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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/29/2026 has been entered.
Response to Amendment
In light of Applicant’s amendment, claim(s) 1-2 is/are amended and claim(s) 8-21 are canceled. Claims 3-4 and 7 were canceled previously. Claim 22 is added. Claims 1-2, 5-6, and 22 are now pending examination.
The rejection(s) under 35 U.S.C. 112(b) and 35 U.S.C. 112(d) to claim(s) 8 is/are withdrawn as the claim has been canceled.
Response to Arguments
Applicant’s arguments, filed 6/29/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and are persuasive. Examiner agrees the newly added limitation of at least “the second ridge joins the outer surface without a step” 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 Therefore, the rejection has been withdrawn.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 Booth.
Regarding the rejection under Vigil, the arguments are not persuasive. Applicant argues Vigil fails to disclose the second ridge as claimed (Remarks Page 11). In the present interpretation, the ridge is not considered to be 31, which Applicant states does not equate to the second ridge. Although the previous interpretation of the art did not account for a second ridge as claimed, the newly presented rejection under Vigil identifies the outer surfaces of the labeled third face and fourth face as forming a ridge, as the outer surfaces are seen as “top edges”. As the meeting point extends akin to the side surface of the labeled cutting structure 30, the “second ridge” meets the outer surface to form an acute angle. Thus, under the newly presented interpretation of the art, Vigil does teach the claims as amended.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “a first face and a second face; the first face has a rectangular shape that is elongated in the axial direction and has a top edge that is parallel to the outer surface, the second face has a rectangular shape that is elongated in the axial direction and has a top edge that is parallel to the outer surface, the first face and the second face are tilted toward each other with the top edge of the first face joining the top edge of the second face to form an acute angle, the top edge of the first face and the top edge of the second face define a first ridge, the slope portion includes a third face and a fourth face, the third face has a right triangular shape that is elongated in the axial direction and has a bottom edge that joins the outer surface and a top edge that continues from a distal end of the top edge of the first face and slopes down to the outer surface, the fourth face has a right triangular shape that is elongated in the axial direction and has a bottom edge that joins the outer surface and a top edge that continues from a distal end of the top edge of the second face and slopes down to the outer surface, the third face and the fourth face are tilted toward each other with the top edge of the third face joining the top edge of the fourth face to form an acute angle, the top edge of the third face and the top edge of the fourth face define a second ridge, the second ridge is at an acute angle to the outer surface, the acute angle is constant throughout the length of the slope portion in the axial direction, and the second ridge joins the outer surface without a step” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-2, 5-6 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification and the drawings fail to include newly claimed components “the third face has a right triangular shape“.
Claims 2, 5-6, and 22 are rejected due to their dependence on claim 1.
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 2 and 5-6 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 2 recites the limitation "the tip-end side edge of the linear protrusion" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as “a tip-end side edge of the linear protrusion”.
Claim 5 recites the limitation "the tip-end side edge of the linear protrusion" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as “a tip-end side edge of the linear protrusion”.
Claim 6 recites the limitation "the tip-end side edge of the linear protrusion" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as “a tip-end side edge of the linear protrusion”.
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 (US 20050149082 A1) (previously of record) and Booth et al. (US 5653690 A) (previously of record).
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 has a triangular cross section (Figure 3A) and 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 linear portion (labeled in Annotated Figure 2A) and a slope portion (labeled in Annotated Figure 2A) (Annotated Figure 2A),
the linear portion extends in the axial direction and includes a first face (labeled in Annotated Figure 2A) and a second face (labeled in Annotated Figure 2A) (Annotated Figure 2A),
the first face has a rectangular shape that is elongated in the axial direction and has a top edge (outer surface of first face) that is parallel to the outer surface (Figure 2A),
the second face has a rectangular shape that is elongated in the axial direction and has a top edge (outer surface of second face) that is parallel to the outer surface (Figure 2A),
the first face and the second face are tilted toward each other with the top edge of the first face joining the top edge of the second face to form an acute angle (Figure 2A),
the top edge of the first face and the top edge of the second face define a first ridge (upper edge of 31) (Figure 2A),
the slope portion includes a third face (labeled in Annotated Figure 2A) and a fourth face (labeled in Annotated Figure 2A corresponding to the depicted third face) (Figure 2A),
the third face has a right triangular shape and has a bottom edge that joins the outer surface and a top edge that continues from a distal end of the top edge of the first face and slopes down to the outer surface (Annotated Figure 2A),
the fourth face has a right triangular shape and has a bottom edge that joins the outer surface and a top edge that continues from a distal end of the top edge of the second face and slopes down to the outer surface (Annotated Figure 2A),
the third face and the fourth face are tilted toward each other with the top edge of the third face joining the top edge of the fourth face to form an acute angle (Annotated Figure 2A),
the top edge of the third face and the top edge of the fourth face define a second ridge (Labeled in Annotated Figure 2A) (Annotated Figure 2A),,
the second ridge is at an acute angle to the outer surface (Figure 5),
the acute angle is constant throughout the length of the slope portion in the axial direction (Figure 2A),
Vigil fails to explicitly disclose the third face has a right triangular shape that is elongated in the axial direction, the fourth face has a right triangular shape that is elongated in the axial direction, the top edge of the third face and the top edge of the fourth face define a second ridge, the slope portion has a length in the axial direction equal to a length of the linear portion in the axial direction and the second ridge joins the outer surface without a step.
However, Yee is directed to a balloon catheter and teaches the slope portion (42) has a length in the axial direction which appears equal to a length of the linear portion (32) in the axial direction (Figure 6; Paragraph 0035). As a result of the modification, the combination would yield in that the third face has a right triangular shape that is elongated in the axial direction, the fourth face has a right triangular shape that is elongated in the axial direction, as the entirety of the slope portion would be stretched axially.
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 slope portion has a length in the axial direction equal to or greater than a length of the linear 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 slope portion has a length in the axial direction equal to or greater than a length of the linear 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).
Further, Booth is directed to a balloon catheter and teaches the ridge of the 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, 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.
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Regarding claim 2, Vigil further discloses wherein a tip-end side edge of the 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 second 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, as best understood in view of the 112(b) issues above, Vigil further disclose wherein a tip-end side edge of the linear protrusion is closer to a base-end side (side closer to proximal end of catheter) 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).
Regarding claim 22, Vigil as modified by Booth discloses the balloon catheter according to claim 1, and Vigil further discloses wherein the first ridge extends in the axial direction (Annotated Figure 2A), the second ridge extends in the axial direction and slopes straight down to the outer surface (Annotated Figure 2A), a distal end of the first ridge is coupled to a proximal end of the second ridge (Annotated Figure 2A), and the combination of Vigil and booth would teach a distal end of the second ridge is coupled to the outer surface without a step (Booth Figure 31-32).
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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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
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
