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 .
Detailed Action
Response to Restriction
Applicant’s election without traverse of Group I (Claims 24-36) and species of liquid (claim 26) and cooled (claims 29 and 34) in the reply filed on 26 September 2025 is acknowledged.
Status of Application
Applicant’s arguments/remarks filed 26 September 2025 are acknowledged. Claims 1-23, 27, and 37-43 are cancelled. Claims 24-26, 28-36, and 44-51 are currently pending. Claims 31 and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 September 2025. Claims 24-26, 28-30, 32-35, and 44-51 are examined on the merits within.
Withdrawn Rejections
3. Applicant’s arguments, filed 26 September 2025, with respect to the 35 U.S.C. 102(a)(1) Rejections have been fully considered and are persuasive. The 35 U.S.C. 102 (a)(1) Rejection of claim 24 has been withdrawn. However, upon further consideration, a new rejection is made in view of Sahatjian (U.S. Patent No. 6,409,716).
New Rejections
Claim Rejections – 35 U.S.C. 112(a) New Matter
4. 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.
5. Claims 32-35 and 48-51 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.
6. Claim 32 recites “at least one of a heater or cooler” and “a controller configured to control the at least one of a heater or a cooler to selectively adjust the temperature of the flowable material.” Although the specification recites that the material may be heated or cooled, there is no mention or description of a heater or cooler or a controller of the heater or cooler. Thus there is no explicit support for these amendments.
Claim Rejections – 35 U.S.C. 102/103
7. 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.
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.
8. Claim(s) 24-26, 28-30, 32-35, and 44-51 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as being unpatentable over Sahatjian (U.S. Patent No. 6,409,716).
Sahatjian et al. teach a catheter and methods for delivering drug to tissue at a desired location of the wall of a body lumen. The catheter is constructed for insertion in a body lumen and has a catheter shaft and an expandable portion mounted on the shaft. The expandable portion is expandable to a controlled pressure to fill the cross-section of the body lumen and press against the wall of the body lumen (i.e., retract tissue). At least a portion of the exterior surface of the expandable portion is defined by a coating of tenaciously adhered swellable hydrogel polymer. Incorporated in the hydrogel polymer is a solution of preselected drug to be delivered to the tissue. See abstract. The drug is an anti-proliferative drug. See column 2, lines 1-46. The hydrogel polymer and drug are selected to allow rapid release of a desired dosage of about 20% or more of the drug solution from the hydrogel polymer coating during compression of the hydrogel polymer coating against the body tissue or the wall when the expandable portion is expanded in the pressure range. The controlled pressure is between 10 and 50 microns. See column 2, lines 47-67. The expandable portion is defined by a coating of soluble polymer and a preselected drug to be delivered to the tissue. The polymer is selected from polylactic and polyglycolic acids. See column 3, lines 15-38. The balloon is inflated with a heated liquid, i.e., saline. See column 9, lines 50-67. The thermal balloon typically operates between 40 - 80°C. See column 9, lines 50-67. The polymer may separate from the ballon with or without application of heat. See column 10, lines 18-30. Since heat is not required, administration can be conducted at room temperature (controlled), which is less than the internal temperature of the body and would meet the limitations of “cool”. The catheter is adapted for insertion in a blood vessel, and the expandable portion is an inflatable dilatation balloon adapted for inflation at pressures in the range for effecting widening of a stenosed blood vessel. See column 2, lines 1-46.
Thus the instant claims are anticipated by Sahatjian et al. In the alternative, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to heat or cool the liquid that fills the balloon dependent on the desired effect of drug released based on the known effective methods of Sahatjian et al. It would have been obvious to control the temperature to achieve the optimal desired effect. In addition, it would have been well within the purview of the skilled artisan at the time the invention was made to configure the implant to reduce adhesions to prevent additional damage to the tissue.
Conclusion
9. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
10. No claims are allowed at this time.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615