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 .
Detailed Action
This is in response to the non-provisional application filed 12/19/2023.
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 13-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication Number 2022/0233263 (Canale et al.)
Regarding claim 13-16, Canale et al. discloses as shown in Figure 3, a system for performing a vascular procedure, comprising: a robotic drive system (support arm 70, linear member 60 via a stage 62a-d, stage translation motors 64a-d, see paragraph [0168], [0169]); a multi-catheter assembly comprising: a first subset of interventional devices (device modules 32a, 32b, see paragraph [0157]) coupled to the robotic drive system; and a second subset of interventional devices (device modules 32c, 32d, see paragraph [0157]) removably coupled to the first subset of interventional devices; wherein the multi-catheter assembly is configured to be robotically driven by the robotic drive system to achieve supra-aortic access while the second subset of interventional devices is coupled to the first subset of interventional devices, and wherein the second subset of interventional devices is capable of being manually driven to a vascular site while the second subset of interventional devices is uncoupled from the first subset of interventional devices (if the second subset of interventional devices are removed from the first subset by hand and manipulated by hand), wherein the second subset of interventional devices is capable of performing a vascular procedure, wherein the vascular procedure comprises a vascular thrombectomy, wherein the first subset of interventional devices is coaxially nested with the second subset of interventional devices. See paragraphs [0004], [0155].
Regarding claims 17, 18 Canale et al. discloses wherein the first subset of interventional devices comprises an access catheter and a guidewire, wherein the second subset of interventional devices comprises a procedure catheter and a guide catheter. See paragraphs [0148]. [0168].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claim(s) 1, 2, 4-6, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2022/0233263 (Canale et al.) in view of U.S. Patent Publication Number 2012/0232476 (Bhat et al.)
Regarding claim 1, Canale et al. discloses as shown in Figure 3, a method of performing a vascular procedure, comprising: providing a multi-catheter assembly comprising a first subset of interventional devices (device modules 32a, 32b, see paragraph [0157]) and a second subset of interventional devices (device modules 32c, 32d, see paragraph [0157]) detachably couplable to the first subset of interventional devices; coupling the first subset of interventional devices to a robotic drive system (support arm 70, linear member 60 via a stage 62a-d, stage translation motors 64a-d, see paragraph [0168], [0169]); robotically driving the multi-catheter assembly to supra-aortic access (see paragraph [0155] which discloses neurovascular which would necessarily require supra-aortic access) while the second subset of interventional devices is coupled to the first subset of interventional devices; and performing a vascular procedure using the second subset of interventional devices.
Canale et al. fails disclose uncoupling the second subset of interventional devices from the first subset of interventional devices; manually driving the second subset of interventional devices to a procedure site.
Bhat et al. from the same filed of endeavor teaches a similar method as shown in Figure 2, where the method includes the step of uncoupling an interventional device and manually driving the interventional devices, for the purpose of proving a safety precaution. See paragraph [0034].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Canale et al. to include the step of uncoupling for each of the second subset of interventional devices and manually driving each of the second subset of interventional devices such that the method included uncoupling the second subset of interventional devices from the first subset of interventional devices; manually driving the second subset of interventional devices to a procedure site in order to provide a safety precaution and allow more precise control over the second subset of interventional devices.
Regrading claim 2, Canale et al. discloses wherein the first subset of interventional devices comprises an access catheter. See paragraphs [0148]. [0168].
Regarding claims 4, 5, 12, Canale et al. discloses wherein the first subset of interventional devices comprises a guidewire, wherein the second subset of interventional devices comprises a procedure catheter and a guide catheter, wherein the second subset of interventional devices comprises a guidewire. See paragraphs [0148]. [0168].
Regarding claim 6, while Canale fails to specifically disclose wherein the vascular procedure comprises a neurovascular thrombectomy, only neurovascular interventional procedure in paragraph [0155]. Canale does acknowledge thrombectomy as a type of neurovascular interventional procedure. See paragraph [0004].
Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Canale such that the neurovascular interventional procedure was a neurovascular thrombectomy in order to treat a neurovascular thrombectomy.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2022/0233263 (Canale et al.) in view of U.S. Patent Publication Number 2012/0232476 (Bhat et al.) as applied to claim 2 above, and further in view of U.S. Patent Publication Number 2011/0257611 (Choi)
Regarding claim 3, Canale et al. fails to disclose wherein coupling the first subset of interventional devices to the robotic drive system comprises magnetically coupling a hub of the access catheter to a first drive magnet.
Choi, from the same field of endeavor teaches a similar method as shown in Figure 1 wherein coupling the first subset of interventional devices to the robotic drive system comprises magnetically coupling a hub (cannula module) of an access catheter to a first drive magnet. See paragraph [0022].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Canale et al. such that coupling the first subset of interventional devices to the robotic drive system comprises magnetically coupling a hub of the access catheter to a first drive magnet as taught by Choi in order to magnetically couple the the first subset of interventional devices to the robotic drive system.
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2022/0233263 (Canale et al.) in view of U.S. Patent Publication Number 2012/0232476 (Bhat et al.) as applied to claim 2 above, and further in view of U.S. Patent Publication Number 2002/0019608 (Mason et al.)
Regarding claim 7, Canale et al. fails to disclose wherein the procedure catheter is detachably couplable to the access catheter or a hub of the access catheter via a luer lock or a hemostatic valve.
Mason et al., from the same field of endeavor teaches a similar method as shown in Figure 1, where a procedure catheter (56) is detachably couplable to the access catheter (62) or a hub of the access catheter via a luer lock or a hemostatic valve. See paragraph [0024].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Canale to include the luer locks taught by Mason such that the procedure catheter is detachably couplable to the access catheter or a hub of the access catheter via a luer lock or a hemostatic valve, in order to fixedly couple the interventional devices disclosed by Canale et al.
Regarding claim 8, Canale in view of Bhat fail to explicitly disclose wherein uncoupling the second subset of interventional devices from the first subset of interventional devices comprises uncoupling the procedure catheter from the access catheter or the hub of the access catheter.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to include the step of uncoupling the procedure catheter from the access catheter or the hub of the access catheter in order to manually drive the procedure catheter as a safety precaution (as suggested by Bhat).
Regarding claim 9, Canale et al. fails to wherein the guide catheter is detachably couplable to the procedure catheter via a luer lock or a hemostatic valve.
Mason et al., from the same field of endeavor teaches a similar method as shown in Figure 1, where a procedure catheter (56) is detachably couplable to a guide catheter (62) or a hub of the access catheter via a luer lock or a hemostatic valve. See paragraph [0024].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Canale to include the luer locks taught by Mason such that wherein the guide catheter is detachably couplable to the procedure catheter via a luer lock or a hemostatic valve, in order to fixedly couple the interventional devices disclosed by Canale et al.
Regarding claim 10, Canale in view of Bhat fail to explicitly disclose uncoupling the guide catheter from the procedure catheter.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to include the step of uncoupling the guide catheter from the procedure catheter in order to manually drive the procedure catheter as a safety precaution (as suggested by Bhat).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2022/0233263 (Canale et al.) in view of U.S. Patent Publication Number 2012/0232476 (Bhat et al.) as applied to claim 5 above, and further in view of U.S. Patent Publication Number 2006/0009737 (Whiting et al.)
Regarding claim 11, Canale fails to disclose proximally removing the access catheter prior to performing the vascular procedure using the procedure catheter.
Whiting et al., from the same field of endeavor teaches a similar method as shown in Figure 1 where the method includes proximally removing the access catheter prior to performing the vascular procedure using the procedure catheter. See claim 38.
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Canale to include the step of removing the access catheter prior to performing the vascular procedure using the procedure catheter in order to reduce the chance of damaging the body accidently.
Claim(s) 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2022/0233263 (Canale et al.) in view of U.S. Patent Publication Number 2002/0019608 (Mason et al.)
Regarding claim 19, Canale et al. fails to disclose wherein the procedure catheter is detachably couplable to the access catheter or a hub of the access catheter via a luer lock or a hemostatic valve.
Mason et al., from the same field of endeavor teaches a similar method as shown in Figure 1, where a procedure catheter (56) is detachably couplable to the access catheter (62) or a hub of the access catheter via a luer lock or a hemostatic valve. See paragraph [0024].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Canale to include the luer locks taught by Mason such that the procedure catheter is detachably couplable to the access catheter or a hub of the access catheter via a luer lock or a hemostatic valve, in order to fixedly couple the interventional devices disclosed by Canale et al.
Regarding claim 20, Canale in view of Bhat fail to explicitly disclose wherein uncoupling the second subset of interventional devices from the first subset of interventional devices comprises uncoupling the procedure catheter from the access catheter or the hub of the access catheter.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to include the step of uncoupling the procedure catheter from the access catheter or the hub of the access catheter in order to manually drive the procedure catheter as a safety precaution (as suggested by Bhat).
Regarding claim 21, Canale et al. fails to wherein the guide catheter is detachably couplable to the procedure catheter via a luer lock or a hemostatic valve.
Mason et al., from the same field of endeavor teaches a similar method as shown in Figure 1, where a procedure catheter (56) is detachably couplable to a guide catheter (62) or a hub of the access catheter via a luer lock or a hemostatic valve. See paragraph [0024].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Canale to include the luer locks taught by Mason such that wherein the guide catheter is detachably couplable to the procedure catheter via a luer lock or a hemostatic valve, in order to fixedly couple the interventional devices disclosed by Canale et al.
Regarding claim 22, Canale in view of Bhat fail to explicitly disclose uncoupling the guide catheter from the procedure catheter.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to include the step of uncoupling the guide catheter from the procedure catheter in order to manually drive the procedure catheter as a safety precaution (as suggested by Bhat).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RICHARD G LOUIS/ Primary Examiner, Art Unit 3771