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
Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 16, 2026.
Applicant’s election of Group I in the reply filed on January 16, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 221. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first lumen, first plunger assembly, and second plunger, nestable within the second lumen must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The disclosure is objected to because of the following informalities:
[0081] there should be a space between “constituent” and “130” in the second to last line
[0088] 135 should be 153
Appropriate correction is required.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 8 recites the connector vent comprises a one-way valve, such a valve is only discussed in conjunction with Figs. 13 in which the vent is not shown as part of the connector. Claim 9 recites the first lumen comprises a vent (shown in Fig. 12), however, claim 1 recites a vent in the connector. There is no embodiment which shows two vents. Claim 11 recites the membrane comprises a membrane which is only discussed in conjunction with Figs. 13, no embodiment discloses the vent of the connector to comprise a membrane.
Claim Objections
Claims 1, 2, and 12 are objected to because of the following informalities:
Claim 1: “and delivered” should be “and be delivered”
Claim 2: “the second state” lacks antecedent basis
Claim 12: “the first plunger assembly” lacks antecedent basis
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites “distally moving the second plunger rod causes the third constituent to be delivered through the first and second ports.” The second lumen which is configured to comprise the third constituent is only connected to the second lumen, the third constituent is not in fluid communication with the first port. It is not clear how the third constituent could be delivered through the first port. For purposes of examination, it is understood that movement of the second plunger causes the first mixture to be delivered through the first port and the third constituent to be delivered through the second port. Claim 4 recites at least one of the first and second plungers, however, both first and second plungers are not positively recited as only one of either the first or second lumens comprises a floating plunger. Claim 12 recites the first lumen, first plunger assembly, and second plunger rod form a plunger assembly nested within the second lumen. It is not clear how the first and second lumens connected to the connector and functioning as recited in claim 1 would be able to be “nested” as claimed. For purposes of examination as the second plunger rod is within the second lumen and is part of the plunger assembly the plunger assembly is taken as nested within the second lumen. Claims 1-3 and 6 should be written such that steps are written functionally; some exemplary language is as follows. Claim 1 should recite “wherein distally moving the second plunger rod is configured to cause.” Claim 2 should recite “wherein the second plunger rod is configured to distally move.” Claim 3 should recite “wherein distally moving the second plunger rod is configured to cause.” Claim 6 should recite “the first floating plunger is configured to advance distally and contact.”
As per MPEP 2173.05(p)(ll), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. It is not clear if the claims are drawn only to structures that are capable of performing the method steps or if the claims are intended to be written as method steps. For the sake of examination, the claims have been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed.
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.
Claim(s) 1-5, 7, 8, and 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koh et al. (US 2020/0238009 A1) in view of Keller et al. (US 2009/0127288 A1).
With regard to claims 1-3, 7, 8, and 10-12, Koh et al. teach a system for producing a mixture to deliver to a treatment site, comprising: a connector (Figs. 1 and 2 member 30) attachable to a proximal end of a delivery system (Figs. 1 and 2 delivery system 35), a multi-lumen chamber (Figs. 1 and 2 members 10 and 20) connected to a proximal end of the connector and comprising a first lumen (Figs. 1 and 2 lumen within 10) aligned and adjacent a second lumen (Figs. 1 and 2 lumen within 20); the first lumen configured to comprise a first constituent in a proximal portion of the first lumen and a second constituent in a distal portion of the first lumen (Fig. 3 constituents in 15 and 16, [0047], [0048]), a first plunger internally positioned within the first lumen to distally move the first constituent into the distal portion to mix with the second constituent in a first state to form a first mixture, the first lumen terminating in a first port (Fig. 1 plunger 13); the second lumen configured to comprise a third constituent, a second plunger rod internally positioned within the second to distally move the third constituent, the second lumen terminating in a second port (Fig. 1 constituent at least in 26 plunger 23); wherein distally moving the second plunger rod causes the third constituent to be delivered through the first and second ports, mix to form the mixture, and delivered through the delivery system ([0039] a hydrogel is produced, [0073]-[0076]). Koh et al. do not disclose a vent or static mixer. However, Keller et al. teach a mixing member attached to a mixing syringe with a static mixer and a vent which comprises a one-way valve and membrane (Fig. 5 vent including channels 47, membrane 42 [0030], valve 43, mixer 3 through a central channel as shown in Fig. 1, connects to luer 4 for delivery system attachment) which is beneficial for preventing air bubbles from affecting the mixing ratio and delivery ([0005]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a venting system in Koh et al. as in Keller et al. as this is effective to prevent air bubbles from affecting the mixture and delivery. As combined the mixing member of Keller et al. would be placed between 35 and 30 and be considered as part of the connector providing a central lumen.
With regard to claim 4, see toggleable plungers 12 and 22 (Fig. 2).
With regard to claim 5, 35 is considered a needle with a hub at the attachment to Keller et al.
With regard to claim 13, see [0047].
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koh et al. (US 2020/0238009 A1) and Keller et al. (US 2009/0127288 A1) as applied to claim 1 above, and further in view of Eibl et al. (US 4,735,616).
With regard to claim 5, Koh et al. teach a device substantially as claimed and delivering a sealant. However, if Koh et al. is not found to comprise a needle, Eibl et al. teach a syringe for delivering a sealant mixture which uses a needle for delivery (Col. 1 lines 5-10, Fig. 1 needle 20 with hub 19). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a needle in place of delivery system 35 of Koh et al. as in Eibl et al. as this provides an art effective means for delivery depending on the location requiring sealant/adhesive. One of ordinary skill would be able to select a suitable delivery system based on treatment.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koh et al. (US 2020/0238009 A1) and Keller et al. (US 2009/0127288 A1) as applied to claim 5 above, and further in view of Bae (US 2004/0097875 A1).
With regard to claim 6, Koh et al. teach using a bypass channel in conjunction with a floating plunger (Fig. 2 channels 14 and 24, plungers 12 and 22) but do not disclose a rib. However, Bae teaches equivalently using a rib to tilt a plunger or a channel to allow passage for components to mix (exemplary Figs. 2C and 4B showing a channel, Figs. 6A-6C show rib 372). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a rib to break a seal and allowing mixing in Koh et al. as Bae teaches such to be an art effective equivalent and would yield the same predictable result.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koh et al. (US 2020/0238009 A1), Keller et al. (US 2009/0127288 A1), and Eibl et al. (US 4,735,616) as applied to claim 5 above, and further in view of Bae (US 2004/0097875 A1).
With regard to claim 6, Koh et al. teach using a bypass channel in conjunction with a floating plunger (Fig. 2 channels 14 and 24, plungers 12 and 22) but do not disclose a rib. However, Bae teaches equivalently using a rib to tilt a plunger or a channel to allow passage for components to mix (exemplary Figs. 2C and 4B showing a channel, Figs. 6A-6C show rib 372). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a rib to break a seal and allowing mixing in Koh et al. as Bae teaches such to be an art effective equivalent and would yield the same predictable result.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koh et al. (US 2020/0238009 A1) and Keller et al. (US 2009/0127288 A1) as applied to claim 1 above, and further in view of Fischer (US 5,643,206).
With regard to claim 9, Koh et al. teach a device substantially as claimed. Koh et al. do not disclose a vent in the first lumen. However, Fischer teaches a mixing syringe in which a vent is provided as an orthogonal hole in the barrel to allow air to exit during mixing and prevent bubbles (Fig. 2 member 28, Col. 4 lines 7-11, Cl. 24 step g). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a vent in the barrel of Koh et al. as Fischer et al. teaches this is beneficial for expelling air during mixing and aids in preventing bubbles.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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 supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783 Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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 supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783