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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/28/2026 has been entered.
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 05/28/2026. Claims 1, 3, 17-19 and 25 are amended. Claims 6, 10-12, 14, 20-21 and 26-32 are cancelled. Claims 33-34 are new. Claims 1-5, 7-9, 13, 15-19, 22-25 and 33-34 are currently pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed 05/28/2026, with respect to the rejection(s) of claim(s) 1-4, 7-9, 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.
1) Applicant continues to argue Stodulka does not disclose the cutting edge with a circular perimeter, and instead discloses a star-like perimeter that is not circular at all, which is not round or fall within the definition of circular (Remarks, pgs. 8-11).
In response to applicant’s first argument, it is respectfully submitted the shape the notches form in the cutting edge of Stodulka does not preclude the perimeter of the cutting edge of Stodulka as being circular. It is further noted this interpretation is consistent with figs. 1-3 of the instant specification, which are described as having a circular perimeter but also including a notch formation. Therefore, if the logic being applied to Stodulka were applied to the instant application, the cutting edge in figs. 1-3 of the instant specification would also not extend circularly due to the presence of the notch formation. The perimeter of the cutting edge of Stodulka and the cutting edge in the instant specification extend similarly because they both include notch formations extending in a circular manner, therefore, the perimeter of the cutting edge of Stodulka is also considered to have a circular perimeter. Applicant further notes the definition of the term ‘circle’ precludes the interpretation of Stodulka disclosing a circular perimeter, however, this argument is narrower than the claim limitation. The claim language describes the perimeter as “circular”, which is broader in definition than the term ‘circle’. Therefore, the claim remains rejected under Stodulka as discussed below.
2) Applicant further argues Stodulka does not disclose an acute angle formed by the two inwardly directed cutting edges (Remarks, pg. 11).
In response to applicant’s second argument, an additional annotated figure has been provided to clearly depict the angle formed by the cutting edges being acute in Stodulka.
3) Applicant further argues the cutting edges of Stodulka are not straight (Remarks, pg. 11).
In response to applicant’s third argument, it is respectfully submitted Stodulka clearly depicts straight portions of the cutting edges past curved portions. The claim language does not require the cutting edges to be straight at the junction between cutting edges or the entirety of the cutting edges to have no curvature.
4) Applicant further argues no analysis is provided for claim 18 (Remarks, pg. 11).
In response to applicant’s fourth argument, it is respectfully submitted Stodulka is not relied on to teach the limitations of claim 18, therefore applicant’s argument is moot, and the limitations of claim 18 have been addressed as discussed below.
5) Applicant further argues Barron does not disclose an asymmetric notch formation because the protrusions extend outwardly, not inwardly from the center of the blade, and there is no indication provided to the indentations that they extend inwardly as opposed to another direction (Remarks, pgs. 11-13).
In response to applicant’s fifth argument, it is respectfully submitted an indentation by definition is considered to extend inward. The term ‘indentation’ is indication of the structure extending inwardly, such that the claim limitation is considered to be met.
6) Applicant further argues the protrusions are not asymmetric because the asymmetry referred to in Barron refers to the overall asymmetry of the blade itself (Remarks, pg. 13).
In response to applicant’s sixth argument, it is respectfully submitted the arguments are narrower than the claim limitations. The claim language does not preclude asymmetry of the notch formation with respect to the blade. Broadest reasonable interpretation of the claim language encompasses any asymmetry of the notch relative to any other structure, such that Barron is considered to disclose the indentations being asymmetric based on location on the blade.
7) Applicant further argues the Office Action provides no reason why the particular selected range would result as a matter of routine optimization or why a POSITA would be motivated to make such changes to Stodulka (Remarks, pgs. 14-15).
In response to applicant’s seventh argument, it is respectfully submitted the rejection explicitly describes how the angle the notches extend is a result effective variable, which one of ordinary skill would’ve considered to modify to optimize identification of the tissue for proper positioning. The rejection describes how the claimed range would be arrived at as a matter of routine optimization, and why one of ordinary skill would’ve considered adjusting the range to optimize proper positioning of the tissue, such that the claimed limitation is considered to be met (see MPEP 2144.05(II)).
8) Applicant further argues the office action provides no disclosure in any prior art wherein a notch formation in a blade is configured to remove about 1.5% or less of donor tissue (Remarks, pg. 15).
In response to applicant’s eighth argument, it is respectfully submitted the rejection relies on routine optimization, which does not require a disclosure in the prior art of a specific amount of donor tissue removed such as 1.5% or less (see MPEP 2144.05(II)). The rejection explicitly describes how the arrangement of the notches is a result effective variable, which one of ordinary skill would’ve considered to modify to optimize identification of the tissue for proper positioning as discussed below.
Applicant’s arguments with respect to new claims 33-34 have been fully considered, and new claims 33-34 are rejected as discussed below.
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 cutting edge (2, pg. 2 ‘Example’; fig. 2) at the distal end of the blade (fig. 2), the cutting edge having a circular perimeter (perimeter of cutting edge 2 considered to be circular, as cutting edge 2 extends in a circular shape as depicted in fig. 2, and broadest reasonable interpretation of the term ‘circular’ is defined as “round” or “of or relating to a circle” according to the Merriam-Webster dictionary definition, such that cutting edge 2 is considered to have a perimeter relating to a circle, further note this appears consistent with fig. 2 of the instant spec., depicting the perimeter of the cutting edge as circular and also incorporating a notch which is not circular) with an asymmetric notch formation (at least one notch 2a) extending inwardly toward a longitudinal axis of the blade (annotated fig. 2), wherein the cutting edge is configured for cutting a correspondingly shaped asymmetric notch in the circumferential perimeter of the corneal graft (marks donor membrane, pg. 2) and indicating the correct orientation of the corneal graft in said endothelial keratoplasty (uniquely distinguishes edges of graft, pg. 2).
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Annotated Figure 2 of Stodulka
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 perimeter of the 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).
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 angle of extension of cutting edges in annotated fig. 2 below).
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Annotated Figure 2 of Stodulka
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, cutting edges incorporate straight portions).
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 a 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 cutting edge (2, pg. 2 ‘Example’; fig. 2) at the distal end of the blade (fig. 2), the cutting edge having a circular perimeter (perimeter of cutting edge 2 considered to be circular, as cutting edge 2 extends in a circular shape as depicted in fig. 2, and broadest reasonable interpretation of the term ‘circular’ is defined as “round” or “of or relating to a circle” according to the Merriam-Webster dictionary definition, such that cutting edge 2 is considered to have a perimeter relating to a circle, further note this appears consistent with fig. 2 of the instant spec., depicting the perimeter of the cutting edge as circular and also incorporating a notch which is not circular) with an asymmetric notch formation (at least one notch 2a) extending inwardly toward a longitudinal axis of the blade (annotated fig. 2), wherein the cutting edge is configured for cutting a correspondingly shaped asymmetric notch in the circumferential perimeter of the corneal graft (marks donor membrane, pg. 2) and indicating 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 cutting edge (2, pg. 2 ‘Example’; fig. 2) at the distal end of the blade (fig. 2), the cutting edge having a circular perimeter (perimeter of cutting edge 2 considered to be circular, as cutting edge 2 extends in a circular shape as depicted in fig. 2, and broadest reasonable interpretation of the term ‘circular’ is defined as “round” or “of or relating to a circle” according to the Merriam-Webster dictionary definition, such that cutting edge 2 is considered to have a perimeter relating to a circle, further note this appears consistent with fig. 2 of the instant spec., depicting the perimeter of the cutting edge as circular and also incorporating a notch which is not circular) with an asymmetric notch formation (at least one notch 2a) extending inwardly toward a longitudinal axis of the blade (annotated fig. 2), wherein the cutting edge is configured for cutting a correspondingly shaped asymmetric notch in the circumferential perimeter of the corneal graft (marks donor membrane, pg. 2) and indicating the 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 cutting edge (includes 12, para. [0017]) at the distal end of the blade (considered to be at distal end), the cutting edge having a circular perimeter (fig. 2) with an asymmetric notch formation (includes 16 and 18 which may be indentations, considered to form notches that are asymmetric due to location on the blade, paras. [0019] and [0036]; fig. 2) extending inwardly toward a longitudinal axis of the blade (indentation considered to extend inwardly), wherein the cutting edge is configured for cutting a correspondingly shaped asymmetric notch in the circumferential perimeter of the corneal graft (paras. [0019] and [0021]) and indicating the 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 a 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 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, 13 and 33-34 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).
Regarding claim 33, Stodulka discloses the blade of claim 1.
However, Stodulka fails to explicitly disclose wherein the notch formation is configured for removing about 3% 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 3% 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).
Regarding claim 34, Stodulka discloses the cutting device of claim 19.
However, Stodulka fails to explicitly disclose wherein the notch formation is configured for removing about 3% 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 3% 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
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/BRIGID K BYRD/Examiner, Art Unit 3771
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