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 .
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 1-5, 7-8, 10, 12. 14-17 are 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.
Regarding claim 1, the phrase "optionally" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claims 2-5, 7-8, 10, 12. 14-17 are rejected for the same reasons as set forth above.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance: No prior arts of record alone or in combination discloses the following:
“(A) a plurality of pellets selected from calcium phosphate pellets and/or calcium phosphate-encapsulating pellets, wherein the calcium phosphate-encapsulating pellets comprise:
40-60% w/w PLGA having an L:G ratio ranging from 75:25 to
40-60% w/w calcium encapsulated within the PLGA;
(B) a plurality of BMP-2 encapsulating pellets comprising
60-90% w/w PLGA having an L:G ratio ranging from 45:55
10-30% w/w 2-hydroxypropyl-β-cyclodextrin,
5-15% w/w poloxamer 407, and
BMP-2, wherein the BMP-2 is encapsulated within the PLGA; and
(C) a viscosity modifier optionally and optionally
(D) an aqueous carrier.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Prior arts
Guelcher et al disclose putty may also refer to composites that have relatively high osteoconductive solid particulate content (e.g., >45 wt %-55 wt %), such as allograft or synthetic allograft. Putties may be molded to retain a particular shape [see 0060-061].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOEL F BRUTUS/Primary Examiner, Art Unit 3797
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