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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a first clip portion, a second clip portion, a first coupling element, a second coupling element in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1- 7, 9 and 15 - 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoechst (GB 1419061; cited prior art).
Regarding claim 1, the Hoechst reference discloses an aseptic coupling arrangement (Fig. 2) comprising:
a first aseptic seal system comprising a first clip portion (4) including a first coupling element (1), and a first aseptic membrane (13), operably coupled to the first clip portion, and disposed over at least a portion of a first pierceable seal (8); and
a second aseptic seal system comprising a second clip portion (18) including a second coupling element (3) configured to operably couple to the first coupling element (Figs. 2 - 4), and a second aseptic membrane (16), operably coupled to the second clip portion and configured to operably couple to the first aseptic membrane (see connection in Figs. 3 and 4), disposed over at least a portion of a second pierceable seal (unlabeled; similar to stopper 8).
Regarding claim 2, wherein the first aseptic membrane (13) and/or the second aseptic membrane (16) is disposed over the entirety of the respective first pierceable seal and/or second pierceable seal (8).
Regarding claim 3, wherein the first aseptic seal system and/or the second aseptic seal system comprises an aseptic seal system of a connector (3), the respective first and/or second pierceable seal being formed as part of the connector. See connector (3) in Figure 1.
Regarding claim 4, wherein the connector is a needle-based connector (see cannula 11 in Figure 2).
Regarding claim 5, wherein the first aseptic seal system and/or the second aseptic seal system comprises an aseptic seal system of a container (2, 5), a bioreactor or an interface plate, the respective first and/or second pierceable seal (8) being formed as part of the container, the bioreactor or the interface plate.
Regarding claim 6, wherein the first pierceable seal and/or the second pierceable seal (8) comprises a hermetic seal, a resealable seal or a septum seal.
Regarding claim 7, wherein the first aseptic seal system and/or the second aseptic seal system is arranged to be actuated by an actuation system (see screw threads in the Figures).
Regarding claim 9, wherein the first clip portion (4) is slidably operably coupled to a portion of a component in which the first pierceable seal is arranged, and/or the second clip portion (18) is slidably operably coupled to a portion (rim 21) of a component (syringe 5) in which the second pierceable seal is arranged.
Regarding claims 15 -19, the method would be inherent during normal use and operation of the device.
Claim(s) 1 and 3 – 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ariagno et al. (8545476).
Regarding claim 1, the Ariagno et al. reference discloses an aseptic coupling arrangement (10; Fig. 2) comprising:
a first aseptic seal system comprising a first clip portion (220, 222, 224) including a first coupling element (30), and a first aseptic membrane (54), operably coupled to the first clip portion, and disposed over at least a portion of a first pierceable seal (76); and
a second aseptic seal system comprising a second clip portion (102, 104, 106) including a second coupling element (20) configured to operably couple to the first coupling element (Fig. 3), and a second aseptic membrane (64), operably coupled to the second clip portion and configured to operably couple to the first aseptic membrane (see connection in Figs. 8 and 9), disposed over at least a portion of a second pierceable seal (86).
Regarding claim 3, wherein the first aseptic seal system and/or the second aseptic seal system comprises an aseptic seal system of a connector, the respective first and/or second pierceable seal being formed as part of the connector. See connector (10) in Figure 1.
Regarding claim 4, wherein the connector is a needle-based connector (40). See col. 4, line 47 – col. 5, line 13).
Regarding claim 5, wherein the first aseptic seal system and/or the second aseptic seal system comprises an aseptic seal system of a container (70, 80), a bioreactor or an interface plate, the respective first and/or second pierceable seal (76, 86) being formed as part of the container, the bioreactor or the interface plate.
Regarding claim 6, wherein the first pierceable seal and/or the second pierceable seal (76, 86) comprises a hermetic seal, a resealable seal or a septum seal. See col. 1, line 64 – col. 2, line 11.
Regarding claim 7, wherein the first aseptic seal system and/or the second aseptic seal system is arranged to be actuated by an actuation system (see trigger mechanism 100). See col. 8, lines 4 – 14.
Regarding claim 8, wherein upon actuation of the first aseptic seal system and/or the second aseptic seal system, the first aseptic membrane (54) and/or the second aseptic membrane (64) is removed from the respective first pierceable seal and/or the second pierceable seal. The first and second aseptic membranes are removed by being pierced by the spikes as seen in Figure 11.
Regarding claim 9, wherein the first clip portion is slidably operably coupled to a portion of a component in which the first pierceable seal is arranged, and/or the second clip portion is slidably operably coupled to a portion of a component in which the second pierceable seal is arranged. See Figures 8 - 11 showing the slidable operation.
Regarding claim 10, wherein the first aseptic seal system and/or the second aseptic seal system is arranged to be actuated to slidably move the first clip portion and/or the second clip portion, thereby removing the first aseptic membrane and/or the second aseptic membrane from the respective first pierceable seal and/or the second pierceable seal. See Figures 8 - 11 showing the slidable operation.
Regarding claim 11, wherein the first aseptic seal system and/or the second aseptic seal system is arranged to be actuated between a first configuration, in which the respective first aseptic membrane (54) and second aseptic membrane (64) are at least partially disposed over their respective first pierceable seal and second pierceable seal (see Figure 8, 54, 76 and 64, 86), and a second configuration, in which the respective first aseptic membrane and second aseptic membrane are removed from their first pierceable seal and second pierceable seal (see Figure 11).
Regarding claim 12, wherein the first clip portion and/or the second clip portion comprise a front wall, a rear wall, side walls adjoining the front and rear walls and a bottom wall, wherein the front wall comprises one or more protruding shoulders. See Annotated Figure.
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Regarding claim 13, wherein the first aseptic membrane (54) and/or the second aseptic membrane (64) comprises an aseptic paper seal or an aseptic polyethylene film. The aseptic membranes are made of elastomeric material.
Regarding claim 14, wherein each of the first aseptic membrane and the second aseptic membrane comprises at least one fold, thereby forming a first surface configured to provide an aseptic seal to the respective first pierceable seal and second pierceable seal, and a second surface configured to mate with the other of the first aseptic membrane and the second aseptic membrane. See folds in aseptic membranes (54, 64) in Figure 11.
Regarding claims 15 -19, the method would be inherent during normal use and operation of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The Robinson et al. (7077835) reference discloses another connector (140; Figures 12 and 13) having a needle and seals similar to Applicant’s device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY LEWIS MAUST whose telephone number is (571)272-4891. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Craig Schneider can be reached at 571-272-3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY L MAUST/ Primary Examiner, Art Unit 3753