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 office action is responsive to the amendment filed on 07/17/2026. As directed by the amendment: claims 1 and 8-10 have been amended and claims 16-18 have been added. Thus, claims 1-18 are presently pending in this application with claims 11-15 withdrawn.
Response to Arguments
Applicant's arguments filed 07/17/2026 have been fully considered but they are not persuasive.
Applicant argues that Vezzu fails to teach the protrusions pointing inwardly and “pulling on the retinal membrane to raise a flap of the retinal membrane”. The Office respectfully disagrees. As shown in fig. 4 of Vezzu, the protrusions point inwardly (i.e. towards the center of the device). The applicant appears to be arguing that the protrusions of Vezzu are not pointed, but The Office notes that claim language does not require that as under broadest reasonable interpretation “pointing inwardly” is interpreted as extending inwardly. 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 protrusions are pointed / form a point) 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). Regarding the language “barbs… configured to pull on the retinal membrane to raise a flap of the retinal membrane”, this language constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Schaller as modified meets the structural limitations of the claim, and the barbs are capable of pulling on the retinal membrane to raise a flap of the retinal membrane. Therefore, The Office maintains that Vezzu teaches the amended limitations of claim 1.
Applicant further argues that it would not be obvious to one of ordinary skill in the art to modify Schaller with Vezzu to have barbs because Schaller has fibers that grasp the membrane and thus does not also need barbs. The Office respectfully disagrees. While Schaller does have fivers that grasp the membrane, one of ordinary skill in the art would see the benefit of also having barbs for the reasons in Vezzu. Adding barbs to Schaller does nothing to change the operation of Schaller but instead enhances it’s ability to perform it’s operation. Furthermore, the surface of Schaller which has been modified to have the barbs is a flat smooth portion of the fibers and not the tips of the fibers that are gripping. Adding Barbs to this surface which also contacts tissue would improve the grasping as taught in Vezzu. Therefore, The Office maintains that it would be obvious to modify Schaller with Vezzu.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the arrays of barbs resembling barbed scales of sharkskin as claimed in claim 16 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 16 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 16 recites “the barbs are disposed as arrays of barbs resembling barbed scales of sharkskin”. The scope of “resembling barbed scales of sharkskin” is unclear. Specifically, how do the arrays of barbs resemble scales of sharkskin (i.e. shape, size, sharpness, etc.)? Additionally there appear to be different types of scales depending on the shark species/age, so determining the shape, size, sharpness of scales of sharkskin is not possible without more information. Finally, if the scope of “scales of sharkskin” could be determined, how similar would art need to be to “scales of sharkskin” to resemble them? Since the scope could not be determined, no prior art has been applied. The Office recommends removing this limitation from the claims.
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, 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 1-9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller (US 20180092702 A1) in view of Hickingbotham (US 20080188877 A1) and Vezzu et al. (US 20150238355 A1).
Regarding claims 1-3 Schaller discloses (fig. 1-3C) an ophthalmic surgical instrument for peeling a retinal membrane, comprising:
a handle 130 (see fig. 1 and [0032]);
an outer tube 202 having a proximal end mounted to the handle 130 (see fig. 1 and [0033]) and a distal end (see fig. 2A and [0033]);
a first arm 204A at least partly housed within the outer tube 202 (see fig. 2A and [0035]) and including a first distal portion having a first pulling surface formed thereon (see annotated fig. 2C below);
a second arm 204B at least partly housed within the outer tube 202 (see fig. 2A and [0035]) and including a second distal portion having a second pulling surface (see annotated fig. 2C below);
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the first distal portion and the second distal portion are configured to deform in order to be withdrawn into the outer tube 202 (see [0035]);
the outer tube configured to change in relative positions to the first arm and the second arm (see [0035]);
wherein the first pulling surface and second pulling surface are configured such that (a) when the outer tube 202 is in a first position relative to the first arm 204A and the second arm 204B (position of fig. 2C), the first pulling surface and the second pulling surface are configured to flare outwardly from one another (see fig. 2C and [0035]) and can both be placed simultaneously in contact with the retinal membrane (see fig. 3A and [0039]-[0040]) and (b) when the outer tube 202 is in a second position relative to the first arm 204A and the second arm 204B, the first pulling surface and the second pulling surface are facing one another and pressed against one another (see fig. 2A), and
wherein the first pulling surface and the second pulling surface are configured to deform in order to at least partially conform to a curvature of the retinal membrane (see fig. 3A-3B and [0035]).
The language “the first pulling surface and the second pulling surface are configured to deform in order to at least partially conform to a curvature of the retinal membrane” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Schaller meets the structural limitations of the claim, and the first pulling surface and the second pulling surface are capable of deforming in order to at least partially conform to a curvature of the retinal membrane. The first and second pulling surfaces are deformable in a curved shape and thus are capable of deforming in a shape that at least partially conform to a curvature of the retinal membrane.
Schaller is silent regarding the first distal portion and the second distal portion each have a width greater than an inner diameter of the distal end of the outer tube.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Schaller to have the first distal portion and the second distal portion each have a width greater than an inner diameter of the distal end of the outer tube since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Schaller would not operate differently with the claimed width as it would still enable the distal portions to grasp tissue. Further, applicant places no criticality on the relative dimensions claimed, indicating simply that portions “may” expand to the claimed relative width (specification [0026]).
Schaller is silent regarding an actuator mounted to the handle and configured to change relative positions of the outer tube and the first arm and the second arm; the actuator is configured to move the outer tube from the first position to the second position responsive to movement of the actuator in a first direction; the actuator is configured to move the outer tube from the second position to the first position responsive to movement of the actuator in a second direction opposite the first direction.
However Hickingbotham, in the same filed of endeavor, teaches (fig. 2) a handle 20 (see fig. 2 and [0024]); an outer tube 40 with a proximal end mounted to the handle 20 (see fig. 2 and [0024]); an actuator 48 mounted to the handle 20 and configured to change relative positions of the outer tube 40 and a first arm and a second arm (see [0024] and fig. 2); the actuator 48 is configured to move the outer tube 40 from a first position to a second position responsive to movement of the actuator in a first direction (see [0024]); the actuator 48 is configured to move the outer tube 40 from the second position to the first position responsive to movement of the actuator 48 in a second direction opposite the first direction (see [0024]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Schaller to have an actuator mounted to the handle and configured to change relative positions of the outer tube and the first arm and the second arm; the actuator is configured to move the outer tube from the first position to the second position responsive to movement of the actuator in a first direction; the actuator is configured to move the outer tube from the second position to the first position responsive to movement of the actuator in a second direction opposite the first direction as taught by Hickingbotham, for the purpose of the use being able to easily move the outer tube to open and close the arms (see Hickingbotham [0024]).
Schaller as modified is silent regarding the first pulling surface and the second pulling surface each have barbs pointing inwardly and configured to pull on the retinal membrane to raise a flap of the retinal membrane.
However Vezzu further teaches (fig. 1-4, 6, and 17-18) a first pulling surface 27 and a second pulling surface 27 each have barbs 66 pointing inwardly (fig. 4 shows that the barbs on 27 are pointing inwardly) and configured to pull on the retinal membrane (see [0031]-[0032] and [0034]) to raise a flap of the retinal membrane (see note below).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Schaller as modified to have the first pulling surface and the second pulling surface each have barbs pointing inwardly and configured to pull on the retinal membrane to raise a flap of the retinal membrane as taught by Vezzu, for the purpose of being able to improve the grasping of the tissue (see Vezzu [0034]).
Note: The language “barbs… configured to pull on the retinal membrane to raise a flap of the retinal membrane” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Schaller as modified meets the structural limitations of the claim, and the barbs are capable of pulling on the retinal membrane to raise a flap of the retinal membrane. Vezzu teaches grasping a retinal membrane thus is capable of pulling on the retinal membrane to raise a flap of the retinal membrane.
Regarding claim 4, Schaller as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Schaller further discloses (fig. 1-3C) the first pulling surface and the second pulling surface are configured to flare outwardly from an outer diameter of the outer tube 202 when extended from the distal end of the outer tube 202 (see fig. 2A and 2C).
Regarding claim 5, Schaller as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Schaller as modified fails to expressly disclose the first pulling surface and the second pulling surface are configured to flare outwardly to at least twice an outer diameter of the outer tube when extended from the distal end of the outer tube. Schaller sets forth that flare outer diameter is a result effective variable, wherein the larger the flare outer diameter (D1 in fig. 3A and D3 in fig. 5A), the more of the tissue that is grasped (see [0039]-[0040] and [0046]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first pulling surface and the second pulling surface are configured to flare outwardly to at least twice an outer diameter of the outer tube when extended from the distal end of the outer tube, for the purpose of being able to grasp more tissue, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 6, Schaller as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Schaller further discloses (fig. 1-3C) the first pulling surface and the second pulling surface are configured to recoil outwardly to an angle appearing to be close to 45 degrees relative to an axis of symmetry of the outer tube (see annotated fig. 2C below).
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Schaller as modified fails expressly teach the angle is at least 45 degrees.
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the angle be at least 45 degrees because Applicant places no criticality on the claimed range indicating that it “may” be withing the claimed range (see [0023]). One of ordinary skill in the art, furthermore, would have expected Schaller as modified’s device, and applicant’s invention, to perform equally well with either the angle taught by Schaller as modified or the claimed at least 45 degree angle because both angles would perform the same function of grasping.
Therefore, it would have been prima facie obvious to modify Schaller as modified to obtain the invention as specified in claim 6 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Schaller as modified.
Regarding claim 7, Schaller as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Schaller further discloses (fig. 1-3C) that the first and second arm are self deforming/expanding (see [0035] and can be formed of a variety of materials including metal (see [0042]). Schaller fails to expressly disclose the first arm and the second arm each comprise nitinol.
However Vezzu, in the same field of endeavor, teaches (fig. 1-4, 6, and 17-18) a first arm 13 and a second arm 14 each comprise nitinol ([0040] discloses that the arms can be the same material as the elongate body 11 and [0026] discloses that the elongate body can be nitinol).
Therefore, the substitution of one known material (nitinol as taught in Vezzu) for another (metal as taught in Schaller) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the nitinol as taught in Vezzu would have yielded predictable results, namely, arms in Schaller as modified that would expand upon retraction of the outer tube. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 8, Schaller as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Schaller as modified teaches in Vezzu that the barbs are disposed such that sliding of the first pulling surface and the second pulling surface outwardly from a longitudinal direction along the retinal membrane is resisted less than sliding of the first pulling surface and the second pulling surface along the retinal membrane inwardly toward the longitudinal direction (the barbs are positioned on the interior surface 27 such that when sliding outwardly from a longitudinal direction along the retinal membrane, the barbs of surface 27 are not engaged with the retinal membrane. This lack of engagement of the barbs on 27 restricts the sliding less than when sliding inwardly toward the longitudinal direction and the barbs on 27 engage the retinal membrane).
Regarding claim 9, Schaller as modified discloses the claimed invention substantially as claimed, as set forth above for claim 8. Schaller as modified teaches in Vezzu the barbs 66 have lengths 67 between 1 µm and 7.5 µm (see [0034]).
Regarding claim 17, Schaller as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Schaller as modified teaches when the first pulling surface and the second pulling surface are pressed flat on the retinal membrane (see Schaller fig. 3A-3C), the barbs point inwardly such that, as the first pulling surface and the second pulling surface are drawn together, the barbs tend to pull on the retinal membrane to raise the flap (see Vezzu fig. 4).
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Schaller in view of Hickingbotham and Vezzu as applied to claim 8 above, and further in view of Taguchi et al. (US 4,909,789).
Regarding claim 10, Schaller as modified discloses the claimed invention substantially as claimed, as set forth above for claim 8. Schaller as modified further teaches the first 66 point toward the first/second arm when the outer tube is in the second position (see Vezzu fig. 4).
Schaller as modified is silent regarding the barbs both point toward the outer tube when the outer tube is in the second position.
Taguchi, in the analogous art of grasping devices, teaches (fig. 1-2) an outer tube and first and second arms, wherein the first and second arms are received fully in the outer tube (see fig. 2).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Schaller as modified to have the first and second arms are received fully in the outer tube as taught by Taguchi, for the purpose of protecting the arms during advancement/retraction.
Schaller as modified teaches the first barbs and the second barbs both point toward the outer tube when the outer tube is in the second position. Schaller as modified (Vezzu) teaches the barbs 66 point toward the first/second arm when the outer tube is in the second position and a further modification is made to have the outer tube cover the first and second arms.
Allowable Subject Matter
Claim 18 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, alone or in combination, fails to teach or render obvious “the barbs partially penetrate the retinal membrane without penetrating an underlying retina”. Vezzu teaches barbs for a retinal membrane, but fails to teach the barbs partially penetrate the retinal membrane without penetrating an underlying retina. While penetrating barbs do exist [e.g. Scheller (US 20030229976 A1), Pierce (US 5,893,878)] there is no disclosure of these barbs being appropriately sized to be capable of partially penetrate the retinal membrane without penetrating an underlying retina.
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 KATHERINE H MENDEZ whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 8 am-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H MENDEZ/Primary Examiner, Art Unit 3771
