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 .
Specification
The use of the term “FENFIT™”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1, 4, 5, 12, 13, 17 and 20 are objected to because of the following informalities:
Regarding claims 1 and 13, a colon should be added after “comprising”.
Regarding claim 4, it should be rewritten as “wherein obtaining the fenestration location and radius comprises obtaining values for the Proximal Graft Distance (PGD) between…--”.
Regarding claim 5, it should be rewritten as “wherein obtaining the fenestration location and radius comprises obtaining values for the Arclength (AL) between…--“.
Regarding claim 12, “aligns” should be removed from “comprising aligning the graft aligns with the tortuosity”.
Regarding claim 13, in line 4, “location” should be rewritten as “location, and”.
Regarding claim 17, there should be a period at the end.
Regarding claim 20, “too” should be rewritten as “tool”. In line 1, “the motors” should be rewritten as “the one or more motors”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 5, and 10-21 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 4 and 5, the term “about” is a relative term which renders the claim indefinite. The term “about” in “between about 0.1 mm and about 500 mm” in claim 4 and “between about -100 mm and +100 mm” in claim 5 are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 10, it recites the limitation "the graft". There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 11, it recites the limitations “the resulting three dimensional fenestrated graft” and “the three dimensional segmented patient anatomy”. There is insufficient antecedent basis for these limitations in the claim.
Regarding claim 12, it recites the limitations “the graft”, “the tortuosity”, and “the vessel”. There is insufficient antecedent basis for these limitations in the claim.
Regarding claim 13, it recites the limitation “the device”. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 15, it is unclear if “a medical implant” is the same as or different than “the medical implant” recited in claim 1, line 4.
Regarding claim 16, it is unclear if “a medical implant” is the same as or different than “the medical implant” recited in claim 1, line 4.
Regarding claim 20, it is unclear if “two or more motors” are the same as or different than “one or more motors” recited at line 5 of claim 13.
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.
Claims 1-3 and 6-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Douthitt et al. (US 20170333175 A1) (hereon referred as Douthitt).
Regarding claim 1, Douthitt teaches an automated method (“formation of the patient-specific prosthesis can be performed…automated process”, paragraph [0020]) for fenestration alignment on a medical implant (“fenestrated stent graft…align the fenestrations with openings”, paragraph [0018]), the method comprising:
Obtaining fenestration location and radius from patient’s anatomy (“position of the fenestrations 165 along the stent graft 160 can be based on anatomic imaging data and/or one or more digital representations of the patient’s anatomy”, paragraph [0027])
Aligning the fenestration location and radius on the medical implant such that the aligning does not collide with a structural component of the implant (“strut pattern information can be used to define fenestrations in locations on a graft without struts…strut patterns are customized to not overlap with fenestration locations”, paragraph [0101]), and
Optionally, marking the fenestration location on the medical implant (“marking fenestration locations along a stent graft”, paragraph [0020]).
Regarding claim 2, Douthitt teaches obtaining the fenestration location and radius from patient’s anatomy comprising obtaining Proximal Graft Distance (PGD) and Arclength (AL) for each fenestration (“longitudinal distances of branch vessels…and relative angular locations of the branch vessels can be estimated and/or calculated…surgeon can mark and cut the stent fabric of a stent graft to define one or more fenestrations”, paragraph [0018]).
Regarding claim 3, Douthitt teaches wherein the patient’s anatomy is represented with a non-invasive imaging of computerized tomography (CT) (“fenestration process involves measurements based on medical images (such as CT scans)”, paragraph [0018]), magnetic resonance imaging (MRI), or radiography (“imaging device can be an x-ray device…MRI”, paragraph [0023]).
Regarding claim 6, Douthitt teaches wherein aligning is an automated process utilizing the fenestration location and radius on the medical implant (“formation of the patient-specific prosthesis can be performed…automated process”, paragraph [0020]).
Regarding claim 7, Douthitt teaches wherein aligning is an automated process permitting digital operations selected from the group consisting of positioning the fenestration location on a two-dimensional reconstruction of the implant (“define a digital representation of the potion of the patient’s anatomy…define, determine, and/or calculate one or more positions along a stent graft”, paragraph [0031]), viewing, storing, modifying, printing, sharing, and three-dimensional reconstruction of the medical implant with fenestration location (“anatomic imaging data…can be displayed in a standard layout for 3-D medical images…3-D cube view…for improved visualization of the anatomy”, paragraph [0068]).
Regarding claim 8, Douthitt teaches wherein the medical implant is selected from the group consisting of stents, implants, vascular grafts, autologous grafts, allogeneic grafts, xenogeneic grafts, synthetic grafts, and hybrid stent grafts (“any suitable implant”, paragraph [0016], “endovascular repair using stent grafts”, paragraphs [0017]).
Regarding claim 9, Douthitt teaches wherein the structural component is selected from the group consisting of struts, wires, seams, and stitches (“fenestrations…may be sutured using gold wires and/or wires of other radiopaque materials”, paragraph [0057], “strut pattern…used to define fenestrations”, paragraph [0101]).
Regarding claim 10, Douthitt teaches wherein the graft is in situ (“stent graft 260 can be positioned within a portion of the patient’s body using any suitable endovascular procedure”, paragraph [0054]).
Regarding claim 11, Douthitt teaches wherein the resulting three-dimensional fenestrated graft is rendered inside the three-dimensional segmented patient anatomy (“modification can be predicted changes to the extracted centerline of the aortic trunk…extracted centerline…a sequence of points in 3-D space...prediction of the shape of the portion of the patient’s anatomy after insertion of a graft”, paragraph [0082]).
Regarding claim 12, Douthitt teaches comprising aligning the graft with the tortuosity of the vessel into which the graft is to be positioned (“data can be adjusted…tortuosity such as vessel diameter…data can be adjusted…with a delivery method of the prosthesis”, paragraph [0079]).
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.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being obvious over Douthitt.
Regarding claims 4 and 5, Douthitt teaches all the limitations of claim 2, and wherein obtaining fenestration location and radius comprising obtaining values for Proximal Graft Distance (PGD) and Arclength (AL) are between about 2 mm and about 10 mm (paragraph [0047]).
It would have been obvious to one of ordinary skill in the art to have recognized that the range of about 0.1 mm and about 500 mm for PGD and -100 mm and +100 mm for AL would be subject to optimization within the claimed range by routine experimentation with a reasonable expectation of success, in order to ensure that the fenestrations are aligned with the graft and prevent collision. Moreover, it would have been obvious to one of ordinary skill in the art at the time of the invention to choose the instantly claimed ranges through process optimization, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05 II and in re Boesch, 205 USPQ 215 (1980).
Claims 13-15, 17, 20, and 21 are rejected under 35 U.S.C. 103 as being obvious over Douthitt in view of Philips (JP 2004528903 A).
Regarding claim 13, Douthitt teaches all the limitations of claim 1, as well as the method of receiving input of the fenestration alignment, but does not teach a system for making a fenestration location on a medical implant comprising a rotating rod, a marker tool, and one or more motors to receive input.
However, Philips teaches a system (sewing device 1, Fig. 1) for marking a fenestration location on a medical implant, the device comprising:
A rotating rod (shuttle tube 20, graft 5, shown in annotated Fig. 1 below) for receiving the medical implant (“tube is controlled by a computer…depending on the movement of the stent graft…rotation”, paragraph [0060]),
A marker tool (sewing arm 10, needle 12, shown in annotated Fig. 1 below) for marking the fenestration location (“apparatus for attaching a wire (preferably a marker wire) to a wall of a tubular medical implant”, paragraph [0059]),
One or more motors operably connected with the rotating rod and/or the marker tool (shuttle drive motor 26, stitch maker motor 16, shown in annotated Fig. 1 below),
Wherein the one or more motors, when in operation, receive input of the fenestration alignment derived from the method of claim 1 (“computer controlled sewing device”, paragraph [0011]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of Douthitt with the system for marking a fenestration location on the implant of Philips and create a device that allows for the fenestration alignment input and marking the fenestration location relative to the patient’s vasculature.
Regarding claim 14, Douthitt in view of Philips teaches all the limitations of claim 13.
Furthermore, Philips teaches wherein the marker tool is operably connected to the one or more motors for positioning the marker tool at the fenestration location (“stitch is formed…driven up by the stitch maker motor 16 away from the graft 5”, paragraph [0086]; stitch maker motor 16, shown in annotated Fig. 1 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Douthitt in view of Philips and configure the marker tool to be operably connected to the motors, allowing for the marker tool to mark or modify the implant at the designated coordinates.
Regarding claim 15, Douthitt in view of Philips teaches all the limitations of claim 13.
Furthermore, Philips teaches a medical implant over the rotating rod (medical implant 5 over rotating rod 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Douthitt in view of Philips and have the medical implant over the rotating rod, for the implant to be marked or modified around the rod.
Regarding claim 17, Douthitt in view of Philips teaches wherein the medical implant is selected from the group consisting of stents, implants, vascular grafts, autologous grafts, allogeneic grafts, xenogeneic grafts, synthetic grafts, and hybrid stent grafts (“any suitable implant”, paragraph [0016], “endovascular repair using stent grafts”, paragraphs [0017] of Douthitt).
Regarding claim 20, Douthitt in view of Philips teaches all the limitations of claim 13.
Furthermore, Philips teaches wherein one of the motors is operably connected to the rotating rod (motor 26 connected to rotating rod 20 shown in annotated Fig. 1 above) and two or more motors are operably connected to the marker too (motor 16 being connected to marker tool 12 shown in annotated Fig. 1 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Douthitt in view of Philips and power the rotating rod and marker tool with a motor.
Regarding claim 21, Douthitt in view of Philips teaches all the limitations of claim 13.
Furthermore, Philips teaches wherein the marker tool is a marker (“apparatus for attaching a wire (preferably a marker wire) to a wall of a tubular medical implant”, paragraph [0059]) or a cauterizing tool.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Douthitt in view of Philips and make the marker tool a marker that can mark and modify the implant.
Claims 16, 18 and 19 are rejected under 35 U.S.C. 103 as being obvious over Douthitt in view of Philips and further in view of Ferrera (US 20040193246 A1).
Regarding claim 16, Douthitt in view of Philips teaches all the limitations of claim 13, but does not teach a mandrel over the rotating rod, and optionally, a medical implant over the mandrel.
However, Ferrera teaches a medical implant over a mandrel (“stent 10 is then placed on a heat-treating mandrel”, paragraph [0087], “stent 10…connected to the control rod 26”, paragraph [0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Douthitt in view of Philips with the system of Ferrera and incorporate a mandrel with the structure of the device in order to produce the fenestrations unique to the patient.
Regarding claims 18 and 19, Douthitt in view of Philips teaches all the limitations of claim 13, but does not teach the one or more motors operably connected with the marker tool being connected via lead screws positioned in any three-dimensional position.
However, Ferrera teaches the one or more motors operably connected with the marker tool being connected via lead screws (“rotational hub 36 optionally further comprises…threaded jack-screw to controllably move the hub 36”, paragraph [0075]) positioned in any three-dimensional position (the structure of the device would be in a three-dimensional position).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Douthitt in view of Philips with the system of Ferrera and connect the motors with the marker tool via lead screws to help assemble the motor structure of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.L.T./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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