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 .
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 42 and 43 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.
Regarding claim 42, the recitation “braided and coil reinforcements” renders the claim indefinite because the claim is unclear if “braided and coil reinforcements” refers to “reinforcement” recited in claim 6 or additional. For examination purposes, examiner construes “braided and coil reinforcements” as part of “reinforcement”.
Regarding claim 43, the recitation “any reinforcement layers” renders the claim indefinite because the claim is unclear if “any reinforcement layers” is positively reciting plurality of reinforcement layers as a part of the claim invention and if “any reinforcement layers” is included as a part of “reinforcement” recited in claim 6 or additional. For examination purposes, examiner construes that “any reinforcement layers” is part of “reinforcement” recited in claim 6 and is positively reciting at least one reinforcement layer as a part of claimed invention.
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.
Claims 1, 2, 6, 8-10, 15, 16, 36-38, 45, 46, 49 and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stern et al. (US 2018/0250498 A1).
Regarding claim 1, Stern teaches a catheter 10 (figure 1) comprising:
an inner layer 18, 34 (when examiner has not used alphabets at the end of the reference character and if the drawings show the alphabet, then examiner is referring to all the reference elements starting with the referred reference character followed by alphabet. For instance, referring element 18 would mean to be referring to all elements starting with number 18 followed by alphabets i.e. 18A, 18B and 18C etc.) comprising a polyolefin- or polyethylene-based thermoplastic elastomeric material (paragraph 0071, lines 1-6, paragraph 0113, lines 4-8);
an outer layer 22, 36; and
a tie layer (paragraph 0110, lines 1-4) disposed between the inner layer and the outer layer, wherein the tie layer comprises a low durometer polymer (paragraph 0110, lines 4-6, “Pellethane 2363-80A”).
Regarding claim 2, Stern teaches wherein the inner layer 34 comprises one or more lubricants (paragraph 0113, lines 4-8, “5 wt.% Ampacet 100329”).
Regarding claim 6, Stern teaches further comprising a reinforcement 20, 38 disposed between the inner layer 22, 34 and the outer layer 22, 36.
Regarding claim 8, Stern teaches wherein the reinforcement includes one or more filar coil wires 20, 38 wrapped circumferentially about a longitudinal axis (axis extending along a length of the catheter) of the catheter.
Regarding claim 9, Stern teaches wherein the reinforcement 38 (paragraph 0112, lines 1-5) is a braided design wire pattern interwoven circumferentially along a longitudinal axis (axis extending along a length of the catheter) of the catheter.
Regarding claim 10, Stern teaches regarding wherein the braided design 20 (paragraph 0086, lines 1-13) includes changes in density or pix per inch along a length of the braided design.
Regarding claim 15, Stern teaches wherein the reinforcement 20 comprises at least one of steel (paragraph 0084, lines 1-7), nitinol, tungsten, non-metallic monofilaments, fibrous bundles, Aramid, polymers, Nylon, or LCP.
Regarding claim 16, Stern teaches wherein the reinforcement 20, 34 includes a circumferential reinforcement (see figures 2 and 3) between the inner layer and the outer layer and a longitudinal reinforcement (see figures 2 and 3) that extends along a longitudinal axis (axis along the length of the catheter) of the catheter.
Regarding claim 36, Stern teaches wherein the braided design 20 includes a first braid reinforcement 20B and a second braid reinforcement 20A placed over the first braid reinforcement 20B (paragraph 0086, lines 15-18, see figure 2 where at least a portion of element 20A is placed over element 20B).
Regarding claim 37, Stern teaches wherein the second braid reinforcement comprises a material that is different from a material that comprises the first braid reinforcement (paragraph 0079, lines 1-4).
Regarding claim 38, Stern teaches wherein the second braid reinforcement comprises a geometry that is different from a geometry that comprises the first braid reinforcement (paragraph 0079, lines 1-6, “round wires”, “flat wires”).
Regarding claim 45, Stern teaches wherein the outer layer 22 comprises a first section 22A and a second section 22I, wherein a stiffness of the first section is different from a stiffness of the second section (paragraph 0091, lines 4-9).
Regarding claim 46, Stern teaches wherein the outer layer 22 comprises a first section 22I and a second section 22A, wherein a trackability of the first section 22I is better than a trackability of the second section 22A (paragraph 0102, due to presence of element 28, trackability of 22I is better than 22A).
Regarding claim 49, Stern teaches wherein the inner layer 34 comprises a first inner layer 34B on a distal portion of the catheter, the first inner layer 34B comprising the thermoplastic elastomeric material (paragraph 0113, lines 4-8), and a second inner layer 34A disposed on a proximal portion of the catheter proximal to the first inner layer 34B, wherein the second inner layer comprises PTFE (paragraph 0113, lines 4-8).
Regarding claim 52, Stern teaches wherein a catheter distal end comprises a radiopaque tip 28.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Stern et al. (US 2018/0250498 A1) in view of Julien (US 2009/0087606 A1).
Regarding claim 3, Stern discloses the claimed invention substantially as claimed, as set forth above in claim 1. Stern is silent regarding wherein the tie layer comprises a maleic anhydride grafted linear low-density polyethylene (LLDPE), or a maleic anhydride modified low density polyethylene (LDPE) or a maleic anhydride modified ethylene vinyl acetate (EVA).
However, Julien teaches a design of a multilayer tubing (figure 1A) wherein the tie layer (paragraph 0080, lines 18-20) comprises a maleic anhydride grafted linear low-density polyethylene (LLDPE), or a maleic anhydride modified low density polyethylene (LDPE) or a maleic anhydride modified ethylene vinyl acetate (EVA) for the purpose of using a well-known material for adhering two layers together (paragraph 0080, lines 18-20).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of the tie layer of Stern to incorporate wherein the tie layer comprises a maleic anhydride grafted linear low-density polyethylene (LLDPE), or a maleic anhydride modified low density polyethylene (LDPE) or a maleic anhydride modified ethylene vinyl acetate (EVA) as taught by Julien for the purpose of using a well-known material for adhering two layers together (paragraph 0080, lines 18-20).
Claims 12, 40 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Stern et al. (US 2018/0250498 A1) in view of Chludzinski et al. (US 6,837,890 B1).
Regarding claim 12, Stern discloses the claimed invention substantially as claimed, as set forth above in claims 1, 6 and 9. Stern is silent regarding wherein the braided design includes a pattern of 1 under 1 over, 2 under 2 over, 2 or 1 under 2 over 2.
However, Chludzinski teaches a design of a catheter (figure 1) comprising wherein the braided design 34 includes a pattern of 1 under 1 over (see figure 2 where element 36 is woven as 1 under 1 over), 2 under 2 over, 2 or 1 under 2 over 2 for the purpose of using a braided structure to provide reinforcing characteristics to the catheter (column 4, lines 52-65).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the braided design of Stern to incorporate wherein the braided design includes a pattern of 1 under 1 over, 2 under 2 over, 2 or 1 under 2 over 2 as taught by Chludzinski for the purpose of using a braided structure to provide reinforcing characteristics to the catheter (column 4, lines 52-65).
Regarding claim 40, Stern discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 6. Stern is silent regarding wherein the reinforcement is embedded in the tie layer.
However, Chludzinski teaches wherein the reinforcement 34 (figure 3) is embedded in the tie layer (column 7, lines 23-26, since the tie layer is used to fuse two layers 30 and 32 together with element 34 being present between elements 30 and 32, the element 34 has to be embedded in the tie layer) for the purpose of using an alternative configuration to bond the two layers together along with the reinforcement (column 7, lines 23-26).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the tie layer of Stern to incorporate wherein the reinforcement is embedded in the tie layer as taught by Chludzinski for the purpose of using an alternative configuration to bond the two layers together along with the reinforcement (column 7, lines 23-26).
Regarding claim 41, Stern discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 6. Stern is silent regarding wherein the tie layer is placed over and under the reinforcement.
However, Chludzinski teaches wherein the tie layer is placed over and under the reinforcement (column 7, lines 23-26, since the tie layer is used to fuse two layers 30 and 32 together with element 34 being present between elements 30 and 32, the tie layer is construed as being placed over and under the reinforcement) for the purpose of using an alternative configuration to bond the two layers together along with the reinforcement (column 7, lines 23-26).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the tie layer of Stern to incorporate wherein the tie layer is placed over and under the reinforcement as taught by Chludzinski for the purpose of using an alternative configuration to bond the two layers together along with the reinforcement (column 7, lines 23-26).
Claims 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Stern et al. (US 2018/0250498 A1) in view of Davies, Jr. et al. (US 2011/0172698 A1).
Regarding claim 41, Stern discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 6. Stern is silent regarding wherein the tie layer is placed over and under the reinforcement.
However, Davies, Jr. teaches a design of a medical balloon wherein the tie layer 516 (figure 5e) is placed over and under the reinforcement 512 (paragraph 0066, lines 5-11, impregnated and coated indicates that the tie layer is placed over and under the reinforcement) for the purpose of bonding the reinforcement layer and two layers together to form a single unit (paragraph 0066).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the tie layer of Stern to incorporate wherein the tie layer is placed over and under the reinforcement as taught by Davies, Jr. for the purpose of bonding the reinforcement layer and two layers together to form a single unit (paragraph 0066).
Regarding claim 42, Stern discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 6 but is silent regarding wherein the tie layer is placed between braided and coil reinforcements.
However, Davies, Jr. teaches wherein the tie layer 516 (figure 5e) is placed between braided and coil reinforcements (paragraph 0066, lines 5-11, see figure 5e and “impregnated” indicates the tie layer is present between the gaps within element 512) for the purpose of bonding the reinforcement layer and two layers together to form a single unit (paragraph 0066).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the tie layer of Stern to incorporate wherein the tie layer is placed between braided and coil reinforcements as taught by Davies, Jr for the purpose of bonding the reinforcement layer and two layers together to form a single unit (paragraph 0066).
Regarding claim 43, Stern discloses the claimed invention substantially as claimed, as set forth above, in claims 1 and 6 but is silent regarding wherein the tie layer is placed between any reinforcement layers.
However, Davies, Jr. teaches wherein the tie layer 516 is placed between any reinforcement layers 512 (paragraph 0066, lines 5-11, “coated fibers” indicates tie layer placed between any reinforcement layers) for the purpose of bonding the reinforcement layer and two layers together to form a single unit (paragraph 0066).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the tie layer of Stern to incorporate wherein the tie layer is placed between any reinforcement layers as taught by Davies, Jr. for the purpose of bonding the reinforcement layer and two layers together to form a single unit (paragraph 0066).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Stern et al. (US 2018/0250498 A1) in view of Lunn et al. (US 6,059,769).
Regarding claim 44, Stern discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 6. Stern does not explicitly recite wherein the reinforcement terminates a fixed distance from a distal end point of the catheter. However, figure 2 of Stern appears to be showing wherein the reinforcement 20 terminates a fixed distance from a distal end point 12B of the catheter.
Additionally, Lunn teaches a design of a medical catheter wherein the reinforcement 32 terminates a fixed distance from a distal end point (end that enters into the patient when using the catheter) of the catheter for the purpose of having a flexibility in the distal end to allow medical catheter with improved tracking and movement in the body vessel (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the reinforcement of Stern to incorporate wherein the reinforcement terminates a fixed distance from a distal end point of the catheter as taught by Lunn for the purpose of having a flexibility in the distal end to allow medical catheter with improved tracking and movement in the body vessel (abstract).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Stern et al. (US 2018/0250498 A1) in view of Pieslak et al. (US 2008/0317991 A1).
Regarding claim 48, Stern discloses the claimed invention substantially as claimed, as set forth above in claim 1. Stern is silent regarding wherein one or more of the inner layer, the tie layer, or the outer layer is cross-linked using e-beam.
However, Pieslak teaches a design of a catheter (figures 1, 2) comprising wherein one or more of the inner layer, the tie layer, or the outer layer 103 is cross-linked using e-beam (paragraph 0027) for the purpose of using a well-known manufacturing process to manufacture a catheter (paragraph 0022, lines 14-19).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the manufacturing of the outer layer of Stern to incorporate wherein one or more of the inner layer, the tie layer, or the outer layer is cross-linked using e-beam as taught by Pieslak for the purpose of using a well-known manufacturing process to manufacture a catheter (paragraph 0022, lines 14-19).
Claims 53 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Stern et al. (US 2018/0250498 A1) in view of Nita et al. (US 5,951,539).
Regarding claim 53, Stern discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 52. Stern is silent regarding wherein the radiopaque tip comprises a polymer including an additive of one or more of tungsten, barium sulfate, bismuth subcarbonate, or bismuth oxychloride.
However, Nita teaches a design of a medical device comprising wherein the radiopaque band 586 (figure 14E) comprises a polymer including an additive (column 18, lines 25-27, “polymer having a high loading of radio-opaque fillers such as those discussed above”) of one or more of tungsten, barium sulfate, bismuth subcarbonate, or bismuth oxychloride (column 13, lines 48-53) for the purpose of visualizing the tube radiographically within the vessel (column 13, lines 48-53).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the radiopaque tip of Stern to incorporate wherein the radiopaque tip comprises a polymer including an additive of one or more of tungsten, barium sulfate, bismuth subcarbonate, or bismuth oxychloride as taught by Nita for the purpose of visualizing the tube radiographically within the vessel (column 13, lines 48-53).
Regarding claim 54, Stern discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 52. Stern further discloses the radiopaque tip 28 comprises a marker band (band formed by element 28). Modified Stern is silent regarding wherein marker band being a split marker band.
However, Nita teaches a design of a catheter wherein the marker band 586 (figure 14E) a split marker band (column 18, lines 25-28) for the purpose of using an alternative shape to visualize the tubing radiographically within the vessel (column 13, lines 48-53, column 18, lines 25-28).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the marker band of Stern to incorporate a split marker band as taught by Nita for the purpose of using an alternative shape to visualize the tubing radiographically within the vessel (column 13, lines 48-53, column 18, lines 25-28).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sanchez et al. (US 2002/0165450 A1): discloses a design of a catheter comprising a band with radiopaque material formed of a polymer with radiopaque additive.
Lobbins et al. (US 2007/0250039 A1): discloses a catheter formed of a composite laminated catheter with reinforcing material infused between two layers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
