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 .
Response to Arguments
Applicant’s amendment filed 06/08/2026 is accepted and entered. Applicant’s amendments to the claims have overcome the previous 112 rejections and the previous 112 rejections have been withdrawn.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Yoshinaga is now cited to disclose the three-layer container multilayered body, as set forth below.
Applicant did not specifically argue the dependent claims.
Claim Interpretation
Claim 1 recites a container multilayered body “consisting of three layers” and further indicates that the intermediate layer “contains a linear low-density polyethylene produced using a single-site catalyst as a main component.” Due to the presence of “as a main component,” it appears that the transitional phrase is only limiting the construction of the multilayered body to be a three-layer structure. In other words, a four-layer multilayered body used to form a container does not read on the claimed limitation, but a three-layer multilayered layer body that has the three layers as claimed, where the intermediate layer contains a linear low-density polyethylene produced using a single-site catalyst as a main component and where the intermediate layer also contains other components does read on the claim.
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 10-12 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 10 recites the limitation “wherein fractions of thicknesses of the innermost layer, the intermediate layer, and the outer layer are 10 to 20 : 210 to 220 : 20.” However, one of ordinary skill in the art would not find it clear what does or does not meet this limitation. In addition to the ratio itself being unclear, one of ordinary skill in the art would not be sure what “fractions of thicknesses” is intended to refer to – does this limitation refer to the percentage of total thickness for each layer of the multilayered body, or does this limitation refer to the specific thickness for each layer (i.e. one layer is 10 microns, the other layer is 20-210 microns, etc.). Due to the lack of clarity of the limitation in both the claim and the specification, any ratio of percentage of total thickness for each layer is interpreted as reading on this claim limitation for the purpose of compact prosecution. Since any ratio is being interpreted as reading on the claim limitation, this limitation is being omitted from the write up below.
Claim 11 recites the limitation "the contents" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the inlet/outlet" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “a bag innermost layer.” It is unclear if this limitation is intended to refer to the innermost layer of the container multilayered body or if this is intended to refer to a different innermost layer. For the purpose of compact prosecution, these limitations are interpreted as referring to the same innermost layer of the container multilayered body.
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, 3, 4, 8, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshinaga (JP 2005-335108; citations to attached translation).
Regarding Claim 1, Yoshinaga discloses a container multilayered body (multilayer film A, Fig. 1) that is used to form a container (¶ [0001-0009]), consisting of three layers:
wherein the three layers are:
an innermost layer (7, Fig. 1) made of a cyclic polyolefin (¶ [0010, 0013, 0017, 0027, 0028]);
an intermediate layer (8, Fig. 1) that is formed so as to be adjacent to the innermost layer (7, Fig. 1) and contains a linear low-density polyethylene produced using a single-site catalyst as a main component (¶ [0010, 0013, 0017, 0027, 0028]); and
an outer layer (9, Fig. 1) made of one of a random polypropylene produced using a single-site catalyst or a polypropylene containing an elastomer (¶ [0010, 0013, 0017, 0020, 0027]).
Regarding Claim 3, Yoshinaga discloses the cyclic polyolefin is a hydrogenated product of a ring-opened polymer of a cyclic olefin monomer (¶ [0019]).
Regarding Claim 4, Claim 1 from which Claim 4 depends does not explicitly require an elastomer. Thus, such limitations of Claim 4 regarding the elastomer being an olefin-based elastomer or/and a styrene-based elastomer is disclosed by Yoshinaga as Yoshinaga discloses the outer layer being made of a random polypropylene produced using a single-site catalyst.
Regarding Claim 8, Yoshinaga discloses the intermediate layer (8, Fig. 1) further contains a high-density polyethylene having a higher density than the linear low-density polyethylene within a range of 30 mass% or less with respect to the total mass of the intermediate layer (8, Fig. 1; ¶ [0028]).
Regarding Claim 9, Yoshinaga discloses the outer layer (9, Fig. 1) consists essentially of one of a random polypropylene produced using a single-site catalyst or a polypropylene containing an elastomer (¶ [0010, 0013, 0017, 0020]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5-7, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura et al (US 2010/0276321) in view of Yoshinaga (JP 2005-335108).
Regarding Claim 5, Nakamura discloses a container (30, Fig. 3A), comprising:
an accommodation portion (holding portion 31, Fig. 3A) that accommodates contents (¶ [0081-0084]),
wherein the accommodation portion (31, Fig. 3A) is made of a container multilayered body (10, Fig. 1) that consists of three layers (¶ [0074]), wherein the three layers are:
an innermost layer (11, Fig. 1) made of a cyclic polyolefin (¶ [0074]);
an intermediate layer (12, Fig. 1) that is formed so as to be adjacent to the innermost layer (11, Fig. 1) and contains a linear low-density polyethylene produced using a single-site catalyst as a main component (¶ [0062]); and
an outer layer (13, Fig. 1; ¶ [0064, 0074]).
Nakamura is silent whether the outer layer is made of one of a random polypropylene produced using a single-site catalyst or a polypropylene containing an elastomer.
Yoshinaga discloses a container multilayered body (multilayer film A, Fig. 1), thus being in the same field of endeavor, that is used to form a container (¶ [0001-0009]), consisting of three layers: wherein the three layers are: an innermost layer (7, Fig. 1) made of a cyclic polyolefin (¶ [0010, 0013, 0017, 0027, 0028]); an intermediate layer (8, Fig. 1) that is formed so as to be adjacent to the innermost layer (7, Fig. 1) and contains a linear low-density polyethylene produced using a single-site catalyst as a main component (¶ [0010, 0013, 0017, 0027, 0028]); and an outer layer (9, Fig. 1) made of one of a random polypropylene produced using a single-site catalyst or a polypropylene containing an elastomer (¶ [0010, 0013, 0017, 0020, 0027]). Yoshinaga indicates that the multilayer film can be used to form medical and pharmaceutical packages (¶ [0001-0009]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the container multilayered body of Nakamura for the container multilayered body of Yoshinaga, as both multilayered bodies consist of three layers of material and are shown to be useful in manufacturing medical and pharmaceutical packaging (as motivated by Yoshinaga ¶ [0001-0009]), and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Regarding Claim 6, Nakamura discloses a medical container (30, Fig. 3A), comprising:
an accommodation portion (holding portion 31, Fig. 3A) that accommodates a liquid medicine (¶ [0047, 0081-0084]),
wherein at least the accommodation portion (31, Fig. 3A) is made of a container multilayered body (10, Fig. 1) that consists of three layers (¶ [0074]), wherein the three layers are:
an innermost layer (11, Fig. 1) made of a cyclic polyolefin (¶ [0074]);
an intermediate layer (12, Fig. 1) that is formed so as to be adjacent to the innermost layer (11, Fig. 1) and contains a linear low-density polyethylene produced using a single-site catalyst as a main component (¶ [0062]); and
an outer layer (13, Fig. 1; ¶ [0064, 0074]).
Nakamura is silent whether the outer layer is made of one of a random polypropylene produced using a single-site catalyst or a polypropylene containing an elastomer.
Yoshinaga discloses a container multilayered body (multilayer film A, Fig. 1), thus being in the same field of endeavor, that is used to form a container (¶ [0001-0009]), consisting of three layers: wherein the three layers are: an innermost layer (7, Fig. 1) made of a cyclic polyolefin (¶ [0010, 0013, 0017, 0027, 0028]); an intermediate layer (8, Fig. 1) that is formed so as to be adjacent to the innermost layer (7, Fig. 1) and contains a linear low-density polyethylene produced using a single-site catalyst as a main component (¶ [0010, 0013, 0017, 0027, 0028]); and an outer layer (9, Fig. 1) made of one of a random polypropylene produced using a single-site catalyst or a polypropylene containing an elastomer (¶ [0010, 0013, 0017, 0020, 0027]). Yoshinaga indicates that the multilayer film can be used to form medical and pharmaceutical packages (¶ [0001-0009]).
Therefore, it would have been obvious to substitute the container multilayered body of Nakamura for the container multilayered body of Yoshinaga, as both multilayered bodies consist of three layers of material and are shown to be useful in manufacturing medical and pharmaceutical packaging (as motivated by Yoshinaga ¶ [0001-0009]), and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Regarding Claim 7, Nakamura further discloses a liquid medicine-containing medical container (31, Fig. 3A; ¶ [0047, 0081-0084]), wherein the liquid medicine is accommodated in the medical container (31, Fig. 3A; ¶ [0047, 0081-0084]) according to Claim 6.
Regarding Claim 11, Nakamura further discloses a hard port portion (32, Fig. 3A) that functions as an inlet/outlet of the contents (¶ [0082-0084]), wherein the hard port portion (32, Fig. 3A) is made of the same cyclic polyolefin as that for the innermost layer (11, Fig. 1; ¶ [0084]).
Regarding Claim 12, Nakamura further discloses a tube (32, Fig. 3A) is used as the inlet/outlet (¶ [0082-0084]), the tube (32, Fig. 3A) is a multilayered tube (¶ [0084]), and at least a tube outer layer to be heat-sealed with a bag innermost layer (11, Fig. 1) is made of the same cyclic polyolefin as that for the bag innermost layer (11, Fig. 1) or a polypropylene containing an elastomer that is adhesive to the cyclic polyolefin (¶ [0084]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshinaga (JP 2005-335108) in view of Nakamura et al (US 2010/0276321).
Regarding Claim 10, Yoshinaga discloses the container multilayered body as set forth above for Claim 1.
Yoshinaga is silent whether a total thickness of the container multilayered body is 100 to 600 microns.
Nakamura discloses a medical container comprising a three layer multilayered body, thus being in the same field of endeavor, where the total thickness of the container multilayered body is 100 to 600 microns (¶ [0070]) to allow for optimum flexibility and strength of the container (¶ [0070]).
Therefore, it would have been obvious to modify the thickness of the container multilayered body of Yoshinaga to be 100 to 600 microns, as taught by Nakamura, to allow for optimum flexibility and strength of the container (as motivated by Nakamura ¶ [0070]).
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 Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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