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 .
Claim Objections
Claim 15 is objected to because of the following informalities: In Line 2, the word “firmly” should be deleted. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: In Line 2, the words “the adjusted sliding position” should be replaced with the words --an adjusted sliding position--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 limitations in this application that are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph are as follows:
“user adjustment element” – Claim 11
“first link member” – Claim 11
“second link member” – Claim 11
“link arrangement” – Claim 11
“fastening element” – Claim 11
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 11-21 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 11 at Line 7 recites the limitation “a second link member integrally rotatably coupling the user adjustment element and the stem support” and at Line 10 recites the limitation “the stem support being integrally rotatably coupled and slidably connected to the user adjustment element” which renders the claim indefinite as it is unclear what is meant by “integrally” with respect to “rotatably coupling/coupled”. Furthermore, the structure disclosed as the second link member is a pin on the femur support which is used to rotatably couple the user adjustment element (6) to the stem support (7) and thus it is unclear if the term “integrally” is referring to the second link member being integral to one of the recited components or if it is further defining the manner in which the user adjustment element and the stem support are rotatably coupled, or something else. For purposes of examination, the limitations are being interpreted as “a second link member rotatably coupling the user adjustment element and the stem support” and “the stem support being rotatably coupled and slidably connected to the user adjustment element”. Appropriate correction is required.
Claim 12 recites “wherein the first link member and the second link member are integrally formed by a fastening element” which renders the claim indefinite as it is unclear 1) how two separate structural members are integrally formed by another fastening element when they are depicted as two separate pins, and 2) if the limitation is stating that each link member is integrally formed by a fastening element or together the two link members are formed by one fastening element, or something else. It appears from the disclosure that the first link member is a pin (8) and the second link member is a pin (9), and thus for purposes of examination, the limitation is being interpreted as “wherein the first link member and the second link member together form a fastening element”. Appropriate correction is required.
Claim 14 recites “wherein the fastening element is formed by two pins that are arranged coaxially and spaced axially apart.” which renders the claim indefinite as it is unclear how the first link member and the second link member together form a fastening element as stated in Claim 12, and further how that fastening element is formed by two pins. Claim 14 appears to be redundantly claiming the same structure, since the first link member is disclosed as a pin (8) and the second link member is disclosed as a pin (9). For purposes of examination, the limitation is being interpreted as “wherein the first link member is a first pin, and the second link member is a second pin arranged coaxially with and spaced axially apart from the first pin.” Appropriate correction is required.
Claim 15 at Lines 1-2 recites the limitation “wherein the link arrangement comprises the fastening element” which renders the claim indefinite as independent Claim 11 recites a first link member, a second link member, and a link arrangement as different structural components, and Claim 12 further defines that the first link member and the second link member together form a fastening element, and thus Claim 15 is rendered indefinite as it is further reciting that the link arrangement comprises the fastening element which is defined as being formed by the first and second link members which are separate structural limitations in the independent claim. For purposes of examination, the claim is being interpreted as “15. (New) The adjustment system according to claim 12
Claim 15 at Line 5 recites the limitation “the outer peripheral surface”. There is insufficient antecedent basis for this limitation. For purposes of examination, the limitation is being interpreted as “an outer peripheral surface of the stem support”. Appropriate correction is required.
Claim 17 at Line 3 recites the term “the longitudinal axis”. There is insufficient antecedent basis for this limitation. For purposes of examination, the term is being interpreted as “a longitudinal axis”. Appropriate correction is required.
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.
Claim(s) 11-13 & 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brugere et al. (France Patent Appl. No. FR 2 711 510).
Regarding Claim 11, Brugere et al. discloses an adjustment system (Figs. 1-8) for adjusting a femur implant (F, Figs. 3-8) in reference to an intramedullary channel of a femur (3, Fig. 8), the adjustment system comprising: a femur support (1, Figs. 1-8) adapted to be connected to the femur implant (Figs. 5-6); a user adjustment element (4, 5, 6, Fig. 1) rotatably held by the femur support around a rotational axis (4 is rotatably mounted inside 1, and the rotational axis is defined centrally through the height of 1, Figs. 6-7, Pg. 4, Lines 14-16); a stem support (2, Figs. 1-8) adapted to be connected to the intramedullary channel (Fig. 8); a first link member (stepped outer circumferential portion of 4 and stepped inner circumferential portion of 1, Figs. 1 & 6-7) rotatably holding the user adjustment element in the femur support; a second link member (4a1 & top surface of 2a, Figs. 1 & 6-7) rotatably coupling the user adjustment element and the stem support; and a link arrangement (inner surface of 4a & outer surface of notch on 2, Figs. 1 & 6-7) slidably connecting the user adjustment element and the stem support (2 is slidable within 4a as seen by arrows in Figs. 4 & 7), the stem support being rotatably coupled and slidably connected to the user adjustment element along a sliding axis that is perpendicular to the rotational axis (sliding axis is defined centrally through length of slot 4a as seen in Figs. 1, 4 & 7 which is perpendicular to the rotational axis through 1), and at least the first link member and the second link member being arranged substantially in a common plane (horizontal plane defined through 1, 4, 4a, 2a & 4a1 as seen in Figs. 6-7), the plane being perpendicular to the rotational axis (the horizontal common plane is perpendicular through the vertical rotational axis extending through 1 as seen in Figs. 6-7).
Regarding Claim 12 as best understood, Brugere et al. discloses wherein the first link member and the second link member together form a fastening element (the arrangement of the stepped outer circumferential portion of 4 and corresponding stepped inner circumferential portion of 1, and 4a1 & corresponding top surface of 2a collectively form a means for fastening 2 to 1, and thus 4, 5, & 6 to F, as seen in Figs. 1 & 6-7).
Regarding Claim 13 as best understood, Brugere et al. discloses wherein a radially outer portion of the fastening element forms the first link member (stepped outer circumferential portion of 4, Figs. 1 & 6-7) and a radially inner portion of the fastening element forms the second link member (4a1, Figs. 1 & 6-7).
Regarding Claim 15 as best understood, Brugere et al. discloses the fastening element being connected to the user adjustment element (the stepped outer circumferential portion of 4 and corresponding stepped inner circumferential portion of 1, and 4a1 & corresponding top surface of 2a, are either portions of 4 or connected thereto as seen in Figs. 6-7), and a second sliding portion of the stem support (central portion of reduced diameter portion of 2, Figs. 1-4) receiving the fastening element (Figs. 6-7), the second sliding guiding portion having an oblong shape elongated in the direction of the sliding axis (cylindrical and wider than it is tall, Figs. 6-7) and forming an outer peripheral surface of the stem support (exterior peripheral surface of 2 at the reduced diameter central portion thereof, Figs. 1-4).
Regarding Claim 16, Brugere et al. discloses wherein the first link member engages with (indirectly, via slot 4a, Figs. 6-7) a circumferential groove in the femur support (circumferential groove formed adjacent to 2a, Figs. 1 & 6-7).
Regarding Claim 17 as best understood, Brugere et al. discloses wherein the second link member (4a1 & top surface of 2a, Figs. 1 & 6-7) engages with an outer peripheral surface of the stem support (exterior peripheral surface of 2 at the reduced diameter central portion thereof, Figs. 1-4), the outer peripheral surface being perpendicular (the vertical height thereof, Fig. 6) to a longitudinal axis of the second link member (horizontal longitudinal axis running centrally through surface 2a, Fig. 1).
Regarding Claim 18, Brugere et al. discloses wherein the link arrangement (inner surface of 4a & outer surface of notch on 2, Figs. 1 & 6-7) is arranged substantially in the common plane with the first link member and the second link member (Figs. 6-7).
Regarding Claim 19, Brugere et al. discloses wherein the link arrangement comprises a first sliding portion of the stem support (central portion of reduced diameter portion of 2, Figs. 1-4) and a sliding guiding portion of the user adjustment element (inner surface of 4a, Figs. 1-7) receiving the first sliding portion, the sliding guiding portion having an oblong shape elongated in a direction of the sliding axis (Fig. 4).
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.
Claim(s) 14 & 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brugere et al. (France Patent Appl. No. FR 2 711 510) in view of McGovern et al. (US PG Pub No. 2008/0177337).
Regarding Claims 14 & 20-21 as best understood, Brugere et al. discloses the claimed invention as stated above in Claim 12, except wherein the fastening element is formed by two pins that are arranged coaxially and spaced axially apart, an offset direction scale indicating an adjusted rotational position of the user adjustment element relative to the femur support, and an offset amount scale indicating the adjusted sliding position of the user adjustment element relative to the stem support.
McGovern et al. discloses an orthopaedic instrumentation system (Fig. 4) comprising a template (30, Fig. 2) for covering a resected surface of a long bone, a bushing guide (42 or 242, Figs. 1 & 2A), and an adjustable offset bushing (66 or 266 or 510, Figs. 3, 3A, 6) that allows easy determination of offset magnitude and orientation of an offset stem of a femoral component and associated intramedullary rod (502, Fig. 5) or a tibial baseplate (Abstract, Paragraph [0005]), wherein in one particular embodiment depicted in Figs. 5-6 comprises a user adjustment element (bushing 510) rotatably mounted in a support (bushing guide 506) around a rotational axis (vertical axis running centrally through opening 508, Fig. 6), a stem support (516) configured to be connected to an intramedullary rod extending through the IM canal (Fig. 5, Paragraph [0033]), and first and second link members (550, 550, Fig. 6, Paragraph [0332]) rotatably holding the user adjustment element in the femur support and rotatably coupling the user adjustment element and the stem support, respectively, (“Pins 550 may be pushed in to engage detents 548 and lock the bushing body in place.”, Fig. 6), wherein the support comprises a set of indicia (509, Paragraphs [0029, 0031]) circumferentially arranged around the opening (508) extending centrally therethrough (Fig. 6) which can align with indicia (543) on an upper component of the user adjustment element to provide a measure of rotational orientation of the center of bore (528) with respect to the center of the opening (508, Paragraph [0031]), and wherein the upper surface (540) of the user adjustment element comprises a set of indicia (542) which can align with indicia (544) on the upper component of the user adjustment element to measure the offset of the center of the bore (528) from the center of the user adjustment element. Furthermore, Paragraph [0033] discloses “In use, an intramedullary reference such as an intramedullary reamer, intramedullary rod, stem trial or stem extender shaft is inserted in a bone such as a femur. Next, cutting guide 500 is inserted over the intramedullary reference so that the intramedullary reference passes through hole 504 in cutting guide 500. Cutting guide 500 is moved around to place it in the desired position that will result in correct resection of the bone. Cutting guide 500 is fixed to the bone in this position. Next, offset bushing 510 is inserted on the intramedullary reference such that the intramedullary reference passes through bore 526 in cylindrical piece 516. Alternatively, offset bushing 510 may be first inserted in bushing guide 506 and this assembly assembled with the cutting guide 500. Cutting guide 500, is inserted over the intramedullary reference so that the intramedullary reference passes through hole 504 in cutting guide 500 which in turn may be pinned to the bone. Trigger flange 514 is moved in slot 538 and bushing body 512 is rotated to allow insertion of offset bushing 510 in hole 508. The offset is noted by reading indicia 542 that corresponds to indicia 544. The orientation is noted by noting alignment between indicia 543 and one of the indicia 509. The offset and orientation together represent the location of the center of the intramedullary canal as represented by the center of the intramedullary reference with respect to the center of offset bushing 510 which in turn may represent the center of the stem of a prosthetic device. Knowing the offset and orientation allows the surgeon to pick the correct part for the prosthetic to be implanted and assemble it in the right orientation.” (Paragraph [0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the user adjustment element and femur support of the system of Brugere et al. to 1) substitute the correspondingly shaped first and second link members/arrangements thereof with a pin/detent style rotatable coupling arrangement comprising first and second pins inserted through opposing apertures through opposite sides of the femur support and detents formed circumferentially around the upper rotatable disc of the user adjustment element, and 2) add two sets of corresponding indicia on the femur support and user adjustment element, respectively, for indicating the rotational position of the UAE relative to the femur support and indicating an offset/sliding position of the UAE relative to the stem support as taught by McGovern et al. as 1) an alternate and functionally equivalent means for rotatably coupling the user adjustment element to the femur support which provides an added benefit of allowing the user adjustment element to be rotated at specific measurable increments, and 2) in order to provide the system with a means for visually identifying and confirming a translational offset and rotational adjustment of the user adjustment element during use in a procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775