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 4/22/2026 has been entered. Claims 1-23 are pending in the application. Claim 23 is new. Claims 3 and 12-22 are withdrawn. The amendments to the claims overcome each and every objection previously set forth in the Non-Final Office Action mailed on 12/22/2025.
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.
Claims 1-2, 6-8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Strickler et al. (US 2008/0097223 A1) in view of Elmaanaoui et al. (US 2020/0345440 A1) and further in view of Gilboa et al. (US 2008/0262297 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 body (handle housing 112) 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) of the flexible catheter sheath (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).
However, Strickler fails to state wherein the coupling mechanism is adapted to detachably connect the handle to the patient interface unit via a push-twist motion where a locking feature of the coupling mechanism engages with a corresponding locking feature of the patient interface unit, the patient interface unit being configured to output a visual signal indicative of correct or incorrect engagement of the handle body.
Elmaanaoui teaches a handle for maneuvering a catheter (see Figs. 1-4B and 5E-6B) wherein the coupling mechanism (connecting portion 1152) is adapted to detachably connect the handle (catheter handle 1122) to the patient interface unit (patient interface unit 1130) via a push-twist motion where a locking feature (keys 1153) of the coupling mechanism (connecting portion 1152) engages with a corresponding locking feature (cutouts 1215) of the patient interface unit (patient interface unit 1130) (see Figs. 1-4B and 5E-6B, par. [0040], [0047], [0055]).
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 coupling mechanism of the handle of Strickler, which utilizes a linear/"push" motion, to include keys to engage with cutouts of the patient interface unit such that the connection between the coupling mechanism and the patient interface unit occurs via a push-twist motion, as taught by Elmaanaoui, as an alternative coupling mechanism which can securely lock the handle and the patient interface unit together (see Elmaanaoui par. [0047]).
However, modified Strickler still fails to state the patient interface unit being configured to output a visual signal indicative of correct or incorrect engagement of the handle body.
Gilboa teaches a patient interface unit (see Fig. 10) being configured to output a visual signal indicator of correct or incorrect engagement of the handle body (scope 100) (see Fig. 10, par. [0009], [0043], [0053]-[0057]).
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 the patient interface unit being configured to output a visual signal indicative of correct or incorrect engagement of the handle body, as taught by Gilboa, in order to determine and communicate to the user in real-time whether the alignment of the handle is correct or needs adjusted (see Gilboa par. [0043], [0053]).
Regarding claim 2, modified Strickler teaches the handle according to claim 1 substantially as claimed. Strickler further teaches 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 connect 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, modified Strickler teaches the handle according to claim 1 substantially as claimed. Strickler further teaches 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, modified Strickler teaches the handle according to claim 1 substantially as claimed. Strickler further teaches 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 8, modified Strickler teaches the handle according to claim 7 substantially as claimed. However, modified 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 modified 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 modified Strickler would not operate differently with the claimed relative lengths and since modified 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]).
Regarding claim 10, modified Strickler teaches the handle according to claim 1 substantially as claimed. Modified Strickler further teaches wherein the reinforced portion (Strickler housing apron 112a) is a portion of the handle body (Strickler handle housing 112) at the proximal end (Strickler proximal/left end of handle housing 112) of the handle body (Strickler 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 (Strickler proximal/left end of handle housing 112) towards the distal end (Strickler distal/right end of handle housing 112) (see Strickler 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 (Strickler pullback and rotation system 200), a user grasps the handle body (Strickler handle housing 112) with a single hand, inserts the coupling mechanism (modified Strickler coupling mechanism, see previous modifications in rejection of claim 1 above) into a receiving port (Strickler catheter interface 205) of the patient interface unit (Strickler pullback and rotation system 200), and rotates the handle body (Strickler handle housing 112) single handedly (see Strickler Figs. 1-4, Strickler par. [0042] and [0052]-[0053], see Elmaanaoui par. [0047], see previous modifications in rejection of claim 1 above; 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, modified Strickler teaches the handle according to claim 10 substantially as claimed. Strickler further teaches 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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Strickler et al. (US 2008/0097223 A1) in view of Elmaanaoui et al. (US 2020/0345440 A1) and further in view of Gilboa et al. (US 2008/0262297 A1), as applied to claim 1 above, and further in view of Gomez et al. (US 2019/0274666 A1).
Regarding claim 4, modified Strickler teaches the handle according to claim 1 substantially as claimed. However, modified 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 modified 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) in view of Elmaanaoui et al. (US 2020/0345440 A1) and further in view of Gilboa et al. (US 2008/0262297 A1), as applied to claim 1 above, further 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, modified Strickler teaches the handle according to claim 1 substantially as claimed. However, modified 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 modified 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 is configured to fit into a circle having 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) is configured to fit into a circle having a diameter equal to or greater than 25 millimeters (see par. [0044], note: 0.5 inches corresponds to 12.7 millimeters, a handle with a diameter of 12.7 mm would fit within a circle having a diameter of 25 mm or greater).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Strickler et al. (US 2008/0097223 A1) in view of Elmaanaoui et al. (US 2020/0345440 A1) and further in view of Gilboa et al. (US 2008/0262297 A1), as applied to claim 1 above, and further in view of Ouyang et al. (US 2016/0367119 A1).
Regarding claim 9, modified Strickler teaches the handle according to claim 1 substantially as claimed. However, modified 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 modified 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]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Strickler et al. (US 2008/0097223 A1) in view of Elmaanaoui et al. (US 2020/0345440 A1) and further in view of Gilboa et al. (US 2008/0262297 A1), as applied to claim 1 above, and further in view of Wenstrom, Jr. et al. (US 2006/0074434 A1).
Regarding claim 23, modified Strickler teaches the handle according to claim 1 substantially as claimed. However, modified Strickler fails to state wherein the outer surface of the handle body defines a triangular 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.
Wenstrom, Jr. teaches a handle (see Figs. 1-3) wherein the outer surface of the handle body (handle 124) defines a triangular cross-section (see Figs. 1-3, par. [0023]) configured to fit into a circle having a diameter smaller than or equal to a maximum grip diameter of an average human hand (see par. [0023], [0034], the user holds the handle 124 with a single hand such that the handle 124 would be sized with a cross-sectional diameter smaller than or equal to a maximum grip diameter of the average human hand).
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 wherein the outer surface of the handle body defines a triangular 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 Wenstrom, Jr., in order to enhance stability of the handle when in use during procedures (see Wenstrom, Jr. par. [0039]).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been fully considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments with respect to claim 5 have been fully considered but they are not persuasive. Applicant argues that Rosenman does not teach configuring handle 14 to fit into a circle having a diameter equal to or greater than 25 mm because 25 mm is nearly twice as large as the 0.5 inches suggested by Rosenman (see Rosenman par. [0044]) and doubling the suggested 0.5 inches would destroy the teachings of Rosenman. However, the rejection of claim 5 does not include a proposed modification to double the suggested 0.5 inch diameter of Rosenman. The claim requires a handle with a cross-section sized to fit into a circle having a diameter of 25 mm or greater. Any handle with a cross-sectional diameter of less than 25 mm would fit into a circle having a diameter of 25 mm or greater. Since Rosenman’s suggested diameter of 0.5 inches (corresponding to 12.7 mm) is less than 25 mm, the claim limitation is taught by Rosenman. It is unclear whether Applicant believes that the claim requires the handle to have a cross-sectional diameter that is equal to or greater than 25 mm, however this is not recited in claim 5.
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 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
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