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.
Claim 6-7, 10, and 17-18 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 6 recites the limitation " the notch" in line 4-5, 7 and 9. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as “the specific notch”.
Claim 7 recites the limitation " the notch" in line 4-5, 7 and 9. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as “the specific notch”.
Claim 10 recites the limitation "toward outside" in line 4. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as going further away from the outer surface of the balloon, i.e., from a base portion to a top portion of the cross-section as described in Applicant’s disclosure, Paragraph 0040. Figure 14.
Claim 17 recites the limitation " the notch" in line 4-5, 7 and 9. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as “the specific notch”.
Claim 18 recites the limitation " the notch" in line 4-5, 7 and 9. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as “the specific notch”.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9 and 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okamoto et al. (US 20240269441 A1).
Regarding claims 1-2, Okamoto discloses a balloon (3) for a balloon catheter having a longitudinal direction extending from a proximal side to a distal side, and radial and circumferential directions, both orthogonal to the longitudinal direction (Figure 1), comprising:
a straight portion (3B), a proximal tapered portion (3C) located further toward the proximal side than the straight portion, and a distal tapered portion (3A) located further toward the distal side than the straight portion (Figure 1; Paragraph 0038), wherein:
the straight portion comprises a cylindrical balloon main body (body of 3B) and a ridge (40) provided on an outer surface of the balloon main body (Figure 1; Paragraph 0043), the ridge protruding outward in the radial direction and extending in the longitudinal direction (Figure 1),
a notch (5) is formed in the ridge (Figure 1; Paragraph 0045), and
the notch comprises a specific notch satisfying a Requirement A and a Requirement B, wherein:
the Requirement A is that, in a cross section taken along the longitudinal direction and passing through a top portion of the ridge, an outer edge of the ridge in the specific notch has a proximal first segment (5P on the proximal side) extending radially outward and linearly inclined proximally, and a proximal second segment (50P on the proximal side) extending radially outward and linearly inclined proximally provided on the proximal side relative to the proximal first segment (Figure 1; Paragraph 0046), and
the Requirement B is that, in the cross section taken along the longitudinal direction and passing through the top portion of the ridge, the outer edge of the ridge in the specific notch has a distal first segment (5P on the distal side) extending radially outward and linearly inclined distally, and a distal second segment (50P on the distal side) extending radially outward and linearly inclined distally provided on the distal side relative to the distal first segment (Figure 1; Paragraph 0046).
Although Okamoto teaches the overall device as claimed, Okamoto fails to explicitly disclose the proximal first segment extends radially outward at an angle P1 of 35° or more and less than 90 with respect to the longitudinal direction from the distal side toward the proximal side, and the proximal second segment extends radially outward at an angle P2 that is smaller than the angle P1 by 20° or more with respect to the longitudinal direction from the distal side toward the proximal side; the distal first segment extends radially outward at an angle Q1 of 35° or more and less than 90 with respect to the longitudinal direction from the proximal side toward the distal side, and the distal second segment extends radially outward at an angle Q2 that is smaller than the angle Q1 by 20° or more with respect to the longitudinal direction from the proximal side toward the distal side. Okamoto teaches a specific notch with the same shape as the claimed invention, i.e., having a proximal first segment extending radially outward and linearly inclined proximally, a proximal second segment extending radially outward and linearly inclined proximally, a distal first segment extending radially outward and linearly inclined distally, and a distal second segment extending radially outward and linearly inclined distally, but it is merely silent to the specific angles of inclination.
It would appear that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Okamoto device to include the proximal first segment extends radially outward at an angle P1 of 35° or more and less than 90 with respect to the longitudinal direction from the distal side toward the proximal side, and the proximal second segment extends radially outward at an angle P2 that is smaller than the angle P1 by 20° or more with respect to the longitudinal direction from the distal side toward the proximal side; the distal first segment extends radially outward at an angle Q1 of 35° or more and less than 90 with respect to the longitudinal direction from the proximal side toward the distal side, and the distal second segment extends radially outward at an angle Q2 that is smaller than the angle Q1 by 20° or more with respect to the longitudinal direction from the proximal side toward the distal side, as it involves only adjusting the angle of a component disclosed as a results effective variable, degree of the rounding and angle of 55p and 50p is tied to the effect the boundary has on damaging the vessel (Okamoto Paragraph 0062). Further, there is no disclosure about the size of angles of inclination thus the angles reasonably could comprise any values, as there Is no teaching away from a particular angle. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to change the angles of the segments to satisfy the claimed angles, 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 involve only routine skill in the art and would have been done with a reasonable expectation of success. [W]here the general conditions of a claim are disclosed 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 3, Okamoto further discloses wherein, when the ridge is equally divided in the longitudinal direction into three sections that are a distal section (3A to V1), an intermediate section (V1 to V2), and a proximal section (V2 to 3C), the specific notch is provided in at least the distal section or the proximal section (the plurality of slits 5 are provided throughout the length of the balloon thus are also provided In both the distal and proximal sections) (Figure 7; Paragraph 0095).
Regarding claim 4, Okamoto further discloses wherein the specific notch is provided in at least the distal section (the plurality of slits 5 are provided throughout the length of the balloon thus are also provided in both the distal and proximal sections) (Figure 7; Paragraph 0095).
Regarding claim 5, Okamoto further discloses wherein the specific notch is provided in at least the proximal section (the plurality of slits 5 are provided throughout the length of the balloon thus are also provided in both the distal and proximal sections) (Figure 7; Paragraph 0095).
As best understood in view of the 112(b) issues above, regarding claim 6, Okamoto further teaches wherein, when the ridge is equally divided in the longitudinal direction into three sections that are a distal section (3A to V1), an intermediate section (V1 to V2), and a proximal section (V2 to 3C), the specific notch is provided in at least each of the distal section and the intermediate section (the plurality of slits 5 are provided throughout the length of the balloon thus are also provided in both the distal and intermediate sections) (Figure 7; Paragraph 0095), but fails to explicitly disclose a maximum length of the specific notch in the longitudinal direction provided in the distal section is longer than a maximum length of the specific notch in the longitudinal direction provided in the intermediate section.
There are a number of choices available to a person of ordinary skill in the art for the relationship between the maximum length of a notch in the distal section and the maximum length of a notch in the intermediate section. Either the maximum length of the notch in the proximal section can be the same, greater than, or less than the maximum length of a notch in the intermediate section. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
As best understood in view of the 112(b) issues above, regarding claim 7, Okamoto further teaches wherein, when the ridge is equally divided in the longitudinal direction into three sections that are a distal section (3A to V1), an intermediate section (V1 to V2), and a proximal section (V2 to 3C), the specific notch is provided in at least each of the proximal section and the intermediate section (the plurality of slits 5 are provided throughout the length of the balloon thus are also provided in both the intermediate and proximal sections) (Figure 7; Paragraph 0095), but fails to explicitly disclose a maximum length of the specific notch in the longitudinal direction provided in the proximal section is longer than a maximum length of the specific notch in the longitudinal direction provided in the intermediate section.
There are a number of choices available to a person of ordinary skill in the art for the maximum length of notches in the proximal section and notches in the intermediate section. Either the maximum length of the notch in the proximal section can be the same, greater than, or less than the maximum length of the notch in the intermediate section. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
Regarding claim 8, Okamoto teaches the balloon according to claim 2 but fails to explicitly disclose wherein the angle P1 is smaller than the angle Q1.
There are a number of choices available to a person of ordinary skill in the art for the relationship between angles P1 and Q1. Either the angle of P1 is greater than, equal to, or less than the angle Q1. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
Regarding claim 9, Okamoto teaches the balloon according to claim 2 but fails to explicitly disclose wherein the angle P1 is greater than the angle Q1.
There are a number of choices available to a person of ordinary skill in the art for the relationship between angles P1 and Q1. Either the angle of P1 is greater than, equal to, or less than the angle Q1. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
Regarding claim 10, as best understood in view of the 112(b) issues above, Okamoto further teaches wherein, in a cross section of the straight portion perpendicular to the longitudinal direction, the ridge is formed such that a width of the ridge gradually decreases toward outside in the radial direction (the ridge is formed in a triangular shape in which the width gets smaller as it travels from closer to the balloon to further away towards the apex, akin to the present invention Fig 14, [0040]) (Figure 1; Paragraph 0044).
Regarding claim 11, Okamoto further teaches wherein the ridge is made of a resin (Paragraph 0042).
Regarding claim 12, Okamoto discloses a balloon catheter (1) comprising the balloon according to claim 1 (see rejection to claim 1 above) (Figure 1; Paragraph 0029).
Regarding claim 13, Okamoto discloses a balloon catheter (1) comprising the balloon according to claim 2 (see rejection to claim 2 above) (Figure 1; Paragraph 0029).
Regarding claim 14, Okamoto further teaches wherein, when the ridge is equally divided in the longitudinal direction into three sections that are a distal section (3A to V1), an intermediate section (V1 to V2), and a proximal section (V2 to 3C), the specific notch is provided in at least the distal section or the proximal section (the plurality of slits 5 are provided throughout the length of the balloon thus are also provided In both the distal and proximal sections) (Figure 7; Paragraph 0095).
Regarding claim 15, Okamoto further teaches wherein the specific notch is provided in at least the distal section (the plurality of slits 5 are provided throughout the length of the balloon thus are also provided in both the distal and proximal sections) (Figure 7; Paragraph 0095).
Regarding claim 16, Okamoto further teaches wherein the specific notch is provided in at least the proximal section (the plurality of slits 5 are provided throughout the length of the balloon thus are also provided in both the distal and proximal sections) (Figure 7; Paragraph 0095).
As best understood in view of the 112(b) issues above, regarding claim 17, Okamoto further teaches wherein, when the ridge is equally divided in the longitudinal direction into three sections that are a distal section (3A to V1), an intermediate section (V1 to V2), and a proximal section (V2 to 3C), the specific notch is provided in at least each of the distal section and the intermediate section (the plurality of slits 5 are provided throughout the length of the balloon thus are also provided in both the distal and intermediate sections) (Figure 7; Paragraph 0095), but fails to explicitly disclose a maximum length of the specific notch in the longitudinal direction provided in the distal section is longer than a maximum length of the specific notch in the longitudinal direction provided in the intermediate section.
There are a number of choices available to a person of ordinary skill in the art for the relationship between the maximum length of a notch in the distal section and the maximum length of a notch in the intermediate section. Either the maximum length of the notch in the proximal section can be the same, greater than, or less than the maximum length of a notch in the intermediate section. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
As best understood in view of the 112(b) issues above, regarding claim 18, Okamoto further teaches wherein, when the ridge is equally divided in the longitudinal direction into three sections that are a distal section (3A to V1), an intermediate section (V1 to V2), and a proximal section (V2 to 3C), the specific notch is provided in at least each of the proximal section and the intermediate section (the plurality of slits 5 are provided throughout the length of the balloon thus are also provided in both the intermediate and proximal sections) (Figure 7; Paragraph 0095), but fails to explicitly disclose a maximum length of the specific notch in the longitudinal direction provided in the proximal section is longer than a maximum length of the specific notch in the longitudinal direction provided in the intermediate section.
There are a number of choices available to a person of ordinary skill in the art for the maximum length of notches in the proximal section and notches in the intermediate section. Either the maximum length of the notch in the proximal section can be the same, greater than, or less than the maximum length of the notch in the intermediate section. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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