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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-10), Liquid Container Species 1a (Figure 2A), Second Container Species 2c (Figures 27-32) and Stopper Species 3a (Figure 2A) in the reply filed on 6/15/2026 is acknowledged. The traversal is on the ground(s) that the subject matter of all claims and species is sufficiently related that a thorough search for the subject matter of any one Group of claims or species would encompass a search for the subject matter of the remaining claims and species. Thus, it is respectfully submitted that the search and examination of the entire application could be made without serious burden. This is not found persuasive because there is a serious search burden for the patentably distinct species as set forth in the Restriction Requirement because at the inventions require a different field of search (e.g., employing different search strategies or search queries for the different structural features (e.g. different liquid container, second container and stopper arrangements, etc.) of the distinct species). The requirement is still deemed proper and is therefore made FINAL. In the reply, Applicant indicated that claims 1-10 read on the elected species. Claim 11 is withdrawn from consideration.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tanoguchi (US 10,065,784) in view of Mitsubishi (JPH05319459), Devouassoux et al. (2014/0262883) and Friesen et al. (US 2007/0163917).
Regarding claims 1 and 10, Tanoguchi discloses liquid-containing combination container (See Fig. 5) comprising: a first container (medicine-filled container at 3a in Fig. 5) that contains a liquid (at 53 as shown in Fig. 7); a tray (tray at 2a) that contains the first container (as shown in Fig. 5), wherein the first container (3a) includes a container body (at 51 in Fig. 7) that includes an opening portion (top opening of 51 that accommodates 52) and a stopper (at 52) that closes the opening portion (as shown in Fig. 7), wherein the stopper has oxygen permeability (water vapor permeable), wherein the container body has a cutout portion (top portion of 3a in Fig. 7) that includes the stopper and an around-portion (portion of 51 near 54 in Fig. 7) around the stopper. Tanoguchi discloses the claimed invention except for the second container, the express disclosure of the specific oxygen permeation amount and humidity of a portion of the container body.
Regarding the second container, Mitsubishi teaches a container set (See Figs. 1-2) comprising a tray (at 1 in Fig. 2) containing an article therein, wherein the tray is contained within a second container (at 3) that has an oxygen barrier property (See [0028]); and an oxygen absorber (at 2) that absorbs oxygen in the second container, for the purpose of maintaining quality within the container set. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the tray with first container therein of Tanoguchi within a second container having an oxygen absorber therein as taught by Mitsubishi in order to ensure proper quality of the contents.
Regarding the specific oxygen permeation, Devouassoux teaches it is well known in the art for a pharmaceutical packaging to have a permeability to oxygen about 1cc per day, atm in order to have the desired shelf life. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first container of Tanoguchi-Mitsubishi to have a permeability to oxygen as taught by Devouassoux in order to have the desired shelf life. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Furthermore, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding the specific humidity, Friesen teaches it is well known in the art for a relative humidity within a pharmaceutical packaging to be 40% relative humidity in order to enhance shelf-life (See [0012]-[0014]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the humidity within the container of Tanoguchi-Mitsubishi-Devouassoux to be 40% RH as taught by Friesen in order to enhance shelf-life. Furthermore, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 2, Mitsubishi teaches the second container is a film container (See Fig. 2).
Regarding claim 3, Mitsubishi teaches the second container includes a film that includes a seal portion (at the right and left sides of 3 in Fig. 2), wherein the seal portion can be seen in a direction in which an opening (top opening) of the tray can be seen.
Regarding claim 4, Tanoguchi discloses the tray includes a recessed portion (cavity within tray 2a).
Regarding claim 5, Tanoguchi discloses the stopper contains silicone (silicone rubber).
Regarding claim 6, Mitsubishi teaches the oxygen absorber is located between the tray and the second container (See Fig. 2).
Regarding claim 7, Tanoguchi discloses the tray includes a bottom wall (bottom wall of 2a in Fig. 5) and a side wall (at 41 in Fig. 5) that is connected to the bottom wall, and wherein the side wall includes a first side wall portion (left-side wall in Fig. 5) that faces the stopper of the first container that is contained in the tray and a second side wall portion (right-side wall in Fig. 5) that faces the first side wall portion.
Regarding claim 8, Tanoguchi-Mitsubishi-Devouassoux-Friesen discloses the claimed invention except for the specifics location of the oxygen absorber. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the oxygen absorber at any location within space between the second container and the tray of Tanoguchi-Mitsubishi-Devouassoux-Friesen in order to absorb the oxygen within the space. The oxygen absorber would perform the same function regardless of its location within the second container. It has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 9, Tanoguchi-Mitsubishi-Devouassoux-Friesen discloses the tray further includes a flange portion (at 44 in Fig. 5 of Tanoguchi and near 1 in Fig. 2 of Mitsubishi) that extends from the first side wall portion and the second side wall portion, and wherein in a state where the liquid-containing combination container is disposed on a placement surface such that the second side wall portion faces the placement surface with the second container interposed therebetween the flange portion is in contact with the second container positioned on the placement surface.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN A REYNOLDS whose telephone number is (571)272-9959. The examiner can normally be reached M-F 9am-5pm.
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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735
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