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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 4 is objected to because of the following informalities: “2,wherein” should be “2, wherein”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: The polymer names should be included in the claim. 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.
Claims 13 and 25 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 13 recites the limitation "the water" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the mixture" in line 6. There is insufficient antecedent basis for this limitation in the claim
Claim 25 recites the limitation "the second temperature" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the first temperature" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the second time period" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 25, it is unclear what "the second time period is longer than the first temperature" corresponds to, therefore claim 25 is indefinite.
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) 1-3, 6-7, 15, and 19-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shah et al. (US 2018/0243484).
Regarding claims 1-3, 6-7, 15, and 19-23: Shah et al. (US ‘484) discloses methods of preparing biocompatible composites [abstract; 0003-0004], wherein Example 1 [Ex. 1; 0058-0068] prepare a suspension of nano hydroxyapatite (HAp [0002]) in a mixture of dichloromethane and 2-butoxyethanol [0060]. Polycaprolactone (PCL [0002]) was dissolved in dichloromethane and the HAp suspension was added to the PCL solution, and mixed to disperse and coat the HAp particles with solubilized PCL [0060]. The resulting mixture can be cast and excess solvent removed, or solvent can be removed to afford an ink with a viscosity of ~ 25 Pa·s with subsequent 3D printing of the ink [0061] to afford a composite structure after drying [Ex. 1; 0058-0068].
Claim(s) 1-3, 6-7, 10-12, 15, 19-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shin et al. (KR 10-2009-0104475) [IDS 9/13/23]. English machine translation for citation.
Regarding claims 1-3, 6-7, 15, and 19-23: Shin et al. (KR ‘475) discloses methods of preparing nanocomposites [abstract], wherein Example 1 [Ex. 1; 0091-0095] dissolves poly(ε-caprolactone) (PCL) in chloroform [0093]. The hydroxyapatite nanoparticles (n-ha) of Manufacturing Example 1 [Man. Ex. 1; 0059-0067] were dispersed into N,N-dimethylformamide (DMF) [0094] and the dispersion was added to the PCL solution, and stirred for 2 h at 80 oC to remove chloroform [0095]. The resulting n-ha/PCL/DMF was stirred at 100-120 oC for 2h, cast onto a mold, dried in air for 24 h, and vacuumed dried for 48 h to afford an n-ha/PCL composite [Ex. 1; 0091-0095].
Regarding claims 10-12: Shin et al. (KR ‘475) discloses Manufacturing Example 1 [Man. Ex. 1; 0059-0067] prepares nano-sized hydroxyapatite (n-ha) by dissolving calcium nitrate and ammonium phosphate in 80 oC water and mixing the solutions to obtain a white precipitate [0060-0061]. Ammonium hydroxide was added to maintain a pH of 11 or more, the mixture was stirred and heated at 80 oC for 2 h, then RT for 24 h [0062]. The resulting nanoparticles were washed with water [0063], added to DMF, stirred for 5 h at 100-120 oC to remove water and vacuumed dried to afford hydroxyapatite nanoparticles [0064-0065].
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.
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.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 2018/0243484) as applied to claim 1 above, and further in view of Shin et al. (KR 10-2009-0104475) (English machine translation for citation).
Regarding claims 10-12: Shah et al. (US ‘484) discloses the basic claimed method [as set forth above with respect to claim 1]; wherein Shah et al. (US ‘484) discloses nanoscale Hap [0060].
Shah et al. (US ‘484) does not disclose preparing a first calcium phosphate dispersion. However, Shin et al. (KR ‘475) discloses methods of preparing nanocomposites [abstract], wherein Manufacturing Example 1 [Man. Ex. 1; 0059-0067] prepares nano-sized hydroxyapatite (n-ha) by dissolving calcium nitrate and ammonium phosphate in 80 oC water and mixing the solutions to obtain a white precipitate [0060-0061]. Ammonium hydroxide was added to maintain a pH of 11 or more, the mixture was stirred and heated at 80 oC for 2 h, then RT for 24 h [0062]. The resulting nanoparticles were washed with water [0063], added to DMF, stirred for 5 h at 100-120 oC to remove water and vacuumed dried to afford hydroxyapatite nanoparticles [0064-0065]. Shah et al. (US ‘484) and Shin et al. (KR ‘475) are analogous art because they are concerned with a similar technical difficulty, namely the preparation of composites containing hydroxyapatite nanoparticles. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined hydroxyapatite nanoparticle synthesis, as taught by Shin et al. (KR ‘475) in the invention of Shah et al. (US ‘484), and would have been motivated to do so since Shin et al. (KR ‘475) discloses the method of Ex. 1 affords dry hydroxyapatite nanoparticles, which leads to even distribution when incorporated into a biodegradable polymer resin [0006-0008; 0034; 0055].
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 2018/0243484) as applied to claim 2 above, and further in view of Riman et al. (WO 2008/089109).
Regarding claim 4: Shah et al. (US ‘484) discloses the basic claimed method [as set forth above with respect to claim 2]; wherein Shah et al. (US ‘484) discloses calcium phosphates, such as tricalcium phosphate (TCP) [0044].
Shah et al. (US ‘484) does not disclose whitlockite. However, Riman et al. (WO ‘109) discloses methods of preparing composites [abstract], wherein the calcium phosphate includes tricalcium phosphate and/or whitlockite [pg. 6, ln. 19-20]. Shah et al. (US ‘484) and Riman et al. (WO ‘109) are analogous art because they are concerned with a similar technical difficulty, namely the preparation of composites containing hydroxyapatite nanoparticles. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined whitlockite, as taught by Riman et al. (WO ‘109) in the invention of Shah et al. (US ‘484), and would have been motivated to do so since Riman et al. (WO ‘109 ) discloses tricalcium phosphate and whitlockite as the calcium phosphate [pg. 6, ln. 19-20] (see also MPEP 2144.06).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (KR 10-2009-0104475) as applied to claim 10 above, and further in view of Riman et al. (US 2007/0196509).
Regarding claim 13: Shin et al. (KR ‘475) discloses the basic claimed method [as set forth above with respect to claim 10]; wherein Shin et al. (KR ‘475) discloses washing with water and adding the washed particles to DMF to remove moisture [0063-00645].
Shin et al. (KR ‘475) does not disclose water removal using centrifugation. However, Riman et al. (US ‘509) discloses methods of preparing nanoscale hydroxyapatite particles [abstract], wherein washing steps can be conducted by centrifugation [0033]. Shin et al. (KR ‘475) and Riman et al. (US ‘509) are analogous art because they are concerned with a similar technical difficulty, namely the preparation hydroxyapatite nanoparticles. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined centrifugation, as taught by Riman et al. (US ‘509) in the invention of Shin et al. (KR ‘475), and would have been motivated to do so since Riman et al. (US ‘509) discloses washing steps can be conducted by centrifugation [0033].
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (KR 10-2009-0104475) as applied to claim 1 above.
Regarding claim 25: Shin et al. (KR ‘475) discloses the basic claimed method [as set forth above with respect to claim 1]; wherein Shin et al. (KR ‘475) discloses drying in air for 24 h with subsequent vacuum drying for 48 h [Ex. 1; 0095].
Differences in tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) [see MPEP 2144.05].
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US 2018/0243484) as applied to claim 1 above.
Regarding claim 25: Shah et al. (US ‘484) discloses the basic claimed method [as set forth above with respect to claim 1].
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) [see MPEP 2144.05].
See attached form PTO-892.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL F PEPITONE whose telephone number is (571)270-3299. The examiner can normally be reached on 7:00 AM - 3:30 PM.
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/MICHAEL F PEPITONE/Primary Examiner, Art Unit 1767
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