Detailed Action
This is the final office action for US application number 18/390,645. Claims are evaluated as filed on January 29, 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 January 29, 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 asserts that Weiland, Dziedzic, Baxter, Kimura, Moody, and Main teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to claims dated January 29, 2026, Examiner notes that such contains amendments that have not been properly annotated per MPEP 714. For example, in claims dated October 27, 2025 claim 4 depended from claim 2, claim 5 depended from claim 4, claim 7 depended from claim 6, and claim 12 depended from claim 11; however, in claims dated January 29, 2026 claim 4 depends from claim 1, claim 5 depends from claim 3, claim 7 depends from claim 5, and claim 12 depends from claim 10 with no annotation of the change. Examiner notes that such amendments are improper and requests adherence to MPEP 714 in making claim amendments. Examiner has attempted to identify the improper amendments and address them accordingly.
With regards to Applicant’s argument that claims 6 and 7 should be rejoined as discussed in the specification in paragraph 124 for pins 1810 and groove 2102 and request for rejoinder of improperly withdrawn claims 6, 7, 3, and 22 (Remarks p. 6, 7, and 9), Examiner notes that specification paragraph 124 discuses anvil 1868 of Figs. 23A-23B with flats 2390 that can interface with pins 1842 in reference to Figs. 23A-23B. Applicants noted pins 1810 and groove 2102 are instead disclosed in paragraph 123 in reference to FIGS. 21A-21B as features of inner sleeve 1808, i.e. not an anvil as provided by claim 6. Thus, claims 6 and 7 have been appropriately withdrawn as detailed on page 2 of the non-final office action dated November 12, 2025. With regards to claims 3 and 22, Applicant has provided no reasoning that such withdraw would be improper. Further, Examiner notes that Applicant indicated in the response dated October 27, 2025 that claims 1, 2, and 4-21 read on the elected species and that claims 3 and 22 are withdrawn from consideration. That is, Applicant withdrew claims 3 and 22 and such was not deemed necessary by the Examiner.
With regards to Applicant’s argument that Applicant is resubmitting references previously crossed out in an IDS and filed with the response on January 29, 2026 (Remarks p. 7), Examiner notes that such references have not been received nor has a corresponding IDS been received for consideration of any references cited therein.
With regards to Applicant’s argument that agreement was reached that independent claim 1 overcomes the cited references subject to further search and consideration (Remarks p. 8), Examiner disagrees and notes that, as provided in the interview summary dated January 27, 2026, Applicant attempted to provide an entire response to an office action within an interview and such is not able to be conducted in the time allotted to interview practice. As noted in the interview summary dated January 27, 2026, there are two distinct rejections of claim 1 in the non-final office action dated November 12, 2025. With regards to the rejection under 35 USC 103 over Weiland in view of Dziedzic, Examiner agrees that instant claim 1 overcomes the rejection. With regards to the rejection under 35 USC 103 over Weiland in view of Dziedzic and Baxter, Examiner disagrees as, as detailed in the rejection below, Baxter discloses that the construction prevents binding or adherence with parts which are strong and durable against the confined rod/shaft (p. 1 lines 42-48) and result in an easy and satisfactory operation of the hook (p. 2 line 114-117). Thus, one would reasonably expect that an easy to operate capture arm (Baxter p. 1 lines 42-48, p. 2 line 114-117) on a pivot pin would be capable of pivoting to selectively expose the opening in response to a force applied to the capture arm by the rod/shaft or an implant that has been secured to a vertebra (Weiland ¶34 discloses use on rods extending along the spine at the end of an implantation operation) sufficient to allow the rod/shaft or an implant to pass therethrough.
With regards to Applicant’s argument that the spring-tongue snap of Baxter does not have a capture arm that can selectively expose the opening in response to a force applied to the capture arm by the implant as a pivoting action would not occur in response to a force applied to the capture arm by the implant and such would be detrimental to the operation of Baxter as such would result in undesired opening of the capture arm and that devices such as Baxter tend to require larger, sustained manual force, e.g. via user’s hand, to pivot the capture arm and maintain it in such a position and allowing the force from an implant to perform this function would change the principle of operation of Baxter (Remarks p. 8), Examiner notes that Applicant has provided to support for these assertions regarding the capabilities of Baxter and such to not appear to be substantiated by the disclosure of Baxter. With regards to the assertion that allowing the force from an implant to perform this function would change the principle of operation of Baxter, Examiner notes that no modification of Baxter has been proposed and such is instead used as a teaching of adding an opening, pivot pin, pocket, and capture arm as detailed below, in the non-final office action dated November 12, 2025, and in the interview summary dated January 27, 2026. Further, Baxter specifically discloses that the construction prevents binding or adherence with parts which are strong and durable against the confined rod/shaft (p. 1 lines 42-48) and result in an easy and satisfactory operation of the hook (p. 2 line 114-117) as well as element E of the capture arm being an actuating spring (p. 1 line 95). Thus, one would reasonably expect that an easy to operate capture arm (Baxter p. 1 lines 42-48, p. 2 line 114-117) on a pivot pin would be capable of pivoting to selectively expose the opening in response to a force applied to the capture arm by the rod/shaft or an implant that has been secured to a vertebra (Weiland ¶34 discloses use on rods extending along the spine at the end of an implantation operation) sufficient to allow the rod/shaft or an implant to pass therethrough.
With regards to Applicant’s argument that agreement was reached that the subject matter of new claims 33 and 37 distinguish over the cited references (Remarks p. 9), Examiner notes that the instant claims 33 and 37 were not provided for the interview but appear to reflect topics discussed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
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 claims 1, 2, 4, 5, 8, 9, and 11-16, the specification appears to lack proper antecedent basis for “the capture arm being pivotably coupled to the outer sleeve and configured to pivot to selectively expose the opening in response to a force applied to the capture arm by the implant to allow the implant to pass therethrough” of claim 1 lines 5-7. That is, paragraph 10 discloses such “In certain embodiments” but is silent at to which of the disclosed embodiments. The only other disclosure of this subject matter appears to be in paragraph 118 with regards to contact with rod 112 with capture arm 126 of Figs. 17B-17E, i.e. non-elected species a) of Figs. 1-12B and 17A-17K. Thus, the specification fails to provide proper antecedent basis for “the capture arm being pivotably coupled to the outer sleeve and configured to pivot to selectively expose the opening in response to a force applied to the capture arm by the implant to allow the implant to pass therethrough” of claim 1 lines 5-7 with regards to the elected species d) of Figs. 18A-28.
As claim 34, the specification appears to lack proper antecedent basis for “the capture arm is configured to pivot to expose the opening in response to a force applied to the capture arm by the implant” of claim 34 lines 1-2. That is, paragraph 10 discloses such “In certain embodiments” but is silent at to which of the disclosed embodiments. The only other disclosure of this subject matter appears to be in paragraph 118 with regards to contact with rod 112 with capture arm 126 of Figs. 17B-17E, i.e. non-elected species a) of Figs. 1-12B and 17A-17K. Thus, the specification fails to provide proper antecedent basis for “the capture arm is configured to pivot to expose the opening in response to a force applied to the capture arm by the implant” of claim 34 lines 1-2 with regards to the elected species d) of Figs. 18A-28.
As claim 38, the specification appears to lack proper antecedent basis for “the capture arm is configured to pivot to expose the opening in response to a force applied to the capture arm by the implant” of claim 38 lines 1-2. That is, paragraph 10 discloses such “In certain embodiments” but is silent at to which of the disclosed embodiments. The only other disclosure of this subject matter appears to be in paragraph 118 with regards to contact with rod 112 with capture arm 126 of Figs. 17B-17E, i.e. non-elected species a) of Figs. 1-12B and 17A-17K. Thus, the specification fails to provide proper antecedent basis for “the capture arm is configured to pivot to expose the opening in response to a force applied to the capture arm by the implant” of claim 38 lines 1-2 with regards to the elected species d) of Figs. 18A-28.
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 capture arm being pivotably coupled to the outer sleeve and configured to pivot to selectively expose the opening in response to a force applied to the capture arm by the implant to allow the implant to pass therethrough” of claim 1 lines 5-7 with regards to the elected species d) of Figs. 18A-28, “the capture arm is configured to pivot to expose the opening in response to a force applied to the capture arm by the implant” of claim 34 lines 1-2, the “lumen that extends therethrough” of claim 37 line 2, and “the capture arm is configured to pivot to expose the opening in response to a force applied to the capture arm by the implant” of claim 38 lines 1-2 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, 33, and 37 is/are objected to because of the following informalities:
Claim 1 line 1 should read “A surgical instrument[[,]] comprising:”.
Claim 33 line 1 should read “A surgical instrument[[,]] comprising:”.
Claim 37 line 1 should read “A surgical instrument[[,]] comprising:”.
Appropriate correction is required.
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, 2, 4, 5, 8, 9, 11-16, 34, and 38 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 claims 1, 2, 4, 5, 8, 9, and 11-16, “the capture arm being pivotably coupled to the outer sleeve and configured to pivot to selectively expose the opening in response to a force applied to the capture arm by the implant to allow the implant to pass therethrough” of claim 1 lines 5-7 appears to be new matter. That is, paragraph 10 discloses such “In certain embodiments” but is silent at to which of the disclosed embodiments. The only other disclosure of this subject matter appears to be in paragraph 118 with regards to contact with rod 112 with capture arm 126 of Figs. 17B-17E, i.e. non-elected species a) of Figs. 1-12B and 17A-17K. Thus, “the capture arm being pivotably coupled to the outer sleeve and configured to pivot to selectively expose the opening in response to a force applied to the capture arm by the implant to allow the implant to pass therethrough” of claim 1 lines 5-7 is new matter with regards to the elected species d) of Figs. 18A-28.
As claim 34, “the capture arm is configured to pivot to expose the opening in response to a force applied to the capture arm by the implant” of claim 34 lines 1-2 appears to be new matter. That is, paragraph 10 discloses such “In certain embodiments” but is silent at to which of the disclosed embodiments. The only other disclosure of this subject matter appears to be in paragraph 118 with regards to contact with rod 112 with capture arm 126 of Figs. 17B-17E, i.e. non-elected species a) of Figs. 1-12B and 17A-17K. Thus, “the capture arm is configured to pivot to expose the opening in response to a force applied to the capture arm by the implant” of claim 34 lines 1-2 is new matter with regards to the elected species d) of Figs. 18A-28.
As claim 38, “the capture arm is configured to pivot to expose the opening in response to a force applied to the capture arm by the implant” of claim 38 lines 1-2 appears to be new matter. That is, paragraph 10 discloses such “In certain embodiments” but is silent at to which of the disclosed embodiments. The only other disclosure of this subject matter appears to be in paragraph 118 with regards to contact with rod 112 with capture arm 126 of Figs. 17B-17E, i.e. non-elected species a) of Figs. 1-12B and 17A-17K. Thus, “the capture arm is configured to pivot to expose the opening in response to a force applied to the capture arm by the implant” of claim 38 lines 1-2 is new matter with regards to the elected species d) of Figs. 18A-28.
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) 4, 5, 12, 37,and 38 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) 4 is/are unclear with regards to its dependency from claim 1 in line 1. Further, Examiner notes that such has been amended without proper annotations relative to the claims dated October 27, 2025. Examiner is interpreting this as referring to, and suggests amending as, “The instrument of claim [[1]]2, wherein”.
Claim(s) 5 is/are unclear with regards to its dependency from withdrawn claim 3 in line 1. Further, Examiner notes that such has been amended without proper annotations relative to the claims dated October 27, 2025. Examiner is interpreting this as referring to, and suggests amending as, “The instrument of claim [[3]]4, wherein”.
Claim(s) 12 is/are unclear with regards to its dependency from cancelled claim 10 in line 1. Examiner is interpreting this as referring to, and suggests amending as, “The instrument of claim 1[[0]]1, wherein”.
Claim(s) 37 is/are unclear with regards to “a lumen that extends therethrough” in line 2 and the intended meaning of therethrough as, e.g. Figs. 25B and 25C show that the lumen does not extend through the left end of the outer sleeve, but Fig. 18A shows a circle on the left end that would commonly represent an opening. Further, claim 5 provides that there is a sharpened edge position on the opposite side of the outer sleeve from the anvil. Examiner is interpreting this as referring to, and suggests amending as, “an outer sleeve having a lumen
Claim(s) 38 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 § 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 of this title, 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.
Claim(s) 1, 2, 4, 5, 9, and 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiland (DE 10128596 and corresponding machine translation as provided with the PTO-892 dated November 12, 2025) in view of Dziedzic et al (US 2009/0062858, hereinafter “Dziedzic”) and Baxter (US 1,032,369).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 1, 2, 4, 5, 9, and 11-16, Weiland discloses a surgical instrument (Figs. 1-7, translation ¶s 1 and 34) comprising: an outer sleeve (1, 38, 14) having a lumen (shown holding 4, 19, and 14 in Fig. 1, indicated with dashed lines in Figs. 3 and 4); and an inner shaft (4) disposed in the lumen of the outer sleeve (Fig. 1), the inner sleeve being capable of rotating relative to the outer sleeve (translation ¶s 29, 31, and 36), the inner shaft including a protruding pin (26, Fig. 2); and an anvil (24, 18, 23, 19) disposed in the lumen of the outer sleeve (Fig. 1) and extending distal to the inner sleeve (Figs. 1 and 2), the anvil being capable of translating without rotating relative to the outer sleeve to cut the implant (along guide grooves 17, translation ¶26), the anvil including a lumen (25, Fig. 2) capable of receiving the protruding pin of the inner shaft (translation ¶30). As to claim 2, Weiland discloses that the inner shaft is capable of rotating relative to the outer sleeve to translate the anvil distally with respect to the outer sleeve (translation ¶36). As to claim 4, Weiland discloses that the anvil further comprises a cutting tip (20, Fig. 2, translation ¶27) at a distal end thereof (Fig. 2) capable of use for cutting the implant (translation ¶27). As to claim 5, Weiland discloses that the cutting tip is V-shaped (Figs. 1 and 2, translation ¶27). As to claim 9, Weiland discloses that the implant comprises a spinal rod (translation ¶s 1 and 34). As to claim 14, Weiland a counter-torque handle (6) capable of mating with the outer sleeve (Fig. 1) capable of preventing rotation of the outer sleeve during rotation of the inner sleeve (translation ¶38). As to claim 15, Weiland that the outer sleeve includes a sharpened edge (15, Figs. 1 and 2) capable of contacting an implant on an opposite side from the anvil (Figs. 1 and 2, translation ¶27). As to claim 16, Weiland that a proximal end of the inner sleeve comprises a drive feature (upper portion of 4 as shown in Fig. 1, Fig. 1) capable of coupling with a torque application device (5) capable of facilitating rotation of the inner sleeve (translation ¶38).
Weiland is silent to an opening formed in a sidewall of the outer sleeve and configured to receive at least a portion of an implant therethrough; a capture arm disposed within the opening, the capture arm being pivotably coupled to the outer sleeve and configured to pivot to selectively expose the opening in response to a force applied to the capture arm by the implant to allow the implant to pass therethrough; the inner shaft being an inner sleeve. As to claim 11, Weiland is silent to the capture arm is biased to be disposed within the opening. As to claim 12, Weiland is silent to the capture arm is biased by a spring disposed in a channel formed in the capture arm that exerts a radially outward force onto the capture arm. As to claim 13, Weiland is silent to a pocket formed on an inner surface of a sidewall of the outer sleeve opposite the opening, the pocket being configured to receive the capture arm when the capture arm selectively exposes the opening.
Dziedzic teaches a similar surgical instrument (Figs. 8A-8B) comprising: an outer sleeve (800) having a lumen (806, Fig. 8A, ¶59); an opening (shown in Figs. 8A and 8B with 810 blocking the opening, ¶61) formed in a sidewall of the outer sleeve (Figs. 8A and 8B) and capable of receiving at least a portion of an implant (626) therethrough (Figs. 8A and 8B, ¶s 60 and 61); a capture arm (810) disposed within the opening (Figs. 8A and 8B), the capture arm being pivotably coupled to the outer sleeve (¶s 60 and 61) and capable of pivoting to selectively expose the opening to allow the implant to pass therethrough (¶60); and an inner shaft (Figs. 8A and 8B) disposed in the lumen of the outer sleeve (Figs. 8A and 8B), the inner sleeve being capable of rotating relative to the outer sleeve (disclosed in ¶65 for Fig. 10A embodiment, where ¶65 discloses that such is discussed in relation to Figs. 7-9); and an anvil (Figs. 8A and 8B) disposed in the lumen of the outer sleeve (Figs. 8A and 8B); and a pivot pin (814).
Baxter teaches a similar instrument (Figs. 1-6) forming a closed hook (Fig. 4) capable of confining a rod or shaft (due to the structure shown in Fig. 4, p. 1 line 48-49, p. 2 lines 29-31), the instrument comprising: an outer sleeve (B); an opening (shown in Fig. 4 with F blocking the opening and shown unblocked in Fig. 3, Figs. 1-3) formed in a sidewall of the outer sleeve (Figs. 3 and 4) and capable of receiving at least a portion of an implant therethrough (due to the structure shown in Figs. 3 and 4, p. 1 line 48-49); a capture arm (F, F’, f, f, E) disposed within the opening (Fig. 4), the capture arm being pivotably coupled to the outer sleeve (about D, Fig. 4, p. 1 lines 42-45) and capable of pivoting to selectively expose the opening (Fig. 4) in response to a force applied to the capture arm by the implant (Fig. 4, p. 1 lines 42-48 discloses construction to prevent binding or adherence with parts which are strong and durable against the confined rod/shaft, p. 1 line 95 discloses actuating spring E, p. 2 line 114-117 discloses construction to result in an easy and satisfactory operation of the hook) capable of allowing the rod/shaft or an implant to pass therethrough (Fig. 4); and a pivot pin (D); wherein the outer sleeve comprises a pocket (C) capable of receiving the capture arm (Figs. 4-6). As to claim 11, Baxter teaches that the capture arm is biased to be disposed within the opening (Fig. 4). As to claim 12, Baxter teaches that the capture arm is biased by a spring (E) disposed in a channel (defined by f, f, and F, Figs. 4-6) formed in the capture arm (Figs. 4-6) that exerts a radially outward force onto the capture arm (Fig. 4). As to claim 13, Baxter teaches that a pocket (C) formed on an inner surface of a sidewall of the outer sleeve opposite the opening (Fig. 4), the pocket being capable of receiving the capture arm when the capture arm selectively exposes the opening (due to the structure shown in Figs. 3-6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to reverse the male-female connection between the inner shaft protruding pin and the anvil lumen such that the inner shaft is an inner sleeve comprising the lumen and the anvil protruding pin is disposed in the lumen of the inner sleeve, since a mere reversal of the essential working parts of a device involves only routine skill in the art. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the outer sleeve as disclosed by Weiland by adding an opening, a pivot pin, a pocket, and a capture arm as taught by Baxter in order to facilitate capturing the rod (Dziedzic ¶60) to confine a ring/rod (Baxter p. 2 lines 29-31, Dziedzic ¶60) using a known structure (Baxter Figs. 1-6) so that the end of the support rod can be inserted into the diamond-shaped cutting opening 31 from the side of the recess 11 (Weiland translation ¶35) for transversely separating implanted support rods extending along the spine which must be cut to the required length at the end of an implantation operation (Weiland translation ¶34), i.e. to enable insertion of the instrument over the rod at any position along a length of a rod to potentially reduce tissue damage due to enlarging an incision to slide the instrument over a free end of the rod.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiland, Dziedzic, and Baxter in view of Kimura et al. (US 2009/0318944, hereinafter “Kimura”).
As to claim 8, the combination of Weiland, Dziedzic, and Baxter discloses the invention of claim 1 but is silent to the anvil includes a coating configured to enhance a hardness thereof.
Kimura teaches a similar surgical instrument (Figs. 1-4 and 9A-9C; where ¶23 discloses that Figs. 9A-9C are a modification of a first embodiment, i.e. of Figs. 5A-7) comprising: an outer sleeve (20, 20a, Figs. 2-4) having a lumen (Figs. 2-4, ¶58); an inner shaft (30) disposed in the lumen of the outer sleeve (Figs. 2-4); and an anvil (31) disposed in the lumen of the outer sleeve (Figs. 2-4) and extending distal to the inner sleeve (Figs. 2 and 4); wherein the anvil includes a coating (33, Figs. 9A-9C) capable of enhancing a hardness thereof (¶101).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the anvil as disclosed by the combination of Weiland, Dziedzic, and Baxter by adding a coating as taught by Kimura in order to improve the durability to wear and damage (Kimura ¶102).
Claim(s) 1, 2, 4, 5, 9, 11, 13-16, and 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiland (DE 10128596 and corresponding machine translation as provided with the PTO-892 dated November 12, 2025) in view of Dziedzic et al (US 2009/0062858, hereinafter “Dziedzic”) and Moody (US 1,790,056).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 1, 2, 4, 5, 9, 11, and 13-16, Weiland discloses a surgical instrument (Figs. 1-7, translation ¶s 1 and 34) comprising: an outer sleeve (1, 38, 14) having a lumen (shown holding 4, 19, and 14 in Fig. 1, indicated with dashed lines in Figs. 3 and 4); and an inner shaft (4) disposed in the lumen of the outer sleeve (Fig. 1), the inner sleeve being capable of rotating relative to the outer sleeve (translation ¶s 29, 31, and 36), the inner shaft including a protruding pin (26, Fig. 2); and an anvil (24, 18, 23, 19) disposed in the lumen of the outer sleeve (Fig. 1) and extending distal to the inner sleeve (Figs. 1 and 2), the anvil being capable of translating without rotating relative to the outer sleeve to cut the implant (along guide grooves 17, translation ¶26), the anvil including a lumen (25, Fig. 2) capable of receiving the protruding pin of the inner shaft (translation ¶30). As to claim 2, Weiland discloses that the inner shaft is capable of rotating relative to the outer sleeve to translate the anvil distally with respect to the outer sleeve (translation ¶36). As to claim 4, Weiland discloses that the anvil further comprises a cutting tip (20, Fig. 2, translation ¶27) at a distal end thereof (Fig. 2) capable of use for cutting the implant (translation ¶27). As to claim 5, Weiland discloses that the cutting tip is V-shaped (Figs. 1 and 2, translation ¶27). As to claim 9, Weiland discloses that the implant comprises a spinal rod (translation ¶s 1 and 34). As to claim 14, Weiland a counter-torque handle (6) capable of mating with the outer sleeve (Fig. 1) capable of preventing rotation of the outer sleeve during rotation of the inner sleeve (translation ¶38). As to claim 15, Weiland that the outer sleeve includes a sharpened edge (15, Figs. 1 and 2) capable of contacting an implant on an opposite side from the anvil (Figs. 1 and 2, translation ¶27). As to claim 16, Weiland that a proximal end of the inner sleeve comprises a drive feature (upper portion of 4 as shown in Fig. 1, Fig. 1) capable of coupling with a torque application device (5) capable of facilitating rotation of the inner sleeve (translation ¶38).
Weiland is silent to an opening formed in a sidewall of the outer sleeve and configured to receive at least a portion of an implant therethrough; a capture arm disposed within the opening, the capture arm being pivotably coupled to the outer sleeve and configured to pivot to selectively expose the opening in response to a force applied to the capture arm by the implant to allow the implant to pass therethrough; the inner shaft being an inner sleeve. As to claim 11, Weiland is silent to the capture arm is biased to be disposed within the opening. As to claim 13, Weiland is silent to a pocket formed on an inner surface of a sidewall of the outer sleeve opposite the opening, the pocket being configured to receive the capture arm when the capture arm selectively exposes the opening.
Dziedzic teaches a similar surgical instrument (Figs. 8A-8B) comprising: an outer sleeve (800) having a lumen (806, Fig. 8A, ¶59); an opening (shown in Figs. 8A and 8B with 810 blocking the opening, ¶61) formed in a sidewall of the outer sleeve (Figs. 8A and 8B) and capable of receiving at least a portion of an implant (626) therethrough (Figs. 8A and 8B, ¶s 60 and 61); a capture arm (810) disposed within the opening (Figs. 8A and 8B), the capture arm being pivotably coupled to the outer sleeve (¶s 60 and 61) and capable of pivoting to selectively expose the opening to allow the implant to pass therethrough (¶60); and an inner shaft (Figs. 8A and 8B) disposed in the lumen of the outer sleeve (Figs. 8A and 8B), the inner sleeve being capable of rotating relative to the outer sleeve (disclosed in ¶65 for Fig. 10A embodiment, where ¶65 discloses that such is discussed in relation to Figs. 7-9); and an anvil (Figs. 8A and 8B) disposed in the lumen of the outer sleeve (Figs. 8A and 8B); and a pivot pin (814).
Moody teaches a similar instrument (Figs. 1-3) forming a closed hook (Figs. 1 and 2) capable of confining a bail/rod/shaft (due to the structure shown in Fig. 1, p. 1 lines 1-5 and 9-13, p. 2 lines 10-15), the instrument comprising: an outer sleeve (2, 8, 6); an opening (shown in Figs. 1 and 2 with 13 blocking the opening and shown unblocked with the dashed lines for 13 in Fig. 2, Figs. 1 and 2) formed in a sidewall of the outer sleeve (Figs. 1 and 2) and capable of receiving at least a portion of an implant therethrough (due to the structure shown in Figs. 1 and 2, p. 1 lines 1-5 and 9-13, p. 2 lines 10-15); a capture arm (13, 11) disposed within the opening (Fig. 1), the capture arm being pivotably coupled to the outer sleeve (about 14, Figs. 1 and 2, p. 1 line 70) and capable of pivoting to selectively expose the opening (Fig. 2) in response to a force applied to the capture arm by the implant (Fig. 2, p. 2 lines 11-16 discloses that capture arm portion 13 is free to be moved by the bails inwardly or outwardly when capture arm portion 11 is pressed inwardly and that there is no possibility of jamming) capable of allowing the rod/shaft or an implant to pass therethrough (Fig. 2, p. 1 lines 1-5 and 9-13, p. 2 lines 11-16); a pivot pin (14, 10); and a spring (16). As to claim 11, Moody teaches that the capture arm is biased to be disposed within the opening (Fig. 2, p. 1 line 95 – p. 2 line 2). As to claim 13, Moody teaches a pocket (5, 5a) formed on an inner surface of a sidewall of the outer sleeve opposite the opening (Fig. 2), the pocket being capable of receiving a distal end of the capture arm when the capture arm selectively exposes the opening (shown with the left dashed 13 in Fig. 2, Fig. 2, p. 1 lines 65-70).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to reverse the male-female connection between the inner shaft protruding pin and the anvil lumen such that the inner shaft is an inner sleeve comprising the lumen and the anvil protruding pin is disposed in the lumen of the inner sleeve, since a mere reversal of the essential working parts of a device involves only routine skill in the art. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the outer sleeve as disclosed by Weiland by adding an opening, a pivot pin, a pocket, a capture arm, and spring as taught by Moody in order to facilitate capturing the rod (Dziedzic ¶60) to confine a ring/rod (Baxter p. 2 lines 29-31, Dziedzic ¶60) using a known structure (Moody Figs. 1 and 2, p. 2 lines 11-16) so that the end of the support rod can be inserted into the diamond-shaped cutting opening 31 from the side of the recess 11 (Weiland translation ¶35) for transversely separating implanted support rods extending along the spine which must be cut to the required length at the end of an implantation operation (Weiland translation ¶34), i.e. to enable insertion of the instrument over the rod at any position along a length of a rod to potentially reduce tissue damage due to enlarging an incision to slide the instrument over a free end of the rod.
As to claims 33-35, Weiland discloses a surgical instrument (Figs. 1-7, translation ¶s 1 and 34) comprising: an outer sleeve (1, 38, 14) having a lumen (shown holding 4, 19, and 14 in Fig. 1, indicated with dashed lines in Figs. 3 and 4); and an inner shaft (4) disposed in the lumen of the outer sleeve (Fig. 1), the inner sleeve being capable of rotating relative to the outer sleeve (translation ¶s 29, 31, and 36), the inner shaft including a protruding pin (26, Fig. 2); and an anvil (24, 18, 23, 19) disposed in the lumen of the outer sleeve (Fig. 1) and extending distal to the inner sleeve (Figs. 1 and 2), the anvil being capable of translating without rotating relative to the outer sleeve to cut the implant (along guide grooves 17, translation ¶26), the anvil including a lumen (25, Fig. 2) capable of receiving the protruding pin of the inner shaft (translation ¶30).
Weiland is silent to an opening formed in a sidewall of the outer sleeve and configured to receive at least a portion of an implant therethrough; a capture arm disposed within the opening, the capture arm being pivotably coupled to the outer sleeve and configured to selectively expose the opening to allow the implant to pass therethrough; a pocket formed on an inner surface of a sidewall of the outer sleeve opposite the opening, the pocket being configured to receive a distal end of the capture arm when the capture arm selectively exposes the opening, the inner shaft being an inner sleeve. As to claim 34, Weiland is silent to the capture arm is configured to pivot to expose the opening in response to a force applied to the capture arm by the implant. As to claim 35, Weiland is silent to the capture arm is biased to be disposed within the opening.
Dziedzic teaches a similar surgical instrument (Figs. 8A-8B) comprising: an outer sleeve (800) having a lumen (806, Fig. 8A, ¶59); an opening (shown in Figs. 8A and 8B with 810 blocking the opening, ¶61) formed in a sidewall of the outer sleeve (Figs. 8A and 8B) and capable of receiving at least a portion of an implant (626) therethrough (Figs. 8A and 8B, ¶s 60 and 61); a capture arm (810) disposed within the opening (Figs. 8A and 8B), the capture arm being pivotably coupled to the outer sleeve (¶s 60 and 61) and capable of pivoting to selectively expose the opening to allow the implant to pass therethrough (¶60); and an inner shaft (Figs. 8A and 8B) disposed in the lumen of the outer sleeve (Figs. 8A and 8B), the inner sleeve being capable of rotating relative to the outer sleeve (disclosed in ¶65 for Fig. 10A embodiment, where ¶65 discloses that such is discussed in relation to Figs. 7-9); and an anvil (Figs. 8A and 8B) disposed in the lumen of the outer sleeve (Figs. 8A and 8B); and a pivot pin (814).
Moody teaches a similar instrument (Figs. 1-3) forming a closed hook (Figs. 1 and 2) capable of confining a bail/rod/shaft (due to the structure shown in Fig. 1, p. 1 lines 1-5 and 9-13, p. 2 lines 10-15), the instrument comprising: an outer sleeve (2, 8, 6); an opening (shown in Figs. 1 and 2 with 13 blocking the opening and shown unblocked with the dashed lines for 13 in Fig. 2, Figs. 1 and 2) formed in a sidewall of the outer sleeve (Figs. 1 and 2) and capable of receiving at least a portion of an implant therethrough (due to the structure shown in Figs. 1 and 2, p. 1 lines 1-5 and 9-13, p. 2 lines 10-15); a capture arm (13, 11) disposed within the opening (Fig. 1), the capture arm being pivotably coupled to the outer sleeve (about 14, Figs. 1 and 2, p. 1 line 70) and capable of selectively exposing the opening (Fig. 2) in response to a force applied to the capture arm by the implant (Fig. 2, p. 2 lines 11-16 discloses that capture arm portion 13 is free to be moved by the bails inwardly or outwardly when capture arm portion 11 is pressed inwardly and that there is no possibility of jamming) capable of allowing the rod/shaft or an implant to pass therethrough (Fig. 2, p. 1 lines 1-5 and 9-13, p. 2 lines 11-16); a pivot pin (14, 10); a spring (16); and a pocket (5, 5a) formed on an inner surface of a sidewall of the outer sleeve opposite the opening (Fig. 2), the pocket being capable of receiving a distal end of the capture arm when the capture arm selectively exposes the opening (shown with the left dashed 13 in Fig. 2, Fig. 2, p. 1 lines 65-70). As to claim 34, Moody teaches that the capture arm is capable of pivoting to expose the opening in response to a force applied to the capture arm by the implant/bail/rod/shaft (p. 2 lines 11-16). As to claim 35, Moody teaches that the capture arm is biased to be disposed within the opening (Fig. 2, p. 1 line 95 – p. 2 line 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to reverse the male-female connection between the inner shaft protruding pin and the anvil lumen such that the inner shaft is an inner sleeve comprising the lumen and the anvil protruding pin is disposed in the lumen of the inner sleeve, since a mere reversal of the essential working parts of a device involves only routine skill in the art. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the outer sleeve as disclosed by Weiland by adding an opening, a pivot pin, a pocket, a capture arm, and spring as taught by Moody in order to facilitate capturing the rod (Dziedzic ¶60) to confine a ring/rod (Baxter p. 2 lines 29-31, Dziedzic ¶60) using a known structure (Moody Figs. 1 and 2, p. 2 lines 11-16) so that the end of the support rod can be inserted into the diamond-shaped cutting opening 31 from the side of the recess 11 (Weiland translation ¶35) for transversely separating implanted support rods extending along the spine which must be cut to the required length at the end of an implantation operation (Weiland translation ¶34), i.e. to enable insertion of the instrument over the rod at any position along a length of a rod to potentially reduce tissue damage due to enlarging an incision to slide the instrument over a free end of the rod.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiland, Dziedzic, and Moody in view of Kimura et al. (US 2009/0318944, hereinafter “Kimura”).
As to claim 8, the combination of Weiland, Dziedzic, and Moody discloses the invention of claim 1 but is silent to the anvil includes a coating configured to enhance a hardness thereof.
Kimura teaches a similar surgical instrument (Figs. 1-4 and 9A-9C; where ¶23 discloses that Figs. 9A-9C are a modification of a first embodiment, i.e. of Figs. 5A-7) comprising: an outer sleeve (20, 20a, Figs. 2-4) having a lumen (Figs. 2-4, ¶58); an inner shaft (30) disposed in the lumen of the outer sleeve (Figs. 2-4); and an anvil (31) disposed in the lumen of the outer sleeve (Figs. 2-4) and extending distal to the inner sleeve (Figs. 2 and 4); wherein the anvil includes a coating (33, Figs. 9A-9C) capable of enhancing a hardness thereof (¶101).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the anvil as disclosed by the combination of Weiland, Dziedzic, and Moody by adding a coating as taught by Kimura in order to improve the durability to wear and damage (Kimura ¶102).
Claim(s) 33-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiland (DE 10128596 and corresponding machine translation as provided with the PTO-892 dated November 12, 2025) in view of Dziedzic et al (US 2009/0062858, hereinafter “Dziedzic”) and Main (US 208,250).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 33-36, Weiland discloses a surgical instrument (Figs. 1-7, translation ¶s 1 and 34) comprising: an outer sleeve (1, 38, 14) having a lumen (shown holding 4, 19, and 14 in Fig. 1, indicated with dashed lines in Figs. 3 and 4); and an inner shaft (4) disposed in the lumen of the outer sleeve (Fig. 1), the inner sleeve being capable of rotating relative to the outer sleeve (translation ¶s 29, 31, and 36), the inner shaft including a protruding pin (26, Fig. 2); and an anvil (24, 18, 23, 19) disposed in the lumen of the outer sleeve (Fig. 1) and extending distal to the inner sleeve (Figs. 1 and 2), the anvil being capable of translating without rotating relative to the outer sleeve to cut the implant (along guide grooves 17, translation ¶26), the anvil including a lumen (25, Fig. 2) capable of receiving the protruding pin of the inner shaft (translation ¶30).
Weiland is silent to an opening formed in a sidewall of the outer sleeve and configured to receive at least a portion of an implant therethrough; a capture arm disposed within the opening, the capture arm being pivotably coupled to the outer sleeve and configured to selectively expose the opening to allow the implant to pass therethrough; a pocket formed on an inner surface of a sidewall of the outer sleeve opposite the opening, the pocket being configured to receive a distal end of the capture arm when the capture arm selectively exposes the opening, the inner shaft being an inner sleeve. As to claim 34, Weiland is silent to the capture arm is configured to pivot to expose the opening in response to a force applied to the capture arm by the implant. As to claim 35, Weiland is silent to the capture arm is biased to be disposed within the opening. As to claim 36, Weiland is silent to the capture arm is biased by a spring disposed in a channel formed in the capture arm that exerts a radially outward force onto the capture arm.
Dziedzic teaches a similar surgical instrument (Figs. 8A-8B) comprising: an outer sleeve (800) having a lumen (806, Fig. 8A, ¶59); an opening (shown in Figs. 8A and 8B with 810 blocking the opening, ¶61) formed in a sidewall of the outer sleeve (Figs. 8A and 8B) and capable of receiving at least a portion of an implant (626) therethrough (Figs. 8A and 8B, ¶s 60 and 61); a capture arm (810) disposed within the opening (Figs. 8A and 8B), the capture arm being pivotably coupled to the outer sleeve (¶s 60 and 61) and capable of pivoting to selectively expose the opening to allow the implant to pass therethrough (¶60); and an inner shaft (Figs. 8A and 8B) disposed in the lumen of the outer sleeve (Figs. 8A and 8B), the inner sleeve being capable of rotating relative to the outer sleeve (disclosed in ¶65 for Fig. 10A embodiment, where ¶65 discloses that such is discussed in relation to Figs. 7-9); and an anvil (Figs. 8A and 8B) disposed in the lumen of the outer sleeve (Figs. 8A and 8B); and a pivot pin (814).
Main teaches a similar instrument (Figs. 1-4) forming a closed hook (Figs. 1 and 2) capable of confining a /rod/shaft (due to the structure shown in Fig. 1, Fig. 1), the instrument comprising: an outer sleeve (a); an opening (shown in Figs. 1 and 2 with b’ blocking the opening and shown unblocked in Fig. 3, Figs. 1-3) formed in a sidewall of the outer sleeve (Figs. 1-3) and capable of receiving at least a portion of an implant therethrough (due to the structure shown in Figs. 1-3, Figs. 1-3); a capture arm (b’) disposed within the opening (Fig. 1), the capture arm being pivotably coupled to the outer sleeve (about c, Figs. 1-3, col. 1 ¶4) and capable of selectively exposing the opening (Fig. 3) in response to a force applied to the capture arm by the implant (when b’ is pushed forward as disclosed in col. 2 ¶2, Fig. 3) capable of allowing the rod/shaft or an implant to pass therethrough (Fig. 3); a pivot pin (c); a spring (f); and a pocket (shown holding b’ and f in Fig. 3, Figs. 2 and 3) formed on an inner surface of a sidewall of the outer sleeve opposite the opening (Figs. 2 and 3), the pocket being capable of receiving a distal end of the capture arm when the capture arm selectively exposes the opening (Fig. 3). As to claim 34, Main teaches that the capture arm is capable of pivoting to expose the opening in response to a force applied to the capture arm by the implant/rod/shaft (when b’ is pushed forward as disclosed in col. 2 ¶2, Fig. 3). As to claim 35, Main teaches that the capture arm is biased to be disposed within the opening (Fig. 2, col. 1 ¶5). As to claim 36, Main teaches that the capture arm is biased by a spring (c) disposed in a channel (e, Figs. 2 and 3, col. 1 ¶5) formed in the capture arm that exerts a radially outward force onto the capture arm (Fig. 3, col. 1 ¶5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to reverse the male-female connection between the inner shaft protruding pin and the anvil lumen such that the inner shaft is an inner sleeve comprising the lumen and the anvil protruding pin is disposed in the lumen of the inner sleeve, since a mere reversal of the essential working parts of a device involves only routine skill in the art. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the outer sleeve as disclosed by Weiland by adding an opening, a pivot pin, a pocket, a capture arm, and spring as taught by Main in order to facilitate capturing the rod (Dziedzic ¶60) to confine a ring/rod (Baxter p. 2 lines 29-31, Dziedzic ¶60) using a known structure (Main Figs. 1-3) so that the end of the support rod can be inserted into the diamond-shaped cutting opening 31 from the side of the recess 11 (Weiland translation ¶35) for transversely separating implanted support rods extending along the spine which must be cut to the required length at the end of an implantation operation (Weiland translation ¶34), i.e. to enable insertion of the instrument over the rod at any position along a length of a rod to potentially reduce tissue damage due to enlarging an incision to slide the instrument over a free end of the rod.
Allowable Subject Matter
Claim 37 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
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