DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 8/15/23. It is noted, however, that applicant has not filed a certified copy of the CN 2023110250322 application as required by 37 CFR 1.55.
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 “locking-and-cutting mechanism” (claim 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: “limiting element” in claim 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 Objections
Claim 1 is objected to because of the following informalities: in line 6, the Examiner suggests deleting “adapted.” Appropriate correction is required.
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 4 recites the limitation "the engaging portion" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claims 15 and 16 each recite “a second insertion portion.” These claims are unclear because neither independent claim 1 nor intervening claim 13 recite “a first insertion portion.” Claims 15 and 16 are indefinite because it is unclear whether there are two insertion portions or just one insertion portion. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reiser et al. (US 2012/0053629 A1) (“Reiser”).
Regarding claim 1, Reiser discloses (Figures 1-18B) a single-anchor mechanism, comprising an anchor (12), a transmission tube (52), a traction wire (36/148), and a limiting element (78), wherein one end of the traction wire is connected to the anchor (paragraph 0049), and the traction wire passes through the transmission tube (Figures 6B and 6C; paragraph 0059); an end portion (20) of the anchor opposite to the transmission tube is provided with an engaging portion (24; paragraph 0039); and the limiting element is connected to the traction wire (Figures 13-18B; paragraphs 0067-0072), and the limiting element (78) abuts against an end portion (56) of the transmission tube (52) away from the anchor (Figures 6A-6C).
NOTE: “limiting element” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, and is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification discloses: the limiting element includes a polymer elastic component, wherein the polymer elastic component can be made of materials such as silicone or rubber. The polymer elastic component is provided with a wire-clamping portion, wherein the wire-clamping portion is configured as a wire hole or wire groove. The traction wire 300 passes through the wire-clamping portion and is in interference fit with the wire-clamping portion. The limiting element disclosed by Reiser is an equivalent limiting element.
Regarding claim 2, Reiser discloses (Figures 13-18B) that the limiting element comprises a polymer elastic component (paragraphs 0067-0072), and the polymer elastic component is provided with a wire-clamping portion; the traction wire is interference-fitted into the wire-clamping portion (paragraphs 0067-0072); and the polymer elastic component abuts against the end portion (56) of the transmission tube (52) away from the anchor.
Claims 1 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khairkhahan et al. (US 2015/0366556 A1) (“Khairkhahan”).
Regarding claim 1, Khairkhahan discloses (Figures 25A-28) a single-anchor mechanism, comprising an anchor (10), a transmission tube (28), a traction wire (14), and a limiting element (22), wherein one end of the traction wire is connected to the anchor (paragraph 0049), and the traction wire passes through the transmission tube (Figure 26B); an end portion (20) of the anchor opposite to the transmission tube is provided with an engaging portion (paragraph 0130); and the limiting element is connected to the traction wire (via 26, paragraph 0134), and the limiting element (22) abuts against an end portion (24) of the transmission tube (28) away from the anchor (Figure 26D).
NOTE: “limiting element” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, and is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification discloses: the limiting element includes a polymer elastic component, wherein the polymer elastic component can be made of materials such as silicone or rubber. The polymer elastic component is provided with a wire-clamping portion, wherein the wire-clamping portion is configured as a wire hole or wire groove. The traction wire 300 passes through the wire-clamping portion and is in interference fit with the wire-clamping portion. The limiting element disclosed by Khairkhahan is an equivalent limiting element.
Regarding claim 19, Khairkhahan discloses (Figures 26A-42) a locking-and-cutting mechanism (40) and the single-anchor mechanism according to claim 1 (see rejection of claim 1 above), wherein the traction wire (14) passes through the locking-and-cutting mechanism, and the locking-and-cutting mechanism is configured to lock the traction wire and cut off any excess traction wire (paragraphs 0139-0142, 0149).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3, 4, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan et al. (US 2015/0366556 A1) (“Khairkhahan”) in view of Mitelberg et al. (US 2020/0178956 A1) (“Mitelberg”).
Regarding claims 3 and 4, Khairkhahan discloses (Figures 26A and 26D) that the transmission tube (28) comprises an engaging member, and the engaging member is connected to the transmission tube. Khairkhahan discloses the engaging member comprises a first insertion portion provided on the engaging member (see Figure 26A annotated below), and the first insertion portion is adapted to a proximal end of the anchor (paragraph 0134). However, Khairkhahan fails to disclose that the transmission tube comprises a spring tube.
PNG
media_image1.png
516
222
media_image1.png
Greyscale
In the same field of endeavor, Mitelberg teaches (Figures 1-3 and 9A-11) a spring tube in the form of an elongate flexible torqueable shaft (paragraph 0060).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the transmission tube disclosed by Khairkhahan to comprise a spring tube, as taught by Mitelberg. This modification would provide a flexible shaft suitable for transmitting torque to the anchor (Mitelberg, paragraph 0060).
Regarding claims 13 and 14, Khairkhahan discloses the invention substantially as claimed. However, Khairkhahan fails to disclose the anchor comprises an anchor-head tube, and the traction wire is connected to the anchor-head tube; and a circumferential surface of the anchor-head tube is provided with a helical groove, a helical barb is formed along a circumference of the anchor-head tube, and a distal end of the helical barb is provided with a pointed tip. Khairkhahan fails to disclose the helical barb is provided with a reverse barb directed towards the helical groove and inclined along the helical groove away from the pointed tip.
In the same field of endeavor, Mitelberg teaches (Figures 10-18) an anchor (342) comprising an anchor-head tube (550), and a traction wire (546) connected to the anchor-head tube; and a circumferential surface of the anchor-head tube is provided with a helical groove (forming helical coil 554), a helical barb is formed along a circumference of the anchor-head tube, and a distal end of the helical barb is provided with a pointed tip (556). Mitelberg teaches (Figure 18) that the helical barb is provided with a reverse barb (576) directed towards the helical groove and inclined along the helical groove away from the pointed tip (paragraph 0080).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the anchor configuration taught by Mitelberg for the anchor configuration disclosed by Khairkhahan. Mitelberg shows that an anchor comprising an anchor-head tube, and the traction wire is connected to the anchor-head tube; a circumferential surface of the anchor-head tube is provided with a helical groove, a helical barb is formed along a circumference of the anchor-head tube, and a distal end of the helical barb is provided with a pointed tip; and wherein the helical barb is provided with a reverse barb directed towards the helical groove and inclined along the helical groove away from the pointed tip, is an equivalent anchor known in the art. Substitution of one known element (the anchor configuration taught by Mitelberg) for another element (the anchor configuration disclosed by Khairkhahan) providing the same function to yield predictable results (anchoring a traction wire to tissue) would have been obvious to one of ordinary skill in the art at the time of the invention.
Regarding claim 15, Khairkhahan as modified by Mitelberg teaches (Mitelberg, Figures 10-18) that the anchor (342) further comprises a connector (552), and the connector is connected to the anchor-head tube (550); the engaging portion comprises a second insertion portion (568) provided on the connector, and the second insertion portion is adapted to the transmission tube; and the connector is provided with an axial through-hole (570), wherein the traction wire (546) passes through the axial through-hole; and a distal end of the traction wire is provided with a protruding head (paragraph 0011), wherein the protruding head abuts against a distal end of the connector (Figure 12).
Regarding claim 16, Khairkhahan as modified by Mitelberg teaches (Mitelberg, Figures 10-18) a proximal end of the anchor-head tube (550) is provided with a second insertion portion adapted to the transmission tube (paragraph 0079).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan et al. (US 2015/0366556 A1) (“Khairkhahan”) in view of Purcell et al. (US 2019/0216601 A1) (“Purcell”).
Regarding claim 17, Khairkhahan discloses the invention substantially as claimed. Khairkhahan discloses (Figure 26B) that the anchor (10) comprises an anchor base (12) and a helical component; a proximal end of the anchor base is connected to the transmission tube (28; Figure 26D, paragraph 0134); and the helical component is connected to the anchor base. However, Khairkhahan fails to disclose that a distal end of the anchor base is provided with a pointed tip and the helical component extends along a circumference of the anchor base.
In the same field of endeavor, Purcell teaches (Figures 2A and 2B) an anchor comprising an anchor base (54) and a helical component (54); a proximal end of the anchor base is connected to a transmission tube, and a distal end (62) of the anchor base is provided with a pointed tip (64); and the helical component is connected to the anchor base and extends along a circumference of the anchor base (paragraphs 0052-0053).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the anchor disclosed by Khairkhahan such that a distal end of the anchor base is provided with a pointed tip and the helical component extends along a circumference of the anchor base, as taught by Purcell. This modification would provide a sharp, tissue piercing distal end positioned distally of the distal end of the coil. This enables the sharp distal end to pierce tissue upon contact, and prior to beginning rotation of the coil to embed the coil within the target tissue. Engaging the tip prior to rotation of the anchor stabilizes the anchor against sideways movement allowing a single placement of the anchor against tissue, and rotation of the coil to engage tissue, without ‘walking’ of the anchor away from the desired target site as will be understood by those of skill in the art (Purcell, paragraph 0053).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan et al. (US 2015/0366556 A1) (“Khairkhahan”) in view of Purcell et al. (US 2019/0216601 A1) (“Purcell”) as applied to claim 17 above, and further in view of Hindrichs et al. (US 2007/0049942 A1) (“Hindrichs”).
Regarding claim 18, Khairkhahan as modified by Purcell teaches the invention substantially as claimed. Purcell further teaches that the helical component is provided with a stopping notch (formed by barb 61). However, the combined teaching fails to teach multiple stopping notches and the multiple stopping notches are arranged at intervals along a helical direction of the helical component.
In the same field of endeavor, Hindrichs teaches (Figure 2) an anchor comprising a helical component (210) provided with multiple stopping notches (formed by barbs 216) arranged at intervals along a helical direction of the helical component.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the helical component taught by Khairkhahan in view of Purcell to have multiple stopping notches arranged at intervals along a helical direction of the helical component, as taught by Hindrichs. This modification would to resist unthreading of the anchor from tissue into which it has been threaded (Hindrichs, paragraph 0043).
Claims 2 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan et al. (US 2015/0366556 A1) (“Khairkhahan”) in view of Rao et al. (US 2023/0069080 A1) (“Rao”).
Regarding claims 2 and 20, Khairkhahan discloses the invention substantially as claimed. Khairkhahan discloses a limiting element (22) that abuts against the end portion of the transmission tube away from the anchor. Khairkhahan discloses that the limiting element has a suture locking knob (26). However, Khairkhahan fails to disclose that the limiting element comprises a polymer elastic component, and the polymer elastic component is provided with a wire-clamping portion; the traction wire is interference-fitted into the wire-clamping portion.
Rao teaches (Figure 21-3) a clamp (288) comprising a polymer elastic component (287) with a wire clamping portion, and a traction wire (289) that is interference-fitted into the wire-clamping portion (paragraph 0146).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the limiting element to comprise a polymer elastic component, and the polymer elastic component to be provided with a wire-clamping portion, the traction wire interference-fit into the wire-clamping portion, as taught by Rao. This modification would allow the limiting element to maintain the desired tension on the traction wire and reduce the risk of damage to the traction wire (Rao, paragraphs 0098 and 0146).
Allowable Subject Matter
Claims 5-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: claim 5 recites that the single-anchor mechanism further comprises a handle and a rotating wheel; and the transmission tube passes through the handle, the transmission tube is connected to the rotating wheel, and the rotating wheel is coaxial with the transmission tube.
Hyde (US 7,087,064 B1; Figures 6 and 11A), Rafiee et al. (US 2007/0244555 A1; Figures 3A-3D), Hammer et al. (US 2010/0280605 A1; Figures 2 and 3), Miller et al. (US 2011/0106247 A1; Figures 12-14), Miller et al. (US 2011/0288635; Figures 2 and 3), Tobis et al. (US 2014/0114390 A1; Figures 11A-11C), Binmoeller et al. (US 2018/0028180 A1) all disclose anchor delivery mechanisms comprising a handle with a rotating wheel and a transmission tube connected to the rotating wheel. However, none of these references, or the references cited above the rejections, when considered alone or in combination, disclose or suggest the features of claim 5 in combination with the limiting element recited in claim 1, where the limiting element is connected to the traction wire, and the limiting element abuts against an end portion of the transmission tube away from the anchor.
Claims 6-12 are dependent on claim 5, thus would also be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
Prosecution Insights