DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The drawings are objected to because
-Fig. 105, elements 1503 and 1526 are blurry or the numbering overlaps with other element numbers.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
-[0129]-should possibly read “Ren et al.”
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 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.
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:
-Claims 1 and 15 recite “external adjustment device” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to be positioned outside the subject and to interact with the adjustable implant. According to the specification the external adjustment device includes a magnet and motor [0028] and equivalents thereof.
-Claim 14 recites “feedback device” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to produce a feedback indicative of information relating to rotation of the magnet about the axis of rotation. According to the specification the feedback device includes a Hall effect device (two additional magnets that move axially in relation to each other as drive shaft rotates [0169] and equivalents thereof.
-Claim 15 recites “magnetically responsive unit” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to generate rotation about an axis of rotation. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
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.
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 Rejections - 35 USC § 112
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 15-20 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.
Claim limitation “magnetically responsive unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While the specification discusses the use of magnets and magnetically responsive materials, there is no indication that magnetically responsive units correspond to these magnets, materials or whether they are used in conjunction with the magnets. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
Claim(s) 1, 8, 9, 10, 11, 12, 13, 14, 15, 16, 19, 20 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Shachar (U.S. 20070016006).
Regarding Claim 1, Shachar teaches a system comprising: an adjustable implant configured for implantation within a subject [0017]—discussion on catheter guidance and control apparatus (CGCI) that allows surgeons to advance and position catheters and [Fig. 30B-E]—depicts implantation of a cardiac pacemaker and electrodes, the adjustable implant comprising: a housing [Fig. 19, element 109 (housing)]; a magnet disposed within the housing and configured for rotation about an axis of rotation [0023]—reference to the magnetic field controlled to rotate the catheter tip, [0049] and [0190-0191]; and a drive transmission operatively coupled to the magnet and configured to alter a dimension of the adjustable implant [0219]—reference to actuator deployed variable length extension cores that control and navigate the CGCI catheter tip, and an external adjustment device configured to be positioned outside the subject and to interact with the adjustable implant [0340; “The magnetic field external to the body can be generated by a permanent magnet or magnets. The control of the external magnetic field can be accomplished by manually administering the field generating devices.”], the external adjustment device comprising: a motor [0278 and 0031]—describes the motors and/or actuators providing tactile feedback to the operator; at least one permanent magnet configured to rotate in response to actuation of the motor [0340] and [0191]—references the permanent magnet achieving torque forces that bend and rotate the tip of the catheter; an encoder configured to monitor positional information of the at least one permanent magnet [0185]—reference to the Hall effect sensor array; and a drive control circuit configured to receive an input signal from the encoder that corresponds to the positional information of the at least one permanent magnet and actuate operation of the motor based at least in part on the input signal [0188], [0210]—reference to the electromagnetic circuit and [0203]—describes signal that allows for measuring rotation of the catheter tip relative to the magnet, thereby rotating the at least one permanent magnet [0234]—describes the torque on the permanent magnet, wherein rotation of the at least one permanent magnet effectuates rotation of the magnet of the adjustable implant and alters the dimension of the adjustable implant [0016]—references the three dimensional movement that can be achieved by the catheter tip and [0234].
Regarding Claim 8, Shachar teaches wherein the drive control circuit is further configured to receive a drive instruction for adjusting the adjustable implant [0333]—reference to field regulation and the regulator receiving command signals and positional data from the computational unit the generate vectors for torque control.
Regarding Claim 9, Shachar teaches wherein the drive instruction comprises a numerical value representing an adjusted dimension of the adjustable implant [0334-0335]—reference to field values and desired position based on vectors related to the catheter and [0337] which references catheter position area and actual distance for a catheter tip.
Regarding Claim 10, Shachar teaches wherein the drive instruction comprises a numerical value representing an increase or a decrease in the dimension of the adjustable implant [Abstract and 0270]—describes the use of retractable cores used to shape magnetic poles and fields in extended and retracted positions.
Regarding Claim 11, Shachar teaches wherein the increase or the decrease in the numerical value representing the dimension of the adjustable implant is proportional to a number of turns of the magnet of the adjustable implant [Figs. 2, 2A]—reference to electromagnetic properties including dimensions and turns.
Regarding Claim 12, Shachar teaches wherein the drive control circuit is operatively coupled to one or more of a display [0279], a keyboard [0183], an input device for inputting a numerical value representing an adjusted dimension of the adjustable implant [0279]—reference to control switches.
Regarding Claim 13, Shachar teaches wherein the drive control circuit comprises a programmable logic controller [Fig. 33, element 528 (Controller Programs)], [0031]—reference to command logic used for the servo system to control stepper motors and [0312]—reference to CGCI controller using low level logic.
Regarding Claim 14, Shachar teaches further comprising a feedback device operatively coupled to the magnet of the adjustable implant and configured to produce a feedback indicative of information relating to rotation of the magnet about the axis of rotation [0278]—describes force feedback used to control position and rotation of the motors/actuators (e.g. permanent-magnet motors/actuators) of the catheter tip.
Regarding Claim 15, Shachar teaches a system comprising: an adjustable implant configured for implantation within a subject [0017]—discussion on catheter guidance and control apparatus (CGCI) that allows surgeons to advance and position catheters and [Fig. 30B-E]—depicts implantation of a cardiac pacemaker and electrodes, the adjustable implant comprising: a housing [Fig. 19, element 109 (housing)]; a magnetically responsive unit disposed within the housing and configured to generate rotation about an axis of rotation [0023]—reference to the magnetic field controlled to rotate the catheter tip, [0049] and [0190-0191]—due to the indefinite nature of the claim, magnetically responsive units is interpreted to be magnetic materials or structures used in conjunction with the generation of magnetic fields such as coils or cores; and a drive transmission operatively coupled to the magnetically responsive unit and configured to alter a dimension of the adjustable implant in response to the rotation [0219]—reference to actuator deployed variable length extension cores that control and navigate the CGCI catheter tip, and an external adjustment device configured to be positioned externally relative to the subject and to interact with the adjustable implant [0340; “The magnetic field external to the body can be generated by a permanent magnet or magnets. The control of the external magnetic field can be accomplished by manually administering the field generating devices.”], the external adjustment device comprising: an actuating member [0278 and 0031]—describes the motors and/or actuators providing tactile feedback to the operator; at least one permanent magnet configured to rotate in response to actuation of the actuating member [0340] and [0191]—references the permanent magnet achieving torque forces that bend and rotate the tip of the catheter; means for monitoring positional information of the at least one permanent magnet [0185]—reference to the Hall effect sensor array, and providing an input signal that corresponds to the positional information of the at least one permanent magnet [0203]—describes signal that allows for measuring rotation of the catheter tip relative to the magnet; and a drive control circuit configured to receive the input signal and actuate operation of the actuating member based at least in part on the input signal [0188], [0210]—reference to the electromagnetic circuit, thereby rotating the at least one permanent magnet [0234]—describes the torque on the permanent magnet, wherein rotation of the at least one permanent magnet effectuates rotation of the magnetically responsive unit and alters the dimension of the adjustable implant [0016]—references the three dimensional movement that can be achieved by the catheter tip and [0234].
Regarding Claim 16, Shachar teaches wherein the magnetically responsive unit comprises a magnet [0049] and [0190-0191].
Regarding Claim 19, Shachar teaches wherein the drive control circuit is further configured to receive a drive instruction for adjusting the adjustable implant [0333]—reference to field regulation and the regulator receiving command signals and positional data from the computational unit the generate vectors for torque control.
Regarding Claim 20, Shachar teaches wherein the drive instruction comprises a numerical value representing an adjusted dimension of the adjustable implant [0334-0335]—reference to field values and desired position based on vectors related to the catheter and [0337] which references catheter position area and actual distance for a catheter tip.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2, 7, 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shachar (U.S. 20070016006) in view of Dumpert (CA 3068216).
Regarding Claim 2, Shachar is silent on wherein the drive transmission comprises a lead screw operatively coupled to the magnet and a nut moveable along a length of the lead screw. Dumpert teaches wherein the drive transmission comprises a lead screw operatively coupled to the magnet and a nut moveable along a length of the lead screw [0151].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a screw and nut configuration as taught by Dumpert to actuate the magnet as suggested by Shachar as Shachar discusses the actuation of a piston type retraction method to effect the magnetic field [0059] with Dumpert because Dumpert teaches the use of this aspect to translate structural items on the mechanism back and forth and from left to right relative to the housing [0151].
Regarding Claim 7, Shachar is silent on wherein the drive control circuit is configured to control at least one of a speed and a rotational direction of the motor. Dumpert teaches wherein the drive control circuit is configured to control at least one of a speed and a rotational direction of the motor [0133]—reference to wheels with separate motors allowing the device to move forward/backward.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate speed and directional control as taught by Dumpert to enable rotation of components of the device as suggested by Shachar as Shachar discusses the ability to use force control to orient the device forward, left, right and back [0304] with Dumpert because Dumpert teaches these features to allow the device to turn while the center portion stays in the same location [0133].
Regarding Claim 18, Shachar is silent on wherein the actuating member is a motor and the drive control circuit is configured to control at least one of a speed and a rotational direction of the motor. Dumpert teaches wherein the actuating member is a motor and the drive control circuit is configured to control at least one of a speed and a rotational direction of the motor [0133]—reference to wheels with separate motors allowing the device to move forward/backward and [0088].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate speed and directional control as taught by Dumpert to enable rotation of components of the device as suggested by Shachar as Shachar discusses the ability to use force control to orient the device forward, left, right and back [0304] with Dumpert because Dumpert teaches these features to allow the device to turn while the center portion stays in the same location [0133].
Claim 3, 4 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shachar (U.S. 20070016006) in view of Whitin (U.S. 20040176683).
Regarding Claim 3, Shachar is silent on wherein the encoder is an optically-based encoder or an audio-based encoder. Whitin teaches wherein the encoder is an optically-based encoder or an audio-based encoder [0080]—reference to optical sensors as passive encoded markers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an optical encoder as taught by Whitin to adjust positions of one or more electromagnet clusters as suggested by Shachar as Shachar discusses the use of systems to provide virtual tip position of the catheter to vary distance and/or angle of electromagnet clusters [0030] with Whitin because Whitin teaches LEDs blinking in coded patterns as active encoded markers [0080].
Regarding Claim 4, Shahar is silent on wherein the encoder comprises a light source and a light receiver operatively coupled to the light source. Whitin teaches wherein the encoder comprises a light source and a light receiver operatively coupled to the light source [0080-0081]—describes LEDs and IR light sources that are used in tandem with IR receivers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include light sources and receivers as taught by Whitin to accurately position instrumentation and implanted devices as suggested by Shachar as Shachar discusses the use of a fiber optic light guide with a responsive tip to deliver light to a internal location [0340] with Whitin because Whitin teaches receiving positional data based on the optical sensing and receiving mechanisms [0080].
Claims 5, 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shachar (U.S. 20070016006) in view of Sangouard (U.S. 6409656).
Regarding Claim 5, Shachar is silent on wherein the at least one permanent magnet comprises a first permanent magnet having a first axis of rotation and a second permanent magnet having a second axis of rotation different from the first axis of rotation. Sangouard teaches wherein the at least one permanent magnet comprises a first permanent magnet having a first axis of rotation and a second permanent magnet having a second axis of rotation different from the first axis of rotation [Col 3, lines 15-25].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include multiple permanent magnets with different axis of rotation as taught by Sangouard to add torque and force combinations as suggested by Shachar as Shachar discusses varying matrices of the coil groups to shape magnetic fields emitted [0307] with Sangouard because Sangouard teaches this arrangement to cause elements and magnets of the structure to rotate [Col 3, lines 21-25].
Regarding Claim 6, Shachar further teaches wherein the input signal corresponds to an angular position of one of the first and second permanent magnets [0235]—discuses angular orientations of conical coil clusters which are interpreted to be the magnetic structure in this embodiment.
Claims 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shachar (U.S. 20070016006) in view of Paden (U.S. 20070236213).
Regarding Claim 17, Shachar is silent on wherein the magnetically responsive unit comprises a resonance beam, and the at least one permanent magnet comprises a magnet having a resonating frequency identical to a resonating frequency of the resonance beam. Paden teaches wherein the magnetically responsive unit comprises a resonance beam, and the at least one permanent magnet comprises a magnet having a resonating frequency identical to a resonating frequency of the resonance beam [0137]—references magnetized structure with resonance frequencies and resonance beams that are symmetric with the sensor.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include magnetic structures with resonance frequencies and beams as taught by Paden to excite certain magnetic structures as suggested by Shachar as Shachar discusses using ultrasonic signals to excite piezoelectric rings and provide rotational measurements of the catheter tip [0203] with Paden because Paden teaches the advantage of this to enable pressure and temperature detection at the same time while eliciting easier excitation from the smaller beam [0137].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Freedman (U.S. 5176618)-device using magnetic fields to control opening and closing of a bodily passageway
-Hakim (U.S. 4595390)-reference to an adjustable shunt valve controlled by application of external magnetic fields
-Chen (U.S. 20030030342)-discusses energy transfer via contactless devices by electromagnetic means
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791