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 .
Status of Claims
The amendments filed September 4, 2026 have been entered.
Claim 19 is cancelled.
Claims 1-14, 17-18 and 20 are amended.
Claims 1-18 and 20 are pending.
Applicant’s amendment necessitated the updated mapping of claims 1 and 17 and the revised rejection of claim 20. Accordingly, THIS ACTION IS MADE FINAL. See MPEP §706.07(a).
Response to Arguments
Applicant argues on line 13 of page 5 through line 13 of page 6 of the remarks filed on September 4, 2026, regarding claim 1, that Lang does not disclose a first outer diameter of at least 0.3 mm at the distal-most end and a larger second outer diameter of at least 0.7 mm located proximally thereof that is effective to inhibit the cannula from entering a horizontal portion of the lacrimal canaliculus, because Lang repeatedly teaches insertion of distal portion 84 into the canaliculus and does not teach a proximal enlarged diameter specifically configured to inhibit entry into the horizontal portion.
However, Examiner respectfully disagrees, because Lang discloses both recited diameters and a structure capable of the recited inhibiting function. Distal portion 84 has an outer diameter of about 24 gauge to about 32 gauge (~0.23 mm to 0.55 mm) (Lang, col. 8, lines 52-55), which includes values of at least 0.3 mm. Proximal portion 88 / slanted wall 94 has an outer diameter of about 18 gauge to about 8 gauge (1.2 mm to ~4.19 mm) (Lang, col. 8, lines 56-59), which is at least 0.7 mm and is proximal to the first diameter. Slanted wall 94 seats against punctum 12 and forms the punctal seal (Lang, fig. 6; col. 9, lines 14-18). Distal portion 84 is only 0.5 mm to 2.5 mm long (Lang, col. 9, lines 14-18). The horizontal canaliculus begins after the short vertical portion. A tip of 0.5-2.5 mm that is stopped by wall 94 at the punctum cannot reach the horizontal portion. Claim 1 requires inhibition of entry into the horizontal portion; it does not forbid short entry into the vertical portion. Functional language is anticipated when the prior-art structure is capable of performing the function (MPEP 2114). Lang’s intended short insertion of 84 into the canaliculus is consistent with, not contrary to, the claimed inhibition of horizontal entry. Therefore, the rejection of claim 1 still stands.
Applicant argues on line 18 of page 5 through line 13 of page 6 of the remarks filed September 4, 2026, regarding claim 17, that Lang does not disclose a distal tip that tapers radially inwardly toward the distal-most end so that an increased proximal diameter blocks advancement into the vertical lacrimal canaliculus beyond 3 mm, such that the tip seals against the punctal os but does not enter the horizontal lacrimal canaliculus.
However, Examiner respectfully disagrees, because Lang discloses slanted wall 94 tapering from body 82 to distal portion 84 (Lang, fig. 5), wall 94 sealing punctum 12 without dilation (Lang, col. 9, lines 14-18), and distal portion 84 being only 0.5 mm to 2.5 mm long so that it does not contact plug 30 (Lang, col. 9, lines 14-18). A tip limited to 0.5-2.5 mm does not advance into the vertical canaliculus beyond 3 mm and does not reach the horizontal canaliculus. The 3 mm limitation now appearing in claim 17 is met by Lang’s disclosed tip length. Therefore, the rejection of claim 17 still stands.
Applicant argues on line 26 of page 6 through line 11 of page 7 of the remarks filed September 4, 2026, regarding claims 3-14, 16, and 20, that neither Lang nor Trudell teaches a distal-most diameter and a larger proximal diameter configured as a penetration-limiting stop that inhibits entry into the horizontal canaliculus, that the claimed dimensions are not arbitrary design choices, and that the references do not recognize the claimed combination of controlled insertion depth, punctal sealing, and prevention of horizontal entry.
However, Examiner respectfully disagrees, because the base structure of a small distal tip and a larger proximal sealing/stop surface is disclosed by Lang (distal portion 84 and slanted wall 94), as set forth in claims 1 and 17. Trudell is relied on for an inward taper and for the teaching that taper length, taper angle, taper position, and the lengths of the small and large-diameter shaft portions “could be made to vary according to practitioner preference” (Trudell, col. 4, lines 9-14). Those are result-effective variables (MPEP 2144.04). The anatomical results Applicant identifies – seal at the punctum without deep canalicular travel – are the same result Lang already describes (seal at punctum 12; short tip so as not to contact plug 30). The secondary references (Qui, Bausch, Fezza, Tulevech) supply only the additional features of wall thickness, deflection/curvature, pre-loaded syringe, and a numeric depth stop, each with the same motivation previously stated. No new structural combination is presented by the amendment. Therefore, the rejection of claims 3-14, 16 and 20 still stand.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 15, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lang (US Patent No. 6,428,502, hereinafter, Lang).
Regarding claim 1, Lang discloses a lacrimal cannula (Lang; cannula 80 in figs. 5) comprising: a hollow tubular body (Lang; body 82 in figs. 5) having a dispensing end (Lang; external annulus 86 and distal portion 84 in figs. 5), a loading end (Lang; hub 92 in figs. 5), and an injection lumen therebetween (Lang; figs. 5; col. 4, lines 56-59);
wherein the dispensing end terminates in a distal tip (Lang; tip of distal portion 84 in fig. 5), the distal tip has a first outer diameter of at least 0.3 mm (Lang; distal portion 84 in fig. 5; col. 8, lines 52-55; distal portion 84 preferably has an outer diameter from about 24 gauge to about 32 gauge (~0.23mm to 0.55mm), so that it can easily be inserted into puncta 12 and 16 without any dilation) at a distal-most end (Lang; distal portion 84 in figs. 5) thereof configured to engage and seal against a punctal os (Lang; punctum 12 in fig. 6), and has a second outer diameter of at least 0.7 mm (Lang; proximal portion 88 preferably has an outer diameter of about 18 gauge to about 8 gauge (1.2mm to ~4.19mm), so that slanted wall 94 forms a smooth surface for contact with the external surface of puncta 12 and 16; col. 8, lines 56-59), which is proximal to the first outer diameter and is effective to inhibit the lacrimal cannula from entering a horizontal portion of the lacrimal canaliculus (Lang; canaliculus 14 in fig. 6; col. 6, lines 18-28; col. 9, lines 14-18).
Regarding claim 2, Lang discloses the lacrimal cannula as in claim 1, wherein the first outer diameter is in a range from 0.3 mm to 0.7 mm (Lang; distal portion 84 in fig. 5; col. 8, lines 52-55; distal portion 84 preferably has an outer diameter from about 24 gauge to about 32 gauge (~0.23mm to 0.55mm), so that it can easily be inserted into puncta 12 and 16 without any dilation).
Regarding claim 15, Lang discloses a syringe assembly comprising: a lacrimal cannula as in claim 1; and a syringe (Lang; syringe 53; col. 8, lines 40-43).
Regarding claim 17, Lang discloses a method for delivering a substance to a patient's lacrimal canaliculus or lacrimal sac, said method comprising: engaging a distal tip (Lang; tip of distal portion 84 in fig. 5) of a hollow tubular body (Lang; body 82 in fig. 5) against the patient's punctal os,
wherein the distal tip tapers radially inwardly in a distal direction toward a distal-most end (Lang; slanted wall 94 tapers radially inwardly from body 82 to distal portion 84 in fig. 5) so that an increased diameter of the distal tip at a location proximal of a distal-most end blocks advancement of the distal tip into a vertical lacrimal canaliculus of the patient beyond a distance of 3 mm (Lang; length of distal portion 84 is 0.5 mm to 2.5 mm; col. 9, lines 14-18), such that the distal tip seals against the punctal os (Lang; slanted wall 94 effectively seals punctum 12 without any dilation of punctum 12, and without the necessity of forcefully pressing cannula 80 against the punctal tissue to create a seal) but does not enter a horizontal lacrimal canaliculus of the patient (Lang; distal portion 84 can be easily inserted into canaliculus 14 without contacting plug 30 and thus interfering with the formation of the punctal seal in figs. 5-6; col. 9, lines 14-18); and
injecting the substance through an injection lumen of the hollow tubular body, out of the distal tip, and into the patient's lacrimal sac and/or lacrimal canaliculus (Lang; col. 9, lines 14-19).
Regarding claim 18, Lang discloses the method as in claim 17, wherein a distal-most end on the distal tip (Lang; tip of distal portion 84 in fig. 5) has a diameter that can fit within the punctal os (Lang; distal portion 84 in fig. 5; col. 8, lines 52-55; distal portion 84 preferably has an outer diameter from about 24 gauge to about 32 gauge (~0.23mm to 0.55mm), so that it can easily be inserted into puncta 12 and 16 without any dilation).
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.
Claims 3-7 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Lang, as applied to claims 1-2 above, in view of Trudell (US Patent No. 5,593,393, hereinafter, Trudell).
Regarding claim 3, Lang discloses the lacrimal cannula as in claim 2 comprising a distal tip (Lang; tip of distal portion 84 in fig. 5), but fails to disclose that the tip tapers radially inwardly in a distal direction toward the distal-most end.
Trudell teaches that the tip tapers radially inwardly in a distal direction toward the distal-most end (Trudell; taper 14 in figs. 1-4).
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 distal tip region of Lang’s cannula to include an inwardly tapered shaft portion between the larger proximal shaft and the small distal tip, as taught by Trudell, in order to facilitate smoother insertion into the punctum, provide a gradual transition to the distal-most end, and improve control of insertion depth while still achieving Lang’s sealing and safety functions.
Regarding claim 4, Lang discloses the lacrimal cannula as in claim 3, wherein the second outer diameter is in a range from 0.7 mm to 2 mm (Lang; proximal portion 88 preferably has an outer diameter of about 18 gauge to about 8 gauge (1.2mm to ~4.19mm), so that slanted wall 94 forms a smooth surface for contact with the external surface of puncta 12 and 16; col. 8, lines 56-59) at a first distance in a range from 1 mm to 3 mm from the distal-most end (Lang; length of distal portion 84 is relatively short in length (0.5mm to 2.5mm) so that it can be easily inserted into canaliculus 14 without contacting plug 30 and thus interfering with the formation of the punctal seal as shown in fig. 6; col. 9, lines 14-18).
Lang does not explicitly disclose selecting a diameter of 0.7mm to 2mm at a first distance of 1mm to 3mm from the distal-most end.
Trudell, however, teaches that in lacrimal cannulas “the length of the small diameter portion of the cannula shaft and large diameter portion can vary” and that “taper length, taper angle, and taper positions could be made to vary according to practitioner preference” in col. 4, lines 9-14, indicating that the specific shaft diameters and the axial positions at which those diameters are reached are adjustable design parameters.
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 dimensions of Lang’s distal and adjacent shaft portions so that the outer diameter at a location 1mm to 3mm from the distal-most end falls within 0.7mm to 2mm, as a routine optimization of the known shaft diameters and distal length, in accordance with Trudell’s teaching that shaft length, diameter, and taper position are results-effective variables that may be adjusted according to practitioner preference to achieve the desired balance of ease of insertion, sealing at the punctum, and depth control of the lacrimal cannula.
Regarding claim 5, Lang discloses the lacrimal cannula as in claim 4 comprising a distal tip (Lang; distal portion 84 in fig. 5), but fails to disclose that the distal tip tapers radially inwardly at a first angle in a range from 10° to 20° over the first distance.
Trudell, however, teaches that in lacrimal cannulas “the length of the small diameter portion of the cannula shaft and large diameter portion can vary” and that “taper length, taper angle, and taper positions could be made to vary according to practitioner preference” in col. 4, lines 9-14, indicating that the specific shaft diameters and the axial positions at which those diameters are reached are adjustable design parameters. (Trudell; taper 14 in figs. 1-4 provides an inward taper between small distal shaft 12 and larger proximal portion 15; Trudell further teaches taper length, taper angle, and taper positions, as well as the length of the small and large diameter portions, may be varied according to practitioner preference).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as shown in annotated fig. 5 of Lang and fig. 1 of Trudell below, to modify the inward taper between the larger shaft and the small distal tip of Lang so that, over the first 1mm to 3mm from the distal-most end, the taper angle is chosen within 10° to 20°, as a routine optimization of taper angle and length in view of Trudell’s teaching that these parameters may be adjusted according to practitioner preference to obtain the desired balance of smooth punctal entry, gradual transition to the distal-most end, and controlled insertion depth.
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Regarding claim 6, Lang discloses the lacrimal cannula as in claim 5, wherein the distal tip (Lang; tip of distal portion 84 in fig. 5) tapers radially outwardly at a second angle in a range from 25° to 60° (Lang; second taper in fig. 5; approximately in the range of 25° to 60°; slanted wall 94 forms a smooth surface for contact with the external surface of puncta 12 and 16; col. 8, lines 56-59; slanted wall 94 preferably forms an angle from about 5° to 30° from line 96 running perpendicularly to the longitudinal axis of cannula 80, as seen in fig. 5, which equates to a 60° to 85° from the longitudinal axis itself), but fails to disclose over a second distance in a range from 2 mm to 5 mm from the distal-most end.
Although Lang does not expressly disclose that this outward flare has a second taper angle specifically within 25° to 60° or that it extends over a second distance of 2mm to 5mm from the distal-most end, Lang does disclose that the distal portion 84 is relatively short in length so that it can be inserted without contacting the plug (col. 9, lines 14-18).
Trudell further teaches that in lacrimal cannulas “the length of the small diameter portion of the cannula shaft and large diameter portion can vary” and that “taper length, taper angle, and taper positions could be made to vary according to practitioner preference” in col. 4, lines 9-14, indicating that the specific shaft diameters and the axial positions at which those diameters are reached are adjustable design parameters.
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 outward flare of Lang’s cone-shaped wall 94 so that, starting just proximally to the first taper region, it diverges from the cannula axis at an angle within 25° to 60° and reaches its full sealing diameter within a second distance of 2mm to 5mm from the distal-most end, as a routine optimization of taper angle, length, and position in view of Trudell’s teaching that these parameters may be adjusted according to practitioner preference to provide sufficient sealing surface at the punctum while locating the shoulder at an anatomically appropriate depth to limit insertion into vertical canaliculus.
Regarding claim 7, Lang discloses the lacrimal cannula as in claim 6, but fails to disclose wherein the injection lumen is tapered radially inwardly in a distal direction from the loading end to the dispensing end.
Trudell, however, teaches a lacrimal cannula wherein the injection lumen (Trudell; hollow tube 20 in fig. 2) is tapered radially inwardly in a distal direction from the loading end to the dispensing end (Trudell; col. 3, lines 8-11; tube 20 starts distally at distal tube opening 10 and extends the length of cannula 16 with a proximal opening with hub 18).
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 injection lumen of Lang to be tapered radially inwardly in a distal direction from the loading end to the dispensing end, as taught by Trudell, in order to reduce injection resistance and facilitate easier delivery of the gel or other substance through the cannula.
Regarding claim 10, Lang discloses the lacrimal cannula as in claim 2, wherein the hollow tubular body comprises a distal-most section, a middle section, and a proximal section (Lang; body 82 with a distal portion 84, a proximal portion 88, and a middle portion in between distal portion 84 and proximal portion 88 as seen in fig. 5) wherein the distal-most section is generally cylindrical having a length in a range from 1.5 mm to 3 mm (Lang; length of distal portion 84 is relatively short in length (0.5mm to 2.5mm) so that it can be easily inserted into canaliculus 14 without contacting plug 30 and thus interfering with the formation of the punctal seal as shown in fig. 6; col. 9, lines 14-18) and an outside diameter along its length in the range from 0.3 mm to 0.7 mm (Lang; distal portion 84 in fig. 5; col. 8, lines 52-55; distal portion 84 preferably has an outer diameter from about 24 gauge to about 32 gauge (~0.23 mm to 0.55 mm), so that it can easily be inserted into puncta 12 and 16 without any dilation).
Lang does not expressly disclose selecting a cylindrical distal-most section having a length specifically within 1.5 mm to 3 mm and an outside diameter specifically within 0.3 mm to 0.7 mm.
Trudell further teaches that, in lacrimal cannulas, “the length of the small diameter portion of the cannula shaft and large diameter portion can vary” and that “taper length, taper angle, and taper positions could be made to vary according to practitioner preference” in col. 4, lines 9-14, indicating that the precise length and diameter of the small distal portion are results-effective design parameters that are routinely adjusted.
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 dimensions of Lang’s distal portion 84 so that the cylindrical distal-most section has a length within 1.5mm to 3mm and an outside diameter within 0.3 mm to 0.7 mm, as a routine optimization of the known 0.5 mm-2.5 mm length and 24 gauge to 32 gauge diameter, as taught by Lang in view of Trudell’s teaching that distal shaft length and diameter are adjustable according to practitioner preference to achieve the desired balance of easy punctal entry, adequate stiffness, and controlled insertion depth.
Regarding claim 11, Lang discloses the lacrimal cannula as in claim 10, wherein the middle section is generally cylindrical having a length in a range from 3 mm to 10 mm (Lang; fig. 5 shows length of proximal portion 88 of cannula body to be approximately in the 3mm to 10mm range) and an outside diameter along its length in the range from 3 mm to 10 mm (Lang; proximal portion 88 preferably has an outer diameter of about 18 gauge to about 8 gauge, or 1.2mm to ~4.19mm).
Lang does not expressly disclose selecting that middle cylindrical section to have a length specifically within 3mm to 10mm and an outside diameter of specifically within 3mm to 10mm.
Trudell further teaches that, in lacrimal cannulas, “the length of the small diameter portion of the cannula shaft and large diameter portion can vary” and that “taper length, taper angle, and taper positions could be made to vary according to practitioner preference” in col. 4, lines 9-14, indicating that the precise length and diameter of the larger-diameter shaft regions and their axial positions are results-effective design parameters that a practitioner selects.
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 dimensions of Lang’s middle shaft portion 88 so that it is generally cylindrical with a length within 3mm to 10mm and an outside diameter within 3mm to 10mm, as a routine optimization of the known larger-diameter shaft dimensions taught by Lang in view of Trudell’s teaching that the lengths and diameters of the small and large shaft portions, and the positions of the tapers between them, may be adjusted according to practitioner preference to provide a short, stiff intermediate section that is comfortable to handle, compatible with standard syringe hubs, and that positions the sealing shoulder at an anatomically appropriate depth to limit insertion.
Regarding claim 12, Lang discloses the lacrimal cannula as in claim 10, wherein the distal-most section is straight and aligned with an axis of the hollow tubular body (Lang; distal portion 84 is shown as a straight extension of the cannula shaft body 82 along the same longitudinal axis).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lang in view of Trudell, as applied to claim 7 above, and further in view of Qui (CN Patent No. 111821097, hereinafter Qui).
Regarding claim 8, modified Lang discloses the lacrimal cannula as in claim 7, which comprises the distal-most end (Lang; slanted wall 94 tapers radially inwardly from body 82 to distal portion 84 in fig. 5) of the distal tip (Lang; tip of distal portion 84 in fig. 5), but fails to disclose that the dispensing end of the hollow tubular body has a wall thickness between an outer surface and an inner wall of the injection lumen in a range between 0.03 mm and 0.2 mm.
Trudell, however, teaches that dispensing end (Trudell; col. 3, lines 8-11; tube 20 starts distally at distal tube opening 10 and extends the length of cannula 16 with a proximal opening with hub 18) is a hollow tubular body (Trudell; col. 3, lines 8-11; tube 20 starts distally at distal tube opening 10 and extends the length of cannula 16 with a proximal opening with hub 18).
Furthermore, Qui teaches that the hollow tubular body at the dispensing end of the cannula has a wall thickness between the outer surface and an inner wall of the injection lumen in a range between 0.03 mm and 0.2 mm (Qui; figs. 1-3, thickness of lacrimal punctum cannula wall 31 is not more than 0.1mm, which is in the range of 0.03mm to 0.2mm).
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 distal-most end of the distal tip of the hollow tubular body of modified Lang to have a wall thickness between the outer surface and an inner wall of the injection lumen in a range between 0.03mm and 0.2mm, as taught by Qui, in order to minimize the outer diameter at the tip while maintaining sufficient structural integrity and allowing a larger internal lumen diameter to further reduce injection resistance.
Regarding claim 9, modified Lang discloses the lacrimal cannula as in claim 8, wherein the loading end of the hollow tubular body is configured to be removably secured to a syringe (Lang; col. 8, lines 40-43; proximal portion 88 is coupled to a hub 92 which is for removably coupling to a conventional syringe 53).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lang in view of Trudell, as applied to claim 10 above, further in view of (Bausch + Lomb (2015), 2015-2016 Ophthalmic Instrument Catalogue [Exhibition Catalogue]), hereinafter Bausch.
Regarding claim 13, Lang discloses the lacrimal cannula as in claim 10, but fails to disclose wherein the distal-most section is straight and deflected at an angle in a range from 10° to 45° relative to an axis of the hollow tubular body.
Bausch teaches wherein the distal-most section is straight and deflected at an angle in a range from 10° to 45° relative to an axis of the hollow tubular body (Bausch (2015), page 43; Lacrimal Cannula, Model Marburg 81075Y5; shows 45° deflected cannula).
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 distal-most section of the lacrimal cannula of Lang to be straight and deflected at an angle in a range from 10° to 45° relative to an axis of the hollow tubular body, as taught by Bausch, in order to improve access and ease of insertion into the vertical portion of the lacrimal canaliculus while maintaining precise tip control.
Regarding claim 14, Lang discloses the lacrimal cannula as in claim 10 but fails to disclose wherein the distal-most section is curved.
Bausch teaches wherein the distal-most section is curved (Bausch (2015), page 43; Lacrimal Cannula, Model Bonn 81080-6; shows gently curved cannula shaft).
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 distal-most section of the lacrimal cannula of Lang to be curved, as taught by Bausch, in order to improve ergonomic access and ease of insertion into the lacrimal canaliculus.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lang, as applied to claim 15 above, in view of Fezza (US Patent No. 8979821, hereinafter, Fezza).
Regarding claim 16, Lang discloses the syringe assembly of claim 15, but fails to disclose that the syringe is pre-loaded with a substance to be delivered to a patient's lacrimal canaliculus.
Fezza teaches that the syringe is pre-loaded with a substance to be delivered to a patient's lacrimal canaliculus (Fezza; col. 10, lines 37-50; fluid comes prepackaged within the syringe cylindrical chamber 60)
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 syringe of Lang to be pre-loaded with a substance to be delivered to a patient’s lacrimal canaliculus, as taught by Fezza, in order to provide a sterile, ready-to-use assembly that eliminates the need for the practitioner to draw up the material immediately prior to use, thereby reducing contamination risk and ensuring accurate dosing.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lang, as applied to claims 17-18 above, in view of (Tulevech, C. B. (1969). A New Canaliculus Irrigating Tip. Archives of Ophthalmology, 81(3), 369-369), hereinafter, Tulevech.
Regarding claim 20, Lang discloses the method as in claim 18, but fails to disclose that the distal-most end of the distal tip is blocked from entering the patient's vertical lacrimal canaliculus beyond a distance of 1 mm.
Tulevech teaches that the distal-most end of the distal tip is blocked from entering the patient's vertical lacrimal canaliculus beyond a distance of 3 mm (Tulevech; teaches a beveled cannula top which extends approximately 3mm beyond tapered shoulder, permitting the instrument to fit snugly into the punctum and preventing the cannula from reaching beyond 3 mm; Tulevech, page 369, para 1).
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 distal-most end of the distal tip of Lang so that it is blocked from entering the patient’s vertical lacrimal canaliculus beyond a distance of 1 mm, as a routine optimization of the known short tip length of Lang (0.5-2.5 mm) and the depth-limiting shoulder of Tulevech, in order to prevent over-insertion and potential bruising of internal tissue at the end of the canaliculus while still achieving an effective seal at the punctal os (MPEP 2144.04). The precise stop depth is a result-effective variable already recognized in both references.
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 ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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