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 Objections
Claim 13-14 are objected to because claim 13 ends in a semi-colon instead of a period. Claims should be a single sentence and end in a period. Since claim 14 depends upon claim 13, that claim is objected based on dependency. 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 2, 10, 13, 15, 16, 17, 18, and 19 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. Claim 2 is construed to be indefinite because the recitation “the corresponding” lacks a positive antecedent basis. Claim 10 is construed to be indefinite because the recitation “the second member” lacks a positive antecedent basis. Claim 13 is construed to be indefinite because the recitation “the alignment” (plural occurrences) lacks a positive antecedent basis. Since claim 19 depends upon an indefinite claim, that claim is construed to be indefinite by dependency. Claim 15 is construed to be indefinite because the recitation “the corresponding” lacks a positive antecedent basis. Since claims 16-18 depend upon an indefinite claim, those claims are construed to be indefinite by dependency.
Claim Rejections - 35 USC § 102
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.
Claims 1-13 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anger (US 5,822,882). The claims are reasonably and broadly construed, in light of the accompanying specification, to be disclosed by Anger as teaching:
a lyophilization fixture (see title and abstract) comprising:
a base member 18; and
a lid member 22 movable between a first position and a second position relative to the base member, the base member and lid member together defining a housing that receives at least a portion of a lyophilization container 40, 12 (shown in figures 4A, 6, 7, and disclosed at column 6 line 26 through column 7 line 36). Anger also discloses the claim 2 feature wherein the lid member includes two or more lid coupling members, and the base member includes two or more base coupling members, each of the two or more base coupling members including slots configured to receive at least a portion of the corresponding lid coupling member (figures 7, 8, 9), the claim 3 feature wherein the two or more lid coupling members includes a first pair of lid coupling members and a second pair of lid coupling members, the first pair of lid coupling members is disposed on a first side of the lid, and the second pair of lid coupling members is disposed on a second side of the lid (figures 9, 10A), the claim 4 feature wherein the two or more base coupling members includes a first pair of base coupling members and a second pair of base coupling members, the first pair of base coupling members is disposed on a first side of the base member and configured to receive at least a portion of the first pair of lid coupling members, and the second pair of lid coupling members is disposed on a second side of the base member and configured to receive at least a portion of the second pair of lid coupling members (figures 10B, 11), the claim 5 feature wherein the first pair of base coupling members and the first pair of lid coupling members define a hinge allowing for movement of the lid member between the first position and the second position (figures 9, 10A), the claim 6 feature wherein the hinge is a first hinge, and the second pair of base coupling members and the second pair of lid coupling members define a second hinge allowing for movement of the lid member between the first position and a third position (figures 10A, 11), the claim 7 feature wherein the base member and the lid member together define a first portion of the lyophilization fixture, the portion of the lyophilization container is a first portion of the lyophilization container, and the lyophilization fixture further includes: a second portion including a frame member configured to support a second portion of the lyophilization container (figures 9, 11), the claim 8 feature wherein the frame member includes: a first section having a first major plane, and a second section having a second major plane that is separated from the first major plane (figures 8, 9), the claim 9 features wherein the frame member further includes: a third section that joins together the first section and the second section (figures 10A, 11), the claim 10 feature wherein the second member is continuous with the base member of the first portion (figures 7, 8), the claim 11 feature wherein the second portion further includes one or more couplers for engaging the lyophilization container (figures 6, 7), the claim 12 feature wherein the two or more couplers are disposed at a distal portion of the second portion away from the first portion (figures 4B, 6), the claim 13 feature, wherein the lyophilization container includes a first section to be received by the first portion of the lyophilization fixture, the first section including a first layer, a second layer aligned with the first layer, and a cavity defined by the alignment of the first and second layers, at least one of the first and second layers preformed to have a three-dimensional shape; and a second section to be received by the second portion of the lyophilization fixture, the second section including a third layer, a fourth layer aligned with the third layer, and a second cavity defined by the alignment of the third and fourth layers, at least one of the third and fourth layers including a breathable membrane (figures 9, 11), the claim 19 feature wherein the frame member further includes: a third section that joins together the first section and the second section (figures 9, 11).
Allowable Subject Matter
Claims 14-18 and 20 are allowable over the prior art of record because the lyophilization fixture and method of using thereof with all the independently claim features including breathable and/or non-breathable lyophilization features is not found in the prior art either singly or in combination.
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 action may teach one or more claim features, but do not rise to a level of anticipation, obviousness, and/or double patenting such that a rejection would be proper and reasonable under current Office practice and procedure. References A, B, C, D, N, cited with this action, are patent publications from the same inventive entity, as the current application. References E, F, G, H, I, J, K, L, cited with this action, teach lyophilization fixtures and methods of using thereof.
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Wednesday, September 9, 2026
/STEPHEN M GRAVINI/Primary Examiner, Art Unit 3753
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