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 § 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 (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 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.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0274715 A1 to Chan et al. (hereinafter “Chan”) in view of US 2010/0274188 to Chang et al. (hereinafter “Chang”).
Regarding claim 1, Chan discloses (see abstract; Figs. 1-10; and [0056]-[0083]) a method comprising: advancing a dilation catheter (200) into a Eustachian tube of a patient via a pharyngeal ostium of the patient (see [0064]); engaging an isthmus of the Eustachian tube with a bulbous tip (212) at a distal end of the dilation catheter (see [0066] and Fig. 9A); ceasing advancement of the dilation catheter in the Eustachian tube in response to the engagement of the isthmus with the bulbous tip (see [0066]); and expanding a dilator (204) of the dilation catheter in the Eustachian tube to thereby dilate the Eustachian tube (see [0064]/[0067]).
Chan fails to disclose the following steps: positioning the dilator in a passageway associated with drainage of a paranasal sinus of the patient; and expanding the dilator to thereby dilate the passageway associated with drainage of the paranasal sinus.
Chang discloses, in the same field of endeavor, a method comprising advancing a dilation catheter into a Eustachian tube of a patient (see [0226]), expanding a dilator of the dilation catheter in the Eustachian tube to thereby dilate the Eustachian tube (see [0226]), removing the dilation catheter from the Eustachian tube (see [0226]), advancing the dilation catheter into a nasal cavity of the patient (see [0226]), positioning the dilator in a passageway associated with drainage of a paranasal sinus of the patient (see [0226]); and expanding the dilator to thereby dilate the passageway associated with drainage of the paranasal sinus (see [0226]) for the purpose of using the same dilation catheter to not only dilate the Eustachian tube, but to also dilate an opening into a paranasal sinus (see [0226]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Chan's method with Chang's use of a dilator in a paranasal sinus in addition to the Eustachian tube in order to use the same dilation catheter to not only dilate the Eustachian tube, but to also dilate an opening into a paranasal sinus.
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.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,121,686 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the current claim is broader than, and thus is “anticipated by”, claim 1 of the ‘686 patent as follows with reference to Column and Line numbers of the issued patent.
Regarding current claim 1, ‘686 claim recites: a method comprising (C14L53): advancing a dilation catheter into a Eustachian tube of a patient via a pharyngeal ostium of the patient (C14L54-55); engaging an isthmus of the Eustachian tube with a bulbous tip at a distal end of the dilation catheter (C14L56-57); ceasing advancement of the dilation catheter in the Eustachian tube in response to the engagement of the isthmus with the bulbous tip (C14L58-60); expanding a dilator of the dilation catheter in the Eustachian tube to thereby dilate the Eustachian tube (C14L61-62); positioning the dilator in a passageway associated with drainage of a paranasal sinus of the patient (C15L1-2); and expanding the dilator to thereby dilate the passageway associated with drainage of the paranasal sinus (C15L3-4).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see the attached PTO-892 Notice of References cited for additional relevant prior art disclosing methods of dilating a sinus cavity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771