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 .
Status of Claims
Claims 1-17 remain pending in the application.
Specification
The disclosure is objected to because of the following informalities:
On page 12 line 24, it recites “In some aspects, the laminate layer 30 may comprise” however later in the paragraph laminate layer is reference number 60. Throughout the instant specification the laminate layer is 60, therefore page 12 line 24 should be amended to change “30” to “60”.
Appropriate correction is required.
Claim Objections
Claims 1, 12, 17 are objected to because of the following informalities:
Claim 1 it is suggested to indent line 4 starting with “a test pad assembly” to make it more clear that the test pad assembly is part of the test strip.
Claim 12 appears to have additional spacings that should be removed between words.
Claim 17 recites “A kit comprising a plurality of the test strip according to claim 1” where it is suggested to recite “A kit comprising a plurality of the test strips according to claim 1” as making it plural test strips helps the claim read more smoothly.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 3, 5-6, 10, 16 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 3 recites “wherein the test pad assembly is laminated with a polyester, a polyethylene terephthalate (PET), an ethylene vinyl acetate (EVA), or any combination thereof.” where it is unclear how the test pad assembly is laminated with a polymer. The claim just lists materials where it is unclear how is the assembly being laminated with a polyester, a PET, or an EVA.
From the instant specification on page 8 lines 15-22 it describes where there is a test pad assembly 20 that has three layers, 30 a reagents layer, 50 an adhesive layer, and 60 a laminate layer. Page 12 lines 24-26 describes the laminate layer comprising the same materials, therefore for examination it will be interpreted that the test pad assembly will be laminated with a laminate layer.
It is suggested to amend claim 3 to recite:
wherein the test pad assembly is laminated with a laminate layer, wherein the laminate layer comprises a polyester, a polyethylene terephthalate (PET), an ethylene vinyl acetate (EVA), or any combination thereof.
Claim 5 recites “further comprising a control pad assembly comprising the reagents substrate material loaded with the pH indicator and the buffer.” where it is unclear if the reagents substrate material is the same or different from the ones described in claim 1. Currently, it sounds as though the control pad assembly is the same as the test pad assembly described prior.
On page 13 lines 8-13 of the instant specification, it describes the control pad assembly 70 that is configured in the same manner as the test pad assembly, which has a reagent layer 30 loaded with the PH indicator and the buffer but not with urase. As further seen in Figure 1, the control pad assembly is separate from the test pad assembly.
Therefore for examination, it will be interpreted that there will be a test pad assembly comprising a reagent substrate material loaded with urase, pH indicator, and buffer, and a control pad assembly that comprises a separate reagent substrate material loaded with the same pH indicator and buffer.
Claim 6 is rejected by virtue of being dependent on a rejected claim.
Claim 10 recites “wherein the pH indicator indicates pH changes over a pH range of about 6 to about 8.” where it is unclear if this is further limiting the transition interval of pH 5 to pH 9 as described on lines 5-6 of claim 1.
It is described on page 7 lines 28-29 that “Suitable pH indicators may have a “transitional interval” or pH range across which they are effective.” which makes it sound like “transition interval” and “pH range” are interchangeable. However page 10 lines 12-15 that describes that the pH indicator changes over the effective range of urease which corresponds to a pH of about 5 to 9, and that in some aspects the pH indicator may be elected such that it detects and indicates pH change over a pH range of about 6 to about 8. This sounds like it is describing that it is urease that has an effective range that corresponds to a pH of 5 to 9 so therefore an indicator is selected that has a range of 6 to 8.
For examination, it will be interpreted that claim 10 is further limiting the transition interval of the pH indicator described in claim 1.
It is suggested to make the phrasings in claim 1 and claim 10 consistent to make it clear that it is the pH range of the indicator that is being further limited. One way is to amend claim 10 to recite “wherein the transition interval of the pH indicator is about 6 to about 8.”
Claim 16 recites “wherein the reagents substrate material is further loaded with the one or more stabilizers at a urease: serum albumin: saccharide molar ratio of about 1:5:1000 to about 1:20:10000.”
First it is unclear because claim 14, of which 16 depends, recites “the reagents substrate material is further loaded with one or more stabilizers” where is 16 stating that there are even more stabilizers loaded in addition to the ones in claim 14?
Second, because claim 14 has optional stabilizers it is unclear if claim 16 is requiring serum albumin and saccharide to now be present, as the ratio is a ratio between urease and two of the optional stabilizers from 14.
If claim 16 does not require both the serum albumin and saccharide, what is the molar ratios for just urease and serum albumin, or just urease and saccharide?
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.
Claim(s) 1, 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Free (US-3145086-A) in view of Ishikawa (US-3932133-A) and as evidenced by Wagstaff (US-4043757-A).
Regarding claim 1, Free teaches a test strip for detecting azotemia or kidney disease in felines and canines comprising:
a test pad assembly, the test pad assembly comprising a reagents substrate material (bibulous cellulose strips; column 2 lines 23-25) loaded with urease (column 2 lines 63-65), a pH indicator (indicator material capable of changing color in the presence of pH change, phenol red; column 2 lines 19-21, 46) with a transition interval of pH 5 to pH 9, and a buffer (phosphate buffer; column 2 line 19, column 3 lines 16-18) for adjusting a pH value of a feline or canine saliva sample to within the transition interval of the pH indicator.
It is evidenced by Wagstaff that phenol red changes from red to yellow over the pH range 6.8 to 8.4 (Wagstaff; column 3 lines 38-40).
The limitations “adherable to the elongate carrier material” and “a buffer for adjusting a pH value of a feline or canine saliva sample to within the transition interval of the pH indicator” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Free and the bibulous cellulose strip is capable of adhering to a carrier material and the phosphate buffer is capable of adjusting a pH value of a sample to within the transition interval of the pH indicator. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Free (see MPEP §2114).
Further, please note that the feline or canine saliva sample has not been positively recited, and is therefore not a part of the claimed test strip.
Free does not teach an elongate carrier material; and
In the same problem solving area of detecting chemical components in a test fluid with a change in color, Ishikawa teaches where a plurality of carriers impregnated with different types of chemical reaction reagents are adhered on an elongate transparent substrate (Ishikawa; column 1 lines 6-21).
It would have been obvious to one skilled in the art to modify the bibulous cellulose strip of Free such that it is adhered to an elongated substrate as taught by Ishikawa because Ishikawa teaches that the elongate substrate is effective for supporting carriers impregnated with chemical reaction reagents (Ishikawa; column 1 lines 15-22).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., adhering the bibulous cellulose strip to an elongate substrate), and that in combination, each element merely would have performed the same function as it did separately (i.e., changing color due to contact with a sample), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to combine the bibulous cellulose strip of reference Free with the elongate substrate of reference Ishikawa, since the result would have been predictable.
The limitation “a test strip for detecting azotemia or kidney disease in felines and canines” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Free and the apparatus of modified Free is capable of detecting azotemia or kidney disease in felines and canines. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Free (see MPEP §2114).
Regarding claim 7, modified Free teaches the test strip according to claim 1. Free further teaches wherein the reagents substrate material comprises cellulose (Free; bibulous cellulose strips see column 2 lines 23-25)
Regarding claim 8, modified Free teaches the test strip according to claim 1. Free further teaches wherein the reagents substrate material is impregnated with the urease, the pH indicator, and the buffer (Free; column 3 lines 16-23 see use of an enzyme system having urease activity, a phosphate or similar buffer, an indicator material, and material or materials capable of stabilizing the mixture, this mixture is used to impregnate bibulous cellulose strips).
Regarding claim 9, modified Free teaches the test strip according to claim 1.
While Free does not address the water absorptivity, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, obviousness as both the claimed material comprises cellulose and the material of the prior art is cellulose. Absent persuasive evidence that the cellulose materials are different, the prior art is considered to have the same properties with respect to water absorptivity as that is claimed. MPEP § 2112.01 (I-IV).
Regarding claim 10, modified Free teaches the test strip according to claim 1. Free teaches phenol red as the indicator, where it is evidenced by wherein Wagstaff that that phenol red changes from red to yellow over the pH range 6.8 to 8.4 (Wagstaff; column 3 lines 38-40).
Regarding claim 11, modified Free teaches the test strip according to claim 1. Free further teaches wherein the pH indicator comprises phenol red (Free; phenol red column 2 lines 19-21, 46).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Free (US-3145086-A) and Ishikawa (US-3932133-A) and in further view of Kitani (US-5788942-A).
Regarding claim 2, modified Free teaches the test strip according to claim 1. Free does not teach wherein the test pad assembly is laminated on a side adhered to the elongate carrier material.
In the analogous art of dry analysis elements for the quantitative analysis of an analyte, Kitani teaches a support (Kitani; abstract, column 10 line 20).
Specifically, Kitani teaches a support made of polyethylene terephthalate, where the support is generally light-transmitting and water-impermeable (Kitani; column 10 lines 21-26). In example 6 described in column 20 lines 41-44, an analysis element K is prepared by laminating a PET sheet that serves as a support to a first reagent layer (color reagent layer) and second reagent layer (porous reagent layer).
It would have been obvious to one skilled in the art to modify the bibulous cellulose of Free such that it is laminated with a PET sheet because Kitani teaches that the PET sheet serves as a support for the analysis element (Kitani; column 20 lines 41-44).
The bibulous cellulose of Free will now have a laminated PET support sheet, where it will be the laminated PET support sheet that is then adhered to the elongate support of Ishikawa.
Regarding claim 3, modified Free teaches the test strip according to claim 2. Kitani further teaches wherein the test pad assembly is laminated with a polyethylene terephthalate (PET) (see claim 2 supra).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Free (US-3145086-A) and Ishikawa (US-3932133-A) and in further view of Sakamoto (US-2008/0019871-A1).
Regarding claim 4, modified Free teaches the test strip according to claim 1. The bibulous cellulose with urease, phosphate buffer, and phenol red of Free has been modified such that it is adhered to the elongate substrate of Ishikawa. However, Ishikawa is not specific as to the adhesive used.
In the analogous art of testing tools, Sakamoto teaches where a base has a plurality of reagent pads and the pads are placed on the base using an adhesive that includes polyurethane based, acrylic based, or epoxy based (Sakamoto; [0031]).
Ishikawa is silent with regards to specific way the chemical reaction test pieces are adhered to the transparent substrate, therefore, it would have been necessary and thus obvious to look to the prior art for conventional adhesives. Sakamoto provides this conventional teaching showing that it is known in the art to use polyurethane, acrylic, or epoxy based adhesives. Therefore, it would have been obvious to one having ordinary skill in the art to adhere the bibulous cellulose of Free to the elongate substrate of Ishikawa with polyurethane, acrylic, or epoxy based adhesives because it is taught by Sakamoto that these adhesives are effective for adhering a reagent pad to a base carrier (Sakamoto; [0031]).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Free (US-3145086-A) and Ishikawa (US-3932133-A) and in further view of Phillips (EP-0110173-B1).
Regarding claim 5, modified Free teaches the test strip according to claim 1. Free does not teach further comprising a control pad assembly comprising the reagents substrate material loaded with the pH indicator and the buffer.
In the same problem solving area of test devices for the colorimetric determination of chemical and biochemical components in colored biological fluids, Phillips teaches a test device (Phillips; page 2 lines 4-6, page 3 line 43).
Specifically, Phillips teaches a test device 1 that has a pad 11 that contains a reagent such that when the sample being analyzed is applied to the pad 11 any analyte present reacts with the reagent system to give a colored compound (Phillips; page 3 lines 43-49). As seen in Figure 2 there is an alternative device 2 that has two adjacent but discontinuous hydrophilic pads, one pad (11) contains the test reagents and the other is “blank” (11a) and does not contain all the reagents necessary to generate the colored compound, where the two pads are close enough for simultaneous sample addition but separate to prevent migration and contamination between the two pads (Phillips; page 4 lines 20-25). As further described on page 4 lines 35-37, the reagents employed react with the analyte in the sample to produce a compound that is characteristically absorptive at a wavelength other than a wavelength at which the colored sample itself substantially absorbs, where on the following page 5 Table 1 provides example reagents such as using glucose oxidase for glucose detection.
It would have been obvious to one skilled in the art to modify the device of modified Free such that there is a “blank” pad that does not contain all the reagents necessary to generate a color change as taught by Phillips because Phillips teaches that by having a blank pad this is useful for comparing the test sample when the reaction to form the colored compound is rapid or essentially instantaneous (Phillips; page 6 lines 2-7).
The elongate substrate of Ishikawa will now have the bibulous cellulose with urease, phosphate buffer, and phenol red, and will have a “blank” pad that does not contain all the reagents necessary to generate the colored compound as taught by Phillips. The reaction between the analyte and urease is what leads to the formation the colored compound, where therefore one skilled in the art would find it obvious that the blank pad will still have the phosphate buffer and phenol red, but not the urease.
Regarding claim 6, modified Free teaches the test strip according to claim 5. The elongate substrate of Ishikawa will now have both the bibulous cellulose of Free and the blank pad of Phillips, where the blank pad of Phillips will similarly be adhered and will be located adjacent to the bibulous cellulose such as it is seen in Figure 2 of Phillips.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Free (US-3145086-A) and Ishikawa (US-3932133-A) and in further view of Bruschi (US-4066403-A).
Regarding claim 12, modified Free teaches the test strip according to claim 1. While Free does teach a phosphate buffer, Free is not specific to the type of phosphate buffer used (Free; column 2 line 19, column 3 lines 16-18).
In the same problem solving area of using urease for the analysis of blood urea nitrogen (BUN), Bruschi teaches that it is desirable to buffer an enzyme layer containing urease to a pH between about 5 and 9.5 and preferably between about 7.5 and 9.0, where a useful buffer includes potassium phosphate (Bruschi; column 10 lines 25-30, 36-43, 49-51).
Free is silent with regards to specific phosphate buffer used, therefore, it would have been necessary and thus obvious to look to the prior art for conventional phosphate buffers. Bruschi provides this conventional teaching showing that it is known in the art to use potassium phosphate. Therefore, it would have been obvious to one having ordinary skill in the art to use potassium phosphate because it is taught by Bruschi that potassium phosphate is an effective buffer used in an enzyme layer that comprises urease that needs to be buffered to about 7.5 to 9.0 (Brushi; column 10 lines 25-30, 36-43, 49-51).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Free (US-3145086-A) and Ishikawa (US-3932133-A) and in further view of Mast (US-3395082-A) and Omoto (US-5183742-A).
Regarding claim 13, modified Free teaches the test strip according to claim 1. Free does not teach wherein the reagents substrate material is further loaded with one or more wetting agents comprising a polyethylene glycol, a polysorbate, or a combination thereof.
In the same problem solving area of detecting urea in fluids, Mast teaches bibulous paper strips impregnated with a test composition (Mast; column 1 lines 30-31, column 4 lines 61-63).
Specifically, Mast teaches a combination of an enzyme system, indicator system, color stabilizer, and a buffer system for providing the system with an optimum pH environment, the enzyme system containing urease (Mast; column 2 lines 37-40, 46-49). Mast further teaches that the composition can include various additives such as wetting agents, more specifically polyethylene glycol (Mast; column 5 lines 16-23).
It would have been obvious to one skilled in the art to modify the bibulous cellulose with urease, indicator, and buffer of Free to further include a wetting agent such as polyethylene glycol as taught by Mast because it is taught by Omoto that wetting agents such as polyethylene glycol improve the wettability of the indicator material (Omoto; column 9 lines 19-26).
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Free (US-3145086-A) and Ishikawa (US-3932133-A) and in further view of Mast (US-3395082-A).
Regarding claim 14, modified Free teaches the test strip according to claim 1. Free does not teach wherein the reagents substrate material is further loaded with one or more stabilizers comprising a serum albumin, a saccharide, or a combination thereof.
In the same problem solving area of detecting urea in fluids, Mast teaches bibulous paper strips impregnated with a test composition (Mast; column 1 lines 30-31, column 4 lines 61-63).
Specifically, Mast teaches where the composition includes a color stabilizer comprising an albumin (Mast; column 2 lines 71-72, column 3 line 1). In a specific example of a composition, the color stabilizer is bovine albumin (Mast; column 5 lines 49-57).
It would have been obvious to one skilled in the art to modify the bibulous cellulose with urease, indicator, and buffer of Free to further include bovine albumin as taught by Mast because Mast teaches that albumin is a color stabilizer (Mast; column 2 lines 71-72, column 3 line 1).
Regarding claim 15, modified Free teaches the test strip according to claim 14. Mast further teaches wherein the one or more stabilizers comprise bovine serum albumin (Mast; column 5 lines 49-57 where bovine albumin is understood to be the same as bovine serum albumin).
Regarding claim 16, modified Free teaches the test strip according to claim 14. Because Free teaches where the stabilizer comprises serum albumin and the list of stabilizers in claim 14 are optional, the limitation of claim 16 is not required as claim 16 requires both the serum albumin and saccharide.
Claim(s) 14, 16 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Free (US-3145086-A) and Ishikawa (US-3932133-A) and in further view of Chu (US-6632681-B1) and Rolland (US-2014/0295415-A1).
Regarding claim 14, modified Free teaches the test strip according to claim 1. If it is determined that the serum albumin and saccharide are both required as the stabilizer, Free does not teach wherein the reagents substrate material is further loaded with both a serum albumin and a saccharide.
In the same problem solving area of dried reagents that are immobilized on a matrix material, Chu teaches where a stabilizing agent can be added to the reagent such as sucrose, maltose, melibiose, polyethylene glycol, bovine serum albumin, buffered saline solution, or combinations thereof (Chu; column 3 lines 42-43, 64-67).
It would have been obvious to one skilled in the art to modify the bibulous cellulose with urease, phenol red, and phosphate buffer to further include bovine serum albumin and sucrose as taught by Chu because it is taught by Rolland that stabilizers added to reagent zones further stabilize enzymes spotted on a substrate (Rolland; [0088]).
Regarding claim 16, modified Free teaches the test strip according to claim 14. The bibulous cellulose with urease, phenol red, and phosphate buffer of Free has been modified by Chu to include sucrose (a saccharide) and bovine serum albumin (a serum albumin) as stabilizers. It would have been obvious to one skilled in the art to adjust the amount of stabilizers present in order to obtain the desired stabilization of the urease present on the bibulous cellulose.
Please note that there has been no established criticality for the claimed molar ratio of urease: serum albumin: saccharide.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Free (US-3145086-A) and Ishikawa (US-3932133-A) and in further view of Eswara (US-5707872-A).
Regarding claim 17, modified Free teaches the test strip according to claim 1 as described supra, however modified Free does not teach how to provide or use the strip.
In the analogous art of solid phases impregnated with assay reagents that has results determined by direct visualization of the color of the solid phase, Eswara teaches kits containing the solid phase (Eswara; abstract).
Specifically, Eswara teaches a kit that contains instructions and at least one packaged strip that is impregnated with the assay reagents, and that there is a box that contains multiple individually packaged strips (Eswara; column 12 lines 32-42, Figure 3).
It would have been obvious to one skilled in the art to provide multiple test strips of modified Free along with instructions as a kit as taught by Eswara because Eswara teaches that it is effective to provide multiple test strips and instructions for use in a kit (Eswara; column 12 lines 32-42).
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nara (US-2015/0152468-A1) teaches a strip device that comprises a reactive test zone and control zone each provided on an individual substrate pad fixedly attached to a base support (Nara; [0013]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796