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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/25/25;8/18/25;6/27/25;3/12/25;2/26/24;10/3/23 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
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 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, 4, 6, 11, 15, 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burgmeier et al. (US 2005/0142314) (“Burgmeier”).
(claims 1 and 15) Burgmeier discloses: a method of forming a continuous tube [0033,0054,0055,0062] having alternating compositions along a length direction of the tube (Fig. 1), the method comprising: extruding a first segment (“the part”) 2 of a tube from a first polymeric composition along a length direction of the tube by a first pump on an extrusion line followed by extruding a second segment 1 of the tube from a second polymeric composition along the length direction of the tube by a second pump on the extrusion line; wherein the first and second polymeric compositions are different (because the amount of crystallization modifier varies [0058] Fig. 1) and the first segment and second segments are integrally joined by a transition segment between the first and second segments, the transition comprising a mixture of the first and second polymeric compositions and is formed during the sequential extrusion of the first and second segments. [0019-0020,0058] (the entire tube (medical device) is formed of a melt processed polymer material, thus each segment is polymeric. Further, the polymer material composition comprises a thermoplastic polymer or mixture therof in at least a portion of the part, the polymer composition further comprises a crystallization modifier. “From a first portion of the inventive part to a second portion therof, the composition is varied in the amount of crystallization modifier employed therein.” [0020] Thus, a transition segment is formed from a first portion to a second portion of the medical device. Since the polymeric composition employs the crystallization modifier to make this transition from one portion to another then at some point along the medical device the transition will comprise a mixture of the first and second polymeric compositions, i.e., a heavy to a medium to a light crystallization modifier as this gradual transition is shown in Fig. 1.)
Claims 2,18: further comprising extruding a third segment with a third polymeric composition by a third pump on the extrusion line; the second and third segments are integrally joined
Claims 4,18: the second and third segments are joined by a second transition segment between the second and third segments, the second transition segment comprising a mixture of the second and third polymeric compositions
Claim 6: the first, second and third polymeric compositions are different from each other (differing crystallization modifier [0058])
(again, the device is polymeric along the entire length and the amount of crystallization modifier added will result in a different polymeric composition) along the length direction integrally joined to the second segment by a transition segment between the second and third segment that comprises a mixture of the second and third polymeric compositions. (Fig. 1) (to the right of “1” segment) [“From a first portion of the inventive part to a second portion therof, the composition is varied in the amount of crystallization modifier employed therein.” [0020] Thus, a transition segment is formed from a first portion to a second portion of the medical device and from a second to a third segment. Since the polymeric composition employs the crystallization modifier to make this transition from one portion to another then at some point along the medical device the transition will comprise a mixture of the first and second polymeric compositions and the second and third, i.e., a heavy to a medium to a light crystallization modifier or light to medium to heavy, as this gradual transition is shown in Fig. 1.)
Claim 11: the first and second compositions include a different type or amount of an additive. [0052-0053]
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 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 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, 5, 7-10, 12, 14, 17, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Burgmeier.
Burgmeier discloses the catheter segments being formed of different compositions, including (claims 3, 5, 8-10, 20) the first (and third) segment compositions include a styrenic based thermoplastic elastomers (TPE), non-hydrogenated styrenic based TPE, thermoplastic polyurethane ester based, ether based or carbonate based, thermal plastic olefin (TPO) (lubricious polymer), or combinations thereof.
the second composition includes a styrenic based TPE, non-hydrogenated and hydrogenated styrenic based TPE and blends thereof, thermoplastic polyurethane ester based, ether based, or carbonate based, EVA, EVA blend with thermoplastic polyurethane (TPU), polyethylene vinyl acetate (EVA) blend with LDPE, TPO, PVC, etc. and combinations thereof.
see [0020-0032, Table 1]
Burgmeier does not directly disclose which segments contain which polymer, however, based on the fact that the polymers are disclosed and that the different segments can be made from differing polymers [0019-0020,0055] (gradient extrusion, etc) [0058, 0060], then it would have been a matter of routine experimentation and design choice how the tube was extruded (including the lengths of the segments—claims 12,17). According to claims 7, 14, 19 also, these segments because of their different compositions would therefore also have differing Shore A hardnessess. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the continuous tube of Burgmeier with any number of compositions, lengths, and with their differing Shore A hardness, as in claims 7, 12, 14, 17 and 19.
Claims 13, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Burgmeier in view of Brukovsky et al. (US 3,690,798) (“Brukovsky”).
Burgmeier discloses the invention as substantially claimed but does not directly disclose the first segment includes a first portion with a first diameter and a second portion with a second stepped-down diameter along the length of the tube toward the second segment. Brukovsky, in the analogous art, teaches an extruder head for extruding parisions whose wall thickness may be varied over the length of the parison, see abstract. Fig. 7 shows five different wall segment thicknesses 26a-e along a length. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the extrusion of Burgmeier with the extrusion as taught by Brukovsky to further modify the diameters of the segments as pertaining to the design needs of the tube.
Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm 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, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEANNA K HALL/Primary Examiner, Art Unit 3783