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
This action is entered in response to Applicant's amendment and reply of 6/22/26. The claims 19, 20, 22-31 are pending. The claims 24 and 30 are amended. Claim 31 is new.
Response to Arguments
Applicant’s arguments filed 10/10/25 with respect to the rejections of 19-27 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (US2018/0221142) have been fully considered but they are not persuasive. Applicant argues, claim 19 requires “distinct spaces” a primary enclosed chamber for the optic and a secondary space for the front haptic, and that the guiding grooves 240g-p of Nguyen cannot satisfy this recitation because they are merely “indentations in the walls of” a single insertion channel. Examiner makes notice, the “distinct spaces” are not claimed and further the enclosed chamber is not positively recited as a structural feature of the claim. Claim 19 defines the recess by being “formed in at least one of the first and second half-shells… open at least from an inside of the at least one of the first and second half-shells… forms a secondary space arranged laterally to the enclosed chamber”. Claim 19 does not require the secondary space to be distinct from the enclosed chamber in any of the limitations. It appears the claim instead the secondary space and enclosed chamber require open communication since the haptic must pass out of the enclosed chamber and into the recess. 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 distinct spaces of the enclosed chamber and secondary space) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant further argues, Nguyen does not disclose the function of the free end of the front haptic “to escape from the enclosed chamber into the recess”. Applicant points to Fig. 7 and states “when open the haptic does not leave the primary insertion channel”. However, this is directed to the open position of the device, the limitation Applicant argues is not disclosed is in the closed position “in the closed position of the half-shells, the recess forms a secondary space”. Applicants points to Fig. 8 and states “when closed the front haptic 20 stretches through the distally positioned insertion nozzle 210”. However, the claimed invention requires this by “an edge arranged on the nozzle side of the half-shells, by engagement with the edge the front haptic is pressed or folded between leg flaps of a folded lens body when the lens is pushed forward”. Therefore, Nguyen and claimed invention both require the features that Applicant argues is a distinction between Nguyen and the claimed invention.
Examiner makes notice, the limitations “for receiving a front haptic” and “allowing the free end of the front haptic to escape from the enclosed chamber into the recess” are statements of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues, the amendment to claims 24 and 30 distinguish over Nguyen. Applicant argues, the wings of Nugyen constitute the entire folding structure. Examiner disagrees, where the wings 231, 232 are carried on the half-shells that are folded together. Applicant further argues, “the recess extends from the at least one of the first and second half-shells into at least one of the respective wings” is not taught by Nguyen. Examiner disagrees, the wings 231, 232 are formed on top of the grooves 240 g-p shown in Fig. 4, with the grooves 240 g-p extending into the body of the wings 231, 232.
Claim Rejections - 35 USC § 102
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 19, 20, 22-27, and 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (US2018/0221142).
Regarding claim 19, Nguyen discloses an injector (100), comprising:
an injector housing (120) with a loading device (200) comprising:
a first half-shell (232) having a first inner surface (surface of channel 220-p2, see Fig. 4) and a second half-shell (231) having a second inner surface (surface of channel 220-p1, see Fig. 4), the first and second half-shells connected in an articulated manner to one another at a first longitudinal side of the first half-shell and the second half shell by a first joint (folding joint, see Fig. 4, [0024]), the first half-shell and the second half shell configured to be movable relative to one another from an open position to a closed position ([0029]), the first and second inner surfaces of the first and second half-shells forming a storage surface (surfaces form insertion channel 220-p that holds IOL, [0026]));
wherein in the open position, the first and second half-shells form an open chamber for positioning or storing the lens in a relaxed state (when the stage 230 is in the initial state as described in [0029] and shown in Fig. 7; the open chamber is interpreted as the insertion channel 220-p when opened in the initial state); and
wherein in the closed position, the first and second half-shells form an enclosed chamber for positioning or storing the lens in a folded state and for ejecting the lens along a longitudinal extent of the first and second half- shells (enclosed chamber is interpreted as the insertion channel 220-p that sits the folded IOL when 231 is attached to 232 with clasp 270; the IOL is intended to be ejected longitudinally via nozzle);
whereby a recess (either of the grooves 240 g-p 1, 240 g-p 2, [0022], [0026], see Fig. 4) for receiving a front haptic of the lens (the lens is not positively recited, where a the recess is capable of receiving a front haptic of a lens with an configuration that would have a front haptic received by the grooves 240 g-p 1, 240 g-p 2, where the grooves 240 g-p 1, 240 g-p 2 are for guiding the IOL during its insertion, therefore a front haptic would be at least capable of being receiving in the guiding grooves, [0022]) is formed in at least one of the first and second half-shells ([0022], see Fig. 4), which recess is open at least from an inside of the at least one of the first and second half-shells (the grooves 240 g-p is open to allow an edge of the IOL 10 to be guided into it, [0031], see Fig. 4), and which recess is configured such that, in the closed position of the half-shells, the recess forms a secondary space (space formed by the grooves 240 g-p 1, 240 g-p 2 in the closed position, see Fig. 9A) arranged laterally to the enclosed chamber (the grooves 240 g-p are arranged laterally to the enclosed chamber 220-p by extending along the sides of the chamber 220-p, see Fig. 4), allowing the free end of the front haptic to escape from the enclosed chamber into the recess (the free end of the front haptic is capable of escaping into the recess/grooves by the lens being positioned in a manner to allow the haptic to enter the grooves 240 g-p, where the lens is not positively recited and the device disclosed is capable of being used with a lens having a haptic in the manner as claimed),
whereas the optics of the lens are positioned in the enclosed chamber (optics are not positively recited, where the optics of the lens are at least capable of being positioned within the enclosed chamber/insertion channel 220-p, where the lens would be positioned in the chamber/insertion channel 220-p during insertion, [0028]);
a nozzle (210) mounted downstream of the loading device (see Fig. 1); and
a plunger (push rod 110) longitudinally displaceable in the injector housing toward the nozzle ([0018]), whereby the plunger pushes through the enclosed chamber (chamber defined by the channel 220-p, [0026]) for ejecting a lens (see Fig. 9B, [0034]),
wherein at least in the closed position of the first and second half-shells, an edge (edge defined by one of the distal guiding rib 240 r-d 1, see Fig. 6; [0040]) is arranged on a nozzle side of the half-shells, by engagement with the edge of the front haptic is pressed or folded between leg flaps of a folded lens body when the lens is pushed forward (the distal guiding ribs 240 r-d are capable folding a front haptic between the leg flaps of an IOL when the lens is pushed forward, where the prior art contemplates different embodiments of the guiding ribs 240 r-d, [0039], [0045]; furthermore, the lens is not positively recited and the device disclosed is capable of being used with a lens having a haptic in the manner as claimed).
Regarding claim 20, Nguyen discloses the injector of claim 19, wherein the edge delimits the recess toward the nozzle, and is formed at a nozzle inlet (see Fig. 6, where the edge or rib 240 r-d extends to the distal end of nozzle, the edge or rib 240 r-d delimits the recess by guiding the IOL when the IOL is passes through the grooves 240 g to the ribs 240 r-d; [0045], see Fig. 6).
Regarding claim 22, Nguyen discloses the injector of claim 19, wherein at least one of the first and second half-shells is provided with a support (proximal guiding rib 240 r-p 1, [0043], see Fig. 8) for the front haptic, the support configured for guiding a free end of the front haptic (the rib 240 r-p 1 is capable of guiding the front haptic, by it guiding an edge of the IOL, [0042], see Fig. 8).
Regarding claim 23, Nguyen discloses the injector of claim 22, wherein the support and the recess are configured and cooperate in such a way that upon closing of the first and second half-shells, from the open position to the closed position, the front haptic increasingly extends beyond the support and out of the forming closed chamber to come to rest in the recess in the closed position (where the ribs and grooves are structured as claimed, thereby are capable of performing the function claimed; see also [0045]).
Regarding claim 24, Nguyen discloses the injector of claim 19, wherein the loading device comprises wings (wings of 231, 232 that extend from halves of cartridge 200, see Fig. 8) formed on the half-shells respectively arranged on a second longitudinal side of the first and second half-shells (see Fig. 8), so that the first and second half-shells can be moved relative to one another from the open position to the closed position by the wings and by rotation about the joint by bringing together the wings ([0024]), wherein the recess extends from the at least one of the first and second half-shells into at least one of the respective wings (cavity formed by the grooves 240 g-p extends into the bottom portion of the wings 231, 232, see Fig. 5B, where in the closed configuration the cavity would still exist as an open groove 240 g-p) creating a cavity as the second space between the wings (cavity formed by the grooves 240 g-p and chamber 220-p in the closed position, [0024]), when the half-shells are in the closed position (either of the grooves 240 g-p 1, 240 g-p 2 would extend between the wings 231, 232 in the closed position, see Fig. 4).
Regarding claim 25, Nguyen discloses the injector of claim 19, wherein each half-shell is provided with at least one slide rail (proximal guiding rib 240 r-p1 and proximal guiding rib 240 r-p 2, see Fig. 8, [0038]), wherein the at least one slide rail is configured for guiding the lens body ([0038]).
Regarding claim 26, Nguyen discloses the injector of claim 19, wherein the loading device comprises a cover member (270) pivotably arranged adjacent the first half-shell, the cover member, in an open position, covers the open chamber (covers the open chamber by extending over the open chamber in the open position, see Fig. 5B), and in a closed position, is positioned substantially outside the enclosed chamber (the chamber is closed by the folding of the IOL stage 230 and therefore the clasp 270 is outside of the chamber, see Fig. 2).
Regarding claim 27, Nguyen discloses the injector of claim 19, wherein the loading device is configured as a cartridge for insertion into the injector housing ([0006]).
Regarding claim 29, Nguyen discloses the injector of claim 19, wherein a space formed between the closed half-shells is cylinder-shaped (insertion channel 220 forms a cylinder by two semi-cylinder halves forming the channel, see Fig. 9A, [0029]), and the recess is formed in such a way that the haptic can escape from the space on a cylinder surface side (the groove 240 g-p is formed within the cylinder and intended to catch edges of the IOL, therefore a haptic is capable of moving from the cylinder surface into the groove, [0036], see Fig. 4).
Regarding claim 30, Nguyen discloses an injector (100), comprising:
an injector (120) housing with a loading device (200) comprising:
a first half-shell (232) having a first inner surface (surface of the channel 220-p2, see Fig. 4) and a second half-shell (231) having a second inner surface (surface of channel 220-p1, see Fig. 4), the first and second half-shells connected in an articulated manner to one another at a first longitudinal side of the first half-shell and the second half shell by a first joint (folding joint, see Fig. 4, [0024]), the first half-shell and the second half shell configured to be movable relative to one another from an open position to a closed position ([0029]), the first and second inner surfaces of the first and second half-shells forming a storage surface (form insertion channel 220-p for the IOL, [0026]);
wherein in the open position, the first and second half-shells form an open chamber for positioning or storing a lens in a relaxed state (when the stage 230 is in the initial state as described in [0029] and shown in Fig. 7; the open chamber is interpreted as the insertion channel 220-p when opened in the initial state); and
wherein in the closed position, the first and second half-shells form an enclosed chamber for positioning or storing the lens in a folded state and for ejecting the lens along a longitudinal extent of the first and second half-shells (enclosed chamber is interpreted as the insertion channel 220-p that sits the folded IOL when 231 is attached to 232 with clasp 270; the IOL is intended to be ejected longitudinally via nozzle); whereby a recess (either of the grooves 240 g-p 1, 240 g-p 2, [0022], [0026], see Fig. 4) for receiving a front haptic (the lens is not positively recited, where a the recess is capable of receiving a front haptic of a lens with an configuration that would have a front haptic received by the grooves 240 g-p 1, 240 g-p 2, where the grooves 240 g-p 1, 240 g-p 2 are for guiding the IOL during its insertion, therefore a front haptic would be at least capable of being receiving in the guiding grooves, [0022]) of the lens is formed in at least one of the first and second half-shells ([0022, see Fig. 4), which recess is open at least from an inside of the at least one of the first and second half-shells (the grooves 240 g-p is open to allow an edge of the IOL 10 to be guided into it, [0031], see Fig. 4), and which recess is configured such that, in the closed position of the half-shells, the recess forms a secondary space (space formed by the grooves 240 g-p 1, 240 g-p 2 in the closed position, see Fig. 9A) arranged laterally to the enclosed chamber (the grooves 240 g-p are arranged laterally to the enclosed chamber 220-p by extending along the sides of the chamber 220-p, see Fig. 4), so that the free end of the front haptic can be positioned in the recess thereby escaping from the enclosed chamber (the free end of the front haptic is capable of escaping into the recess/grooves by the lens being positioned in a manner to allow the haptic to enter the grooves 240 g-p, where the lens is not positively recited and the device disclosed is capable of being used with a lens having a haptic in the manner as claimed), whereas the optics of the lens is positioned in the enclosed chamber (optics are not positively recited, where the optics of the lens are at least capable of being positioned within the enclosed chamber/insertion channel 220-p, where the lens would be positioned in the chamber/insertion channel 220-p during insertion, [0028]),
a nozzle (210) mounted downstream of the loading device (see Fig. 1); and
a plunger (push rod 110) longitudinally displaceable in the injector housing toward the nozzle ([0018]), whereby the plunger pushes through the enclosed chamber (chamber defined by the channel 220-p, [0026]) for ejecting a lens (see Fig. 9B, [0034]),
wherein the loading device comprises wings (wings of 231, 232 that extend from halves of cartridge 200, see Fig. 8) formed on the half-shells respectively arranged on a second longitudinal side of the first and second half-shells (see Fig. 8), so that the first and second half-shells can be moved relative to one another from the open position to the closed position by rotation about the joint by bringing together the wings ([0024]), wherein the recess (grooves 240 g-p 1, 240 g-p 2) extends from the at least one of the first and second half shells into at least one of the wings (cavity formed by the grooves 240 g-p extends into the bottom portion of the wings 231, 232, see Fig. 5B, where in the closed configuration the cavity would still exist as an open groove 240 g-p) creating a cavity as the secondary space between the wings when the half-shells are in the closed position (either of the grooves 240 g-p 1, 240 g-p 2 would extend between the wings 231, 232 in the closed position, see Fig. 4).
Regarding claim 31, Nguyen discloses an injector, comprising:
an injector (120) housing with a loading device (200) comprising:
a first half-shell (232) having a first inner surface (surface of channel 220-p2, see Fig. 4) and a second half-shell (231) having a second inner surface (surface of channel 220-p1, see Fig. 4), the first and second half-shells connected in an articulated manner to one another at a first longitudinal side of the first half-shell and the second half shell by a first joint (folding joint, see Fig. 4, [0024]), the first half-shell and the second half shell configured to be movable relative to one another from an open position to a closed position ([0029]), the first and second inner surfaces of the first and second half-shells forming a storage surface (form insertion channel 220-p for the IOL, [0026]); wherein in the open position, the first and second half-shells form an open chamber for positioning or storing a lens in a relaxed state (when the stage 230 is in the initial state as described in [0029] and shown in Fig. 7, the open chamber is interpreted as the insertion channel 220-p when opened in the initial state); and wherein in the closed position, the first and second half-shells form an enclosed chamber for positioning or storing the lens in a folded state and for ejecting the lens along a longitudinal extent of the first and second half-shells (enclosed chamber is interpreted as the insertion channel 220-p that sits the folded IOL when 231 is attached to 232 with clasp 270; the IOL is intended to ejected longitudinally via nozzle); whereby a recess (grooves 240 g-p 1, [0022], [0026], see Fig. 4) for receiving a front haptic (the lens is not positively recited, where a the recess is capable of receiving a front haptic of a lens with an configuration that would have a front haptic received by the groove 240 g-p 1, where the groove 240 g-p 1, are for guiding the IOL during its insertion, therefore a front haptic would be at least capable of being receiving in the guiding grooves, [0022]) of the lens is formed in at least one of the first and second half-shells ([0022], see Fig. 4), which recess is open at least from an inside of the at least one of the first and second half-shells (the grooves 240 g-p is open to allow an edge of the IOL 10 to be guided into it, [0031], see Fig. 4), and which recess is configured such that, in the closed position of the half-shells, the recess forms a secondary space (space formed by the grooves 240 g-p 1 in the closed position, see Fig. 9A) arranged laterally to the enclosed chamber (the groove 240 g-p-1 arranged laterally to the enclosed chamber 220-p by extending along the sides of the chamber 220-p, see Fig. 4), allowing the free end of the front haptic to escape from the enclosed chamber into the recess (the free end of the front haptic is capable of escaping into the recess/grooves by the lens being positioned in a manner to allow the haptic to enter the groove 240 g-p-1, where the lens is not positively recited and the device disclosed is capable of being used with a lens having a haptic in the manner as claimed), whereas the optics of the lens is positioned in the enclosed chamber (optics are not positively recited, where the optics of the lens are at least capable of being positioned within the enclosed chamber/insertion channel 220-p, where the lens would be positioned in the chamber/insertion channel 220-p during insertion, [0028]),
whereby at least one of the first and second half-shells is provided with a support (surface formed by the groove 240 g-p 2, [0022]) for the front haptic, the support configured for guiding a free end of the front haptic (surface is for guiding the IOL and would capable of guiding a free end of the front haptic, [0022]), and whereby the support and the recess are configured and cooperate in such a way that upon closing of the first and second half-shells, from the open position to the closed position, the front haptic increasingly extends beyond the support and out of the forming closed chamber to come to rest in the recess in the closed position (the front haptic is capable of extending out of the support defined by groove 240 g-p 2 and out of the closed chamber and into the recess or groove 240 g-p 1 by rotating the IOL, where the IOL is capable of being rotated to be repositioned in the stage 230, see Fig. 4);
a nozzle (210) mounted downstream of the loading device (see Fig. 1); and
a plunger (push rod 110) longitudinally displaceable in the injector housing toward the nozzle ([0081]), whereby the plunger pushes through the enclosed chamber (chamber defined by the channel 220-p, [0026]) for ejecting a lens (see Fig. 9B, [0034]), wherein at least in the closed position of the first and second half-shells, an edge (edge defined by raised rib 240 r-d 1, [0035]) is arranged on a nozzle side of the half-shells (see Fig. 4), by engagement with the edge the front haptic is pressed or folded between leg flaps of a folded lens body when the lens is pushed forward (the guiding rib 240 r-d 1 is capable of performing the claimed function by being a raised rib that could engage the front haptic).
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 of this title, 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.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US2018/0221142) in view of Sinding (WO2005/020853).
Regarding claim 28, Nguyen discloses the injector of claim 19; yet, is silent regarding wherein the loading device is configured as an integral part of the injector housing. Sinding teaches an IOL lens injector with a cartridge that may be integral (page 13, lines 26-33). Therefore, it would have been obvious to one having ordinary skill in the before the effective filing date of the claimed invention to have provided Nguyen’s loading device as an integral part of the injector housing as taught by Sinding. Doing so would provide the added benefit of eliminating the need for mounting the lens in the cartridge (page 13, lines 27-30).
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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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