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 amendments filed on 10/13/2025 has been entered. Claim 8 has been amended; claim 12 has been cancelled; claims 21-24 have been added; claims 14-20 have been withdrawn. Accordingly, claims 1-11, and 13-24 are pending and under consideration.
Applicant’s amendments to the claims have overcome each and every 35. U.S.C. 112(d) rejection previously set forth in the Non-final Office action mailed on 07/15/2025. Therefore, all 35 U.S.C. 112(d) rejections are hereby withdrawn.
Response to Arguments
Applicant's arguments filed 10/13/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the actuation mechanism changes the physical length of the needle driver or the plunger driver) are not recited in the rejected claim 1, especially the limitation of a “physical length”. Although the claim is interpreted in light of the specification, limitations from the specification are not read into the claim. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In light of further search and consideration, claim 21, which does recite a physical length of the needle driver or the plunger driver, is rejected under 35 U.S.C. 103 as being unpatentable over Horvath in view of Tanaka US 2009/0171366 A1 (newly cited). See rejection of claims below.
Applicant’s arguments filed 10/13/2025, with respect to claim 8 have been fully considered and are persuasive. The rejection of claim 8 has been withdrawn.
Claim Rejections - 35 USC § 102
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 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 1-6, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horvath et al US 2015/0133946 A1 (previously cited, hereinafter Horvath), as cited in the IDS.
Regarding claim 1, Horvath discloses an intraocular shunt inserter 100 (Fig. 1B – inserter 100) for treating glaucoma (Abstract – “An inserter for treating glaucoma”), comprising:
a housing 102 (Fig. 1B – housing 102);
a needle assembly 104 (Fig. 2 – needle assembly 104) at least partially disposed within the housing 102 (Fig. 2) and comprising a needle 120 (Fig. 2 – needle component 120) and a needle driver 164 (Fig. 3 and Fig. 6A – needle driver 164) coupled to a proximal end portion of the needle 120 (Fig.. 2 – needle driver 174 coupled to the right end of needle component 120);
a plunger assembly 122+162 (Fig. 3 and Fig. 5A – plunger 122 and plunger driver 162) at least partially disposed within the housing 102 (Fig. 2-3) and comprising a plunger 122 (Fig. 2) and a plunger driver 162 (Fig. 3) coupled to a proximal end portion of the plunger 122 (Fig. 3 and Par. 166 – “the plunger 122 can be coupled to a plunger mount 142. The plunger mount 142, shown in FIGS. 3 and 5A-5B, can be fixedly coupled to a proximal end portion or midsection of the plunger 122… the plunger mount 142 can be coupled to a plunger driver 162 of the drive assembly 130”), the plunger 122 (Fig. 3) being at least partially disposed within a lumen of the needle 120 (Fig. 3, and Par. 164 – “The plunger 122 can be slidably movable within a lumen of the needle component 120”), the plunger 122 (Fig. 3) being configured to advance a shunt through the lumen of the needle (Par. 12 – “a plunger, disposed within the lumen, movable along the axis to result in an axial force on a shunt to urge the shunt distally relative to the needle”); and
an actuation mechanism 160 (Fig. 2-3 – drive component 160) being rotatable (Par. 171 – “rotation of the drive component 160…”) to change at least one of a length of the needle driver 164 or a length of the plunger driver 162 (Par. 194 – “the rotational movement of the drive component 160 can result in longitudinal movement along the longitudinal axis 178 to the plunger driver 162 and/or the needle driver 164”) for permitting a clinician to adapt the inserter 100 (Fig. 1) for a given surgical procedure (Par. 155 – “it is contemplated that although particular embodiments may be disclosed or shown in the context of ab interno procedures, such embodiments can be used in ab externo procedures”).
Regarding claim 2, Horvath suggests the invention of claim 1. Horvath further discloses wherein the plunger driver 162 (Fig. 2 and Fig. 11) moves in an opposing direction to the needle driver 164 (Fig. 2 and Fig. 11; Par. 196 – “As demonstrated, as the protrusion 182 moves through the angled portion 232 of the first groove 172, the plunger driver 162 can be advanced in a distal direction along the longitudinal axis 178”, and Par. 197 – “the needle driver 164 will be proximally retracted along the longitudinal axis 178 relative to the drive component 160 as the protrusion 184 is moved through the angled portion 242 of the second driving groove 174”) upon movement of the actuation mechanism 160 (Fig. 11, Par. 194 – “the rotational movement of the drive component 160 can result in longitudinal movement along the longitudinal axis 178 to the plunger driver 162 and/or the needle driver 164”, and Par. 196-197 demonstrates that the plunger driver 162 extends distally from position 1 through 3 of groove 172, while the needle driver 164 retracts proximally from position 3 through 5 of groove 174 as the drive component 160 rotates; thus moving in opposing direction).
Regarding claim 3, Horvath suggests the invention of claim 1. Horvath further discloses wherein the plunger driver 162 (Fig. 2 and Fig. 11) extends (Fig. 11 – plunger driver 162 extends from position 1 through 3, and Par. 196 – “the plunger driver 162 can be advanced in a distal direction along the longitudinal axis 178”) and the needle driver 164 (Fig. 2 and Fig. 11) retracts (Fig. 11 – needle driver 164 retracts from position 3 through 5, and Par. 197 – “the needle driver 164 will be proximally retracted along the longitudinal axis 178 relative to the drive component 160”) upon movement of the actuation mechanism 160 (Par. 194 – “the rotational movement of the drive component 160 can result in longitudinal movement along the longitudinal axis 178 to the plunger driver 162 and/or the needle driver 164”).
Regarding claim 4, Horvath suggests the invention of claim 1. Horvath further discloses wherein the actuation mechanism 160 (Fig. 2-3) comprises an oblong cam 174 (Fig. 11 – driving groove 174), wherein the oblong cam 174 (Fig. 11) is rotatable within a body of the needle driver 164 (Figs. 15 – groove 174 rotates and provides movement for protrusion 184 of needle driver 164) about an axis 240 (Fig. 11 – straight portion 240; the rotating axis of groove 174 comprises the straight portion 240) oriented perpendicular relative to a longitudinal axis 178 (Fig. 11 – longitudinal axis 178; straight portion 240 is perpendicular to the longitudinal axis 178) of the inserter 100 (Fig. 2, and Fig. 11).
Regarding claim 5, Horvath suggests the invention of claim 1. Horvath further discloses wherein the actuation mechanism 160 (Fig. 2-3) comprises an oblong cam 172 (Fig. 11 – driving groove 172), wherein the oblong cam 172 (Fig. 11) is rotatable within a body of the plunger driver 162 (Figs. 15 – groove 172 rotates and provides movement for protrusion 182 of plunger driver 164) about an axis 230 (Fig. 11 – straight portion 230) oriented perpendicular relative to a longitudinal axis 178 (Fig. 11 – longitudinal axis 178; straight portion 230 is perpendicular to the longitudinal axis 178) of the inserter 100 (Fig. 2, and Fig. 11).
Regarding claim 6, Horvath suggests the invention of claim 1. Horvath further discloses wherein the actuation mechanism 160 (Fig. 2) comprises an oblong cam 170 (Fig. 11 - groove 170) that comprises a major axis and a minor axis (see annotated Fig. 11 below), and wherein the length of the needle driver 164 (Fig. 2) and the length of the plunger driver 164 (Fig. 2) changes by rotating the oblong cam 170 (Fig. 11, and Par. 194 – “the protrusion 180 moves between the positions illustrated in FIG. 11. This longitudinal movement of the protrusion 180 along the longitudinal axis 178 can result in rotational movement of the drive component 160. And as discussed herein, the rotational movement of the drive component 160 can result in longitudinal movement along the longitudinal axis 178 to the plunger driver 162 and/or the needle driver 164”) to align the major axis with the longitudinal axis 178 (see annotated Fig. 11 below – the major axis aligns with the longitudinal axis at the third position, and Par. 194 – “This longitudinal movement of the protrusion 180 along the longitudinal axis 178”, thus indicating alignment) of the inserter 100 (Fig. 2).
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Annotated Fig. 11 of Horvath
Regarding claim 23, Horvath suggests the invention of claim 1. Horvath further discloses wherein the change in length comprises a lengthening of at least one of the needle driver 164 or the plunger driver 162 (Par. 194 – “the rotational movement of the drive component 160 can result in longitudinal movement along the longitudinal axis 178 to the plunger driver 162 and/or the needle driver 164”; thus driver can be lengthened via advancement).
Regarding claim 24, Horvath suggests the invention of claim 1. Horvath further discloses wherein the change in length comprises a foreshortening of at least one of the needle driver 164 or the plunger driver 162 (Par. 194 – “the rotational movement of the drive component 160 can result in longitudinal movement along the longitudinal axis 178 to the plunger driver 162 and/or the needle driver 164”; thus driver can be shortened via retraction).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Horvath as applied to claim 1 above.
Regarding claim 7, Horvath suggests the invention of claim 1. Horvath further discloses further comprising a key 106 (Fig. 1 and Fig. 13A – slider component 106), wherein the key 106 (Fig. 1 and Fig. 13A) is engaged with the actuation member 160 (Fig. 2, and Par. 183 – “The drive component 160 can comprise one or multiple engagement grooves to engage with the slider component 106”) to move the actuation member 160 (Figs. 14, and Par. 194 – “As the slider component is moved longitudinally along the housing 102, the protrusion 180 moves between the positions illustrated in FIG. 11. This longitudinal movement of the protrusion 180 along the longitudinal axis 178 can result in rotational movement of the drive component 160”).
However, Horvath does not disclose a removable key and is releasably engaged.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the slider component of Horvath to be separable, as The Courts have held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961) (see MPEP § 2144.04). Furthermore, one of ordinary skill in the art would have been motivated to do so in order to provide ease of replacement and repair of the device.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Horvath in view of Tanaka US 2009/0171366 A1 (newly cited, hereinafter Tanaka).
Regarding claim 21, Horvath suggests the invention of claim 1. However, Horvath does disclose wherein rotation of the actuation mechanism 160 (Fig. 2-3 – drive component 160) causes a portion of at least one of the needle driver 164 or the plunger driver 162 to change a length (Par. 194 – “the rotational movement of the drive component 160 can result in longitudinal movement along the longitudinal axis 178 to the plunger driver 162 and/or the needle driver 164”) of the needle driver 164 or the plunger driver (Fig. 2-3).
However, Horvath does not disclose at least one of the needle driver or the plunger driver to deform so as to change a physical length.
Tanaka, in the same field of endeavor of intraocular insertion tools (Title), teaches the plunger driver 130 (Fig. 18 – plunger 130) to deform (Par. 117 – “the plunger 130 as a whole will experience elastic deformation”) so as to change a physical length (Claim 3- “produce elastic deformation of the plunger member in a prescribed lengthwise section of the axial direction”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Horvath to further include axial elastic deformation of the plunger driver as taught by Tanaka, so that a contact load across the plunger can be increased smoothly, and operating resistance can be varied smoothly (Par. 23 of Tanaka).
Allowable Subject Matter
Claim 22 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.
Regarding claim 22, no art on record, alone, or in combination could be found to teach: wherein rotation of the actuation mechanism displaces walls of an aperture defined in the needle driver or the plunger driver, thereby changing the length of the needle driver or the length of the plunger driver.
The closest prior art of record is Horvath.
As established above, Horvath substantially discloses claim 1. However, Horvath does not disclose the limitation of claim 22. Furthermore, Horvath does not even suggest any modification to form openings on the driver body for any length changing purposes. No prior arts of record have been found to teach the claimed limitation of an aperture on the driver body that can be displaced as claimed to change the length of said driver. It would not have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have significantly modified the needle/plunger driver of Horvath to include apertures whose walls can be displaced to change a length of said driver.
Therefore, claim 22 is indicated for allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 8, no art on record, alone, or in combination could be found to teach: a component driver comprising an actuation member and a body defining an aperture, wherein, upon displacement of walls of the aperture, the component driver elongates from a first length to a second length upon movement of the actuation member for changing a longitudinal relative position of at least one of a distal end portion of the plunger, when coupled to a proximal end portion of the plunger, or a distal end portion of the needle, when coupled to a proximal end portion of the needle, in combination with the remaining claimed features.
The closest prior art of record is Horvath.
As previously established in the Office Action mailed on 07/15/2025, Horvath substantially discloses claim 8. However, Horvath does not disclose a component driver comprising an actuation member and a body defining an aperture, wherein, upon displacement of walls of the aperture, the component driver elongates from a first length to a second length upon movement of the actuation member. Furthermore, Horvath does not even suggest any modification to form openings on the driver body for any length changing purposes. No prior arts of record have been found to teach the claimed limitation of an aperture on the driver body that can be displaced as claimed to change the length of said driver. It would not have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have significantly modified the needle/plunger driver of Horvath to include apertures whose walls can be displaced to change a length of said driver.
Therefore, claim 8 is indicated for allowable subject matter. Accordingly, claims 9-11, and 13 are also indicated for allowable subject matter.
Conclusion
THIS ACTION IS MADE FINAL. 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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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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.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781