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 .
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 the 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/16/26 has been entered.
Accordingly, claim 1 is amended, claims 6-8, 13-20 are withdrawn.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 11-12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by SBAIZ et al. (US 20180296356 A1).
SBAIZ discloses a Patient-Specific Instrument {PSI} system for shoulder arthroplasty (Fig 1-6; para [0954}-(G080h para [6082] further teaches the customized scapular-anchor uses CT to conform to the scapular anatomy of a single patient), the system comprising: at least one shoulder PSI (1: Fig 1-6; para (0054) Including a main body contoured to conform to a surface of a bone in-a shoulder of a patient (2; Fig 1; para [0054]; glenoid support 2 is taught to be positioned at the glenoid of the patient and is further taught to be ; customized to match the anatomy of the anatomic modal of Fig 5-8, para [0066] and is considered to conform to the outer glenoid surface or the patient's scapula) and at least one contact support element contoured to conform to at least one corresponding contact surface of the bone in the shoulder (7, 8 collectively; Fig’ 1-6; para (0076): projections 7 and 8 are taught to have shapes that are customized for any patient and adapting to the specific anatomy and are considered to conform to the coracoid process 52 and the acromial process 53, respectively), wherein the contouring of the main body and the at least one contact support element is operable to provide an indication of a mispositioning of the at least one shoulder PSI relative to the bone in the shoulder (Fig 1-8: para [0066}-(0073); wherein the at least one shoulder PSI comprises at least one protrusion 100, fig. 10, and 200, fig. 11 that extends from the main body and away from the surface of the bone in the shoulder of the patient, when the at least one shoulder PSI is located on the surface of the bone in the shoulder of the patient figs 10-11,
Since it is known in the art that the prothesis can be exchanged or replaced, wherein the site of www.bing.com/search?q=reasons+of+replacing+or+exchanging+prosthesis&FORM=AWRE explains the decision to replace or exchange a prosthesis is influenced by various factors, including the type of prosthesis, the individual's lifestyle, and the device's condition. Here are
some key reasons for considering a replacement or exchange:
Significant Changes in Weight.
Visible Wear and Tear.
Changes in Activity Level.
Persistent Discomfort or Pain.
Therefore, for any of the above reasons, the at least one shoulder PSI is capable of being intra-operatively positionable on the bone in the shoulder of the patient for modification of the bone of the shoulder prior to implantation of a shoulder prosthesis during the shoulder arthroplasty, and wherein the at least one shoulder PSI is capable of being intra-operatively removable from and replaceable with the shoulder prosthesis after modification of the bone of the shoulder of the patient.
wherein when the system of figs 10 and 11 are assembled, the at least one protrusion 100, 200 will be located only on an exterior and outward facing surface of the at least one shoulder PSI.
the customized surfaces of the anchor 1 designed to conform to a specific patient's anatomy are reasonably considered to provide an indication that the anchor 1 is mispositioned relative to the scapula of the patient - for example, the projection 7 and 6 are specifically designed to conform to coracoid and acromial processes, respectively, wherein the misalignment of the projections 7 and 6 with the coracoid and acromial processes: 62 and 53 provides an indication that the anchor 1 is mispositioned relative to the scapula of the patient); As per claim 2, Lima teaches the system of claim 7, wherein the bone in the shoulder of the patient is a native scapula (Fig 1-6; para (0054), wherein the at least one shoulder PS) comprises. a glenoid PSI (1; Fig 1-6; para [0054)), wherein the main. body includes a main glenoid boy contoured to conform to a glenoid surface of a glenoid of the scapula (2: Fig 1; para (0054); glenoid support 2 is taught to. be positioned at the glenoid of the patient and is further taught to be customized to match the anatomy of the anatomic model of Fig 5-9, para [0966] and is considered to conform to the outer glenoid surface or the patient's scapula}, wherein the at least one contact support element includes at least one contact leg contoured to conform to at least one corresponding contact surface of the scapula (7,8 collectively; Fig 4-6; para [6076]: projections 7 and 8 are taught to have shapes that are customized for any patient and adapting to the specific anatomy and are considered to conform to the coracoid process 52 and the acromial process 53, respectively), and wherein the contouring of the main glenoid body and the at least one contact leg is operable 16 provide an indication of a mispositioning of the glenoid PSI relative to the scapula (Fig 1-9; para [9066}-[0076]; the customized surfaces of the anchor 1 designed to conform to a specific patient's anatomy are reasonably considered to provide an Indication that the anchor 1 is mispositioned relative to the scapula of the patient - for example, the projections 7 and 8 are specifically designed to conform to coracoid and acromial processes, respectively, wherein the misalignment of the projections 7 and 8 with the coracoid and acromial processes 52 and 53 provides an indication that the anchor 1 is mispositioned relative to the scapula of the patient), wherein the glenoid PSI includes at least one scapula contact leg configured to : conform to at least one scapula contact surface proximate to the glenoid of the scapula (8; Fig 6-8: para [0076]; projection 8 is taught to have-a shape customized to conform to the patient and is reasonably considered to conform to a surface of the acromial process 53 of scapula 50 proximate to the glenoid), wherein the glenoid Includes a coracoid contact lag configured to conform to the coracoid contact surface proximate to a coracoid of the scapula {7; Fig 5-6: para [0076]; prelection 7 is taught to have a shape customized to conform to the patient and is reasonably considered to conform to a surface of the coracoid process 52, considered to be proximate to. another portion of the coracoid of the patient), wherein one or more of contact leg is removable from the glenoid PSI intra-operatively to adapt to any patient-specific tissue configuration {Fig 1-6; para [0073]; the projections 7 and 8 are taught to be assembled with glenoid support 2 in the implantation step to facilitate the surgery and possible future revisions and are considered capable of adapting to patient-specific osseous tissue configurations}, further comprising: at least one protrusion positioned on a contact surface of the at least one shoulder PSI (Fig 1-6; para [G080); the distal surface 3 is shown to have a protrusion extending from the distal surface ’S, in-which pin 3 is shown to contact in. Fig 4), wherein the at least one protrusion extends outward from the contact surface (Fig 4, para (0070}-[0075)).
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.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over SBAIZ in view of DR SHAH MANISH (WO 2020255152 A1).
SBAIZ fails to teach further comprising: a handle coupled to an interior contact surface of the at least one shoulder PSI, wherein the handle extends outward from a contact surface, and wherein the handle is operable to manipulate or adjust the at least one shoulder PSI relative to the bone in the shoulder.
DR SHAH MANISH teaches a similar system (Fig 1-3; pg 18, ln 10- pg 20, ln 6) comprising a handle (SH; Fig 1-3: pg-18, In 10 - pg.20; in6} coupled to an interior contact surface of at least one shoulder implant (Fig 1-3; pg 18, In 16 - pg 20,.ln 6: the glenoid ring handle GH is shown to be threaded at the distal and and connects to the hole for glenoid ring handle HGH, wherein the hole HGH is shown to extend through the entirety of the glenoid ring. and further, the threads of the glenoid handle GH are shown to be similar in length compared to the thickness of the glenoid ring - wherein the coupling of the glenoid handle GH and the hole HGH is couple the handle GH to the bottom surface of the glenoid ring, similar to the surface taught by SBAIZ), wherein the handle extends outward from a contact surface (Fig 1-3: pg 18, In 16- pg 26, In 6), and wherein the handle is operable to manipulate or adjust the at least one shoulder implant relative to a bone in a shoulder (Fig 4-3; pg.18, In 10 - pg 20, In 6; the glenoid handle GH to used to adjust the glenoid ring relative to the. glenoid of the scapula of the shoulder, similar io the PSI taught by SBAIZ ), the handle is removable from the interior contact surface of the-at least one shoulder PSI (Fig 1-3: pg 18, In 10-pg 20, In 6: the handle GH is threaded with the hold HGH and to considered to be removable).
It would have been obvious to one of ordinary skill in the art.to have employed the teachings of DR SHAH MANISH with the system taught by SBAIZ, in order to improve implantation of the at least one shoulder PSI.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive.
Applicant argues that “there is no teaching of Sbaiz where the at least one shoulder PSI, or equivalent structural component, is positionable on the bone of the shoulder of the patient prior to the implantation of a shoulder prosthesis, as the anchor 1 is itself the shoulder prosthesis. In addition, Applicant submits there is no contemplated embodiment nor suggestion that the structure of Sbaiz is capable of being removed from the bone of the shoulder, as the anchor 1 is itself the shoulder prosthesis. Specifically, Sbaiz discloses the use of stabilization screws 12 to affix the anchor 1 to the scapula (see e.g., Sbaiz, paragraphs [0077]-[0080]). Applicant submits that Sbaiz does not anticipate using the anchor 1 in an intra-operative capacity that is positionable and removable from the scapula prior to installation of the actual shoulder prosthesis, as the anchor 1 of Sbaiz is itself the shoulder prosthesis.”
In response to applicant's argument that “SBAIZ fails to teach the intra-operative capacity that is positionable and removable from the scapula prior to installation of the actual shoulder prosthesis”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Also, it is known in the art that the prothesis can be exchanged or replaced, (see the following site: www.bing.com/search?q=reasons+of+replacing+or+exchanging+prosthesis&FORM=AWRE) which explains the decision to replace or exchange a prosthesis is influenced by various factors, including the type of prosthesis, the individual's lifestyle, and the device's condition. Here are
some key reasons for considering a replacement or exchange:
Significant Changes in Weight.
Visible Wear and Tear.
Changes in Activity Level.
Persistent Discomfort or Pain.
Therefore, for any of the above reasons, the at least one shoulder PSI is capable of being intra-operatively positionable on the bone in the shoulder of the patient for modification of the bone of the shoulder prior to implantation of a shoulder prosthesis during the shoulder arthroplasty, and wherein the at least one shoulder PSI is capable of being intra-operatively removable from and replaceable with the shoulder prosthesis after modification of the bone of the shoulder of the patient.
Applicant argues that there is no teaching, suggestion, or motivation to modify Sbaiz in view of DR SHAH MANISH.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, It would have been obvious to one of ordinary skill in the art.to have employed the teachings of DR SHAH MANISH with the system taught by SBAIZ, in order to improve implantation of the at least one shoulder PSI.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMEH RAAFAT BOLES whose telephone number is (571)270-5537. The examiner can normally be reached 9-5 pm.
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/SAMEH R BOLES/Primary Examiner, Art Unit 3775