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 .
Specification
The abstract of the disclosure is objected to because it contains legal phraseology in the terms “this disclosure relates to” and “said compositions and biomimetic scaffolds”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Status of the Claims
Claims 1, 3, 6-7, 9-10, 12-14, 16, 24-25, 29, 32, 69, 77, 79, 82, and 131-132 are pending and under current examination.
Claim Objections
Claim 132 is objected to because of the following informalities:
Claim 132 recites the abbreviation “PEEK” without indicating what the abbreviation means. The Examiner suggests amending the claim to recite the full term with the abbreviation in parentheses in the first instance that such appears in the claims.
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.
Claim 32 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 32 recites “…the ratio of the ex vivo hematoma to bone substitute is from 1000:1 to 1:1000”. This renders the claim indefinite because it is impossible to discern which property is compared in the ratio (i.e. weight or volume).
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.
Claims 1, 3, 9-10, 12-4, 16, 24-25, 29, 69, 77, 79, and 82 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glatt (WO2020/061067, publication date: 3/26/2020, cited in the IDS filed 9/12/2024).
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 hematomas can include a carrier such as a biodegradable biomaterial scaffolds of poly(lactide-co-glycolide) (PLGA) (pg. 22, second paragraph). The instant specification defines bone substitutes to include synthetic polymers (pg. 19 line 28 of instant specification), therefore the Examiner considers the biomaterial scaffold of Glatt to read on the bone substitute limitation of the instant claim.
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 claim 16, 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).
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).
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.
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, 7, 9-10, 12-4, 16, 24-25, 29, 32, 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).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1, 3, 9-10, 12-4, 16, 24-25, 29, 32, 69, 77, 79, and 82, Glatt anticipates the relevant limitations as described above.
Regarding claim 7, Glatt teaches that the ex vivo hematomas can include a carrier such as a biodegradable biomaterial scaffolds of poly(lactide-co-glycolide) (PLGA) (pg. 22, second paragraph).
Regarding claim 32, 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 hematomas can include a carrier such as a biodegradable biomaterial scaffolds of poly(lactide-co-glycolide) (PLGA) (pg. 22, second paragraph). Glatt also discloses that the ex vivo hematoma further comprises a therapeutic agent (Claim 9).
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 claims 1, 3, 9-10, 12-4, 16, 24-25, 29, 32, 69, 77, 79, and 82, Glatt anticipates the relevant limitations as described above.
Regarding claims 7, 131, and 132, Glatt doesn’t teach a single embodiment or example meeting all limitation of the invention of claims 7, 131, and 132.
Regarding claim 32, Glatt does not teach a ratio of ex vivo hematoma to bone substitute.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
As noted in the anticipation in the rejection above Glatt anticipated claims 1, 3, 9-10, 12-4, 16, 24-25, 29, 32, 69, 77, 79, and 82; so in anticipating claims 1, 3, 9-10, 12-4, 16, 24-25, 29, 32, 69, 77, 79, and 82, said claims are also considered obvious under 35 U.S.C. 103 over Glatt for the reasons set forth below (“lack of novelty is the epitome of obviousness” May, 574 F.2d at 1089, 197 USPQ at 607 (citing in re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Within the broader scope of Glatt all of the limitations of the invention of claims 7, 131, and 132 are met. It would have been prima facie obvious for one having ordinary skill in the art to choose the limitations in the instant claims from those disclosed by Glatt and arrive at this conclusion because such was contemplated by Glatt.
Regarding claim 32, the ratio of ex vivo hematoma to bone substitute is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal ratio in order to best achieve the desired results as such would provide the desired dose of therapeutic present in the ex vivo hematoma. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where 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. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Glatt teaches that the ex vivo hematoma further comprises a therapeutic agent (Claim 9). The Examiner considers it prima facie obvious to optimize the ratio of ex vivo hematoma to bone substitute, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amount of ex vivo hematoma present would have a direct effect on the amount of therapeutic present in the composition and therefore be an optimizable variable.
Claim 6 is 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), as applied to claims 1, 3, 7, 9-10, 12-4, 16, 24-25, 29, 32, 69, 77, 79, 82, and 131-132, and further in view of Turzi (U.S. Patent Application No. 2018/0153969, publication year: 2018, cited in the IDS filed 9/12/2024).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Glatt teaches and renders obvious the relevant limitations of claim 1 as described above.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Glatt does not teach a bone substitute comprising demineralized bone matrix or a substitute derived from a biological product. However, this deficiency is cured by Turzi.
Turzi teaches a wound healant preparation (Abstract) that may be used together with bone filling materials such as hydroxyapatite or demineralized bone [0388]. The compositions are useful in the regeneration and or rejuvenation of bones and are particularly useful for bone defects or disorders such as graft or bone fracture [0369].
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (the polymer carrier of Glatt and the demineralized bone or hydroxyapatite of Turzi for use in a composition to treat bone defects and bone fractures). See MPEP 2144.06 (II).
Conclusion
No claims are allowed.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614