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
Applicant’s election without traverse of Group I in the reply filed on 3/13/2026 is acknowledged.
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
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 6, 7, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauer et al (US 2016/0271363) in view of O’Keefe et al (WO 2023/192800A1).
Regarding claim 1, 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 1 differs from Bauer in calling for a density of the at least one of PTFE and ePTFE varies along a length of the integral tube. O’Keefe teaches a shaft formed from PTFE and ePTFE (page 5, para 19) wherein the density of the distal section of the tube is less than the density of the first section of the tube (page 4, para. 15) thereby forming a more flexible distal section that prevents damage to the body lumen as the shaft is inserted. 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 and ePTFE varies along the length of the tube as taught by O’Keefe so that the distal section of the catheter is more flexible than the proximal section to allow for safe insertion of the shaft into a body lumen.
Regarding claim 6, O’Keefe further teaches that the integral tube comprises an articulation joint (fig. 3: distal end articulates and forms an articulation joint). As discussed above with regard to claim 1, O’Keefe further teaches that the articulation joint (distal end) is less dense than the proximal portion (page 13-14, para. 66). 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 sheath of O’Keefe to include an articulation joint, where the articulation joint is less dense than the tubing portion proximal to the articulation joint as taught by O’Keefe to provide a sheath that is readily steerable through the body lumen to the desired location.
Claim 7 differs from Bauer in calling for a braid or a coil surrounding an outermost surface of the integral tube. O’Keefe discloses a braid or a coil around the outermost surface of the tube to enhance pushability to the tube and thereby increase ease of insertion into the body (page 9, lines 33-35; fig. 7). 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 tube of Bauer to have a braid or could around the outermost surface of the tube as taught by O’Keefe to provide added pushability to the tube to allow the sheath to be easily inserted into the body.
Regarding claim 14, O’Keefe teaches a density of a proximal portion of the integral tube differs from a density of a distal portion of the integral tube as discussed above with regard to claim 1 (page 4, para. 15). 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 a distal portion of the tube differs from a density of the proximal end of the tube as taught by O’Keefe to allow for safe insertion of the shaft into a body lumen.
Claim(s) 1-3, 10-13 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 1, 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 1 differs from Bauer in calling for a density of the at least one of PTFE and ePTFE varies along a length of the integral 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 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 2, Bauer in view of Shannon teaches that the density varies within a cross-section of the integral tube as discussed above with regard to claim 1 where Shannon teaches the inner layer of the tube has a higher density that the outer layer of the tube (col. 7, lines 4-10).
Regarding claim 3, Bauer in view of Shannon teaches that a density of a radially inner portion of the integral tube differs from a density of a radially outer portion of the integral tube as discussed above with regard to claims 1 and 2 where Shannon teaches the inner layer of the tube has a higher density that the outer layer of the tube (col. 7, lines 4-10).
Regarding claim 10, Shannon further teaches a mandrel extending through at least one of the plurality of lumens (col. 6, lines 32-35) to allow for forming and treating of the lumen to achieve the desired material characteristics. 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 sheath of Bauer to include a mandrel within a lumen as taught by Shannon to allow for forming and treatment of the tubing to have the desired material characteristics.
Claim 11 call for the at least one mandrel to be at a temperature greater than or equal to 250 degrees Celsius. As discussed above, this claim limitation has been rejected under 112(b) as the scope of the claim is not clear. For the purposes of this examination, this is interpreted to be a manufacturing step and therefore is interpreted as a product-by-process limitation. Shannon teaches that the mandrel is heated to achieve the desired material characteristics of the lumen and therefore the structure resulting from the claimed manufacturing step is the same as that taught by Bauer in view of Shannon.
Claim 12 calls for the tube to comprise a plurality of mandrels extending through the more than one lumens of the plurality of lumens. Shannon teaches a mandrel extending through the lumen as discussed above with regard to claim 10 (col. 6, lines 32-39) in order to shape and treat the lumen to have the desired characteristics. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a mandrel in the lumen as taught by Shannon and further since Bauer teaches multiple lumens, it would have been obvious to provide a mandrel for each lumen as each lumen requires shaping and treatment.
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, this claim limitation has been rejected under 112(b) as the scope of the claim is not clear. For the purposes of this examination, this is interpreted to be a manufacturing step and therefore is interpreted as a product-by-process limitation. Shannon teaches that the mandrel is heated to achieve the desired material characteristics of the lumen and therefore the structure resulting from the claimed manufacturing step is the same as that taught by Bauer in view of Shannon.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauer in view of O’Keefe as applied to claim 7 above, and further in view of Bagaosian et al (US 6,270,477).
Claim 8 differs from the teachings above in calling for the one of the braid or the coil to at a temperature of at least 250 degrees Celsius. As discussed above with regard to the 112(b) rejection, this limitation is unclear. For the purposes of this examination, this is interpreted to be a product-by-process limitation wherein during manufacturing of the shaft, the braid or coil reaches a temperature of at least 250 degrees Celsius. Bagaosian teaches a shaft formed from a polymer tubing and a braid or coil wherein the braid or coil is heated to at least 250 degrees Celsius to for a bonded unitary tube (col. 2, line 66 – col. 3, line 11). Therefore, 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 device of Bauer in view of O’Keefe such that the braid or coil is heated to at least 250 degrees Celsius as taught by Bagaosian to form a bond between the tubular members and the coil or braid to prevent delamination during use.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauer in view of O’Keefe as applied to claim 7 above, and further in view of Gerbo et al (US 11,064,871).
Claim 9 differs from Bauer in view of O’Keefe in calling for at least one of a pitch, a material, and a thickness of a wire of the one of the braid and the coil varies along a length of the one of the braid and the coil. Gerbo teaches a shaft having a braid where the pitch of the braid varies so that the braid is more rigid at the proximal end (col 23, lines 10-14). 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 braid of Bauer in view of O’Keefe as discussed above with regard to claim 7 to include a pitch that variers along a length of the braid as taught by Gerbo to provide a stiffer proximal end for increase pushability of the shaft within the body.
Claim(s) 1, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tagaki et al (US 4,279,245) in view of Shannon.
Regarding claim 1, Tagaki teaches a medical device comprising a shaft 3, wherein the shaft includes an integral tube defining a plurality of lumens 9, 11, 12, 13 (fig. 2), the tube comprising PTFE (col. 2, lines 52-59).
Claim 1 differs from Tagaki in calling for the density of the PTFE to vary along a length of the integral 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 thereby providing an inner surface with reduced friction for easier insertion of elements therethrough (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 Tagaki 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.
Regarding claim 15, Tagaki discloses that the medical device is an endoscope (col. 1, lines 16), the shaft is connected to a handle at a proximal end of the shaft (fig. 1), and the plurality of lumens include a working channel and lumens capable of receiving articulation wires (col. 1, lines 21-27).
Allowable Subject Matter
Claims 4, 5 are 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: the subject matter of the claims indicated above could not be found and was not suggested by the prior art of record.
Regarding claim 4, the prior art fails to teach or fairly suggest the integral tube including an articulation join, wherein at least two regions separated about a circumference of the articulation joint have densities less than other regions about the circumference.
Conclusion
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.
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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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