in vivo instrumented end to increase performance. Specifically for Claim 17, Brister teaches the in vivo portion comprises PET ([0108] “the sensor 32 includes a distal portion 42, also referred to as the in vivo portion, adapted to extend out of the mounting unit for insertion under the host’s skin”; [0165] “the distal portion 42 includes a porous material disposed over some portion thereof…Suitable porous materials include…polyester”)
Brister provides a motivation to combine at [0165] with “the porous material surrounding the sensor advantageously enhances and extends sensor performance and lifetime in the short term by slowing or reducing cellular migration to the sensor and associated degradation that would otherwise be caused by cellular invasion if the sensor were directly exposed to the in vivo environment.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that including a porous polyester section would be useful for an analyte sensor to have better performance an longevity to obtain percutaneous measurements.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the analyte sensor with a distal in vivo portion with sensors disclosed in Halac with the porous material disposed over the distal in vivo portion with sensors taught by Brister, creating a single analyte sensor for percutaneous measurements that performs with greater longevity and accuracy.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of Happy, further in view of Donnay.
Regarding Claim 48, Halac discloses A system for measurement of an analyte level ([Abstract]), comprising:
an analyte sensor (Overall Figure 2, used to sense an analyte; [0169] “an analyte sensor attached to a sensor carrier”)(Examiner notes that these structures together are collectively used as an analyte sensor”) having an in vivo portion ([0207] “ in vivo portion of the sensor 138”) configured to be positioned in contact with an interstitial fluid of a user ([0212] “….through the interstitial fluid surrounding the sensor 138”) and an ex vivo portion ([0207] “ex vivo portion of the sensor 138”), the analyte sensor having,
a flexible substrate (Fig 52B; [0296] “elongate substrate 4800”; Fig 51A and 51B; [0293] “elongate substrate 4800…flexible, or a combination rigid/flexible substrate.”)
a membrane ([0210] “membrane 108…typically formed of multiple layers”) configured to regulate analyte influx disposed on the in vivo portion (Fig 3D; [0210] “membrane 108 covering at least a portion of the distal in vivo portion of the sensor 138…typically formed of multiple layers…interference domain, an enzyme domain, a diffusion resistance domain…”);
at least one working electrode ([0212] “the working electrode 211 a”) located on the in vivo portion ([0211] “the two electrodes 211 a and 212 a…affixed to a distal in vivo portion…”),
a reference electrode (Fig 3D, “reference electrode 212 a.”; [0212]) located on the in vivo portion ([0209] “…in vivo portion of the sensor 138…forms an electrode 212 a.”); and
a plurality of electronic components mounted on the ex vivo portion (Fig 53A; [0297] “portion 4802 may form a standalone processing circuit for sensor 138 (e.g., an implementation of sensor electronics 112.)“; [0173] “sensor electronics 112…electronic circuitry associated with measuring and processing data generated by the analyte sensor 138.”; [0184]; [0187] “sensor electronics 112 may comprise an application-specific integrated circuit (ASIC) 205 coupled to a user interface 222.”; Fig 2, “ASIC 205”), the plurality of electronic components (Fig 2, “ASIC 205”; [0173] “sensor electronics 112”) comprising a processor (Fig 2, [0185] “a processor module 214 “), a battery ([0194] “a source of power, such as a battery 234.”), and an antenna (Fig 2, “telemetry module 232”; [0321] “Circuitry 5806 may include communications circuitry such as one or more antennas…”);
a sensor control device housing the analyte sensor (Fig 53A; [0297] “installation on on-skin sensor assembly 600.”)(Examiner notes that the sensor assembly is used to control where the “analyte sensor 138” is placed on the body, and it houses it in position at its distal end.); and
an applicator for delivery of the analyte sensor (Fig 53A and Fig 53B; [0297] “installation on on-skin sensor assembly 600…envelope portion 4804”)(Examiner notes that the “envelope portion 4804” is used to deliver the analyte sensor 138 through the gap 180.) including:
a sensor carrier (Fig 53A and B; Fig 52A and B; “sensor carrier 402”),
wherein the at least one working electrode is configured to sense an analyte level in the interstitial fluid of the user ([0212] “….through the interstitial fluid surrounding the sensor 138”, “The magnitude of this current…on the working electrode 211 a is a measure of analyte concentration…”),) and the antenna being further configured to receive generated signals associated with the sensed analyte level (Fig 2, “telemetry module 232”; [0039] “communications circuitry operable by the processing circuitry to send and receive data associated with each of the analyte sensors…”)
Halac does not disclose using photonic soldering, a sensor control device housing the analyte sensor; an applicator for delivery of the analyte sensor including: a housing including a sensor carrier configured to secure the sensor control device within an interior of the applicator; and an applicator cap removably coupled to the housing to seal the interior of the applicator;
Happy teaches how photonic soldering is used in printed electronics. Specifically for Claim 48, Happy teaches using photonic soldering ([Page 1, Paragraph 2 and 3] “curing and annealing of printed inks with flash tubes…”, “Inks cured to the temperature at which they become conductive using IR ovens requires substrates that can withstand these temperatures, like polyimides, ceramics, and epoxy fiberglass.”; Figure 1: “After: High-conductive printed electronic pattern with superior performance and throughput not possible by other methods”; Figure 2).
The motivation for Claim 48 to combine Halac with Happy is the same as that described in more detail in Claim 4. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the FR-4 material combination flexible and rigid printed circuit board substrate disclosed by Halac with photonic soldering electronic components onto printed circuit board substrate taught by Happy, creating a single analyte measurement system with photonic soldered electronics, increasing the ease of manufacturability for the associated materials and geometry.
Happy does not teach a sensor control device housing the analyte sensor; an applicator for delivery of the analyte sensor including: a housing including a sensor carrier configured to secure the sensor control device within an interior of the applicator; and an applicator cap removably coupled to the housing to seal the interior of the applicator;
Donnay teaches an apparatus for insertion of an analyte sensor in the skin of a subject including a housing. Specifically for Claim 48, Donnay teaches a sensor control device housing the analyte sensor (Fig 150, “sensor hub 4022”; [0272])(Examiner notes the 112f interpretation above of sensor control device as a moveable structure with an attached sensor, as shown in Applicant’s Figures 14A and 14B to “control” where the sensor is relative to the body.) and
an applicator ([0273] “Inserter 3700”; Fig 150 – Fig 156) for delivery of the analyte sensor ([0273] “Inserter 3700”; Fig 150 – Fig 156; [0273] “…the sharp carrier 3716 is advanced distally…advancing the sensor hub”)(Examiner notes that the analyte sensor on the sensor hub is delivered distally when the sensor hub is advanced.) including:
a housing (Fig. 150, “housing 3702”) including a sensor carrier (Fig 150; [0273] “sensor hub 4022 is supported by the sharp carrier 3716, with the sharp 324 extending distally in a surrounding position about the sensor…”) configured to secure the sensor control device (Fig 150; “sensor hub 4022”) within an interior of the applicator (Fig 150; [0273] “sensor hub 4022 is supported by the sharp carrier 3716, with the sharp 324 extending distally in a surrounding position about the sensor…”, shown in the interior of “housing 3702” of “inserter 3700”); and
an applicator cap (Fig. 150, “cap 3704”) removably coupled to the housing to seal the interior of the applicator (Fig. 150, Fig 151, “cap 3704”; [0273] “…cap 3704 attached to the housing 3702”, “…cap 3704 is removed”).
The motivation for Claim 48 to combine Halac with Donnay is the same as that described in more detail in Claim 12. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the analyte sensor on a substrate with anchoring features compatible with a housing disclosed in Halac with the inserter applicator structure housing for an analyte sensor taught by Donnay, creating a single analyte sensor system with interior sensors stored and deployed from a clean housing environment.
Conclusion
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791