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 1-7, drawn to an implantable device for collecting data regarding one or more characteristics of a bone of a patient, classified in A61B5/4504.
II. Claims 8-12, drawn to a system configured to be implanted in a patient, classified in A61B5/4851.
II. Claims 13-20, drawn to a method of monitoring one or more characteristics of a patient, classified in A6134/10.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the implantable device of the system of group II does not require the specific features of the implantable device of claim 1. The subcombination has separate utility such as a device for insertion into the body to measure characteristics of a bone.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Inventions I and III are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus as claimed can be used to practice another and materially different process (i.e. the implant device can be inserted anywhere to provide measurements).
Inventions II and III are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus as claimed can be used to practice another and materially different process (the implant system can be inserted used in other methods and is not only limited to the process of group III).
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 separate status in the art in view of their different classification; the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or 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 Pierre Angers-Nguyen on 1/28/2026 a provisional election was made without traverse to prosecute the invention of group III, claims 13-20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-12 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/16/2024 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Currently no claims appear to invoke a 35 USC 112(f) interpretation.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Johannaber et al (US 2018/0161168 A1) in view of Splieth et al (US 2012/0259334 A1).
Johannaber discloses a method of monitoring one or more characteristics of a patient (element 1200; figure 12), the method comprising:
preparing a bone for insertion of a trial prosthesis (step 1202; paragraphs [0144]-[0148]; figure 12)
implanting a sensing device (implant sensors, elements 1106a-n; figures 1-4 and 11) within a medullary canal of the bone (wherein examiner notes that a medullary canal is present in order to insert stem of humeral component [elements 102, 202, 302, or 402] of trial implant into humerus; step 1204; paragraphs [0060]-[0094] and [0144]-[0148]; figures 1-4 and 12);
operating the sensing device during a trialing of a joint of the patient while sensing device is implanted within the medullary canal to generate data regarding the one or more characteristics of the patient (step 1206; paragraphs [0144]-[0148]; figure 12); and
communicating the generated data from the sensing device (element 1100; figure 12) to a remote computing device (user interface; element 1104) external of the patient (wherein data from sensors 1106a-1106n are transmitted via controller element 1102 via wireless signal to user interface such as computing device outside the body; steps 1208-1210; paragraphs [0142]-[0148]; figures 11-13).
However, Johannaber does not explicitly disclose that the preparing the bone for insertion comprises reaming a medullary canal of a bone.
Splieth teaches a trial implant having a stem for orthopedic surgery wherein the trial implant is inserted into a canal (element 202) which has been reamed into a bone (reamer is used to form opening for trial prosthesis), such as the humerus (element 200; paragraphs [0028], [0042]-[0043]) wherein the trial implant stem (distal portion, element 14) includes anchoring features (arm elements 20 and 22 having textured outside surface elements 28 and 29 for engaging with the bone to prevent rotational and axial movement of the trial implant; paragraphs [0031]-[0037]; figures 2, 3, 5, 6, 8-10, 12 and 13).
Regarding claims 13-20; Johannaber teaches preparing the bone for a humeral trial implant having a humeral stem. Splieth teaches forming a medullary canal in the humerus for receiving a trial implant having a stem. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Johannaber method for monitoring one or more characteristics of a patient such that the preparing step includes reaming a medullary canal of a bone as taught by Splieth in order to prepare to receive Johannaber’s trial implant stem in the humerus.
Further regarding claims 14 and 15; the Johannaber/Splieth combination as described above discloses inserting the humeral component on the trial implant into the medullary canal; however, the Johannaber/Splieth combination is silent to anchoring the sensing device within medullary canal using one of one or more anchoring features.
Splieth further teaches providing the stem of a trial implant with one or more anchoring features (elements formed by grooves on outer surfaces, elements 28 and 29, of stem arm, elements 20 and 22) to anchor and prevent rotational and axial movement of a trial implant in the medullary canal of a humeral bone (paragraphs [0031]-[0037]; figures 2, 3, 5, 6, 8-10, 12 and 13).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Johannaber/Splieth combination to include anchoring features on the stem of the humeral component in order to anchor the trial implant in the bone and prevent rotation and axial movement of the implant during the trialing of the bone.
Further regarding claim 15; Splieth teaches the one or more anchoring features comprise a plurality of fins spaced around a circumference of the sensing device (wherein features formed by intersecting grooves, element 42, are formed circumferentially on outer surface, elements 28 and 29; paragraphs [0031]-[0037]; figures 2, 3, 5, 6, 8-10, 12 and 13). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Johannaber/Splieth combination as described above would also include a plurality fins spaced around a circumference of the stem as taught by Splieth in order to anchor the trial implant in the bone.
Further regarding claim 16; the Johannaber/Splieth combination is described in the rejection of claims 14 and 15 above. Splieth further teaches extending one or more anchoring features to abut against the bone within the medullary canal to anchor the stem implant within the medullary canal (wherein arm elements 20 and 22 are radially extended to engage the anchoring features of the textured outer surface elements 28 and 29 against the inner surface of the medullary canal; paragraphs [0031]-[0037], specifically [0035]; figures 2, 3, 5, 6, 8-10, 12 and 13).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Johannaber/Splieth combination to extend one or more anchoring features to abut against the bone within the medullary canal to answer the sensing device within the medullary canal as taught by Splieth in order to prevent rotational and axial movement of the trial implant in the bone.
Further regarding claim 17 and 18; the Johannaber/Splieth combination is described in the rejection of claim 16 above. Splieth further teaches anchoring the anchoring features (arm elements 20 and 22 having anchoring features formed on outer surfaces 28 and 29) of the stem within the medullary canal using a tool (driver, element 32) coupled to the trial implant (paragraphs [0031]-[0037], specifically [0035]; figures 2, 3, 5, 6, 8-10, 12 and 13).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Johannaber/Splieth combination as described above would also include a tool coupled to the sensing device to anchor the trial implant within the bone in order to prevent rotation and axial movement of the implant during trialing.
Further regarding claim 18; the Johannaber/Splieth combination is described in the rejection of claim 17 above. Splieth further teaches the anchoring the stem within the medullary canal using the tool (driver element 32) includes actuating with the tool (element 32) a component (arm elements 20 and 22) of the trial implant stem to extend one or more anchoring features (textured outer surface elements 28 and 29) against the bone within the medullary canal; paragraphs [0031]-[0037], specifically [0035]; figures 2, 3, 5, 6, 8-10, 12 and 13).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Johannaber/Splieth combination as described in the rejections above would also utilize a tool for actuating the components of the sensing device to extend the one or more anchoring features against the bone within the medullary canal as taught by Splieth in order to prevent rotational and axial movement of the sensing trial implant during trialing of the implant.
Further regarding claim 19; Johannaber further teaches removing the sensing device from the medullary canal after the trialing of the joint is complete and prior to resection of the bone of the patient (discloses removing trial components before completing the surgical procedure; paragraph [0145]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Johannaber/Splieth combination would also comprise removing the sensing device from the medullary canal after the trialing of the joint is complete and prior to resection of the bone of the patient.
Further regarding claim 20; the Johannaber/Splieth combination as described in the rejection of claim 19 teaches withdrawing the sensing device from the medullary canal after trialing of the joint is complete. Splieth teaches the trial implant is removed after the implant position is properly established/sized by retracting the one or more anchoring features from contact with the bone within the medullary canal (wherein the drive tool, element 35, is used to actuate movement of the arms, elements 20 and 22, from the expanded position to a retracted position; paragraph [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to remove the sensing device of the Johannaber/Splieth combination by retracting the one or more anchoring features from contact with the bone within the medullary canal as taught by Splieth.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2022/0338807 A1 to Pack; discloses a trial instrument for ligature reconstruction which teaches a similar concept to the claimed method as depicted in figure 5.
US 2017/0079799 A1 to Smith et al; discloses a variable prosthesis.
US 2020/0405219 A1 to Trabish et al; discloses an orthopedic system for pre-operative, intra-operative, and post-operative assessment.
US 2019/0388158 A1 to Mahfouz; discloses methods and devices for knee surgery with inertial sensors.
US 11,998,456 B2 to Roche et al; discloses a shoulder joint implant selection system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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, Jacqueline Cheng can be reached at 571-272-5596. 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.
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791