Detailed Action
This is the final office action for US application number 18/087,471. Claims are evaluated as filed on February 2, 2026.
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 .
Response to Arguments
Applicant's arguments filed February 2, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that support for the claim amendments can be found through the originally filed application including paragraph 159 and 231 as well as Figs. 3 and 93 (Remarks p. 5), Examiner notes that paragraph 159 and Fig. 3 are disclosed in regards to the non-elected instrument species A)1) of Figs. 1-7 and 9 and paragraph 231 and Fig. 93 are disclosed in regards to the elected instrument species A)14) of Figs. 93-101E. However, there does not appear to be a disclosure that the structures of paragraph 159 and Fig. 3 are part of those of paragraph 231 and Fig. 93. Further, a comparison of Fig. 3 and Fig. 93 shows that the structure may be similar but that in Fig. 93 the lock 302 is absent. Thus, Examiner suggests that support for the use of the structures of paragraph 159 and Fig. 3 in/with/as those of paragraph 231 and Fig. 93 be identified to overcome the new matter rejection below.
With regards to Applicant’s argument that one would readily understand the structure of a “depth adjustment mechanism” and a “drive mechanism” as the specification shows examples of “drive features” in Figs. 79-81 and 95A-95D and paragraphs 219-220 and 232 and while such include a broad class of structures, that alone is insufficient to overcome the presumption that 112f does not apply when the term “means” is not used (Remarks p. 6), Examiner notes that there appears to be some mixing of concepts presented. To clarify, there has been no interpretation of a “depth adjustment mechanism” and a “drive mechanism” as such terms are not present in the claims. Further, it has not been asserted that “drive features” is unclear or unsupported by the original disclosure. As detailed in MPEP 2181, the claim interpretation paragraphs below, and those of the non-final office action dated October 31, 2205, limitations that meet the three-prong test will be interpreted under 35 USC 112f where: the claim limitation uses a generic placeholder term that is modified by functional language and is not modified by sufficient structural features for performing the claimed function. Thus, as “drive feature” “configured to independently translate…..” recites the generic placeholder “feature” modified by the functions of “drive” and “configured to independently translate…..” and is not modified by any structural features, such is appropriately interpreted under 35 USC 112f.
With regards to Applicant’s argument that Applicant’s request that the term “drive features” not be construed pursuant to 35 USC 112f and that such should include all the corresponding structure of Figs. 79-81 and 95A-95D and paragraphs 219-220 and 232a as well as all the corresponding structure disclosed in the specification and drawings as well as equivalents thereof (Remarks p. 6), Examiner notes that the claim language controls the required interpretation and it is not within the Examiner’s authority to amend the claim language. With regards to the interpretation, as detailed in MPEP 2181, the claim interpretation paragraphs below, and those of the non-final office action dated October 31, 2205, “drive features” is “being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof”.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/562,046, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The disclosure of Application No. 62/562,046 fails to provide adequate support for at least a body including a plurality of sockets slidably coupled to the body and configured to receive and capture a ball to form a ball and socket joint; a first tissue manipulating implement including a ball configured to be coupled to the body via one of the plurality of sockets and capable of polyaxial movement relative to the socket when coupled; and a second tissue manipulating implement including a ball configured to be coupled to the body via one of the plurality of sockets and capable of polyaxial movement relative to the socket when coupled; wherein the first and second tissue manipulating implements are configured to be opposed to one another such that they can move any of toward and away from one another when coupled; and wherein each tissue manipulating implement is configured to be coupled to the body with movement of the ball into one of the plurality of sockets of the body of claim 1 as well as for “the support instrument comprising a lock configured to translate longitudinally relative to a longitudinal axis of the support instrument to lock the support instrument relative to the implantable anchor” of claim 1 lines 11-13 for an instrument comprising “a plurality of sockets slidably coupled to the body” of claim 1 line 3 where “each of the plurality of sockets is disposed at an end of an arm extending from the body” of claim 1 lines 18-19.
The disclosure of the prior-filed application, Application No. 62/562,055, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The disclosure of Application No. 62/562,055 fails to provide adequate support for at least a body including a plurality of sockets slidably coupled to the body and configured to receive and capture a ball to form a ball and socket joint of claim 1 as well as for “the support instrument comprising a lock configured to translate longitudinally relative to a longitudinal axis of the support instrument to lock the support instrument relative to the implantable anchor” of claim 1 lines 11-13 for an instrument comprising “a plurality of sockets slidably coupled to the body” of claim 1 line 3 where “each of the plurality of sockets is disposed at an end of an arm extending from the body” of claim 1 lines 18-19.
The disclosure of the prior-filed application, Application No. 16/139,434, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The disclosure of Application No. 16/139,434 fails to provide adequate support for at least “the support instrument comprising a lock configured to translate longitudinally relative to a longitudinal axis of the support instrument to lock the support instrument relative to the implantable anchor” of claim 1 lines 11-13 for an instrument comprising “a plurality of sockets slidably coupled to the body” of claim 1 line 3 where “each of the plurality of sockets is disposed at an end of an arm extending from the body” of claim 1 lines 18-19
Accordingly, the effective filing date is considered September 24, 2018.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 1, the specification appears to lack proper antecedent basis for “the support instrument comprising a lock configured to translate longitudinally relative to a longitudinal axis of the support instrument to lock the support instrument relative to the implantable anchor” of lines 11-13 for an instrument comprising “a plurality of sockets slidably coupled to the body” of line 3 where “each of the plurality of sockets is disposed at an end of an arm extending from the body” of lines 18-19. That is, the elected instrument species of Figs. 93-101E is disclosed to have a plurality of sockets slidably coupled to the body and disposed at an end of an arm extending from the body as shown e.g. in Fig. 95C and a support instrument 9302 as shown in Fig. 93; however, such is silent to a disclosure “the support instrument comprising a lock configured to translate longitudinally relative to a longitudinal axis of the support instrument to lock the support instrument relative to the implantable anchor”. Instead, Fig. 3 shows support instrument 102 for the non-elected instrument of species A)1) Figs. 1-7 and 9, as having lock 302, which is disclosed for “coupling with and translating or sliding along or relative to the elongate body 108” of support instrument 102; however, the embodiment of Figs. 1-7 and 9 does not have sockets slidably coupled to the body and disposed on an arm extending from the body as shown in e.g. Fig. 4. While review of Figs. 1 and 93 shows that support instruments 102 and 9302 have some similarities, Fig. 93 notably is absent the lock 302 of support instruments 102 and the specification appears to be silent to a disclosure of using lock 302 with instrument 9302. Further, such was not originally claimed. Thus, the specification fails to provide proper antecedent basis for “the support instrument comprising a lock configured to translate longitudinally relative to a longitudinal axis of the support instrument to lock the support instrument relative to the implantable anchor” of lines 11-13 for an instrument comprising “a plurality of sockets slidably coupled to the body” of line 3 where “each of the plurality of sockets is disposed at an end of an arm extending from the body” of lines 18-19. As noted in the interview and interview summary, Examiner suggests identification of support for using lock 302 in the elected species.
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 “the support instrument comprising a lock configured to translate longitudinally relative to a longitudinal axis of the support instrument to lock the support instrument relative to the implantable anchor” of claim 1 lines 11-13 for an instrument comprising “a plurality of sockets slidably coupled to the body” of line 3 where “each of the plurality of sockets is disposed at an end of an arm extending from the body” of lines 18-19 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 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: “drive features” in claim 33 line 1.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1, 3, 4, 6-8, 11, 13, and 33-40 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claims 1, 3, 4, 6-8, 11, 13, and 33-40, “the support instrument comprising a lock configured to translate longitudinally relative to a longitudinal axis of the support instrument to lock the support instrument relative to the implantable anchor” of claim 1 lines 11-13 for an instrument comprising “a plurality of sockets slidably coupled to the body” of line 3 where “each of the plurality of sockets is disposed at an end of an arm extending from the body” of lines 18-19 appears to be new matter. That is, the elected instrument species of Figs. 93-101E is disclosed to have a plurality of sockets slidably coupled to the body and disposed at an end of an arm extending from the body as shown e.g. in Fig. 95C and a support instrument 9302 as shown in Fig. 93; however, such is silent to a disclosure “the support instrument comprising a lock configured to translate longitudinally relative to a longitudinal axis of the support instrument to lock the support instrument relative to the implantable anchor”. Instead, Fig. 3 shows support instrument 102 for the non-elected instrument of species A)1) Figs. 1-7 and 9, as having lock 302, which is disclosed for “coupling with and translating or sliding along or relative to the elongate body 108” of support instrument 102; however, the embodiment of Figs. 1-7 and 9 does not have sockets slidably coupled to the body and disposed on an arm extending from the body as shown in e.g. Fig. 4. While review of Figs. 1 and 93 shows that support instruments 102 and 9302 have some similarities, Fig. 93 notably is absent the lock 302 of support instruments 102 and the specification appears to be silent to a disclosure of using lock 302 with instrument 9302. Further, such was not originally claimed. Thus, “the support instrument comprising a lock configured to translate longitudinally relative to a longitudinal axis of the support instrument to lock the support instrument relative to the implantable anchor” of lines 11-13 for an instrument comprising “a plurality of sockets slidably coupled to the body” of line 3 where “each of the plurality of sockets is disposed at an end of an arm extending from the body” of lines 18-19 constitutes new matter. As noted in the interview and interview summary, Examiner suggests identification of support for using lock 302 in the elected species.
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) 3 and 4 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) 3 and 4 recites/recite the limitation "the anchor extension" in claim 3 line 2, claim 3 line 3, and claim 4 line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “the support extension”.
Claim(s) 4 is/are unclear with regards to “the lock” in line 1 and if such is intended to refer to that of claim 1 line 12 or claim 3 line 1. Examiner is interpreting this as referring to, and suggests amending as, “wherein the lock of the body includes a pawl”.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
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.
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.
/AMY R SIPP/Primary Examiner, Art Unit 3775