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 .
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 10, 12, 13, 15-18 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Parmar (WO 2016/029228, hereinafter “Parmar”) in view of Spenser et al (U.S. Pat. 7,819,844 B2, hereinafter “Spenser”).
Regarding claim 1, Parmar discloses a guidewire placement apparatus, comprising: a sterile enclosed tube 29 (see Fig. 23) comprising: a needle (known from the Seldinger technique; see pg. 4, line 24), a guidewire (see pg. 6, line 3), and a first ferromagnetic component, 34 coupled to the guidewire (pg. 6, line 3);
a first external ferromagnet 23 (see Fig. 3) mounted outside of the sterile enclosed tube (see also pg. 6, lines 6-8 describing external magnets),
wherein the guidewire passes through an opening of the first ferromagnetic component (see Fig. 5, showing a guidewire 38 extending through a first internal magnet 34 within the sterile enclosed tube 29);
wherein the first ferromagnetic component is coupled to the first external ferromagnet (see pg. 6, lines 11-12);
wherein the largest dimension of the enclosed tube is the length direction (pg. 6, lines 5-6) and wherein the first external ferromagnet is translatable in the direction of the length of the sterile enclosed tube (pg. 6, lines 6-8); and
wherein the guidewire is coupled to the first external ferromagnet via the first ferromagnetic component (see pg. 6, lines 6-8, disclosing “a first external magnet that is coupled to the first ferromagnetic component that is coupled to the guidewire”),
wherein translation of the first external ferromagnet causes translation of the guidewire via translation of the first ferromagnetic component (see pg. 6, lines 7-8 disclosing that the first external magnet is translatable in the direction of the length of the enclosed tube; such translation would expectedly cause translation of the first ferromagnetic component and the guidewire coupled thereto);
an uncoupling mechanism comprising the first ferromagnetic component, the first external ferromagnet, and the guidewire (i.e., the first ferromagnetic component, first external ferromagnet and guidewire are combined to form an “uncoupling mechanism”),
wherein the uncoupling mechanism is adapted to reversibly or irreversibly uncouple the guidewire from the first external ferromagnet by rotation and/or additional translation of the first external ferromagnet (see pg. 20, line 14 to pg. 21, line 7 describes various uncoupling mechanisms allowing the guidewire or needle to uncouple from the one or more external magnets).
It is noted that Parmar does not appear to disclose that a change in orientation or position of the first ferromagnetic component causes the first ferromagnetic component to impinge on and lock onto the guidewire, the ability of the first ferromagnetic component to undergo a change in its orientation or position to impinge upon and lock the guidewire in place.
Spenser discloses a mechanism for coupling and decoupling from a guidewire, comprising an actuator with a central orifice that can impinge, crimp and lock on a guidewire to hold the guidewire in place (see Fig. 6a-6b showing a guidewire crimping component 64 and a guidewire 100 held in place by the component 64, which is actuated by a spring 61). Further, Spenser teaches that the actuator can be electromagnetically actuated (see col. 6, lines 50-58), such that it is understand that a magnetic decoupling mechanism could act on the actuator to perform the impinging, crimping and locking function.
A skilled artisan would have found it obvious at the time of the invention to modify the device of Parmar, according to the teaching in Spenser, so as to provide an electromagnetic mechanism to change the position of an electromagnetic actuator, such that a central orifice of the actuator becomes closed and impinges or locks upon the guidewire, since such a guidewire clamp was well-known for producing an adequate, yet reasonably attainable holding force on the guidewire (see Spenser at col. 6, lines 55-58) and modifying the device of Parmar accordingly would have led to a reasonable expectation of success in holding the guidewire in place according to need (see Spenser at col. 1, lines 55-61).
Regarding claims 2-4, Parmar discloses a second ferromagnetic component, a second external ferromagnet and an uncoupling mechanism comprising the two aforementioned components along with the needle (see pg. 6, lines 10-14 disclosing a second external magnet coupled to a second ferromagnetic actuator coupled to the catheter; the catheter is also coupled to the needle) and the decoupling mechanism is adapted to uncouple reversibly from the second magnet by rotation/additional translation of the second external ferromagnet (such as by pushing or pulling against the support tube of the enclosed catheter assembly, which is interpreted to be reversible; see pg. 20, lines 16-19) or irreversibly uncouple from the second external magnet (such as by a breakaway release; see pg. 20, lines 19-27).
However, Parmar does not appear to disclose that a change in orientation or position of the second ferromagnetic component causes the second ferromagnetic component to impinge upon and lock onto the needle.
Spenser discloses a mechanism for coupling and decoupling from a guidewire, comprising an actuator with a central orifice that can impinge, crimp and lock on an elongated member to hold it in place (see Fig. 6a-6b showing a guidewire crimping component 64 and a guidewire 100 held in place by the component 64, which is actuated by a spring 61). Further, Spenser teaches that the actuator can be electromagnetically actuated (see col. 6, lines 50-58), such that it is understand that a magnetic decoupling mechanism could act on the actuator to perform the impinging, crimping and locking function.
A skilled artisan would have found it obvious at the time of the invention to modify the device of Parmar, according to the teaching in Spenser, so as to provide an electromagnetic mechanism to change the position of an electromagnetic actuator, such that a central orifice of the actuator becomes closed and impinges or locks upon the needle, in order to produce an adequate, yet reasonably attainable holding force on the needle (see Spenser at col. 6, lines 55-58); modifying the device of Parmar accordingly would have led to a reasonable expectation of success in holding the needle in place according to need (see Spenser at col. 1, lines 55-61).
Regarding claim 10, Parmar discloses that the sterile enclosed tube further comprises a catheter 35b (see Parmar at Fig. 5), wherein the catheter is coupled with a catheter magnetic actuator 35a, 34 (see Fig. 5) and wherein the catheter magnetic actuator has a corresponding external catheter magnetic actuator (catheter rotor translator 23).
Regarding claim 12, Parmar discloses a dilator 50 (see Fig. 9) which has mounted over it a vascular introducer sheath tube or drainage catheter 43 (see Fig. 9).
Regarding claim 13, Parmar discloses that the ferromagnetic component comprises a ring magnet adapted to change from dipole to quadrupole field shape (see an encircling dipole magnetic array, which would be understood to change field shape from dipole to quadrupole; see pg. 17, lines 17-19).
Regarding claim 15, Parmar discloses that the needle, guidewire, dilator and sheath is each independently controlled through the sterile enclosed tube via its own dedicated magnetic actuator (see actuators 6, 23, 27, 34).
Regarding claim 16, Parmar discloses a second ferromagnetic component 36 (see Fig. 2) within the sterile tube, a second external ferromagnet 2 mounted outside the sterile tube; wherein the second ferromagnetic component is coupled to the needle and to the second external ferromagnet (see pg. 6, lines 10-12, disclosing the second ferromagnetic component coupled to the second external ferromagnet coupled to the catheter; the catheter is coupled to the needle).
Regarding claims 17 and 18, Parmar discloses a dilator 50 (see Fig. 9) and a sheath 43 (see Fig. 9), but does not appear to disclose the third ferromagnetic component within the sterile tube, a third external ferromagnet mounted outside the sterile tube, wherein the third ferromagnetic component is coupled to the dilator and to the third external ferromagnet; and a fourth ferromagnetic component within the sterile tube, a fourth external ferromagnet mounted outside the sterile tube, wherein the fourth ferromagnetic component is coupled to the sheath and to the fourth external ferromagnet.
However, Parmar teaches that the apparatus is designed to contain multiple magnetic actuators, or at least two such actuators, for actuating various parts of the apparatus (see pg. 6, lines 10-20), and that the design of the system allows the operator to manipulate endovascular tools through a typical Seldinger technique without moving positions to grasp such tools (see pg. 4, lines 17-26).
Accordingly, a skilled artisan would have found it obvious to modify the apparatus of Parmar to include a third and a fourth ferromagnet, coupled to respective third and fourth ferromagnetic components and to other components such as a dilator and a sheath, respectively, as such a modification would not have resulted in undue experimentation and would have been useful for the operator to manipulate additional tools without moving positions to grasp such tools, with a reasonable expectation of success.
Regarding claim 20, Parmar discloses that the uncoupling mechanism further comprises a capability to change the shape of a magnetic field about the first external ferromagnet (see an encircling dipole magnetic array, which would be understood to change field shape from dipole to quadrupole; see pg. 17, lines 17-19), which constitutes a change in the shape magnetic field of the first external magnet relative to a magnetic field of the first ferromagnetic component by rotation and/or translation of the first external ferromagnet.
Regarding claim 21, Parmar discloses a guidewire placement apparatus, comprising: a sterile enclosed tube 29 (see Fig. 23) comprising: a needle (known from the Seldinger technique; see pg. 4, line 24), a catheter 35b (see Fig. 4), and a first ferromagnetic component 34 (with linkage 35a) coupled to the catheter (see pg. 12, lines 13-14 disclosing centrally fenestrated magnetic elements 34 coupled to the catheter 35b);
a first external ferromagnet 23 (see Fig. 3; see pg. 5, line 16, disclosed to be a “second external magnet”, but for mapping this element to the claimed invention it is interpreted to be a “first external ferromagnet”) mounted outside of the sterile enclosed tube (see also pg. 6, lines 6-8 describing external magnets and pg. 10, lines 25-27 disclosing that 23 mounts to the catheter 35b),
wherein the catheter passes through an opening of the first ferromagnetic component (see Fig. 5, showing the catheter passing through an opening in the element 35a of the first ferromagnetic component),
wherein the first ferromagnetic component is coupled to the first external ferromagnet (see pg. 6, lines 11-12; the external magnet 23 is coupled to the second ferromagnetic actuator, which is coupled to the catheter);
wherein the largest dimension of the enclosed tube is the length direction (pg. 6, lines 5-6) and wherein the first external ferromagnet is translatable in the direction of the length of the sterile enclosed tube (pg. 6, lines 17-18 disclosing that the “second external magnet” is translatable in the direction of the length of the enclosed tube); and
wherein the catheter is coupled to the first external ferromagnet via the first ferromagnetic component (see pg. 6, lines 11-12; the external magnet 23 is coupled to the second ferromagnetic actuator, which is coupled to the catheter),
wherein translation of the first external ferromagnet causes translation of the catheter via translation of the first ferromagnetic component (pg. 6, lines 17-18 disclosing that the “second external magnet” is translatable in the direction of the length of the enclosed tube; such translation would expectedly cause translation of the external magnet’s corresponding ferromagnetic component and the catheter coupled thereto);
an uncoupling mechanism comprising the first ferromagnetic component, the first external ferromagnet, and the catheter (i.e., the first ferromagnetic component, first external ferromagnet and catheter are combined to form an “uncoupling mechanism”),
wherein the uncoupling mechanism is adapted to reversibly or irreversibly uncouple the catheter from the first external ferromagnet by rotation and/or additional translation of the first external ferromagnet (see pg. 20, line 14 to pg. 21, line 7, describing various uncoupling mechanisms, e.g., 35a, 36, allowing the catheter to uncouple from the one or more external magnets).
It is noted that Parmar does not appear to disclose that a change in orientation or position of the first ferromagnetic component causes the first ferromagnetic component to impinge on and lock onto the catheter, the ability of the first ferromagnetic component to undergo a change in its orientation or position to impinge upon and lock onto the catheter.
Spenser discloses a mechanism for coupling and decoupling from an elongate member, comprising an actuator with a central orifice that can impinge, crimp and lock on to the member to hold it in place (see Fig. 6a-6b showing a guidewire crimping component 64 and a member 100 held in place by the component 64, which is actuated by a spring 61). Further, Spenser teaches that the actuator can be electromagnetically actuated (see col. 6, lines 50-58), such that it is understand that a magnetic decoupling mechanism could act on the actuator to perform the impinging and locking function.
A skilled artisan would have found it obvious at the time of the invention to modify the device of Parmar, according to the teaching in Spenser, so as to provide an electromagnetic mechanism to change the position of an electromagnetic actuator, such that a central orifice of the actuator becomes closed and impinges or locks upon the catheter, since such a clamp for locking on an elongate member was well-known for producing an adequate, yet reasonably attainable holding force on the member (see Spenser at col. 6, lines 55-58) and modifying the device of Parmar accordingly would have led to a reasonable expectation of success in holding the catheter in place according to need (see Spenser at col. 1, lines 55-61).
Regarding claim 22, Parmar discloses a second ferromagnetic component 34 (pg. 6, line 3), a second external ferromagnet (another magnet 23), and an uncoupling mechanism comprising the second ferromagnetic component, the second external ferromagnet, and the needle (i.e., the second ferromagnetic component, second external ferromagnet and needle are combined to form an “uncoupling mechanism”),
wherein the second ferromagnetic component is coupled to the needle and to the second external ferromagnet, wherein the uncoupling mechanism is adapted to reversibly or irreversibly uncouple the needle from the second external ferromagnet by rotation/additional translation of the second external ferromagnet (see pg. 20, line 14 to pg. 21, line 7 describes various uncoupling mechanisms allowing the guidewire or needle to uncouple from the one or more external magnets).
It is noted that Parmar does not appear to disclose that a change in orientation or position of second first ferromagnetic component causes the second ferromagnetic component to impinge on and lock onto the needle, the ability of the first ferromagnetic component to undergo a change in its orientation or position to impinge upon and lock the needle in place.
Spenser discloses a mechanism for coupling and decoupling from a guidewire, comprising an actuator with a central orifice that can impinge, crimp and lock on an elongate member to hold the member in place (see Fig. 6a-6b showing a guidewire crimping component 64 and an elongate member 100 held in place by the component 64, which is actuated by a spring 61). Further, Spenser teaches that the actuator can be electromagnetically actuated (see col. 6, lines 50-58), such that it is understand that a magnetic decoupling mechanism could act on the actuator to perform the impinging, crimping and locking function.
A skilled artisan would have found it obvious at the time of the invention to modify the device of Parmar, according to the teaching in Spenser, so as to provide an electromagnetic mechanism to change the position of an electromagnetic actuator, such that a central orifice of the actuator becomes closed and impinges or locks upon the needle, since an elongate member clamp was well-known for producing an adequate, yet reasonably attainable holding force on the member (see Spenser at col. 6, lines 55-58) and modifying the device of Parmar accordingly would have led to a reasonable expectation of success in holding the needle in place according to need (see Spenser at col. 1, lines 55-61).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Parmar in view of Spenser, further in view of Abitbol (U.S. Pub. 2018/0160885 A1, hereinafter “Abitbol”).
Regarding claim 8, it is noted that Parmar, in view of Spenser, does not appear to disclose that the sterile enclosed tube is suspended from an overhead support.
Abitbol discloses a medical device with a handpiece that can be suspended from an overhead support (see Fig. 3 showing a control section 306 for suspending, overhead, a handpiece 150).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Parmar, in view of Spenser, so that the sterile enclosed tube is suspended from an overhead support, in order to provide a well-known way to support and stabilize the sterile flexible tube with a reasonable expectation of success.
Claims 9 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Parmar in view of Spenser, in view of Abitbol, further in view of Rachlin et al (WO 2015/157727 A2, hereinafter “Rachlin”).
Regarding claims 9 and 23, it is noted that Parmar, in view of Spenser, does not appear to disclose that the sterile enclosed tube is suspended from an overhead support, in particular suspended from an overhead support by a “bungee cord” (interpreted to mean a flexible cord).
Abitbol discloses a medical device with a handpiece that can be suspended from an overhead support (see Fig. 3 showing a control section 306 for suspending, overhead, a handpiece 150).
Further, Rachlin discloses suspending a medical handpiece from a support using a “bungee” cord, interpreted to mean a flexible, elastic cord (see Fig. 15A, bungee cord 1502 holding handpiece 1501 from a support 1503/1504).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Parmar, in view of Spenser, so that the sterile enclosed tube is suspended from an overhead support, using a bungee cord in order to provide a well-known way to support and stabilize the sterile flexible tube with a reasonable expectation of success.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Parmar in view of Spenser, further in view of Chu et al (U.S. Pat. 11,129,737 B2, hereinafter “Chu”).
Regarding claim 11, it is noted that Parmar, in view of Spenser, does not appear to disclose that the guidewire transitions in stiffness from “floppy” (interpreted to mean flexible) at a proximal end to a rigid shaft at a distal end.
Chu discloses a guidewire for a catheter or guidewire placement apparatus, comprising a proximal end having a “floppy” or flexible proximal end, and a rigid distal end (the rigid distal end would form a “shaft” since the guidewire is elongate) (see col. 19, lines 45-57).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Parmar, in view of Spenser, so that the guidewire transitions in stiffness from “floppy” (interpreted to mean flexible) at a proximal end to a rigid shaft at a distal end, in order to avoid causing damage to surrounding tissue during use of the guidewire (see Chu at col. 19, lines 45-57).
Claims 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Parmar in view of Spenser, further in view of Burkholz et al (U.S. Pub. 2017/0348511 A1, hereinafter “Burkholz”).
Regarding claim 14, it is noted that Parmar, in view of Spenser, does not appear to disclose that the guidewire is notched to allow mechanical locking with an internal magnet.
Burkholz discloses a catheter or guidewire placement apparatus comprising a guidewire which is notched to allow mechanical locking with another magnetized feature (see para [0086] disclosing a magnetizable notch in the wire).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Parmar, in view of Pfeffer, so that the guidewire is notched, as a well-known means for interlocking with a magnetized feature, with a reasonable expectation of success.
Regarding claim 19, it is understood that the uncoupling mechanism could be reversibly disengaged and removed, which would result in the first external ferromagnet to be removed from the rest of the apparatus as well.
Response to Arguments
Applicant's arguments filed in the Remarks section of the reply dated 07/07/2025 have been fully considered.
Regarding the rejections under 35 U.S.C. 103, Applicant first argued that the rejection was based on hindsight reasoning (see Remarks, pg. 3).
In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, the case for obviousness was based specifically on the references of Parmar and Spenser; therefore, it does not include knowledge gleaned only from Applicant’s disclosure. Applicant’s request to reconsider the combination of references (see Remarks, pg. 3) has been granted, but the request is not accompanied by specific arguments as to why the obviousness finding was the result of hindsight reconstruction.
Second, Applicant argued that the Examiner’s rejection was “merely conclusory” (see Remarks, pg. 3). However, the Examiner provided the necessary reasoned explanation to support the legal conclusion of obviousness. Specifically, the conclusion of obviousness stated not only that such a guidewire clamp was well-known, but also that it would have produced an adequate, yet reasonably attainable holding force on the guidewire (see Spenser at col. 6, lines 55-58) and that modifying the device of Parmar accordingly would have led to a reasonable expectation of success in holding the guidewire in place according to need (see Spenser at col. 1, lines 55-61).
Third, Applicant argued that Spenser teaches away from the claimed invention (see Remarks, pg. 4). Applicant argued that Spenser’s actuator and locking element produce a higher holding force than the claimed invention. However, neither the claimed invention, nor Spenser, disclose any specific force values that would allow them to be quantitatively compared, much less to the degree sufficient to conclude that Spenser’s force is greater than the claimed invention.
Fourth, Applicant argued that the claimed provides a “synergistic advantage that is absent in the locking mechanism of Spenser” (see Remarks, pg. 4). Applicant may be implying that the claimed invention would provide an unexpected result, because it has been held that evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating “synergism”; citing Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989)).
However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected (see MPEP 716.02(a)). In this case, the effect is expected from the combination of references.
Fifth, Applicant argued that the combination of Parmar and Spenser will result in the claimed invention (see Remarks, pg. 4). But Examiner notes that the prima facie case of obviousness relied on modifying the device of Parmar, according to the teaching in Spenser, so as to provide an electromagnetic mechanism to change the position of an electromagnetic actuator, such that a central orifice of the actuator becomes closed and impinges or locks upon the guidewire, since such a guidewire clamp was well-known for producing an adequate, yet reasonably attainable holding force on the guidewire (see Spenser at col. 6, lines 55-58) and modifying the device of Parmar accordingly would have led to a reasonable expectation of success in holding the guidewire in place according to need (see Spenser at col. 1, lines 55-61). In other words, the prima facie case of obviousness does not rely merely on activating the existing locking mechanism of Spenser by electromagnetic means. Rather, a skilled artisan would have found it obvious to combine Parmar and Spenser so that the first ferromagnetic component had the structure and function identified in the claimed invention, with a reasonable expectation of success. Further, Applicant’s arguments appear to attack the references of Parmar and Spenser individually (e.g., arguing Spenser does not disclose claimed features that the Office action already stated were disclosed in Parmar, and vice-versa), when the case for obviousness was based on a combination of references.
Applicant alleged that claims 8, 9, 11, 14 and 19 were patentable based on their dependency from claim 1 (see Remarks pg. 5), but the merits of the aforementioned claims was not specifically addressed.
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 SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 10/1/2025