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 24-38 are pending in the application. Claims 31-38 are withdrawn. Claims 1-24 have been previously cancelled. Claims 24-30 are rejected.
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.
Claim(s) 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by applicant cited Khairkhahan et al (US PG Pub 2015/0366556).
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Regarding claim 24, Khairkhahan teaches a suture fastener (202) for fastening1 one or more sutures, the suture fastener shaped so as to define:
a spiral portion (wire 204) shaped so as to define at least one arm having a free radially- outward end (See annotated Fig. 5B); and
a radially-inward portion (inner end of spiral) that is disposed radially inward from the spiral portion (See annotated Fig. 5B),
wherein the suture fastener, when in a resting state, has an unlocked conical helical configuration, in which the spiral portion is conically helical (See Fig. 5B; paragraph [0082]),
wherein the suture fastener is configured2, upon being axially plastically3 deformed (note the wire may be made of stainless steel which is inherently capable of plastic deformation. See paragraph [0082]), when one or more portions of the one or more sutures pass through respective portions of the suture fastener (note the anchor is capable of having suture passed through the openings between adjacent spiral windings), to transition from the unlocked conical helical configuration (As seen in Fig. 5B) to a locked planar spiral configuration (as seen in Fig. 5D), in which the spiral portion is planar spiral and the one or more sutures are fixedly coupled to the suture fastener (note that if sutures were placed between adjacent windings they would be compressed an locked within the device when it is in the locked planar configuration), and
wherein the radially-inward portion is neither helical nor spiral (note the inward portion is a terminus of the spiral), both when the suture fastener is in the unlocked conical helical configuration and when the suture fastener is in the locked planar spiral configuration (note the inward portion stays the same in both configurations. Se Figs. 5B and 5D).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 27 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over applicant cited Khairkhahan et al (US PG Pub 2015/0366556).
Regarding claim 27, Khairkhahan teaches the fastener as set forth in claim 24 above and further teaches when the suture fastener is in the locked planar spiral configuration (as seen in Fig. 5D), a height of the suture fastener is less than 25% of a greatest dimension of the suture fastener. As plainly seen in Fig. 5D, the height of the device in the locked planar configuration is roughly equivalent to the width of the wire and the greatest dimension is the diameter which is at least six times the width of the wire since there are at least three turns of the wire on each side of the midline. Thus, the height is roughly 1/6th or 16.67% the greatest dimension. (See also paragraphs [0082]-[0085])
Alternatively, the height of the fastener in the locked planar configuration is disclosed to be a result effective variable which assists with a low offset from the prosthesis which may reduce the likelihood of damaging surrounding tissue or prosthesis components. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying the height in the locked planar configuration to be less than 25% of the greatest dimension of the fastener as it only involves adjusting the dimension of a component already disclosed to be adjustable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the height of the fastener to be less than 25% of the greatest dimension of the fastener as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05
Claim(s) 25 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Khairkhahan et al (US PG Pub 2015/0366556).
Regarding claim 25, Khairkhahan teaches the fastener as set forth in claim 24 above but does not explicitly teach the radially-inward portion is shaped so as to define a non-circular and non-spiral opening. As seen in Figs. 5B and 5D, Khairkhahan teaches the radially inward portion in this embodiment is solid.
Khairkhahan teaches an alternate embodiment of an anchor which has an interior opening (214) which may be a variety of shapes including rectangular, triangular, hexagonal or other geometries (See Figs. 5E; paragraph [0085]). Khairkhahan teaches the opening can be different shapes to “accommodate various geometries of drive shafts”.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device as seen in Figs. 5B &5D of Khairkhahan to incorporate the radially inward non-circular opening as seen in Fig. 5E since Khairkhahan already contemplates the benefits of non-circular, non-spiral openings at the center of an anchoring device. Making such a modification would allow for a more efficient suture anchoring device.
Regarding claim 28, Khairkhahan teaches the fastener as set forth in claim 24 above and further teaches an area of an upper surface of the radially-inward portion is significantly smaller than a total area of an upper surface of the suture fastener, including the radially-inward portion and the spiral portion. (See annotated Fig. 5D above). As can be plainly seen in Figs. 5B and 5D of Khairkhahan, the radially inward portion is no more than 1/6th the total area. The entire upper surface is formed of turns of the wire. The radially inward portion is 1 width of the wire. As seen in the Figure, there are at least 3 widths of the wire on either side of the central radially inward portion. Thus the area of the radially inward portion is no more than 16.67% of the total area.
Khairkhahan does not explicitly teach the area of the upper surface of the radially-inward portion is between 5% and 15% of a total area of an upper surface of the suture fastener.
As disclosed, the area of the radially inward is a result effective variable which assists with a low offset from the prosthesis which may reduce the likelihood of damaging surrounding tissue or prosthesis components. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Khairkhahan to have the area of the upper surface of the radially-inward portion is between 5% and 15% of a total area of an upper surface of the suture fastener, as it only involves adjusting the dimension of a component already disclosed to be adjustable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the area of the upper surface of the radially-inward portion to be between 5% and 15% of a total area of an upper surface of the suture fastener as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan et al (US PG Pub 2015/0366556) as applied to claim 24 above, and further in view of applicant cited Miraki et al (US PG Pub 2016/0270776).
Regarding claim 26, Khairkhahan teaches the fastener of claim 24 as set forth above but is silent as to the height of the suture fastener in the locked planar spiral configuration.
Miraki teaches an analogous suture fastener that has a locked planar configuration where the thickness of the fastener is between 0.001 inches to about 0.1 inches (See paragraph [0030]) or “the clips can have a thickness of 0.5 mm or less, 1 mm or less, 1.5 mm or less, and/or 2 mm or less” (See paragraph [0054]).
It would have been obvious to one of ordinary skill in the art at the time of filing as a matter of design choice to have the height (thickness) of the fastener in the locked planar configuration to be less than 5mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See also MPEP §2144.04(IV)(A).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan et al (US PG Pub 2015/0366556) as applied to claim 24 above, and further in view of Hyde (US PG Pub 2006/0030885).
Regarding claim 29, Khairkhahan teaches the fastener of claim 24 as set forth above but does not explicitly teach the spiral portion is shaped so as to define two arms having free radially-outward ends, respectively, such that the suture fastener is shaped as a double helix in the unlocked conical helical configuration, and a double planar spiral in the locked planar spiral configuration. Khairkhahan teaches the device has one spiral coil.
Hyde teaches an analogous anchoring device where the end can have a single spiral coil or a double helix coil (See paragraph [0052]). Hyde teaches a double helix anchor can increase retentive or anchoring strength.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the suture fastener as taught by Khairkhahan to have two free arms resulting in a double helix in the unlocked configuration and a double spiral in the locked planar configuration since both single and double spirals are known advantageous anchoring configurations. Additionally, to do so would be a mere duplication of a working part of the device. The mere duplication of essential working parts involves only routine skill in the art. Additionally, the court has held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See also MPEP §2144.04(VI)(B).
Furthermore, it would have been obvious as a matter of design choice to one of ordinary skill in the art at the time of invention to modify the single spiral as taught by Khairkhahan to be a double spiral or whatever 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).
Claim(s) 30 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over applicant cited Khairkhahan et al (US PG Pub 2015/0366556) in view of Li et al (US Pat No. 5,715,942).
Regarding claim 30, teaches the fastener of claim 24 as set forth above but does not explicitly teach a sterile packaging in which the suture fastener is removably disposed.
Li teaches an analogous suture fastener which is disposed in sterile packaging (50) along with a suture and a suture needle. It is noted that sterile packaging is widely known and used in the medical arts to ensure that implanted devices and the tools for inserting them are free of contamination which can lead to undesirable complications for the patient.
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the sterile packaging of Li in the device of Khairkhahan such that the suture fastener was disposed within sterile packaging since sterile packaging is in standard use throughout the medical arts and is known to help reduce contamination and infection when implanting devices within a patient.
Response to Arguments
Applicant's arguments filed November 14, 2025 have been fully considered but they are not persuasive.
The specific limitation at issue reads: “…wherein the suture fastener is configured, upon being axially plastically deformed, when one or more portions of the one or more sutures pass through respective portions of the suture fastener, to transition from the unlocked conical helical configuration to a locked planar spiral configuration, in which the spiral portion is planar spiral and the one or more sutures are fixedly coupled to the suture fastener…”
Applicant first argues that Khairkhahan (US PG Pub 2015/0366556) cannot be relied upon because the anchor is delivered by being loaded into a delivery catheter which is a straight tube.
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 (i.e. the delivery device) are not recited in the rejected claim(s). 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). It is further noted that applicant has elected to pursue the invention of a suture fastener, not a system which includes a delivery device.
It is noted that the 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). In the instant case the suture fastener as taught by Khairkhahan is capable of performing the recited functions, namely the materials listed for the fastener are capable of plastic deformation (See paragraphs [0082] and [0097]). It is noted that the claim as currently presented is ambiguous as to whether or not plastic deformation of the fastener is affirmatively required.
In the instant case, the claim requires the suture fastener to transition from the unlocked conical helical configuration to the locked planar spiral configuration when portions of the sutures pass through the suture fastener to fixedly couple the suture and fastener which Khairkhahan clearly does.
It is further noted that Khairkhahan provides that the fastener may be made from a variety of materials including stainless steel which is inherently capable of plastic deformation. See paragraph [0082]. If applicant wishes to claim a specific material which has a particular type of plastic deformation, applicant is free to add such limitations to the claims. Likewise, if applicant wishes to claim a specific arrangement of the suture fastener during delivery, applicant is free to add such specific limitations to the claims provided such limitations are supported by the specification and fall within the elected invention.
Applicant next argues with respect to claim 25, that “the driver head of Fig. 5 E would serve no purpose in the anchor of 5 B and 5D”. This is unpersuasive. Khairkhahan clearly discusses Figs. 5A-E as a connected group with various features. One of ordinary skill in the art would be sufficiently capable of determining how to use the variously disclosed features together. MPEP§ 2145 III states: “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). See also In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.”); and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”).
With regards to rejoinder, it is noted that applicant elected to pursue invention I, claims 24-30 without traverse in the response filed May 2, 2025. The Restriction will be reconsidered at allowance, but rejoinder is not appropriate at this time.
Next applicant cites related parent application 16/967999 as being relevant to patentability of the instant claims. It is noted that the claims of the ‘999 application were directed to a suture fastener system and the reasons for allowance were based on the combination of the fastener arrangement along with the particular specific features of the delivery device.
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.
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/R.S.H/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
1 It is noted that this is a recitation of intended use in the preamble and not given full patentable weight, in that the prior art is not required to disclose this function/method of use. Since the body of the claim in the instant case fully and intrinsically sets forth all the limitations of the claimed invention, the preamble recitation of intended use is not considered a claim limitation. Additionally, MPEP 2111.02(II) states: “If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)” In the instant case, the claims are directed to a fastener and do not explicitly require a suture as part of the invention. Additionally, the anchoring device as taught by Khairkhahan is capable of performing the recited function, namely fastening sutures.
2 It is noted that the 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). In the instant case the suture fastener as taught by Khairkhahan is capable of performing the recited functions, namely the materials used for the fastener are capable of plastic deformation. It is noted that the claim is ambiguous as to whether or not plastic deformation of the fastener is explicitly required.
3 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. It is noted that Khairkhahan also states appropriate biomaterials for the various features of the device may include PEEK (polyether ether ketone) which is also know to be capable of plastic deformation.