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
The amendment filed 6/8/26 has been entered. Claims 1-5, 7, 9-14, 16-22, 24-28 remain pending in the application, with claims 14, 16-22, 24 remaining withdrawn. Applicant’s amendments to the (Specification, Drawings, and Claims) have not overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 3/6/26.
Specification
The disclosure is objected to because of the following informalities:
[0243] Af and Mf subscripts are lowercase and should be uppercase (AF and MF); consistency is needed
[0269] “yard” should read “yarn”
Appropriate correction is required.
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.
Claim(s) 1, 3-5, 7, 9, 12, 25, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farzin-Nia (USPN 6818076), herein Nia.
Regarding Claim 1, Nia teaches a shape memory coil (see Fig. 2; abstract "stranded wire…made of a shape memory and/or superelastic material, such as Ni/Ti or alloys thereof. Furthermore, the stranded wire may be coiled"; Col. 3 Line 30 "stranded and coiled wire 16 of the present invention") comprising:
a coiled shape memory yarn having a coil direction around a coil axis (see Fig. 1; Col. 2 Line 32 “stranded wire 10”),
wherein the coiled shape memory yarn comprises a plurality of microfilaments having a twist direction around a yarn axis (see Figs. 1, 2; Col. 2 Lines 33-37 "plurality of strands 12…are twisted…together. The stranded wire 10 comprises at least two strands 12"), and
wherein the plurality of microfilaments comprises a shape memory alloy (Col. 2 Line 54 “Ni/Ti-based alloys”).
Nia at least suggests wherein the plurality of microfilaments has an average diameter less than about 10 micrometers (as best understood in light of the 112(b) rejections-- Col. 2 Lines 38-40 "by way of example and not limitation, about 2 to 7 strands having a diameter of about 0.0005 inch to about 0.007 inch" , which is 12.7 micrometers- 177.8 micrometers; wherein about 12.7 micrometers can be considered close to or equal to the claimed about 10 micrometers, especially in light of the expansive range claimed; Col. 2 Lines 36-38 "Stranded wire 10 comprises at least two strands 12 and up to as many strands 12 as may be practical for the particular application. By way of example and not limitation, about 2 to 7 strands").
Nia discloses the general conditions of the claimed invention except for the express disclosure of 10 micrometers. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention decrease the diameter, since the claimed values are merely an optimum or workable range. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Even if the range measured did not overlap but was merely close, a prima facie case of obviousness still exists. See MPEP 2144.05, Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nia’s strands/microfilaments to be about 10 µm based on the application desired (Col. 2 Lines 36-38), without unexpected results.
Regarding Claim 3, modified Nia teaches all the claimed limitations as discussed above in Claim 1.
Nia further teaches wherein the coil direction of the yarn and the twist direction of the plurality of microfilaments are the same (see Figs. 1, 2 wherein the coil angle of Fig. 2 and the twist angle of Fig. 1 are in the same direction).
Regarding Claim 4, modified Nia teaches all the claimed limitations as discussed above in Claim 1.
Nia at least suggests wherein the plurality of microfilaments includes between about 10 and about 1000 microfilaments (see Fig. 1; Col. 2 Lines 36-38 "Stranded wire 10 comprises at least two strands 12 and up to as many strands 12 as may be practical for the particular application. By way of example and not limitation, about 2 to 7 strands", wherein 7 can be considered close to or equal to the claimed about 10, especially in light of the expansive range claimed).
Nia discloses the general conditions of the claimed invention except for the express disclosure of 10 microfilaments. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to increase the number of strands/microfilaments, since the claimed values are merely an optimum or workable range. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Even if the range measured did not overlap but was merely close, a prima facie case of obviousness still exists. See MPEP 2144.05, Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nia’s strands/microfilaments to be at least 10 based on the application desired (Col. 2 Lines 36-38), without unexpected results.
Regarding Claim 5, modified Nia teaches all the claimed limitations as discussed above in Claim 1.
Nia further teaches wherein the shape memory alloy comprises at least one of a nickel-titanium alloy or a copper-zinc-aluminum alloy (Col. 2 Line 54 “Ni/Ti-based alloys”).
Regarding Claim 7, Nia teaches a method for manufacturing a shape memory coil (if a prior art, in its normal and usual operation, would necessarily describe a device capable of performing the steps of the method or process, then the device claimed will be considered to be inherent by the prior art process or method. When the prior art process or method is the same as a process or method described in the specification for describing the claimed device, it can be assumed the process or method will inherently describe the claimed device capable of performing the different steps of the process or method. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02; as such, for structure for the method, see Fig. 2; abstract "stranded wire…made of a shape memory and/or superelastic material, such as Ni/Ti or alloys thereof. Furthermore, the stranded wire may be coiled"; Col. 3 Line 30 "stranded and coiled wire 16 of the present invention") comprising:
coiling a shape memory yarn to form a coiled shape memory yarn that has a coil direction around a coil axis (see Fig. 1; Col. 2 Line 32 “stranded wire 10”),
wherein the coiled shape memory yarn comprises a plurality of microfilaments having a twist direction around a yarn axis (see Figs. 1, 2; Col. 2 Lines 33-37 "plurality of strands 12…are twisted…together. The stranded wire 10 comprises at least two strands 12"), and
wherein the plurality of microfilaments comprises a shape memory alloy (Col. 2 Line 54 “Ni/Ti-based alloys”).
Nia at least suggests wherein the plurality of microfilaments has an average diameter less than about 10 micrometers (as best understood in light of the 112(b) rejections-- Col. 2 Lines 38-40 "by way of example and not limitation, about 2 to 7 strands having a diameter of about 0.0005 inch to about 0.007 inch" , which is 12.7 micrometers- 177.8 micrometers; wherein about 12.7 micrometers can be considered close to or equal to the claimed about 10 micrometers, especially in light of the expansive range claimed; Col. 2 Lines 36-38 "Stranded wire 10 comprises at least two strands 12 and up to as many strands 12 as may be practical for the particular application. By way of example and not limitation, about 2 to 7 strands").
Nia discloses the general conditions of the claimed invention except for the express disclosure of 10 micrometers. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention decrease the diameter, since the claimed values are merely an optimum or workable range. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Even if the range measured did not overlap but was merely close, a prima facie case of obviousness still exists. See MPEP 2144.05, Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nia’s strands/microfilaments to be about 10 µm based on the application desired (Col. 2 Lines 36-38), without unexpected results.
Regarding Claim 9, modified Nia teaches all the claimed limitations as discussed above in Claim 7.
Nia further teaches twisting the plurality of microfilaments to define the twist direction (see Fig. 1).
Regarding Claim 12, modified Nia teaches all the claimed limitations as discussed above in Claim 7.
Nia further teaches wherein the yarn is coiled to create a torsional imbalance to define the coil direction *(see Figs. 1, 2 wherein the coil angle of Fig. 2 and the twist angle of Fig. 1 are in the same direction, and therefore torsional imbalance) and
wherein the coil direction of the yarn and the twist direction of the plurality of microfilaments are the same (see above).
Regarding Claim 25, modified Nia teaches all the claimed limitations as discussed above in Claim 1.
Modified Nia further teaches wherein the plurality of microfilaments have an average diameter less than 10 micrometers (about 12.7 µm or about 10 µm constitutes less than 10 µm, for similar reasons and motivation as indicated in the rejection of Claim 1).
Regarding Claim 27, modified Nia teaches all the claimed limitations as discussed above in Claim 7.
Modified Nia further teaches wherein the plurality of microfilaments have an average diameter less than 10 micrometers (about 12.7 µm or about 10 µm constitutes less than 10 µm, for similar reasons and motivation as indicated in the rejection of Claim 7).
Claim(s) 2, 10, 11, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farzin-Nia (USPN 6818076), herein Nia, in view of Li et al (US Publication 2015/0219078), herein Li.
Regarding Claim 2, modified Nia teaches all the claimed limitations as discussed above in Claim 1.
Nia does not explicitly teach wherein the coil direction of the yarn and the twist direction of the plurality of microfilaments are different (see Figs. 1, 2 wherein the coil angle of Fig. 2 and the twist angle of Fig. 1 are in the same direction).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nia such that the coil direction and twist direction are different as there are a finite number of solutions without unexpected results.
Nevertheless, Li also teaches wherein the coil direction and the twist direction are different (see Fig. 18A; where R is counterclockwise and r is clockwise; [0050] "turns…applied to the fiber (r), the twist…applied on the mandrel (R)", wherein R is coil direction, r is twist direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nia’s twist/coil direction to be different as taught by Li in order to counteract unwanted movement ([0204]), as is known in the art for coils.
Regarding Claim 10, modified Nia teaches all the claimed limitations as discussed above in Claim 7.
Nia teaches wherein the shape memory yarn is coiled to define the coil direction (see Fig. 2).
Nia does not explicitly teach wherein the coil direction of the shape memory yarn and the twist direction of the plurality of microfilaments are opposite (see Figs. 1, 2 wherein the coil angle of Fig. 2 and the twist angle of Fig. 1 are in the same direction).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nia such that the coil direction and twist direction are different as there are a finite number of solutions without unexpected results.
Nevertheless, Li also teaches wherein the coil direction and the twist direction are different (see Fig. 18A; where R is counterclockwise and r is clockwise; [0050] "turns…applied to the fiber (r), the twist…applied on the mandrel (R)", wherein R is coil direction, r is twist direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nia’s twist/coil direction to be different as taught by Li in order to counteract unwanted movement ([0204]), as is known in the art for coils.
Nia also does not explicitly teach wherein the shape memory yarn is coiled around a mandrel to define the coil direction.
Li also teaches coiling around a mandrel (see Fig. 18B; [0051] "Fig. 18B shows…monofilament that has been coiled by wrapping on…mandrel"; see Fig. 18A; [0050] "Fig. 18A shows…apparatus for fiber coiling about a mandrel").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nia’s coiling to be around a mandrel as taught by Li as a known method for a filament coil.
Regarding Claim 11, modified Nia teaches all the claimed limitations as discussed above in Claim 10.
Nia further teaches heat treating the shape memory yarn to torque balance the shape memory yarn (Col. 4 Lines 15-16 "twisted wire is subjected to a heat treatment to set the shape of the twisted configuration. This heat treatment prevents the stranded wire from unraveling"; Nia teaches the prevention of unraveling and therefore the recitation of torque balance).
Regarding Claim 13, modified Nia teaches all the claimed limitations as discussed above in Claim 12.
Nia does not explicitly teach plying the shape memory yarn with one or more shape memory yarns to torque balance the shape memory yarn (as best understood in light of the 112(b) rejections).
Li teaches plying to torque balance ([0055] "Figs. 21A-21D…SZ plying the coiled nylon fiber to produce a torque balanced two-ply structure"; [0156] "plying two...twisted fibers using...coiling to produce a SZ two-ply fiber").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li’s yarn to be plied as taught by Li in order to torque balance ([0055]), and/or counteract unwanted movements ([0204]).
Claim(s) 26, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farzin-Nia (USPN 6818076), herein Nia, in view of Lessar (USPN 7138582).
Regarding Claim 26, modified Nia teaches all the claimed limitations as discussed above in Claim 1.
Nia does not explicitly teach wherein the plurality of microfilaments are arranged in a plurality of clusters within the coiled shape memory yarn.
However, Nia does teach yarn in a fatigue-resistant medical application (Col. 2 Lines 1-7 "at least a portion of the stranded wire is coiled to form a coil spring…may be an orthodontic bite fixing device ,a stent, a ligature in an orthodontic bracket, an archwire in an orthodontic bracket, or any other coil spring that benefits from improved fatigue resistance in use"),
and modified Nia does further teach microfilament diameter of about 0.0005 inch (see rejection of Claim 1, Col. 2 Lines 38-40).
Lessar teaches wherein the plurality of microfilaments, each of about 0.0005 inches, are arranged in a plurality of clusters within the coiled shape yarn of a fatigue-resistant medical application (see Fig. 2a for coils; Col. 2 Lines 23-25 "Fig. 2a…three-filar conductor winding for use in a medical...embodiment"; Col. 4 Lines 9-10 "three-filar coil 60 having individual wires 65a, 65b, and 65c"; Col. 4 Lines 40-42 "conductors take the form of...stranded, cabled...wire conductor", wherein stranded indicates at least two clusters, and therefore a yarn with coil shapes; nevertheless, Col. 4 Lines 54-59 “cabled conductor 160 includes strands 132 through 138…all of which are formed from…described above”, which means Fig. 2a can be applied into Fig. 3A; Col. 4 Lines 54-55 "cabled conductor 160 includes strands 132 through 138...diameter of each strand...between 0.0005 inch and 0.005 inch"; Col. 2 Lines 10-13 “desirable…to provide…conductor having…improved fatigue resistance”, wherein Fig. 3a shows 7 clusters of a yarn with coil shapes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nia’s single coil to be stranded as taught by Lessar as a known arrangement for medical applications desiring fatigue resistance (Col. 2 Lines 10-13), which Nia desires as well (Col. 2 Lines 1-7), depending on the increased level of fatigue resistance desired, and/or for reinforcement as is known in the art (wherein an increase in the number of strands indicates greater reinforcement) and/or for higher flex life or tensile strength (see extrinsic evidence Cerra 2010/0096162 [0015]), especially being in the same art of endeavor as medical applications, especially with medical applications with particular diameters.
Regarding Claim 28, modified Nia teaches all the claimed limitations as discussed above in Claim 7.
The body of Claim 28 is the same as the body of Claim 27. As such, see the aforementioned rejection of the body of Claim 27 for the rejection of the body of Claim 28.
Response to Arguments
Applicant's arguments filed 6/8/26 have been fully considered but they are not persuasive.
Pertaining to remarks beginning on page 16 that one of ordinary skill in the art would not have understand 12.7 micrometers as being close to equal to the claimed about 10 micrometers because the person of ordinary skill would have assessed the microfilament according to cross-sectional area, and not the claimed diameter, and such areas utilizing 12.7 µm and 10 µm result in vastly different areas—examiner respectfully disagrees. First, Nia teaches about 12.7 µm to teach the claimed about 10 µm. Furthermore, 12.7 µm falls in the range of about 10 µm, meeting the claim—for example, 12.7 µm is closer to 10 than 20. The original disclosure provides no specific range for the term “about” (for example, ±10%). As such, under broadest reasonable interpretation, 12.7 µm falls in the range of about 10 µm, even more so as Nia teaches about 12.7 µm, which even more so is in the range of about 10 µm. The claim is not directed to area, but to diameter. Without a specifically defined range for the term “about” in the original disclosure, the arguments are not able to be found persuasive.
As such, any remarks pertaining to the cross-sectional area on pages 17-18 are similarly not persuasive.
Pertaining to remarks on page 17 that the applicant range of diameter is “relatively small” and therefore the claims are not taught—examiner respectfully disagrees. Such a specific value of 5 µm is not yet claimed to narrow the broadest reasonable interpretation of “less than about 10 µm”. Without a specific definition of the term “relatively” or “small” in the original disclosure, the disclosure of “relatively small” in [0111] does not provide support for a narrower interpretation of the term “about” in “about 10 µm” such that it would overcome “about 12.7 µm” taught by Nia.
Similarly, pertaining to remarks on page 17 that the applicant range of diameter is “relatively small” such as “5-µm diameter yarn” and therefore the claims are not taught—examiner respectfully disagrees. Applicant recites [0148] (corrected from [0147] as indicated in the remarks’ footnotes), indicating that flexural rigidity of the instant application utilizing 1519 filament, 5 µm yarn is better than a monofilament utilizing 203 µm diameter yarn as an example of “relatively small.” However, this is not persuasive, as the claimed range of “about 10 µm” is not being interpreted to mean a value as large as 203 µm, but “about 12.7 µm.” Again, without a specific definition of the term “about”, the argument is not persuasive.
Pertaining to remarks beginning on page 17 that Nia’s 0.0005 inch is nearly an order of magnitude smaller than the smallest diameter of shape memory alloy spring sold on the assignee’s website such as 0.01 inches to 0.014 inches and therefore one of ordinary skill in the art would not have understood Nia’s disclosure 0.0005 inches (used to teach 12.7 µm) being a workable range —examiner respectfully disagrees. First, applicant relies SKU # 704-6047—nowhere in the non-patent literature (NPL) provided in the information disclosure statement (IDS) is it indicated that the value of 0.01 is in inches. No units are found disclosed on the NPL. On the contrary, a further look at the website specification for SKU # 704-6047 only discloses “diameter 0.010 x 0.030”, in a pack of 3, and seemingly that the length of the coil is 7 inches long (see extrinsic evidence SKU 704-6047-1 NPL and extrinsic evidence SKU 704-6047-2 NPL under “specifications”). Similarly, applicant utilizes SKU #221-5512 to teach 0.014 inches—nowhere in the NPL is it indicated that the value of 0.014 is in inches. No units are found disclosed on the NPL. On the contrary, a further look at the website specification for SKU #221-5512 only discloses “diameter 0.012 x 0.030”, in a pack of 3, and seemingly that the length of the coil is 7.5 inches long (see extrinsic evidence SKU 221-5512-1 NPL and extrinsic evidence SKU 221-5512-2 NPL under “specifications”, wherein the image at least suggests 7.5” as the length). As such, the argument is not found persuasive.
Nevertheless, even if Ormco website was persuasively in inches, the argument is still not persuasive, as Nia clearly discloses 0.0005 inches, which is public disclosure relevant as prior art, and which one of ordinary skill in the art would take at face-value without any reason to doubt the disclosure. Even if one of ordinary skill in the art were to check the Ormco website, such ranges on the website do not teach away from Nia’s disclosure of 0.0005 inches; options may have been narrowed on the website due to market demands.
Examiner further directs attention to the rejection with Lessar, which similarly teaches 0.0005 inches (12.7 µm).
Pertaining to remarks on page 18 that one of ordinary skill in the art would not have reduced the size of the strand due to substantially reduced flexural rigidity—examiner respectfully disagrees. As aforementioned, about 12.7 µm can be considered to be about 10 µm without reduction. Even if reduction were required, it is not found persuasive that such a change, even if it affected cross-section, is so significant as to substantially reduce flexural rigidity—the example in [0148] is relative to a 203 µm diameter yarn, which about 12.7 µm clearly does not encompass.
For the term “about” to be further considered, and/or for the diameter to be further considered for criticality/unexpected results, applicant could present experimental data in a declaration or affidavit under 37 CFR 1.132 (see MPEP 716) indicating that “about” would only allow up to 11 µm before undesired results (wherein the definition of “undesired results” would have to be persuasively indicated in the original disclosure). For example, the original disclosure would have to indicate that, relative to Fig. 14A, an undesirable result is a structural strain of 90% at a force 11N, and the affidavit/declaration would have to show that experiments were performed such that 11 µm diameter results in such an undesirable result, leading applicant to conclude the specified range of about 10 µm, such that “about” is less than 1 µm. (This is only an example; for the term “about’ To be interpreted as less than 1 µm would mean that 9 µm would also lead to undesirable results, but 9 µm is encompassed in applicant claimed range). Examiner notes that the provisional application 63/077,350 only supports up to and including Fig. 14B.
Conclusion
The prior art made of record and not relied upon but is considered pertinent to applicant's disclosure and can be used to formulate a rejection if necessary: Luo et al (USPN 11427938) directed to coiled yarn; Mitchell et al (US Publication 2021/0102335), Domingo (US Publication 2012/0312444) directed to clusters.
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 Grace Huang whose telephone number is (571)270-5969. The examiner can normally be reached M-Th 8:30am-5:30pm EST.
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/GRACE HUANG/Primary Examiner, Art Unit 3732
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