DETAILED ACTION
Receipt is acknowledged of applicant’s Preliminary Amendment filed 4/26/2024.
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 .
Status of the Claims
Claims 1-20 are cancelled. Claims 21-38 are newly added. Accordingly, claims 21-38 remain pending in the application and are currently under examination.
Information Disclosure Statement
The IDS dated 5/12/2023 has ben considered. A signed copy is enclosed herewith.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at [0685] of the instant specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 21 is objected to because of the following informalities: “matrix material” is recited at lines 5-6 and line 8. For proper antecedent basis, it is suggested that the word “the” is inserted prior to each of said recitations of “matrix material”. Appropriate correction is required.
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 21-38 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 21 recites the limitations, “a polymerizable matrix material or polymeric matrix material which fills the gaps between the fiber bundles” in lines 2-3 of the claim, “matrix material filing interstitial spaces between fibers” in lines 5-6 of the claim, and “wherein each of the fibers includes a plurality of filaments, each filament coated with matrix material” in lines 7-8 of the claim. There is insufficient antecedent basis for “matrix material” in the claim. It is unclear whether the recitations of “matrix material” as it relates to the interstitial spaces between fibers and the filament coating refers to the polymerizable matrix material or polymeric matrix material that fills the gaps between the fiber bundles or whether the “matrix material” is an additional different matrix material.
Claim 27 recites the limitation, “wherein the filaments have a polymeric or polymerizable coating”. Claim 27 depends from claim 21. Claim 21 recites, “each filament coated with matrix material”. The claim is indefinite because it is unclear if the matrix material coating of claim 21 and the polymeric or polymerizable coating of claim 27 are one in the same or separate elements.
Claim 36 recites the limitation, “wherein an aspect ratio of the elongated composite is about 1:50 or more, and/or the aspect ratio is about 1:5 or less”. The claim is indefinite because it is unclear how the elongated composite can simultaneously have an aspect ratio of about 1:50 or more and about 1:5 or less. The instant specification at [0188] states,
The aspect ratio of the pin may be about 1:50 or more, 1:40 or more, or even 1:30 or more. The aspect ratio of the pin may be about 1:5 or less, 1:10 or less, or even 1:20 or less. The cross-sectional aspect ratio of the pin may be about 1:30 or more, 1:20 or more, or even 1:10 or more. The cross-sectional aspect ratio of the pin may be about 1:1 or less, 1:3 or less, or even 1:5 or less. Emphasis added.
Accordingly, the instant specification explains an elongated composite (such as a pin) can have an aspect ratio of about 1:50 or more OR about 1:5 or less. The instant specification also indicates that an elongated composite can have an cross-sectional aspect ratio of about 1:5 or less. However, the claim does not specify that the aspect ratio is a cross-sectional aspect ratio. It is suggested that the claim is amended to either remove “and” from the claim or clarify that the aspect ratio of about 1:5 or less refers to a cross-sectional aspect ratio.
Claim 37 recites the limitation "a polymeric matrix" in the 2nd line of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 37 depends from claim 21. Claim 21 recites, “a polymerizable matrix material or polymeric matrix material” in lines 2-3 of the claim. The claim is indefinite because it is unclear whether “a polymer matrix” is referring to the “polymerizable matrix material or polymeric matrix material” of claim 21, or to an additional different polymeric matrix. Additionally, the instant specification at [0552] indicates that the outer/cover region can have a polymeric matrix that is the same or different from the polymeric matrix of the core region.
Dependent claims 22-26, 28-35 and 38 do not remedy the indefinite issues and as such said dependent claims suffer from the same deficiencies.
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 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent No. 11,484,627 B2 in view of D’Agostino et al. (US 2020/0305936 A1, Oct. 1, 2020, hereafter as “D’Agostino”).
The instant claims are drawn to an elongated composite for an implant comprising: i) a core region including a plurality of fiber bundles and a polymerizable matrix material or polymeric matrix material which fills gaps between the fiber bundles; and ii) an outer region surrounding the core region; wherein each of the fiber bundles comprises a plurality of continuous fibers and matrix material filling interstitial spaces between fibers; and wherein each of the fibers includes a plurality of filaments, each filament coated with matrix material, and the outer region includes a coating free of continuous fibers.
The patented claims are drawn to a composite comprising: a core structure comprising at least one reinforcement component, the at least one reinforcement component comprising a degradable matrix and a plurality of fibers arranged in bundles, wherein the plurality of fibers are disposed within the degradable matrix; and an outer region formed on the core structure, wherein the outer region comprises at least one layer, and further wherein the outer region comprises a degradable polymer; wherein the composite is a screw, pin or anchor; the at least one reinforcement component is present in an amount at least 20 volume percent of the composite; and the fibers are present in an amount of 10 to 75 volume percent of the composite. The patented claims further recites polymeric degradable matrix materials, the plurality of fibers comprise a plurality of filaments, the filaments are twisted, the core having sheets that are arranged in layers, etc.
The patent does not explicitly recite that the fiber bundles comprises a plurality of continuous fibers.
However, the patent states that the composite is formed from the basic building blocks of the matrix and reinforcing elements, wherein the reinforcing elements may be formed using textile engineering techniques and primarily continuous, bio-degradable, bio-resorbable or bio-neutral fibers (col. 67, lines 58-62). Accordingly, the specification effectively limits the “fibers” recited in the claims as primarily continuous fibers.
The examiner has relied upon the specification to delineate the scope of the invention embraced by the patent, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
The patent does not explicitly recite that the filaments are coated.
However, D’Agostino teaches a composite implant comprising at least one reinforcing element embedded within a matrix for the purpose of bone repair ([0029]). D’Agostino teaches that the reinforcing element includes rods or fibers and that the rod/fiber component may comprising a plurality of filaments ([0194]-[0196] and [0317]; Fig. 8). D’Agostino teaches that the filaments can be coated for the purpose of improving integration of the filaments into the degradable matrix ([0495]; claim 78).
Both D’Agostino and the patent are drawn to composite implants for bone repair, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include coated filaments into the patent with a reasonable expectation of success. A skilled artisan would have been motivated to do so because D’Agostino teaches that coating filaments is effective in improving integration of the filaments into the surrounding degradable matrix.
Thus, the instant claims are unpatentable over the patent in view of D’Agostino.
Pertinent Art
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Preiss-Bloom et al. (WO 2019/123462 A1, June 27, 2019, hereafter as “Preiss-Bloom”) teaches a medical implant comprising a plurality of fiber bundles, each bundle comprising a polymer binding the fiber bundles and a plurality of uni-directionally aligned continuous reinforcement fibers (abstract; claim 1). Preiss-Bloom teaches that the fiber bundle contains a number of individual fibers in close proximity to each other but generally with some amount of polymer interspersed between the fibers within the bundle (page 15, 2nd full paragraph). Preiss-Bloom teaches that each fiber is a stand-alone component and preferably comprises a single filament (page 15, 2nd full paragraph).
Olson et al. (CA 2650542 A1, Nov. 8, 2007, hereafter as “Olson”) teaches a bone repair composite comprising a core and a sheath, the core comprises a combination of a first set of polymeric yarns coated with an apatite calcium phosphate mineral layer and the sheath comprises either polymer or a combination of a second set of polymeric yarns or one or more polymer coatings.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 3:30 pm.
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617