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
The claims filed on January 28th, 2026, have been entered. Claims 1-3, 6, 8-13, 17-18, and 20-21 remain pending in the Application.
Response to Arguments
Applicant's arguments filed January 28th, 2026, have been fully considered but they are not persuasive.
The claim amendment requiring that “the agitator has a fixed shape” overcomes the previously presented 35 USC 103 rejections over Mische in view of Sos. However, this limitation comprises new matter and has been rejected under 112(a).
Applicant also argues that the combination of Mische et al. (U.S. Patent No. 5,279,546) and Sos (Pub. No. 2016/0367285) is improper because Mische et al. creates an isolated treatment area using two balloons while maintaining safe pressure levels within the area, and teaches away from using any kind of expansion system, such as the macerator 200 of Sos, within the treatment area with the discussion of the middle balloon in the system of Baran (C1:63-C2:L2). Examiner respectfully disagrees with this particular argument. Mische et al. does teach away from the additional balloon in Baran, as a balloon inflating in an otherwise closed treatment area will necessarily increase the pressure in the treatment area and could rupture arterial walls. However, the macerator wires of Sos, as shown in FIG. 11, do not cover a substantial volume, and while they expand and contract, the expansion and contraction does not change the amount of volume that the wires occupy, in contrast to a balloon. Therefore, using the macerator 200 of Sos within the treatment area established by Mische et al. would not lead to the problems discussed in Mische et al. with a middle third balloon.
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.
Claims 1-3, 6, 8-13, 17-18, and 20-21 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. Claim 1 has been amended to include the limitation “wherein the agitator has a fixed shape”. The term “fixed” or a synonym does not appear in the present Specification at all, and Applicant did not point to any disclosures which supported the amendment in their Remarks, which forced the Examiner to look for evidence that the amendment was supported by the Specification. However, the Specification teaches away from the agitator comprising a fixed shape. For example, [00102] states that “the agitator may be connected to the inner catheter which runs along the catheter lumen of the outer sheath by three wires, connected on the left, right, and bottom planes of the agitator. This allows for flexibility in the overall catheter system, as the agitator is able to ride along bends made in the catheter.” For the agitator to travel along the bends, the agitator must be able to bend and flex, which would constitute changes in the shape of the agitator.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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