Ex Parte SongDownload PDFPatent Trial and Appeal BoardJun 3, 201411741943 (P.T.A.B. Jun. 3, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 11/741,943 04/30/2007 Xuedong Song KCX-1346 (64347646US01) 3971 22827 7590 06/03/2014 DORITY & MANNING, P.A. POST OFFICE BOX 1449 GREENVILLE, SC 29602-1449 EXAMINER ANDERSON, CATHARINE L ART UNIT PAPER NUMBER 3778 MAIL DATE DELIVERY MODE 06/03/2014 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte XUEDONG SONG __________ Appeal 2012-003706 Application 11/741,943 Technology Center 3700 __________ Before DONALD E. ADAMS, LORA M. GREEN, and JEFFREY N. FREDMAN, Administrative Patent Judges. PER CURIAM. DECISION ON APPEAL This is a decision on appeal1 under 35 U.S.C. § 134 from the Examiner’s rejection of claims 1-15 and 18-35. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 The Real Party in Interest is Kimberly-Clark Worldwide, Inc. (App. Br. 1.) Appeal 2012-003706 Application 11/741,943 2 STATEMENT OF THE CASE The claims are related to absorbent articles for testing bodily fluids for analytes. Claim 1 is representative of the claims on appeal and reads as follows: 1. An absorbent article for testing a bodily fluid suspected of containing an analyte, the absorbent article comprising: an outer cover; a bodyside liner; an absorbent core positioned between the outer cover and the bodyside liner; and an insert for testing a bodily fluid suspected of containing an analyte, the insert comprising a cover; a lateral flow device encased within the cover, and an attachment mechanism configured to attach a liquid permeable back coversheet of the insert to the bodyside liner of the absorbent article, wherein the lateral flow device is configured to perform a heterogeneous assay to separate one species from another species prior to detection and comprises a chromatographic medium that defines a detection zone, the detection zone being configured for exhibiting a signal indicative of the presence or absence of the analyte in the bodily fluid, wherein the back coversheet of the insert is attached to the bodyside liner of the absorbent article. Appeal 2012-003706 Application 11/741,943 3 Issue The Examiner has rejected claims 1-7, 9, 10, 12-15, and 18-352 under 35 U.S.C. § 103(a) as obvious in view of Diehl3 and Dostoinov4 (Ans. 4-7). The Examiner has also rejected claims 8 and 11 under 35 U.S.C. § 103(a) as obvious in view of Diehl, Dostoinov, and Kaylor5 (Ans. 7-8). Because Appellant does not separately argue that rejection, we will consider the rejections together. We focus our initial analysis on independent claim 1. The issue presented is: Has the Examiner established by a preponderance of the evidence that Diehl and Dostoinov would have made obvious the absorbent article of claim 1 with an insert comprising a lateral flow device configured to perform a heterogeneous assay, wherein a back coversheet of the insert is attached to the bodyside liner of the absorbent article? Findings of Fact FF1. The Examiner finds that “Diehl discloses an absorbent article comprising an outer cover 26, a bodyside liner 24, and an absorbent core 28 . . . [such that] [a]n insert 60 for testing a bodily fluid is attached to the article” (Ans. 5 (citing Diehl, Figure 1)). 2 The initial statement of the rejection in the Answer (pg. 4) did not reference claims 20-22, 25, and 33. On pages 6 and 7 of the Answer, however, the Examiner discusses claim 20-22, 25, and 33 and thus it appears that the omission of these claims from the statement of the rejection was an inadvertent error. 3 Diehl et al., US 7,365,238 B2, issued Apr. 29, 2008. 4 Dostoinov et al., US 2004/0133090 A1, published Jul. 8, 2004. 5 Kaylor et al., US 2005/0131287 A1, published Jun. 16, 2005. Appeal 2012-003706 Application 11/741,943 4 FF2. The Examiner finds that the Diehl “insert 60 is attached to the bodyside liner of the article by an attachment mechanism” (id. (citing Diehl, col. 8, ll. 15-18)). FF3. The Examiner finds that the Diehl “insert 60 comprises a cover 75, a lateral flow device 70, and a back coversheet 80 . . . [wherein the] lateral flow device comprises a chromatographic medium defining a detection zone” (id. (citing Diehl, col. 6, ll. 30-52)). FF4. The Examiner finds that the Diehl “device 60, as shown in figures 3 and 9, . . . comprises a substrate that transports fluid along the length of the substrate by wicking” (id. at 8 (citing Diehl, col. 9, ll. 57-67)). FF5. The Examiner finds that the “device 60 of Diehl therefore creates the flow of liquid in a lateral direction of the article, and fulfills the claim limitation of a lateral flow device” (id.). FF6. Diehl discloses that, in one embodiment, [T]he dehydration indicator 60 may be located in regions of the article other than the urine loading zone. In these embodiments, . . . at least a portion of the fluid transport element 160 is located in, or adjacent to, the urine loading zone in order to acquire fluid prior to transporting, e.g., wicking, fluid to the dehydration indicator 60. (Diehl, col. 9, ll. 54-64.) FF7. The Examiner finds that the Diehl discloses a “lateral flow device [that] detects the ionic strength of the user’s urine, but does not disclose . . . a heterogeneous assay to separate one species from another prior to detection” (Ans. 5). Appeal 2012-003706 Application 11/741,943 5 FF8. The Examiner finds that Dostoinov teaches “an absorbent article having a lateral flow device . . . [that is] capable of separating a plurality of species to be detected” (id. (citing Dostoinov, Figure 1; ¶ 0024)). FF9. The Examiner finds that Dostoinov’s lateral flow device “allows for the simultaneous detection of several species . . . [and] is useful in the rapid detection and diagnosis of a patient” (id. (citing Dostoinov, ¶ 0016)). FF10. Dostoinov discloses a sanitary-hygienic article comprising “a liquid-permeable upper face layer, an impervious to liquid lower layer, an absorbing core and a functional diagnostic means disposed between the absorbing core and the lower layer” (Dostoinov 2, ¶ 0020). FF11. Dostoinov discloses that the “functional diagnostic means can be made in the form of at least one layer . . . divided into sections . . . [such that] each section is a pocket with an indicating testing strip disposed in it” (id. at 2, ¶ 0026). FF12. Dostoinov discloses that “when the facing out . . . side of the pocket is made from transparent material, the lower impervious to water layer is also made transparent” (id. at 3, ¶ 0029). FF13. Dostoinov discloses that if “the capsule [pocket] and the lower water-impervious layer are made from transparent material or have transparent windows, aligned relative to each other, the visual inspection [of the test strip] can be made” without taking off the absorbent article (id. at 4, ¶ 0061). FF14. The Examiner concludes that it would “have been obvious to one of ordinary skill in the art . . . to configure the lateral flow device of Appeal 2012-003706 Application 11/741,943 6 Diehl to separate and detect a plurality of species, as taught by Dostoinov, to provide for the rapid detection and diagnosis of a patient” (Ans. 5). FF15. The Specification discloses that a “lateral flow assay device generally includes a chromatographic medium (e.g., porous membrane) that defines a detection zone for providing a signal indicative of the presence or absence of an analyte” (Spec. 3:30-32). FF16. The Specification discloses that the chromatographic medium “may be made from any of a variety of materials through which the test sample is capable of passing” (id. at 4:32-33). FF17. The Specification discloses that a “heterogeneous assay is one in which a species is separated from another species prior to detection” (id. at 4:11-12). FF18. The Specification discloses that, in one embodiment, the lateral flow device [I]s positioned on the bodyside liner 102 such that the application zone 16 is located towards the crotch region . . . and the absorbent material 18 is positioned towards the waist region of the diaper 100. As such, the detection zone 20 and the control zone 22 are positioned away from the crotch region of the diaper, helping to inhibit any contamination from the urine discharged by the wearer. (Id. at 22:31-23:3.) Principles of Law The Supreme Court has emphasized that “the [obviousness] analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Appeal 2012-003706 Application 11/741,943 7 Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” (Id. at 417.) Moreover: The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 425 (CCPA 1981). Analysis Appellant argues that Diehl does not disclose or suggest “a lateral flow device having a chromatographic medium that defines a detection zone” (App. Br. 6). Appellant argues that the Diehl “indicator simply indicates the ionic strength of the fluid” (id.). Appellant argues that the Diehl “configuration is completely different than . . . [a] lateral flow device configured to perform a heterogeneous assay to separate one species from another species prior to detection and [that] comprises a chromatographic medium that defines a detection zone” (id.). These arguments are not persuasive. As recognized by the Examiner (Ans. 8), Diehl discloses an ionic strength detection device that comprises a detection zone and a substrate that transports fluid along the length of the substrate by wicking, and thus Diehl discloses a lateral flow device that comprises a chromatographic medium that defines a detection zone (FFs 6 and 7). Although, Diehl does not disclose a lateral flow device for Appeal 2012-003706 Application 11/741,943 8 performing a heterogeneous assay, Dostoinov does disclose an absorbent article comprising a lateral flow device for performing a heterogeneous assay (FF 8). We agree with the Examiner that these cited references would have made obvious the incorporation of a lateral device for performing a heterogeneous assay into an absorbent article by attaching the device to the body liner surface of the article, and thereby arrive at the invention of claim 1, because Diehl discloses such an attachment location for lateral flow devices (FFs 2 and 3). Appellant argues that “one of ordinary skill in the art would not have modified the dehydration indicator of Diehl, et al., configured[ ]to indicate the ionic strength of a fluid, to be a lateral flow device configured to exhibit a signal indicative of the presence or absence of the analyte in the bodily fluid” (App. Br. 7 (emphasis removed)). Appellant argues that “[s]uch a modification would render the dehydration indicator of Diehl, et al. to be unsatisfactory for its intended purpose: i.e., to indicate the ionic strength of a fluid” (id. (emphasis removed)). These arguments are not persuasive. The arguments fail to recognize that the obvious combination is the substitution of the tests of Dostoinov for the test for dehydration of Diehl, and is not focused on the specific tests being performed. Further, Dostoinov discloses that more than one diagnostic test strip may be incorporated into an absorbent article, and thus a single absorbent article could incorporate both a dehydration indicating lateral flow device and heterogeneous assay device (FF 11). Additionally, the combination of the references would have made obvious an alternative Appeal 2012-003706 Application 11/741,943 9 attachment location, i.e., attachment to the bodyside liner, for the Dostoinov heterogeneous assay lateral flow device. Appellant argues that the Dostoinov “diagnostic capsule is ‘joined with the lower layer or with the absorbing layer’ . . . [and] [t]he ‘lower layer’ . . . is the liquid impermeable layer 7” (App. Br. 7-8). Appellant argues that, “if one of ordinary skill in the art would have substituted the diagnostic capsule of Dostoinov, et al. for the dehydration indicator of Diehl, et al., the placement of the testing strip would necessarily be ‘joined with the lower layer or with the absorbing layer,’” which would not result in the article of claim 1 with the back cover sheet of the insert attached to the bodyside liner (id. at 8 (emphasis removed)). These arguments are not persuasive. The Examiner relies on Diehl for disclosing the placement of an assay device attached to the bodyside liner of an absorbent article (FFs 2 and 3). The Examiner relies on Dostoinov as disclosing that a particular assay device, i.e., a device that is capable of separating a plurality of species, is known for use in absorbent articles (FF 8). In accord with In re Keller, the test for obviousness is what the combined teachings of the references would have suggested to an ordinary artisan, and obviousness does not require the bodily incorporation of all of the features of one reference into a second reference. Appellant argues that Dostoinov “teaches away from the presently claimed location of the insert” (App. Br. 8). Appellant argues that Dostoinov discloses “placement of the testing strip ‘joined with the lower layer or with the absorbing layer,’ . . . [which] is completely at odds with the requirement of independent claim 1, which requires that the back coversheet Appeal 2012-003706 Application 11/741,943 10 of the insert be attached to the bodyside liner of the absorbent article” (id. at 9). These arguments are not persuasive. Although Dostoinov discloses that the testing strips are contained in a layer between the absorbent core and the lower layer, the purpose of this particular placement appears to be so that the diagnostic assay results can be viewed through a transparent window in the lower layer (FFs 12 and 13). Thus, one of skill in the art would understand that, if it is not necessary to view the strips through the absorbent article, the test strips could be disposed on the body facing surface of the absorbent article, as disclosed in Diehl (FFs 12 and 13). Thus, we affirm the rejection of claim 1 as being obvious in view of Diehl and Dostoinov. Claims 2-7, 9, 10, 12-15, and 18-35 have not been argued separately from claim 1 and therefore fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii). The Examiner has also rejected claims 8 and 11 as obvious in view of Diehl, Dostoinov, and Kaylor (Ans. 7-8). The Examiner relies on Diehl and Dostoinov as discussed above and relies on Kaylor to supply dependent claim limitations. Since Appellant has not argued this rejection separately, we also affirm this rejection. Conclusion of Law The preponderance of the evidence supports the Examiner’s conclusion that Diehl and Dostoinov would have made obvious the absorbent article of claim 1 with an insert comprising a lateral flow device configured to perform a heterogeneous assay, wherein a back coversheet of the insert is attached to the bodyside liner of the absorbent article. Appeal 2012-003706 Application 11/741,943 11 SUMMARY We affirm the rejection claims 1-15 and 18-35 under 35 U.S.C. § 103(a). TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED cdc Copy with citationCopy as parenthetical citation