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 .
Response to Amendment
Claims 1,4, 7, 8, 10-20 are pending in the application. Claims 11-20 are withdrawn. Claims 1 and 4 have been amended. Claims 1, 4, 7, 8, and 10 are rejected.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4, 8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Torrie et al (US Pat. No. 7,153,312) in view of Sullivan (US PG Pub 2013/0165972).
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Regarding claim 1, Torrie teaches an anchor system (See Fig. 2I), comprising:
a first implant (18) connected to a length of suture (10), the length of suture folded such that a tensioning limb extends from the first implant and a locking limb extends from the first implant (See Fig. 2I, note both ends of the suture extend from the first implant; See also Col. 4, line 67 – Col. 5, line 32);
a second implant (16) fixed to the locking limb (See Fig. 2I);
an adjustment mechanism (slip knot 28) having a first end and a second end in the length of suture between the first implant and the second implant (See annotated Fig. 2I), wherein the first end is closer to the first implant and the second end is closer to the second implant (See annotated Fig 2I; Col. 5, lines 15-31); and
wherein the second implant is fixed to the locking limb via a pierce hitch1 (60) in the locking limb (See Figs. 2B-2D; Col. 4, line 66 – Col. 5, line 15); and
wherein the pierce hitch (60) is formed between the second implant (16) and the second end of the adjustment mechanism (See Fig. 2I) by inserting an end of the locking limb through a hole from a first side to a second side in the locking limb and the second implant is fixed to the locking limb by the length of suture passing through the pierce hitch (See Figs. 2A-2D and Col. 4, line 66 – Col. 5, line 15).
Torrie does not explicitly teach the adjustment mechanism is an eye splice2 formed in the length of suture. Torrie teaches the adjustment mechanism is a one way adjustable slip knot. (See Col. 5, lines 15-31) Torrie teaches the slip knot (28) may instead be an adjustable retaining elements (See Figs. 12A-12C; Col. 7, lines 47 through Col. 8, line 28).
Sullivan teaches an analogous implantable anchor system featuring first and second implants (50 & 60) connected by a one-way (self-locking) adjustable eye splice (85). (See paragraph [0031] and Fig. 1) Sullivan teaches a splice in the suture advantageously allows the system to be knotless while still allowing for adjustment of the tension and position of the two implantable anchors (See paragraph [0016]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system as taught by Torrie to have the adjustment mechanism be an eye splice formed in the length of suture as taught by Sullivan instead of a slip knot since a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art (slip knot) for the corresponding element (eye splice) disclosed in the specification. (See MPEP §2183). As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B). It is further noted that applicant has not disclosed that having an eye splice as the adjustment mechanism solves any stated problem or is for any particular purpose. It appears the device would perform equally well with either design. Applicant’s own specification states “in other embodiments, the adjustment mechanism 108 is a sliding knot. The adjustment mechanism 108 can be any one-way adjustable locking construct.”
Regarding claim 4, modified Torrie teaches the system of claim 1 as set forth above and further teaches eye splice is in the locking limb. (See Figs. 2A-2I; Col. 5, lines 15-31). Note that Torrie teaches the knot is in the locking limb and in order for the tensioning limb to be able to adjust the system, the eye splice would also need to be in the locking limb.
Regarding claim 8, modified Torrie teaches the system of claim 1 as set forth above and further teaches a pair of spaced, adjacent apertures in each of the first (18a, 18b) and second (16a, 16b) implants. (See Figs. 2A and 2E; Col. 4, line 66-Col. 5, line 7)
Regarding claim 10, modified Torrie teaches the system of claim 8 as set forth above and further teaches the length of suture extends through the pair of spaced, adjacent apertures in each of the first and second implants. (See Figs. 2A-2I; Col. 4, line 66-Col. 5, line 7)
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Torrie et al (US Pat. No. 7,153,312) in view of Sullivan (US PG Pub 2013/0165972), as applied to claim 1 above, and further in view of previously cited Collins et al (US PG Pub 2012/0290006).
Regarding claim 7, Torrie teaches the system of claim 1 as set forth above but does not explicitly teach the first implant and the second implants are rectangular3. Torrie does not explicitly describe the shape of the first and second implants, however the Figures show flat trapezoidal or generally arrow shaped implants.
Collins teaches an analogous anchoring system featuring first and second implants (300 and 400) connected by a suture with a one way adjustable mechanism (500). Collins teaches the implants may have a variety of shapes including “oval,…round, rectangular, or of any other suitable shape” (See paragraph [0012]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system as taught by Torrie to have the first and second implants by rectangular as taught by Collins, or whatever other shape was desired or expedient. A change in shape or form is generally recognized as a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant (produced unexpected results). In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). See also MPEP §2144.04(IV)(B).
Additionally, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art (trapezoidal shaped implants) for the corresponding element (rectangular implants) disclosed in the specification. (See MPEP §2183). As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B).
Response to Arguments
Applicant's arguments filed July 13, 2026 have been fully considered but they are not persuasive.
Applicant argues the device of Torrie is “materially different” (See argument page 6). This is unpersuasive. MPEP §2141.01(a)(I) states “ A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212.”.
In the instant case, Torrie is clearly analogous art, since the invention of Torrie is explicitly “an adjustable suture lock loop for use in soft tissue repair” (see Field of Disclosure). Torrie explicitly states “Referring to FIG. 1, a closure device 8 for mending a tear 12 in soft tissue 14, e.g., meniscus of the knee joint”. See Detailed Description paragraph [0009]). Applicant’s specification states “The present invention is directed generally to surgical tools and instruments and, more particularly, to a system and method for repairing soft tissue tears such as meniscal tears.”. Thus Torrie is clearly and unambiguously analogous art.
Applicant argues that the manner in which Torrie’s suture anchor is formed is “materially different” than the instant application. This is unpersuasive. It is noted
instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II).
Additionally, it is noted that if applicant were to amend the claims to include the specific formation steps of the pierce hitch, such limitations would be product-by-process limitations. As noted by the court in Thorpe. “[e]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe. 777 F.2d 695, 698 (Fed. Cir. 1985) (citations omitted). The court further stated in Brown. “[w]e are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product by process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 173 USPQ 685, 688 (CCPA 1972)
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s) (i.e., “the claimed "pierce hitch" is not merely any passage of one suture portion through another. The instant application describes the pierce hitch as formed by creating a hole in the length of suture, placing a threader through the hole, threading or weaving the first end of the suture through the threader, pulling the threader through the hole to create a loop, and tensioning the first end to minimize the loop and create the pierce hitch. See para. [0064]. The application further explains that the pierce hitch functions as a self-collapsing noose around the pierce hitch tail and is stationary relative to the adjustment mechanism. See para. [0065]”). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
As set forth above, Torrie teaches the structural requirements of the pierce hitch as currently claimed. Specifically, Torrie teaches “the pierce hitch (60) is formed between the second implant (16) and the second end of the adjustment mechanism (See Fig. 2I) by inserting an end of the locking limb through a hole from a first side to a second side in the locking limb and the second implant is fixed to the locking limb by the length of suture passing through the pierce hitch (See Figs. 2A-2D and Col. 4, line 66 – Col. 5, line 15).” As can be explicitly seen in Digs. 2A-2D, the knot as taught by Torrie’s is formed by inserting an end of the suture through a hole from a first side to a second side in the suture where the second implant (16) is fixed (locked) to the suture by the length of suture passing through the hole. This is deemed to be sufficient to meet the limitation as presently claimed.
Applicant next appear to argue that Torrie is “materially different” than the claimed invention because the adjustment mechanism (slip knot) is formed separately and that Torries locking region 60 and slip knot 28 “are distinct structures performing distinct functions within Torrie’s closure device. It is noted that applicant’s own pierce hitch and eye splice are distinct structures performing distinct functions within the closure device. Specifically, applicant’s pierce hitch locks the second implant in place which is both functionally and structurally the same as Torrie’s locking region 60 as seen in Figs. 2A-2D. Likewise, applicant’s eye splice is a one way adjustable mechanism which is functionally identical to Torrie’s slip knot. As noted above, Sullivan teaches a one way adjustable (self-locking) splice (85) which is functionally and structurally identical to applicant’s claimed eye splice. (See Sullivan paragraph [0031] and Fig. 1).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Torrie explicitly contemplates a variety of one way adjustable mechanisms (See Torrie Figs. 12A-12C; Col. 7, lines 47 through Col. 8, line 28). Sullivan teaches a splice in the suture advantageously allows the system to be knotless while still allowing for adjustment of the tension and position of the two implantable anchors (See paragraph [0016]). It is widely known in the art that “knotless” constructs are advantageous for a variety of reasons including being low profile, ability to be delivered through a smaller opening, and do not require complicated knot tying during the procedure which saves time. Additionally, neither the claim, nor the originally filed specification give any reason for or criticality to the adjustment mechanism being an eye splice. Furthermore, Paragraph [0062] of the instant application as published states “In some embodiments, the adjustment mechanism 108 is an eye splice (i.e., finger trap), while in other embodiments, the adjustment mechanism 108 is a sliding knot. The adjustment mechanism 108 can be any one-way adjustable locking construct.”
As stated in MPEP 2144.06(II), substituting art equivalents known for the same purpose is a prima facie obvious. This section goes on to state: “However, an applicant’s expressed recognition of an art-recognized or obvious equivalent may be used to refute an argument that such equivalency does not exist.); Smith v. Hayashi, 209 USPQ 754 (Bd. of Pat. Inter. 1980)”. In the instant case, applicant has expressly recognized that “sliding knots” and “any one-way adjustable locking constructs” are known art equivalents to the claimed “eye splice”. As set forth above, the substitution of Sullivan’s splice as the one way adjustment mechanism is a known art equivalent of the slip knot as taught by Torrie. Such a substitution is prima facie obvious.
In the arguments, applicant attempts to explain how and why they believe the invention as described in the application differs from the reference, however the presently pending claim limitation(s) fail to adequately distinguish over the prior art. In so far as differences between the invention as disclosed in the application and the applied reference(s) may exist, applicant has failed to clearly articulate such differences with sufficient specificity in the claimed limitations so as to make the claims patentably distinct from the references as applied in the grounds of rejection above.
The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Mondays, Tuesdays, Thursdays, and Fridays generally between 9:30am and 2:30pm .
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/R.S.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
1 Applicant is free to be their own lexicographer (see MPEP §2173.05(a)) and the provided definition in the specification will control interpretation of the term in the claims. (See MPEP §2111.01(IV)(A)). In the instant case, applicant has defined “pierce hitch” as “To create a pierce hitch 116, a hole 118 is formed in the length of suture 106 between the first end 120 and the second end 122. A threader 124 or another similar device is placed through the hole 118 in the length of suture 106, as shown in FIG. 3A. Thereafter, the first end 120 of the suture 106 is threaded or woven through the threader 124, as shown in FIG. 3B. Then, the threader 124 is pulled through the hole 118 in the length of suture 106, creating a loop 125 in the suture 106, as can be seen in FIG. 3C. To minimize the loop 125, thereby creating the pierce hitch 116 shown in FIG. 3D, the first end 120 of the suture 106 is tensioned.” (See specification paragraph [0064] as published). As clearly seen in Figs. 2A-2D and described in Col. 5, lines 1-15 of Torrie, lock 60 is formed in a substantially similar manner and has the same structural characteristics of the claimed “pierce hitch”.
2 It is noted that neither the claim, nor the originally filed specification give any reason for or criticality to the adjustment mechanism being an eye splice. Additionally, Paragraph [0062] of the instant application as published states “In some embodiments, the adjustment mechanism 108 is an eye splice (i.e., finger trap), while in other embodiments, the adjustment mechanism 108 is a sliding knot. The adjustment mechanism 108 can be any one-way adjustable locking construct.”
3 It is noted that neither the claim, nor the originally filed specification give any reason for or criticality to the first and second implants being rectangular. Paragraph [0063] of the specification as published states “However, the implants 102, 104 may have any other geometric configuration”
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