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 .
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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, 3, 6-9, 11, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 6,673,079 to Kane.
As to Claim 1, Kane discloses a system (Figs. 14-17) for performing distraction osteogenesis of a bone segment of an anatomical extremity of a human or animal subject (Col. 2, Lines 15-32). The system comprises a proximal bone fixture component (241, Fig. 14) configured to engage a proximal portion of the bone segment (227b), a movable distractor component (225) configured to be positionable distal of the proximal bone fixture component (Fig. 14, Col. 10, Lines 34-55), and to engage a region (227) of the anatomical extremity located distal of the bone portion engageable by the bone fixture component (Fig. 14), drive means (221) configured to apply a distraction force between the bone fixture component (241) and the movable distractor component (225, Col. 10, Lines 34-67 – Col. 11, Lines 1-8), and a control component arranged to control operation of the drive means automatically (automated actuators described in Col. 10, Lines 17-33).
As to Claim 3, Kane discloses a system wherein the control component is configured to operate the drive means in a continuous manner (Col. 9, Lines 21-24, Col. 11, Lines 6-8).
As to Claim 6, Kane discloses a system wherein the proximal bone fixture component and the movable distractor component interconnect via a transitional arrangement comprising force transfer means (223) configured to apply the distraction force between the components (Col. 10, Lines 35-63).
As to Claim 7, Kane discloses a system wherein the drive means is configured as a linear drive means (221) connected to the movable distractor component and configured to move the distractor component along a linear vector away from the bone fixture component (Col. 10, Lines 35-63).
As to Claim 8, Kane discloses a system wherein the movable distractor component comprises grip means for gripping the distal region of the anatomical extremity (grip formed by heads of 241 against bone, Fig. 14, Col. 10, Lines 45-51).
As to Claim 9, Kane discloses a method for performing distraction osteogenesis of a bone segment of an anatomical extremity of a human or animal subject (Col. 2, Lines 15-32). The method comprises the steps of fixing a proximal bone fixture component (241, Fig. 14) to a proximal portion of the bone segment (227b), utilizing a movable distractor component (225) to engage a region (227) of the anatomical extremity positioned distal of the proximal bone portion (Fig. 14), utilizing a drive means (221)to apply a distraction force between the bone fixture component (241) and the movable distractor component (225, Col. 10, Lines 34-67 – Col. 11, Lines 1-8), and controlling operation of the drive means automatically using a control component (automated actuators described in Col. 10, Lines 17-33).
As to Claim 11, Kane discloses a method which includes operating the control component to drive the drive means in a continuous manner (Col. 9, Lines 21-24, Col. 11, Lines 6-8).
As to Claim 14, Kane discloses a method wherein the proximal bone fixture component and the movable distractor component interconnect via a transitional arrangement comprising force transfer means (223) configured to apply the distraction force between the components (Col. 10, Lines 35-63).
As to Claim 15, Kane discloses a method which includes utilizing the drive means (221) to move the distractor component along a linear vector away from the proximal bone fixture component (Col. 10, Lines 35-63).
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 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,673,079 to Kane in view of U.S. Patent Pub. No. 2014/0025075 to Hokanson.
As to Claims 2 and 10, Kane discloses the claimed invention except for wherein the anatomical extremity comprises a hand.
Hokanson discloses a system (10) and method [0048] for performing distraction osteogenesis of a bone segment of an anatomical extremity of a human or animal subject [0014], wherein the anatomical extremity comprises a hand (Fig. 2, [0014, 0033]) in order to allow for the device to be used to perform external distractor for the treatment of complex fracture luxations of the PIP of the hand [0014].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distraction osteogenesis system of Kane with the hand modification of Hokanson in order to allow for the device to be used to perform external distractor for the treatment of complex fracture luxations of the PIP of the hand.
Claims 4, 5, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,673,079 to Kane in view of U.S. Patent Pub. No. 2012/0296234 to Wilhelm et al.
As to Claims 4, 5, 12, and 13, Kane discloses the claimed invention except for wherein the control component includes a user interface module for setting parameters of automatic operation and control of the drive means, wherein the user interface module is configured to be separable in a tool-free manner from the remainder of the control component.
Wilhelm discloses a system (100, Fig. 1) and method [0005]for performing distraction osteogenesis of a bone segment of an anatomical extremity of a human or animal subject [0004] wherein the control component (10) includes a user interface module (50) for setting parameters of automatic operation and control of the drive means [0028, 0031, 0032], wherein the user interface module (50) is configured to be separable in a tool-free manner from the remainder of the control component (seen as separate component in Fig. 1, [0028]) in order to provide a means for easily observable data of the control component to be provided to the patient and medical professionals [0028].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distraction osteogenesis system of Kane with the control component modification of Wilhelm in order to provide a means for easily observable data of the control component to be provided to the patient and medical professionals.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775