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 .
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 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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 23, 2025 and February 10, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation - 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.
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 is: “holding element” in claim 9.
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 § 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 1-5, 7-10, and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malinowski (U.S. Patent No. 8137362).
Regarding claim 1, Carroll discloses a fixation device (Fig. 2) for fastening a therapy device in an opening arranged in a bone, comprising a sleeve element (annotated Fig. 2 below) which is configured to be received in the opening (col. 6, ll. 1-16), wherein the sleeve element comprises a first sleeve element portion (combination of shell (100) and collet (200); annotated Fig. 2) and a second sleeve element portion (300’), wherein the first sleeve element portion surrounds the second sleeve element portion in an installed state (col. 6, ll. 11-16), wherein the first sleeve element portion is configured as a cylindrical hollow body (100’; Fig. 2) with a longitudinal axis,
PNG
media_image1.png
658
778
media_image1.png
Greyscale
wherein the first sleeve element portion has a first end and a second end (annotated Figs. 4A-4B below), wherein the first end of the first sleeve element portion includes a grip element (160), wherein the second end of the first sleeve element portion includes an extension (annotated Fig. 4B),
PNG
media_image2.png
742
727
media_image2.png
Greyscale
wherein the second sleeve element portion is configured as a cylindrical hollow body (300’; Fig. 2) having a longitudinal axis, wherein the second sleeve element portion contains a projection arrangement (annotated Fig. 2 above), wherein the first sleeve element portion and the second sleeve element portion are rotatable about one another in such a way that the projection arrangement is arranged in a first position adjacent to the extension (e.g., when clamp (300’) is tightened onto shell (100’); col. 4, ln. 65 – col. 5, ll. 3) and the projection arrangement is arranged at a distance from the extension in a second position (e.g., when clamp (300’) is separated from shell (100’) or when projections (330) first enter slots (120) of the shell; Fig. 2).
Regarding claim 2, Malinowski discloses wherein the first sleeve element portion includes a first flange and a second flange (annotated Figs. 4A-4B above).
Regarding claim 3, Malinowski discloses wherein the extension projects beyond the second flange in a direction of the longitudinal axis of the cylindrical hollow body of the first sleeve element portion (Fig. 4B).
Regarding claim 4, Malinowski discloses wherein the extension extends over a part of a circumference of the first sleeve element portion (Fig. 4B).
Regarding claim 5, Malinowski discloses wherein the extension has a segment length which is in a range of from 10% to 40% inclusive of a circumference of the cylindrical hollow body of the first sleeve element portion (Fig. 4B).
Regarding claim 7, Malinowski discloses wherein the extension has a profiling (outer surface profile) on the outside (Fig. 4B).
Regarding claim 8, Malinowski discloses wherein the second sleeve element portion has an outside which includes at least one recess (340; Fig. 12; col. 4, ll. 63-65).
Regarding claim 9, Malinowski discloses wherein the second sleeve element portion includes a holding element (annotated Fig. 4A above; the labelled “holding element” meets or is an equivalent of the corresponding structure described in the specification as performing the claimed function).
Regarding claim 10, Malinowski discloses wherein the projection arrangement includes a first projection and a second projection (annotated Fig. 2 above), wherein the projection arrangement can include a profiling (outer surface profile of each projection).
Regarding claim 12, Malinowski discloses wherein the first sleeve element portion contains a longitudinal slot (central lumen of sleeve (100’) receiving collet (200’); alternatively, collet (200’) includes a slot (270; Fig. 6)).
Regarding claim 13, Malinowski discloses wherein the longitudinal slot extends from the first end of the first sleeve element portion to the second end of the first sleeve element portion (Figs. 4A-4B; Fig. 6).
Regarding claim 14, Malinowski discloses wherein the second sleeve element portion contains a longitudinal slot (annotated Fig. 2 above).
Regarding claim 15, Malinowski discloses wherein the longitudinal slot extends from a first end of the second sleeve element portion to a second end of the second sleeve element portion (Fig. 2).
Regarding claim 16, Carroll discloses a navigation system (including medical device and associated placement instrumentation (col. 6, ll. 1-7), insertion tool (900; Fig. 10; col. 5, ll. 40-59) and the fixation device (Fig. 2)) comprising a fixation device (Fig. 2) for fastening a therapy device in an opening arranged in a bone, wherein the fixation device comprises a sleeve element (annotated Fig. 2 below) which is configured to be received in the opening (col. 6, ll. 1-16), wherein the sleeve element comprises a first sleeve element portion (combination of shell (100) and collet (200); annotated Fig. 2) and a second sleeve element portion (300’), wherein the first sleeve element portion surrounds the second sleeve element portion in an installed state (col. 6, ll. 11-16), wherein the first sleeve element portion is configured as a cylindrical hollow body (100’; Fig. 2) with a longitudinal axis,
PNG
media_image1.png
658
778
media_image1.png
Greyscale
wherein the first sleeve element portion has a first end and a second end (annotated Figs. 4A-4B below), wherein the first end of the first sleeve element portion includes a grip element (160), wherein the second end of the first sleeve element portion includes an extension (annotated Fig. 4B),
PNG
media_image3.png
742
727
media_image3.png
Greyscale
wherein the second sleeve element portion is configured as a cylindrical hollow body (300’; Fig. 2) having a longitudinal axis, wherein the second sleeve element portion contains a projection arrangement (annotated Fig. 2 above), wherein the first sleeve element portion and the second sleeve element portion are rotatable about one another in such a way that the projection arrangement is arranged in a first position adjacent to the extension (e.g., when clamp (300’) is tightened onto shell (100’); col. 4, ln. 65 – col. 5, ll. 3) and the projection arrangement is arranged at a distance from the extension in a second position (e.g., when clamp (300’) is separated from shell (100’) or when projections (330) first enter slots (120) of the shell; Fig. 2).
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 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Malinowski.
Regarding claim 6, Malinowski discloses the invention substantially as claimed, except for the extension has an axial length that is in a range of from 5% to 50% inclusive of the distance measured between the first end and the second end in a direction of the longitudinal axis of the first sleeve element portion. It would have been an obvious matter of design choice to adjust an axial length of the extension to be within the claimed range, since applicant has not disclosed that such dimension solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the device of Malinowski. Further, Applicant appears to have placed no criticality on the claimed range.
Regarding claim 11, Malinowski discloses the invention substantially as claimed, except for the second sleeve element portion having an inside diameter of at least 3 mm. It would have been an obvious matter of design choice to adjust an inside diameter of the second sleeve element portion of at least 3 mm, since applicant has not disclosed that such range of diameter value solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the device of Malinowski. Further, Applicant appears to have placed no criticality on the claimed range.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Manikowski in view of Simon et al. (U.S. Patent Application Publication No. 20080081982; hereinafter “Simon”).
Regarding claim 17, Manikowski discloses wherein the fixation device is configured to fasten a first tracker in the opening arranged in the bone (the fixation device is structured to be capable of being fastened to a first tracker, such as at balls (160; Fig. 4A) and lacks structure that would prevent such fastening).
The system of Malinowski is not explicitly disclosed with the system including a therapy device which includes a second tracker, a tracking system, a computing unit, and a display unit.
Simon, a reference in the surgical navigation field of endeavor, teaches providing a navigation system with a therapy device (52;Fig. 2) which includes a second tracker (“tracking device;” para. [0100]), a tracking system (10), a computing unit (31; para. [0052]) and a display unit (34), wherein the tracking system is configured to determine a position of the therapy device relative to at least one of the first tracker or the second tracker (para. [0100]), wherein the computing unit is configured to calculate the position of the therapy device in an anatomical coordinate frame (paras. [0100]-[0101]), wherein the display unit is configured to display a virtual position of the therapy device with respect to registered preoperative images or 3D models (Figs. 7-8; para. [0079]) to facilitate precise positioning of an instrument to assist treating a patient (para. [0101]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the navigation system with a therapy device which includes a second tracker, a tracking system, a computing unit and a display unit, wherein the tracking system is configured to determine a position of the therapy device relative to at least one of the first tracker or the second tracker, wherein the computing unit is configured to calculate the position of the therapy device in an anatomical coordinate frame, wherein the display unit is configured to display a virtual position of the therapy device with respect to registered preoperative images or 3D models, in view of Simon, in order to facilitate accurate placement of a stimulation therapy device to treat a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wilson et al. (U.S. Patent Application Publication No. 20050251144) disclosing a cranial anchor bolt (Figs. 2-6); and
Cantor et al. (U.S. Patent Application Publication No. 20240008896) disclosing an expandable surgical access port (Figs. 13-15C).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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, Elizabeth Houston can be reached at (571) 272-7134. 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.
/JONATHAN A HOLLM/Examiner, Art Unit 3771
