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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19, drawn to a system/instrument, classified in A61F2/4606.
II. Claim 20, drawn to a method for positioning implant components, classified in A61F2/4637.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process of using that product, namely, arranging the first implant component inferior relative to the second implant component, positioning an implant component relative to a talar of a patient, or for use with positioning implant components in a wrist of a patient.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a different status in the art in view of their different classifications;
The inventions have acquired a separate status in the art due to the their recognized divergent subject matter; and/or
The inventions require a different field of search (for example, searching different groups/subgroups or electronic resources, or employing different search strategies of search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Jacquelyn A. Graff on 07 January 2026 a provisional election was made without traverse to prosecute the invention of group I, claims 1-19. Affirmation of this election must be made by applicant in replying to this Office action. Claim 20 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 8 and 15 are objected to because of the following informalities:
Claim 8, line 3: --a-- should be added between “comprising” and “first”.
Claim 15, line 2: --portion-- should be added between “body” and “,”.
Appropriate correction is required.
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.
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: coupling mechanism in claim 1 and coupling portion in claim 8.
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.
Claim 15 is 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 15 recites the limitation "the actuation" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Luna et al., U.S. PG-Pub 2015/0257899.
Regarding claim 1, Luna et al. discloses a system, comprising: an implant system (1000), comprising: a tibial component (1100); a talar component (1200); an intermediate component (1300) (Fig. 96 and paragraph [0252]); and
an instrument (3100) comprising: a handle portion (3124); a head portion (portion of 3102 with channels 3120 and near 3300) comprising a releasable coupling mechanism (3500) configured to releasably couple with the tibial component (Figs. 90, 92, 93A and 94 and paragraph [0244]); and a body portion (3116, 3128), wherein the body portion is disposed between the handle portion and the head portion (Figs. 90 and 92).
Regarding claim 2, Luna et al. discloses wherein the head portion (portion of 3102 with channels 3120 near 3300) is configured to releasably couple with the intermediate component (1300) (Figs. 90 and 92 and paragraph [0243]).
Regarding claim 3, Luna et al. discloses wherein the tibial component (1100) and the intermediate component (1300) are simultaneously releasably coupled with the head portion of the instrument (portion of 3102 with channels 3120 near 3300) such that the tibial component is positioned superior relative to the intermediate component (Figs. 92, 95A and 95B and paragraph [0249]).
Regarding claim 4, Luna et al. discloses wherein the handle portion (3124) of the instrument (3100) comprises a gripping portion (3124 is a handle; therefore, it is gripped by a surgeon) and a threaded rod (threading 3130 of rod 3110), wherein the threaded rod extends at least partially into and through the body portion (3116, 3128) of the instrument (Figs. 89 and 90).
Regarding claim 5, Luna et al. discloses wherein the body portion (3116, 3128) of the instrument (3100) comprises a complementary threading (via threaded opening 3106) that receives at least a portion of the threaded rod (3110) (Figs. 89 and 90 and paragraph [0239]).
Regarding claim 6, Luna et al. discloses wherein manipulation of the gripping portion (3124) actuates the threaded rod (3110) along a longitudinal axis of the instrument (Figs. 95A-95B and paragraph [0247]).
Regarding claim 7, Luna et al. discloses wherein actuation of the threaded rod (3110) along the longitudinal axis repositions the intermediate component (1300) relative to the tibial component in a proximal-distal direction (Figs. 95A-95B and paragraphs [0248]-[0249]).
Regarding claim 8, Luna et al. discloses an instrument comprising: a handle (3124) coupled with a rod (3110); a body portion comprising a first end (3148) and a head portion (portion of 3102 with channels 3120 near 3300), the body portion configured to receive the rod in a central portion thereof (central portion of 3148); and a coupling portion (3300, 3500) configured to releasably couple with one or more components of an implant system (Figs. 89, 90, 92, 93A and 94).
Regarding claim 9, Luna et al. discloses wherein actuation of the handle (3124) moves the rod (3110) to actuate a first implant component relative to a second implant component so as to position the first implant component adjacent the second implant component (Figs. 94-95B and paragraphs [0247]-[0249]).
Regarding claims 10 and 11, Luna et al. discloses wherein the coupling portion (3300, 3500) comprises a projection (3302) configured to engage at least a portion of at least one of the one or more components of the implant system; and an actuator (3140) configured to facilitate engagement with and release of at least one of the one or more components of the implant system (Figs. 92, 95A-95B and paragraph [0248]).
Regarding claims 12 and 13, Luna et al. discloses wherein the first implant component is an insert for a total ankle replacement implant; and wherein the second implant component is a tibial tray for a total ankle replacement implant (see total ankle replacement implant in Fig. 96).
Regarding claim 14, Luna et al. discloses wherein the rod (3110) comprises a first threading (3130) disposed along a length of the rod (Fig. 89).
Regarding claim 15, Luna et al. further comprises a second threading (via threaded aperture 3106) disposed in the body, wherein the second threading is complimentary to a receives the first threading and actuation of the handle (3124) causes translation of the rod through the body via the first and second threading (Figs. 89, 90, 95A-95B and paragraph [0247]).
Regarding claim 16, Luna et al. discloses wherein the first implant component is releasably couplable with the second implant component (see implant 1000 in Fig. 96).
Regarding claims 17-19, Luna et al. discloses wherein the coupling portion (3300, 3500) is configured to releasably couple with the second implant component such that the second implant component remains in a fixed position while the first implant component is actuated (Figs. 95A-95B); wherein the coupling portion comprises a catch (3308) and a notch (space formed between 3308 and upper surface of 3102 when 3300 is connected to 3102); and wherein the second implant component comprises a complimentary geometry to the catch and the notch such that the catch is received by a portion of the second implant component (Figs. 90-92).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin 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.
/ERIC S GIBSON/ Primary Examiner, Art Unit 3775