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 responsive to the amendment filed on 07/24/2026. As directed by the amendment: claims 1, 3, and 5 have been amended and claims 4, 7-8, and 13-15 have been cancelled. Thus, claims 1-3, 5-6, and 9-12 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 7, filed 07/24/2026, with respect to drawing objections have been fully considered and are persuasive. The applicant’s cancellation of claims with claimed subject matter not shown in the figures overcomes the drawing objection. The drawing objections have been withdrawn.
Applicant's arguments, see pages 7-8, filed 07/24/2026, with respect to the USC 112(b) rejections have been fully considered but they are not persuasive. The applicant has cancelled claims 13-15 which overcome the 112(b) rejections of claims 13-15. The applicant asserts that the terms proximal and distal as used by the applicant in claim 5 is by its definition as known by one of ordinary skill in the art, specifically “proximal” means “a position or end that is closer to the user than that of the distal portion or end” and “distal” means “away from the physician”. They state that Fig. 2 and [0127] of their patent application publication shows that the tether hypotube portion 33 is more proximal than the bare mandrel portion 31, e.g. more to the left side of the drawing. The examiner respectfully disagrees.
By applicant’s own definition in page 7 of the arguments, the left side of the drawing in Fig. 2 is not proximal. That is away from the handle and towards the implant, hence away from the physician, and hence distal. As such the tether hypotube portion 33 is more distal (NOT proximal) than the bare mandrel portion.
As such the rejection of claim 5 will be maintained.
Applicant's arguments, see pages 8-14, filed 07/24/2026, with respective to the rejections of claim 1 and 4 under 35 U.S.C. 102(a)(1) as being anticipated by Soltis et al (US 20170143980 A1), herein referenced to as “Soltis” have been fully considered but they are not persuasive.
The applicant has amended claim 1 to incorporate the limitations of now cancelled claim 4. The applicant argues that Soltis does not teach the limitations of claim 4 incorporated into claim 1. Specifically, they argue that the examiner’s mapping of Soltis is a mischaracterization of Soltis. They argue that Soltis is not configured as prescribed by claim 1 and that Soltis does not have through-holes with differentiated cross-sections.
The examiner respectfully disagrees.
As indicated, elements 130 discloses a slider housing, as 131, is a sliding element, hence a sliding body (as it can slide up (proximally) Fig. 10A and down (distally) Fig. 10B) embedded within the housing 130. Additionally, the elements as annotated (see annotated Fig. 8 below) are through-holes as they are openings that go through the respective elements. Hence the structural limitations are met, and the functional limitations are as well, as the mandrel extends through the first section and the second sections of the through-hole of the slider body in the different configurations. The limitation does not require any exclusionary limitation in which the mandrel cannot extend through one section while in the other. As such Soltis discloses the limitations of claim 1 + 4.
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As such the rejection of claims will be maintained.
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.
Claim 5 is 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “further proximal” in claim 5 is used by the claim to mean “situated away from the point of attachment or origin,” (which is towards the medical implant) while the accepted meaning is “next to or nearest the point of attachment or origin” (which is away from the medical implant towards the control handle” The term is indefinite because the specification does not clearly redefine the term.
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.
Claim(s) 1-3, 5-6, and 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soltis et al (US 20170143980 A1), herein referenced to as “Soltis”.
Claim 1
Soltis discloses: A control handle 120 (see Fig. 4, [0065]) for controlling functions of a delivery system 100 (see Fig. 4, [0065]) for implanting a medical device 10 (see Figs. 1-4, [0065]), wherein the delivery system 100 comprises: - an elongate delivery catheter 102 (see Fig. 4, [0065]), and - a mandrel 116 + 110 + 112 (see Figs. 4 and 8, [0065]) being displaceable longitudinally (see [0065]-[0066], longitudinally slidably disposed within 102) relative to the delivery catheter 102; wherein the control handle 120 comprises: - a slider mechanism 132 + 134 (see Figs. 1-11A, [0066]), and - a handle housing 126 + 128 (see Figs. 4 and 8, [0066]); wherein the slider mechanism 132 + 134 is configured for being displaceable in a longitudinal direction (see Figs. 10A-11A, 132 + 134 are displaceable in longitudinal directions relative to the housing 126 + 128) relative to the handle housing 126 + 128 between a fully undeployed position (see Fig. 10A, [0097]) and a fully deployed position (see Fig. 10B, [0101]) such as to thereby displacing the mandrel 116 (see Fig. 9-10E, [0101], 116 is fixed within 130, and thus distally pushes 116 which in turn pushes 118 + 112, see also [0089]) relative to the delivery catheter by a deployment distance the distance of 179 (see Figs. 9-10E, [0094]); wherein the slider mechanism 132 + 134 is further configured such that, in the fully undeployed position (see Fig. 10A), the mandrel 116 is fixed relative to the slider mechanism 134 such that the mandrel 116 is not displaceable relative to the slider mechanism 132 beyond a predetermined stop position the position at 180 (see Figs. 9 and 10B, [0094]) due to a mechanical mandrel motion blockage 180 (see Fig. 9, [0094], 180 prevents 134 and hence 116 from proceeding further distally), whereas, in a tether position 181 + 183 (see Fig. 10B, [0101) being beyond the fully deployed position (see Fig. 10B, after the motion of 192), the mandrel 116 is movable in the longitudinal direction relative to the slider mechanism 132 beyond the predetermined stop position 180 due to the mandrel motion blockage 180 being released (see Fig. 10B, [0101], 134 is no longer stopped by 180 with the motion of 192, hence allow for further distal movement of 116), wherein the slider body 131 + 135 + radial flange and the slider housing 130 each comprise a through-hole (see annotated Fig. 8 below, 130 has a lumen which is it’s through-hole) extending in the longitudinal direction the longitudinal direction of 120 such that the mandrel 116 extends longitudinally through both through-holes (see annotated Fig. 8 below), wherein the through-hole of the slider body 131 + 135 comprises two sections (see annotated Fig. 8 below) with a first section (see annotated Fig. 8 below) having a smaller cross-sectional dimension (see annotated Fig. 8 below) than a second section (see annotated Fig. 8 below) such that, when the slider body 131 + 135 is in the pulled-down configuration (at Fig. 10A), the mandrel 116 extends through the first section (see annotated Fig. 8 below) and when the slider body 131 + 135 is in the pulled-up configuration (at Fig. 10B, after the motion of 192), the mandrel 116 extends through the second section (see annotated Fig. 8 below).
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Claim 2
Soltis discloses: The control handle of claim 1, see 102 rejection above. Soltis further discloses: wherein the slider mechanism 134 is configured such that, when the slider mechanism is displaced to the fully deployed position (see Fig. 10B, after the motion of 192) and then all forces applied by a user are released, the slider mechanism automatically displaces into the tether position 181 + 183, thereby releasing the mandrel motion blockage.
The language, " when the slider mechanism is displaced to the fully deployed position and then all forces applied by a user are released, the slider mechanism automatically displaces into the tether position thereby releasing the mandrel motion blockage," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Solits meets the structural limitations of the claim, and is capable of when the slider 134 is positioned after the motion of 192, the slider is in the tether position of 181 + 183, as no longer blocked by 180.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Claim 3
Soltis discloses: The control handle of claim 2, see 102 rejection above. Soltis further discloses: wherein the slider body 131 is arranged at the slider housing in a manner such as to be elastically biased in a lateral direction away (see Fig. 8, [0093], 135 is biased laterally radially towards 128 and away from 130, while 133 is biased towards 130) from the slider housing 130; wherein the slider body and the slider housing are configured such that, as long as the slider mechanism is positioned at the fully undeployed position or somewhere between the fully undeployed and fully deployed position, the slider body is kept fixed to the slider housing in the pulled-down configuration, whereas, upon arriving at the fully deployed position, the fixation is released such that the slider body automatically displaces in a lateral direction away from the slider housing into the pulled-up configuration due to the elastic biasing, thereby releasing the mandrel motion blockage.
The language, "wherein the slider body and the slider housing are configured such that, as long as the slider mechanism is positioned at the fully undeployed position or somewhere between the fully undeployed and fully deployed position, the slider body is kept fixed to the slider housing in a pulled-down configuration, whereas, upon arriving at the fully deployed position, the fixation is released such that the slider body automatically displaces in a lateral direction away from the slider housing into a pulled-up configuration due to the elastic biasing, thereby releasing the mandrel motion blockage," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Solits meets the structural limitations of the claim, and is capable of the slider body, while between the fully undeployed position (Fig. 10A) and the fully deployed position (Fig. 10B, after the motion of 192) for the slider body to be kept fixed to 130 in a pulled-down configuration, as 135 is biased to keep 131 fixed to 130 and 128, and that at the fully deployed position 131 stays at a “pulled-up configuration” in that the movement of 192 is a lateral upwards movement along the longitudinal axis, in a circumferential direction, staying there due the elastic biasing of 135, while at the same time being no longer blocked at 180.
Claim 5
Soltis discloses: The control handle of claim 3, see 102 rejection above. Soltis further discloses: wherein the mandrel 112 + 110 + 116 comprises a bare mandrel portion 116 (see Figs. 8-9, [0065]-[0066]) and a tether hypotube portion 110 (see Figs. 8-9, [0065]-[0066]) being arranged further proximal (see 112b rejection above, the applicant reinterprets proximal as distal, and 110 is distal to 116) to the bare mandrel portion 116, wherein the bare mandrel portion has a first cross-sectional dimension the diameter of 116 (see Fig. 8, which is less than the diameter of 110) and the tether hypotube portion 110 has a second cross-sectional dimension the diameter of 110 (see Fig. 8, the diameter of 110 is larger than the diameter of 116, as 110 receives 116) being larger than the first cross-sectional dimension, wherein the first section (see annotated Fig. 8 below claim 1) of the through-hole of the slider body 131 + 135 + radial flange has a cross-sectional dimension being smaller (see annotated Fig. 8 below claim 1, the first portion has a smaller diameter, approximately the diameter of 116 which fits within 110) than the second cross-sectional dimension the diameter of 110 of the tether hypotube portion 110 whereas the second section (see annotated Fig. 8 below claim 1) of the through-hole of the slider body has a cross-sectional dimension (see annotated Fig. 8 below claim 1, the second section has a bigger diameter than that of 110) being larger than the second cross-sectional dimension of the tether hypotube portion 110.
Claim 6
Soltis discloses: The control handle of claim 1, see 102 rejection above. Soltis further discloses: wherein the control handle 120 further comprises a haptic deployment feedback mechanism 135 (see Figs. 8-10E, [0093]-[0094], meets the definition of a bumper, see 112(f) interpretation above, as it is protruding portion that engages against another protrusion of 180), the haptic deployment feedback mechanism 135 being configured for generating a haptic deployment feedback to a user of the control handle upon the slider mechanism being displaced beyond at least one predetermined deployment feedback position (see Fig. 10B, [0095], before the motion of 192 and along 198, 198 is longitudinally between Fig. 10A and Fig. 10B after the motion of 192) situated longitudinally between the fully undeployed position (see Fig. 10A) and the fully deployed position (see Fig. 10B, after the motion of 192).
The language, "being configured for generating a haptic deployment feedback to a user of the control handle upon the slider mechanism being displaced beyond at least one predetermined deployment feedback position situated longitudinally between the fully undeployed position and the fully deployed position," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Soltis meets the structural limitations of the claim, and is capable of the bumper protrusion of 135 engaging with a protrusion of 180 such that there is haptic feedback in the form of the device no longer capable of being distally pushed by the user, and when displaced beyond the predetermined deployment feedback position by being rotated no longer being engaged and hence the user no longer feels incapable of pushing the slider further distally.
Claim 9
Soltis discloses: The control handle of claim 6, see 102 rejection above. Soltis further discloses: wherein the haptic deployment feedback mechanism 135 comprises at least one ridge 180 (see Fig. 8-10E, [0093]-[0094], is a wall or protrusion that contacts the bumper, hence a ridge) and at least one bumper 135 (see Figs. 8-10E, [0093]-[0094], meets the definition of a bumper, see 112(f) interpretation above, as it is protruding portion that engages against another protrusion of 180), the ridge 180 being arranged at one of the handle housing 128 (see Fig. 9 and 10A, 180 is part of the housing of 128) and the slider mechanism (will not be examined here due to being an optional claim limitation) and the bumper 135 being arranged at the other one of the handle housing (will not be examined here due to being an optional claim limitation) and the slider mechanism 134 (see Fig. 9, 135 is part of 134), and being configured such as to induce a retracting force 180 (see Fig. 9, [0094], 180 stops distal movement hence a retracting force, onto 134 if axial pushing force is applied before the motion of 192 along 198, stopping 134, unless rotation occurs) onto the slider mechanism 132 + 134 upon a user longitudinally pushing the slider mechanism 134 beyond the at least one deployment feedback position (see Fig. 10B, [0095], before the motion of 192 and along 198).
Claim 10
Soltis discloses: The control handle of claim 9, see 102 rejection above. Soltis further discloses: wherein the slider mechanism 134 is guided in the handle housing 128 upon being longitudinally displaced and wherein the deployment feedback mechanism is configured such that the ridge and the bumper are elastically biased towards each other in a lateral direction crossing the longitudinal direction.
The language, "upon being longitudinally displaced and wherein the deployment feedback mechanism is configured such that the ridge and the bumper are elastically biased towards each other in a lateral direction crossing the longitudinal direction," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Soltis meets the structural limitations of the claim, and is capable of the bumper 135 and the ridge 180 being elastically biased towards other in a lateral (radial) direction crossing the longitudinal (axial) direction as 135 is designed to be elastically biased radially inwards (see [0093], as unless a depressive force by the user is used to raise 135 from 128) and 180 is designed to engage 135 (see [0094], which is lateral (radial) direction crossing the longitudinal (axial) direction).
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.
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) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soltis in view of Oster et al (US 20110137252 A1), herein referenced to as “Oster”.
Claim 11 and Claim 12
Soltis discloses: The control handle of claim 1, see 102 rejection above. Soltis does not explicitly disclose: further comprising a valve arranged in the slider mechanism such as to prevent back-bleeding through a lumen of the delivery catheter; wherein the valve is formed by a membrane held in the slider mechanism in a cross-sectional direction and having a through-hole configured for tightly enclosing the mandrel extending through the slider mechanism and through the through-hole of the membrane.
However, Oster in a similar field of invention teaches a control handle 100 (see Figs. 18-19) with a slider mechanism 500 (see Figs. 18-19), a delivery catheter 400 (see Figs. 18-19), and a mandrel 700 + 700a (see Figs. 18-19). Oster further teaches: further comprising a valve 800 + 800a (see Figs. 18-19, [0094]) arranged in the slider mechanism 500 (see [0994]) such as to prevent back-bleeding through a lumen the lumen of 400 (see Fig. 18, [0094], closes the passage, which prevents back-bleeding or back-flow) of the delivery catheter 400; wherein the valve 800 + 800a is formed by a membrane 800a (see Fig. 18, [0094], 800a is a membrane held in 500) held in the slider mechanism 500 in a cross-sectional direction (see Figs. 18-19) and having a through-hole the through hole of 800 which 700a extends through (see Fig. 19) configured for tightly enclosing the mandrel 700 + 700a extending through the slider mechanism 500 and through the through-hole (see Fig. 19, 700A extends through 800, and the valve only opening with insertion of 700a hence, tightly enclosing 700) of the membrane 800a.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Soltis to incorporate the teachings of Oster and teach a control handle with a valve arranged in the slider mechanism such as to prevent back-bleeding through a lumen of the delivery catheter; wherein the valve is formed by a membrane held in the slider mechanism in a cross-sectional direction and having a through-hole configured for tightly enclosing the mandrel extending through the slider mechanism and through the through-hole of the membrane. Motivation for such can be found in Oster as this can keep the passage of the slider closed and only openable to the mandrel when the pieces are arranged together (see [0036]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schultz (US 20110054446 A1) teaches a control handle with a sliding body + housing with laterally displaceable through-hole to lock/unlock a mandrel 35 (see Figs. 24-25)
THIS ACTION IS MADE FINAL. 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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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