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 Objections
Claim 10 is objected to because of the following informalities: the subject matter of claim 10 has been added to independent claim 1 such that claim 10 does not add any limitation as such it should be canceled. 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 14 and 27 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 14 recites the limitation "said polymer surface" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "said polymer surface" in line 7. There is insufficient antecedent basis for this limitation in the claim.
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) 1, 3-4 and 6-13, and 15-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Preiss-Bloom et al (US Pub 2017/0246356).
With respect to claim 1, Preiss-Bloom discloses an implant (see fig 35 below) comprising a plurality of bioabsorbable mineral fibers and polymer (paragraph 74) wherein the implant comprises a core (fig 35, 602), surface layer and one or more protrusions on the surface layer (fig 35, 600); wherein the mineral content of the protrusion is lower than the mineral content of the implant core (paragraph 35) wherein the protrusions are between 0.01 mm and 0.3 mm, 0.02 mm and 0.2 mm or 0.02 and 0.1 mm in width at the tip (fig 35 and paragraph 147 discloses that the wall thickness can be .2mm paragraph 149 discloses that the protrusions or ribs have a width less than the thickness, the tips would be less than the width such that if the base width is .2mm the tip would have a value within the claimed ranges). With respect to claim 3, Preiss-Bloom discloses wherein the relative height of the protrusions increases the pull out strength of the implant by at least 50% compared with an implant without protrusions (paragraph 246 discloses the strength is 50% more and paragraph 281, 65% more). With respect to claim 4, Preiss-Bloom discloses wherein the protrusions are between 0.05 mm and 2 mm, 0.1 mm and 1 mm or 0.2 and 0.8 mm in height (paragraph 187, .1mm-2mm). With respect to claim 6, Preiss-Bloom discloses wherein the protrusions are in the shape of ribs, threads, hooks, quills, spikes, burrs or clips (paragraph 149 “ribs” and fig 35). With respect to claim 7, Preiss-Bloom discloses wherein the protrusions are in the shape of ribs (paragraph 149). With respect to claim 8, Preiss-Bloom discloses wherein the cross-section of the protrusions are in the shape of circles or hexagons (fig 35 circular shape). With respect to claim 9, Preiss-Bloom discloses wherein the protrusions are between 0.10 mm and 2 mm, 0.2 mm and 1 mm or 0.4 and 0.8 mm in width at the base where the protrusion meets the implant (paragraph 147-149 in paragraph 147 the wall thickness is disclosed as being between .2-10mm while paragraph 149 discloses the ribs having a base width between less than 100% to 20% of the wall thickness meeting the claimed ranges). With respect to claim 10, Preiss-Bloom discloses wherein the protrusions are between 0.01 mm and 0.3 mm, 0.02 mm and 0.2 mm or 0.02 and 0.1 mm in width at the tip (fig 35 and paragraph 147 and 148 the tips would be less than the width such that if the base width is .2mm the tip would have a value within the claimed ranges). With respect to claim 11, Preiss-Bloom discloses wherein the length of the implant is between 10 mm and 200 mm, or 15 mm and 150 mm (paragraphs 221, 227 lengths of .5-50cms disclosed). With respect to claim 12, Preiss-Bloom discloses wherein the implant diameter is between 1 mm and 14 mm, 1 mm and 10 mm, 1.5 mm and 6 mm or 2.0 mm and 4 mm (paragraph 217, .5-8mm). With respect to claim 13, Preiss-Bloom discloses wherein the implant is cannulated (fig 35). With respect to claim 15, Preiss-Bloom discloses wherein the protrusions are unidirectional (fig 35). With respect to claim 16, Preiss-Bloom discloses wherein the protrusions are a combination of unidirectional and bidirectional (rib shaped). With respect to claim 17, Preiss-Bloom discloses wherein said body composition comprises a biodegradable polymer; wherein said biodegradable polymer comprises a homopolymer or a copolymer; wherein said copolymer comprises a random copolymer, block copolymer, or graft copolymer; wherein said polymer comprises a linear polymer, a branched polymer, or a dendrimer, of 49natural or synthetic origin; wherein said polymer comprises lactide, glycolide, caprolactone, valerolactone, carbonates (e.g., trimethylene carbonate, tetramethylene carbonate, and the like), dioxanones (e.g., 1,4-dioxanone), 8- valerolactone, 1,dioxepanones )e.g., 1,4-dioxepan-2-one and 1,5-dioxepan-2- one), ethylene glycol, ethylene oxide, esteramides, y-ydroxyvalerate, - hydroxypropionate, alpha-hydroxy acid, hydroxybuterates, poly (ortho esters), hydroxy alkanoates, tyrosine carbonates, polyimide carbonates, polyimino carbonates such as poly (bisphenol Aiminocarbonate) and poly (hydroquinone-iminocarbonate,(pol yurethanes, polyanhydrides, polymer drugs (e.g., polydiflunisol, polyaspirin, and protein therapeutics), sugars; starch, cellulose and cellulose derivatives, polysaccharides, collagen, chitosan, fibrin, hyaluronic acid, polypeptides, proteins, poly (amino acids), polylactides (PLA), poly-L-lactide (PLLA), poly-DL-lactide (PDLLA); polyglycolide (PGA); copolymers of glycolide, glycolide/trimethylene carbonate copolymers (PGA/TMC); other copolymers of PLA, such as lactide/tetramethylglycolide copolymers, lactide/trimethylene carbonate copolymers, lactide/d- valerolactone copolymers, lactide/f-caprolactone copolymers, L-lactide/DL- lactide copolymers, glycolide/L-lactide copolymers (PGA/PLLA), polylactide- co-glycolide; terpolymers of PLA, such as lactide/glycolide/trimethylene carbonate terpolymers, lactide/glycolide/ c: - caprolactone terpolymers, PLA/polyethylene oxide copolymers; polydepsipeptides; unsymmetrically 3,6- substituted poly-I ,4-dioxane-2,5-diones; polyhydroxyalkanoates; such as polyhydroxybutyrates (PHB); PHB/bhydroxyvalerate copolymers (PHB/PHV); poly-b-hydroxypropionate (PHPA); poly-p-dioxanone (PDS); poly-d-valerolactone - poly-c:-capralactone, poly(c:caprolactone- D L-lactide) copolymers; methylmethacrylate-N-vinyl pyrrolidone copolymers; polyesteramides; polyesters of oxalic acid; polydihydropyrans; polyalkyl-2- cyanoacrylates; polyurethanes (PU); polyvinylalcohol (PV A); polypeptides; poly-b-malic acid (PMLA): poly-b-alkanoic acids; polycarbonates; polyorthoesters; polyphosphates; poly(ester anhydrides); and mixtures thereof; and derivatives, copolymers and mixtures thereof (paragraph 99-100 discloses various biodegradable polymers listed). With respect to claim 18, Preiss-Bloom discloses wherein the polymer is in a form of a polymer matrix (paragraph 106); wherein said polymer matrix comprises a polymer selected from the 50group consisting of PLLA (poly-L-lactide), PDLLA (poly-DL-lactide), PLDLA, PGA (poly-glycolic acid), PLGA (poly-lactide-glycolic acid), PCL (Polycaprolactone), PLLA-PCL and a combination thereof (paragraph 108). With respect to claim 19, Preiss-Bloom discloses wherein if PLLA is used, the matrix comprises at least 30% 50%, or at least 70% PLLA (paragraph 108 discloses each range). With respect to claim 20, Preiss-Bloom discloses wherein if PDLA is used, the matrix comprises at least 5%, at least 10%, or at least 20% PDLA (paragraph 108 discloses each range). With respect to claim 21, Preiss-Bloom discloses wherein an inherent viscosity (IV) of the polymer matrix alone is in the range of 0.2-6 dl/g, 1.0 to 3.0 dl/g, 1.5 to 2.4 dl/g, or 1.6 to 2.0 dl/g (paragraph 109), wherein IV is measured according to a flow time of a polymer solution through a narrow capillary relative to the flow time of the pure solvent through the capillary (paragraph 110). With respect to claim 22, Preiss-Bloom discloses wherein said mineral material of said body composition comprises ranges of the following elements, all mol %:Na20: 11.0 - 19.0 (paragraph 114), CaO: 9.0-14.0 (paragraph 115), MgO: 1.5 - 8.0 (paragraph 116), B203: 0.5 -3.0 (paragraph 117), A1203: 0- 0.8 (paragraph 118), P203: 0.1 -0.8 (paragraph 119), SiO2: 67 – 73 (paragraph 120). With respect to claim 23, Preiss-Bloom discloses wherein said mineral material of said body composition comprises ranges of the following elements, all mol %:Na20: 12.0 - 13.0 mol. % (paragraph 122), CaO: 9.0 - 10.0 mol. % (paragraph 123), MgO: 7.0 - 8.0 mol. % (paragraph 124) B203: 1.4-2.0 (paragraph 125) mol.% P203: 0.5 -0.8 mol.% (paragraph 126) ,SiO2: 68- 70 mol.% (paragraph 126). With respect to claim 24, Preiss-Bloom discloses wherein said mineral material of said body composition comprises ranges of the following elements, all mol %:Na20: 11.0 - 19.0, CaO: 8.0- 14.0, MgO: 2 - 8.0, B203: 1 - 3.0, A1203: 0-0.5, P203: 1-2, SiO2: 66 - 70 % mol % (paragraphs 114-127). With respect to claim 25, Preiss-Bloom discloses and wherein a height of the protrusions is in a ratio to the measured dimension of the implant, in a range of 1:40 to 40:1 (paragraph 187 states the height of the protrusions are between .1mm-2mm while paragraph 218 discloses the diameter of the implant being .5-8mm placing the ratio within the claimed ratio).
With respect to claim 26, Preiss-Bloom discloses an implant (see fig 35 below) comprising a plurality of bioabsorbable mineral fibers and polymer (paragraph 74) wherein the implant comprises a core (fig 35, 602), surface layer and one or more protrusions on the surface layer (fig 35, 600); wherein the mineral content of the protrusion is lower than the mineral content of the implant core (paragraph 35). wherein said ratio is in a range of 1:2 to 2:1, wherein said measured dimension of the implant is diameter of the implant wherein the diameter of the implant is greater than 4mm (paragraph 187 states the height of the protrusions are between .1mm-2mm while paragraph 218 discloses the diameter of the implant being .5-8mm placing the ratio within the claimed ratio such that a disclosed value of 2mm and 4mm are included meeting the claim limitation).
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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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Preiss-Bloom et al (US Pub 2017/0246356).
Preiss-Bloom discloses the claimed invention except for specifically disclosing wherein mineral content of the protrusion as a percentage of the entire composition is 10-40, 15-35, or 20-35 percentage points lower than the mineral content of the implant body as a percentage of its entire composition. Preiss-Bloom does disclose each layer having fibers in the abstract and that the composition can be different in each layer (paragraph 92) but does not specifically disclose the percentage difference. With regard to claim 5, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to have wherein mineral content of the protrusion as a percentage of the entire composition is 10-40, 15-35, or 20-35 percentage points lower than the mineral content of the implant body as a percentage of its entire composition, since 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.
Claim(s) 14 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Preiss-Bloom et al (US Pub 2017/0246356) in view of Preiss-Bloom et al (WO 2020044327).
With respect to claim 27, Preiss-Bloom ‘356 discloses an implant (see fig 35 below) comprising a plurality of bioabsorbable mineral fibers and polymer (paragraph 74) wherein the implant comprises a core (fig 35, 602), surface layer and one or more protrusions on the surface layer (fig 35, 600); wherein the mineral content of the protrusion is lower than the mineral content of the implant core (paragraph 35).
With respect to claims 14 and 27 Preiss-Bloom ‘356 discloses wherein the fiber structure is maintained, wherein at least 50, 65, 80, 85, 90, 95% of surface fibers retain their geometric structure (Table 2d discloses 68,43% fiber structure) but does not specifically disclose wherein said surface is ablated to a controlled extent, such that a structure of said fibers is maintained upon ablation of said polymer surface; wherein the fiber structure is maintained.
Preiss-Bloom ‘327 disclose wherein said surface is ablated to a controlled extent, such that a structure of said fibers is maintained upon ablation of said polymer surface; wherein the fiber structure is maintained (page 9, ll. 4-8) wherein at least 50, 65, 80, 85, 90, 95% of surface fibers retain their geometric structure (page 9, line 6) to maximize the roughness and porosity (page 8 line 15-17).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Preiss-Bloom ‘356 to include wherein said surface is ablated to a controlled extent, such that a structure of said fibers is maintained upon ablation of said surface; wherein the fiber structure is maintained in view of Preiss-Bloom ‘327 in order to maximize the roughness and porosity.
Response to Arguments
Applicant’s arguments, see remarks, filed 9/18/2025, with respect to the objection of claim 23 have been fully considered and are persuasive. The objection of claim 23 has been withdrawn.
Applicant’s arguments, with respect to the U.S.C. 112 rejections of claims 1-24 have been fully considered and are persuasive. The U.S.C. 112 rejections of claims 1-24 has been withdrawn. The rejection to claim 14 is maintained as there is a second instance of “said polymer surface” that has not been amended.
Applicant's arguments filed 9/18/2025 have been fully considered but they are not persuasive. The applicant argues that Preiss-Bloom does not disclose that the width of the tip would be between 0.01 mm and 0.3 mm, 0.02 mm and 0.2 mm or 0.02 and 0.1 mm in width at the tip. The examiner respectfully disagrees. Paragraph 147 discloses that the wall thickness can be .2mm while paragraph 149 discloses that the protrusions or ribs have a width less than the thickness, the tips would be less than the width as in paragraph 150 and figure 35 shows the tips having a width less than the base. Such that if the base width is .2mm the tip would have a value within the claimed ranges.
The rejection is deemed proper.
Applicant’s arguments with respect to claim(s) 14 and new claim 27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.J.C/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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