DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The 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:
Claim 14:
a provision unit configured to provide
a measuring unit configured to measure
an evaluation unit configured to evaluate
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.
Claim 14:
a provision unit configured to provide has no corresponding structure disclosed in the specification.
a measuring unit configured to measure has no corresponding structure disclosed in the specification.
an evaluation unit configured to evaluate has no corresponding structure disclosed in the specification.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 14 is rejected because the specification, as originally filed, fails to disclose a provision unit, a measuring unit and an evaluation unit as interpreted under 35 U.S.C. 112f described above.
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 limitations “provision unit”, “measuring unit” and “evaluation unit” invoke 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. 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 § 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 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.
Claim(s) 1-2, 5-7, 9-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over NPL “Machine Learning and Deformation Modeling for Workflow-Compliant Image Fusion during Endovascular Aortic Repair” to Breininger in view of U.S. Publication No. 2013/0324833 to Barley et al. “Barley”.
As for Claims 1, 5, 11 and 14, Breininger discloses a method for adjusting a reference x-ray image of a hollow organ of a patient to a live (e.g. intraoperative) X-ray image of an object (e.g. catheter) introduced into the hollow organ (Abstract; Pages 3-4 “1.1 Motivation”) including steps of providing a reference image of the hollow organ, record at least one live image registered with the reference image (Page 13, Fig. 1.5, “Image fusion”; Page 35). Breininger also discloses conventional steps of segmentation in order to perform the fused visualization (Pages 13-14, 16-17; Fig. 1.6, Instrument segmentation) which provides an original profile of the organ in its broadest reasonable interpretation and a step to provide a “deformation correction” (Page 18). While Breininger explains the deformation is caused by the inserted instrument (Pages 18, 97), Breininger does not expressly disclose utilizing a shape sensing system to measure haptic information and adjusting/deforming the reference image using the boundary conditions based on shape sensing data.
Barley teaches from within a similar field of endeavor with respect to image guided interventional systems and methods (Abstract) where shape data acquired with a fiber optic shape acquisition system; Paragraphs [0005] and [0022]-[0025]) is used as input to a shape deformation module so that 3D deformations, deflections, and other changes associated with the medical device or instrument and/or its surrounding region can be visualized to accurately reflect real-time vascular anatomy (Paragraphs [0023] and [0025]). Barley explains where haptic information such as pressure, strain, shear or contact may be provided to the deformation module (Paragraphs [0022]-[0025], [0029]).
Accordingly, one skilled in the art would have been motivated to have modified Breininger’s deformation processing and display means to utilize shape data acquired with a shape sensing system to morph patient anatomy as described by Barley in order to improve the accuracy of the visualized image data. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143). Examiner notes in the modified system, the deformed anatomy’s profile is modeled and reproduced based on the shape sensing boundary conditions in its broadest reasonable interpretation.
With respect to Claim 2, Examiner notes the optical fiber sensing (e.g. Fiber Bragg gratings (FBG, Rayleigh scattering optical fiber, etc.) in the modified catheter would be connected to the catheter in order to sense the catheter’s shape as described above.
As for Claim 6, the original x-ray image data would have a space between the current profile and the catheter until the catheter’s movement imposes strain/force onto the organ to justify the deformation as described above.
Regarding Claim 7, any of the pressure, strain, shear or contact measured as described above may be considered “further item information” in its broadest reasonable interpretation.
As for Claim 9, Examiner notes that entry points of the organ would be used for the reproduced organ if and when the catheter is located in an entry point and is inducing strain on the organ.
With respect to Claims 10 and 12, Breininger explains the live imaging may include sequential operation of x-ray imaging (Page 26). Thus, the modified system and method would use at least two images while haptic information (e.g. shape sensing data) is obtained to morph/deform the organ’s current profile in its broadest reasonable interpretation.
Claim(s) 3-4, 7-8, 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Breininger and Barley as applied to claim 1 above, and further in view of U.S. Publication No. 2024/0183382 to Bartholomew et al. “Bartholomew”.
As for Claims 3 and 13, Breininger and Barley disclose a system and method for adjusting a reference x-ray image based on, at least in part, shape sensing data as described above. While Barley explains where haptic information such as pressure, strain, shear or contact may be provided to the deformation module (Paragraphs [0022]-[0025], [0029]), the art of record does not specify a friction force as claimed.
Bartholomew teaches from within a similar field of endeavor with respect to catheters with shape sensing means (Paragraph [0147]) where force and torque may be derived from strain measurements on FBG sensors (Paragraphs [0216]-[0218]).
Accordingly, one skilled in the art would have been motivated to have measured catheter force (e.g. friction force) as the catheter is inserted along the anatomy as described by Bartholomew in order to morph/deform anatomy profiles using all types of measured data to enhance the accuracy of the updated anatomy profile.
With respect to Claim 4, Examiner notes the modified system and method which deforms the anatomy based on, at least in part, the shape sensing data (e.g. direction, force, strain, shear, etc.) would distort/shape the organ in the same way if and when the instrument imposes the same force on the claimed anatomy in its broadest reasonable interpretation.
Regarding Claims 7-8, Bartholomew discloses determining a radius of curvature (Paragraph [0175]). Accordingly, one skilled in the art would have been motivated to have used any all available data to deform/morph the representation of the organ in a more realistic fashion.
As for Claim 15, Bartholomew discloses wherein the catheter system can be driven by a robotic control system (Paragraphs [0002], [0005]-[0006], [0023] and [0143]). One skilled in the art would have been motivated to have used a robotic drive system in order to enhance the accuracy and precision of catheter movement within the body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
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