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 11-12 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 11 recites the limitation "the room”. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the freeze storage”. There is insufficient antecedent basis for this limitation in the claim.
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, 10-12, 21-23 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 / comprising a first end and a second end (adjacent 200 with adjacent 230 and 220), the container configured to contain the medicament (capable of performing the above intended use), the first end comprising / defining 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 defining at least one groove (body of 400 as in fig 1 with groove such as shown adjacent 420/425 in fig 1b); and at least one resilient portion in the main body and forming a seal with the container (as in for example in fig 2),
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:
10. The container assembly of claim 1,
wherein: the at least one resilient portion comprises a first resilient portion and a second resilient portion, the at least one groove comprises a first groove and a second groove, the first resilient portion is at least partially retained by the first groove and the second resilient portion is at least partially retained by the second groove, the first resilient portion is configured to form a temperature resilient seal with the container, and the second resilient portion is configured to stabilize the plunger assembly in the container (the combined reference discloses multiple portions with grooves, as for example in figure 2 of the secondary reference, and they are capable of performing the above intended use).
11. The container assembly of claim 1, wherein the room temperature is around 200C and the freeze storage of the medicament is carried out at -50°C to -200°C (the Office notes the 112 rejection above; nevertheless, 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 the 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).
21. (New) The container assembly of claim 1, wherein the main body and the container have similar or equivalent thermal expansion properties (primary reference paragraph 47, 49). If there is any question to the above, the Office notes that it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the material because it has been held that selection of a known material on the basis of its suitability for the intended use was an obvious extension of the prior teaching. In re Leshin, 125 USPQ 416.
22. (New) The container assembly of claim 1, wherein the leading portion comprises an inert film. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify (by providing the above) in order to assist the prevention of contamination. Further, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the material because it has been held that selection of a known material on the basis of its suitability for the intended use was an obvious extension of the prior teaching. In re Leshin, 125 USPQ 416.
23. (New) The container assembly of claim 1, wherein the plunger assembly is configured to maintain a static position when the container assembly is in the freeze storage (capable of performing the above intended use).
Claim(s) 1, 10-12, 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silverman (WO 2018160991 A1) in view of Auernhammer (WO 2016113409 A1) and Laubach (US 10258744 B2)
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 / comprising a first end and a second end (adjacent 200 with adjacent 230 and 220), the container configured to contain the medicament (capable of performing the above intended use), the first end comprising / defining 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 defining at least one groove (body of 400 as in fig 1 with groove such as shown adjacent 420/425 in fig 1b); and at least one resilient portion in the main body and forming a seal with the container (as in for example in fig 2),
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 the claimed invention above. In order to expedite prosecution for Applicant the Office notes that if there is any question to Applicant’s amendment and an outer diameter of the seal surface is approximately equal to an outer diameter of a leading portion of the main body, Laubach discloses similar art and also discloses an outer diameter of the seal surface is approximately equal to an outer diameter of a leading portion of the main body (the dimensions are “approximately equal” as the dimensions are close as in fig 1). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the Combined Reference in view of Laubach (by providing the above dimensions) in order to provide an enhanced fit between the surfaces to improve the movement and securement of the elements.
The Combined Reference discloses:
10. The container assembly of claim 1,
wherein: the at least one resilient portion comprises a first resilient portion and a second resilient portion, the at least one groove comprises a first groove and a second groove, the first resilient portion is at least partially retained by the first groove and the second resilient portion is at least partially retained by the second groove, the first resilient portion is configured to form a temperature resilient seal with the container, and the second resilient portion is configured to stabilize the plunger assembly in the container (the combined reference discloses multiple portions with grooves, as for example in figure 2 of the secondary reference, and they are capable of performing the above intended use).
11. The container assembly of claim 1, wherein the room temperature is around 200C and the freeze storage of the medicament is carried out at -50°C to -200°C (the Office notes the 112 rejection above; nevertheless, 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 the 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).
21. (New) The container assembly of claim 1, wherein the main body and the container have similar or equivalent thermal expansion properties (primary reference paragraph 47, 49). If there is any question to the above, the Office notes that it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the material because it has been held that selection of a known material on the basis of its suitability for the intended use was an obvious extension of the prior teaching. In re Leshin, 125 USPQ 416.
22. (New) The container assembly of claim 1, wherein the leading portion comprises an inert film. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify (by providing the above) in order to assist the prevention of contamination. Further, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the material because it has been held that selection of a known material on the basis of its suitability for the intended use was an obvious extension of the prior teaching. In re Leshin, 125 USPQ 416. The Office notes that Laubach also discloses inert film (adjacent 30).
23. (New) The container assembly of claim 1, wherein the plunger assembly is configured to maintain a static position when the container assembly is in the freeze storage (capable of performing the above intended use).
Response to Arguments
Applicant's arguments with respect to the claims have been considered, but are moot because in view of the amendment the search has been updated, new prior art has been identified and a new rejection has been made. Applicant states that Silverman does not disclose that the dimensions are “approximately equal”. The Office notes that the dimensions are close and there are “approximately equal” by definition. Nevertheless, in order to expedite prosecution for Applicant the Office notes that if there is any question to Applicant’s amendment and an outer diameter of the seal surface is approximately equal to an outer diameter of a leading portion of the main body, Laubach discloses similar art and also discloses an outer diameter of the seal surface is approximately equal to an outer diameter of a leading portion of the main body (the dimensions are “approximately equal” as the dimensions are close as in fig 1). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the Combined Reference in view of Laubach (by providing the above dimensions) in order to provide an enhanced fit between the surfaces to improve the movement and securement of the elements.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. 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
