Ex Parte CohnDownload PDFPatent Trial and Appeal BoardNov 26, 201311545812 (P.T.A.B. Nov. 26, 2013) 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. 11/545,812 10/10/2006 Jay N. Cohn 600.559US2 9767 7590 11/26/2013 Schwegman, Lundberg, Woessner & Kluth, P.A. P.O. Box 2938 Minneapolis, MN 55402 EXAMINER STOKLOSA, JOSEPH A ART UNIT PAPER NUMBER 3762 MAIL DATE DELIVERY MODE 11/26/2013 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 JAY N. COHN __________ Appeal 2012-003107 Application 11/545,812 Technology Center 3700 __________ Before TONI R. SCHEINER, LORA M. GREEN, and ERICA A. FRANKLIN, Administrative Patent Judges. SCHEINER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 from the final rejection of claims directed to a method of accessing cardiovascular health. The Examiner has rejected the claims as lacking written descriptive support. We have jurisdiction under 35 U.S.C. § 6(b). 1 Appellant identifies the Real Party-In-Interest as the Regents of the University of Minnesota (App. Br. 2). Appeal 2012-003107 Application 11/545,812 2 STATEMENT OF THE CASE Claims 5 and 9-13 are pending and on appeal. Claims 1-4, 6-8, 14, and 15 have been canceled (App. Br. 4). Claim 5 (disputed limitations emphasized) is representative: 5. A method of assessing cardiovascular ailments in a human subject from a population of subjects seeking assessment of their cardiovascular health, and treating the subject to reverse or slow progression of the ailments, comprising: a) assessing early markers for arterial and left ventricular disease by performing a first set of tests on the subject, the first set of tests consisting of: 1) measuring arterial elasticity using pulse contour analysis to provide separate assessment of the elasticity of the large conduit arteries and the small arteries that serve as sites of reflected waves in the circulation; 2) measuring blood pressure at rest and during exercise; 3) imaging the optic fundus of the subject and analyzing the image or images for the A:V ratio and the presence of A:V crossing changes; 4) analyzing a urine sample from the subject for the albumin excretion creatinine; 5) determining the wall thickness of at least one large artery; b) assessing early cardiac disease wherein a second set of tests are performed on at least some of the subjects from the population, the second set of tests consisting of: 1) an electrocardiogram; 2) a cardiac ultrasound to screen the left ventricle for transverse diameter and wall thickness; 3) a test to determine plasma brain natriuretic peptide concentration levels as a marker for left ventricular dysfunction; and 4) a pulmonary function test using forced expiratory volume measurements; c) individually scoring the early markers and cardiac disease assessments using a three point scoring system indicating normal, borderline, and abnormal results and using the individual scores to produce at least one overall score wherein the resultant overall score provides a risk Appeal 2012-003107 Application 11/545,812 3 assessment on a scale wherein one end of the scale indicates no treatment is needed and the other end represents the greatest evidence of disease in need of treatment and wherein a low score of the three point scoring system is classified as normal, an intermediate score of the three point scoring system is classified as borderline, and a high score of the three point scoring system is classified as abnormal; and d) intervening in the progression of cardiovascular illness in the subject by providing one or more treatments for the subject in order to reverse or slow the progression of actual or suspected cardiovascular ailments identified in the assessment. Claims 5 and 9-13 stand rejected under 35 U.S.C. § 112, first paragraph, as lacking written descriptive support for claim language added by amendment. This is a new matter rejection. We reverse. WRITTEN DESCRIPTION Issue The issue raised by this appeal is whether amending the claims to recite that the claimed assessment method consists of, rather than comprises, a specific set of tests introduced new matter into the claims. Discussion According to the Examiner, “Applicant appears to disclose that some tests are optionally included or excluded” in assessing cardiovascular health (Ans. 7), and this “is in clear contradiction to the requirements of using ‘consisting of’ terminology within the claims” (id. at 8). Thus, the Examiner finds that the Specification does not provide support for “the newly added claim limitation that the early marker tests are a closed set consisting of measuring arterial elasticity, measuring blood pressure at rest and during exercise, imaging the optic fundus, analyzing urine samples for albumin, and Appeal 2012-003107 Application 11/545,812 4 determining wall thickness” (id. at 4-5), or for “the newly added claim limitation that the early cardiac disease tests are a closed set” (id. at 6). Appellant contends that: [T]he specification discloses, in at least one embodiment, a specific set of tests that are equal to ten separate tests, and that the scoring range is 0-20 (see page 5 of [Appellant’s] specification; note that the blood pressure test is listed on one line but is actually two tests as evidenced in Figure 2). This constitutes a clear disclosure of a closed set of tests, as the scoring range has a fixed upper limit, and the ranges of scores separating patients into categories are also fixed, neither of which would be possible if the tests administered were “open” and could be arbitrarily reduced or expanded. Furthermore, even if an alternate embodiment has an additional test for high risk patients, that embodiment does not render the other embodiment without the high risk test an “open set” of tests. The same is true for still another alternate embodiment, wherein the specification also contemplates that the set of tests could be expanded . . . but this alternate embodiment does not negate the disclosure and teaching of the closed test set embodiment. (App. Br. 12-13.) The Examiner “acknowledges there appears to be at least one embodiment where ten tests are used; however the specification lacks evidence and support that only 10 tests are used and no other possible combination of tests are used” (Ans. 6). This is a distinction without a difference. There is no dispute that the Specification explicitly discloses each of the ten tests listed in the claims,2 as well as a small number of additional tests, some of which, like the ankle- 2 Appellant notes that “measuring blood pressure at rest and during exercise” is actually two tests, as shown in Figure 2 of the Specification (App. Br. 12). Appeal 2012-003107 Application 11/545,812 5 brachial index, are relevant when assessing high-risk patients (see, e.g., Spec. 4: 17-20, 24). It is well settled that alternative elements which are positively recited in the Specification may be explicitly excluded from the claims. See In re Johnson, 558 F.2d 1008, 1019 (CCPA 1977) (“[The] specification, having described the whole, necessarily described the part remaining.”). Moreover, the Specification discloses that “[a]n abnormal test contributes 2 points to an overall disease assessment score, a borderline test 1 point and a normal test 0. The overall score (range 0 to 20) provides a continuum from no disease to severe disease” (Spec. 5: 6-8). This, too, is consistent with an assessment consisting of ten tests. We agree with Appellant that the mere “disclosure of multiple possibilities does not mean there is no support for a closed set of tests as claimed” (Reply Br. 2). On this record, the Examiner has not identified any valid impediment to claiming both “a set of tests that include[s] a particular test and a set of tests that excludes that particular test” (id.). Accordingly, we agree with Appellant that the amendment of the claims to recite “consisting of,” rather than “comprising,” did not introduce new matter into the claims. CONCLUSION The Examiner has not established that the claims lack written descriptive support in the Specification as filed. The rejection of claims 5 and 9-13 under 35 U.S.C. § 112, first paragraph, is reversed. REVERSED cdc Copy with citationCopy as parenthetical citation