DETAILED ACTION
The following is a final office action is response to communications received on 10/02/2025. Claims 19-39 are currently pending and addressed below.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 10/02/2025 have been fully considered. Applicant argues that as all the previous claims have been cancelled, the prior art fails to on any of the new claims. A new ground(s) of rejection is made, addressing all of the claim limitations as necessitated by amendment.
Claim Rejections - 35 USC § 112
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.
Claims 21-31 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.
Claim 21 states “wherein, at a first location along the length, the plurality of thicknesses comprises: a first thickness on the lateral side; and a first thickness on the medial side, wherein the first thickness on the medial side and the first thickness on the lateral side are different from one another.” The underlined limitation is indefinite. If the length is defined between anterior and posterior portions, as defined in claim 19, “a first location” along said length would be a singular point and therefore not have any thicknesses on either the medial or lateral side. For examination purposes, the examiner assumes that applicant intends to claim “wherein, at a first cross- sectional location along the length”. This appears to coincide with instant Figures 2-6.
Claims 23 & 26 are similarly indefinite.
Claim 29 states “wherein the plurality of thicknesses comprises: an anterior thickness at the anterior portion; and a posterior thickness at the posterior portion, wherein the anterior thickness and the posterior thickness are different from one another.” This limitation is indefinite as it is unclear what is being claimed. In claims 21 23 & 26, first, second, and third thicknesses have been claimed. However, it is unclear how any of these thicknesses can comprise an anterior or a posterior thickness.
Appropriate correction is required.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 19-21, 23, 25, 26, 28 & 33-35 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Steines et al. (US 2007/0233269).
PNG
media_image1.png
441
666
media_image1.png
Greyscale
PNG
media_image2.png
266
862
media_image2.png
Greyscale
Regarding Claim 19, Steines teaches an apparatus, comprising:
a prosthetic meniscus (200) configured to replace a natural meniscus of a patient, wherein the prosthetic meniscus comprises:
a central portion (shown) comprising an upper surface (202) configured for engagement with a femur of the patient (Fig 2G) and an opposite, lower surface (distal side) configured for engagement with a tibia of the patient (Fig 2G);
an outer portion (206) surrounding the central portion; and
a length (shown) defined between an anterior portion and a posterior portion,
wherein the outer portion comprises:
a medial side (shown);
an opposite, lateral side (shown); and
a plurality of thicknesses varying along the length on the lateral side and the medial side (Figs 2C-2E),
wherein the plurality of thicknesses is configured to maintain the prosthetic meniscus between the tibia and the femur without penetrating anatomy to secure prosthetic meniscus within a knee joint [0114].
Regarding Claim 20, Steines teaches wherein the plurality of thicknesses on the medial side and the plurality of thicknesses of the lateral side are different from one another (Figs 2C-2E).
Regarding Claim 21, Steines teaches wherein at a first location (Figs 2C) along the length, the plurality of thicknesses comprises: a first thickness on the lateral side; and a first thickness on the medial side, wherein the first thickness on the medial side and the first thickness on the lateral side are different from one another (shown).
Regarding Claim 23, Steines teaches wherein at a second location (Fig 2D) along the length, the plurality of thicknesses comprises: a second thickness on the lateral side; and a second thickness on the medial side, wherein the second thickness on the medial side and the second thickness on the lateral side are different from one another (shown).
Regarding Claim 25, Steines teaches wherein the first thickness on the medial side, the first thickness on the lateral side (Fig 2C), the second thickness on the medial side, and the second thickness on the lateral side (Fig 2C) are different from one another.
Regarding Claim 26, Steines teaches wherein at a third location (Fig 2E) along the length, the plurality of thicknesses comprises: a third thickness on the lateral side; and a third thickness on the medial side, wherein the third thickness on the medial side and the third thickness on the lateral side are different from one another (shown).
Regarding Claim 28, Steines teaches wherein the first thickness on the medial side, the first thickness on the lateral side, the second thickness on the medial side, the second thickness on the lateral side, the third thickness on the medial side, and the third thickness on the lateral side are different from one another (Figs 2C-2E).
Regarding Claim 33, Steines teaches wherein the plurality of thicknesses comprises: a thickness on the medial side; and a thickness on the lateral side, wherein the thickness on the medial side and the thickness on the lateral side are offset from one another in a superior-inferior direction (Figs 2C-2E).
Regarding Claim 34, Steines teaches wherein at least one of the thickness on the medial side or the thickness on the lateral side is offset from the lower surface in the superior-inferior direction (Figs 2C-2E).
Regarding Claim 35, Steines teaches wherein 1at least one of the thickness on the medial side or the thickness on the lateral side is offset from the upper surface in the superior-inferior direction (Figs 2C-2E).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 22, 24 & 27 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steines et al. (US 2007/0233269).
Regarding Claims 22, 24 & 27, as set forth supra, Steines discloses the invention substantially as claimed. Further, Steines teaches that the customization of the device thicknesses allows for a near anatomic fit within the joint, thus minimizing bone removal, and resulting in enhanced chance of successful surgery [0060]. Steines device is designed to replicate the thickness, contour and curvature of the joint [0077] by altering the device thicknesses along its length [0117] and is self-centering to remain within the joint space without anchors [0099].
However, Steines does not disclose wherein: the first thickness on the lateral side is between 5.1 mm and 8.8 mm, the first thickness on the medial side is between 5.7 mm and 9.3 mm; the second thickness on the lateral side is between 8 mm and 12.1 mm, the second thickness on the medial side is between 5.8 mm and 9.1 mm; the third thickness on the lateral side is between 4.6 mm and 7.8 mm, and the second thickness on the medial side is between 5.8 mm and 9.5 mm.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Steines to have the first thickness on the lateral side is between 5.1 mm and 8.8 mm, the first thickness on the medial side is between 5.7 mm and 9.3 mm; the second thickness on the lateral side is between 8 mm and 12.1 mm, the second thickness on the medial side is between 5.8 mm and 9.1 mm; the third thickness on the lateral side is between 4.6 mm and 7.8 mm, and the second thickness on the medial side is between 5.8 mm and 9.5 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Steines et al. would not operate differently with the claimed thicknesses and as the meniscal device is intended to operate in the same manner (i.e. without any penetrating the anatomy) the device would function appropriately having the claimed thicknesses. Further, as Steines and the instant application are directed towards an unanchored meniscal prosthesis to replicate the native meniscus, constructing the Steines device from the dimensions as claimed.
Allowable Subject Matter
Claim 32 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 36-39 are allowed.
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 BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774