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 Objections
Claim 36 is objected to because of the following informalities: on line 1, Applicant has “(update to end wall shape version)”. Such is assumed to be a remnant of preparing the claim set. 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.
Claim(s) 19-21 and 34-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haggstrom (US 7,141,035).
Regarding claim 19, Haggstrom discloses as medical catheter (figs 19-21) comprising: an elongate member 12 defining a longitudinal axis and including: an outer wall 22/24, a septum 26, wherein the outer wall and the septum together define a first lumen 16 and a second lumen 18, a first end wall 454 at which the outer wall terminates to a first side of the septum, and a second end wall 460 at which the outer wall terminates to a second side of the septum that is opposite the first side of the septum (fig 19).
Regarding claim 20, wherein the first end wall and the second end wall are angled at a non-perpendicular angle with respect to the longitudinal axis (fig 19; second end wall is configured similar to first – Col.13 ll 25-27).
Regarding claim 21, wherein the first end wall and the second end wall are not parallel to one another (fig 19).
Regarding claim 34, wherein at least one of the first end wall or the second end wall defines a radiused blood contacting surface configured to reduce shear stresses on blood entering and exiting the first or second lumen (see fig 19 and curved surfaces, especially 454 have a radial curve).
Regarding claim 35, wherein the septum extends to a septum extension disposed distal to the first and second lumens (fig 19).
Regarding claim 36, Haggstrom discloses a medical catheter comprising: (update to end wall shape version) an elongate member 12 defining a longitudinal axis and including: an outer wall 22/24, a septum 26, wherein the outer wall and the septum together define a first lumen 16 and a second lumen 18, a first end wall 454 at which the outer wall terminates to a first side of the septum, wherein the first end wall is angled at a non-perpendicular angle with respect to the longitudinal axis (fig 19), and a second end wall 460 at which the outer wall terminates to a second side of the septum that is opposite the first side of the septum (second end wall is configured similar to first – Col.13 ll 25-27), wherein the second end wall is angled at a non-perpendicular angle with respect to the longitudinal axis (fig 19), and wherein the second end wall is not parallel to the first end wall (fig 19).
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(s) 22-26,28, 30-33, 37 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haggstrom (US 7,141,035) in view of Pui et al (US 2003/0143315).
Regarding claims 22-26 and 30, while Haggstrom substantially discloses the invention as claimed, it does not disclose a first wall insert mounted to the first end wall; and a second wall insert mounted to the second end wall. Note that insert is interpreted in light of Applicant’s specification as the insert is not inserted into anything, but covers parts of the device (see inserts 74 and 82 in Applicant fig 5).
Pui discloses an insert in the form of a coating to achieve various beneficial effects (¶63), the coatings may include anti-thrombogenic agents and antimicrobials (¶64) or radiopaque coatings to allow imaging (¶4). Pui also envisions the coating may be a drug matrix layer for localized delivery (¶68, impregnated into polymer).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Haggstrom with a first wall insert mounted to the first end wall; and a second wall insert mounted to the second end wall, the insert comprising a second material different than the first material, the second material comprising a radiopaque material, an anti-thrombogenic material and/or an antimicrobial agent as taught by Pui to allow imaging, prevent clotting and/or kill microbes, respectively.
Regarding claim 28, while Haggstrom substantially discloses the invention as claimed, it does not disclose wherein the second material comprises a polymer.
Pui discloses the coating materials may include polymeric materials (¶63). These can assist in controlled release of bioactive material (¶63).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Haggstrom such that the second material comprises a polymer (and a bioactive material) as taught by Pui to allow for controlled release of said bioactive material.
Regarding claim 31, while Haggstrom substantially discloses the invention as claimed, it does not disclose the at least one of the antithrombogenic agent or the antimicrobial agent is impregnated in the second material.
Pui discloses the coating materials may include polymeric materials (¶63). These can assist in controlled release of bioactive material (¶63).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Haggstrom such that the at least one of the antithrombogenic agent or the antimicrobial agent is impregnated in the second material is impregnated in the second material to assist in controlled release of bioactive/antimicrobial/antithrombogenic material.
Regarding claim 32, wherein at least one of the first wall insert or the second wall insert defines a channel configured to receive a respective at least one of the first end wall or the second end wall (the coating will conform to the surface it covers and thus have a channel to receive the respective end wall).
Regarding claim 33, wherein at least one of the first wall insert or the second wall insert is configured to enclose rough or sharp edges of a respective at least one of the first end wall or the second end wall (the coating will conform to the surface it covers and thus cover and rough or sharp edges).
Regarding claims 37 and 38, Haggstrom discloses a medical catheter comprising: an elongate member defining a longitudinal axis and including: an outer wall 22/24, a septum 26, wherein the outer wall and the septum together define a first lumen 16 and a second lumen 18, a first end wall 454 at which the outer wall terminates to a first side of the septum, and a second end wall at which the outer wall terminates to a second side of the septum that is opposite the first side of the septum 460.
While Haggstrom substantially discloses the invention as claimed, it does not disclose a first wall insert mounted to the first end wall; and a second wall insert mounted to the second end wall, wherein at least one of the first wall insert or the second wall insert comprises at least one of an anti-thrombogenic agent or an antimicrobial agent.
Pui discloses an insert in the form of a coating to achieve various beneficial effects (¶63), the coatings may include anti-thrombogenic agents and antimicrobials (¶64) or radiopaque coatings to allow imaging (¶4). Pui also envisions the coating may be a drug matrix layer for localized delivery (¶68, impregnated into polymer).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Haggstrom such that it includes a first wall insert mounted to the first end wall; and a second wall insert mounted to the second end wall, wherein at least one of the first wall insert or the second wall insert comprises at least one of an anti-thrombogenic agent or an antimicrobial agent as taught by Pui to assist in preventing clotting and/or killing microbes.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haggstrom (US 7,141,035) in view of Pui et al (US 2003/0143315) and Stigall et al (US 2014/0276028).
Regarding claim 27, while Haggstrom substantially discloses the invention as claimed, it does not disclose wherein the second material comprises a metal.
Stigall discloses a device may be made radiopaque through tungsten doping (¶39). Tungsten is a metal.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Haggstrom and Pui such that it comprises a metal (in the form of tungsten doping) as taught by Stigall as part of a specific radiopaque means to allow the device to be visualized.
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 19-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,992,628. Although the claims at issue are not identical, they are not patentably distinct from each other because they are generally broader and the differences are rendered obvious in view of the references used in the art rejections above. While the patent targets the septum extension specifically and the pending claims target the ends of the outer walls, they are both seen as distally exposed coverings such that to also include the patented subject matter on the distal ends of the walls is seen as duplicating essential subject matter and the benefits would be obvious to one of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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