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 Amendment
The amendment filed 17 June 2026 has been entered. Claims 1-6 and 8-14 are currently pending in the application. The rejections of record from the office action dated 16 April 2026 not repeated herein have been withdrawn.
Claim Rejections - 35 USC § 103
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 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 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.
Claims 1-6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (US 2008/0063825 A1) in view of Proicou et al. (US 2004/0001655 A1).
Regarding claims 1-6 and 8-12, Mori discloses a medical bag comprising a multilayer film comprising a heat seal layer and a cyclic olefin layer, formed by welding the heat seal layers facing each other, wherein the medical bag contains a medical fluid, wherein the bag comprises a mouth member comprising cyclic olefin polymer, wherein the bag may be formed such that the mouth member is sandwiched between the opposing heat seal layers (i.e. a package comprising a bag main body, at least one mouth part member joined to the bag main body and a liquid content accommodated in the bag main body, wherein the bag main body of the package has as a forming material a laminate having a sealant layer and is formed into a bag shape by bonding sealant layers facing each other where the sealant layers are on an inner side, the mouth part member is joined to the bag main body by being sandwiched between the sealant layers facing each other; sealant layer is composed of one or more layers and includes a layer formed of a cyclic olefin resin as a main component; mouth part member contains a cyclic olefin resin as a forming material)(abstract, [0011], [0016]-[0017], [0020]-[0021], [0115], [0142]).
Mori does not disclose a water vapor barrier layer made of a fluorine resin or that the fluorine resin is polychlorotrifluoroethylene.
Proicou discloses a multilayer bag for holding a liquid pharmaceutical, wherein the bag is formed by heat sealing inner heat seal layers, comprising a moisture barrier layer that comprises polychlorotrifluoroethylene (PCTFE) that is transparent to allow visual inspection (i.e. a water vapor barrier layer made of fluorine resin; polychlorotrifluoroethylene)([0011]-[0012], [0022]).
Mori and Proicou are analogous art because they both teach about multilayer bag for holding medical liquids formed by heat sealing inner layers. It would have been obvious to one of ordinary skill in the art to incorporate the PCTFE barrier layer of Proicou into the bag of Mori in order to provide a bag having good moisture vapor barrier properties and/or to provide good barrier properties and that is transparent to allow visual inspection.
While there is no specific disclosure of the volume of the content of the medical bag, it is the examiner’s position that would have been obvious to make the bag having a volume of content 0.1 to 20 cm3 depending on the end use of the bag and the amount of medical fluid desired to be stored within the bag.
Change in size and shape is not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). MPEP 2144.04[R-1].
While there is no specific disclosure of a relationship between an area of the bag main body which comes into contact with the liquid content and the volume as set forth in Formula I, it is the examiner’s position that any area of the bag that comes into contact with the liquid contents could be considered to be “an area of the bag main body which comes into contact with the liquid content” and therefore, the size of this area could be picked such that it satisfies the requirements of Formula I. Alternatively, it is noted that the relationship between an area of the bag main body which comes into contact with the liquid content and the volume would depend on the size and shape of the bag and how full the bag is (i.e. the amount of liquid contents) and given that it would have been obvious to have the bag have any size and/or shape and/or fullness depending on the desired end use of the bag, it would have been obvious to meet this limitation.
Change in size and shape is not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). MPEP 2144.04[R-1].
Regarding claim 2, it is clear that the mouth port is for discharging the contents of the bag and therefore, the when the content is discharged, the volume of the bag body will be reduced accordingly.
Regarding claim 3, given that the bag of modified Mori has an identical moisture barrier layer to that claimed and as set forth in the instant examples (i.e. polychlorotrifluoroethylene)(see instant specification Table 1), it is the examiner’s position that it will intrinsically meet this limitation. Alternatively, it would have been obvious to make the bag having a moisture vapor transmission in the range claimed in order to provide a bag with good moisture barrier properties in order to better preserve the contents of the bag.
Regarding claim 4, while there is no specific disclosure of the thickness of the water vapor barrier layer, given that the thickness of the water vapor barrier layer will affect the amount of water vapor barrier properties and the cost of the film, it is the examiner’s position that it would have been obvious to one of ordinary skill in the art to make the water vapor barrier layer have a thickness in the claimed range depending on the end use of the bag and the desired water vapor barrier properties/cost.
Regarding claim 5, Mori discloses that the total thickness of the film may be 30 to 80 µm (i.e. overlapping 15 µm to 200 µm)([0061]). Alternatively, given that the total thickness of the laminate would affect the strength of the bag, it is the examiner’s position that it would have been obvious to have the total thickness in the claimed range depending on the desired end use of the bag and the desired strength.
Regarding claims 9-11, given that the bag is for holding medical fluids, it would have been obvious to one of ordinary skill in the art to make the contents of the bag a pharmaceutical product, an injection and/or hormones, medical narcotics, local anesthetics, analgesics, anticancer drugs or antibiotics because these are all well-known medical fluids and in order to provide a bag having these medical fluids depending on the desired end use of the bag, for example being used in to hold antibiotics, etc.
Regarding claim 12, Mori discloses that the seal layer may be 15 to 30 µm (i.e. overlapping 30 µm to 60 µm) ([0091]). Mori teaches a barrier layer may be around 20 µm or 7-20 µm thick (i.e. overlapping 15 to 25 µm)([0124], [0047]). It is the examiner’s position that it would have been obvious to make the barrier layer of modified Mori around 20 µm or 7-20 µm thick because it is well known to do so and would amount to nothing more than using a known barrier layer thickness in a known environment to accomplish an entirely expected result. Alternatively, given that the thickness of the water vapor barrier layer will affect the amount of water vapor barrier properties and the cost of the film, it is the examiner’s position that it would have been obvious to one of ordinary skill in the art to make the water vapor barrier layer have a thickness in the claimed range depending on the end use of the bag and the desired water vapor barrier properties/cost.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (US 2008/0063825 A1) and Proicou et al. (US 2004/0001655 A1), as applied to claim 1 above, in view of Hooven et al. (US 2017/0196771 A1).
Regarding claims 9-11, modified Mori discloses all of the claim limitations as set forth above. Mori does not specifically disclose an injectable pharmaceutical product or hormones, medical narcotics, local anesthetics, analgesics, anti-cancer drugs or antibiotics.
Hooven discloses that medical fluid may encompass injectables and antibiotics ([0011]).
Mori and Hooven are analogous art because they both teach about medical fluids. It would have been obvious to one of ordinary skill in the art to use injectables/antibiotics as the medical fluid of modified Mori, since these are common medical fluids as taught by Hoover and in order to provide a bag having these medical fluids and to protect them during storage and shipping.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (US 2008/0063825 A1) in view of Proicou et al. (US 2004/0001655 A1) and Hollowell et al. (US 2011/0054416 A1).
Regarding claim 13, Mori discloses a medical bag comprising a multilayer film comprising a heat seal layer and a cyclic olefin layer, formed by welding the heat seal layers facing each other, wherein the medical bag contains a medical fluid, wherein the bag comprises a mouth member comprising cyclic olefin polymer, wherein the bag may be formed such that the mouth member is sandwiched between the opposing heat seal layers (i.e. a package comprising a bag main body, at least one mouth part member joined to the bag main body and a liquid content accommodated in the bag main body, wherein the bag main body of the package has as a forming material a laminate having a sealant layer and is formed into a bag shape by bonding sealant layers facing each other where the sealant layers are on an inner side, the mouth part member is joined to the bag main body by being sandwiched between the sealant layers facing each other; sealant layer is composed of one or more layers and includes a layer formed of a cyclic olefin resin as a main component; mouth part member contains a cyclic olefin resin as a forming material)(abstract, [0011], [0016]-[0017], [0020]-[0021], [0115], [0142]).
Mori does not disclose a water vapor barrier layer made of a fluorine resin or that the fluorine resin is polychlorotrifluoroethylene.
Proicou discloses a multilayer bag for holding a liquid pharmaceutical, wherein the bag is formed by heat sealing inner heat seal layers, comprising a moisture barrier layer that comprises polychlorotrifluoroethylene (PCTFE) that is transparent to allow visual inspection (i.e. a water vapor barrier layer made of fluorine resin; polychlorotrifluoroethylene)([0011]-[0012], [0022]).
Mori and Proicou are analogous art because they both teach about multilayer bag for holding medical liquids formed by heat sealing inner layers. It would have been obvious to one of ordinary skill in the art to incorporate the PCTFE barrier layer of Proicou into the bag of Mori in order to provide a bag having good moisture vapor barrier properties and/or to provide good barrier properties and that is transparent to allow visual inspection.
Mori does not disclose that the medical fluid consists of a mixture comprising a liquid and at least one of a solid, a gas, a powder and a granule.
Hollowell discloses that medicines come in the form of a mixture of a liquid and a powder or granule ([0087]).
Mori and Hollowell are analogous art because they both teach about medical fluids. It would have been obvious to one of ordinary skill in the art to use a medical fluid consisting of a mixture of a liquid and a powder or granule as taught by Hollowell in the medical bag of Mori in order to provide a medical bag having a well-known type of medical fluid and to store this type of medial fluid and protect this type of medical fluid from moisture that would dilute it and because doing so would amount to nothing more than using a known material in a known environment to accomplish an entirely expected result.
While there is no specific disclosure of the volume of the content of the medical bag, it is the examiner’s position that would have been obvious to make the bag having a volume of content 0.1 to 20 cm3 depending on the end use of the bag and the amount of medical fluid desired to be stored within the bag.
Change in size and shape is not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). MPEP 2144.04[R-1].
While there is no specific disclosure of a relationship between an area of the bag main body which comes into contact with the liquid content and the volume as set forth in Formula I, it is the examiner’s position that any area of the bag that comes into contact with the liquid contents could be considered to be “an area of the bag main body which comes into contact with the liquid content” and therefore, the size of this area could be picked such that it satisfies the requirements of Formula I. Alternatively, it is noted that the relationship between an area of the bag main body which comes into contact with the liquid content and the volume would depend on the size and shape of the bag and how full the bag is (i.e. the amount of liquid contents) and given that it would have been obvious to have the bag have any size and/or shape and/or fullness depending on the desired end use of the bag, it would have been obvious to meet this limitation.
Change in size and shape is not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). MPEP 2144.04[R-1].
Regarding claim 14, Mori discloses that the seal layer may be 15 to 30 µm (i.e. overlapping 30 µm to 60 µm) ([0091]). Mori teaches a barrier layer may be around 20 µm or 7-20 µm thick (i.e. overlapping 15 to 25 µm)([0124], [0047]). It is the examiner’s position that it would have been obvious to make the barrier layer of modified Mori around 20 µm or 7-20 µm thick because it is well known to do so and would amount to nothing more than using a known barrier layer thickness in a known environment to accomplish an entirely expected result. Alternatively, given that the thickness of the water vapor barrier layer will affect the amount of water vapor barrier properties and the cost of the film, it is the examiner’s position that it would have been obvious to one of ordinary skill in the art to make the water vapor barrier layer have a thickness in the claimed range depending on the end use of the bag and the desired water vapor barrier properties/cost.
Response to Arguments
Applicant's arguments filed 17 June 2026 have been fully considered but they are not persuasive.
Applicant argues that Mori discloses that the sealing layer is preferably linear polyethylene and one of ordinary skill in the art would not be motivated to change to a cyclic olefin and cyclic olefin would likely prevent the intended purpose of Mori.
Applicant’s argument is unpersuasive given that Mori discloses a multilayer film comprising a heat seal layer and a cyclic olefin layer ([0016]). It is the examiner’s position that the heat seal layer and cyclic olefin layer of Mori can be considered to be a sealant layer comprising one or more layers including a layer formed of cyclic olefin resin as a main component.
Applicant argues that limiting the sealing layer to one containing cyclic olefins, it is possible to provide a packaging structure with excellent non-adsorption properties with respect to the content.
Applicant’s argument is unpersuasive given that the structure of Mori can be considered to be a sealant layer comprising one or more layers including a layer formed of cyclic olefin resin as a main component.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a sealant layer consisting of a layer formed of cyclic olefin resin as a main component) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Further, it is noted that “the arguments of counsel cannot take the place of evidence in the record”, In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) (MPEP 716.01(c)(II)). It is the examiner’s position that the arguments provided by the applicant regarding whether limiting the sealing layer to one containing cyclic olefins, it is possible to provide a packaging structure with excellent non-adsorption properties with respect to the content must be supported by a declaration or affidavit.
Applicant argues that the cited combination fails to disclose the claimed volume V of the content accommodated inside the bag main body is 0.1 to 20 (cm3) and the relationship between the liquid-contacting area S of the bag main body and the volume V satisfies 0.5≤V/S≤0.25 and examiner’s assertion that the relationship would depend on the size and shape of the bag and how full it is relies on improper hindsight.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues that the claimed V/S parameter is not merely an arbitrary matter of size and shape but is tied to storage suitability for small liquid volumes and points to the data set forth in Tables 4-5.
Applicant’s argument is unpersuasive given that the data presented is not commensurate in scope with the scope of the claims because the data is directed to V/S of 0.05 to 0.219, while instant claim 1 recites 0.05 to 0.25 and the data is directed to a filled volume of 0.5 to 3.5 cm3. while the instant claims recite 0.1 to 20 cm3. Further it is noted that the data is presented for a bag having PCTFE layer at 15 µm as the water vapor barrier and an adhesive interlayer, while instant claim1 broadly recites water vapor barrier layer made of a fluorine resin and no adhesive layer and data is presented for a bag having a sealant layer comprising a first layer of PE at 30 µm and a second layer of COP at 10 µm, while instant claim 1 broadly recites sealant layer composed of one or more layers and includes a layer formed of a cyclic olefin resin as a main component.
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 JAMES C YAGER whose telephone number is (571)270-3880. The examiner can normally be reached 9-6 EST M-F.
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, Aaron Austin can be reached at (571) 272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES C YAGER/ Primary Examiner, Art Unit 1782
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