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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 1 recites “a peripheral protrusion”. An embodiment having a single peripheral protrusion is not disclosed in the specification and therefore lacks proper antecedent basis for the claimed subject matter. It is noted that Fig. 14G shows a single protrusion, however, this protrusion is located in the center of the body and is not peripheral.
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 “a peripheral protrusion” recited in claim 1 must be shown or the feature(s) canceled from the claim(s). It is noted that fig. 13G shows a single protrusion, however, this protrusion is located in the center of the body, and is therefore not peripheral. 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
Claims 4, 17 and 18 are objected to because of the following informalities: Claim 4 recites “the protrusion” in lines 1 and 2, which appears to be referring to – the peripheral protrusion –. Claim 17 recites “an other” in line 1, which appears to be a misspelling of the word – another –. Claim 18 recites “trapezoidally shaped side surfaces” in line 2, which appears to be referring to – substantially trapezoidally shaped substantially parallel surfaces”, as recited in claim 12.
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.
Claims 1-20 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 1, 12, and 20 each recite the limitations “configured to be disposed in a joint”, in lines 5-6 and "not being coupled to the one or more bones" in lines 3-4. These limitations are contradictory. It is unclear how the body can be implanted in a joint without being coupled to the bones of the joint. For the purpose of further examination, the examiner interprets the limitation “not being coupled to the one or more bones” as: indirect or “floating” contact, as described in paragraph 0066 of applicant’s specification.
Claims 1, 12, and 20 each recite the limitation “substantially similar radii of curvature” in lines 2-3. A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. The term “substantially similar” renders the claim indefinite because it is unclear from the specification what applicant intends to cover by the recitation of “substantially similar”. See MPEP 2173.05b.
Claim 10 recites the limitation “substantially similar dimensions” in line 1. A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. The term “substantially similar” renders the claim indefinite because it is unclear from the specification what applicant intends to cover by the recitation of “substantially similar”. See MPEP 2173.05b.
Claim 19 recites the limitation “substantially similar and directionally opposite radii of curvature” in lines 1-2. A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. The term “substantially similar” renders the claim indefinite because it is unclear from the specification what applicant intends to cover by the recitation of “substantially similar”. See MPEP 2173.05b.
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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2009/0254190 A1 to Gannoe et al. (Gannoe).
Regarding at least claim 1
Gannoe teaches a carpometacarpal joint replacement system for replacing the trapezium bone in the hand (abstract).
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Gannoe meets the limitations of a device, comprising: a body (200) having a top surface, a bottom surface, and at least two substantially parallel surfaces (sides facing in and out of the page shown in fig. 2), the two substantially parallel surfaces having substantially similar radii of curvature and each of the at least two substantially parallel surfaces being substantially trapezoidally shaped (fig. 2 shows that the two substantially parallel surfaces have substantially similar radii of curvature and are substantially trapezoidally shaped), the top surface having a top radius of curvature and the bottom surface having a bottom radius of curvature (fig. 2 shows the top and bottom surfaces each having a curvature that necessarily has a radius), the body being configured to be disposed in a joint (paragraph 0047 discloses disposing the body of the device in the CMC joint), the top, bottom, and substantially parallel surfaces configured to be in intermittent contact with bone surfaces of one or more bones comprising the joint (paragraph 0049 discloses an opening through the body that couples the implant device via bridging tissue formation and also discloses that the surfaces of the body articulate with adjacent bones, make direct contact with native bone and cartilage and aid and promote the stability of the trapezial implant device within the CMC joint – therefore, the surfaces of the body are configured to be in intermittent contact with the bone surfaces of one or more bones comprising the CMC joint at least to the same extent as applicant’s as described in paragraphs 00269 and 00297, for example), the body not being coupled to the one or more bones (paragraph 0049 discloses that the body is coupled via bridging tissue formation, such as in hematoma distraction arthroplasty or encapsulation – each of these couplings are construed to meet this limitation, particularly in view of the 112 rejection above); and a peripheral protrusion disposed substantially at an intersection of at least two surfaces, the peripheral protrusion being formed with the body, the peripheral protrusion being substantially spherical (the peripheral protrusion as shown in annotated fig. 2 above is disposed substantially at an intersection of at least two surfaces, is formed with the body 200, and is substantially spherical, particularly since the term spherical is defined as: of, or pertaining to, spheres) and configured to prevent expulsion of the body from the joint (the peripheral protrusion is configured to prevent expulsion of the body from the joint because it protrudes from the articulating surface and guides proper articulation of the CMC joint; paragraph 0046).
Regarding at least claim 2
Gannoe teaches the device of claim 1, wherein the peripheral protrusion is configured to maintain anatomical alignment of the device when inserted into the joint (paragraph 0046 discloses the same anatomical configuration of the trapezium bone which is configured to maintain anatomical alignment in the joint).
Regarding at least claim 3
Gannoe teaches the device of claim 1, wherein the peripheral protrusion is in intermittent contact with the one or more bones (fig. 1 shows that the peripheral protrusion contacts with the one or more bones intermittently during articulation of the CMC joint).
Regarding at least claim 4
Gannoe teaches the device of claim 1, wherein the protrusion is disposed substantially at an intersection of at least two surfaces at a location at which the protrusion is configured to move the device in a direction that is substantially opposite to a force transmitted by a bone surface or another bone surface (the protrusion is fully capable of moving the device in a substantially opposite direction to a force transmitted by a bone surface or another bone surface as claimed by applicant because the protrusion extends above the articulation surface and therefore maintains the implant position within the joint during articulation by counteracting forces transmitted by surrounding bone surfaces).
Regarding at least claim 5
Gannoe teaches the device of claim 1, wherein the peripheral protrusion is disposed substantially at an intersection of three surfaces (the protrusion is shown to be disposed substantially at an intersection of the two surfaces shown in annotated fig. 2 below and at least one of the parallel surfaces which are facing in or out of the page).
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Regarding at least claim 6
Gannoe teaches the device of claim 1, wherein the peripheral protrusion is disposed between proximally-positioned channel openings (see annotated fig. 2 below which shows channel openings which lead to the concavities of the surfaces 205 and 215).
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Regarding at least claim 7
Gannoe teaches the device of claim 1, wherein the top surface is substantially concave to align the body with a bone surface of the one or more bones of the joint (the top surface includes surface 215 which is concave to align the body with a bone surface as shown in fig. 1 and disclosed in paragraph 0052).
Regarding at least claim 8
Gannoe teaches the device of claim 1, wherein the top surface is substantially convex to align the body with a bone surface of the one or more bones of the joint (annotated fig. 2 below shows a convex portion of the top surface to align the body with a bone surfaces as shown in fig. 1).
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Regarding at least claim 9
Gannoe teaches the device of claim 1, wherein the top surface includes two intersecting channels, each channel having two channel openings (see annotated fig. 2 below which shows two intersecting channels indicated by dashed lines and two channel openings which lead to the concavities of the curvature of the surface).
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Regarding at least claim 10
Gannoe teaches the device of claim 1, wherein the two substantially parallel surfaces have substantially similar dimensions (the parallel surfaces which face in and out of the page as shown in fig. 2 have substantially similar dimensions as claimed).
Regarding at least claim 11
Gannoe teaches the device of claim 1, wherein the body includes a front surface (210) and a back surface (205), each of having four sides (side facing in the page, side facing out of the page, side on the right, and side on the left) and having radii of curvature to substantially fit a surface of the bone surface of one or more bones comprising the joint (fig. 1 shows that both surfaces have a curvature with a radius that substantially fits a surface of the bone surface of one or more bones comprising the joint).
Regarding at least claim 12
Gannoe meets the limitations of aa body (200) having a top surface, a bottom surface, and at least two substantially parallel surfaces (sides facing in and out of the page shown in fig. 2), the two substantially parallel surfaces having substantially similar radii of curvature and each of the at least two substantially parallel surfaces being substantially trapezoidally shaped (fig. 2 shows that the two substantially parallel surfaces have substantially similar radii of curvature and are substantially trapezoidally shaped), the top surface having a top radius of curvature and the bottom surface having a bottom radius of curvature (fig. 2 shows the top and bottom surfaces each having a curvature that necessarily has a radius), the body being configured to be disposed in a joint (paragraph 0047 discloses disposing the body of the device in the CMC joint), the top, bottom, and substantially parallel surfaces configured to be in intermittent contact with bone surfaces of one or more bones comprising the joint (paragraph 0049 discloses an opening through the body that couples the implant device via bridging tissue formation and also discloses that the surfaces of the body articulate with adjacent bones, make direct contact with native bone and cartilage and aid and promote the stability of the trapezial implant device within the CMC joint – therefore, the surfaces of the body are configured to be in intermittent contact with the bone surfaces of one or more bones comprising the CMC joint at least to the same extent as applicant’s as described in paragraphs 00269 and 00297, for example), the body not being coupled to the one or more bones (paragraph 0049 discloses that the body is coupled via bridging tissue formation, such as in hematoma distraction arthroplasty or encapsulation – each of these couplings are construed to meet this limitation, particularly in view of the 112 rejection above); and a plurality of peripheral protrusions disposed substantially at an intersection of at least two surfaces, the plurality of peripheral protrusions being formed with the body, the plurality of peripheral protrusions being substantially spherical (the plurality of peripheral protrusions as shown in annotated fig. 2 above is disposed substantially at an intersection of at least two surfaces, is formed with the body 200, and is substantially spherical, particularly since the term spherical is defined as: of, or pertaining to, spheres) and configured to prevent expulsion of the body from the joint (the peripheral protrusion is configured to prevent expulsion of the body from the joint because it protrudes from the articulating surface and guides proper articulation of the CMC joint; paragraph 0046).
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Regarding at least claim 13
Gannoe teaches the device of claim 12, further comprising the body being configured to be inserted into a synovial capsule substantially located within the joint (fig. 1 shows the body being inserted into a synovial capsule substantially located within the CMC joint).
Regarding at least claim 14
Gannoe teaches the device of claim 12, wherein the top surface radius of curvature is associated with a distal or proximal end of the one or more bones comprising the joint (fig. 1 shows the curvature of the top surface being associated with a distal or proximal end of the one or more bones comprising the CMC joint).
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Regarding at least claim 15
Gannoe teaches the device of claim 12, wherein the bottom surface radius of curvature is associated with a distal or proximal end of the one or more bones comprising the joint (at least portion 220 of bottom surface has a curvature that is associated with a distal or proximal end of the one or more bones comprising the CMC joint as disclosed in paragraph 0048).
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Regarding at least claim 16
Gannoe teaches the device of claim 12, wherein the plurality of peripheral protrusions are configured to substantially retain the device in a synovial capsule in the joint (paragraph 0046 discloses the same anatomical configuration of the trapezium bone which is configured to maintain anatomical alignment in the joint, therefore, the protrusions are configured to substantially retain the device in a synovial capsule in the CMC joint in the same way as the protrusions of the natural trapezium bone are).
Regarding at least claim 17
Gannoe teaches the device of claim 12, wherein the device is disposed in a joint to replace an other bone in the joint (paragraph 0046 discloses the same anatomical configuration of the trapezium bone which is configured to maintain anatomical alignment in the joint).
Regarding at least claim 18
Gannoe teaches the device of claim 12, wherein the plurality of peripheral protrusions are disposed at least in part on four corners of each of the trapezoidally shaped side surfaces (fig. 2 shows the plurality of peripheral protrusions disposed at least in part on four corners of each of the trapezoidally shaped surfaces).
Regarding at least claim 19
Gannoe teaches the device of claim 12, wherein the top surface and the bottom surface have substantially similar and directionally opposite radii of curvature (fig. 2 shows that the curvatures of the top and bottom surfaces are substantially similar, particularly since the term substantially is broad and also in view of the 112 rejection above, and directionally opposite since the curvatures face opposite directions).
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Regarding at least claim 20
Gannoe meets the limitations of aa body (200) having a top surface, a bottom surface, and at least two substantially parallel surfaces (sides facing in and out of the page shown in fig. 2), the two substantially parallel surfaces having substantially similar radii of curvature and each of the at least two substantially parallel surfaces being substantially trapezoidally shaped (fig. 2 shows that the two substantially parallel surfaces have substantially similar radii of curvature and are substantially trapezoidally shaped), the top surface having a top radius of curvature and the bottom surface having a bottom radius of curvature (fig. 2 shows the top and bottom surfaces each having a curvature that necessarily has a radius), the body being configured to be disposed in a joint (paragraph 0047 discloses disposing the body of the device in the CMC joint), the top, bottom, and substantially parallel surfaces configured to be in intermittent contact with bone surfaces of one or more bones comprising the joint (paragraph 0049 discloses an opening through the body that couples the implant device via bridging tissue formation and also discloses that the surfaces of the body articulate with adjacent bones, make direct contact with native bone and cartilage and aid and promote the stability of the trapezial implant device within the CMC joint – therefore, the surfaces of the body are configured to be in intermittent contact with the bone surfaces of one or more bones comprising the CMC joint at least to the same extent as applicant’s as described in paragraphs 00269 and 00297, for example), the body not being coupled to the one or more bones (paragraph 0049 discloses that the body is coupled via bridging tissue formation, such as in hematoma distraction arthroplasty or encapsulation – each of these couplings are construed to meet this limitation, particularly in view of the 112 rejection above); and a plurality of peripheral protrusions disposed substantially at an intersection of at least two surfaces, the plurality of peripheral protrusions being formed with the body, the plurality of peripheral protrusions being substantially spherical (the plurality of peripheral protrusions as shown in annotated fig. 2 above is disposed substantially at an intersection of at least two surfaces, is formed with the body 200, and is substantially spherical, particularly since the term spherical is defined as: of, or pertaining to, spheres) and configured to prevent expulsion of the body from the joint (the peripheral protrusion is configured to prevent expulsion of the body from the joint because it protrudes from the articulating surface and guides proper articulation of the CMC joint; paragraph 0046), a quantity of the plurality of peripheral protrusions being determined by a type associated with the joint (the peripheral protrusions are determined by a type associated with the joint because they are designed and used in the joint as shown in fig. 1).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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