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 .
Priority
The foreign priority to EP22194533.0 filed 09/08/2022 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) filed 09/01/2023 and 05/27/2025 are acknowledged. The information disclosure statement filed 09/01/2023 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but information referred to therein has not been considered.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11 and 14) in the reply filed on 04/06/2026 is acknowledged.
The restriction is therefore made final.
Claims 12-13 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, and claim 2 has been cancelled.
Claims 1, 3-11, 14, and 16 are pending and under current examination.
Specification
The disclosure is objected to because of the following informalities: the tables provided should have figure captions.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 6, 9, and 10 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 claims 6, 9, and 10, the phrase “preferably” renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "preferably"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 14 is dependent on claim 12, which was not elected in the restriction. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 3-9, 11, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wenz (WO 2005105170 A1) in view of Shulz (US 20120004594 A1) as evidenced by Cherecheş (Journal of Molecular Liquids, 2022, 256, 1-5), hereinafter Cherecheş.
Regarding claims 1, 5, 6, and 16, Wenz teaches a bone replacement composition comprising polyethylene glycol (i.e. polyether, see claim 12), that hardens in an aqueous environment (see claim 1). While Wenz does not teach the melting point of polyethylene glycol (i.e. PEG 400, para. [0043]), Cherecheş teaches that the melting point of PEG 400 is reported in literature to be 4-8 ºC (pg. 5, col. 2 line 22). The PEG 400 taught in Wenz has a melting point that is less than 25 ºC, and as such the melting point described in instant claim 1 is obvious. See MPEP § 2144.05(I). Further, Wenz teaches that the PEG is a non-aqueous component of the composition (i.e. water content less than 1 wt.%, para. [0039]). Wenz describes that the composition comprises calcium sulfate hemihydrate, calcium sulfate anhydrite, and calcium phosphates (i.e. calcium containing salts, see claim 3). Wenz teaches that the composition is viscous during delivery and achieves a wax-like consistency, but when it comes in contact with aqueous body fluid, it allows the composition to harden to a crystalline state (para. [0038]). Wenz teaches that the composition can comprise calcium chloride (i.e. pharmaceutically active ingredient), in an amount of about 3 wt.% (para. [0047]) and hydroxyapatite (i.e. particulate inorganic filler) in an amount of about 16 wt.% (para. [0047]). Wenz further discloses an example that does not comprise the inorganic filler (i.e. 0 wt.%, para. [0048]). The concentrations of the pharmaceutically active ingredient and inorganic filler described in instant claim 1 overlap with that taught in examples 5 and 6 of Wenz, and as such are obvious. MPEP § 2144.05(I).
While Wenz teaches most elements of instant claim 1, it fails to teach the catalyst which accelerates the setting reaction of the composition. Shulz teaches a composition for selective replacement of degenerative bone material, and explains that catalysts may be present in the composition to accelerate production of bone regeneration material. The catalysts of Shulz can make up 1 wt.% of the composition (para. 0084]).
Wenz and Shulz are considered to be analogous to the claimed invention because they are in the same field of compositions for bone regeneration. While Wenz fails to teach the presence of a catalyst in the composition, Shulz teaches that a catalyst can be added to the composition in an amount up to 1 wt.%. The range of the concentration of a catalyst taught in instant claim 1 overlaps with that of Shulz, and as such is obvious. Further, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of instant invention, to add a catalyst to the composition taught in Wenz, for their benefit of accelerating the setting reaction., as taught in Shulz MPEP § 2143(I)(a).
Regarding claims 3 and 4, Wenz teaches that the composition comprises 20-40 wt.% PEG and 60-80 wt.% calcium sulfate hemihydrate (see claim 15). The concentrations of polyethylene glycol and calcium sulfate hemihydrate overlap with those taught in Wenz, and as such they are obvious.
Regarding claim 7, Wenz teaches that the composition can comprise ammonium sulfate (para. [0023]). While Wenz does not teach that the ammonium sulfate functions as a catalyst, it demonstrates that it is effective in a bone replacement composition. Shulz teaches that the catalysts can be selected from ammonium sulfate and potassium sulfate, which are effective to alter the consistency and setting time of the composition (para. [0092]).
While Wenz does not explicitly state that the ammonium sulfate in the composition acts as a catalyst, Shulz teaches that both ammonium sulfate and potassium sulfate function to accelerate the curing of the bone replacement composition. It would have been obvious to one of ordinary skill in the art to incorporate the ammonium sulfate and potassium sulfate into the composition taught in Wenz, for their benefit of acting as catalysts, as taught in Shulz above. MPEP § 2143(I)(a).
Regarding claim 8, Wenz teaches the composition can comprise a mineral composition such as magnesium carbonate (see claim 3) and hydroxyapatite (para. [0047]).
While Wenz teaches the claimed invention as above, it fails to teach the pharmaceutically active ingredients of instant claim 9.
Regarding claims 9 and 14, Shulz teaches that the bone regenerative material can include biologically active agents such as gentamicin, tobramycin, vancomycin, ketoconazole, miconazole, and griseofulvin (para. [0092]). One of ordinary skill in the art at the time of the effective filing date would have had a reasonable expectation of success in incorporating the pharmaceutically active ingredients taught in Shulz into the composition taught in Wenz, for their benefit of providing a localized or systemic effect to the patient, as taught in Shulz (para. [0092]). MPEP § 2143(I)(a).
Regarding claim 11, Wenz teaches an example of a bone replacement composition that comprises calcium sulfate hemihydrate and PEG 400, but does not comprise any surfactants (para. [0048]).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wenz (WO 2005105170 A1) in view of Shulz (US 20120004594 A1) as evidenced by Cherecheş (Journal of Molecular Liquids, 2022, 256, 1-5), in further view of Qiu (CN 104056305 A).
Wenz teaches the claimed invention as above, but fails to teach the particle size of the calcium-containing salt.
Regarding claim 10, Qiu teaches a self-solidifying bone repairing material that comprises polyethylene glycol (see claim 1). The composition of Qiu comprises tetra calcium phosphate, with a particle size of 1-90 µm (see claim 2). Further, the composition comprises tricalcium phosphate, with a particle size of 1-90 µm for the small particles and 180-500 µm for the large particles (see claim 3). The range of the particle size of instant claim 10 overlaps almost entirely with that of Qiu, and as such is obvious. MPEP § 2144.05(I).
Wenz, Shulz, and Qiu are considered to be analogous to the claimed invention because they are in the same field of compositions used for bone replacement materials. It would have been obvious to one of ordinary skill in the art to substitute the calcium-containing salt taught in Wenz to have a particle size within the same range of the tetra calcium phosphate taught in Qiu, to yield predictable results, as Qiu teaches that these particle sizes are effective in bone repairing compositions. MPEP § 2143(I)(b).
Conclusion
Claims 1, 3-11, 14, and 16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Makenna Miller whose telephone number is (571)272-9852. The examiner can normally be reached Mon-Fri 7:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
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