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 .
Status of claims
Claim 1 remains pending in the application.
Drawings
Figures 1A and 1B should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weigl (US-2019/0126265-A1) in view of McNeely (US-2017/0087517-A1).
Regarding claim 1, Weigl teaches a device comprising:
a base support (backing 1012) ([0081], Figure 10);
disposed on the base support (1012), a first membrane (diversion pad 1004) and a second membrane (sample pad 1006) defining a gap therebetween ([0081], Figure 10, [0082] describes that instead of a fluid impermeable barrier a flow limiting structure can be placed between diversion pad 1004 and sample pad 1006, thus there will be a gap between diversion pad 1004 and sample pad 1006 defined on the backing 1012);
a bridge cover (loading pad 1008) disposed above the gap and extending from the first membrane (1004) to the second membrane (1006) ([0081], Figure 10); and
[0078] of Weigl describes a loading pad formed of cellulose, high-density cellulose, glass, polyester, nylon, cotton, mono-component fiber, or bi-component fiber, and describes that the loading pad is formed from a material that rapidly takes up sample fluid applied to the loading pad. One skilled in the art would find it obvious that the loading pad being formed of a material that rapidly takes up sample fluid applied to it would be hydrophilic.
a soluble matrix (flow limiting structure) in contact with the first membrane (1004) and an underside of the bridge cover (1008), ([0081] describes Figure 10 to have a fluid impermeable barrier 1002, where [0082] describes instead of a fluid impermeable barrier, flow limiting structure includes a dam formed from a dissolvable material where the dissolvable material is dissolvable by the sample fluid. Therefore, when the flow limiting structure is dissolvable, it will have the same structure as 1002 seen in Figure 10.
While Weigl does describe that the flow limiting structure is dissolvable, it is unclear if it possesses a capillary drawing force sufficient to draw liquid out of the first membrane and into the soluble matrix, causing the soluble matrix to at least partially dissolve or disintegrate in the liquid, whereby the liquid is released into a space defined between the bridge cover and the base support and caused to pass across the gap to be reabsorbed into the second membrane.
In the analogous art of soluble matrixes that dissolve, McNeely teaches a soluble porous material with capillarity where liquid must enter the pores of the soluble matrix before it dissolves so that the liquid is on both sides of the junction between the initial membrane and soluble matrix (McNeely; [0060]).
It would have been obvious to one skilled in the art to modify the dissolvable flow limiting structure of Weigl such that it has a porosity (and thus capillary drawing force) as taught by McNeely because McNeely teaches that a soluble matrix with pores that dissolves is useful for drawing liquid out of a membrane (McNeely; [0016], [0060]).
Based on Figure 10 and [0081]-[0082] of Weigl and McNeely, sample will be placed onto loading pad 1008 and will travel to both diversion pad 1004 and sample pad 1006 where one skilled in the art would find it obvious that liquid will enter the pores of the flow limiting structure from the sides contacting the diversion pad, sample pad, and loading pad, where as the dissolvable flow limiting structure dissolves some amount of fluid from the diversion pad will be in the space that was once occupied by the flow limiting structure and that fluid can pass to the sample pad. Further, the gap as stated above is defined on the backing 1012 where there is neither the diversion pad nor sample pad, where “the space” is the area defined between the gap and the underside of the loading pad 1008.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gasperino (US-2016/0084796-A1) teaches a lateral flow assay 100 that has at least one hydrophilic porous layer 110, where it is seen in Figure 1A and 1B that there are two hydrophilic porous layers 110 separated by a gap 115 (Gasperino; [0025]).
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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