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 .
Status of Claims
As directed by the amendment filed on 9 March 20, 2026: claim(s) 5, 8, 12, 15 have been amended. Thus, claims 1-15 are presently pending.
Election/Restrictions
Newly submitted claims 16-20 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The claims to the different species recite the mutually exclusive characteristics of such species:
Species I: comprising an elastic material overmolded into the valve housing, and having a flat outer surface adjacent to the distal housing end.
Species II: comprising a valve housing comprising an internal passageway extending along a main axis from a distal valve housing end to a proximal valve housing end.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 16-20 have been withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant's arguments filed 9 March 20, 2026 have been fully considered but they are not persuasive.
Regarding the argument that the “statements in Jepson teach away from the proposed modification to Linkner, and clearly indicate that there would not be a reasonable expectation that the modification would be successful”, Jepson explicitly teaches that “it is desired for the overmolded part to have a flat surface, because a flat surface is believed to aid in the disinfection of the surface prior to use” ([0066]). While Jepson seeks to improve upon the flat surface design and lists some undesirable challenges presented by a flat surface design, Jepson does not explicitly state that the use of a conventional flat overmolded septum would result in a device inoperable for its intended purpose ([0066-0067]). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Linkner; Rita V. et al. (US 20200276085 A1) in view of Jepson et al. (US 20100108681 A1).
Regarding Claim 1, Linkner discloses a valve ("side port 112" [0084]) comprising:
a valve housing (the part of vial adapter 110 comprising wall 134 [0087]; FIG. 13) extending from a distal housing end having a distal edge surface to a proximal housing end (see FIG. 14A); and
a valve member ("one way valve" & "leaf valve" [0087]) accommodated in the valve housing (FIG. 14A) and configured to close the valve when the valve is in a closed operating state ("normally closed to provide a closed system" [0087]),
the valve member comprising a valve opening ("channel 115" [0087]; FIG. 14A),
the valve opening configured to be closed when the valve is in the closed operating state ("normally closed to provide a closed system" [0087]) and to provide fluid passage through the valve when the valve is in an open operating state ("male part of the syringe can open the valve when the syringe is attached" [0087]).
Linkner fails to specify the valve opening being a slit, the valve member comprising an elastic material overmolded into the valve housing, and having a flat outer surface adjacent to the distal housing end. However, Jepson teaches a fluid container comprising a needleless port assembly (Abstract; FIG. 1), the valve opening being a slit (“overmolded slit septum 114” [0063]; FIGs. 1-2), the valve member comprising an elastic material (“overmolded slit septums formed from silicone rubber” [0069]) overmolded into the valve housing (“overmolded slit septum 114” [0063]-[0069]; FIG. 3), and having a flat outer surface (“it is desired for the overmolded part to have a flat surface” [0066]) adjacent to the distal housing end (see FIG. 3). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Linkner to incorporate the teachings of Jepson to suitably eliminate “the need for mechanical or adhesive attachment” while aiding “in the disinfection of the surface prior to use” ([0066]-[0067]).
Regarding Claim 2, Linkner discloses a bond between the valve member and the valve housing is fluid-tight ("vacuum is applied through side channel 115" [0089]; NOTE: since vacuum is achievable through side channel 115, it is implied that the bond between all connected elements, including between the valve member and the valve housing, is fluid/gas-tight).
Regarding Claim 3, Linkner fails to specify the valve member comprises at least one thermoplastic elastomer. However, Jepson teaches a fluid container comprising a needleless port assembly wherein the valve member comprises at least one thermoplastic elastomer (“admin port is usually defined by a thermoplastic tube or chimney having a solid thermoplastic membrane” [0005]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Linkner to incorporate the teachings of Jepson to suitably “prevent access to the solution in the container” ([0005]).
Regarding Claim 4, Linkner fails to specify at least one of: the valve housing is made of a material having a tensile modulus and/or flexural modulus of at least 700 MPa; said material of the valve housing comprises a polyolefin; and said material of the valve housing comprises an engineering plastic. However, Jepson teaches the valve housing is made of an engineering plastic (“rigid housing (which may be made of metal, glass or plastic” [0065]).
Regarding Claim 5, Linkner discloses the valve member is configured to provide a fluid-tight connection with a liquid manipulation device ("vacuum is applied through side channel 115" [0089]; NOTE: since vacuum is achievable through side channel 115, it is implied that the bond between all connected elements, including between the valve member and the valve housing, is fluid/gas-tight).
Regarding Claim 6, Linkner discloses the valve member is formed in a way to tightly connect a male Luer connector according to ISO 80369-7 or a male connector according to ISO 80369-6 ("luer valve side port" & "luer lock" [0087]; FIG. 14A).
NOTE: It is the Office's position that the design standard for a structural property does not impart a patentable weight. The property is attributed to the material and structure, not the standard. As such, a reference does not need to recite “according to ISO 80369-7 or … according to ISO 80369-6“ to read on the claim language.
Regarding Claim 7, Linkner discloses the flat outer surface of the valve member is essentially flush or entirely flush with the distal edge surface of the valve housing (see FIG. 14A).
Regarding Claim 8, Linkner discloses a method of manufacturing the valve according to claim 1,
the method comprising the steps of:
A) manufacturing or providing the valve housing ("vial adapter 110" [0083]; FIGs. 12-14); and
B) overmolding the valve member into the valve housing ("luer valve side port is attached to the vial adapter 110 by bonding, overmolding" [0087]).
Regarding Claims 9-10, Linkner discloses a cap for a fluid container ("vial adapter 110" [0083]-[0084]; FIGs. 12-14), the cap comprising:
(i) a body (see FIG. 14A) comprising a container connection portion adapted to be tightly connected to a container opening of a container body ("vial 140 includes a chamber 142 for holding the neurotoxin, a rubber stopper 144 and a band or ring 146, e.g., a metal ring, circumferentially surrounding the rubber stopper 144 for holding the rubber stopper 144 in the vial 140" [0084]; FIG. 14A);
(ii) a first port ("top port 114" [0084]; FIG. 14A) comprising a port housing ("internal proximal wall 113" [0084]) and a seal member ("sealed ports" 114 [0088]); and and
(iii) a second port ("side port 112" [0084; FIG. 14A) comprising the valve according to claim 1 ([0084]-[0087]).
Linkner fails to specify the seal member is elastic, accommodated in the port housing, and sealingly closing the port housing; wherein the seal member is overmolded into the port housing. However, Jepson teaches a seal member ("slit septum 114” [0063]) that is elastic ("silicone rubber" [0069]), accommodated in the port housing ("housing 108" [0063]), and sealingly closing the port housing ("compression seal" [0070]); wherein the seal member is overmolded into the port housing ("overmolded slit septum 114" [0063]). Therefore, it would have been obvious to modify the device of Linkner to incorporate the teachings of Jepson to allow needleless connection/disconnection of container ports for access to the container ([0002]-[0008]).
Regarding Claim 11, Linkner discloses at least one of:
the first port is an administration port ("needle can include a resealable member at a proximal end for insertion of a needle of syringe 162 to inject saline" [0084]);
the second port is a needle-free port ("luer lock with external threads 130" [0087]);
the valve housing is formed monolithically with the body (see FIG. 14A); and
the port housing is formed monolithically with the body (see FIG. 14A).
Regarding Claim 12, Linkner fails to specify the seal member has an outer surface and wherein at least one of: (i) the outer surface of the seal member is essentially flush or entirely flush with an outer edge surface of the port housing; (ii) the outer surface of the seal member has a concave portion indicating a piercing point. However, Jepson teaches the cap wherein the seal member has an outer surface ("inner and outer surfaces 130, 132 of the slit septum 114" [0064]; FIG. 3), and wherein at least one of:
(i) the outer surface of the seal member is essentially flush or entirely flush with an outer edge surface of the port housing (see FIG. 3);
(ii) the outer surface of the seal member has a concave portion indicating a piercing point ("inwardly-concave overmolded slit septum" [0064]; FIG. 3).
Therefore, it would have been obvious to modify the device of Linkner to incorporate the teachings of Jepson to allow needleless connection/disconnection of container ports for access to the container ([0002]-[0008]).
Regarding Claim 13, Linkner fails to specify a peel-off foil, the peel-off foil at least one of: is arranged atop the seal member seen in a direction of insertion of an administration device; and is arranged atop the valve member seen in a direction of insertion of a liquid manipulation device. However, Jepson teaches a peel-off foil ("peelable foil seal" [0100]), the peel-off foil is arranged atop the seal member seen in a direction of insertion of an administration device ("port assembly may have a peelable foil seal disposed over the opening" [0100]). Therefore, it would have been obvious to modify the device of Linkner to incorporate the teachings of Jepson to protect the sterility of the ports ([0100]).
Regarding Claim 14, Linkner discloses a fluid container ("vial (bottle) 140" [0084]; FIG. 12) comprising:
a cap ("vial adapter 110" [0084]; FIG. 12) according to claim 9; and
a container body that is hollow and having a container body opening portion ([0084]; FIG. 13),
wherein the body of the cap is in fluid-tight connection with the container body opening portion ([0088]-[0090]; FIG. 14A).
Regarding Claim 15, Linkner discloses a method ([0056]) of manufacturing a cap ("vial adapter 110" [0084]; FIG. 12) for a fluid container ("vial (bottle) 140" [0084]; FIG. 12), the cap comprising a body (FIG. 13), a first fluid port with a port housing ("top port 114" [0084]; FIG. 14A), and a second fluid port ("side port 112" [0084; FIG. 14A) comprising the valve according to claim 1 (see discussion above),
the method comprising the steps of:
A) manufacturing or providing the body ("vial adapter 110" [0084]), the port housing, and the valve housing (FIGs. 12-14);
C) overmolding the valve member of the valve into the valve housing of the valve ("luer valve side port is attached to the vial adapter 110 by bonding, overmolding" [0087]).
Linkner fails to specify a seal member that is elastic and the step of overmolding the seal member into the port housing. However, Jepson teaches a seal member ("slit septum 114” [0063]) that is elastic ("silicone rubber" [0069]) and the step of overmolding the seal member into the port housing (“overmolded slit septum 114” [0063]). Therefore, it would have been obvious to modify the device of Linkner to incorporate the teachings of Jepson to allow needleless connection/disconnection of container ports for access to the container ([0002]-[0008]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781