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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The limitation “wherein the one or more grooves comprise only the second groove” neither further limits nor includes all of the limitations of claim 1 since claim 1 requires the one or more grooves comprises both the first and second groove. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 1-2, 5-10, 13-14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 11051945 B2 (hereafter --Faccioli--).
Regarding Claim 1, Faccioli discloses an artificial joint stem (1) comprising: a base comprising one or more grooves disposed on a surface (the “surface” is the outside layer of the base and the inside surfaces of the holes (6), as they are one curved two-dimensional locus of points/boundary of a three-dimensional region (see Merriam Webster online for this definition of “surface”)) of the base (see annotated stem, base, and grooves in Figures 1, 2 and 7 below); and a coating film containing a calcium phosphate-based material and an antimicrobial material disposed on a part of the surface of the base (see column 9, lines 38-43, see also column 5 lines 30-33, see also column 4, lines 54-67 denoting that the “filler,” which is antimicrobial and can contain a calcium phosphate material as shown above, can be within the first grooves, which is on a part of the surface of the base, as explained below), wherein among the one or more grooves, a first groove (6) is located in a region where the coating film is disposed (see column 4, lines 54-67 denoting that the “filler,” which is antimicrobial and can contain a calcium phosphate material as shown above, can be within the first grooves), where a second groove (see annotated grooves in Figure 1, 2 and 7 below) is located in a region where the surface of the base is exposed from the coating film (see annotated second groove in Figure 1 below, see also annotated region in Figure 1 below) and a total length of the first groove is smaller than a total length of the second groove (see annotated first and second groove types in Figures 1, 2, and 7 below, in that the second groove is much longer than the circumference of the first groove type (holes)). Regarding the interpretation of the term “surface,” the Examiner is considering the inside surface of the first grooves (holes 6) to be a part of the “surface” as claimed. The term “surface,” being defined as “a curved two-dimensional locus of points (such as the boundary of a three-dimensional region)” (see Merriam Webster online) supports this interpretation as the outer wall and the inside of the first grooves (holes (6)) are continuous and part of a three-dimensional region. Due to the Examiner giving the term “surface” it’s broadest reasonable interpretation under the above definition, the limitation “a coating film containing a calcium phosphate-based material and an antimicrobial material disposed on a part of the surface of the base” is therefore met by this definition of “surface” as the reference discloses that the coating can be within the holes (6) (first grooves) (see also column 4, lines 54-67), and therefore is on a part of the surface, since the surfaces on the inside of the holes (6) (first grooves) are considered to be a part of the surface as claimed.
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Regarding Claim 2, Faccioli discloses the artificial joint stem according to claim 1, wherein the first groove is connected to the second groove (see annotated grooves in Figures 1, 2, and 7 above, being connected through body of the implant).
Regarding Claim 5, Faccioli discloses the artificial joint stem according to claim 1, wherein the one or more grooves comprise a plurality of first grooves (see annotated plurality of first grooves (holes 6) Figures 1, 2, and 7 above).
Regarding Claim 6, Faccioli discloses the artificial joint stem according to claim 1, wherein the first groove has a component along a width direction of the base (see annotated components in Figure 6 below). As the groove is a part of the body of the base, the sides of the groove read as a “component” along the base.
Regarding Claim 7, Faccioli discloses the artificial joint stem according to claim 6, wherein in the first groove, a component along the width direction of the base is smaller than a component along a direction orthogonal to the width direction (see annotated components in Figure 6 below).
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Regarding Claim 8, Faccioli discloses the artificial joint stem according to claim 1, wherein the first groove comprises a plurality of linear portions (see annotated linear portions in Figure 6 above). The linear portions of the first groove can include a straight line on the inside of the groove, and can include the surface on the outside edge of the groove on the outer surface of the base.
Regarding Claim 9, Faccioli discloses the artificial joint stem according to claim 8, wherein the plurality of linear portions intersect each other at a right angle (see annotated linear portions and right angle in Figures 6 above).
Regarding Claim 10, Faccioli discloses the artificial joint stem according to claim 6, wherein in the second groove, a component along the width direction of the base is smaller than a component along a direction orthogonal to the width direction (see annotated components in Figures 1, 2, and 7 above).
Regarding Claim 13, Faccioli discloses the artificial joint stem according to claim 1, wherein among the surface of the base, an area of a region where the coating film is disposed is greater than an area of a region where the surface of the base is exposed from the coating film (see annotated regions in Figure 3 below). The inside surface of the grooves (holes, 6) as explained above in the claim 1 rejection, are being considered to be a part of the claimed surface. Since the coating is said to be within the holes/grooves, and “a region” can be defined as any part of any section of the base surface, the selected regions fit the limitation as claimed.
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Regarding Claim 14, Faccioli discloses the artificial joint stem according to claim 6, wherein within the surface of the base, a length along an orthogonal direction orthogonal to the width direction of the base in the region where the coating film is disposed, is smaller than a length along the orthogonal direction in the region where the surface of the base is exposed from the coating film (see annotated “lengths” in Figures 3 and 7 below). The length of a first groove from the inner wall to the outer wall, where the coating is disposed on, can be smaller than a defined “length” on the base where the base is exposed from the coating. Due to the term “regions” being subjective, a “length” in any “region” can be shorter than any “length” along another region.
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Regarding Claim 16, Faccioli discloses an artificial joint stem comprising: a base comprising one or more recesses disposed on a surface (the “surface” is the outside layer of the base and the inside surfaces of the holes (6), as they are one curved two-dimensional locus of points/ boundary of a three-dimensional region (see Merriam Webster online for this definition of “surface”)) of the base (see annotated stem, base, and recesses in Figure 1 below); and a coating film containing a calcium phosphate-based material and an antimicrobial material disposed on a part of the surface of the base (see column 9, lines 38-43, see also column 5 lines 30-33, see also column 4, lines 54-67 denoting that the “filler,” which is antimicrobial and can contain a calcium phosphate material as shown above, can be within the first grooves, which is on a part of the surface of the base, as explained below), wherein a first recess is located in a region where the coating film is disposed (see column 4, lines 54-67 denoting that the “filler,” which is antimicrobial and can contain a calcium phosphate material as shown above, can be within the holes (first recesses)), is a second recess is located in a region where the surface of the base is exposed from the coating film (see annotated second recess being on the outer wall in Figure 1 below), and a total opening area of the first recess is smaller than a total opening area of the second recess (see annotated total opening areas of first and second recesses in Figure 1 below). Regarding the interpretation of the term “surface,” the Examiner is considering the inside surface of the first grooves (holes 6) to be a part of the “surface” as claimed. The term “surface,” being defined as “a curved two-dimensional locus of points (such as the boundary of a three-dimensional region)” (see Merriam Webster online) supports this interpretation as the outer wall and the inside of the first grooves (holes (6)) are continuous and part of a three-dimensional region. Due to the Examiner giving the term “surface” it’s broadest reasonable interpretation under the above definition, the limitation “a coating film containing a calcium phosphate-based material and an antimicrobial material disposed on a part of the surface of the base” is therefore met by this definition of “surface” as the reference discloses that the coating can be within the holes (6) (first grooves) (see also column 4, lines 54-67), and therefore is on a part of the surface, since the surfaces on the inside of the holes (6) (first grooves) are considered to be a part of the surface as claimed.
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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 1-9, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 4795472 A (hereafter -- Crowninshield --), in view of US 11051945 B2 (hereafter --Faccioli--).
Regarding Claim 1, Crowninshield discloses an artificial joint stem comprising: a base comprising one or more grooves disposed on a surface of the base (see annotated base and grooves in Figure 2 below); and a coating film (30), wherein among the one or more grooves a first groove (see annotated first groove in Figures 2 and 3 below, see also column 3, lines 45-52) is located in a region where the coating film is disposed (see annotated coating 30 in Figure 3 below, see also column 3, lines 49-52, see also column 4, lines 8-12), where a second groove (see annotated second groove in Figure 2 below, being the portion of the groove 15 that is a part of the uncoated portion of the stem) is located in a region where the surface of the base is exposed from the coating film (see also column 4, lines 8-12, see also column 4, lines 29-32), and a total length of the first groove is smaller than a total length of the second groove (see annotated first and second grooves in Figures 2 and 3 below, in which one “first groove” is very small in comparison to the second groove).
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Crowninshield fails to disclose a coating film containing a calcium phosphate-based material and an antimicrobial material.
Faccioli discloses an artificial joint stem (1) comprising: a base comprising one or more grooves disposed on a surface of the base (see annotated stem, base, and grooves in Figures 1, 2 and 7 below); wherein among the one or more grooves, a first groove (6) is located in a region where the coating film is disposed (see column 4, lines 54-67 denoting that the “filler,” which is antimicrobial and can contain a calcium phosphate material as shown above, can be within the first grooves), where a second groove (see annotated grooves in Figure 1, 2 and 7 below) is located in a region where the surface of the base is exposed from the coating film (see annotated region in Figure 1 below) and a total length of the first groove is smaller than a total length of the second groove (see annotated first and second groove types in Figures 1, 2, and 7 below, in that the second groove is much longer than the circumference of the first groove type (holes)). Faccioli teaches having a coating film containing a calcium phosphate-based material and an antimicrobial material disposed on a part of the surface of the base (see column 9, lines 38-43, see also column 5 lines 30-33, see also column 4, lines 54-67 denoting that the “filler,” which is antimicrobial and can contain a calcium phosphate material as shown above, can be within the first grooves, which is on a part of the surface of the base).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the coating film of Walter to have an antimicrobial material and calcium phosphate, as taught by Faccioli, as by doing so would oppose an infection underway in the implant zone of the prosthetic device, as well as would be beneficial to the surrounding tissue in which the bone implant comes into contact (see column 7, lines 7-9 and lines 23-28).
Regarding Claim 2, Crowninshield as modified discloses the artificial joint stem according to claim 1, wherein the first groove is connected to the second groove (see annotated grooves in Figures 2 and 3 above, being connected through body of the implant).
Regarding Claim 3, Crowninshield as modified discloses the artificial joint stem according to claim 1, a depth of the first groove is smaller than a depth of the second groove (see annotated depths of first and second grooves in Figure 4 above).
Regarding Claim 4, Crowninshield as modified discloses the artificial joint stem according to claim 1, wherein a width of the first groove is smaller than a width of the second groove (see annotated widths of the first and second grooves in Figure 4 above).
Regarding Claim 5, Crowninshield as modified discloses the artificial joint stem according to claim 1, wherein the one or more grooves comprise a plurality of first grooves (see annotated first grooves in Figures 2 and 3 above, see also column 3, lines 45-52).
Regarding Claim 6, Crowninshield as modified discloses the artificial joint stem according to claim 1, wherein the first groove has a component along a width direction of the base (see annotated width component in Figure 3 above). As the groove is a part of the body of the base, the sides of the groove read as a “component” along the base.
Regarding Claim 7, Crowninshield as modified discloses the artificial joint stem according to claim 6, wherein in the first groove, a component along the width direction of the base is smaller than a component along a direction orthogonal to the width direction (see annotated components in Figure 3 above).
Regarding Claim 8, Crowninshield as modified discloses the artificial joint stem according to claim 1, wherein the first groove comprises a plurality of linear portions (see annotated linear portions in Figure 3 below).
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Regarding Claim 9, Crowninshield as modified discloses the artificial joint stem according to claim 8, wherein the plurality of linear portions intersect each other at a right angle (see annotated linear portions and right angle in Figure 3 above).
Regarding Claim 12, Crowninshield as modified discloses the artificial joint stem according to claim 1, wherein at least one of the one or more grooves comprises one end portion and another end portion in a width direction of the respective groove, and a depth at the one end portion is smaller than a depth at the other end portion (see annotated end portions in Figure 3 above).
Regarding Claim 15, Crowninshield as modified discloses the artificial joint stem according to claim 1, wherein the base comprises a rough surface (40) located on the surface (see column 3, lines 33-35)and only the first groove (41) is located on the rough surface (see annotated first groove 41 in Figures 2 and 3 above, see also column 3, lines 33-42, see also column 3, lines 43-52, in terms of the second groove not being in the rough surface: see annotated second groove in Figure 2 above, being a groove on the non-textured portion of the implant, see also column 4, lines 29-32, see also column 4, lines 27-29).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5007931 A: This reference discloses an artificial joint stem with grooves and a rough surface.
US 20120010722 A1: This reference discloses an artificial joint stem with grooves and a rough surface.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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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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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774