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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/15/2023 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Currently, no claim limitations are being interpreted as invoking a 35 USC 112(f) interpretation.
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 1-11 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 1 recites the limitations “a patch outside” in the last line of the claim. The claim limitation is indefinite in the context of the claim in that is unclear if the limitation “a patch outside” is referring to another patch outside of the current patch, or to an outside environment of the patch.
For the purpose of advancing prosecution, the examiner will interpret the limitation “a patch outside” to be an environment outside of the patch based on the examiner’s understanding of the specification.
Claims 2-11 are rejected as being dependent on rejected claim 1 and not remedying the indefinite issue of claim 1.
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.
(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, 3-5 and 7-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee et al (US 11,559,225).
Regarding claims 1, 3-5 and 7-11; Lee discloses a patch for attaching a sensor to human skin (figures 23, 23a and 26a-c), the patch comprising:
an adhesive layer (element 312) arranged on an underside of the patch, the adhesive layer being adapted to adhere to human skin (column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c);
a protective layer (top surface of electronics module, element 254) arranged on an upper side of the patch, facing away from the underside (column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c); and
a sweat conduction element (wherein microfluidic channels, element 306, conduct sweat through the channels in substrate body, element 302; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c));
wherein the patch has an area (element 350) for receiving the sensor (wherein electronics module element 254 is equivalent of reusable electronic module element 12 and can have a temperature sensor; column 7, line 43 – column 8, line 10; column 21, line 1 – column 22, line 41; figures 3, 23, 23a and 26a-c); ,
wherein the sweat conduction element (microfluidic channel, elements 306) extends in a base surface of the patch (wherein lower disposable part, element 300, acts as the base of the completed patch; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c), and
wherein the sweat conduction element (elements 306) is connected to a side surface of the patch or to a peripheral surface of the patch to dissipate sweat to a patch outside (wherein microfluidic channels, elements 306, have an outlet, element 310, to the outside peripheral surface of the patch via vent holes element 327; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c)).
Further regarding claim 3; Lee discloses the sweat conduction element is configured as a sweat conduction slit (wherein microfluidic channels, elements 306 meet the BRI of a sweat conduction slit as they are cutout of substrate material, element 304; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c).
Further regarding claim 4; Lee discloses the patch comprises a plurality of sweat conduction elements (microfluidic channel, elements 306) including the sweat conduction element and at least another sweat conduction element (wherein Lee discloses there can be more than one microfluidic channel, element 306; column 21, line 1 – column 22, line 41, specifically column 21, lines 14-18; figures 23, 23a and 26a-c).
Further regarding claim 5; Lee discloses the protective layer comprises a material for thermal insulation of the sensor (cover of electronics module, element 254a, is disclosed as being made of a glass-reinforced epoxy laminate material, such as FR4 which has a thermal conductivity of about .25 W/mK, thus making it a good thermal insulator (column 19, lines 32-38), and/or wherein the adhesive layer comprises an adhesive selected from silicone adhesive, acrylic adhesive and/or hydrogel
Examiner’s Note: the broadest reasonable interpretation (BRI) of “and/or” is “or”, and thus Lee discloses the BRI of the claim 5 as it discloses the first limitation of the protective layer comprises a material for thermal insulation of the sensor. For the sake of advancing prosecution, the examiner further noted that Lee discloses the use of an adhesive (element 312), but is silent to what the adhesive is made of, but would be obvious in a 35 USC 103 rejection in view of MPEP 2144.05.
Further regarding claim 7; Lee discloses an electrically conductive element (element 318 and 320) in or on the adhesive layer (wherein electrical traces can be on bottom of element 322, which would be adjacent/on adhesive element 312), wherein the electrically conductive element is arranged to form an electrical connection between the human skin and the sensor (wherein the electrodes and electrical traces would provide an electrical connection to the skin when sweat is present; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c).
Further regarding claim 8; Lee discloses the protective layer (electronics module, element 254) is configured to form a first structural unit (interchangeable electronics module), wherein the adhesive layer is arranged to form a second structural unit (element 300) and, and wherein the second structural unit (element 300) is detachably connected to the first structural unit, so that the first structural unit is reusable (wherein electronics module, element 254, is connectable and removeable from adhesive patch, element 300, via connection means elements 350, 352 and 354; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c).
Further regarding claim 9; Lee discloses the sensor is configured as a temperature sensor and/or as a heat flow sensor (wherein it is disclosed that the electronics module, element 254, can include a temperature sensor; column 7, line 43 – column 8, line 10, column 21, line 1 – column 22, line 41; figures 3, 23, 23a and 26a-c).
Further regarding claim 10; Lee discloses the patch comprising the sensor (wherein combined patch of element 254 and element 300 includes the temperature sensor in the electronics module; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c).
Further regarding claim 11; Lee discloses the protective layer is not interrupted by perforations or other ventilation openings (wherein the examiner notes that element 254a of electronics module is the protective layer on the top of the patch and is uninterrupted by perforations or other ventilation openings; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c).
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.
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 11,559,225 B1).
Regarding claims 2 and 6; Lee is described in the rejection of claim 1 above; however, the third embodiment of Lee depicted in figures 23, 23a and 26a-c and relied for the rejection of claim 1 does not explicitly disclose the sweat conduction element comprises a sweat conduction material, wherein the sweat conduction material comprises a material selected from a porous plastic fiber composite, a sintered porous plastic, and/or a textile.
Lee does teach an alternative embodiment in figure 13 wherein the sweat conducting element (element 206) is a sweat conducting material, wherein the sweat conducting material comprises a material selected from a porous plastic fiber composite, a sintered porous plastic, and/or a textile (column 17, lines 22-60; figure 13).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the sweat conducting element of Lee’s third embodiment (element 302) with an alternative sweat conducting element made of a sweat conducting material comprises a material selected from a porous plastic fiber composite, a sintered porous plastic, and/or a textile of Lee’s embodiment of figure 13, as simple substitution of one known element for another to yield a predictable result (Lee’s third embodiment wherein flexible substrate layer 302 with the microfluidic channels is replaced by a sweat conducting of sweat conducting material, element 206, from Lee’s embodiment depicted in figure 13).
Further regarding claim 6; Lee discloses the sweat conducting material comprises a textile (wherein the examiner notes that cotton, polyester, and nylon are examples of textiles; column 17, lines 43-49).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2004/0215098 A1 to Barton et al; discloses a skin patch including a temperature sensor.
US 2022/0039662 A1 to Koele et al; discloses a sensor patch having a protective layer.
US 2019/0008448 A1 to Begtrup et al; discloses a sweat electrolyte loss monitoring device.
US 2020/0093416 A1 to Rogers et al; discloses thin, soft, skin-mounted microfluidic networks for detect and analysis of targets of interest in sweat.
US 6,479,015 B1 to Long et al; discloses an apparatus for monitoring a level of a chemical species in a body fluid.
US 11,460,430 B2 to Hagen et al; discloses a sweat simulation collecting and sensing system.
KR 2017-0028783 to Yoon; discloses a patch type thermometer with improved permeability.
US 2018/0028071 A1 to Shi; discloses a wearable patch for measuring temperature and electrical signals.
US 2021/0181208 A1 to Rogers et al; discloses an epidermal microfluidic sensor for sweat collection and analysis from aquatic athletes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791