Detailed Action
This is the first office action on the merits for US application number 19/200,178.
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 of species c), Figs. 11-26, in the reply filed on August 17, 2026 is acknowledged. Applicant indicated that all pending claims read on the elected species. 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)).
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 29/902712, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 29/902712 fails to provide adequate support for at least the screw comprising rhenium of claims 1-14.
Thus, the claims are considered as of May 6, 2024.
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:
As to claims 6 and 7, the specification appears to lack antecedent basis for said transition region “absent threading”. This is a negative limitation, i.e. the claim is requiring that the transition region does not have threading. Negative limitations are not per se improper, but they must be supported by the originally filed disclosure. As provided by MPEP 2173.05(i), any negative limitation or exclusionary proviso must have basis in the original disclosure; if alternative elements are positively recited in the specification, they may be explicitly excluded in the claims; and the mere absence of a positive recitation is not basis for an exclusion. The specification is silent regarding the transition region does not having threading. As noted above, the absence of a positive recitation is not a proper basis of support for a negative limitation. Additionally, since the specification is silent on the matter of the transition region having threading, then the “alternative elements” rationale discussed above in the MPEP is not applicable. Thus, the specification fails to provide proper antecedent basis for the transition region “absent threading”. Examiner suggests cancelling this limitation.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 420 on Fig. 12 and 270 on Figs. 18 and 24.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1-14 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 1 is/are unclear with regards to “awt.%” in line 9 and the intended meaning and scope. Examiner is interpreting this as referring to an alloy that is at least 5% rhenium and suggests amending to clarify.
Claim(s) 2 is/are unclear with regards to “forms a tapered profile of said head portion along a central axis of said head portion” and how the head tapered profile can be reasonably construed to be “along” a central axis of the head portion, i.e. “in a line matching the length or direction of” (https://www.merriam-webster.com/dictionary/along). As shown in at least Applicant’s Fig. 15, the taper defines the periphery and does not appear to be reasonably construed to be central. Examiner is interpreting this as referring to, and suggests amending as, “forms a tapered profile of said head portion
As to claims 12-14, the term “less that a cross-sectional area a similar shaped orthopedic screw formed of stainless steel, cobalt chromium alloy, or titanium alloy; said orthopedic screw has” in each of claims 12-14 is a relative term which renders the claim indefinite. The term “a similar shaped orthopedic screw” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. That is, no details have been provided regarding the “similar shaped orthopedic screw formed of stainless steel, cobalt chromium alloy, or titanium alloy” to enable one to ascertain the scope of claims 12-14. Further, it is unclear if the subsequently recited limitations refer to the screw of line 1 or the screw of lines 3-4. Finally, it appears that the provided limitations regarding strength, corrosion, ion release rate, and hardness are merely a result of the final limitation of the screw being formed of a metal alloy that includes at least 5% rhenium. As this limitation is provided in a claim having mostly clear scope, i.e. claim 1, Examiner is interpreting this as referring to the invention of claim 1 and suggests cancelling claims 12-14.
Claim(s) 3-11 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base 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 of this title, 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.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Epperly (US 2016/0278826) in view of Sluder et al. (US 2019/0357946, hereinafter “Sluder”).
The claimed phrases “formed”, “forms”, or the like are being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 1-14, Epperly discloses an orthopedic screw (18) capable of use with a medical device (Figs. 1A-1C, ¶30); said orthopedic screw is capable of being secured to a screw opening in the medical device (Figs. 1A-1C, ¶30); said orthopedic screw includes a head portion (82) and a body portion (84) that is connected to the bottom of said head portion (Fig. 6, ¶45) and extends downwardly from said head portion (Fig. 6); said head portion includes head threading (86/94, 86/96) on an outer surface of head portion (Figs. 5-8); said body portion includes body threading (88) on an outer surface of said body portion (Figs. 5 and 6-9); one or more of b) a thread length of said body threading is different from a thread length of said head threading (Fig. 6), c) a thread angle of said body threading is different from a thread angle of said head threading (¶45), d) a root depth of said body threading is different from a root depth of said head threading (Fig. 8); said orthopedic screw is at least partially formed of a material (Figs. 5-10). As to claim 2, Epperly discloses that said head portion of said orthopedic screw includes a tapered portion (Figs. 6, 8, and 10, ¶45) that forms a tapered profile of said head portion (Figs. 6, 8, and 10); said head threading is at least partially located on said tapered portion (Figs. 6 and 8); said tapered portion constitutes 20-100% of a longitudinal length of said head portion (Figs. 6, 8, and 10). As to claim 3, Epperly discloses that an angle of taper of said tapered portion is constant along 60-100% of said tapered portion (Figs. 6, 8, and 10, ¶45). As to claims 4 and 5, Epperly discloses that said head threading on said tapered portion also has a tapered profile (Figs. 6 and 8). As to claims 6 and 7, Epperly discloses that said body portion includes a tapered transition region (90, see illustration of Fig. 10, Figs. 6, 8, and 10) that terminates at said head portion (Figs. 6 and 8); said transition region absent threading (Figs. 6 and 8, ¶45). As to claims 8 and 9, Epperly discloses that a bottom portion of said body portion includes a cut face (Figs. 6 and 8); said cut face intersects a portion of said body threading (Figs. 6 and 8) thereby forming a break in said body threading (Figs. 6 and 8). As to claims 10 and 11, Epperly discloses that a top surface of said head portion has a non-circular profile (Fig. 7); said top surface of said head portion includes a plurality of curvilinear regions having different radii (Fig. 7).
Epperly is silent to the material being a metal alloy that includes at least 5 awt.% rhenium.
Sluder teaches a similar orthopedic screw (150) capable of use with a medical device (Figs. 1A, 1B, and 3-5B); said orthopedic screw is capable of being secured to a screw opening in the medical device (Figs. 1A, 1B, and 3-5B); said orthopedic screw includes a head portion (152) and a body portion (154) that is connected to the bottom of said head portion (Fig. 1B) and extends downwardly from said head portion (Fig. 1B); said body portion includes body threading (Fig. 1B) on an outer surface of said body portion (Fig. 1B); said orthopedic screw is at least partially formed of a metal alloy that includes at least 5 awt.% rhenium (¶49 disclosed that the devices disclosed can be made of molybdenum-rhenium alloy that is at least 40 weight percent (wt %) rhenium).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify that the material as disclosed by Epperly is the metal alloy that includes at least 5 awt.% rhenium as taught by Sluder in order to select a known material in bone repair (Epperly Figs. 1A-1C; Sluder Figs. 3-5B) that has superior strength when manufactured with smaller overall dimensions than when manufactured from other materials (Sluder ¶34).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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