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 .
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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the curved longitudinal axis, the beams, the intervening hollowed spaces, laterally opposed internal surfaces, longitudinally opposed internal surfaces, and the channel for removal of unfused alloy powder must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 Objections
Claim 1 is objected to because of the following informalities: In line 5 “the proximal region outer shell” is assumed to be a typo. The examiner suggests amending this to be “the proximal region of the stem” and has been examined as such. Appropriate correction is required.
Claims 3 and 4 are objected to because of the following informalities: In line 1 “the selective hollowing comprises” is assumed to be a typo. The examiner suggests amending this to be “the selectively hollowed proximal region comprises” and has been examined as such. Appropriate correction is required.
Claims 7 and 8 are objected to because of the following informalities: In line 2 of claim 7 and line 1 of claim 8 “the central spine” is assumed to be a typo. The examiner suggests amending this to be “the curved central spine” and has been examined as such. Appropriate correction is required.
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 2 is 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 2 recites the limitation "selectively hollowed spaces" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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)(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.
Claims 1-3, 11-14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sommerich (US Patent No. 5,725,586).
Regarding claim 1, Sommerich discloses a femoral stem device (Fig. 2, prosthesis 100) comprising, a stem (Fig. 2, stem 110) and a neck (Fig. 2, neck 14), wherein the stem (110) comprises an outer shell (Col. 5, lines 30-35), wherein the stem (110) comprises a proximal region (Fig. 2, 110a) and a distal region (Fig. 2, 110b), wherein an interior of the proximal region (110a) is selectively hollowed (Fig. 2, hollow 36), wherein a loading of the device comprises deforming (Col. 5, lines 30-45, the stem is a “bendable shaft”, Col. 6, lines 15-22) laterally disposed walls (Fig. 2a, inner wall 44, outer wall 40) of the proximal region of the stem (Col. 5, line 29).
Regarding claim 2, Sommerich discloses wherein the deforming (Col. 5, lines 30-45, the stem is a “bendable shaft”, Col. 6, lines 15-22) comprises lateral deformation (Col. 6, lines 17-22, low level of bending stiffness, Fig. 2a, band 32b) of the walls (Fig. 2a, inner wall 44, outer wall 40) adjacent to the selectively hollowed spaces (Fig. 2, hollow 36).
Regarding claim 3, Sommerich discloses wherein the selectively hollowed proximal region (Fig. 2, hollow 36) comprises an entire hollowing (Figs. 2-2A, Col. 6, lines 38-50, hollowing terminates at distal region 110b) of the proximal region interior (110a).
Regarding claim 11, Sommerich discloses wherein the deformation (Col. 2, lines 62-67, Col. 5, lines 30-45, the stem is a “bendable shaft”) transfers at least a portion of the loading (Col. 2, lines 62-67) into a femur (Col. 1, lines 11-14).
Regarding claim 12, Sommerich discloses wherein the walls (Fig. 2a, inner wall 44, outer wall 40) comprise a width of 2 mm (Col. 5, lines 31-32).
Regarding claim 13, Sommerich discloses wherein the stem (Fig. 2, stem 110) is configured for implantation into a femur (Col. 5, line 44).
Regarding claim 14, Sommerich discloses wherein the distal region (Figs. 2 and 2B) of the stem (Fig. 2, stem 110) is solid (Col. 6, lines 44-47).
Regarding claim 16, Sommerich discloses wherein the neck (Fig. 2, neck 14) is configured for attachment to a femoral head (Fig. 2, femoral head 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sommerich (US Patent No. 5,725,586) as applied to claim 1 above, and further in view of Sunavala-Dossabhoy et al. (US PG Pub No. 2019/0110897 A1).
Regarding claim 4, Sommerich fails to disclose wherein the selectively hollowed proximal region (Fig. 2, hollow 36) comprises a partial hollowing of the proximal region interior (Fig. 2, 110a). Sunavala-Dossabhoy also discloses a femoral stem prosthesis (Figs. 14-15, load dissipating arthroplasty prosthesis 2) with a selectively hollowed proximal region (Fig. 15). Sunavala-Dossabhoy teaches wherein the selectively hollowed proximal region (see annotated Fig. 15 below) comprises a partial hollowing (see annotated Fig. 15 below) of the proximal region interior (see annotated Fig. 15 below). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sommerich’s femoral stem device wherein the selective hollowing comprises a partial hollowing of the proximal region interior, as taught by Sunavala-Dossabhoy, in order to provide uniform force dissipation (Paragraph [0036]).
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Regarding claim 5, Sommerich as modified by Sunavala-Dossabhoy discloses wherein the partial hollowing (see annotated Fig. 15 above) provides a curved central spine (Fig. 15, shaft 16).
Regarding claim 6, Sommerich as modified by Sunavala-Dossabhoy discloses wherein the curved central spine (see annotated Fig. 15 above) is aligned with a curved longitudinal axis (see annotated Fig. 15 above) of the stem proximal region (see annotated Fig. 15 above).
Regarding claim 7, Sommerich as modified by Sunavala-Dossabhoy discloses wherein the partial hollowing (see annotated Fig. 15 above) comprises beams (Fig. 15, shock absorber 8) laterally extending from the curved central spine (Fig. 15, shaft 16).
Regarding claim 8, Sommerich as modified by Sunavala-Dossabhoy discloses wherein the curved central spine (16) and beams (8) define a series of intervening hollowed spaces (see annotated Fig. 15 above).
Regarding claim 9, Sommerich as modified by Sunavala-Dossabhoy discloses wherein the intervening hollowed spaces (see annotated Fig. 15 above) comprise laterally opposed internal surfaces (see annotated Fig. 15 above).
Regarding claim 10, Sommerich as modified by Sunavala-Dossabhoy discloses wherein the intervening hollowed spaces (see annotated Fig. 15 above) comprise longitudinally opposed internal surfaces (see annotated Fig. 15 above).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sommerich (US Patent No. 5,725,586), as applied to claim 14 above, and further in view of Ng (US PG Pub No. 2022/0354656 A1).
Regarding claim 15, Sommerich fails to disclose wherein the solid stem is partially hollowed to provide a channel for removal of unfused alloy powder. Ng also discloses a femoral stem device (Figs. 1-4, stem 100) with a solid distal end (see annotated Fig. 4 below). Ng teaches wherein the solid stem (see annotated Fig. 4 below) is partially hollowed (see annotated Fig. 4 below) to provide a channel (see annotated Fig. 4 below) for removal of excess cement (Paragraphs [0007 and 0029]), thereby capable of removing unfused alloy powder as claimed. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sommerich’s solid stem wherein the solid stem is partially hollowed to provide a channel for removal of unfused alloy powder, as taught by Ng, in order to facilitate easier cleaning after implantation (Paragraphs [0028, 0029, and 0031].
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Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Sommerich (US Patent No. 5,725,586) as applied to claim 1 above, and further in view of Ren et al. (Foreign Patent No. CN219461541U).
Regarding claim 17, Sommerich fails to disclose wherein the femoral stem device comprises Titanium grade 5 (Ti-6Al-4V). Ren also discloses a femoral stem device (Fig. 1). Ren teaches wherein the femoral stem device (Fig. 1) comprises Titanium grade 5 (Ti-6Al-4V) (Attached translation Paragraph [00066]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sommerich’s femoral stem device wherein the femoral stem device comprises Titanium grade 5 (Ti-6Al-4V), as taught by Ren, in order to ensure the quality of the prosthesis (Attached translation Paragraph [00066]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Xue et al. (US Patent No. 10,278,823 B1) also discloses a femoral stem device (Fig. 3A, femoral stem 300) comprising a stem (Fig. 3A) and a neck (Fig. 3A), and a selectively hollowed proximal region (Fig. 3A, above and below plate 345).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.L.C./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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