DETAILED ACTION
Prior to the First Action on the Merits, the Applicant elected to amend the application. Claims 1-13 are pending with no claims canceled and claims 1-13 currently amended.
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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the jaws (claim 4), three limiters (claim 5), four limiters (claim 6), a ring (claim 9), a brake (claim 12), and “means magnetically affecting the specific part” (claim 12) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the guiding element as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1” has been used to label various portions of the surgical instrument with no distinction between the various portions. For example, Fig 5 labels a thin portion of the surgical instrument with reference character “1”, then labels the thicker portion of the surgical instrument with reference character “1”.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “2” has been used to designate both the “first limiter” and the “second limiter”; however, the limiters perform different functions and contain different structures relative to the claimed invention.
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.
Claim Objections
Claims 4, 5, 7, 10, 11, and 13 are objected to because of the following informalities:
Regarding claims 4, 7, 10, and 11, the claims recite, “so as”, which is an optional linking phrase with no impact on the structure of the sentence. In each usage, “so as” could be omitted with no impact to the meaning of the claims, which may cause confusion in the understanding of the claimed invention.
Regarding claim 5, the claim recites, “has three limiters (2)” with “(2)” not being a part of the canceled claim limitations despite the surrounding claims having been amended to omit the character references. For the purposes of examination, the Examiner assumes the Applicant intended to omit “(2)” from claim 5.
Regarding claim 13, the claim recites, “as well as”, which is an optional linking phrase with no impact on the structure of the sentence. In each usage, “as well as” could be omitted with no impact to the meaning of the claims, which may cause confusion in the understanding of the claimed invention.
Regarding claim 13, the claims recites, “displaying images corresponding to the specific position”, which shifts the verb tense used throughout the remainder of the claim. For the purposes of examination, the Examiner assumes the Applicant intended to recite “display” rather than “displaying”.
Appropriate correction is required.
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 claim limitations that use the word “means” or “step” but is nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation recites sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation is: “…by means of a pivotal measuring arm…” in claims 1 and 13 because the limitation recites the pivotal measuring arm as structure for the attachment method for fixing the “other limiter” to the disk.
Because this claim limitation is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this limitation 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 to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation does not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-13 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.
The claims are narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claims must be in one sentence form only. Note the format of the claims in the patents cited.
The Examiner lists the following rejections as examples of indefinite language. The Examiner urges the Applicant to perform a comprehensive review of the application to remedy the copious forms of indefinite language found therein.
The following claim limitations invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
“means of resistance” in claims 1, 8, and 13;
“means for measuring the angle of rotation of the disk” in claims 1 and 13;
“means of locking” in claim 12; and
“means magnetically affecting the specific part” in claim 12.
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. For the examples listed above, the following apply either independently or in combination with each other: (i) the disclosure is devoid of any structure that performs the function in the claim, (ii) the structure described in the specification does not perform the entire function in the claim, or (iii) no association between the structure and the function can be found in the specification. 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.
The term “it” in claims 1, 4, and 13 is a relative term which renders the claim indefinite. The term “it” 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. As a result of using the term “it”, the structure of the claims cannot be ascertained; therefore, they are found to be indefinite.
The term “appropriately” in claims 1 and 13 is a relative term which renders the claim indefinite. The term “appropriately” 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. As a result of using the term, the force or torque necessary for achieving the claimed invention is indefinite.
Regarding claims 2, 3, and 12 the phrase "takes the form" and “in the form of” renders the claims indefinite because it is unclear whether the Applicant is implying the claimed invention may take a different form; thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Regarding claims 2 and 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 4, the claim recites, “initial/base position”; however, it is unclear whether the forward slash is intended to indicate the initial position and the base position are equivalent or the Applicant intends for the invention to unlock after the disk returns to its initial position or its base position, which may be different positions.
For the purposes of examination, the Examiner interprets the forward slash to indicate the initial position is the same as the base position.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the ambiguity resulting from the recitation of “and is configured” wherein a plurality of claim elements are recited directly prior to the aforementioned recitation (e.g., “the device” and “a guiding element”); thereby rendering the scope of the claim unascertainable as it is unclear whether the device or the guiding element “is configured to redirect the surgical instrument” as recited within claim 7.
Furthermore, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “concurrent” in claim 7 is used by the claim with an unintelligible meaning while the accepted meaning is “happening, existing, or operating at the same time.” The term is indefinite because the specification does not clearly redefine the term, or the claim is indefinite for not properly disclosing the elements and the element’s function(s) that are occurring simultaneously with the other element’s function(s).
The term “properly” in claim 8 is a relative term which renders the claim indefinite. The term “properly” 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. As a result of using the term “properly”, the selection process regarding the means of resistance is indefinite.
Claim 8 recites the limitation "the group" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted step is the method at which the means of resistance are selected from the group of means.
Furthermore, claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for reciting a “group of means that comprises springs, parts made of an elastomer, and an electric motor.” It is unclear whether the list of “springs, parts made of an elastomer, and an electric motor” are required qualifications for an item to be within the group (i.e., all items listed are required for an item to qualify within the group) or whether the Applicant is stating that the selection process is choosing from any one of the items in the group, which comprises springs, parts made of an elastomer, and an electric motor.
Regarding claim 11, the claim recites, “casing/handle”; however, it is unclear whether the forward slash is intended to indicate the casing and the handle are equivalent or the Applicant intends for the invention to embed accelerometric sensors in the casing or handle, which may be different locations. Alternatively, the Applicant could have meant to recite the accelerometric sensors could be in the casing and the handle, which may be different locations.
For the purposes of examination, the Examiner interprets the forward slash to indicate the accelerometric sensor could be placed in the casing or the handle, which may be different positions.
The phrase “relevant parts” in claim 12 is a relative phrase which renders the claim indefinite. The phrase “relevant parts” 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. It is unclear how one determines a part to be relevant in the given context.
Furthermore, there is insufficient antecedent basis for this limitation in the claim.
The phrase “specific part” in claim 12 is a relative phrase which renders the claim indefinite. The phrase “specific part” 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. It is unclear which part is being specifically referenced.
Furthermore, there is insufficient antecedent basis for this limitation in the claim.
Regarding claim 13, the claim recites, “a surgical instrument, especially of the kind used to carry out transcatheter operations”. It is unclear whether the Applicant is intending to recite specific surgical instruments or whether this is an optional claim limitation not intending to provide weight to the surrounding limitations.
Claim 13 recites the limitation "the elements" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation, “a surgical instrument” for a second time on line 11 despite having already recited “a surgical instrument” on line 3. It is unclear whether the Applicant is introducing a second surgical instrument or whether both recitations are referring to the same surgical instrument.
The phrase “one part” in claims 1 and 13 is a relative phrase which renders the claim indefinite. The phrase “one part” 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. Specifically, the Applicant has failed to disclose how the surgical instrument is broken into parts within the disclosed application.
Regarding claims 1 and 13, the claims recite the limitation, “it is in the shape of a rotationally mounted disk”. The Examiner understands a disk is commonly known to be in the shape of a cylinder or other three-dimensional variant of a circle; however, it is unclear how a disk’s shape is further modified by being rotationally mounted.
Furthermore, the claim then recites, “the disk” with the only prior disk recited being the “rotationally mounted disk”, which is recited as a figurative model intended to aid in visualization of the aforementioned “it”, rather than a tangible entity. It is unclear whether the Applicant intended to recite the rotationally mounted disk as a tangible entity or the rotationally mounted disk is intended purely for aiding in visualization of the claimed invention, which means, regarding the limitation, “the disk”, there is insufficient antecedent basis for the limitation.
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.
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.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Saliterman [US4642055A], Ohlsson [US20060127864A1], and Bevirt [US6705871B1].
Regarding claim 1 (Currently Amended), Saliterman discloses:
A device for measuring the position of a surgical instrument (Saliterman, col 4, lines 11-12, “Catheter position sensor 44 measures how far the tip of catheter tubing 30 has advanced past sensor 44”),
wherein it is in the shape of a rotationally mounted disk (Saliterman, Fig 9A, Wheel 122), which, on the inner side of its envelope, has a track that serves as a guide for the surgical instrument (Saliterman, Guides 124, 126),
wherein a first limiter is attached to the disk at one of the ends of said track and is configured so that when the surgical instrument is brought to the first limiter and a part of the surgical instrument that is larger than the opening in the first limiter is pressed against the first limiter, rotation of the disk is caused (Saliterman, col 7, lines 52-58, “As catheter 30 passes through pressure roller assembly 49, it passes from tubing 42 through guide 124 to guide 126 and then to tubing 46. Guides 124 and 126 are split and are cut away so that catheter 30 makes contact with wheel 122. Thus, movement of catheter 30 in either direction will cause rotation of wheel 122 and shaft 130.”),
wherein at least one other limiter is attached to the disk, and bringing a part of the surgical instrument that is larger than the opening in that the at least one other limiter to a second limiter and pressing it against said second limiter causes the second limiter to move (Saliterman, col 4, lines 8-22, “From three-to-one combiner 40, the catheter tubing 30 passes through guide tube 42, catheter position sensor 44, guide tube 46, and into acoustic detection chamber 48. Catheter position sensor 44 measures how far the tip of catheter tubing 30 has advanced past sensor 44 to allow computer 12 to determine where anatomically the tip of catheter tubing 30 would be located within an actual human body. In the preferred embodiment which will be described in further detail later (in conjunction with FIGS. 9A-9C), catheter position sensor 44 preferably includes pressure roller 49 connected to optical shaft encoder 50.”),
wherein the pass-through opening for inserting the surgical instrument in said at least one other limiter is smaller than the pass-through opening for inserting the surgical instrument in the limiter that precedes it when viewed from the side from which the surgical instrument is to be inserted, in particular, smaller than the pass-through opening for inserting the surgical instrument in the first limiter (Saliterman, Figs 7B, 8B, and 9A-B),
wherein the device additionally has means for measuring the angle of rotation of the disk and the angle of pivoting of each of at least one measuring arm and converting the measurement result into an electrical signal (Salierman, claim 3, “encoder means for providing signals as a function of rotation of the roller means.” and Saliterman, col 8, lines 57-60, “In addition, if elected, the student may observe on display 14 a simulation of a chest fluoroscopic display and thereby watch catheter 30 advance into the chest as it is being advanced into manikin 22.”).
Saliterman does not explicitly disclose the use of limiters and the means as disclosed within the instant application.
Ohlsson, however, discloses:
Each limiter of the at least two limiters has a pass-through opening smaller than at least one part of the surgical instrument, through which parts of the surgical instrument are to be inserted (Ohlsson, [0019], “The device comprises: a number of moveable carriages corresponding to the number of the real instruments, a track, and an interconnecting member. The interconnecting member interconnects the carriages serially. Each carriage is provided with an opening for enabling reception of the instruments.”),
wherein the disk and each of the limiters are fitted with means of resistance that act - with an appropriately matched force or torque - on the disk and on each of the limiters counteracting their movement under the influence of the pressure from the surgical instrument (Ohlsson, [0019], “Each carriage further comprises members for receiving a movement from the instrument and generating a force, fed back to the instrument with respect to a simulation characteristic.”).
It would have been obvious to one of ordinary still in the art before the effective filing date of the claimed invention to include in the training system of Saliterman the ability to use carriages/limiters as taught by Ohlsson since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Saliterman/Ohlsson does not disclose a pivotal arm.
Bevirt, however, discloses:
means of a pivotal measuring arm (Bevirt, col 3, lines 59-61, “The gimbal mechanism includes multiple members that are pivotably coupled to each other to provide two revolute degrees of freedom”),
One of ordinary skill in the art would have recognized that applying the known technique of Bevirt to Saliterman/Ohlsson would have yielded predictable results and resulted in an improved system before the effective filing date of the claimed invention. It would have been recognized that applying the technique of a pivotal arm to the teachings of Saliterman/Ohlsson would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such mechanical features into similar systems/methods. Further, applying the pivotal arm to Saliterman/Ohlsson with carriages/limiters operated accordingly, would have been recognized by those of ordinary skill in the art as resulting in an improved system that would reduce friction, thereby reducing noise and drag commonly associated with older systems.
Regarding claim 2 (Currently Amended), Saliterman/Ohlsson/Bevirt discloses:
The device according to claim 1 wherein the means of measuring the angle of rotation of the disk takes the form of an angle sensor such as an absolute encoder, incremental encoder, potentiometer, or resolver (Saliterman, col 2, lines 66-68, “FIG. 9A is a top view of the optical encoder and pressure roller which senses position of the catheter within the trainer.” and Saliterman, col 14, lines 62-67, “The received signals from microphone 184 are amplified by an amplifier and unipolar feedback limiter circuit formed by operational amplifier (op amp) 250, capacitor 252, potentiometer 255, resistors 254, 256, 258, 260 and 262, and Zener diode 264.”).
Regarding claim 3 (Currently Amended), Saliterman/Ohlsson/Bevirt discloses:
The device according to claim 2 wherein the means of measuring the angle of pivoting of each of at least one measuring arm takes the form of an angle sensor such as an absolute encoder, incremental encoder, or potentiometer.
Given the pivotably coupled members of Bevirt, measuring the pivot angle with an encoder, as disclosed by Saliterman, is the standard method for digitizing the position. Furthermore, Ohlsson tracks carriage position, wherein converting this to angle measurement in a rotary system would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as all elements are disclosed herein.
Regarding claim 4 (Currently Amended), Saliterman/Ohlsson/Bevirt discloses:
The device according to claim 2, wherein the device is fitted with jaws for locking the surgical instrument, configured so as to lock the surgical instrument in its target position and to unlock it only after the disk returns to its initial/base position (Ohlsson, [0019], “Each carriage further comprises members to receive and lock at least one instrument.”).
Regarding claim 5 (Currently Amended), Saliterman/Ohlsson/Bevirt discloses:
The device according to claim 2, wherein the device has three limiters Ohlsson, [0074], “The first interconnecting member 26A, is arranged between the opening 22 and the first carriage 16A, the second interconnecting member 26B is arranged between the first carriage 16A and the second carriage 16B and the third interconnecting member 26C is arranged between the second carriage 16B and the third carriage 16C.”).
Regarding claim 6 (Currently Amended), Saliterman/Ohlsson/Bevirt discloses:
The device according to claim 2, wherein the device has four limiters.
Although, Ohlsson does not explicitly disclose a fourth carriage/limiter, it would’ve been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the disclosure of Ohlsson provides scalability as Ohlsson recites in the Abstract, “The device (100) comprises a number of moveable carriages (16A-16C) corresponding to the number of the real instruments.” Therefore, the addition of a fourth limiter is simply a duplication of parts as discussed in the MPEP2144.04, Section VI, B, and reproduced below for ease of reference:
In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.).
Regarding claim 7 (Currently Amended), Saliterman/Ohlsson/Bevirt discloses:
The device according to claim 2, wherein the device additionally has a guiding element attached to the disk and is configured so as to redirect the surgical instrument being inserted from above in relation to the plane of rotation of the disk in the direction concurrent to the track of the disk (Saliterman, col 7, lines 52-54, “As catheter 30 passes through pressure roller assembly 49, it passes from tubing 42 through guide 124 to guide 126 and then to tubing 46.”).
Regarding claim 8 (Currently Amended), Saliterman/Ohlsson/Bevirt discloses:
The device according to claim 2, wherein all the means of resistance are properly selected from the group of means that comprises springs, parts made of an elastomer, and an electric motor (Saliterman, col 8, lines 9-12, “the means for urging catheter 30 toward wheel 122 can take the form of a counter pressure wheel which is spring loaded to be urged in the direction toward wheel 122.” and Ohlsson, [0019], “Each carriage further comprises members for receiving a movement from the instrument and generating a force, fed back to the instrument with respect to a simulation characteristic.” and Bevirt, col 4, lines 19-21, “The actuators provide a force on the linear axis member and the sensors sense the position of the linear axis member in the three degrees of freedom.”).
Regarding claim 9 (Currently Amended), Saliterman/Ohlsson/Bevirt discloses:
The device according to claim 1, wherein at least one limiter apart from the first limiter is mounted on a ring that is attached on the external surface of the disk or on a linear guide (Ohlsson, Fig 2).
Regarding claim 10 (Currently Amended), Saliterman/Ohlsson/Bevirt discloses:
The device according to claim 1, wherein the device also has optical sensors located behind the first limiter, configured so as to measure the orientation of the surgical instrument (Bevirt, col 12, lines 25-27, “Sensors 87 a, 87 b, and 87 c are preferably relative optical encoders which provide signals to measure the angular rotation of a shaft of the transducer.” and Bevirt, col 42, Appendix A, “Calculate the needle's orientation angles”).
Regarding claim 11 (Currently Amended), Saliterman/Ohlsson/Bevirt discloses:
The device according to claim 1, wherein the device also has accelerometric sensors located in the casing/handle of the surgical instrument, configured so as to measure the orientation of the surgical instrument.
An accelerometric sensor is a simple substitution of the optical encoders taught by Bevirt that would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as accelerometric sensors were commonly used within the art as an alternative to other forms of orientation measurement sensors.
Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious before the effective filing date of the claimed invention.
Regarding claim 12 (Currently Amended), Saliterman/Ohlsson/Bevirt discloses:
The device according to claim 1, wherein instead of openings smaller than the relevant parts of the surgical instrument, the limiters comprise means of locking the specific part of the surgical instrument, either in the form of a brake or means magnetically affecting the specific part of the surgical instrument (Bevirt, col 13, lines 31-36, “Passive actuators can also be used for actuators 86a, 86b, and 8c. Magnetic particle brakes, friction brakes, or pneumatic/hydraulic passive actuators can be used in addition to or instead of a motor to generate a passive resistance or friction in a degree of motion.”).
Regarding claim 13 (Currently Amended), the claim shares similar limitations to claim 1. For citations on rejection, see the rejection of claim 1 above.
Claim 1 of the instant application does not recite a manikin; however, Saliterman discloses:
A system for simulating transcatheter operations, which includes:
a manikin (Saliterman, col 3, lines 49-53, “As shown in FIG. 2, trainer 10 includes a life-like manikin 22 of a portion of an upper torso and right arm which is supported on chassis 24. Manikin 22 includes three sites at which a student can practice insertion of the catheter”).
Conclusion
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/Z.J.P./Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715