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 .
Priority
This application claims priority from provisional application 62/911,861 filed 10/07/2019
Status of Claims
Claims 1-20 are pending.
Election/Restrictions
Applicant’s election without traverse of Species 6 (Figures 22A-23B) in the reply filed on 07/07/2026 is acknowledged.
Information Disclosure Statement
The Information Disclosure Statements filed on 02/12/2025, 10/08/2025, and 11/21/2025 have been considered by the examiner.
Claim Rejections - 35 USC § 103
It is noted that in their current form many of the claims are so broadly claimed that any container or case would anticipate them because the dimensions and scale of the lumen and sections are not positively claimed. For example USPN 4,446,900 directed at a firearm carrying case.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rupp et al (Rupp) US 2017/0065415 A1 in view of Gantert USPN 6,722,496 B2.
1. Rupp discloses a balloon cover 58 for a balloon catheter (Figures 13-16), comprising:
a first shell member and a second shell member ([0062] discloses the cover in Figures 13-16 is a clam shell with 2 cover portions), wherein the first and second shell members are configured to matingly engage with each other to define a lumen that is configured to receive a distal portion of the balloon catheter (Figures 13-16);
wherein the first shell and second shell member comprises a plurality of complementary protrusions and cavities ([0062] discloses the complementary protrusions 302 and openings are used to ensure proper alignment of the cover)
when the first and second shell members are matingly engaged with each other, the plurality of first protrusions are received by the plurality of second openings
However, Rupp does not disclose the first shell member comprises a plurality of first wedges juxtaposed with a plurality of first cavities and the second shell member comprises a plurality of second wedges juxtaposed with a plurality of second cavities (Figure 8 shows the peaks and valleys that line the edges of each of the clam shells),
Gantert teaches that it is old and well known in the art of clam shell containers to provide the first and second shells each with a plurality of wedges juxtaposed with a plurality of cavities (Figures 2 and 8 show the alternating wedges and cavities of the first upper shell member, and 3:20-23 discloses the foam wedges and cavities can fill the entire cavity) for the purpose of maintaining the alignment of the shells and stabilizing the contents therewithin.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to replace the protrusions of the first shell member and the openings of the second shell member of Rupp with the alternating peaks and valleys of Gantert in order to increased surface area of contact and tapered surfaces for guiding the alignment of the first and second shell members.
2. Rupp discloses the first and second shell members are completely separable from each other (this claim language is considered extremely broad because it doesn’t require the members to be able to be rejoined or how they are separable, the two shells of Rupp are inherently separable if the operator uses the proper cutting tool and/or force).
In regards to claims 3. 4. and 16. Rupp, does not disclose the use of longitudinal hinges or larches. However, these components are old and extremely well known in the art of shell containers. Gantert teaches the use of hinges (20 Figure 2) in order to provide smooth opening and closing as well as complementary latches (48 Figure 2) in order to provide a lock for keeping the container closed. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the cover of Rupp with hinges and clasps as taught by Gantert in order to provide more control over the opening and closing of the cover as well as a means for securing it in the closed position.
5. Rupp discloses a sleeve 97 configured to slide over the first and second shell members so as to retain the first and second shell members matingly engaged [0064].
6. Rupp discloses the lumen comprises a nosecone section (far left section of 93 adjacent the tip) configured to receive a nosecone of the balloon catheter (Figures 13-16) and a balloon section (94/95/96) configured to receive a balloon of the balloon catheter (Figures 13-16).
7. Rupp discloses the balloon section comprises a proximal portion (95) configured to receive a proximal portion of the balloon, a distal portion (94) configured to receive a distal portion of the balloon (Figures 13-16), and an intermediate portion (96) between the proximal and distal portions of the balloon section (Figures 13-16), wherein the intermediate portion is configured to receive a valve retaining portion of the balloon located between the proximal and distal portions of the balloon (Figures 13-16).
8. Rupp discloses the lumen has a varying diameter defined by inner surfaces of the first and second shell members, wherein the intermediate portion has a smaller diameter than a distal end portion of the proximal portion of the balloon section and a proximal end portion of the distal portion of the balloon section (Figures 13-16).
9. Rupp as modified discloses the first and second wedges, and the first and second cavities are in the balloon section (as explained above the 2 complementary protrusions and openings of Rupp have been replaced with peaks and valleys that extend along the entire flat surface surrounding the lumen including within the balloon section 94/95/96).
10. Rupp discloses the nosecone section comprises a neck portion (the far left section of 93), wherein the neck portion has a smaller diameter than remaining portions of the nosecone section (the far left section of 93 has the smallest diameter because it tapers inward towards that end).
11. 17. Rupp as modified discloses the first shell member has two opposing first longitudinal edges and the second shell member has two opposing second longitudinal edges, wherein the first longitudinal edges are configured to mate with the corresponding second longitudinal edges to form two longitudinal parting lines (Figures 13-16).
12. 18. Rupp as modified discloses the first wedges and first cavities are located adjacent and along with the first longitudinal edges, and the second wedges and second cavities are located adjacent and along with the second longitudinal edges (as explained above the 2 complementary protrusions and openings of Rupp have been replaced with peaks and valleys that extend along the entire flat surface surrounding the lumen including along the longitudinal edges).
13. Rupp as modified discloses the first wedges and first cavities located along the two opposing first longitudinal edges are symmetric about an axial axis of the first shell member, and the second wedges and second cavities located along the two opposing second longitudinal edges are symmetric about an axial axis of the second shell member (as explained above the 2 complementary protrusions and openings of Rupp have been replaced with peaks and valleys that extend symmetrically along the entire flat surface surrounding the lumen).
14. 19. Rupp discloses the first and second wedges protrude above the respective first and second longitudinal edges and the first and second cavities recess below the respective first and second longitudinal edges (the original protrusions and openings of Rupp extend above and below the edges in order to provide the surfaces of the shell members to uniformly seal together, therefore the modification to use the alternating peaks and valleys would maintain the same heights and depths).
15. Rupp as modified by Gantert above discloses a balloon cover (58 Figures 13-16 of Rupp) for a balloon catheter (58 Figures 13-16 of Rupp), comprising:
a first shell member and a second shell member [0062 of Rupp] configured to matingly engage each other so as to enclose a distal end portion of the balloon catheter (58 Figures 13-16 of Rupp);
wherein the first shell member comprises a plurality of first wedges and first cavities and the second shell member comprises a plurality of second wedges and second cavities, and wherein the first wedges and first cavities are configured to interlock with the corresponding second cavities and second wedges when the first and second shells are matingly engaged with each other (see modification in view of Gantert in reference to claim 1 above).
20. Rupp as modified by Gantert above discloses a medical assembly, comprising:
a balloon catheter comprising an inflatable balloon (Figures 1-2 of Rupp); and
a balloon cover (Figures 13-16 of Rupp) comprising a first shell member and a second shell member [0062 of Rupp];
wherein the first and second shell members are configured to matingly engage with each other to define a lumen that is configured to receive at least the inflatable balloon ([0062] Figures 13-16 of Rupp);
wherein the first shell member comprises a plurality of first wedges and first cavities and the second shell member comprises a plurality of second wedges and second cavities, and wherein the first wedges and first cavities are configured to interlock with the corresponding second cavities and second wedges when the first and second shells are matingly engaged with each other (see modification in view of Gantert in reference to claim 1 above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774