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 .
Status of the Claims
Claims 1, 3, 9-10, 12-14, 24-25, 29, 69, 77, 79, 82, and 131-132 are pending and under current examination. Claims 6-7, 16, and 32 are cancelled.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites the limitation “wherein the ex vivo hematoma has fibrin fibers having a thickness of at about 150nm +/-10% to about 300nm +/-10%”. This is grammatically incorrect and should be amended to read “wherein the ex vivo hematoma has fibrin fibers having a thickness of about 150nm +/-10% to about 300nm +/-10%”.
Appropriate correction is required.
Withdrawn Claim Objections and Rejections
All objects to the specification are withdrawn in view of the amended abstract filed 7/7/2026.
All rejections pertaining to claims 6-7, 16, and 32 are moot because the claims are cancelled in the amendments to the claims filed 7/7/2026.
All objections to claim 132 are withdrawn in view of the amendments to the claims filed 7/7/2026.
All rejections not reiterated have been withdrawn.
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 3 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.
Claim 3 recites the limitation “about 150nm +/- 10% to about 300nm +/- 10%”. The specification provides no definition for the term “about”. This renders the claim indefinite because it is impossible to determine how different a lower or upper limit of the range may be to qualify as “about 150nm” or “about 300nm”.
Claim Rejections - 35 USC § 103
Applicant’s amendments to the claims filed 7/7/2026 have necessitated the new grounds of rejection.
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.
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.
Claims 1, 3, 9-10, 12-14, 24-25, 29, 69, 77, 79, 82, and 131-132 are rejected under 35 U.S.C. 103 as being unpatentable over Glatt (WO2020/061067, publication date: 3/26/2020, cited in the IDS filed 9/12/2024, of record) in view of Yim (U.S. Patent No. 5,385,887, issue year: 1995).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1, Glatt discloses a composition for treating bone injury compromising an ex vivo hematoma comprising isolated whole blood, sodium citrate, calcium chloride, thrombin, or thrombin and calcium chloride (pg. 2, Summary first paragraph). The ex vivo hematoma can be formulated for local administration and can be applied to a solid bioscaffold to bridge gaps that may be present in the solid bioscaffold itself while also providing mechanical support independently (pg. 22, third paragraph). Existing treatments for skeletal defects, including bone graft substitutes, require prolonged treatment involving multiple surgeries, are expensive, have high complication rates, and are associated with a significant risk of treatment failure (pg. 6-7). The composition may be used in a method to improve the structural and biological properties of an induced blood blot in order to enhance the healing of large segmental bone defects (pg. 11, fourth paragraph).
Regarding claim 3, Glatt discloses that the ex vivo hematoma comprises fibrin fibers having a thickness of at least 150-300 nm +/- 10% (pg. 2, Summary first paragraph).
Regarding claim 9, Glatt discloses that the ex vivo hematomas can include an antibiotic (Claim 4 and pg. 19 second paragraph).
Regarding claim 10, Glatt discloses that the ex vivo hematomas can comprise one or more growth factors, including BMP-2, BMP-7, BMP-4, BMP-9, BMP-14, platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF-2) (Claims 5 and 6).
Regarding claim 12, Glatt discloses that the whole blood comprises viable cells and one or more biological factors (Claim 7).
Regarding claim 13, Glatt discloses that 50-70% of the viable cells of the whole blood remain viable after formation of the hematoma (Claim 8).
Regarding claim 14, Glatt discloses that the ex vivo hematoma further comprises a therapeutic agent (Claim 9).
Regarding 24, Glatt discloses that the therapeutic agent in the ex vivo hematoma is BMP-2 (Claim 19).
Regarding claim 25, Glatt discloses that the dose of BMP-2 present in the ex vivo hematoma is at least 0.01mg (Claim 20).
Regarding claim 29, Glatt discloses that the composition can be formulated as a liquid or gel (pg. 15 third paragraph, Claim 24).
Regarding claim 69, Glatt discloses a method of promoting bone healing or producing bone replacement material or implants, the method comprising administering to a subject in need thereof of a therapeutically effective amount of the composition (Claim 27).
Regarding claim 77, Glatt discloses that the composition used in the method of promoting bone healing may be formulated as a clot or scaffold (Claim 35).
Regarding claim 79, Glatt discloses that the composition used in the method of promoting bone healing is administered locally, implanted, or delivered percutaneously (Claim 37).
Regarding claim 82, Glatt discloses that the subject in the method of promoting bone healing has a skeletal defect (Claim 40), a large segmental bone defect (Claim 41), one or more bone fractures (Claim 42), or one or more bone injuries (Claim 43).
Regarding claim 131, Glatt teaches that an immediate formulation can be applied to a solid bioscaffold (pg. 22 third paragraph).
Regarding claim 132, Glatt teaches that the solid bioscaffold may include titanium cages or other metallic implants. The formulations may also be used to augment healing when PEEK spinal cages are used (pg. 22 third paragraph-pg. 23 first paragraph).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 1, Glatt does not teach a bone substitute comprising the species recited by the instant claim. However, this deficiency is cured by Yim.
Yim teaches a composition useful for the preparation of formulations of osteoinductive proteins which can be used to promote the formation of cartilage and/or bone for repair of tissue damage and fractures (col. 2 lines 43-47). An exemplary composition is a malleable composition of porous particles, calcium sulfate hemihydrate-containing substance, rhBMP-2, and blood clot to span the bony defect which is desired to be treated (col. 11 lines 21-26). The calcium sulfate hemihydrate-containing substance improves osteoconduction of the formulation and retention at the wound site, reduces formulation setup time, and improves handling characteristics (col. 7 lines 50-54).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claim 1, it would have been prima facie obvious to one of ordinary skill in the art of filing to combine the ex vivo hematoma of Glatt with a bone substitute. One would have understood in view of Yim that a composition for repairing bone comprising BMP-2 and a blood clot may be improved by the addition of a calcium sulfate hemihydrate containing substance. It would have been obvious to include such a substance with the ex vivo hematoma of Glatt. One of ordinary skill in the art would have been motivated to include calcium sulfate in the composition of Glatt in order to impart improved osteoconduction and retention at the wound site, reduced formulation setup time, and improved handling characteristics to the composition. The artisan of ordinary skill in the art would have had reasonable expectation of success because Yim teaches that calcium sulfate hemihydrate may be combined with a blood clot and BMP-2 to form a composition for repairing bone.
Response to Arguments
Applicant's arguments filed 7/7/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the teachings of Turzi 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.
On page 9, Applicant argues that Glatt fails to teach or suggest a composition comprising each of the components of the amended claim 1. This is not found persuasive. As described in the obviousness rejection above, it would have been obvious in view of the teachings of Yim to combine the ex vivo hematoma of Glatt with the calcium sulfate hemihydrate of Yim in order to render a bone repair composition with improved performance characteristics.
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 1, 3, 9-10, 12-14, 24-25, 29, 69, 77, 79, 82, and 131-132 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-158 of copending application no. 19/610,089.
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims render obvious the instant claims.
Inter alia, the claims of the ‘089 application embrace a composition comprising an ex vivo hematoma comprising isolated whole blood, sodium citrate, thrombin and calcium chloride. The composition also comprises a bone substitute such as coral, calcium sulfate, a calcium phosphate cement, β-tri-calcium phosphate ceramics, and bioactive glasses. The ex vivo hematoma also comprises fibrin fibers having a thickness of 100-400nm +/-10%. The ex vivo hematoma may also comprise an antibiotic, a therapeutic agent, and one or more growth factors such as BMP-2 and BMP-7. The whole blood comprises viable cells and one or more biological factors and 50-70% of the viable cells of the whole blood remain viable after formation of the hematoma. BMP-2 may be present in an amount of at least 0.01mg. The composition may be formulated as a gel, a liquid, a powder, a paste, granules or a putty. The composition may be utilized in a biomimetic scaffold comprising PEEK, titanium or metallic allow. The claims of the ‘089 application also embrace a method of promoting bone healing comprising implanting a biomimetic scaffold comprising the ex vivo hematoma into a site of interest in a subject that has a skeletal defect or nonunion.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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