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
The amendment filed on 4/15/2025 has been entered. Claims 1-22 are pending in the application. Claims 3 and 12-22 remain withdrawn. The amendments to the claims overcome each and every objection previously set forth in the Non-Final Office Action mailed on 4/15/2025.
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 1-2 and 4-11 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 introduces “a handle body having…an inner surface…defining a tubular passage” in lines 2-3 and introduces “a tubular passage of the handle body” in lines 10-11. It is unclear whether the tubular passages are intended to be the same or different. For examination purposes, the Examiner interprets “a tubular passage” in line 10 as “the tubular passage”.
Claims 2 and 4-11 are rejected by virtue of their dependency on rejected claim 1.
Claim 6 introduces “the flexible catheter sheath includes a working channel” in line 2. However, claim 6 depends from claim 1, which introduces “the imaging core being arranged in a working channel” in lines 9-10. It is unclear whether the working channels of claims 1 and 6 are intended to be the same or different. For examination purposes, the Examiner interprets “a working channel” in claim 6 as “the working channel”.
Claims 7-8 are rejected by virtue of their dependency on rejected claim 6.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-2, 6-7, and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strickler et al. (US 2008/0097223 A1).
Regarding claim 1, Strickler discloses a handle (see Figs. 1-3) for maneuvering a catheter (see par. [0042]-[0043]), the handle comprising:
a handle body (handle housing 112) having an outer surface (outer surface of handle housing 112) and an inner surface (inner surface of handle housing 112), the inner surface (inner surface of handle housing 112) defining a tubular passage (space within handle housing 112) extending along a longitudinal axis (longitudinal axis through handle housing 112) from a proximal end (proximal/left end of handle housing 112) to a distal end (distal/right end of handle housing 112) of the handle body (handle housing 112) (see Figs. 1-3);
wherein the handle includes a coupling mechanism (catheter locking levers 116) at the proximal end (proximal/left end of handle housing 112) (see Figs. 1-3, par. [0052]-[0053]), a strain relief sleeve (jacket fixing block 112b and flexible nose portion 112c) at the distal end (distal/right end of handle housing 112) (see Figs. 1-3, par. [0045]), and a reinforced portion (housing apron 112a) between the proximal end (proximal/left end of handle housing 112) and the distal end (distal/right end of handle housing 112) of the handle body (handle housing 112) (see Figs. 1-3, par. [0045]),
wherein the strain relief sleeve (jacket fixing block 112b and flexible nose portion 112c) at the distal end (distal/right end of handle housing 112) of the handle body (handle housing 112) is adapted to irremovably secure a flexible catheter sheath (catheter jacket 82) and an imaging core (optical fiber bundle ofb) to the handle (see Figs. 1-3, par. [0045]-[0047]; jacket fixing block 112b rigidly bonds to catheter jacket 82 and flexible nose portion 112c prevents crimping of the catheter jacket 82; optical fiber bundle ofb is further in a locked position relative to 112b/c when the carriage 118 is locked relative to housing 112), the imaging core (optical fiber bundle ofb) being arranged in a working channel (channel through catheter jacket 82) that extends through the tubular passage (space within handle housing 112) of the handle body (handle housing 112) and along the longitudinal axis (longitudinal axis through handle housing 112) (see Figs. 1-3, par. [0039] and [0046]),
wherein the imaging core (optical fiber bundle ofb) includes a rigid pullback portion (proximal portion of optical fiber bundle ofb which is located within handle housing 112) arranged in the tubular passage (space within handle housing 112) of the handle body (handle housing 112), and a first connector (carriage 118 including female duplex optical coupler 120) attached to a proximal end of the imaging core (optical fiber bundle ofb) (see Figs. 1-3, par. [0039], [0046], [0054], [0056]),
wherein the coupling mechanism (catheter locking levers 116) at the proximal end (proximal/left end of handle housing 112) of the handle body (handle housing 112) is adapted to detachably connect the handle to a patient interface unit (pullback and rotation system 200) having a second connector (male optical duplex coupler 312) (see Figs. 1-3, par. [0052]-[0053], [0054], [0056], ring engagement noses 116n of catheter locking levers 116 engage with interface release ring 210 of catheter interface 205 to releasably attach catheter system 100 to the pullback and rotation system 200),
wherein the first connector (carriage 118 including female duplex optical coupler 120) of the imaging core (optical fiber bundle ofb) is configured to engage with the second connector (male optical duplex coupler 312) (see Figs. 1-3, par. [0054] and [0056]-[0057]),
wherein the reinforced portion (housing apron 112a) between the proximal end (proximal/left end of handle housing 112) and the distal end (distal/right end of handle housing 112) of the handle body (handle housing 112) is configured to increase a flexural rigidity at the proximal end (proximal/left end of handle housing 112) of the handle body (handle housing 112) (see Figs. 1-3, par. [0045], housing apron 112a adds an extra layer of protective material to handle housing 112 and thus increases a flexural rigidity of the proximal/left end of handle housing 112).
Regarding claim 2, Strickler discloses the handle according to claim 1, wherein the handle body (handle housing 112) is ergonomically sized and shaped for grasping by a hand of a user (see par. [0042]) so that the user can connect or disconnect the handle to or from the patient interface unit (pullback and rotation system 200) single handedly (see Figs. 1-4, par. [0042] and [0052]-[0053], note: the limitation "so that the user can connector or disconnect the handle to or from the patient interface unit single handedly" is a functional limitation rather than a structural requirement of the claim. Handle housing 112 is shaped and configured to be held in a hand of the user and thus could be used to single handedly connect the handle housing 112 to the pullback and rotation system 200).
Regarding claim 6, Strickler discloses the handle according to claim 1, wherein the flexible catheter sheath (catheter jacket 82) includes a working channel (channel through catheter jacket 82) spanning from a proximal end (proximal/left end of catheter jacket 82) to a distal end (distal/right end of catheter jacket 82) of the flexible catheter sheath (catheter jacket 82) (see Figs. 1-3), and
wherein the tubular passage (space within handle housing 112) of the handle body (handle housing 112) and the working channel (channel through catheter jacket 82) of the flexible catheter sheath (catheter jacket 82) are linearly aligned with each other and configured to pass therethrough the imaging core (optical fiber bundle ofb) (see Figs. 1-3, par. [0039] and [0041]).
Regarding claim 7, Strickler discloses the handle according to claim 6, wherein the patient interface unit (pullback and rotation system 200) includes a moving platform (carriage drive system 300) configured to linearly pull the imaging core (optical fiber bundle ofb) a predetermined pullback length into the patient interface unit (pullback and rotation system 200) while the flexible catheter sheath (catheter jacket 82) and the handle body (handle housing 112) remain stationary (see par. [0054] and [0061]), and
wherein a length of the handle body (handle housing 112) is equal to or greater than the predetermined pullback length (see Figs. 1-5, par. [0054] and [0061], manual pulley 214 and the associated mechanisms for linear translation of the optical fiber bundle ofb can be operated to pull the optical fiber bundle ofb back into the pullback and rotation system 200 by a predetermined length that is less than the length of the handle housing 112).
Regarding claim 10, Strickler discloses the handle according to claim 1,
wherein the reinforced portion (housing apron 112a) is a portion of the handle body (handle housing 112) at the proximal end (proximal/left end of handle housing 112) of the handle body (handle housing 112) that tapers from a first diameter to a second diameter smaller than the first diameter in a direction from the proximal end (proximal/left end of handle housing 112) towards the distal end (distal/right end of handle housing 112) (see Figs. 1-3, par. [0045], housing apron 112a tapers from the proximal/left end of handle housing 112 to the distal/right end of handle housing 112),
wherein, to attach the handle to the patient interface unit (pullback and rotation system 200), a user grasps the handle body (handle housing 112) with a single hand, inserts the coupling mechanism (catheter locking levers 116) into a receiving port (catheter interface 205) of the patient interface unit (pullback and rotation system 200), and rotates the handle body (handle housing 112) single handedly (see Figs. 1-4, par. [0042] and [0052]-[0053], note: the limitation "wherein, to attach the handle to the patient interface unit, a user grasps the handle body with a single hand, inserts the coupling mechanism into a receiving port of the patient interface unit, and rotates the handle body single handedly" is a functional limitation rather than a structural requirement of the claim. Handle housing 112 is configured to be held in a hand of the user and thus could be used to perform these operations single-handedly).
Regarding claim 11, Strickler discloses the handle according to claim 10, wherein, after attachment of the handle to the patient interface unit (pullback and rotation system 200), the reinforced portion (housing apron 112a) of the handle body (handle housing 112) abuts against a housing of the patient interface unit (pullback and rotation system 200) (see Figs. 1-3), and
wherein the coupling mechanism (catheter locking levers 116) and the reinforced portion (housing apron 112a) make the handle body (handle housing 112) robust enough to support a weight of an entirety of the patient interface unit (pullback and rotation system 200) during handling and manipulations of the handle and the patient interface unit (pullback and rotation system 200) by the user (see Figs. 1-4, par. [0042], [0045], and [0052]-[0053], the catheter locking levers 116 and the housing apron 112a aid in supporting the weight of the device and allowing the handle to be used for handling and manipulations of the handle and the pullback and rotation system 200).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Strickler et al. (US 2008/0097223 A1), as applied to claim 1 above, in view of Gomez et al. (US 2019/0274666 A1).
Regarding claim 4, Strickler discloses the handle according to claim 1. However, Strickler fails to explicitly state wherein the outer surface of the handle body defines a triangular cross-section or a circular cross-section configured to fit into a circle having a diameter smaller than or equal to a maximum grip diameter of an average human hand.
Gomez teaches a handle for maneuvering a catheter (see Figs. 1-6) wherein the outer surface of the handle body (main body 101, hand purlicue area 106, and ballast 104) defines a circular cross-section (see Figs. 1-6) configured to fit into a circle having a diameter smaller than or equal to a maximum grip diameter of an average human hand (see Figs. 1-6, par. [0012]-[0013] and [0028]-[0029], at least the hand purlicue area 106 is shown such that the thumb and middle fingers can curl around the device to touch such that the circular cross-sectional diameter of the handle body is smaller than the maximum grip diameter).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Strickler to be sized such that the outer surface of the handle body defines a circular cross-section configured to fit into a circle having a diameter smaller than or equal to a maximum grip diameter of an average human hand, as taught by Gomez, in order to create an ergonomic handle with a universal shape that accommodates all of the most common types of grips and which fits comfortable in the user's hand and reduces the fatigue associated with prolonged use of the handle (see Gomez par. [0012]-[0013]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Strickler et al. (US 2008/0097223 A1), as applied to claim 1 above, in view of Gomez et al. (US 2019/0274666 A1) and further in view of Rosenman et al. (US 2002/0082584 A1).
Regarding claim 5, Strickler discloses the handle according to claim 1. However, Strickler fails to explicitly state wherein the outer surface of the handle body defines a triangular cross-section or a circular cross-section configured to fit into a circle having a diameter equal to or greater than 25 millimeters and equal to or smaller than a maximum grip diameter of an average human hand.
Gomez teaches a handle for maneuvering a catheter (see Figs. 1-6) wherein the outer surface of the handle body (main body 101, hand purlicue area 106, and ballast 104) defines a circular cross-section (see Figs. 1-6) configured to fit into a circle having a diameter equal to or smaller than a maximum grip diameter of an average human hand (see Figs. 1-6, par. [0012]-[0013] and [0028]-[0029], at least the hand purlicue area 106 is shown such that the thumb and middle fingers can curl around the device to touch such that the circular cross-sectional diameter of the handle body is smaller than the maximum grip diameter).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Strickler to be sized such that the outer surface of the handle body defines a circular cross-section configured to fit into a circle having a diameter smaller than or equal to a maximum grip diameter of an average human hand, as taught by Gomez, in order to create an ergonomic handle with a universal shape that accommodates all of the most common types of grips and which fits comfortable in the user's hand and reduces the fatigue associated with prolonged use of the handle (see Gomez par. [0012]-[0013]).
However, modified Strickler still fails to explicitly state wherein the outer surface of the handle body has a diameter equal to or greater than 25 millimeters.
Rosenman teaches a handle for maneuvering a catheter (see Figs. 1-2) wherein the outer surface of the handle body (handle 14) has a diameter equal to or greater than 25 millimeters (see par. [0044], note: 0.5 inches corresponds to 12.7 millimeters).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of modified Strickler to include that the outer surface of the handle body has a diameter equal to or greater than 25 millimeters, as taught by Rosenman, in order to ensure that the handle is small to keep the weight and bulk of the handle to a minimum (see Rosenman par. [0044]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Strickler et al. (US 2008/0097223 A1), as applied to claim 7 above.
Regarding claim 8, Strickler discloses the handle according to claim 7. However, Strickler fails to explicitly state wherein the length of the handle body is in a range of 1 to 1.5 times the predetermined pullback length.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Strickler to include wherein the length of the handle body is in a range of 1 to 1.5 times the predetermined pullback length since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the handle of Strickler would not operate differently with the claimed relative lengths and since Strickler already teaches that the length of the handle body is equal to or greater than the predetermined pullback length, the handle would function appropriately having the claimed relative lengths. Further, it appears that Applicant places no criticality on the range claimed, indicating simply that the relative lengths “can” be within the claimed range (see Specification par. [0062] and [0073]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Strickler et al. (US 2008/0097223 A1), as applied to claim 1 above, in view of Ouyang et al. (US 2016/0367119 A1).
Regarding claim 9, Strickler discloses the handle according to claim 1. However, Strickler fails to explicitly state wherein the handle body and the flexible catheter sheath are sterile components configured for single use, and wherein the patient interface unit is an unsterile electronic component configured for multiuse.
Ouyang teaches a handle for maneuvering a catheter (see Figs. 1-3) wherein the handle body (handle portion 140) and the flexible catheter sheath (cannula 120) are sterile components configured for single use (see par. [0046] and [0048]), and wherein the patient interface unit (display module 150 and battery module 160) is an unsterile electronic component configured for multiuse (see par. [0046] and [0048]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Strickler to include wherein the handle body and the flexible catheter sheath are sterile components configured for single use, and wherein the patient interface unit is an unsterile electronic component configured for multiuse, as taught by Ouyang, in order to significantly lessen or avoid stringent decontamination and disinfection procedures as well as the risk of cross-contamination and hospital acquired diseases (see Ouyang par. [0046]).
Response to Arguments
Applicant's arguments filed 4/15/2025 have been fully considered but they are not persuasive.
In regards to independent claim 1, Applicant argues that Strickler fails to teach the added limitations in the amendment of “wherein the strain relief sleeve at the distal end of the handle body is adapted to irremovably secure…an imaging core to the handle, the imaging core being arranged in a working channel that extends through a tubular passage of the handle body and along the longitudinal axis, wherein the imaging core includes a rigid pullback portion arranged in the tubular passage of the handle body, and a first connector attached to a proximal end of the imaging core” and the “patient interface unit having a second connector, wherein the first connector of the imaging core is configured to engage with the second connector”. However, the Examiner respectfully disagrees. As described in the rejection of claim 1 above, Strickler discloses that the strain relief sleeve (jacket fixing block 112b and flexible nose portion 112c) at the distal end (distal/right end of handle housing 112) of the handle body (handle housing 112) is adapted to irremovably secure an imaging core (optical fiber bundle ofb) to the handle (see Figs. 1-3, par. [0045]-[0047]; optical fiber bundle ofb is further in a locked position relative to 112b/c when the carriage 118 is locked relative to housing 112), the imaging core (optical fiber bundle ofb) being arranged in a working channel (channel through catheter jacket 82) that extends through the tubular passage (space within handle housing 112) of the handle body (handle housing 112) and along the longitudinal axis (longitudinal axis through handle housing 112) (see Figs. 1-3, par. [0039] and [0046]). The imaging core (optical fiber bundle ofb) includes a rigid pullback portion (proximal portion of optical fiber bundle ofb which is located within handle housing 112) arranged in the tubular passage (space within handle housing 112) of the handle body (handle housing 112), and a first connector (carriage 118 including female duplex optical coupler 120) attached to a proximal end of the imaging core (optical fiber bundle ofb) (see Figs. 1-3, par. [0039], [0046], [0054], [0056]). The patient interface unit (pullback and rotation system 200) has a second connector (male optical duplex coupler 312) (see Figs. 1-3, par. [0054], [0056]), wherein the first connector (carriage 118 including female duplex optical coupler 120) of the imaging core (optical fiber bundle ofb) is configured to engage with the second connector (male optical duplex coupler 312) (see Figs. 1-3, par. [0054] and [0056]-[0057]). Thus, the Examiner maintains that Strickler still teaches each of the added limitations in combination with the remaining limitations of claim 1 as recited.
Conclusion
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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783