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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/08/2026 has been entered.
Status of Claims
Claims 45 and 48-50 have been amended. Claims 45-46 and 48-69 are pending and have been examined.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 48 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 48 recites “the sample feeding area” and there is no antecedent basis for this limitation as no sample feeding area is currently claimed in any of the claims from which claim 48 depends.
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.
Claim(s) 45-46 and 48-59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fuller et al. (US 2016/0121322, Pub Date: 05/05/2016, hereinafter “Fuller”).
Regarding claim 45, Fuller teaches a device for detecting a presence of an analyte in a fluid sample (abstract and Figure 2), comprising: a carrier element (second body portion 116); the carrier element including a testing element (test strips 108) and a carrier body carrying the testing element, the carrier body defining a fluid inlet at one end and a recessed area adjacent to the fluid inlet, the recessed area forming a chamber in which liquid is received during use (carrier body interpreted as the interior of body portion 116 carrying the strips 108, which defines a fluid inlet at portion 200a of Figure 3 that receives the collection sponge and a recessed area adjacent to the fluid inlet is interpreted as the recess area at 202a; paragraph 0100, oral mixture is drawn through recess 202); and a baffle being in the chamber formed by the recessed area (see 172a of Figure 3), wherein the baffle comprises a transverse dividing element (divider 172a), the dividing element divides the chamber into a first area (area upstream of divider 172a) and a second area (area downstream of divider 172a), and the first area is arranged between the dividing element and the fluid inlet (area between divider 172a and cavity 200).
Although Fuller does not specifically teach that excessive fluid flowing into the first area from the fluid inlet encounters the dividing element and then flows into the second area, and the claims are drawn to the device itself, such functional limitations would not correspond to any structural differences in the claimed product. For these reasons, the recitations do not clearly invoke any additional structural limitations of the device itself, particularly when the claims are given their broadest reasonable interpretation. As such, this language is directed to the intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, as long as the baffle dividing element (172a) is capable of encountering excess fluid, it reads on the claims. Fuller teach that the device includes a baffle meeting all the structural requirements of claim 45, therefore, these features would appear to necessarily have the capability of allowing excess fluid to flow from the first area to the dividing element and then to the second area, as claimed.
Regarding claim 46, Fuller teaches the device wherein the device further comprises a diversion element, the diversion element being adjacent to the fluid inlet (see Figure 8, collection sponge 112).
Regarding claim 48, Fuller teaches the device wherein one end of the diversion element is arranged at the first area, and the other end thereof covers a part of the sample feeding area (see Figure 8, collection sponge arranged at the interpreted first area and on upstream area of test strip; paragraph 0079, strips 108 directly contact collection sponge 112).
Regarding claim 49, Fuller teaches the device wherein the second area is configured to receive a fluid sample or configured to receive excessive fluid sample flowing to the outside of the diversion element (Figure 13, second area receives sample as it flows through test element).
Regarding claim 50, Fuller teaches the device wherein one end of the diversion element covers the fluid inlet, or a part of the diversion element in the first area covers the fluid inlet (see Figures 3, 6 and 8 – collection sponge 112 partially covering area interpreted as inlet).
Regarding 51, Fuller teaches the device wherein the device comprises a collector, and the collector (cap assembly 104) comprises an absorbing element and a connecting rod (see Figure 2, absorbing element 112 and connecting rod 244).
Regarding claim 52, Fuller teaches the device wherein the collector and the carrier body are detachably connected with each other (see Figure 2 – cap assembly 104 detaches from body 102).
Regarding claim 53, Fuller teaches the device wherein the device further comprises an accommodating element (see Figure 2, first body portion 114), the accommodating element comprises an accommodating chamber (first end 124), and the carrier element is arranged in the accommodating chamber (first body portion 114 mates with the claimed carrier element – interpreted as second body portion 116).
Regarding claim 54, Fuller teaches the device wherein the carrier element is configured to be inserted in the accommodating chamber in only one direction (see Figure 2, mating between first and second body portion).
Regarding claim 55, Fuller teaches the device wherein the accommodating chamber further comprises a connecting element (cap engagement portion 122), the connecting rod of the collector is detachably connected to a guiding channel of the carrier through the connecting element (plunger 244 is detachably connected to the channels of 202 of the carrier through the cap engagement portion 122).
Regarding claim 56, Fuller teaches the device wherein the connecting element further comprises a thread structure (paragraph 0037).
Regarding claim 57, Fuller teaches the device wherein the carrier body defines at least one vent hole communicated to the outside atmosphere (vent portion 130).
Regarding claim 58, Fuller teaches the device wherein the testing element is covered by a transparent thin film (paragraph 0041).
Regarding claim 59, Fuller teaches the device wherein the fluid sample is saliva (paragraph 0081).
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.
Claim(s) 60-69 are rejected under 35 U.S.C. 103 as being unpatentable over Fuller et al. (US 2016/0121322), as applied to claim 45 above, and further in view of Cope (US 5,658,531).
Regarding claims 60-69, Fuller teaches the device as described above comprising: a carrier element (second body portion 116): the carrier element including a testing element (test strips 108) and a carrier body carrying the testing element, the carrier body defining a fluid inlet at one end and a recessed area adjacent to the fluid inlet, the recessed area forming a chamber in which liquid is received during use (carrier body interpreted as the interior of body portion 116, which defines a fluid inlet at portion 200a of Figure 3 that receives the collection sponge and a recessed area adjacent to the fluid inlet is interpreted as the recess area at 202a; paragraph 0100, oral mixture is drawn through recess 202); and a baffle being in the chamber formed by the recessed area (see 172a of Figure 3).
While Fuller fails to explicitly teach the receiving device of claims 60-69, Cope teaches a disposable assay device (abstract). Regarding claim 60, Cope teaches a receiving device (Figure 2, column 4, lines 31-45), comprising a chamber (internal area bounded by 10; Figure 2, 1A) and the chamber comprises a first sealed chamber that is configured to accommodate a treatment solution (12 containing 14; Figure 2, 1A; column 4, lines 31-45, column 3, lines 11-41) and a piercing element that is movable in the chamber; and the sealed space comprises the first sealed chamber (piercing of 16 by 28; Figure 2; column 4, lines 31-45; column 3, lines 62-64). Regarding claim 61, Cope teaches wherein the piercing element forms an air sealed space so that the air in the sealed space can be compressed in the chamber of the receiving device (space within 10 sealed by 32, Figure 2; column 4, lines 31-45 and column3, lines 23-41). Regarding claim 62, Cope teaches the chamber of the receiving device comprises a second chamber (Figure 2, arrangement of 28 within space between 16 and 32), a partial part of the piercing element is arranged in the second chamber, and at least part of the sealed space that is compressed is arranged in the second chamber (Figure 10, 32 sealing space within 10).
Regarding claim 63, Cope teaches the piercing element has a first position (position of 28 in Figure 2) and a second position in the second chamber of the receiving device (Figure 2, entry of 28 into 12; column 4, lines 31-45; column 3, line 62 – column 4, line 3).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute for the cap assembly of Fuller, a receiving device as taught by Cope because it would have been no more than the simple substitution of one sampling device for another in order to transfer fluids to the testing portion of the device for analysis.
Regarding the functional limitations of claims 61 and 64-69, although Fuller in view of Cope do not teach these specific functional limitations, such limitations are drawn to intended use of the device and therefore the prior art only need to be capable of performing the recited intended use. So long as the chambers and piercing element of Fuller in view of Cope are capable of performing the recited intended uses (e.g., treatment solution enters first chamber by increased pressure, fluid forms a first mixed solution when piercing element is at a second position, increased pressure forces mixed solution to pass through absorbing element, etc.), it reads on the claims. Fuller in view of Cope teach the same structural limitations as recited in the claims, therefore they are considered capable of performing the same intended use.
Response to Arguments
Applicant’s arguments filed 06/08/2026 have been considered but are not found to be persuasive. Applicant argues that Fuller fails to describe the claimed baffle since item 172a of Fuller, that is interpreted as the claimed baffle dividing element, is just a bridge that retains the test strip. While Applicants have incorporated more structure of the baffle/dividing element into claim 45 that was previously recited in claim 47, the device of Fuller remains anticipatory as the structural components are all present. While Fuller does not explicitly teach the intended use limitation involving the excessive fluid flow, Fuller only needs to be capable of performing this intended use. Even though the component 172a is utilized as a bridge, it is still maintained that if enough fluid were introduced into the device of Fuller from the 1st area, the test strip would also be overwhelmed with excess fluid and some amount of fluid would be capable of flowing into the second area downstream from 172a. Examiner further recommends looking to specification paragraph 0115, referenced in applicant’s remarks, that provides additional structural details of the baffle (relative width/height requirements, presence of notch, shape, etc.) that allows the claimed feature to perform the claimed functions and that could further structurally distinguish from the invention of Fuller.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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