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 .
Response to Amendment
Applicant amendments filed 04/16/2026 have been entered. Applicant amendments overcomes the previous specification objection, claim objections, and 112(b) rejections set forth in the Office Action mailed 12/16/2025, the previous specification objection, claim objections, and 112(b) rejections are withdrawn.
Status of Claims
Claims 1, 3-18 remain pending in the application.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 it appears that the indent on line 3 has been removed, where the indent should be added for “an elongate carrier material; and” as this would make it more clear that the carrier material is part of the test strip.
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 1, 3-18 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
Line 2 it is unclear if by saying “saliva sample taken from the felines and canines” if it means that the saliva sample being tested is from both felines and canines, or if it is meant to say that the test strip detects azotemia or kidney disease in felines and canines, but that the sample is taken from either a feline or canine subject.
Lines 6-7 recites “a feline or canine saliva sample”, where it is unclear if this sample is the same or different from the saliva sample recited on line 2 which recites “saliva sample taken from the felines and the canines”
For examination, it will be interpreted that they are the same.
It is suggested to amend lines 6-7 to recite “[[a]] the feline or canine saliva sample”
Claims 3-18 are rejected by virtue of being dependent on a rejected claim.
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.
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, 3, 7-11, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Free (US-3145086-A) as evidenced by Wagstaff (US-4043757-A), and in view of Kitani (US-5788942-A) and Ishikawa (US-3932133-A), and in the alternative over Yamamoto (US-2010/0062414-A1).
Regarding claim 1, Free teaches a test strip, the test strip 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 sample to within the transition interval of the pH indicator,
wherein the reagents layer comprises the reagents substrate material loaded with the urease, the pH indicator and the buffer (see supra where the bibulous strips have urease, phenol red and phosphate buffer), and
The limitation “for adjusting a pH value of a feline or canine saliva sample to within the transition interval of the pH indicator” 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 Free and the buffer of Free is capable of adjusting a pH value of saliva 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 saliva sample has not been positively recited in the claim, and is therefore not a part of the claimed test strip.
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).
While Free does teach a bibulous material that holds the urase, pH indicator, and buffer, Free does not teach that the bibulous material has a laminate layer.
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 test pad assembly will now have the bibulous cellulose material of Free that is laminated with a PET sheet as taught by Kitani.
The method of the reagents layer is freeze-dried on the laminated layer is a product-by-process limitation. 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 and is therefore taught by Free (MPEP § 2113). The burden is on applicants to show product differences in product-by-process claims.
Please note that Free teaches that the bibulous cellulose strips impregnated with urease, buffer, and indicator material are then dried (Free; column 2 lines 23-25).
Alternatively, if it is determined that the reagents layer is freeze-dried on the laminate layer is not a product-by-process limitation, then in the analogous art of sample liquid analytical chips with a reaction region, Yamamoto teaches where the reaction reagent layer is freeze-dried (Yamamoto; abstract, [0070]).
Specifically, Yamamoto teaches where a reaction reagent layer is freeze-dried which allows for the improvement of the storage stability of the enzymes, antibodies, and so on that are in the reaction reagent layer (Yamamoto; [0070]).
It would have been obvious to one skilled in the art to modify the reagents in the bibulous cellulose strips of Free such that they are freeze-dried as taught by Yamamoto because Yamamoto teaches that freeze-drying allows for the improvement of storage stability of enzymes (Yamamoto; [0070]).
Free does not teach an elongate carrier material nor that the test pad assembly is adhered to the elongate carrier material.
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 with laminated PET sheet of modified 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).
One skilled in the art would find it obvious that if the reagent carriers are adhered or attached to the test piece, there would therefore need to be some sort of layer of adhesive.
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 with PET sheet 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 supporting carriers), 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 with PET sheet of modified Free with the elongate substrate of reference Ishikawa, since the result would have been predictable.
Therefore, the test pad assembly will be made up of the adhesive layer of Ishikawa, the PET sheet of Kitani, and the bibulous cellulose material of Free, where these components are on the elongate substrate of Ishikawa.
The limitation “for detecting azotemia or kidney disease in felines and canines using a saliva sample taken from the felines and the 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 Free (see MPEP §2114).
Please note that the saliva sample is not positively recited in the claim, and is therefore not a part of the claimed test strip.
Regarding claim 3, modified Free teaches the test strip according to claim 1. Kitani further teaches wherein the laminate layer comprises a polyethylene terephthalate (PET) (Kitani; column 20 lines 41-44).
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 of the test pad assembly 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).
Regarding claim 18, modified Free teaches the test strip according to claim 1. While Free teaches that the preferred indicator is phenol red, Free describes other indicators which can be used including bromthymol blue (understood to be a typo of bromothymol).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Free (US-3145086-A), Kitani (US-5788942-A) and Ishikawa (US-3932133-A), and in the alternative rejection Yamamoto (US-2010/0062414-A1), and in further view of Sakamoto (US-2008/0019871-A1).
Regarding claim 4, modified Free teaches the test strip according to claim 1. While Ishikawa teaches carriers adhered on an elongate transparent substrate, 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 with PET layer of modified 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), Kitani (US-5788942-A) and Ishikawa (US-3932133-A), and in the alternative rejection Yamamoto (US-2010/0062414-A1), 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, but not loaded with the urease.
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), Kitani (US-5788942-A) and Ishikawa (US-3932133-A), and in the alternative rejection Yamamoto (US-2010/0062414-A1), 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), Kitani (US-5788942-A) and Ishikawa (US-3932133-A), and in the alternative rejection Yamamoto (US-2010/0062414-A1), and in further view of Mast (US-3395082-A1) 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), Kitani (US-5788942-A) and Ishikawa (US-3932133-A), and in the alternative rejection Yamamoto (US-2010/0062414-A1), 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), Kitani (US-5788942-A) and Ishikawa (US-3932133-A), and in the alternative rejection Yamamoto (US-2010/0062414-A1), 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), Kitani (US-5788942-A) and Ishikawa (US-3932133-A), and in the alternative rejection Yamamoto (US-2010/0062414-A1), and in further view of Eswara (US-5707872-A).
Regarding claim 17, modified Free teaches the test strips 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.
Yager (US-2023/0201824-A1) teaches a reagent depot disposed on or in a fibrous pad, where by lyophilizing or freeze-drying reagents disposed on or in the fibrous pad, the reactivity of the reagents is preserved or elongated in time (Yager; [0037]).
Response to Arguments
Applicant’s amendments to the claims and arguments, see page 9, filed 04/16/2026, with respect to the rejection(s) of claim(s) 1, 7-11 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Free (US-3145086-A) as evidenced by Wagstaff (US-4043757-A), Kitani (US-5788942-A) and Ishikawa (US-3932133-A), and in the alternative over Yamamoto (US-2010/0062414-A1).
In response to applicant's argument that the claimed test strips have a longevity that allows them to be used as “at home” diagnostic device to detect azotemia or kidney disease using a saliva sample taken from felines and canines, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., device being an “at home” diagnostic device) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Further, it is respectfully noted that the saliva sample has not been positively recited in the claim, and is therefore not a part of the claimed test strip.
Applicant argues on page 12 that in the rejection of claim 1, it is already asserted that “… it would be obvious 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”, and therefore for claim 2 modified Free already has support (i.e., the elongated substrate). Therefore, it is argued that there would be no motivation to add additional support when one is already present.
Examiner respectfully disagrees. In the current rejection, Free is modified by Kitani to include the PET layer motivated because Ishikawa teaches that the PET layer is effective for supporting carriers impregnated with chemical reaction reagents. Free in view of Kitani is then modified with Ishikawa to adhere the reagent layer and PET layer to an elongate carrier material motivated because Ishikawa teaches that the elongate carrier is effective for supporting carriers impregnated with chemical reaction reagents. While it is agreed that there are two supports, the supports are serving different purposes. The PET layer supports the reagent layer directly, but then the elongate carrier supports multiple carriers.
Additionally, in both the previous Office Action and the present action on pages 9-8, it is maintained that one skilled in the art would find it obvious to combine the elements as claimed by known methods (e.g., adhering the bibulous cellulose strip with PET sheet to an elongate substrate), please see above rejection.
Applicant’s argument on page 13 that the laminate layer serves a different function than that of a support, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., laminate layer negating potential effects of the adhesive on the physicochemical properties of the reagents layer) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, applicant arguments regarding the laminate layer are to the intended use of the laminate layer.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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