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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6 and 11-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Status
Drawing objections are overcome.
Claims 1-6 and 12-22 are examined below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “12” has been used to designate both a non-e and an outer face (page 21). 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. 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 § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-6, 12, 14, 16-19 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vergari (US 2018/0008416 A1) in view of Bergin (US 2007/0118229 A1).
Regarding claim 1, Vergari discloses a bone implant comprising (100, prosthetic element, fig. 1):
a main body (1, central body, fig. 1) comprising a hollow body (2, axial cavity, fig. 1) having a first end (see annotated fig. 1, below) and a second end (see annotated fig. 1, below), the first end and the second end being open in an axial direction (fig. 1) to define a first opening at the first end (see annotated fig. 1, below) and a second opening at the second end (see annotated fig. 1, below), the main body comprising a load-bearing material (¶ [0039]); and
the main body comprising a wall (18, outer surface, fig. 18) defining a first side (see annotated fig. 1, below), a second side opposite the first side (see annotated fig. 1, below), a third side (see annotated fig. 1, below) and a fourth side opposite the third side (see annotated fig. 1, below),
the first side defining a first cutout that (13, notch, fig. 1) is open and contiguous with the first opening at the first end (fig. 1),
the second side defining a second cutout (14, notch, fig. 1) that is also open and contiguous with the first opening at the first end (fig. 1).
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Vergari fails to teach a plurality of protrusions. However, Bergin discloses a bone implant that includes a plurality of shaped bodies which protrude from the main body in a radial direction (912, bone engagement members, fig. 16)and comprise the at least one in vivo degradable/in vivo resorbable material (¶ [0091-0094]) and the plurality of shaped bodies comprising a first group of shaped bodies that protrude radially from the third side (912, bone engagement members, fig. 16) and a second group of shaped bodies that protrude radially from the fourth side (912, bone engagement members, fig. 16). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Vergari to include protrusions as taught by Bergin in order to engage with the bone (¶ [0018], Bergin).
Regarding claim 2, Vergari further discloses the main body has a corner-free cross section (fig. 1).
Regarding claim 3, Vergari further discloses the main body is conical and has an at least sectionally tapering inner diameter (¶ [0023]).
Regarding claim 5, Vergari further discloses the load-bearing material is an in vivo nondegradable/in vivo nonresorbable material (¶ [0006]).
Regarding claim 6, Vergari further discloses the load-bearing material is selected from the group consisting of metals, alloys, ceramics, plastics, and combinations thereof (¶ [0006]).
Regarding claim 12, Vergari further discloses the main body comprises a porous and/or microstructured surface (¶ [0006]).
Regarding claim 14, Vergari fails to teach the at least one in vivo degradable/in vivo resorbable material is selected from the group consisting of polyhydroxyalkanoates, calcium, phosphates and combinations thereof. However, Bergin further discloses the at least one in vivo degradable/in vivo resorbable material is selected from the group consisting of polyhydroxyalkanoates, calcium, phosphates and combinations thereof (¶ [0013], ¶ [0094]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Vergari to include the at least one in vivo degradable/in vivo resorbable material is selected from the group consisting of polyhydroxyalkanoates, calcium, phosphates and combinations thereof as taught by Bergin in order to engage with the bone (¶ [0018], Bergin).
Regarding claim 16, Vergari further discloses the main body has a circular, oval or elliptical cross section (fig. 1).
Regarding claim 17, Vergari further discloses the load-bearing material is selected from the group consisting of titanium, tantalum, titanium alloys, polyetherketones, polyetheretherketone, polyetherketoneketone, polyetheretheretherketone, polyetheretherketoneketone, polyetherketoneetherketoneketone, polyolefins and combinations thereof (¶ [0026]).
Regarding claim 18, Vergari further discloses the main body and/or the plurality of shaped bodies have an open-pored surface (¶ [0006]).
Regarding claim 19, Vergari fails to teach the at least one in vivo degradable/in vivo resorbable material is selected from the group consisting of polylactide, polyglycolide, polycaprolactone, (β-tricalcium phosphate, hydroxyapatite and combinations thereof. However, Bergin further discloses the at least one in vivo degradable/in vivo resorbable material is selected from the group consisting of polylactide, polyglycolide, polycaprolactone, (β-tricalcium phosphate, hydroxyapatite and combinations thereof (¶ [0013], ¶ [0094]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Vergari to include the at least one in vivo degradable/in vivo resorbable material is selected from the group consisting of polylactide, polyglycolide, polycaprolactone, (β-tricalcium phosphate, hydroxyapatite and combinations thereof as taught by Bergin in order to engage with the bone (¶ [0018], Bergin).
Regarding claim 21, Vergari further discloses the first cutout is U- shaped (fig. 1, ¶ [0027]) and the second cutout is U-shaped (fig. 1, ¶ [0027]).
Regarding claim 22, Vergari further discloses the first cutout is diametrically opposite the second cutout (fig. 1, ¶ [0027]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vergari in view of Bergin as applied to claim 1 above, and further in view of Polguj (Morphological study of linea aspera variations).
Regarding claim 4, Vergari in view of Bergin fails to teach the main body has a wall thickness of 1 mm to 30 mm. However, Polguj discloses the largest bone in the body, the femur, has an average diameter of 32.5 mm ± 2.3 mm in females and 33.1 mm ± 1.9 mm in males (Table 1). Therefore, it would have been obvious to try for someone of ordinary skill in the art before the effective filling date of the claimed invention to modify the bone implant of Vergari and Bergin to include the main body has a wall thickness of 1 mm to 30 mm as taught by Polguj in order for the implant to work with the known anatomies of patients.
Claim(s) 13, 15 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vergari in view of Bergin as applied to claim 1 above, and further in view of Biris (WO 2016/057684 A1).
Regarding claim 13, Vergari in view of Bergin fails to teach the in vivo degradable/in vivo resorbable material comprises two materials with different in vivo degradation rates/in vivo resorption rates. However, Biris discloses a biocompatible structures for regeneration of tissue that includes the at least one in vivo degradable/in vivo resorbable material comprises at least two in vivo degradable/in vivo resorbable materials (100, first base structure, 200, second base structure, fig. 1A) which differ from one another with regard to their in vivo degradation rate/in vivo resorption rate (page 37, lines 16-19). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone implant of Vergari and Bergin to include the in vivo degradable/in vivo resorbable material comprises two materials with different in vivo degradation rates/in vivo resorption rates as taught by Biris in order to accommodate regeneration of different tissues (abstract, Biris).
Regarding claim 15, Vergari in view of Bergin fails to teach producing the bone implant by an additive manufacturing process. However, Biris further discloses producing the bone implant by an additive manufacturing process (page 55 line 37 – page 56 line 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone implant of Vergari and Bergin to include producing the bone implant by an additive manufacturing process as taught by Biris in order to make a three-dimensional solid object of virtually any shape (page 55, line 27-28, Biris).
Regarding claim 20, Vergari in view of Bergin fails to teach the at least two in vivo degradable/in vivo resorbable materials are selected from the group consisting of polyhydroxyalkanoates, calcium phosphates and combinations thereof. However, Biris further discloses the at least two in vivo degradable/in vivo resorbable materials are selected from the group consisting of polyhydroxyalkanoates, calcium phosphates and combinations thereof (page 5 line 28- page 6 line 13). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the bone implant of Vergari and Bergin to include the at least two in vivo degradable/in vivo resorbable materials are selected from the group consisting of polyhydroxyalkanoates, calcium phosphates and combinations thereof as taught by Biris in order to accommodate regeneration of different tissues (abstract, Biris).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH C EDWARDS can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774