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
This is a first action on the merits for this regular application filed on 09/04/2024
Specification
The disclosure is objected to because of the following informalities: The prior art references cited in paragraphs [0004, 0006, 0013-0014, 0016, 0018, and 0087] in the specification should be submitted in a Disclosure Statement. Appropriate correction is required.
The abstract of the disclosure is objected to because the separate statemen “Figure to be published with the abbreviation: Fig” should not be part of the abstract. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-14 and 16 are objected to because of the following informalities: It is respectfully requested that the term “characterized in that” be replaced with the term “wherein” consistent with the US drafting claim language. The same applies to claims 1-14 and 16. Appropriate correction is required.
Claims 2-12, 14 and 16 are objected to because of the following informalities: Please add the word “The” at the beginning of the preambles for claims 2-14, 14 and 16.
In claim 2, line 1 and before the word “polymer”, add the term “gas-barrier”
In claim 1, line 1 and before the word “bag”, add the letter “A”
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.
Claims 1-16 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.
In claim 1, lines 2 and 5, Applicant refers to the term “element”. Then on line 6, Applicant recites “said other elements”. The examiner is unable to determine the metes and bounds of claim 1 since it is not clearly recited to which elements Applicant is referring to? It is respectfully requested that the claim be amended to clearly describe what elements Applicant is referring to. The same applies to claim 10-12.
In claim 5, line 2; Applicant recite “it”. The examiner is unable to determine the metes and bounds of claim 5 since it is not clear what “it” is referring to? The applicant is respectfully amend claim 5 to replace “it” with the term that is being referenced.
Claim 15, line 1; Applicant recites “Use of a film” without providing any steps. It is respectfully requested that Applicant amend claim 15 to include the terms of either “method or process” of using a film. And to further recite steps showing how this film is used.
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.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wolf et al. (US 2019/0230919 A1).
Regarding claims 1 and 15, Wolf et al. discloses a Bag system (Fig.1A) and the use of a film for the treatment of a biological fluid by electromagnetic irradiation [0016 and 0055-0056], said bag system comprising at least one element consisting of an irradiation bag that is capable of being intended to contain the biological fluid [0064] to be irradiated, said irradiation bag being made of a material that is capable of being permeable [0066] to said electromagnetic radiation, said system comprising one or more other elements selected from the group consisting of at least one storage bag (Fig.1A:102) and a tubing (Fig.1A:106) , at least one of said other elements being made of a polymer material formulated with at least one plasticizer [0135-0136], wherein the bag further comprises at least one protective film [(Fig.1A:101) forming a barrier means to said plasticizer and covering said irradiation bag (Fig.1A:102), said protective film being made of a gas-barrier polymer material having a permeability to oxygen of less than or equal to 100 cm³ /m²/24 h at a temperature of 23°C and a relative humidity of 50% ([0060 and Tables 1 and 2};
a gas-barrier polymer material having a permeability to oxygen of less than or equal to 100 cm³/m²/24 h [0060] at a temperature of 23°C and a relative humidity of 50% as a barrier to releasable plasticizers of polyvinyl chloride [0135-0136 and 0168].
Regarding claim 2, Wolf et al. discloses that the polymer material of the protective film is a water vapor barrier polymer material with a permeability to water vapor of less than or equal to 10 g/m²/24 h ([0060 and Tables 1 and 2) at a temperature of 23°C and a relative humidity of 50%.
Regarding claim 3, Wolf et al. discloses that the protective film is transparent [0063].
Regarding claim 4, Wolf et al. discloses that the protective film comprises at least one layer of polyester or polypropylene [0060].
Regarding claim 5, Wolf et al. discloses that the bag system comprises two protective films [0060] arranged on either side of the irradiation bag.
Regarding claim 6, Wolf et al. discloses that the two protective films together form a sleeve [0063] with at least one open end in which the irradiation bag is arranged.
Regarding claim 7, Wolf et al. discloses that the electromagnetic irradiation treatment is a UV radiation treatment and the irradiation bag is made of a material permeable to UV radiation [0082-0088].
Regarding claim 8, Wolf et al. discloses that the irradiation bag is free [0082-0088] of photosensitive agent.
Regarding claim 9, Wolf et al. discloses that each of said other elements is made from a material or materials formulated without phthalate or terephthalate [0062].
Regarding claim 10, Wolf et al. discloses that the elements of the bag system comprise one or more elements selected from the group consisting of a storage bag, a sampling bag, tubing, a connector, a clamp, a vent and (Fig.1A:102, 101, 106 and 30) combinations thereof.
Regarding claim 11, Wolf et al. discloses that each of said other elements of said bag system is made of a material or materials other than polyvinyl chloride plasticized with di-2-ethylhexyl phthalate or di-2-ethylhexyl terephthalate [0062].
Regarding claim 12, Wolf et al. discloses that each of said elements of the bag system is made either of polyvinyl chloride plasticized with a plasticizer selected from the group consisting of a
cyclohexanedicarboxylic acid ester, a citrate ester [0136], a trimellitate ester or a mixture thereof, or of a material other than plasticized polyvinyl chloride.
Regarding claim 13, Wolf et al. discloses that an assembly for the treatment of a biological fluid by wherein the bag system is sterilely confined [0254-0255] in said package.
Regarding claim 14, Wolf et al. discloses that the package is formed of a porous non-woven sheet and of a transparent film sheet [0125].
Regarding claim 16, Wolf et al. discloses that the film is made of a water vapor-barrier polymer material having a permeability to water vapor of less than or equal to 10 g/m²/24 h at a temperature of 23°C and a relative humidity of 50% ([0060 and Tables 1 and 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONZER R CHORBAJI whose telephone number is (571)272-1271. The examiner can normally be reached M-F 5:30-12:00 and 6:00-9:00.
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, Jill J Warden can be reached at (571)272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MONZER R CHORBAJI/Primary Examiner, Art Unit 1799
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