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 .
Specification
The disclosure is objected to because of the following informalities: paragraph [0002] should be amended to provide the most current status (e.g. US Patent Number) for the related application(s).
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.
Claims 1, 3-8, 10-15 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Askew et al (2009/0192505).
Regarding claim 1, Askew et al provide a method of reducing mucous production in an airway of a patient comprising advancing a flexible endoscope (10) through an airway passage (Figure 1A, for example), inserting a flexible cryospray catheter (20) through a working channel of the endoscope (Figure 1B, for example), supplying a cryospray through the catheter to target tissue (Figure 2B, for example) wherein the target tissue comprises goblet cells (para. [0230], for example).
Regarding claim 3, see again paragraph [0230]. Regarding claim 4, the device is advanced to a pre-identified region to treat targeted tissue. Regarding claims 5 and 6, the targeted region includes the bronchi and principal bronchi (see Figures and para. [0122], for example). Regarding claim 7, the catheter may be moved to treat an array of tissue (para. [0153], for example).
Regarding claim 8, Askew et al again disclose a method of reducing mucous production in an airway comprising the steps of advancing a flexible endoscope (10) through a trachea (Figure 1A) and advancing a flexible cryospray catheter (20) through a channel of the endoscope (Figure 1B). The catheter has at least one radial aperture (Figure 2b) and cryogen is provided through the aperture to treat mucosal tissue (para. [0230-0231], for example). Regarding claims 10-14, see above discussion of claims 3-7.
Regarding claim 15, Askew et al disclose a method of reducing over-proliferating goblet cells in an airway (para. [0230-0231], for example) comprising advancing a flexible endoscope (10) through an airway passage and inserting a flexible catheter (20) through the endoscope to treat target tissue as discussed with respect to claims 1 and 8 above. Tissue is remodeled to reduce a goblet cell count as discussed at paragraphs [0230-0231].
Regarding claims 17-20, see again the discussion of claims 4-7 above.
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.
Claims 2, 9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Askew et al (‘505) in view of the teaching of Wittenberger (2012/0035601).
The Askew et al device and method has been addressed previously. Askew et al fail to expressly disclose the step of providing a pre-determined, metered cryospray to tissue. The examiner maintains that any amount provided by the Askew et al device may be considered a “predetermined” amount. However, to further show that it is generally known to meter the amount of cryogen delivered to tissue, attention is directed to the Wittenberger system which specifically teaches that it is known to provide a predetermined volume of cryogen to a treatment site to elicit a specific result. See, for example, paragraph [0057] of Wittenberger.
To have provided the Askew et al device with means to provide a predetermined metered dose of cryospray to treat tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Wittenberger fairly teaches it is known to use predetermined doses of cryogen to treat tissue.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,963,709. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘709 anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mulcahey et al (9,867,648) and Krimsky (2010/0057065) disclose other endoscopic devices to treat airway tissue with cryogen energy.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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, Linda Dvorak can be reached at (571) 272-4764. 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.
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/January 18, 2026