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 Interpretation
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 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
receiving module in claims 6, 7, 13, and 19-20.
steering drive module in claims 6, 7, and 13.
electrically powered actuator module in claim 1.
axial drive module in claims 6, 7, 13, and 14.
control module in claims 15 and 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Paragraph 0038 of the provided specification defines the receiving module as a “robotic catheter cradle”. Paragraph 0038 of the provided specification defines the steering drive module as “a drive member and an actuator”. Paragraph 0086 of the provided specification defines the electrically powered actuator module as an “actuator”. Paragraph 0099 of the provided specification defines the axial drive module as an “actuator”. Paragraph 0053 of the provided specification defines the control module as a “processor”.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 6 is objected to because of the following informalities:
in claim 6, line 9: the comma after “and” should be deleted.
Appropriate correction is required.
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 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.
Claim 25 is 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 25 states that the “steerable sheath is sutured into a blood vessel of the patient”. There is insufficient support in the specification as to how the steerable sheath can still move and be controlled while being attached to a blood vessel. Furthermore, the specification fails to provide any support for suturing the steerable sheath to the patient.
Claims 6-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 6, it is unclear what is meant by “controllably deflected” in line 9. A sheath can be controlled to be deflected, but the term “controllably deflected” is unclear,
Claim 19 recites the limitation "the axis of rotation relative to the frame" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the term “relatives a relative term which renders the claim indefinite. The term “axis of rotation relative to the frame” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Any axis of rotation could be relative to the frame.
The term “substantially parallel” in claim 20 in line 2 is a relative term which renders the claim indefinite. The term “substantially parallel” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Either something is parallel or it is not.
In regards to claim 21, it is unclear what is meant by “monitor configured to monitor a visual display of a status in the steerable sheath” in lines 1-2. A monitor is a type of display. It is unclear how a monitor can monitor something. For purposes of examination, the claim is being interpreted as “monitor configured to display a visual display of a status in the steerable sheath”.
In regards to claim 22, it is unclear how a monitor can comprise an optical sensor. For purposes of examination the claim is being interpreted as “wherein the apparatus comprises an optical sensor”.
In regards to claim 23, it is unclear how a monitor can comprise a magnetic sensor. For purposes of examination, the claim is being interpreted as “wherein the apparatus comprises a magnetic sensor”.
In regards to claim 25 it is unclear how the steerable sheath can be moved if it is sutured to the patient. If the user tried to move the sheath it would either not move or rip out stitches.
Also, claims 13, 20, and 25 each reads as a method step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claims not explicitly rejected above are rejected because they depend from claims rejected above as indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism
.
Claims 13, 16, and 25 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). According to one interpretation, Claims 13 and 16 claim the human body in the form of “the patient” as part of the claimed apparatus. Also, according to one interpretation, Claim 25 requires the human body as part of the claimed apparatus with the expression “ wherein the steerable sheath is sutured into a blood vessel of the patient” in lines 1-2.
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.
Claims 6, 13-14, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz (US 20140257333 A1) in view of Popovic (US 20160338787 A).
In regards to claim 6, Blumenkranz teaches an apparatus comprising:
a receiving module ([0057] manipulator assembly 202) extending along a longitudinal axis and configured to releasably receive at least a handle of a steerable sheath after a distal end of the steerable sheath has been manually introduced into a patient independently of the receiving module ([0057] manual actuator 220, interventional instrument 210 includes a handpiece 212 and a flexible body 214);
a steering drive module configured to robotically operate at least one interface of the handle to selectively control an powered actuator module of the handle to actuate at least one guidewire of the steerable sheath such that a distal end of the steerable sheath is controllably deflected ([0075] drive inputs engage with a motorized drive mechanism);
and an axial drive module configured to robotically translate the steerable sheath ([0057] the manipulator assembly 202 includes an insertion drive 206 and a pitch and/or yaw drive 208.).
Blumenkranz fails to teach an electrically powered actuator module of the handle. Popovic teaches a steerable guidewire controlled with an electrically powered actuator ([0015]). It would have been prima facie obvious to a person of ordinary skill in the art to substitute the drive systems of Blumenkranz with an electrically powered actuator like the one described in Popovic. Doing so would merely be a simple substitution of one known element for another (an electrically powered rotational actuator for a mechanically powered rotational actuator) to obtain predictable results.
In regards to claim 13, modified Blumenkranz teaches the apparatus of claim 6, wherein manual introduction of the steerable sheath into the patient comprises insertion of the distal end into the patient independent of an introducer associated with at least one of the receiving module, the steering drive module, and the axial drive module (Blumenkranz [0059] “With the instrument 210 disconnected from the assembly 202, the instrument 210 can be held directly by a user, and the user manually advances or withdraws the flexible body”).
In regards to claim 14, modified Blumenkranz teaches the apparatus of claim 6, wherein the axial drive module is configured to robotically insert the steerable sheath (Blumenkranz [0057-0058]). Modified Blumenkranz does not explicitly teach the axial drive module extracting the steerable sheath. However, it would be prima facie obvious to a person of ordinary skill in the art that if the module is capable of moving to insert the sheath then it is also capable of extracting it.
In regards to claim 20, modified Blumenkranz teaches the apparatus of claim 6, wherein translate the steerable sheath comprises translating the receiving module in a direction substantially parallel to the longitudinal axis (Blumenkranz [0083]).
In regards to claim 21, modified Blumenkranz teaches the apparatus of claim 6, wherein the receiving module further comprises a monitor configured to display a visual display of a status in the steerable sheath (Blumenkranz [0046]).
In regards to claim 22, modified Blumenkranz teaches the apparatus of claim 21, comprising an optical sensor (Blumenkranz [0057] optical fiber 216).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz (US 20140257333 A1) in view of Popovic (US 20160338787 A1) as applied to claim 6, in view of Hauck (US 20070185404 A1).
In regards to claim 7, Blumenkranz in view of Popovic teaches the apparatus of claim 6, wherein the receiving module, the steering drive module, and the axial drive module are configured such that the steerable sheath may, without the distal end being withdrawn from the patient, be removed by a human operator from the receiving module into a manual mode that permits mechanically independent manual operation of the steerable sheath from the handle to the patient ([0059]). Blumenkranz in view of Popovic fails to teach the operator using the same interface as the steering drive module. Hauck teaches a steering drive module interacting with an interface (Fig 7 actuator 58), and then a user controlling the same catheter in manual mode using the same interface (Fig 9 actuator 58). It would have been prima facie obvious to a person of ordinary skill in the art to modify the drive system of Blumenkranz in view of Popovic so that the user can interact with it as well to control the electronic actuator like the device of Hauck. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the user to control the motorized drive mechanism of Blumenkranz in view of Popovic while in manual mode thereby allowing more user control.
In regards to claim 8, Blumenkranz in view of Popovic teaches the apparatus of claim 6. Blumenkranz in view of Popovic fails to teach a device wherein the at least one interface is configured to be manually manipulated by a human operator. Hauck teaches a steering drive module interacting with an interface (Fig 7 actuator 58), and then a user controlling the same catheter in manual mode using the same interface (Fig 9 actuator 58). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the drive system of Blumenkranz in view of Popovic so that the user can interact with it as well to control the electronic actuator like the device of Hauck. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of allowing the user to control the motorized drive mechanism of Blumenkranz in view of Popovic while in manual mode thereby allowing more user control.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz (US 20140257333 A1) in view of Popovic (US 20160338787 A1) in view of Hauck (US 20070185404 A1) as applied to claim 8, further in view of Bedell (US 20120203142 A1).
In regards to claim 9, modified Blumenkranz teaches the apparatus of claim 8. Modified Blumenkranz fails to teach a device wherein the at least one interface comprises a collar rotatable about the handle. Badell teaches a collar rotatable about the handle as a user interface ([0028] cylinder 150).It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to make the drive input of the motorized drive mechanism of Modified Blumenkranz a collar rotatable about the handle like the interface of Badell. Doing so would merely be choosing from a finite number of identified, predictable solutions (collar, buttons, lever, joystick, touchpad) with a reasonable expectation of success in order to control the motors.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz (US 20140257333 A1) in view of Popovic (US 20160338787 A1) in view of Hauck (US 20070185404 A1) as applied to claim 8, further in view of Shelton (US 20190200977 A1).
In regards to claim 10, modified Blumenkranz teaches the apparatus of 8. Modified Blumenkranz fails to teach a device wherein the at least one interface comprises a linear slide. Shelton teaches a linear slide to control a motor ([1346]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to make the drive input of the motorized drive mechanism of modified Blumenkranz a slide that both the steering drive module and user can interact with like the interface of Shelton. Doing so would merely be choosing from a finite number of identified, predictable solutions (collar, buttons, lever, joystick, touchpad, linear slide) with a reasonable expectation of success in order to control the motors.
In regards to claim 11, modified Blumenkranz teaches the apparatus of claim 8. Modified Blumenkranz fails to teach a device wherein the at least one interface comprises a lever. Shelton teaches a lever for controlling a motor ([1346]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to make the drive input of the motorized drive mechanism of modified Blumenkranz a lever that both the steering drive module and user can interact with like the interface of Shelton. Doing so would merely be choosing from a finite number of identified, predictable solutions (collar, buttons, lever, joystick, touchpad, linear slide) with a reasonable expectation of success in order to control the motors.
In regards to claim 12, modified Blumenkranz teaches the apparatus of claim 8. Modified Blumenkranz fails to teach a device wherein the at least one interface comprises an electronic touch input. Shelton teaches a touch input for controlling a motor ([1346]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to make the drive input of the motorized drive mechanism of modified Blumenkranz a touch input that both the steering drive module and user can interact with like the interface of Shelton. Doing so would merely be choosing from a finite number of identified, predictable solutions (collar, buttons, lever, joystick, touchpad, linear slide) with a reasonable expectation of success in order to control the motors.
Claims 15, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz (US 20140257333 A1) in view of Popovic (US 20160338787 A1) as applied to claim 6, further in view of Marchand (US 20080065011 A1).
In regards to claim 15, Blumenkranz in view of Popovic teaches the apparatus of claim 6, further comprising a control module configured to control motion of the steerable sheath relative to the patient body (Blumenkranz the hybrid instrument system 10 [0051]). Blumenkranz in view of Popovic fails to teach a dilator coupled to the patient. Marchand teaches using a dilator that expands the inner diameter of the body vessel in order to introduce a guidewire and device ([0090]). It would be prima facie obvious to a person of ordinary skill in the art to modify the device of Blumenkranz in view of Popovic to include a dilator that expands an inner diameter of the body vessel for the steerable sheath to enter like the device of Marchand. Doing so would allow the steerable sheath to more easily enter a lumen in the patient.
In regards to claim 17, modified Blumenkranz teaches the apparatus of claim 15, wherein the motion comprises at least one of insertion and extraction (Blumenkranz [0083] If it can be inserted it can be retracted).
In regards to claim 18, modified Blumenkranz teaches the apparatus of claim 15, wherein the motion comprises rotation about an axis of rotation parallel to the longitudinal axis (Blumenkranz [0083]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz (US 20140257333 A1) in view of Popovic (US 20160338787 A1) in view of Marchand (US 20080065011 A1) as applied to claim 15, further in view of Vollmers (US 20130165964 A1).
In regards to claim 16, modified Blumenkranz teaches the apparatus of claim 15, wherein the control module is further configured to control motion of the steerable sheath relative to a proximal end of the dilator (Blumenkranz the hybrid instrument system 10 [0051]). Modified Blumenkranz fails to teach an apparatus wherein the dilator is sutured to the patient. Vollmers teaches a way of anchoring an implantable device to a blood vessel using sutures ([0030][0035]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to anchor the dilator to the patient using a suture like the method of Vollmers. Doing so would allow for the dilator to stay in place when the steerable sheath is being inserted.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz (US 20140257333 A1) in view of Popovic (US 20160338787 A1) further in view of Marchand (US 20080065011 A1) as applied to claim 18, further in view of Piecuch (US 20170325906 A1).
In regards to claim 19, modified Blumenkranz teaches the apparatus of claim 18 including the receiving module comprising a cradle configured to releasably receive the handle ([0057] “A latching mechanism 218 mechanically couples the handpiece 212 to the manipulator assembly 202”). Modified Blumenkranz fails to teach a frame rotatably suspending the cradle such that the cradle rotates about an axis of rotation relative to the frame. Popovic teaches Piecuch a frame (first proximal portion 68) and that supports an instrument holder (instrument holder 70) and allows the entire instrument to rotate ([0038]). It would be prima facie obvious to a person of ordinary skill in the art to attach the manipulator assembly of Blumenkranz to a frame with a rotatable motor like the device of Piecuch that allows the entire instrument to move about a rotational axis. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of providing another axis of rotation for the device to be positioned relative to the patient.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz (US 20140257333 A1) in view of Popovic (US 20160338787 A1) as applied to claim 21, further in view of Tegg (US 20200085483 A1).
In regards to claim 23, Blumenkranz in view of Popovic teaches the apparatus of claim 21. Blumenkranz in view of Popovic fails to teach the apparatus of claim 21 comprising a magnetic sensor. Tegg teaches magnetic positioning sensors for use in positioning a catheter into a lumen in a patient ([0029]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to include a magnetic sensor on the steerable sheath of Blumenkranz in view of Popovic in order to determine the position of the catheter like the device of Tegg.
Claims 24 is rejected under 35 U.S.C. 103 as being unpatentable over Blumenkranz (US 20140257333 A1) in view of Popovic (US 20160338787 A1) as applied to claim 6, further in view of Sholev (US 20190069917 A1).
In regards to claim 24, Blumenkranz in view of Popovic teaches the apparatus of claim 6. Blumenkranz in view of Popovic fails to teach an apparatus wherein the steerable sheath further comprises a battery operably coupled to supply power to the actuator of the handle. Sholev teaches a medical instrument with a battery pack in the handle to supply power to the instrument ([0096]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to power the drive unit of Blumenkranz in view of Popovic with a battery located in the handle like the device of Sholev. Doing so would allow for the steerable sheath to be wireless when in manual mode.
Allowable Subject Matter
Claim 25 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(a), 35 U.S.C. 112(b), and 35 U.S.C. 101, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter. The prior art does not teach or suggest “wherein the steerable sheath is sutured into a blood vessel of the patient” along with the other features of claim 25.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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/LUCY EPPERT/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791