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 .
Election/Restrictions
Claims 7-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 23 June 2026.
Applicant's election with traverse of Group I, claims 1-6 in the reply filed on 23 June 2026 is acknowledged. The traversal is on the ground(s) that there are overlapping technical features between the two groups and there would be no undue burden. This is not found persuasive because:
The common technical feature (i.e., the balloon of claim 1) that is shared between the groups I and II does not make a contribution over the prior art as stated in the previous office action and in the grounds of rejection below. Therefore, the groups I and II still lack unity a posteriori for the same reasons as set forth in the previous office action.
Further, “undue search burden” is not a requirement to establish a proper restriction requirement under the Unity of Invention standard for Patent Cooperation Treaty (PCT) patent applications. The “undue search burden” is a requirement under US Restriction Practice. Regardless, the two groups would result in an undue search burden as they are of different categories of invention (i.e. an article and a method) that would require different text searches as well as searches in different CPC classes.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Alston et al. (US 20170367705 A1) (previously cited) in view of Sridharan (US 20070138694 A1) (newly cited).
Regarding claim 1, Alston teaches a balloon for a balloon catheter, the balloon having a longitudinal axis direction and a circumferential direction that is along a circumference of the balloon in an inflated state in a cross section perpendicular to the longitudinal axis direction, comprising a straight tubular part (715), a proximal tapered part located proximal to the straight tubular part (710), and a distal tapered part located distal to the straight tubular part, wherein a proximal end of the straight tubular part is defined as the position of 0%, and a distal end of the straight tubular part is defined as the position of 100% in the longitudinal axis direction (Alston, Par. 0093, 0103, and Fig. 7A). Alston teaches the balloon is made of a resin having a molecular orientation that can be in a circumferential, axial, or helical direction (Alston, Par. 0100-0103 and Figs 7A-7B). Alston teaches the molecular orientation can be controlled by the angle of wrapping of the resin (Alston, Par. 0103).
Alston is silent regarding a main orientation direction of the molecular orientation in a proximal section from a position of 0% to a position of 10%, and a distal section from a position of 90% to a position of 100% being a circumferential direction, and is silent regarding a longitudinal axis direction component of the molecular orientation in a central section from a position of 40% to a position of 60% is more than a longitudinal axis direction component of the molecular orientation in the proximal section and the distal section.
Sridharan teaches a balloon for a balloon catheter wherein the balloon is made by winding a material (Sridharan, Abstract and Par. 0001). Sridharan teaches the balloon comprises a straight section wherein the angle of winding at the center is about 15-35 degrees relative to the longitudinal axis and gradually increases in each direction towards the distal and proximal ends to an angle of 50-89 degrees (Sridharan, Par. 0007-0008 and 0015).
Alston and Sridharan are analogous art as they both teach balloons for a balloon catheter comprising a material that is winded. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have wound the material of Alston at the angles taught by Sridharan. This would allow for a section with greater resistance to expansion, improved performance characteristics, and ease of manufacture (Sridharan, Abstract and Par. 0006-0007).
This would further result in proximal and distal ends at positions of 0-10% and 90-100% respectively each having an angle of winding of 50-89 degrees, which is greater than 45 degrees and thus would have a main orientation direction of the circumferential direction. This would further result in the central section from a position of 40-60% that has an angle of winding of 15-35 degrees, which is less than 45 degrees and would thus have a main orientation direction of the longitudinal direction and would thus have a longitudinal axis component greater than the longitudinal axis component of the proximal and distal sections.
Regarding claim 2, modified Alston teaches the central section has an angle of winding of 15-35 degrees, which is less than 45 degrees and would thus have a main orientation direction of the longitudinal direction (Sridharan, Par. 0015; Alston, Par. 0103).
Regarding claim 3, modified Alston teaches the angle of winding relative to the longitudinal direction gradually increases from the central section towards the position of 0% and 100%, and thus teaches the longitudinal axis direction component of the molecular orientation gradually decreases from the central section towards the positions of 0% and 100% (Sridharan, Abstract, Par. 0007-0008, and 0015; Alston, Par. 0103).
Regarding claim 4, modified Alston teaches the angle of winding goes from 15-35 degrees at the central portion of 40-60% to 50-89 degrees at the distal and proximal sections at 0-10% and 90-100% (Sridharan, Abstract, Par. 0007-0008, and 0015; Alston, Par. 0103), and would thus change from the longitudinal axis direction to the circumferential direction at a position of 10-40% and a position of 60-90%.
Regarding claim 6, modified Alston teaches a balloon catheter comprising the balloon of claim 1 (Alston, Par. 0117).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Alston et al. in view of Sridharan as applied to claim 1 above, further in view of Dib et al. (US 20170043138 A1) (newly cited).
Regarding claim 5, modified Alston teaches all of the elements of the claimed invention as stated above for claim 1. Modified Alston is silent regarding a film thickness of the balloon in the central section being thinner than a film thickness of the balloon in the proximal section and the distal section.
Dib teaches a balloon for a balloon catheter with a central section, a proximal section, and a distal section wherein a film thickness of the balloon in the central section being thinner than a film thickness of the balloon in the proximal section and the distal section (Dib, Abstract, Par. 0009-0010, 0017, and 0030).
Modified Alston and Dib are analogous art as they both teach balloons for balloon catheters. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the balloon of modified Alston to be thinner in the central section than the proximal and distal sections. This would allow for a difference in stretchability and bendability of the balloon, allowing for different shapes such as a prolate spheroid when inflated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS J KESSLER JR whose telephone number is (571)272-3075. The examiner can normally be reached 7:30-5:30 M-Th.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin can be reached at 571-272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS J KESSLER/Examiner, Art Unit 1782
Prosecution Insights