CTNF 18/294,617 CTNF 95652 DETAILED ACTION In application filed on 02/02/2024, Claims 1-9 are pending. The claim set submitted on 02/02/2024 is considered because this is the most recent claim set. Claims 1-9 are considered in the current office action. Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 02/02/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections 07-29-01 AIA Claim s 1-2 are objected to because of the following informalities: Claim 1 recites “the respective seating grooves”. It appears that this limitation should be recited as “the seating grooves”. Consistent language should be used and appropriate correction is required. Claim 2 recites “the pore holes”. It appears that this limitation should be recited as “a plurality of the port holes”. Consistent language should be used and appropriate correction is required. Claim Rejections - 35 USC § 112 07-34-01 Claim 8 is 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. 07-34-05 AIA Claim 8 recites the limitation " the plurality of seating grooves " in Claim 8 . There is insufficient antecedent basis for this limitation in the claim. For the purpose of expedited prosecution, the limitation the plurality of seating grooves" is interpreted by the Examiner as “a plurality of seating grooves". Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1 and 6-9 are rejected under 35 U.S.C. 102 ( a) (1 ) as being anticipated by Lange et al. (US3802842A, submitted in IDS 02/02/2024) . Regarding Claim 1, Lange teaches a urine testing kit comprising: a reagent paper (referred to as indicator layer [ Figs 1-6, ref. 4]) which reacts with urine (See Abstract… least one indicator layer containing detection reagents; See Page 54-55…the case of using the test strip in a stream of urine); a substrate part (referred to as a holder 2, which preferably consists of a stiff or rigid synthetic resin foil [Fig. 3-4, ref. 2; Col. 3, lines 20-22]) having a seating groove (See Figs. 3-4…space between adhesive layers where the indicator layer is positioned) formed on its upper surface (See Figs. 3-4 for the upper surface of a holder 2) in which the reagent paper (referred to as indicator layer [ Figs 1-6, ref. 4]) is seated (See Figs. 3-4…space between adhesive layers where the indicator layer is positioned); and a cover part (referred to as meshwork [Figs. 3-4, ref. 1]) which is coupled to the upper surface (See Figs. 3-4 for the upper surface of a holder 2) of the substrate part (referred to as a holder 2, which preferably consists of a stiff or rigid synthetic resin foil [Fig. 3-4, ref. 2; Col. 3, lines 20-22]) and covers an entrance (See Annotated Fig. 4) of the seating groove (See Figs. 3-4…space between adhesive layers where the indicator layer is positioned), wherein a pore hole (referred to as holes in the meshwork [Col. 3, lines 62-66]) is formed (See Col. 3, lines 62-66…adhesive layer passes through the holes in the meshwork and covers the meshwork 1 on the upper side) in the cover part (referred to as meshwork [Figs. 3-4, ref. 1]) through which the urine sprayed (See Col. 2, lines 43- 50…liquid investigated penetrates through the holes of the meshwork; Col. 2, lines 54…stream of urine) on an upper surface (referred to as meshwork [Figs. 3-4, ref. 1]; under BRI, the meshwork has a upper surface) of the cover part (referred to as meshwork [Figs. 3-4, ref. 1]) is injected into the seating groove (See Figs. 3-4…space between adhesive layers where the indicator layer is positioned). In addition, Claim 1 recites a reagent paper, a substrate part, a cover part, seating groove and a pore hole and then recites how these structure function with respect to urine. Claim 1 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). PNG media_image1.png 691 1299 media_image1.png Greyscale Annotated Figs. 1-6, Lange Regarding Claim 6 , Lange teaches that a material of the substrate part (referred to as a holder 2, which preferably consists of a stiff or rigid synthetic resin foil [Fig. 3-4, ref. 2; Col. 3, lines 20-22]) comprises one or more of kraft paper, sugarcane resin, paper, and corn starch (See Col. 3, lines 36-43…The holder 2 is preferably made from a synthetic resin, for example, polystyrene, polyvinvyl chloride, a polyester or a polyamide. However, it is also possible to impregnate an absorbent material, for example wood, paper or cardboard, with a water-repellent material or to cover an absorbent material with a water-resistant film, thereby teaching “paper’). Regarding Claim 7 , Lange teaches that a material of the cover part (referred to as meshwork [Figs. 3-4, ref. 1]) is a hydrophilic material comprising one or more of Polyvinyl alcohol, Poly Latic Acid, Polycaprolactone, Sodium Carboxymethyl Cellulose, Polyhydroxyalkanoates (PHAs), Polybutylene adipate terephthalate (PBAT), Polycaprolactone (PCL), and Polybutylene succinate (PBS) (See Col. 4, lines 13-23…The meshwork 1 can consist of regularly woven filaments in the form of a fabric…It is preferred to use synthetic resin fabrics of monofile or spun filaments which can consist of cellulose materials, for example cotton, cellulose; Under BRI, Sodium Carboxymethyl Cellulose (often called CMC or cellulose gum) is a cellulose material. Specifically, it is a chemically modified cellulose derivative). Regarding Claim 8 , Lange teaches that a plurality of the seating grooves are provided (See Annotated Figs. 1-6; See Figs. 3-4…spaces between adhesive layers where the indicator layers are positioned), the substrate part (referred to as a holder 2, which preferably consists of a stiff or rigid synthetic resin foil [Fig. 3-4, ref. 2; Col. 3, lines 20-22]) is provided in the form of a stick (See Fig. 1-6, ref. 2 for the shape of a stick) extending (See Annotated Figs. 1-6 for “extending”) in a first direction (See Annotated Figs. 1-6), and the plurality of seating grooves (See Annotated Figs. 1-6; See Figs. 3-4…spaces between adhesive layers where the indicator layers are positioned) are aligned along the first direction (See Annotated Figs. 1-6). Regarding Claim 9 , Lange teaches that the cover part (referred to as meshwork [Figs. 3-4, ref. 1]) is formed of a transparent material (See Col. 4, lines 17-18…in which the fibre structure is not uniform, provided that they have the necessary transparency and stability, thereby teaching “formed of a transparent material”) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-22-aia AIA Claim s 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Lange et al. (US3802842A, submitted in IDS 02/02/2024) as applied to claim 1 above, and further in view of Betts-LaCroix et al. (US10416084B1) . Regarding Claim 2 , Lange teaches wherein the pore holes (referred to as holes in the meshwork [Col. 3, lines 62-66]) are formed in a position (See Annotated Fig. 4) facing the entrance (See Annotated Fig. 4) of the seating groove (See Figs. 3-4…space between adhesive layers where the indicator layer is positioned). Lange does not teach that the pore holes are formed at a density (number/cm 2 ) of 4/cm 2 to 20/cm 2 and a diameter of the pore hole is formed to be less than or equal to 1.0 mm. In the analogous art of a test pad comprising multiple urine attribute patches and urine detection patches in a BAYER pattern, Betts-LaCroix teaches that the pore holes are formed at a density (number/cm 2 ) of 4/cm 2 to 20/cm 2 (See Col. 7, lines 30-31…An optional top protection layer may have an exemplary hole pattern of 0.2 mm holes on a 1 mm or 0.5 mm spacing; This exemplary teaching under BRI converts to 2.5 holes to 5 – 2.5 holes per mm 2 . Further, since a square has equal sides, the same number of holes can fit along the width; Thus total holes is 25 holes to 6.25 holes per mm 2 ;See Col.7 , lines 37-39…Hole size may thus need to vary with the type and age of the rodents) and a diameter of the pore hole is formed to be less than or equal to 1.0 mm (See Col. 7. Lines 34-35…A suitable hole diameter is 0.1 to 0.8 mm). Further, Betts-LaCroix teaches that the hole size may vary (Col 7, lines 30-40). MPEP § 2144.05, Part II, Subpart B holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In the design and fabrication of microfluidic devices, the selection of optimal experimental conditions including structural geometry and dimensions affects fluidic transport parameters such as pressure and flow rate which in turn affect transport profile of the desired analytes in the samples. Thus, the pore holes are formed at a particular density are a result effective variables. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the urine testing kit of Lange to have the pore holes are formed at a density (number/cm 2 ) of 4/cm 2 to 20/cm 2 and a diameter of the pore hole is formed to be less than or equal to 1.0 mm, as taught by Betts-LaCroix, for the benefit of allowing holes of suitable size that allows urine to flow through quickly enough (Betts-LaCroix, Col. 7, lines 40-43), allowing for the automated measurement of animal health, in particular via urine analysis, in particular automated urine analysis of animals in a vivarium (Betts-LaCroix, Col. 1, lines 6-10). Regarding Claim 3 , the urine testing kit of claim 2 is obvious over Lange in view of Betts-LaCroix. Lange teaches that a plurality of the seating grooves (See Figs. 3-4…spaces between adhesive layers where the indicator layers are positioned) are provided, and the pore holes (referred to as holes in the meshwork [Col. 3, lines 62-66; Figs. 3-4, refs. 1]) are formed for the respective seating grooves (See Figs. 3-4…spaces between adhesive layers where the indicator layers are positioned). Regarding Claim 4 , the urine testing kit of claim 3 is obvious over Lange in view of Betts-LaCroix. Lange teaches that a plurality of the reagent papers (referred to as indicator layer [ Figs 1-6, ref. 4; See Col. 4, lines 65-66…one or more indicator layers 4]) are provided, and each of the reagent papers (referred to as indicator layer [ Figs 1-6, ref. 4; See Col. 4, lines 65-66…one or more indicator layers 4]) is placed in a different seating groove (See Figs. 3-4…spaces between adhesive layers where the indicator layers are positioned) . 07-21-aia AIA Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lange et al. (US3802842A, submitted in IDS 02/02/2024) as applied to claim 1 above . Regarding Claim 5 , Lange teaches that the reagent paper (referred to as indicator layer [ Figs 1-6, ref. 4; See Col. 4, lines 65-66…one or more indicator layers 4]) is seated in close contact (See Annotated Figs. 3-4) with a bottom surface of the seating groove (See Figs. 3-4…spaces between adhesive layers where the indicator layers are positioned; under BRI, the spaces have a bottom surface), and a distance (See Fig. 3-4 for the claimed distance) from a lower surface of the cover part (referred to as meshwork [Figs. 3-4, ref. 1]; under BRI, the meshwork has a lower surface) to an upper surface of the reagent paper (referred to as indicator layer [ Figs 1-6, ref. 4; See Col. 4, lines 65-66…one or more indicator layers 4]; under BRI, the indicator layer has a upper surface ). Lange does not teach that a distance from a lower surface of the cover part to an upper surface of the reagent paper is 1.0 mm or less. However, Lange does teach that the urine testing kit of Claim 1 is a microfluidic device where the only difference between the prior art and the claim that a distance from a lower surface of the cover part to an upper surface of the reagent paper is 1.0 mm or less. The Federal Circuit 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 (See MPEP § 2144.05, Part II, Subpart B; In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design and fabricate a urine testing kit where the distance from a lower surface of the cover part to an upper surface of the reagent paper is 1.0 mm or less, for the benefit of providing for the first time, reproducible analytic values which are independent of the time of immersion. This signifies a considerable increase in the degree of certainty in the use of the test strips (Lange, Col. 3, lines 2-7). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm. 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, Lyle Alexander can be reached on (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797 Application/Control Number: 18/294,617 Page 2 Art Unit: 1797 Application/Control Number: 18/294,617 Page 3 Art Unit: 1797 Application/Control Number: 18/294,617 Page 4 Art Unit: 1797 Application/Control Number: 18/294,617 Page 5 Art Unit: 1797 Application/Control Number: 18/294,617 Page 6 Art Unit: 1797 Application/Control Number: 18/294,617 Page 7 Art Unit: 1797 Application/Control Number: 18/294,617 Page 8 Art Unit: 1797 Application/Control Number: 18/294,617 Page 9 Art Unit: 1797 Application/Control Number: 18/294,617 Page 10 Art Unit: 1797 Application/Control Number: 18/294,617 Page 11 Art Unit: 1797 Application/Control Number: 18/294,617 Page 12 Art Unit: 1797 Application/Control Number: 18/294,617 Page 13 Art Unit: 1797 Application/Control Number: 18/294,617 Page 14 Art Unit: 1797
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