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
Applicant's arguments regarding the rejections under 35 USC 112, filed 04/28/2026, have been fully considered but they are not persuasive. Applicant indicates that the 112(a) rejection is overcome by the amendment. Examiner acknowledges the amendment to claim 22 does overcome the rejection under 112(a), however the amendments to claim 1 and 23 do not overcome the rejection under 112(a) (See 112(a) rejection below).
Applicant did not submit any arguments that point out disagreements with the examiner’s contentions nor does applicant provide any evidence as to where support can be found in the disclosure of the application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-9, 11-15, 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites an embodiment having “at least one strand defining interlocking loops, wherein the at least one strand defining interlocking loops extends around 360 degrees of the implantable device”. Figures 3-5 show one not row from a front view with each strand 110, 112 only labeled once. Nothing shows what is happening to the strand outside of the knot row. Nor is there any indication that the other unlabeled strands are continuations of 110 or 112. Figs. 6A-6C show a top view of the circumference but nothing in this view depicts a strand necessarily extend around 360 degrees. The written disclosure ([0041], [0043] for example) only seems to describe how the interlocking loops are formed and does not describe what happens to the strand beyond that. Thus, there is no written disclosure that describes the strand forming the interlocking loops as extending around the circumference or 360 degrees of the device.
The claim goes on to recites that each interlocking loop includes at least two strands forming the interlocking loop. The disclosure does no support provide support for an embodiment having one strand forming the interlocking loop where the one strand extends around 360 degrees AND the interlocking loops formed with two strands. The disclosure does provides support for interlocking strands formed by two overlapping strands but not for the scope of the claimed invention.
Claim 23 recites “…interlocking loops extending around 360 degrees of the implantable device …” The term “extend”, which means “to cover an amount of space”, indicates that the locking loops together cover the amount of space extends around 360 degrees of the medical device. However, the locking loops are disclosed as being spaced at discreet points around the medical device (Fig. 6a-6c) and do not in fact extend (in a continuous manner) around the device. The specification [0050] and [0051] does provide support for the interlocking loops being spaced or positioned about the circumference but does not provide support for interlocking loops extending around 360 degrees.
Applicant has not pointed out where the amended claim is supported, nor does there appear to be a written description of the claim limitations noted above in the application as filed.
Claims 3-9, 11-15 inherit the deficiencies of claim 1.
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 1, 3-9, 11-15 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 1 recites in line 3 “at least one strand defining interlocking loops” and then recites in line 13 “at least two strands forming the interlocking loops”. It is unclear if the “at least two strands” is further limiting the previous recitation of “at least one strand” or if is introducing additional structure. Claim 1 further recites “one strand of a loop” in line 14 and “a strand of an adjacent loop” in line 15. It is unclear if these limitations are introducing additional strands or if they are be a subset of the previously recited “at least one strand” or “at least two strands”
Claims 3-9, 11-15 inherit the deficiencies of claim 1.
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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Treacy (US 2016/0199207 in view of in view of Yoshimura (U.S. Pub. No. 2009/0326640).
Treacy discloses a delivery system comprising: an implantable medical device (20); a constraining mechanism including an elongate member (Fig. 7) including at least one strand (6, Fig. 3a, 3b 9[0025] suture loops) defining interlocking loops (10, Fig. 4) positioned about 360 degrees of the implantable medical device along a length of the implantable medical device (Fig. 7), the elongate member including a free end defining a deployment line (16, [0029] where the retrieval line assists in deployment by retrieving the suture loops), the constraining mechanism configured to releasably constrain the implantable medical device in a delivery configuration [0027], and a lock line (8) arranged through a portion of the interlocking loops and configured to be withdrawn and released from the constraining mechanism to enable release of the constraining mechanism from the implantable medical device [0027], wherein the lock line is configured to interfere with release of the interlocking loops when the lock line is engaged with the interlocking loops ([0026] lock line secures the suture loops to the stent) and wherein the deployment line is configured to release the implantable medical device when the lock line is disengaged from the constraining mechanism and the deployment line is actuated (16, [0029] where the retrieval line releases the suture loops from the stents).
Treacy does not explicitly teach the lock line comprises an adhesive as claimed.
However, Yoshimura teaches an implantable medical device (2; Fig. 14(b)), a constraining mechanism (3; Fig. 14(b)) configured to releasably contain the implantable medical device (2; see Fig. 5-6), and a lock line (4; Fig. 14(b)) arranged through the constraining mechanism (3) and configured to release the constraining mechanism (3), wherein the lock line (4) comprises an adhesive on an exterior surface of the lock line (pp. [0168]), wherein the adhesive on the lock line is arranged through a portion of openings in the constraining mechanism (pp. [0168], the “wire” is taught as being fixed to the holes formed in the “sheet-shaped member” that the wire runs through.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lock line of Treacy to incorporate the teachings of Yoshimura by providing an adhesive to the exterior of the lock line, where the adhesive is arranged where the lock line connects with the restraining mechanism (i.e., the interlocking loops). Doing so would ensure reliable fixation between the lock line and the constraining mechanism, as taught by Yoshimura (pp. [0168]) which would ensure the implantable medical device is not unintendedly deployed early.
It is further noted, adding an adhesive to the exterior of the lock line of Treacy would increase the friction between the interlocking loops because the force required to move the lock line through the interlocking loops would be greater than it would be without the adhesive.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH HOUSTON whose telephone number is (571)272-7134. The examiner can normally be reached generally M-F 8:00-4:30.
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/ELIZABETH HOUSTON/ Supervisory Patent Examiner, Art Unit 3771
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