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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath et al. (Pub. No.: US 2014/0236066 A1).
Claim 15 of U.S. Patent No. 11,523,940 B2 fails to disclose delivering the glaucoma drainage system into an anterior chamber of an eye of a patient, the second fluid conduit end positionable within the anterior chamber.
Horvath teaches (fig. 8) a method of treatment (abstract) and thus in the same field of endeavor, comprising: delivering a glaucoma drainage system (shunt 300) into an anterior chamber (310) of an eye of a patient (¶ 0133), a second end (restrictive end 304) of a fluid conduit positionable within the anterior chamber (fig. 8, ¶ 0133) in order to direct aqueous humor flow from the anterior chamber to an outlet (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 15 of U.S. Patent No. 11,523,940 B2 such that it includes delivering the glaucoma drainage system into an anterior chamber of an eye of a patient, the second fluid conduit end positionable within the anterior chamber, as taught by Horvath, in order to remove aqueous humor from an anterior chamber of the eye (Horvath, ¶ 00041).
Regarding claim 2, claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath fail to disclose trimming a length of the fluid conduit after delivering the glaucoma drainage system to the anterior chamber.
Horvath further teaches (fig. 9) trimming a length of the fluid conduit after delivering the glaucoma drainage system to the anterior chamber (¶ 0135) in order to modify a flow resistance (¶ 0136).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath such that it comprises trimming a length of the fluid conduit after delivering the glaucoma drainage system to the anterior chamber, as taught by Horvath, in order to modify a flow resistance (Horvath ¶ 0136).
Regarding claim 3, claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath disclose selecting the length of the fluid conduit to match the anatomy of the patient (Horvath ¶ 0094).
Regarding claim 4, claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath disclose selecting the length of the fluid conduit to generally correspond to a pressure drop across the fluid conduit (Horvath ¶ 0026).
Regarding claim 6, claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath disclose positioning the glaucoma drainage system between a scleral tissue (Horvath, sclera 24) and a conjunctival tissue (Horvath, conjunctiva 18) of the eye (¶ 0087, fig. 2).
Regarding claim 10, claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath disclose puncturing a tissue (Horvath cornea 12) of the patient to access the anterior chamber (Horvath, fig. 1, ¶ 0084).
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath.
Claim 15 of U.S. Patent No. 11,523,940 B2 fails to disclose delivering the glaucoma drainage system to an eye of the patient, advancing the second end of the tube to a position within an anterior chamber of the eye; and adjusting a length of the tube after removing the stiffening member.
Horvath teaches (fig. 8) a method of treatment (abstract) and thus in the same field of endeavor, comprising: delivering a glaucoma drainage system (shunt 300) into an eye of a patient (¶ 0133), advancing a second end (restrictive end 304) of tube to a position within an anterior chamber (fig. 8, ¶ 0133) in order to direct aqueous humor flow from the anterior chamber to an outlet (abstract) and adjusting a length of the tube (¶ 0135) in order to modify a flow resistance (¶ 0136).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 15 of U.S. Patent No. 11,523,940 B2 such that it includes delivering the glaucoma drainage system to an eye of the patient, advancing the second end of the tube to a position within an anterior chamber of the eye; and adjusting a length of the tube after removing the stiffening member, as taught by Horvath, in order to remove aqueous humor from an anterior chamber of the eye (Horvath, ¶ 00041) and in order to modify a flow resistance (Horvath, ¶ 0136).
Regarding claim 14, claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath disclose positioning the glaucoma drainage system between a scleral tissue (Horvath, sclera 24) and a conjunctival tissue (Horvath, conjunctiva 18) of the eye (¶ 0087, fig. 2).
Regarding claim 15, claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath disclose removing the first stiffening member comprises applying tension to the stiffening member such that a coiled portion of the stiffening member at least partially unravels upon application of tension.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath.
Claim 15 of U.S. Patent No. 11,523,940 B2 fails to disclose delivering the glaucoma drainage system to an eye of the patient, advancing the glaucoma drainage system between one or more tissues of the eye; and positioning the second fluid conduit end into an anterior chamber of the eye.
Horvath teaches (fig. 8) a method of treatment (abstract) and thus in the same field of endeavor, comprising: delivering a glaucoma drainage system (shunt 300) into an eye of a patient (¶ 0133), advancing the glaucoma drainage system between one or more tissues of the eye (¶ 0087); and positioning the second fluid conduit end (restrictive end 304) into an anterior chamber of the eye (¶ 0133, fig. 8) in order to direct aqueous humor flow from the anterior chamber to an outlet (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 15 of U.S. Patent No. 11,523,940 B2 such that it includes delivering the glaucoma drainage system to an eye of the patient, advancing the glaucoma drainage system between one or more tissues of the eye; and positioning the second fluid conduit end into an anterior chamber of the eye., as taught by Horvath, in order to remove aqueous humor from an anterior chamber of the eye (Horvath, ¶ 00041).
Regarding claim 20, claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath fail to disclose trimming a length of the fluid conduit after removing the coiled stiffening member.
Horvath further teaches (fig. 9) trimming a length of the fluid conduit (¶ 0135) in order to modify a flow resistance (¶ 0136).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 15 of U.S. Patent No. 11,523,940 B2 in view of Horvath such that it comprises trimming a length of the fluid conduit, as taught by Horvath, in order to modify a flow resistance (Horvath ¶ 0136).
Claim Objections
Claims 9, 11, 15-16 and 19 are objected to because of the following informalities:
Claim 9, ln. 1 should read ---removing [[a]] the stiffening member---
Claim 11, ln. 10 should read ---from the anterior chamber to [[a]] the body of---
Claim 15, ln. 2 should read ---applying tension to the stiffening member such that a coiled portion---
Claim 16, ln. 2 should read ---accessing a first end of the first stiffening member---
Claim 19, ln. 2 should read ---into [[an]] the anterior chamber---
Appropriate correction is required.
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 3 and 12-13 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.
Claim 3 recites the limitation "the anatomy" in ln. 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the biological tissue" in ln. 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 is rejected due to dependency on claim 12.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 11, 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Camras (Pub. No.: US 2017/0087016 A1 in view of Silvestrini et al. (Pub. No.: US 2010/0137981 A1).
Regarding claim 11, Camras discloses (fig. 1-2) a method of treatment (¶ 0002) comprising:
Delivering a glaucoma drainage system (implantable ocular drainage device 30) to an eye of a patient (¶ 0027), the glaucoma drainage system including a body (outlet assembly 34), a tube (tubular body 32) having a first end (outlet 42) in fluid communication with the body (fig. 1, ¶ 0028) and a second end (inlet 44), and a lumen (46) extending from the first end to the second end (fig. 1, ¶ 0028);
Advancing the second end of the tube to a position within an anterior chamber of the eye (¶ 0028); and adjusting a length of the tube (¶ 0029).
Camras fails to disclose wherein at least a portion of a first stiffening member is associated with the tube; removing the first stiffening member from the tube such that the tube is operable to transfer fluid from the anterior chamber to a body of the glaucoma drainage system through the lumen; and adjusting the length after removing the first stiffening member.
Silvestrini teaches (fig. 6a-6c) a method of treatment (¶ 0002) and thus in the same field of endeavor comprising a glaucoma drainage system including a tube (implant 105, ¶ 0030), wherein at least a portion of a first stiffening member (elongate delivery wire 715) is associated with the tube (fig. 6A, ¶ 0062); removing the first stiffening member from the tube such that the tube is operable to transfer fluid from the anterior chamber to a body of the glaucoma drainage system through the lumen (fig. 6c, ¶ 0064), wherein the first stiffening member is configured to aid in implanting the system (¶ 0062-¶ 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Camras such that it includes at least a portion of a first stiffening member associated with the tube; and removing the first stiffening member from the tube such that the tube is operable to transfer fluid from the anterior chamber to a body of the glaucoma drainage system through the lumen, as taught by Silvestrini, in order to provide an aid in implanting the system (Silvestrini, ¶ 0062-¶ 0063).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Camras in view of Silvestrini such that the length of the tube is adjusted after removing the first stiffening member as the stiffening member is rigid (Silvestrini, ¶ 0061) and would not allow for the tube to be adjusted by cutting (Camras, ¶ 0029).
Regarding claim 14, Camras discloses positioning the glaucoma drainage system between a scleral tissue and a conjunctival tissue of the eye of the patient (fig. 2B, ¶ 0027).
Regarding claim 16, Camras in view of Silvestrini disclose wherein removing the first stiffening member further comprises accessing a first end of the stiffening member via front clear-cornea approach (Silvestrini, ¶ 0082).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Camras in view of Silvestrini, as applied to claim 11 above, and further in view of Horvath et al. (Pub. No.: US 2014/0236066 A1).
Regarding claim 12, Camras in view of Silvestrini fail to disclose wherein the tube further comprises a second stiffening member associated with the tube, the method further comprising puncturing the biological tissue with an end of the second stiffening member to access the anterior chamber.
Horvath teaches (fig. 1-2) a method of treatment (abstracta) and thus in the same field of endeavor, comprising: a second stiffening member (delivery device 40) associated with a tube (shunt 50) (¶ 0086), the method further comprising puncturing the biological tissue with an end of the second stiffening member to access the anterior chamber (10) (¶ 0085) in order to deploy the system (¶ 0084).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Camras in view of Silvestrini such that the tube further comprises a second stiffening member associated with the tube, the method further comprising puncturing the biological tissue with an end of the second stiffening member to access the anterior chamber, as taught by Horvath, in order to deploy the system (Horvath ¶ 0084).
Regarding claim 13, Camras in view of Silvestrini and further in view of Horvath disclose removing the second stiffening member after positioning a second end of the tube within the anterior chamber (Horvath fig. 1-2, ¶ 0084-¶ 0086).
Allowable Subject Matter
Claims 1-10 and 17-20 allowed.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is an examiner’s statement of reasons for allowance:
Claim 1 recites “removing a stiffening member from the fluid conduit by applying tension to the stiffening member, at least a portion of the stiffening member having coiled configuration that at least partially unravels upon application of tension to the stiffening member”.
Marchand (Pub. No.: US 2018/0206990 A1) discloses a method comprising a stiffening member having a coiled configuration (fig. 27-28). Marchand fails to disclose the coiled configuration unravelling upon application of tension. Rather, Marchand discloses that upon pulling an actuator, the helical flexible member extends outwardly (¶ 0151), thus teaching away.
Badawi et al. (Pub. No.: US 2016/0287438 A1) discloses (fig. 9) a method comprising a stiffening member having a portion having a coiled configuration (¶ 0154). However, Badawi fails to disclose, teach or suggest partial unravelling upon application of tension.
Stegmann et al. (Pub. No.: US 2012/0010702 A1) discloses (fig. 8a-8b) a method of treatment comprising a stiffening member having a coiled configuration. However, Stegman fails to disclose removal of the stiffening member and unravelling of the stiffening member.
Silvestrini et al. (Pub. No.: US 2009/0182421 A1) discloses (fig. 33) discloses a stiffening member having a coiled configuration that at least partially unravels upon application of tension to the stiffening member (¶ 0196). However, Silvestrini fails to disclose removing the stiffening member.
Tu et al. (Pub. No.: US 2007/0282244 A1) discloses (fig. 5B) discloses a guidewire having a coiled configuration. However, Tu fails to disclose, teach or suggest unravelling upon application of tension.
Grieshaber et al. (Pat. No.: US 6,375,642 B1) discloses (fig. 14) a method comprising a support member having a coil configuration. However, Grieshaber fails to disclose removing the support member and at least partially unravelling upon tension.
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.”
Accordingly, claim 1 and its dependents, claims 2-10, are allowable over the prior art.
Similarly, claim 17 recites “removing the coiled stiffening member by applying tension to a first end of the stiffening member to at least partially unravel the stiffening member”.
Accordingly, claim 17 and its dependents, claims 18-20, are allowable over the prior art.
Claim 15 is 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.
Claim 15 recites “wherein removing the stiffening member further comprises applying tension to the stiffening member such that a coiled portion of the stiffening member at least partially unravels upon application of tension”. Accordingly, claim 15 includes the same allowable subject matter discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. 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.
/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
Prosecution Insights