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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Applicant is reminded that there abstract it not to exceed 150 words in length.
Claim Objections
Claim 1 is objected to because of the following informalities: Applicant uses the phrase “to posterior surface” in lines 23-24. This should read “to the posterior surface”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: Applicant uses the term “the difference between the distance between the reference surface and the support surface”. This should read “the difference in distance between the reference surface and the support surface”. Appropriate correction is required.
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 1-9 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 1 recites the limitations "the compressive load applied to the backing plate” in lines 4-5, “the posterior surface of the patella" in lines 15-16, “the increment between” in line 25 and “the increment between” in line 27. There is insufficient antecedent basis for these limitations in the claim. For the purpose of examination, the limitations have been interpreted to read “a compressive load applied to the backing plate” in lines 4-5, “a posterior surface of the patella" in lines 15-16, “an increment between” in line 25 and “an increment between” in line 27.
Claim 2 recites the limitations "the increment" in lines 4 and 5. There is insufficient antecedent basis for these limitations in the claim.
For the purpose of examination, they have been interpreted to read “an increment”.
Claim 3 recites the limitations "the thickness of the second shim" in line 1, “the thickness of the first shim”, “the difference in thickness between the first and second shims” in lines 2-3, and “the difference between the distances between the reference surface and the support surface”. There is insufficient antecedent basis for these limitations in the claim.
For the purpose of examination, the limitations have been interpreted to read “a thickness of the second shim" in line 1, “a thickness of the first shim”, “a difference in thickness between the first and second shims” in lines 2-3, and “a difference in distances between the reference surface and the support surface” in lines 3-4.
Claim 4 recites the limitation "the angle" in line 1. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of examination, the limitation has been interpreted to read “an angle”.
Claim 6 recites the limitation "the angle" in line 2. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of examination, the limitation has been interpreted to read “an angle”.
Claim 7 recites the limitations "the thickness of the second shim" in line 1, “the thickness of the first shim” in line 2, “and “the differences between the distances between the reference surface and the support surface”. There is insufficient antecedent basis for these limitations in the claim. For the purpose of examination, the limitations have been interpreted to read “a thickness of the second shim" in line 1, “a thickness of the first shim” in line 2, “and “a difference in distance between the reference surface and the support surface angle”. Additionally, Applicant recites “”in which the thickness of the second shim is greater than the thickness of the first shim and which includes first and second spacer inserts”. It is unclear what “which” is referencing as it could be referencing the thicknesses or that the overall assembly includes first and second spacer inserts. For the purpose of examination, it has been interpreted that the overall assembly includes the first and second spacer inserts.
Claims 5and 8-9 are rejected under 35 U.S.C. 112(b) as they depend from a rejected base claim and do not rectify the issue(s) at hand.
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.
Claims 1, 3-4 and 6-9 are rejected under 35 U.S.C. 103 as being obvious over Wright et al. (US 2013/0030443) in view of Naybour et al (WO 2021/240135).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Wright et al. disclose an assembly for use in knee surgery, which comprises a cutting instrument (¶92, ¶167) having a cutting head (606, figure 13) for cutting the patella on a selected resection plane (¶92, ¶167), a clamp (16) for a patella having opposing jaws (figure 3A) which can be moved towards one another to clamp the patella between them (¶19, ¶24), the clamp providing a reference surface (178) for engaging the posterior surface of the patella (figure 9), a support surface (142) for supporting the cutting head of the cutting instrument, thereby locating the cutting instrument relative to the clamp, at least first (490, figure 3B) and second (494, figure 3B) locator inserts which can be mounted individually or in one or more combinations on or relative to the clamp, providing a physical connection between the reference and support surfaces which define first and second positions of the support surface relative to the reference surface (figures 1, 3B, ¶134-135), and thereby define first (pre-clamping/final positioning ¶136) and second positions (post clamping/in final position, ¶136) for the resection plane relative to posterior surface of the patella (figures 9-13, ¶136 via “height can be adjusted intraoperatively), in which the increment between the first and second positions of the bearing surface defined by the combinations of the first and second shims relative to the patella matches the increment between the first and second positions of the support surface relative to the reference surface (figures 8-13, ¶136 as the adjustment in height impacts all increments/distances between the bearing surfaces and support surfaces).
Wright et al. fails to expressly teach or disclose their assembly comprises a patella sensor component comprising a backing plate which can be fitted to the patella and which has at least one sensor which can generate a signal corresponding to the compressive load applied to the backing plate, ii. at least first and second shims which provide a patella bearing surface for articulation against a surface on the patient's femur, and which can be positioned individually or in one or more combinations on the backing plate so as to face the patient's femur, the combinations defining first and second positions of the bearing surface relative to the patella.
Naybour et al. disclose a patellar sensor component (figures 1-15) which comprises a backing plate (86, figures 14-15) which can be fitted to the patella (figures 14-15) and which has at least one sensor (130, 132, 134, 136, figure 9) which can generate a signal corresponding to the compressive load applied to the backing plate (page 12, lines 15-17), at least first (200) and second (202) shims which provide a patella bearing surface for articulation against a surface on the patient's femur (figures 12, 14 and 15), and which can be positioned individually or in one or more combinations on the backing plate so as to face the patient's femur (figure 14), the combinations defining first and second positions of the bearing surface relative to the patella (figures 12, 14-15). The patella sensor as the sensor allows for assessment of tension in soft tissue which is connected to a patient's patella, in particular in the quadriceps. The tension of the quadriceps throughout the range of motion of the joint is affected by the thickness of the patella: the tension is greater when the thickness of the patella is greater. The invention provides the possibility of obtaining information about tension in the soft tissue in the patient's native knee when it is articulated, and then planning the 20 preparation of the patella for receiving the patella component of the knee joint prosthesis so that the soft tissue tension after surgery is approximately the same as the tension before surgery, or differs from the tension pre-surgery in a way that is selected by the surgeon.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have provided the assembly of Wright et al. to include the patellar sensor component of Naybour et al. as the sensor component allows for assessment of tension in soft tissue which is connected to a patient's patella, in particular in the quadriceps. Which provides the possibility of obtaining information about tension in the soft tissue in the patient's native knee when it is articulated, and then planning the preparation of the patella for receiving the patella component of the knee joint prosthesis so that the soft tissue tension after surgery is approximately the same as the tension before surgery, or differs from the tension pre-surgery in a way that is selected by the surgeon.
Regarding claim 3, Wright et al. in view of Naybour et al. disclose the thickness of the second shim (202of Naybour) is greater than the thickness of the first shim (202, figure 12), and the difference in thickness between the first and second shims matches the difference between the distances between the reference surface and the support surface when in their first and second relative positions (figures 12, 14-15). Regarding claim 4, Wright et al. in view of Naybour et al. disclose each shim (200, 202, 204) has principal opposite surfaces and the angle between the principal surfaces of the second shim is greater than the angle between the principal surfaces of the first shim (page 9, lines 1-5, page 10, lines 5-14), and the difference between the angles between the principal surfaces of the first and second shims matches the difference between the angles between the reference surface and the support surface when in their first and second relative positions (page 9, lines 1-5, page 10, lines 5-14).
Regarding claim 6, Wright et al. in view of Naybour et al. disclose each shim has principal opposite surfaces and the angle between the principal surfaces of the second shim is greater than the angle between the principal surfaces of the first shim (page 9, lines 1-5, page 10, lines 5-14 of Naybour), and in which the difference between the angles between the reference surface and the support surface when the first and second connector inserts respectively are mounted on the clamp matches the difference between the angles between the principal surfaces of the first and second shims (page 9, lines 1-5, page 10, lines 5-14).
Regarding claim 7, Wright et al. in view of Naybour et al. disclose the thickness of the second shim is greater than the thickness of the first shim (figure 12 of Naybour) and which includes first and second spacer inserts (206’s of Naybour), and in which the difference between the distances between the reference surface and the support surface when the first and second spacer inserts respectively are in mounted on the clamp matches the difference between the thicknesses of the first and second shims (figures 12, 14-15). Regarding claim 8, Wright et al. in view of Naybour et al. disclose the backing plate and the shims include cooperating engagement features (206’s and 130, 132, 134, 136 of Naybour) by which shims can be fastened to the backing plate (page 29, lines 18-21). Regarding claim 9, Wright et al. in view of Naybour et al. disclose the assembly includes a patella implant component (316, figure 23 of Naybour).
Allowable Subject Matter
Claims 2 and 5 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.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 2, none of the cited art anticipates or renders obvious the limitation of “a third locator insert”. With respect to claim 5, none of the cited art anticipates or renders obvious each of the first and second locator inserts comprises a connector insert which can be mounted on the claim and a spacer insert which can be mounted on the connector insert.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00. 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, Anita Coupe can be reached at 571-270-3614. 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.
/MATTHEW J LAWSON/ Primary Examiner, Art Unit 3619