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
Applicant’s arguments with respect to claim(s) 1-7 and 9-10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Status
The drawing objections, specification objections, and 112 rejections have been overcome.
Claims 1-14 are examined below.
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 11 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 11 recites “a base” in line 2. It is unclear if this is the same base recited in line 1 or a separate and additional base. For examination purposes, it is understood to be the same base.
Claim 11 recites “a tip” in line 3. It is unclear if this is the same tip recited in line 1 or a separate and additional tip. For examination purposes, it is understood to be the same tip.
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 –
Claim(s) 1-3 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Collins (US 5,649,944 A).
Regarding claim 1, Collins discloses a corneal trephine (8, punch, fig. 3D) comprising a tubular body (fig. 3D) having a cross section including a rounded portion (806, center portion, fig. 3D) and an elongated tail portion (802, tabbed portion, fig. 3D) extending from the rounded portion, the cross-section of the tubular body having a continuous perimeter (fig. 3D), the tubular body having a leading edge extending around the perimeter (822, cutting edge, fig. 3D), the leading edge being a cutting blade configured to cut into a cornea (822, cutting edge, fig. 3D).
Regarding claim 2, Collins further discloses the cross section having a major axis (see annotated fig. 3D, below) and a minor axis (see annotated fig. 3D, below), the major axis encompassing the tail portion and the rounded portion (fig. 3D).
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Regarding claim 3, Collins further discloses the cross section being symmetrical about the major axis (fig. 3D).
Regarding claim 14, keyholes come in many shapes. Therefore, the claiming of a keyhole shape is considered clearly obvious over Collins.
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) 4-7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view of Dunn (US 2005/0149092 A1).
Regarding claim 4, Collins fails to teach a convex curvature. However, Dunn discloses a tissue punch that includes the leading edge having a convex curvature (¶ [0004], fig. 4A). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Collins to include a convex curvature as taught by Dunn since it is a simple substitution of one known element for another to obtain predictable results.
Regarding claim 5, Collins fails to teach the convex curvature matches the curvatures of a patient’s cornea. However, although Dunn does not explicitly state that the convex curvature is configured to match the curvature of a cornea of a patent, the convex curvature would inherently match the curvature of at least some corneas.
Regarding claim 6, Collins fails to teach low and crest points. However, Dunn further discloses the leading edge includes low points (see annotated fig. 4A, below), and wherein the convex curvature of the leading edge extends from low points on the leading edge at or around the points at which the major axis (70, major axis, fig. 6A) intersects the leading edge to crest points (54, apex, fig. 4A) on the leading edge at or towards a mid point of the major axis. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Collins to include low and crest points as taught by Dunn since it is a simple substitution of one known element for another to obtain predictable results.
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Regarding claim 7, Collins fails to teach the complex curvature is symmetrical. However, Dunn further discloses the complex curvature is symmetrical about the major axis (fig. 6B). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Collins to include the complex curvature is symmetrical as taught by Dunn since it is a simple substitution of one known element for another to obtain predictable results.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view of Rowsey (US 5,584,881 A).
Regarding claim 9, Collins fails to teach a punch block. However, Rowsey further discloses a punch block (64, block, fig. 6), the punch block having a curved surface (col 6, lines 39-45), wherein the curvature of the leading edge is complimentary to the curved surface of the punch block (fig. 6). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Collins to include a punch block as taught by Rowsey for constituting a support for the donor material during the cutting by the trephine (col 6, liens 39-45, Rowsey).
Regarding claim 10, Collins further discloses an alignment device (3 and 7, nest and guide pins, fig. 3A) to align the trephine with respect to the punch block.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view of Cumming (US 2014/0155871 A1).
Regarding claim 11, Collins discloses a base (see annotated fig. 3D, below) and a tip (see annotated fig. 3D, below), the tail portion extends between a base, at the intersection between the tail portion and the rounded portion, and a tip (fig. 3D).
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Collins fails to teach the width of the tail is greater at the base compared to the tail. However, Cumming discloses a corneal graft that includes the width of the tail is greater at the base of the tail portion compared with at the tip of the tail portion (fig. 2). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Collins to include the width of the tail is greater at the base compared to the tail as taught by Cumming since it is a simple substitution of one known element for another to obtain predictable results.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view of Cumming (US 2014/0155871 A1) and Dunn (US 2005/0149092 A1).
Regarding claim 12, Collins further discloses a major axis (see annotated fig. 3D, below) and a minor axis (see annotated fig. 3D, below), the major axis encompassing the tail portion and the rounded portion (fig. 3D).
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Collins fails to teach the width of the major axis intersecting the perimeter at a point in the elongated tail and at a point in the rounded portion. However, Cumming discloses a corneal graft that includes teaching the use of a singular extension (¶ [0043]) and the major axis intersecting the perimeter at a first point in the elongated tail portion (see annotated fig. 2, below) and at an oppositely opposed second point in the rounded portion (see annotated fig. 2, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Collins to include the teaching by Cumming in order to facilitate centration and maintain shape (¶ [0044], Cumming).
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Collins in view of Cumming fails to teach the leading edge has a convex curvature. However, Dunn discloses a tissue punch that includes a side view profile the leading edge (fig. 4A) having a continuous convex curvature (¶ [0004], fig. 4A) extending continuously along the major axis from the first point on the perimeter where the major axis intersects the perimeter to the second point on the perimeter where the major axis intersects the perimeter (fig. 4A). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Collins and Cumming to include the leading edge has a convex curvature as taught by Dunn since it is a simple substitution of one known element for another to obtain predictable results.
Regarding claim 13, Collins fails to teach a crest. However, Dunn further discloses a crest at or around the midpoint of the major axis (54, apex, fig. 4A). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Collins to include a crest as taught by Dunn since it is a simple substitution of one known element for another to obtain predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rogers (US 5,092,874 A) discloses a trephination press with an alignment device and punch block.
Dorawa (ES 2377887 T3) discloses an irregularly shaped punch.
Gibbs (US 3,990,451 A) discloses a tissue punch with a convex blade.
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 TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774