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 .
Remarks
This Office Action fully acknowledges applicant’s remarks filed 06/04/2026. Claims 1-6 and 8-17 are pending. Claims 1, 5, 8, 9, and 13 have been amended. Claim 7 has been cancelled. Claims 15-17 are newly added.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 8, and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 8 each recite that the second porous layer comprises “an ordered array of pores”; however, applicant’s specification merely discloses “an ordered array-like porous layer” in the last sentence on page 3.
It is unclear what is intended by the expression “an ordered array-like” compared to what the applicant considers to be an ordered array of pores. It is also unclear how the term “like” is interpreted by applicant to structurally modify an “ordered array” and/or “array”. Applicant’s specification merely states “an ordered array-like porous layer”, but does not define a structure associated with “an ordered array-like porous layer”. Thus, Applicant’s disclosure does not support the limitation “an ordered array of pores” as recited in claims 1 and 8. Claims 2-6 and 16 are rejected as being dependent on claims 1 and 9.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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.
1. Claims 1-6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2005/0196875 to Blatt et al.
Blatt et al. teaches a lateral flow device that includes a sample treatment zone that includes two or more layer including a depth filter material 26 (such as glass fiber, metal fiber, synthetic fiber, paper, or natural or synthetic fabric) and a membrane 28 (such as S&S cellulose acetate, nitrocellulose, regenerated cellulose having an average pore size of from about 0.2 µm to about 7 µm; and Nucleopore or Poretics polycarbonate at pore sizes of about 0.2 µm to about 5 µm. these different filter materials read on applicant’s claimed first and second porous layers. [0079]
These two or more layers of the depth filter material and membrane read on applicant’s filter membrane having first and second porous layers.
Blatt et al. further teaches a porous member that reads on applicant’s carrier membrane and which includes zones 16 and 18 that read on a test line and control line. (Fig. 4)
The porous member includes an a bibulous strip 12 that wicks and reads on applicant’s absorbent pad. [0050]
As to the newly added limitation to claim 1 which recites that the second porous layer comprises an “ordered array of pores,” looking to applicant’s original disclosure for interpreting the term “ordered array of pores” reveals that applicant only discloses “an ordered array-like porous layer,” but does not support or disclose an “ordered array of pores.”
The second membrane of Blatt et al. is interpreted as being an ordered array-like porous layer in that the pores can be spaced apart in multiple directions, howbeit randomly. The pores of Blatt et al. would form and function like a simple sieve.
I.) Regarding applicant’s claim 1, as noted above Blatt et al. renders all the elements of claim 1 obvious.
Therefore, Blatt et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Blatt et al. renders claim 1 obvious from which claim 2 depends.
Claim 2 recites a sample pad in fluid communication with the filter membrane and the carrier membrane.
Blatt et al. teaches applying a sample to the filter material 26 which, because it can include “one, two, or several layers,” reads on a sample pad, which would be in fluid communication with the filter membrane and the carrier membrane as shown in Fig. 4 of Blatt et al.
Therefore, Blatt et al. renders claim 2 obvious.
III.) Regarding applicant’s claim 3, as noted above Blatt et al. renders claim 1 obvious from which claim 3 depends.
Claim 3 recites that second porous layer of the filter membrane contacts the sample pad.
In Blatt et al. the upper layer of the filter membrane contacts the sample pad noted above.
Therefore, Blatt et al. renders claim 3 obvious.
IV.) Regarding applicant’s claim 4, as noted above Blatt et al. renders claim 1 obvious from which claim 4 depends.
Claim 4 recites a conjugate pad in fluid communication with the filter membrane and the carrier membrane.
In Fig. 5 Blatt et al. depicts that a transport mesh 36 can be provided beneath the filter membrane, which transport mesh reads on applicant’s claimed conjugate pad.
Therefore, Blatt et al. renders claim 4 obvious.
V.) Regarding applicant’s claim 5, as noted above Blatt et al. renders claim 1 obvious from which claim 5 depends.
Claim 5 recites a conjugate pad in fluid communication with the sample pad and the carrier membrane.
In Fig. 5 Blatt et al. depicts that a transport mesh 36 can be provided beneath the filter membrane, which transport mesh reads on applicant’s claimed conjugate pad. The filter membrane is readable on a sample pad inasmuch as the test sample is applied to the filter membrane.
Therefore, Blatt et al. renders claim 5 obvious.
V.) Regarding applicant’s claim 6, as noted above Blatt et al. renders claim 1 obvious from which claim 6 depends.
Claim 6 recites that the lateral flow device is for an immunoassay.
The recited use of the lateral flow device in claim 6 does not incorporate any structural elements to the device of claim 1.
Therefore, Blatt et al. renders claim 6 obvious via rendering claim 1 obvious from which claim 6 depends.
Vi.) Regarding applicant’s claim 15, as noted above Blatt et al. renders claim 1 obvious from which claim 15 depends.
Claim 15 recites that pores of the second porous layer have a second diameter in the range of about 20 nm to about 100 nm.
Blatt et al. does not teach that the pores of the second porous layer have a second diameter in the range of about 20 nm to about 100 nm.
It would have been obvious to one of ordinary skill in the art to modify Blatt et al. to provide the pores of the second porous layer with diameter in the range of about 20 nm to about 100 nm for purposes of filtering out unwanted cells, particulate matter, or debris from the samples disclosed in paragraph [0044].
Therefore, Blatt et al. renders claim 15 obvious.
2. Claims 8 and 16 are rejected under 35 USC 103 as being unpatentable over Blatt et al.
As noted above, Blatt et al. teaches a lateral flow device that includes a sample treatment zone that includes two or more layer including a depth filter material 26 (such as glass fiber, metal fiber, synthetic fiber, paper, or natural or synthetic fabric) and a membrane 28 (such as S&S cellulose acetate, nitrocellulose, regenerated cellulose having an average pore size of from about 0.2 µm to about 7 µm; and Nucleopore or Poretics polycarbonate at pore sizes of about 0.2 µm to about 5 µm. these different filter materials read on applicant’s claimed first and second porous layers. [0079]
These two or more layers of the depth filter material and membrane read on applicant’s filter membrane having first and second porous layers.
As to the newly added limitation to claim 8 which recites that the second porous layer comprises an “ordered array of pores,” looking to applicant’s original disclosure for interpreting the term “ordered array of pores” reveals that applicant only discloses “an ordered array-like porous layer,” but does not support or disclose an “ordered array of pores.”
The second membrane of Blatt et al. is interpreted as being an ordered array-like porous layer in that the pores can be spaced apart in multiple directions, howbeit randomly. The pores in Blatt et al, would form and function as a simple sieve.
I.) Regarding applicant’s claim 8, as noted above Blatt et al. renders all the elements of claim 8 obvious.
Therefore, Blatt et al. renders claim 8 obvious.
II.) Regarding applicant’s claim 16, as noted above, Blatt renders claim 8 obvious from which claim 16 depends.
Claim 16 recites that the pores of the surface layer have a size in the range of about 20 nm to about 100 nm.
Blatt et al. does not teach that the pores of the second porous layer have a second diameter in the range of about 20 nm to about 100 nm.
It would have been obvious to one of ordinary skill in the art to modify Blatt et al. to provide the pores of the second porous layer with diameter in the range of about 20 nm to about 100 nm for purposes of filtering out unwanted cells, particulate matter, or debris from the samples disclosed in paragraph [0044].
Therefore, Blatt et al. renders claim 16 obvious.
3. Claims 9-14 and 17 are rejected under 35 USC 103 as being unpatentable over Blatt et al. in view of International Patent Application Publication No. WO2015/048244 to Wiesner et al. (cited by applicant)
As noted above, Blatt et al. teaches a lateral flow device that includes a sample treatment zone that includes two or more layer including a depth filter material 26 (such as glass fiber, metal fiber, synthetic fiber, paper, or natural or synthetic fabric) and a membrane 28 (such as S&S cellulose acetate, nitrocellulose, regenerated cellulose having an average pore size of from about 0.2 µm to about 7 µm; and Nucleopore or Poretics polycarbonate at pore sizes of about 0.2 µm to about 5 µm. these different filter materials read on applicant’s claimed first and second porous layers. [0079]
These two or more layers of the depth filter material and membrane read on applicant’s filter membrane having first and second porous layers.
Blatt et al. further teaches a porous member that reads on applicant’s carrier membrane and which includes zones 16 and 18 that read on a test line and control line.
The porous member includes an a bibulous strip 12 that wicks and reads on applicant’s absorbent pad. [0050]
Blatt et al. does not teach that a surface layer and an asymmetric substructure, wherein the surface layer is isoporous.
Wiesner et al. teaches that films that are used for membranes that have asymmetric structures and isoporous surfaces provide both desirable selectivity and permeability. ([0009], [0061] and Abstract)
It would have been obvious to one of ordinary skill in the art to modify Blatt et al to use a filter membrane comprising: a surface layer and an asymmetric substructure, wherein the surface layer is isoporous, as taught by Wiesner et al. based on such membranes providing both desirable selectivity and permeability.
Blatt et al. in view of Wiesner et al. does not teach that the filter membrane has a surface layer that has a thickness of 20 nm to 500 nm and the pore sizes range from about 20 nm to about 1 micron and that the asymmetric substructure has a thickness of about 20 nm to about 500 nm and has pore size in the range of 100 nm to about 1 micron.
In Blatt et al. in view of Wiesner et al. it would have been obvious to one of ordinary skill in the art to conduct routine engineering optimization experimentation to determine a suitable thickness and pore size range of both the surface layer and the asymmetric substructure for using the device for testing different desired samples, including providing the surface layer with a thickness of 20 nm to 500 nm and a pore size from about 20 nm to about 1 micron and provide the asymmetric substructure with a thickness of about 20 nm to about 500 nm and a pore size in the range of 100 nm to about 1 micron.
Therefore, Blatt et al. in view of Wiesner et al. renders claim 9 obvious.
II.) Regarding applicant’s claim 10, as noted above Blatt et al. in view of Wiesner et al. renders claim 9 obvious from which claim 10 depends.
Claim 10 recites that the lateral flow device operates using passive capillary action.
Claim 10 does not recite any structural limitation(s) that limit the device of claim 10, which Blatt et al. renders obvious.
Nevertheless, it is noted that the device of Blatt et al. operates using passive capillary action.
Therefore, Blatt et al. in view of Wiesner et al. renders claim 10 obvious.
III.) Regarding applicant’s claim 10, as noted above Blatt et al. in view of Wiesner et al. renders claim 9 obvious from which claim 10 depends.
Claim 10 recites a sample pad in fluid communication with the filter membrane and the carrier membrane.
Blatt et al. teaches applying a sample to the filter material 26 which, because it can include “one, two, or several layers,” reads on a sample pad, which would be in fluid communication with the filter membrane and the carrier membrane as shown in Fig. 4 of Blatt et al.
Therefore, Blatt et al. in view of Wiesner et al. renders claim 10 obvious.
IV.) Regarding applicant’s claim 11, as noted above Blatt et al. in view of Wiesner et al. renders claim 10 obvious from which claim 11 depends.
Claim 11 recites that second porous layer of the filter membrane contacts the sample pad.
In Blatt et al. the upper layer of the filter membrane contacts the sample pad noted above.
Therefore, Blatt et al. in view of Wiesner et al. renders claim 11 obvious.
V.) Regarding applicant’s claim 12, as noted above Blatt et al. in view of Wiesner et al. renders claim 9 from which claim 124 depends.
Claim 12 recites a conjugate pad in fluid communication with the filter membrane and the carrier membrane.
In Fig. 5 Blatt et al. depicts that a transport mesh 36 can be provided beneath the filter membrane, which transport mesh reads on applicant’s claimed conjugate pad.
Therefore, Blatt et al. in view of Wiesner et al. renders claim 12 obvious.
VI.) Regarding applicant’s claim 13, as noted above Blatt et al. in view of Wiesner et al. renders claim 9 from which claim 13 depends.
Claim 13 recites a conjugate pad in fluid communication with the sample pad and the carrier membrane.
In Fig. 5 Blatt et al. depicts that a transport mesh 36 can be provided beneath the filter membrane, which transport mesh reads on applicant’s claimed conjugate pad. The filter membrane is readable on a sample pad inasmuch as the test sample is applied to the filter membrane.
Therefore, Blatt et al. in view of Wiesner et al. renders claim 13 obvious.
VII.) Regarding applicant’s claim 14, as noted above Blatt et al. in view of Wiesner et al. renders claim 9 obvious from which claim 14 depends.
Claim 14 recites that the lateral flow device is for an immunoassay.
The recited use of the lateral flow device in claim 14 does not incorporate any structural elements to the device of claim 9.
Therefore, Blatt et al. in view of Wiesner et al. renders claim 14 obvious via rendering claim 9 obvious from which claim 14 depends.
VIII.) Regarding applicant’s claim 17, as noted above Blatt et al. in view of Wiesner et al. renders claim 9 obvious from which claim 17 depends.
Claim 17 recites that the pores of the surface layer have a size in the range of about 20 nm to about 100 nm.
Blatt et al. does not teach that the pores of the second porous layer have a second diameter in the range of about 20 nm to about 100 nm.
It would have been obvious to one of ordinary skill in the art to modify Blatt et al. to provide the pores of the second porous layer with diameter in the range of about 20 nm to about 100 nm for purposes of filtering out unwanted cells, particulate matter, or debris from the samples disclosed in paragraph [0044].
Therefore, Blatt et al. renders claim 17 obvious.
Response to Arguments
Applicant's arguments filed 06/04/2026 have been fully considered but they are not persuasive.
On pages 6-7 of applicant’s response applicant argues that Blatt et al. does not disclose or suggest a second porous layer comprising an ordered array of pores forming a simple sieve adjacent a first porous layer of randomly oriented pores.
As noted above, applicant’s original disclosure only supports “an ordered array-like porous layer,” but does not include a description of such “an ordered array-like porous layer.”
As noted above, the second membrane of Blatt et al. is interpreted as being an ordered array-like porous layer in that the pores can be spaced apart in multiple directions, howbeit randomly. The pores of Blatt et al. would form and function like a simple sieve.
On page 7 of applicant’s response applicant argues that Blatt et al. does not teach or suggest an isoporous surface layer, having a narrow pore-size distribution, over an asymmetric substructure.
This argument is moot inasmuch as Wiesner et al. has been relied upon as teaching that films that are used for membranes that have asymmetric structures and isoporous surfaces provide both desirable selectivity and permeability. ([0009], [0061] and Abstract)
It would have been obvious to one of ordinary skill in the art to modify Blatt et al to use a filter membrane comprising: a surface layer and an asymmetric substructure, wherein the surface layer is isoporous, as taught by Wiesner et al. based on such membranes providing both desirable selectivity and permeability.
In response to applicant’s argument regarding claim 7 on 8 or applicant’s reply, the examiner notes that applicant canceled claim 7.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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