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 Arguments
Applicant's arguments filed 7/16/2026 have been fully considered.
Regarding the amendment to claim 1, the examiner agrees that Applicant has amended claim 1 to include subject matter previously indicated allowable. this overcomes the prior rejection and therefore the rejection is withdrawn.
Regarding the rejections under 112(b), Applicant’s arguments have been considered and are not persuasive. Applicant has not argued against the rejection, nor amended the claims and therefore the rejections have not been overcome. As stated in the prior office action, the claims are being interpreted as product by process limitations, however, they are not clearly written as such, and are therefore unclear as written.
Regarding the 103 rejections, the examiner agrees that the amendments to the claims to include allowable subject matter overcomes the rejection and the rejection is therefore withdrawn.
Regarding the new claims, Applicant’s argument are not convincing. The claim limitation “wherein a density of a radially in portion of the integral tube differs from a density of a radially outer portion of the integral tube” was previously recited in original claim 3 and was rejected. Applicant has not provided a response to that rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8, 11, 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 calls for one of the braid or the coil to be at a temperature of at least 250 degrees Celsius. The scope of this claim limitation is unclear. Claim 1, from which claim 8 depends, recites a medical device. Heating the braid or coil to 250 degrees Celsius is describes as a manufacturing step of the device, not as a part of the device. in other words, it is not clear that the device of claim 1 includes the braid at 250 degrees Celsius. Therefore, this limitation is being interpreted as a product by process limitation wherein the coil or braid is heated to at least 250 degrees Celsius.
Claim 11 calls for the at least one mandrel to be at a temperature greater than or equal to 250 degrees Celsius. As discussed above with regard to claim 8, heating the mandrel to 250 degrees Celsius is describes as a manufacturing step of the device, not as a part of the device. in other words, it is not clear that the device of claim 1 includes the mandrel at 250 degrees Celsius. Therefore, this limitation is being interpreted as a product by process limitation wherein the mandrel is heated to at least 250 degrees Celsius.
Claim 13 calls for a first mandrel of the plurality of mandrels to be at a first temperature, and a second mandrel of the plurality of mandrels to be at a second temperature different from the first temperature. As discussed above with regard to claims 8 and 11, heating the mandrels is describes as a manufacturing step of the device, not as a part of the device. in other words, it is not clear that the device of claim 1 includes the first mandrel of the plurality of mandrels to be at a first temperature, and the second mandrel of the plurality of mandrels to be at a second temperature different from the first temperature. Therefore, this limitation is being interpreted as a product by process limitation wherein the first mandrel of the plurality of mandrels to be at a first temperature, and the second mandrel of the plurality of mandrels to be at a second temperature different from the first temperature.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 21, 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauer et al (US 2016/0271363) in view of Shannon et al (US 9,364,360).
Regarding claim 21, Bauer discloses a medical device comprising a shaft 115 (fig. 3), wherein the shaft includes an integral tube defining a plurality of lumens 170 (fig. 3; page 3, para. 0031), the integral tube comprised of at least one of PTFE and ePTFE (page 6, para. 0060).
Claim 21 differs from Bauer in calling for a density of a radially inner portion of the tube to differ from a density of a radially outer portion of the tube. Shannon teaches a shaft formed from PTFE wherein the density of the inner section of the tube is greater than the density the outer section of the tube, specifically, the inner layer of the tube has a higher density that the outer layer of the tube (col. 7, lines 4-10) thereby providing an inner surface with reduced friction for easier insertion of elements therethrough and for easier removal of the forming mandrel (col. 7, lines 4-10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft of Bauer such that the density of the PTFE varies along the length of the tube as taught by Shannon so that the inner portion of the tube has a low friction surface to ease insertion of elements through the lumen and to improve ease of removal of the forming mandrel.
Regarding claim 23, Bauer discloses that the lumens are nonconcentric within the cross-section of the integral tube (fig. 3), and therefore the structure resulting from the combination described above with regard to claim 21 includes the density nonconcentric with a cross-section of the integral tube.
Regarding claim 24, Bauer discloses a medical device comprising a shaft 115 (fig. 3), wherein the shaft includes an integral tube defining a plurality of lumens 170 (fig. 3; page 3, para. 0031), the integral tube comprised of at least one of PTFE and ePTFE (page 6, para. 0060).
Claim 24 differs from Bauer in calling for a density of a first wall defining a first lumen differs from a density of a second wall defining a second lumen. Shannon teaches a shaft formed from PTFE wherein the density of the inner wall of the lumen is greater than the density the outer section of the tube (col. 7, lines 4-10) thereby providing an inner surface with reduced friction for easier insertion of elements therethrough and for easier removal of the forming mandrel (col. 7, lines 4-10). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft of Bauer to modify the density of inner wall of the lumen of the tube as taught by Shannon so that the inner portion of the tube has a low friction surface to ease insertion of elements through the lumen and to improve ease of removal of the forming mandrel. The result is that the density of the wall of the first lumen is different than the density of the wall of the second lumen.
Regarding claim 25, Bauer discloses that the first wall and the second wall are in the same cross-sectional plane of the tube (fig. 3).
Regarding claim 26, Bauer discloses that the lumens are nonconcentric within the cross-section of the integral tube (fig. 3), and therefore the structure resulting from the combination described above with regard to claim 21 includes the density nonconcentric with a cross-section of the integral tube.
Allowable Subject Matter
Claims 1-3, 5-7, 9, 10, 12, 14, 15 are allowed.
Claim 22 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: see prior office actions.
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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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