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 Amendment
This office action is in response to the amendment filed September 19, 2025. Claims 1, 22, and 23 are amended. Claims 2, 10 and 16-21 are canceled. Claims 1, 3-9, 11-15, and 22-23 are pending and addressed below.
Response to Arguments
Applicant’s amendments to the claims have overcome each and every claim objection set forth in the Non-Final Office Action dated July 10, 2025.
Applicant's arguments filed September 19, 2025 have been fully considered and are persuasive with respect to claim 1 regarding King and Blaeser in that neither reference teaches the amended claim language of the interlocking loops extending around an entirety of a circumference of the implantable medical device.
Applicant’s arguments with respect to claims 22 and 23 regarding Blaeser (U.S. Pat. No. 6514281) have been fully considered but they are not persuasive.
With respect to claim 22, Applicant argues Blaeser does not disclose the newly amended claim language of “an elongate member defining interlocking loops,” “the elongate member including a free end defining a deployment line,” and “wherein the lock line is configured to interfere with release of the interlocking loops when the engaged 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.” Examiner respectfully disagrees. The “sheath” 22 of Blaeser can be considered an elongate member and it defines the interlocking loops (“rings” 34) because the rings can be embedded in the sheath (Col. 3, lines 24-25), thus the rings would be defined within the sheath. Further, the lock line (44) of Blaeser interferes with release of the interlocking loops as the interlocking loops cannot be released until the lock line is removed (Col. 5, lines 48-58), and the deployment line (43) is configured to release the implant because the deployment line is used to remove the sheath from the implant after the lock line has been removed (Col. 5, lines 48-58). Therefore, the argument is unpersuasive.
With respect to claim 23, the same claim language added to claim 22 has also been added to claim 23, and as discussed above, is taught by Blaeser.
Claim Objections
Claims 22 and 23 are objected to because of the following informalities:
Claims 22 and 23, lines 13-14 recite “the lock line is configured to interfere with release of the interlocking loops when the engaged.” This is an incomplete thought. Examiner suggests claims 22 and 23 recite “the lock line is configured to interfere with release of the interlocking loops when the lock line is engaged with the interlocking loops.”
Claim 23 recites “a deployment line” in line 6 and again in line 7. Examiner suggests the second recitation recite “the deployment line” for consistency with the claim.
Appropriate correction is required.
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, and 11-15 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 “a constraining mechanism including interlocking loops extending around an entirety of a circumference of the implantable medical device,” in lines 3-4. There is no explicit, implicit, or inherent support that the interlocking loops extend around an entirety of a circumference of the implantable medical device and wherein one strand of a loop overlaps with a strand of an adjacent loop to form the interlocking loop anywhere in the Specification or Drawings. That is to say, it is understood that it is the point of overlap of the two strands that form the interlocking loop not the strands themselves. The Specification defines an interlocking loop as when a loop of one strand overlaps with a loop of another strand (para. [0007] of Applicant’s Specification). The Specification further discloses the interlocking strands are interwoven to form a knot and the knot is formed of interlocking loops. The interlocking can extend along the longitudinal length of the device to form a knot row (para. [00043]) and that multiple knot rows can be spaced around a circumference of the implantable device (para. [0008] & [00051]). These knot rows are disclosed as distinct points spaced around the circumference, as seen in Figs. 6A-6C, and not located around an entirety of the circumference (i.e., they are not located at every possible point around the circumference). Further, Figs. 6A-6C and 7B of the Drawings are the only display of where the interlocking loops shown in Figs. 3-5 lie along the device and also support the interlocking loops being located at a few location around the circumference as opposed to an entirety of the circumference.
It is noted, it seems Applicant has support to more broadly claim that the interlocking loops extend around a circumference of the implantable medical device without reciting “an entirety.”
Claims 3-9 and 11-15 are rejected based upon their dependency from 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.
Claims 1, 3-9, and 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 “a constraining mechanism including interlocking loops extending around an entirety of a circumference of the implantable medical device,” in lines 3-4. It is unclear if Applicant intends to broadly recite that the constraining mechanism, which appears to include the interlocking loops and a deployment line, extends around an entirety of a circumference of the implantable medical device or narrowly recite that just the interlocking loops extend around an entirety of a circumference of the implantable medical device
Claims 3-9 and 11-15 are rejected based upon their dependency from claim 1.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blaeser, et. al. (U.S. Pat. No. 6514281) hereinafter, “Blaeser,” in view of Yoshimura (U.S. Pub. No. 2009/0326640).
Regarding claim 22, Blaeser teaches a delivery system comprising:
an implantable medical device (74; Fig. 4);
a constraining mechanism (22 and 34; Fig. 4) including an elongate member (“sheath” 22; Fig. 4) defining interlocking loops (34; Fig. 4, it is noted, the “rings” 34 are taught as being embedded in sheath 22, Col. 3, lines 24-25) positioned about a circumference of the implantable medical device (It is noted, “about” is given its BRI to mean “close” or “near.” See, e.g., Fig. 3B showing the proximity between the interlocking loops and implantable medical device 40/42.) along a length of the implantable medical device (see multiple elements 34 in Fig. 4 extending a length), the elongate member (34) including a free end (see annotated Fig. 4 below) defining a deployment line (43; Fig. 4), the constraining mechanism (22, 34) configured to releasably constrain the implantable medical device (20) in a delivery configuration (Fig. 4), and
a lock line (44; Fig. 4) arranged through a portion of the interlocking loops (34) and configured to be withdrawn to enable release of the constraining mechanism (Col. 5, lines 37-58) to enable release of the constraining mechanism (22, 34) from the implantable medical device (74, Col. 5, lines 52-58), wherein the lock line (44) is configured to interfere with release of the interlocking loops (34)(Col. 5, lines 48-58) when the engaged and wherein the deployment line (43) is configured to release the implantable medical device (74) when the lock line (44) is disengaged from the constraining mechanism (22, 24) and the deployment line (43) is actuated (Col. 5, lines 48-58).
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However, Blaeser does not explicitly teach the lock line comprises an adhesive as claimed.
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 Blaeser 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 Eller 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.
Regarding claim 23, Blaeser teaches a delivery system comprising:
an implantable medical device (74; Fig. 4);
a constraining mechanism (22 and 34; Fig. 4) including at least one strand defining interlocking loops (34; Fig. 4) configured to releasably constrain the implantable medical device (20) in a delivery configuration (Fig. 4) and further defining a deployment line (43; Fig. 4) operable to cause release of the interlocking loops (34) when a force is applied thereto (Col. 5, lines 52-58), and configured to release the implantable medical device (74) to a deployed configuration when a deployment line (43; Fig. 4) of the constraining mechanism (22, 34) is actuated (Col. 4, lines 33-36), and
a lock line (44; Fig. 4) arranged through a portion of the interlocking loops (34) and configured to be withdrawn to enable release of the constraining mechanism (Col. 5, lines 37-58), wherein the lock line (44) is configured to interfere with release of the interlocking loops (34)(Col. 5, lines 48-58) when the engaged and wherein the deployment line (43) is configured to release the implantable medical device (74) when the lock line (44) is disengaged from the constraining mechanism (22, 24) and the deployment line (43) is actuated (Col. 5, lines 48-58).
However, Blaeser does not explicitly teach the lock line comprises an adhesive as claimed.
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 Blaeser 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 Eller 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Faber (US 20160184118 A1) teaches a constraining mechanism in Figs. 6-9 similar to that taught in King (previously cited) but also teaches the loops (182; Fig. 7) forming interlocking loops can extend around the entire device (para. [0047]).
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 DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL ICET/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771