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 .
This office action is in response to applicant’s communication of 12/30/2025. Currently claims 1-7, 9-17, and 19-20 are pending and rejected below.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9-17, and 19-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gunderson et al. (US 2014/0074022 A1).
Gunderson discloses a removable loading tool and protector for a medical device (as in figures 8-14), comprising: a body (210) having a generally tubular configuration and comprising a proximal end (214), a distal end (212), an intermediate region (242) disposed between the proximal end and the distal end, and a lumen disposed therethrough; and a proximal region having a length and extending from the proximal end of the body, the proximal region comprising at least one slit (244) positioned adjacent to the proximal end of the body; wherein the proximal region has a first inner diameter and the intermediate region has a second inner diameter, the first inner diameter of the proximal region being greater than the second inner diameter of the intermediate region (see figures 10).
Concerning the claim language of and “the distal end has a beveled configuration having an angle with respect to a longitudinal axis (see 240 portion). Examiner is of the position that this is a sloping edge or angled edge (with respect to the longitudinal axis. Although the prior art states this to be a “flared” portion this does not prevent the sloping angled edge to be considered a “beveled configuration”. Applicant has not provided a “special definition” of the term “beveled”. Examiner is of the position that the distal end portion near 240 of Gunderson would teach and anticipated a “beveled configuration”.
Concerning claim 2 and the first inner diameter of the proximal region is uniform throughout its length (See figure 10 interior diameter).
Concerning claim 3 and the first inner diameter of the proximal region varies throughout its length (see figure 14).
Concerning claim 4 and the proximal region comprises a first section having an inner diameter and a tapered second section, the tapered second section positioned distal to the uniform first section (see figure 11).
Concerning claim 5 and the inner diameter of the first section of the proximal region is equal to the first inner diameter of the proximal region and is uniform throughout its length (see figure 10 for example).
Concerning claim 6 and the tapered second section forms an angle of 45 degrees or less with respect to a longitudinal axis of the body (see figures 10 angle and also para [0047]).
Concerning claim 7 and the tapered second section forms an angle of 30 degrees with respect to a longitudinal axis of the body (see figures 10 angle and also para [0047]).
Concerning claim 9 and the angle of the beveled configuration of the distal end ranges from 10 to 90 degrees (see figures 10 angle and also para [0047]).
Concerning claim 10 and a rib is disposed about an outer surface of the body proximate to the distal end (see 218).
Concerning claim 11 and the slit has a length and the length of the slit is less than the length of the proximal region (see figures 8).
Concerning claim 12 and a medical device assembly comprising: a catheter having a proximal end, a distal end, and a lumen therethrough; a drug coated expandable medical device disposed about a distal portion of the catheter (see para [0007]), the expandable medical device having a distal end and a proximal end; and a loading tool and protector removably disposed about the catheter and the medical device, the loading tool and protector comprising, a body having a generally tubular configuration and comprising a proximal end, a distal end, an intermediate region disposed between the proximal end and the distal end, and a lumen disposed therethrough; and a proximal region having a length and extending from the proximal end of the body, the proximal region comprising at least one slit positioned adjacent to the proximal end of the body; wherein the proximal region has a first inner diameter and the intermediate region has a second inner diameter, the first inner diameter of the proximal region being greater than the second inner diameter of the intermediate region (see previously identified structures and also figures 8-14).
Concerning the claim language of and “the distal end has a beveled configuration having an angle with respect to a longitudinal axis (see 240 portion). Examiner is of the position that this is a sloping edge or angled edge (with respect to the longitudinal axis. Although the prior art states this to be a “flared” portion this does not prevent the sloping angled edge to be considered a “beveled configuration”. Applicant has not provided a “special definition” of the term “beveled”. Examiner is of the position that the distal end portion near 240 of Gunderson would teach and anticipated a “beveled configuration”.
Concerning claim 13 and the expandable medical device is a balloon (see 230).
Concerning claim 14 and the first inner diameter of the proximal region of the loading tool and protector is uniform throughout its length (See figure 10 interior diameter).
Concerning claim 15 and the first inner diameter of the proximal region of the loading tool and protector varies throughout its length (see figure 14).
Concerning claim 16 and the proximal region of the loading tool and protector comprises a first section having an inner diameter and a tapered second section, the tapered second section positioned distal to the uniform first section (see figures 10 device).
Concerning claim 17 and the tapered region of the proximal region of the loading tool and protector forms an angle of 45 degrees or less with respect to a longitudinal axis of the body (see figures 10 angle and also para [0047]).
Concerning claim 19 and a rib is disposed about an outer surface of the body of the loading tool and protector proximate to the distal end (see 218).
Concerning claim 20 and a medical device assembly comprising: a catheter having a proximal end, a distal end, and a lumen therethrough; a drug coated expandable balloon disposed about a distal portion of the catheter (para 0007]), the expandable balloon having a distal end and a proximal end; and a loading tool and protector removably disposed about the catheter and the expandable balloon, the loading tool and protector comprising, a body having a generally tubular configuration and comprising a proximal end, a beveled distal end, an intermediate region disposed between the proximal end and the distal end, and a lumen disposed therethrough; and a proximal region having a length and extending from the proximal end of the body, the proximal region comprising a first section, a tapered second section, and at least one slit positioned adjacent to the proximal end of the body and within the first section, the slit having a length; and wherein the first section of the proximal region has a first inner diameter and the intermediate region has a second inner diameter, the first inner diameter of the first section of the proximal region being greater than the second inner diameter of the intermediate region, and wherein the length of the slit is less than the length of the proximal region (see discussion regarding the structures discussed above and further figures 8-14 for examples). Concerning the claim language of and “the distal end has a beveled configuration having an angle with respect to a longitudinal axis (see 240 portion). Examiner is of the position that this is a sloping edge or angled edge (with respect to the longitudinal axis. Although the prior art states this to be a “flared” portion this does not prevent the sloping angled edge to be considered a “beveled configuration”. Applicant has not provided a “special definition” of the term “beveled”. Examiner is of the position that the distal end portion near 240 of Gunderson would teach and anticipated a “beveled configuration”.
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Response to Arguments
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive. Examiner is of the position that the amended claim language is taught in the prior art Gunderson.
Again, as stated in the rejection above the claim language of and “the distal end has a beveled configuration having an angle with respect to a longitudinal axis (see 240 portion). Examiner is of the position that this is a sloping edge or angled edge (with respect to the longitudinal axis. Although the prior art states this to be a “flared” portion this does not prevent the sloping angled edge to be considered a “beveled configuration”. Applicant has not provided a “special definition” of the term “beveled”. Examiner is of the position that the distal end portion near 240 of Gunderson would teach and anticipated a “beveled configuration”. During examination, claim limitations are to be given their broadest reasonable reading. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989); In re Prater, 415 F.2d 1393, 1404-1405, 162 USPQ 541, 550-51 (CCPA 1969). Under this examination and reading of the claim term “bevel” examiner is of the position that the sloping angled surface of Gunderson near the distal end by 240 is a bevel configuration even if “flared” as discussed in applicant’s remarks.
The elements disclosed in Gunderson are fully capable of satisfying all structural, functional, spatial, and operational limitations in the amended claims, as currently written, and the rejection is made.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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