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 .
Response to Amendment
The Amendment filed 1/14/2026 has been entered. Claims 18-37 remain pending in the application. Applicant’s amendments to the Specification, Drawings and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 10/14/2025.
The drawings were received on 1/14/2026. These drawings are acceptable.
The specification was received on 1/14/2026. This specification is acceptable.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/20/2025 was filed after the mailing date of the Non-Final Rejection on 10/14/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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 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.
Claims 18, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over O’ Connor (US 3,543,967) in view of Grabenkort et al. (US 6,440,101 B1).
Regarding claim 18, O’ Connor discloses a method (column 6, lines 20-26) of degassing a composition in a syringe having accumulated material over a delivery end 12 of a syringe (figure 1), the method comprising:
removing gas (column 6, lines 20-26) from the composition (composition inside the syringe shown in figure 1) within the syringe after removing a syringe cap 26 including a protruding member (see “P” in figure 1 below) but is silent regarding a protruding member that extends longitudinally into the syringe and through the accumulated material thereby forming a tunnel through the accumulated material.
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However, Grabenkort teaches a design of a syringe with a cap (figure 4) comprising a protruding member (see “PM” in figure 4 below) that extends longitudinally into the syringe 100 and through the accumulated material 170 thereby forming a tunnel through the accumulated material (as shown in figure 4, element “PM” in figure 4 below is forming a portion of the tunnel through the accumulated material 170) for the purpose of using an alternative configuration to seal an interior of the syringe (column 4, lines 58-59).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the protruding member of O’ Connor to incorporate a protruding member that extends longitudinally into the syringe and through the accumulated material thereby forming a tunnel through the accumulated material as taught by Grabenkort for the purpose of using an alternative configuration to seal an interior of the syringe (column 4, lines 58-59).
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Regarding claim 20, O’ Conor discloses wherein the syringe cap 26 further comprises a plug portion (see “PP” in figure 1 above) having a first end (see “F” in figure 1 above) and a second end (see “S” in figure 1 above), wherein the plug portion (see “PP” in figure 1 above) is configured to attach to the delivery end 12 of the syringe.
Regarding claim 21, O’ Connor discloses the protruding member (see “P” in figure 1 above) extends a certain length but does not explicitly disclose the protruding member extends about 2 mm to about 20 mm, as required by the claim.
There is no evidence of record that establishes that changing the length of the protruding member would result in a difference in function of the O’ Connor’s syringe cap. Further, a person having ordinary skill in the art, being faced with modifying the length of the protruding member of O’ Connor would have reasonable expectation of success in making such a modification and it appears that the syringe cap would function as intended being given the claimed length. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the length “may” be within the claimed range, and offering other acceptable length values (e.g. 1 mm in paragraph 0076) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the length of the protruding member of O’ Connor to have the length between about 2 mm to about 20 mm as an obvious matter of design choice within the skill of the art.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over O’ Connor (US 3,543,967) in view of Grabenkort et al. (US 6,440,101 B1) as applied to claim 18 above, and further in view of Casey, II et al. (US 7,883,490 B2).
Regarding claim 19, O’ Connor/Grabenkort (hereinafter referred as “modified O’ Connor”) discloses the claimed invention substantially as claimed, as set forth above in claim 18. Modified O’ Connor is silent regarding wherein the accumulated material is a visualization agent.
However, Casey, II teaches a design of a syringe 1 (figure 1A) wherein the accumulated material is a visualization agent 6, 8 for the purpose of visualizing the occluding vessels as needed for the medical purpose (column 1, lines 11-21).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the accumulated material of O’ Connor to incorporate wherein the accumulated material is a visualization agent as taught by Casey, II for the purpose of visualizing the occluding vessels as needed for the medical purpose (column 1, lines 11-21).
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over O’ Connor (US 3,543,967) in view of Grabenkort et al. (US 6,440,101 B1) as applied to claim 18 above, and further in view of Chiekh (US 6,349,850 B1).
Regarding claim 22, modified O’ Connor discloses the claimed invention substantially as claimed, as set forth above in claim 18. Modified O’ Connor is silent regarding wherein after removing gas from the composition, the syringe cap is reengaged, and the composition is reconstituted. However, examiner construes that these steps are obvious for medical practitioner to perform such as in a situation where after priming, medical practitioner has to wait to inject the composition, the medical practitioner could perform the steps of after removing gas from the composition, the syringe cap is reengaged, and the composition is reconstituted to maintain syringe sterility and reconstituting to ensure uniform mixture after the syringe is left stable for small duration of time. Additionally, Chiekh teaches a method for preparing an injectable preparation wherein the contents are mixed again after waiting for a small duration of time (column 7, lines 26-29) for the purpose of mixing the syringe components again after waiting for small duration of time (column 7, lines 26-29). O’ Connor already mentions the step of mixing by keeping the syringe cap attached to the syringe (column 6, lines 15-20). Therefore, one of ordinary skill in the art when modifying the method of O’ Connor in view of Chiekh would reattach the syringe cap after priming and the composition is reconstituted if one of ordinary skill in the art sees a need to mix the composition again after priming the syringe.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the method step of modified O’ Connor to incorporate the step of wherein after removing gas from the composition, the syringe cap is reengaged, and the composition is reconstituted as taught by Chiekh for the purpose of mixing the syringe components again after waiting for small duration of time (column 7, lines 26-29).
Regarding claim 23, modified O’ Connor discloses the claimed invention substantially as claimed, as set forth above in claim 18. O’ Connor further discloses wherein upon constitution of the composition, the syringe is attached to a delivery catheter and prepared for injection (column 6, lines 20-26, “hypodermic needle” is construed as a delivery catheter). Furthermore, modified O’ Connor modified in view of Chiekh, as explained in the rejection of claim 22 above, would result in the method step of wherein upon reconstitution of the composition, the syringe is attached to a delivery catheter and prepared for injection because O’ Connor teaches attaching the hypodermic needle when preparing for injection.
Allowable Subject Matter
Claims 24-37 are allowed.
The following is an examiner’s statement of reasons for allowance:
Claims 24-37 were previously indicated allowable in the Office Action mailed on 10/14/2025.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 1/14/2026 have been fully considered but they are not persuasive.
Applicant argues on page 8, line 18-page 11, line 4 that the combination of O’Connor in view of Grabenkort et al. fails to disclose “a syringe cap including a protruding member ... through the accumulated material” because the cited protruding member is a delivery passage 108 i.e. a hollow pathway to carry/transport the mixed drug. Therefore, applicant further concludes that the cited protruding member differs from the claimed protruding member which is not a channel itself but rather creates a channel/tunnel through the accumulated material. Examiner respectfully disagrees. Applicant relies on figure 4 to indicate that element 108 is pointing to the cited protruding member “PM” and element 108 is a channel. Grabenkort further discloses figures 5-8 as a method of making however, the element 108 refers to a different structure compared to the structure shown in figure 4. Furthermore, applicant recites that element 110 is used for sealing the delivery passage 108 (see column 5, lines 32-35, column 4, lines 58-60). While looking from figure 4 and referring to element 108 could seem that element 108 and the cited “PM” are same structure i.e. a delivery passage, examiner thinks that reference of element 108 in figure 4 in view of the specification disclosure is purely an error. Examiner believes that figure 5 correctly shows the referenced feature of element 108. For the purpose of argument if we construe that element 108 in figure 4 is correctly referring to the delivery passage, although examiner does not concede, then there are several other questions such as why would there be two different passage channels (one inside element 108 and other being an outlet of element 108)? How would element 110 perform sealing if element 108 is a delivery passage? If element 108 was indeed referring to be a part of element 106 then why shading used for element 108 is different from element 106 and same as element 110? If instead, element 108 pointed in figure 4 is construed as an error and is instead construed as referring to the structure shown in figure 5 then all the reference in the specification gives clear structural features of the device. Thus, the cited “PM” is correctly disclosing the claimed protrusion member.
Applicant further argues on page 11, lines 5-16 that the combination of O’Connor in view of Grabenkort et al. fails to disclose “a syringe cap including a protruding member ... through the accumulated material” because Grabenkort’s delivery passage 108 is not a part of closure 110. Examiner respectfully disagrees. As explained in the response to the arguments above, examiner believes element 108 to be referring to a wrong structure in figure 4 instead, element 108 appears to be correctly identifying the structure shown in figure 5. If element 108 was indeed construed as a part of element 106 then the element 108 should been shaded using same shading as used for element 106 instead of same as element 110.
In response to applicant's argument based upon the age of the references, contentions that the reference patents are old are not impressive absent a showing that the art tried and failed to solve the same problem notwithstanding its presumed knowledge of the references. See In re Wright, 569 F.2d 1124, 193 USPQ 332 (CCPA 1977).
Conclusion
THIS ACTION IS MADE FINAL. 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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783