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
Applicant's election with traverse of Invention I in the reply filed on May 6, 2026 is acknowledged. The traversal is on the ground(s) that one would inevitably find Invention II when searching for Invention I and vice versa. This is not found persuasive because the claims have different requirements. Searching for Invention II does not require any evacuated chamber or connecting to any separate device. This lack of overlap is deemed to amount to a serious burden.
For these reasons the requirement is still deemed proper and is therefore made FINAL.
Claims 1-16 are examined herein and claims 17-20 are withdrawn from consideration.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,883,170 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims would anticipate the pending claims. The step of providing the application device is disclosed by the patented claims.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-5, 12, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0275955 A1 to Haghgooie et al. (“Haghgooie”) in view of US 2014/0309551 A1 to Burkholz et al. (“Burkholz”).
As to claim 1, Haghgooie discloses a method of collecting a biological fluid sample (see [0008], [0031]) comprising:
providing a biological fluid collection device having a housing having an inlet, an outlet, and a passageway extending between the inlet and the outlet ([0005], [0027]-[0028], [0031] – showing housing with an inlet and a passageway);
a collection chamber inside the housing and in fluid communication with the passageway (see [0005]-[0006], [0031] and Fig 1, element 33);
an evacuated chamber inside the housing and containing a vacuum (see Fig 1, element 35);
an activation member and a seal configured to cooperate with the activation member to transition the seal from a closed position in which the vacuum is enclosed within the evacuated chamber to an open position in which the vacuum is applied to the inlet to draw the sample within the collection chamber (see [0044], [0047]);
applying pressure to the activation member to transition the seal from the closed position to the open position to draw a fluid sample into the passageway (see [0030] and [0047] – “The seal can be activated using any suitable technique, e.g., automatically, remotely, manually, etc. In some cases, the seal may be self-activating, e.g., upon application to the skin of a subject. The seal may be activated once, or multiple times in some cases. The seal may be activated, for example, by pushing a button, flipping a switch, moving a slider, turning a dial, or the like.”).
Haghgooie does not disclose the step of connecting the biological fluid collection device to a separate collection device, said separate collection device configured to collect the fluid sample from a fluid source. In a related device, Burkholz discloses connecting a fluid collection device to a separate collection device, said separate collection device configured to collect the fluid sample from a fluid source (see Fig 9, element 110 (collection device) and [0045]-[0047], [0059]-[0061] and Fig 14).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the blood collection device of Haghgooie with the connecting to a separate device as shown by Burkholz in order to achieve the predictable result shown by Burkholz of allowing the collected blood to be transferred to a device that can dispense blood in order to test it on, for example, a test strip.
As to claims 4-5, Haghgooie further discloses providing a cap and covering the outlet of the housing, the cap including a venting portion, wherein the venting portion allows air to pass therethrough and prevents the sample from passing therethrough (see [0035] – membrane cap allowing air to pass but not liquid).
As to claim 12, Burkholz further discloses wherein the separate fluid collection device is configured to withdraw a blood sample (see [0033]-[0044] – vascular access device 12 collects blood).
As to claim 15, Burkholz further discloses wherein the inlet includes a connector housing interface and, wherein the separate fluid collection device comprises a fluid line having an interface and wherein the method comprises connecting the connector housing interface with the fluid line interface (see [0033], [0038] and Fig 1 showing luer access adapters and male luer).
Allowable Subject Matter
Claims 2-3 and 6-11 would be allowable if rewritten to overcome the rejection(s) under obviousness-type double patenting set forth in this Office action, or the filing of a terminal disclaimer, and to include all of the limitations of the base claim and any intervening claims.
Claims 13-14, and 16 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-Tu, 8:30 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791
Prosecution Insights