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 .
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 21-50 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. Claims 21 and 36 are construed to be indefinite because the recitation “the sensed condition” lacks a positive antecedent basis. Since claims 22-35 and 37-50 depend upon an indefinite claim, those claims are construed to be indefinite by dependency.
Allowable Subject Matter
Claims 21-50 are allowable over the prior art of record because the method of lyophilizing a therapeutic composition or system for lyophilization of pharmaceutical productions with all the independently claimed features including moving containers through a vacuum drying chamber with sensors of a therapeutic composition condition or independent temperature control of a sensed condition is not found in the prior art either singly or in combination.
Claims 21-50 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other prior art references cited with this application may teach one or more features of the claimed invention, but do not rise to a level of anticipation, obviousness, and/or double patenting such that a rejection would be proper or reasonable under current Office practice and procedure. References A, B, N, cited with this action, are patent publications from the same inventive entity as the current application. References C, D, E, F, G, H, I, J, K, L, M, O, P, Q, R, S, cited with this application, are patent publications that teach therapeutic composition lyophilizing methods or pharmaceutical product lyophilization systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN MICHAEL GRAVINI whose telephone number is (571)272-4875. The examiner can normally be reached M-Th 5:30 am to 5:00 (mid day flex) first F 6:00 am t0 11:00 am.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Craig Schneider can be reached at 571 272 3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Monday, July 27, 2026
/STEPHEN M GRAVINI/Primary Examiner, Art Unit 3753
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