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
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Applicant is reminded to avoid using the term “disclosed herein”.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “passive locking mechanism” in claims 16 and 19.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 13 and 18 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.
Claim 13 recites the limitation "the facets" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the inner annular ridge of the plate" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Stinchfield et al. (US 2014/0107787) in view of Mueller et al. (US 8,152,851).
Regarding claim 1, Stinchfield et al. disclose a vertebral body replacement device dimensioned for implantation between a first and second vertebral bone, comprising an expandable body (10) configured to expand from a first end (26) to a second end (44) along a longitudinal axis (A1), the expandable body having an outer column (22), an inner column (40) threadedly coupled and translatable relative to the outer column along the longitudinal axis (figures 6-9), and an expansion ring (158); wherein the expansion ring is rotatable about the longitudinal axis to translate the outer column relative to the inner column to adjust a body length of the expandable body (¶58-59), the expansion ring comprising a plurality of radially extending teeth (88) for engaging with an arm (80/86) of the outer column and a plurality of teeth (74) for engaging with an inserter device; the outer column comprising the arm for engaging a tooth of the plurality of radially extending teeth of the expansion ring (figure 7); a first end (44/45) of the inner column; and wherein the arm of the outer column has a first, locked configuration in which the expansion ring cannot rotate relative to the outer column (¶58-59, ¶67) and a second, unlocked configuration in which the arm is expanded outwardly to disengage the tooth of the plurality of radially extending teeth to allow the expansion ring to rotate relative to the outer column (¶58-59, ¶67). Stinchfield et al. fail to expressly teach or disclose a first end of the inner column comprising a connector for attachment to an endplate, the endplate comprising a set screw and a plate, wherein the endplate is connectable to the inner column.
Mueller et al. disclose a vertebral body replacement device (figure 95) having an outer column (340) and an inner column (320) the inner column comprising a connector (figure 95) for attachment to an endplate, the endplate comprising a set screw (512) and a plate (392), wherein the endplate is connectable to the inner column (figures 95-96) the endplate and set screw allow for the placement of a plate and therefore the device at multiple axes via the connection between the inner column and endplate (column 12, lines 34-46).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the vertebral body replacement device of Stinchfield et al. as taught by Mueller et al. to have a first end of the inner column comprising a connector for attachment to an endplate, the endplate comprising a set screw and a plate, wherein the endplate is connectable to the inner column as it allows for the placement of a plate and therefore the device at multiple axes via the connection between the inner column and endplate.
Regarding claim 2, Stinchfield et al. disclose the outer column comprises a first arm (80) for engaging a first tooth (86) of the plurality of radially extending teeth of the expansion ring. However, fails to expressly teach or disclose the outer column further comprises a second arm for engaging a second tooth of the plurality of radially extending teeth of the expansion ring.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the outer column of Stinchfield et al. to have a second arm for engaging a second tooth of the plurality of radially extending teeth of the expansion ring, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 3, Stinchfield et al. disclose the first arm and second arm are integrally formed with the outer column by slots cut out of a wall of the outer column (figure 7). Regarding claim 4, Stinchfield et al. disclose the first arm and the second arm each comprise an inwardly facing sloped face (86, figure 7).
Regarding claim 5, Stinchfield et al. disclose in the first arm and the second arm comprise an inwardly extending projection (86) for engaging a tooth (88) of the plurality of radially extending teeth of the expansion ring (figure 7).
Regarding claim 6, Stinchfield et al. disclose the expandable body comprises a first endplate (344/345) at the first end and a second endplate (326/327) at the second end (figure 17).
Regarding claim 7, Stinchfield et al. disclose the first and second endplates independently have one of the following shapes: square, circular, rectangular, oval, and kidney-bean shaped (figure 13).
Regarding claim 8, Stinchfield et al. in view of Mueller et al. disclose at least one endplate is modular and connectable to the first or second end (figures 95-96 of Mueller).
Regarding claim 9, Stinchfield et al. in view of Mueller et al. disclose the connector and the endplate are configured to mechanically engage to achieve a locked orientation relative to each other (column 12, lines 39-46 of Mueller).
Regarding claim 10, Stinchfield et al. in view of Mueller et al. disclose the endplate is configured to connect the first or second end at two or more angles relative to the vertebral body replacement device (column 12, lines 34-39 of Mueller). Regarding claim 11, Stinchfield et al. discloses at least one of the first and second endplates is integral to the inner or outer column, respectively (figure 13).
13. The vertebral body replacement device of claim 1, wherein an inner annular ridge of the plate forms an aperture with an inner diameter pattern, the aperture to receive the facets of the connector of the inner column, and wherein an inner diameter pattern of the set screw is connectable to the facets of the connector of the inner column.
Regarding claim 17, Stinchfield et al. disclose a vertebral body replacement system comprising an expandable body (10) configured to expand from a first end (26) to a second end (44) along a longitudinal axis (A1), the expandable body having an outer column (22), an inner column (40) threadedly coupled and translatable relative to the outer column along the longitudinal axis (figures 6-9), and an expansion ring (158); wherein the expansion ring is rotatable about the longitudinal axis to translate the outer column relative to the inner column to adjust a body length of the expandable body (¶58-59. ¶67); the outer column comprising a first end (26) and a second end (25), and wherein the first end comprises a connector for attachment to a set screw of an endplate; and an endplate comprising a set screw and a plate; and wherein the endplate is connectable to the outer column.
Stinchfield et al. fail to expressly teach or disclose the first end comprising a connector for attachment to a set screw of an endplate and wherein the endplate is connectable to the outer column.
Mueller et al. disclose a vertebral body replacement device (figure 95) having an outer column (340) and an inner column (320) the outer column having a first end comprising a connector (figure 95) for attachment to an endplate, the endplate comprising a set screw (512) and a plate (390), wherein the endplate is connectable to the outer column (figures 95-96) the endplate and set screw allow for the placement of a plate and therefore the device at multiple axes via the connection between the inner column and endplate (column 12, lines 34-46).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the vertebral body replacement device of Stinchfield et al. as taught by Mueller et al. to have the first end comprising a connector for attachment to a set screw of an endplate and wherein the endplate is connectable to the outer column as it allows for the placement of a plate and therefore the device at multiple axes via the connection between the inner column and endplate.
Regarding claim 19, Stinchfield et al. disclose the device further comprises a passive locking mechanism (figure 7, ¶58-59, ¶67).
Regarding claim 20, Stinchfield et al. disclose the passive locking mechanism comprises the expansion ring comprising a plurality of radially extending teeth (88) for engaging with an arm of the outer column (80/86) and a plurality of teeth (74) for engaging with an inserter device; the outer column comprising the arm for engaging a tooth of the plurality of radially extending teeth of the expansion ring (figure 7); and wherein the arm of the outer column has a first, locked configuration in which the expansion ring cannot move relative to the outer column (figure 7, ¶58-59, ¶67) and a second, unlocked configuration in which the arm is expanded outwardly to disengage from the plurality of radially extending teeth to allow the expansion ring to rotate relative to the outer column (figure 7, ¶58-59, ¶67).
Allowable Subject Matter
Claim 14-16 are allowed.
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 13 and 18 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.
The following is a statement of reasons for the indication of allowable subject matter: None of the cited art alone or in combination anticipates or renders obvious the above claims. Specifically, the connector having facets (claims 12, 14 and 18).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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, Anita Coupe can be reached at 571-270-3614. 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.
/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
