DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/18/2026 has been entered.
Response to Arguments
In view of the amendments filed 3/16/2026, all prior art rejections presented in the office action mailed 12/11/2025 have been withdrawn and a new rejection is presented below addressing the claims as newly amended.
New 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 24 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 24 recites the limitation "the porous structure". There is insufficient antecedent basis for this limitation in the claim.
New 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) 18, 23-24 and 29-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JMD (2019), as evidenced by Yang (2020) and Denst (1950).
JMD discloses the use of Ezechbone granules for clinical use in sternal closure (pg. 1). JMD discloses that the patient who had previous surgery of the sternum was not healing properly (pg. 2-3) and when the staples were removed, the wound started oozing blood and it was found that the area between the two sternotomy halves didn’t heal (pg. 4). Reconstructive surgery of the sternum was conducted (pg. 6). After the wound was cleaned to remove blood clots, a special technique was used to facilitate sternum closure (pg. 7), Ezechbone granules were sprinkled on the sternum to promote bone healing (pg. 9) which resulted in clean and healed skin wounds (pg. 10).
As evidenced by the originally filed specification, Ezechbone granules have a particle size of about 0.4-1.2mm, a porosity of about 70-80 vol% and are made up of hydroxyapatite, TTCP, DCP (dicalcium phosphate) and CSH (pg. 8). Yang shows these granules to have interconnected pores (pg. 27).
Regarding claim 18: As discussed above, the surgical site comprises a sternum cavity (i.e. a bone cavity) oozing with blood (i.e. bone bleeding) and the Ezechbone granules are applied to the bleeding surgical site prior to closure of a wound, reading on “applying a hemostatic composition to a surgical site prior to closure of a wound” after a surgical treatment in a patient. JMD teaches the surgery to be success which results in clean and healed skin wounds. While JMD doesn’t explicitly state that bleeding was reduced, the prior art anticipates the performance of the claimed steps with the claimed composition as such bleeding would necessarily be reduced which is supported by JMD teaching the wound to be clean and healed.
Regarding claim 23: As discussed above, Ezechbone granules have a particle size of about 0.4-1.2mm.
Regarding claim 24: As evidenced by Yang, Ezechbone granules have pore sizes ranging from 60-180 µm (pg. 10).
Regarding claim 29: As evidenced by Denst, the sternum is a source of blood marrow. As JMD shows the sternum (i.e. bone) to be cut and the sternum internally comprises bone marrow, cutting this bone or cavity would necessarily expose the bone marrow.
Regarding claim 30: As discussed above, the surgical site is a surgically created sternum cavity and surgery is to close the sternum.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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