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
Newly submitted claim 39 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The original and new inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: The inventions lack unity of invention because even though the inventions of these groups require the technical feature of a multi-connector port, this technical feature is not a special technical feature as it does not make a contribution over the prior art in light of the rejections of claim 18 below.
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 Accordingly, claim 39 withdrawn from consideration as being directed to a non-elected invention.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.
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.
Claim(s) 18, 22-24, 26, and 28-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cady et al. (US 5,083,686).
Regarding claims 18 and 26 Cady discloses a multi-connector port having an air connection for sterile air,
comprising a plurality of accesses arranged on a connecting piece at least one comprises a self-closing diaphragm, (See Cady Abstract and Fig. 1-3 wherein a multi connector port 120 has an air connection 360 for sterile air, a plurality of accesses 329/334 arranged on a connecting piece 320. At least one of the accesses comprises a septum 328, i.e. a self-closing diaphragm.)
and at least one line arranged on the connecting piece and fluidly coupled to the plurality of accesses the at least one line having a first end connected to the connecting piece and a second end connected to a vessel. (See Cady Abstract and Fig. 1-3 At least one line,314,306 fluidly connected to the accesses and having an first end on the connected piece and a second end connected to a vessel 205.)
a fixing device fixedly connecting the multi-connector port to a handling system and configured to position and hold the multi-connector port in position. (See Cady Figs. 1-3 wherein outer surfaces of the cap 302 as well as threads 304 are a fixing device which fixes multi-connector port into a fixed position such that a handling device including robotic ones may be fixedly connected thereto.)
It is noted the fixing device of cady is fully capable of being fixedly connected to a handling system including a handling robot. The handling system is not a part of the multi-connector port but an outside system which may interface with the multi-connector port. Since the fixing devices of Cady are fully capable of interacting with and being fixed to handling robots if one so wished such limitations represent intended uses of the claim device which do not define structural elements from the cited prior art. In other words the structure or any connection of a handling system to the device does not limit the structure of the multi-connector port. See MPEP 2114 and 2115.
Regarding claim 22 Cady discloses all the claim limitations as set forth above as well as the device wherein the air connection is configured to draw the sterile air into a tip. (See Cady Fig. 3 wherein the air connection allows one to draw sterile air into a tip if one so wished.)
Regarding claim 23 Cady discloses all the claim limitations as set forth above as well as the device wherein the at least one access, the air connection and the at least one line are fluidically connected to one another via the at least one connecting piece. (See Cady Fig. 3 wherein the air connection and line are fluidically connected to one another via the at least one connecting piece 302.)
Regarding claim 24 Cady discloses all the claim limitations as set forth above as well as the device further comprising exactly two accesses a first media inlet and a second media outlet access. (See Cady wherein there are two accesses which may be used to inlet or outlet media as one so wished.)
Regarding claim 28 Cady discloses all the claim limitations as set forth above as well as the device further comprising a cap covering the at least one access or the air connection.(See Cady Fig. 3 wherein cap 368 is provided to cover the air connection 360)
Regarding claim 29 Cady discloses all the claim limitations as set forth above as well as the device wherein the first self-closing diaphragm is configured as a pierceable septum. (See Cady Fig. 3 and Col. 5 Lines 26-33 wherien the self-closing diaphragm is a septum pierceable by a syringe.)
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.
The following rejection is provided assuming arguendo with respect to the handling system/robot being structural.
Claim 18-24, 26, and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cady et al. (US 5,083,686) as applied to claims above, and further in view of Schroeder et al. (US 2002/0039785).
Regarding claims 18 and 26 Cady discloses a multi-connector port having an air connection for sterile air,
comprising a plurality of accesses arranged on a connecting piece at least one comprises a self-closing diaphragm, (See Cady Abstract and Fig. 1-3 wherein a multi connector port 120 has an air connection 360 for sterile air, a plurality of accesses 329/334 arranged on a connecting piece 320. At least one of the accesses comprises a septum 328, i.e. a self-closing diaphragm.)
and at least one line arranged on the connecting piece and fluidly coupled to the plurality of accesses the at leas one line having a first end connected to the connecting piece and a second end connected to a vessel. (See Cady Abstract and Fig. 1-3 At least one line,314,306 fluidly connected to the accesses and having an first end on the connected piece and a second end connected to a vessel 205.)
a fixing device fixedly connecting the multi-connector port to a handling system and configured to position and hold the multi-connector port in position. (See Cady Figs. 1-3 wherein outer surfaces of the cap 302 as well as threads 304 are a fixing device which fixes multi-connector port into a fixed position such that a handling device including robotic ones may be fixedly connected thereto.)
Cady discloses all the claim limitations as set forth above as well as the device further comprising a fixing device but does not specifically disclose it connected to a handling robot.(See Cady Fig. 3 wherein a fixing device, i.e. various openings in fluidic lines, are provided and such a fixing devices may be handled by a handling robot.)
Schroeder et al. disclose a robotic fluid handling system which is fixedly connected to a fixing device of a fluid port in a cell culture system to allows additional and/or removal of materials form the device. (See Schroeder Figs. 3A-3B and [0021] wherein a robotic fluid handling system grips fixedly onto a fluid port and fluid transfer system to allow addition and removal of materials.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a robot handling system comprising a fluid transfer system and gripping elements fixedly connected to a mixing device of the fluid ports of Cady as described by Schroder because such robotic handling systems reduce manual interaction and labor as would be desirable in the device of Cady.
Regarding claim 22 Cady discloses all the claim limitations as set forth above as well as the device wherein the air connection is configured to draw the sterile air into a tip. (See Cady Fig. 3 wherein the air connection allows one to draw sterile air into a tip if one so wished.)
Regarding claim 23 Cady discloses all the claim limitations as set forth above as well as the device wherein the at least one access, the air connection and the at least one line are fluidically connected to one another via the at least one connecting piece. (See Cady Fig. 3 wherein the air connection and line are fluidically connected to one another via the at least one connecting piece 302.)
Regarding claim 24 Cady discloses all the claim limitations as set forth above as well as the device further comprising exactly two accesses a first media inlet and a second media outlet access. (See Cady wherein there are two accesses which may be used to inlet or outlet media as one so wished.)
Regarding claim 28 Cady discloses all the claim limitations as set forth above as well as the device further comprising a cap covering the at least one access or the air connection.(See Cady Fig. 3 wherein cap 368 is provided to cover the air connection 360)
Regarding claim 29 Cady discloses all the claim limitations as set forth above as well as the device wherein the first self-closing diaphragm is configured as a pierceable septum. (See Cady Fig. 3 and Col. 5 Lines 26-33 wherien the self-closing diaphragm is a septum pierceable by a syringe.)
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cady et al. (US 5,083,686) alone or in view of Schroeder et al. (US 2002/0039785) as applied to claims above, and further in view of Wickland et al. (US 6,395,050.).
Regarding claim 19 Cady discloses all the claim limitations as set forth above but does not specifically disclose a second self-closing diaphragm with the sterile filter.
Wickland et al. discloses a vent filter for use with drums wherein the vent filter is provided with a septum, i.e. self-closing diaphragm, in order to allow head space sampling of the device. (See Wickland Abstract and Fig. 2 wherein a air filter 40 is provide with a septum 62 to allow sampling of the drum headspace.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a septum in the air connection of Cady as described by Wickland because doing so allows sampling of a device headspace as would be desirable to ensure the materials are as required.
Regarding claim 20 Cady discloses all the claim limitations as set forth above as well as the device wherein the sterile filter has a pore diameter of less than or equal to 0.22 microns. (See Cady Col. 6 Lines 33-37 wherein the filter has a porosity, i.e. pore diameter, of 0.2 microns.)
Regarding claim 21 Cady discloses all the claim limitations as set forth above as well as the device wherein a side of the sterile filter facing away from the second self-closing diaphragm is in contact with outside air. (See Cady and Wickland wherein a side of air filter 40 facing away from the septum 62 is in contact with outside air to allow venting.)
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cady et al. (US 5,083,686) alone or in view of Schroeder et al. (US 2002/0039785) as applied to claims above, and further in view of Brown et al. (US 5,350,080).
Regarding claim 27 Cady discloses all the claim limitations as set forth above but does not specifically disclose the device wherein the multi- connector port is adapted to be sterilizable, and wherein the sterilization is performed by via autoclaving, irradiation, or with ethylene oxide.
It is noted that Brown et al. discloses a multi-connector port and notes that it is known that such systems employing such ports must be sterilizable by known techniques including by gamma irradiation. (See Brown Abstract and col. 1 Line 58-Col. 2 Line 35)
It would have been obvious to one of ordinary skill in the art at the time of filing to make the multi-connector port of Cady adapted to be sterilizable by irradiation as describe by Brown because doing so ensures the system and parts thereof remain free of contamination as would be desirable in the device of Cady.
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
Applicant argues “Cady fails to expressly or inherently disclose each and every recitation of amended independent claim 18. More specifically, Cady fails to expressly or inherently disclose "a fixing device fixedly connecting the multi-connector port to a handling system and configured to position and hold the multi-connector port in position," as recited in amended independent claim 18.
Cady discloses a dispensing assembly fixed to a vessel and a supplementation assembly fixed to a vessel. In the configuration disclosed by Cady, the dispensing assembly is not moveable relative to the vessel, but restricted to the dispensing ports of the drums. As shown in FIGS. 1 and 2 of Cady (provided below for reference), the "[d]ispensing port 210 is provided so that the dispensing assembly 130 may be securely and sealably attached thereto." Cady, column 3, lines 40-42. Moreover, the dispensing port is threaded to facilitate secure and immobile attachment, where a"[d]ispensing cap 302 is designed to attach via buttress threads 304 to dispensing port 210 of drum 110a" (Cady, Column 4, lines 4-5) where "[b]uttress threads 614 are designed such as to mate with the corresponding buttress threads on the dispensing port 210 of the drum 110" (Cady, Column 8, lines 20-23).”
Applicant also argues “As disclosed in Cady, the dispensing cap 302 is attached to the drum 110 with buttress threads 304 to the dispensing port 210 of the drum 110. The configuration as disclosed in Cady seals the dispensing cap to the dispensing port in a manner that eliminates the ability to vertically or horizontally displace the dispensing port without breaking the seal. Rather, Cady discloses a dispensing port of a single, fixed position, in which the "dispensing port 210 is formed as part of body 205." Cady, column 3, lines 44-45. Cady does not expressly or inherently disclose a configuration in which the dispensing cap is "fixedly [connected]...to a handling system and configured to exactly position the multi-connector port and to hold the multi-connector port in position," as recited in amended claim 18.”
It is noted that the outside body of the multi-connector port as well as the threads read on applicant’s broadly claimed fixing device. It is noted that such elements are fully capable of being handled by a robot and the nature of the threads clearly fix the port in position relative to the vessel.
Furthermore even assuming arguendo with respect to such features the examiner combined additional art showing the obviousness of fixing a fluid handling system to a port and applicant did not address such a combination and rational and as such applicant’s arguments with respect to such features are moot.
It appears as is applicant envisions the fixing device to have specific structural characteristics that allow interaction with a specific handling system but so broadly claims such a fixing device that it reads on any structure which may be handled in any manner, i.e. grasped, moved, touched, screwed, etc. It is suggested that applicant claim more specific structural elements differentiating the claimed fixing device rather than rely on broad functional limitations and intended uses.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HURST/Primary Examiner, Art Unit 1799