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 .
Specification
The disclosure is objected to because of the following informalities:
Paragraphs 0039, 0045, 0071, 0080, and 0081 refer to “barrier film 214”, which is not found in the drawings. It is unclear whether this is a feature that should be shown in the drawings, or if the feature is intended to refer to “barrier film 314” (see Paragraph 0043 and Fig. 3).
Paragraph 0045 refers to “spike port body 208”, but reference character 208 appears to refer to “additional ports” (see Paragraph 0039 and Fig. 2).
Paragraph 0048 refers to “barrier membrane 306”, but reference character 306 appears to refer to an “internal gasket” (see Paragraph 0044).
Paragraph 0066 refers to “barrier film 714”, which is not found in the drawings. It is unclear whether this is a feature that should be shown in the drawings, or if the feature is intended to refer to “barrier film 614” (see Paragraph 0062 and Fig. 6).
Paragraph 0078 refers to “fitment 502”, “sheets 504”, and “bag 500”, but these reference characters are used elsewhere to refer to different features (see Paragraph 0056 and Fig. 5).
Appropriate correction is required.
Claim Objections
Claims 1, 3, 11, 13, and 18 are objected to because of the following informalities: each claim recites “first and second side walls” or similar. For clarity, the features should be recited separately (e.g., --a first side wall and a second side wall-- or similar, depending on context). Appropriate correction is required.
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.
Claim 17 is 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.
The claim recites “the fitment body” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1-3, 6-10, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rani (US 7,350,669).
Regarding claim 1, Rani discloses a fitment (20) for a bag (10), comprising: a fitment body (22) including first and second side walls (30, 32; Fig. 6), each of the first and second side walls extending between opposing end points (see 34, 36; Fig. 7), the fitment body comprising a biocompatible material (Col. 3, lines 24-35), wherein the fitment body includes a spike port aperture (42), and the fitment body includes one or more guide features (40), the guide features configured to separate a spike inserted into the spike port aperture (chamber 72 of 40 constrains spike in central location; Col. 5, lines 48-65; Figs. 8-9) from a bag sheet attached to one or both of the first and second side walls (Col. 3, lines 59-63).
Regarding claim 2, Rani further discloses that the one or more guide features include a guide projection extending from the fitment body (40 is a cylindrical member extending from 22; Col. 4, lines 1-4), wherein the spike port aperture extends through the guide projection (see 72 in Fig. 9).
Regarding claim 3, Rani further discloses that the one or more guide features include a plurality of wings (38) extending from the first and/or second side walls (Col. 3, lines 63-67; Figs. 5-6).
Regarding claims 6-8, Rani further discloses that the spike port aperture includes a barrier membrane (46) that is formed integrally with the fitment body (Figs. 8-9), and further discloses a barrier film (70) located at an end of the spike port aperture (Fig. 11).
Regarding claims 9-10, Rani further discloses an internal gasket disposed in the spike port aperture (46 can alternatively be disposed anywhere along the length of 40; Col. 4, lines 8-12) and further discloses a barrier film (70) located at an end of the spike port aperture (Fig. 11).
Regarding claims 16-20, Rani discloses a method of inserting a spike into a bag (Col. 5, lines 40-47), comprising directing the spike into a spike port aperture (42) provided on a fitment included in the bag and driving the spike through a puncture barrier (46) disposed in the spike port aperture, wherein one or more guide features (40) are disposed between the spike and one or more sheets forming the bag once the spike has been inserted into the bag (see Figs. 8-9).
Rani further discloses that the one or more guide features include a guide projection extending from the fitment body (40 extends from 22; Col. 4, lines 1-4), wherein the spike port aperture extends through the guide projection (see Figs. 8-9), and the one or more guide features include a plurality of wings extending from first and/or second side walls of the fitment (see 38 extending from 30, 32 in Figs. 8-9).
Rani further discloses that the method includes driving the spike through a second puncture barrier (70 may be defeatable by penetration; Col. 5, lines 1-4) provided on the fitment as the spike enters the spike port aperture (see Fig. 11).
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 4-5 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Rani in view of Brosch et al. (US 2018/0021218).
Regarding claims 4-5, Rani discloses the fitment of claim 1, but does not disclose a plurality of additional ports formed integrally in the fitment body.
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 Rani with additional ports, as taught by Borsch 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 Rani, modified in view of Brosch et al., would work appropriately if arranged as claimed, especially considering that Brosch et al. already contemplates a variety of port arrangements.
Regarding claim 11, Rani discloses a bag, comprising: a fitment (20) including a fitment body (22) including first and second side walls (30, 32), each of the first and second side walls extending between opposing end points (see 34, 36; Fig. 7), wherein the fitment body includes a spike port aperture (42) and one or more guide features (40); and one or more polymer sheets (Col. 3, lines 8-17), the one or more polymer sheets joined to the first and second side walls (Col. 3, lines 54-60), the one or more polymer sheets sealed to form the bag (Col. 3, lines 17-20), wherein the one or more guide features extend into an internal space defined by the fitment and the one or more polymer sheets (inlet 44 of 40 communicates with reservoir 14; Col. 4, lines 7-15), the one or more guide features configured to separate a spike inserted into the spike port aperture (chamber 72 of 40 constrains spike in central location; Col. 5, lines 48-65) from the one or more polymer sheets (see Figs. 8-9).
Rani teaches that the fitment body comprises a polymer material that has low permeability to oxygen and is sterilizable (Col. 3, lines 24-34), 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 Rani 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, Rani 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 and/or second side walls, as described above regarding claims 2 and 3.
Regarding claims 14-15, Rani further discloses that the spike port aperture includes a feature (46) that may be configured as a barrier membrane formed integrally with the fitment (as described above regarding claims 6-7) or as an internal gasket disposed in the spike port aperture (as described above regarding claim 9).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form. Levy et al. (US 2023/0096642), Aswad et al. (US 5,620,433), Shigemoto (US 2023/0190580), and Miller et al. (US 5,125,919) provide exemplary devices relevant to at least the independent claims of the instant application. In particular, Aswad et al. explicitly teaches that a guide feature prevents the spike from contacting the sheets of the bag (see Col. 2, lines 52-58). Additionally, Rabia et al. (US 2019/0046407; see Fig. 2B) and Yoshida (US 2017/0202740; see Fig. 3D) provide examples of guide projections extending into a bag beyond a fitment body.
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL C PATTERSON/Examiner, Art Unit 3754
/PAUL R DURAND/Supervisory Patent Examiner, Art Unit 3754