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 .
Information Disclosure Statement
No IDS has been filed.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action.
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) because the claim limitation 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 limitation is:
“liquid blocking element” in claims 11-20, which reads on a non-absorbent element configured to cover the porous membrane and apply pressure to the porous membrane to reduce absorption capacity (see paragraph [0156]) and known functional equivalents
Because this claim limitation is being interpreted under 35 U.S.C. 112(f), it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f), applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f).
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.
Claims 21-23 are rejected under 35 U.S.C. 112(bas 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.
Independent claim 21 states that “according to the water absorption function of the water absorption area, the porous membrane is provided to contact with different kinds of liquids for many times, whereby completing the test of the analyte in the liquid sample”. The meaning and scope of this phrase is unclear. It is not clear what kind of absorption effect is being described and what level of performance is required. For example, the term “the porous membrane is provided to contact with different kinds of liquids many times” may be taken to mean that the device is intended for repeated use over an extended lifespan in which many different tests are performed. Alternatively, the term may be interpreted to mean that the device receives different liquids during a single test and that the apparatus is a single-use device that is disposed after testing.
Claims 22 and 23 are rejected as being dependent on claim 21.
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.
Claims 1-10 and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lambert (WO 2006071247).
With respect to claims 1 and 21, Lambert discloses a device for testing an analyte in a liquid sample. The device includes a testing area (Figure 1:50) and a water absorption area (Figure 1:100) downstream from the testing area. A liquid sample (Figure 1:120) contacts the testing area and interacts with one or more first receptors (Figure 1:60, 80) immobilized on the testing area, wherein the receptors are capable of specifically binding to analytes (Figure 1:110) in the liquid sample. This is described in paragraph [0060]. The absorption area 100 is described as a wicking pad, and therefore functions to draw liquid away from the testing area via capillary forces.
With respect to claim 2, Lambert discloses the apparatus as described above. Lambert indicates that a plurality of different receptors (Figure 2:61, 62, 63) are immobilized onto the testing area to create an array. The receptors bind to different analytes (Figure 2:110A, 110B, 110C) in the liquid sample. This is taught in paragraph [0063].
With respect to claim 3, Lambert discloses the apparatus as described above. Lambert teaches that the testing area is located on a porous membrane (“test strip 10 with backing substrate 20 has a sample pad 30, conjugate pad 40, nitrocellulose membrane component 50”).
With respect to claim 4, Lambert discloses the apparatus as described above. Lambert indicates that the testing area 50 is formed on a nitrocellulose membrane that directly receives liquid sample from the sample pad and conjugate pad on a first end. Liquid flows through the nitrocellulose membrane to interact with the receptors, and is allowed to contact the absorption area at a second end of the nitrocellulose membrane.
With respect to claims 5-9, 22 and 23, Lambert discloses the apparatus as described above. The nature of the liquid added to the claimed device is not a structural feature of the device and does not further limit the claimed device. Rather, the liquid is added during a testing operation and therefore describes an intended use. Apparatus claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114.
With respect to claim 10, Lambert discloses the apparatus as described above. The nitrocellulose membrane of Lambert is fully capable of contacting different kinds of liquids.
Claims 1-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwind (WO 2005005991)1.
With respect to claims 1 and 21, Schwind discloses a device for testing an analyte in a liquid sample. The device includes a testing area (Figure 1:6) and a water absorption area (Figure 1:3) downstream from the testing area. A liquid sample contacts the testing area and interacts with one or more first receptors (Figure 1:I-VI) immobilized on the testing area, wherein the receptors are capable of specifically binding to analytes in the liquid sample (“identifying a number of analytes or the derivatives thereof in a liquid sample, consisting in the application of the sample to the charging zone (5) of a membrane (2) of the device…whereby this sample is present in an amount sufficient for causing the sample liquid to flow through the indicator zones toward the absorption area (3), and for causing the analytes or the derivatives thereof in the sample liquid to form a complex in the indicator zones”).
With respect to claim 2, Schwind discloses the apparatus as described above. Schwind indicates that a plurality of different receptors (Figure 1:I-VI) are immobilized onto the testing area to create an array. The receptors bind to different analytes in the liquid sample (“diagonally staggered point-shaped indicator zones 1-XI provided in defined X and Y positions, consisting of the following binding elements…”)
With respect to claim 3, Schwind discloses the apparatus as described above. Schwind teaches that the testing area is located on a porous membrane (Figure 2:2).
With respect to claim 4, Schwind discloses the apparatus as described above. Schwind indicates that the testing area 6 is formed on a porous membrane that directly receives liquid sample at a first end (Figure 2:5). Liquid flows through the porous membrane to interact with the receptors, and is allowed to contact the absorption area 3 at a second end of the nitrocellulose membrane.
With respect to claims 5-9, 22 and 23, Schwind discloses the apparatus as described above. The nature of the liquid added to the claimed device is not a structural feature of the device and does not further limit the claimed device. Rather, the liquid is added during a testing operation and therefore describes an intended use. Apparatus claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114.
With respect to claim 10, Schwind discloses the apparatus as described above. The porous membrane of Schwind is fully capable of contacting different kinds of liquids.
With respect to claims 11-20, Schwind discloses the apparatus as described above. Schwind additionally teaches that a liquid blocking element (Figure 2:4) is used to block or reduce the flow rate of a liquid added to the porous membrane. Schwind shows different configurations of the blocking element 4 across Figs. 1-15. In Figs. 14 and 15, the liquid blocking element 4a, 4b is located around the testing area in order to divide the porous membrane into a sample contacting area, a testing area and an area in contact with the absorption area. Figs. 5 and 6 show a different embodiment in which the liquid blocking element 4 creates a liquid reservoir located on the porous membrane and configured to directly receive a liquid.
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 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.
Claims 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lambert (WO 2006071247) as applied to claim 3, and further in view of Schwind (WO 2005005991) and Rachamim (US 20230062903).
Lambert discloses the apparatus as described above, however does not appear to teach a liquid blocking element.
Schwind discloses a device for testing an analyte in a liquid sample. The device includes a testing area (Figure 1:6) and a water absorption area (Figure 1:3) downstream from the testing area. A liquid sample contacts the testing area and interacts with one or more first receptors (Figure 1:I-VI) immobilized on the testing area, wherein the receptors are capable of specifically binding to analytes in the liquid sample (“identifying a number of analytes or the derivatives thereof in a liquid sample, consisting in the application of the sample to the charging zone (5) of a membrane (2) of the device…whereby this sample is present in an amount sufficient for causing the sample liquid to flow through the indicator zones toward the absorption area (3), and for causing the analytes or the derivatives thereof in the sample liquid to form a complex in the indicator zones”). Schwind additionally teaches that a liquid blocking element (Figure 2:4) is used to block or reduce the flow rate of a liquid added to the porous membrane. Schwind shows different configurations of the blocking element 4 across Figs. 1-15. In Figs. 14 and 15, the liquid blocking element 4a, 4b is located around the testing area in order to divide the porous membrane into a sample contacting area, a testing area and an area in contact with the absorption area. Figs. 5 and 6 show a different embodiment in which the liquid blocking element 4 creates a liquid reservoir located on the porous membrane and configured to directly receive a liquid.
Rachamim discloses a device for testing an analyte in a liquid sample. The device includes a testing area (Figure 1:122) and a water absorption area (Figure 3:“Absorption pad”) downstream from the testing area. A liquid sample contacts the testing area and interacts with one or more first receptors (Figure 1:120) immobilized on the testing area, wherein the receptors are capable of specifically binding to analytes in the liquid sample. A reaction liquid (Figure 1:160) may be added to the resting area to generate a detectable signal. Rachamim additionally teaches that a liquid blocking element is used to block or reduce the flow rate of a liquid added to the porous membrane. Rachamim specifically states that the flow rate should be reduced at the testing area to improve accuracy of the detection result (“Advantageously, reducing of the flow rate (e.g., when the analyte binds to a capture reagent) may improve in detection of the analyte relative to conventional lateral flow assays where flow of the analyte is not reduced upon binding of the analyte to a capture reagent”). See paragraphs [0029]-[0031] and [0062]-[0066].
Before the effective filing date of the claimed invention, it would have been obvious to provide the Lambert device with a liquid blocking element configured to divide the porous membrane into a plurality of different flow regions. Schwind teaches that a liquid blocking element provides the beneficial effect of preventing unwanted transfer of liquid across the test device (“the sealing element primarily has the effect of a liquid barrier and permits the directional distribution of sample liquid and test reagents into the porous membrane”). Rachamim further shows how the liquid blocking element should be utilized to reduce the flow rate of liquid at the testing area in order to extend contact time with receptors immobilized in the testing area.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Shin (US 20230031808), Momiyama (US 20110189063) and Gibboni (US 5447689) references teach the state of the art regarding methods for selectively reducing flow rate in a test strip.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
1 See provided English translation
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