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 .
Information Disclosure Statement
No IDS has been filed in this application. Applicant is reminded that each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the U.S. Patent and Trademark Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability. 37 CFR 1.56.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1-10 in the reply filed on 01/23/2026 is acknowledged. The traversal is on the ground(s) that applicant does not believe that examining the full claim set would present any serious search or examination burdens. This is not found persuasive because the invention requires a different field of search in addition the inventions of Group I and Group II have separate status in the art. Furthermore, the examination of any intended use limitation and/or functional language as recited in the apparatus of claims 1-10 would yield a different examination of the same limitation in that of the method claims 11-20 as it has been held that process limitations do not have patentable weight in an apparatus claim. See MPEP § 2114, that states “Expressions relating the apparatus to contents thereof and to an intended operation are of no significance in determining patentability of the apparatus claim.” Similarity, the examination of any product-by-process language as recited in the apparatus of claims 1-10 would yield a different examination of the same limitation in that of the method claims 11-20 as it has been held that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP § 2113.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/23/2026.
The requirement is still deemed proper and is therefore made FINAL.
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, 4-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erdenberger et al. (hereinafter Erdenberger) US 2014/0349385.
Regarding claim 1, Erdenberger discloses a bioprocessing system, comprising: a single-use bag (bag 128) configured to carry out a bioprocessing operation [0076-0078]; at least one port (port 305) welded to the single-use bag [0211], the at least one port including a channel (flow artery 623) for providing fluidic access to an interior volume of the single-use bag [0218]; and at least one mating ring (barbed fastener 602/802); wherein the at least one port includes a first feature configured to engage with a corresponding second feature of the at least one mating ring, such that the at least one mating ring can be locked to the at least one port (This lower body section 650 has screw grooves 652 on its outer surface allowing the second sparger base 600 to rotatably attach within the barbed fastener 602 by engaging threads 654. [0214]). Also see [0083, 0223-0233].
Applicant is reminded that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP § 2113.
Regarding claim 2, Erdenberger discloses the first feature comprises at least one groove and the second feature comprises at least one protrusion, and wherein the at least one mating ring is locked to the at least one port by inserting the at least one protrusion into the at least one groove and rotating the at least one mating ring relative to the at least one port (This lower body section 650 has screw grooves 652 on its outer surface allowing the second sparger base 600 to rotatably attach within the barbed fastener 602 by engaging threads 654. [0214 and 0218]).
Regarding claim 4, Erdenberger discloses a port plate (port plate 614) comprising at least one opening (central port 622), the at least one opening corresponding to a location of the at least one port (flow artery 623); wherein when the at least one opening is aligned with the at least one port and the at least one mating ring is locked to the at least one port as shown in Fig, 24, the port plate is secured to the single-use bag [0211 and 0218].
Regarding claim 5, Erdenberger discloses wherein the single-use bag is configured to be placed in an outer vessel, the outer vessel having an opening corresponding to a location of the at least one port (The bag support structure 104 has a bag support structure wall 106 that forms the outer structure of the bag support structure 104. The bag support structure wall 106 includes a bottom plate 300 that forms the bottom of the bag support structure 104. The bag support structure wall 106 has an agitator port 301 or aperture formed in the center of the bottom plate 300. [0174]), and wherein the at least one mating ring includes an alignment feature, the alignment feature configured to align the port plate with the opening (The bag support structure wall insert 307 may have a flange 315 along the outer edge of the disc-shaped bag support structure wall insert 307 that fits over the slotted edge 303 of the agitator port 301. [0176]).
Regarding claim 6, Erdenberger discloses wherein the at least one mating ring further comprises a probe support or angle guide, the probe support configured to physically support a probe attached to the at least one port (The sensor transducer 906 is attached to a wire 918 that is guided through the sensor passageway 912 in order to place the sensor transducer 906 at a desired position within the bag 128. [0232]).
Regarding claim 7, Erdenberger discloses wherein the probe support or angle guide is configured to maintain the probe at an angle relative to a longitudinal axis of the channel as shown in Fig. 27.
Regarding claim 8, Erdenberger does not expressly disclose a protective cover (bag support structure wall 106) shipping [0072 and 0081].
As to covering the at least one port during and when the cover is aligned with the at least one port and the at least one mating ring is locked to the at least one port, the cover is secured to the single-use bag, the device disclosed by Erdenberger is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Erdenberger is capable of providing the operating condition.
Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 10, Erdenberger discloses that the at least one port comprising a plurality of ports and the at least one mating ring (barbed fastener 602) comprises a plurality of mating rings, and wherein each of the plurality of mating rings is configured to lock to a corresponding port of the plurality of ports (The agitation and bulkhead system 200 may also include one or more bulkhead units 138 that are fit within apertures in bottom of the bag 128 and the bag support structure wall 106. As used herein, the term "bulkhead" means a fitting that attaches through a wall for allowing passage of, for example, a fluid, tubing, and so forth. [0083]). Also see Figs. 21 and 23; and [0197 and 0210-0212].
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 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Erdenberger US 2014/0349385 as applied to claims 1-2, 4-8 and 10 above.
Regarding claim 3, Erdenberger does not expressly disclose that the first feature comprises at least one snap lock and the second feature comprises at least one protrusion, and wherein the at least one mating ring is locked to the at least one port by inserting the at least one protrusion into the at least one snap lock.
However, Erdenberger does disclose a functional equivalent first feature and second feature i.e., This lower body section 650 has screw grooves 652 on its outer surface allowing the second sparger base 600 to rotatably attach within the barbed fastener 602 by engaging threads 654 [0214 and 0218]. Erdenberger also discloses the use of a press fit locking feature [0103].
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill to make a simple substitution of one known element (snap lock) for another (screw lock) motivated by an expectation of success, since it appears that the invention would perform equally well with the screw lock or press fit feature of Erdenberger.
Regarding claim 9, Erdenberger does not expressly disclose wherein the at least one mating ring further comprises an attachment mechanism configured to be attached to a hook or clip.
However, Erdenberger does disclose a lift assembly 102 includes a lifting component 108 mounted on the assembly support structure 112 and movable relative to the assembly support structure 112. The lifting component 108 can be in the form of one or more lifting bars 116 including hooks 118 that can be used to support a flexible bag such as a collapsible bag in a collapsed or un-collapsed configuration [0073].
Therefore, it would have been obvious to one of ordinary skill in the art to modify the at least one mating ring Erdenberger with an attachment mechanism configured to be attached to a hook, and wherein when the hook or clip is attached, the hook or clip is configured to further attach to an external structure in order to provide an alternative support structure. Further, it appears that the invention would perform equally well with the support structure of Erdenberger.
As to wherein when the hook or clip is attached, the hook or clip is configured to further attach to an external structure, the device disclosed by Erdenberger is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Erdenberger is capable of providing the operating condition.
Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
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