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 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 12-16 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 claim 12, line 11, the recitation of “a dilator” along with other features of the dilator renders the claim indefinite because the claim is unclear if “a dilator” is positively claimed as a part of an introducer sheath or if an introducer sheath is capable to be used with the dilator having a specific claimed feature. For examination purposes, examiner construes that “an introducer sheath” is capable to be used with a claimed dilator.
Claims 13-16 being dependent on claim 12 are also rejected.
Claim Rejections - 35 USC § 102
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 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, 5, 7, 8, 10-14 and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gareth et al. (EP 3030306 B1).
Regarding claim 1, Gareth teaches a medical device 50 (figure 1), comprising:
an introducer sheath 300 (figure 4), the introducer sheath comprising a tubular structure (paragraph 0025, lines 4-5, “tubular members”) comprising a wall (wall of element 300) defining a sheath lumen (paragraph 0025, lines 4-5, “respective lumen”) extending longitudinally throughout the tubular structure, the tubular structure defining a longitudinal axis (longitudinal axis of element 300) therethrough, the tubular structure further comprising:
a first longitudinal sheath section 618 having a first sheath stiffness (page 8, lines 45-46); and
a second longitudinal sheath section 616 distal to the first longitudinal sheath section 618, the second longitudinal sheath section having a second sheath stiffness (page 8, lines 42-43, 35D is less than 45D) that is less than the first sheath stiffness; and
a sheath transition (transition between elements 616 and 618) from the first longitudinal sheath section to the second longitudinal sheath section; and
a dilator 100 configured to occupy the sheath lumen, the dilator 100 comprising:
a shaft (shaft of element 100) comprising a wall (wall of element 100) defining a dilator lumen (paragraph 0025, lines 4-5, “tubular members”) extending longitudinally throughout the shaft, the shaft defining a second longitudinal axis (longitudinal axis of element 100) that is coaxial with the longitudinal axis when the dilator 100 occupies the sheath lumen (figure 1), the shaft further comprising:
a first longitudinal dilator section 100c having a first dilator stiffness (page 6, lines 24-26); and
a second longitudinal dilator section 100b distal to the first longitudinal dilator section 100c, the second longitudinal dilator section 100b having a second dilator stiffness (page 6, lines 24-27) that is less than the first dilator stiffness; and
a dilator transition (transition between 100c and 100b) from the first longitudinal dilator section to the second longitudinal dilator section; and
wherein the sheath transition is offset longitudinally from the dilator transition when the dilator occupies the sheath lumen (page 6, lines 35-40, page 8, lines 37-46, the length of 100a is about 0.4 cm to about 4 cm, length of 100b is about 7cm to about 15 cm therefore, dilator transition is located between about 7.4 cm to about 19cm, the length of 612 is about 4.57 mm, length of element 614 is about 4.06 mm, length of 616 is about 7.37 and therefore, sheath transition is located at about 8.233 cm thus, sheath transition is offset longitudinally from the dilator transition. Additionally, if longitudinally offset could be achieved by relative movement of the dilator with respect to the sheath).
Regarding claim 2, Gareth teaches wherein the first sheath stiffness is less than the first dilator stiffness (page 8, lines 45-46, durometer of about 45D corresponds to EXP ((45+50)*0.0235-0.6403 = 4.91 MPa which is less than 0.8 GPa).
Regarding claim 3, Gareth teaches wherein the sheath transition is distal to the dilator transition (as explained in the rejection of claim 1, sheath transition is located at about 8.233 cm and dilator transition is located between about 7.4 cm to about 19 cm. Compared to about 7.4 cm, 8.233 cm is located distal thereby having the sheath transition being distal to the dilator transition. Furthermore, depending on the positioning of the dilator inside the sheath, the sheath transition being distal to the dilator transition could be achieved).
Regarding claim 5, Gareth teaches wherein the dilator transition is distal to the sheath transition (as explained in the rejection of claim 1, sheath transition is located at about 8.233 cm and dilator transition is located between about 7.4 cm to about 19 cm. Choosing a value of the dilator transition greater than 8.233 cm would result in having the dilator transition located distal to the sheath transition as required by the claim).
Regarding claim 7, Gareth teaches wherein the second longitudinal sheath section 616 comprises a distal sheath tip (tip formed by elements 614, 612 together) at a distal end (end of element 616 where element 614 is connected) of the second longitudinal sheath section 616; and
wherein when the dilator 100 occupies the sheath lumen, the second longitudinal dilator section 100b (paragraph 0040, paragraphs 3A-3D, the element 100b is extending at least one centimeter through elements 614, 612, additionally claim does not require element 100b to extend distally out of element elements 614 and 612 therefore since element 100b has a length of at least 1 centimeter as explained in paragraph 0034 and since element 100b is extending distally through element 614, 612, Gareth teaches the claimed limitation) is configured to extend distally at least one centimeter through the distal sheath tip 614, 612.
Regarding claim 8, Gareth teaches wherein the shaft further comprises a third longitudinal dilator section 100a distal to the second longitudinal dilator section 100b, the third longitudinal dilator section 100a having a third dilator stiffness different from the second dilator stiffness 100b (page 6, lines 25-27).
Regarding claim 10, Gareth teaches wherein the third dilator stiffness is greater than the second dilator stiffness and/or equal to the first dilator stiffness (page 6, lines 25-27).
Regarding claim 11, Gareth teaches a longitudinal dilator length is greater than a longitudinal sheath length (page 6, lines 30-31, paragraph 0048, line 4).
Regarding claim 12, Gareth teaches an introducer sheath 300 (figure 4) comprising a tubular structure (paragraph 0025, lines 4-5, “tubular members”) comprising a wall (wall of element 300) defining a sheath lumen (paragraph 0025, lines 4-5, “respective lumen”) extending longitudinally throughout the tubular structure, the tubular structure defining a longitudinal axis (longitudinal axis of element 300) therethrough, the tubular structure further comprising:
a first longitudinal sheath section 618 having a first sheath stiffness (page 8, lines 45-46); and
a second longitudinal sheath section 616 distal to the first longitudinal sheath section 618, the second longitudinal sheath section having a second sheath stiffness (page 8, lines 42-43, 35D is less than 45D) that is less than the first sheath stiffness; and
a sheath transition (transition between elements 616 and 618) from the first longitudinal sheath section to the second longitudinal sheath section; and
wherein a dilator 100 is configured to occupy the sheath lumen such that the sheath transition is offset longitudinally (page 6, lines 35-40, page 8, lines 37-46, the length of 100a is about 0.4 cm to about 4 cm, length of 100b is about 7cm to about 15 cm therefore, dilator transition is located between about 7.4 cm to about 19cm, the length of 612 is about 4.57 mm, length of element 614 is about 4.06 mm, length of 616 is about 7.37 and therefore, sheath transition is located at about 8.233 cm thus, sheath transition is offset longitudinally from the dilator transition. Additionally, if longitudinally offset could be achieved by relative movement of the dilator with respect to the sheath) from a dilator transition (transition between elements 100c and 100b) from a first longitudinal dilator section 100c to a second longitudinal dilator section 100b; and
wherein the dilator comprises a shaft (shaft of element 100), the shaft comprising a wall (wall of element 100) defining a dilator lumen (paragraph 0025, lines 4-5, “tubular members”) extending longitudinally throughout the shaft, the first longitudinal dilator section 100c having a first dilator stiffness (page 6, lines 24-26); and the second longitudinal dilator section 100b distal to the first longitudinal dilator section 100c and having a second dilator stiffness (page 6, lines 24-27) that is less than the first dilator stiffness.
Regarding claim 13, Gareth teaches wherein the first sheath stiffness is less than the first dilator stiffness (page 8, lines 45-46, durometer of about 45D corresponds to EXP ((45+50)*0.0235-0.6403 = 4.91 MPa which is less than 0.8 GPa).
Regarding claim 14, Gareth teaches wherein the sheath transition is distal to the dilator transition (as explained in the rejection of claim 1, sheath transition is located at about 8.233 cm and dilator transition is located between about 7.4 cm to about 19 cm. Compared to about 7.4 cm, 8.233 cm is located distal thereby having the sheath transition being distal to the dilator transition. Furthermore, depending on the positioning of the dilator inside the sheath, the sheath transition being distal to the dilator transition could be achieved).
Regarding claim 16, Gareth teaches wherein the dilator transition is configured to be distal to the sheath transition (as explained in the rejection of claim 12, sheath transition is located at about 8.233 cm and dilator transition is located between about 7.4 cm to about 19 cm. Choosing a value of the dilator transition greater than 8.233 cm would result in having the dilator transition located distal to the sheath transition as required by the claim).
Regarding claim 17, Gareth teaches a dilator 100, comprising a shaft (shaft of element 100), the shaft comprising:
a wall (wall of element 100) defining a dilator lumen (paragraph 0025, lines 4-5, “tubular members”) extending longitudinally throughout the shaft;
a first longitudinal dilator section 100c having a first dilator stiffness (page 6, lines 24-26); and
a second longitudinal dilator section 100b distal to the first longitudinal dilator section 100c, the second longitudinal dilator section 100b having a second dilator stiffness (page 6, lines 24-27) that is less than the first dilator stiffness; and
a dilator transition (transition between 100c and 100b) from the first longitudinal dilator section to the second longitudinal dilator section; and
wherein the dilator is configured to occupy a sheath lumen (paragraph 0025, lines 4-5, “respective lumen”, lumen of element 300) of an introducer sheath 300 (figure 4) such that a sheath transition (transition between elements 616 and 618) from a first longitudinal sheath section 618 to a second longitudinal sheath section 616 is offset longitudinally from the dilator transition (page 6, lines 35-40, page 8, lines 37-46, the length of 100a is about 0.4 cm to about 4 cm, length of 100b is about 7cm to about 15 cm therefore, dilator transition is located between about 7.4 cm to about 19cm, the length of 612 is about 4.57 mm, length of element 614 is about 4.06 mm, length of 616 is about 7.37 and therefore, sheath transition is located at about 8.233 cm thus, sheath transition is offset longitudinally from the dilator transition. Additionally, if longitudinally offset could be achieved by relative movement of the dilator with respect to the sheath); and
wherein the introducer sheath 300 (figure 4) comprising a tubular structure (paragraph 0025, lines 4-5, “tubular members”) comprising a wall (wall of element 300) defining a sheath lumen (paragraph 0025, lines 4-5, “respective lumen”) extending longitudinally throughout the tubular structure, the tubular structure defining a longitudinal axis (longitudinal axis of element 300) therethrough, the tubular structure further comprising the first longitudinal sheath section 618 having a first sheath stiffness (page 8, lines 45-46); and the second longitudinal sheath section 616 distal to the first longitudinal sheath section 618, the second longitudinal sheath section having a second sheath stiffness (page 8, lines 42-43, 35D is less than 45D) that is less than the first sheath stiffness.
Regarding claim 18, Gareth teaches wherein the first sheath stiffness is less than the first dilator stiffness (page 8, lines 45-46, durometer of about 45D corresponds to EXP ((45+50)*0.0235-0.6403 = 4.91 MPa which is less than 0.8 GPa).
Regarding claim 19, Gareth teaches wherein the sheath transition is configured to be distal to the dilator transition (as explained in the rejection of claim 1, sheath transition is located at about 8.233 cm and dilator transition is located between about 7.4 cm to about 19 cm. Compared to about 7.4 cm, 8.233 cm is located distal thereby having the sheath transition being distal to the dilator transition. Furthermore, depending on the positioning of the dilator inside the sheath, the sheath transition being distal to the dilator transition could be achieved).
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) 4, 6, 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gareth et al. (EP 3030306 B1) in view of Haarer (US 2016/0001045 A1).
Regarding claim 4, Gareth discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 3. Gareth further discloses wherein the second dilator stiffness is greater than the second sheath stiffness (as shown in calculation in claim 2, 45D is approximately 4.91 MPa which is less than 0.3GPA, therefore, 35D will also be less than 0.3GPa). Gareth is silent regarding wherein the second dilator stiffness is less than the first sheath stiffness.
However, Haarer teaches a design of a medical device (figure 1) wherein the second dilator stiffness is less than the first sheath stiffness (paragraph 0086, lines 9-13, paragraph 0087, lines 1-4, the drawings do not show element 115 however, examiner construes that L2 in figure 6 represents element 115 and since element 102, 103 which together are components of a dilator is able to give the curve shape, the stiffness of elements 102, 103 together is construed to be less than the stiffness in portion represented by L1 or portion proximal to element 115. If portion represented by element L1 was less stiff than elements 102, 103 together than the curve shape could be achieved in L1 portion as well, however prior art teaches the curve only in element 115 area) for the purpose of achieving the desired shape to access the blood vessel (paragraph 0004).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first sheath stiffness to incorporate wherein the second dilator stiffness is less than the first sheath stiffness as taught by Haarer for the purpose of achieving the desired shape to access the blood vessel (paragraph 0004). Furthermore, it appears that one of ordinary in the art would have a reasonable expectation of success in modifying the second dilator stiffness and the first sheath stiffness of Gareth as it involves only adjusting the stiffness of the dilator and the sheath. Haarer and Gareth already teach the effect of having stiffer dilator and sheath portions and how the stiffer dilator portion with respect to the sheath portion or stiffer sheath portion with respect to the dilator portion affects the curvature of the combined sheath and dilator system. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second dilator stiffness and the first sheath stiffness to achieve the second dilator stiffness is less than the first sheath stiffness as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclose in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 6, Gareth discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 5. Gareth is silent regarding wherein the second dilator stiffness is less than the second sheath stiffness.
However, Haarer teaches wherein the second dilator stiffness is less than the second sheath stiffness (paragraph 0086, lines 9-13, paragraph 0087, lines 1-8, since curving is imparted only in element 115 which is construed as a portion of L2 and not in L3, the stiffness of the sheath is construed to be higher than the second dilator stiffness) for the purpose of preventing ovalization (paragraph 0087, lines 1-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the second dilator stiffness and the second sheath stiffness as taught by Haarer for the purpose of preventing ovalization (paragraph 0087, lines 1-8). Furthermore, it appears that one of ordinary in the art would have a reasonable expectation of success in modifying the second dilator stiffness and the second sheath stiffness of Gareth as it involves only adjusting the stiffness of the dilator and the sheath. Haarer and Gareth already teach the effect of having stiffer dilator and sheath portions and how the stiffer dilator portion with respect to the sheath portion or stiffer sheath portion with respect to the dilator portion affects the curvature of the combined sheath and dilator system. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second dilator stiffness and the second sheath stiffness to achieve the second dilator stiffness is less than the second sheath stiffness as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclose in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 15, Gareth discloses the claimed invention substantially as claimed, as set forth above in claims 12 and 14. Gareth further discloses wherein the second dilator stiffness is greater than the second sheath stiffness (as shown in calculation in claim 13, 45D is approximately 4.91 MPa which is less than 0.3GPA, therefore, 35D will also be less than 0.3GPa). Gareth is silent regarding wherein the second dilator stiffness is less than the first sheath stiffness.
However, Haarer teaches a design of a medical device (figure 1) wherein the second dilator stiffness is less than the first sheath stiffness (paragraph 0086, lines 9-13, paragraph 0087, lines 1-4, the drawings do not show element 115 however, examiner construes that L2 in figure 6 represents element 115 and since element 102, 103 which together are components of a dilator is able to give the curve shape, the stiffness of elements 102, 103 together is construed to be less than the stiffness in portion represented by L1 or portion proximal to element 115. If portion represented by element L1 was less stiff than elements 102, 103 together than the curve shape could be achieved in L1 portion as well, however prior art teaches the curve only in element 115 area) for the purpose of achieving the desired shape to access the blood vessel (paragraph 0004).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first sheath stiffness to incorporate wherein the second dilator stiffness is less than the first sheath stiffness as taught by Haarer for the purpose of achieving the desired shape to access the blood vessel (paragraph 0004). Furthermore, it appears that one of ordinary in the art would have a reasonable expectation of success in modifying the second dilator stiffness and the first sheath stiffness of Gareth as it involves only adjusting the stiffness of the dilator and the sheath. Haarer and Gareth already teach the effect of having stiffer dilator and sheath portions and how the stiffer dilator portion with respect to the sheath portion or stiffer sheath portion with respect to the dilator portion affects the curvature of the combined sheath and dilator system. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second dilator stiffness and the first sheath stiffness to achieve the second dilator stiffness is less than the first sheath stiffness as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclose in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 20, Gareth discloses the claimed invention substantially as claimed, as set forth above in claims 17 and 19. Gareth further discloses wherein the second dilator stiffness is greater than the second sheath stiffness (as shown in calculation in claim 18, 45D is approximately 4.91 MPa which is less than 0.3GPA, therefore, 35D will also be less than 0.3GPa). Gareth is silent regarding wherein the second dilator stiffness is less than the first sheath stiffness.
However, Haarer teaches a design of a medical device (figure 1) wherein the second dilator stiffness is less than the first sheath stiffness (paragraph 0086, lines 9-13, paragraph 0087, lines 1-4, the drawings do not show element 115 however, examiner construes that L2 in figure 6 represents element 115 and since element 102, 103 which together are components of a dilator is able to give the curve shape, the stiffness of elements 102, 103 together is construed to be less than the stiffness in portion represented by L1 or portion proximal to element 115. If portion represented by element L1 was less stiff than elements 102, 103 together than the curve shape could be achieved in L1 portion as well, however prior art teaches the curve only in element 115 area) for the purpose of achieving the desired shape to access the blood vessel (paragraph 0004).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first sheath stiffness to incorporate wherein the second dilator stiffness is less than the first sheath stiffness as taught by Haarer for the purpose of achieving the desired shape to access the blood vessel (paragraph 0004). Furthermore, it appears that one of ordinary in the art would have a reasonable expectation of success in modifying the second dilator stiffness and the first sheath stiffness of Gareth as it involves only adjusting the stiffness of the dilator and the sheath. Haarer and Gareth already teach the effect of having stiffer dilator and sheath portions and how the stiffer dilator portion with respect to the sheath portion or stiffer sheath portion with respect to the dilator portion affects the curvature of the combined sheath and dilator system. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second dilator stiffness and the first sheath stiffness to achieve the second dilator stiffness is less than the first sheath stiffness as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclose in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gareth et al. (EP 3030306 B1) in view of Trask et al. (US 2009/0312786 A1).
Regarding claim 9, Gareth discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 8. Gareth is silent regarding wherein the third dilator stiffness is less than the second dilator stiffness.
However, Trask teaches a design of a dilator 50 (figure 2) wherein the third dilator stiffness (stiffness of element 51c) is less than the second dilator stiffness (stiffness of element 51b, paragraph 0042) for the purpose of using a well-known alternative design of the dilator to move easily through the vasculature (paragraph 0021).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the third dilator stiffness of Gareth to incorporate wherein the third dilator stiffness is less than the second dilator stiffness (paragraph 0021).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783