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 group I, claims 1-18 in the reply filed on 1 May 2026 is acknowledged.
Applicant argues that “This election is made with traverse for the following reasons. The invention of group I and the invention of group II are not mutually exclusive. Moreover, the inventions as claimed are capable of use together. Granted, the modular test swab control system of group I requires an overflow reservoir, which is not required of the system of group II. And, granted, the modular test swab control system of group II requires the top plate having a downwardly extending flex plate, which is not required of the system as set forth in independent claim 1 of group I (but is required in dependent claim 11). However, none of this makes the invention of group I and the invention of group II mutually exclusive. Indeed, contrary to the assertion of the Examiner, the modular test swab control systems of group I and group II can be used together. See, for example, in FIG. 4 of the instant application, wherein the downwardly extending flex plate 50 and the overflow reservoir 51 are used together. See also, for example, claim 11 of group I, which recites “wherein the top plate further comprises a flex plate extending downwardly …” (Response to Election/Restriction, pg. 9, par. 2).
The argument that the invention of group I and the invention of group II are not mutually exclusive is persuasive; therefore, the restriction requirement is withdrawn.
Claims 1-20 are examined herein.
Claim Interpretation
Claims 1-14 and 19-20 recite a modular test swab control system. The intended use of this system is interpreted in light of the specification as a modular test swab control system designed to perform rapid lateral flow immunoassay (LFIA)-type tests or other swab-based tests in a portable setting. The system fully integrates all the necessary components for the rapid detection of target analytes that are collected on a fiber swab. The system is configured so that a test result is visible on an immunochromatographic test strip that is visible through a "results" window in the system. ([0001]).
The following is a quotation of 35 U.S.C. 112(f):
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are “a test swab receiver assembly configured to hold and retain the test swab head” in claim 1 and a test swab retention module configured to hold and retain a test swab head and test sample-entraining liquid in claim 19.
The limitation meets the three-prong test as follows:
The generic placeholders are “receiver assembly” and “retention module”.
The functional language that modifies the generic placeholder is “configured to hold and retain”.
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed functions. No structural limitations are provided in the claims for performing the function.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof of holding and retaining the test swab head.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-14 are 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 1 recites that the lid selectively covers the swab head and the assembly holds/retains the swab head but it's unclear if the components are providing the same function or if there is a missing structural correlation between the claimed lid and assembly. It is also unclear if the lid is part of the assembly.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claims 1-4, 7-14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Niedbala et al. (PGPub 20030064526) as evidenced by Irmscher et al. (PGPub 2019034426).
Regarding claim 1, 7, and 9, Niedbala teaches a sample collector and test device for performing a lateral flow test ([0007]). The sample collector (10) (Fig. 1) is the test swab (12) of instant disclosure.
The test swab-retaining and lateral flow cassette modules are combined in a single cassette (100) placed in a housing module (108) (Fig. 1). The housing provides a circular entrance opening (166) for receipt of the sample collector (Fig. 1 and [0049]), which is functionally equivalent to the test swab receiver assembly of instant disclosure configured to hold and retain the test swab head.
The cassette (100) comprises an upper housing (121) (Fig. 7) and a lower housing (130) (Fig. 6) structurally equivalent to the top plate and base plate of instant disclosure. The upper housing comprises a viewing window (184) (Fig. 1), which is structurally equivalent to the test results window of instant disclosure.
The lower housing (130) comprises a platform (183a) (Fig. 6), which supports the test strip (194) sandwiched between the upper housing (121) and the lower housing (130).
The platform (183a) is raised above the surface of the lower housing (130) providing space for fluid overflow, which is structurally equivalent to the overflow reservoir of instant disclosure.
The sample collector (10) comprises a sponge (90) (Fig. 1) at the collector end, which absorbs a fluid sample. The collector is inserted into the opening (166) for transfer of the sample into cassette (100) ([0034]). Figs. 9-11 demonstrate the collector inserted into the cassette, where the sponge (90) (Fig. 11) comes into contact with the sample receiving portion of assay strip (194) (Fig. 9). The sample is delivered to the assay strip (194) by compressing the sponge (90) and squeezing out the sample-entraining liquid.
These structural elements meet the wherein clauses of claim 1 reciting wherein the system is structured so when the test swab head is hydrated, sample-entraining liquid flows from the test swab head down through the test swab receiver to the immunochromatographic test strip so that a test result is visible through the test results window in the top plate and claim 19 reciting wherein the system is structured so when the test swab head is hydrated, sample-entraining liquid flows downwardly from the test swab head to the immunochromatographic test strip so that a test result is visible through the test results window in the top plate.
Niedbala does not specifically teach a test swab-retaining lid selectively covering a test swab head of claim 1 and the test swab retaining lid comprises a hinged lid of claim 7, and the test swab receiver assembly comprises a hood that has a concave surface so that the test swab receiver cradles the test swab head of claim 9. The function of the lid that can be selectively closed is to protect the test swab head and secure the test swab in the test swab receiver (Specification [0009]). Niedbala teaches the cassette (100) designed in such way that the protection of the sponge (90) and securing it in the cassette (100) is achieved by: (a) specific design of the sample collector, wherein a plug (40) (Fig. 2) protects the sponge from the top and (b) walls (172) (Fig. 8) and walls (120a) and (120b) (Fig. 7) secure the sample collector in the cassette. As such, the plug (40) and the walls (172), (120a), and (120b) of Niedbala form a structure capable of performing the protection and securing function of the lid of instant disclosure. The walls (172), (120a), and (120b) provide cradling of the sponge (90). If the prior art structure is capable of performing the intended use function, then it meets the claims.
Niedbala does not specifically teach a lateral flow cassette module selectively attached to the test swab retention module. However, MPEP 2144.04 instructs that making parts separable is obvious. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose."). In instant case the lateral flow cassette module selectively attached to the test swab retention module would still perform the same function as the module attached permanently and the structure elements of such module pertinent to its function would not be different in its selectively or permanently attached variants.
Regarding claim 2 and 3, Niedbala teaches that the sponge (90) (fig. 1) at the collector end when inserted into the opening (166) for transfer of the sample into cassette (100) is surrounded by the walls (172), (120a), and (120b) (Fig. 7), which are structural equivalents of the swab seat and swab receiver of instant disclosure. The sponge is completely enveloped by the walls and plug (40) (Fig. 2). As can be seen on Figs. 9-11 the walls (172), (120a), and (120b) enclose the sponge (90) at least partially, meeting the corresponding limitation of claim 3.
Regarding claim 4, Niedbala teaches that entrance opening (166) provides access to a well area formed by a well portion (108) (Figs. 9-11) of housing (102) for retaining the collected sample expressed from the sample collector. The bottom of the well (108) is a structural equivalent of the outlet port of instant disclosure, because it lets the sample to flow from the sponge to the test strip (194) (Fig. 9).
Regarding claim 8, Niedbala does not specifically teach the test swab head can be disconnected from a test swab stem when the test swab head is positioned in the test swab receiver. However, MPEP 2144.04 instructs that making parts separable is obvious. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose."). In instant case the sample collector handle (12) (Fig. 1) could be made breakable if it were considered desirable. Additionally, Irmscher provides evidence that most cotton swabs are provided with a predetermined breaking point ([0210]).
Regarding claim 10, Niedbala teaches the cassette (100) comprises the circular entrance opening (166) for receipt of the sample collector (Fig. 1 and [0049]) and the walls (120a) and (120b) (Fig. 7). Together, the circular entrance opening (166) and the walls (120a) and (120b) form a receiving end that funnels the sample to the test strip, meeting the corresponding limitation of claim 10.
Regarding claims 11 and 19, Niedbala does not specifically teach a top plate having a downwardly extending flex plate for holding the test strip in position during a test. However, Niedbala teaches that the test strip (194) is sandwiched between the upper housing (121) and the platform (183a) of the lower housing (130). As can be seen on Fig. 7, the viewing window (184) is formed by a protruding downward from the upper housing (121) wall-like structure that presses down on the test strip and holds the test strip. The wall-like structure secures the test strip along the entire length of the viewing window. If the prior art structure is capable of performing the intended use function, then it meets the claim.
Regarding claim 12, Niedbala does not specifically teach raised platform comprises a sample pad platform, an intermediate platform, and a terminal platform. Niedbala teaches the lower housing (130) comprises a platform (183a) (Fig. 6) for supporting the assay strip, which supports the test strip sandwiched between the upper housing (121) and the lower housing (130). Additionally, the reference teaches that the beginning of the test strip (194) extends into the well (108) space and is supported on that end by ramp (146) (Fig. 6). As such, Niedbala teaches that the raised platform supporting the test strip comprises two parts: the ramp (146) and the platform (183a).
MPEP 2144.04 instructs that making parts separable is obvious. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose."). In instant case the platform (183a) could be split into two parts to support the intermediate and terminal areas of the test strip if it were considered desirable.
Regarding claims 13-14, Niedbala teaches the test strip (194) is sandwiched between the upper housing (121) and the lower housing (130), and supported by the platform (183a), the ramp (146), and the ramp ledge (146a) (Fig. 6). Additionally, the test strip is supported from side movements by the walls (144a) and (144b) in the sample receiving region of the strip and by two wall-like structures in the terminal end of the strip (see two left-to-right arrows in the insert below). The longitudinal movements of the strip are limited by the wall (138a) in the lower housing (130) (Fig. 9) and a wall-like structure in the terminal end of the strip (see one right-to-left arrow in the insert below). Therefore, Niedbala teaches that the test strip is well supported from multiple directions and to be held in position during a test.
The three wall-like structures indicated in the terminal part of the platform (183a) in the insert below form a collar-like structure that supports the test strip; therefore, the collar-like structure in Fig. 6 meets the claim. The specification fails to disclose the function of the collar.
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Regarding claim 20, Niedbala teaches the lower housing (130) comprises a platform (183a) (Fig. 6), which supports the test strip sandwiched between the upper housing (121) and the lower housing (130), meeting the limitation reciting wherein the base plate further comprises at least one raised platform, the immunochromatographic test strip being sandwiched between the flex plate and the raised platform.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Niedbala as applied to claim 4 above, in view of Nguyen (PGPub 20220065842).
The teachings of Niedbala have been set forth above.
Niedbala does not teach a frangible membrane and the lateral flow module comprises upwardly extending teeth to puncture the frangible membrane.
Regarding claims 5 and 6, Nguyen teaches immunoassay devices for testing liquid specimens, and more particularly devices for collection, storage, and preliminary screening of materials such as pathological, forensic, and/or environmental specimens ([0001]) and analyzing specimens using chromatographic strips (Abstract) without having to open the vessel or contact its contents ([0009]). Nguyen also teaches a frangible membrane and the lateral flow module comprises upwardly extending teeth to puncture the frangible membrane.
Specifically, Nguyen teaches collection vial (10) with an aperture forming a drain (14) in the closed bottom of the vial that can be sealed by a removable barrier (17) (Fig. 2). The barrier may be a frangible web of glass, foil, or plastic ([0039]). The sample solution (70) from the vial is delivered to the test strip using a pintle (32) that projects upwardly from the post in alignment with the drain (14) of the vial so that it can puncture and thus break the barrier (17) when the vial is forcibly pushed all the way down into the compartment. When this occurs, the solution (70) in the vial flows down and contacts the bottom portion of the test strip (42) (Fig. 3 and [0044]). The pintles of Nguyen are interpreted as teeth of claim 6 in light of the specification disclosing a set of upwardly extending "teeth" or other means (spikes, blades, etc.) of puncturing the frangible membrane ([0037]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Niedbala, by employing a frangible seal as taught by Nguyen, in order to be able to analyze specimens without having to open the vessel or contact its contents (Nguyen [0009]). One having ordinary skill in the art would have been motivated to make such a change because Niedbala teaches that effective seal of the collected sample within the test device helps minimize the instances where an administer of the test may come into contact with the collected sample (Niedbala [0008]). The use of such combination would have been desirable to those of ordinary skill in the art for the reasons mentioned above.
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because Niedbala and Nguyen as similarly drawn to sample analysis by lateral flow assays and Nguyen teaches application of this approach to liquid samples in vials analyzed by lateral flow.
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
Claims 15-18 are free of the prior art.
The methods of conducting lateral flow immunoassay tests of claims 15-18 are not known in the art. The prior art neither teaches nor suggests the methods of conducting lateral flow immunoassay tests using: (a) a test swab retaining lid of claim 1 is not known in the prior art as a separate structure - Niedbala teaches a functionally equivalent structure that cannot be opened; therefore, step (c) of claim 15 reciting opening the test swab retaining lid cannot be rejected as obvious; and (b) the lateral flow cassette module selectively attached to the test swab retention module of claim 1 is not known in the prior art as a selectively attached structure - Niedbala teaches the test swab receiver assembly combined with the lateral flow cassette module in one housing; therefore, step (e) of claim 18 reciting connecting the test swab retaining module to a lateral flow cannot be rejected as obvious.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (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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/ALEXANDER ALEXANDROVIC VOLKOV/Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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