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 .
Drawings
The drawings are objected to because Fig. 2A, 3A, 6A, 7A, 10A, 11A, 11B, 14A, 15A and 15B contain text which is of insufficient legibility. It is recommended to resubmit these figures with increased font size for better legibility and reproducibility characteristics. 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.
Specification
The disclosure is objected to because of the following informalities:
[0055] “angled section (28)” should be “angled section (26)”
[0055] “curved section (26)” should be “curved section (28)” [two instances]
Appropriate correction is required.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
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. 63/629,712, 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. 63/629,712 does not disclose any units of measurement (metric/imperial) and range values to align with the measurements required in claims 3, 4, 6, 9, 10, 15, 16, 18 and 19. Further, 63/629,712 does disclose deltoid cobra wings as required by claim 12.
Accordingly, the effective filing date of claims 3, 4, 6, 9, 10, 12, 15, 16, 18, 19 is 11/21/2024, and the effective filing date of claims 1, 2, 5, 7, 8, 11, 13, 14, 17, and 20 is 11/21/2023.
Claim Interpretation
The term “approximately” found in claims 3, 4, 6, 7, 9, 10, 15,16, 17 and 18 has been interpreted in light of the broadest range definition found in the specification in paragraph [0047]. Approximate degree measurements will be considered in the range of ±5°, and approximate inch measurements will be considered ±0.05 inches.
Claim Objections
Claim 10 is objected to because of the following informalities: Claim 10, line 2, “1.5 inches” should be “R1.5 inches”. Appropriate correction is required.
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) 1-2, 8, 12-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosa et al. (US Publication No. 2021/0137510 A1).
Regarding Claim 1, Rosa discloses a retractor device (20), comprising: a tip portion (24); an armature portion (26); and a handle portion (22) (Fig. 1) [0028]; wherein the retractor device is configured to provide control of surrounding hard and/or soft tissue of a surgical site [0054].
Regarding Claim 2, the tip portion (24) comprises a leading edge, a top surface, and a bottom surface (see below).
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Regarding Claim 8, the armature portion (26) comprises a straight section, an angled section, and a curved section (see below).
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Regarding Claim 12, the armature portion includes deltoid cobra wings (see below for structure which is fully capable of functioning to engage the deltoid).
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Regarding Claim 13, the retractor device is fully capable of providing control of surrounding hard and/or soft tissue of a surgical site during reverse shoulder replacement surgery [0001] (fig. 12).
Regarding Claim 14, Rosa discloses a retractor device (20), comprising: a tip portion (24); comprising: a leading edge; a top surface; and a bottom surface (see below);
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an armature portion (26), comprising: a straight section; an angled section; and a curved section (see below);
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a handle portion (22), comprising: a flat section (facets on outer hexagonal cross section of handle are flat sections, see Fig. 6); and an optional ring section (ring section is not required by the claim); wherein the retractor device is fully capable of providing control of surrounding hard and/or soft tissue of a surgical site during reverse shoulder replacement surgery [0001] (fig. 12).
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) 6-7, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosa et al. (US Publication NO. 2021/0137510 A1).
Regarding Claims 6-7, 18, Rosa discloses the retractor as described in the rejections of claim 2 and 14 above. Rosa is silent to the top surface comprising an angle ranging between approximately 30-60° or approximately 45°, however Rosa does disclose that the top surface forms an angle α in Fig. 7 and that angle α is in the range of 0-90 degrees [0047].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select an angle within the range disclosed by Rosa in order to effectively contact the glenoid during the shoulder surgery. It would have been obvious to choose both an angle ranging between approximately 30-60° or approximately 45° because this angle directly reflects the shape of the anatomy which the retractor can accommodate. One of ordinary skill in the art would have a reasonable expectation of success to modify the angle of the top surface to be approximately 45° to accommodate anatomy best-fit by said angle.
Claim(s) 5, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosa et al. (US Publication NO. 2021/0137510 A1) in view of Gil et al. (US Patent No. 10,939,939 B1)
Regarding Claims 5 and 17, Rosa discloses the retractor as described in the rejections of claims 2 and 14 above. Rosa is silent to the leading edge and the bottom surface comprise a series of raised ridges or knurls. However, Rosa shows in Fig. 12 that these surfaces operate against the bone/tissue when in use [0043].
Gil discloses a bone engaging surface in the analogous art of bone retractors which has surface features (raised ridges 376 or knurls 370) which help the retractor bite into the bone to inhibit movement of the bone (slipping) relative to the retractor (col. 12; ln. 21-48)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bone contacting surfaces (leading edge and bottom surface) of Rosa with surface features such as ridges or knurls as taught by Gil in order to inhibit slipping of the retractor on the bone.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosa et al. (US Publication NO. 2021/0137510 A1) in view of Shimizu et al. (US Publication No. 2017/0172555 A1).
Regarding Claims 11, Rosa discloses the retractor as described in the rejection of claim 1 above. Rosa is silent to the handle portion (22) comprising a flat section and a ring section, however does discloses that the handle (22) is shaped like the handles commonly used for handpieces and hand tools [0052].
Shimizu discloses a handle shape (910, Fig. 31)in the analogous art of retractors which comprises a flat section and a ring section (see figure below) for the purpose of providing a conventional feeling of a metal made retractor [0162].
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the shape of the handle of Rosa with the shape taught by Shimizu in order to use a known handle shape which will predicably allow for the manual manipulation of the hand-held retractor.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosa et al. (US Publication NO. 2021/0137510 A1) in view of Angibaud et al. (US Publication No. 2012/0209392 A1).
Regarding Claim 20, Rosa discloses a method of using a retractor device in shoulder replacement surgery [0001, 0054-0055], comprising: providing a retractor device (20), comprising: a tip portion (24); comprising: a leading edge; a top surface; and a bottom surface (see below);
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an armature portion (26), comprising: a straight section; an angled section; and a curved section (see below);
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a handle portion (22), comprising: a flat section (facets on outer hexagonal cross section of handle are flat sections, see Fig. 6); and an optional ring section (ring section is not required by the claim);
utilizing the retractor device to provide control of surrounding hard and/or soft tissue of a surgical site during the shoulder surgery [0054-0055] (Fig. 12).
Rosa describes the retractor as useful when reaming the glenoid during the shoulder surgery [0043, 0055]; however, Rosa is silent to the shoulder surgery being a reverse shoulder replacement surgery.
Angibaud discloses reaming the glenoid during a reverse shoulder replacement surgery in the same field of endeavor to prepare the joint for the implant [0066].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the retractor device of Rosa during a reverse shoulder replacement surgery as taught by Angibaud in order to assist in reaming the glenoid.
Claim(s) 3, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosa et al. (US Publication NO. 2021/0137510 A1) in view of Ryshkus et al. (US Publication No. 2015/0173733 A1).
Regarding Claims 3 and 15, Rosa discloses the retractor as described in the rejections of claims 2 and 14 above. Rosa shows he leading edge as curved (Fig. 1 shows the curve between tips 36) and describes the leading edge as gripping the surface of the bone [0043], but is silent to the leading edge comprises a curvature ranging between approximately R.375-R.875 inches.
Ryshkus teaches a bifurcated retractor tip in the analogous art of joint retractor tools which comprises a radius of curvature (424) between the prongs of the tip which ranges from about 5mm to about 25mm (0.2-0.98 inches) [0063] (fig. 15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a radius of curvature within the range of R.375-R.875 inches for the leading edge since Ryshkus teaches this size is suitable for engaging a bony surface for retraction purposes.
Claim(s) 4, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosa et al. (US Publication NO. 2021/0137510 A1).
Regarding Claims 4 and 16, Rosa discloses the retractor as described in the rejections of claims 2 and 14 above. Rosa shows the bottom surface as having a curvature but is silent to the curvature ranging between approximately R.125-R.875 inches.
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Rosa does disclose that the tip can be at a variety of angles relative to the handle [0047] and also that the tip wraps around the glenoid (Fig. 11). The depth of the tip portion (dimension B shown in Fig. 7) is also described as adjustable through a range of 0-30mm (0-1.18 inches) [0049]. Changing the radius of curvature would directly affect how deep or shallow the bend in the bottom surface would be to accommodate the anatomy. It would have been obvious to one having ordinary skill to optimize the radius of curvature of the bottom surface through routine experimentation to best accommodate the anatomy of the patient, a curvature ranging between approximately R.125-R.875 inches would have been obvious to best-fit a glenoid of that size.
Claim(s) 9, 10, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosa et al. (US Publication NO. 2021/0137510 A1).
Regarding Claims 9-10 and 19, Rosa discloses the retractor as described in the rejections of claims 8 and 14 above. Rosa discloses that the curved section has a radius of curvature between 15-30 cm (5.9-11.8 inches) [0043] (fig. 4). Rosa is silent to the curved section comprises a curvature ranging between approximately R1-R3 inches, or approximately R1.5 inches. However, different sized patients would require different sized tools. For pediatric patients, a much smaller tool would be necessary and therefore it would be obvious to reduce the dimensions of the retractor to accommodate such a small patient. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to reduce the radius of curvature of the curved section of the retractor between R1-3 inches or approximately R1.5 inches as a result of routine optimization of the size of the retractor to accommodate a smaller patient. One of ordinary skill would have had a reasonable expectation of success as scaling down the retractor would not change any operation, merely optimize the retractor for use on a smaller patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773