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 Arguments
The previous drawings objection has been withdrawn in light of applicant’s amendment to the specification made 7/06/2026.
The rejection of claims 1, 6-11 and 14-21 under 35 U.S.C. 112(a) as failing to comply with the written description requirement has been withdrawn in light of applicant’s amendment made 7/06/2026. However, upon further consideration, a new ground(s) of rejection is made in view of Eaton et al. (US 5,312,413).
Claim Objections
Claim 10 is objected to because it depends from canceled claim 3. For the purposes of examination, claim 10 has been interpreted to depend from independent claim 1. Appropriate correction is required.
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.
Claims 14-15 are 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. Claims 14-15 depend from claim 11 and recite subject matter which has been incorporated into independent claim 11. Therefore, claims 14-15 do not further limit the subject matter of claim 11. 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 § 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.
Claim(s) 1, 6-9, 11, 14-17 and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eaton et al. (US 5,312,413).
Regarding claims 1 and 20, Eaton discloses a surgical device (Figs. 5-8) comprising: a main housing (handle 33); an actuator (annular actuator or ring 32) coupled to a first portion of the main housing (Figs. 5-6); a shaft (linear proximal portion of 30 extending from handle 33; Fig. 5) extending along a shaft axis (longitudinal axis of linear proximal portion of 30) from a proximal end to a distal end (Fig. 5), wherein a first portion (proximal end) of the shaft is coupled to a second portion of the main housing (Fig. 5); a distal housing assembly (distal portion of device beginning at the bend/curve; Fig. 5) disposed at the distal end of the shaft (Fig. 5), the distal housing assembly comprising: a housing portion (upper and lower halves 40, 41) extending from a proximal end to a distal end along a housing axis (axis along distal portion of blade at an angle relative to the longitudinal axis of the shaft; Fig. 5), wherein at least a portion of the housing axis is non-linear (at the bend/curve; Fig. 5), and wherein a portion of the housing portion that is at or adjacent to the proximal end of the housing portion is coupled to a second portion (distal end) of the shaft that is at or adjacent to the distal end of the shaft (Fig. 5); a slot portion (opening between 40, 41 that blade 30 resides within) at least partially defined by a portion of the housing portion (Figs. 5-6), the slot portion extending along a slot axis from a slot proximal end to a slot distal end (Figs. 5-6), wherein the slot axis is aligned with the housing axis (Figs. 5-6), and a blade portion (distal portion of 30) having a blade tip (Fig. 6) configured to cut through tissue (as blade cuts through eye tissue; columns 1-2, lines 64-68, 1-12), the blade tip being disposed at a distal end of the blade portion (Fig. 6), wherein at least a portion of the blade portion is disposed within the slot portion (Fig. 6), wherein the blade portion is coupled to the actuator (via handle 33) such that (a) when the actuator is in a first actuator position (retracted), the blade tip is in a first blade position in which the blade tip is disposed proximal to the distal end of the housing portion (Figs. 5-6) and (b) when the actuator is in a second actuator position (extended), the blade tip displaces to a second blade position in which the blade tip is disposed distal to the distal end of the housing portion (column 6, lines 1-10); and a projection portion (widened distal end face portion surrounding distal portion of blade 30 in the circled area of annotated Fig. 6; it is noted the top half of the annular projection is not shown for clarification purposes in Fig. 6) that extends along a portion of an outer surface of the housing portion (Fig. 6), wherein the projection portion is an annular ring (as halves 40, 41 are welded to each other to form an annular ring by encircling the blade laterally; column 5, lines 64-67) having a semi-circular cross-sectional shape (see annotated Fig. 6 below) that extends along the portion of the outer surface of the housing portion (Fig. 6), wherein the annular ring is entirely disposed within a projection plane that intersects the housing axis but is not normal to the housing axis (see annotated Figs. 5-6 below; it is noted that the projection plane may be drawn at any angle relative to the housing axis as long as it includes the entirety of the circled projection portion of annotated Fig. 6), and wherein the projection plane makes an acute angle with a reference plane that is normal to the housing axis and that intersects the housing axis at a point in which the projection plane intersects the housing axis (see annotated Figs. 5-6 below), and the acute angle is between 10 degrees and 70 degrees (as the projection plane may be drawn at any angle relative to the reference plane as along as it includes all of the projection portion circled in annotated Fig. 6).
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Regarding claim 6, Eaton discloses wherein the housing portion includes a first housing portion (40) and a second housing portion (41) coupled to the first housing portion (as halves 40, 41 are welded to each other; column 5, lines 64-67), wherein the slot portion (opening between 40, 41) is at least partially defined by a portion of the second housing portion and a portion of the first housing portion (Fig. 5).
Regarding claim 7, Eaton discloses wherein the shaft axis is linear (Figs. 5-6).
Regarding claim 8, Eaton discloses wherein at least a portion of the housing axis has the shape of an arc (along the bend/curve; see annotated Fig. 5 above).
Regarding claim 9, Eaton discloses wherein the blade tip has a V-shape that is symmetrical about the housing axis (Fig. 6).
Regarding claims 11 and 21, Eaton discloses a distal housing assembly (distal portion of device beginning at the bend/curve; Fig. 5) configured to be disposed at a distal end of a shaft (linear proximal portion of 30 extending from handle 33; Fig. 5) of a surgical device (Figs. 5-8), the distal housing assembly comprising: a housing portion (upper and lower halves 40, 41) extending from a proximal end to a distal end along a housing axis (Figs. 5-6), wherein at least a portion of the housing axis is non-linear (at the bend/curve; Fig. 5), and wherein a portion of the housing portion that is at or adjacent to the proximal end of the housing portion is configured to be coupled to a portion of the shaft (Fig. 5); a slot portion (opening between 40, 41) at least partially defined by a portion of the housing portion (Fig. 5), the slot portion extending along a slot axis from a slot proximal end to a slot distal end, wherein the slot axis is aligned with the housing axis (Figs. 5-6), and a blade portion (distal portion of 30) having a blade tip (tip of 30) configured to cut through tissue (as blade cuts through eye tissue; columns 1-2, lines 64-68, 1-12), the blade tip being disposed at a distal end of the blade portion (Fig. 5), wherein at least a portion of the blade portion is disposed within the slot portion (Figs. 5-6), the blade portion being configured to be coupled to an actuator (annular actuator or ring 32 via handle 33) of the surgical device such that (a) when the actuator is in a first actuator position (retracted), the blade tip is in a first blade position in which the blade tip is disposed proximal to the distal end of the housing portion (Figs. 5-6) and (b) when the actuator is in a second actuator position (extended), the blade tip displaces to a second blade position in which the blade tip is disposed distal to the distal end of the housing portion (column 6, lines 1-10); and a projection portion (widened distal face portion surrounding distal portion of blade 30 in circled area of annotated Fig. 6) that extends along a portion of an outer surface of the housing portion (Fig. 6), wherein the projection portion is an annular ring (as halves 40, 41 are welded to each other to form an annular ring by encircling the blade laterally; column 5, lines 64-67) having a semi-circular cross-sectional shape (see annotated Fig. 6) that extends along the portion of the outer surface of the housing portion (Fig. 6), wherein the annular ring is entirely disposed within a projection plane that intersects the housing axis but is not normal to the housing axis (see annotated Figs. 5-6 below; it is noted that the projection plane may be drawn at any angle relative to the housing axis as long as it includes the entirety of the circled projection portion of annotated Fig. 6), and wherein the projection plane makes an acute angle with a reference plane that is normal to the housing axis and that intersects the housing axis at a point in which the projection plane intersects the housing axis (see annotated Figs. 5-6 below), and the acute angle is between 10 degrees and 70 degrees (as the projection plane may be drawn at any angle relative to the reference plane as along as it includes all of the projection portion circled in annotated Fig. 6).
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Regarding claim 14, Eaton discloses wherein the projection plane makes an acute angle with a reference plane that is normal to the housing axis and that intersections the housing axis at a point in which the projection plane intersects the housing axis (see annotated Figs. 5-6 above).
Regarding claim 15, Eaton discloses wherein the projection plane is not normal to the shaft axis (see annotated Fig. 6 above, where the shaft axis would be along the shown housing axis in Fig. 6).
Regarding claim 16, Eaton discloses wherein at least a portion of the housing axis has the shape of an arc (along the bend/curve; see annotated Fig. 5 above).
Regarding claim 17, Eaton discloses wherein the blade tip has a V-shape that is symmetrical about the housing axis (Fig. 6).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 10 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eaton et al. (US 5,312,413) in view of Storz (US 4,656,999).
Regarding claim 10, Eaton discloses the actuator (32) moves the first housing relative to the blade portion in order to expose the distal end of the blade, but fails to disclose wherein the actuator is a lever pivotably coupled to the first portion of the main housing, the blade portion being coupled to the lever such that (a) when the lever is in a first lever position, the blade tip is in the first blade position in which the blade tip is disposed proximal to the distal end of the housing portion and (b) when the lever is in a second lever position, the blade tip displaces to the second blade position in which the blade tip is disposed distal to the distal end of the housing portion.
However, Storz teaches a housing assembly (slideway 3) with a blade portion (blade 2; Figs. 1-3) therein wherein an actuator (movable half 7) is a lever pivotably coupled to a first portion of main housing (Fig. 1), the blade portion being coupled to the lever such that (a) when the lever is in a first lever position (un-moved), the blade tip is in a first blade position (retracted) in which the blade tip is disposed proximal to the distal end of the housing portion (Fig. 1; column 3, lines 24-27) and (b) when the lever is in a second lever position (pulled), the blade tip displaces to a second blade position (extended) in which the blade tip is disposed distal to the distal end of the housing portion (column 3, lines 21-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute for the actuator of Eaton the pivotable lever actuator as taught by Storz because the substitution of one known element for another would have yielded the predictable result of extending and retracting the blade portion from the housing portion.
Regarding claims 18-19, Eaton fails to explicitly disclose wherein the blade portion comprises a flexible material.
However, Storz teaches a housing assembly (slideway 3) with a blade portion (blade 2; Figs. 1-3) therein wherein an actuator (movable half 7) is a lever pivotably coupled to a first portion of main housing (Fig. 1), the blade portion being coupled to the lever such that (a) when the lever is in a first lever position (un-moved), the blade tip is in a first blade position (retracted) in which the blade tip is disposed proximal to the distal end of the housing portion (Fig. 1; column 3, lines 24-27) and (b) when the lever is in a second lever position (pulled), the blade tip displaces to a second blade position (extended) in which the blade tip is disposed distal to the distal end of the housing portion (column 3, lines 21-29). Therefore, the blade portion (2) must be flexible to slide/translate from the retracted position to the extended position along the bend/curve in the housing assembly (3; Figs. 1-3).
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 material of the blade portion of Eaton to be flexible as taught by Storz and/or to substitute for the actuator of Eaton the pivotable lever actuator as taught by Storz because the substitution of one known element for another would have yielded the predictable result of extending and retracting the blade portion from the housing portion. Further, 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Morawski et al. (US 2008/0058844 A1) is noted for teaching a semi-circular shaped projection at an angle relative to the housing axis.
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
