DETAILED ACTION
The following is a non-final office action is response to communications received on 01/09/2023. Claims 133-151 are currently pending and addressed below.
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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the gap between the side of the main body of the intermediate at the first composite region facing the substrate and the substrate constitutes a pocket structure formed by the intermediate and the substrate, with the gap being greater than the gap between the side of the main body of the intermediate at the second composite region facing the substrate and the substrate; and there is no porous surface structure at the gap 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 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 134, 136, 137, 139-147 & 149-152 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.
Claims 134, 145 & 150 recites the limitation "the main body" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 134, 145 & 150 recites the limitation "the gap" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claims 134, 145 & 150 recites the limitation "the side" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claims 136, 146 & 151 recites the limitation "said main body" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 136, 146 & 151 recites the limitation "the bumps" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 139 recites the limitation "said first polar electrode" in 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 142 recites the limitation "the power supply" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 149 recites the limitation "the femoral stem" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 149 recites the limitation "the hip joint” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 149 recites the limitation "the acetabular cup" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 149 recites the limitation "the internal cup body" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 149 recites the limitation "tibial component" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 149 recites the limitation "the tibial tray" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 149 recites the limitation "the distal surface of the tibial tray" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 149 recites the limitation "the connection" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 149 recites the limitation "the femoral condyles" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 149 recites the limitation "the knee joint" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 149 recites the limitation "the main structure" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 149 recites the limitation "the internal fixation surface" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim.
Claim 142 is indefinite as it is unclear what the limitation “in lateral clearance-fit (clearance no less than zero)” is intended to mean. It would appear that a clearance must have some inherent distance, and therefore be greater than zero.
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) 133, 135 & 139 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rostoker et al. (US 4,829,152).
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Regarding Claim 133, Rostoker teaches a connected structure (Fig 29) of a porous surface structure (16) and a substrate (20), comprising: a pre-connected or integrally formed composite body (14 & 16) of a porous surface structure (16) and an intermediate (14): and a substrate (20), which is connected to the said intermediate and/or the said porous surface structure to achieve the connection of the said composite body to the said substrate (Fig 29): said composite body comprising a first composite region (14) corresponding to a first stiffness: a remaining composite region (16) in the composite body other than the first composite region, which at least contains a second composite region (16) corresponding to a second stiffness (resulting from the porous material densified due to the impregnation of material to a near zero porosity as taught in Col 19: lines 42-44), and the first stiffness is less than the second stiffness .
Regarding Claim 135, Rostoker teaches wherein said porous surface structure in the said composite is called a first porous structure (16); said intermediate is a solid structure, or a second porous structure (14) and at least a portion of said second porous structure has a higher solid volume fraction than said first porous structure (porous material densified due to the impregnation of material to a near zero porosity as taught in Col 19: lines 42-44),
Regarding Claim 139, as best understood (see 112 rejection supra), Rostoker teaches a method for preparing a connected structure of a porous surface structure and a substrate as described in Claim 133, comprising: forming a composite by pre-connecting the porous surface structure (16) to an intermediate (14) or integrally forming the composite; bringing said intermediate and/or said porous surface structure into contact with the substrate (20); bringing a first polar electrode (91 near top of figure) into conductive contact with said porous surface structure (Fig 29) and/or intermediate of said composite and bringing said substrate (20) into conductive contact with a second polar electrode (91 near bottom of figure), thereby forming a current circuit; said composite body comprising a first composite region corresponding to a first stiffness (as taught in rejection claim 133); a remaining composite region in the composite body other than the first composite region, which at least contains a second composite region corresponding to a second stiffness; and the first stiffness is less than the second stiffness (as taught in the rejection of claim 133); the first composite region (14) and the second composite region (16) of said composite body are resistance welded to said substrate (Col 21: lines 13-19), respectively, to achieve the connection of the composite body to the substrate.
Claim(s) 133, 136-138, 148 & 149 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shetty et al. (US 5,198,308).
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Regarding Claim 133, Shetty teaches a connected structure of a porous surface structure and a substrate (Fig 3), comprising: a pre-connected or integrally formed composite body (134 & 130) of a porous surface structure (fiber pad 24) and an intermediate (134); and a substrate (112), which is connected to the said intermediate and/or the said porous surface structure to achieve the connection of the said composite body to the said substrate (Fig 3); said composite body comprising a first composite region (114) corresponding to a first stiffness: a remaining composite region (134) in the composite body other than the first composite region (114), which at least contains a second composite region (134) corresponding to a second stiffness: and the first stiffness is less than the second stiffness. Note: Col 3: lines 25-44 teaches a porous fiber pad (24) with a lower stiffness, and a solid layer (130/134) with a second stiffness. As both materials/structures are constructed from the same material, the porous and non-porous structure would have inherently different stiffnesses.
Regarding Claim 136, as best understood (see 112 rejection supra), Shetty teaches wherein said substrate (112) comprises a surface attachment layer (130), said surface attachment layer being pre-connected or integrally formed with the main body of the substrate (Fig 3), said surface attachment layer (130) being located between a main body of the intermediate (134) of the composite and the main body of the substrate (112).
Regarding Claim 137, Shetty teaches wherein the said main body of the intermediate (134) has one of a flat surface (Fig 3) proximal to the said substrate (112), or raised structures on the surface proximal to said substrate staggered relative to the raised structures on the surface attachment layer of the said substrate.
Regarding Claim 138, Shetty teaches wherein said substrate is connected with said intermediate and/or said porous surface structure with laser welding and/or resistance welding (Blocks 44 & 46 of Figure 4).
Regarding Claim 148, Shetty teaches a prosthesis (Fig 1), including a connected structure as in Claim 133, wherein the substrate (112) forms a prosthetic body, at least a portion of the surface of said prosthetic body serving as an area for connecting to said composite body (128), said intermediate and/or porous surface structure being connected to said connection area of the said prosthetic body such that said porous surface structure is located in said connection area of the said prosthetic body (Fig 1).
Regarding Claim 149, as best understood (see 112 rejection supra), Shetty teaches wherein said prosthesis includes femoral condyles of the knee joint (Fig 1).
Allowable Subject Matter
Claims 140, 141, 143, 144, 147 & 152 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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