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 with traverse of Group I, claims 1 – 11, in the reply filed on June 10, 2026 is acknowledged. The traversal is on the ground(s) that WO 2016/122148 Al ("Kim") does not teach the claimed MVTR or teach details of the layers in order to determine the MVTR would be inherent. Although, the Examiner agrees with this position, the lack of unity is maintained. As evidenced by the rejection over Manicka et al. (WO 2009036313 A1) below, the technical feature is not a special technical feature as it does not make a contribution over the prior art. It should be noted that Manicka et al. teach the breathable tape comprises an MVTR of at least about 400 g/m.sup.2/24hrs, the gel cover comprises at least about 400 g/m.sup.2/24hrs and the MVTR through the breathable tape, the gel cover and the breathable cover may comprise at least about 400 g/m.sup.2/24hrs [0093]. Manicka et al. specifically notes that MVTR values as specified above can provide improved comfort, for example such that in many embodiments skin does not itch [0054].
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim 7 is 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 7 recites the limitation "first layer (D)" in line 2. There is insufficient antecedent basis for this limitation in the claim. Note claim 1 refers to (D) as “further layer”.
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 – 6 and 9 – 11 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Manicka et al. (WO 2009036313 A1).
Manicka et al. is directed to an adherent device with multiple physiological sensors (Title). Manicka et al. teach the device connected to at least four electrodes, electrocardiogram circuitry, accelerometer etc. is connected to an adhesive patch which is used to adhere to the skin of a patient (Abstract). [0010] In many embodiments, the adhesive patch is mechanically coupled to the at least four electrodes, the impedance circuitry, the electrocardiogram circuitry and the accelerometer, such that the patch is capable of supporting the at least four electrodes, the impedance circuitry, the electrocardiogram circuitry and the accelerometer when the adherent patch is adhered to the skin of the patient.
Manicka et al. teach that the device comprises: a breathable tape with an adhesive coating where the tape may comprise a porous fabric to allow transmission of water vapor while the device is worn by the patient [0018], at least one electrode is affixed to the breathable tape and capable of electrically coupling to a skin of the patient [0018], a least one gel can be disposed over a contact surface of the at least one electrode to electrically connect the electrode to the skin [0018], a printed circuit board, for example, a flex printed circuit board, connected to the breathable tape [0018], a breathable cover, which may be water resistant, disposed over the circuit board and electronic components and connected to at least one of the electronics components, the printed circuit board or the breathable tape [0018] and a gel cover positioned between the breathable tape and the printed circuit board to inhibit a flow of the gel through the breathable tape [0088]. Manicka et al. teach that the gel cover can be made of a polyester, polyurethane and can be a foam [0161]. Manicka et al. teach as shown in Figures 1A – 1F an electronics housing 160 may be disposed under cover 162 to protect the electronic components [0146].
The Examiner equates the printed circuit board to Applicant’s “electronic device (B)”, breathable tape with an adhesive coating to Applicant’s “first polymeric layer (A)” and “adhesive (E)”, a gel cover to Applicant’s “a second polymeric layer (C)” OR “a polymeric foam (F)”, a least one gel to Applicant’s “filled with a material” and breathable cover OR electronics housing to Applicant’s “at least one further layer” which applies to claims 1, 3, 6 and 11.
As claims 1 – 2 and 4, Manicka et al. teach the breathable tape comprises an MVTR of at least about 400 g/m.sup.2/24hrs, the gel cover comprises at least about 400 g/m.sup.2/24hrs and the MVTR through the breathable tape, the gel cover and the breathable cover may comprise at least about 400 g/m.sup.2/24hrs [0093]. Manicka et al. specifically notes that MVTR values as specified above can provide improved comfort, for example such that in many embodiments skin does not itch [0054].
As to claim 3, Manicka et al. teach the breathable tape comprises a tricot-knit polyester fabric backing with an acrylate adhesive coating and the gel cover comprises a polyurethane, non-woven backing with an acrylate adhesive coating [0021].
As to claim 5, Manicka et al. teach that the electronic component can have sensors [0135 – 0140] and sensing electrodes, battery, memory, logic, and wireless communication capabilities [0125] among other components (see entire document).
As to claims 9, 10 and 11, Manicka et al. teach breathable cover or Applicant’s “further layer” can be made of a stretchable material made of polyester, nylon or polyamide having a water repellant coating (see claims 91, 95 – 102). Manicka et al. teach the electronics housing 160 or “further layer” may comprise a water proof material, for example a sealant adhesive such as epoxy or silicone coated over the electronics components and/or PCB or may comprise metal and/or plastic [0146]. Manicka et al. teach that the gel cover can be made of a polyester, polyurethane and can be a foam [0161].
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.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Manicka et al. (WO 2009036313 A1).
As noted above in the 102 rejection, The Examiner equates the printed circuit board to Applicant’s “electronic device (B)”, breathable tape with an adhesive coating to Applicant’s “first polymeric layer (A)” and “adhesive (E)”, a gel cover to Applicant’s “a second polymeric layer (C)” OR “a polymeric foam (F)”, a least one gel to Applicant’s “filled with a material” and breathable cover OR electronics housing to Applicant’s “at least one further layer”.
Manicka et al. fail to teach the ratio of the surface area of the first polymeric layer (A) to the surface area of the first layer (D) (“at least one further layer”) is in a range of from 100:1 to 1.5:1 as required by claim 7 and the further layer (D) has a thickness of 1 to 500 um and/or surface area of in the range of 0.1 to 900 cm3 as required by claim 8. Manicka notes that the size of various components can be adjusted [0172], [0200], [0224]. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the ratio of the surface area to include the claimed range. One would have been motivated to provide a difference in surface size to tailor the mechanical properties of the electronic patch. It has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER A BOYD whose telephone number is (571)272-7783. The examiner can normally be reached M-F 8 am - 5 pm with alternating Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sri Kumar can be reached at (571) 272-7769. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BOYD/Supervisory Patent Examiner, Art Unit 1786
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