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 .
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.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites in the last paragraph “a distance between each of the first coupling site and the second coupling site with a mounting aperture is increased”. However, claim 1 has already previously recited a mounting aperture. It is unclear if this latter recitation of a mounting aperture is referring to the same aperture or an additional aperture. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret the last paragraph of claim 1 as - - a distance between each of the first coupling site and the second coupling site with the mounting aperture is increased - -.
Claim 8 recites “a plurality of mounting apertures”. It is unclear if this plurality of mounting apertures is in addition to the centrally located mounting aperture of claim 1 (and therefore requires at least three mounting apertures in total); or if the construct comprises a plurality of mounting apertures including the mounting aperture from claim 1 (and therefore requiring at least two mounting apertures in total). For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 8 as - - a plurality of mounting apertures in addition to the centrally located mounting aperture - -.
Claim(s) 2-7, 9-18 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
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.
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) 1-8, 10-16 and 18 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Kubaik et al (US 2019/0209289).
Kubaik et al discloses the following limitations:
Claim 1. A construct capable (230) of compressing tissue (Figs. 18A-18B), comprising:
a dynamic tensioning device (234) configured to be implanted in a subject and defining a plurality of coupling sites (258), the dynamic tensioning device being deformable superelastically from a resting state (Fig. 18B) to a stretched state ([0101] discusses the embodiment of Figs. 18A-18B is similar to the previous embodiments, wherein [0076] discusses the material property of capture member 14, akin to capture member 234 cited as the dynamic tensioning device. The capture member is formed from Nitinol which is a well-known superelastic material and therefore the cited dynamic tensioning device is capable of deforming superelastically from a resting state to a stretched state);
wherein:
the dynamic tensioning device defines a first coupling site (a first one of aperture 258) and a second coupling site (a second one of aperture 258) of the plurality of coupling sites with a structural member ([0076]; body of laser cut sheet which includes central portion 252, spokes 250, structures 256 and tines 159) therebetween;
the plurality of coupling sites are disposed radially around a centrally located mounting aperture (254) formed by the structural member and configured for anchoring the dynamic tensioning device ([0101]-[0102]).
Kubaik et al fails to explicitly disclose a distance between each of the first coupling site and the second coupling site with the mounting aperture is increased in the stretched state relative to the resting state. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention that the distance between each of the first coupling site and the second coupling site with the mounting aperture is capable of being increased in the stretched state relative to the resting state due to the material properties of the cited dynamic tensioning device (234). Applicant is reminded claim 1 is directed to an apparatus claim and not a method of use and therefore the prior art only needs to be capable of achieving the claimed configurations and not an active step of demonstrating a stretched state. The cited dynamic tensioning device (234) of Kubaik et al is formed of Nitinol as discussed ([0076]) which is a well-known superelastic material. Such a material would be capable of stretching and therefore a user would be able pull and stretch structure (256) radially outward from central mounting aperture (254), which would increase the distance between each of the coupling sites (258) and the mounting aperture. Therefore, claim 1 is considered as made obvious based upon the disclosure of Kubaik et al.
Claim 2. The construct of claim 1, further comprising a plurality of sutures (16) (not shown in Figs. 18A-18B, but can be seen in Fig. 1) ([0069], [0072]; “one or more flexible members” may be formed of suture material and/or as a suture), wherein the plurality of sutures are capable of coupling to the dynamic tensioning device at the plurality of coupling sites (258) (a user can thread one of the flexible members 16 through aperture 258 if desired).
Claim 3. The construct of claim 2, wherein the plurality of sutures (16) comprise a first suture (a first of the “one or more” flexible member) capable of coupling to the first coupling site of the dynamic tensioning device, and wherein the plurality of sutures further comprise a second suture (a second of the “one or more” flexible member 16) capable of coupling to the dynamic tensioning device at the second coupling site (a user can thread one of the flexible members 16 through the first aperture 258 if desired and thread another one of the flexible members 16 through the second aperture 258 if desired).
Claim 4. The construct of claim 1, wherein the plurality of coupling sites comprise three coupling sites (258) (Fig. 18B; there are at least three coupling sites).
Claim 5. The construct of claim 4, wherein the three coupling sites each define a lobe (256) arranged in multi-lobe configuration having three lobes (Fig. 18B; there are at least three lobes).
Claim 6. The construct of claim 1, wherein the plurality of coupling sites comprise four coupling sites (258) (Fig. 18B; there are at least four coupling sites).
Claim 7. The construct of claim 6, wherein the four coupling sites each define a lobe (256) arranged in a multi-lobe configuration having four lobes (Fig. 18B; there are at least four lobes).
Claim 8. The construct of claim 1, further comprising a plurality of mounting apertures in addition to the centrally located mounting aperture (Fig. 18B; the other three aperture 258, wherein two of the apertures 258 are interpreted as the first and second coupling site in claim 1, and the remaining three apertures are interpreted as the plurality of mounting apertures of claim 8).
Claim 10. The construct of claim 1, further comprising a fastener (230) capable of engaging bone and connected to the dynamic tensioning device (234) via at least one of the plurality of coupling sites (legs 246 of cited fastener 230 is inserted through aperture 258; [0101]-[0102]; Fig. 4 shows an illustrative example of the coupling of the two elements).
Claim 11. The construct of claim 1, wherein the construct comprises a fastener (230) capable of extending through the mounting aperture and into bone, to attach the dynamic tensioning device to the bone. One of legs 246 of cited fastener 230 is capable of being disposed through mounting aperture 254 to attach the cited dynamic tensioning device (234) to bone.
Claim 12. The construct of claim 1, wherein the dynamic tensioning device (234) has an outer surface (top surface seen in Fig. 18B) opposite an inner surface (bottom surface in Fig. 18B) that is capable of facing bone, wherein a central axis (axis extending through aperture 254) extends through the dynamic tensioning device transverse to the outer and inner surfaces.
Claim 13. The construct of claim 12, wherein a distance from the structural member to the central axis varies along the structural member to form a plurality of protrusions (256+259) each projecting away from the central axis, and wherein each protrusion defines one of the plurality of coupling sites (254) ([Fig. 18B; [0101]-[0102]).
Claim 14. The construct of claim 13, wherein the dynamic tensioning device (234) defines two or more apertures (Fig. 18B; the three remaining apertures 258; wherein two of the apertures 258 are interpreted as the first and second coupling site in claim 1, and the remaining three apertures are interpreted as the two or more apertures of claim 14).
Claim 15. The construct of claim 14, wherein the dynamic tensioning device (234) is formed as a single piece and capable of being operative without extending into the bone ([0076]; laser cut from a single sheet of material, the bottom back side of the cited dynamic tensioning device in Fig. 18B can be placed against bone without extending into the bone since there are no protrusions or tines on that side).
Claim 16. The construct of claim 15, wherein the dynamic tensioning device (234) has an inner surface (bottom surface in Fig. 18B) to face the bone, and wherein the inner surface is free of protrusions for entering the bone (the protrusions 259 are on the outer (top) side and therefore the inner (bottom) surface does not have any protrusions and is capable of facing bone).
Claim 18. The construct of claim 1, wherein the dynamic tensioning device (234) is mountable on a proximal humerus. The structure of the cited dynamic tensioning device can be placed on a proximal humerus and mounted in any known way (fasteners, anchors, screws, sutures, etc or using tines 259).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12178423 (parent application US Serial No. 17/538,789).
Although the claims at issue are not identical, they are not patentably distinct from each other because the elements of claims 1-18 of the instant application are to be found in claims 1-13 of the patent. Thus the difference between claims 1-18 of the instant application and claims 1-13 of the patent lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the invention of claims 1-13 of the patent is in effect a “species” of the “generic” invention of claims 1-18 of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1-18 are anticipated by claims 1-13 of the patent, it is not patentably distinct from claims 1-13 of the patent.
Allowable Subject Matter
Claims 9 and 17 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, rewritten to obviate the 35 U.S.C. 112 rejections and if the above double patenting rejection is obviated.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Kubaik et al discloses the invention substantially as claimed above.
In regards to claim 9, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed construct comprising, inter alia, a needle connected to the dynamic tensioning device via at least one of the plurality of coupling sites. Instead, Kubaik et al discloses a needle (134) that is instead inserted through the centrally located mounting aperture (54) ([0090]). It would not have been obvious to modify the construct of Kubaik et al to have the needle connected to the dynamic tensioning device via any one of the plurality of coupling sites (258) as those sites are instead intended for the legs (246) of the cited fastener (232).
In regards to claim 17, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed construct comprising, inter alia, a bone screw for passing through the mounting aperture to anchor the dynamic tensioning device. Instead, the construct of Kubaik et al is intended to be secured to tissue (5) and then using a separate bone anchor (162) with suture (174) to couple the tissue to bone (Figs. 11-14; [0091]-[0095], [0102]). The bone anchor of Kubaik et al is not intended nor sized for passing through the mounting aperture to anchor the dynamic tensioning device.
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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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.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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