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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/398,626, 16/400,263, 17/410,162, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 21 calls for “a radial support band” having a distal face residing in a plane substantially parallel to the plane of the catheter distal face and having an angle between about 45 degrees and about 80 degrees. There is no support for such a radial support band in the disclosure. The disclosure describes a radiopaque marker band having the orientation described in the claim, but is not clear that the radiopaque marker band provides radial support as it is not described as performing this function.
The filing date of the instant claims is the filing date of the preliminary amendment: 9/12/2024.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 21 calls for “a radial support band” having a distal face residing in a plane substantially parallel to the plane of the catheter distal face and having an angle between about 45 degrees and about 80 degrees. There is no support for such a radial support band in the disclosure. The disclosure describes a radiopaque marker band having the orientation described in the claim, but is not clear that the radiopaque marker band provides radial support as it is not described as performing this function. For the purposes of this rejection only, it is assumed that the claimed radial support band refers to the disclosed radiopaque marker element.
Claims 22-40 inherit the deficiencies of claim 21.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-29, 31-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 6, 9, 11, 14, 16, 18, 19, 21-23 of U.S. Patent No. 11,123,090. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the elements of the application claims can be found in the patent claims.
Regarding claim 21 of the application, claim 1 of the patent recites a catheter (claim 1, line 42) comprising: an elongate flexible tubular body (claim 1, line 44) comprising: a catheter distal face residing on a first plane, the first plane crossing a longitudinal axis of the elongate flexible tubular body at a first nonorthogonal angle relative to the longitudinal axis (claim 1, lines 56-57); and a radial support band positioned in a distal zone of the elongate flexible tubular body and proximal to the catheter distal face (claim 1, lines 53-55), the radial support band comprising a distal face residing on a second plane, the second plane crossing the longitudinal axis at a second nonorthogonal angle relative to the longitudinal axis (claim 1, lines 62-63), wherein the first plane is approximately parallel to the second plane (claim 1, lines 65-66), and wherein the second nonorthogonal angle is between about 45 degrees and about 80 degrees (claim 1, lines 58-69, 64-65: about 55 degrees to about 65 degrees anticipates the claimed range). The difference between the application claim and the patent claim lies in the fact that the patent claim includes more features and is therefore more specific. It has been held that the generic claim is anticipated by the specific claim. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the patent claim anticipates the application claim, the application claim is not patentably distinct therefrom.
See table below for claim by claim correlation:
Application
11,123,090
21
1
22
1
23
14
24
16
25
1
26
1
27
9
28
11
29
21
31
23
32
22
33
1
34
2
35
3
36
6
37
18
38
19
39
1
Claims 21, 22, 25, 26, 29, 31-32, 36, 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 15 of U.S. Patent No. 12,042,160. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the elements of the application claims can be found in the patent claims.
Regarding claim 21 of the application, claim 1 of the patent recites a catheter (claim 1, line 42) comprising: an elongate flexible tubular body (claim 1, line 44) comprising: a catheter distal face residing on a first plane, the first plane crossing a longitudinal axis of the elongate flexible tubular body at a first nonorthogonal angle relative to the longitudinal axis (claim 1, lines 45-48); and a radial support band positioned in a distal zone of the elongate flexible tubular body and proximal to the catheter distal face (claim 1, lines 49-51), the radial support band comprising a distal face residing on a second plane, the second plane crossing the longitudinal axis at a second nonorthogonal angle relative to the longitudinal axis (claim 1, lines 51-55), wherein the first plane is approximately parallel to the second plane (claim 1, lines 55-56), and wherein the second nonorthogonal angle is between about 45 degrees and about 80 degrees (claim 1, lines 57-58: about 55 degrees to about 65 degrees anticipates the claimed range). The difference between the application claim and the patent claim lies in the fact that the patent claim includes more features and is therefore more specific. It has been held that the generic claim is anticipated by the specific claim. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the patent claim anticipates the application claim, the application claim is not patentably distinct therefrom.
See table below for claim by claim correlation:
Application
12,042,160
21
1 or 7
22
2
25
3
26
4
29
5
30
6
31
5
32
15
36
7
39
1
Claims 40, 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,040,160 in view of Wang et al (US 2017/0239440). Claim 40 differs from the patent claims above in calling for the outer diameter of the elongate flexible tubular body to be between about 0.07 in and about 0.15 in. Claim 41 calls for the outer diameter to be equal to or less than 9F. The examiner notes that these diameters overlap even though they are stated with different units. Yang teaches a catheter having an outer diameter between 0.03 in and 0.112 in (note 9F = 0.118 in) to provide for insertion into thing vessels (page 4, para. 0067). 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 elongate member of claim 1 of the patent to have an outer diameter as taught by Yang to provide a catheter that is suitable for insertion into a small vessel for treatment therein.
Allowable Subject Matter
Claims 21-41 are allowable over the prior art of record but for the 112(a) rejection and double patenting rejections above.
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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