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 .
Claim Objections
Claim 16 is objected to because of the following informalities: there are two periods at the end of the sentence. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Millet US 6,146,814.
Regarding claim 1, Millet discloses a catheter (catheter 10, c 1 ln 47-48) and shown in Figs. 2-3) comprising: a hollow shaft (tubular section 12, c 1 ln 48-49); a linear member provided on an outer periphery of the hollow shaft (electroplated portion of the metal layer, c 1 ln 53-56, formed into metal stripes 22, c 2 ln 9); and a metallic film (electrolessly plated or sputtered conductive metal portion of the metal layer, c 1 ln 56-56, formed into metal stripes 22, c 2 ln 9) that is positioned between the outer periphery of the hollow shaft and the linear member and is joined to the outer periphery of the hollow shaft and the linear member (the process of making the catheter described by Millet in c 1 ln 46 to c 2 ln 32, though not identical, mirrors the process of manufacture set forth in applicants P0041-0042, wherein the electrolessly plated or sputtered conductive metal portion of the metal layer is positioned and joined as claimed).
Regarding claim 2, Millet discloses the catheter according to claim 1, wherein the linear member is wound around the outer periphery of the hollow shaft in a spiral manner (helical metal stripes 22, c 2 ln 8-9 and Fig. 2).
Claim Rejections - 35 USC § 103
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.
Claims 3-4, 7-9, 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Millet.
Regarding claim 3, Millet discloses the catheter according to claim 2.
Millet does not teach wherein a height of the linear member is larger than a width of the linear member in a transverse cross-section of the linear member.
Millet teaches that metallic elements may be provided to reinforce the physical structure of the polymeric body, wherein the size, shape and distribution of metallic elements can substantially affect properties of the catheter such as ease with which the tube can be bent and resistance of the tube to kinking and collapse during use, c 1 ln 24-29. Therefore, the size and shape of the linear member is a result effective variable in that changing the size and shape of the linear member affects properties of the catheter including flexibility and resistance to kinking. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Millet as claimed as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, Millet teaches the catheter according to claim 3.
Millet does not teach wherein the width of the linear member is larger at an inner side of the linear member in a radial direction where the linear member is joined to the metallic film than at an outer side of the linear member in the radial direction.
However, Applicant teaches in P0042 that the claimed shape (trapezoidal) is a result of the manufacturing process wherein the outer side in the radial direction has a larger amount of melting. Millet teaches a similar process of manufacture wherein etchant is used to remove metal, c 2 ln 7-9. Therefore, because Millet teaches a similar manufacturing process, one of ordinary skill in the art would expect the claimed structure to result.
Additionally, Millet teaches that metallic elements may be provided to reinforce the physical structure of the polymeric body, wherein the size, shape and distribution of metallic elements can substantially affect properties of the catheter such as ease with which the tube can be bent and resistance of the tube to kinking and collapse during use, c 1 ln 24-29. Therefore, the size and shape of the linear member is a result effective variable in that changing the size and shape of the linear member affects properties of the catheter including flexibility and resistance to kinking. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Millet as claimed as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 7, Millet discloses the catheter according to claim 1.
Millet does not teach wherein the linear member is formed in a grid pattern on the outer periphery of the hollow shaft.
Millet teaches that metallic elements may be provided to reinforce the physical structure of the polymeric body, wherein the size, shape and distribution of metallic elements can substantially affect properties of the catheter such as ease with which the tube can be bent and resistance of the tube to kinking and collapse during use, c 1 ln 24-29. Therefore, the size and shape of the linear member is a result effective variable in that changing the size and shape of the linear member affects properties of the catheter including flexibility and resistance to kinking. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Millet as claimed as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 8, Millet discloses the catheter according to claim 1.
Millet does not teach wherein a height of the linear member is larger than a width of the linear member in a transverse cross-section of the linear member.
Millet teaches that metallic elements may be provided to reinforce the physical structure of the polymeric body, wherein the size, shape and distribution of metallic elements can substantially affect properties of the catheter such as ease with which the tube can be bent and resistance of the tube to kinking and collapse during use, c 1 ln 24-29. Therefore, the size and shape of the linear member is a result effective variable in that changing the size and shape of the linear member affects properties of the catheter including flexibility and resistance to kinking. Therefore, It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Millet as claimed as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 9, Millet teaches the catheter according to claim 8.
Millet does not teach wherein the width of the linear member is larger at an inner side of the linear member in a radial direction where the linear member is joined to the metallic film than at an outer side of the linear member in the radial direction.
However, Applicant teaches in P0042 that the claimed shape (trapezoidal) is a result of the manufacturing process wherein the outer side in the radial direction has a larger amount of melting. Millet teaches a similar process of manufacture wherein etchant is used to remove metal, c 2 ln 7-9. Therefore, because Millet teaches a similar manufacturing process, one of ordinary skill in the art would expect the claimed structure to result.
Additionally, Millet teaches that metallic elements may be provided to reinforce the physical structure of the polymeric body, wherein the size, shape and distribution of metallic elements can substantially affect properties of the catheter such as ease with which the tube can be bent and resistance of the tube to kinking and collapse during use, c 1 ln 24-29. Therefore, the size and shape of the linear member is a result effective variable in that changing the size and shape of the linear member affects properties of the catheter including flexibility and resistance to kinking. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Millet as claimed as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 12, Millet discloses the catheter according to claim 1.
Millet does not teach wherein a width of the linear member is larger at an inner side of the linear member in a radial direction where the linear member is joined to the metallic film than at an outer side of the linear member in the radial direction.
However, Applicant teaches in P0042 that the claimed shape (trapezoidal) is a result of the manufacturing process wherein the outer side in the radial direction has a larger amount of melting. Millet teaches a similar process of manufacture wherein etchant is used to remove metal, c 2 ln 7-9. Therefore, because Millet teaches a similar manufacturing process, one of ordinary skill in the art would expect the claimed structure to result.
Additionally, Millet teaches that metallic elements may be provided to reinforce the physical structure of the polymeric body, wherein the size, shape and distribution of metallic elements can substantially affect properties of the catheter such as ease with which the tube can be bent and resistance of the tube to kinking and collapse during use, c 1 ln 24-29. Therefore, the size and shape of the linear member is a result effective variable in that changing the size and shape of the linear member affects properties of the catheter including flexibility and resistance to kinking. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Millet as claimed as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 18, Millet teaches the catheter according to claim 12.
Millet does not teach wherein the width of the linear member gradually decreases from the inner side of the linear member to the outer side of the linear member.
However, Applicant teaches in P0042 that the claimed shape (trapezoidal) is a result of the manufacturing process wherein the outer side in the radial direction has a larger amount of melting. Millet teaches a similar process of manufacture wherein etchant is used to remove metal, c 2 ln 7-9. Therefore, because Millet teaches a similar manufacturing process, one of ordinary skill in the art would expect the claimed structure to result.
Additionally, Millet teaches that metallic elements may be provided to reinforce the physical structure of the polymeric body, wherein the size, shape and distribution of metallic elements can substantially affect properties of the catheter such as ease with which the tube can be bent and resistance of the tube to kinking and collapse during use, c 1 ln 24-29. Therefore, the size and shape of the linear member is a result effective variable in that changing the size and shape of the linear member affects properties of the catheter including flexibility and resistance to kinking. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Millet as claimed as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 11, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Millet in view of Kanemasa et al. (Kanemasa) US 2016/0051796 A1.
Regarding claim 11, Millet discloses the catheter according to claim 8.
Millet teaches that the catheter body 10 is a polymer layer in c 2 ln 43.
Millet does not teach wherein the hollow shaft comprises: an inner layer made of PTFE; and an intermediate layer that is provided on an outer periphery of the inner layer and is made of PAE.
However, Kanemasa teaches a catheter comprising: an inner layer made of PTFE (inner layer 22 made of PTFE, P0059); and an intermediate layer (layer 34 of outer layer 38, P0061 and shown in Fig. 2 to include layers 34 and 36) that is provided on an outer periphery of the inner layer and is made of PAE (PAE, P0061).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Millet with a PTFE liner for the purpose of supplying a medicinal solution or reducing sliding resistance within the lumen as taught by Kanemasa P0059, and to modify the polymer layer of Millet with PAE for the purpose of proving a specific type of polymer material for a catheter having a PTFE liner.
Regarding claim 14, Millet teaches the catheter according to claim 12.
Millet does not teach wherein the hollow shaft comprises: an inner layer made of PTFE; and an intermediate layer that is provided on an outer periphery of the inner layer and is made of PAE.
However, Kanemasa teaches a catheter comprising: an inner layer made of PTFE (inner layer 22 made of PTFE, P0059); and an intermediate layer (layer 34 of outer layer 38, P0061 and shown in Fig. 2 to include layers 34 and 36) that is provided on an outer periphery of the inner layer and is made of PAE (PAE, P0061).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Millet with a PTFE liner for the purpose of supplying a medicinal solution or reducing sliding resistance within the lumen as taught by Kanemasa P0059, and to modify the polymer layer of Millet with PAE for the purpose of proving a specific type of polymer material for a catheter having a PTFE liner.
Regarding claim 17, Millet discloses the catheter according to claim 1.
Millet does not teach wherein the hollow shaft comprises: an inner layer made of PTFE; and an intermediate layer that is provided on an outer periphery of the inner layer and is made of PAE.
However, Kanemasa teaches a catheter comprising: an inner layer made of PTFE (inner layer 22 made of PTFE, P0059); and an intermediate layer (layer 34 of outer layer 38, P0061 and shown in Fig. 2 to include layers 34 and 36) that is provided on an outer periphery of the inner layer and is made of PAE (PAE, P0061).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Millet with a PTFE liner for the purpose of supplying a medicinal solution or reducing sliding resistance within the lumen as taught by Kanemasa P0059, and to modify the polymer layer of Millet with PAE for the purpose of proving a specific type of polymer material for a catheter having a PTFE liner.
Potentially Allowable Subject Matter
Claims 5-6, 10, 13 and 15-16 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.
Reasons for Potential Allowance
The following is an Examiner's statement of reasons for potential allowance: the claims in this application are potentially allowed because the prior art of record fails to disclose either singularly or in combination the claimed catheter.
The closest prior art is Millet US 6,146,814.
Regarding claim 5, 10, 13 and 15, Millet fails to teach among all the limitations or render obvious a catheter as claimed, which includes wherein: the metallic film includes stainless steel, and the linear member includes a nickel-cobalt alloy, in combination with the total structure and function of the catheter as claimed.
Millet teaches use of copper or copper-based alloys in c 1 ln 51-53. P0012 of Applicant’s written description teaches that the nickel-cobalt alloy improves torqueability, which indicates criticality of the material for this intended use. MPEP 2144.07 recites “…The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” However, the prior art does not teach use of the claimed materials positioned and joined as claimed as suitable for improving torqueability.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783