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 .
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 1, 2, 6, 14, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, and 16-20 of U.S. Patent No. 12,390,623. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 1, 2, 6, 14, and 18 of the current application and the invention of claims 1, 3-5, and 16-20 of the patent lies in the fact that the invention of claims 1, 3-5, and 16-20 of the patent includes more elements and is thus more specific. Thus the invention of claims 1, 3-5, 16-20 of the patent is in effect a "species" of the "generic" invention of claims 1, 2, 6, 14, and 18 of the current application. It has been held that the generic invention is “anticipated” by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1, 2, 6, 14, and 18 are anticipated by claims 1, 3-5, and 16-20, claims 1, 2, 6, 14, and 18 are not patentably distinct from claims 1, 3-5, and 16-20.
U.S. Patent 12,390,623
Current Application
1, 3, 16, 18
1, 2
1, 4, 16, 19
6
1, 5, 16, 20
14, 18
Allowable Subject Matter
Claims 1, 2, 6, 14, and 18 are allowable over the prior art. However, claims 1, 2, 6, 14, and 18 are rejected under nonstatutory double patenting as discussed above.
Claims 3-5, 7-13, 15-17, and 19 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1:
Takahashi (U.S. Publication 2009/0069822) discloses a method comprising:
(claim 1) forming a tunnel extending from an oral position on a side of a duodenal papilla to a bile duct (see Figure 9)
(claim 1) dilating a lumen of the tunnel (see Figure 13)
The Takahashi reference fails to disclose the method wherein the tunnel is formed from an oral ridge of a duodenal papilla located on an oral side of a natural opening of a duodenal papilla and inserting a balloon into the tunnel. The examiner was unable to find a reference or a combination of references that disclose and/or teach the limitations of claim 1 as presented.
Regarding claim 6:
Takahashi (U.S. Publication 2009/0069822) discloses a method comprising:
(claim 6) forming a tunnel extending from an oral position of a side of a duodenal papilla to a bile duct (see Figure 9)
The Takahashi reference fails to disclose the method wherein the tunnel is formed from an oral ridge of a duodenal papilla located on an oral side of a natural opening of a duodenal papilla and inserting a knife into the tunnel. The examiner was unable to find a reference or a combination of references that disclose and/or teach the limitations of claim 6 as presented.
Regarding claim 14:
Takahashi (U.S. Publication discloses a method comprising:
(claim 14) forming a tunnel extending from an oral position of a side of a duodenal papilla to a bile duct (see Figure 9)
(claim 14) inserting a catheter (tool 50 is received within an endoscope and can be interpreted as a catheter, i.e. a thin tube inserted into one of the channels of blood vessels in the body to remove fluids, create an opening into an internal cavity, or administer injections (www.dictionary.com/browse/catheter)), so that at least a part of the catheter (52) is located within the tunnel (for example see Figure 9)
The Takahashi reference fails to disclose the method wherein the tunnel is formed from an oral ridge of a duodenal papilla located on an oral side of a natural opening of a duodenal papilla. The examiner was unable to find a reference or a combination of references that disclose and/or teach the limitations of claim 14 as presented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
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