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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/03/2026 has been entered.
Response to Amendment
Claims 1 and 11 have been amended. Claims 8-9 and 14-15 have been cancelled. No new matter has been entered.
The Drawings filed 02/03/2026 contain new matter and are thus not entered. However, upon reconsideration and upon consideration of Applicant’s remarks, the prior objection to the Drawings for claimed subject matter not shown has also been withdrawn so that the Drawings as filed are sufficient and no changes are needed to the Drawings.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Claims 1 and 11 are objected to for a typographical error wherein the claim recites “translatable along the outside of the housing in a direction of away from the single needle” and should instead recite “translatable along the outside of the housing in a direction away from the single needle”.
Claims 1 and 11 are objected to for a typographical error wherein the claim recites “translatable along the outside of the housing in a direction of away from the single needle” and should instead recite “to extract a sample through a needle
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5-7, 10, 11, and 16 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim introduces new matter where it recites “said cover comprising a tab extending therefrom depressing the injection button and extraction button to open the plurality of valves before priming”. This is new matter because Applicant’s Specification (see Applicant’s Specification at [0040]) only discloses “The cover 112 may also include a tab which interacts with the injection button 108 and the extraction button 110 such that the plurality of valves in the priming mechanism are open when the cover 112 is at the open position”, which does not include that the tab depresses the injection button and the extraction button to open the valves as claimed. An interaction with the buttons such that the valves are open when the cover is open does not necessarily require that the tab itself functions to depress the buttons to open the valves before priming, as the Specification’s disclosure allows for intervening structures to be involved where the claim requires a direct connection, thus making the claim an entry of new matter.
Similarly, regarding claim 11, the claim introduces new matter where it recites “an open position in which a tab extending therefrom depresses an injection button and an extraction button to open a plurality of valves of a priming mechanism”. This is new matter because Applicant’s Specification (see Applicant’s Specification at [0040]) only discloses “The cover 112 may also include a tab which interacts with the injection button 108 and the extraction button 110 such that the plurality of valves in the priming mechanism are open when the cover 112 is at the open position”, which does not include that the tab depresses the injection button and the extraction button to open the valves as claimed. An interaction with the buttons such that the valves are open when the cover is open does not necessarily require that the tab itself functions to depress the buttons to open the valves before priming, as the Specification’s disclosure allows for intervening structures to be involved where the claim requires a direct connection, thus making the claim an entry of new matter.
Claims 3, 5-7, 10, and 16 are dependent on claims 1 and 11, respectively, and thus are rejected based on their requirement of the new matter of claims 1 and 11.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner notes that the newly added limitation regarding the tab on the housing overcomes the previous rejection but is still rejected as new matter as called out in the rejection under 35 U.S.C. §112(a) above, and pending resolution of said new matter rejection, further consideration will be required to come to a determination on patentability.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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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.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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