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 .
Applicant’s arguments, filed 06 July 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 18 is objected to because of the following informalities: “vitro:” in line 3 should be recited as --- in vitro, ---. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: immediately after “comprising” in line 4 there should be recited --- : ---. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: “sulfate;” in the antepenultimate line should be recited as --- sulfate, ---. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: “the patient” in the last line of the claim should be recited as --- a patient to be treated ---. Appropriate correction is required.
Claims 23 and 24 are objected to because of the following informalities: immediately prior to “blood” in line 1 of each claim there should be recited --- autologous ---. Appropriate correction is required.
Claims 25-27 are objected to because of the following informalities: immediately prior to “autologous” in line 2 of each claim there should be recited --- of the ---. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: immediately prior to “blood” in line 2 there should be recited --- autologous ---. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: immediately before “binder” in line 2 there should be recited --- of the ---. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 18 and 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Skinner et al. (US 2017/0106119 A1, 04/20/2017) (hereinafter Skinner) in view of Coraça-Huber et al. (“Calcium carbonate powder containing gentamicin for mixing with bone grafts”, 08/11/2014) (hereinafter Huber).
Skinner discloses treating a bone defect having at least one cavity by inserting an implantable matrix ([0017]) comprising an effective amount of at least one therapeutic agent having hemostatic and/or antimicrobial activity ([0012]). The hemostatic and/or antimicrobial agent may be in microparticle form ([0067]), and may include aminoglycosides ([0092]) such as gentamicin sulfate ([0094]). The matrix may comprise a resorbable ceramic including calcium sulfate ([0162]), and an inorganic material or bone substitute material including calcium carbonate ([0167]). The resorbable ceramic and bone may be in the form of particles ([0164]). The antimicrobial agent may comprise about 0.25 to 2.0% w/w of the matrix ([0091]). The matrix further comprises bioactive agents ([0188]) including autologous tissue materials such as blood or blood fractions, and cells from the patient to be treated, which can be incorporated into the material to be implanted in the patient (i.e. mixed in vitro) ([0190-0191]). The matrix may also be seeded with harvested bone cells ([0163]). The matrix or implantable article may be in the form of low-viscosity, highly flowable or injectable materials ([0128]). The matrix may be used to repair bone at a target tissue site, including for general arthroplasty (i.e. joint repair/replacement surgery) ([0187]).
Skinner differs from the instant claim insofar as not explicitly disclosing wherein the particles comprise an instantly claimed binder.
However, Huber discloses a resorbable bone graft substitute powder (Herafill®) that may be mixed with bone chips at a 1:1 w/w ratio (abs) suitable as a bone void-filling material as well as an antibiotic carrier (p. e670, col. II, ¶ 2). Herafill® powder is composed of calcium sulfate, calcium carbonate, and hydrogenated triglyceride tripalmitate as a bonding additive containing gentamicin sulfate (p. e670, col. II, ¶ 4), equivalent to 1% gentamicin base (p. e670, col. III, ¶ 1). Bone chips were prepared from the spongious tissue and mixed to achieve homogeneous bone quality (p. e670, col. II, ¶3). The antibiotic-loaded cancellous bone can be used in arthroplasties (p. e671, col. III, ¶ 1). The study found effective reduction of Staphylococcus (abs).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included a Herafill® powder in the implantable matrix of Skinner, since it is a known and effective particulate material suitable as a bond void filling material and capable of providing a reduction of bacterial infection as taught by Huber.
Regarding claims 18 reciting an amount of gentamicin sulfate, as discussed above, Huber discloses 1 % w/w gentamicin base, which would appear to equate to an amount of gentamicin sulfate that overlaps with the instantly claimed range, thus making the claimed range obvious.
Regarding claims 18, 29 and 30 reciting a binder, a melting point of binder, and a subclass of binder, respectively, as noted by paras. [0038-0039] of the instant Specification, glycerol tripalmitate is a triglyceride suitable as a hydrophobic binder having a melting point of at least 45 °C. Therefore, the hydrogenated triglyceride tripalmitate of Huber meets the limitation of the binder as instantly claimed.
Regarding claim 28 reciting an amount of binder, although Huber does not explicitly disclose an amount of hydrogenated triglyceride tripalmitate as a bonding additive, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amounts (i.e. from 7 to 12 weight percent) through routine experimentation based on the level of bonding desired. See MPEP § 2144.05(II)(A).
Regarding claim 21, Skinner further discloses wherein biocompatible ceramics and bone particles (i.e. mineral materials) may have an average particle diameter between about 0.4 and 5.0 mm ([0155-0156]). Accordingly, the claimed ranges (i.e. 0.5 to 10 mm) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. about 0.4 to 5 mm). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate particle sizes would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in mm. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claim 22, Skinner further discloses wherein the term “particle” includes those having irregular geometries/shapes ([0027]). Regarding the claim reciting wherein the particles are obtainable by breaking an agglomerate, such recitation is interpreted as a product-by-process limitation as evidenced by the term “obtainable.” Accordingly, the claim is interpreted as not requiring the steps set forth in the claim, but only the structure implied by the steps. See MPEP § 2113(I). Moreover, in any case, since Skinner discloses particles having irregular geometries/shapes, it appears one of ordinary skill in the art would reasonably expect such shapes to be obtainable by breaking an agglomerate.
Regarding claim 23, Skinner further discloses wherein the hemostatic agent may comprise a biocompatible material for promoting blood clotting ([0076]). Accordingly, since the matrix of Skinner comprises a biocompatible material for promoting blood clotting, one of ordinary skill in the art would reasonably expect the blood to coagulate after being mixed with the particles and prior to filling the defect.
Regarding claim 24, as discussed above, Skinner discloses blood and blood fractions. Therefore, it would have been obvious to one of ordinary skill in the art that the blood of Skinner refers to complete, or whole, blood.
Regarding claims 25 and 26, although Skinner does not explicitly disclose a mixing ratio of the particles with blood, the selection of appropriate weight percentages of bioactive agents would appear to require no more than routine testing on the part of the skilled artisan, and so it would have been obvious to determine workable ranges to arrive at the claimed ratio. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claim 27, the limitations of claim 27 have been addressed when addressing the limitations of claims 23 and 25 as discussed above. Therefore, claim 27 is rejected based on the same reasons set forth above in rejecting claims 23 and 25.
Response to Arguments
Applicant’s assertion about Skinner not teaching “particles” comprising a mixture of calcium sulfate, alkaline earth carbonate, binder, and gentamicin sulfate and the antimicrobial agent has been considered but is moot in view of the new ground of rejection necessitated by Applicant’s amendment.
The Examiner further notes that the instant claims do not recite wherein the particles “each” comprise “a mixture of” calcium sulfate, alkaline earth carbonate, binder, and gentamicin sulfate as asserted by Applicant. Under the broadest interpretation, the claims may be interpreted as a mixture of particles containing calcium sulfate, alkaline earth carbonate, binder, and/or gentamicin sulfate. The Examiner suggests amending the claims as supported by para. [029] of the instant Specification, which appears to be directed to the embodiment alleged by Applicant.
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 18 and 21-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 7,923,019 in view of Skinner et al. (US 2017/0106119 A1, 04/20/2017) (hereinafter Skinner) and Coraça-Huber et al. (“Calcium carbonate powder containing gentamicin for mixing with bone grafts”, 08/11/2014) (hereinafter Huber).
The patented claims differ from the instant claims insofar as not expressly teaching all the features of the claimed invention, such as mixing with autologous blood comprising viable cells in vitro.
However, these features are known in the art. As noted in the current rejections, the teachings of Skinner render obvious claims 18, 21-28 and 30; the teachings of Skinner in view of Huber render obvious claim 29.
Therefore, as claims 1-6 of U.S. Patent No. 7,923,019, Skinner, and Huber all disclose compositions comprising a bone filling material, it would have been obvious to one of ordinary skill in the art to have modified the patented claims and to include the teachings of Skinner and Huber as discussed in the rejections above, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I).
Response to Arguments
Applicant’s assertion of overcoming patentability has been considered but are moot because new rejections necessitated by Applicant’s amendment has been made.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Leiblein et al. (“Size matters: effect of granule size of the bone graft substitute (Herafill®) on bone healing using Masquelet’s induced membrane in a critical size defect model in the rat’s femur,” 11/13/2019), directed to treating bone defects with Herafill® granules with bone marrow derived mononuclear cells.
Neoh et al. (WO 2007/064304 A1, 06/07/2007, IDS reference), directed to a gentamicin-loaded bone cement comprising calcium sulfate, calcium carbonate, and binder.
Vogt et al. (US 2008/0038311 A1, 02/14/2008, IDS reference), directed to a bone replacement material containing calcium carbonate and antibiotics.
Bohner et al. (US 2009/0028954 A1, 01/29/2009), directed to a bone replacement material comprising particles of calcium sulfate and calcium carbonate, and antimicrobial drugs.
Ehrenborg et al. (US 2016/0015856 A1, 01/21/2016), directed to bone substitute compositions comprising calcium sulfate and antibiotic.
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 LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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