DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Claim Rejections - 35 USC § 102
3. 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.
4. Claims 15 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tiegs U.S. 8,406,843 (herein referred to as “Tiegs”).
5. Regarding Claim 15, Tiegs teaches a stud for use in an electrode assembly (Figs. 1-3, ref num 14 used on ref num 10), comprising:
a projection configured for directly engaging a connector (Fig. 1, ref num 14 comprises a projection that connects to ref nums 42 and 50, see Figs. 4, 5A), the projection comprising a first retainer (Fig. 3, ref num 14 comprises retainer, ref num 16) for engaging and retaining a first type of connector to the stud (Col. 4, lines 36-37, “The bore 16 is sized and configured to mate with a tool 42”) and a second retainer (Fig. 2, ref num 14 contains a second retainer configured to mate with ref num 50) for engaging and retaining a second type of connector to the stud (Col. 4, lines 12-21, “The electrode stud 14 is sized and configured to make an electrical connection with the lead wires of a monitoring apparatus 50 as shown in FIG. 5. The current industry standard is to utilize a snap fit between an electrode and the lead wires of a monitoring apparatus 50. The illustrated embodiment shows an electrode element 10 adapted to mate with current industry standard lead wires. However, it is contemplated that the particular external configuration of the electrode stud 14 may be altered based on the particular monitoring apparatus 50 it is to be used with”). The first and second types of connectors having different connection methods (Col. 6, lines 19-22, “The medical provider may then insert the head 44 of the drive tool 42 into the bore 16 formed in the electrode stud 14. The tool 44 may be turned by its handle 46 to abrade the skin 52”; Fig. 5A, ref num 50 = second type of connector, Col. 4, lines 12-14, “The electrode stud 14 is sized and configured to make an electrical connection with the lead wires of a monitoring apparatus 50 as shown in FIG. 5”).
6. Regarding Claim 17, Tiegs teaches the second retainer (Fig. 2 and 7, retainer formed by ref num 14) comprises a second recess in the outer surface of the stud (see Fig. 2, recess formed between top of ref num 14 and ref num 18).
7. Regarding Claim 18, Tiegs teaches the second retainer comprises a section of the outer side surface of the stud spaced away from the recess (Fig. 2, ref num 18 is the section spaced away from the recess).
8. Regarding Claim 19, Tiegs teaches the projection comprises a generally cylindrical outer side surface and one of a domed upper surface or an angled surface extending from a top of the outer side surface (see Fig. 3, ref num 14 has this shape).
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer U.S. 8,123,568 (herein referred to as “Meyer”) and in view of Tiegs.
11. Regarding Claim 1, Meyer teaches an electrode assembly (Figs. 2 and 7) comprising: electrode pad (Fig. 7, ref num 50) including a patient contact side for engaging skin of a patient (Col. 5, lines 47-49, “A pressure sensitive adhesive coating and an adhesive hydrogel (not shown) may be applied to tissue contacting surface of electrode base 52”) and a connector side (opposite side of the tissue contacting side; Fig. 7, top side) for attaching a connector to the electrode pad (Fig. 7, ref num 100); and a stud mounted on the connector side of the electrode pad (Fig. 7, ref num 54) for directly engaging the connector to retain the connector to the electrode pad (Fig. 9; Col. 6, lines 34-39, “Electrode connector 100 includes terminal aperture 106, hinge aperture 108 and slits 110,112 each of which extend through connector base 102 and connector shoe 104. Terminal aperture 106 defines a generally circular configuration and is adapted to receive male terminal 54 of biomedical electrode 50”), the stud comprising a first retainer (Fig. 7, ref num 56) for engaging and retaining a first type of connector to the stud (Fig. 7, ref num 56 engages and retains ref num 100) and a second type of connector (Fig. 11 and 15, ref num 150).
Meyer fails to teach a second retainer for engaging and retaining the second type of connector to the stud, the first and second types of connectors having different connection methods.
Tiegs teaches an electrode assembly of analogous art (Figs. 1 and 2), wherein the assembly comprises an electrode pad including a patient contact side (Fig. 1, ref num 10; Fig. 3, ref num 28 = patient contact side) and a connector side (Fig. 3, ref num 26); as well as a stud (Fig. 3, ref num 14) for directly engaging a connector (Figs. 2, 4, 5A, and 5B, ref nums 42 and 50 are connectors) to retain the connector to the electrode pad (Figs. 4, 5A, ref nums 42 and 50 are retained to ref num 14), such that there is a first and second type of connector having different connection methods (Fig. 4, ref num 42 = first type of connector, Col. 6, lines 19-22, “The medical provider may then insert the head 44 of the drive tool 42 into the bore 16 formed in the electrode stud 14. The tool 44 may be turned by its handle 46 to abrade the skin 52”; Fig. 5A, ref num 50 = second type of connector, Col. 4, lines 12-14, “The electrode stud 14 is sized and configured to make an electrical connection with the lead wires of a monitoring apparatus 50 as shown in FIG. 5”). The stud comprises a first retainer for engaging the first type of connector (Fig. 3, ref num 14 comprises retainer, ref num 16; Col. 4, lines 36-37, “The bore 16 is sized and configured to mate with a tool 42”), and a second retainer for engaging the second type of connector (Fig. 2, ref num 14 contains a second retainer configured to mate with ref num 50; Col. 4, lines 12-21, “The electrode stud 14 is sized and configured to make an electrical connection with the lead wires of a monitoring apparatus 50 as shown in FIG. 5. The current industry standard is to utilize a snap fit between an electrode and the lead wires of a monitoring apparatus 50. The illustrated embodiment shows an electrode element 10 adapted to mate with current industry standard lead wires. However, it is contemplated that the particular external configuration of the electrode stud 14 may be altered based on the particular monitoring apparatus 50 it is to be used with”). By having multiple retainers, this allows the electrode to be connected to multiple types of connectors for various purposes (ref num 42 provides one purpose, i.e., abrading the skin, while ref num 50 provides a separate purpose, monitoring the electrode; Col. 2, lines 41-45). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Meyer and the stud have a first and second retainer in order to connect various types of connectors that fulfill different purposes, as this achieves the same expected result of performing the desired treatment.
12. Regarding Claim 2, Meyer teaches the first retainer (Fig. 7, ref num 56) comprises a recess in an outer side surface of the stud (Fig. 7, recess is formed between ref num 56 and upper side of ref num 52).
13. Regarding Claim 3, Meyer fails to teach the second retainer comprises a second recess in the outer surface of the stud.
Tiegs teaches the second retainer (Fig. 2 and 7, retainer formed by ref num 14) comprises a recess in the outer surface of the stud (see Fig. 2, recess formed between top of ref num 14 and ref num 18). This formation aids with retaining the second connector (Col. 4, lines 12-21, “The electrode stud 14 is sized and configured to make an electrical connection with the lead wires of a monitoring apparatus 50 as shown in FIG. 5. The current industry standard is to utilize a snap fit between an electrode and the lead wires of a monitoring apparatus 50. The illustrated embodiment shows an electrode element 10 adapted to mate with current industry standard lead wires. However, it is contemplated that the particular external configuration of the electrode stud 14 may be altered based on the particular monitoring apparatus 50 it is to be used with”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Meyer to include the second retainer with a recess in order to connector the second connector with the electrode pad.
14. Regarding Claim 4, Meyer fails to teach the second retainer comprises a section of the outer side surface of the stud spaced away from the recess.
Tiegs teaches the second retainer comprises a section of the outer side surface of the stud spaced away from the recess (Fig. 2, ref num 18 is the section spaced away from the recess). This formation aids with retaining the second connector (Col. 4, lines 12-21, “The electrode stud 14 is sized and configured to make an electrical connection with the lead wires of a monitoring apparatus 50 as shown in FIG. 5. The current industry standard is to utilize a snap fit between an electrode and the lead wires of a monitoring apparatus 50. The illustrated embodiment shows an electrode element 10 adapted to mate with current industry standard lead wires. However, it is contemplated that the particular external configuration of the electrode stud 14 may be altered based on the particular monitoring apparatus 50 it is to be used with”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Meyer to include the second retainer with a recess in order to connector the second connector with the electrode pad.
15. Regarding Claim 5, Meyer teaches the stud comprises a generally cylindrical projection extending outwardly from the electrode pad (Fig. 2 and 7, ref num 54 is cylindrical).
16. Regarding Claim 6, Meyer teaches the projection comprises a generically cylindrical outer side surface and one of a domed upper surface or angled surfaces extending from a top of the outer side surface. (Col. 5, lines 44-47, “Male terminal 54 may have a bulbous arrangement whereby the upper portion of the male terminal 54 has a greater cross-sectional dimension than a lower portion of the male terminal 50”).
17. Regarding Claim 7, Meyer teaches the outer side surface includes a first section disposed above the first retainer and a second section disposed below the first retainer (see Fig. 7, there is a section above ref num 56 and a section below ref num 56).
18. Regarding Claim 8, Meyer teaches the first retainer comprises a recess in the outer side surface (Fig. 7, recess is formed between ref num 56 and upper side of ref num 52).
19. Regarding Claim 9, Meyer teaches the first section has an outer dimension that is constant along a height of the projection (see Fig. 7, ref num 54 has an outer dimension that is constant along the height of the projection; It would have been an obvious matter of design choice to have the outer dimension be constant, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955)).
20. Regarding Claim 10, Meyer teaches the second section has an outer dimension that is constant along the height of the projection (see Fig. 7, ref num 54 has an outer dimension that is constant along the height of the projection; It would have been an obvious matter of design choice to have the outer dimension be constant, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955)).
21. Regarding Claim 11, Meyer fails to teach the outer side surface includes a third section disposed below the second retainer.
Tiegs teaches an outer side surface includes a third section disposed below the second retainer (Fig. 2, ref num 18 forms the third section below a second retainer). This formation aids with retaining the second connector (Col. 4, lines 12-21, “The electrode stud 14 is sized and configured to make an electrical connection with the lead wires of a monitoring apparatus 50 as shown in FIG. 5. The current industry standard is to utilize a snap fit between an electrode and the lead wires of a monitoring apparatus 50. The illustrated embodiment shows an electrode element 10 adapted to mate with current industry standard lead wires. However, it is contemplated that the particular external configuration of the electrode stud 14 may be altered based on the particular monitoring apparatus 50 it is to be used with”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Meyer to include a third section below the second retainer in order to connector the second connector with the electrode pad.
22. Regarding Claim 12, Meyer fails to teach the second retainer comprises a recess in the outer side surface.
Tiegs teaches the second retainer (Fig. 2 and 7, retainer formed by ref num 14) comprises a recess in the outer surface of the stud (see Fig. 2, recess formed between top of ref num 14 and ref num 18). This formation aids with retaining the second connector (Col. 4, lines 12-21, “The electrode stud 14 is sized and configured to make an electrical connection with the lead wires of a monitoring apparatus 50 as shown in FIG. 5. The current industry standard is to utilize a snap fit between an electrode and the lead wires of a monitoring apparatus 50. The illustrated embodiment shows an electrode element 10 adapted to mate with current industry standard lead wires. However, it is contemplated that the particular external configuration of the electrode stud 14 may be altered based on the particular monitoring apparatus 50 it is to be used with”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Meyer to include the second retainer with a recess in order to connector the second connector with the electrode pad.
23. Regarding Claim 13, Meyer fails to teach the second section defines the second retainer.
Tiegs teaches the second retainer (Fig. 2 and 7, retainer formed by ref num 14) is defined by a second section (see Fig. 3, section below ref num 16 is the second section, which acts as the second retainer to hold ref num 50). This formation aids with retaining the second connector (Col. 4, lines 12-21, “The electrode stud 14 is sized and configured to make an electrical connection with the lead wires of a monitoring apparatus 50 as shown in FIG. 5. The current industry standard is to utilize a snap fit between an electrode and the lead wires of a monitoring apparatus 50. The illustrated embodiment shows an electrode element 10 adapted to mate with current industry standard lead wires. However, it is contemplated that the particular external configuration of the electrode stud 14 may be altered based on the particular monitoring apparatus 50 it is to be used with”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Meyer to include the second retainer defined by the second section in order to connector the second connector with the electrode pad.
24. Regarding Claim 14, Meyer fails to teach the stud is free of a bulbous shape where an outer cross-sectional dimension of the stud tapers continuously from an upper portion to a lower portion such that the upper portion has a greater cross-sectional dimension than the lower portion.
However, it would have been an obvious matter of design choice to make the different portions of the stud 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.
25. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tiegs.
26. Regarding Claim 16, Tiegs teaches the first retainer comprises a recess (Fig. 3, ref num 16). Tiegs fails to teach the recess is in an outer side surface of the projection. However, Tiegs contemplates that the recess may be formed on the outer side surface (Col. 6, lines 5-7, “with the stud 14 could be formed with an external multi-faceted configuration, rather than an interior bore 16”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tiegs since it has been held that 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.
27. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Tiegs and in view of Yeargers U.S. 2023/0104654 (herein referred to as “Yeargers”).
28. Regarding Claim 20, Meyer teaches an electrode assembly (Figs. 2 and 7) comprising:
a. an electrode pad (Fig. 7, ref num 50) including a patient contact side for engaging skin of a patient (Col. 5, lines 47-49, “A pressure sensitive adhesive coating and an adhesive hydrogel (not shown) may be applied to tissue contacting surface of electrode base 52”) and a connector side (opposite side of the tissue contacting side; Fig. 7, top side) for attaching a snap-type connector to the electrode pad (Fig. 7, ref num 100; Col. 1, lines 31-33, “Various mechanisms for connecting the female terminal to the male terminal are known including "snap on" connections”); and
b. a stud mounted on the connector side of the electrode pad (Fig. 7, ref num 54) for directly engaging the snap-type connector to retain the snap-type connector to the electrode pad (Fig. 9; Col. 6, lines 34-39, “Electrode connector 100 includes terminal aperture 106, hinge aperture 108 and slits 110,112 each of which extend through connector base 102 and connector shoe 104. Terminal aperture 106 defines a generally circular configuration and is adapted to receive male terminal 54 of biomedical electrode 50”), the stud comprising a retainer (Fig. 7, ref num 56) for engaging and retaining the snap-type connector to the stud (Fig. 7, ref num 56 engages and retains ref num 100).
Meyer fails to teach a removal force of at least 2 lbs (8.9 N) being required for detaching the snap-type connector from the electrode assembly.
Yeargers teaches detaching a snap-type connector from an electrode assembly with at least 2 lbs of removal force (para 0042, “pen the connector structure 12 to receive the electrode post may be in the range of 15-45 Newtons (N). The force at 90 degrees to then remove or peel off the connector structure would be in the range of 1-6 Newtons”). This provides a connection that can be easily removed without significant force, providing ease to the user (para 0003-0004). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Meyer to have a removal force of at least 2 lbs in order to provide ease of removing the connection to the user.
Conclusion
29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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