DETAILED ACTION
Notice of AIA Status
The present application, filed on 3/7/2024, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 40, 43, 50, 52-54 and 59 are rejected.
Claims 41-42, 44-45, 51 and 55-58 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.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 40-45) in the reply filed on 9/17/26 is acknowledged.
Claim Objections
Claim 52 is objected to because of an informality.
Claim 52 recites “a plug in and opening of the housing”. For clarity, consider rephrasing the limitation to ‘a plug in an opening of the housing’.
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.
Claim 43 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 43 recites “the plug”. There is insufficient antecedent basis for the limitation in the claims. Consider reciting ‘a plug’ when introducing the plug in claim 43 or amending the claim dependency such that claim 43 depends on claim 42.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 40, 50 and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Loudermilk (US20200383664, cited in the 7/10/26 Information disclosure statement IDS).
With respect to claim 40, Loudermilk (US20200383664) teaches a device (an assembled Dual Swab Device 1 in [0042]) comprising
a housing (housing 2 in [0042]) including a first chamber (tube 2B in [0042]) and a second chamber (test chamber 2C in [0042]) in fluid communication with the first chamber (tube 2b) (see [0042], which recites “test chamber 2C is in fluid communication with tube 2B”);
a sample swab (strip swab assembly 5B in [0043]) configured to be received at least partially in the first chamber (tube 2B) (see [0043], which recites “strip swab assembly 5B is inserted into swab tube 2B”); and
a vent (opening/vent 20 in [0043]) configured to control flow of a fluid from the first chamber (tube 2B) to the second chamber (test chamber 2C) by releasing air pressure in at least one of the first chamber (tube 2B) and the second chamber generated in response to the sample swab (strip swab assembly) being received in the first chamber (tube 2B) (see [0043], which recites “air is vented from test chamber 2C into test swab tube 2B via a vent opening (see opening/vent 20 of FIG. 3, which provides flow communication for air venting between test chamber 2C and swab tube 2B) … while being inserted, pressure from the compressed swab forces saliva into test chamber 2C, air is vented from test chamber 2C via opening/vent 20 into swab tube 2B where it may escape out the top, thereby reducing “back pressure” experienced by the user pushing swab assemblies 5A and 5B into housing 2”).
With respect to claim 50, Loudermilk teaches the device of claim 40, wherein, in response to the releasing of the air pressure, the fluid is allowed to flow from the first chamber (tube 2B) to the second chamber (test chamber 2C) (see [0043]).
With respect to claim 53, Loudermilk teaches the device of claim 40, further comprising a probe (one or more strips 7 in [0043]) disposed in the second chamber (test chamber 2C) ( (see also [0043], which recites “fluids are introduced into test chamber 2C of housing 2 so that the presence or absence of one or more target analytes (e.g., drugs, disease markers, etc.) may be detected based on the particular characteristics of the one or more strips 7”).
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 52 is rejected under 35 U.S.C. 103 as being unpatentable over Loudermilk (US20200383664) in view of Tan (US20110178427).
With respect to claim 52, Loudermilk teaches the device of claim 40 wherein the vent (opening/vent 20) includes an opening (vent opening in [0043]) of the housing (housing 2) (see [0043], which recites “air is vented from test chamber 2C into test swab tube 2B via a vent opening (see opening/vent 20 of FIG. 3, which provides flow communication for air venting between test chamber 2C and swab tube 2B”).
Loudermilk fails to teach or reasonably suggest that the vent includes a plug configured to allow air to pass therethrough.
In the analogous art of fluidic devices, Tan teaches a plug in (vent plug 900 a in [0064]) being configured to allow air to pass therethrough (see [0064], which recites “The vent plug location in each of these embodiments is such that no air can flow out of the flashback chamber 226 into the housing interior 220 without passing through the vent mechanism (900 a, b, c)”) (see Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as disclosed by Loudermilk such that the vent includes a plug in an opening of the housing, as disclosed by Tan, with a reasonable expectation of success, for the benefit of enabling air to pass through the vent while restricting passage of liquid through the vent (see [0063]-[0064] of Tan).
Claims 54 and 59 is rejected under 35 U.S.C. 103 as being unpatentable over Loudermilk (US20200383664) in view of Fabra (US20130244241).
With respect to claim 54, Loudermilk teaches the device of claim 40.
Loudermilk fails to teach or suggest the housing further includes a third chamber in fluid communication with the first chamber.
In the analogous art of fluidic devices, Fabra teaches a housing (cartridge housing 102 in [0112]) includes a third chamber (storage chamber in [0112]) in fluid communication with a first chamber (transfer chamber in [0112], which recites “the transfer chamber may align its inlet port to a second outlet port along the top of cartridge housing 102 to draw in another liquid stored in another storage chamber. This procedure may be repeated as many times as desired depending on the protocol necessary for the particular molecular test”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as disclosed by Loudermilk by incorporating a third chamber as disclosed by Fabra such that the housing further includes a third chamber in fluid communication with the first chamber with a reasonable expectation of success for the benefit of enabling fluid to be selectively transferred between chambers for performing a protocol of a particular test (see [0112] of Fabra).
With respect to claim 59, Loudermilk teaches the device of claim 40.
Loudermilk fails to teach that the vent is hydrophobic and is configured to retain the fluid in the second chamber.
In the analogous art of analytical devices, Fabra teaches a hydrophobic vent configured to retain fluid in a chamber (see [0050], which recites “vent/suction ports 212 is … allows the port to be either vented to atmosphere, or pressurized. The various ports may include a hydrophobic material … so as to prevent leakage through the ports in the absence of any applied pressure”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as disclosed by Loudermilk such that the vent is hydrophobic as disclosed by Fabra with a reasonable expectation of success for the benefit of preventing leakage of fluid through the vent in absence of applied pressure (see [0050] of Fabra).
Allowable Subject Matter
Claims 41-42, 44-45, 51 and 55-58 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.
In addition, claim 43 would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b), set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
With respect to claim 41, Loudermilk teaches the device of claim 40, wherein the housing (housing 2) includes a first opening (top of swab tube 2B, see [0052]) (see [0043], which recites “there is not a seal present at the top of swab tube 2B while swab assembly 5B is being inserted”) in fluid communication with the first chamber (tube 2B) and a second opening (opening/passage 23 in [0043]) in fluid communication with the second chamber (test chamber 2C);
wherein the sample swab (strip swab assembly 5B) is configured to seal the first opening (top of swab tube 2B).
Loudermilk fails to teach or reasonably suggests a flow path through the housing via the first opening, the first chamber, the second chamber and the second opening and wherein the vent is positioned in the second opening.
With respect to claim 43, Loudermilk teaches the device of claim 40.
Loudermilk fails to teach or reasonably suggests a base station configured to selectively activate the vent to contain or release the air pressure by covering or uncovering the plug, respectively.
With respect to claim 44, Loudermilk teaches the device of claim 40.
Loudermilk fails to teach or reasonably suggests the housing further includes a third chamber in fluid communication with the first chamber, and
wherein the vent is configured to control flow of the fluid from the first chamber to the third chamber, or
wherein the device further includes an additional vent configured to control flow of the fluid from the first chamber to the third chamber.
With respect to claim 45, Loudermilk teaches the device of claim 40.
Loudermilk fails to teach or reasonably suggest the housing further includes a channel between the second chamber and a second opening of the housing, wherein a length of a flow path through the channel is greater than a straight-line distance between the second chamber and the second opening.
With respect to claim 51, Loudermilk teaches the device of claim 40.
Loudermilk fails to teach or reasonably suggest that the housing further includes a first opening at a first end and a second opening at a second end, a channel being disposed between the second chamber and the second opening, the channel being configured to collect excess fluid from the first chamber in response to the flow of the fluid from the first chamber to the second chamber.
With respect to claim 55, Loudermilk in view of Fabra teaches the device of claim 54.
Loudermilk in view of Fabra fails to teach or reasonably suggest that the vent is configured to control, at least in part, flow of the fluid from the first chamber to the third chamber.
With respect to claim 56, Loudermilk in view of Fabra teaches the device of claim 54.
Loudermilk in view of Fabra fails to teach or reasonably suggest an additional vent that is configured to control, at least in part, flow of the fluid from the first chamber to the third chamber.
With respect to claim 57, Loudermilk teaches the device of claim 40.
Loudermilk fails to teach or reasonably suggest a base station configured to activate the vent to release the air pressure, wherein the vent is a plug including a cover on the plug, and the base station is configured to remove the cover on the plug to release the air pressure.
With respect to claim 58, Loudermilk teaches the device of claim 40.
Loudermilk fails to teach or reasonably suggest a base station configured to activate the vent to release the air pressure, wherein the vent is a plug including a cover on the plug, and wherein the base station is configured to remove the cover on the plug to release the air pressure in response to the sample swab being received in the first chamber.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN BORTOLI whose telephone number is (571)270-3179. The examiner can normally be reached 9 AM till 6 PM EST Monday through Thursday.
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, Lyle Alexander can be reached at (571)272-1254. 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.
/JONATHAN BORTOLI/Examiner, Art Unit 1797
Prosecution Insights