DETAILED ACTION
This action is pursuant to claims filed on 3/2/2026. Claims 1-9 are pending. A non-final rejection on the merits of claims 1-9 is as follows.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/2/2026 has been entered.
Response to Arguments
Applicant's arguments filed 3/2/2026 on pages 4-5 regarding a portion of the surface of the body electrode oriented toward the release sheet corresponding to the first area not being adhesive have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Hoffman is not used to teach the newly added limitation. Instead, Acquista has been used to teach a non-adhesive surface oriented toward the release sheet that is disposed in the first area. Therefore, claim 1 remains rejected.
Claims 2-9 remain rejected because claim 1 remains rejected.
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 4,635,641 A) in view of Meyerson et al. (hereinafter ‘Meyerson’, US 20180184902 A1) and in further view of Acquista et al (hereinafter ‘Acquista’, US 2017/0258402 A1)..
Regarding independent claim 1, Hoffman discloses a body electrode unit (electrode 100 Fig. 1) comprising:
a body electrode (electrode 100 Fig. 1) configured to be attached to a body (Col 4, lines 36-45: the electrode assembly affixes to the body);
and a release sheet (release liner 122 in Fig. 1) to which the body electrode is attached (Col 4, lines 36-45: the release liner covers the adhesive surface of the electrode),
wherein the body electrode comprises at least a first electrode (electrode 103 in Fig. 1) and a second electrode (electrode 102 in Fig. 1), the first electrode and the second electrode being put together to form a single continuous shape (adhesive backing 104 to which the electrodes are attached in Figs 1 and 2 is continuous),
wherein the release sheet comprises a first processed part (first processed part is cut 124 in Fig. 1) configured to facilitate a separation of the release sheet (Col 4, lines 36-45: the processed part 124 allows the assembly to be bent to gain finger access to the releasable liner to separate from the adhesive backing), the first processed part being provided in a first area between a position at which the first electrode is attached and a position at which the second electrode is attached (processed part 124 in Fig. 1 is disposed on the liner 122 in an area between the first and second electrode – the entire area between the first and second electrodes is the “first area”), and
wherein a surface of the body electrode is oriented toward the release sheet (underside of 104 is oriented toward the release sheet as seen in Fig. 1).
Hoffman additionally contemplates different shapes of the adhesive backing and the possibility that the adhesive could be non-continuous (Col 5, lines 33-52).
While it is the opinion of the examiner that the cut 124 meets the claim limitation of a “processed part” because it is a part where the release sheet was processed (i.e. cut), the claim is further rejected in view of Meyerson in order to further advance prosecution.
Meyerson teaches a patch on which a plurality of sensors are disposed comprising an adhesive disposed on the bottom of the patch which is in turn covered by a release liner ([Abstract], [0032]). The release liner can be made of a variety of materials and is intended to be easily removed from the adhesive prior to use, similar to the release layer of Hoffman ([0033]). Meyerson further teaches that the release liner may comprise two halves separated by a seam as shown in Fig. 6. The seam can be a cut, like Hoffman, or be a score line or perforation to facilitated the removal of the release liner ([0066]). Meyerson thus teaches that including perforations or a score line (which is consistent with the “processed part” of the instant application) is a known and equivalent alternative to a cut to facilitate the removal of a release liner. The substitution of one known element (the cut of Hoffman) for another (the score line or perforations of Meyerson) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution for the perforations would have yielded predictable results, namely, providing a processed part in the release liner to facilitate the removal of said release liner prior to use.
However, the Hoffman/Meyerson combination is silent to a portion of the surface corresponding to the first area is not adhesive.
Acquista teaches an electrode patch for obtaining physiological data with multiple electrodes adhering to the skin. Acquista further teaches a backing with adhesive electrode mounting portions and non-adhesive connecting portions ([0062]). The adhesive electrode mounting portions are connected by non-adhesive connection portions which provide flexibility and strain relief when the circuit is attached to the body ([0063]: 510 connects electrode 501 to 502). Connecting the adhesive electrode portions of Hoffman with a non-adhesive connecting section of Acquista would be of routine skill in the art and maintain the operability of Hoffman. Furthermore, utilizing a non-adhesive connecting section would mean that a portion of the surface oriented towards the release sheet corresponding to the first area, which is the location between the first and second electrodes, would be non-adhesive, thus meeting the claim limitation. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to combine the adhesive mounting portions of the Hoffman/Meyerson combination with the non-adhesive connecting portion of Acquista in order to connect the adhesive mounting portions with a non-adhesive portion in order to provide a degree of flexibility and strain relief when the circuit is attached to the body ([0063]).
Regarding claim 2, the Hoffman/Meyerson/Acquista combination discloses the invention substantially as claimed in claim 1 above. Additionally, Hoffman further discloses a third electrode (Col 5, lines 15-25: the present invention may incorporate more than two electrodes), wherein the first electrode, the second electrode, and the third electrode are put together to form the single continuous shape (the three electrodes form a continuous shape as shown in Figs. 6-8).
However, the Hoffman/Meyerson/Acquista combination is silent as to whether the release sheet comprises a second processed part to facilitate separation of the release sheet between the second and third electrodes.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to duplicate the first processed part between the second and third electrodes, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Duplicating the processed part would further aid in the removal of the adhesive liner from each electrode and aid in the placement in the desired body location (Col 4, lines 36-45) without effecting the functionality of the electrodes themselves or resulting in a new or unexpected result.
Regarding claim 3, the Hoffman/Meyerson/Acquista combination discloses the invention substantially as set forth in claims 2/1 and described above. The combination further discloses a first electrode mounting portion (far side of the adhesive pad 104 where electrode 103 is mounted in Fig. 1) on which the first electrode is mounted (electrode 103 mounts to the adhesive pad 104 at the far side), the first electrode mounting portion being adhesive (Col 4, lines 1-20: adhesive pad 104 is adhesive); a second electrode mounting portion (near side of adhesive pad 104 where electrode 102 is mounted in Fig. 2) on which the second electrode is mounted (electrode 102 mounts to the adhesive pad 104 at the near side), the second electrode mounting portion being adhesive (Col 4, lines 1-20: adhesive pad 104 is adhesive); and a first connection portion connecting the first electrode mounting portion and the second electrode mounting portion to each other, the first connection portion being non-adhesive (as explained in the combination above, the first connection portion would be the non-adhesive connection between the first and second electrodes as taught by Acquista - [0063]: 510 connects electrode 501 to 502).
Regarding claim 4, the Hoffman/Meyerson/Acquista combination discloses the invention substantially as set forth in claim 3/2/1 and described above. Hoffman further discloses a third electrode mounting portion where the third electrode is mounted (Fig. 8, nearest side of backing 104 where third electrode 503 is mounted) with the third electrode mounting portion being adhesive (Col 4, lines 1-20: adhesive pad 104 is adhesive).
Hoffman contemplates different shapes of the adhesive backing and also the possibility that the adhesive could be non-continuous (Col 5, lines 33-52).
However, the Hoffman/Meyerson/Acquista combination as it stands is silent to the connection means between multiple electrodes with a non-continuous adhesive on the backing.
Acquista further teaches a second non-adhesive connection portion that connects a second and third electrode ([0063]: 510 connects electrode 502 to 503). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to further combine the adhesive mounting portions of the Hoffman/Meyerson/Acquista combination with the additional non-adhesive connecting portion of Acquista in order to connect the adhesive mounting portions with a non-adhesive backing portion in order to provide a degree of flexibility and strain relief when the circuit is attached to the body ([0063]).
Regarding claim 5, the Hoffman/Meyerson/Acquista combination discloses the body electrode unit according to claim 1, wherein a notch is at a side end of the first processed part (visible cut on the vertical edge of processed part 124 in Fig. 1 – which would inherently be the same for a score line in the combination since a score line is a partial cut in the release liner; similarly, a perforation of the combination terminating at the edge would inherently create a notch facing the side and disposed at a side of the release liner by removing a small amount of material at the edge).
Regarding claim 6, the Hoffman/Meyerson/Acquista combination discloses the body electrode unit according to claim 1, wherein the first processed part is partially cut in a thickness direction of the release sheet (processed part 124 in Fig. 1 is a clear cut in the thickness direction of the release sheet; in the Hoffman/Meyerson/Acquista combination, a score line, by definition, is a partial cut in a thickness direction of the release sheet [0066]).
Regarding claim 7, the Hoffman/Meyerson/Acquista combination discloses the body electrode unit according to claim 1, wherein the first processed part is perforated (in the Hoffman/Meyerson/Acquista combination, the processed part can be perforated [0066]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman/Meyerson/Acquista as applied to claim 3/2/1 above in view of Gozani et al (hereinafter ‘Gozani’, US 2010/0210965 A1).
Regarding claim 8, the Hoffman/Meyerson/Acquista combination discloses the invention substantially in claim 3/2/1 as described above. Hoffman further discloses a first electrode mounting portion that may contain multiple electrodes (multiple electrodes 403 on first mounting portion in Fig. 7).
However, the Hoffman/Meyerson/Acquista combination is silent to the use of a neutral electrode used to reduce noise.
Gozani teaches an electrode patch used to stimulate and measure neuromuscular function. Gozani further teaches a neutral or inactive electrode used to eliminate noise in the signal ([0120]). Reducing noise in the signal would provide signal enhancement to Hoffman for use in therapeutic and diagnostic applications. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to combine the neutral electrode of Gozani as one of the multiple electrodes on the first electrode mounting patch of the Hoffman/Meyerson/Acquista combination in order to eliminate noise generated by the stimulation signal. This can be done easily by one of ordinary skill in the art, as demonstrated by Gozani, and leads to the predictable outcome of noise reduction.
Regarding claim 9, the Hoffman/Meyerson/Acquista/Gozani combination discloses the invention substantially in claim 8/3/2/1 as described above. Hoffman further discloses the electrode comprising a cathode and anode on a single patch as shown in Fig. 1 (Col 3, lines 40-50).
Hoffman also contemplates having multiple electrodes on the first electrode mounting portion as shown in Fig. 7 where there are 3 electrodes (403) on the side of the first mounting portion. Hoffman also discloses that the electrodes may be arranged in a variety of ways and may be of various shapes and sizes (Col 5, lines 15-25) and does not state that including the cathode and anode on the same mounting portion would have an adverse effect on the desired treatment effects, thus the cathode and anode can both be present on the first mounting portion.
However, the Hoffman/Meyerson/Acquista/Gozani combination as it stands is silent on the inclusion of the neutral electrode being closer to the negative electrode.
Gozani further teaches the neutral electrode being closest to the negative, or active detection, electrode as seen in Fig. 3 (negative electrode 75 and neutral electrode 80). This is done to further reduce noise in the signal during signal detection ([0120]). Reducing noise in the signal would provide signal enhancement to Hoffman for use in therapeutic and diagnostic applications. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to combine the neutral electrode placement of Gozani with the cathode/anode arrangement of the Hoffman/Meyerson/Acquista/Gozani combination in order to further eliminate noise generated by the stimulation signal. This can be done easily by one of ordinary skill in the art, as demonstrated by Gozani, and leads to the predictable outcome of noise reduction.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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