DETAILED ACTION
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 2/2/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 5, 15-16, 18-19, 21-23, 25, and 27-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allegra et al. (WO 2019/178247 A1, hereinafter Allegra).
For claim 1, Allegra discloses a sample collection device (Fig 2A) ([0081-0086]), comprising:
a housing (200) extending from a first portion (230) to a second portion (one-way valve [0084]), the housing defining a fluid channel from the first portion to the second portion (Fig 2A) ([0081-0086]), wherein the first portion is configured to receive an exhalation airflow (Fig 2A) ([0081-0086]);
a porous sample collection media (220) comprising a nonwoven filtration layer having a neutral electrostatic charge and disposed within the housing and in fluid communication with the fluid channel (Fig 2A) ([0081-0086]);
a fluid inlet port (222) defining a hole through the housing and disposed in fluid communication with the porous sample collection media (Fig 2A) ([0081-0086]), wherein the fluid inlet port is configured to direct a test fluid (204) onto the porous sample collection media (Fig 2A) ([0081-0086]);
a metered fluid dose element (202) movably attached to the fluid inlet port and configured to dispense a metered dose of the test fluid into the fluid inlet port (Fig 2A) ([0081-0086]); and
an assay (210) disposed within the housing and contacting the porous sample collection media (Fig 2A) ([0081-0086]), wherein the assay is configured to receive fluid from the porous sample collection media (Fig 2A) ([0081-0086]).
For claim 2, Allegra discloses the sample collection device of claim 1, wherein the housing further comprises a screen (filter in [0084]) disposed between the fluid channel and the assay (Fig 2A) ([0081-0086]), and wherein the screen is configured to prevent direct fluid communication between the exhalation airflow and the assay (Fig 2A) ([0081-0086]).
For claim 5, Allegra discloses the sample collection device claim 1, wherein the housing comprises:
a first housing part (230) comprising the first portion and the second portion, the first housing part further defining the fluid channel from the first portion to the second portion (Fig 2A) ([0081-0086]); and
a second housing part (right part of 200) (Fig 2A) ([0081-0086]) engaged with the first housing part and comprising the fluid inlet port (Fig 2A) ([0081-0086]), wherein the porous sample collection media and the assay are disposed within the second housing part (Fig 2A) ([0081-0086]), the second housing part further defining one or more apertures (218) disposed in fluid communication with the porous sample collection media and configured to allow the exhalation airflow to pass through the porous sample collection media (Fig 2A) ([0081-0086]).
For claim 15, Allegra discloses the sample collection device of claim 1, wherein the housing further comprises a display window (214) configured to allow visual inspection of at least a portion of the assay (Fig 2A) ([0081-0086]).
For claim 16, Allegra discloses the sample collection device of claim 1, further comprising a screen (filter in [0084]) disposed in the housing and upstream of the porous sample collection media (Fig 2A) ([0081-0086]), wherein the screen includes one or more flow apertures therethrough (Fig 2A) ([0081-0086]).
For claim 18, Allegra discloses the sample collection device of claim 1, wherein the fluid inlet port comprises a protrusion extending away from an outer surface of the housing (Fig 2A) ([0081-0086]).
For claim 19, Allegra discloses the sample collection device of claim 1, wherein the metered fluid dose element is movably attached to the fluid inlet port via a threaded connection (Fig 2A) ([0081-0086]).
For claim 21, Allegra discloses the sample collection device of claim 1, wherein the porous sample collection media includes a surface area and the metered fluid dose element comprises a fluid reservoir having a volume (Fig 2A) ([0081-0086]), and wherein the volume divided by the surface area is in a range from 10 microliters/cm2 to 400 microliters/cm2.
For claim 22, Allegra discloses the sample collection device of claim 21, wherein the volume of the fluid reservoir is in a range from 50 microliters to 500 microliters (Fig 2A) ([0081-0086]).
For claim 23, Allegra discloses the sample collection device of claim 1, wherein the porous sample collection media comprising the nonwoven filtration layer inherently has an electrostatic charge (Fig 2A) ([0081-0086]).
For claim 25, Allegra discloses the sample collection device of claim 1, wherein the test fluid is at least one of an aqueous fluid, an aqueous buffer solution, an aqueous fluid including a surfactant, a saline solution, or a saline solution including a surfactant (Fig 2A) ([0081-0086]).
For claim 27, Allegra discloses the sample collection device of claim 1, wherein the assay is fixedly attached to the porous sample collection media (Fig 2A) ([0081-0086]).
For claim 28, Allegra discloses the sample collection device of claim 1, wherein the assay is configured to detect virus or pathogen presence in the exhalation airflow ([00148].
For claim 29, Allegra discloses the sample collection device of claim 1, wherein the assay is a lateral flow assay (Fig 2A) ([0081-0086]).
For claim 30, Allegra discloses the sample collection device of claim 1, wherein the assay is a vertical flow assay (Fig 2A) ([0081-0086]).
For claim 31, Allegra discloses the sample collection device of claim 5, wherein one of the first portion and the second portion is a mouthpiece portion and the other of the first portion and the second portion is an air outlet portion (Fig 2A) ([0081-0086]).
For claim 32, Allegra discloses a method for testing an exhalation airflow (Fig 2A) ([0081-0086]), the method comprising:
coupling a porous sample collection media (220) with an assay (210), such that the assay is configured to receive a fluid from the porous sample collection media (Fig 2A) ([0081-0086]), the porous sample collection media comprising a nonwoven filtration layer having a neutral electrostatic charge (Fig 2A) ([0081-0086]);
receiving the porous sample collection media and the assay within a housing (200), the housing defining a fluid channel configured to receive the exhalation airflow (Fig 2A) ([0081-0086]);
flowing the exhalation airflow through the porous sample collection media (Fig 2A) ([0081-0086]), wherein the porous sample collection media is disposed in fluid communication with the fluid channel and forms a loaded porous sample collection media (Fig 2A) ([0081-0086]);
flowing a metered dose of 50 microliters to 400 microliters of a test fluid (204) through the loaded porous sample collection media disposed in the fluid channel forming an eluent (Fig 2A) ([0081-0086]); and
collecting and testing, by the assay, the eluent (Fig 2A) ([0081-0086]).
For claim 34, Allegra discloses the method of claim 32, wherein testing the eluent comprises detecting a presence of virus or pathogen in the eluent ([00184]).
For claim 35, Allegra discloses the method of claim 32, further comprising a metered fluid dose element (202) that is detachably connected to a fluid inlet port of the housing (Fig 2A) ([0081-0086]).
Response to Arguments
Applicant's arguments filed 2/2/26 have been fully considered but they are not persuasive. Applicant argues the 102 rejection under Allegra, specifically arguing the following:
“there is no mention in the specification of Allegra et al. of a nonwoven filtration layer and particularly, Allegra et al do not disclose, suggest, or teach a nonwoven filtration layer having an electrostatic charge. By contrast, claims 1 and 32 of the present invention require a porous sample collection media including a nonwoven filtration layer having an electrostatic charge. This nonowoven filtration layer having an electrostatic change of the present invention is configured to filter pathogens from the exhalation airflow. (Page 9, paragraph [0067]). Without the electrostatic charge, the force of just exhalation airflow, as used in the present invention, would not be enough to get the needed filtration. Rather, a filter, such as the one taught in Allegra et al., would require an external air moving device, such as a pump. (See, for example, Page 25, para. [0076]). Allegra et al do not disclose, suggest, or teach a nonwoven filtration layer having an electrostatic charge”
In response the Examiner respectfully disagrees and notes the following:
As broadly as structurally and/or functionally claimed and absent any special definition in the instant Specification upon which Applicant does not appear to rely, Allegra’s reaction chamber 220 may fairly and reasonably be considered at least “porous sample collection media comprising a nonwoven filtration later having an electrostatic charge”, particularly absent any structural and/or functional limitations to the contrary. Chamber 220 is porous to receive, collect, filter, and transmit a breath sample. Chamber 220 is not woven and would at least inherently have a neutral electrostatic charge. The claims are not specific to any positive, negative or degree of electrostatic charge present on the nonwoven filtration layer. Allegra’s reaction chamber is at least the structural equivalent of the claimed “porous sample collection media”.
The Examiner respectfully notes the open-ended inclusive nature of the transitional phrase comprising in the claims, not precluding additional elements. See MPEP 2111.03(I). Thus, the requisite use of an air moving device or pump does not preclude portions of Allegra’s device/method from reading on the claimed invention.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “configured to filter pathogens from the exhalation airflow” and/or “the electrostatic charge is needed to get filtration”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. 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.
Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Prosecution Insights