DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed June 15, 2026.
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 21, 23, 25-28, 30, 34, 35 and 38 have been amended. Claims 1-20, 32, 36 and 37 have been cancelled. Claims 39-43 are newly added. Accordingly, claims 21-31, 33-35 and 38-43 remain pending in the application and are currently under examination.
Withdrawn Objections/Rejections
Applicant’s amendment renders the objection to the specification moot. Specifically, the specification has been amended to remove the hyperlink. Thus, said objection has been withdrawn.
Applicant’s amendment renders the objection to the claim 21 moot. Specifically, the claim has been amended to replace “matrix material” with “a matrix material” in order to describe “a matrix material” is different than the previously recited “a polymerizable matrix material or a polymeric matrix material”. Thus, said objection has been withdrawn.
Applicant’s amendment renders the rejections under 35 USC 112(b) of claims 21-38 moot. Specifically, the claims have either been amended to remedy the indefinite issues or cancelled. Thus, said rejections have been withdrawn.
Maintained/Modified Rejections
The following rejection has been maintained, but modified due to Applicant’s amendments:
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 21-31, 33-35 and 38 stand rejected and claims 38-43 are newly 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 a 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 a matrix material filling interstitial spaces between the continuous fibers; wherein each of the continuous fibers includes a plurality of filaments, each filament of the filaments coated with a matrix material over at least a portion of a surface of each filament, and the outer region includes a coating; wherein the fiber bundles comprise a fiber volume of 30 volume percent or more; wherein the core region and the outer region comprise different mechanical properties; wherein the outer region comprises filler dispersed in an outer region matrix material; wherein the filler of the outer region is about 1% or more by volume of the outer region matrix material; and wherein a ratio of the continuous fibers of the core region to the filler of the outer region is about 1:0.01 or more.
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 patented claims further recite “wherein the outer region comprises a degradable polymer and at least one biodegradable or bioabsorbable filler”. The patented claims also recite that the outer layer may comprises threads.
It is noted that the fibers in an amount of 10 to 75 volume percent of the composite overlaps with the instant claim range of “30 volume percent or more”. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (MPEP 2144.05(I)).
The patent does not explicitly recite that the filler is dispersed in an outer region matrix material; however, Example 95 exemplifies such an embodiment in which an outer coating is infused (dispersed) with hydroxyapatite.
The patent does not explicitly recites that the filler in the outer region is about 1% or more by volume of the outer region matrix material. However, the patent states that filler may be present in an amount ranging from about 10 to about 50 wt% of the matrix composition and more than 50 wt% is also possible. Accordingly, the patent discloses that the filler is present in amounts that are overlapping with the instant claims range of “about 1% or more by volume”.
While the patent does not explicitly recite a ratio of the fibers of the core region to the filler of the outer region is about 1:0.01 or more, the patent does recite that the fibers are in an amount of 10 to 75 volume percent and states that the filler may be present in an amount ranging from about 10 to about 50 wt%. Accordingly, a ratio range can be deduced as 1:0.13 to 1:5 which overlaps with the instant range of about 1:0.01 or more.
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.
Regarding limitations directed to properties such as flexural modulus and the like and the core region and the outer region having “different mechanical properties” or different degradation rates, said limitations are dependent on the materials utilized in the core region and outer region. The composite of the patent/D’Agostino appears to be similar to that of the instant composite. MPEP states 2112.01,
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Thus, one of ordinary skill would reasonably expect the similar composite of the patent/D’Agostino would posses the same characteristics or properties as that of the claimed invention.
Thus, the instant claims are unpatentable over the patent in view of D’Agostino.
Response to Arguments
Applicant's arguments, filed 6/15/2026, regarding the double patenting rejection have been fully considered but they are not persuasive.
Applicant argues that the amendments to claim 21 render the double patenting rejection moot. Remarks, pages 10-11.
In response, it is respectfully submitted that the rejection has been modified according to the claim amendments. The new claim limitations are addressed above in the rejection.
Thus, for these reasons, Applicant’s arguments are found unpersuasive. Said rejection is maintained at this time, but may be overcome by filing a terminal disclaimer.
New Rejections
In light of Applicant’s amendments, the following rejections have been newly added:
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-31, 33-35 and 38-43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21, 42 and 43 recite, “wherein the fiber bundles comprise a fiber volume of 30 volume percent or more”. The instant specification states,
[0276] The fiber bundles may have a fiber volume of about 40% or more, 50% or more, or even 60% or more. The fiber bundles may have a fiber volume of about 95% or less, 90% or less, 80% or less, or even 70% or less. The remaining volume may be occupied by empty space (e.g., air). The empty space may arise from interfacial spaces between adjacent and contacting fibers. The fiber volume may depend from the cross-sectional shape and/or cross-sectional length/width of the fibers and the packing of the fibers together. For example, circular cross-section fibers may give rise to more interstitial spaces as compared to square cross-section fibers.
[0334] The fibrous bundles may or may not be impregnated with polymeric material. The fibrous bundles may have a fiber volume of about 10% to about 90%, about 40% to about 70%, or even about 50% to about 60%. The remaining volume may be occupied by polymeric material ("polymeric material").
[0735] The fiber bundles may be defined by a fiber volume. The fiber volume may be between about 30% and 80%, more preferably between about 40% and 70%, more preferably between about 50% and 60%.
The limitation, “30 volume percent or more” implies a range of 30-100%, however the instant specification only discloses fiber bundles having a fiber volume of up to about 95%. Accordingly, the instant disclosure does not provide guidance for fiber bundles having a fiber volume of greater than about 95% to 100%. Thus, the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21, 42 and 43 recite, “wherein the filler of the outer region is about 1% or more by volume of the outer region matrix material”. The instant specification states,
[0400] The filler may be present in a polymeric material, reinforcement elements, or both in an amount of about 1% or more, 5% or more, 10% or more, 20% of more, 25% or more, or even 30% or more, by volume. The filler may be present in a polymeric material, reinforcement elements, or both, in an amount of about 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, or even 65% or less, by volume.
[0440] The size of the filler may be sufficiently small to avoid appreciably increasing the viscosity of the polymeric matrix material. The filler may be a high aspect ratio filler (e.g., 10:1 or more, 20:1 or more, or even 30:1 or more). The filler may include surface modification in order to improve the interface between the filler and polymeric matrix material. The filler may be present in the polymeric matrix material in an amount of about 5% or more, 7% or more, 9% or more, or even 11% or more, by weight of the polymeric matrix material. The filler may be present in the polymeric matrix material in an amount of about 19% or less, 17% or less, 15% or less, or even 13% or less, by weight of the polymeric matrix material.
The limitation, “about 1% or more” implies a range of about 1-100%, however the instant specification only discloses filler material in an amount of to about 90%. Accordingly, the instant disclosure does not provide guidance for a filler material volume of greater than about 90% to 100%. Thus, the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. It is noted that incorporating the limitations of claim 40 into independents claim 21, 42 and 43 would overcome this rejection.
Claim 21 recites, “wherein a ratio of the continuous fibers of the core region to the filler of the outer region is about 1:0.01 or more”. The instant specification states,
[0447] A ratio of reinforcement elements included in the cores and reinforcement elements included in the outer regions may be about 1:0.01 or more, 1:0.1 or more, or even 1:0.5 or more. A ratio of reinforcement elements included in the cores and reinforcement elements included in the outer regions may be about 1:2 or less, 1:1.5 or less, or even 1:1 or less.
The limitation, “about 1:0.01 or more” implies a range without a maximum ratio, however the instant specification only discloses a maximum ratio of 1:2. Accordingly, the instant disclosure does not provide guidance for a ratio of the continuous fibers of the core region to the filler of the outer region greater than about 1:2. Thus, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 39 recites, “wherein the filler of the outer region is about 5% or more by volume of the outer region matrix material”. The instant specification states,
[0400] The filler may be present in a polymeric material, reinforcement elements, or both in an amount of about 1% or more, 5% or more, 10% or more, 20% of more, 25% or more, or even 30% or more, by volume. The filler may be present in a polymeric material, reinforcement elements, or both, in an amount of about 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, or even 65% or less, by volume.
[0440] The size of the filler may be sufficiently small to avoid appreciably increasing the viscosity of the polymeric matrix material. The filler may be a high aspect ratio filler (e.g., 10:1 or more, 20:1 or more, or even 30:1 or more). The filler may include surface modification in order to improve the interface between the filler and polymeric matrix material. The filler may be present in the polymeric matrix material in an amount of about 5% or more, 7% or more, 9% or more, or even 11% or more, by weight of the polymeric matrix material. The filler may be present in the polymeric matrix material in an amount of about 19% or less, 17% or less, 15% or less, or even 13% or less, by weight of the polymeric matrix material.
The limitation, “about 5% or more” implies a range of about 5-100%, however the instant specification only discloses filler material in an amount of to about 90%. Accordingly, the instant disclosure does not provide guidance for a filler material volume of greater than about 90% to 100%. Thus, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Dependent claims 22-31, 33-35 and 38-41 do not remedy the written description issue and as such said dependent claims suffer from the same deficiencies.
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.
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 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.
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 - 5:00 pm.
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Casey S. Hagopian
Examiner, Art Unit 1617
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617
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