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
It is noted that no IDS has been filed. Applicant is reminded of the duty to disclose all known prior art resulting from all prior art searches.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No elements are interpreted under 112(f).
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 2 and 15 is 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.
In regard to Claim 2, the disclosure does not provide adequate support for an adhesive test strip configured to overlay the blood test strip and seal in the blood sample in the plurality of blood circles as recited. The specification only discusses an adhesive layer in paragraph 0011 of the publication “The sealing strip S includes an adhesive AD on an underside thereof but not including areas matching with the blood circles B.” This recitation clearly recites that the adhesive does not cover the blood circles, which contradicts the claim. Therefore, the claim fails the written description requirement. In the rejection that follows, it is assumed that the claim means to recite the blood circles do not contain the adhesive overlay
In regard to Claim 15, the disclosure does not provide any support for a blood proofing agent as recited in the claim. It is also unclear what constitutes said blood proofing agent given the lack of written description (see rejection below). Therefore, the claim fails the written description requirement.
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.
Claims 4, 11, and 15 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.
In regard to Claim 4, it is unclear what is meant by the plurality of patches “seal” in the respective blood samples. This appears disclosed in paragraph 0011 of the publication: “FIG. 2 are top views of a test strip seal and sealing patches in accordance with an embodiment of the present disclosure… The first patch P1 is circular or non-circular but large enough to cover a blood circle and include a chemical for treating the blood sample on an underside AD (cross hatched from top to bottom) thereof. The second patch P2 is similar to the first patch P1 but includes a raised perimeter R for allowing the blood sample to pool there beneath.”
However, this disclosure does not explain or seem to refer to patches P1 or P2 as a “seal.” Furthermore, it is unclear what constitutes said patches since P1 is referred to including a chemical and P2 includes a raised perimeter (which appears recited in claim 5. Therefore, clarification for the patches to seal the blood samples is required.
In regard to Claim 11, the recitation of “graduated” is unclear because it does not specify exactly what is meant. While the specification discloses that the blood circles may have a graduated size, this is not presently recited. Clarification is requested. In the rejection below, the claim has been interpreted with the blood circles having a graduated size.
In regard to Claim 15, since the disclosure lacks written description regarding the blood proofing agent, it is unclear what is meant by said blood proofing agent.
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.
Claim(s) 1, 4, 6, and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Barstis et al (US Pub No. 20140051173).
In regard to Claim 1, Barstis et al disclose a test card 10, 30 comprising:
a blood test strip 14 a, b laminated 16a,b,c on a bottom portion of the test card and configured to define a plurality of blood circles 20, 22, 38, 40, 42, 44, 46, 48 free of the lamination on a top portion of the test card capable and thus configured to receive a blood sample therein, best seen in Figure 1 and 4 – “release openings 20 provided in first laminate backing 16a and in further registry with corresponding release openings 22 in parafilm 12. Release openings 20 and 22 are in registry with those test strips 14 for which testing for a particular chemical compound and/or active agent is desired” (0033, 0066);
an identifying indicia 34 (ID zone) configured with information linking the blood sample with a donor of the blood sample, best seen in Figure 4 (0066); and
a chemical treatment 17 (reagent) of the test card proximal the plurality of blood circles, best seen in Figure 1 – “One or more vessels 18 are disposed between first and second laminate backings 16a and 16b with each vessel having a wall 18a for containment of an unstable or corrosive reagent 17 therein (see FIGS. 3 and 3A). Vessels 18 may be independent tubular members as shown that are placed in registry with release openings 20” (0033).
4. The test card of claim 1, further comprising a plurality of patches configured to seal in the respective blood samples in the plurality of blood circles – “the wax to melt through the paper and form a continuous hydrophobic barrier surrounding the desired assay region” (0031).
6. The test card of claim 1, wherein the chemical treatment of the test card proximal the plurality of blood circles varies from one blood circle to the next – “test strip 14a may be employed for detecting acetaminophen or vitamin C, while test strip 14b may be employed for detecting starch or vitamin C” (0033, 0066).
12. The test card of claim 1, wherein the lamination is impervious to blood cells and blood serum and blood platelets – the hydrophobic barrier is impervious to all fluids including to blood cells and blood serum and blood platelets (0031).
13. The test card of claim 1, wherein the identifying indicia 34 includes a QR (quick response) code, best seen in Figure 4 (0055-0056).
14. The test card of claim 1, wherein the identifying indicia 34 includes a bar code, best seen in Figure 4 (0055-0056).
15. The test card of claim 1, wherein the chemical treatment of the test card includes a blood proofing agent configured to prevent a leakage of the blood sample into the test card from the plurality of blood circles – “the chance of bleed-over of hydrophobic agent into the lanes is eliminated” due to the wax treatment (0031-0032).
Claim(s) 1, 4-5, 12-13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nuno Ayala et al (WO 2020218913). See Translation for citations.
In regard to Claim 1, Nuno Ayala et al disclose a test card (abst) comprising:
a blood test strip 2 – “porous laminar piece (2), which can be made of cellulose, chromatographic paper, filter paper” laminated 3 on a bottom portion of the test card – a horizontal hydrophobic laminar base, “A more preferred embodiment of the horizontal hydrophobic sheet base (3) is when it is a printed coating of solid wax ink,” best seen in Figure 8 (abst) and
configured to define a plurality of blood circles 5 (reaction site) free of the lamination on a top portion of the test card configured to receive a blood sample therein, best seen in Figure 7 (abst);
an identifying indicia 13 configured with information linking the blood sample with a donor of the blood sample, best seen in Figure 11 (abst); and
a chemical treatment of the test card proximal the plurality of blood circles – “then the detection agent is placed on the retention means (7); An example of the detection agent is that reagent or substance that is useful to detect and / or diagnose some information and / or condition present in a substance of interest.”
4. The test card of claim 1, further comprising a plurality of patches configured to seal in the respective blood samples in the plurality of blood circles – “An example of this retention means (7) is a hydrophobic ring formed of a circular vertical wall (7) also made of hydrophobic materials, preferably solid hydrophobic materials, such as: waxes, saturated hydrocarbons, polymers and / or a combination of them, to name a few examples” best seen in Figure 7-8.
5. The test card of claim 1, further comprising a plurality of patches each having a raised perimeter 7 configured to seal in a pool of the blood sample in the plurality of blood circles – “An example of this retention means (7) is a hydrophobic ring formed of a circular vertical wall (7) also made of hydrophobic materials, preferably solid hydrophobic materials, such as: waxes, saturated hydrocarbons, polymers and / or a combination of them, to name a few examples” best seen in Figure 7-8.
12. The test card of claim 1, wherein the lamination is impervious to blood cells and blood serum and blood platelets – “A more preferred embodiment of the horizontal hydrophobic sheet base (3) is when it is a printed coating of solid wax ink” which would be impervious to all liquids.
13. The test card of claim 1, wherein the identifying indicia includes a QR (quick response) code – “So an Identity reference (13) will contain a unique sequential number for each test; which is also very useful for when you want to make subsequent queries or reviews of said tests. Some examples of identification reference (13) can be a linear code, QR code.”
15. The test card of claim 1, wherein the chemical treatment of the test card includes a blood proofing agent configured to prevent a leakage of the blood sample into the test card from the plurality of blood circles – “An example of this retention means (7) is a hydrophobic ring formed of a circular vertical wall (7) also made of hydrophobic materials, preferably solid hydrophobic materials, such as: waxes, saturated hydrocarbons, polymers and / or a combination of them, to name a few examples” best seen in Figure 7-8.
Claim Rejections - 35 USC § 103
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.
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Nuno Ayala et al in view of Jacono et al (US Pub No. 20090263854).
Nuno Ayala disclose the invention above but do not expressly disclose an adhesive test strip configured to overlay the blood test strip and seal in the blood sample in the plurality of blood circles but be free of adhesive over the plurality of blood circles.
Jacono et al teach that it is well-known in the art to provide an analogous test card 30 comprising an adhesive layer configured to overlay the blood test strip and seal in the blood sample in the plurality of blood circles but be free of adhesive over the plurality of blood circles – “the bottom surface of the overlamina may be attached to the second (i.e., top) surface of the middle lamina using an adhesive” (0083), wherein Figure 8 shower opening 25 in overlamina 20 “for receiving a sample suspected of containing an analyte of interest, the opening being in fluid communication with the assay strip 30” as an effective configuration for said test card (0060).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Nuno Ayala such that it includes an adhesive test strip configured to overlay the blood test strip and seal in the blood sample in the plurality of blood circles but be free of adhesive over the plurality of blood circles as taught by Jacono et al as an effective configuration for its use. Also see 112 rejection for Claim 2.
Claims 7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Nuno Ayala et al in view of Ringold et al (US Pub No. 20200170557).
In regard to Claim 7 and 10, Nuno Ayala disclose the invention above but do not expressly disclose the chemical treatment of the test card proximal the plurality of blood circles comprises a blood stabilizer or a PKU (pyruvate kinase) blood reagent.
Ringold et al teach that it is well-known in the art to provide an analogous test card comprising the chemical treatment of the test card proximal the plurality of blood circles comprises a blood stabilizer 410 (abst, 0081, 0099) as well as PKU (pyruvate kinase) blood reagent (0005).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Nuno Ayala such that the chemical treatment of the test card proximal the plurality of blood circles comprises a blood stabilizer or a PKU (pyruvate kinase) blood reagent as taught by Ringold et al to effectively stabilize the blood sample as well as advantageously test for PKU from the sample as desired.
In regard to Claim 11, Nuno Ayala et al in view of Ringold et al disclose the test card of claim 1, wherein the chemical treatment of the test card proximal the plurality of blood circles comprises a PKU (phenylketonuria) blood reagent configured to determine PKU levels in the blood sample but do not expressly disclose a graduated PKU reagent.
it would have been obvious to one of ordinary skill in the art at the time of filing to modify Nuno Ayala as modified by Ringold et al such that the size of the blood circles is graduated in size since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984).
In the instant case, the device of Nuno Ayala would not operate differently with the graduated sized blood circles. Also see 112 rejection above.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nuno Ayala et al in view of Le Bui et al (US Pub No. 20020188263).
Nuno Ayala disclose the invention above but do not expressly disclose the chemical treatment of the test card proximal the plurality of blood circles comprises a blood preservative.
Le Bui teach that it is well-known in the art to provide an analogous test card comprising a chemical treatment of a preservative to preserve the collected sample (0021).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Nuno Ayala such that the chemical treatment of the test card proximal the plurality of blood circles comprises a blood preservative as taught by Le Bui to effectively preserve the collected sample.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nuno Ayala et al in view of Palmer et al (US Pub No. 20160022225).
Nuno Ayala disclose the invention above but do not expressly disclose the chemical treatment of the test card proximal the plurality of blood circles comprises a blood grouping reagent including solutions that determine blood groups.
Palmer teach that it is well-known in the art to provide an analogous test sampler comprising solutions to determine blood groups/blood typing (0003).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Nuno Ayala such that the chemical treatment of the test card proximal the plurality of blood circles comprises a blood grouping reagent including solutions that determine blood groups as taught by Palmer to effectively provide desired blood typing from the collected sample.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong Q NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791