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 .
Status of the Claims
This Office Action is responsive to the amendment filed September 18, 2026. As directed by the amendment: Claims 21, 25, 33, 34, and 37 have been amended. Claims 1-20, 22, and 23 have been cancelled. Claim 41 is newly added. Claims 21 and 24-41 are presently pending in this application.
Claim Rejections - 35 USC § 112(a)
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.
Claims 21 and 24-41 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.
Regarding claims 21 and 34, ll. 8-9, the phrases “and the lower gouge is configured to excise cartilage away from a cartilage surface and into the opening while the upper jaw is in the open position” and “excising cartilage away from a cartilage surface and into the opening of the lower gouge while the upper jaw is in the open position” renders new matter as the originally filed disclosure is silent on this feature. Applicant is suggested to cancel any new matter in order to overcome this rejection.
Claims 24-33 and 36-41 are rejected on being dependent to a rejected base claim.
Examiner’s Note
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.
Claim Rejections - 35 USC § 102
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.
Claim(s) 21, 24-26, and 29-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kappel et al. (US 2016/0081678), herein referred to as Kappel.
Regarding claim 21, Kappel discloses a device (300) (figures 5 and 6) for harvesting cartilage from a subject (considered functional) comprising a body portion (312), a lower gouge (310b) extending from the body portion (312), the lower gouge (310b) being fixed relative to the body portion (312) (¶55) and having an opening (308) (¶56) extending axially along a portion thereof (figure 5), and an upper jaw (310a) coupled to the body portion (312), the upper jaw (310a) being rotatable (¶55) relative to the lower gouge (310b) between an open position (figure 5) and a closed position (figure 6), wherein the opening (308) of the lower gouge (310b) is exposed when the upper jaw (310a) is in the open position (figure 5), and the lower gouge (310b) is configured to (i.e. capable of) excise cartilage away from a cartilage surface and into the opening while the upper jaw is in the open position (¶9) (considered functional), and wherein, after the lower gouge (310b) excises the cartilage while the upper jaw (310a) is in the open position (figure 5), the opening of the lower gouge (310b) is enclosed by the upper jaw (310a) when in the closed position (¶9 and figure 6) to retain the excised cartilage within the opening (considered functional).
Regarding claim 24, Kappel discloses wherein the device (300) is configured to (i.e. capable of) be inserted into the subject via a cannula (304) (figures 5 and 6).
Regarding claim 25, Kappel discloses wherein the device (300) is configured to (i.e. capable of) retract the excised cartilage retained within the enclosed opening of the lower gouge (310b) into the cannula (304) for extraction (considered functional).
Regarding claim 26, Kappel discloses wherein the device (300) is configured to (i.e. capable of) be completely contained within the cannula (304) (¶55).
Regarding claims 29, 30, Kappel discloses wherein the device (300) is configured to (i.e. capable of) excise and harvest cartilage from the subject in a minimally invasive manner, wherein the cartilage comprises live cartilage for treatment of damaged cartilage (considered functional).
Regarding claim 31, Kappel discloses wherein the device (300) is configured to (i.e. capable of) be inserted into a knee or a shoulder of the subject (considered functional).
Regarding claim 32, Kappel discloses wherein the device (300) is capable of providing about 200 mg of cartilage in 3-5 passes as this is considered functional.
Regarding claim 33, Kappel is capable of having wherein the cartilage is articular cartilage from a medial femoral condyle, a lateral femoral condyle, or an intercondylar notch as this is considered functional.
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) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kappel (US 2016/0081678).
Regarding claim 27, Kappel’s device discloses all the features/elements as claimed but lacks a detailed description on wherein the cannula has an outer diameter of about 2.77 mm.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kappel’s device with wherein the cannula has an outer diameter of about 2.77 mm, since such a modification is considered optimization of the size of the prior art and one of ordinary skill I the art would have come up with the measurement as claimed. Furthermore, it would be patient dependent.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kappel (US 2016/0081678) in view of Cunningham et al. (US 2009/0248052), herein referred to as Cunningham.
Regarding claim 28, Kappel’s device discloses all the features/elements as claimed but lacks wherein the upper jaw is actuated by a sliding thumb grip.
However, Kappel teaches an actuator for moving the jaws between the open and closed configurations as would be understood by those skilled in the art (¶44). In addition, Cunningham teaches actuators such as a sliding thumb grip (38 or 40) (figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Kappel’s device having an actuator with a sliding thumb grip as taught by Cunningham, since such a modification would provide a specific type of controlling actuator.
Claim(s) 34-38 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kappel (US 2016/0081678) in view of Maenhout et al. (US 2011/0301498), herein referred to as Maenhout.
Regarding claim 34, Kappel discloses all the features/elements as claimed including the device according to claim 21 (see claim 21 above) but lacks a detailed description on a method of harvesting cartilage from a subject, the method comprising inserting into a knee or shoulder of a subject.
However, Maenhout teaches a method of harvesting cartilage from a subject (¶1), the method comprising inserting into a knee (¶1) or shoulder of a subject.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Kappel’s device with a method of harvesting cartilage from a subject, the method comprising inserting into a knee of a subject as taught by Maenhout, since such a modification would allow a medical professional to treat the knee of a patient.
Thus, the modified Kappel’s method has excising cartilage away from a cartilage surface (¶1 of Maenhout) and into the opening of the lower gouge (310b of Kappel) while the upper jaw (310a of Kappel) is in the open position (¶9 of Kappel), and after excising the cartilage (¶1 of Maenhout), actuating the upper jaw (310a of Kappel) to the closed position (¶9 of Kappel) to enclose and retain the excised cartilage (¶1 of Maenhout) within the opening of the lower gouge (310b of Kappel).
Regarding claim 35, the modified Kappel’s method has wherein the cartilage is from non-load-bearing surfaces of at least one of medial and lateral femoral condyles (¶1 of Maenhout).
Regarding claim 36, the modified Kappel’s method has wherein the cartilage is harvested for an autologous chondrocyte implantation procedure (¶2 of Maenhout).
Regarding claim 37, the modified Kappel’s method discloses all the features/elements as claimed but lacks a detailed description on further comprising harvesting about 200 mg of articular cartilage in 3-5 passes.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Kappel’s method with harvesting about 200 mg of articular cartilage in 3-5 passes, since the prior art discovering optimum or workable ranges involves routine experimentation in the art.
Regarding claim 38, the modified Kappel’s method has wherein the cartilage is harvested for a clinical articular cartilage biopsy procedure (¶1, ¶2 of Maenhout).
Regarding claim 40, the modified Kappel’s method has wherein the cartilage is harvested without an arthroscopic surgery (Abstract of Kappel).
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kappel and Maenhout as applied to claims above, and further in view of Johnson (US 6,030,400).
Regarding claim 39, the modified Kappel’s method discloses all the features/elements as claimed but lacks a detailed description on wherein the method is performed under local anesthesia.
However, Johnson teaches cartilage can be harvested on an outpatient basis in a procedure requiring only local anesthesia (col. 1, ll. 25-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Kappel’s method with local anesthesia as taught by Johnson, since providing local anesthesia would reduce the pain of the patient.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kappel and Maenhout as applied to claims above, and further in view of Mazza (US 5,005,585).
Regarding claim 41, the modified Kappel’s method discloses all the features/elements as claimed but lacks a detailed description on wherein excising the cartilage and retaining the excised cartilage are performed in a single pass.
However, Mazza teaches obtaining tissue with a single pass (col. 2, ll. 13-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Kappel’s method with performing in a single pass as taught by Mazza, since such a modification would minimize distortion and maintaining the configuration integrity of the tissue (col. 2, ll. 13-16).
Response to Arguments
Applicant's arguments filed September 18, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 5-6, under 35 U.S.C. 102(a)(1), of the Remarks are directed to the amended claims and the reference Kappel. Applicant argues that “Kappel does not disclose the operative relationship now required by claim 21” and “Kappel cannot excise cartilage without closing the jaw”. However, the Examiner respectfully disagrees because as generally claimed, Kappel discloses the lower gouge (310b) is configured to (i.e. capable of) excise cartilage away from a cartilage surface and into the opening while the upper jaw is in the open position (¶9) (considered functional), and wherein, after the lower gouge (310b) excises the cartilage while the upper jaw (310a) is in the open position (figure 5), the opening of the lower gouge (310b) is enclosed by the upper jaw (310a) when in the closed position (¶9 and figure 6) to retain the excised cartilage within the opening (considered functional). A recitation of the 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 structure is capable of performing the intended use, then it meets the claim. Furthermore, Kappel discloses “as the jaws are moved to the closed configuration” is interpreted as the upper jaw is in an open position.
Applicant’s argues on page 7, under 35 U.S.C. 103, of the Remarks that “Cunningham does not teach the feature for which it is cited”. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Kappel teaches an actuator for moving the jaws between the open and closed configurations as would be understood by those skilled in the art (¶44). In addition, Cunningham teaches actuators such as a sliding thumb grip (38 or 40) (figure 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Kappel’s device having an actuator with a sliding thumb grip as taught by Cunningham, since such a modification would provide a specific type of controlling actuator. Thus, it is the modified Kappel’s device that has the upper jaw (310a of Kappel) is actuated by a sliding thumb grip (38 or 40 of Cunningham).
Applicant arguments on pages 7-8 of the Remarks are directed to the reference Maenhout. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.
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.
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/SI MING KU/Primary Examiner, Art Unit 3775
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