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
The information disclosure statement (IDS) submitted on May 28, 2024 is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
“fluid outlet end 29”
“fluid inlet end 22”
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. 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 Objections
Claim 1 is objected to because of the following informalities:
In the preamble of claim 1, the limitation “a sample comprising” should be changed to “a sample, comprising”.
Appropriate correction is required.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kobori et al. (“Kobori”) (US 2007/0015140 A1).
With respect to claim 1, Kobori discloses a sample processing device 3 for the detection of an antibody or antigen in a sample, the device comprising (see Fig. 1):
a buffer container 1 for receiving a buffer fluid 11 therein;
a buffer cap 2 snuggly mountable to an open end 12 of the buffer container, the buffer cap 2 having a fluid outlet end 25 and an opposing fluid inlet end (top half of cap 2), the fluid inlet end being contactable with the buffer container 1; and
a filter 21-23 arranged at the fluid inlet end of the buffer cap, the filter being coated with a color conjugate comprising a color reagent (colloidal gold) coupled to a polymer (antibody) (see [0023] and [0028]), wherein the filter and the color conjugate form a single unit (see Fig. 1).
With respect to claims 2 and 4, the color conjugate comprises colloidal gold nanoparticles (see [0037]).
With respect to claim 3, the color conjugate comprises a colloidal conjugate solution comprising colloidal nanoparticles and the polymer (during use, the colloidal conjugate mixes with liquid sample 11 and forms a solution, see Fig. 1).
With respect to claims 5-13, the claims are product-by-process claims. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In this case, given that the claimed product is a color conjugate incorporated into a filter, the claimed properties are not evident in the product (e.g. the optical density recited in claim 13 is not applicable to the product, given that the product is not in the form of a solution). Moreover, given that Kobori discloses that the colloidal gold nanoparticles are produced from a solution comprising hydrogen tetrachloroaurate and trisodium citrate (stabilizer) (see [0037]), the claimed processes do not appear to produce a product that is patentably distinct from the colloidal gold nanoparticles taught by Kobori. Consequently, the claims are deemed to anticipated by Kobori.
With respect to claim 14, the polymer comprises an antibody for the detection of the antigen (influenza A/B) in the sample (see [0023]).
With respect to claim 15, the fluid inlet end of the buffer cap comprises a base (top of element 24 in Fig. 1), a wall (sidewalls of element 24) projecting outwardly from the base, and an opening defined by the wall (it is evident the wall is hollow and connects the base to the fluid outlet end 25).
With respect to 16, the filter 21-23 is snuggly fitted within the opening (see [0040] disclosing that the filter is “housed in the cap”; see also Fig. 1 illustrating the snugness with which the filter is “housed in the cap”).
With respect to claim 17, the device is part of a kit that further comprises a test device 4 comprising a membrane (see [0032]) having a test region A/B and a control region R (see Fig. 1 and [0036]; letter “R” detects IgG, which functions as control); and
a buffer (see [0030]).
With respect to claims 18 and 19, the control region R of the membrane comprises a polymer (anti-IgG) immobilized thereon arranged to bind to IgG (i.e. polymer coupled to the colloidal gold nanoparticles) (see [0036]).
With respect to claim 20, the test regions “A” and “B” of the membrane (see Fig. 1) comprise polymers (antibodies) immobilized thereon arranged to bind to an antigen (influenza A/B) in the sample (see [0036]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. 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, Luan Van can be reached at 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL S HYUN/Primary Examiner, Art Unit 1796
Prosecution Insights