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 .
Response to Amendment
The amendment filed 11/21/2025 has been entered. Claims 1-20 are pending in the application.
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 1-3, 6, 8, 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of U.S. Patent No. 11,432, 962. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the instant claims are anticipated by the claims of the patent. Specifically, all of the elements of instant claim 1 are taught by claims 1 and 10 of patent ‘962. Additionally, all of the elements of instant claims 2, 3, 6, 8, 9 are taught by claim 1.
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.
Claims 1-9, 12, 14-16, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Badawi (US 2013/0253438) in view of Matsuzawa (US 2012/0253297).
Regarding Claim 1, Badawi discloses a medical device (1000, Fig 10A) comprising: an outer sheath (1012, Fig 10A); a microcannula (1022, Fig 10B) movably housed within the outer sheath and having a proximal end, a distal tip, a cavity and a central longitudinal axis (Para 0089); and a plurality of orifices (1304, Fig 13B) disposed on the distal tip of the microcannula, each orifice defining a channel extending to the central longitudinal axis, and each orifice configured to deliver a substance radially outwardly from the distal tip of the microcannula (Para 0092), wherein the distal tip of the microcannula is configured to extend out from a distal opening of the outer sheath when the microcannula is in an extended position and to be housed within the outer sheath when the microcannula is in a retracted position (Para 0019-0020).
Badawi is silent regarding one or more first protrusions disposed on an inner circumferential surface of an inner diameter of the outer sheath and extending circumferentially inward at a distal end of the outer sheath and one or more second protrusions located on an outer circumferential surface of the microcannula
Matsuzawa teaches an analogous medical device comprising an outer sheath (14, Fig 4) and inner member (10, Fig 4) movably housed within the outer sheath (Para 0062); one or more first protrusions (see annotated Fig 2B) disposed on an inner circumferential surface of an inner diameter of the outer sheath and extending circumferentially inward at a distal end of the outer sheath (the protrusions indicated in the annotated Fig 2B extend inward relative to an inner diameter defined by the grooves 20) and one or more second protrusions (26, Fig 3B) located on an outer circumferential surface of the microcannula (See Fig 3B).
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 outer sheath and microcatheter to include one or more first protrusions and one or more second protrusions, respectively, as Matsuzawa teaches that these protrusions can be useful in locating the elements using ultrasound such that positioning of the medical device can be confirmed (Para 0008).
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Regarding Claim 2, the modified invention of Badawi and Matsuzawa discloses a handle (1002, Fig 10A -Badawi) coupled to the proximal end of the microcannula (Para 0088-0089 -Badawi); and a control mechanism (1014, 1020, Fig 10B -Badawi) coupled to the handle, the control mechanism configured to extend and retract the distal tip of the microcannula out of and into the opening of the outer sheath, respectively (Para 0082, 0088 -Badawi).
Regarding Claim 3, the modified invention of Badawi and Matsuzawa discloses an actuator (1014, Fig 10B -Badawi) coupled to the microcannula, the actuator configured to extend the distal tip of the microcannula out of the opening of the outer sheath (Para 0082, 0088 -Badawi).
Regarding Claim 4, the modified invention of Badawi and Matsuzawa discloses the actuator (1014, Fig 10B -Badawi) is configured to extend the distal tip of the microcannula out of the opening of the outer sheath upon receiving a threshold amount of force (Para 0082, 0088 -Badawi).
Regarding Claim 5, the modified invention of Badawi and Matsuzawa discloses the distal tip is configured to be extended to penetrate trabecular meshwork of an eye while the outer sheath remains outside of the trabecular meshwork (Para 0100 -Badawi; As the microcannula is configured to extend out of the sheath, it is capable and configured for performing this function.).
Regarding Claim 6, the modified invention of Badawi and Matsuzawa discloses the handle (1002, Fig 10A -Badawi) comprises a track (1020, Fig 10B -Badawi), and wherein the actuator (1014, Fig 10B -Badawi) comprises a slide disposed within the track and configured to linearly slide along the track (Para 0082 -Badawi; the linear gear or track 1020 receives the gear or slide of actuator 1014 that slides along the linear gear/track).
Regarding Claim 7, the modified invention of Badawi and Matsuzawa discloses a first portion of the slide (gear) is one of bent and folded (Oxford Dictionary defines bent as “to change direction to form a curve or an angle; to make something change direction in this way”, thus a curved gear can be interpreted as bent), and wherein the first portion of the slide extends radially outwardly of the central longitudinal axis through the track (See Fig 10B -Badawi).
Regarding Claim 8, the modified invention of Badawi and Matsuzawa discloses the track (1020, Fig 10B -Badawi) has a width perpendicular to the central longitudinal axis and a plurality of narrowed sections defined by opposing pairs of flanges (teeth) protruding inwardly towards the central longitudinal axis (Best seen in analogous track 404 shown in Fig 4A -Badawi).
Regarding Claim 9, the modified invention of Badawi and Matsuzawa discloses an axial spacing between adjacent pairs of flanges correlates to an amount of the substance to be injected via the microcannula (Para 0108; movement of linear gear from correlates to an amount of substance to be injected and movement of the linear gear is dictated by the teeth spacing).
Regarding Claim 12, the modified invention of Badawi and Matsuzawa discloses the substance is a viscoelastic fluid (Para 0078), wherein the handle comprises a reservoir (1016, Fig 10B -Badawi) containing the viscoelastic fluid and an actuator (1014, Fig 10B -Badawi) configured to eject the viscoelastic fluid radially outwardly through the orifices (Para 0108 -Badawi).
Regarding Claim 14, the modified invention of Badawi and Matsuzawa discloses wherein one of: the first and second protrusions each include multiple protrusions equidistantly spaced apart (See Figs 2B and 3B; Para 0037, 0043 -Matsuzawa); the second protrusions are proximal to the first protrusions when the distal tip of the microcannula is in the retracted position; and the second protrusions are distal to the first protrusions when the distal tip of the microcannula is in the extended position.
Regarding Claim 15, Badawi discloses a medical device (1000, Fig 10A) comprising: a microcannula (1022, Fig 10B) having a proximal end (end of microcannula 1022 coupled to linear gear 1020, Fig 10B), a distal tip (end of microcannula 1022 extending from cannula 1012, Fig 10B), a cavity (inner lumen) and a central longitudinal axis; an outer sheath (1012, Fig 10A) movably housed around the microcannula (Para 0089); a handle (1002, Fig 10A) coupled to the proximal end of the microcannula (Para 0088-0089); and a plurality of orifices (1304, Fig 13B) disposed on the distal tip of the microcannula, each orifice defining a channel extending to the central longitudinal axis, and each orifice configured to deliver a substance outwardly from the distal tip of the microcannula (Para 0092), wherein the distal tip of the microcannula is configured to extend out from a distal opening of the outer sheath when the outer sheath is in a retracted position and to be housed within the outer sheath when the outer sheath is in an extended position (Para 0019-0020).
Badawi is silent regarding a first protrusion disposed on an inner circumferential surface of an inner diameter of the outer sheath and extending circumferentially inward at a distal end of the outer sheath; a second protrusion located on an outer circumferential surface of the microcannula.
Matsuzawa teaches an analogous medical device comprising an outer sheath (14, Fig 4) and inner member (10, Fig 4) movably housed within the outer sheath (Para 0062); one or more first protrusions (see annotated Fig 2B) disposed on an inner circumferential surface of an inner diameter of the outer sheath and extending circumferentially inward at a distal end of the outer sheath (the protrusions indicated in the annotated Fig 2B extend inward relative to an inner diameter defined by the grooves 20) and one or more second protrusions (26, Fig 3B) located on an outer circumferential surface of the microcannula (See Fig 3B).
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 outer sheath and microcatheter to include one or more first protrusions and one or more second protrusions, respectively, as Matsuzawa teaches that these protrusions can be useful in locating the elements using ultrasound such that positioning of the medical device can be confirmed (Para 0008).
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Regarding Claim 16, the modified invention of Badawi and Matsuzawa discloses the outer sheath (1012, Fig 10A -Badawi) is configured to move in a proximal direction when a distal portion of the outer sheath is pressed against trabecular meshwork of an eye (Para 0100-0101 -Badawi; as the cannula can be advanced and retracted from the eye, it is configured or capable of moving in a proximal direction when a distal portion of the outer sheath is pressed against trabecular meshwork).
Regarding Claim 18, the modified invention of Badawi and Matsuzawa discloses the substance is a viscoelastic fluid (Para 0078), wherein the handle comprises a reservoir (1016, Fig 10B -Badawi) containing the viscoelastic fluid and an actuator (1014, Fig 10B -Badawi) configured to eject the viscoelastic fluid radially outwardly through the orifices (Para 0108 -Badawi).
Regarding Claim 19, the modified invention of Badawi and Matsuzawa discloses a method of delivering fluid, comprising: inserting the medical device of claim 1 (See rejection of claim 1 above) through an incision in an anterior chamber of an eye; extending the distal tip of the microcannula out of the distal opening of the outer sheath, through a trabecular meshwork of the eye and into a Schlemm's canal of the eye; and delivering fluid through the microcannula and out of the plurality of orifices positioned within the Schlemm's canal (Para 0100).
Regarding Claim 20, the modified invention of Badawi and Matsuzawa discloses a method of delivering fluid, comprising: inserting the medical device of claim 15 (See rejection of claim 15 above) through an incision in an anterior chamber of an eye; pressing a distal portion of the outer sheath against a trabecular meshwork of the eye; moving the outer sheath in a proximal direction (Para 0101; the claim does not specify the order of steps, thus the proximal movement of the outer sheath is being interpreted as the removal of the device including the outer sheath at the conclusion of the procedure); advancing the distal tip through the trabecular meshwork and into a Schlemm's canal of the eye; and delivering fluid through the microcannula and out of the plurality of orifices positioned within the Schlemm's canal (Para 0100).
Claims 10-11, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Badawi (US 2013/0253438) in view of Matsuzawa (US 2012/0253297) and further in view of Pappone (US 2008/0249522).
Regarding Claim 10, the modified invention of Badawi and Matsuzawa discloses all of the elements of the invention as discussed above, however, is silent regarding a first orifice among the plurality of orifices is spaced 180 degrees apart from a second orifice among the plurality of orifices.
Pappone teaches a catheter (18, Fig 1) comprising a plurality of orifices (25, Fig 2) at a distal tip (21, Fig 2) wherein a first orifice (See annotated Fig 4A) among the plurality of orifices is spaced 180 degrees apart from a second orifice (See annotated Fig 4A) among the plurality of orifices.
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 orifices to be arranged as taught by Pappone in order to have all around expulsion of fluid (Para 0046). Additionally, Pappone teaches that the number and configuration of the orifices can be adjusted based on the intended use of the catheter (Para 0046).
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Regarding Claim 11, the modified invention of Badawi and Matsuzawa discloses all of the elements of the invention as discussed above, however, is silent regarding the plurality of orifices are disposed at the same distance from the proximal tip on the central longitudinal axis.
Pappone teaches a catheter (18, Fig 1) comprising a plurality of orifices (25, Fig 2) at a distal tip (21, Fig 2) wherein the plurality of orifices are disposed at the same distance from the proximal tip on the central longitudinal axis (As seen in Fig 4 and 4A, there is a circumferential arrangement of orifices at the same distance).
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 orifices to be arranged as taught by Pappone in order to have all around expulsion of fluid (Para 0046). Additionally, Pappone teaches that the number and configuration of the orifices can be adjusted based on the intended use of the catheter (Para 0046).
Regarding Claim 17, the modified invention of Badawi and Matsuzawa discloses all of the elements of the invention as discussed above, however, is silent regarding wherein one of: a first orifice among the plurality of orifices is spaced 180 degrees apart from a second orifice among the plurality of orifices; the plurality of orifices are disposed at the same distance from the proximal tip on the central longitudinal axis; and for each of the plurality of orifices, a radially outer end is positioned distal to a radially inner end, such that each of the orifices is configured to deliver the substance distally and radially outwardly from the microcannula.
Pappone teaches a catheter (18, Fig 1) comprising a plurality of orifices (25, Fig 2) at a distal tip (21, Fig 2) wherein a first orifice (See annotated Fig 4A above) among the plurality of orifices is spaced 180 degrees apart from a second orifice (See annotated Fig 4A above) among the plurality of orifices.
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 orifices to be arranged as taught by Pappone in order to have all around expulsion of fluid (Para 0046). Additionally, Pappone teaches that the number and configuration of the orifices can be adjusted based on the intended use of the catheter (Para 0046).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Badawi (US 2013/0253438) in view of Matsuzawa (US 2012/0253297) and further in view of Schwartz (US 2005/0197633).
Regarding Claim 13, the modified invention of Badawi and Matsuzawa discloses all of the elements of the invention as discussed above, however, is silent regarding for each of the plurality of orifices, a radially outer end is positioned distal to a radially inner end, such that each of the orifices is configured to deliver the substance distally and radially outwardly from the microcannula
Schwartz teaches a cannula comprising a plurality of orifices (66, Fig 7) at a distal tip, wherein for an orifice (66c, Fig 10), a radially outer end is positioned distal to a radially inner end, such that the orifice is configured to deliver the substance distally and radially outwardly from the cannula (Para 0100).
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 orifices to have a radially outer end is positioned distal to a radially inner end as taught by Schwartz in order to achieve a desired cloud pattern (Para 0016, 0100).
Response to Arguments
Applicant’s arguments filed 11/21/2025, on pages 7-8, regarding Matsuzawa failing to teach one or more first protrusions disposed on an inner circumferential surface of an inner diameter of the outer sheath and extending circumferentially inward at a distal end of the outer sheath have been fully considered but are not persuasive. As detailed in the rejection above, the protrusions indicated in the annotated Fig 2B extend inward relative to an inner diameter defined by the grooves 20. Therefore, Matsuzawa still reads on the amended claimed limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785