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 .
Claims 1-20 are pending.
Information Disclosure Statement
The IDS forms submitted on 1/15/2025 (3 documents: 17, 6, and 7 pages) and 2/21/2025 (1 document: 10 pages) have been reviewed and considered.
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)(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.
Claim(s) 1-4, 6, and 9-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SPIROFF (US 3828767 A).
Re 1, SPIROFF teaches of a method of forming at least one eyelet (see proximal holes 62) in a catheter (A) shaft with a proximal end portion and a distal end portion (see Figs. 5, 6, 7, and 8), comprising:
cooling at least a portion of the catheter shaft (see Col. 2, lines 15-25); and
punching at least one eyelet in the at least a portion of the catheter shaft (see Col. 2, lines 31-52).
See also the stencil (jig 64) for placing over a catheter shaft with at least one opening (or guide bore 74), wherein the at least one opening corresponds to at least one eyelet of the catheter shaft (Co. 2, lines 31-52);
See also a machining device (punch 66, block 68) for punching eyelet holes into the catheter shaft with a channel (bore 70) for receiving at least a portion of the catheter (Col. 2, lines 31-52; Fig. 6).
Re 2 (upon 1), further see SPIROFF teaches of comprising inserting a mandrel (32) into a lumen of the catheter shaft (A) (see Col. 2, lines 15-25).
Re 3 (upon 1), further SPIROFF comprising placing a stencil (see jig 64) over at least a portion of the catheter shaft, the stencil having openings (see guide bore 74) corresponding to a location of the at least one eyelet in the catheter shaft (see Col. 2, lines 31-52).
Re 4 (upon 3), wherein SPIROFF teaches of placing of the stencil is done before punching at least one eyelet in the catheter shaft (see Col. 2, lines 31-63).
Re 6 (upon 2), wherein the inserting of the mandrel (32) is done before punching (see punch 66) at least one eyelet (proximal holes 62) in the catheter shaft (see Col. 2, lines 15-25 and then Col. 2, lines 32-52).
See Figs. 1-8 of SPIROFF for claims 9-11.
Re 9 (upon 1), wherein the portion of the at least a portion of the catheter shaft comprises a proximal portion of the catheter shaft (see Figs. 1-8).
Re 10 (upon 2), wherein the mandrel is inserted from a distal end of the catheter shaft (see Figs. 1, 2, and 4).
Re 11 (upon 3), wherein the stencil is placed over the proximal end portion of the catheter shaft (see Fig. 6).
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) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over SPIROFF as applied to claim 1 above, and further in view of CARLSSON (WO 2017/108879, see IDS)
Re 12 (upon 1), wherein the punching includes punching at least two eyelets.
See Fig. 6 of SPIROFF.
Further in analogous reference, see CARLSSON, wherein pairs of punching members 6a-c are provided and are taught be movable in operation including simultaneously or sequentially, see page 13, lines 10-13, that allows for forming plural eyelets within a catheter.
Such operations are known and it would have been obvious for one of ordinary skill in the art to have modified SPIROFF of the plural punching as taught by CARLSSON in allowing for plural eyelets to be formed in the catheter, see KSR rationale, MPEP 2143, wherein this is seen as combining prior art elements according to known methods to yield predictable results.
Re 13 (upon 12), wherein the punching of at least two eyelets is done simultaneously (See Col. 3, lines 11-64 of SPIROFF) (see operation by CARLSSON above concerning the simultaneous operation).
Re 14 (upon 12), wherein the punch of at least two eyelets is done consecutively (See Col. 3, lines 11-64 of SPIROFF) (see operation by CARLSSON above concerning the consecutive operation).
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over SPIROFF as applied to claims 3 and 6 above, and further in view of MCFARLANE (US 4404159 A).
Re 5 (upon 3), wherein the placing of the stencil is before cooling at least a portion of the catheter shaft and the stencil is at a selected cooling temperature, the cooling at least a portion of the catheter shaft comprising cooling the catheter shaft by contact with the stencil.
Wherein, see in MCFARLANE, Col. 2, lines 13-26: “It is another object of this invention to provide a die which is preferably in two pieces which are maintained in spaced axial relation from one another when not in use forming a tip and which are in abutting engagement with one another while the tip forming process is taking place and wherein a cooling means, such as a water cooling jacket is provided for the portion of the die about the cylindrical zone adjacent the feathered end of the tube and the heated portion does not transfer all of the heat required to form the tip but, rather, a temperature gradient is maintained between the two pieces so that the cooled portion is at all times at a lower temperature than the heated portion.”
It would have been obvious for one of ordinary skill in the art to have modified the SPIROFF system with the device for cooling at least a portion of the shaft as taught by MCFARLANE as it allows for cooling and allows for a temperature gradient along the formed portion.
Re 7 (upon 6), wherein cooling at least a portion of the catheter shaft and the mandrel is at a selected cooling temperature, the cooling at least a portion of the catheter shaft comprises cooling the catheter shaft by contact with the mandrel. See teaching above of SPIROFF in view of MCFARLANE, wherein the teaching encompasses the claimed cooling, including at selected cooling temperature.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over SPIROFF as applied to claim 1 above, and further in view of BRIN (US 5545149 A) or AUGUSTINE (US 2007/0256791 A1).
Re 8 (upon 1), wherein the cooling at least a portion of the catheter shaft includes applying air or gas to at least a portion of the catheter shaft.
SPIROFF does teach of general cooling, see Col. 2, lines 19-25.
Wherein, BRIN teaches of the use of air cooling that is used for the cooling of the catheter, see Col. 5, lines 60-65, as known in the catheter manufacturing. See also AUGUSTINE that teaches of an air flow rate being used for cooling, further teaching of nitrogen gas as an alternative cooling medium, see [0085-0086].
It would have been obvious for one of ordinary skill in the art to modify SPIROFF to include utilizing air cooling as taught by BRIN, or AUGUSTINE, particularly to aid in conforming the material to the contours of the mandrel, see in BRIN Col. 2, lines 5-18.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over SPIROFF as applied to claim 1 above, and further in view of YANG (US 8992949 B1).
Re 15 (upon 1), wherein cooling of the at least a portion of the catheter shaft comprises cooling the at least a portion of the catheter shaft to a temperature of between about -40 C to about 5 C.
SPIROFF does teach of general cooling, see Col. 2, lines 19-25
See in YANG, Col. 24, lines 4 to Col. 42, the molding a different temperature molds corresponds to the teaching of different cooling temperatures and wherein the various cooling temperatures can affect the cracks that may occur in the polymer. The differences in the temperature will affect the properties of the formed product with different cracks and rigidity as desired by the user.
Although the reference does not explicitly state the claimed range, there is an overlapping ranges taught in the reference and the claimed range. Here, regarding the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 (I).
Whereupon, it would have been obvious for one of ordinary skill in the art to modify the cooling of SPIROFF with the temperature taught by YANG as known conditions upon the polymer materials, see Col. 24, lines 1-3 and 32-42.
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over SPIROFF as applied to claim 1 above, and further in view of YANG (US 8992949 B1) and NYMAN (US 2014/0180261 A1)
Re 16 (upon 1), wherein the catheter shaft comprises PVC and wherein cooling of the at least a portion of the catheter shaft comprises cooling the at least a portion of the catheter shaft to a temperature of between -30 C to about 5 C.
SPIROFF does teach of general cooling, see Col. 2, lines 19-25.
Regarding PVC, see in NYMAN teaching of forming the catheter shaft from a variety of polymer including PVC, see [0028].
It would have been obvious for one of ordinary skill in the art to modify SPIROFF of the particular material used as taught by NYMAN as a known alternate material, see in KSR rationale, MPEP2143, wherein this is seen as combining prior art elements according to known methods to yield predictable results.
Regarding the temperatures, see in YANG, Col. 24, lines 4 to Col. 42, the molding a different temperature molds corresponds to the teaching of different cooling temperatures and wherein the various cooling temperatures can affect the cracks that may occur in the polymer. The differences in the temperature will affect the properties of the formed product with different cracks and rigidity as desired by the user.
Although the reference does not explicitly state the claimed range, there is an overlapping ranges taught in the reference and the claimed range. Here, regarding the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 (I).
Whereupon, it would have been obvious for one of ordinary skill in the art to modify the cooling of SPIROFF with the temperatures as taught by YANG as known conditions upon the polymer materials, see Col. 24, lines 1-3 and 32-42.
Re 17 (upon 1), wherein the catheter shaft comprises TPE and wherein cooling of the at least a portion of the catheter shaft comprises cooling the at least a portion of the catheter shaft to a temperature of between -19 C to about 4 C.
(see teaching above in claim 16 which is applicable also for claim 17)
Further, regarding TPE, see in NYMAN teaching of forming the catheter shaft from a variety of polymer such as polyurethanes, latex rubbers, silicon rubbers, other rubbers, and also thermoplastic elastomers, see [0028], these would encompass the claimed TPE (or otherwise known as thermoplastic elastomers).
Re 18 (upon 1), wherein the catheter shaft comprises TPO and wherein cooling of the at least a portion of the catheter shaft comprises cooling the at least a portion of the catheter shaft to a temperature of between -40 C to about 4 C.
(see teaching above in claim 16 which is applicable also for claim 17)
Further, regarding TPO, see in NYMAN teaching of forming the catheter shaft from a variety of polymer such as polyolefines, see [0028], these would encompass the claimed TPO (or otherwise known as thermoplastic olefins).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over SPIROFF (US 3828767 A) in view of MCFARLANE (US 4404159 A).
Re 19, SPIROFF teaches of a system for forming at least one eyelet (proximal holes 62) in a catheter (A) including a catheter shaft with a proximal end and a distal end (see Figs. 5-8), comprising:
a stencil (jig 64) for placing over a catheter shaft with at least one opening (guide bore 74, see Fig. 6), wherein the at least one opening corresponds to at least one eyelet (proximal holes 62) of the catheter shaft;
a mandrel (32) for inserting into a catheter shaft (34); and
a machining device (jig 64, punch 66, block 68) for punching eyelet holes into the catheter shaft with a channel for receiving at least a portion of the catheter (see Fig. 6) (see Col. 2, lines 31-52).
SPIROFF does not specifically teaches of: “a device for cooling at least a portion of the catheter shaft”. Though SPIROFF does teach of general cooling, see Col. 2, lines 19-25.
Wherein, see in MCFARLANE, Col. 2, lines 13-26: “It is another object of this invention to provide a die which is preferably in two pieces which are maintained in spaced axial relation from one another when not in use forming a tip and which are in abutting engagement with one another while the tip forming process is taking place and wherein a cooling means, such as a water cooling jacket is provided for the portion of the die about the cylindrical zone adjacent the feathered end of the tube and the heated portion does not transfer all of the heat required to form the tip but, rather, a temperature gradient is maintained between the two pieces so that the cooled portion is at all times at a lower temperature than the heated portion.”
It would have been obvious for one of ordinary skill in the art to have modified the SPIROFF system with the device for cooling at least a portion of the shaft as taught by MCFARLANE as it allows for cooling and allows for a temperature gradient along the formed portion.
Re 20 (upon 19), wherein the device for cooling is a separate cooling device.
See MPEP 2144.04 (IV) (C) regarding making an element separable, as it would have ben obvious for one of ordinary skill in the art to have further modify the cooling device of the modified MCFARLANE to be further a separate cooling device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892 form, of particular note:
JP07-213616A teaches of punch 2 for catheter 1, see Figs. 1-4.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMMANUEL S LUK whose telephone number is (571)272-1134. The examiner can normally be reached Monday-Friday 9 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xiao S Zhao can be reached at 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMANUEL S LUK/Primary Examiner, Art Unit 1744
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