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 .
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.
Response to Arguments
Claim 1 was amended to recite “the first and second vertical portions and the first and second horizonal portions are configured to elastically deform to fit within the outer tube”. Applicant argues this amendment overcomes Schaller’024 in view of Ryan’289 because Ryan’289, relied on to teach the first and second pulling surfaces and first and second gripping surfaces, teaches the pulling surfaces 130 are transparent projections configured to displace fluid and/or tissues around the wound. Examiner notes that Ryan’289 further teaches the pulling surface 130 can be made of polycarbonate or glass (paragraph [0018]). Although polycarbonate is known to exhibit elasticity, there is no evidence the pulling and gripping surfaces of Ryan’289’s arms would have the degree of elasticity to necessary to deform to fit within a tube, as required by amended claim 1. However, upon further search and consideration, a new reference is relied upon to render this limitation obvious. See the updated rejection below.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 was amended to recite: “a first vertical portion comprising a first pulling surface” and “a first horizontal portion comprising a first gripping surface”. However, the specification discloses: “The vertical portions 114a, 114b each define inward facing gripping surfaces 116a, 116b” at paragraph [0019] and “The horizontal portions 118a, 118b each include downward facing pulling surfaces 120a, 120b” at paragraph [0020]. Therefore, the claims are not consistent with the specification. Examiner expects this a typographical error.
The claim language regarding the second vertical portion and second horizontal portion was also amended and has the same issue.
This does not materially affect examination of the claims, but correction is requested so the claims are consistent with the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 fails to further limit claim 1. Claim 1 was amended to recite the first and second vertical portions of the arms and the first and second horizontal portions of the arms are configured to elastically deform to fit within the outer tube. Claim 6 recites, more broadly, that the arms are configured to elastically deform to fit within the outer tube. Therefore, Claim 6 fails to further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller et al. (US Patent Publication 2014/0379024) in view of CN 205433802 (hereafter CN’802) in view of Andre (US Patent Publication 2011/0295289).
Claims 1, 6: Schaller’024 teaches an ophthalmic surgical instrument (100) for peeling a retinal membrane (paragraph [0002]), comprising:
a handle (100);
an actuator (110a, 110b) mounted on the handle;
an outer tube (130) having a proximal end mounted to the handle (proximal end of tube 130 is mounted to handle via 150);
a first arm (124a) extending outwardly relative to a distal end of the outer tube having a first gripping surface (the inside of the arm is the gripping surface); and
a second arm (124b) extending outwardly relative to the distal end of the outer tube having a second gripping surface (the inside of the arm is the gripping surface), the second gripping surface facing the first gripping surface (Figures 3a, 3b),
wherein the actuator is configured to cause the first arm and the second arm to withdraw into the outer tube thereby causing the first arm and the second arm to move toward one another for raising a flap of the retinal membrane between the first gripping surface and the second gripping surface, and gripping of the flap between the first gripping surface and the second gripping surface (paragraph [0026], [0027] describes that when actuator 110a, 110b is squeezed, 160 is moved in direction 133; which causes shaft 122 and arms 124a, 124b to be withdrawn into tube 130 so that the arms move closer together into a closed/grasping configuration).
Schaller’024 does not teach the claimed configuration of the first and second arms.
Like Schaller’024, CN’802 is for grasping tissue during surgery. Like Schaller’024, CN’802 teaches a first arm and a second arm (Figure 1 shows two arms 4)
Each arm comprises a vertical portion (4-2) comprising a first pulling surface (bottom of element 4-2 with respect to the page) and a first horizontal portion (4-1) comprising a first gripping surface (surface of vertical portion 4-2 which contacts the same inner surface on the opposite arm) substantially perpendicular to the first pulling surface (Figure 1).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the grasping arms taught by Schaller’024 by substituting the grasping arms, as taught by CN’802, in order to provide an instrument which allows for enhanced gripping of tissue in a region with limited space (“beneficial effects” of CN’802).
Schaller’024 teaches the arms are made of stainless steel, titanium or plastic or any other appropriate material (paragraph [0020]). CN’802 is silent regarding the material.
Andre’289 teaches a pair of arms (2a, 2b) for grasping in eye surgery which can be made out of an elastic, shape memory metal material in order to increase the flexibility of the device (paragraphs [0019], [0054], [0056]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Schaller’024 in view of CN’802, by constructing the vertical and horizontal components of the arms of a shape memory metal or plastic, as taught by Andre’289, in order to ensure the arms are flexible and because it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 2: Schaller’024 teaches the actuator (110a, 110b) is configured to extend the outer tube (130) in relation to the handle (100) over the first arm and the second arm responsive to movement of the actuator in a first direction (tube 130 moves in direction 131 when handle 110a, 110b is squeezed – paragraph [0026]).
Claim 3: Schaller’024 teaches the actuator (110a, 110b) is configured to withdraw the outer tube (130) from over the first arm and the second arm responsive to movement of the actuator in a second direction opposite the first direction (tube 130 moves in direction 133 when the actuator 110a, 110b is released – paragraph [0027]).
Claim 4: Schaller’024 teaches the arms (124a, 124b) are configured to extend outwardly from an outer diameter of the outer tube (130) when extended outwardly from a distal end of the outer tube (Figure 3a). This outward extension is necessary to allow clearance for grasping tissue.
CN’802’s arms (4, 4) extend outwardly when in the open configuration.
In the modified device of Schaller’024 in view of CN’802, the open arms (4, 4) would extend outwardly from the tube in order to allow the arms to have sufficient clearance to grasp tissue between them.
Claim 5: Schaller’024 shows the arms (124a, 124b) are biased to recoil outwardly when extended from the distal end of the outer tube (see Figures 3a, 3b).
CN’802’s arms (4, 4) extend outwardly when in the open configuration.
Neither Schaller’024 nor CN’802 teach the degree to which the arms open relative to the tube/proximal end such that it is twice a diameter of the outer tube.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the clearance between the arms in the open configuration such that it is twice the diameter of the tube, 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.
Specifically, one of ordinary skill in the art would understand that modifying the clearance between the arms would change the size of the object grasped by the jaws. Depending on the intended application or intended object grasped by the arms, it would be obvious to modify the clearance between the jaws so that it is sufficient to grasp the desired material but not overly large such that it is cumbersome or hard to control by the user.
Claim 7: Andre’289 discloses the arms can be made of a shape memory metal (paragraph [0056]) does not specifically teach the arms are constructed of nitinol. However, it is deemed to be within the level of ordinary skill in the art to use a known material. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” See §MPEP 2144.07.
Claim 10: CN’802 teaches the first and second pulling surfaces (bottom of element 4-2 with respect to the page) are formed on a respective flange extending outwardly from a respective gripping surface (see Figures 1).
Claims 8, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller’024 in view of CN’802 in view of Andre’289, as applied to claim 1, further in view of Khristov et al. (US Patent Publication 2020/0178964).
Claim 8: Schaller’024 in view of CN’802 does not teach the first and second pulling surfaces (4-2) have barbs.
Khristov’964 teaches a device having a pair of arms (16, 20) for grasping tissue during eye surgery (paragraph [0043]). The arms having barbs (68, 70 or 72, 74; Figures 3a, 3b, 9, 10) on the bottom on the bottom of the arms to enhance tissue grip.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by CN’802 with barbs on the first and second pulling surfaces, as taught by Khristov’964, in order to enhance grip of the tissue.
Claim 9: Khristov’964 does not teach the size of the barbs.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to cause the device of Schaller’024 in view of CN’802 in view of Khristov’964 to have a barbs with lengths between 0.8 and 8 microns 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’024, as modified, would not operate differently with the claimed barb length and since the barbs are intended to enhance the grip of eye tissue, as in the present application. Further, the device would function appropriately having the claimed length. Further, Applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges (specification at paragraph [0022]).
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.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 5 March 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771