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 because in paragraph 0051 element 520 is labeled a tooth whereas it is labeled as housing in paragraphs 0055-56 and element 803 is not within the drawings. 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.
Specification
The disclosure is objected to because of the following informalities: the cross-reference data needs to be updated to reflect the status of each copending application, please insert patent numbers when appropriate.
Appropriate correction is required.
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.
Claims 2-7, 9, 11-14, 16-18 and 21-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Anderson et al. US 2012/0172690 in the IDS.
Regarding claim 2: Anderson discloses a fixation component 118 (“fixation element assembly”, figures 3B, 4B) for an IMD 16A (figures 1, 3A/3B, the fixation component comprising:
a base portion 111 (figure 4B, paragraph 0053); and
a plurality of tines 103 (figure 4B) that are elastically deformable between a pre-set position and an open position (paragraph 0064), wherein prior to defining the preset position (considered to be the position within catheter 200, figure 5A) of the plurality of tines, each tine of the plurality of tines comprises:
a hook segment (figure 7B and 8B) extending from a proximal end near the base portion, and
a distal segment 106 (figures 7B and 8B) extending from the hook segment to a distal end,
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[AltContent: textbox (Figure 1: Anderson figures 7A/7B and 8A/8B/8C/8D.)]wherein the hook segment defines a first width at or around the proximal end of the hook segment, wherein the tine defines a second width between the proximal end of the hook segment and the distal end of the distal segment, and wherein the distal end of the distal segment defines a third width,
wherein the second width is less the third width (in figure 8B the third width is greater than the second and first width, which is also the second width less than the third width).
Regarding claim 3: Anderson discloses that each tine has an asymmetrical taper (figure 8B).
Regarding claim 4: Anderson disclose the distal segment and a tissue piercing tip (paragraphs 0052, 0062, 0064, 0071-73 and 0080).
Regarding claims 5-6: Anderson discloses that the tines are made of Nitinol (paragraph 0053) which is a known shape memory alloy.
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Regarding claim 7: Anderson discloses that the tines have a uniform thickness (paragraph 0087 “generally consistent thickness”).
Regarding claim 9: Anderson discloses that a first centerline defining the second width is aligned with a second centerline defining the third width (figure 8B).
Regarding claim 11: Anderson discloses a medical device system 180 (figure 5A) comprising:
an implantable medical device 16A (figure 5A) comprising a hermetically sealed housing (paragraph 0049, the housing is implanted and protects the battery and electronics and is inherently hermetically sealed) and a fixation component 118 (“fixation element assembly”, figures 3B, 4B) attached to IMD 16A (figures 1, 3A/3B, the fixation component comprising:
a plurality of tines 103 (figure 4B) that are elastically deformable between a pre-set position and an open position (paragraph 0064), wherein prior to defining the preset position (considered to be the position within catheter 200, figure 5A) of the plurality of tines, each tine of the plurality of tines comprises:
a hook segment (figure 7B and 8B) extending from a proximal end near the base portion, and
a distal segment 106 (figures 7B and 8B) extending from the hook segment to a distal end,
wherein the hook segment defines a first width at or around the proximal end of the hook segment, wherein the tine defines a second width between the proximal end of the hook segment and the distal end of the distal segment, and wherein the distal end of the distal segment defines a third width,
wherein the second width is less the third width (in figure 8B the third width is greater than the second and first width, which is also the second width less than the third width).
Regarding claim 12: Anderson discloses that each tine has an asymmetrical taper (figure 8B).
Regarding claim 13: Anderson disclose the distal segment and a tissue piercing tip (paragraphs 0052, 0062, 0064, 0071-73 and 0080).
Regarding claim 14: Anderson discloses that the tines have a uniform thickness (paragraph 0087 “generally consistent thickness”).
Regarding claim 16: Anderson discloses that a first centerline defining the second width is aligned with a second centerline defining the third width (figure 8B
Regarding claim 17: Anderson discloses a medical device system 180 (figure 5A) comprising:
a delivery catheter 200 (figure 5A) extending from a proximal end to a distal end 202 (figure 5A) and containing an IMD (figure 5A)
an implantable medical device 16A (figure 5A) comprising a hermetically sealed housing (paragraph 0049, the housing is implanted and protects the battery and electronics and is inherently hermetically sealed) and a fixation component 118 (“fixation element assembly”, figures 3B, 4B) attached to IMD 16A (figures 1, 3A/3B, the fixation component comprising:
a plurality of tines 103 (figure 4B) that are elastically deformable between a pre-set position and an open position (paragraph 0064), wherein prior to defining the preset position (considered to be the position within catheter 200, figure 5A) of the plurality of tines, each tine of the plurality of tines comprises:
a hook segment (figure 7B and 8B) extending from a proximal end near the base portion, and
a distal segment 106 (figures 7B and 8B) extending from the hook segment to a distal end,
wherein the hook segment defines a first width at or around the proximal end of the hook segment, wherein the tine defines a second width between the proximal end of the hook segment and the distal end of the distal segment, and wherein the distal end of the distal segment defines a third width,
wherein the second width is less the third width (in figure 8B the third width is greater than the second and first width, which is also the second width less than the third width).
Regarding claim 18: Anderson discloses that each tine has an asymmetrical taper (figure 8B).
Regarding claim 20: Anderson discloses that a first centerline defining the second width is aligned with a second centerline defining the third width (figure 8B).
Regarding claim 21: Anderson discloses that the tines have a uniform thickness (paragraph 0087 “generally consistent thickness”).
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.
Claims 8, 10, 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. US 2012/0172690 in the IDS in view of Peterfeso et al. US 6,240,322.
Regarding claim 10: Anderson discloses the claimed invention however Anderson does not disclose that the third width is less than the first width. Peterfeso however teaches of a plurality of tines 115 (figure 2A) which has the tine attached to the body using ring 120, the first width is considered to be this attachment area of the ring 120 which is larger than the distal end 118, and the second diameter 116 is also less than the third diameter (figure 2A). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Anderson to include that the third width is less than the first width as taught by Peterfeso, in order to allow for collapsibility during implantation (column 4, lines 35-55).
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[AltContent: textbox (Figure 2: Peterfeso figure 2A.)]Regarding claims 8, 15 and 19: Anderson discloses the claimed invention however Anderson does not disclose a first centerline defining the second width is offset from a second centerline defining the third width. Peterfeso however teaches of a tine with disclose a first centerline defining the second width is offset from a second centerline defining the third width. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Anderson to include a first centerline defining the second width is offset from a second centerline defining the third width, as taught by Peterfeso, in order to allow for collapsibility during implantation (column 4, lines 35-55).
Double Patenting
The claims were reviewed and compared against the copending applications. It was determined that none of the previously filed cases include that the second width is less than the first width. Therefore no double patenting rejection have been made because this case has some more narrow claim language.
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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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
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