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 Arguments
Applicant's arguments filed 7/22/26 have been fully considered but they are not persuasive.
With regard to claims 1 and 12, Applicant argues that “neither Hinchcliffe nor Hebert, alone or in combination, teaches or suggests a navigation system having an ablation element disposed on the inner member or the outer member.” Remarks at 5-7. However, as detailed in infra rejections, Hebert teaches the newly introduced claim feature of “an ablation element disposed on the inner member or the outer member.” For example, Hebert teaches a laser fiber optic element for laser treatment including laser lithotripsy, i.e., ablation of stones/calcifications, disposed on one of the inner catheter/microcatheter/micro-endoscope or outer catheter, [0100], [0104], [0124], [0129], [0153]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of adding a CMOS camera and a laser fiber optic element for laser treatment to one of the inner and outer members to Hinchcliffe’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a CMOS camera and laser fiber optic element to one of the inner and outer members allows for in-vivo visualization systems that are suitable for viewing and/or performing diagnostic and therapeutic modalities in the human body including laser lithotripsy. See, e.g., Hebert, [0048] and [0100]. Therefore, Applicant’s arguments are not persuasive.
With regard to claims 2-4 and 13-15, Applicant further argues that “[t]he Examiner has not established that Hebert's valve structure would be incorporated into Hinchcliffe's adjustable inner/outer member system while also maintaining the claimed locking relationship between the valve, lumen, and inner member.” Remarks at 8. First, there is no indication in the record that Hebert’s valve structure would prevent the claimed locking relationship. Second, as per MPEP 716.01(c) "[t]he arguments of counsel cannot take the place of evidence in the record." In re Schulze, 346 F. 2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)." Third, in response to applicant's argument that Hebert’s valve structure must be bodily incorporated into Hinchliffe’s adjustable inner/outer member system, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Again, Applicant provides no evidence to support Applicant’s allegation that Hebert’s teaching of a rotating hemostatic valve coupled to the inner member cannot be applied to Hinchcliffe’s known inner member and connector coupled to the inner member. The Office has provided evidentiary support including a rationale that this “achieve[s] the predictable result that adding a hemostatic valve allows flushing/irrigation/insufflation that improves the visualization.” Applicant’s bare assertion provides no analysis or evidence to rebut the evidence and rationale of record. See also, MPEP 2141.03 I. (“"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396). Therefore, Applicant’s argument is not persuasive.
With regard to claim 5, Applicant further argues that “Altman's drug reservoir does not necessarily correspond to a fluid mixer integrated with the navigation system lumen and fluid management system as claimed. The Examiner's interpretation effectively treats any reservoir capable of containing multiple fluids as a mixer. However, the claimed fluid mixer provides controlled mixing within the navigation system to facilitate delivery through the device.” First, in response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the claimed fluid mixer provides controlled mixing within the navigation system to facilitate delivery through the device) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 5 merely recites “the fluid management system comprises a fluid mixer.” This encompasses any fluid management system comprising any fluid mixer, the plain meaning of fluid mixer being a chamber/reservoir wherein there is an amount of mixing between two or more fluids within the chamber/reservoir. For example, Applicant’s Fig. 8 shows mixer 860 being a t-shaped lumen/chamber/reservoir that passively accepts input from a connector 850 and a timed infusion element 870 and passively outputs to valve 840. The mixer itself is a passive element that provides a common output for input fluids thereby mixing/combining the fluids. Therefore, as Altman teaches a drug reservoir that passively accepts input of multiple agents and passively outputs, the drug reservoir is similarly a passive element that provides a common output for input fluids thereby mixing/combining the fluids. Moreover, no means or manner of “controlled mixing” as argued by the Applicant is recited in the claim.
Second, Applicant has removed any alleged integration of the fluid management system with the navigation system lumen from claim 1 from which claim 5 depends. In arguendo, in response to applicant's argument that Altman’s drug reservoir must be bodily incorporated into Hinchcliffe in further view of Hebert’s connector and lumen, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Applicant provides no evidence to support Applicant’s allegation that Altman’s drug reservoir cannot be applied to Hinchcliffe in further view of Hebert’s connector and lumen. As per MPEP 716.01(c) "[t]he arguments of counsel cannot take the place of evidence in the record." In re Schulze, 346 F. 2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)."The Office has provided evidentiary support including a rationale that this “achieve[s] the predictable result that this increases workflow flexibility by allowing for drug volume to be loaded before, during or after implantation of the catheter into the body.” Applicant’s bare assertion provides no analysis or evidence to rebut the evidence and rationale of record. See also, MPEP 2141.03 I. (“"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396). Therefore, Applicant’s argument is not persuasive.
With regard to claim 6, Applicant further argues that “Altman's infusion control relates to delivering therapeutic agents through a catheter and does not teach or suggest a timed infusion element integrated into the claimed navigation system having inner and outer members, imaging capability, and an ablation element.” Remarks at 9. First, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Altman alone is not relied upon to teach the combination of features alleged. Applicant must address the combination of teachings relied upon in the rejection of record, Hinchcliffe in further view of Hebert in further view of Altman.
Second, in response to applicant's argument that Altman’s timed agent delivery elements must be bodily incorporated into Hinchcliffe in further view of Hebert’s teachings of a “navigation system having inner and outer members imaging capability, and an ablation element”, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant provides no evidence to support Applicant’s allegation that Altman’s timed agent delivery elements cannot be applied to Hinchcliffe in further view of Hebert’s teachings of a navigation system having inner and outer members imaging capability, and an ablation element. As per MPEP 716.01(c) "[t]he arguments of counsel cannot take the place of evidence in the record." In re Schulze, 346 F. 2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)." The Office has provided evidentiary support including a rationale that this “achieve[s] the predictable result that this allows for controlled dosage of agents.” Applicant’s bare assertion provides no analysis or evidence to rebut the evidence and rationale of record. See also, MPEP 2141.03 I. (“"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396). Therefore, Applicant’s argument is not persuasive.
Applicant further argues that “the Examiner's rejection again relies on combining unrelated teachings without any articulated reason why a skilled artisan would modify Hinchcliffe's guidewire system in this manner.” Remarks at 9. As addressed above, the Office has provided evidentiary support including a rationale that this “achieve[s] the predictable result that this allows for controlled dosage of agents.” Applicant’s bare assertion provides no analysis or evidence to rebut the evidence and rationale of record. Therefore, Applicant’s argument is not persuasive.
With regard to claims 7 and 18, Applicant argues that “Hebert does not teach a flushing element incorporated into the claimed navigation system having an integrated ablation element.” However, as addressed above and detailed in infra rejections, Hinchcliffe in further view of Hebert teaches an ablation element as alleged. Further, as admitted by the Applicant, Hinchcliffe in further view of Hebert teaches the claimed flushing element. Therefore, Applicant’s argument is not persuasive.
With regard to claims 8 and 19, Applicant argues that Hinchcliffe alone does not teach an ablation element. However, as addressed above and detailed in infra rejections, Hinchcliffe in further view of Hebert teaches the claimed ablation element. Therefore, Applicant’s argument is not persuasive.
With regard to new claims 21 and 22, Applicant argues that the references of record do not teach a laser ablation element. However, as detailed in infra rejections, Hinchcliffe in further view of Hebert teaches the claimed laser ablation element. Therefore, Applicant’s argument is not persuasive.
Claims 1-9, 12-15, and 17-22 are pending in the present application. Claims 10-11, and 16 are cancelled. As detailed in infra rejections: claims 1-4, 7-9, and 21 are rejected over the combination of Hinchcliffe and Hebert; claims 5-6 are rejected over the combination of Hinchcliffe and Hebert and Altman; and claims 12-15, 17-20, and 22 are rejected over the combination of Hinchcliffe and Altman and Hebert.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9, 12-15, and 17-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, line 7 and claim 12, line 7 each recite “an ablation element disposed on the inner member or the outer member.” While there is support for “an ablation element disposed on the inner member,” there does not appear to be support for “an ablation element disposed on… the outer member.” Applicant’s specification filed 1/17/25 at paragraph [0028] states “the system may include a laser element to ablate the stones prior to removal.” The specification further states at paragraph [0049] “a laser element (not shown) may be incorporated into the system 400 so that ablation of the stone(s) may be achieved prior to capturing and removing them from the patient. The laser element may be incorporated into the inner member 410, or another member separate from that shown.” Neither paragraph [0028] or [0049] provide support for disposing the ablation element on the outer member as recited. There is only support for disposing the ablation element on the inner member as recited.
Claims 2-9 and 13-15, and 17-22 are rejected as depending from rejected independent claims 1 and 12, respectively.
Claims 2, 5-7, 13, and 17-18 each incorporate the ablation element recited in independent claim 1, line 7 and independent claim 12, line 7, respectively, and recite “the fluid management system.” There does not appear to be support in Applicant’s specification filed 1/17/25 for an embodiment that encompasses the combination/incorporation of an ablation element and a fluid management system.
Claims 3-4 and 14-15 are rejected as depending from rejected claims 2 and 13, respectively.
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 2-7 and 13-18 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.
Claims 2, 5-7, 13, and 17-18 recites the limitation "the fluid management system" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 3-4 and 14-15 are rejected as depending from rejected claims 2 and 13, respectively.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 7-9, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over applicant’s prior art Hinchliffe et al. (U.S. Pub. No. 2010/0305475), hereinafter “Hinchliffe,” in further view of Hebert (U.S. Pub. No. 2014/0135576), hereinafter “Hebert.”
Regarding claim 1, Hinchliffe discloses a navigation system (“medical guidewire system” Abstract) comprising:
an inner member (“a first inner member” [0014]; see also inner, intermediate, and outer members in Figs. 1-2a, and 4-30);
an outer member (“third outer member” [0014]) sized for positioning around the first inner member (“a first inner member having a first outer diameter, a second intermediate member having a second outer diameter larger than the first outer diameter, and a third outer member having a third diameter longer than the second outer diameter” [0014]; see also inner, intermediate, and outer members in Figs. 1-2a, and 4-30);
a lumen between one of the inner and outer members (“The lumen of the outer member forms a gap for fluid flow therethrough” Abstract; “The outer member has a longitudinally extending lumen to receive the inner member… The lumen of the outer member forms a gap for fluid flow therethrough.” [0018]; “an outer member having an inner diameter forming a first lumen… [t]he outer member has a longitudinally extending lumen to receive the intermediate member” [0022]; see also lumens between the outer, intermediate, and inner members in Figs. 1-2a, and 4-30),
a locking element for fixing the inner member to the outer member (The second and third members have an interlocking frictional engagement and the first and second members have a clamping engagement.” [0014]; “The inner member can be selectively lockable with the outer member.” [0019]; “In one embodiment, the inner wire has a locking member thereon movable by engagement with the intermediate member to a locking position to fix the position of the inner and intermediate members, and the intermediate member has a flared handle portion frictionally engageable with the outer member to fix the position of the outer and intermediate members.” [0023]; “Handle portions as used herein include integral handles, separate handles attached to the members or a proximal end portion of the member which interlocks with another member.” [0085]-[0087]; “The members in the embodiment of FIGS. 13-16 have engagement regions with an interlocking feature in the form of a rotational pin and slot arrangement.” [0097]-[0108]; see also locking engagements between the inner, intermediate, and outer members in Figs. 13-16, 22-24, and 27-28).
However, Hinchliffe does not appear to disclose one of the inner and outer members comprises a camera element; and an ablation element disposed on the inner member or the outer member.
However, in the same field of endeavor of surgical navigation instruments, Hebert teaches one of the inner and outer members comprises a camera element (one of the inner catheter/microcatheter/micro-endoscope or outer catheter comprises a complementary metal oxide semi-conductor (CMOS) module, [0022], [0025], [0031]-[0033], [0042]-[0043]; CMOS module is a camera, [0142]); and
an ablation element disposed on the inner member or the outer member (a laser fiber optic element for laser treatment including laser lithotripsy, i.e., ablation of stones/calcifications, disposed on one of the inner catheter/microcatheter/micro-endoscope or outer catheter, [0100], [0104], [0124], [0129], [0153]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of adding a CMOS camera and a laser fiber optic element for laser treatment to one of the inner and outer members to Hinchcliffe’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a CMOS camera and laser fiber optic element to one of the inner and outer members allows for in-vivo visualization systems that are suitable for viewing and/or performing diagnostic and therapeutic modalities in the human body including laser lithotripsy. See, e.g., Hebert, [0048] and [0100].
Regarding claim 2, Hinchcliffe discloses the fluid management system comprises a seal coupled to the inner member (connector couples to the lumen to manage the fluid entering the lumen, [0101]-[0117], Figs. 29-30; connector comprises an internal collar/seal coupled to the inner member, [0110], [0114]).
However, Hinchliffe does not appear to disclose the seal comprises a valve.
However, in the same field of endeavor of surgical navigation instruments, Hebert teaches the fluid management system comprises a valve coupled to the inner member (fluid management system comprises a rotating hemostatic valve (RHV) coupled to the inner catheter, [0041], [0107]-[0114], [0132]-[0135], [0137]-[0139]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of providing a hemostatic valve coupled to the inner catheter to Hinchcliffe’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a hemostatic valve allows flushing/irrigation/insufflation that improves the visualization. See, e.g., [0133]-[0134].
Regarding claim 3, Hinchliffe discloses a fluid connector coupled to the seal and having one or more injection ports (connector coupled to the internal collar/seal and having one or more side arms, [0112], [0116]).
However, Hinchcliffe does not appear to disclose the seal comprises a valve.
However, in the same field of endeavor of surgical navigation instruments, Hebert teaches a fluid connector coupled to the valve and having one or more injection ports (side arm is coupled to the valve wherein the side arm provides access for lubrication, irrigation, and/or insufflation, [0110], [0112]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of providing a hemostatic valve coupled to the inner catheter and a side arm to Hinchcliffe’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a hemostatic valve coupled to a side arm allows flushing/irrigation/insufflation that improves the visualization. See, e.g., [0133]-[0134].
Regarding claim 4, Hinchcliffe discloses the locking member couples the seal to the lumen (knob/lock/interlock couples the internal collar/seal to the lumen of the inner/outer/intermediate member, [0109]-[0117]).
However, Hinchliffe does not appear to disclose the seal comprises a valve.
However, in the same field of endeavor of surgical navigation instruments, Hebert teaches the locking member couples the valve to the lumen (winged hub (luer) and/or end cap couples the valve to the lumen, [0110], [0112], [0114]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of providing a hemostatic valve coupled to the lumen via a luer and/or end cap to Hinchcliffe’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a hemostatic value coupled to the lumen via a luer and/or end cap allows flushing/irrigation/insufflation that improves the visualization. See, e.g., [0133]-[0134].
Regarding claim 7, Hinchcliffe does not appear to disclose the fluid management system comprises a flushing element.
However, in the same field of endeavor of surgical navigation instrument, Hebert teaches the fluid management system comprises a flushing element (connector couples to the lumen to manage the fluid entering the lumen, [0101]-[0117], Figs. 29-30; syringe can be coupled to side arm to introduce fluid, [0036]; side arm is coupled to the valve wherein the side arm provides access for lubrication, irrigation, and/or insufflation, [0110], [0112]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of providing a hemostatic valve coupled to the inner catheter and a side arm that can be coupled to a syringe to introduce fluid to Hinchcliffe’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a hemostatic valve coupled to a side arm coupled to a syringe for introducing fluid allows flushing/irrigation/insufflation that improves the visualization. See, e.g., [0133]-[0134].
Regarding claim 8, Hinchcliffe discloses the outer member (“third outer member” [0014]) has an inner diameter greater than the outer diameter of the inner member (“a first inner member having a first outer diameter, a second intermediate member having a second outer diameter larger than the first outer diameter, and a third outer member having a third diameter longer than the second outer diameter” [0014]; see also inner, intermediate, and outer members in Figs. 1-2a, and 4-30), the outer member comprising a flexible tube having a first distal region with a first flexibility and a second proximal region with a second flexibility, the first flexibility being greater than the second flexibility (laser cut slots, [0088], [0090]; varied spacing between the slots on various portions along the tube to provide areas of different flexibility such as greater flexibility at the distal portion with closer slot spacing and lower flexibility at the proximal portion with farther slot spacing, [0089], [0091]; slots on outer tube, [0090], [0092], see also Figs. 17, 18, 18A, and 18B).
Regarding claim 9, Hinchcliffe discloses the inner member is adjustable to provide for varying diameters or stiffness (“the inner and outer members are relatively slidable to adjust a stiffness of the guidewire system” Abstract; “the third member has a third stiffness greater than the first stiffness of the first member, and the second member is movable with respect to the third member to provide the third member with a second stiffness greater than the third stiffness.” [0015]; “The guidewire system comprises a guidewire 10 have three coaxial members, or in some embodiments two coaxial members, movable with respect to one another to adjust the stiffness and size (outer diameter) of the guidewire.” [0065]; “In use, selective positioning of the three wires with respect to one another varies the diameter of the guidewire being advanced through the vascular system and varies the stiffness of the guidewire.” [0080]).
Regarding claim 21, Hinchcliffe does not appear to disclose the ablation element comprises a laser for tissue ablation.
However, in the same field of endeavor of surgical navigation instruments, Hebert teaches the ablation element comprises a laser for tissue ablation (a laser fiber optic element for laser treatment including laser lithotripsy, i.e., ablation of stones/calcifications, disposed on one of the inner catheter/microcatheter/micro-endoscope or outer catheter, [0100], [0104], [0124], [0129], [0153]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of adding a CMOS camera and a laser fiber optic element for laser treatment to one of the inner and outer members to Hinchcliffe’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a CMOS camera and laser fiber optic element to one of the inner and outer members allows for in-vivo visualization systems that are suitable for viewing and/or performing diagnostic and therapeutic modalities in the human body including laser lithotripsy. See, e.g., Hebert, [0048] and [0100].
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over applicant’s prior art Hinchliffe in further view of Hebert as applied to claim 1 above, and further in view of Altman et al. (U.S. Pub. No. 2002/0177772), hereinafter “Altman.”
Regarding claim 5, while Hinchcliffe discloses a fluid management system (connector couples to the lumen to manage the fluid entering the lumen, [0101]-[0117], Figs. 29-30), Hinchliffe in further view of Hebert does not appear to teach the fluid management system comprises a fluid mixer.
However, in the same field of endeavor of surgical navigation instruments, Altman teaches the fluid management system comprises a fluid mixer (agents such as therapeutic agents and contrast agents may be combined in a drug reservoir, [0079], [0114]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Altman’s known technique of housing agents such as therapeutic agents and contrast agents in a drug reservoir to Hinchliffe in further view of Hebert’s known apparatus providing for injection of various fluids (e.g., Hinchcliffe, [0117]) to achieve the predictable result that this increases workflow flexibility by allowing for drug volume to be loaded before, during or after implantation of the catheter into the body. See, e.g., Altman, [0079].
Regarding claim 6, while Hinchcliffe discloses a fluid management system (connector couples to the lumen to manage the fluid entering the lumen, [0101]-[0117], Figs. 29-30), Hinchcliffe in further view of Hebert does not appear to teach the fluid management system comprises a timed infusion element.
However, in the same field of endeavor of surgical navigation instruments, Altman teaches the fluid management system comprises a timed infusion element (agent delivery over time is controlled using various elements, [0078], [0094], [0124], [0125]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Altman’s known technique of controlling the delivery of agent over time using a control element to Hinchliffe in further view of Hebert’s known apparatus providing for injection of various fluids (e.g., Hinchcliffe, [0117]) to achieve the predictable result that this allows for controlled dosage of agents. See, e.g., Altman, [0078] and [0124].
Claims 12-15, 17-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over applicant’s prior art Hinchliffe in further view of Altman in further view of Hebert.
Regarding claim 12, Hinchliffe discloses a navigation system (“medical guidewire system” Abstract) comprising:
an inner member (“a first inner member” [0014]; see also inner, intermediate, and outer members in Figs. 1-2a, and 4-30);
an outer member (“third outer member” [0014]) sized for positioning around the first inner member (“a first inner member having a first outer diameter, a second intermediate member having a second outer diameter larger than the first outer diameter, and a third outer member having a third diameter longer than the second outer diameter” [0014]; see also inner, intermediate, and outer members in Figs. 1-2a, and 4-30);
a lumen between one of the inner and outer members (“The lumen of the outer member forms a gap for fluid flow therethrough” Abstract; “The outer member has a longitudinally extending lumen to receive the inner member… The lumen of the outer member forms a gap for fluid flow therethrough.” [0018]; “an outer member having an inner diameter forming a first lumen… [t]he outer member has a longitudinally extending lumen to receive the intermediate member” [0022]; see also lumens between the outer, intermediate, and inner members in Figs. 1-2a, and 4-30),
a locking element for fixing the inner member to the outer member (The second and third members have an interlocking frictional engagement and the first and second members have a clamping engagement.” [0014]; “The inner member can be selectively lockable with the outer member.” [0019]; “In one embodiment, the inner wire has a locking member thereon movable by engagement with the intermediate member to a locking position to fix the position of the inner and intermediate members, and the intermediate member has a flared handle portion frictionally engageable with the outer member to fix the position of the outer and intermediate members.” [0023]; “Handle portions as used herein include integral handles, separate handles attached to the members or a proximal end portion of the member which interlocks with another member.” [0085]-[0087]; “The members in the embodiment of FIGS. 13-16 have engagement regions with an interlocking feature in the form of a rotational pin and slot arrangement.” [0097]-[0108]; see also locking engagements between the inner, intermediate, and outer members in Figs. 13-16, 22-24, and 27-28).
However, Hinchcliffe does not appear to disclose the outer member is steerable.
However, in the same field of endeavor surgical navigation instruments, Altman teaches the outer member is steerable (outer steerable guide catheter is steerable and has a lumen through which an inner drug delivery tube is disposed, [0109]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Altman’s known technique of providing for steering of an outer member containing an inner member to Hinchcliffe’s known apparatus providing for an outer member containing an inner member to achieve the predictable result that providing a steerable guide catheter allows for navigation to the region for drug delivery. See, e.g., Altman, [0099].
However, Hinchcliffe in further view of Altman does not appear to teach an ablation element disposed on the inner member or the outer member.
However, in the same field of endeavor of surgical navigation instruments, Hebert teaches an ablation element disposed on the inner member or the outer member (a laser fiber optic element for laser treatment including laser lithotripsy, i.e., ablation of stones/calcifications, disposed on one of the inner catheter/microcatheter/micro-endoscope or outer catheter, [0100], [0104], [0124], [0129], [0153]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of adding a CMOS camera and a laser fiber optic element for laser treatment to one of the inner and outer members to Hinchcliffe in further view of Altman’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a CMOS camera and laser fiber optic element to one of the inner and outer members allows for in-vivo visualization systems that are suitable for viewing and/or performing diagnostic and therapeutic modalities in the human body including laser lithotripsy. See, e.g., Hebert, [0048] and [0100].
Regarding claim 13, Hinchcliffe discloses the fluid management system comprises a seal coupled to the inner member (connector couples to the lumen to manage the fluid entering the lumen, [0101]-[0117], Figs. 29-30; connector comprises an internal collar/seal coupled to the inner member, [0110], [0114]).
However, Hinchliffe does not appear to disclose the seal comprises a valve.
However, in the same field of endeavor of surgical navigation instruments, Hebert teaches the fluid management system comprises a valve coupled to the inner member (fluid management system comprises a rotating hemostatic valve (RHV) coupled to the inner catheter, [0041], [0107]-[0114], [0132]-[0135], [0137]-[0139]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of providing a hemostatic valve coupled to the inner catheter to Hinchcliffe in further view of Altman’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a hemostatic valve allows flushing/irrigation/insufflation that improves the visualization. See, e.g., [0133]-[0134].
Regarding claim 14, Hinchliffe discloses a fluid connector coupled to the seal and having one or more injection ports (connector coupled to the internal collar/seal and having one or more side arms, [0112], [0116]).
However, Hinchcliffe does not appear to disclose the seal comprises a valve.
However, in the same field of endeavor of surgical navigation instruments, Hebert teaches a fluid connector coupled to the valve and having one or more injection ports (side arm is coupled to the valve wherein the side arm provides access for lubrication, irrigation, and/or insufflation, [0110], [0112]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of providing a hemostatic valve coupled to the inner catheter and a side arm to Hinchcliffe in further view of Altman’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a hemostatic valve coupled to a side arm allows flushing/irrigation/insufflation that improves the visualization. See, e.g., [0133]-[0134].
Regarding claim 15, Hinchcliffe discloses the locking member couples the seal to the lumen (knob/lock/interlock couples the internal collar/seal to the lumen of the inner/outer/intermediate member, [0109]-[0117]).
However, Hinchliffe does not appear to disclose the seal comprises a valve.
However, in the same field of endeavor of surgical navigation instruments, Hebert teaches the locking member couples the valve to the lumen (winged hub (luer) and/or end cap couples the valve to the lumen, [0110], [0112], [0114]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of providing a hemostatic valve coupled to the lumen via a luer and/or end cap to Hinchcliffe in further view of Altman’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a hemostatic value coupled to the lumen via a luer and/or end cap allows flushing/irrigation/insufflation that improves the visualization. See, e.g., [0133]-[0134].
Regarding claim 17, while Hinchliffe discloses a fluid management system (connector couples to the lumen to manage the fluid entering the lumen, [0101]-[0117], Figs. 29-30), Hinchliffe does not appear to disclose the fluid management system comprises a timed infusion element.
However, in the same field of endeavor of surgical navigation instruments, Altman teaches the fluid management system comprises a timed infusion element (agent delivery over time is controlled using various elements, [0078], [0094], [0124], [0125]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Altman’s known technique of controlling the delivery of agent over time using a control element to Hinchliffe’s known apparatus providing for injection of various fluids (e.g., Hinchcliffe, [0117]) to achieve the predictable result that this allows for controlled dosage of agents. See, e.g., Altman, [0078] and [0124].
Regarding claim 18, while Hinchliffe discloses a fluid management system (connector couples to the lumen to manage the fluid entering the lumen, [0101]-[0117], Figs. 29-30), Hinchcliffe does not appear to disclose the fluid management system comprises a flushing element.
However, in the same field of endeavor of surgical navigation instrument, Hebert teaches the fluid management system comprises a flushing element (syringe can be coupled to side arm to introduce fluid, [0036]; side arm is coupled to the valve wherein the side arm provides access for lubrication, irrigation, and/or insufflation, [0110], [0112]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of providing a hemostatic valve coupled to the inner catheter and a side arm that can be coupled to a syringe to introduce fluid to Hinchcliffe in further view of Altman’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a hemostatic valve coupled to a side arm coupled to a syringe for introducing fluid allows flushing/irrigation/insufflation that improves the visualization. See, e.g., [0133]-[0134].
Regarding claim 19, Hinchcliffe discloses the outer member (“third outer member” [0014]) has an inner diameter greater than the outer diameter of the inner member (“a first inner member having a first outer diameter, a second intermediate member having a second outer diameter larger than the first outer diameter, and a third outer member having a third diameter longer than the second outer diameter” [0014]; see also inner, intermediate, and outer members in Figs. 1-2a, and 4-30), the outer member comprising a flexible tube having a first distal region with a first flexibility and a second proximal region with a second flexibility, the first flexibility being greater than the second flexibility (laser cut slots, [0088], [0090]; varied spacing between the slots on various portions along the tube to provide areas of different flexibility such as greater flexibility at the distal portion with closer slot spacing and lower flexibility at the proximal portion with farther slot spacing, [0089], [0091]; slots on outer tube, [0090], [0092], see also Figs. 17, 18, 18A, and 18B).
Regarding claim 20, Hinchcliffe discloses the inner member is adjustable to provide for varying diameters or stiffness (“the inner and outer members are relatively slidable to adjust a stiffness of the guidewire system” Abstract; “the third member has a third stiffness greater than the first stiffness of the first member, and the second member is movable with respect to the third member to provide the third member with a second stiffness greater than the third stiffness.” [0015]; “The guidewire system comprises a guidewire 10 have three coaxial members, or in some embodiments two coaxial members, movable with respect to one another to adjust the stiffness and size (outer diameter) of the guidewire.” [0065]; “In use, selective positioning of the three wires with respect to one another varies the diameter of the guidewire being advanced through the vascular system and varies the stiffness of the guidewire.” [0080]).
Regarding claim 22, Hinchcliffe in further view of Altman does not appear to teach the ablation element comprises a laser for tissue ablation.
However, in the same field of endeavor of surgical navigation instruments, Hebert teaches the ablation element comprises a laser for tissue ablation (a laser fiber optic element for laser treatment including laser lithotripsy, i.e., ablation of stones/calcifications, disposed on one of the inner catheter/microcatheter/micro-endoscope or outer catheter, [0100], [0104], [0124], [0129], [0153]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Hebert’s known technique of adding a CMOS camera and a laser fiber optic element for laser treatment to one of the inner and outer members to Hinchcliffe’s known system comprising an outer sheath and inner member to achieve the predictable result that adding a CMOS camera and laser fiber optic element to one of the inner and outer members allows for in-vivo visualization systems that are suitable for viewing and/or performing diagnostic and therapeutic modalities in the human body including laser lithotripsy. See, e.g., Hebert, [0048] and [0100].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Clerc et al. (U.S. Pub. No. 2012/0041534) discloses a camera navigation system with an inner member, a middle member, and an outer member with diameters selected such that the inner member is disposed within the middle member and the middle member is disposed within the outer member with a proximally positioned camera embedded within or attached to the outer member to monitor therapeutic/surgical procedures performed using the distal end of the navigation system.
Crowley et al. (U.S. Patent No. 6,004,269) discloses a catheter navigation system with a guidewire and an inner and outer member wherein the outer member has a lumen containing the inner member and a gap between the inner member and the outer member, the outer member is a flexible tube with differing inflatable regions of flexibility, an ultrasonic visualization element, and a locking element that locks the inner and outer members to one another.
Sadaat et al. (U.S. Pub. No. 2007/0293724) discloses placement of a camera on or in the inner member of a guidewire device.
Igov (U.S. Pub. No. 2015/0080933), Ellman (U.S. Pub. No. 2016/0000514), and Hausen (U.S. Pub. No. 2005/0182437) disclose placement of a camera on or in the outer sheath of a guidewire device with internal lumens and members.
Altman (U.S. Patent No. 6,547,787) discloses a navigation system with an inner and outer member and fluid management system coupled to the lumen between one of the inner and outer members.
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.
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/J.M./Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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