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 a certified copy of foreign application PCT/EP2022/065780, however the present application does not properly claim priority to the submitted foreign application. If this copy is being filed to obtain priority to the foreign filing date under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a), applicant must also file a claim for such priority as required by 35 U.S.C. 119(b) or 365(b), and 37 CFR 1.55. If the application was filed before September 16, 2012, the priority claim must be made in either the oath or declaration or in an application data sheet; if the application was filed on or after September 16, 2012, the claim for foreign priority must be presented in an application data sheet.
If the application being examined is an original application filed under 35 U.S.C. 111(a) (other than a design application), the claim for priority must be presented during the pendency of the application, and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior foreign application. See 37 CFR 1.55(d)(1). If the application being examined is a national stage application under 35 U.S.C. 371, the claim for priority must be made within the time limit set forth in the PCT and Regulations under the PCT. See 37 CFR 1.55(d)(2). Any claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) not presented within the time period set forth in 37 CFR 1.55 is considered to have been waived. If a claim for foreign priority is presented after the time period set forth in 37 CFR 1.55, the claim may be accepted if the claim properly identifies the prior foreign application and is accompanied by a grantable petition under 37 CFR 1.55(e) to accept an unintentionally delayed claim for priority and the applicable petition fee under 37 CFR 1.17(m)(1) or (m)(2).
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 4 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 4 recites the limitation "deforming the contact face" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does recite “deforming said sleeve element” and “forming a contact face of the contact element” wherein the “contact element” is formed by the “deforming of the sleeve element”. While there is antecedent basis for “deforming the sleeve to obtain a contact element” which then has a “contact face”, there is no antecedent basis for the additional deformation of the “contact face” as recited in claim 4.
NOTE: For the purposes of prior art, the examiner is considering the limitation to be “as a result of the deforming the sleeve” in accordance with claim 1. Examiner recommends amending claim 4 to recite -- as a result of the deforming the sleeve, the contact face comprises a convex curvature-- or --wherein the contact face comprises a convex curvature--.
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 –
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.
Claims 1-3, 5, 7-8 and 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cross, Jr. et al. (US 20100146783 A1).
As to claim 1, Cross, Jr. et al. discloses a method for fabricating a medical electrode device for implantation into a patient (Figures 2-4; [0038-0040]), the method comprising: providing a sleeve element (crimp sleeve, depicted as 98 in Figures 3-4; [0039]) having an inner lumen (conduit, depicted as 96 in Figure 3; [0039]); inserting an electrical supply line (conductor, depicted as 18 in Figures 3-4; [0039]) into the lumen of the sleeve element ([0039]; Figures 3-4); and deforming said sleeve element to obtain a contact element for the medical electrode device ([0039]; “crimp sleeve 98 is crimped to create a stable electrical attachment”; Therefore, the crimped contact point is considered to be the “contact element”; Figure 4), a portion of the sleeve element forming a contact face of the contact element for electrically contacting tissue ([0039-0040]; “crimp sleeve 98 is also used provide a strong mechanical connection between conductor 18 and electrode 20” [0039]; Since the crimp creates a “contact face” which provides sufficient electrical connection between the conductor and the electrode, the examiner considers “the portion of the sleeve element forming a contact face of the contact element” to be “for electrically contacting tissue” via the electrical connection with the electrode), wherein as a result of deforming the sleeve element a crimp connection between the contact element and the electrical supply line is established ([0039]; “crimp sleeve 98 is crimped to create a stable electrical attachment” and “crimp sleeve 98 is also used provide a strong mechanical connection between conductor 18 and electrode 20”[0039]).
As to claim 2, Cross, Jr. et al. discloses the sleeve element (crimp sleeve, depicted as 98 in Figures 3-4; [0039]), prior to the deforming, comprises a cylindrical shape, the lumen extending through the sleeve element (Figures 3-4; [0039]).
As to claim 3, Cross, Jr. et al. discloses wherein deforming includes: compressing the sleeve element such that the lumen is eliminated ([0039], “crimp sleeve 98 is crimped to create a stable electrical attachment”. “Crimping” is compressing or flattening the sleeve and thus the sleeve lumen. As such, through the compression of the sleeve, the lumen is “eliminated”. This is in accordance with the Applicants specification. See paragraph 21 of US Patent Application Publication 20240371546 A1 of the instant application).
As to claim 5, Cross, Jr. et al. discloses deforming through crimping ([0039]) or compression of the sleeve but does not explicitly disclose that the appearance of the crimp or that crimping causes “a claw portion”. The broadest reasonable interpretation (BRI) of a “claw portion” would be a portion that has tip or point. As such, by crimping or compressing the sleeve a flattened portion would be created. That flattened portion would thus have an edge that is constructed as tip or point disposed on the side of the compressed tube. As such, the examiner considers the edge of the compressed or flattened tube to form “at least one claw portion on the contact element”. And since the electrode(s), with the associated contact element (Figure 4), are embedded within the material of the carrier element (Figure 2), the examiner considers Cross, Jr. et al. to disclose “forming at least one claw portion on the contact element” (by flattening the tube to compress the lumen and create a tip or point on the edge of the tube) for engaging with a carrier element (first paddle portion, depicted as 22 in Figure 2) of the electrode device (via the electrode, depicted as 20 in Figure 4; Figure 2).
As to claim 7, Cross, Jr. et al. discloses inserting the electrical supply line into the lumen of the sleeve element with a portion carrying an electrically insulating cover ([0039]; “At the distal end of conductor 18 a portion of the conductor's coating is removed in preparation for attachment to electrode 20”), wherein as a result of the deforming an electrical connection between the contact element and the electrical supply line is established ([0039]; “Conductor 18 is then inserted approximately halfway through conduit 96 of crimp sleeve 98.” and “Next, crimp sleeve 98 is crimped to create a stable electrical attachment”).
As to claim 8, Cross, Jr. et al. discloses after said deforming, placing said contact element (Figure 4) on a carrier element (paddle portion, depicted as 22 in Figure 2; [0032]; “Electrode 20 sets upon first paddle portion 22” ([0032]), see each individual electrode depicted in Figures 3-4) of the medical electrode device.
As to claim 10, Cross, Jr. et al. discloses that as a result of the placing the contact face of the contact element is flush with a face of the carrier element (Figures 2 and 4; [0014, 0017]).
As to claim 11, Cross, Jr. et al. discloses prior to said deforming, placing the sleeve element on a carrier element of the medical electrode device (Figures 2-4; [0034-0035, 0039]), wherein as a result of the deforming the contact element is fastened to the carrier element (the contact element is formed when the sleeve is crimped. As such, the crimped conductor is now engaged with the electrode and fastened to the carrier element, paddle portion depicted as 22 in Figure 2).
As to claim 12, Cross, Jr. et al. discloses “Crimp sleeve 98 is then laser welded to electrode 20 at arches 110 & 112 located at proximal end 100 and distal end 102 respectively. Therefore, the improved connection between electrode 20 and conductor 18 provides an improved mechanical connection” ([0039]). Therefore, the sleeve is heated via laser welding to mechanically connect to the electrode (Figure 4) and embed the sleeve element within the electrode (Figure 4) that is disposed in the material of the carrier element (first paddle portion, depicted as 22 in Figure 2). Therefore, the examiner considers Cross, Jr. et al. “to embed” the heated “sleeve element in material of the carrier element” (Figures 2 and 4).
As to claim 13, Cross, Jr. et al. discloses said placing includes: placing the sleeve element (Figure 4) in a reception opening of the carrier element (cavity, depicted as 26 in Figure 2), wherein as a result of the deforming the contact element is fastened in the reception opening of the carrier element (the electrodes, depicted in Figures 3-4, reside within the cavity, depicted as 26 in Figure 2. As such, the sleeve element is fastened in a reception opening of the carrier element).
As to claim 14, Cross, Jr. et al. discloses the electrode(s) (depicted as 20 in Figures 1-4) are embedded in the cavity of the first paddle portion (Figure 2; [0034]), the examiner considers the contact face, formed from the crimping of the sleeve (Figure 4; [0039]), to be “flush with a face of the carrier element” (paddle portion, depicted as 22 in Figure 2) as depicted in Figures 1-4. Therefore, , Jr. et al. discloses “as a result of the deforming, the contact face of the contact element is flush with a face of the carrier element” (Figures 1-4).
As to claim 15, Cross, Jr. et al. discloses a medical electrode device for implantation into a patient (Figures 1 and 5, [0002]), comprising: a lead body (depicted as 12 in Figures 1 and 5) extending longitudinally along a longitudinal axis (Figures 1 and 5); and a flattened electrode end arranged at a distal end of the electrode body (paddle, depicted as 16 in Figures 1 and 5) and comprising a carrier element (first paddle portion, depicted as 22 in Figures 2 and 2a) and a multiplicity of contact elements ([0039]; “crimp sleeve 98 is crimped to create a stable electrical attachment” and “crimp sleeve 98 is also used provide a strong mechanical connection between conductor 18 and electrode 20”[0039]; Therefore the crimped contact point is considered to be the “contact element”. And since there is a plurality of electrodes, depicted as 20 in Figures 1, 2 and 2a, with each having the associated contact elements (Figure 3), there is thus a plurality or multiplicity of associated contact elements) arranged on the carrier element (Figure 1, 2 and 2a), wherein at least one of the contact elements ([0039]; “crimp sleeve 98 is crimped to create a stable electrical attachment”; Therefore the crimped contact point is considered to be the “contact element”; Figure 4) is formed by crimping from a sleeve element ([0039]), an electrical supply line (conductor, depicted as 18 in Figures 3-4; [0039]) being inserted into the sleeve element (crimp sleeve, depicted as 98 in Figures 3-4; [0039]) and being connected to the contact element by a crimp connection formed by the sleeve element ([0039]; “crimp sleeve 98 is crimped to create a stable electrical attachment” and “crimp sleeve 98 is also used provide a strong mechanical connection between conductor 18 and electrode 20”[0039]), wherein a portion of the sleeve element forms a contact face of the contact element for electrically contacting tissue ([0039-0040]; “crimp sleeve 98 is also used provide a strong mechanical connection between conductor 18 and electrode 20” [0039]; Since the crimp creates a “contact face” which provides sufficient electrical connection between the conductor and the electrode, the examiner considers “the portion of the sleeve element forming a contact face of the contact element” to be “for electrically contacting tissue” via the electrical connection with the electrode).
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 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Cross, Jr. et al. (US 20100146783 A1).
As to claim 4, as best understood in light of the rejection under 35 U.S.C. 112 above, Cross, Jr. et al. discloses crimping the sleeve to create a contact element (“crimp sleeve 98 is crimped to create a stable electrical attachment” and “crimp sleeve 98 is also used provide a strong mechanical connection between conductor 18 and electrode 20”[0039]; Therefore the crimped contact point is considered to be the “contact element”). Cross, Jr. et al. discloses the invention substantially as claimed but does not explicitly disclose the deformation, or crimping of the tube, creates a “convex curvature”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the crimping of Cross, Jr. et al. to enable a crimping that forms a curvature, particularly a convex curvature that would arc towards the internal recess portion of the electrode (depicted as 20 in Figure 4), in order to provide the predictable results of enabling a uniform construction of the paddle portion with electrodes that positioned flush and make sufficient contact with the first paddle portion (Figure 2).
As to claim 9, Cross, Jr. et al. discloses crimping the sleeve to create a contact element (“crimp sleeve 98 is crimped to create a stable electrical attachment” and “crimp sleeve 98 is also used provide a strong mechanical connection between conductor 18 and electrode 20”[0039]; Therefore the crimped contact point is considered to be the “contact element”) and laser welding (heating) the crimping sleeve to the electrode ([0039]) but does not explicitly disclose “heating the contact element to embed the contact element in material of the carrier element”. Thus Cross, Jr. et al. discloses heating the crimp sleeve ([0039]) and embedding the electrode(s), with the associated contact element (Figure 4), within the material of the carrier element (Figure 2), but does not explicitly disclose by “heating the contact element” to facilitate embedding “the contact element in material of the carrier element”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the crimping means of Cross, Jr. et al. to include crimping by heating since heat crimping is extremely well known in machinery and mechanical and thermal deformation of metal are extremely well known in machinery. As such a modification of the means of manufacturing of the crimped component, from mechanically to thermally, would provide the predictable results of creating an effective product through alternative well-known manufacturing processes to optimize assembly and manufacture. Therefore, the modified Cross, Jr. et al. would have a contact element, created by thermal crimping (“heating the contact element”), which is then “embedded” in “the material of the carrier element” (Figure 2) via the associated electrode (Figure 4). Therefore, the modified Cross, Jr. et al. discloses “heating the contact element” to “embed the contact element” (via the electrode, Figure 4) “in material of the carrier element” (Figure 2).
Claim 6 is are rejected under 35 U.S.C. 103 as being unpatentable over Cross, Jr. et al. (US 20100146783 A1) in view of May (US 3,980,806).
Cross, Jr. et al. discloses the invention substantially as claimed with deforming the sleeve through crimping nut does not explicitly disclose “forming at least one depression groove on the contact element for interacting with the electrical supply line”. May discloses in col. 10, lines 15-27, “As illustrated in FIGS. 9 and 11, the crimping indentations 58 formed in the sleeve 10 have a spherical configuration with a radius of curvature equal to that of the ball bearings 70. The spherical crimping indentations 58 substantially and uniformly reduce the stress concentrations applied to the conductor at the crimp location. As compared to square crimping indentations having sharp corners with high stress concentrations, the spherical indentations 58 eliminate sharp crimp corners”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the crimping of Cross, Jr. et al. to include “forming at least one depression groove on the contact element for interacting with the electrical supply line” as disclosed by May (Figures 9 and 11) in order to provide the predictable results of reducing “high stress concentrations” at the crimping locations (May, col. 10, lines 15-27) to optimize construction and reduce friction and failure of the conductor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796