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 .
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.
Election/Restrictions
Applicant’s election without traverse of Invention Group I in the reply filed on June 26, 2026 is acknowledged.
Claims 28-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group of Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 26, 2026.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: there is lack of antecedent basis in the originally filed specification for those limitation(s) triggering 35 U.S.C. 112(a), new matter rection(s) as presented hereinbelow.
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.
Claims 11-27 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.
This is a continuation application. The original written description for the filed claims must be present in the original filing of the parent application.
Independent claim 11 recites the limitation “advancing the insert adaptor comprises aligning an aperture defined through the insert adaptor with the post of the tibial base trial component such that a portion of the post is visible through the aperture, wherein the aperture is oriented orthogonal to the slot and in fluid communication with the slot.” Examiner is unable to find written description support in the original disclosure for this limitation. In particular, Examiner is unable to find written description support specifically describing “advancing the insert adaptor comprises aligning an aperture defined through the insert adaptor with the post of the tibial base trial component such that the post is visible through the aperture”. Examiner could only find an “aperture that is oriented orthogonal to the slot (164) and in fluid communication with the slot (164)” of the insert adapter (14) in Applicant’s originally filed specification to be aperture (140). However, Examiner is unable to find written description support in the original disclosure for the contemplated method step of specifically or intentionally “advancing the insert adapter (14) comprises aligning an aperture (140) defined through the insert adapter (14) with the post (58) of the tibial base trail component (12)” … “such that the post (58) of the tibial base trial component (12) is visible through the aperture.” Among other things, the original filed disclosure does not expressly disclose the method step of looking through the aperture at the post or the like as required by the new independent claim. Thus, the claims contain new matter.
Dependent claims 12, 16, 23 and 26 contains new matter for substantially this same rationale.
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 11-27 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 11 recites the limitation “an orthopedic prosthetic assembly” in line 18. It is unclear if this is the same or related to “an orthopedic prosthetic assembly” recited in lines 1-2.
Claim 11, lines 15-16, recites the limitation “the tibial trial component”. Moreover, “the tibial trial component” is referenced again in line 19 (last line of the claim). It is unclear if the claim is referencing the tibial trial base component or tibial trial insert, each as recited earlier in the claim or some other trial component. It is unclear how a tibial trial prosthetic assembly [composed of components] may, itself, be considered a “tibial trial component”.
Claim 19 recites the limitation “of the tibial trial component” in line 3. It is unclear if the claim is referencing the tibial trial base component or tibial trial insert, each as recited earlier in the claim or some other trial component. It is further unclear how the insert is said to be “of” a trial component. Does the insert, itself, not already consist of a trial component? This limitation “tibial trial component” is found again in lines 4-5 and is further unclear. Similarly, the claim is indefinite for referencing “a second tibial trial component” at the end of claim 19.
Independent claim 22 recites the limitation “a tibial trial component” in lines 13-14. However, it is unclear how a set of components is said to form a “component” (e.g., rather than an assembly or something else).
Claim 27 depends from claim 22. Claim 27 recites the limitation “a body of the tibial insert trial” in lines 3-4. It is unclear if this is the same or related to “a body of the tibial insert trial” recited in claim 22, line 15, upon which claim 27 depends.
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.
Claims 22-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hileman U.S. patent no. 6,217,618 B1.
Regarding claim 22, Hileman discloses a method of assembling an orthopedic prosthetic assembly (10), the method comprising: aligning a slot (44- e.g., figure 1) defined through an outer sidewall (40) of an insert adapter (22) (e.g., figure 1) with a post (30) of a tibial baseplate component (18); advancing the insert adapter (22) toward the post (30) of the tibial base component (18) to receive the post (30) into the slot (44) of the insert adapter (22) (e.g., see at least figures and col. 3, lines 40-44), wherein advancing the insert adaptor (22) comprises aligning an aperture (upper surface is open to slot 44, see at least figure 1) defined through the insert adapter (22) with the post (30) of the tibial base component (18), wherein the aperture (upper surface is open to slot 44, see at least figure 1) is oriented orthogonal to the slot (44); engaging a locking tab (arms 50) of the insert adaptor (22) onto a stem of the post (30) of the tibial base component (18) to couple the insert adapter (22) to the tibial base component (e.g., see at least figures; and col. 2, lines 45-52; and col. 3, lines 44-50, -wherein when retainer 22 is rotated about post 30, walls 50 prevent or lock the removal of 22 from 18 when side 42 of adapter 22 is located against retainer 32 –); and coupling a tibial insert (“bearing”- 20) to the insert adapter (22) to form a tibial component (e.g., see at least col. 3, lines 50-53, etc.); and wherein an opening of the aperture (upper surface is open to slot 44, see at least figure 1) defined on a superior side of the insert adapter (22) (e.g., figure 1) is covered by a body of the tibial insert (20) while the tibial insert (20) is coupled to the insert adapter (22) (e.g., see at least figures 1 and 5-6).
Regarding claim 23, Hileman further discloses advancing the insert adapter (22) toward the post (30) of the tibial base component (18) comprises sliding the post (30) of the tibial base component (18) within the slot (44) defined through the outer sidewall (4) of the insert adapter (22) to a position at which the portion of the post (30) is visible through the aperture (upper surface is open to slot 44, see at least figure 1) of the insert adapter (22) (e.g., see at least figure 1; and col. 3, lines 40-50, etc.).
Regarding claim 24, Hileman further discloses advancing the insert adapter (22) toward the post (30) of the tibial base component (18) comprises advancing the insert adapter (22) to move (i) a superior flange (32) of the post (30) of the tibial base component (18) into a superior slot section (48) of the slot (44) defined in the outer sidewall (40) of the insert adapter (22) (e.g., see at least figures 1, 5 and 6; and col. 2, lines 62-65, etc.); and (ii) the stem of the post (30) of the tibial base component (18) into an inferior slot section of the slot defined in the outer sidewall of the insert adapter (e.g., see at least figures 1, 5 and 6; and col. 2, lines 56-60; and col. 3, lines 42-44).
Regarding claim 25, Hileman further discloses engaging the locking tab (50) of the insert adapter (22) comprises positioning a pair of arms (50) of the locking tab onto the stem of the post (i.e., when retainer 22 is rotated about post 30, walls 50 prevent or lock the removal of 22 from 18 when side 42 of adapter 22 is located against retainer 32 – e.g., see at least figures; and col. 2, lines 45-52; and col. 3, lines 44-50).
Regarding claim 26, Hileman discloses the method further comprising visually confirming the locking tab has engaged the post of the tibial base component (18) by viewing the portion of the post through the aperture of the insert adapter (e.g., figures).
Regarding claim 27, Hileman discloses coupling the tibial insert (20) to the insert adapter (22) comprises receiving a body of the insert adapter (22) into an aperture (60) defined in an inferior surface of the body of the tibial insert (20) (e.g., see at least figure 1; and col. 3, lines 50-53).
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 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hileman U.S. patent no. 6,217,618 B1 in view of Braun et al. U.S. publication no. 2017/0049582 A1 (“Braun”).
Regarding claim 11, Hileman discloses a method of assembling an orthopedic prosthetic assembly (10), the method comprising: aligning a slot (44- e.g., figure 1) defined through an outer sidewall (40) of an insert adapter (22) (e.g., figure 1) with a post (30) of a tibial baseplate component (18) positioned on a proximal end of a tibial of a patient’s joint (e.g., see at least col. 2, lines 56-65; and col. 3, lines 60-64); advancing the insert adapter (22) toward the post (30) of the tibial base plate component (18) to receive the post (30) into the slot (44) (e.g., see at least figures and col. 3, lines 40-44), wherein advancing the insert adaptor (22) comprises aligning an aperture (upper surface is open to slot 44, see at least figure 1) defined through the insert adapter (22) with the post (30) of the tibial base component (18) such that a portion of the post (30) is visible through the aperture (upper surface is open to slot 44, see at least figure 1) (e.g., see at least figure 1; and col. 3, lines 40-50, etc.), wherein the aperture (upper surface is open to slot 44, see at least figure 1) is oriented orthogonal to the slot (44) and in fluid communication with the slot (e.g., see at least figure 1); coupling the insert adapter (22) to the tibial base component (18) such that the tibial adapter (22) is permitted to rotate relative to the tibial base component (18) (e.g., see at least col. 2, lines 43-45 and 59-62; and col. 3, lines 44-46, etc.); coupling a tibial insert (“bearing”- 20) to the insert adapter (22) to form a tibial component (e.g., see at least col. 3, lines 50-53, etc.); and moving the patient’s joint through a range of motion including extension and flexion.
Hileman is silent regarding “trialing” an orthopedic assembly, wherein the baseplate and insert are “trial components” and the movement of the patient’s joint through a range of motion including extension and flexion is for the purposes of evaluating a configuration of an orthopedic prosthetic assembly including the tibial trial substantially as claimed.
In the same field of endeavor, namely knee joint prosthesis, Braun teaches including an orthopedic assembly in a trialing kit including baseplate and insert trials of different sizes, and wherein a method includes the step of moving the patient’s joint through a range of motion including extension and flexion for the purposes of evaluating a configuration of an orthopedic prosthetic assembly including the tibial trial (e.g., see at least abstract; and paragraphs [0004], [0006], [0008]-[0009], [0051], [0059], etc.).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to follow the guidance or suggestion of Braun to include a set of trial insert and baseplates in the invention of Hileman (no modification to any configuration of the device of multiplicity of components and component sizes), in order to optimize the fit of the knee orthopedic implant during a surgical procedure with predictable results and a reasonable expectation of success.
Regarding claim 12, Hileman further discloses advancing the insert adapter (22) toward the post (30) of the tibial base component (18) comprises sliding the post (30) of the tibial base component (18) within the slot (44) defined through the outer sidewall (4) of the insert adapter (22) to a position at which the portion of the post (30) is visible through the aperture (upper surface is open to slot 44, see at least figure 1) of the insert adapter (22) (e.g., see at least figure 1; and col. 3, lines 40-50, etc.).
Regarding claim 13, Hileman further discloses advancing the insert adapter (22) toward the post (30) of the tibial base component (18) comprises advancing the insert adapter (22) to move (i) a superior flange (32) of the post (30) of the tibial base component (18) into a superior slot section (48) of the slot (44) defined in the outer sidewall (40) of the insert adapter (22) (e.g., see at least figures 1, 5 and 6; and col. 2, lines 62-65, etc.); and (ii) a stem of the post (30) of the tibial base component (18) into an inferior slot section of the slot defined in the outer sidewall of the insert adapter (e.g., see at least figures 1, 5 and 6; and col. 2, lines 56-60; and col. 3, lines 42-44).
Regarding claims 14 and 15, Hileman further discloses advancing the insert adapter (22) toward the post (30) of the tibial base component (18) comprises engaging a locking tab (arms 50) of the insert adaptor (22) onto the post (30) of the tibial base component (18), wherein engaging the locking tab (50) of the insert adapter (22) comprises positioning a pair of arms (50) of the locking tab in a channel of the post (i.e., “channel” if formed between retainer head 32 and plateau 24, such that when retainer 22 is rotated about post 30, walls 50 prevent or lock the removal of 22 from 18 when side 42 of adapter 22 is located against retainer 32 – e.g., see at least figures; and col. 2, lines 45-52; and col. 3, lines 44-50).
Regarding claim 16, Hileman discloses the method further comprising visually confirming the locking tab has engaged the post of the tibial base trial by viewing the portion of the post through the aperture of the insert adapter (e.g., figures).
Regarding claim 17, Hileman discloses coupling the tibial insert (20) to the insert adapter (22) comprises covering the aperture (upper surface is open to slot 44, see at least figure 1) of the insert adapter (22) with a body of the tibial insert (20) (e.g., see at least figures 1 and 5-6).
Regarding claim 18, Hileman discloses coupling the tibial insert (20) to the insert adapter (22) comprises receiving a body of the insert adapter (22) into an aperture (60) defined in an inferior surface of the body of the tibial insert (20) (e.g., see at least figure 1; and col. 3, lines 50-53).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11-27 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,744,718. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are narrower than the present application claims in some regards and broader in others. With respect to those limitations making the patent application claims narrower than the present application claims, species anticipates genus. With respect to those limitations making the patent claims broader than the present application claims, such limitations are known to prior art to Hileman U.S. patent no. 6,217,618 B1 in view of Braun et al. U.S. publication no. 2017/0049582 A1 (“Braun”). Allowable clams 19-21 are not patentably distinct from allowable claims of the patent. For example, the method step of “moving the tibial insert trial of the tibial trial component in a superior direction to decouple the tibial insert trial from the insert adapter of the tibial trial component; selecting a second tibial insert trial having a different size from the trial insert trial; and moving the second insert trial in an inferior direction to couple the second tibial insert trial to the insert adapter to form a second tibial trial component” along with all of the other limitations contained within the claim is anticipated by [is a variation of the limitations--] “assembling a tibial trial component by aligning an insert adapter with a tibial insert trial and advancing the insert adaptor into an aperture defined in the tibial insert trial to form the tibial trial component, wherein advancing the insert adaptor into the aperture of the tibial insert trial includes receiving a pin located in the aperture defined in the tibial insert trial into an aperture of the insert adaptor” –[i.e., when read in light of the guidance in the original disclosure along with all of the other limitations in the claim].
Allowable Subject Matter
Claim 19-21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) and (b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims and if non-statutory double patenting rejection is overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA LYNN WATKINS whose telephone number is (571)270-1456. The examiner can normally be reached Mon. & Tues. 3-8pm and Thurs. 12-6pm.
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/MARCIA L WATKINS/Primary Examiner, Art Unit 3774
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