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Claims 27-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 March 10, 2026.
Applicant's election with traverse of the election between Groups I and II in the reply filed on May 11, 2026 is acknowledged. The traversal is on the ground(s) that “The Office Action’s requirement that the special technical feature recited by the claims be patentable over the cited references confuses the Unity of Invention requirement with the requirements for patentability,” and that “the International Preliminary Report on Patentability… confirm[ed] that the international examiner agreed there was Unity of Invention” is not persuasive.
First, Examiner points to MPEP 1850 and PCT Rule 13. Which states at (II): “With respect to a group of inventions claimed in an international application, unity of invention exists only when there is a technical relationship among the claimed inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” is defined in PCT Rule 13.2 as meaning those technical features that define a contribution which each of the inventions, considered as a whole, makes over the prior art. The determination is made on the contents of the claims as interpreted in light of the description and drawings (if any).
Whether or not any particular technical feature makes a “contribution” over the prior art, and therefore constitutes a “special technical feature,” should be considered with respect to novelty and inventive step. For example, a document discovered in the international search shows that there is a presumption of lack of novelty or inventive step in a main claim, so that there may be no technical relationship left over the prior art among the claimed inventions involving one or more of the same or corresponding special technical features, leaving two or more dependent claims without a single general inventive concept.”
Lack of unity of invention may be directly evident “a priori,” i.e., before considering the claims in relation to any prior art, or may only become apparent “a posteriori,” i.e., after taking the prior art into consideration. For example, independent claims to A + X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art.
Thus, Examiner notes as discussed in the Restriction Requirement dated March 10, 2026 that a lack of unity became apparent a posteriori since the common feature among the groups is “a balloon for a perfusion balloon catheter, an elongate element, at least two lobes that are disposed mutually spaced angularly about a central longitudinal and that project angularly, and a longitudinally-extending spine channel.” The prior art of Verduin Jr. (US. Pat No. 5,501,667) shows the feature was already known as discussed on page 3 of the Restriction Requirement. Therefore, the above feature cannot serve as the special technical feature linking the groups, and no remaining common special technical feature exists.
Regarding Applicant’s argument that the ISA found unity of invention is not persuasive. Unity of invention during U.S. national stage examination is determined by the examiner under 37 CFR 1.475 and 1.499 and the principles set forth in MPEP 1850 and 1893.03(d). The ISA’s treatment of the claims during the international phase is not controlling on the Office’s determination during the national stage examination. The claims lack a common special technical feature as discussed in the Restriction Requirement dated March 10, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Verduin, Jr. (U.S. Pat No. 5,501,667).
Regarding claim 1, Verduin discloses a balloon 12 for a perfusion balloon catheter 10 (Fig. 1), the balloon comprising: a flexible envelope 41 defining at least two lobes 47 that are disposed mutually spaced angularly about a central longitudinal axis (i.e., through 3—3 as shown in Fig. 1) and that project radially (Fig. 5), when the envelope is expanded under internal fluid pressure (Col. 3 lines 3-11), to define a plurality of longitudinal perfusion channels 40 (Col. 4 lines 7-25) outside the envelope between the at least two lobes (Fig. 5); and a spine structure 44 arranged within the envelope (Fig. 5); wherein the spine structure extends outwardly with respect to the central longitudinal axis (Fig. 5) to join the envelope at a plurality of junctions (i.e., at 40, 45) disposed angularly between the at least two lobes in alignment with the plurality of perfusion channels (Fig. 5), and wherein the spine structure defines a longitudinally-extending spine channel 20 that surrounds the central longitudinal axis (i.e., see Fig. 1).
Regarding claim 2, Verduin discloses the balloon of claim 1. Verduin also discloses the spine structure includes a plurality of tensile links (i.e., three links 45; Col. 4 lines 12-15) disposed between the spine channel and the respective junctions (Fig. 5 i.e., at least since they extend through 20); and each tensile link of the plurality of tensile links lies in a radial plane that intersects the central longitudinal axis (Fig. 5).
Regarding claim 3, Verduin discloses the balloon of claim 1. Verduin also discloses wherein the spine channel is defined by a tube 14 that surrounds the central longitudinal axis (Figs. 1, 5).
Regarding claim 4, Verduin discloses the balloon of claim 3. Verduin also discloses the tube has a cross-sectional shape of variable radius from the longitudinal axis (i.e., see Fig. 2); and the cross-sectional shape of the tube has a greater radius in angular alignment with the plurality of junctions and a lesser radius in angular alignment with the at least two lobes (Fig. 2 i.e., at least by way of 40).
Regarding claim 5, Verduin discloses the balloon of Claim 2. Verduin also discloses the plurality of tensile links are a plurality of webs formed integrally with the envelope (Fig. 5; Col. 4 lines 12-15).
Regarding claim 6, Verduin discloses the balloon of Claim 5. Verduin also discloses wherein: the plurality of webs are extruded integrally with the envelope (Col. 4 lines 35-50); and the at least two lobes are blow-moulded portions of the envelope disposed between the plurality of webs (Col. 4 lines 51-57).
Regarding claim 7, Verduin discloses the balloon of Claim 6. Verduin also discloses the spine channel is extruded integrally with the plurality of webs and the envelope (Col. 4 lines 35-50).
Regarding claim 8, Verduin discloses the balloon of Claim 1. Verduin also discloses the plurality of junctions and the at least two lobes are arranged equiangularly spaced in circumferential alternation around the central longitudinal axis (Fig. 5).
Regarding claim 9, Verduin discloses the balloon of Claim 1. Verduin also discloses in a longitudinally-central portion of the expanded envelope, the at least two lobes are curved about respective longitudinal axes that are parallel to each other and to the central longitudinal axis (i.e., Fig. 5 shows two of the lobes being parallel; see also Figs. 4 and 6).
Regarding claim 10, Verduin discloses the balloon of Claim 9. Verduin also discloses the at least two lobes each extend around more than 270 degrees of arc about their respective longitudinal axis ( Fig. 5).
Regarding claim 11, Verduin discloses the balloon of Claim 9. Verduin also discloses the expanded envelope includes a plurality of transition portions 31, 34 that taper in longitudinally-outward directions from respective ends of the longitudinally-central portion of the expanded envelope (Fig. 3).
Regarding claim 12, Verduin discloses the balloon of Claim 11. Verduin also discloses: at least one transition portion of the plurality of transition portions tapers down to a longitudinally-extending tubular neck 14 (Fig. 1); and the neck includes an outer wall that is an integral continuation of the envelope (Figs. 1 and 3).
Regarding claim 13, Verduin discloses the balloon of Claim 12. Verduin also discloses the outer wall of the neck has a substantially circular cross-section (i.e., as shown at A of Fig. 1).
Regarding claim 14, Verduin discloses the balloon of Claim 12. Verduin also discloses the spine channel terminates longitudinally inboard of a longitudinally outboard end of the neck (i.e., at A of Fig. 1).
Regarding claim 15, Verduin discloses the balloon of Claim 14. Verduin also discloses the spine channel terminates within the neck (i.e., see Fig. 1 at A)), longitudinally outboard of the at least one transition portion adjoining the neck (Fig. 1 at A).
Regarding claim 16, Verduin discloses the balloon of Claim 12. Verduin also discloses the neck is an inflation tube that is in fluid communication with all of the at least two lobes (Col. 5 lines 6-23).
Regarding claim 17, Verduin discloses the balloon of Claim 12. Verduin also discloses fluid communication with the envelope is provided via a gap defined between the spine channel and the outer wall of the neck (Col. 5 lines 6-23).
Regarding claim 18, Verduin discloses the balloon of Claim 17. Verduin also discloses the gap is a radial gap defined between the spine channel and the outer wall of the neck (Fig. 1).
Regarding claim 19, Verduin discloses the balloon of Claim 18. Verduin also discloses: the spine structure includes a plurality of tensile links 44 disposed between the spine channel and the respective junctions (i.e., at least since 44 Fig. 5 would cross 20); each tensile link of the plurality of tensile links lies in a radial plane that intersects the central longitudinal axis (Fig. 5); the plurality of tensile links are a plurality of webs formed integrally with the envelope (Fig. 5; Col. 3 lines 49-58)); and the plurality of webs extend across the radial gap from the spine channel to the outer wall of the neck (Fig. 5 i.e., at least since 20 terminates at proximal ends of A).
Regarding claim 20, Verduin discloses the balloon of any of Claim 12. Verduin also discloses the neck is arranged in coaxial alignment with the spine channel (Fig. 1, 3).
Regarding claim 21, Verduin discloses a perfusion balloon catheter (Fig. 1), comprising at least one balloon according to Claim 1.
Regarding claim 22, Verduin discloses the catheter of Claim 21. Verduin also discloses a shaft 14 including an inner tube 28 and an outer tube (i.e., 14), wherein: the balloon is mounted on the shaft (Fig. 1); the inner tube of the shaft is disposed within the outer tube of the shaft (Figs. 1, 2, 5); the outer tube of the shaft is sealed to a proximal end of the balloon (Fig. 1; Col. 3 lines 39-47); and the inner tube of the shaft extends through the balloon along the spine channel and is sealed to a distal end of the balloon (Col. 3 lines 39-47).
Regarding claim 23, Verduin discloses the catheter of claim 22. Verduin also discloses in a longitudinally-central portion of the expanded envelope, the at least two lobes are curved about respective longitudinal axes that are parallel to each other (i.e., Fig. 5, each longitudinal axis going through a lobe are parallel to each other) and to the central longitudinal axis (Fig. 5); the expanded envelope includes a plurality of transition portions (i.e., at least at 31 and 34 for example of Fig. 3) that taper in longitudinally-outward directions from respective ends of the longitudinally-central portion of the expanded envelope (Fig. 3); at least one transition portion of the plurality of transition portions tapers down to a longitudinally-extending tubular neck (i.e., at 14 of Fig. 1); the neck includes an outer wall that is an integral continuation of the envelope (Col. 4 lines 4-25); and the outer tube of the shaft is attached to the neck at the proximal end of the balloon (Fig. 1).
Regarding claim 24, Verduin discloses the catheter of Claim 23. Verduin also discloses the inner tube of the shaft is attached to another neck disposed at the distal end of the balloon (i.e., Fig. 1).
Regarding claim 25, Verduin discloses the catheter of Claim 22. Verduin also discloses an annulus 47 defined between the inner tube and outer tube of the shaft is in fluid communication with the envelope (Col. 5 lines 49-55).
Regarding claim 26, Verduin discloses the catheter of Claim 22. Verduin also discloses the inner tube of the shaft opens distally and defines a longitudinal conduit 29 extending continuously through the balloon (Fig. 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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