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 .
Response to Amendment
In light of Applicant’s amendment, claim(s) 1 and 8 is/are amended and claim(s) 3-4 and 7 is/are canceled. Claims 19-21 are added. Claims 1-2, 6, and 8-21 are now pending examination.
The rejection(s) under 35 U.S.C. 112(b) to claim(s) 13-14 is/are withdrawn.
Response to Arguments
Applicant’s arguments, filed 3/12/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 102 have been fully considered and are persuasive. Examiner agrees the newly added limitation “the first slope portion has a length in the axial direction equal to or greater than a length of the non-slope portion in the axial direction” overcomes the previous rejection as written. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Vigil in view of Yee.
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 8 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 8 recites “a non-slope portion”, however, claim 1 from which this claim depends was amended to positively recite “a non-slope portion”. Therefore, it is indefinite as to whether the claim refers to the same non-slope portion as claim 1 or a second non-slope portion.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 8 recites the limitations “wherein the linear protrusion includes a non-slope portion that joins the base-end side edge of the first slope portion, the ridge in the non-slope portion extends parallel to the outer surface in the non-slope portion”, which are already recited in amended claim 1, and the limitations “the tip-end side edge of the linear protrusion is closer to a base-end side than is a tip- end side edge of the straight tube portion, the straight tube portion includes a no-protrusion region that does not include the linear protrusion, and the no-protrusion region is closer to the tip-end side than is the linear protrusion” are the same as the dependent claim 6, which depends from claim 2. Thus, claim 8 fails to further limit the claim from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Thus, claim 8 is rejected under the rejection of claim 6.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 5-6, 8-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vigil et al. (US 5320634 A) (previously of record) in view of Yee et al. (US 20050149082 A1).
Regarding claim 1, Vigil discloses a balloon catheter (10) comprising:
a balloon (12) that is inflatable and deflatable and disposed on a tip-end side (13) of the balloon catheter (Figure 1; Col 3, line 38-39), wherein
the balloon comprises a straight tube portion (labeled in Annotated Figure 5) having a cylindrical shape (Figure 5; Col 3, line 51-54), and
a diameter of the balloon is largest at the straight tube portion among portions (22a, 22b) of the balloon in a state where the balloon is inflated (Figure 5; Col 3, line 51-61); and
a linear protrusion (28) that protrudes from an outer surface of the straight tube portion and extends in an axial direction of the straight tube portion (Figure 5; Col 4, line 19-24), wherein
the linear protrusion includes a ridge (perimetral edge of 28, labeled in Annotated Figure 2A) at a projected end of the linear protrusion (as is evident in the present disclosure, the ridge is the outer surface edges of the protrusion, as the cross-section of Figure 3B indicates ridge 33 as the tip of the protrusion 30 in the cross-section), wherein the ridge extends in a longitudinal direction of the linear protrusion (the outer circumference of the linear protrusion would extend in a longitudinal direction of the linear protrusion) (Figure 2A, 5),
the linear protrusion includes a slope portion (labeled in Annotated Figure 5) that extends over at least a part of the linear protrusion along the longitudinal direction, wherein the ridge slopes down to the outer surface in the slope portion (Figure 2A; 5),
the slope portion includes a first slope portion in which the ridge slopes down to the outer surface toward the tip-end side (Figure 2A, 5), and
the linear protrusion has a projection height from the outer surface that becomes lower toward the tip-end side in the axial direction within a region between a base-end side edge of the first slope portion and a tip-end side edge of the linear protrusion (Figure 2A),
the linear protrusion includes a non-slope portion (31) that joins the base-end side edge of the first slope portion, and the ridge in the non-slope portion extends parallel to the outer surface (Figure 2A, 5; Col 4, line 23-24).
Vigil fails to explicitly disclose the first slope portion has a length in the axial direction equal to or greater than a length of the non-slope portion in the axial direction.
However, Yee is directed to a balloon catheter and teaches the first slope portion (42) has a length in the axial direction which appears equal to a length of the non-slope portion (32) in the axial direction (Figure 6; Paragraph 0035).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Vigil such that the first slope portion has a length in the axial direction equal to or greater than a length of the non-slope portion in the axial direction, as taught by Yee, as both references and the claimed invention are directed to balloon catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vigil with the teachings of Yee by incorporating the first slope portion has a length in the axial direction equal to or greater than a length of the non-slope portion in the axial direction in order to ensure smooth insertion of the balloon with minimal tissue damage.
There are a finite number of choices available to a person of ordinary skill in the art for length differences between a first slope portion and a non-slope portion. Either the length of the slope portion can be equal to, less than, or greater than the length of the non-slope portion. 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 2, Vigil further discloses wherein a tip-end side edge of the first slope portion (side of protrusion close to the distal end of the catheter) matches the tip-end side edge of the linear protrusion, and the ridge joins the outer surface at the tip-end side edge of the first slope portion (Figure 2A, 5).
Regarding claim 5-6 and 8, Vigil further disclose wherein the tip-end side edge of the linear protrusion is closer to a base-end side (side closer to proximal end of catheter; labeled in Annotated Figure 2A) than is the tip-end side edge of the straight tube portion (Figure 5), the straight tube portion includes a no-protrusion region (Labeled in Annotated Figure 5) that does not include the linear protrusion, and the no-protrusion region is closer to the tip-end side than is the linear protrusion (Figure 5).
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Regarding claims 9-10, Vigil further discloses wherein the first slope portion includes a tip-end side slope region (labeled in Annotated Figure 2A) and a base-end side slope region (Labeled in Annotated Figure 2A) that is disposed closer to a base-end side (proximal region of catheter) than is the tip-end side slope region, and a slope angle of the ridge to the outer surface in the tip-end side slope region is different from a slope angle of the ridge to the outer surface in the base-end side slope region (Figure 2A).
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Regarding claims 11-12, Vigil further discloses wherein the slope angle of the ridge in the tip-end side slope region is smaller than the slope angle of the ridge in the base-end side slope region (the angle of the slope in the base-end side slope region is approximately 90 degrees, while the angle of the slope in the tip end side slope region is an acute angle, thus is smaller than 90 degrees) (Figure 2A).
Regarding claims 13-14, Vigil further discloses wherein the slope portion further includes a second slope portion (Labeled in Annotated Figure 2A) that extends from a base-end side edge of the first slope portion toward a base-end side, the ridge in the second slope portion slopes down in a direction same as a direction in which the ridge in the first slope portion slopes down (Figure 2A), and the ridge at a tip-end side edge of the second slope portion is closer to the outer surface than is the ridge at the base-end side edge of the first slope portion (Figure 2A).
Regarding claim 15-16, Vigil further discloses wherein the slope portion further includes a third slope portion (labeled in Annotated Figure 2a) that is closer to a base-end side (labeled in Annotated Figure 2A) than is the first slope portion, and the ridge in the third slope portion slopes down to the outer surface toward the base-end side (Figure 2A).
Regarding claim 17, Vigil further discloses wherein the third slope portion extends from the base-end side edge of the first slope portion toward the base-end side (Figure 2A), and the ridge in the third slope portion joins the ridge in the first slope portion at a border between the first slope portion and the third slope portion (Figure 2A).
Regarding claim 18, Vigil further discloses the slope portion further includes a third slope portion (labeled in Annotated Figure 2A) that is closer to a base-end side than is the first slope portion (Figure 2A), the ridge in the third slope portion slopes down to the outer surface toward the base-end side (Figure 2A), the third slope portion extends from the base-end side edge of the first slope portion toward the base-end side (Figure 2A) and the ridge in the third slope portion joins the ridge in the first slope portion at a border between the first slope portion and the third slope portion (Figure 2A).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vigil in view of Yee and further in view of Booth.
Regarding claim 19, Vigil as modified by Yee teaches the balloon catheter according to claim 1, and further teaches wherein the ridge of the first slope portion is at an acute angle to the outer surface of the straight tube portion (Annotated Figure 5), and the acute angle is constant throughout the length of the first slope portion in the axial direction (Annotated Figure 5) but fails to explicitly disclose the ridge of the first slope portion joins the outer surface of the straight tube portion without a step.
However, Booth is directed to a balloon catheter and teaches the ridge of the first slope portion (perimetral edge of 252) joins the outer surface of the straight tube portion (body of 250) without a step (Figure 31-32; Col 14 line 26-31).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Vigil as modified by Yee to remove the step to form, as taught by Booth, as both references and the claimed invention are directed to balloon catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vigil as modified by Yee with the teachings of Booth by incorporating no step in order to prevent the protrusion from getting stuck during insertion and insuring a smooth incision.
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Booth et al. (US 5653690 A) in view of Vigil.
Regarding claim 20, Booth discloses a balloon catheter (10) (Figure 31-32; Col 12 line 29-31) comprising:
a balloon (250) that is inflatable and deflatable and disposed on a tip-end side of the balloon catheter (distal end of 12) (Figure 31-32; Col 12 line 29-41),
wherein the balloon comprises a straight tube portion (middle portion of 250) having a cylindrical shape (Figure 31-32; Col 12 line 29-41), and
a linear protrusion (252) that protrudes from an outer surface of the balloon and extends in an axial direction of the straight tube portion (Figure 32; Col 12 line 29-32), wherein the linear protrusion includes a ridge (perimetral edge of 252) that slopes down to the outer surface toward the tip-end side (as is evident in the present disclosure, the ridge is the outer surface edges of the protrusion, as the cross-section of Figure 3B indicates ridge 33 as the tip of the protrusion 30 in the cross-section) (Figure 32), and
the ridge of the linear protrusion slopes for an entire length of the linear protrusion in the axial direction (the outer circumference of the linear protrusion would extend in a longitudinal direction of the linear protrusion along the entire length of the protrusion) (Figure 32).
Booth fails to explicitly disclose wherein a diameter of the balloon is largest at the straight tube portion among portions of the balloon in a state where the balloon is inflated; and a linear protrusion that protrudes from an outer surface of the straight tube portion.
However, Vigil is directed to a balloon catheter and teaches the balloon (12) comprises a straight tube portion (labeled in Annotated Figure 5) having a cylindrical shape (Figure 5; Col 3, line 51-54), and a diameter of the balloon is largest at the straight tube portion among portions (22a, 22b) of the balloon in a state where the balloon is inflated (Figure 5; Col 3, line 51-61); and a linear protrusion (28) that protrudes from an outer surface of the straight tube portion and extends in an axial direction of the straight tube portion (Figure 5; Col 4, line 19-24).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Booth such that the diameter of the balloon is largest at the straight tube portion among portions of the balloon in a state where the balloon is inflated and a linear protrusion protrudes from an outer surface of the straight tube portion and extends in an axial direction of the straight tube portion, as taught by Vigil, as both references and the claimed invention are directed to balloon catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Booth with the teachings of Vigil by incorporating the diameter of the balloon is largest at the straight tube portion among portions of the balloon in a state where the balloon is inflated and a linear protrusion that protrudes from an outer surface of the straight tube portion and extends in an axial direction of the straight tube portion as it has been held that changing the shape was a matter a choice one of ordinary skill in the art would have found obvious. See MPEP 2144. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, alternative embodiments of Booth, such as Figure 25 teach in its deflated state, the barbed balloon 200 comprises an elastic cylindrical body 202 concentrically aligned with a centerline 203 of the catheter body 12, thus would comprise a straight portion with a cylindrical shape (Figure 25-27; Col 10 line 58-60).
Regarding claim 21, Booth further discloses wherein the ridge of the linear protrusion is at an acute angle to the outer surface of the straight tube portion (Figure 32),
the acute angle is constant throughout the length of the linear protrusion in the axial direction (Figure 32),
and the ridge of the linear protrusion joins the outer surface of the straight tube portion without a step (Figure 32).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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