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 .
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-8, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herbert (US 2003/0075469).
Regarding claim 1, Herbert discloses a fitment (1; Fig. 1) for a bag (Fig. 5), comprising: a fitment body (2) including a first side wall and a second side wall (7, 8; Fig. 2), each of the first side wall and the second side wall extending between opposing end points (Paragraph 0037; see Figs. 1-2), the first side wall and the second side wall defining a central region of the fitment body (see Fig. 1), the fitment body comprising a biocompatible material (TPE; Paragraph 0036), wherein the central region of the fitment body includes a spike port aperture (9), and the fitment body includes one or more guide features (16), the guide features configured to separate a spike inserted into the spike port aperture from a bag sheet attached to one or both of the first side wall and the second side wall (Paragraphs 0023, 0039), wherein the one or more guide features are configured, when the bag sheet is attached to one or both of the first side wall and the second side wall to form a bag, to extend from the central region of the fitment body into an internal space of the bag (e.g., shown as 27 in Fig. 5).
Regarding claim 2, Herbert further discloses that the one or more guide features include a guide projection extending from the fitment body, wherein the spike port aperture extends through the guide projection (see the portion of 16 below the central region in Fig. 1).
Regarding claim 3, Herbert further discloses that the one or more guide features include a plurality of wings (each half of 16, separated by 18, 19; Fig. 3) extending from the first side wall and/or the second side wall (extending from each side to protect the bag; Paragraphs 0023, 0039).
Regarding claim 4, Herbert further discloses a plurality of additional ports (4, 34) formed integrally in the fitment body (see Fig. 1). Herbert additionally discloses that the fitment may include multiple spike ports (Paragraph 0013).
Regarding claims 6-8, Herbert further discloses that the spike port aperture includes a barrier membrane (11) that is formed integrally with the fitment body (see Fig. 1), and further discloses a barrier film located at an end of the spike port aperture (tear-off film; Paragraph 0025).
Regarding claims 16-18, Herbert discloses a method of inserting a spike into a bag (see the Abstract; Fig. 5), comprising: directing the spike into a spike port aperture (via shoulder 14; Paragraph 0038) provided on a fitment included in the bag, the fitment including a fitment body having a first side wall and a second side wall defining a central region of the fitment body, the spike port aperture being provided in the central region of the fitment body (see above regarding claim 1), and driving the spike through a puncture barrier disposed in the spike port aperture (spike pierces membrane 11; Paragraph 0039), wherein one or more guide features (see above regarding claim 1) are disposed between the spike and one or more sheets forming the bag once the spike has been inserted into the bag (Paragraph 0023), wherein the one or more guide features extend from the central region of the fitment body into an internal space of the bag (see above regarding claim 1).
Herbert further discloses that the one or more guide features include a guide projection extending from the fitment body, wherein the spike port aperture extends through the guide projection (see above regarding claim 2), and the one or more guide features include a plurality of wings extending from the first side wall and/or the second side wall of the fitment (see above regarding claim 3). Thus, Herbert discloses all of the steps recited in claims 16-18 through normal operation of the disclosed device.
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.
Claims 9-10 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Herbert.
Herbert discloses the fitment of claim 1 and the method of claim 16, and further discloses an internal gasket (13) disposed in a port aperture (see 10 in Fig. 1). Herbert teaches that the internal gasket (i.e., pierceable septum) “permits a permanent closure even after the membrane has been pierced” (Paragraph 0020; Examiner understands this to mean that the internal gasket is provided to prevent leakage after the initial piercing). Since Herbert discloses the internal gasket only with respect to port aperture 10, which is described as receiving a cannula for injection of material, rather than port aperture 9, which is described as receiving a spike for withdrawal of material, Herbert is not considered to explicitly disclose an internal gasket disposed in the spike port aperture.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the application to provide the same internal gasket on the spike port aperture, since this would similarly prevent leakage when a spike is inserted in the spike port aperture. Considering that the bag/fitment disclosed by Herbert is intended for use with medical solutions (Paragraph 0002), Examiner notes that it is well known in the art to use such a device in an inverted manner (i.e., hanging from a bottom edge of the bag). In this application especially, one having ordinary skill in the art may be concerned with preventing leakage, as evidenced in US 6,485,479 to Knierbein (see Col. 4, lines 21-28; element 12 in Fig. 4) and US 4,516,977 to Herbert (see Col. 10, lines 28-37; element 44 in Fig. 4).
Herbert further discloses a barrier film located at an end of the spike port aperture (tear-off film; Paragraph 0025), as claimed in claim 10. Thus, Herbert discloses/renders obvious the inventions of claims 9 and 10. When the internal gasket is applied to the spike port aperture, it additionally provides a second puncture barrier as the spike enters the spike port aperture, thus meeting the limitations of method claims 19-20 during normal use of the device.
Claims 5 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Herbert in view of Brosch et al. (US 2018/0021218).
Regarding claim 5, Herbert discloses the fitment of claim 4 and further notes that the fitment may include multiple additional ports (Paragraph 0013), but does not explicitly disclose that the spike port aperture is located between two of the plurality of additional ports.
Brosch et al. teach a similar fitment (200; Fig. 2A) having a plurality of additional ports (220, 230) formed integrally in the fitment body (Paragraph 0060). Brosch et al. teach these features as providing a means for connecting various parts or objects to communicate with the interior of a bag (“such as tubing, connectors, hoses, syringes or the like”; Paragraph 0058), and notes that a variety of combinations of ports would be contemplated by one of skill in the art (Paragraph 0059).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to provide the fitment of Herbert with additional ports, as taught by Brosch et al., in order to enable communication of additional parts or objects with the interior of a bag (e.g., to fill the bag with a fluid). Having done so, it would be an obvious matter of design choice to arrange the ports such that the spike port aperture is located between two of the plurality of additional ports (see the illustrated embodiment of Borsch et al. having three ports in Fig. 2A). Applicant appears to have placed no criticality on any particular arrangement of ports, and it appears that the fitment of Herbert, modified in view of Brosch et al., would work appropriately if arranged as claimed, especially considering that both Herbert and Brosch et al. already contemplate a variety of port arrangements.
Regarding claim 11, Herbert discloses a bag, comprising: a fitment having one or more guide features (as described above regarding claim 1); and one or more polymer sheets (30, 31; Paragraph 0046), the one or more polymer sheets joined to the first side wall and the second side wall (described as “the long sides of the base part 20” in Paragraph 0046 and Fig. 5), the one or more polymer sheets sealed to form the bag (Paragraph 0046), wherein the one or more guide features extend from the central region of the fitment body into an internal space defined by the fitment and the one or more polymer sheets (see 27 in Fig. 5), the one or more guide features configured to separate a spike inserted into the spike port aperture from the one or more polymer sheets (Paragraph 0023).
Herbert teaches that the fitment body comprises a polymer material “which can be welded to the known polyolefin films of the bags” (Paragraphs 0016-0017), but does not explicitly disclose a fluoropolymer material. However, Brosch et al. teach a similar fitment body (body of 200) comprising a fluoropolymer material (fitment and bag may be composed of the same fluoropolymer material; Paragraph 0007). Brosch et al. teach the use of this material based in part on its permeability and sterilizability properties (Paragraph 0046) and that using the same material for the fitment and the bag may enhance attachment (Paragraph 0007).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to make the fitment body of Herbert from a fluoropolymer material, as taught by Brosch et al., in order to achieve the desired permeability and sterilizability properties. One having ordinary skill in the art would additionally be motivated to use a fluoropolymer material for the fitment in order to enhance attachment when using a fluoropolymer bag.
Regarding claims 12-13, Herbert further discloses that the one or more guide features include a guide projection extending from the fitment body, wherein the spike port aperture extends through the guide projection, and a plurality of wings extending from the first side wall and/or the second side wall, as described above regarding claims 2 and 3.
Regarding claims 14-15, Herbert further discloses that the spike port aperture includes a barrier membrane formed integrally with the fitment (as described above regarding claims 6-7). Herbert also renders obvious an internal gasket disposed in the spike port aperture (as described above regarding claim 9).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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. According to Examiner’s best understanding of Applicant’s Remarks and amendments dated 6/2/2026, Applicant intends to distinguish the instant invention from the prior art by requiring one or more guide features that are not “bounded by surrounding structure” (as described with respect to Rani; see Remarks, Page 11, first full Paragraph). Examiner notes that the guide feature disclosed by Rani is considered to extend into an internal space of the bag (the area between side walls 30 and 32 is within the bag). The amendments, however, which further define the claimed structure with respect to a central region, necessitated further search and consideration, resulting in the new grounds of rejection using the Herbert reference.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form for additional examples of fitment bodies having features relevant to the instant application. In particular, Mahal (US 4,479,989) discloses a fitment, bag, and method relevant to the independent claims of the instant application.
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 MICHAEL C PATTERSON whose telephone number is (571)270-5558. The examiner can normally be reached M-F 7:30-4:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Paul Durand can be reached at 571-272-4459. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL C PATTERSON/Examiner, Art Unit 3754
/PAUL R DURAND/Supervisory Patent Examiner, Art Unit 3754 August 19, 2026
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