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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Claims 1-11, drawn to a tubing with a disconnect fitting, classified in F16L 37/02.
II. Claims 12-20, drawn to a method of aseptically disconnecting a fluid line, classified in A61M 39/20.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the tubing of invention I can be used for a materially different process, such as one that does not include first and second bioprocess components.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions are drawn to different statutory classes of invention. The different classifications of each are evidence of a search burden if restriction is not required. The claims provide distinct pathways to potential patentable subject matter and thus demonstrate an examination burden if restriction were not required. Either of the above is sufficient to establish the requisite burden.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these 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.
During a telephone conversation with Anitha Shankar Narayan on 29 September 2026 a provisional election was made without traverse to prosecute the invention of Invention I, claims 1-11. Affirmation of this election must be made by applicant in replying to this Office action. Claims 12-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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- is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent Application Publication No. 2011/0155274 A1 to Zumbrum (Zumbrum).
With regard to claim 1, Zumbrum discloses a tubing disconnect (Zumbrum, title, abstract), comprising:
a collar (15, fig. 1, paragraph 0021) disposed around at least a portion of a flexible tubing (shown in fig. 1), the collar having a first end portion, an opposite second end portion, and a middle axis (the first and second ends are the two opposite ends of the collar as shown in fig. 2); and
a middle portion (the portion between the first and second ends) extending between the first and second end portions (as defined above), and at least a portion of the first and second end portions being configured to compressively grip the flexible tubing to avoid movement of the collar on the flexible tubing (paragraphs 0021 and as shown in fig. 7).
With regard to claim 2, Zumbrum discloses the tubing disconnect as recited in claim 1 as set forth above, and further discloses wherein each of the first and second end portions comprises a proximal end closest to the middle axis and a distal end furthest from the middle axis (shown in fig. 6).
With regard to claim 3, Zumbrum discloses the tubing disconnect as recited in claim 1 as set forth above, and further discloses wherein the first end portion comprises a proximal end closest to the middle axis and a distal end furthest from the central axis (shown in fig. 6).
With regard to claim 9, Zumbrum discloses the tubing disconnect as recited in claim 1 as set forth above, and further discloses wherein the flexible tubing is in fluid communication between a first bioprocess component and a second bioprocess component (paragraph 0002, describing the need to transfer fluids from the manufacture of biopharmaceuticals and biotechnology applications).
With regard to claim 10, Zumbrum discloses the tubing disconnect as recited in claim 9 as set forth above, and further discloses wherein the first bioprocess component is a bioreactor and the second bioprocess component is a storage container (paragraph 0002, describing a situation where a sample of fluid is isolated from first bioprocess component and then the sample is sealed).
With regard to claim 11, Zumbrum discloses the tubing disconnect as recited in claim 9 as set forth above, and further discloses wherein the first bioprocess component is a fluid source, and the second bioprocess component is a fluid receiver (paragraph 0002).
Allowable Subject Matter
Claims 4-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record fails to teach or suggest a tubing disconnect wherein a diameter of the collar radially decreases between the proximal end and the distal end of the first end portion, together in combination with the other elements of claim 4. The remaining claims depend from claim 4 and are allowable for at least the same reasons.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references disclose sterile connections: USPNs 2012/0204990, 2022/0252194, 20220299144, 2005/0253390, 2021/0162192, 2005/0090797, 2006/0252298, 2021/0388926, 2021/0215286, 2026/0115445, 12171975 and 2011/0155274.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID R DEAL whose telephone number is (469)295-9216. The examiner can normally be reached M-F generally 8-4 pm CST.
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 supervisors can be reached at: Craig M Schneider (571) 272-3607 and Ken Rinehart (571) 272-4881. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID R DEAL/ Primary Examiner
Art Unit 3753
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