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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/06/2024 and 01/30/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-6, 8, 13, 17-20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-22 of U.S. Patent No. 11,529,224 to Radhakrishnan. Although the claims at issue are not identical, they are not patentably distinct from each other because application claims is anticipated by patent claims 16-22.
Regarding claim 2, patent claims 15 and 19 of Radhakrishnan ‘224 recites implanting a valve in a bronchial passageway of a patient, comprising: providing a valve having a cracking pressure in the range of 121-160 inches H2O (column 13, lines 44-45; column 14, lines 31-32); and implanting the valve in a bronchial passageway that feeds air to a targeted lung region (column 13, lines 29-30; column 4, lines 15-16), wherein the valve transitions between a closed configuration that blocks air flow in the inspiratory direction (column 13, lines 33-34; column 14, lines 19-22) and an open configuration that permits air flow in an expiratory direction (column 13, lines 34-36; column 14, lines 22-23); wherein the valve is in the closed configuration when exposed to no air flow, air flow in the inspiratory direction, and air flow in the expiratory direction at normal breathing pressures (column 13, lines 37-40; column 14, lines 24-27), and wherein the valve is in the open configuration when exposed to air flow in the expiratory direction at coughing pressures (column 13, lines 40-43; column 4, lines 27-30).
Regarding claim 3, patent claims 15 and 19 of Radhakrishnan ‘224 recites wherein the valve comprises a first lip, a second lip, and two opposed inclined flaps leading to the first and second lips (column 13, lines 31-32, and 50-51; column 14, lines 17-19).
Regarding claim 4, patent claims 16 of 20 of Radhakrishnan ‘224 recites wherein the two opposed inclined flaps are oriented at an angle with respect to one another in the closed configuration and the first and second lips are parallel with respect to one another and a longitudinal axis of the valve in the closed configuration (column 13, lines 46-54; column 14, lines 33-38).
Regarding claim 5, patent claims 17 and 21 of Radhakrishnan ‘224 recites wherein the first and second lips extend longitudinally in contact with one another beyond the two inclined flaps while in the closed configuration (column 14, lines 1-4; column 14, lines 39-42).
Regarding claim 6, patent claims 18 and 22 of Radhakrishnan ‘224 recites wherein a length of the parallel and contacted first and second lips extending longitudinally beyond the two inclined flaps and the angle of the inclined flaps with respect to one another are configured such that the valve is in the closed configuration when exposed to no air flow, air flow in the inspiratory direction, and air flow in the expiratory direction at normal breathing pressures, and such that the valve is in the open configuration when exposed to air flow in the expiratory direction in the range of 121-160 inches H20 (column 14, lines 5-14, column 14, lines 43-52).
Regarding claim 8, patent claim 16 and 20 of Radhakrishnan ‘224 recites wherein the two inclined flaps are oriented at an angle relative to a longitudinal axis of the valve while in the closed configuration (column 13, lines 52-53; column 14, lines 33-35).
Regarding claim 13, patent claims 15 and 19 of Radhakrishnan ‘224 recites implanting a flow control device in a bronchial passageway of a patient (column 13, lines 44-45; column 14, lines 31-32), comprising: providing a flow control device having a cracking pressure in the range of 121- 160 inches H2O (column 13, lines 44-45; column 14, lines 31-32); and implanting the flow control device in a bronchial passageway that feeds air to a targeted lung region (column 13, lines 44-45; column 14, lines 31-32), wherein the flow control device transitions between a closed configuration that blocks air flow in the inspiratory direction (column 13, lines 33-34; column 14, lines 19-22) and an open configuration that permits air flow in an expiratory direction (column 13, lines 34-36; column 14, lines 22-23); wherein the flow control device is in the closed configuration when exposed to no air flow, air flow in the inspiratory direction, and air flow in the expiratory direction at normal breathing pressures (column 13, lines 37-40; column 14, lines 24-27), and wherein the valve is in the open configuration when exposed to air flow in the expiratory direction at coughing pressures (column 13, lines 40-43; column 4, lines 27-30).
Regarding claim 17, patent claims 15 and 19 of Radhakrishnan ‘224 recites wherein the flow control device comprises a valve having a first lip, a second lip, and two opposed inclined flaps leading to the first and second lips (column 13, lines 31-32, and 50-51; column 14, lines 17-19).
Regarding claim 18, patent claims 16 and 20 of Radhakrishnan ‘224 recite wherein the two opposed inclined flaps are oriented at an angle with respect to one another in the closed configuration and the first and second lips are parallel with respect to one another and a longitudinal axis of the valve in the closed configuration (column 13, lines 46-54; column 14, lines 33-38).
Regarding claim 19, patent claims 17 and 21 of Radhakrishnan ‘224 recites wherein the first and second lips extend longitudinally in contact with one another beyond the two inclined flaps while in the closed configuration (column 14, lines 1-4; column 14, lines 39-42).
Regarding claim 20, patent claims 18 and 22 of Radhakrishnan ‘224 recites wherein a length of the parallel and contacted first and second lips extending longitudinally beyond the two inclined flaps and the angle of the inclined flaps with respect to one another are configured such that the valve is in the closed configuration when exposed to no air flow, air flow in the inspiratory direction, and air flow in the expiratory direction at normal breathing pressures, and such that the valve is in the open configuration when exposed to air flow in the expiratory direction in the range of 121-160 inches H20 (column 14, lines 5-14, column 14, lines 43-52).
Therefore, patent claims 16-22 of U.S. Patent No. 11,529,224 is in essence a “species” of the generic invention of application claims 2-6, 8, 13, 17-20. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 2-3, 13, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-10 of U.S. Patent No. 11,857,406 to Radhakrishnan. Although the claims at issue are not identical, they are not patentably distinct from each other because application claims is anticipated by patent claims 9-10.
Regarding claim 2, patent claim 9 of Radhakrishnan ‘406 recites implanting a valve in a bronchial passageway of a patient (column 12, lines 50-51), comprising: providing a valve having a cracking pressure in the range of 121-160 inches H2O (column 12, lines 64-65); and implanting the valve in a bronchial passageway that feeds air to a targeted lung region (column 12, lines 50-51), wherein the valve transitions between a closed configuration that blocks air flow in the inspiratory direction (column 12, lines 52-54) and an open configuration that permits air flow in an expiratory direction (column 12, lines 54-55); wherein the valve is in the closed configuration when exposed to no air flow, air flow in the inspiratory direction, and air flow in the expiratory direction at normal breathing pressures (column 12, lines 56-59), and wherein the valve is in the open configuration when exposed to air flow in the expiratory direction at coughing pressures (column 12, lines 59-63).
Regarding claim 3, patent claim 10 of Radhakrishnan ‘406 recites wherein the valve comprises a first lip, a second lip, and two opposed inclined flaps leading to the first and second lips (claim 10).
Regarding claim 13, patent claim 9 of Radhakrishnan ‘406 recites implanting a flow control device in a bronchial passageway of a patient (column 12, lines 50-51), comprising: providing a flow control device having a cracking pressure in the range of 121- 160 inches H2O (column 12, lines 64-65); and implanting the flow control device in a bronchial passageway that feeds air to a targeted lung region (column 12, lines 50-51), wherein the flow control device transitions between a closed configuration that blocks air flow in the inspiratory direction (column 12, lines 52-54) and an open configuration that permits air flow in an expiratory direction (column 12, lines 54-55); wherein the flow control device is in the closed configuration when exposed to no air flow, air flow in the inspiratory direction, and air flow in the expiratory direction at normal breathing pressures (column 12, lines 56-59), and wherein the flow control device is in the open configuration when exposed to air flow in the expiratory direction at coughing pressures (column 12, lines 59-63)..
Regarding claim 17, patent claim 10 of Radhakrishnan ‘406 wherein the flow control device comprises a valve having a first lip, a second lip, and two opposed inclined flaps leading to the first and second lips (claim 10).
Therefore, patent claims 9-10 of U.S. Patent No. 11,857,406 is in essence a “species” of the generic invention of application claims 2-3, 13, and 17. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 15, and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 7 and 21 recites the limitation "the length of the parallel and contacted first and second lips" in line 1. There is insufficient antecedent basis for this limitation in the claim. The examiner suggests amending the claim to read “a length of the parallel and contacted first and second lips”.
Claim 15 recites the limitation "the frame" in line 1. There is insufficient antecedent basis for this limitation in the claim. The examiner suggests amending the claim to read “a frame”.
Allowable Subject Matter
Claims 2-21 would be allowable if (1) a timely filed terminal disclaimer(s) in compliance with 37 CFR 1.321(c) or 1.321(d) is filed to overcome the nonstatutory double patenting rejection(s) set forth in this Office action; and (2) Claims 7, 15, and 21 are rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this office action.
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record is Deem et al (US 2003/0070683 A1) which does not teach or render obvious the cumulative claim limitations. It is noted that Deem teaches a method for implanting a valve in a bronchial passageway of a patient, the method comprising:; and implanting the valve in a bronchial passageway that feeds air to a targeted lung region, wherein the valve transitions between a closed configuration that blocks air flow in the inspiratory direction and an open configuration that permits air flow in an expiratory direction (paragraph 0063; paragraph 0068, lines 5-10); wherein the valve is in the closed configuration when exposed to no air flow (paragraph 0068, lines 8-10), air flow in the inspiratory direction (paragraph 0068, lines 8-10), and air flow in the expiratory direction at normal breathing pressures (paragraph 0109, lines 12-14 “only open for high pressure events such as coughing”), and wherein the valve is in the open configuration when exposed to air flow in the expiratory direction at coughing pressures (paragraph 0109).
However, the prior art either individually or in combination with, does not teach or render obvious providing a valve having a cracking pressure in the range of 121-160 inches H2O within the context of the cumulative claim limitations.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA LYNEE ZIMMERMAN whose telephone number is (313)446-4864. The examiner can normally be reached Mon. 8:30 AM-6:30 PM, Tues. - Fri. 8:30-4:00 PM.
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/REBECCA LYNEE ZIMMERMAN/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774