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 .
Applicants are respectfully reminded that they and other individuals, as set forth in 37 CFR 1.56, have a duty to bring to the attention of the Office any material prior art or other information cited or brought to their attention in any related foreign application. See MPEP 2001.06(a).
The individuals covered by 37 CFR 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are “material to patentability” of the application in question. The individuals covered by 37 CFR 1.56 cannot assume that the examiner of a particular application is necessarily aware of other applications which are “material to patentability” of the application in question, but must instead bring such other applications to the attention of the examiner. See Dayco Prod., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003). For example, if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications. Similarly, the prior art references from one application must be made of record in another subsequent application if such prior art references are “material to patentability” of the subsequent application. See Dayco Prod., 329 F.3d at 1369, 66 USPQ2d at 1808. See MPEP 2001.06(b).
Election/Restrictions
Applicant’s election without traverse of species A, figures 1-2b, claims 1-3, 10-12 in the reply filed on 10/10/2025 is acknowledged. Claims 4-9, 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on the above date. Claim 2 is also withdrawn as being to Applicant’s non-elected species.
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.
Claim(s) 1, 3, 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silverman (WO 2018160991 A1) in view of Auernhammer (WO 2016113409 A1)/
Silverman discloses:
1. A container assembly (figs 1-2) for containing and delivering a medicament (capable of performing the above intended use), the container assembly (100) comprising: a container having a first end and a second end (adjacent 200 with adjacent 230 and 220), the first end comprising a first opening (aperture as in fig 1a); and a plunger assembly at least partially disposed in the container (adjacent 400), the plunger assembly comprising: a main body (body of 400 as in fig 1); and at least one resilient portion in the main body and forming a seal with the container (as in for example in fig 2), wherein the plunger assembly is configured to: form a temperature resilient seal with the container such that the container assembly is operable to: contain a medicament between the seal and the first opening at: (a) room-temperature and (b) during freeze storage of the medicament; and be moveable relative to the container at room temperature (capable of performing the above intended use; the prior art also discloses environment as in paragraphs 31, 32 and also for example intended contents as in paragraph 27).
Silverman discloses the claimed invention above with the exception of the following which is disclosed by Auernhammer: the portions at least partially retained by a groove (such as 3.2.2.1 and 3.2.2.2 as in fig 2, 1). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Silverman in view of Auernhammer (by applying the concept of a groove/portion and ensuring that the portion is within a groove) in order to provide that the portion is removable of which provides replaceability such as when the portion breaks. The above feature allows for separate cleaning as well.
The Combined Reference discloses:
3. The container assembly of claim 1, wherein the resilient portion is configured to provide an interference fit with the container (as in the primary reference fig 2).
10. The container assembly of claim 1, wherein the plunger assembly comprises at least two resilient portions, and wherein: one of the at least two resilient portions is configured to form the temperature resilient seal; and the other of the at least two resilient portions is configured to stabilize the plunger assembly in the container (the combined reference discloses multiple portions with a groove and they are capable of performing the above intended use).
11. The container assembly of claim 1, wherein room temperature is around 200C and the freeze storage of the medicament is carried out at -50°C to -200°C (capable of performing the above intended use; the prior art also discloses environment as in paragraphs 31, 32 and also for example intended contents as in paragraph 27).
12. The container assembly of claim 1, wherein freeze storage of the medicament is carried out at cryogenic or at ultralow temperatures (capable of performing the above intended use; the prior art also discloses environment as in paragraphs 31, 32 and also for example intended contents as in paragraph 27).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW D PERREAULT whose telephone number is (571)270-5427. The examiner can normally be reached Monday - Friday 7:00am-5:30pm. 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, Anthony Stashick can be reached at (571)272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW D PERREAULT/Primary Examiner, Art Unit 3735
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