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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-20 is/are pending. Claim(s) 6 and 13-20 is/are withdrawn.
Election/Restrictions
Applicant’s election of Group I and Species 1-2 in the reply filed on 3/16/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 6 and 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-III and Species 1-1, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/16/2026.
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 7-8 and 10-11 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.
Claims 7-8 each recites “the plurality of perforations”. It is unclear which plurality of perforations is being referred back to, that in claim 1 (for the head) or that in claim 3 (for the stem). For purposes of examination the Examiner considers this language to be met when either plurality meets the claimed requirements.
Claims 10-11 recites “LCE” and “the LCE cap”. It is unclear what limitation is being claimed as the “LCE” abbreviation is not introduced in claim 10 or earlier in the claim chain. For purposes of examination the Examiner considers this language to represent the liquid-crystalline elastomer introduced in claim 1. The Examiner suggests introducing the abbreviation with the first instance of this feature in the claims.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Shaha
Shaha RK, Merkel DR, Anderson MP, Devereaux EJ, Patel RR, Torbati AH, Willett N, Yakacki CM, Frick CP. Biocompatible liquid-crystal elastomers mimic the intervertebral disc. J Mech Behav Biomed Mater. 2020 Jul;107:103757. doi: 10.1016/j.jmbbm.2020.103757. Epub 2020 Mar 30. PMID: 32276188
Claim(s) 1-3, 5, 8, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz, et al (Schwartz) (US 2013/0184820 A1) in view of Shaha.
Regarding Claim 1, Schwartz teaches a device for a metatarsophalangeal (MTP) joint (e.g. embodiment of Figures 54-59), the device comprising:
a stem (e.g. Figure 55, #488);
a head (e.g. Figure 55, #470) located at a proximal end of the stem (e.g. Figure 55, where the end with the head is considered proximal) and comprising a plurality of perforations formed through the head (e.g. Figure 55, #s 476),
and a cap formed over the head (e.g. Figure 54, #406) made of a material (e.g. [0149], [0095])
Schwartz discloses the invention substantially as claimed but fails to teach the material is a liquid-crystalline elastomer.
Shaha teaches a liquid-crystalline elastomer used as an orthopedic material (e.g. abstract) that provides a material that is able to provide load-bearing in biomedical systems (e.g. abstract) and match that of orthopedic applications (e.g. abstract).
Schwartz is concerned with the same field of endeavor as the claimed invention, namely bone implants with stems, heads, and caps.
Shaha is concerned with the same field of endeavor as the claimed invention, namely liquid-crystalline elastomers used in orthopedic implants.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schwartz such that the cap material is the liquid-crystalline elastomer as taught by Shaha as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of Here, the substituted elements function is known as discussed supra. Specifically, Shaha teaches liquid crystalline elastomer materials that are able to be modified “to mimic the mechanical function of biological tissue” (e.g. Shaha, abstract).
Regarding Claim 2, the head includes an inner portion having a greater thickness than an outer portion (e.g. Schwartz, Figure 55, the portion of the head at the radially outer section #472 is axially thinner than the radially inner section having #478).
Regarding Claim 3, there is a plurality of perforations formed through the stem (e.g. Schwartz, Figure 55, #s 484).
Regarding Claim 5, the stem comprises a radially extending prong (e.g. Schwartz, Figure 55, #s 482).
Regarding Claim 8, the plurality of perforations includes perforations of at least two different diameters (e.g. Schwartz, Figure 55, the perforations in the head are of a different size than those in the stem).
Regarding Claim 10, the head comprises an island around which LCE of the LCE cap may cure to secure the LCE cap to the head (e.g. Schwartz, Figures 54-55; the portion shown in Figure 55 over which the cap in Figure 54 is placed).
Regarding Claim 11, the LCE cap is formed over a lip of the head (e.g. Schwartz, Figures 54-55; the portion shown in Figure 55 over which the cap in Figure 54 is placed).
Regarding Claim 12, the stem is tapered at a distal end (e.g. Schwartz, Figure 55, where toward the bottom in the figure is considered distal).
Claim(s) 4, 7, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz, et al (Schwartz) (US 2013/0184820 A1) in view of Shaha as discussed supra and further in view of Dreyfuss (US 2010/0191340 A1).
Regarding Claim 4, Schwartz and Shaha discloses the invention substantially as claimed but fails to teach the stem comprises a threaded surface.
Dreyfuss teaches an implant having a stem and a head where the stem has a threaded surface and a countersunk threaded bore (e.g. Figures 2, 3(a)-3(d)).
Dreyfuss is concerned with the same field of endeavor as the claimed invention, namely bone implants with stems, heads, and caps.
Schwartz is concerned with the same field of endeavor as the claimed invention, namely bone implants with stems, heads, and caps.
Shaha is concerned with the same field of endeavor as the claimed invention, namely liquid-crystalline elastomers used in orthopedic implants.
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 combination of Schwartz and Shaha such that the stem has a threaded surface and a countersunk threaded bore as taught by Dreyfuss in order to provide lateral fixation with the bone via the outer threads (e.g. Dreyfuss, [0034]) and in order to provide a means for replacing part of the implant as needed for the internal cannulation (e.g. Dreyfuss, [0033]).
Regarding Claim 7, at least one perforation of the plurality of perforations is inline with a hollow of the stem (the central bore as discussed supra for claim 4).
Regarding Claim 9, the head includes a countersunk bore that is axially aligned with a bore of the stem (discussed supra for claim 4).
Relevant Prior Art
Volpe RH, Mistry D, Patel VV, Patel RR, Yakacki CM. Dynamically Crystalizing Liquid-Crystal Elastomers for an Expandable Endplate-Conforming Interbody Fusion Cage. Adv Healthc Mater. 2020 Jan;9(1):e1901136. doi: 10.1002/adhm.201901136. Epub 2019 Dec 5. PMID: 31805223.
Volpe teaches liquid crystalline elastomer material used to make a spinal fusion cage (e.g. abstract).
US 2004/0230315 A1 to Ek teaches a bone implant having a stem, a head, and a cap (e.g. abstract, Figures 2-3).
US 2020/0078185 A1 to Marks et al teaches a bone implant with a stem, a head, and a cap (e.g. abstract, Figures 3-12).
US 2003/0225456 A1 to Ek teaches a bone implant having a stem and a head (e.g. Figures 1-3).
US 2008/0249577 A1 to Dreyfuss teaches a bone implant having a stem and a head (e.g. Figures 5-6).
US 2011/0257753 to Gordon, et al teaches a bone implant having a stem and a head (e.g. Figures 8C, 10A, 10C).
US 6,575,986 B2 to Overaker teaches a bone implant having a stem, a head, and openings (e.g. Figures 1-2).
US 2012/0172880 to Dee teaches a bone implant having a stem, a head, openings, and threads (e.g. Figures 2-3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 4/14/2026
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