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 .
Election/Restrictions
Applicant’s election without traverse of claims 14 – 25 in the reply filed on 03/13/2026 is acknowledged.
Claims 1 – 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/13/2026.
Claim Objections
Claims 14, 16, and 18 are objected to because of the following informalities:
Claim 14 recites “the patella” in line 6, although does not rise to the level of a 101 issue, as the line is understood by the Examiner to mean “the patella component” as previously defined, the Examiner suggests the line be amended to read “the patella component” for the purpose of maintaining consistent language throughout the claims;
Claim 16 recites “the first spacer” and “the second spacer” in lines 1 and 2, although the lines do not rise to the level of being indefinite, as the lines are understood by the Examiner to mean “a first spacer of the at least two spacers” and “a second spacer of the at least two spacers” as the “first spacer” and the “second spacer” were not previously defined, the Examiner suggests the claim 16 be amended to read either to read “wherein the at least two spacers comprises a first spacer and a second spacer, wherein the first spacer…” or “wherein a first spacer of the at least two spacers …and a second spacer of the at least two spacers” for the purpose of providing proper antecedent basis for the claimed terms;
Claim 18 recites “the first spacer”, “the second spacer”, and “a third spacer” in lines 1,2, and 3, although the lines do not rise to the level of being indefinite, as the lines are understood by the Examiner to mean “a first spacer of the at least three spacers”, “a second spacer of the at least three spacers”, and “a third spacer of the at least three spacers” as the “first spacer”, the “second spacer”, and the “third spacer” were not previously defined, the Examiner suggests the claim 18 be amended to read either to read “wherein the at least three spacers comprises a first spacer, a second spacer, and a third spacer, wherein the first spacer…” or “wherein a first spacer of the at least three spacers …a second spacer of the at least three spacers…and a third spacer of the at least three spacers” for the purpose of providing proper antecedent basis for the claimed terms;
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 14 – 25 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.
Regarding claim 14, the phrases “one of the set of couplable spacers" and “multiple of the set of couplable spacers” renders the claim indefinite because it is unclear whether Applicant is intending to further narrow the claim to include multiple “sets” of couplable spacers such that the “implantation spacer” is either a “set” of spacers (i.e., multiple spacers in a set) or multiple sets of spacers (i.e., multiple spacers in multiple sets of spacers) or if Applicant is intending for the phrases to mean “one of the spacers in the set of couplable spacers” and “multiple spacers in the set of couplable spacers”. Based on Applicant’s disclosure, wherein the “implantation spacer” comprises either a single spacer or multiple spacers in the kit, the Examiner is reading the claim to mean the latter.
Regarding claims 16 and 18, the phrase "whereby the implantation spacer in the kit" renders the claim indefinite because the “implantation spacer” it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 21, 23, 24, and 25, the phrases "each of the set of couplable spacers" and/or “one of the set of couplable spacers to another of the set of couplable spacers” render the claim indefinite because it is unclear whether Applicant is intending to further include multiple “sets” of couplable spacers and further define each “set” within each claim or if Applicant is intending to the phrases to mean “each of the spacers in the set of couplable spacers” and “one of the spacers of the set of couplable spacers to another spacer of the set of couplable spacers”, respectively, and thus further defining each “spacer” in the singular set of couplable spacers. For the purpose of examination, and based on Applicant’s disclosure, the Examiner will read the claims to mean the latter.
Claims 15 – 25 are rejected as being indefinite for being dependent on an indefinite claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 14 recites “a set of couplable spacers”, Claim 15, which depends on Claim 14, recites “wherein the set of couplable spacers further includes at least two spacers”; however, because “a set” inherently comprises “at least two” elements, Claim 15 is seen as reiterating that the “set” of Claim 14 is a “set”. Therefore, Claim 15 does not further limit Claim 14. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 14, 15, 17, 19, and 21 – 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cipolletti et al (US 2012/0209391 A1).
Regarding claim 14, Cipolletti discloses a total knee replacement kit (modular prosthesis) (abstract, paragraphs [0005 – 0011], [0027 – 0035] and Figs. 1-16), comprising:
a femoral component (femoral portion 10), a tibial component (tray portion 1), and a patella component (patellar portion) (paragraph [0028] and Fig. 1); and
a set of couplable spacers (augment blocks 2-4,7) selectively engageable with one another (paragraph [0030 – 0031] and Figs. 1-4), wherein the femoral component, the tibial component, and the patella in the kit are each selected based on a predetermined compatible size for implantation together as part of a total knee replacement system (modular prosthesis) (paragraphs [0027 – 0028]) along with an implantation spacer (augment blocks 2-4) comprising multiple [spacers in the set] (augment blocks 2-4,7) of the set of couplable spacers (augment blocks 2-4,7) in the kit engaged with one another to achieve the desired thickness (paragraph [0030 – 0035]) (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation which requires that the structure of the prior art be capable of functioning in the manner claimed; with that said, the components and the patella are capable of being selected by a predetermined compatible size as claimed).
Regarding claim 15, Cipolletti discloses wherein the set of couplable spacers (augment blocks 2-4,7) includes at least two spacers (augment blocks 2-4,7) (paragraphs [0028 – 0029] and Figs. 1-16).
Regarding claim 17, Cipolletti discloses wherein the set of couplable spacers (augment blocks 2-4,7) includes at least three spacers (augment blocks 2-4,7) (paragraphs [0028 – 0029] and Figs. 1-16).
Regarding claim 19, Cipolletti discloses wherein the kit (modular prosthesis) further includes a bearing component (tibial articular portion 9) having a predetermined size and shape commensurate for implantation with the femoral component, the tibial component, and the patella component in the total knee replacement system (paragraphs [0028 – 0029]).
Regarding claim 21, Cipolletti discloses wherein each of the set of couplable spacers (augment blocks 2-4,7) comprise a different thickness (paragraph [0040], Fig. 15, claim 16).
Regarding claim 22, Cipolletti discloses including a lock (augment block locking bolt 5) preventing each of the couplable spacers (augment blocks 2-4,7) from sliding relative to one another when selectively engaged (paragraph [0034] and Fig. 4).
Regarding claim 23, Cipolletti discloses wherein each of the set of couplable spacers (augment blocks 2-4,7) include a central aperture (aperture through augment blocks shown in Fig. 7) having a size and shape for select pass-through reception of an intramedullary stem of the tibial component (paragraph [0018] and Figs. 4 – 7).
Regarding claim 24, Cipolletti discloses wherein each of the set of couplable spacers include a keyed aperture (aperture through augment blocks shown in Fig. 7) having a size and shape for pass-through reception of at least a portion of a downwardly projecting rod of the tibial component in one orientation (paragraph [0018] and Figs. 4 – 7).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cipolletti et al (US 2012/0209391 A1).
Regarding claims 16 and 18, as discussed above, Cipolletti discloses the total knee replacement kit of claims 15 and 17. Additionally, Cipolletti discloses wherein there the spaces in the set of couple spaces (augment blocks 2-4 and 7) have different thicknesses (paragraph [0040], Fig. 15, claim 16).
However, Cipolletti is silent regarding (i) [claim 16] the specific thickness values for each of the spaces wherein the first spacer comprises a thickness of 2 millimeters and the second spacer comprises a thickness of 4 millimeters, whereby the implantation spacer in the kit comprises a thickness of 2 millimeters, 4 millimeters, or 6 millimeters or (ii) [claim 18] wherein the first spacer comprises a thickness of 2 millimeters and the second spacer comprises a thickness of 4 millimeters, and the third spacer comprises a thickness of 4 millimeters, whereby the implantation spacer in the kit comprises a thickness of 1 millimeter to 7 millimeters in 1 millimeter increments.
As to the above, there is no evidence of record that establishes that changing the thicknesses of each spacer would result in a difference in function of the Smith et al. device. Further, a person having ordinary skill in the art, being faced with modifying the spacers (i.e., the augment blocks 2-4 and 7) of Cipolletti, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thicknesses. Lastly, Applicant has not disclosed that the claimed ranges solves any stated problem, indicating that the thickness of each spacer “may” be within the claimed range, and offering other acceptable ranges (e.g., specification at paras. [0009] and [0013]) and therefore there appears to be no criticality placed on the ranges as claimed such that it produces an unexpected result.
Therefore, 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 first spacer to have a thickness of 1mm (or 2mm), the second spacer to have thickness of 2mm (or 4mm), the third spacer to have thickness of 4mm, and the implantation spacer comprising a thickness of 1mm – 7mm in 1mm increments or a thickness of 2mm, 4mm, or 6mm) as an obvious matter of design choice within the skill of the art.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Cipolletti et al (US 2012/0209391 A1) as applied to claim 14 above, and further in view of Taylor et al (US 2014/0309747 A1).
Regarding claim 20, as discussed above, Cipolletti discloses the total knee replacement kit of claim 14.
However, Cipolletti is silent regarding (i) a sterile wrap surrounding the total knee replacement kit.
As to the above, Taylor teaches a medial system comprising a sterile wrap (sterile package 1900) surrounding the implant (paragraph [0121]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Cipolletti to include, a sterile wrap based on the teachings of Taylor, for the purpose of keeping the components of the system sterile prior to use.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Cipolletti et al (US 2012/0209391 A1) as applied to claim 14 above, and further in view of Engh (US 6,139,581).
Regarding claim 25, as discussed above, Cipolletti discloses the total knee replacement kit of claim 14.
However, Cipolletti is silent regarding (i) an adhesive having a chemical composition for bonding one of the set of couplable spacers to another of the set of couplable spacers.
As to the above, Engh teaches, in the same field of endeavor, a knee replacement kit comprising a femoral component (femoral implant 12), a tibial component (plateau element 120; which equates to the tray portion 1 of Cipolletti), and a spacer (wedge element 130/compensation element 150; which equates to one of the augment blocks of Cipolletti), wherein the spacer (wedge element 130/compensation element 150) comprises an adhesive to couple the spacer to the bottom surface of the tibial component (plateau element 120) (abstract, col. 7 lines 7 – 30, and Fig. 7).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the augment blocks of Cipolletti to include an adhesive as claimed, based on the teachings of Engh, for the purpose of aiding in further securing the connection between the coupled augment blocks.
Alternatively, it should be understood that Cipolletti and Engh are known references in the art that teach a means for connecting two structures of a knee replacement system (abstract, paragraphs [0030 – 0035], and Figs. 1 – 4 – Cipolletti ; abstract, col. 7 lines 7 – 30, and Fig. 7 – Engh); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one connection means for another (i.e., the interlocking features for an adhesive), and the results of the substitution would have been predictable and resulted in the modified augmented blocks of Cipolletti being able to function as intended to couple to each other. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lin et al (US 2015/0238316 A1), Green, II et al (US 2022/0168111 A1), and Burkinshaw (US 6,214,052 B1) teach knee replacement systems with modular spacers.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew Restaino/Primary Examiner, Art Unit 3771