Detailed Action
This is the first office action on the merits for US application number 19/213,935.
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/Restrictions
Applicant's election with traverse of the fastening species A)1) in Figs. 1-6 and the device species B)1) of Figs. 1-6 and 18 in the reply filed on September 11, 2026 is acknowledged. The traversal is on the ground(s) that the asserted mutually exclusive characteristics are not adequately explained nor is the asserted search burden in light of the relationships between the identified species.
The argument that there are relationships between the identified species is not found persuasive because, as detailed by MPEP 808.01(a) and 808.02, where MPEP 808.01(a) provides that “A requirement for restriction is permissible if there is a patentable difference between the species as claimed and there would be a serious search and/or examination burden on the examiner if restriction is not required”, “In applications where only generic claims are presented, restriction cannot be required unless the generic claims recite or encompass such a multiplicity of species that an unduly extensive and burdensome search would be necessary to search the entire scope of the claim.”, and MPEP 808.02 provides that “In order to demonstrate a serious search burden, the examiner must show by appropriate explanation one of the following: (A) Separate classification thereof: This shows that each invention has attained recognition in the art as a separate subject for inventive effort, and also a separate field of search. Patents need not be cited to show separate classification. (B) A separate status in the art when they are classifiable together: Even though they are classified together, each invention can be shown to have formed a separate subject for inventive effort when the examiner can show a recognition of separate inventive effort by inventors. Separate status in the art may be shown by citing patents which are evidence of such separate status, and also of a separate field of search. (C) A different field of search: Where it is necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s) (e.g., searching different classes/subclasses or electronic resources, or employing different search queries), a different field of search is shown, even though the two are classified together. The indicated different field of search must in fact be pertinent to the type of subject matter covered by the claims. Patents need not be cited to show different fields of search.” That is, Examiner agrees that there are similarities across the disclosure, but the election of species is required based upon the mutually exclusive differences. Applicant’s disclosure provides such multiplicity of species with mutually exclusive differences that examination of all at one time is unduly extensive and burdensome and, as identified in the office action dated July 16, 2026, a search of all would require multiple searches to cover the mutually exclusive structures in different areas of the classification and require searching mutually exclusive features.
The argument that the asserted mutually exclusive characteristics are not adequately explained is not found persuasive because these are readily shown by a cursory comparison of Applicant’s figures in this mechanical art area. That is, a cursory review of Figs. 1-6 easily shows that the structures shown for the fastening structure 4 is an IM rod as disclosed in ¶73 that is disclosed to have a rigid connection with 5 in ¶67 have a mutually exclusive shape relative to those quickly evident from a cursory review of Figs. 7-9 that easily shows that the specially formed bone clamp/fastening structure 4 as disclosed in ¶83 and 86. A similar level of review shows mutually exclusive shaped between those of Figs. 1-6, Figs. 7-9 and those of Fig. 10 per ¶86, Fig. 11 per ¶87, Fig. 12 per ¶88, Fig. 14 per ¶89, Fig. 14 per ¶90, and Fig. 15-17 per ¶s 91, 94, 95, 97, and 98. Similarly, the device 10 of Figs. 1-6 and 18 is disclosed to be distinct from the device of Figs. 15-17 and the device of Figs. 19a-20 in at least that linear translation is achieved via a threaded spindle 24 in Figs. 1-6 and 18, guide rail 34 in Figs. 15-17, and the partially smooth spindle 24 in Figs. 19-20b. In summary, one of ordinary skill in the art would readily recognize that an IM rod is a completely difference device from an clamp, which are mutually exclusive structures from the shown connectors 7 which each have mutually exclusive shapes, and a threaded spindle is mutually exclusive from a rail and a partially threaded spindle, i.e. a structure cannot simultaneously possess of the disclosed features for the 8 disclosed fastening structures and the 3 disclosed devices. Accordingly, Examiner has unmistakably shown distinctness between the two recited groups.
The argument that the asserted search burden has not been adequately explained is not found persuasive because as identified in the office action dated July 16, 2026, a search of all would require multiple searches to cover the mutually exclusive structures in different areas of the classification and require searching mutually exclusive features. That is, searching and examination of all the mutually exclusive features for the 8 disclosed fastening structures and the 3 disclosed devices is overly burdensome for the 17.7 hours of search, consideration, and examination provided for disposal of the instant application. That is, although there would be some overlap in searching fields, there are different subclasses to be searched for different structures and simultaneously searching the sheer volume of mutually exclusive disclosed features would be burdensome. Accordingly, Examiner has unmistakably shown a serious search and examination burden on the examiner if restriction is not required between the identified groups.
The requirement is still deemed proper and is therefore made FINAL.
Applicant identified that claims 1, 2, 5, 6, 8, and 9 encompass the elected species. Accordingly, claims 3, 4, 7, and 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 11, 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “- a rotatable connecting element arranged rotatably about the base element, wherein the rotatable connecting element is arranged rotatably about the base element longitudinal axis such that the base element longitudinal axis forms an axis of rotation for the rotatable connecting element” of claim 1 lines 9-13, “a first connecting element drive 13” of claim 1 lines 12-13, and “the rotatable connecting element, the displaceable connecting element and the connecting element are drivable independently of each other by means of corresponding connecting element drives” of claim 5 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1 lines 1-2 should read “without user interaction, the resection device comprising:”.
Claim 1 line 9 should read “a rotatable connecting element
Claim 1 lines10-11 should read “the base element longitudinal axis[[,]] such that”.
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: a “fastening element” in claim 1 line 3, a “rotatable connecting element” in claim 1 line 9, a “first connecting element drive” in claim 1 lines 11-12, a “displaceable connecting element” in claim 1 line 14, a “second connecting element drive” in claim 1 lines 14-15, and a “third connecting element drive” in claim lines 18-19.
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(s) 1, 2, 5, 6, 8, and 9 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 1 is/are unclear with regards to “- a rotatable connecting element arranged rotatably about the base element, wherein the rotatable connecting element is arranged rotatably about the base element longitudinal axis such that the base element longitudinal axis forms an axis of rotation for the rotatable connecting element” in lines 9-13 and how it can reasonably be construed that rotatable connecting element 1 which is identified as housing 22 in ¶70 and equivalents thereof is capable of rotating about base element 5 as claimed. That is, no structure has been shown that enables housing 22 to rotate nor has its connection to any other structure been clearly shown or described. Further, lines 12-11 provide that “rotatable connecting element includes the first connecting drive”, but such contradicts specification ¶70 which provides that “the rotatable connecting element 1 can be driven by a first connecting element drive 13” as it is unclear how an element can be reasonably construed to drive itself or why drive 13 is absent in Fig. 18, which is disclosed to shown device 10 (¶99) as though such is the same device as Figs. 1-6 but that includes drive 13. Thus, Applicant’s original disclosure is inconsistent with regards to the scope of the 35 USC 112f claim term that Applicant has used, but it would appear that the first connecting element drive 13 is responsible for the claimed function of rotating housing 22 but the structure responsible for this function is not shown or consistently defined with regards to any other shown structure. Examiner suggests amending to use a claim limitation that can be interpreted under BRI with a consistent usage in Applicant’s original disclosure that has also been shown. In the interest of providing compact prosecution, Examiner is interpreting this as broadly supported and suggests amending to clarify.
Claim(s) 1 is/are unclear with regards to “the displaceable connecting element includes a second connecting element drive, wherein the displaceable connecting element is configured to execute a linear movement along or parallel to the base element longitudinal axis relative to the base element” in lines 14-17 and how displaceable connecting element 2 as shown in Figs. 1-6 and 18 to be the same structure as holder 37 but is identified as drive 23, spindle 24, and slide 27/holder 37 in ¶102 or equivalents thereof can be reasonably construed to include the drive 23 that is shown at the top of rotatable connecting element 1 or how it can be reasonably construed that displaceable connecting element 2 as shown in Figs. 1-6 and 18 to be positioned laterally of spindle 24 can be reasonably construed to be capable of executing a linear movement along or parallel to the base element longitudinal axis relative to the base element 5 for the shown structures. Further, such is unclear as to the scope of “to the base element longitudinal axis relative to the base element” and what is intended to be construed of an axis relative to the structure itself. Examiner is interpreting this broadly and suggests amending to clarify. In particular, claim 1 lines 9-17 provide claim terms that are shown in the drawings to be different structures or connected differently that identified in the specification; thus, Examiner suggests amending to use claim terms that can be interpreted under BRI to alleviate the reliance on the specification that provides the structure for the 35 USC 112f claim terms that are described as one collection of structures and shown to be another structure or are not shown at all.
Claim(s) 5 is/are unclear with regards to “means of corresponding connecting element drives” in line 3 and the corresponding structure and equivalents thereof that are in addition to the first connecting element drive of claim 1 lines 12-13, the second connecting element drive of claim 1 line 15, and the third connecting element drive of claim 1 lines 18-19. Examiner is interpreting this as referring to the first connecting element drive of claim 1 lines 12-13, the second connecting element drive of claim 1 line 15, and the third connecting element drive of claim 1 lines 18-19, and suggests amending to clarify.
Claim(s) 8 is/are unclear with regards to “the fastening element is configured as a fastening means” in lines 1-2 and the intended meaning of this phrase. Examiner is interpreting this as referring to, and suggests amending as, “the fastening element is one of an intramedullary rod, a modified intramedullary rod, a bone nail, a bone clamp, a bone screw, and a holder fastened with pin elements”.
Claim(s) 9 is/are unclear with regards to “the end effector comprises a tool selected from the group consisting of a milling device, a sawing device, and a drilling device, wherein the tool can comprise a ball end mill” in lines 1-3 and how to tool can simultaneously consist of a milling device, a sawing device, or a drilling device and yet comprise a ball end mill. Examiner is interpreting this as referring to, and suggests amending as, “the end effector comprises a tool selected from the group consisting of a milling device, a sawing device, and a drilling device
Claim(s) 2 and 6 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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, 2, 5, 6, 8, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Madier Vigneux et al. (US 2024/0156469, hereinafter “Madier”).
As to claim 1, Madier discloses a resection device (700, Figs. 1, 2, and 8A-8G, ¶s 5 and 77 disclose use for resection, ¶s 70 and 77 disclose that 702 may be attached to implantable device 102 as shown in the preceding figures, i.e. Figs. 1 and 2, or bracket 714) capable of resecting at least one bone of a bone arrangement without user interaction (Figs. 8A-8G, ¶s 5 and 77 disclose use for resection of bone, ¶76 discloses that the system may be operated autonomously), the resection device comprising: - a fastening element (102/714, Figs. 1, 2, 8A-8C, and 8E-8G, ¶s 70 and 77 disclose that 702 may be attached to implantable device 102 as shown in the preceding figures, i.e. Figs. 1 and 2, or bracket 714), the fastening element being capable of being rigidly fastened to the bone arrangement (Figs. 1, 2, 8A-8C, and 8E-8G, ¶s 70 and 77), and - a base element (712, 722), wherein the fastening element can be coupled to the base element such that the base element forms a rigid connection with the fastening element (Figs. 1, 2, 8A-8C, and 8E-8G, ¶s 70 and 77), wherein the base element includes a base element longitudinal axis (R1 of 722, Fig. 8G, ¶72), and - a rotatable connecting element (720) arranged rotatably about the base element (Figs. 8E-8G, ¶72), wherein the rotatable connecting element is arranged rotatably about the base element longitudinal axis (Figs. 8E-8G, ¶72) such that the base element longitudinal axis forms an axis of rotation (R1 of 722, Fig. 8G, ¶72) for the rotatable connecting element (Figs. 8E-8G, ¶72), wherein the rotatable connecting element includes a first connecting element drive (motor of 720 of ¶77, ¶s 72 and 77), and - a displaceable connecting element (728), wherein the displaceable connecting element includes a second connecting element drive (728C, Fig. 8D, ¶75), wherein the displaceable connecting element is capable of executing a linear movement (of end effector 706, Figs. 8D, 8E, and 8G, ¶73) parallel to the base element longitudinal axis relative to the base element (Figs. 8D, 8E, and 8G, ¶73), and - a connecting element (706B), wherein the connecting element includes a third connecting element drive (motor per ¶74, ¶74), wherein the connecting element is connected to one of the rotatable or displaceable connecting elements (via 724 and 726, Fig. 8G) via a pivot joint (726), wherein the pivot joint includes a pivot joint axis of rotation (R2, Fig. 8G, ¶72), wherein the connecting element is rotatable about the pivot joint axis of rotation (Fig. 8G, ¶72), - wherein the connecting element includes an end effector (706A) capable of use for bone resection (¶74 discloses that 706 is a cutting tool in the form of a reamer, mill, or other tool, ¶s 5 and 77 disclose use for resection).
As to claim 2, Madier discloses that the pivot joint axis of rotation is arranged at an angle of 60 degrees up to and including 90 degrees to the axis of rotation (Fig. 8G).
As to claim 5, Madier discloses that the rotatable connecting element, the displaceable connecting element and the connecting element are drivable independently of each other by means of corresponding connecting element drives (Figs. 8A-8G, ¶s 73, 74, and 77).
As to claim 6, Madier discloses that at least one of the connecting element drives is housed in a compact, removable block (710 which is shown removed in Figs. 8D-8G per ¶69, Figs. 8A-8C, ¶69).
As to claim 8, Madier discloses that the fastening element is one of an intramedullary rod, a modified intramedullary rod, a bone nail, and a holder fastened with pin elements (102/714, Figs. 1, 2, 8A-8C, and 8E-8G, ¶s 70 and 77 disclose that 702 may be attached to implantable device 102 as shown in the preceding figures, i.e. Figs. 1 and 2, or bracket 714).
As to claim 9, Madier discloses that the end effector comprises a tool selected from the group consisting of a milling device, a sawing device, and a drilling device (¶74 discloses that 706 is a cutting tool in the form of a reamer, mill, or other tool).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
