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 .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract is not a concise statement describing what is new or improvement to the art it pertains. Currently, the abstract discloses a sample collection device, however the abstract does not disclose an improvement made by the device to the art. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-6 and 8-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beck et al US20140366609 (hereinafter “Beck”).
Regarding claim 1, Beck discloses a sample collection device (Portable drug sampling device, abstract. Fig 4A-C) comprising: a housing (housing-406) extending from a mouthpiece end (inlet-407) to an air outlet end (outlet-408), the housing defining an airflow channel from the mouthpiece end to the air outlet end (Paragraph 0105-0108), the mouthpiece end configured to receive an exhalation airflow (user exhales into the mouthpiece-401); a porous sample collection media (filter membrane/sampling membrane, Paragraph 0089, 0099 and 0107-0108) fixed within the housing and along the airflow channel; a mouthpiece end cap (mouthpiece-401 and plug-409) replaceably coupled to the mouthpiece end; and an air outlet end cap (plug-410) replaceably coupled to the air outlet end.
Regarding claim 2, Beck discloses one of the mouthpiece end cap (mouthpiece-401) and the air outlet end cap, comprise a nozzle or liquid dropper. (See Fig 4B, Paragraph 0105-0106)
Regarding claim 3, Beck discloses one of the mouthpiece end cap (mouthpiece-401) or the air outlet end cap (plug-410), comprise a liquid reservoir (tubular element-40 has a trap section -402) having a metered dose of liquid (Fig 4A-C, Paragraph 0103-0104).
Regarding claim 4, Beck discloses liquid reservoir defines a volume in a range from 50 microliters to 500 microliters. (Paragraph 0082)
Regarding claim 5, Beck discloses the porous sample collection media (filter membrane/ sampling membrane) defines a surface area value and the liquid reservoir (tubular element-40 has a trap section -402) defines a volume value, and the volume value divided by the surface area value is in a range from 10 microliters/cm2 to 400 microliter/cm2, or from 10 microliters/cm2 to 250 microliter/cm2. (Paragraph 0082, 0089, 0099 and 0107-0108)
Regarding claim 6, Beck discloses the nozzle or liquid dropper (See Fig 4B, Paragraph 0105-0106) further comprises a sealing cap configured to close-off the nozzle or liquid dropper (plug-409).
Regarding claim 8, Beck discloses the porous sample collection media (filter membrane/ sampling membrane) comprises a nonwoven filtration layer having an electrostatic charge. (Paragraph 0097, 0099, 0119)
Regarding claim 9, Beck discloses the nonwoven filtration layer is hydrophobic. (Paragraph 0039, 0097, 0099, 0119, 0121)
Regarding claim 10, Beck discloses the nonwoven filtration layer is formed from at least one of polypropylene or polylactide. (Paragraph 0039, 0097, 0099, 0119)
Regarding claim 11, Beck discloses the nonwoven filtration layer is pleated. (Paragraph 0039, 0097-0101, 0119, 0121)
Regarding claim 12, Beck discloses the nonwoven filtration layer has a thickness in a range from 200 to 1000 micrometers, or from 250 to 750 micrometers. (Paragraph 0039, 0097-0101, 0119, 0121)
Regarding claim 13, Beck discloses the liquid reservoir (tubular element-40 has a trap section -402) contains a liquid that is at least one of an aqueous fluid, an aqueous buffer solution, an aqueous fluid including a surfactant, a saline solution, or a saline solution including a surfactant. (Paragraph 0066, 0075-0079, 0117)
Regarding claim 14, Beck discloses a pre-filter (trap section-111, tubular element-303) fixed within the housing and along the airflow channel and between the mouthpiece end and the porous sample collection media. (Paragraph 0067, 0079)
Regarding claim 15, Beck discloses the housing (housing-406) has a length value L from the mouthpiece end (inlet-407) to the air outlet end (outler-408), and the porous sample collection media (filter membrane/ sampling membrane) is recessed from both the mouthpiece end and the air outlet end at least 20% of the length value L. (Fig 4A-C, Paragraph 0035, 0063-0065)
Regarding claim 16, Beck discloses the housing (housing-406) is formed of a polymer. (Paragraph 0017, 0043, 0071, 0073, 0108)
Regarding claim 17, Beck discloses the mouthpiece end cap (mouthpiece-401) is tethered to the housing (housing-406). (Paragraph 0080)
Regarding claim 18, Beck discloses the air outlet end cap (plug-410) is tethered to the housing (housing-406). (See Fig 4C which shows a tethered line connected to the plug, Paragraph 0107-0108)
Regarding claim 19, Beck discloses an assay configured to receive liquid from the sample collection device (filter membrane/sampling membrane). (Fig 4C, Paragraph 0014-0015, 0072, 0107, 0116)
Regarding claim 20, Beck discloses the assay detects the presence of a virus, a pathogen, or other analytes of interest. (Paragraph 0038-0042, 0072, 0104, 0109, 0115-0017)
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.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Beck et al US20140366609 (hereinafter “Beck”) in view of Wu et al US20040237674 (hereinafter “Wu”).
Regarding claim 7, Beck discloses the device according to claim 2.
However, Beck fails to disclose the housing, mouthpiece end cap, or air outlet end cap are configured to be squeezed by a user to urge liquid out of the airflow channel and through the nozzle or liquid dropper. Wu discloses the housing, mouthpiece end cap, or air outlet end cap are configured to be squeezed by a user to urge liquid out of the airflow channel and through the nozzle or liquid dropper. (Fig 6-8, Paragraph 0057)
It would have been obvious to one of ordinary skill in the art before the effective filing date to include the design of Wu into Beck for the purpose of creating a more efficient device. The modification would allow for supplying a user desired amount of a sample as to not waste the sample.
Conclusion
The prior art as cited on the PTO-892 is made of record and not relied upon but considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIGEL H PLUMB whose telephone number is (571)272-8886. The examiner can normally be reached Monday-Friday 7am-5pm.
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/NIGEL H PLUMB/Examiner, Art Unit 2855
/Eric S. McCall/Primary Examiner, Art Unit 2855