Ould DETAILED ACTION
This Office Action is in response to election/restriction filed 10 April 2026.
Notice of 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 .
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.
Election/Restrictions
Applicant’s election without traverse of Claims 1-20 (Invention I, Species I Figures 1-3) in the reply filed on 10 April 2026 is acknowledged.
Claims 21-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 April 2026
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 4, 5, 7 and 14 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 pre-AIA the applicant regards as the invention.
Claim 4 recites the limitation “the sliding slot” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation “the leg” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “the releasing part of the leg” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the releasing part of the leg contacts the implant. However, the implant is only introduced functionally in claim 1 and not positively recited. Therefore, it is unclear how Applicant intends to limit this claim.
Claim 14 recites the limitation “the releasing part of the leg” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Berra et al. (US Patent Publication 2007/0198078) in view of Jackson et al. (US Patent Publication 2020/0281720).
Claim 1: Berra’078 teaches an implant detaching mechanism configured to detach an implant (Figure 1) from an implant holder (Figure 13-14, 29-32), said implant detaching mechanism comprising:
a catheter having a guidewire shaft (620), an inner shaft (640), a handle (670; Figure 10, 11);
a release block (638) and a pusher block (636), combinedly forming the implant holder (Figure 13-14, 29-32);
the release block (638) having a detaching end that has an impact surface (see annotated copy of Figure 32 below); and
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the pusher block (636) having at least a pin (639) configured to engage with the implant (Figure 13-14, 30, 31),
wherein the pusher block (636) is fixed on the inner shaft (620) (paragraph [0353]) and the release block (638) is fixed on the guidewire shaft (640) (paragraph [0353]), and relative movement between the inner shaft and the guidewire shaft is configured to cause a corresponding movement of the release block and the pusher block (paragraph [0353]);
wherein, on the pusher block and the release block being moved towards or apart from each other, a force applied on the pin or on the implant that is engaged with the pin, facilitates detachment of the implant from the pin (the implant is not positively recited; when the pusher block and release block are moved towards each other, the pin 639 impacts the release block, see Figure 31; this could facilitate detachment of an implant).
Berra’078 does not teach the catheter includes rotary knob.
Like Berra’078, Jackson’’720 teaches an implant delivery device that includes a catheter (Figure 11) with an inner shaft (1109) and a guidewire shaft (1120) with a proximal end having a handle (1101). Jackson’720 teaches providing the handle with a rotary knob (1104 or 1106) that allows axial translation of the inner sheath and guidewire lumen (paragraph [0092], [0094]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Berra’078 with a handle having a rotary knob, as taught by Jackson’720, in order to allow controlled relative movement between the inner shaft and guidewire shaft (paragraph [0084]).
Claim 2: Berra’078 teaches the release block (636) has a leg with an end is connected to the detaching end (see annotated figure below).
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Claim 3: Berra’078 teaches the pusher block (636) has a sliding slot (see annotated copy of Figure 29 below).
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Claim 4: Berra’078 teaches the leg of the release block (638) is accommodated in the sliding slot in a sliding manner (Figures 30, 32).
Claim 5: Berra’078 teaches the leg has a releasing part along its length and of a symmetric or asymmetric shape (Figure 32).
Claim 6: Berra’078 teaches pusher block and the release block being moved towards each other, at one point, the impact surface at the detaching end of the release block impacts the pin (Figure 31; paragraph [0353] teaches the pusher block and release block move relative to each other; Figures 30-32 show the pin 639 and the impact surface contact each other) and the resultant impact force contributes in detachment of the implant that is engaged to the pin (the implant is not positively recited, but because the pin and the impact surface contact to each other, implant could be designed such that this contact contributes to the detachment of the implant engaged to the pin).
Claim 7: Berra’078 teaches the releasing part of the leg (i.e. the free end of the leg on release block) is configured to contact an implant that is engaged to the pin (639) upon moving the pusher block (636) and the release block (638) towards or apart from each other thereby applying a force on the engaged implant that causes detachment of the implant from the pin (the leg is capable of contacting an implant that is engaged with pin 639 -see Figure 30; the implant is not a positively recited element, but the implant could be designed such that it is detached from the pin when a force is applied to it by the pusher block or release block).
Claim 8: Jackson’720 teaches the inner shaft (1109) of the catheter is movable in the longitudinal direction on rotation of the rotary knob (1106) (paragraph [0087]).
Claim 9: Jackson’720 teaches the guidewire shaft (1120) of the catheter is movable in a longitudinal direction on rotation of the rotary knob (1104) (paragraph [0084]).
Claim 10: Berra’078 teaches the implant holder has a plurality of legs (see annotated copy of Figure 32 below) attached to the release block (638) and a plurality of sliding slots present in the pusher block (see annotated copy of Figure 29 in the rejection to claim 3 above).
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Claim 11: Berra’078 teaches the implant holder has a plurality of pins (639) attached to the pusher block (636) at an equal distance in the circumferential direction (Figure 29 shows six pins 639 each spaced equally apart).
Claim 12: Berra’078 teaches the implant holder has a plurality of pins (639) attached to the pusher block (636) at an unequal distance in the circumferential direction (Figure 29 shows two of the pins 639 are spaced 60 degrees from each other in the clockwise circumferential direction and are spaced 300 degrees from each other in the counterclockwise direction).
Claim 13: Berra’078 teaches the impact surface (identified in the rejection to claim 1 above) at the detaching end has a surface configuration selected from flat or curved (Figure 32)
Claim 14: Berra’078 teaches the releasing part (middle portion) of the of the leg (identified in the rejection to claim 2 above) has a linear edge (Figure 32).
Claim 15: Berra’078 teaches the shape of the pin (639) on the pusher block (636) is triangular (Figure 29).
Claim 16: Berra’078 teaches the pusher block (636) has a pushing surface and a seating notch between the pushing surface and the pin (see annotated figure below).
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Claim 17, 18: Berra’078 does not explicitly disclose the what material the implant detaching mechanism or implant holder is made from. It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to construct the device from a claimed material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Furthermore, it is deemed to be within the level of ordinary skill in the art to use a known material. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” See §MPEP 2144.07.
Claim 20: Berra’078 teaches the implant is a stent (note: independent claim 1 recites “the implant detaching mechanism is configured to detach an implant” and the implant is not a positively recited element of the invention).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Berra’078 in view of Jackson’720, as applied to claim 1, further in view of Murray III et al. (US Patent Publication 2023/0030051)
Claim 19: Berra’078 does not teach the implant holder has a radiopaque marker on its circumferential surface.
Like Berra’078, Murray’051 teaches a device for delivering an implant (stent) to the body that has an implant holder (22) at the distal end. Murray’051 teaches the implant holder (22) can include a radiopaque marker to permit the surgeon to guide the implant to the proper position within the body.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Berra’078 with a radiopaque marker on the implant holder, as taught by Murray’051, to aid in delivering the implant to the proper location in the body.
Claims 1, 2, 5, 8, 9, 11-15, 17, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Glynn et al. (US Patent Publication 2010/0268315) in view of Jackson et al. (US Patent Publication 2020/0281720).
Claim 1: Glynn’315 teaches an implant detaching mechanism configured to detach an implant (402) from an implant holder (Figure 6), said implant detaching mechanism comprising:
a catheter having a guidewire shaft (106) and an inner shaft (118);
a release block (112) and a pusher block (120), combinedly forming the implant holder (Figure 6);
the release block (112) having a detaching end (end near 308) that has an impact surface (308); and
the pusher block (120) having at least a pin (124) configured to engage with the implant (Figure 6),
wherein the pusher block (120) is fixed on the inner shaft (118) (paragraph [0037]) and the release block (112) is fixed on the guidewire shaft (106) (paragraph [0033], [0036]), and relative movement between the inner shaft and the guidewire shaft is configured to cause a corresponding movement of the release block and the pusher block (paragraph [0051]);
wherein, on the pusher block and the release block being moved towards or apart from each other, a force applied on the pin or on the implant that is engaged with the pin, facilitates detachment of the implant from the pin (paragraph [0051]).
Glynn’315’s catheter (Figure 1) will necessarily have a proximal end that is outside of the body. This is considered the handle. However, Glynn’315 does not teach the catheter includes rotary knob.
Like Glynn’315, Jackson’’720 teaches an implant delivery device that includes a catheter (Figure 11) with an inner shaft (1109) and a guidewire shaft (1120) with a proximal end having a handle (1101). Jackson’720 teaches providing the handle with a rotary knob (1104 or 1106) that allows axial translation of the inner sheath and guidewire lumen (paragraph [0092], [0094]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Glynn’315 with a handle having a rotary knob, as taught by Jackson’720, in order to allow controlled relative movement between the inner shaft and guidewire shaft (paragraph [0084]).
Claim 2: Glynn’315 teaches the release block (112) has at least a leg (316) whose one end is connected to the detaching end (Figure 3).
Claim 5: Glynn’315 teaches the leg (316) has a releasing part (322) along its length and of a symmetric or an asymmetric shape (Figure 3).
Claim 8: Jackson’720 teaches the inner shaft (1109) of the catheter is movable in the longitudinal direction on rotation of the rotary knob (1106) (paragraph [0087]).
Claim 9: Jackson’720 teaches the guidewire shaft (1120) of the catheter is movable in a longitudinal direction on rotation of the rotary knob (1104) (paragraph [0084]).
Claim 11: Glynn’315 teaches the implant holder has a plurality of pins (124) attached to the pusher block (120) at an equal distance in the circumferential direction (Figure 6 shows 4 pins 124 each spaced equally apart).
Claim 12: Glynn’315 teaches the implant holder has a plurality of pins (124) attached to the pusher block (120) at an unequal distance in the circumferential direction (Figure 6 shows 2 of the pins 124 are spaced 90 degrees from each other in the clockwise circumferential direction and are spaced 270 degrees from each other in the counterclockwise direction).
Claim 13: Glynn’315 teaches the impact surface (308) at the detaching end has a surface configuration selected from flat or curved (Figure 2, 3).
Claim 14: Glynn’315 teaches the releasing part (322) of the of the leg (316) has a linear edge (d1, Figure 3).
Claim 15: Glynn’315 teaches the shape of the pin (124) on the pusher block (12) is circular (Figure 6).
Claim 17, 18: Glynn’315 does not explicitly disclose the what material the implant detaching mechanism or implant holder is made from. It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to construct the device from a claimed material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Furthermore, it is deemed to be within the level of ordinary skill in the art to use a known material. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” See §MPEP 2144.07.
Claim 20: Glynn’315 teaches the implant is a stent (note: independent claim 1 recites “the implant detaching mechanism is configured to detach an implant” and the implant is not a positively recited element of the invention).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Glynn’315 in view of Jackson’720, as applied to claim 1, further in view of Zhang et al. (US Patent Publication 2018/0369006).
Claim 16: Glynn’315 does not teach the pusher block has a pushing surface and a seating notch between the pushing surface and the pin.
Like Glynn’315, Zhang’006 teaches a device for delivering an implant to the body that has a pusher block (Figure 5) with a pin (2733) and a pushing surface (see annotated copy of Figure 5 below). There is a seating notch (2711) between the pushing surface and the pin to provide space for engaging the implant (paragraph [0055]).
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It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Glynn’315 with a pushing surface and seating notch, as taught by Zhang’006, in order to aid keeping the implant from slipping along the pusher block during delivery.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Glynn’315 in view of Jackson’720, as applied to claim 1, further in view of Murray III et al. (US Patent Publication 2023/0030051)
Claim 19: Glynn’315 does not teach the implant holder has a radiopaque marker on its circumferential surface.
Like Glynn’315, Murray’051 teaches a device for delivering an implant (stent) to the body that has an implant holder (22) at the distal end. Murray’051 teaches the implant holder (22) can include a radiopaque marker to permit the surgeon to guide the implant to the proper position within the body.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Glynn’315 with a radiopaque marker on the implant holder, as taught by Murray’051, to aid in delivering the implant to the proper location in the body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Wednesday 9:30 am-5 pm and alternating Thursdays.
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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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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 15 June 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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