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
The amendment filed on July 20, 2026 has been entered and considered and an action on the merits follows.
Terminal Disclaimer
The terminal disclaimer filed on July 20, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of the full statutory term of U.S. 12,115,085 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
Claims 1-4, 6-7, and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Buskirk (hereinafter "VB") (US 4,696,227).
Regarding claim 1, VB discloses a system comprising:
a first press component (a housing 12) defining a cavity (fig. 2) (figs. 5-6) configured to receive a material (fig. 2), wherein the first press component formed from a transparency material to provide an operator with a full view of an operation of the press (col. 5, lines 61-63); and
a second press component (a piston 22) including a projection (62, 64; fig. 3) insertable into the cavity (fig. 2), wherein the second press component (22) is made of a transparent or semi-transparent material (col. 5, lines 56-60).
Regarding the recitation "configured to change a dimension of harvested tissue" in the preamble and the amended limitation, “to permit a user to determine when the harvested tissue has been compressed to substantially a width of the cavity”, said recitations are used to describe an intended use of the press device. Recitations of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art teaches the structures of the claimed invention, then the prior art is capable of performing the intended use, therefore, the prior art meets the claimed limitation. See In Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP 2111.02 and 2114(11).
As set forth above, VB discloses both of the first and second press components are made of the transparent material, and thus any material in the cavity is visible through the first and second press components and a user can determine when a material has been compressed to a width of the cavity since both of the first and second press are made of transparent material.
Regarding claim 2, the system as recited in claim 1, VB discloses wherein the second press component is made of a transparent material (see claim 1 above).
Regarding claim 3, the system as recited in claim 1, VB discloses wherein both of the first and second press components are made of a transparent material or semi-transparent material (see claim 1 above).
Regarding claim 4, the system as recited in claim 3, VB discloses wherein both of the first and second press components are made of a transparent material (see claim 1 above).
Regarding claim 6, the system as recited in claim 1, VB discloses wherein the first press component (12) is a bottom press component (fig. 2) and the second press component (22) is a top press component (fig. 2).
Regarding claim 7, the system as recited in claim 6, VB discloses the second (22) press components is made of a transparent material as set forth in claim 1 above, and thus, VB discloses wherein: the projection (62, 64) of the second press component (22) which includes a main downward-facing forming surface (64), at least the main downward-facing forming surface (64) of the second press component (22) is made of a transparent material because the main downward-facing forming surface (64) is part of the second press component (22),
VB also discloses the first press component (12) is made of a transparent or semi-transparent material as set forth in claim 1 above; and thus, VB discloses the cavity, which is bound in part by a main upward-facing forming surface of the first press component (12) (see fig. 2), and at least the main upward facing forming surface is made of a transparent material because the main upward facing forming surface is part of the first press component (12).
Regarding claims 27 and 28, the claimed recitations are used to describe an intended use of the press device. Recitations of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art teaches the structures of the claimed invention, then the prior art is capable of performing the intended use, therefore, the prior art meets the claimed limitation. See In Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP 2111.02 and 2114(11).
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.
Claims 1-4, 6, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Neichel et al. (hereinafter "Neichel") (US 2017/0273795 A1) in view of Van Buskirk (hereinafter "VB") (US 4,696,227).
Regarding claim 1, Neichel discloses a system configured to change a dimension of harvested tissue (see "bone graft blank" in abstract and para. 75, a bone graft blank is made from harvest bone tissue, is reshaped to form a bespoke bone grail), comprising: a first press component (508) defining a cavity (540) (figs. 5-6) configured to receive harvested tissue (see para. 65); and a second press component (528) including a projection (800) insertable into the cavity (fig. 6),
Neichel discloses wherein the first press component (508) is made of a transparent or semi-transparent material (see para. 65, lines 11-13, which is discloses the press component (508) is clear so that a user can observe the compression of the bone graft) such that when harvested tissue is in the cavity and when the projection is inserted into the cavity, the harvested tissue is visible through the first press component.
Neichel does not expressly disclose the second press component is made of a transparent or semi-transparent material.
VB discloses a press for pressing small scale object comprising a first press component (a housing (12)) defining a cavity (fig. 2) to receive an object (80), and a second press component (a piston 22) (fig. 2), wherein the first press component formed from a transparency material to provide an operator with a full view of an operation of the press (col. 5, lines 61-63) and the second component (22) also formed from a transparency material to enhance the aesthetic qualities of the press (col. 5, lines 56-60).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the second press component of Neichel from a transparency material, as taught by VB, to enhance the aesthetic qualities of the press (col. 5, lines 56-60).
Modified Neichel discloses both of the first and second press components are made of transparency material; therefore, the harvested tissue is visible through the first and second press components and a user can determine when the harvested tissue has been compressed to a width of the cavity.
Regarding claim 2, the system as recited in claim 1, as set forth above, modified Neichel discloses wherein the second press component is made of a transparent material.
Regarding claim 3, the system as recited in claim 1, as set forth above, modified Neichel discloses wherein both of the first and second press components are made of a transparent material or semi-transparent material.
Regarding claim 4, the system as recited in claim 3, as set forth above, modified Neichel discloses wherein both of the first and second press components are made of a transparent material.
Regarding claim 6, the system as recited in claim 1, Neichel discloses wherein the first press component (508) is a bottom press component (fig. 5) and the second press component (528) is a top press component (fig. 5).
Regarding claim 12, the system as recited in claim 1, Neichel discloses further comprising a press (see "a bone press 500" in para. 82) configured to move the first press component and second press component toward one another (fig. 6).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Neichel and VB, further in view of Kaplan (US 7,189,245).
Regarding claim 5, the system as recited in claim 4, as set forth above, modified Neichel discloses both of the first and second press components are made of transparent material. Neichel does not expressly disclose the transparent material is a clear polycarbonate material.
Kaplan can be applied to teach a system for handling implantable tissue comprises a component made of a clear polycarbonate material (tip 30 of the implantable cannula 28 is made from a clear polycarbonate material, see col. 4, line 65).
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 press components of Neichel by making them of clear polycarbonate material as disclosed by Kaplan in order to improve visual observation of the system in action (Kaplan col. 4, the last three lines).
Claims 1-4, 6-7, 12, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (hereinafter “Nelson”) (US 2002/0025358 A1) in view of Van Buskirk (hereinafter "VB") (US 4,696,227).
Regarding claim 1, Nelson discloses a system configured to change a dimension of harvested tissue (see "a composite acetabular allograft” in para. 13, which is a harvested tissue), comprising:
a first press component (28) defining a cavity (see a semi-circular cavity formed by a dotted line in fig. 2) configured to receive harvested tissue; and
a second press component (36) including a projection (see a semi-circular structure protrudes downward from a horizontal portion of the upper mold 36 in fig. 2) insertable into the cavity (see para. 43),
Nelson does not expressly disclose the first press component and the second press component are made of a transparent or semi-transparent material.
VB discloses a press for pressing small scale object comprising a first press component (a housing (12)) defining a cavity (fig. 2) to receive an object (80), and a second press component (a piston 22) (fig. 2), wherein the first press component formed from a transparency material to provide an operator with a full view of an operation of the press (col. 5, lines 61-63) and the second component (22) also formed from a transparency material to enhance the aesthetic qualities of the press (col. 5, lines 56-60).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the first and second press components of Nelson from a transparency material, as taught by VB, to enhance the aesthetic qualities of the press (col. 5, lines 56-60).
Modified Nelson discloses both of the first and second press components are made of transparency material; therefore, the harvested tissue is visible through the first and second press components and a user can determine when the harvested tissue has been compressed to a width of the cavity.
Regarding claim 2, the system as recited in claim 1, as set forth above, modified Nelson discloses wherein the second press component (36) is made of a transparent material.
Regarding claim 3, the system as recited in claim 1, as set forth above, modified Nelson discloses wherein both of the first (28) and second (36) press components are made of a transparent material or semi-transparent material.
Regarding claim 4, the system as recited in claim 3, as set forth above, modified Nelson discloses wherein both of the first and second press components are made of a transparent material.
Regarding claim 6, the system as recited in claim 1, Nelson discloses wherein the first press component (28) is a bottom press component (fig. 1) and the second press component (36) is a top press component (fig. 2).
Regarding claim 7, the system as recited in claim 6, modified Nelson discloses both of the first (28) and second (36) press components are made of a transparent material as set forth above; therefore, the projection of the second press component (36) and the main upward facing forming surface of the first press component (28) are inherently made of the transparent material.
Regarding claim 12, the system as recited in claim 1, Nelson discloses further comprising a press (see figs. 1-2) configured to move the first press component (28) and second press component (36) toward one another (figs. 1-2).
Regarding claim 26, the system as recited in claim 1, Nelson discloses wherein: the cavity is bound in part by a main upward-facing forming surface (see a curved dot-line in fig. 2), the projection includes a main downward-facing forming surface (see a curved surface where the reference number 36 pointed to in fig. 2), and a height of the projection is substantially equal to a depth of the cavity (see fig. 2) such that, when the projection is inserted into the cavity, the main downward-facing forming surface and the main upward-facing forming surface are substantially parallel (both surfaces are parallel to one another along a curve line as shown in fig. 2, it is noted that the claim does not require that they are parallel along a horizontal line as shown in figure 5 of the instant invention) to one another and are spaced apart to compress the harvested tissue therebetween (fig. 2).
Allowable Subject Matter
Claims 16-18, 21-25 and 29 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 16, the claim is allowed because the prior art of record, considered alone or combination, neither anticipated nor renders obvious “a system configured to change a dimension of harvested tissue, comprising… wherein the second press component includes at least one guide pin, wherein the at least one guide pin and the projection are spaced-apart from one another and both project from a surface of the second press component in a common direction, and wherein the first press component includes at least one guide opening configured to receive the at least one guide pin to align the first and second press components when the projection is inserted into the cavity”, in combination with the rest of the claimed limitations.
Claims 17-18 and 22-25 are allowable in virtue of their dependence upon claim 16.
Regarding claim 21, the claim is allowed because the prior art of record, considered alone or combination, neither anticipated nor renders obvious “A method of changing a dimension of harvested tissue, comprising:… aligning a second press component relative to the first press component by receiving first and second guide pins of the second press component in respective first and second guide openings of the first press component, wherein the first and second guide pins are spaced-apart from a projection of the second press component”, in combination with the rest of the claimed limitations.
Claim 29 is allowable in virtue of its dependence upon claim 21.
Amended claims 16 and new method claim 21 require a guide pin on the second press component and a guide opening in the first press component. There is no motivation to provide Van Buskirk and Neichel with a guide opening and a guide pin based on the structure of their devices. Therefore, claims 16 and 21 are deemed allowable over the art of record.
Response to Arguments
In Applicant's arguments filed on July 20, 2026, Applicant argued that Van Buskirk and Neichel do not disclose the amended recitation, “to permit a user to determined when the harvested tissue has been compressed to substantially a width of the cavity” as claimed in claim 1. This argument has been fully considered. However, as noted above, said recitations are used to describe an intended use of the press device. Recitations of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art teaches the structures of the claimed invention, then the prior art is capable of performing the intended use, therefore, the prior art meets the claimed limitation. Van Buskirk discloses both of the first and second press components are made of the transparent material, and thus any material in the cavity is visible through the first and second press components and a user can determine when a material has been compressed to a width of the cavity since both of the first and second press are made of transparent material.
Modified Neichel discloses both of the first and second press components are made of transparency material; therefore, the harvested tissue is visible through the first and second press components and a user can determine when the harvested tissue has been compressed to a width of the cavity.
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 JIMMY T NGUYEN whose telephone number is (571)272-4520. The examiner can normally be reached Mon-Fri 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHRISTOPHER L TEMPLETON can be reached at 571-270-1477. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JIMMY T. NGUYEN
Primary Examiner
Art Unit 3725
/JIMMY T NGUYEN/ Primary Examiner, Art Unit 3725
