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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/28/2026 has been entered.
Information Disclosure Statement
The information disclosure statement filed 8/28/2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. Specifically, it does not include an English translation or a concise explanation of the relevance of the listed Foreign Patent Document. It has been placed in the application file, but the information referred to therein has not been considered.
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 26, 27 and 30 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.
Re claim 26, the claim has been amended to recite a first port “at the top”. The phrase “the top” lacks proper antecedent basis. It is unclear if the “top” belongs to the “pharmaceutical bag” as a whole or one of the elements that form the “pharmaceutical bag” recited in the claim (i.e. either of the “films”, either of the “seals”, or either of the “chambers”). Additionally, it is unclear what defines the “top” – that is, it is unclear if the “top” is a surface or a section. For the sake of examination, the “top” is interpreted being the upper half section of the pharmaceutical bag. Claims 27 and 30 are rejected due to their dependence on claim 26.
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.
Claims 26 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pepper (PG PUB 2009/0113753).
Re claim 26, Pepper discloses a flexible pharmaceutical bag 300 (Fig 37,38; it is noted that all reference characters cited below refer to Fig 37,38 unless otherwise noted) comprising: a front film (the sheet to the left of the outer seal 74 in Fig 4B); a back film (the sheet to the right of the outer seal 74 in Fig 4B); an outer seal 74 (best seen in Fig 4A,4B) joining the front film to the back film around a perimeter of the pharmaceutical bag (as seen in Fig 4B); a breakable seal 22 (Para 213,104-106) joining the front film and the back film interior of the outer seal, the breakable seal defining a first chamber 12 and a second chamber 14 separated from the first chamber, wherein the first chamber is configured to hold a lyophilized pharmaceutical product (it is noted that the italicized text constitutes functional language and, therefore, “a lyophilized pharmaceutical product” is not a part of the claimed invention; this limitation is met in view of Para 90), wherein the second chamber is configured to hold a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber (it is noted that the italicized text constitutes functional language and, therefore, “a reconstituting solution” is not a part of the claimed invention; this limitation is met in view of Para 91), a first port 304 attached to the first chamber (as seen in Fig 37), the first port configured to allow passage of water vapor from the pharmaceutical product during lyophilizaton of the pharmaceutical product (Para 209), wherein the pharmaceutical bag is orientable in a vertical or angled vertical position (the position seen in Fig 37) which the first port at the top (as seen in Fig 37), such that spillage of the pharmaceutical product is avoided when water vapor from the pharmaceutical product passes through the first port during the lyophilization of the pharmaceutical product (Para 209), wherein the breakable seal breaks before the outer seal when a predetermined amount of pressure is applied to the flexible pharmaceutical bag (Para 106) and wherein the lyophilized pharmaceutical product is 200 mg or 400 mg of thiotepa (as set forth above, the “lyophilized pharmaceutical product” is not a part of the claimed invention; since the first chamber contains lyophilized liquid plasma (Para 90,209), this limitation is met).
Re claim 27, Pepper discloses that the first chamber and the second chamber are defined by the outer seal and the breakable seal (as seen in Fig 37).
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.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Pepper et al. (PG PUB 2009/0113753) in view of Laubacher et al. (PG PUB 2010/0290718).
Re claim 30, Pepper discloses all the claimed features except that the pharmaceutical bag also includes an inner seal joining the front film to the back film and extending from a first side of the outer seal to a second side of the outer seal, wherein the breakable seal extends from the inner seal to a third side of the outer seal that is located opposite to the first side of the outer seal, and wherein the second side of the outer seal extends from the first side to the third side of the outer seal. Laubacher, however, teaches a pharmaceutical bag (as seen in Fig 6) comprising an outer seal ** having a first side (to the right, labeled in Fig A below), a third side (to the left, labeled in Fig A below) located opposite to the first side (as seen in Fig 6 and Fig A below), and a second side (to the top, labeled in Fig A below) extending from the first side to the third side (as seen in Fig 6 and Fig A below), an inner seal (seam 64 + the upper seam 62, labeled in Fig A below) extending from the first side to the second side (as seen in Fig 6 and Fig A below), and a breakable seal (the left seam 62, labeled in Fig A below) extending from the inner seal to the third side (as seen in Fig 6 and Fig A below) to define a first chamber 36 for holding a first product and a second chamber 38 for holding a second product to be mixed (as seen in Fig 6); Laubacher teaches that providing both an inner seal and a breakable seal provides the bag with a relief valve that gives the operator an indication that the contents of the first chamber have been added to the contents of the second chamber (Para 23). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Pepper to include an inner seal along with the breakable seal, as taught by Laubacher, for the purpose of providing the bag with a relief valve that gives the operator an indication that the contents of the first chamber have been added to the contents of the second chamber (Para 23).
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Terminal Disclaimer
The terminal disclaimers filed on 8/28/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 9,931,458, US Patent No. 11,497,683, and US Patent Application No. 19/222,448 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Allowable Subject Matter
Due to the terminal disclaimers filed 8/28/2026 overcoming the double patenting rejections set forth in the last Office Action, claims 15-25, 28 and 29 are allowable. Please see the 2/13/2026 Office Action for a detailed statement of reasons for indication of allowance.
Response to Arguments
Applicant's arguments filed 8/28/2026 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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