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 a response to applicant’s arguments and amendment filed 10/22/2025. Claims 1-3, 8-9, 17-19 and 25 are amended. Claims 6, 10-12, 14, 20-21 and 26-32 are cancelled. Claims 1-5, 7-9, 13, 15-19 and 22-25 are currently pending.
The rejection of claims 8-9 and 17-18 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 10/22/2025, with respect to the rejection(s) of claim(s) 1-4, 7-10, 12, 15-17, 19 and 22-25 under 35 U.S.C. 102(a)(1) as being anticipated by Stodulka; claims 1 and 17-18 under 35 U.S.C. 102(a)(2) as being anticipated by Barron; and claims 5 and 13 under 35 U.S.C. 103 as being unpatentable over Stodulka, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendment to the claims.
Applicant argues Stodulka does not disclose an inwardly directed asymmetric notch cut into a circular edge forming the circumferential perimeter of a circular graft, because Stodulka instead discloses a star shape defining the cutting end of the blade (Remarks, pgs. 6-7).
In response to applicant’s first argument, it is respectfully submitted the arguments are narrower than the claim limitations. As discussed below, the term ‘circular’ encompasses the definition “of or relating to a circle” or “having the form of a circle”. Further, the tubular body 1a of Stodulka is considered to be round/circular and depicted as such in fig. 2, such that a cutting edge 2 formed on the distal end of the tubular body is also considered to be circular. Stodulka further describes the cutting edge 2 equipped with asymmetric notches, as opposed to alternatively being provided with asymmetric notches, which are depicted as extending in a circular manner along the cutting edge of the tubular body. Therefore, the cutting edge being provided with asymmetric notches on the distal end of the tubular body is not mutually exclusive from the cutting edge extending in a circular manner. As depicted in fig. 2, portions of the cutting edge extend in a circular manner along the tubular body, such that the claimed limitation is met.
Applicant further argues Stodulka does not teach an asymmetric notch defined by a longitudinally directed channel formed in a circular peripheral side wall as required by claim 18 (Remarks, pg. 7).
In response to applicant’s second argument, it is respectfully submitted Stodulka is not relied upon to teach the limitations of claim 18; therefore, applicant’s argument is moot.
Applicant further argues Barron does not disclose an asymmetrical notch, and instead discloses an outpouch 14 which appears to be symmetrical and protrudes outwardly from the graft (Remarks, pgs. 7-8).
In response to applicant’s third argument, it is respectfully submitted Barron explicitly states protrusions may comprise indentations instead of protrusions, which are considered to be notches. Further, the claim language does not limit what the term ‘asymmetrical’ applies to, such that an indentation positioned asymmetrically on the circular cutting edge of Barron is considered to meet the claimed limitations.
Applicant further argues Stodulka does not teach the trephine blade as claimed with respect to claims 1 and 17-18 rejected under 35 U.S.C. 103 (Remarks, pgs. 8-11).
In response to applicant’s fourth argument, it is respectfully submitted claims 1 and 17-18 were not rejected over Stodulka under 35 U.S.C. 103; as discussed in the non-final rejection, claims 1 and 17-18 were rejected as being anticipated by Barron under 35 U.S.C. 102(a)(2). Therefore, applicant’s argument is moot. Further, with respect to claim 17, annotated fig. 2 depicts a channel formed in the peripheral side wall of Stodulka as claimed.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-9, 15-17, 19, and 22-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stodulka (WO 2014/187435 A1) (all references previously of record).
Regarding claim 1, Stodulka discloses (see abstract; pgs. 1-3; figs. 1-2) a trephine blade (fig. 2) for use in the preparation of a circular corneal graft for endothelial keratoplasty (pg. 1, field of technology), the blade comprising a circular cutting edge (2, note cutting edge 2 formed on end of tubular body 1a, which is considered to be circular such that the cutting edge 2 is considered to be circular, further note broadest reasonable interpretation of the term ‘circular’ is defined as “round” or “of or relating to a circle” (see Merriam-Webster dictionary definition), such that tubular body 1a is considered to be round or having a shape relating to a circle, therefore meeting the claimed limitation, pg. 2 ‘Example’; fig. 2) at one end of a circular peripheral side wall of the blade (cutting edge 2 formed at one end of peripheral side wall of tubular body) and extending around the peripheral side wall for cutting a circumferential perimeter of the corneal graft from donor corneal tissue (considered to extend around the side wall, note notches 2a are on the periphery of cutting edge 2, such that cutting edge 2 is considered to provide a circumferential perimeter of tissue), the circular cutting edge incorporating an asymmetric notch formation (at least one notch 2a) for cutting a correspondingly shaped asymmetric notch in the circumferential perimeter of the corneal graft (marks donor membrane, pg. 2) to indicate correct orientation of the corneal graft in said endothelial keratoplasty (uniquely distinguishes edges of graft, pg. 2).
Regarding claim 2, Stodulka discloses the blade of claim 1. Stodulka further discloses wherein the asymmetric notch in the circumferential perimeter of the corneal graft is shaped to indicate whether the endothelial layer of the corneal tissue is facing upwardly or downwardly, when the corneal tissue is viewed from above (indicates upper and lower sides of graft, considered to indicate direction the tissue is facing, pg. 2).
Regarding claim 3, Stodulka discloses the blade of claim 1. Stodulka further discloses wherein the notch formation is defined by an inwardly directed cutting edge (annotated fig. 2) of the blade and a further cutting edge (annotated fig. 2) extending from an inner end of the inwardly directed cutting edge to the circular cutting edge of the blade (depicted in fig. 2, see rounded portions at apex of notches, considered to extend around the tubular body and therefore meet the definition of the cutting edge being circular).
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Annotated Figure 2 of Stodulka
Regarding claim 4, Stodulka discloses the blade of claim 3. Stodulka further discloses wherein the inwardly directed cutting edge and the further cutting edge are oriented at an acute angle relative to one another (angle formed between cutting edges depicted as acute, see cutting edges in annotated fig. 2).
Regarding claim 7, Stodulka discloses the blade of claim 3. Stodulka further discloses wherein the inwardly directed cutting edge and the further cutting edge of the notch formation are both straight cutting edges (depicted in fig. 2).
Regarding claim 8, Stodulka discloses the blade of claim 3. Stodulka further discloses wherein the inwardly directed cutting edge extends radially with respect to the longitudinal axis of the blade (considered to extend in a radial direction relative to the longitudinal axis, depicted in fig. 2).
Regarding claim 9, Stodulka discloses the blade of claim 3. Stodulka further discloses wherein the notch formation of the blade is configured to form a notch in the circumferential perimeter of the donor corneal tissue that is in the shape of the number "7" (depicted in fig. 2 in the shape of a 7) when the corneal tissue is viewed from above with the endothelium layer of the corneal tissue facing down (at least one notch 2a considered to form a “7”-shape when the graft is viewed, as the orientation of the tissue is recited functionally, and notches 2a are shaped appropriately to form a “7”-shape in the tissue, regardless of the orientation of the tissue).
Regarding claim 15, Stodulka discloses the blade of claim 1. Stodulka further discloses the blade being tubular (tubular body 1a) with a through passageway (tubular body considered to have a lumen, fig. 2) extending from one end of the blade (proximal end of cutting instrument depicted in fig. 2) to the opposite end of the blade (distal end of cutting instrument depicted in fig. 2) defining the cutting edge of the blade (fig. 2).
Regarding claim 16, Stodulka discloses the blade of claim 15. Stodulka further discloses wherein the notch formation protrudes into the through passageway of the blade (fig. 2).
Regarding claim 17, Stodulka discloses the blade of claim 1. Stodulka further discloses wherein the notch formation is defined by a longitudinally directed channel formed in the circular peripheral side wall of the blade (channel/indent depicted on exterior surface of tubular body forming notches 2a, annotated fig. 2).
Regarding claim 19, Stodulka discloses (see abstract; pgs. 1-3; figs. 1-2) a cutting device (figs. 1-2) for the preparation of a circular corneal graft for endothelial keratoplasty (pg. 1, field of technology), the device comprising a trephine blade (fig. 2) having a circular cutting edge (2, note cutting edge 2 formed on end of tubular body 1a, which is considered to be circular such that the cutting edge 2 is considered to be circular, further note broadest reasonable interpretation of the term ‘circular’ is defined as “round” or “of or relating to a circle” (see Merriam-Webster dictionary definition), such that tubular body 1a is considered to be round or having a shape relating to a circle, therefore meeting the claimed limitation, pg. 2 ‘Example’; fig. 2) at one end of a circular peripheral side wall of the blade (cutting edge 2 formed at one end of peripheral side wall of tubular body) and extending around the peripheral side wall for cutting a circumferential perimeter of the corneal graft from donor corneal tissue (considered to extend around the side wall, note notches 2a are on the periphery of cutting edge 2, such that cutting edge 2 is considered to provide a circumferential perimeter of tissue), the circular cutting edge incorporating an asymmetric notch formation (at least one notch 2a) for cutting a correspondingly shaped asymmetric notch in the circumferential perimeter of the corneal graft (marks donor membrane, pg. 2) to indicate correct orientation of the corneal graft in said endothelial keratoplasty (uniquely distinguishes edges of graft, pg. 2), the blade being retained by the device for the cutting of the donor corneal tissue by the blade (depicted in fig. 1).
Regarding claim 22, Stodulka discloses the device of claim 19. Stodulka further discloses the device being a punch (device depicted in fig. 1 considered to be a punch, cuts and marks tissue and incorporates a vacuum for tissue fixation, pg. 2).
Regarding claim 23, Stodulka discloses the device of claim 22. Stodulka further discloses wherein the blade is housed within the punch in use (fig. 1).
Regarding claim 24, Stodulka discloses the device of claim 19. Stodulka further discloses wherein the blade is arranged for being driven toward the donor corneal tissue to effect the cutting of the donor tissue for preparation of the corneal graft with operation of the device (considered to be driven via spring 3 when in use, pg. 2; fig. 1).
Regarding claim 25, Stodulka discloses (see abstract; pgs. 1-3; figs. 1-2) a method for preparing a circular corneal graft for use in endothelial keratoplasty (pgs. 1-3), comprising the steps of:
providing a trephine blade (fig. 2) for cutting donor corneal tissue to provide the corneal graft (pg. 1, field of technology), the blade having a circular cutting edge (2, note cutting edge 2 formed on end of tubular body 1a, which is considered to be circular such that the cutting edge 2 is considered to be circular, further note broadest reasonable interpretation of the term ‘circular’ is defined as “round” or “of or relating to a circle” (see Merriam-Webster dictionary definition), such that tubular body 1a is considered to be round or having a shape relating to a circle, therefore meeting the claimed limitation, pg. 2 ‘Example’; fig. 2) at one end of a circular peripheral side wall of the blade (cutting edge 2 formed at one end of peripheral side wall of tubular body) and extending around the peripheral side wall for cutting a circumferential perimeter of the corneal graft from the donor corneal tissue (considered to extend around the side wall, note notches 2a are on the periphery of cutting edge 2, such that cutting edge 2 is considered to provide a circumferential perimeter of tissue outside of notches 2a), the circular cutting edge incorporating an asymmetric notch formation (at least one notch 2a) for cutting a correspondingly shaped asymmetric notch in the circumferential perimeter of the corneal graft (marks donor membrane, pg. 2) to indicate correct orientation of the corneal graft in said endothelial keratoplasty (uniquely distinguishes edges of graft, pg. 2);
cutting the donor corneal tissue with the blade (marks donor membrane, pg. 1, field of technology and pg. 2); and
retrieving the cut corneal tissue incorporating the notch (consequent transplantation considered to encompass retrieval, abstract, pgs. 1-3).
Claim(s) 1 and 17-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Barron (US 2021/0121328 A1).
Regarding claim 1, Barron discloses (see abstract; paras. [0015]-[0037]; figs. 1-5) a trephine blade (10, para. [0016]; fig. 1) for use in the preparation of a circular corneal graft for endothelial keratoplasty (para. [0002]), the blade comprising a circular cutting edge (includes 12, para. [0017]) at one end of a circular peripheral side wall of the blade (depicted in fig. 1) and extending around the peripheral side wall for cutting a circumferential perimeter of the corneal graft from donor corneal tissue (depicted in figs. 1-2), the circular cutting edge incorporating an asymmetric notch formation (includes 16 and 18 which may be indentations, paras. [0019] and [0036]; fig. 2) for cutting a correspondingly shaped asymmetric notch in the circumferential perimeter of the corneal graft (paras. [0019] and [0021]) to indicate correct orientation of the corneal graft in said endothelial keratoplasty (paras. [0019] and [0021]).
Regarding claim 17, Barron discloses the blade of claim 1. Barron further discloses wherein the notch formation is defined by a longitudinally directed channel formed in the circular peripheral side wall of the blade (exterior channel forms 14 which 18 is located on, figs. 1-2).
Regarding claim 18, Barron discloses the blade of claim 17. Barron further discloses wherein the channel extends along the circular peripheral side wall from the one end of the blade to an opposite end of the blade (depicted in figs. 1-2).
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.
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) 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Stodulka.
Regarding claim 5, Stodulka discloses the blade of claim 4.
However, Stodulka fails to explicitly disclose wherein the acute angle is in a range of from about 70° to about 80°.
Stodulka discloses (pgs. 1-3) that the arrangement of the notches needs to be optimized “for obvious identification of the obverse and reverse side of the donor membrane for its proper positioning during consequent transplantation.” As seen in fig. 2, the notches have a specific angle for marking of the tissue, and as such the angle formed by the notches is disclosed to be a result effective variable in that changing the angle formed by the notches changes the identification of the sides of corneal tissue, which affects the positioning of the tissue and success of the procedure. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Stodulka to have an angle within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, 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 Stodulka by making the angle formed by the notches to be between 70 and 80 degrees as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 13, Stodulka discloses the blade of claim 1.
However, Stodulka fails to explicitly disclose wherein the notch formation is configured for removing about 1.5% or less of the corneal donor tissue.
Stodulka discloses (pgs. 1-3) that the arrangement of the notches needs to be optimized “for obvious identification of the obverse and reverse side of the donor membrane for its proper positioning during consequent transplantation.” As seen in fig. 2, the notches have a specific angle for marking of the tissue to remove a specific amount of tissue, and as such the formation of the notches, which directly impacts the amount of tissue removed, is disclosed to be a result effective variable in that changing the formation of the notches changes the identification of the sides of corneal tissue and amount of tissue removed, which affects the positioning of the tissue and success of the procedure. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Stodulka to be configured to remove the tissue as claimed, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, 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 Stodulka by making the angle formed by the notches to be configured to remove 1.5% or less of the tissue as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771