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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the brachytherapy sensor cable in figure 1A as described in the specification (pg 9, lines 11-12). Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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 1 and 15 are objected to because the claim states “a hollow conduit…so that the brachytherapy sensor cable can be moved through a lumen”. It does not appear that the presence of the hollow conduit is what makes the sensor cable be able to be moved through the lumen. Also of note is in the spec as filed, and in the regions that are not essentially copying the claims, on page 9 line 13-18 has the hollow conduit and the sensor cable being moved through a lumen as two separate thoughts “The sensor cable 100 comprises a hollow conduit 150 of helical strands 160, wherein a proximal part 130 of the sensor cable may be connectable to the afterloader system, in the example by a connector 180, to be further described below. The sensor cable 100 can be moved through a lumen towards an applicator positioned in a human body in a way conventional for afterloader systems.”
Claim 14 and 17 are objected to because the claim states “brachy therapy” and it should be corrected to read “brachytherapy”, as one word.
Claim 15 is objected to because it is suggested that the brachytherapy sensor cable be positively recited (A brachytherapy system comprising a brachytherapy sensor cable comprising…; and a brachytherapy control system comprising…). As currently written the details of the sensor cable are all intended use. As long as the control system is capable of being coupled to a brachytherapy sensor cable with the specific limitations, the claim limitation is met. A brachytherapy sensor cable with all the specific limitations does not have to exist.
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 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 16: Treatment planning module calculating Biological Effective Dose
Claim 17: image module arranged to create a three-dimensional channel path profile
Claim 17: target and organ delineation module arranged to identify a treatment target and organs at risk
Claim 17: a process module for processing brachytherapy control data
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. A review of the specification shows the corresponding structure:
Claim 16: Treatment planning module: There is no corresponding structure identified by the specification for the treatment planning module.
Claim 17: Image module: As identified by the specification, pg 13, line 20 “the reference markers associated with the conduit may be detected by a medical imaging system, such as magnetic resonance imaging (MRI), (computed) tomography (CT), (computed) radiography (CR), X-ray, elastography, thermography, photo acoustic imaging, tomography, angiography, optical, near infrared spectroscopy, electromagnetic, nuclear medical, and/or ultrasound imaging.”
Claim 17: Target and organ delineation module: There is no corresponding structure identified by the specification for the treatment planning module.
Claim 17: Process Module: As identified by the specification, pg 13, line 27, “the reference marker detection data may be transmitted to a processor for use with the planning treatment software and/or treatment delivery software”
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.
Claims 16-17 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. Although the specification describes providing a treatment planning module for calculating a biological effective dose, the specification does not provide enough written description on the corresponding structure for the treatment planning module. Further, the does not describe the specific steps, equations, or input data required to calculate the dose. The specification mentions broadly “a treatment planning module may be provided for calculating a Biological Effective Dose for brachytherapy treatment, based on the actual registered three- dimensional channel path profile from the sensor registration, of a treatment path for providing brachytherapy treatment in patient's tissue to be treated”. Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. Generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. See MPEP 2106.01 and 2163.
Claims 17 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. Although the specification describes calculating a creating a three-dimensional path profile but does not describe the specific steps, equations, or input data required to determine the path. The specification mentions broadly “an image module; arranged to create a three-dimensional channel path profile of a treatment path for providing brachytherapy treatment in patient's tissue to be treated”. Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. Generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. See MPEP 2106.01 and 2163.
Claims 17 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. Although the specification describes providing a target delineation module, there are no specific steps described as to how the module will determine the treatment target. The specification mentions broadly “a target and organ delineation module may be provided; arranged to identify a treatment target and organs at risk in the received image”. Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. Generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. See MPEP 2106.01 and 2163.
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, 3-4, 12, 15 -17 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.
Regarding claims 1 and 15, the limitation “the hollow conduit of the distal part” has insufficient antecedent basis. There is only a hollow conduit of a proximal part previously claimed. Suggested claim amendment of “a hollow conduit in the distal part” is added to this claim.
Regarding claim 3, the limitation “hollow conduit” renders the claim unclear as it is not clear whether the conduit of helical strands is the same or different than the hollow conduit. Suggested claim amendment is to add “the hollow conduit of” before “the proximal”.
Regarding claim 4, the limitation “hollow conduit” renders the claim unclear as it is not clear whether the conduit of helical strands is the same or different than the hollow conduit. Suggested claim amendment is to add “the hollow conduit of” before “the distal”.
Regarding claim 12, the limitation “the sensor is provided in a capsule fixed to the distal part” seems to contradict the limitation in claim 1 which states “a distal part of the brachytherapy sensor cable comprises a sensor” because if the capsule is fixed to the distal part, then the capsule is not the distal part, so for claim 12 is the sensor in the distal part or is it in the capsule? Suggested claim amendment is changing “fixed to the distal part” to “fixed to a distal end of the hollow conduit of the distal part” (assuming the suggested amendment to claim 1 is also incorporated).
Regarding claim 16, the limitation “the brachytherapy control system….further comprising a treatment” renders the claim unclear as it is not clear if a treatment is referring to a treatment source or a calculated treatment plan. It would not appear that the applicant has support for the control system comprising the treatment source (i.e. the control system and the treatment source would seem to be 2 separate parts of an overall brachytherapy system).
Regarding claims 15 and 17, the limitations “three-dimensional channel path profile of a treatment path” renders the claim unclear as it is not clear what a channel path profile is. The specification does not appear to provide any further details nor are there any drawings directed to a “three-dimensional channel path profile”.
Regarding claim 17, there is insufficient antecedent basis for the limitation “a three-dimensional channel path profile”. Suggested amendment is “the three-dimensional channel path profile”.
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, 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De Vries (EP 3031494), as cited in the applicant’s IDS.
Regarding claim 1, a brachytherapy sensor cables wherein the brachytherapy sensor cable comprises:
a hollow conduit (paragraph [0044] “Verification element 8 is electrically coupled via a signal conductor 12 extending through or along cable 10” Fig 5A, element 10 is the hollow conduit.)
in a proximal part of the brachytherapy sensor cable so that the brachytherapy sensor cable can be moved through a lumen towards an applicator positioned in a human body (Fig 5A, element 8 is the sensor moved through hollow conduit element 10. Fig 5B shows the sensor cable moved through a lumen in an applicator (element 1). Paragraph [0041] “The conduit includes a hollow inner portion dimensioned
to receive a radiotherapy source or a verification element” ”)
wherein a distal part of the brachytherapy sensor cable comprises a sensor, (The examiner notes in figure 5A where element 8 as the distal part. ”)
and wherein a hollow passage is formed between the proximal part and the distal part to guide signal wiring of the sensor through the hollow conduit of the distal part and the proximal part (The examiner notes that in fig 5A elements 8 and 12 are wired inside through the conduit 10. The inside space of element 10 is the hollow passage formed between the distal part (near element 8) and the proximal part (near element 14).)
Regarding claim 14, De Vries discloses the device of claim 1 and wherein the proximal part of the brachytherapy sensor cable is connectable to an afterloader system to be used in a brachy therapy treatment. (paragraph [0016] “The control element may be included as part of 50 a brachytherapy treatment delivery system. At least one of the drive device and the controller may be included within an afterloader. The control element may include a wire or a cable.”)
Regarding claim 15, De Vries discloses a brachytherapy control system to be coupled to a brachytherapy sensor cable (paragraph [0016] “The control element may be included as part of 50 a brachytherapy treatment delivery system. At least one of the drive device and the controller may be included within an afterloader. The control element may include a wire or a cable.”), wherein the brachytherapy sensor cable comprises
a hollow conduit (paragraph [0044] “Verification element 8 is electrically coupled via a signal conductor 12 extending through or along cable 10” Fig 5A, element 10 is the hollow conduit.) in a proximal part of the brachytherapy sensor cable so that the brachytherapy sensor cable can be moved through a lumen towards an applicator positioned in a human body (Fig 5A, element 8 is the sensor moved through hollow conduit element 10. Fig 5B shows the sensor cable moved through a lumen in an applicator (element 1). Paragraph [0041] “The conduit includes a hollow inner portion dimensioned
to receive a radiotherapy source or a verification element””)
wherein a distal part of the brachytherapy sensor cable comprises a sensor, (The examiner notes in figure 5A where element 8 as the distal part.)
and wherein a hollow passage is formed between the proximal part and the distal part to guide signal wiring of the sensor through the hollow conduit of the distal part and the proximal part (The examiner notes that in fig 5A elements 8 and 12 are wired inside through the conduit 10. The inside space of element 10 is the hollow passage formed between the distal part (near element 8) and the proximal part (near element 14).)
wherein the brachytherapy control system is programmed to process input data from the sensor to create a three-dimensional channel path profile of a treatment path for providing brachytherapy treatment in patient’s tissue to be treated. (paragraph [0033] “through the conduit may mimic the path that the radiotherapy source will take through the conduit, so use of the verification element to determine positioning relative to a reference marker may allow a healthcare provider to determine whether the radiotherapy source will be correctly
positioned.” paragraph [0064] “The control system may include {drive) electronics with a switching unit….This switching configuration may integrate an electromagnetic tracking system with the position verification system and allow the reference markers, the electromagnetic tracking data, and the dwell positions of the verification element to be merged and/or synchronized into a single two-dimensional or three-dimensional spatial positioning database.”)
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Vries in view of Whiting (US 2012/0035590), as cited in the applicant’s IDS.
Regarding claim 2, De Vries teaches the device of claim 1, but fails to teach, wherein the proximal part has a lateral stiffness higher than the lateral stiffness of the distal part.
Whiting teaches a method for accessing a target site in the body by transferring a guidewire with different stiffness areas. (paragraph [0067] “changes to the diameter of the guidewire 10 along the length of the guidewire may also be used alter the stiffness and flexibility along those portions.” Paragraph [0069] “the distal tip of the core may be tapered to create a smooth transition from the stiff portion to the flexible portion of the guidewire.” Paragraph [0069] “the guidewire has a multi-piece construction comprising a moveable inner core and an outer helical wound coil, with an opening at its proximal end and a closed-off distal end,” The examiner is modifying hollow conduit to be be made of wound elements with varying diameters to change the stiffness as taught by Whiting.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the system taught by De Vries in view of Whiting to have the stiffness and flexibility be altered. One of ordinary skill in the art would have been able to recognize that increased stiffness of the cable may improve the steerability of the cable to the target site while providing flexible portions of the cable once inserted into the patient.. See paragraph [0071] of Whiting.
Claim(s)3--6, 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Vries in view of Whiting further in view of Zhou (US 8377035).
Regarding claims 3 and 4, De Vries and Whiting teach device of claim 2, and but fail to teach wherein the proximal part comprises a conduit of helical strands (of claim 3) and wherein the distal part comprises a conduit of helical strands (of claim 4).
Zhou teaches a reinforcement member for medical devices made of helical strands. (col 6, line 19 “a first set of one or more strands 36B are wound in a first helical direction and a second set of one or more strands 38B are wound in a second helical direction different than the first helical direction.”)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the system taught by De Vries in view of Whiting to have helical distal and proximal ends. One of ordinary skill in the art would have been able to recognize that it is often necessary for the elongate member to be resistant to kinking while still being flexible and capable of transferring a twisting force. The reinforcement member provides torsional rigidity, column strength, kink resistance, and allows for improved torque response of such elongate members. Where a braid layer is disposed between an inner layer and an outer layer, the braid layer may reduce the structural integrity of the elongate device by limiting the area of adhesion between the inner and outer layers. See col 1, line 17 of Zhou.
Regarding claim 5, De Vries teaches the device of claim 4 but fails to teach wherein a number of helical strands in the distal part is greater than a number of helical strands of the proximal part.
Zhou teaches a medical device shaft meant to be incorporated into guide catheters where the number of strands vary in either direction. (Column 6, line 19 “in FIG. 4B, a first set of one or more strands 36B are wound in a first helical direction and a second set of one or more strands 38B are wound in a second helical direction different than the first helical direction. The number of strands 36B in the first set is different than the number of strands 38B in the second set. Each set wound in each direction may have one or more strands 36B/38B, but differ in number.” The examiner notes here that the number of strands can vary in each direction, the examiner is modifying the system taught by De Vries and Whiting to have a greater number of strands in the distal part compared to the proximal part.)
It would have been prima facie obvious to one of ordinary skill to modify the system taught by
De Vries and Whiting to have a varied number of strands in the distal and proximal direction. One of ordinary skill in the art would have been able to recognize that the number of strands or filaments used in such a braided reinforcing member 32 will often depend upon the desired characteristics of the braid, and the patterns or techniques used to form the braid. See col 4, line 65 of Zhou.
Regarding claim 6, De Vries, Whiting, and Zhou teach the device of claim 5, and Zhou further teaches wherein the helical strands in the distal part is of a different material to the helical strands of the proximal part. (Column 6, line 43 “a braid structure having strands of different shapes (cylindrical wires versus ribbons, for example), using strands of different compositions (multi-filament versus single filament, strands of different materials, etc.), uneven weaving patterns (for example a three-over-two pattern as shown in FIG. 6), or combinations thereof, are included.” The examiner notes here that the strands are made of different materials, the examiner is modifying the system taught by De Vries and Whiting to have strands of a different material in the distal part and the proximal part.)
It would be prima facie obvious to one of ordinary skill in the art to modify the system taught by De Vries, Whiting, and Zhou to have different materials in the proximal and distal part. One of ordinary skill in the art would have been able to recognize that the flexibility of the cable would need to differ in the distal part and proximal part due to the distal part being inserted and guided in the body to find the implanted markers.
Regarding claim 8, De Vries and Whiting teach the device of claim 4, but fail to teach wherein the helical strands of the proximal part and the distal part of the hollow conduit differ in cross sectional form.
Zhou teaches the use of strands of different shapes. (column 1, line 33 “a reinforcement layer is provided having interwoven strands of different sizes and/or shapes” The examiner is modifying the distal and proximal side to have different shaped cross sectional strands.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by De Vries and Whiting to have different shaped strands by Zhou. One of ordinary skill in the art would have been able to recognize by varying sizes, shapes and numbers of strands in a braid layer, torque and anti-kink characteristics of different strand sizes may be combined while reducing braid layer thickness. See column 1 line 38 of Zhou.
Regarding claim 9, De Vries and Whiting teach the device of claim 4 but fails to teach wherein a cross sectional form at least the proximal part of the sensor cable is oblate.
Zhou teaches filaments of an oval cross sectional shape. (column 5, line 6 “the cross-sectional shape of the filaments can be circular, oval, or multisided, for example, triangular, square, rectangular, pentagonal, hexagonal, and so fourth.”)
It would have been prima facie obvious to one of ordinary skill to modify the system taught by
De Vries and Whiting to be oval shaped. One of ordinary skill in the art would have been able to recognize that the required shape of the filaments would depend on the characteristics of the cable and application needed and further the shape of the sensor cable is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. Please see MPEP 2144.04, section IV, B; In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Vries in view of Whiting further in view of Wulfman (US 6818001).
Regarding claim 7, De Vries and Whiting teach the device of claim 4, but fails to teach wherein the helical strands in the distal part strands are enclosed by a bushing that is welded to the proximal part.
Wulfman teaches an intraluminal assembly with a bushing connected to the hollow tube by welding. (Column 23, line 20 “proximal bushing 250 may be fixedly joined to the assembly tube by any conventional connection, such as welds and adhesives, as well as mechanical connections such as compression fitting.“)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the system taught by De Vries and Whiting to have a welded bushing as taught by Wulfman. One of ordinary skill in the art would have been able to recognize that a bushing would reduce friction within the structure and that welding would prevent the helical cables from moving around or rubbing or against the inside of the tube.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Vries in view of Whiting further in view of Hedger (US 2012/0004493).
Regarding claim 10, De Vries and Whiting teach the device of claim 4 but fail to teach wherein the hollow passage is formed by a weld that connects at least some of the helical strands from the distal part to the proximal part of the brachytherapy sensor cable.
Hedger teaches a system for delivering brachytherapy source with a weld connecting two parts of of a guide wire. (Paragraph [0018] “The cable 42 comprises a linking member 60 at the proximal end 75 for connecting the guide wire 40 to a coupling element 70…the linking member 60 comprises a weld.”)
It would be prima facie obvious to one of ordinary skill in the art to modify the system taught by De Vries and Whiting have a welding connection as taught by Zhou. One of ordinary skill in the art would have been able to recognize that the two parts of the sensor cable would need to be secure especially if it is inserted into a patient.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Vries in view of Vaughan (US 2019/0231441).
Regarding claim 11, De Vries teaches the device of claim 1 but fails to teach wherein the sensor is a 5-DOF sensor.
Vaughan teaches a three-dimensional tracking system for surgical tools (paragraph [0044] “Embodiments may also be applied to other procedures and interventions, such as, for example, radiation therapy interventions such as brachytherapy.” Paragraph [0043] “a small 3 DOF sensor or 5 DOF sensor is embedded within the needle tip, which is in turn hooked into the tissue volume of interest.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system of De Vries in view of Vaughan. One of ordinary skill in the art would have been able to recognize that 5DOF sensors are relatively inexpensive to more complex sensors and require less computational complexity when processing positional and orientational data. See paragraph [004] of Vaughan.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Vries in view of Bharat (US 2016/0199668), as cited in the applicant’s IDS.
Regarding claim 12, De Vries teaches the device according to claim 1, but fails to teach wherein the sensor is provided in a capsule fixed to the distal part.
Bhara teaches a brachytherapy dose system with a sensor in a capsule. (paragraph [0072] “The introduction element 113 comprises an ultrasound sensor…At the tip of the introduction element 113 the radiation source 10 is arranged, which comprises a capsule 55, which is preferentially a stainless steel capsule” The examiner notes the tip of the introduction element is the distal part.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by De Vries and Whiting to have a capsule around the sensor. One of ordinary skill would have been able to recognize that the sensor would need protection from the environment inside the body.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Vries in view of Bharat (US 2016/0199668) further in view of Eskuri (US 7785273)
Regarding claim 13, De Vries and Bharat teach the device according to claim 12, and Bharat further teaches wherein the capsule is formed of stainless steel (paragraph [0072] “which is preferentially a stainless steel capsule”, but fails to teach wherein the sensor is provided in a polymer shaft embedded in the capsule.
Eskuri teaches a reinforced guidewire with a polymer shaft. (column 6, line 40 “As shown in FIG. 2, a reinforcing member 20 may be disposed about a proximal portion 16 of the distal section 15 of the core wire 14.” And column 6, line 43 “The reinforcing member may be a tubular segment 20 formed of a variety of materials including metals, metal alloys, polymers, and the like.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by De Vries in view of Bharat. One of ordinary skill in the art would have been able to recognize that the stainless steel capsule is a biocompatible material that is rigid and will protect the sensor. Thus, it would be beneficial to have that layer as the outermost layer. However, a suitable superelastic alloy will provide a reinforcing member that exhibits some enhanced ability, relative to some other non-superelastic materials, of substantially recovering its shape without significant plastic deformation, upon the application and release of stress, for example, during placement of the catheter in the body. need reinforcing structure to prevent it from breaking. See Column 3, line 64 of Eskuri.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Vries in view of Owens (US 2018/0369611).
Regarding claim 16, De Vries teaches the brachytherapy control system according to claim 15 but fails to teach that the system further comprises a treatment; and a treatment planning module calculating a Biological Effective Dose for brachytherapy treatment.
Owens teaches a system for adaptive radiotherapy that adapts or updates radiotherapy treatment plans that calculate a biological effective dose. (paragraph [0007] “methods for evaluating a treatment plan based on real-time acquired imaging data.” And paragraph [0070] “Modifications to a treatment plan may include absolute dose values for each target region, dose limits for each target region and/or cumulatively for the patient, biological effective dose values,”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system of De Vries in view of Owens. One of ordinary skill in the art would have been able to recognize the biological effective dose would give an indication on whether healthy tissue would be impacted by the radiation.
Regarding claim 17, De Vries and Owens teach the system of claim 16 and De Vries further teaches wherein the treatment planning module comprises:
an image module arranged to create a three-dimensional channel path profile of a treatment path for providing brachytherapy treatment in patient's tissue to be treated (paragraph [0033] “through the conduit may mimic the path that the radiotherapy source will take through the conduit, so use of the verification element to determine positioning relative to a reference marker may allow a healthcare provider to determine whether the radiotherapy source will be correctly positioned.” paragraph [0064] “This switching configuration may integrate an electromagnetic tracking system with the position verification system and allow the reference markers, the electromagnetic tracking data, and the dwell positions of the verification element to be merged and/or synchronized into a single two-dimensional or three-dimensional spatial positioning database.” paragraph [0073] “a treatment plan may be generated for the patient based on images or image data acquired using any desired imaging modality (e.g., PET, SPECT, MRI, CT, X-ray, etc.)” The examiner notes that a treatment plan would inherently have a step of providing a treatment.)
but fails to teach a target and organ delineation module arranged to identify a treatment target and organs at risk in a received image; and a process module for processing brachy therapy control data in accordance with a treatment plan and the said identified treatment targets and organs at risk.
Owens teaches:
a target and organ delineation module arranged to identify a treatment target and organs at risk in a received image; (paragraph [0073] “a treatment plan may be generated for the patient based on images or image data acquired using any desired imaging modality (e.g., PET, SPECT, MRI, CT, X-ray, etc.)…..Evaluating biological activity and/or physiological data may comprise extracting various parameters of the patient and/or target region(s), including, but not limited to, target region delineation, target region isocenters, and/or OAR location”)
and a process module for processing brachy therapy control data in accordance with a treatment plan and the said identified treatment targets and organs at risk. (paragraph [0130] “ processor may be any suitable processing device configured to run and/or execute a set of instructions or code and may include one or more data processors, image processors, graphics processing units, physics processing units, digital signal processors, and/or central processing units. The processor may be, for example, a general purpose processor, Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), or the like. The processor may be configured to run and/or execute application processes and/or other modules, processes and/or functions associated with the system and/or a network associated therewith.”; paragraph [0073] “Evaluating biological activity and/or physiological data may comprise extracting various parameters of the patient and/or target region(s), including, but not limited to, target region delineation, target region isocenters, and/or OAR location”)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Eigler (US 2011/0022057) teaches a guide wire with a helical wire for adjusting an implant.
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
