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
Claims 1, 18 are objected to because of the following informalities:
In line 21 of claim 1 “ each opening” should read as “each opening of the plurality of openings”.
In line 22 of claim 1 “ each opening” should read as “each opening of the plurality of openings”.
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 3-5, 18-20 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 3 recites the limitation "a second opening …a second cross strut" in lines 9-10. It is unclear if it means “at least one [[a]] second opening … at least one [[a]] second cross strut” or it means “each of [[a]] second opening … the corresponding [[a]] second cross strut”. For the purpose of examination, the examiner will interprets the limitation as “at least one [[a]] second opening … at least one [[a]] second cross strut”.
Claim 4 recites the limitation " wherein the first quadrilateral shape is different from the second quadrilateral shape, and wherein the first triangular shape is different from the second triangular shape " in last two lines. It is unclear if it means “wherein the first quadrilateral shape is different from the second quadrilateral shape, or wherein the first triangular shape is different from the second triangular shape” or it means “wherein the first quadrilateral shape or wherein the first triangular shape is different from the second quadrilateral shape, or or wherein the first triangular shape is different from the second triangular shape”.
Claim 18 recites the limitation "the elongate body" in line 13. It is unclear if it is referring to “elongated body” in line 3 or it is referring to new limitation For the purpose of examination, the examiner will interprets the limitation as it is referring to “elongated body” in line 3
Claim 19 recites the limitation "a second opening …a second cross strut" in lines 9-10. It is unclear if it means “at least one [[a]] second opening … at least one [[a]] second cross strut” or it means “each of [[a]] second opening … the corresponding [[a]] second cross strut”. For the purpose of examination, the examiner will interprets the limitation as “at least one [[a]] second opening … at least one [[a]] second cross strut”.
Claim 20 recites the limitation " wherein the first quadrilateral shape is different from the second quadrilateral shape, and wherein the first triangular shape is different from the second triangular shape " in lines 8-9. It is unclear if it means “wherein the first quadrilateral shape is different from the second quadrilateral shape, or wherein the first triangular shape is different from the second triangular shape” or it means “wherein the first quadrilateral shape or wherein the first triangular shape is different from the second quadrilateral shape, or or wherein the first triangular shape is different from the second triangular shape”.
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.
Claim(s) 1-15, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krieger et al. (US 20160317185 A1) (“Krieger”) in view of Petersen et al. (US 20100286626 A1) (“Petersen”).
Re claim 1, Krieger discloses a medical device (100, Fig.1-4c, the device is described in general in Fig, 1 and the embodiment of Fig, 4c shows the strut, ¶0037) comprising: an elongated body ( body of 100) extending along a longitudinal axis (101) from a proximal end (114) to a distal end (116), wherein the elongated body comprises: an inner surface (inner surface of 112, form a lumen 118, Fig. 3) defining an inner lumen extending along the longitudinal axis ( lumen 118, ¶0028), and a plurality of interconnecting struts (structure around the holes 130’”) extending around an outer perimeter of the elongated body (Fig. 4c) and defining a plurality of openings (¶0037, 130’”) disposed on a portion of an outer surface of the elongated body and along the longitudinal axis and extending towards the inner lumen of the elongated body (Fig. 4c), wherein the plurality of interconnecting struts comprises: a plurality of helical struts(annotated Fig.4c of Krieger), wherein each helical strut of the plurality of helical struts extends along the elongated body from the proximal end to the distal end and around the outer perimeter of the elongated body (annotated Fig.4c of Krieger), and wherein the plurality of helical struts defines one or more coils extending around the outer perimeter along a longitudinal length of the elongated body (annotated Fig.4c of Krieger), a plurality of first cross struts (annotated Fig.4c of Krieger), wherein each first cross strut extends between longitudinally adjacent coils of the one or more coils (annotated Fig.4c of Krieger) and a plurality of second cross struts (annotated Fig.4c of Krieger), wherein each second cross strut extends between a first cross strut of the plurality of first cross struts and a coil of a helical strut of the plurality of helical struts (annotated Fig.4c of Krieger), wherein each opening is defined by two or more of: one or more helical struts of the plurality of helical struts, one or more first cross struts of the plurality of first cross struts, or one or more second cross struts of the plurality of second cross struts (annotated Fig.4c of Krieger), but it fails to disclose an outer coating disposed on the outer surface of the elongated body, wherein at least a portion of the outer coating is disposed on sidewalls of the plurality of interconnecting struts.
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Annotated Fig.4c of Krieger
However, Petersen discloses a medical device (Fig, 1-6b) and wherein an outer coating disposed on the outer surface of the elongated body (¶0035), wherein at least a portion of the outer coating is disposed on sidewalls of the plurality of interconnecting struts (the coat will cover the body 12 and sidewall of cutout 34, 20, Fig. 3, ¶0035).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the medical device of Krieger to include coat so that an outer coating disposed on the outer surface of the elongated body, wherein at least a portion of the outer coating is disposed on sidewalls of the plurality of interconnecting struts as taught by Petersen for the purpose of fully cover the body with material with specific durometer to allow further stiffness to the body (Petersen, ¶0035).
Re claim 2, Krieger discloses wherein the plurality of openings defines a helical pattern wound around the longitudinal axis (Fig. 4c) and extending along the longitudinal length of the elongated body (Fig. 1, Fig. 4c), and wherein one or more openings of the plurality of openings extends between the outer surface and the inner surface of the elongated body (¶0037).
Re claim 3, Krieger discloses wherein the plurality of openings comprises: a plurality of first openings (130”’), wherein each first opening is defined by one or more helical struts and one or more first cross struts (annotated Fig.4c of Krieger), but it fails to discloses a plurality of second openings, wherein each second opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, and a plurality of third openings, wherein each third opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, wherein a second opening is separated from a corresponding third opening by a second cross strut, wherein a combined area of the second opening, the third opening, and the second cross strut is equal to an area of a first opening, and wherein the second cross strut is configured to increase tensile strength of the elongated body.
However, Petersen discloses a medical device (Fig, 1-6b) and wherein a plurality of second openings (, ¶0031, Annotated Fig. 6a of Petersen), wherein each second opening is defined by one or more helical struts (Annotated Fig. 6a of Petersen), one or more first cross struts ( struts lower than second opening), and one or more second cross struts ( struts between second and third opening), and a plurality of third openings (Annotated Fig. 6a of Petersen), wherein each third opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, (Annotated Fig. 6a of Petersen) wherein a second opening is separated from a corresponding third opening by a second cross strut (¶0027, Annotated Fig. 6a of Petersen), wherein a combined area of the second opening, the third opening, and the second cross strut is equal to an area of a first opening, and wherein the second cross strut is configured to increase tensile strength of the elongated body (Annotated Fig. 6a of Petersen, ¶0031).
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Annotated Fig. 6a of Petersen
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the medical device of Krieger to include second openings and third openings so that a plurality of second openings, wherein each second opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, and a plurality of third openings, wherein each third opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, wherein a second opening is separated from a corresponding third opening by a second cross strut, wherein a combined area of the second opening, the third opening, and the second cross strut is equal to an area of a first opening, and wherein the second cross strut is configured to increase tensile strength of the elongated body as taught by Petersen for the purpose of using an art recognized pattern of the openings to increase the flexibility (Petersen, ¶0031, ¶0034).
Re claim 4, the modified Krieger discloses wherein each first opening of the plurality of first openings defines a rectangular shape (Fig. 4c), wherein each second opening of the plurality of second openings defines a first quadrilateral or a first triangular shape (Petersen, Fig. 6c), and wherein each third opening of the plurality of third openings defines a second quadrilateral or a second triangular shape (Petersen, Fig. 6c), wherein the first quadrilateral shape is different from the second quadrilateral shape, and wherein the first triangular shape is different from the second triangular shape ((Petersen, Fig. 6c, ¶0027, the size and shapes can be different).
Re claim 5, the modified Krieger discloses wherein the second opening, the third opening, and the second cross strut are disposed between two helically adjacent first openings (Annotated Fig. 6a of Petersen).
Re claim 6, Krieger discloses wherein the plurality of openings defines a first helix wound around the longitudinal axis of the elongated body in a first direction (annotated Fig.4c of Krieger), and a second helix wound around the longitudinal axis of the elongated body in a second direction (annotated Fig.4c of Krieger), and wherein the first direction is different from the second direction (annotated Fig.4c of Krieger), and wherein the first helix and the second helix intersect at one or more locations along the longitudinal length of the elongated body (annotated Fig.4c of Krieger).
Re claim 7, the modified Krieger discloses wherein the outer coating is capable to reflow around at least one interconnecting strut of the plurality of interconnecting struts in response to heating to a temperature of up to about 400℃ (Petersen, ¶0035).
Re claim 8, Krieger discloses wherein the elongated body comprises a hypotube comprising a metallic alloy (¶0047), and wherein each opening of the plurality of openings is formed via a laser-cutting technique (¶0030).
Re claim 9, Krieger discloses a method of manufacturing the medical device of claim 1 ( see the rejection of claim 1), the method comprising: receiving, by processing circuitry of a device manufacturing system (Fig. 12, ¶0059), a set of dimensions and locations of the plurality of openings disposed on the elongated body of the medical device based on mechanical properties of the medical device (step 1004), and causing, by the processing circuitry and based on the set of dimensions and locations of the plurality of openings, a cutting component of the device manufacturing system to form the plurality of openings on the outer surface of the portion of the elongated body (step of 1008).
Re claim 10, Krieger discloses wherein the plurality of openings defines a helical pattern wound around the longitudinal axis and extending along the longitudinal length of the elongated body (annotated Fig.4c of Krieger),
Re claim 11, Krieger discloses wherein one or more openings of the plurality of openings extends between the outer surface and the inner surface of the elongated body (annotated Fig.4c of Krieger).
Re claim 12, Krieger discloses further comprising: forming an outer layer around the outer surface of the elongated body by at least: disposing a material defining the outer layer into the plurality of openings, and affixing the material on sidewalls of the plurality of interconnecting struts (step 1010).
Re claim 13, Krieger discloses determining, by the processing circuitry, the mechanical properties of the elongated body of the medical device; and determining, by the processing circuitry, the set of dimensions and locations of the plurality of openings to satisfy threshold conditions of mechanical properties of the elongated body (step 110, 1004).
Re claim 14, Krieger discloses wherein the plurality of openings comprises: a plurality of first openings (130”’), wherein each first opening is defined by one or more helical struts and one or more first cross struts (annotated Fig.4c of Krieger), but it fails to discloses a plurality of second openings, wherein each second opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, and a plurality of third openings, wherein each third opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, wherein a second opening corresponds to a third opening and separated from the corresponding third opening by a second cross strut, wherein a combined area of the second opening, the third opening, and the second cross strut is equal to an area of a first opening, and wherein the second cross strut is configured to increase tensile strength of the elongated body.
However, Petersen discloses a medical device (Fig, 1-6b) and wherein a plurality of second openings (, ¶0031, Annotated Fig. 6a of Petersen), wherein each second opening is defined by one or more helical struts (Annotated Fig. 6a of Petersen), one or more first cross struts ( struts lower than second opening), and one or more second cross struts ( struts between second and third opening), and a plurality of third openings (Annotated Fig. 6a of Petersen), wherein each third opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, (Annotated Fig. 6a of Petersen) wherein a second opening is separated from a corresponding third opening by a second cross strut (¶0027, Annotated Fig. 6a of Petersen), wherein a combined area of the second opening, the third opening, and the second cross strut is equal to an area of a first opening, and wherein the second cross strut is configured to increase tensile strength of the elongated body (Annotated Fig. 6a of Petersen, ¶0031).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the medical device of Krieger to include second openings and third openings so that a plurality of second openings, wherein each second opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, and a plurality of third openings, wherein each third opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, wherein a second opening corresponds to a third opening and separated from the corresponding third opening by a second cross strut, wherein a combined area of the second opening, the third opening, and the second cross strut is equal to an area of a first opening, and wherein the second cross strut is configured to increase tensile strength of the elongated body as taught by Petersen for the purpose of using an art recognized pattern of the openings to increase the flexibility (Petersen, ¶0031, ¶0034).
Re claim 15, the modified Krieger discloses wherein each first opening of the plurality of first openings defines a rectangular shape (Fig. 4c), wherein each second opening of the plurality of second openings defines a first quadrilateral or a first triangular shape (Petersen, Fig. 6c), and wherein each third opening of the plurality of third openings defines a second quadrilateral or a second triangular shape (Petersen, Fig. 6c), wherein the first quadrilateral shape is different from the second quadrilateral shape, and wherein the first triangular shape is different from the second triangular shape ((Petersen, Fig. 6c, ¶0027, the size and shapes can be different) , and wherein the second opening, the third opening, and the second connecting strut are disposed between two helically adjacent first openings ((Annotated Fig. 6a of Petersen).
Re claim 17, Krieger discloses further comprising determining the mechanical properties of the medical device by at least: determining, by the processing circuitry, threshold mechanical property values of the medical device (¶0059, desired stiffness, step 1002-1004), generating, by the processing circuitry, a set of dimensions and locations of the plurality of openings (step 1006); determining, by the processing circuitry, mechanical property values of the medical device having the plurality of openings defining by the generated set of dimensions and locations, comparing, by the processing circuitry (localized stiffness, step 1006, ¶0059), the determined mechanical property values to the threshold mechanical property values, and in response to determining that the determined mechanical properties values satisfy the threshold mechanical property values, transmitting, by the processing circuitry, cutting instructions to the cutting component, the cutting instructions being configured to cause the cutting component to form the plurality of openings on the elongated body based on the generated set of dimensions and locations of the plurality of openings (step 1008, ¶0059).
Re claim 18, Krieger discloses a system comprising a catheter (100, Fig.1-9, the device is described in general in Fig, 1. 9 ¶0055 and the embodiment of Fig.4c shows the strut, ¶0037) comprising: an elongated body (body of 100) extending along a longitudinal axis (101) from a proximal end (114) to a distal end (116), wherein the elongated body comprises: an inner surface (inner surface of 112, form a lumen 118, Fig. 3) defining an inner lumen extending along the longitudinal axis ( lumen 118, ¶0028), and a plurality of interconnecting struts (structure around the holes 130’”) extending around an outer perimeter of the elongated body (Fig. 4c) and defining a plurality of openings (¶0037, 130’”) disposed on a portion of an outer surface of the elongated body and along the longitudinal axis extends from outer surface towards the inner surface of the elongated body (Fig. 4c), wherein the plurality of interconnecting struts comprises: a plurality of helical struts (annotated Fig.4c of Krieger), wherein each helical strut of the plurality of helical struts extends along the elongate body from the proximal end to the distal end and around the outer perimeter of the elongated body (annotated Fig.4c of Krieger), and wherein the plurality of helical struts defines one or more coils extending around an outer perimeter along a longitudinal length of the elongated body (annotated Fig.4c of Krieger), a plurality of first cross struts (annotated Fig.4c of Krieger), wherein each first cross strut extends between longitudinally adjacent coils of the one or more coils (annotated Fig.4c of Krieger) and a plurality of second cross struts (annotated Fig.4c of Krieger), wherein each second cross strut extends between a first cross strut of the plurality of first cross struts and a coil of a helical strut of the plurality of helical struts (annotated Fig.4c of Krieger), wherein each opening is defined by two or more of: one or more helical struts of the plurality of helical struts, one or more first cross struts of the plurality of first cross struts, or one or more second cross struts of the plurality second cross struts (annotated Fig.4c of Krieger), and a guidewire (¶055) configured to be navigated within the inner lumen of the elongated body of the catheter (¶055), and wherein the plurality of openings defines a helical pattern wound around the longitudinal axis and extending along the longitudinal length of the elongated body (annotated Fig.4c of Krieger), but it fails to disclose an outer coating disposed on the outer surface of the elongated body, (, wherein at least a portion of the outer coating is disposed on sidewalls of the plurality of struts.
However, Petersen discloses a medical device (Fig, 1-6b) and wherein an outer coating disposed on the outer surface of the elongated body (¶0035), wherein at least a portion of the outer coating is disposed on sidewalls of the plurality of interconnecting struts (the coat will cover the body 12 and sidewall of cutout 34, 20, Fig. 3, ¶0035).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the medical device of Krieger to include coat so that an outer coating disposed on the outer surface of the elongated body, wherein at least a portion of the outer coating is disposed on sidewalls of the plurality of interconnecting struts as taught by Petersen for the purpose of fully cover the body with material with specific durometer to allow further stiffness to the body (Petersen, ¶0035).
Re claim 19, Krieger discloses wherein the plurality of openings comprises: a plurality of first openings (130”’), wherein each opening of the first plurality of openings defines a first geometric shape (Fig. 4c), wherein each first opening is defined by one or more helical struts and one or more first cross struts (annotated Fig.4c of Krieger), but it fails to discloses a plurality of second openings, wherein each second opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, and a plurality of third openings, wherein each third opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, wherein a second opening corresponds to a third opening and is separated from the corresponding third opening by a second cross strut, wherein a combined area of the second opening, the third opening, and the second cross strut is equal to an area of a first opening, and wherein the second cross strut is configured to increase tensile strength of the elongated body.
However, Petersen discloses a medical device (Fig, 1-6b) and wherein a plurality of second openings (, ¶0031, Annotated Fig. 6a of Petersen), wherein each second opening is defined by one or more helical struts (Annotated Fig. 6a of Petersen), one or more first cross struts ( struts lower than second opening), and one or more second cross struts ( struts between second and third opening), and a plurality of third openings (Annotated Fig. 6a of Petersen), wherein each third opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, (Annotated Fig. 6a of Petersen) wherein a second opening is separated from a corresponding third opening by a second cross strut (¶0027, Annotated Fig. 6a of Petersen), wherein a combined area of the second opening, the third opening, and the second cross strut is equal to an area of a first opening, and wherein the second cross strut is configured to increase tensile strength of the elongated body (Annotated Fig. 6a of Petersen, ¶0031).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the medical device of Krieger to include second openings and third openings so that a plurality of second openings, wherein each second opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, and a plurality of third openings, wherein each third opening is defined by one or more helical struts, one or more first cross struts, and one or more second cross struts, wherein a second opening corresponds to a third opening and is separated from the corresponding third opening by a second cross strut, wherein a combined area of the second opening, the third opening, and the second cross strut is equal to an area of a first opening, and wherein the second cross strut is configured to increase tensile strength of the elongated body as taught by Petersen for the purpose of using an art recognized pattern of the openings to increase the flexibility (Petersen, ¶0031, ¶0034).
Re claim 20, the modified Krieger discloses wherein each first opening of the plurality of first openings defines a rectangular shape (Fig. 4c), wherein each second opening of the plurality of second openings defines a first quadrilateral or a first triangular shape (Petersen, Fig. 6c), and wherein each third opening of the plurality of third openings defines a second quadrilateral or a second triangular shape (Petersen, Fig. 6c), wherein the first quadrilateral shape is different from the second quadrilateral shape, and wherein the first triangular shape is different from the second triangular shape ((Petersen, Fig. 6c, ¶0027, the size and shapes can be different) and wherein the plurality of openings defines a first helix wound around the longitudinal axis of the elongated body in a first direction (annotated Fig.4c of Krieger), and a second helix wound around the longitudinal axis of the elongated body in a second direction (annotated Fig.4c of Krieger), and wherein the first direction is different from the second direction (annotated Fig.4c of Krieger), and wherein the first helix and the second helix intersect at one or more locations along the longitudinal length of the elongated body (annotated Fig.4c of Krieger)..
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krieger in view of Petersen and further in view Cottone (US 20180093070 A1).
Re claim 16, Krieger fails to disclose wherein the mechanical properties comprise one or more of a maximum bending force of the catheter, a reaction movement to twisting of the catheter, or a tensile strength of the catheter, and wherein the maximum bending force is determined by a three-point bending displacement test, wherein the reaction movement to twisting is determined by a global twist rotation test, and wherein the tensile strength is determined by a global tensile displacement test.
However, Cottone discloses a catheter (Fig. 1-6q, ¶0247) and wherein the mechanical properties comprise one or more of a maximum bending force of the catheter, a reaction movement to twisting of the catheter, or a tensile strength of the catheter, and wherein the maximum bending force is determined by a three-point bending displacement test, wherein the reaction movement to twisting is determined by a global twist rotation test, and wherein the tensile strength is determined by a global tensile displacement test ( displacement test, ¶0247).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the medical device of Krieger so that the mechanical properties comprise one or more of a maximum bending force of the catheter, a reaction movement to twisting of the catheter, or a tensile strength of the catheter, and wherein the maximum bending force is determined by a three-point bending displacement test, wherein the reaction movement to twisting is determined by a global twist rotation test, and wherein the tensile strength is determined by a global tensile displacement test as taught by Cottone for the purpose of for the evaluate the flexibility of the tubular (Cottone, ¶0247).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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