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 Objections
Claim(s) 4 and 10 recite(s) the limitation “such that […]”. It is suggested to replace the phrase “such that” with the term —wherein— to ensure the positive recitation of all elements in the claim. The use of the phrase “such that” may be interpreted as a negative limitation in the claim, resulting in an interpretation of subsequent limitations (i.e., “such that the base component and the engagement component form an X shape or a cross shape when press fit together and viewed from above” in claims 4 and 10) as preferred or suggested limitations, and therefore may be excluded from examination.
Claim 15 is objected to for grammatical informalities. The claim recites the limitation “wherein rotating the handle adjust an orientation of the distal portion of the intraluminal imaging device”. It is suggested to amend the claim to use the term ‘adjusts’ for correctness.
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.
Claims 14-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. In the present application, the claimed invention is directed to an abstract idea. Claims that depend directly or indirectly from the independent claim (claim 14) are also rejected due to said dependency.
Claim 14 is drawn to a method of intraluminal imaging, which does fall under the statutory categories of invention. However, claim 14 recites the limitations of “inserting an intraluminal imaging device into a patient body; advancing a distal portion of the intraluminal imaging device to a desired location within the patient body; coupling a handle of the intraluminal imaging device to an intraluminal imaging device stabilizer by snap-fitting the handle to a raised support structure of the intraluminal imaging device stabilizer; and obtaining imaging data of a region of interest of the patient body using the intraluminal imaging device.” The limitations of claim 14 recited directly above set forth the abstract idea of organizing human activity, as the only structures required to perform these limitations is a conventional, generic ‘intraluminal imaging device’ as is well known in the art, and an ‘intraluminal imaging device stabilizer’. Thus, this claim reads on organizing human activity and/or a mental process.
This judicial exception is not integrated into a practical application because the claimed limitations recited above merely comprise a list of actions to be performed by a user with an intraluminal imaging device, which reads on simply organizing human activity and/or a mental process. While this abstract idea does require a structure, the structures required are an “intraluminal imaging device” which is a generic element (i.e., an imaging catheter) well known in the art for performing medical imaging; and a ‘stabilizer’ whose structure merely needs to ‘snap-fit’ with the handle of the ‘intraluminal imaging device’ which is a function that may already be performed by the user’s hand/fingers. The inclusion of a generic catheter imaging element does not add a meaningful limitation to the abstract idea because this amounts to simply implementing the abstract idea of using the imaging catheter.
Furthermore, the claim is silent in regard to how the ‘stabilizer’ is configured to snap-fit with a ‘raised support structure’. The lack of clarity or structure further contributes to why this judicial exception is not integrated into a practical application.
Analyzing the claim as a whole, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the limitations recited in claim 14, both when considered separately and in combination, amount to nothing more than organizing human activity. This is exemplified by the fact that each and every limitation of claim 14 can be performed simply by a user. The user already performs the functions of “inserting an intraluminal imaging device into a patient body;” and “advancing a distal portion of the intraluminal imaging device to a desired location within the patient body;” amounting to insignificant pre-solution activity. The user also performs the method step of “obtaining imaging data of a region of interest of the patient body using the intraluminal imaging device”, amounting to data collection which is an insignificant post-solution activity. The method step of “coupling a handle of the intraluminal imaging device to an intraluminal imaging device stabilizer by snap-fitting the handle to a raised support structure of the intraluminal imaging device stabilizer;” may be performed by hand. In the example as discussed above, the ‘stabilizer’ may be the user’s hand whose fingers (i.e., raised support structure) ‘snap-fit’ with the handle of the imaging catheter – these limitations merely describe holding and using the ‘intraluminal imaging device’. Also, the claim does not purport to provide any “improvement” to the technology, which weighs against patentability. Viewing all the claim limitations individually, or as a combination, the claim as a whole does not add significantly more to the abstract idea.
Claims 15-19 depend directly from claim 14, and therefore these dependent claims rely upon the same abstract idea as the independent claim, as set forth above. Additionally, dependent claims 15-19 do nothing more than further limit the specificity of the abstract idea, and do not remedy the patentability issues described above. Accordingly, claims 15-19 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea. Claims 14-19 are not patent eligible.
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.
Claim(s) 5-6, 12-13 and 18-19 is/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(s) 6 and 13 are rejected at least by virtue of dependency upon a rejected base claim.
Claims 5 and 12 recite the limitation “extend at an oblique angle with respect to a base plate of the engagement component”. There is insufficient antecedent basis for this limitation in the claims. In particular, it is not clear what the ‘base plate’ is specifically referring to. In an interpretation, the “base plate” may refer to the ‘base component’ coupled to the ‘engagement component’; and in another, distinct interpretation the “base plate” may refer to a surface of the ‘engagement component’. For the purposes of examination, the broadest reasonable interpretation, including those discussed above, is applied to limitation.
Claims 6 and 13 recite the limitation “maintain the handle of the intraluminal imaging device in a raised position spaced from a surface on which the stabilizer is positioned”. There is insufficient antecedent basis for this limitation in the claims. In particular, it is not clear what the ‘surface’ is specifically referring to, because there is no prior recitation or indication that the ‘stabilizer’ is positioned upon a surface. It is suggested to amend the claim(s) to clarify what the ‘surface’ is relative to the ‘stabilizer’ and to clearly describe the position and orientation of the respective claim elements.
Claim 18 recites the limitation “wherein the assembling the intraluminal imaging device stabilizer”. There is insufficient antecedent basis for this limitation in the claims. There is no prior recitation of an ‘assembly’ step. It is suggested to amend the claim(s) to clarify the limitations and to clearly describe an ‘assembling’ step.
Claim 19 recites the limitation “wherein the coupling the base component and the engagement component includes”. There is insufficient antecedent basis for this limitation in the claims. There is no prior recitation of a ‘coupling’ step. It is suggested to amend the claim(s) to clarify the limitations and to clearly describe a ‘coupling’ step or to amend the dependency of the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-9 and 11-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jenkins et al. (US20150182726A1, 2015-07-02; hereinafter “Jenkins”).
Regarding claim 1, Jenkins teaches a stabilizer for an intraluminal imaging device (“A system comprising: a first remotely-controlled catheter positioning system […] an imaging catheter coupled to the first remotely-controlled catheter positioning system;” [clm 14]; “The various embodiments include a system and methods for controlling a remotely controlled catheter positioning system to maintain a therapeutic or diagnostic catheter within the field of view of an ultrasound imaging catheter while both are positioned within a patient's body.” [0002]; [0084-0106], [fig. 1A, 6-11; see fig. 8 reproduced below]), the stabilizer comprising:
a base component (“a sled member coupled to the modular plate; and a sled base configured to advance the sled member” [clm 14]; “The sled member 878 may be attached to the catheter handle 702 by the modular plate 884 and the handle control assembly 882.” [0091]; “The remotely-controlled catheter positioning system 110 may include a linear sled bed or sled base 936 which supports a linear sled member 938,” [0095]; The sled member (i.e., base component) may be supported by sled base and receives catheter control handle [0084-0106], [fig. 1A, 6-11; see fig. 8 reproduced below]); and
an engagement component coupled to the base component (“a modular plate configured to receive a proximal portion of a catheter; a sled member coupled to the modular plate; and” [clm 14]; “A sled member 878 may be capable of receiving a catheter control handle in a handle control assembly 882 and mounted to a modular plate 884. A handle control assembly 882 may include clamps 886 and 888 and a molded nest 890.” [0090]; “The sled member 878 may be attached to the catheter handle 702 by the modular plate 884 and the handle control assembly 882. […] As the modular plate 884 is detachable from sled member 878, different handles may be used for different types of catheters.” [0091]; The modular plate (i.e., engagement component) is detachably mounted to the sled member [0084-0106], [fig. 1A, 6-11; see fig. 8 reproduced below]),
the engagement component including a raised support structure sized and shaped for snap-fit engagement with a handle of an intraluminal imaging device (“A handle control assembly 882 may include clamps 886 and 888 and a molded nest 890. The knob 812 of the catheter handle 702 may be secured in the molded nest 890 by friction or snap-in fit.” [0090]; “Different modular plates 884 and handle control assemblies 882 may be used dependent upon the type/make of catheter used.” [0091]; “The catheter handle 702 of catheter 125 may be engaged into the modular plate 884 at three points, namely, clamps 886 and 888 and the molded nest 890. The catheter handle 702 may be snap fit into molded nest 890” [0093]; The modular plate comprises handle control assembly (i.e., raised support structure) to engage via snap fit with catheter handle [0084-0106], [fig. 1A, 6-11; see fig. 8 reproduced below]),
wherein the raised support structure comprises:
a first support arm;
a second support arm (“a cardiac ablation catheter with a corresponding modular plate 884 may be used. A fastening mechanism may include clamps, such as clamps 886 and 888 may attach the catheter 125 to the modular plate 884.” [0092]; “The proximal end of catheter handle 702 may be mounted to the modular plate 884 through the use of the clamp 886 and the distal end may be mounted onto the modular plate 884 through the use of the clamp 888. The clamps 886, 888 may be snap fit.” [0093]; The clamps 886, 888 (i.e., first and second support arms) mount the catheter handle to the handle control assembly of the modular plate [0084-0106], [fig. 1A, 6-11; see fig. 8 reproduced below]); and
a cradle extending between and connecting the first support arm and the second support arm, wherein the cradle is sized and shaped for snap-fit engagement with the handle of the intraluminal imaging device (“A handle control assembly 882 may include clamps 886 and 888 and a molded nest 890. The knob 812 of the catheter handle 702 may be secured in the molded nest 890 by friction or snap-in fit.” [0090]; “The catheter handle 702 of catheter 125 may be engaged into the modular plate 884 at three points, namely, clamps 886 and 888 and the molded nest 890. The catheter handle 702 may be snap fit into molded nest 890 or secured by friction.” [0093]; The molded nest (i.e., cradle) disposed between and connecting the clamps is configured to secure catheter handle using snap-fit [0084-0106], [fig. 1A, 6-11; see fig. 8 reproduced below]).
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The modular plate 884 snap-fits with catheter handle 702 via handle control assembly 882 and is detachably mounted to sled member 878 (Jenkins [fig. 8])
Regarding claim 2, Jenkins teaches the stabilizer of claim 1,
Jenkins further teaching wherein the base component is press fit engaged with the engagement component (“a sled member coupled to the modular plate; and” [clm 14]; “The modular plate 884 may subsequently be attached to the sled member 878 by snap fit. The modular plate 884 may have protrusions (not shown) effective to secure the modular plate 884 to the sled member 878.” [0093]; [0084-0106], [fig. 1A, 6-11], [see claim 1 rejection]).
Regarding claim 3, Jenkins teaches the stabilizer of claim 2,
Jenkins further teaching wherein the engagement component extends across the base component in a direction perpendicular to a length of the base component (“a sled member coupled to the modular plate; and” [clm 14]; “Different modular plates 884 and handle control assemblies 882 may be used dependent upon the type/make of catheter used.” [0091]; “The catheter handle 702 of catheter 125 may be engaged into the modular plate 884 at three points, namely, clamps 886 and 888 and the molded nest 890. The catheter handle 702 may be snap fit into molded nest 890” [0093]; [0084-0106], [fig. 1A, 6-11; see fig. 8 reproduced below], [see claim 1 rejection]).
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The modular plate 884 extends in x-axis perpendicular to z-axis (i.e., length direction) of sled member (Jenkins [fig. 8])
Regarding claim 5, Jenkins teaches the stabilizer of claim 1,
Jenkins further teaching wherein each of the first support arm and the second support arm extend at an oblique angle with respect to a base plate of the engagement component (“A handle control assembly 882 may include clamps 886 and 888 and a molded nest 890.” [0090]; “A fastening mechanism may include clamps, such as clamps 886 and 888 may attach the catheter 125 to the modular plate 884.” [0092]; “The proximal end of catheter handle 702 may be mounted to the modular plate 884 through the use of the clamp 886 and the distal end may be mounted onto the modular plate 884 through the use of the clamp 888. The clamps 886, 888 may be snap fit.” [0093]; The clamps extend outwards at an angle from a base portion of the modular plate [0084-0106], [fig. 1A, 6-11; see fig. 8 reproduced below], [see claim 1 rejection]).
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Clamps 886, 888 project at an angle from portion of the modular plate 884 (Jenkins [fig. 8], annotated)
Regarding claim 6, Jenkins teaches the stabilizer of claim 5,
Jenkins further teaching wherein the first support arm and the second support arm are sized and shaped to maintain the handle of the intraluminal imaging device in a raised position spaced from a surface on which the stabilizer is positioned (“The modular plate 884 and handle control assembly 882 may be specific to the type/manufacture of the catheter 125 shown. Different modular plates 884 and handle control assemblies 882 may be used dependent upon the type/make of catheter used.” [0091]; “The catheter handle 702 of catheter 125 may be engaged into the modular plate 884 at three points, namely, clamps 886 and 888 and the molded nest 890. […] The proximal end of catheter handle 702 may be mounted to the modular plate 884 through the use of the clamp 886 and the distal end may be mounted onto the modular plate 884 through the use of the clamp 888. The clamps 886, 888 may be snap fit.” [0093]; “The remotely-controlled catheter positioning system 110 may include a linear sled bed or sled base 936 which supports a linear sled member 938, a mounting arm 940 which supports sled base 936 […] The mounting arm 940 may be attached to either the left or right side bars of an operative surface 956,” [0095]; The catheter system 110 may be supported in a raised position relative to the sled base 936 and operative surface 956 [0084-0106], [fig. 1A, 6-11; see fig. 9 reproduced below], [see claim 1 rejection]).
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Sled member 938 mounted to catheter in a raised position relative to sled base 936 and operative surface 956 (Jenkins [fig. 9])
Regarding claim 7, Jenkins teaches an intraluminal imaging system (“A system comprising: a first remotely-controlled catheter positioning system […] an imaging catheter coupled to the first remotely-controlled catheter positioning system;” [clm 14]; “The various embodiments include a system and methods for controlling a remotely controlled catheter positioning system to maintain a therapeutic or diagnostic catheter within the field of view of an ultrasound imaging catheter while both are positioned within a patient's body.” [0002]; [0084-0106], [fig. 1A, 6-11], [see claim 1 rejection]), comprising:
an intraluminal imaging device (“an imaging catheter coupled to the first remotely-controlled catheter positioning system; and” [clm 14]; “An ultrasound catheter 114 (or other imaging catheter) may be installed on or attached to the remotely-controlled catheter positioning system 110.” [0032]; “the ultrasound catheter 114 may be configured to perform ultrasound imaging and to be steerable through various patient's organs, such as human anatomy (e.g., cardiovascular systems, etc.)” [0084]; [0031-0034, 0084-0106], [fig. 1A, 6-11], [see claim 1 rejection]) including:
a handle sized and shaped for handheld use (“the ultrasound catheter 114 may also include a steering mechanism 624 […] The steering mechanism may be a handle, a slide actuator, a rotatable control knob, handle or wheel, or other suitable manipulating member mounted in a control handle 623.” [0085]; [0084-0106], [fig. 1A, 6-11], [see claim 1 rejection]); and
a distal portion coupled to the handle, the distal portion sized and shaped for introduction into a patient body and including an imaging array (“The ultrasound catheter 114 may include an elongated tubular member 115 that may be made of various materials, […] The ultrasound catheter 114 may be configured with different sections of varying flexibility so that the tubular member 115 may bend and otherwise be contorted within a patient's organ.” [0084]; “A tubular member 115 of the ultrasound catheter 114 may have a proximal end 614 (or proximal portion) and a distal end 215 (or distal portion). Distal portions of the tubular member 115 may be more flexible than proximal portions to improve maneuverability and decrease the risk of damage to a patient's organ.” [0085]; “An ultrasound transducer 216 may be at the distal end 215 of the tubular member 115. The transducer 216 may be formed from an array of individual ultrasound elements 618.” [0086]; [0084-0106], [fig. 1A, 6-11], [see claim 1 rejection]); and
an intraluminal imaging device stabilizer (“A system comprising: a first remotely-controlled catheter positioning system […] an imaging catheter coupled to the first remotely-controlled catheter positioning system;” [clm 14]; “The various embodiments include a system and methods for controlling a remotely controlled catheter positioning system to maintain a therapeutic or diagnostic catheter within the field of view of an ultrasound imaging catheter while both are positioned within a patient's body.” [0002]; [0084-0106], [fig. 1A, 6-11], [see claim 1 rejection])) including:
a base component (“a sled member coupled to the modular plate; and a sled base configured to advance the sled member” [clm 14]; “The sled member 878 may be attached to the catheter handle 702 by the modular plate 884 and the handle control assembly 882.” [0091]; “The remotely-controlled catheter positioning system 110 may include a linear sled bed or sled base 936 which supports a linear sled member 938,” [0095]; [0084-0106], [fig. 1A, 6-11], [see claim 1 rejection]); and
an engagement component coupled to the base component (“a modular plate configured to receive a proximal portion of a catheter; a sled member coupled to the modular plate; and” [clm 14]; “A sled member 878 may be capable of receiving a catheter control handle in a handle control assembly 882 and mounted to a modular plate 884. A handle control assembly 882 may include clamps 886 and 888 and a molded nest 890.” [0090]; “The sled member 878 may be attached to the catheter handle 702 by the modular plate 884 and the handle control assembly 882. […] As the modular plate 884 is detachable from sled member 878, different handles may be used for different types of catheters.” [0091]; [0084-0106], [fig. 1A, 6-11], [see figclaim 1 rejection]),
the engagement component including a raised support structure sized and shaped for snap-fit engagement with the handle of the intraluminal imaging device (“A handle control assembly 882 may include clamps 886 and 888 and a molded nest 890. The knob 812 of the catheter handle 702 may be secured in the molded nest 890 by friction or snap-in fit.” [0090]; “Different modular plates 884 and handle control assemblies 882 may be used dependent upon the type/make of catheter used.” [0091]; “The catheter handle 702 of catheter 125 may be engaged into the modular plate 884 at three points, namely, clamps 886 and 888 and the molded nest 890. The catheter handle 702 may be snap fit into molded nest 890” [0093]; [0084-0106], [fig. 1A, 6-11], [see claim 1 rejection]).
Regarding claim 8, Jenkins teaches the system of claim 7,
Jenkins further teaching wherein the base component is press fit engaged with the engagement component (“a sled member coupled to the modular plate; and” [clm 14]; “The modular plate 884 may subsequently be attached to the sled member 878 by snap fit. The modular plate 884 may have protrusions (not shown) effective to secure the modular plate 884 to the sled member 878.” [0093]; [0084-0106], [fig. 1A, 6-11], [see claim 2 rejection]).
Regarding claim 9, Jenkins teaches the system of claim 8,
Jenkins further teaching wherein the engagement component extends across the base component in a direction perpendicular to a length of the base component (“a sled member coupled to the modular plate; and” [clm 14]; “Different modular plates 884 and handle control assemblies 882 may be used dependent upon the type/make of catheter used.” [0091]; “The catheter handle 702 of catheter 125 may be engaged into the modular plate 884 at three points, namely, clamps 886 and 888 and the molded nest 890. The catheter handle 702 may be snap fit into molded nest 890” [0093]; [0084-0106], [fig. 1A, 6-11], [see claim 3 rejection]).
Regarding claim 11, Jenkins teaches the system of claim 7,
Jenkins further teaching wherein the raised support structure includes:
a first support arm;
a second support arm (“a cardiac ablation catheter with a corresponding modular plate 884 may be used. A fastening mechanism may include clamps, such as clamps 886 and 888 may attach the catheter 125 to the modular plate 884.” [0092]; “The proximal end of catheter handle 702 may be mounted to the modular plate 884 through the use of the clamp 886 and the distal end may be mounted onto the modular plate 884 through the use of the clamp 888. The clamps 886, 888 may be snap fit.” [0093]; [0084-0106], [fig. 1A, 6-11], [see claim 1 rejection]); and
a cradle extending between and connecting the first support arm and the second support arm, wherein the cradle is sized and shaped for snap-fit engagement with the handle of the intraluminal imaging device (“A handle control assembly 882 may include clamps 886 and 888 and a molded nest 890. The knob 812 of the catheter handle 702 may be secured in the molded nest 890 by friction or snap-in fit.” [0090]; “The catheter handle 702 of catheter 125 may be engaged into the modular plate 884 at three points, namely, clamps 886 and 888 and the molded nest 890. The catheter handle 702 may be snap fit into molded nest 890 or secured by friction.” [0093]; [0084-0106], [fig. 1A, 6-11], [see claim 1 rejection]).
Regarding claim 12, Jenkins teaches the system of claim 11,
Jenkins further teaching wherein each of the first support arm and the second support arm extend at an oblique angle with respect to a base plate of the engagement component (“A handle control assembly 882 may include clamps 886 and 888 and a molded nest 890.” [0090]; “A fastening mechanism may include clamps, such as clamps 886 and 888 may attach the catheter 125 to the modular plate 884.” [0092]; “The proximal end of catheter handle 702 may be mounted to the modular plate 884 through the use of the clamp 886 and the distal end may be mounted onto the modular plate 884 through the use of the clamp 888. The clamps 886, 888 may be snap fit.” [0093]; [0084-0106], [fig. 1A, 6-11], [see claim 5 rejection]).
Regarding claim 13, Jenkins teaches the system of claim 12,
wherein the first support arm and the second support arm are sized and shaped to maintain the handle of the intraluminal imaging device in a raised position spaced from a surface on which the intraluminal imaging device stabilizer is positioned (“The modular plate 884 and handle control assembly 882 may be specific to the type/manufacture of the catheter 125 shown. Different modular plates 884 and handle control assemblies 882 may be used dependent upon the type/make of catheter used.” [0091]; “The catheter handle 702 of catheter 125 may be engaged into the modular plate 884 at three points, namely, clamps 886 and 888 and the molded nest 890. […] The proximal end of catheter handle 702 may be mounted to the modular plate 884 through the use of the clamp 886 and the distal end may be mounted onto the modular plate 884 through the use of the clamp 888. The clamps 886, 888 may be snap fit.” [0093]; “The remotely-controlled catheter positioning system 110 may include a linear sled bed or sled base 936 which supports a linear sled member 938, a mounting arm 940 which supports sled base 936 […] The mounting arm 940 may be attached to either the left or right side bars of an operative surface 956,” [0095]; [0084-0106], [fig. 1A, 6-11], [see claim 6 rejection]).
Regarding claim 14, Jenkins teaches a method of intraluminal imaging (“A method for a computing device to generate repositioning instructions for a first remotely-controlled catheter positioning system to position a first catheter […] performing image analysis on imagery generated based on data from the first catheter;” [clm 1]; “wherein the first catheter is an ultrasound catheter.” [clm 7]; “The various embodiments include a system and methods for controlling a remotely controlled catheter positioning system to maintain a therapeutic or diagnostic catheter within the field of view of an ultrasound imaging catheter while both are positioned within a patient's body.” [0002]; [0048-0071, 0084-0106], [fig. 1A, 3-4, 6-11], [see claim 1 rejection]), comprising:
inserting an intraluminal imaging device into a patient body (“The computing device 105 may be a programmable device configured to generate instructions and transmit signals for controlling the insertion and positioning of catheters by the remotely-controlled catheter positioning system 110.” [0031]; “Based on the control signals received from the computing device 105 via the connection 111, the remotely-controlled catheter positioning system 110 may manipulate the ultrasound catheter 114 within a patient, such as by advancing, retracting, and/or rotating the ultrasound catheter 114, […] the ultrasound catheter 114 may be manipulated within the patient (e.g., a human, horse, various mammals, etc.) so that its distal end 215 is positioned within an organ 130 of the patient.” [0032]; “a tubular member 120 (e.g., a catheter sheath) may be inserted into a patient by use of various known procedures and devices.” [0088]; [0048-0071, 0084-0106], [fig. 1A, 3-4, 6-11]);
advancing a distal portion of the intraluminal imaging device to a desired location within the patient body (“Based on the control signals received from the computing device 105 via the connection 111, the remotely-controlled catheter positioning system 110 may manipulate the ultrasound catheter 114 within a patient, such as by advancing, retracting, and/or rotating the ultrasound catheter 114, […] the ultrasound catheter 114 may be manipulated within the patient (e.g., a human, horse, various mammals, etc.) so that its distal end 215 is positioned within an organ 130 of the patient.” [0032]; [0048-0071, 0084-0106], [fig. 1A, 3-4, 6-11]);
coupling a handle of the intraluminal imaging device to an intraluminal imaging device stabilizer by snap-fitting the handle to a raised support structure of the intraluminal imaging device stabilizer (“A handle control assembly 882 may include clamps 886 and 888 and a molded nest 890. The knob 812 of the catheter handle 702 may be secured in the molded nest 890 by friction or snap-in fit.” [0090]; “Different modular plates 884 and handle control assemblies 882 may be used dependent upon the type/make of catheter used.” [0091]; “The catheter handle 702 of catheter 125 may be engaged into the modular plate 884 at three points, namely, clamps 886 and 888 and the molded nest 890. The catheter handle 702 may be snap fit into molded nest 890” [0093]; [0048-0071, 0084-0106], [fig. 1A, 3-4, 6-11], [see claim 1 rejection]); and
obtaining imaging data of a region of interest of the patient body using the intraluminal imaging device (“performing image analysis on imagery generated based on data from the first catheter;” [clm 1]; “The computing device may receive the ultrasound data from the ultrasound catheter directly when the computing device is directly coupled to the ultrasound catheter or from an ultrasound imaging system, which receives the ultrasound data from the ultrasound catheter and renders ultrasound images.” [0049]; [0048-0071, 0084-0106], [fig. 1A, 3-4, 6-11]).
Regarding claim 15, Jenkins teaches the method of claim 14,
Jenkins further teaching further comprising: rotating, while the handle of the intraluminal imaging device is positioned within the raised support structure of the intraluminal imaging device stabilizer, the handle of the intraluminal imaging device relative to the intraluminal imaging device stabilizer, wherein rotating the handle adjust an orientation of the distal portion of the intraluminal imaging device (“Based on the control signals received from the computing device 105 via the connection 111, the remotely-controlled catheter positioning system 110 may manipulate the ultrasound catheter 114 within a patient, such as by advancing, retracting, and/or rotating the ultrasound catheter 114, as well as actuating or bending a tip of the tubular member 115 by actuating a control manipulator on the catheter handle.” [0032]; “The remotely-controlled catheter positioning system 110 may be connected to the remote controller 102 which may be used to receive inputs from clinicians (or users). […] The distal end 972 may be rotated to control right roll and left roll of a catheter,” [0097]; [0048-0071, 0084-0106], [fig. 1A, 3-4, 6-11]).
Regarding claim 16, Jenkins teaches the method of claim 14,
Jenkins further teaching further comprising: moving, while the handle of the intraluminal imaging device is coupled to the intraluminal imaging device stabilizer, the handle of the intraluminal imaging device and the intraluminal imaging device stabilizer to adjust a position of the distal portion of the intraluminal imaging device (“Based on the control signals received from the computing device 105 via the connection 111, the remotely-controlled catheter positioning system 110 may manipulate the ultrasound catheter 114 within a patient, such as by advancing, retracting, and/or rotating the ultrasound catheter 114, as well as actuating or bending a tip of the tubular member 115 by actuating a control manipulator on the catheter handle.” [0032]; [0048-0071, 0084-0106], [fig. 1A, 3-4, 6-11]).
Regarding claim 17, Jenkins teaches the method of claim 14,
Jenkins further teaching further comprising: adjusting, while the handle of the intraluminal imaging device is coupled to the intraluminal imaging device stabilizer, an orientation of an imaging array in the distal portion of the intraluminal imaging device using at least one actuator on the handle of the intraluminal imaging device (“Based on the control signals received from the computing device 105 via the connection 111, the remotely-controlled catheter positioning system 110 may manipulate the ultrasound catheter 114 within a patient, such as by advancing, retracting, and/or rotating the ultrasound catheter 114, as well as actuating or bending a tip of the tubular member 115 by actuating a control manipulator on the catheter handle.” [0032]; “The remotely-controlled catheter positioning system 110 may be connected to the remote controller 102 which may be used to receive inputs from clinicians (or users). […] The distal end 972 may be rotated to control right roll and left roll of a catheter,” [0097]; [0048-0071, 0084-0106], [fig. 1A, 3-4, 6-11]).
Regarding claim 18, Jenkins teaches the method of claim 14,
Jenkins further teaching wherein the assembling the intraluminal imaging device stabilizer includes coupling a base component and an engagement component (“The modular plate 884 may subsequently be attached to the sled member 878 by snap fit. The modular plate 884 may have protrusions (not shown) effective to secure the modular plate 884 to the sled member 878.” [0093]; [0084-0106], [fig. 1A, 6-11], [see claim 2 rejection]).
Regarding claim 19, Jenkins teaches the method of claim 14,
Jenkins further teaching wherein the coupling the base component and the engagement component includes press fitting the base component and the engagement component together (“The modular plate 884 may subsequently be attached to the sled member 878 by snap fit. The modular plate 884 may have protrusions (not shown) effective to secure the modular plate 884 to the sled member 878.” [0093]; [0084-0106], [fig. 1A, 6-11], [see claim 2 rejection]).
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.
Claim(s) 4 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins as applied to claims 2 and 8 above, in view of Moore (US6292681B1, 2001-09-18; hereinafter “Moore”).
Regarding claim 4, Jenkins teaches the stabilizer of claim 2,
Jenkins further teaching wherein the base component and the engagement component each have a rectangular outer profile when viewed from above and are press fit together (“a sled member coupled to the modular plate; and” [clm 14]; “The modular plate 884 may subsequently be attached to the sled member 878 by snap fit. The modular plate 884 may have protrusions (not shown) effective to secure the modular plate 884 to the sled member 878.” [0093]; The modular plate and sled member have a rectangular profile and snap fit together [0084-0106], [fig. 1A, 6-11], [see claim 1 rejection]);
but Jenkins may fail to explicitly teach an X-shape or a cross shape.
However, in the same field of endeavor, Moore teaches a stabilizer for an intraluminal imaging device (“A motor drive assembly, comprising: a main body adapted for attachment to a catheter assembly;” [clm 1]; [fig. 1-8]);
Moore further teaching wherein the base component and the engagement component each have a rectangular outer profile when viewed from above such that the base component and the engagement component form an X shape or a cross shape when press fit together and viewed from above (“a base plate means attachable to the pullback carriage means” [clm 3]; “The motor drive unit 22 is also provided with an (optional) base plate 118 that is removably mounted to the pullback carriage 48, […] Preferably, a bottom surface 117 of the base plate 118 is suitably configured such that the motor drive unit 22 will be stably supported on a flat structure (e.g., such as an operating table), […] Notably, the base plate 118 can preferably be snapped onto the base of the pullback carriage 48” [col.5-6, ln.60-26]; [fig. 1-8; see fig. 1, 3 reproduced below]).
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The pullback carriage and pullback arm (i.e., engagement component) and base plate (i.e., base component) form a cross shape when viewed from angle perpendicular to orientations of figures 1 and 3, above the imaging system (Moore [fig. 2, 3])
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the stabilizer for an intraluminal imaging device taught by Jenkins with an X-shape or a cross shape as taught by Moore. It would have been an obvious matter of design choice to use an X-shape or a cross shape, since Applicant has not disclosed that shape of the elements solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the bases taught by either Jenkins or Moore. The combined system may enable improved medical procedures by relieving a clinician of a burden of frequently repositioning and imaging catheter while performing therapeutic or diagnostic procedures with another catheter (Jenkins [0002]). Furthermore, the system facilitates a disposable base plate which may be removably mounted to the pullback carriage, allowing for the motor drive unit to be stably placed on a support structure such as a table (Moore [col.4, ln.14-17]).
Regarding claim 10, Jenkins teaches the system of claim 8,
Jenkins further teaching wherein the base component and the engagement component each have a rectangular outer profile when viewed from above and are press fit together (“a sled member coupled to the modular plate; and” [clm 14]; “The modular plate 884 may subsequently be attached to the sled member 878 by snap fit. The modular plate 884 may have protrusions (not shown) effective to secure the modular plate 884 to the sled member 878.” [0093]; The modular plate and sled member have a rectangular profile and snap fit together [0084-0106], [fig. 1A, 6-11], [see claim 1 rejection]);
but Jenkins may fail to explicitly teach an X-shape or a cross shape.
However, in the same field of endeavor, Moore teaches a stabilizer for an intraluminal imaging device (“A motor drive assembly, comprising: a main body adapted for attachment to a catheter assembly;” [clm 1]; [fig. 1-8]);
Moore further teaching wherein the base component and the engagement component each have a rectangular outer profile when viewed from above such that the base component and the engagement component form an X shape or a cross shape when press fit together and viewed from above (“a base plate means attachable to the pullback carriage means” [clm 3]; “The motor drive unit 22 is also provided with an (optional) base plate 118 that is removably mounted to the pullback carriage 48, […] Preferably, a bottom surface 117 of the base plate 118 is suitably configured such that the motor drive unit 22 will be stably supported on a flat structure (e.g., such as an operating table), […] Notably, the base plate 118 can preferably be snapped onto the base of the pullback carriage 48” [col.5-6, ln.60-26]; [fig. 1-8], [see claim 4 rejection]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to modify the stabilizer for an intraluminal imaging device taught by Jenkins with an X-shape or a cross shape as taught by Moore. It would have been an obvious matter of design choice to use an X-shape or a cross shape, since Applicant has not disclosed that shape of the elements solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the bases taught by either Jenkins or Moore. The combined system may enable improved medical procedures by relieving a clinician of a burden of frequently repositioning and imaging catheter while performing therapeutic or diagnostic procedures with another catheter (Jenkins [0002]). Furthermore, the system facilitates a disposable base plate which may be removably mounted to the pullback carriage, allowing for the motor drive unit to be stably placed on a support structure such as a table (Moore [col.4, ln.14-17]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schaer et al. (US20230371924A1, 2023-11-23) teaches medical tool positioning and control devices, systems, and methods including handle assemblies that allow a steerable shaft to be steered, while allowing the separate movement of a medical tool. The handle assemblies can allow for rotation and axial movement of the medical tool, and optionally with an actuator disposed distal to a second actuator that controls steering of the steerable shaft [abst].
Ream (US5827313A, 1998-10-27) teaches a longitudinal mover which permits the controlled longitudinal movement of a catheter-transported operative device, such as a rotatable ultrasonic transducer [col.1, ln.6-11].
Belef et al. (US6398755B1, 2002-06-04) teaches a catheter system that provides for the controlled longitudinal movement of an elongate element—such as a rotatable catheter core with an operative clement, for example an ultrasonic transducer [col.1, ln.27-33].
Hickey et al. (US20070129634A1, 2007-06-07) teaches a support device that allows the adjustable, yet rigid placement of a probe or other medical instrument against a region of interest/treatment on a patient [abst].
Foley et al. (US20110028894A1; 2011-02-03) teaches a system for remotely controlling the positioning within the body of a patient of an elongated medical device optionally having a control handle, comprises a robotic system and a remote controller configured to control the robotic device [abst].
Altmann et al. (EP1779802B1, 2016-04-06) teaches sensing the position and orientation of an object placed within a living body, and particularly stabilizing the position and orientation of an intravascular probe within a moving internal organ of a living body [0001].
Funda et al. (US5749362A, 1998-05-12) teaches an instrument which is placed in relation to the designated object and which is capable of sending information about the object to a computer. Image processing methods are used to generated images of the object and determine positional information about it. Various input apparatus are attached to the transmitting or other used instruments to provide control inputs to the computer [abst].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at 5712727230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797