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 Arguments
In view of the claim amendments, lack of clarity issues have resulted in a 112(b) Rejection set forth below.
In view of the amendments, the 103 Rejection is withdrawn.
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 1-5, 8, 10-14, 17, 19-22 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.
Claims 1 and 20 both recite “the attachment region” but the claims recite “an attachment clip” prior to the recitation of “the attachment region”. Therefore, “the attachment region” does not have proper antecedent basis. Claim 13 recites “engage an attachment clip disposed along an attachment region of a pullback assembly”. Therefore, it is suggested claim 1 and 20 be modified accordingly to differentiate between the attachment clip and attachment region and have proper antecedent basis.
Claims 1, 13, and 20 are amended are where the “pullback assembly includes an arcuate lower region disposed distally of the attachment region that is complimentary in shape to the non-circular cross-sectional shape of the grip region”. The claim language “region disposed distally of the attachment region” is unclear and is considered indefinite as it’s not clear where the pullback assembly is disposed distally of the attachment region and has this arcuate shape. Figure 6 and the claims also refer to the “attachment clip” of the “attachment region” and therefore it is additionally not clear if the arcuate region of the pullback assembly is disposed distal to specifically the “attachment clip”.
Upon further review of the specification, “FIG. 7 depicts the arcuate lower region 176 disposed along the pullback sled 172 (e.g., where the pullback sled 172 is shown in phantom line). It can be appreciated that the arcuate lower region 176 may have a shape that is complementary to that of the pullback sled 172 (e.g., which may have a curved or arcuate shape). This may help to reduce rotation of the telescope hub 142 relative to the pullback assembly 168. In some instances, the shape/profile of the telescope hub 142 may be described as being “form fit” or having a form fit with the pullback sled 172 (e.g., the attachment region 166)” [0055]. Claims additionally do not recite the components of the pullback assembly to include the pullback sled 172 and the motor drive unit 170 where the attachment clip 172 is attached along various locations of the pullback sled [specification, 0053].
Therefore, as stated in the above paragraph and as per figure 8, the arcuate lower grip region 176 is disposed long the pullback sled 172 which may have a curved or arcuate shape and where the arcuate shape of the telescope hub 142 is described as being “form fit with the pullback sled 172” (attachment region 166). It is suggested that claims 1, 13, and 20 clarify the components of the pullback assembly to include the pullback sled/motor where the attachment clip can be disposed along locations of the pullback sled and include language with respect to the arcuate shape of the pullback sled that results in the “form fit” configuration with the shape/profile of the telescope hub/grip region 176.
Claim 13 recites the “telescope hub” but does not specify the connection between the “telescope hub” of the catheter shaft and the “pullback assembly”. Claims 1 and 20 recite the coupling or securing the telescope hub or imaging device to a pullback assembly. It is suggested claim 13 recite this “connection” component between the catheter shaft or telescope hub and the pullback assembly.
The dependent claims do not provide further clarity and therefore stand rejected under 112(b).
Other Relevant Prior Art:
Marshall et al. (2017/0164925):
Directed to an intravascular imaging catheter with telescoping pullback section with distal grip 128 coupling one of the telescopes to the distal sheath of the distal section and a proximal grip coupled to the other of the telescopes [0051, 0052]. But does not teach of the claimed combination of the elements/components of the imaging device with the configuration of the grip region/pullback assembly. The prior art does not teach of “an intravascular imaging device, comprising: a catheter shaft including a proximal region, an imaging window region, and a distal end region having a guidewire lumen formed therein; wherein the catheter shaft includes a telescoping assembly having a telescope hub configured to be secured to a pullback assembly; wherein the telescope hub includes a proximal flange, a loading region disposed distal of the proximal flange, and a grip region disposed distal of the loading region; wherein the loading region is configured to engage an attachment clip disposed along a loading region of the pullback assembly; wherein the grip region has a non-circular cross-sectional shape; wherein the pullback assembly includes an arcuate lower region disposed distally of the attachment region that is complimentary in shape to the non-circular cross-sectional shape of the grip region; and an imaging core disposed within the catheter shaft”.
Conclusion
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.
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BR
/BAISAKHI ROY/ Primary Examiner, Art Unit 3797
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