DETAILED ACTION
This action is in response to applicant's amendments filed 08/12/25.
The examiner acknowledges the amendments to the claims.
Claims 21-44 are pending in this application.
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 .
Terminal Disclaimer
The terminal disclaimer filed on 08/12/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent Nos. 11723799, 10729579 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-44 have been considered but are moot in view of the new grounds of rejection set forth in this office action.
Claim Objections
Claim 44 is objected to because of the following informalities:
Lines 3, 6 recite “the tip” but should read as --the tip portion--.
Lines 4, 6 recite “the surgical injector tool”, “the injector tool”, and should rather read as --the injector portion--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 44 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 44 recites “means for injecting the secured tissue into a transplantation area of the eye”. However, claim 21, upon which Claim 44 depends, already recites a means for injecting, or “an injector portion” that comprises defines an internal channel where tissue is held in place and also defines an open region from which the tissue is injected. It is unclear if the “means for injecting” is referring back to the “injector portion” or is referring to another element. For examination purposes, the limitation will be read as “the means for injecting” referring back to the previously recited “injector portion”.
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 21-22, 25-27, 29-30, 32-33, 36, 39-40, 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over Hickingbotham et al., hereinafter “Hickingbotham” (U.S. Pub. No. 2013/0178822) in view of Inoue et al., hereinafter “Inoue” (U.S. Patent No. 9,808,372) (or see corresponding disclosure in Inoue et al. [WO 2012/018006 A1] and English translation of the description).
Regarding claim 21, Hickingbotham discloses a surgical device for performing tissue transplantation within an eye (see abstract) comprising:
a hollow handle portion (handpiece 4; Figures 4, 11C) configured to convey a liquid fluid through the hollow handle portion (via mandrel 1 attached to liquid pump which conducts liquid through the handpiece 4; [0075], [0078], [0081], [0149], [0210]), the hollow handle portion having a distal end: and
an injector portion (including mandrel guide 2 that includes a proximal length 6 and distal end including nozzle 8) fluidically coupled to the hollow handle portion and defining an internal channel via which the liquid fluid is conveyed (via mandrel 1 within mandrel guide 2; Id.), the injector portion comprising:
an elongate body portion 2 having opposing distal and proximal ends defining the internal channel extending from the distal end to the proximal end configured to enshroud a tissue for transplantation (Figure 12; [0269]), wherein the tissue is capable of being held in place via vacuum (suction) pressure (Id.), the proximal end of the elongate body portion (portion of 2 proximal to port 25; Figure 4) being securely coupled to the distal end (including distal endcap 24 including port 25) of the hollow handle portion 4 (Figure 4, [0088], [0127]: “the proximal length of guide [2] is coupled to…the delivery unit support [e.g. 4] [e.g. for support]” and “member 2 or 1 is relatively fixed to the delivery unit support [e.g. 4]”); it is noted that “securely coupled” does not necessitate that the proximal end of the elongate body portion 2 be longitudinally fixed to the distal end of the hollow handle portion 4, but rather is attached or held fast to the distal end of the hollow handle portion) to receive liquid fluid conveyed through the hollow handle portion (via mandrel 1 within guide 2 attached to liquid pump which conducts liquid through the handpiece 4; [0075], [0078], [0081], [0149], [0210]);
a tip portion (nozzle 8) defined at the distal end of the elongate body portion configured for insertion into an eye; and
an open region (Figure 12) defined at the distal end of the elongate body portion in fluid communication with the internal channel such that the tissue within the internal channel is expelled from the open region and injected into the eye ([0270]), wherein an injection pressure opposing the vacuum (suction) is capable of being applied to the tissue in the internal channel (Id.).
However, Hickingbotham does not expressly disclose a liquid fluid in the internal channel, wherein the tissue is held in place within the internal channel when the vacuum pressure is applied to the tissue via the liquid fluid present in the internal channel, and the injection pressure opposing the vacuum pressure is applied to the tissue via the liquid fluid in the internal channel.
In the same field of art, namely surgical device for performing tissue transplantation within an eye, Inoue teaches an injector portion 23 fluidically coupled to a handle portion 24 conveying liquid (such as water or liquid 75, through negative/positive pressure supplied by a syringe unit 22 acting through a valve 27; see abstract, Figures 11B, 12B, col. 18, lines 4-8, col. 19, lines 29-31), the injector portion defining an internal channel 33 via which the liquid fluid is conveyed (Id.), the injector portion comprising an internal channel 33 configured to enshroud a tissue 2e for transplantation (Figure 13C, col. 19, lines 27-31), wherein the tissue is held in place within the internal channel when a vacuum (negative) pressure is applied to the tissue via liquid fluid present in the internal channel (Id.; liquid 75 is sucked together with corneal endothelium layer 2e), and an open region 34 (Figure 4A) in fluid communication with the internal channel 33 such that the tissue within the internal channel is expelled from the open region and injected into the eye when an injection (positive) pressure opposing the vacuum (negative) pressure is applied to the tissue via the liquid fluid in the internal channel (Figures 14A-14C, col. 19, lines 58-67; by receiving positive pressure the corneal endothelium layer 2e is pushed out of the opening 34 together with the liquid 75).
It would have been obvious to one of ordinary skill (at the time of invention) before the effective filing date to modify Hickingbotham with a liquid fluid in the internal channel to hold and apply tissue as claimed, as taught by Inoue, since Hickingbotham acknowledges that tissue and liquid fluid may be conveyed, and the liquid fluid may provide protective benefits to tissue to reduce damage during surgery (Inoue; col. 18, lines 37-53).
Regarding claim 22, Hickingbotham as modified teaches the tip portion 8 comprises a substantially flat shaped tip (Hickingbotham; Figure 12).
Regarding claim 25, Hickingbotham as modified teaches the claimed invention, as discussed above, except for the tip portion comprising a tapered angled edge tip, although teaches the tip portion can be tapered at the distal end (Hickingbotham; [0099]).
Inoue further teaches tip portion 36 (Figure 4B) comprising a tapered angled edge tip (obliquely cut shape; col. 9, lines 1-21).
It would have been obvious to one of ordinary skill before the effective filing date to modify Hickingbotham as modified to have a tapered angled edge tip, as taught by Inoue, since Hickingbotham acknowledges that different shapes of the tip may be used for different delivery applications ([0189], [0162]) and a tapered shape facilitates entry into a patient’s subretinal space ([0099]).
Regarding claim 26, Hickingbotham as modified teaches the tip portion is tapered at the distal end (Hickingbotham; [0099]).
Regarding claim 27, Hickingbotham as modified teaches the tissue is a sheet of tissue (Hickingbotham, [0206]; the device is capable of delivering a sheet of retinal tissue).
Regarding claims 29-30, Hickingbotham as modified teaches the claimed invention including a syringe pump or other device capable of producing vacuum and pressure (liquid pumps; [081], [0149]), or a syringe 105 (Figure 11C) wherein the syringe is configured to house a reservoir of the liquid fluid, wherein the syringe is fluidically coupled to the handle portion 4 to convey the liquid fluid between the syringe and the handle portion. However, Hickingbotham as modified does not teach the syringe pump or other device coupled to the syringe and configured to regulate the vacuum and insertion pressures.
Inoue further teaches a syringe pump or other device capable of producing vacuum and pressure (col. 37, lines 39-45) coupled to a syringe 22 (Figure 3) and configured to regulate the vacuum and insertion pressures (col. 14, lines 13-34).
It would have been obvious to one of ordinary skill before the effective filing date to modify Hickingbotham as modified with a syringe pump or other device coupled to the syringe, as taught by Inoue, in order to facilitate selective actuation of applying vacuum and insertion pressure for a user (Id.).
Regarding claim 32, Hickingbotham as modified teaches the handle portion 4 (Figure 4) defines a handle internal channel (containing mandrel 1) in fluid communication with the internal channel of the elongate body portion 2 when the proximal end of the elongate body portion is coupled to the handle portion (via mandrel 1 which conducts liquid through the handpiece 4; [0075], [0078], [0081], [0149], [0210]).
Regarding claim 33, Hickingbotham as modified teaches wherein the distal end portion of the handle portion 4 is configured to detachably couple to the proximal end of the elongate body portion 2 of the injector portion (via endcap 24; Figure 8, para [0156]; [0017]).
Regarding claim 36, Hickingbotham in view of Inoue teaches a surgical method for transplanting tissue into an eye comprising:
vacuuming a tissue 2e (using negative pressure; Inoue, Figures 13A-13C, col. 19, lines 23-31) into an aperture 34 of the open region of the tip portion 36 of the surgical injector portion as claimed in claim 21 (as discussed above), wherein the aperture provides a suction force to the tissue via a liquid fluid 75 (Id.; liquid 75 is sucked together with the corneal endothelium layer 2e):
inserting the tip portion 36 of the injector portion into an implantation area of the eye 1 (Figure 14B, col. 19, lines 52-57); and
injecting the tissue 2e into the implantation area by providing, via the liquid fluid 75, an injection force (positive pressure; col. 19, lines 58-67) to the tissue that is opposite to the suction force.
Regarding claim 39, Hickingbotham as modified teaches the claimed invention, as discussed above, except for the tip portion comprising a tapered angled edge tip.
Inoue further teaches tip portion 36 (Figure 4B) comprising a tapered angled edge tip (obliquely cut shape; col. 9, lines 1-21).
It would have been obvious to one of ordinary skill before the effective filing date to modify Hickingbotham as modified to have a tapered angled edge tip, as taught by Inoue, since Hickingbotham acknowledges that different shapes of the tip may be used for different delivery applications ([0189], [0162]) and a tapered shape facilitates entry into a patient’s subretinal space ([0099]).
Regarding claim 40, Hickingbotham as modified teaches the tissue is a sheet of tissue (Hickingbotham, [0206]; the device delivers a sheet of retinal tissue).
Regarding claim 42, Hickingbotham as modified teaches the implantation area is in a subretinal space in the eye (Id.).
Regarding claim 43, Hickingbotham as modified teaches the tissue comprises retinal pigment epithelial cells (Hickingbotham, see abstract and [0266]).
Regarding claim 44, Hickingbotham in view of Inoue teaches a system for performing tissue transplantation within an eye comprising:
the surgical device of claim 21 (as discussed above);
means for hydraulically securing a tissue 2e (Inoue) in the internal channel 33 (syringe unit 22 imparts negative pressure such that liquid 75 is sucked together with the corneal endothelium layer 2e; Figures 13A-13C, col. 19, lines 23-31, abstract); and
means for injecting the secured tissue into a transplantation area of the eye an injector portion (Hickingbotham; including mandrel guide 2 that includes a proximal length 6 and distal end including nozzle 8).
Claims 28, 34-35, 41 are rejected under 35 U.S.C. 103 as being unpatentable over Hickingbotham (U.S. Pub. No. 2013/0178822) in view of Inoue (U.S. Patent No. 9,808,372) (or see corresponding disclosure in Inoue et al. [WO 2012/018006 A1] and English translation of the description), as applied to claims 21 and 36 above, and further in view of Hughes (U.S. Patent No. 6,579,256).
Regarding claims 28, 35, 41, Hickingbotham as modified teaches the clamed invention, as discussed above except for the injector portion is S-shape or flattened S-shape, or wherein the elongate body portion or injector portion defines a longitudinal axis having a middle portion that curves away from the longitudinal axis, although Hickingbotham generally teaches a curved injector portion ([0093]).
In the same field of art, namely devices for tissue transplantation, Hughes teaches an elongate injection portion 30 being an S-shape (Figure 10) and defines a longitudinal axis having a middle portion that curves away from the longitudinal axis (see annotated Figure 10 below, dashed line representing longitudinal axis).
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It would have been obvious to one of ordinary skill before the effective filing date to modify the elongate body portion/injector portion to be an S-shape or having a middle portion that curves away from the longitudinal axis, as taught by Hughes, since the curvature facilitates manipulation of the portion within the eye (Hughes; col. 9, lines 43-51)
Regarding claim 34, Hickingbotham as modified the claimed invention, as discussed above, including the distal end of the elongate body portion having a proximal end portion being steeper than a distal end portion (see annotated Figure 4B of Inoue below), except for the distal end of the elongate body portion having a concave configuration.
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In the same field of art, namely devices for tissue transplantation, Hughes teaches an elongate body portion 30 (Figure 10) having a concave configuration (col. 9, lines 43-51).
It would have been obvious to one of ordinary skill before the effective filing date to modify the elongate body portion to have a concave configuration, as taught by Hughes, since the concavely curved configuration facilitates manipulation of the portion within the eye (Hughes; col. 9, lines 43-51).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Hickingbotham (U.S. Pub. No. 2013/0178822) in view of Inoue (U.S. Patent No. 9,808,372) (or see corresponding disclosure in Inoue et al. [WO 2012/018006 A1] and English translation of the description), as applied to claim 29 above, and further in view of Giungo et al., hereinafter “Giungo” (U.S. Patent No. 5,868,728).
Regarding claim 31, Hickingbotham as modified teaches the claimed invention, as discussed above, except for the syringe pump is electronically controlled.
In the same field of art, namely devices for tissue transplantation, Giungo teaches a syringe pump (col. 4, lines 32-39) coupled to a syringe 20 (Figure 2) and being electronically controlled (via microprocessor 22; col. 9, lines 40-44).
It would have been obvious to one of ordinary skill before the effective filing date to modify the syringe pump to be electronically controlled, as taught by Giungo, in order to enhance accuracy and precision in delivery and manipulation of materials in the eye (Giungo; col. 1, line 66 to col. 2, line 4).
Allowable Subject Matter
Claims 23-24 and 37-38 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: None of the prior art of record, alone or in combination, teaches or renders obvious a surgical device for performing tissue transplantation within an eye including, inter alia, an injection portion comprising an elongate body portion that is configured to enshroud a tissue for transplantation wherein the tissue is held in place when a vacuum pressure is applied to the tissue via liquid fluid, and is injected into the eye when an injection pressure opposing the vacuum pressure is applied to the tissue via the liquid fluid, and a tip portion defined at a distal end of an elongate body portion configured for insertion into an eye, the tip portion comprising a semicircular edge tip or tapered rounded edge tip. There is no articulated reasoning with rational underpinning to support the legal conclusion of obviousness to arrive at the claimed subject matter by modifying the tip portion edge of Hickingbotham in view of Inoue to be semicircular or tapered rounded, which may reduce the sharpness of the tip and interfere with the easy insertion into the eye.
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 DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771