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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the connecting sleeve located distally of a distal end of the second element (claim 5), must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 5 and 14 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.
Claim 5 recites that the connecting sleeve, element 8 in applicants figure 1, is located distal of a distal end of the second element. Distal and proximal are not labeled in applicants figure. It is known in the art that the distal end is towards the implantable electrode and proximal is towards the portion of the lead that contacts the pacing and/or implanted device. The only drawing in applicants disclosure is figure 1. The conductive sleeve 8 is located proximally to the second element 4. Therefore this language is considered to be indefinite. It is noted that the drawings are objected to for the same issue.
Claim 14 recites that the implantable cardiac electrode is not further processed for additional cleaning of the housing. This language is indefinite in that it is unclear if this is a method step due to the negative limitation in the claim language. Further, any additional “cleaning” of the device could certainly be performed during a sterilization procedure and is not considered to be an additional step of manufacturing.
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.
Claims 1, 3-4, 6-11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Felling et al. US 22010/0305672 herein Felling in view of Foster et al. US 2011/0009939 herein Foster and further in view of Valentine et al. US 2012/0203317 herein Valentine.
Regarding claims 1, 3, 7-11 and 14: Felling discloses and implantable cardiac lead 14 (figures 1-2) which includes a distal helical electrode 24 (figures 1-2 and “the fixation helix 24 is electrically active”, paragraph 0021) the distal helical electrode is considered to be a fixation screw, the distalmost point on the helical electrode 24 is considered to be an electrode tip and is secured to the tissue (paragraph 0021); the helical electrode is within housing 56 (figures 3A and 3B). Feeling further discloses a first element considered to be the tubular housing 56 (figures 3A/3B) which is a sleeve-like shape and defines the interior region of the lead which houses the helical electrode, and a second element considered to the guide 64 (figures 3A/3B). In the Felling disclosure the guide can be a separate component (paragraph 0028 “the guide element 64 is formed as a separate element that is subsequently attached or otherwise secured to the housing 56.”). Felling however is unclear about how the guide is operably attached to the housing and therefore does not specifically disclose that the second element/ guide is inserted into the receiving space so that the first element/housing overlaps the second element/guide and that the housing and guide are bonded together [AltContent: textbox (Figure 1: Felling figure 3B and Foster Figure 3B.)]in the overlapping area.
Foster however teaches of an implantable lead with a fixation helix (abstract) which includes housing 50 (figures 3B and 4) and a fixation ring 78 (figures 3B and 4) which fixes the distal seal 70 (figures 3B and 4) to the housing 50 (figures 3B and 4). The distal seal 70 (figure 3B) of Foster guides the helix 24 (figure 3B) via aperture 80 (figure 3B) in the same way as the guide/opening 82 (Felling 3A) of Feeling. The fixation ring is constructed of PEEK and the housing is also constructed of PEEK (paragraphs 0060 and 0043 respectively) which is a well-known thermoplastic i. The fixation ring is adhered to the housing via melting (paragraph 0060), adhesives and ultrasonic welding are also contemplated. In this design the PEEK fixation ring 78 (figure 4) is fixed to the housing 50 (figure 4) as well as the distal seal 70 (figure 4).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify how the Felling’s guide 64 (Felling figure 3A) is attached to the distal end of the lead by modifying the distal end of Felling to include a PEEK fixation ring which operably fixes the distal seal to the distal end of the lead, as taught by Foster, in order to attach the distal guide to the lead body using the same material PEEK, as taught by Foster in order to operably attach the guide to the lead body. Stated another way, the teachings of Foster demonstrate that the guide can be inserted in the lead body to create overlapping sections between the guide and the body and the lead body is operably attached to the guide via methods such as ultrasound welding.
In the combined rejection above the materials for the guide and the lead body are considered to be PEEK as discussed in both prior art refences. Therefore, Foster in view of Felling (herein Foster/Feeling) does not specifically disclose wherein the first element comprises at least in the overlapping area a first material being transparent for light having a first wavelength, and wherein the second element comprises at least in the overlapping area a second material that is absorbing for light having the first wavelength”. This language is considered to be specific to the housing/ sleeve, as seen in applicants figure 1 consisting of transparent PEEK and the second element consisting of black PEEK.
Valentine however teaches of an enclosure for an active implant (abstract) using direct through-transmission laser welding of PEEK to PEEK filled with carbon black, which is considered to be black PEEK (paragraph 0138). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Foster/Felling to include direct through-transmission laser welding of PEEK to PEEK filled with carbon black as taught by Valentine, in order to create a hermetic weld.
Regarding claim 4: Felling discloses a central bore 66/68 (figure 3A) which attaches to the helical electrode 24 (figure 38) to operably move the helical electrode into and out of the lead body.
Regarding claim 6: Felling disclose a protrusion 84 (“engaging surface”, figure 3B) which is on a part of housing 56 which protrudes from the wall and controls axial movement along a longitudinal direction while allowing for radial movement (paragraph 0032).
Claims 2 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Felling et al. US 22010/0305672 herein Felling in view of Foster et al. US 2011/0009939 herein Foster and further in view of Valentine et al. US 2012/0203317 herein Valentine and further in view of McKenzie et al. US 2011/0270356 herein McKenzie.
Regarding claim 2: Feeling/Foster/Valentine discloses the claimed invention however Feeling/Foster/Valentine does not disclose a wavelength for the laser welding to be between 600 -1000 nm. McKenzie however teaches of a polymer encapsulation for a medical device (abstract and title) which includes laser welding using wavelengths of 800 -2500 nm (paragraph 0104). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Felling/Foster/Valentine to include laser welding using wavelengths of 800 -2500 nm as taught by McKenzie in order to join the two polymers hermetically (McKenzie, paragraph 0103 and 0111).
Regarding claim 13: Feeling/Foster/Valentine discloses the claimed invention however Feeling/Foster/Valentine does not disclose laser scan welding with an exposition time lying between 10-20 seconds. McKenzie however teaches of using laser scan welding (paragraph 0142). In this disclosure it is taught that weld strength is increased with rising laser intensity in conjunction with lower speeds (paragraph 0142) McKenzie further teaches that the strongest bonds were created using 4 mm/sec and 8 mm/second speeds. It would have been obvious to one of ordinary skill in the art to modify Feeling/Foster/Valentine to include laser scan welding as well as to adjust the speed and laser intensity to create the bonds needed.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Felling et al. US 22010/0305672 herein Felling in view of Foster et al. US 2011/0009939 herein Foster and further in view of Valentine et al. US 2012/0203317 herein Valentine and further in view of Salys et al. US 7,092,766 herein Salys.
Regarding claim 5: Felling/Foster/Valentine discloses the claimed invention however Felling/Foster/Valentine does not disclose a connecting sleeve arranged around the electrode lead which creates an electrically conductive connection between the electrode lead and the fixation element. Salys however teaches of a conductive sleeve 82 (figure 4) which connects the helical shaft 80 for electrical continuity (figure 4). It therefore would have been obvious to one or ordinary skill in the art at the time the invention was filed to modify Felling/Foster/Valentine to include a conductive sleeve around the helical shaft, as taught by Salys, in order to create electrical continuity.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Felling et al. US 22010/0305672 herein Felling in view of Foster et al. US 2011/0009939 herein Foster and further in view of Valentine et al. US 2012/0203317 herein Valentine and further in view of Arai et al. US 2013/0192751 herein Arai.
Regarding claim 12: Felling/Foster/Valentine discloses the claimed invention however Felling/Foster/Valentine does not specifically disclose the use of laser spot welding. Arai discloses laser bonding or welding using spot welding (paragraph 0035), the materials for this procedure include PEEK (paragraph 0033). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Felling/Foster/Valentine to include laser spot welding of PEEK, as taught by Arai, in order to bond thermoplastics (paragraph 0033).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
i https://www.gtweed.com/materials/peek-vs-pek-vs-ptfe/