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
Applicant's election with traverse of species a) figures 2-4, claims 1-20 in the reply filed on 10/23/2025 is acknowledged. The traversal is on the grounds that species b) figures 9a-9c illustrate features that are combinable and should be examined together with species a) figures 2-4. This is found persuasive. Therefore, the election of species has been modified as follows:
a) figures 2-4, 9a-9c;
b) figures 10a-10b; and
c) figures 13a-13c.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Reference numeral 127b is not shown, [0079.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-5, 7-14, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Demotte et al (US 20180256777 A1).
Regarding claim 1, Delmotte discloses a system for producing a mixture to deliver to a treatment site, comprising:
a mixing lumen 3 (contains a dry powder) attachable to a proximal end of a delivery system 10;
a multi-lumen chamber 4 connected to a proximal end of the mixing lumen, the multi- lumen chamber comprising a first lumen 1 aligned and adjacent a second lumen 2;
the first lumen 1 configured to receive a first constituent in a first state, the first constituent being insertable through a first port into the first lumen (port seen in fig 1B), the first lumen comprising a first plunger to move the first constituent from the first lumen to the mixing lumen [0074]; and
the second lumen 2 configured to comprise a second constituent, the second lumen comprising a second plunger to distally move the second constituent and the first constituent in a second state, and the second lumen terminating in a second port [0074] (port seen in fig 1B);
wherein in the second state, distally moving the second plunger causes the first constituent and the second constituent to be delivered through the first and second ports and mixed together within the mixing lumen to form the mixture [0074].
Regarding claim 2, wherein the first port comprises a luer fitting configured to receive a distal end of a syringe, and wherein the distal end of the syringe and the first port are configured to removably connect with each other (see Delmotte et al (2004/0068266) incorporated by reference showing the luer fitting [0075] as old and well known in the art).
Regarding claim 3, wherein the first port is configured so that air can be purged from the first lumen through the first port (see port in figure 1B that is configured to do so).
Regarding claim 4, wherein the mixing lumen is comprised in a connector 5, the connector comprising a first asymmetric coupler positioned on a proximal end of the connector; and wherein the multi-lumen chamber comprises a second asymmetric coupler positioned on a distal end of the multi-lumen chamber and configured to removably connect to the first asymmetric coupler [0072].
Regarding claim 5, the connector 5 further comprising at or adjacent the first asymmetric coupler; a first tube configured to be in fluid communication with the first port and the mixing lumen in the second state; and a second tube configured to be in fluid communication with the second port and the mixing lumen in the second state ( see also US 4359049, US 4631055, and US 5116315 incorporated by reference in [0075].
Regarding claim 7, wherein the first and second asymmetric couplers each comprise an asymmetric outer surface profile shaped as a mirror of the other (see figure 1B, and also Delmotte (2004/0068266).
Regarding claim 8, wherein the first lumen comprises a hydrophilic polymer prior to injection of the first constituent into the first lumen [0027].
Regarding claim 9, wherein Delmotte is capable of injecting the first constituent through the first port into the first lumen by a syringe causes the first plunger to move proximally so the first lumen so the first constituent is received in the first lumen in the first state [0073].
Regarding claim 10, wherein Delmotte is capable to once the first and second constituents are comprised within the first and second lumens, respectively, the second plunger is configured to distally move a first distance to purge air from the multi-lumen chamber.
Regarding claim 11, wherein the mixture is a hydrogel (example 3 in [0100]).
Regarding claim 12, wherein in a first state, the system further comprises a retainer 6 removably positioned between a flange of the second plunger and the multi-lumen chamber so as to prevent movement of the second plunger; and wherein in the second state, the retainer is removed so that the second plunger is capable of moving in order to distally move the second plunger to cause at least one of the first constituent and the second constituent and mix together in the mixing lumen to form the mixture.
Regarding claim 13, Delmotte discloses a method for producing a mixture by a mixing system 10, the mixing system comprising a multi-lumen chamber 4 connected to a proximal end of a mixing lumen 3, the multi-lumen chamber 4 comprising a first lumen 1 aligned and adjacent a second lumen 2,
the first lumen configured to receive a first constituent in a first state [0074], the first constituent being insertable through a first port into the first lumen, the first lumen comprising a first plunger to move the first constituent from the first lumen to the mixing lumen; and
the second lumen comprising a second constituent, a second plunger, and the second lumen terminating in a second port [0074], the method comprising:
moving the first constituent from the first lumen to the mixing lumen by the first plunger;
distally moving the second constituent and the first constituent by the second plunger; and
distally moving the second plunger thereby causing the first constituent and the second constituent to be delivered through the first and second ports and mixed together within the mixing lumen to form the mixture [0074, 0076].
Regarding claim 14, wherein the first port comprises a luer fitting configured to receive a distal end of a syringe, and wherein a distal end of the syringe and the first port are configured to removably connect with each other (see Delmotte et al (2004/0068266) incorporated by reference showing the luer fitting [0075] as old and well known in the art).
Regarding claim 18, wherein the mixing lumen is comprised in a connector 5 comprising a first asymmetric coupler positioned on a proximal end of the connector; wherein the multi-lumen chamber comprises a second asymmetric coupler positioned on a distal end of the multi-lumen chamber and configured to removably connect to the first asymmetric coupler, wherein the first and second asymmetric couplers each comprise an asymmetric outer surface profile shaped as a mirror of the other (see Delmotte et al (2004/0068266) incorporated by reference showing the luer fitting [0075] as mirror from each other as old and well known in the art). .
Regarding claim 20, further comprising: positioning a hydrophilic polymer in the first lumen prior to injection of the first constituent into the first lumen [0050, 0053].
Allowable Subject Matter
Claims 6, 15-17, 19 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Mon-Thur 8am- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783