CTNF 18/551,012 CTNF 98022 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Drawings 06-36 AIA The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the filter housing recited in claim 7 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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 § 112 07-30-02 AIA 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. 07-34-01 Claims 1-6, 8 and 13 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, lines 6-7 recite pores with a second diameter in the range of about “20 to less than about 1 mircon. -100 nm.” This recite range is unclear due to the recitation of “-100 nm.” Claims 2-6 are indefinite as they depend from claim 1. 07-34-05 Claim 5 recites “the sample pad” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 8, lines 5-6 recite pores with a second diameter in the range “of 20–100 nm about 20 nm to less than about 1 micron.” This recitation is unclear due to the recitation of “20–100 nm about 20 nm.” 07-34-05 Claim 13 recites “the sample pad” in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA 1. Claim s 1-6 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by 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] I.) Regarding applicant’s claim 1, Blatt et al. teaches all the elements of claim 1. Therefore, Blatt et al. anticipates claim 1. II.) Regarding applicant’s claim 2, as noted above Blatt et al. anticipates claim 1 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. anticipates claim 2. III.) Regarding applicant’s claim 3, as noted above Blatt et al. anticipates claim 1 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. anticipates claim 3. IV.) Regarding applicant’s claim 4, as noted above Blatt et al. anticipates claim 1 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. anticipates claim 4. V.) Regarding applicant’s claim 5, as noted above Blatt et al. anticipates claim 1 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. anticipates claim 5. V.) Regarding applicant’s claim 6, as noted above Blatt et al. anticipates claim 1 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. anticipates claim 6 via anticipating claim 1 from which claim 6 depends . 07-15 AIA 2. Claim 8 is rejected under 35 USC 102( a)(1 ) as being anticipated by Blatt et al . As noted above, Blatt et al. teaches a lateral flow device that includes a sample treatment zone that includes tow 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. I.) Regarding applicant’s claim 8, as noted above Blatt et al. teaches all the elements of claim 8. Therefore, Blatt et al. anticipates claim 8 . 07-15 AIA 3. Claim s 1, 2 and 6 are rejected under 35 USC 102( a)(1 ) as being anticipated by U.S. Patent No. 6,737,277 to Kang et al . Kang et al teaches a lateral flow device that includes a filter membrane (212 and 214), the filter membrane includes a first porous layer (212) having randomly oriented pores having a first diameter greater than 100 nm (column 6, lines 33-38) and a second porous layer (214) that is adjacent the first porous layer and has pores with a second diameter in the range of about 20 nm to less than about 1 micron (column 6, lines 37-41 ). Kang et al. teach that the a carrier membrane include a test line (218) and a control line (228) and that the carrier membrane is in fluid communication with the filter membrane. (Fig. 4) Kang et al. further teaches an absorbent pad (wicking membrane 16) in fluid communication with the carrier membrane, wherein the lateral flow device operates using passive capillary action. (column 3, lines 54-60) I.) Regarding applicant’s claim 1, as noted above Kang et al. teaches all the elements of claim 1. Therefore, Kang et al. anticipates claim 1. II.) Regarding applicant’s claim 2, as noted above Kang et al. anticipates claim 1 from which claim 2 depends. Claim 2 recites sample pad in fluid communication with the filter membrane and the carrier membrane. Kang et al. teaches a sample pad 224 upon which a sample is placed. The same pad is fluid communication with the filter membrane and the carrier membrane. (Fig. 4) Therefore, Kang et al. anticipates claim 2. III.) Regarding applicant’s claim 6, as noted above Kang et al. anticipates claim 1 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, Kang et al. anticipates claim 6 via anticipating claim 1 from which claim 6depends . 07-15 AIA 4. Claim 8 is rejected under 35 USC 102( a)(1 ) as being anticipated by Kang et al . As noted above Kang et al. teaches a lateral flow device that includes a filter membrane (212 and 214), the filter membrane includes a first porous layer (212) having randomly oriented pores having a first diameter greater than 100 nm (column 6, lines 33-38) and a second porous layer (214) that is adjacent the first porous layer and has pores with a second diameter in the range of about 20 nm to less than about 1 micron (column 6, lines 37-41 ). I.) Regarding applicant’s claim 8, as noted above Kang et al. teaches all the elements of claim 8. Therefore, Kang et al. anticipates claim 8 . 07-21-aia AIA 5. Claim 7 is rejected under 35 USC 103 as being unpatentable over U.S. Patent No. 10,220,354 to Heldal Heldal teaches a filter membrane 1 (Fig. 1), that includes: a first porous layer, the first porous layer having randomly oriented pores having a first diameter greater than 100 microns (first porous layer may have an average pore size which is at least 2, 3, 5 or 10 times the pore size of the second porous layer, column 16, lines 49-52); a second porous layer, the second porous layer being adjacent the first porous layer and having pores with a second diameter in the range of 20-100 nm about 20 nm to less than about 1 micron ("the pore size of one or both of the porous layer may be from 1 to 60 nm or 10 to 40 nm", column 16, lines 53-54). Heldal does not teach a filter housing. It would have been obvious to one of ordinary skill in the art to provide a filter housing for purposes of storing or shipping the filter membrane. Alternatively, it would have been obvious to one or ordinary skill in the art to provide a housing in which to hold the filter and configured to allow liquid to pass through the membrane filter based on Heldal teaching such use in the Background section, column 1, lines 10-21. I.) As noted above, Heldal teaches or renders obvious all the elements of claim 7. Therefore, Heldal renders claim 7 obvious . 07-21-aia AIA 6. Claim s 9-14 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 tow 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 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. 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. I.) Regarding applicant’s claim 9, as noted above Blatt et al. teaches or renders all the elements of claim 9 obvious. Therefore, Blatt et al. renders claim 9 obvious. II.) Regarding applicant’s claim 10, as noted above Blatt 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. renders claim 10 obvious. III.) Regarding applicant’s claim 10, as noted above Blatt 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. renders claim 10 obvious. IV.) Regarding applicant’s claim 11, as noted above Blatt 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. renders claim 11 obvious. V.) Regarding applicant’s claim 12, as noted above Blatt 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. renders claim 12 obvious. VI.) Regarding applicant’s claim 13, as noted above Blatt 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. renders claim 13 obvious. VII.) Regarding applicant’s claim 14, as noted above Blatt 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. anticipates claim 14 via render claim 9 obvious from which claim 14 depends. Conclusion 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /M.S.G./Examiner, Art Unit 1798 /CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798 Application/Control Number: 18/551,012 Page 2 Art Unit: 1798 Application/Control Number: 18/551,012 Page 3 Art Unit: 1798 Application/Control Number: 18/551,012 Page 4 Art Unit: 1798 Application/Control Number: 18/551,012 Page 5 Art Unit: 1798 Application/Control Number: 18/551,012 Page 6 Art Unit: 1798 Application/Control Number: 18/551,012 Page 7 Art Unit: 1798 Application/Control Number: 18/551,012 Page 8 Art Unit: 1798 Application/Control Number: 18/551,012 Page 9 Art Unit: 1798 Application/Control Number: 18/551,012 Page 10 Art Unit: 1798 Application/Control Number: 18/551,012 Page 11 Art Unit: 1798