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/ Amendments
The arguments/ amendments, dated 7/17/2026, neither argue nor amend to alter the awarded priority date of the claims are discussed in the office action, dated 2/29/2026. As such, Examiner is maintaining the priority dates for the claims as established in the office action, dated 2/29/2026.
The arguments, dated 7/17/2026, did not argue with the objections as discussed in the office action, stated 2/9/2026, instead Applicant appeared to agree with many of them and corrected many of them, however some we neither discussed nor amended to correct. As such, some of them have been maintained (as detailed below).
The arguments, dated 7/17/2026, with respect to the rejection of claim(s) 10, 18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph state that the claim(s) have been amended as suggested by the Examiner (to be consistent with the embodiment associated with fig. 26). Although the amendment was made correctly in claim 18 it was not made correctly in claim 10. As such, the rejection of 10 has been maintained (as detailed below).
The arguments, dated 7/17/2026, with respect to the rejection of claim(s) 1-19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph state that the claim(s) have been amended to correct the outstanding issues. However, not all the claims were amended as stated or amended in a consistent manner. As such, some of the aforementioned rejection(s) are maintained (as detailed below).
The arguments, dated 7/17/2026, with respect to the rejection of claim(s) 1, 4-7, 9, 11-15, 17 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) based on Chen et al. (US 2009/0024224 A1 – as previously cited), have been fully considered but they are not considered persuasive.
With respect to claim 1: Applicant argues: Examiner relies on the doctrine of inherency to assert that the gaps (9) and channels (15), as disclosed by Chen et al., corresponds the linear cuts (as required by claim(s) 1, 2, and 19) and the circular cuts (as required by claim 11) respectively; asserting these structures inherently serve to decrease a radius of curvature of the outer surface of the graft. Applicant disagrees with this assertion – Chen et al. discloses the aforementioned structures for cell infiltration; there is no discussion/ disclosure of decreasing the radius of curvature of the graft (i.e. this is missing limitation and is not necessarily present in Chen et al.). The plurality of linear cuts or circular cuts (as claimed) serve to decrease the radius of curvature of the graft from a first radius of curvature to a second radius of curvature is a specific functional limitation that is nor disclosed nor suggested by Chen et al.. Examiner disagrees with this argument. The gaps (9) and channels (15), as disclosed by Chen et al., are identical/ substantially identical to the linear cuts (as required by claim(s) 1, 2, and 19) and the circular cuts (as required by claim 11) (as the aforementioned structures have the same general shape). As such, Examiner is justified in concluding the gaps (9) and channels (15), as disclosed by Chen et al., is inherently able to function such that they can serve to decrease the radius of curvature of the graft from a first radius of curvature to a second radius of curvature (see MPEP 2112 III-IV). Further, once a reference teaching a product appearing to be substantially identical is made, and the Examiner has presented evidence of reasoning to show inherency (as discussed above), then the burden of proof shifts to Applicant as to why the structure does not inherently function in the claimed manner and mere statement or opinion that the product appearing to be substantially identical to the claim is not sufficient (see MPEP 2184 III). (Please note: Applicant presents no additional substantive remarks concerning the rejection of claim(s) 4, 12.)
With respect to claim 5: Applicant additionally argues: the range for the gaps (9), as disclosed by Chen et al., only marginally overlaps with the upper end of the claimed range (1 mm). Additionally, the precise and narrow range of the slit widths creates the desired flexibility (creates the functionality) of the graft. As discussed above, gaps (9), as disclosed by Chen et al., will inherently function (i.e. have flexibility) in the manner as claimed. It appears Applicant is trying to argue the criticality of of the claimed range vs the larger range, as disclosed by Chen et al.. However, Applicant has not presented any evidence demonstrating the across the range nor any evidence of unexpected results within the narrow range (see MPEP 2131.03).
With respect to claim 13: Applicant additionally argues: the range for the channels (15), as disclosed by Chen et al., overlaps some with the claimed range of 0.01mm to 1mm there is no discussion of the channels functioning in the manner as claimed. As discussed above, channels (15), as disclosed by Chen et al., will inherently function in the manner as claimed. Additionally, Chen et al. give a specific example of the channels having a diameter of 1 mm (paragraph [0139]); it has been held when a specific example in the prior art is within the claimed range it anticipates the claimed range (see MPEP 2131.03 I).
With respect to claim(s) 6-7, 14-15: Applicant additionally argues: the gaps (9) and channels (15), as disclosed by Chen et al., are not “defined” by a cartesian coordinate system and maybe merely mapped by a cartesian/ polar coordinate system. Examiner disagrees with this argument. It appears Applicant is assigning a special definition to the term “defined” (which is not defined in the originally filed disclosure) which appears to be related to the method of selecting/ positioning the aforementioned structures. The gaps (9) and channels (15), as disclosed by Chen et al., positions are specifically chosen and positioned (paragraphs [0137-0139]), and the method of actually machining these structures may use a measurement/ coordination system cartesian/ polar coordinate system; however, this then makes the aforementioned claim requirement a -product-by-process limitation. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered linear cuts/ gaps. Manufacturing steps such as their formation of using a cartesian/ polar coordinate system are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
With respect to claim(s) 9 and 17: Applicant additionally argues: the graft collectively forms a substantially round shape, but does not disclose the substantially round graft being configured to complement the radius of curvature of the implant site. Examiner disagrees with this argument. The substantially round graft is configured to match the size, contour, and location of the defect site (paragraphs [0009-0010, 0072, 0118-0119]).
The arguments, dated 7/17/2026, with respect to the rejection of claim(s) 8, 16 (and potentially 10, 18, see note below) under 35 U.S.C. 103 based on Chen et al. (US 2009/0024224 A1 – as previously cited) in view of Hodorek et al. (US 2006/0235542 A1 – as previously cited), have been fully considered but they are not considered persuasive.
With respect to claim(s) 8, 10, 16, 18: Applicant argues: Chen et al. discloses a biological tissue implant and Hodorek et al. teaches a synthetic implant, and one of ordinary skill in the art would not have been motivated with the combine such fundamentally different types of implant. Additionally, Applicant argues that the motivation to combine the pegs, as taught by Hodorek et al., to the outer surface of boney region, as disclosed by Chen et al., in order to improve the connection of the graft it the underlying bone is conclusory and does not provide sufficient basis for combining the references. Examiner disagrees with these arguments. In making the aforementioned combination, Examiner is not adding the synthetic pegs, as taught by Hodorek et al., to the to the outer surface of boney region, as disclosed by Chen et al.; instead, Examiner is providing a justification for reshaping the already existing outer surface of boney region, as disclosed by Chen et al., such that it includes pegs, as taught by Hodorek et al. (thus resulting in the outer surface of boney region having pegs made from the same biological tissue as the rest of the outer surface of boney region). As for the justification thereof, Examiner is relying on the justification as taught by Hodorek et al. – which specifically teaches the pegs as enhancing the connection between the implant and the native tissue. Further although the implants are made from different materials they are within the same art (repair of damaged tissue along an articulation surface of a joint); as such, the problems recognized and cured by one (dislodgement within an articulating surface) would be obvious to try with another implant positioned in the same area of the body for the same purpose (regardless of the material used to manufacture).
Priority
Claim(s) 1-4, 6-7, 9, 11-12, 14-15, 17 are awarded a priority date of October 11, 2022 (the filing date of 63/415054); claim(s) 5, 8, 10, 13, 16, 18-19 are awarded a priority date of October 11, 2023 (the filing date of the current application).
Claim Objections
Claim(s) 2, 19 is/are objected to because of the following informalities:
Within claim 2, line 3: “curvature said” should be replaced with --curvature, said-- (for grammatical purposes).
Within claim 2, line 4: “layer and” should be replaced with --layer; and-- (for grammatical purposes).
Within claim 19, line 9: “includes” should be replaced with –includes:-- (for grammatical purposes).
Within claim 19, line 12: “the first set of cuts” should be replaced with --the first set of linear cuts-- (in order to maintain consistent claim terminology).
Within claim 19, lines 13-14 the two “wherein” clauses appear to be missing paragraph breaks (such that they are each their own paragraphs).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 10 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Within claim 10, lines 1-2: Applicant claims, “the cartilage layer further comprises a surface and at least three distinct boney portions protruding from the outer surface of the boney region”; Examiner can not find a written description for the cartilage layer COMPRISING at least three distinct boney portions which are a SUBSTRUCTURE of the boney region (which is distinct from the cartilage layer). Within Applicant’s disclosure Applicant discloses the embodiment associated with fig. 26, which includes boney pegs extending from the outer surface of the boney layer (not the cartilage layer as required by claim 10). Examiner is curious if Applicant intended to claim: “The flexible osteochondral graft of claim 1, further comprising at least three distinct boney portions protruding from the outer surface of the boney region” (which would be consistent with the embodiment/ features associated with fig. 26).
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(s) 1-19 is/are 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.
Within claim 1, line 4: Applicant claims, “a boney region attached to the cartilage layer and having an outer surface”; Examiner is interpreting the “and having an outer surface” as modifying the boney region (i.e. the boney region has an outer surface); additionally, within claim 1, line 7: Applicant claims, “the outer surface of the cartilage layer” (i.e. the cartilage layer must have previously claimed an outer surface in order this one to be “the” instead of “an”); as such, it is unclear, and therefore indefinite if the “outer surface” within claim 1, line 4 should be modifying the cartilage layer OR if there is merely lack of antecedent basis for “the outer surface of the cartilage layer” within claim 1, line 7. Claim(s) 3-10, which depend from claim 1, inherit all the problems associated with claim 1.
Claim 1 recites the limitation "the radius of curvature if the outer surface of the cartilage layer" in line 7. There is insufficient antecedent basis for this limitation in the claim. (Please note: Examiner is unsure if the aforementioned claim requirement should instead read --a radius of curvature of the graft-- (in order to link to the radius of curvature of the whole graft from claim 1, line 4-5.))
Within claim 2, line 5: Applicant claims, “a boney region attached to the cartilage layer and having an outer surface”; Examiner is interpreting the “and having an outer surface” as modifying the boney region (i.e. the boney region has an outer surface); additionally, within claim 2, line 8: Applicant claims, “the outer surface of the cartilage region” (i.e. the cartilage layer/ region must have previously claimed an outer surface in order this one to be “the” instead of “an”); as such, it is unclear, and therefore indefinite if the “outer surface” within claim 2, line 5 should be modifying the cartilage layer OR if there is merely lack of antecedent basis for “the outer surface of the cartilage region” within claim 2, line 5.
Within claim 2, lines 1-5: Applicant claims, “the plurality of linear cuts includes […] a second set of linear cuts within the boney region extending from a location between the surface on the predetermined depth of the first set and substantially through an opposing boney surface”; it is unclear, and therefore indefinite, where the plurality of linear cuts must be located. Within the aforementioned claim requirement the second set of linear cuts (which appear to be a subset of the broader plurality of linear cuts) extends between a location between the surface on the predetermined depth of the first set and substantially through an opposing boney surface (I.e. NOT in the outer surface of the boney region); however, within claim 1, lines 5-6 (from which claim 2 depends) the broader set of linear cuts are defined as in/ spanning the outer surface of the boney region. As such, it appears claim 2 is trying to redefine where the plurality of linear cuts maybe located. (PLEASE NOTE: Applicant may want to consider amending claims 1 and 2 such that there is a first set of linear cuts provided in the outer surface of the boney region and a second set of linear cuts within the boney region […]).
Claim 2 recites the limitation "the radius of curvature" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the outer surface" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the cartilage region" in line 8. There is insufficient antecedent basis for this limitation in the claim. (Please note: Examiner is unsure if the claim clause “the radius of curvature of the outer surface of the cartilage region” should instead read --a radius of curvature of the graft-- (in order to link to the radius of curvature of the whole graft from claim 1, line 4-5.))
Within claim 3, lines 1-7: Applicant claims, “the plurality of linear cuts includes a first set of linear cuts extending from the outer surface of the boney region to a first predetermined depth, a second set of linear cuts within the boney region extending from a location between the outer surface and the first predetermined depth to a second predetermined depth, and a third set of linear cuts within the boney region extending from a location between the first predetermined depth and the second predetermined depth and extending substantially through an opposing boney surface”; it is unclear, and therefore indefinite, where the plurality of linear cuts must be located. Within the aforementioned claim requirement the second third sets of linear cuts (which appear to be a subset of the broader plurality of linear cuts) extends between/ thru a location not including the outer surface of the boney region (I.e. NOT in the outer surface of the boney region); however, within claim 1, line 6 (from which claim 3 depends) the broader set of linear cuts (i.e. ALL the linear cuts) are defined as in/ spanning the outer surface of the boney region. As such, it appears claim 3 is trying to redefine where the plurality of linear cuts maybe located.
Within claim 10, lines 1-2: Applicant claims, “the cartilage layer further comprises a surface and at least three distinct boney portions protruding from the outer surface of the boney region”; it is unclear, and therefore indefinite, how the cartilage layer cane COMPRISE at least three distinct boney portions which are a SUBSTRUCTURE of the boney region (which is distinct from the cartilage layer). Within Applicant’s disclosure Applicant discloses the embodiment associated with fig. 26, which includes boney pegs extending from the outer surface of the boney layer (not the cartilage layer as required by claim 10). Examiner is curious if Applicant intended to claim: “The flexible osteochondral graft of claim 1, further comprising at least three distinct boney portions protruding from the outer surface of the boney region” (which would be consistent with the embodiment/ features associated with fig. 26).
Claim 11 recites the limitation "the radius of curvature of the outer surface" in line 7. There is insufficient antecedent basis for this limitation in the claim. (Please note: there is only antecedent basis for the radius of curvature of the graft (within claim 11, lines 1-2).) Claim(s) 12-18, which depend from claim 11, inherit all the problems associated with claim 11.
Within claim 19, line 6: Applicant claims, “an outer surface of the boney region”; it is unclear, and therefore indefinite, if this is the same as OR different from the outer surface (within claim 19, line 4).
Claim 19 recites the limitation "the radius of curvature of the outer surface" in line 7. There is insufficient antecedent basis for this limitation in the claim. (Please note: there is only antecedent basis for the radius of curvature of the graft (within claim 19, lines 1-2).)
Within claim 19, lines 9-13: Applicant claims, “the plurality of linear cuts includes […] a second set of linear cuts within the boney region extending from a location between the surface on the predetermined depth of the first set of cuts and substantially through an opposing boney surface”; it is unclear, and therefore indefinite, where the plurality of linear cuts must be located. Within the aforementioned claim requirement the second set of linear cuts (which appear to be a subset of the broader plurality of linear cuts) extends between a location between the surface on the predetermined depth of the first set and substantially through an opposing boney surface (I.e. NOT in the outer surface of the boney region); however, within claim 9, lines 6-7: the broader set of linear cuts are defined as in/ spanning the outer surface of the boney region. As such, it appears the aforementioned claim requirement is trying to redefine where the plurality of linear cuts maybe located.
Claim 19 recites the limitation "the surface" in line 13. There is insufficient antecedent basis for this limitation in the claim. (Please note: there is only antecedent basis for the outer surface (within claim 19, line 4.).
Within claim 19, line 13: Applicant claims, “a predetermined depth”; it is unclear, and therefore indefinite, if this is the same as OR different from the predetermined depth within claim 19, lines 11-12.
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, 11-15, 17 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Chen et al. (US 2009/0024224 A1 – as previously cited).
With respect to claim 1:
Chen et al. discloses a flexible osteochondral graft (plug 8a or 8b), as can be seen in fig. 2, for implantation into an implant site having a radius of curvature (paragraphs [0075-0076]), said graft (plug 14) comprising:
a cartilage layer (cartilage cap 6) (paragraphs [0075-0076]); and
a boney region (osteochondral bone portion 7) attached to the cartilage layer (cartilage cap 6) and having an outer surface (bottom most surface thru which gaps 9 are bored) (paragraphs [0075-0076]), wherein the graft (plug 8a or 8b) has a harvested state (when harvested) with a first radius of curvature (radius of the cartilage cap 6 when harvested) and an implantation state (after the formation of the gaps 9) wherein the outer surface (bottom most surface thru which gaps 9 are bored) of the boney region (osteochondral bone portion 7) is provided with a plurality of linear cuts (gaps 9) that serve to decrease the radius of curvature of the outer surface (bottom most surface thru which gaps 9 are bored) from the first radius of curvature (radius of the cartilage cap 6 when harvested) in the harvested state (when harvested) to a second radius of curvature (radius of the cartilage cap 6 after implantation) configured to complement the radius of curvature of the implant site (paragraphs [0075-0076]). (PLEASE NOTE: With respect to “[the] plurality of linear cuts that serve to decrease the radius of curvature of the outer surface from the first radius of curvature in the harvested state to a second radius of curvature configured to complement the radius of curvature of the implant site”; in the aforementioned claim clause Applicant is claiming a property – specifically, the ability to alter/ decrease the radius of curvature of the outer surface (the articulating surface of the cartilage cap 6) due to the inclusion of the plurality of gaps. As discussed by Applicant within paragraphs [0049-0050], this increased flexibility appears to be a direct result of the inclusion of the cuts/ slits within the graft. Thus the plurality of liner cuts (gaps 9), as disclosed by Chen et al., would inherently create the variable/ decreasing radius of curvature of the articulating surface of the cartilage cap (6) as claimed within the aforementioned claim requirement (as the aforementioned structures have the same general shape (are identical/ substantially identical to) as the claimed structures which allow the graft to function in the claimed manner) (even if this inherent feature was not recognized nor recited by Chen et al. at the time (see MPEP 2112).)
With respect to claim 4:
Wherein the linear cuts (gaps 9) extend at least 50% into the boney region (the whole length of the osteochondral bone portion 7) into the boney region (osteochondral bone portion 7) (paragraph [0076]).
With respect to claim 5:
Wherein the linear cuts (gaps 9) have a width between 0.01mm and 1mm (the width is 10%-50% of the diameter, the diameter being 8-20 mm; thus the width can be .8-10mm) (paragraph [0076]).
With respect to claim 6:
Wherein the linear cuts (gaps 9) are defined by a Cartesian coordinate system (as can be seen in bottom view of the graft (plug 8b) with linear cuts (gaps 9) in fig. 2, the linear cuts (gaps 9) are arranged in a pattern that can be mapped/ created using a Cartesian coordinate system).
With respect to claim 7:
Wherein the linear cuts (gaps 9) are defined by a polar coordinate system (as can be seen in bottom view of the graft (plug 8a) with linear cuts (gaps 9) in fig. 2, the linear cuts (gaps 9) are arranged in a pattern that can be mapped/ created using a polar coordinate system).
With respect to claim 9:
Wherein the cartilage layer (cartilage cap 6) and the boney region (osteochondral bone portion 7) collectively form a substantially round (substantially cylindrical/ round shape), as can be seen in fig. 2, oblong, oval, rectangular, or irregular shape.
With respect to claim 11:
Chen et al. discloses a flexible osteochondral graft (plug 14), as can be seen in fig. 2, for implantation into an implant site having a radius of curvature (paragraphs [0075-0076]), said graft (plug 14) comprising:
a cartilage layer (cartilage cap 6) (paragraphs [0075-0076]); and
a boney region (osteochondral bone portion 7) attached to the cartilage layer (cartilage cap 6) and having an outer surface (bottom most surface thru which channels 15 are bored) (paragraphs [0075-0076]), wherein the graft (plug 14) has a harvested state (when harvested) with a first radius of curvature (radius of the cartilage cap 6 when harvested) and an implantation state (after the formation of the channels 15) wherein the outer surface (bottom most surface thru which channels 15 are bored) of the boney region (osteochondral bone portion 7) is provided with a plurality of circular cuts (channels 15) that serve to decrease the radius of curvature of the outer surface (bottom most surface thru which channels 15 are bored) from the first radius of curvature (radius of the cartilage cap 6 when harvested) in the harvested state (when harvested) to a second radius of curvature (radius of the cartilage cap 6 after implantation) configured to complement the radius of curvature of the implant site (paragraphs [0075-0076]). (PLEASE NOTE: With respect to “[the] plurality of circular cuts that serve to decrease the radius of curvature of the outer surface from the first radius of curvature in the harvested state to a second radius of curvature configured to complement the radius of curvature of the implant site”; in the aforementioned claim clause Applicant is claiming a property – specifically, the ability to alter/ decrease the radius of curvature of the outer surface (the articulating surface of the cartilage cap 6) due to the inclusion of the plurality of circular cuts. As discussed by Applicant within paragraphs [0049-0050], this increased flexibility appears to be a direct result of the inclusion of the cuts/ slits within the graft. Thus the plurality of circular cuts (channels 15), as disclosed by Chen et al., would inherently create the variable/ decreasing radius of curvature of the articulating surface of the cartilage cap (6) as claimed within the aforementioned claim requirement (as the aforementioned structures have the same general shape (are identical/ substantially identical to) as the claimed structures which allow the graft to function in the claimed manner) (even if this inherent feature was not recognized nor recited by Chen et al. at the time (see MPEP 2112).)
With respect to claim 12:
Wherein the circular cuts (channels 15) extend at least 50% (the whole length of the osteochondral bone portion 7) into the boney region (osteochondral bone portion 7)) (paragraph [0076]).
With respect to claim 13:
Wherein the circular cuts (channels 15) have a diameter between 0.01mm and 1mm (0.5-1 mm) (paragraphs [0076, 0139]).
With respect to claim 14:
Wherein the circular cuts (channels 15) are defined by a Cartesian coordinate system (as can be seen in bottom view of the circular cuts (channels 15) in fig. 2, the circular cuts (channels 15) are arranged in a pattern that can be mapped/ created using a Cartesian coordinate system).
With respect to claim 15:
Wherein the circular cuts (channels 15) are defined by a polar coordinate system (as can be seen in bottom view of the circular cuts (channels 15) in fig. 2, the circular cuts (channels 15) are arranged in a pattern that can be mapped/ created using a polar coordinate system).
With respect to claim 17:
Wherein the cartilage layer (cartilage cap 6) and the boney region (osteochondral bone portion 7) collectively form a substantially round (substantially cylindrical/ round shape), as can be seen in fig. 2, oblong, oval, rectangular, or irregular shape.
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.
Claim(s) 8, 10, 16, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2009/0024224 A1 – as previously cited) in view of Hodorek et al. (US 2006/0235542 A1 – as previously cited).
Chen et al. discloses the invention substantially as claimed, as discussed above. However, Chen et al. does not disclose a protrusion extending from the outer surface (bottom most surface thru which gaps 9/ channels 15 are bored) of the boney region (osteochondral bone portion 7) (as required by claim(s) 8 and 16).
Hodorek et al. teaches a graft (implant 10), as can be seen in figs. 1-4, for implantation into an implantation site having an implantation site radius of curvature, said graft (implant 10) comprising:
a cartilage layer (top portion with bearing surface 20) (paragraph [0037]); and
a boney region (bottom portion 22) attached to the cartilage layer (top portion with bearing surface 20) and having an outer surface (bottom surface of bottom portion 22 not including the pegs 28), wherein the outer surface (bottom surface of bottom portion 22 not including the pegs 28) of the boney region (bottom portion 22) is provided with a cuts (parting lines 32) that serve to increase the flexibility of the graft (implant 10) thereby allowing the graft (implant 10) to complement the implantation site radius of curvature (paragraphs [0023, 0037-0038]). The boney region (bottom portion 22) further comprises protrusions (pages 28) extending from the outer surface (bottom surface of bottom portion 22 not including the pegs 28) which can further enhance the connection of the graft (implant 10) to the underlying bone (paragraph [0037]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to reshape the outer surface (bottom most surface thru which gaps 9/ channels 15 are bored), as disclosed by Chen et al., to include at least three protrusions (the four pegs 28), as taught by Hodorek et al., in order to improve the connection of the graft (plug 8a, 8b, 14) to the underlying bone, as taught by Hodorek et al. (paragraph [0037]).
Allowable Subject Matter
Claim(s) 3 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim(s) 2, 19 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: With respect to claim(s) 2-3 and 19: See the reasons for indicating allowable subject matter within the office action dated 2/19/2026.
Conclusion
THIS ACTION IS MADE FINAL. 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 REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA S PRESTON/Examiner, Art Unit 3774
