DETAILED ACTION
The following is a non-final office action is response to communications received on 11/20/2025. Claims 1-13, 15, 18-20, 27, 37 & 44 are currently pending and addressed below. Claims 1-11 & 27 are withdrawn.
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 Group II in the reply filed on 11/20/2025 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)).
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 15, 20, 37, & 44 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 15 states “wherein at least one of the first material property or the second material property includes a surface coating treatment.” It is unclear how one of the first material property or the second material property could include a surface treatment. The material property is inherent to the material and would not itself include a surface treatment. The examiner assumes the applicant intended to state: “wherein at least one of the first material section section
Claims 20 & 44 are similarly Indefinite. Appropriate correction is required.
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 12, 13, 15, 18-20, 37 & 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11-16 & 19 of copending Application No. 18/255,647 (reference application). The elements of the instant application are to be found in the Patent and therefore are anticipated. Although the conflicting claims are not identical, they are not patentably distinct from each other because the Patent and the instant application all recite the same basic structure with a permutation of similar elements throughout.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding Claim 12, application claim 11 also recite a device for repairing a part of a bone in a subject, the device comprising: a first section having a first material property; a second section having a second material property; the first section being connected to the second section forming an asymmetric implant, wherein the first section and the second section are configured to optimize the bone-implant interface.
Regarding Claim 20, application claims 11 & 14 also recite a device for repairing a part of a bone in a subject, the device comprising: a first section having a first material property; a second section having a second material property, the first section being connected to the second section; and wherein at least one of the first material property or the second material property includes a surface coating treatment forming an asymmetric implant configured to optimize the bone-implant interface.
Regarding Claim 13, application claims 12 & 13 recite the same limitations.
Regarding Claim 15, application claims 11, 14 & 15 recite the same limitations.
Regarding Claim 18, application claims 12 & 13 recite the same limitations.
Regarding Claims 19 & 37, application claim 11 recites the same limitations.
Regarding Claim 44, application claim 11 recites the same limitations.
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.
Claim(s) 12, 13, 15, 18-20, 37 & 44 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamilton et al. (US 5,480,449). Please refer to the figure below in consideration of the following rejection:
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Regarding Claim 12, Hamilton teaches a device (10) for repairing a part of a bone in a subject, the device comprising: a first section (14) having a first material property (Col 5: lines 46-61); a second section (13) having a second material property (Col 5: lines 22-45); the first section being connected to the second section forming an asymmetric implant (Fig 2), wherein the first section and the second section are configured to optimize the bone-implant interface (as the stem shape illustrated in Fig 2 mimics the prepared intermedullary cavity).
Regarding Claim 13, Hamilton teaches wherein the first material property includes at least one of elasticity, surface coating treatment, porosity, thickness (Fig 2), or shape, and wherein the second material property includes at least one of elasticity, surface coating treatment, porosity, thickness (Fig 2), or shape.
Regarding Claim 15, as best understood (see 112 rejection supra), Hamilton teaches wherein at least one of the first material property or the second material property includes a surface coating treatment (14) of the device, and wherein the surface coating treatment corresponds to a location of uneven stress distribution (fully capable of as the surface coating is applied along the entire stem), and wherein the surface coating treatment is asymmetric on the surface of the device (Fig 2), and wherein the location of uneven stress distribution of the bone corresponds to a location of reduced bone thickness (fully capable of as the surface coating is applied along the entire stem).
Regarding Claim 18, Hamilton teaches wherein the bone is a humerus and a joint that includes the bone is a shoulder (Col 4: lines 63-64).
Regarding Claims 19 & 37, Hamilton teaches wherein the first section and the second section are configured to reduce stress shielding (Col 3: lines 51-54).
Regarding Claim 20, as best understood (see 112 rejection supra), Hamilton teaches the device as set forth in the rejection of claims 11 & 15.
Regarding Claim 44, as best understood (see 112 rejection supra), Hamilton teaches the device as set forth in the rejection of claims 20 & 37.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774