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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 4 recites that the three-dimensional shape has “an open-box configuration”. Examiner cannot find support for this limitation within Applicant’s Specification; therefore, the metes and bounds of the limitation are not readily understood.
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) 1-8, 10-12, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parakininkas et al. (US 2020/0288703 A1; hereinafter Parakininkas).
Regarding claims 1 and 11, Parakininkas discloses a lyophilization container comprising a first section (102) including a first layer and a second layer aligned with the first layer (see Figure 1; Examiner considers the front side to be one layer and the back side to be a second layer), and a cavity defined by the alignment of the first and second layers (see Par. 0029-0030), at least one of the first and second layers being preformed to have a three-dimensional shape, the first and second layers being different parts of a continuous sheet (see Par. 0034).
Regarding claims 2-8, Parakininkas discloses a container wherein the three-dimensional shape includes a planar surface and sides angled away from the planar surface. Examiner considers the front and rear surfaces to be planar and the sides and corners to be angled. Examiner also considers the front side and rear side to present a three-dimensional shape insofar as said sides contour and flex to attach at the sides.
Regarding claim 10, Parakininkas discloses a container wherein the cavity is a first cavity, and the lyophilization container further includes a second section (106) 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 (see Figure 1; Examiner considers the front side to be one layer and the back side to be a second layer), at least one of the third and fourth layers including a breathable membrane (see Par. 0029).
Regarding claim 12, Parakininkas discloses a container wherein one of the first and second sections of the lyophilization container includes one or more apertures (308) for securing the lyophilization container to a lyophilization fixture (see Figures 3A-4 and 7).
Regarding claim 14, Parakininkas discloses a container that further includes an occluding section (108) disposed between the first section and the second section,
the occluding section movable between a first configuration and a second configuration, the occluding section in the first configuration preventing liquid movement between the first and second cavities, and the occluding section in the second configuration allowing for liquid movement between the first and second cavities (see Par 0039 and 0056).
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments, see Pages 8-9, filed 01/05/2026, with respect to the rejection(s) of claim(s) 1-8, 10, 12, and 14 under USC 102(a)(1)—in view of McCarthy have been fully considered and are persuasive. McCarthy lacks the first and second layers being different parts of a continuous sheet. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of USC 102(a)(1)--Parakininkas.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER R DEMEREE whose telephone number is (571)270-1982. The examiner can normally be reached 9:00 am - 5:00 pm, Monday through Friday.
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, NATHAN J NEWHOUSE can be reached at (571)272-4544. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER R DEMEREE/Primary Examiner, Art Unit 3734
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