DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/21/2023 and 11/25/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-14 are pending and being examined.
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 9-13 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 9 recites the limitation "the surface" in line 5. There is insufficient antecedent basis for this limitation in the claim, thus the limitation is unclear. The limitation is unclear as to which surface the Applicant is referring to. Specifically, is the Applicant referring to the processed surface, the surface of the opening portion, a surface on the case? The examiner interprets that the Applicant is referring to the processed surface of the inner peripheral wall. Claims 10-13 are rejected by virtue of dependency on claim 9.
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 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.
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 1-5 and 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Jacono et al (US 20090263854 A1; hereinafter “Jacono”) in view of Azuma et al (US 20200355679 A1; hereinafter “Azuma”).
Regarding claim 1, Jacono teaches an assay cartridge that is attachably and detachably loaded into an immunochromatographic assay apparatus1 (Jacono; Abstract; assay device), the assay cartridge comprising:
a carrier having an assay region in which a color development state changes depending on whether a sample is positive or negative (Jacono; para [71]; a label zone (e.g., label pad comprising a mobilizable reagent) to a test zone (comprising, for example, an immobilized capture reagent) and control zone);
a case in which the carrier is accommodated (Jacono; para [56]; Fig. 1; support strip 12 and overlamina 20 form the carrier); and
an opening portion that is provided in the case, is used for observing an observation region including the assay region, and is illuminated by a light source in the immunochromatographic assay apparatus2 (Jacono; para [60]; Overlamina 20 may also include an second opening 26 for viewing at least a portion of the assay strip),
wherein at least a part of an inner peripheral wall of the opening portion is a processed surface having been subjected to a roughening treatment3 (Jacono; para [67]; embossed pattern provides tapered edges, such as edges 29 in FIG. 2A; examiner interprets the angled portion of the tapered edge as the processed surface).
1 The limitation “attachably and detachably loaded into an immunochromatographic assay apparatus” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation 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. See MPEP § 2114. The assay cartridge disclosed by Jacono teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or function language of attachably and detachably loaded into an immunochromatographic assay apparatus. Jacono teaches that the labels can be detected by a reader or similar detection (Jacono; para [121]).
2 The limitation “is illuminated by a light source in the immunochromatographic assay apparatus” is interpreted as intended use and/or functional language. Examiner notes that “the immunochromatographic assay apparatus” are not positively recited elements of the claim, and therefore, are not elements of the claimed assay cartridge. Thus, the light source is not a required element of the claimed invention.
3 The Applicant is advised that the limitation “having been subjected to a roughening treatment” is a product-by-process limitation. There is no apparent difference between the apparatus as claimed and the prior art as taught by Jacono. Generally, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP § 2113(I). The process of subjecting the processed surface to the roughening treatment does not structurally change the surface, so Jacono teaches the structure implied by a processed surface as claimed.
Jacono does not teach processed surface having an angle of 50° or more with respect to a surface of the observation region.
However, Azuma teaches an analogous art of an immunochromatographic test device (Azuma; Abstract) comprising a carrier having an assay region in which a color development state changes depending on whether a sample is positive or negative (Azuma; para [44, 45]; Antigen 308 then binds to any of capture antibodies 310 and 311 that have been immobilized to test line 1 (TL1) 305 and test line 2 (TL2) 306… introducing the sample into the sample pad of the test strip and the detection window 205 for visually or optically detecting the coloration state of the test lines 305, 306 and the control line 307); a case in which the carrier is accommodated (Azuma; para [45]; a complex of the lower housing 100 and immunochromatographic test strip 150 mounted on the lower housing 100 and the upper housing 200 arranged to cover the test strip 150 mounted thereon); and an opening portion that is provided in the case, is used for observing an observation region including the assay region, and is illuminated by a light source in the immunochromatographic assay apparatus (Azuma; para [45]; the detection window 205 for visually or optically detecting the coloration state of the test lines 305, 306 and the control line 307), wherein at least a part of an inner peripheral wall of the opening portion is a processed surface having an angle of 50° or more with respect to a surface of the observation region (Azuma; para [51]; the inclined portion 206 and 207 around the detection window 205 is advantageously sloped gently, preferably degrees to 60 degrees relative to the top surface of the housing). It would been obvious to one of ordinary skill in the art before the effective filing date to have modified the processed surface of Jacono to have an angle of 50° or more with respect to a surface of the observation region as taught by Azuma, because Azuma teaches the angle of the inclined portion allows for visual/optical detection without the shadow of the upper hosing falling on the membrane (Azuma; para [52]).
Regarding claim 2, modified Jacono teaches the assay cartridge according to claim 1 (the processed surface of Jacono is modified to teach an angle of 50° or more as taught by Azuma), wherein the angle is in a range of 70° or more and 90° or less (Jacono; para [67] Fig. 1; embossed pattern provides tapered edges, such as edges 29 in FIG. 2A; Azuma; para [51]; the inclined portion 206 and 207 around the detection window 205 is advantageously sloped gently, preferably degrees to 60 degrees relative to the top surface of the housing). In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of an angle in a range of 70° or more and 90° or less is a result effective variable that gives the well-known and expected results of detection opening. In the absence of a showing of unexpected results, the Office maintains the processed surface would have been within the skill of the art as optimization of a results effective variable. As such the angle is a variable that can be modified, among others, the angles range would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention, without showing unexpected results, the claimed angle cannot be considered critical.
Regarding claim 3, modified Jacono teaches the assay cartridge according to claim 1, wherein the opening portion has a rectangular shape (Jacono; Fig. 1), and the processed surface is formed on a wall surface of the inner peripheral wall extending in a longitudinal direction (Jacono; Fig. 1). The “processed surface” is defined in claim 1 as a structure having an angle of 50°. Thus, Jacono teaches the processed wall as seen in Fig. 2A which is part of the opening portion extends longitudinally.
Regarding claim 4, modified Jacono teaches the assay cartridge according to claim 3, wherein the assay region is a line-shaped assay line, and the assay line is disposed along a direction intersecting the longitudinal direction (Jacono; Fig. 1). The assay is visible in Fig. 1 as denoted by “30” which extends longitudinally and intersects the opening as seen in Fig. 5.
Regarding claim 5, modified Jacono teaches the assay cartridge according to claim 1, wherein the processed surface is formed over an entire circumference of the inner peripheral wall (Jacono; Fig. 1). The “processed surface” is defined in claim 1 as a structure having an angle of 50° which is around the entire perimeter of the detection window.
Regarding claim 7, modified Jacono teaches the assay cartridge according to claim 1, wherein the roughening treatment is an emboss processing (Jacono; para [67]; embossed pattern provides tapered edges, such as edges 29 in FIG. 2A.
Regarding claim 8, modified Jacono teaches the assay cartridge according to claim 1, wherein the opening portion has a rectangular shape (Jacono; Fig. 1, 5), and in a case where an opening width in the direction along the surface of the observation region and in a short side direction of the opening portion is denoted as D, and a height of the inner peripheral wall in the direction orthogonal to the opening width is denoted as H, 0.5D ≤ H ≤ 1.5D. The limitation “in a case where an opening width in the direction along the surface of the observation region and in a short side direction of the opening portion is denoted as D, and a height of the inner peripheral wall in the direction orthogonal to the opening width is denoted as H, 0.5D ≤ H ≤ 1.5D” suggests that “[if] an opening width in the direction along the surface of the observation region and in a short side direction of the opening portion is denoted as D, and a height of the inner peripheral wall in the direction orthogonal to the opening width is denoted as H, 0.5D ≤ H ≤ 1.5D, [then] 0.5D ≤ H ≤ 1.5D”. Thus, the dimensional limitation is not a required element if the condition is not met.
Regarding claim 9, modified Jacono teaches the assay cartridge according to claim 1, wherein in a case where the inner peripheral wall of the opening portion is a first inner peripheral wall, the assay cartridge has a second inner peripheral wall that rises in a direction away from the surface along an intersection direction intersecting the surface of the observation region, around the opening portion (Jacono; Fig. 1). The examiner notes that Jacono teaches the opening is tapered. Thus, the tapered portion forms two surfaces as seen in Fig. 1 which is an angled surface and a normal surface. The normal surface is interpreted as the first inner peripheral wall and the angled surface is interpreted as the second inner peripheral wall. Further, the limitation “wherein in a case where…the assay cartridge has a second inner peripheral wall” suggests that “[if] the inner peripheral wall of the opening portion is a first inner peripheral wall, [then] the assay cartridge has a second inner peripheral wall”. The examiner notes that the limitation does not require the second inner peripheral wall under the condition that the inner peripheral wall is not the first inner peripheral wall. Examiner suggests the Applicant amend the claim to read “
Regarding claim 10, modified Jacono teaches the assay cartridge according to claim 9, wherein a plane portion extending in a direction along the surface of the observation region is provided around the opening portion, and the second inner peripheral wall rises from an end edge of the plane portion on a side opposite to the opening portion (Jacono; Fig. 1). The examiner notes that Jacono teaches the opening is tapered. Thus, the tapered portion forms two surfaces as seen in Fig. 1 which is an angled surface and a normal surface. The angled surface is interpreted as the second inner peripheral wall and extends outward from the opening.
Regarding claim 11, modified Jacono teaches the assay cartridge according to claim 9, wherein the second inner peripheral wall rises from an end edge of the first inner peripheral wall (Jacono; Fig. 1). The examiner notes that Jacono teaches the opening is tapered. Thus, the tapered portion forms two surfaces as seen in Fig. 1 which is an angled surface and a normal surface. The angled surface is interpreted as the second inner peripheral wall and begins from the normal surface which is interpreted as the first inner peripheral wall.
Regarding claim 12, modified Jacono teaches the assay cartridge according to claim 9, wherein at least a part of the second inner peripheral wall is subjected to the roughening treatment (Jacono; para [67]; embossed pattern provides tapered edges, such as edges 29)
Regarding claim 13, modified Jacono teaches the assay cartridge according to claim 9, wherein the second inner peripheral wall is inclined at an angle smaller than the angle of the first inner peripheral wall ((Jacono; para [67]; embossed pattern provides tapered edges, such as edges 29
Regarding claim 14, modified Jacono teaches the assay cartridge according to any one of claim 1, wherein a structure having a convex shape in a direction away from the surface of the observation region is provided around the opening portion, and at least a part of an outer peripheral wall of the structure is subjected to the roughening treatment (Jacono; Fig. 1). The examiner notes that Jacono teaches the opening is tapered. Thus, the tapered portion forms two surfaces as seen in Fig. 1 which is an angled surface and a normal surface. The normal surface which has an angle with respect to the strip of 90 degrees, and the angled surface with respect to the strip is less than 90 degrees as this portion is tapered.
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: modified Jacono does not teach nor suggest “wherein among parameters defining surface roughness of the processed surface, an arithmetic average height Sa is 100 μm or less”. Specifically, the surface roughness parameter is a result of the embossing process. The prior art fails to teach the detection window comprising an arithmetic average height of 100 μm or less.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796 /DUANE SMITH/ Supervisory Patent Examiner, Art Unit 1759