Ex Parte Katagiri et alDownload PDFPatent Trial and Appeal BoardJan 26, 201812225181 (P.T.A.B. Jan. 26, 2018) 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. 12/225,181 09/16/2008 Chika Katagiri 053466-0468 6393 22428 7590 01/30 Foley & Lardner LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 EXAMINER GODDARD, LAURA B ART UNIT PAPER NUMBER 1642 NOTIFICATION DATE DELIVERY MODE 01/30/2018 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): ipdocketing @ foley. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHIKA KATAGIRI, JOTARO NAKANISHI, and TOSHIHIKO HIBINO Appeal 2017-002614 Application 12/225,1811 Technology Center 1600 Before DEBORAH KATZ, RICHARD J. SMITH, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims a method for determining skin sensitivity caused by external stimulation. The Examiner rejected the claims on appeal under 35 U.S.C. § 101 as not directed to patent eligible subject matter, under 35 U.S.C. § 102(b) as anticipated, and under 35 U.S.C. § 103(a) as obvious. We affirm the rejection under Section 101 but reverse the rejections under Sections 102 and 103. 1 According to Appellants, the real party in interest is Shiseido Company, Ltd. App. Br. 2. Appeal 2017-002614 Application 12/225,181 STATEMENT OF THE CASE The Specification discloses that “[t]he sensitivity of the skin to various external irritation and stress varies from person to person, and for example, even though one person may develop rough skin by sensitively reacting to a certain drug, another person may not exhibit any reaction whatsoever.” Spec. 2. “In the past, the degree of skin sensitivity was only determined after rough skin had developed.” Id. This is a problem because “once rough skin has developed, there is both a considerable physical and psychological burden, more time is required for recovery or scars may result that are difficult to treat.” Id. “[I]f it were possible to measure and recognize in advance the degree of sensitivity and reactivity to external irritation and stress of an individual’s skin, it would be possible to prevent rough skin in advance, and also would be possible to select skin care that is appropriate for highly sensitive skin.” Id. “Squamous cell carcinoma antigen (SCCA) is an antigen extracted from squamous cell carcinoma cells that exhibits high concentrations in the blood in squamous cell carcinoma of the neck of the cervix, lungs, esophagus and skin, and is frequently used to diagnose squamous cell carcinoma.” Id. The Specification asserts that “[t]he inventors of the present invention found that the degree of sensitivity and reactivity of skin is related to the amount of SCCA in the epidermis, and that subjects having higher levels of SCCA in the epidermis demonstrated high reactivity to skin irritation.” Id. at 4. “The present invention provides a method of evaluating the degree of skin sensitivity and reactivity on the basis of the expression of squamous cell carcinoma antigen (SCCA), more specifically SCCA-1 and/or SCCA-2, and particularly SCAA-1, in skin comeocytes.” Id. 2 Appeal 2017-002614 Application 12/225,181 Claims 1,3, and 5—10 are on appeal. Claim 1 is illustrative and reads as follows: 1. A method for determining skin sensitivity caused by external stimulation, comprising: (a) quantifying squamous cell carcinoma antigen (SCCA) expression in isolated skin comeocytes from a subject in need thereof to obtain a quantified level of said SCCA expression, wherein the skin comeocytes are obtained from a skin homy layer specimen harvested by tape stripping, and (b) comparing the quantified level of said SC[C]A expression with a control and correlating an increased level of said SCCA expression with skin sensitivity selected from the group consisting of atopic dry skin having atopic dermatitis, allergic skin having pollenosis, and exposed skin having parakeratosis. App Br. 12. The claims stand rejected as follows: Claims 1,3, and 5—10 were rejected under 35U.S.C. § 101 as not directed to patent-eligible subject matter. Claims 1,5, and 7—10 were rejected under 35 U.S.C. § 102 as anticipated by Tazi-Ahnini.2 Claim 3 was rejected under 35 U.S.C. § 103(a) as obvious over the combination of Tazi-Ahnini and Takeda.3 2 Tazi-Ahnini et al., WO 02/44736 A2, published June 6, 2002 (“Tazi- Ahnini”). 3 Takeda et al., Overexpression of Serpin Squamous Cell Carcinoma Antigens in Psoriatic Skin, 118(1) J. Investigational Dermatology 147— 54 (2002) (“Takeda”). 3 Appeal 2017-002614 Application 12/225,181 Claim 6 was rejected under 35 U.S.C. § 103(a) as obvious over the combination of Tazi-Ahnini and Berardesca.4 PATENT-ELIGIBLE SUBJECT MATTER Determination of subject matter eligibility involves a two-step test. First one must determine if the claimed subject matter is directed to a judicially recognized exception such as a product of nature. Mayo Collaborative Serves, v. Prometheus Lab., Inc. 132 S. Ct. 1289, 1297 (2012). If the claims address a judicially recognized exception, the next step is to determine if the claims recite additional elements that transform the nature of the claim. Id. In finding that the pending claims were not directed to patent-eligible subject matter, the Examiner found that the claims were directed to a law of nature — the correlation between naturally occurring levels of squamous cell carcinoma antigen (“SCCA”) in skin comeocytes and skin sensitivity. Final Act.5 2. Having determined that the claims were directed to a law of nature, the Examiner next considered whether the claims recited additional elements that amounted to significantly more than the judicial exception. Id. The Examiner found that the step of quantifying levels of SCCA, including through the use of ELISA and antibodies, was a routine step that did not amount to significantly more than the natural principal itself. Id. at 2—3. The Examiner further found that the “correlating” step was a “mental process, and abstract idea that is an observation of the natural principle]” 4 Berardesca et al., Trans epidermal Water Loss and Skin Surface Hydration in the Non-Invasive Assessment of Stratum Corneum Function, 38(2) Derm. 50-53 (1990) (“Berardesca”). 5 Office Action mailed May 13, 2015 (“Final Act.”). 4 Appeal 2017-002614 Application 12/225,181 and thus did not add significantly more than the natural principle itself. Id. at 3. Based on these findings, the Examiner concluded that the additional recited elements did not add enough to confer patent eligibility on the claimed law of nature. We agree with the Examiner that the claims are directed to patent- ineligible subject matter. We address Appellants’ arguments below. Appellants do not challenge the Examiner’s findings under the first step of the subject matter eligibility test. With respect to the second step of the subject matter eligibility determination, Appellants argue that the claimed method qualifies as significantly more than the judicial exception itself because it provides “a significant advancement in the field of skin care.” App. Br. 9. Appellants contend that prior to the filing of the present application, “the degree of skin sensitivity was only determined after rough skin had developed” which put a “considerable physical and psychological burden” on patients, required more time for recovery, and caused scars that were difficult to treat. Id. (quoting Spec. 2.) Appellants assert that the claimed invention provides a “practical solution” to these problems, qualifying as “a significant advancement in the field of skin care.” Id. We are not persuaded. Our reviewing court has made clear that the relative importance of an alleged invention is not determinative of whether the subject matter claimed is patent-eligible. For example, the Federal Circuit rejected an argument similar to that raised by Appellants in Ariosa Diagnostics, Inc. v. Sequenom, Inc. 788 F.3d 1371 (Fed. Cir. 2004). In that case, the Federal Circuit found that the importance of the method embodied in claims directed to non- invasive pre-natal screening did not justify its patentability, explaining: 5 Appeal 2017-002614 Application 12/225,181 Sequenom also notes that “the method reflects a significant human contribution in that [Drs.] Lo and Wainscoat combined and utilized man-made tools of biotechnology in a new way that revolutionized prenatal care.” Id. We agree but note that the Supreme Court instructs that “[groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Myriad Genetics, Inc., 133 S.Ct. at 2117. The discovery of the BRCA1 and BRCA2 genes was a significant contribution to the medical field, but it was not patentable. Id. at 2117. While Drs. Lo and Wainscoat’s discovery regarding cffDNA may have been a significant contribution to the medical field, that alone does not make it patentable. We do not disagree that detecting cffDNA in maternal plasma or serum that before was discarded as waste material is a positive and valuable contribution to science. But even such valuable contributions can fall short of statutory patentable subject matter, as it does here. 788 F.3d at 1379—1380. Thus, even accepting Appellants’ assertion that their method represents “a significant advancement in the field of skin care,” this alone does not render the method to be patentable subject matter. Appellants argue that the SCAA comparison step recited in the claims “has never been practiced in the prior art” and the claims thus recite something “significantly more than the judicial exception.” App. Br. 10. We are not persuaded. Appellants’ argument conflates the novelty requirement with the requirement that the claims be directed to patent- eligible subject matter. The question is not whether the subject matter of the claims has been disclosed in the prior art, but whether the claims do more than recite the application of a natural law. See, Mayo v. Prometheus, 566 U.S. 66, 77—78 (2012) (finding claims directed to “relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective” patent ineligible, noting 6 Appeal 2017-002614 Application 12/225,181 that a patent cannot, “simply recite a law of nature and then add the instruction ‘apply the law.’”). Here, the comparison step does not add “significantly more” to the judicial exception embodied in the claims — i.e. the principle that the level of SCCA correlates with skin sensitivity. Appellants argue that claim 3 is independently patentable because it recites the use of an enzyme-linked immunosorbent assay (ELISA) to measure the level of SCCA, which adds “significantly more” to the claimed method than the judicial exception itself. According to Appellants, when the SCCA-binding antibody is introduced in the ELISA, it is “transformed into a different state to form an antigen-antibody complex through an immunological ‘lock and key’ system.” Id. at 9-10. We are not persuaded. “‘Simply appending conventional steps, specified at a high level of generality,’ [is] not enough to supply an inventive concept.” Ariosa, 788 F.3d at 1377. Here, the Examiner cited Takeda as evidence that it was “known in the prior art and routine to perform the steps of quantifying levels of SCCA in skin comeocyte samples using antibodies or ELISA.” Ans. 10. Appellants do not contest this finding. The step of performing an ELISA thus does not add “significantly more” to the claimed method so as to bring it outside the scope of the judicial exception. Considering the steps of the claimed method individually and as an ordered combination, we find that the claimed method does not add enough to the judicial exception to render the subject matter recited patent-eligible. Accordingly, we affirm the Examiner’s rejection of the pending claims as not directed to patent-eligible subject matter. 7 Appeal 2017-002614 Application 12/225,181 ANTICIPATION The Examiner finds that Tazi-Ahnini disclose “a method of detecting protein or nucleic acid expression levels or quantifying of SCCA 1 in skin samples, wherein the skin samples encompass the stratum comeum (homy layer) collected by tape stripping.” Final Act. 5. The Examiner further found that Tazi-Ahnini disclosed assaying normal skin and testing for comparison and that the quantity of SCAA correlated with psoriasis and eczema, which are skin sensitivities. The Examiner found that the “correlating” steps recited in the claims “do not require physical steps to be performed and do not limit the claims to a particular stmcture, [and] therefore do not distinguish the claimed method from that taught by the prior art.” Id. Appellants argue that the Examiner failed to accord proper patentable weight to the “correlating” step and that the Tazi-Ahnini does not teach or suggest the step of “comparing the quantified level of said SC[C]A expression with a control and correlating an increased level of said SCCA expression with skin sensitivity selected from the group consisting of atopic dry skin having atopic dermatitis, allergic skin having pollenosis, and exposed skin having parakeratosis.” App. Br. 7. As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): “[T]he examiner bears the initial burden ... of presenting a prima facie case of unpatentability.” Appellant has persuaded us that the Examiner has not carried the burden of establishing that the claimed invention was anticipated by the cited prior art. Tazi-Ahnini discloses comparing the expression of protease inhibitor genes, including SCCA, in psoriatic patients to the expression of such genes 8 Appeal 2017-002614 Application 12/225,181 inpatients with normal skin. See, e.g., Tazi-Ahnini 170—171. However, the Examiner does not identify, and we do not find, any comparison of SCCA expression to levels to those “skin having atopic dermatitis, allergic skin having pollenosis, and exposed skin having parakeratosis.” The pending claims require correlating a quantified level of SCAA expression with skin sensitivity selected for atopic dermatitis, pollenosis, and/or parakeratosis. While this correlation can be performed mentally, the correlation necessarily requires reference to an external standard — i.e., skin sensitivity values for the recited conditions. Accordingly, we are not persuaded by the Examiner’s contention that the “‘correlating’ steps do not require physical steps to be performed and do not limit the claims to a particular structure, [and] therefore do not distinguish the claimed method from that taught and practiced by the prior art.” Ans. 12. Accordingly, we reverse the Examiner’s rejection of claims 1,5, and 7—10 as anticipated by Tazi-Ahnini. OBVIOUSNESS The Examiner’s obviousness rejections apply Tazi-Ahnini in the same manner as discussed in connection with anticipation. Accordingly, we reverse the rejection of claims 3 and 6 as obvious for the reasons discussed above. SUMMARY For these reasons and those set forth in the Examiner’s Answer, and the Final Office Action, we affirm the Examiner’s rejection of claims 1, 3, and 5—10 under 35 U.S.C. § 101 as not directed to patent-eligible subject matter. 9 Appeal 2017-002614 Application 12/225,181 For the reasons set forth herein, we reverse the Examiner’s rejection of claims 1,5, and 7—10 under 35 U.S.C. § 102 as anticipated by Tazi- Ahnini, the Examiner’s rejection of claim 3 under 35 U.S.C. § 103(a) as obvious over the combination of Tazi-Ahnini and Takeda, and the Examiner’s rejection of claim 6 under 35 U.S.C. § 103(a) as obvious over the combination of Tazi-Ahnini and Berardesca. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 10 Copy with citationCopy as parenthetical citation