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 .
Response to Amendment
The amendment filed December 5th, 2025 has been entered. Claims 1-11 remain pending in the application. Applicant’s amendments to the claims have overcome the 112(b) rejections previously set forth in the Non-Final Office Action mailed August 22nd, 2025.
Response to Arguments
Applicant's arguments filed December 5th, 2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument, see Pages 6-8, regarding Anderson’s gel layer, the examiner does not find these arguments persuasive. Anderson teaches drying the bioadhesive gel layer to a low water content wherein all tack is lost. The examiner interprets this to mean wherein the outer edge of the bioadhesive layer loses all tack, wherein the water content of the layer is less than 25% w/w, wherein the water would be stored throughout the center of the bioadhesive gel layer, as “all tack is lost” would be monitored from the outer peripheral edge of the layer. Therefore the examiner does not find these arguments persuasive. Further, applicant’s arguments regarding the teardrop configuration are not persuasive as the shape of the configuration is configured by the use of a mold (Claim 8) and therefore the hydration configuration does not further clarify the criticality of the teardrop shape.
Therefore the examiner does not find the applicant’s arguments persuasive. Claims 1-3 and 6-9 remain rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Anderson et al. (US Pat. 5645062) herein referred to as “Anderson”, Claims 4-5 remain rejected under 35 U.S.C. 103 as being unpatentable over Anderson in view of Way et al. (US Pat. 4955381) herein referred to as “Way”, and Claims 10-11 remain rejected under 35 U.S.C. 103 as being unpatentable over Anderson.
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 3 and 7-11 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.
Regarding claim 3, it is unclear if the applicant is trying to claim product by process by reciting ”wherein the hydrated portion is formed responsive to submerging the gel layer in water for a defined period”. It is unclear as to how the peripheral region of the gel layer remains dehydrated after it is rehydrated. Further clarification is needed within the claim to understand how the pad is produced to comprise the hydrated gel core and the dehydrated outer peripheral edge when the dehydrated layer is placed in water to form the hydrated gel core.
Regarding claim 7, it is unclear how exposing the gel layer to water forms a dehydrated portion of the gel layer as recited in line 7 of claim 7. The examiner interprets this to mean that the dehydrated gel layer forms a hydrated gel layer when it is exposed to water. However, it is unclear as to how the gel layer is formed as the gel layer is dehydrated and then rehydrated but the core of the gel layer is hydrated, and the peripheral region is dehydrated? It is unclear as to how the peripheral region of the gel layer remains dehydrated after it is rehydrated. Further clarification is needed within the claim to understand how the pad is produced to comprise the hydrated gel core and the dehydrated outer peripheral edge.
Claim Rejections - 35 USC § 102
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 and 6-9 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Anderson et al. (US Pat. 5645062) herein referred to as “Anderson”.
Regarding claim 1, Anderson discloses an adhesive pad for retaining an electrode against a patient's skin (the foetal electrode sensor 12 is coated with a film-forming layer 17 (seen as the adhesive pad), Col. 5, lines 22-28, Figures 13A and 13B), the adhesive pad (the film-forming layer 17 may be prepared using a bioadhesive gel or viscous solution and drying to a lower water content, drying being completed when all tack is lost from the resulting dried film, Cool. 5, lines 35-44) comprising: a gel layer comprising a dehydrated portion and a hydrated portion, (the film-forming layer 17 may be prepared using a bioadhesive gel or viscous solution and drying to a lower water content, drying being completed when all tack is lost from the resulting dried film, Cool. 5, lines 35-44, wherein the water content of the layer is less than 25% w/w, wherein the water would be stored throughout the center of the bioadhesive gel layer, as “all tack is lost from the resulting dried film” would be monitored from the dried film on the outer peripheral edge of the layer), wherein the dehydrated portion comprises a peripheral region of the gel layer that surrounds the hydrated portion (the layer 17 is activated by moisture when the electrode 10 is offered to a moist surface, Col. 5, lines 26-27, and Col. 3, lines 14-33) and define a non-tacky external shell (the film-forming layer 17 may be prepared using a bioadhesive gel or viscous solution and drying to a lower water content, drying being completed when all tack is lost from the resulting dried film, Cool. 5, lines 35-44), and wherein the hydrated portion forms a core of the gel layer (the film-forming layer 17 may be prepared using a bioadhesive gel or viscous solution and drying to a lower water content, drying being completed when all tack is lost from the resulting dried film, Cool. 5, lines 35-44, wherein the water content of the layer is less than 25% w/w, wherein the water would be stored throughout the center of the bioadhesive gel layer, as “all tack is lost” would be monitored from the outer peripheral edge of the layer), and a non-adhesive layer coupled to the gel layer (insulating substrate 11 carries the gel layer 17, Figures 11-13).
Regarding claim 2, Anderson discloses the adhesive pad of claim 1, wherein the dehydrated portion of the gel layer comprises dehydrated water-soluble adhesive gel (the film-forming layer 17 may be prepared using a bioadhesive gel or viscous solution and drying to a lower water content, drying being completed when all tack is lost from the resulting dried film (outer edge is the dried film), Col. 5, lines 35-44 and Col. 3, lines 14-33).
Regarding claim 3, Anderson discloses the adhesive pad of claim 2, wherein the hydrated portion is formed responsive to submerging the gel layer in water for a defined period (even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698; 227 USPQ 964, 966 (Fed. Cir. 1985)), and wherein the hydrated portion is adapted to be malleable and tacky (the adhesive property of the layer 17 is activated by moisture when the electrode is offered to a moist surface, Col. 5, lines 26-27, and Col. 5, lines 35-44).
Regarding claim 6, Anderson discloses the adhesive pad of claim 1, wherein the non-adhesive gel layer is configured as a flexible substrate (the electrode device 10 should be relatively thin, lightweight, and flexible in order to minimize the strength of adhesion required, those skilled in the art will recognize a number of widely available materials that meet the requirements for the substrate 11, Col. 4 lines 48-55).
Regarding claim 7, Anderson discloses a method for producing an adhesive pad for adhering to a patient's skin, the method comprising: forming viscous water-soluble adhesive gel to define a gel layer having a specific shape (the film-forming layer 17 may be prepared using a bioadhesive gel or viscous solution by conventional means known in the art, Col. 5 lines 35-44); joining a non-adhesive substrate to the gel layer (the layer may be formed by casting the polymer solution directly onto the electrode device 10 comprising substrate 11, Col. 6, lines 59-67); dehydrating the gel layer to form a dehydrated gel layer (the layer may be formed by casting the polymer solution directly onto a head 20 of the electrode device 10 and drying to remove the water, thus forming, a pliable, non-tacky, non-adhesive, film, Col 6, lines 59-67); and exposing the gel layer to water to form a dehydrated gel layer and a hydrated portion of the gel layer (the adhesive property of the layer 17 is activated by moisture when the electrode is offered to a moist surface, Col. 5, lines 26-27, and Col. 5, lines 35-44), wherein the dehydrated portion of the gel layer comprises a peripheral region of the gel layer that surrounds the hydrated portion and wherein the hydrated portion forms a core of the gel layer (the film-forming layer 17 may be prepared using a bioadhesive gel or viscous solution and drying to a lower water content, drying being completed when all tack is lost from the resulting dried film, Cool. 5, lines 35-44, wherein the water content of the layer is less than 25% w/w, wherein the water would be stored throughout the center of the bioadhesive gel layer, as “all tack is lost from the resulting dried film” would be monitored from the dried film on the outer peripheral edge of the layer).
Regarding claim 8, Anderson discloses the method of claim 7, wherein forming the gel comprises introducing the gel into a cavity defined by a mold, and wherein the cavity defines the specific shape (layer 17 may be directly deposited, using a suitable template, onto head 20 (seen as introducing the gel into a cavity defined by a mold), Col. 6 lines 59-67, and Col 7, lines 1-2).
Regarding claim 9, Anderson discloses the method of claim 8, wherein joining the substrate to the gel layer comprises placing the substrate within the cavity before introducing the gel into the cavity (substrate 11 defines a portion of the cavity and is therefore present within the cavity before the gel 17 is introduced, Col. 6 lines 59-67 and Col. 7, lines 1-2), and wherein introducing the gel into the cavity comprises arranging the gel to cover a portion of the substrate (gel layer 17 at least partly covers the substrate 11, Figures 11-13).
Claim Rejections - 35 USC § 103
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.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson in view of Way et al. (US Pat. 4955381) herein referred to as “Way”.
Regarding claim 4, discloses the adhesive pad of anyone of the preceding claimsclaim1, wherein the gel layer defines an electrode portion dimensioned to cover and extend beyond the electrode to allow adhering the electrode portion to the electrode and the skin (gel layer 17 defines an electrode portions and covers and extends beyond the electrode sensor 12, allowing the adhering of the electrode portion to the electrode and the skin, Figures 11-13).
However Anderson does not explicitly disclose a tail portion extending from the electrode-portion, the tail portion dimensioned to cover and extend beyond a portion of a wire attached to the electrode to allow adhering the tail portion to the wire and the skin.
Way discloses an electrode have multiple conductive pads (Abstract) wherein the adhesive pad includes a tail portion extending from the electrode-portion, the tail portion dimensioned to cover and extend beyond a portion of a wire attached to the electrode to allow adhering the tail portion to the wire and the skin (plastic foam cover 6, the foam backing is advantageously covered with a medical grade adhesive which will enable the foam backing to adhere directly to the metal foils 7, 8, and to the human body, Col. 4, lines 58-68, Figure 1).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Anderson to incorporate the teachings of Way by including wherein the adhesive pad includes a tail portion extending from the electrode-portion, the tail portion dimensioned to cover and extend beyond a portion of a wire attached to the electrode to allow adhering the tail portion to the wire and the skin. The motivation to do so being to adhere the foam backing to the metal foils as well as to the patients skin (Way, Col. 4, lines 58-68).
Regarding claim 5, Anderson in view of Way discloses the adhesive pad of claim 4.
However Anderson does not explicitly disclose wherein the gel layer defines a peripheral profile surrounding the electrode portion and the tail portion, wherein the peripheral profile has a teardrop shape.
Way discloses wherein the adhesive layer defines a peripheral profile surrounding the electrode portion and the tail portion, wherein the peripheral profile has a teardrop shape (adhesive foam backing layer 6 defines a teardrop shape, Figure 1).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Anderson to incorporate the teachings of Way by including wherein the gel layer defines a peripheral profile surrounding the electrode portion and the tail portion, wherein the peripheral profile has a teardrop shape. The motivation to do so being to adhere the foam backing to the metal foils as well as to the patients skin (Way, Col. 4, lines 58-68).
Further it would have been an obvious matter of design choice to make the different portions of the gel layer of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson.
Regarding claim 10, Anderson discloses the method of claim 8.
Anderson discloses wherein dehydrating the gel layer comprises a first dehydration stage where the gel layer is dehydrated while arranged in the cavity (the layer 17 may be prepared using a bioadhesive gel or viscous solution by conventional means known in the art and drying to a low water content, Col. 5, lines 35-39, and Col. 7, lines 1-9).
However Anderson does not explicitly disclose an intermediary stage where the gel layer and the substrate are removed from the cavity, and a second dehydration stage where the gel layer is dehydrated when removed from the cavity.
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to include an intermediary stage where the gel layer and the substrate are removed from the cavity, and a second dehydration stage where the gel layer is dehydrated when removed from the cavity because applicant has not disclosed that an intermediary stage where the gel layer and the substrate are removed from the cavity, and a second dehydration stage where the gel layer is dehydrated when removed from the cavity provides an advantage, is used for a particular purpose, or solves a stated problem. Furthermore, one of ordinary skill in the art would have expected the gel adhesive layer as disclosed by Anderson and applicant’s invention to perform equally well with either a single dehydration step taught by Anderson or the claimed intermediary stage where the gel layer and the substrate are removed from the cavity, and a second dehydration stage where the gel layer is dehydrated when removed from the cavity because both dehydration steps would perform the same function of dehydrating the gel adhesive layer. Therefore, it would have been prima facie obvious to modify Anderson to obtain the invention as specified in claim 10 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Anderson.
Regarding claim 11, Anderson discloses the method of claim 10.
However Anderson does not explicitly disclose wherein a duration of the first dehydration stage is greater than a duration of the second dehydration stage.
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to include wherein a duration of the first dehydration stage is greater than a duration of the second dehydration stage because applicant has not disclosed that wherein a duration of the first dehydration stage is substantially greater than a duration of the second dehydration stage provides an advantage, is used for a particular purpose, or solves a stated problem. Furthermore, one of ordinary skill in the art would have expected the gel adhesive layer as disclosed by Anderson and applicant’s invention to perform equally well with either a single dehydration step taught by Anderson or the claimed wherein a duration of the first dehydration stage is substantially greater than a duration of the second dehydration stage because both dehydration steps would perform the same function of dehydrating the gel adhesive layer. Therefore, it would have been prima facie obvious to modify Anderson to obtain the invention as specified in claim 11 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Anderson.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cornell (US 6044287) discloses a medical electrode comprising edge biting.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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