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 .
Election/Restrictions
Applicant’s election of Group I and Species 1 in the reply filed on 8/26/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Accordingly, claims 4 and 15 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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 1-3, 5-14 and 16-18 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.
Claims 1 and 10 each recite method steps of “a liquid medication is received”, “the liquid medication exits the housing”, “gases exit from the interior chamber”, claims 5 and 10 each recite the method steps of “the shroud blocking the e-beam radiation […] or attenuating the e-beam”, claims 6 and 11 each recite the method step of “the gas vented out of the housing via the vent hole passes”, and claims 8 and 17 each recite the method step of “attenuating the e-beam radiation”. The recitation of these method steps render the claims indefinite. As per MPEP 2173.05(p)(II), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. It is not clear if the claims are drawn only to structures that are capable of performing the method steps or if the claims are intended to be written as method claims. For the sake of examination, the claims have been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed. Accordingly, it is suggested to amend the claims so that these steps are only functionally recited (for example, using “configured to” or similar language). Claims 2, 3, 7, 9, 12-14, 16 and 18 are rejected due to their dependence on claim 1.
Claims 8 and 17 each recite the phrase “the gas permeable plug” on lines 1-2, but this phrase lacks proper antecedent basis. Claim 7 and 16 each introduce “a gas permeable plug”, but claims 8 and 17 do not depend on claims 7 and 16, respectively. It is unclear if claims 8 and 17 were intended to depend on claims 7 and 16, respectively, or if claims 8 and 17 were intended to introduce “a gas permeable plug”. For the sake of examination, the former is the interpretation applied to the claims. Accordingly, it is suggested to amend claim 8 to recite dependence on claim 7 and to amend claim 17 to recite dependence on claim 16.
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 1, 2 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scagliarini et al. (PG PUB 2004/0104160).
Re claim 1, Scagliarini discloses an intravenous (IV) medication filter device 1 (Fig 2,3,13), the filter device comprising: a housing 3+4 (Fig 2,3) defining an interior chamber 26 (Fig 3), the housing having an inlet 29 (Fig 2,3) through which a liquid medication is configured to be received (Para 29,42), an outlet 24 (Fig 2,3) through which the liquid medication is configured to exit the housing (Para 28,42), and a vent hole 53+54 (Fig 13) through which gases are capable of exiting from the interior chamber (Para 34,37); a hydrophilic filtration media 30 (Fig 3) disposed inside the interior chamber of the housing (as seen in Fig 14), the hydrophilic filtration media configured to filter the liquid medication between the inlet and the outlet (Para 37); and a hydrophobic gas filter 44 disposed inside or outside the housing at the vent hole (as seen in Fig 14, the filter 44 is disposed inside the housing), the hydrophobic gas filter configured to prevent entry of contaminants into the interior chamber via the vent hole (Para 37), wherein the vent hole is shaped to block electron beam (e-beam) radiation from reaching the hydrophobic gas filter or attenuate the e-beam radiation directed toward the hydrophobic gas filter (as seen in Fig 13,14).
Re claim 2, Scagliarini discloses that the vent hole does not encompass any linear path that intersects the hydrophobic gas filter but does not extend through the housing (as seen in Fig 14).
Re claim 3, Scagliarini discloses that the vent hole is an elongated conduit oriented at an acute angle to the hydrophobic gas filter (as seen in Fig 14).
Claims 1, 2, 5, 9, 10, 12, 13 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guala (PG PUB 2021/0046243).
Re claim 1, Guala discloses an intravenous (IV) medication filter device 1 (Fig 1), the filter device comprising: a housing 2 (Fig 1) defining an interior chamber (formed between walls 25 and 26 in Fig 5), the housing having an inlet 9 (Fig 1) through which a liquid medication is received (Para 23), an outlet 10 (Fig 1) through which the liquid medication exits the housing (Para 23), and a vent hole 11a+12 (Fig 1,2) through which gases exit from the interior chamber (Para 31); a hydrophilic filtration media 16 (Fig 4; Para 25) disposed inside the interior chamber of the housing (as seen in Fig 4), the hydrophilic filtration media configured to filter the liquid medication between the inlet and the outlet (Para 32); and a hydrophobic gas filter 24 (Fig 4; Fig 4 shoes two hydrophobic filters 24 but it is the one near inlet 9 that is the “hydrophobic gas filter” in the rejection; Para 25) disposed inside or outside the housing at the vent hole (as seen in Fig 4, the gas filter is disposed inside the housing), the hydrophobic gas filter configured to prevent entry of contaminants into the interior chamber via the vent hole (Para 31), wherein the vent hole is shaped to block electron beam (e-beam) radiation from reaching the hydrophobic gas filter or attenuate the e-beam radiation directed toward the hydrophobic gas filter (as seen in Fig 4, the vent hole is significantly smaller than the size of the gas filter 24 and, therefore, it attenuates the e-beam radiation directed toward the gas filter 24).
Re claim 2, Guala discloses that the vent hole does not encompass any linear path that intersects the hydrophobic gas filter but does not extend through the housing (as seen in Fig 4, the vent hole does not intersect the hydrophobic gas filter).
Re claim 5, Guala discloses a shroud (seen in Fig 2 and labeled in Fig A below) positioned over the vent hole outside of the housing, the shroud blocking the e-beam radiation from reaching the hydrophobic gas filter or attenuating the e-beam radiation directed toward the hydrophobic gas filter (as seen in Fig 4, the shroud is significantly smaller than the size of the gas filter 24 and, therefore, it attenuates the e-beam radiation directed toward the gas filter 24).
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Re claim 9, Guala discloses that the housing has an increased thickness (at the “shroud” labeled in Fig A above and seen in Fig 2) around a perimeter of the vent hole relative to a remainder of the housing (as seen in Fig 2).
Re claim 10, Guala discloses an intravenous (IV) medication filter device 1 (Fig 1), the filter device comprising: a housing 2 (Fig 1) defining an interior chamber (formed between walls 25 and 26 in Fig 5), the housing having an inlet 9 (Fig 1) through which a liquid medication is received (Para 23), an outlet 10 (Fig 1) through which the liquid medication exits the housing (Para 23), and a vent hole 11a+12 (Fig 1,2) through which gases exit from the interior chamber (Para 31); a hydrophilic filtration media 16 (Fig 4; Para 25) disposed inside the interior chamber of the housing (as seen in Fig 4), the hydrophilic filtration media configured to filter the liquid medication between the inlet and the outlet (Para 32); and a hydrophobic gas filter 24 (Fig 4; Fig 4 shoes two hydrophobic filters 24 but it is the one near inlet 9 that is the “hydrophobic gas filter” in the rejection; Para 25) disposed inside or outside the housing at the vent hole (as seen in Fig 4, the gas filter is disposed inside the housing), the hydrophobic gas filter configured to prevent entry of contaminants into the interior chamber via the vent hole (Para 31), and a shroud (seen in Fig 2 and labeled in Fig A above) positioned over the vent hole outside of the housing, the shroud blocking electron beam (e-beam) radiation from reaching the hydrophobic gas filter or attenuating the e-beam radiation directed toward the hydrophobic gas filter (as seen in Fig 4, the shroud is significantly smaller than the size of the gas filter 24 and, therefore, it attenuates the e-beam radiation directed toward the gas filter 24).
Re claim 12, Guala discloses that the vent hole is shaped to block electron beam (e-beam) radiation from reaching the hydrophobic gas filter or attenuate the e-beam radiation directed toward the hydrophobic gas filter (as seen in Fig 4, the vent hole is significantly smaller than the size of the gas filter 24 and, therefore, it attenuates the e-
Re claim 13, Guala discloses that the vent hole does not encompass any linear path that intersects the hydrophobic gas filter but does not extend through the housing (as seen in Fig 4, the vent hole does not intersect the hydrophobic gas filter).
Re claim 18, Guala discloses that the housing has an increased thickness (at the “shroud” labeled in Fig A above and seen in Fig 2) around a perimeter of the vent hole relative to a remainder of the housing (as seen in Fig 2).
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 3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Guala (PG PUB 2021/0046243) in view of Scagliarini et al. (PG PUB 2004/0104160).
Re claims 3 and 14, Guala discloses all the claimed features except that the vent hole is an elongated conduit oriented at an acute angle to the hydrophobic gas filter. Scagliarini, however, teaches a filter 1 (Fig 2,3,13) comprising a hydrophobic gas filter 44 (Fig 14) and a housing 3+4 (Fig 2,3) with a vent hole 53+54 (Fig 13,14) in the form of an elongated conduit oriented at an acute angle to the hydrophobic gas filter (as seen in Fig 13,14). Scagliarini teaches that angling the vent hole ensures a high air flow from the filter (Para 39). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Guala to include the vent hole as an elongated conduit oriented at an acute angle to the hydrophobic gas filter, as taught by Scagliarini, for the purpose of ensuring a high air flow from the filter (Para 39).
Claims 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Guala (PG PUB 2021/0046243) in view of Kwok et al. (PG PUB 2009/0044810).
Re claims 6 and 11, Guala discloses all the claimed features except that the shroud has side openings through which the gas vented out of the housing via the vent hole passes. Kwok, however, teaches a filter comprising a housing 58 (Fig 5) with a vent hole (extending through holder 58, Fig 5), a hydrophobic gas filter 60 (Fig 5) in the housing (as seen in Fig 5), and a shroud 62 (Fig 5) positioned over the vent hole outside the housing (as seen in Fig 5), the shroud having side openings (Para 45 – “grid”) through which gas is vented out of the housing via the vent hole (Para 45). Kwok teaches that the provision of such a shroud protects the filter (Para 45). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Guala to include the shroud so that it has side openings therethrough, as taught by Kwok, for the purpose of providing means to protect the filter (Para 45).
Claims 7, 8, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Guala (PG PUB 2021/0046243) in view of Kim (PG PUB 2021/0379298).
Re claims 7, 8, 16 and 17, Guala discloses all the claimed features except a gas permeable plug disposed in the vent hole (as required by claims 8 and 16), wherein the gas permeable plug is porous for the gas to pass through as the gas exits the housing via the vent hole while also attenuating the e-beam radiation directed toward the hydrophobic gas filter. Kim, however, teaches a filter 800 (Fig 5) comprising a housing 910 (Fig 5) having a vent hole 910h+914 (Fig 7), a hydrophobic gas filter 960 (Fig 5; Para 85), and a permeable plug 970 (Fig 5) disposed in the vent hole (as seen in Fig 5,7), wherein the gas permeable plug is porous for gas to pass though as gas exists the housing via the vent hole (Para 99). Kim teaches that such a plug acts as a back-up to the gas filter in case the gas filter becomes damaged (Para 99). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Guala to include a permeable plug, as taught by Kim, for the purpose of providing a back-up to the gas filter in case the gas filter becomes damaged (Para 99). When modified by the plug of Kim, the plug would reside in Guala’s vent hole 11a+12 (as it resides in Kim’s vent hole 910h+914); in doing so, the reside over the gas filter and, therefore, will attenuate e-beam radiation directed toward the gas filter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior art of record discloses at least the subject matter of claim 1: US Pat 4,642,098 to Lundquist, US Pat 5,779,674 to Ford, and US Pat 7,141,097 to Leahey. Additionally, it is noted that the above cited Kim reference also fully discloses the subject matter of claims 1, 2, 7, 8 and 9.
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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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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