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 .
Election/Restrictions
Applicant’s election of Group II, claims 18-22, in the reply filed on 05 January 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Accordingly, claims 1-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 21 is objected. The Examiner notes that there are two instances of claim 21, containing limitations of different scopes. For the purpose of examination and to allow compact prosecution, the Examiner has referred to the two instances of claim 21 as “claim 21-1” (first instance) and “claim 21-2” (second instance). However, Applicant must appropriately renumber the claims to avoid confusion.
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.
Claim 20 is 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.
Regarding claim 20, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 18-21 (i.e. 21-1) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coraça-Huber et al. (“Calcium carbonate powder containing gentamicin for mixing with bone grafts”, 08/11/2014) (hereinafter Huber).
Huber discloses Herafill® powder mixed with bone chips 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 (p. e670, col. II, ¶ 4), and 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). Accordingly, Huber discloses a method of treating bone defects as instantly claimed.
Regarding claim 20, as discussed above, Huber discloses mixing with bone chips from spongious tissue (i.e. cancellous bone).
Regarding claim 21-1, as discussed above, Huber discloses wherein the antibiotic-loaded cancellous bone mixture can be used in arthroplasties (i.e. joint repair/replacement surgery). Thus debridement of bone prior to filling the bone would flow naturally from such teaching.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Skinner et al. (US 2017/0106119 A1, 04/20/2017) (hereinafter Skinner).
Skinner discloses treating a bone defect having at least one cavity by inserting an implantable matrix ([0017]), which comprises an effective amount of at least one therapeutic agent having hemostatic and/or antimicrobial activity ([0012]). Antimicrobial agent includes 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 matrix may comprise gel-forming agents including vegetable oils ([0130]). Oils of vegetable origins include soybean oil ([0048]). The antimicrobial agent may comprise about 0.25 to 2.0% w/w of the matrix ([0091]).
As noted by para. [038] of the instant Specification, triglyceride is an example of a binder. Thus the soybean oil of Skinner, containing triglycerides, meets the limitation of a binder as instantly claimed. Together these would provide a method of treatment of bone defect as instantly claimed.
The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as 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. See MPEP § 2143 (I)(A).
Regarding the claimed amount of gentamicin sulfate, the claimed range (i.e. more than 0 to at most 2.5 percent by weight) 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 0.25 to 2.0 % w/w). 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).
Regarding claims 19 and 20, Skinner further discloses wherein the matrix further comprises bioactive agents ([0188]) such as tissue materials including blood, which can be incorporated into the material to be implanted in the patient (i.e. mixed in vitro) ([0190]) homogeneously ([0191]).
Regarding claim 21-1, Skinner further discloses wherein the matrix may be used to repair bone at a target tissue site, including for general arthroplasty (i.e. joint repair/replacement surgery) ([0187]). Thus debridement of bone prior to filling the bone would flow from such teaching.
Regarding claim 21-2, Skinner further discloses wherein matrix may comprise a mineral component as particulates having an average particle diameter between about 0.4 and 5.0 mm ([0155]). Such mineral material can include bone particles ([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).
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, alternatively it appears to be reasonably obvious to one of ordinary skill in the art that such shapes are obtainable by breaking an agglomerate.
Claims 21 (i.e. 21-2)-22 are rejected under 35 U.S.C. 103 as being unpatentable over by Coraça-Huber et al. (“Calcium carbonate powder containing gentamicin for mixing with bone grafts”, 08/11/2014) (hereinafter Huber) in view of Skinner et al. (US 2017/0106119 A1, 04/20/2017) (hereinafter Skinner).
Regarding claim 21-2, the disclosure of Huber has been discussed in detail above, and differs from the instant claims insofar as not explicitly disclosing wherein the mixture further comprises particles having a mean diameter as instantly claimed.
However, the disclosure of Skinner is discussed in detail above. Skinner further discloses wherein including a mineral component can effectively provide a scaffold for bone growth. As discussed above, the mineral material can be particulates having an average particle diameter between about 0.4 and 5 mm. The particles may also have an irregular shape.
Accordingly, it would have been obvious to one of ordinary skill in the art to have included particles having an average particle diameter between about 0.4 and 5 mm since it is a known and effective particle size range to provide a scaffold for bone growth in bone defect treatment materials as taught by Skinner.
Regarding claim 22, it would have been obvious to one of ordinary skill in the art to have included particles having an irregular shape since it is a known and effective shape to provide a scaffold for bone growth in bone defect treatment materials as taught by Skinner.
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 18-22 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).
Regarding claim 18, although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims disclose a bone substitute material comprising calcium sulfate dihydrate, calcium carbonate, glycerol tripalmitate (i.e. a binder), and 0.1-10% by weight of aminoglycoside antibiotics including gentamicin, and thus reads on the pending claim. Since the patented claims teach a bone substitute material, treating bone defects would flow from such teaching.
In regard to claims 19-22, the patented claims differ from the instant claims insofar as not expressly teaching all the features of the claimed invention, such as mixing with 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 18-22.
Therefore, as claims 1-6 of U.S. Patent No. 7,923,019 and Skinner both disclose compositions comprising a bone replacement 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 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).
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
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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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612