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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/13/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
Figures 3-10 of the submitted drawings are not of sufficient quality to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figs. 3-10 are not of sufficient quality to distinguish the components displayed and marked therein. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-14, 16-19 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khairkhahan (US 2019/0247042 A1).
Regarding claim 1, Khairkhahan discloses:
A locking device (clip 10, see Fig. 1) comprising:
a body (clip body 10, see Fig. 1) having a first opposing member (first half 12, see Fig. 1) connected to a second opposing member (second half 14, see Fig. 1) by a hinge element (hinge 16, see Fig. 1 and Para. [0025]), each opposing member being resiliently movable about the hinge element between a locked position and an unlocked position (hinge 16 is formed from as an integral, living hinge portion of the clip body that elastically deforms to transition the two halves of the clip body between open (Fig. 2A) and closed (Fig. 2B) configurations; see Para. [0025]);
wherein the hinge is configured to maintain a compressive force between opposing surfaces of the opposing members (the hinge is configured to elastically deform, during transition between the open and closed configurations, and will maintain a compressive force in the locking zone 18 between the first and second halves 12/14; see Para. [0025]-[0026]);
a channel disposed adjacent the body and extending partially or entirely through a thickness of the body (open gap above hinge 16 which extends through a thickness of the disk body; see Examiner’s Diagram of Fig. 2 below and Para. [0027]); and
a slot disposed adjacent the channel (locking zone 18 positioned above the open gap, see Examiner’s Diagram of Fig. 2 below; see also Para. [0026]), the slot being open when the device is transitioned from the locked position to the unlocked position (locking zone 18 is open when transitioning between opened and closed configurations; see Figs. 2A-2B);
wherein the opposing surfaces are separated from one another in the unlocked position and the slot is open (opposing suture engagement surfaces of the locking zone 18 are separate from one-another in the open configuration; see Fig. 2A and Para. [0026]); and
wherein the opposing surfaces are in close proximity to one another in the locked position to apply a compressive force to an object within the slot and the slot is closed (opposing suture engagement surfaces of the locking zone 18 are closed against one another in the closed configuration in order to secure a suture length SL therebetween; see Fig. 2B and Para. [0026]).
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Examiner’s Diagram of Fig. 2B
Regarding claim 2, Khairkhahan discloses the invention of claim 1, Khairkhahan further discloses wherein the body has an outer perimeter surface (see Fig. 1 and Para. [0028]).
Regarding claim 3, Khairkhahan discloses the invention of claim 2, Khairkhahan further discloses wherein the body is defined by a planar substrate having a front surface and an opposing back surface, the surfaces being bound by the outer perimeter surface (see Figs. 1 and 3B; see also Para. [0028]).
Regarding claim 4, Khairkhahan discloses the invention of claim 3, Khairkhahan further discloses wherein the opposing front and back surfaces are circular, elliptical, square, rectangular or triangular (see Figs. 1 and 3B showing wherein the surfaces of the clip body are circular).
Regarding claim 5, Khairkhahan discloses the invention of claim 1, Khairkhahan further discloses wherein the body is composed of a resilient shape memory material (see Para. [0009] and [0025] mentioning wherein the clip is formed from a metal or polymeric material that can elastically deform).
Regarding claim 6, Khairkhahan discloses the invention of claim 5, Khairkhahan further discloses wherein the shape memory material is a composite, ceramic, alloy or polymer (see Para. [0009] mentioning wherein the material used to form the clip may be either metallic or polymeric).
Regarding claim 8, Khairkhahan discloses the invention of claim 5, Khairkhahan further discloses wherein the shape memory material is configured to resiliently return to the locked position from the unlocked position (the material of the clip, particularly at the hinge 16, is configured to elastically deform to transition between an open and closed configuration; see Para. [0025]).
Regarding claim 9, Khairkhahan discloses the invention of claim 1, Khairkhahan further discloses wherein the channel traverses the entire thickness of the body (see Examiner’s Diagram of Fig. 2B above showing the channel extending entirely through the thickness of the clip body).
Regarding claim 10, Khairkhahan discloses the invention of claim 9, Khairkhahan further discloses wherein the channel is disposed in the center of the body (see Examiner’s Diagram of Fig. 2B above; the channel is disposed within the clip body away from the outer perimeter and thus is within the center of the clip body).
Regarding claim 11, Khairkhahan discloses the invention of claim 1, Khairkhahan further discloses wherein the slot is defined by a groove in the opposing surface of the first opposing member or the opposing surface of the second opposing member (engagement surfaces of the locking zone 18 include a groove formed in the first half 12; see Figs. 1-2A).
Regarding claim 12, Khairkhahan discloses the invention of claim 11, Khairkhahan further discloses wherein the slot is shaped to accommodate a ridge formed on the opposing surface (the groove in the first half 12 accommodates a ridge in the second half 14; see Figs. 1-2A).
Regarding claim 13, Khairkhahan discloses the invention of claim 1, Khairkhahan further discloses wherein the slot is disposed off-center in the body (engagement surfaces of locking zone 18 are off center in the open position; see Fig. 2A).
Regarding claim 14, Khairkhahan discloses the invention of claim 1, Khairkhahan further discloses wherein the hinge is formed by a strip of the body connecting the first and second opposing members, and wherein the strip is coextensive with the outer perimeter surface (the hinge is formed from a strip of the material of the disk body on the outer perimeter; see Fig. 1 and Para. [0025]).
Regarding claim 16, Khairkhahan discloses the invention of claim 1, Khairkhahan further discloses wherein the opposing surfaces are operable to apply a compressive force to a tensioning element traversing the slot in the locked position (first and second halves 12/14 tightly close against the suture lengths SL within the locking zone 18; see Fig. 2B and Para. [0026]).
Regarding claim 17, Khairkhahan discloses the invention of claim 16, Khairkhahan further discloses wherein the tensioning element is a suture, wire or string (suture lengths SL; see Para. [0026]).
Regarding claim 18, Khairkhahan discloses the invention of claim 2, Khairkhahan further discloses an outer collar member at least partially surrounding the outer perimeter surface (a magazine 44 comprising housing 52 surrounding the outer perimeter of the clip body 10; see Figs. 4, 5B-5B and Para. [0030]).
Regarding claim 19, Khairkhahan discloses the invention of claim 18, Khairkhahan further discloses wherein the outer collar member extends along the entire thickness of the body (housing 52 extends an entire thickness of the disk body; see Fig. 5A).
Regarding claim 23, Khairkhahan discloses the invention of claim 1, Khairkhahan further discloses wherein the body is disc shaped (see Figs. 1 and 3B) and the slot, channel and hinge are disposed along the midline of the disc in the locked position (see Fig. 2B showing the open gap, locking zone 18 and hinge 16 formed along a centerline of the clip body in the closed configuration).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 7 and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan (US 2019/0247042 A1) in view of Marquez (US 2019/0290428 A1).
Regarding claim 7, Khairkhahan discloses all of the limitations of the invention of claim 6.
However, Khairkhahan does not expressly disclose wherein the alloy is nitinol or steel.
In the same field of endeavor, namely suture locking bodies, Marquez teaches a suture fastener (suture fastener 110, see Fig. 4A and Para. [0080]-[0081]) that may be formed from a shape memory material consisting of either nitinol or steel (see Para. [0081]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the clip of Khairkhahan to be formed from nitinol as disclosed by Marquez since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)). Since Khairkhahan provides an express disclosure that the clip may be formed from a elastic metal or polymeric material (see Para. [0009] and [0025]-[0026]), one of ordinary skill in the art would have expected the device of Khairkhahan to function normally should the clip be formed from nitinol, as a known alternative material, since nitinol is a biocompatible, elastomeric metal encompassed by the disclosed of Khairkhahan.
Regarding claim 20, Khairkhahan discloses all of the limitations of the invention of claim 18.
However, Khairkhahan does not expressly disclose wherein outer collar member is composed of a resilient shape memory material.
In the same field of endeavor, namely suture locking bodies, Marquez teaches a suture fastener (suture fastener 250, see Fig. 10A and Para. [0101]) and an outer collar member surrounding the peripheral edge of the suture fastener (clamp 252 having collar 292 that peripherally surrounds suture fastener 250; see Figs. 10A-13B and Para. [0101] and [0106]); wherein the outer collar may be formed from nitinol (see Para. [0101] and [0106]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the magazine and housing of Khairkhahan to be formed from nitinol as disclosed by Marquez to provide a known biocompatible material disclosed by analogous art to be used to form the magazine and housing of Khairkhahan. Additionally, it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Regarding claim 21, the combination of Khairkhahan and Marquez disclose the invention of claim 20, Khairkhahan, as modified by Marquez, further discloses wherein the shape memory material is a composite, ceramic, alloy or polymer (see Marquez Para. [0101] and [0106] mentioning wherein the outer collar is formed from nitinol, as incorporated into the device of Khairkhahan to be used in the formation of the magazine 44 and housing 52; nitinol is a nickel-titanium alloy).
Regarding claim 22, the combination of Khairkhahan and Marquez disclose the invention of claim 21, Khairkhahan, as modified by Marquez, further discloses wherein the alloy is nitinol or steel (see Marquez Para. [0101] and [0106]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan (US 2019/0247042 A1).
Regarding claim 15, Khairkhahan discloses all of the limitations of the invention of claim 1.
However, Khairkhahan does not expressly disclose wherein the channel is square or rectangular shaped when in the locked position.
It appears that the device of Khairkhahan would function/operate equally well with the “channel” being in the shape of a square through-hole, as an alternative to the circular shape shown in Figs. 1-2B. Since Khairkhahan does not provide any disclosure pertaining to the shape of the channel, one of ordinary skill in the art would interpret the shape of the channel to be a non-critical element that may be changed without departing from the scope of function of the invention, so long as the opening remains present in its current location. Thus, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to cause the “channel” of the clip of Khairkhahan to comprise a square or rectangular shape because the shape appears to be an arbitrary design consideration which fails to patentably distinguish over Khairkhahan. Further, Applicant does not disclose any criticality to the claimed shape, indicating that alternative shapes including ovoid or ellipsoid, may be used interchangeably with the claimed “square or rectangular” shape per Para. [0043] of the Specification. Given the lack of criticality, it has been held that changes in shape are a matter of choice which a person of ordinary skill in the art would find obvious absent persuasive evidence that the particular configuration was significant (see MPEP 2144; In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2020/0000458 A1 to Miraki, US 2017/0119374 A1 to Gaerke, US 2013/0282028 A1 to Conklin, US 2016/0270776 A1 to Miraki and US 4291698 A to Heinz all disclose suture retention and locking devices having two halves joined by a hinge capable of assuming an open and closed configuration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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