DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 4, 2026 has been entered.
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 1, 3-14, 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 11883040. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1, 3-6, 10-14,16-18 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Lo et al. (U.S. Patent No. 9579106).
Lo et al. discloses a method of pre-operative planning for fabricating a patient-specific template for use in a reverse shoulder implant procedure, the method comprising: using software that contains a scan of a patient's shoulder (Column 4, Lines 50-55); pre-operatively identifying patient-specific anatomy from the scan of the patient's shoulder (Column 4, Lines 50-55); determining at least one of a desired location, inclination, or version/retroversion (Column 5, Lines 4-7); virtually enabling a glenoid base plate to be placed on the scan of the patient's shoulder (Column 5, Lines 25-30); and receiving the patient-specific template based upon the scan of the patient's shoulder and the identified patient-specific anatomy (Figure 28, step 140, after manufacture, it can be construed that the template is received), using the patient-specific template to receive a guide wire at the pre-operatively determined location, inclination, or version/retroversion (Column, Lines 4-24 ) (Claim 6); wherein the patient-specific template is configured to optimize placement of one or more screws through the patient-specific template (Column5, Lines 62-67 and Column 6, Line 1).
Regarding claim 3, the scan is a CT (CAT) scan (Column 4, Line 51).
Regarding claim 4, the scan is an MRI scan (Column 4, Line 51).
Regarding claim 5, the patient-specific template includes an opening to receive a guide, the guide being arranged and configured to receive the guide wire therethrough (Claim 6).
Regarding claim 6, wherein using the patient-specific template comprises: mounting the patient-specific template onto the patient's shoulder; and inserting the guide wire through the patient-specific template and into the patient's shoulder (Claims 3 and 6).
Regarding claim 10, Lo et al. discloses a method of pre-operative planning for fabricating a patient-specific template for use in a reverse shoulder implant procedure, the method comprising: using software that contains a scan of a patient's shoulder including a glenoid cavity of the patient' shoulder (Column 4, Lines 50-55); identifying patient-specific anatomy from the scan of the patient's shoulder (Column 4, Lines 50-55); determining at least one of a desired location, inclination, or version/retroversion (Column, Lines 4-24); virtually enabling a glenoid component of a reverse shoulder implant to be placed on the scan of the patient's shoulder within the glenoid cavity (Column 5, Lines 25-30); and receiving the patient-specific template, which is based upon the scan of the patient's shoulder and the identified patient-specific anatomy (Figure 28, step 140, it is considered that placing an order is simply instructing a process to manufacture); and using the patient-specific template to receive a guide wire at the pre-operatively determined location, inclination, or version/retroversion (Column, Lines 4-24) (Claim 6); wherein the patient-specific template is configured to optimize placement of one or more screws through the patient-specific template (Column5, Lines 62-67 and Column 6, Line 1).
Regarding claim 11, determining the position of the glenoid component is performed virtually on the scan (Column 4, Lines 50-55).
Regarding claim 12, the scan is a CT (CAT) scan (Column 4, Line 51).
Regarding claim 13, the scan is an MRI scan (Column 4, Line 51).
Regarding claim 14, placing the patient-specific template on the scan of the patient's shoulder comprises aligning a center of the patient-specific template with an optical center of the glenoid cavity (Column 5, Lines 55-67), the optical center of the glenoid cavity corresponds with an intersection of a superior-inferior axis and an anterior-posterior axis (Figure 30).
Regarding claim 16, the patient-specific template includes an opening to receive a guide, the guide being arranged and configured to receive the guide wire therethrough (Claim 6).
Regarding claim 17, the method further comprising: mounting the fabricated patient-specific template onto the glenoid cavity of the patient's shoulder, inserting the guide wire into the glenoid cavity; and inserting at least one instrument over the guide wire to prepare the glenoid cavity for receiving the glenoid component (Claims 3 and 6).
Regarding claim 18, the at least one instrument is a drill configured to drill a hole in the glenoid cavity to receive a post of the glenoid component (Column 6, Lines 9-12).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7-9 and 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lo et al. (U.S. Patent No. 9579106) in view of Rauscher et al. (U.S. Publication No. 2011/0029088).
Regarding claims 7 and 9, Lo et al. discloses the claimed invention except for using the guide wire to drill a hole in the glenoid cavity and also inserting a tool over the guide wire. Rauscher et al. teaches a glenoid alignment tool using a guide wire to drill a hole using a cannulated drill bit to prepare the glenoid surface. It would have been obvious to one skilled in the art at the time the invention was made to use the wire of Lo et al. to drill a hole in the glenoid cavity using a cannulated drill bit slide over the wire in view of Rauscher et al. as such provides a proper alignment for the glenoid preparation.
Regarding claim 9 and 19, it can be construed from Lo et al. and Rauscher that the template and instrument and wire are removed prior to implanting the glenoid implant.
Response to Arguments
In response to Applicant’s argument that Lo fails to disclose the patient-specific template is configured to optimize placement of one or more screws through the patient specific template, the Examiner respectfully disagrees. The limitation does not add an essential step to the method (i.e. does not actually require a screw to be passed through the template) nor does it add structure. The specification is also silent as to what is regarded as the optimal placement of the screws. As such, the limitation is considered functional within the method. The function is not essential to the method and the only structure required is a patient specific template and thus Lo et al. anticipates the limitation by providing the patient specific template. Furthermore, the disclosure of having holes adds more evidence that the structure supports the claimed function. With regard to “optimize” its definition is “to make as perfect, effective, or functional as possible,” (Merriam-webster online). Thus a hole makes passing screws as effective as possible.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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/ANDREW YANG/ Primary Examiner, Art Unit 3775