Ex Parte KonofalDownload PDFPatent Trials and Appeals BoardMay 22, 201910559293 - (D) (P.T.A.B. May. 22, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 10/559,293 01/19/2006 38824 7590 05/24/2019 NORTON ROSE FULBRIGHT US LLP Attn: MN IP Docket 98 San Jacinto Boulevard Suite 1100 Austin, TX 78701-4255 FIRST NAMED INVENTOR Eric Konofal 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 ATTORNEY DOCKET NO. CONFIRMATION NO. CABR-022/US 1547 EXAMINER KASSA, TIGABU ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 05/24/2019 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): mnipdocket@nortonrosefulbright.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ERIC KON OF AL Appeal2018-007451 Application 10/559,293 1 Technology Center 1600 Before DONALD E. ADAMS, ELIZABETH A. LA VIER, and RYAN H. FLAX, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This Appeal under 35 U.S.C. § 134(a) involves claims 1, 5-9, and 23- 25 (Ans. 2 3). Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE. 1 Appellant identifies "NLS Pharma AG" as the real party in interest (Appellant's January 8, 2018 Appeal (Br.) 2). 2 Examiner's May 3, 2018 Answer. Appeal2018-007451 Application 10/559,293 STATEMENT OF THE CASE Appellant's disclosure "relates to the use of iron or of a pharmaceutically acceptable salt thereof, alone or in combination with one or more psychostimulant compounds, for preparing a medicinal product for use in the treatment of ADHD and of the associated symptoms" (Spec. 1: 8- 12). Claims 1, 5-8, 24, and 25 are representative and reproduced below: 1. A method for the treatment of attention deficit hyperactivity disorder (ADHD) as defined in the DSM IV in a patient in need thereof comprising administering an effective amount of an iron supplement in the form of a pharmaceutically acceptable iron salt or organic iron or iron atom to said patient wherein said patient is a child of between 5 and 12 years old affected by a ferritin deficiency with a serum ferritin concentration of less than 50 µg/L and who also has a normal serum concentration of soluble transferrin receptors, and wherein iron is administered in a dosage that corresponds to a daily intake of ferrous sulfate of between 100 mg and 2 g per day, in one or more intakes, in the absence of another active agent. (Br. 9.) (Id.) (Id.) (Id.) 5. The method as claimed in claim 1, wherein the pharmaceutically acceptable iron salt is selected from ferrous salts and ferric salts. 6. The method as claimed [in] claim 24, wherein the iron salt is ferric sulfate. 7. The method as claimed in claim 1, wherein the pharmaceutically acceptable iron atom is in the form of iron dextran, iron sucrose, iron polymaltose or iron sorbitol. 2 Appeal2018-007451 Application 10/559,293 (Id.) (Id.) (Id.) 8. The method as claimed in claim 1, wherein the pharmaceutically acceptable organic iron is in the form of iron biglycinate, iron glycinate or iron protein succinylate. 24. The method of claim 5, wherein the pharmaceutically acceptable iron salt is selected from the group consisting of ferric ammonium citrate, ferric pyrophosphate, ferritin, ferrocholinate, ferrous ascorbate, ferrous aspartate, ferrous chloride, ferrous sulfate, ferrous tartrate, ferrous fumarate, ferrous gluconate, ferrous gluceptate, ferrous glycine sulfate, ferrous lactate, ferrous oxalate and ferrous succinate. 25. The method of claim 6, wherein the ferrous sulfate is gastroprotected. Grounds of rejection before this Panel for review: I. Claims 1, 5, 6, 9, 23, and 24 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination ofBruner, 3 Yehuda, 4 Goldman, 5 Arnold, 6 and Beguin. 7 3 Bruner et al., Randomised study of cognitive effects of iron supplementation in non-anaemic iron-deficient adolescent girls, 348 THE LANCEt 992-96 (1996). 4 Yehuda et al., Brain Iron: [A] lesson from animal models, 50 AM J. CLIN. NUTR. 618-29 (1989). 5 Goldman et al., Diagnosis and Treatment of Attention- Deficit/Hyperactivity Disorder in Children and Adolescents, 279 JAMA 1100----07 (1998). 6 L. Eugene Arnold, Alternative Treatments for Adults with Attention-Deficit Hyperactivity Disorder (ADHD), 931 ANNALS NEW YORK ACADEMY OF SCIENCES 310--41 (2001). 7 Yves Beguin, Soluble transferrin receptor for the evaluation of erythropoiesis and iron status, 329 CLINICA CHEMICA ACTA 9-22 (2003). 3 Appeal2018-007451 Application 10/559,293 II. Claim 7 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Bruner, Y ehuda, Goldman, Arnold, Beguin, and Barton. 8 III. Claim 8 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Bruner, Y ehuda, Goldman, Arnold, Beguin, and Pineda. 9 IV. Claim 25 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Bruner, Y ehuda, Goldman, Arnold, Beguin, and Horvath. 10 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Bruner discloses that "[i]ron deficiency is a systemic condition, which has many non-haematological consequences: it impairs physical endurance, work capacity, infant growth and development, and depresses immune function" and "people who receive iron for iron-deficiency anaemia 8 Barton et al., Intravenous Iron Dextran Therapy in Patients with Iron Deficiency and Normal Renal Function Who Failed to Respond to or Did Not Tolerate Oral Iron Supplementation, 109 AM. J. MED. 27-32 (2000). 9 Pineda et al., Effectiveness of Treatment of Iron-Deficiency Anemia in Infants and Young Children With Ferrous Bis-glycinate Chelate, 17 NUTRITION 381-84 (2001). 10 Horvath et al., Tardyferon therapy in hyposiderosis of infancy and childhood, 40 THER. HUNG. 40--3 (1992). Consideration limited to PubMed Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/1585284 (last accessed March 19, 2014). 4 Appeal2018-007451 Application 10/559,293 commonly report improved memory, attention, mood, and energy before any improvement in haemoglobin indices." (Bruner 992; see Final Act. 3). FF 2. Bruner discloses that "[d]ecreased brain iron stores may impair the activity of iron-dependent enzymes necessary for the synthesis, function, and degradation of neurotransmitters, such as dopamine, serotonin, and noradrenaline" (Bruner 992; see Final Act. 3). FF 3. Bruner provides a "[ r ]andomised study of cognitive effects of iron supplementation in non-anaemic iron-deficient adolescent girls," wherein "[p]articipants were randomly assigned oral ferrous sulphate (650 mg twice daily) or placebo for 8 weeks" and observed that "[a]fter the 8-week intervention, the treatment group had a significantly higher mean serum ferritin concentration than the control group" and "even in the absence of anaemia, iron supplementation improves some aspects of cognitive functioning in iron-deficient adolescent girls" (Bruner, Title; id. at 992, 994, and 995; see Final Act. 3). FF 4. Examiner finds that Bruner does not disclose "iron supplementation of individuals with ADHD" or a "patient population having [an] age between 5 and 12 years old" (Final Act. 4). FF 5. Yehuda discloses: Iron deficiency (ID) and anemia are the most prevalent nutritional disorders in the world. The behavioral changes induced by ID in adults include unusual lethargy, irritability, apathy, listlessness, fatigue, lack of ability to concentrate, pagophagia (pathological craving for ice) and pica, inattention, hypoactivity, and sometimes a decreased IQ. In children ID may be one of the causes of hyperactivity. (Yehuda 618; see Final Act. 4.) 5 Appeal2018-007451 Application 10/559,293 FF 6. Y ehuda discloses: Nutritionally induced ID in rats can serve as a very useful model for ID in humans. Not only does this model appear to mimic the mode of action of ID ( decrease in the functional activity of the D2 dopaminergic system, as evident from the changes in thermoregulation, motor activity, stereotypy, and pain threshold), but ID rats exhibited cognitive deficits in learning and memory tasks that involve attention, as do humans suffering from ID. A positive correlation was found between the behavioral changes, the length of the feeding period, and the level of Hb in the blood. (Y ehuda 624; see Final Act. 4; cf Y ehuda 618 ("there are many differences between the rates of neuronal and biochemical development in rats and in humans"); id. at 622 (Yehuda's "results showed that ID rats learning capacity was significantly inferior to that of control rats. The longer the rates were kept on the ID diet, the greater the deficit in learning" and ID rats "fed an iron-supplemented diet and [ water maze tested] 2, 4, 6 or 8 wk later [exhibited] [n]o restoration of learning and/or memory").) FF 7. Goldman discloses that "[ e ]pidemiologic studies using standardized diagnostic criteria suggest that 3% to 6% of the school-aged population ( elementary through high school) may suffer from ADHD, although the percentage of US youth being treated for ADHD is at most at the lower end of this prevalence range" (Goldman 1100; see Final Act 5 (Goldman's disclosure that "3% to 6% of the school-aged population (elementary school through high school) may suffer from ADHD which clearly overlaps with [Appellant's] age group [of] between 5 and 12") (emphasis omitted)). FF 8. Examiner finds that Arnold sites the research of Bruner et al. in the context of ADHD. Arnold, furthermore notes that in a trial of gastroprotected ferritin in 33 iron-deficient children, Burattini et 6 Appeal2018-007451 Application 10/559,293 al. found a decrease of hypreractivity. Arnold concludes that iron supplementation may be particularly relevant for ADHD women of menstruation, whose iron stores are often compromised (Iron Supplementation, p 319). Arnold, furthermore, indicates that the review depends mostly on research in children/adolescents (top of page 311 ). (Final Act. 5 ( emphasis omitted).) FF 9. Examiner finds that the combination of Bruner, Y ehuda, Goldman, and Arnold does not "teach the normal serum concentration of soluble transferrin receptors" and finds that Beguin makes up for this deficiency (Final Act. 6 (citing Beguin § 4.1 and Figure 3)) (Examiner finds that "Beguin teaches serum [transferrin] levels are marginally increased in nonanemic iron-deficient subjects but more dramatically so in patients with iron deficiency anemia. Therefore, the serum levels of [ transferrin] may be ... within the range that is considered normal")). ANALYSIS Rejection I: Based on the combination of Bruner, Y ehuda, Goldman, Arnold, and Beguin, Examiner concludes that, at the time Appellant's invention was made, it would have been prima facie obvious "to provide iron supplementation to iron deficient individuals with ADHD because Y ehuda et al. teach the link between iron deficiency and hyperactivity in children" and to provide iron supplementation to individuals with ADHD having ages between 5 and 12 because Goldman ... indicates that ... 3% to 6% of the school-aged population (elementary school 7 Appeal2018-007451 Application 10/559,293 through high school) may suffer from ADHD which clearly overlaps with the age group between 5 and 12. (Final Act. 6-7 ( emphasis omitted)). Examiner also concludes that, at the time of Appellant's claimed invention, it would have been prima facie obvious to a person of ordinary skill in this art to "optimize the dosage of iron since routine optimization is within the purview of the ordinarily skilled artisan" and "provide iron supplements to patients with iron deficiency and normal serum [transferrin] levels [because] iron deficient individuals need supplementation with iron even if serum [transferrin] levels are within normal range" (id. at 8). We are not persuaded. Appellant and Examiner both appreciate that "Bruner, is not directed towards treatment of ADHD" or a "patient population having [an] age between 5 and 12 years old" (FF 4; see also Br. 3). To the contrary, as Appellant explains, "Bruner examines the cognitive effects of iron supplementation in a group that is at risk of developing iron deficiency because of increased demand during puberty and menstrual losses" (Br. 3; see id. ("the cohort examined by Bruner is a group of high school girls aged 13-18," which is outside the age range set for the in Appellant's claimed invention)). Appellant further explains that, in contrast to Appellant's claimed invention, "the cohort examined by Bruner is merely supplemented with iron because it is a high iron-demand group" that "did not present ADHD symptoms" (id.; see id. ("The tests employed by Bruner did not seek to examine or address" the clinically recognized "criteria for diagnosis of ADHD")). Thus, Appellant contends "treating ADHD in children between the ages of 5 and 12 years old[, as set forth in Appellant's claimed invention,] is different from supplementing iron in the high iron-demand 8 Appeal2018-007451 Application 10/559,293 group of pubescent girls that are outside of the presently claimed age range" (Br. 3). Appellant explains that, as with Bruner, "Y ehuda [also] does not focus on a young, developing patient population that presents ADHD," but instead "employs a post-developmental rat model in which behavioral changes are induced by iron deficiency" (Br. 4). Thus, Appellant contends that Yehuda's "non-developmental cohort of rats provides subjects with neuronal physiologies that are distinct from the 5 to 12 year-old children population recited in ... [Appellant's] claims" (id.; see also id. at 4--5 (Yehuda concedes "that the rate of neuronal development is different between rats and humans" and found that feeding ID rats an iron-supplemented diet failed to restore learning and/or memory of the ID rats); FF 6; cf Ans. 7-8 and 9- 10). For the foregoing reasons, we agree with Appellant's contention that "Y ehuda does not cure the deficiencies of Bruner" (Br. 5). As Appellant explains, although "Goldman indicates 3% to 6% of the school-aged population may suffer from ADHD," "Goldman ... does not teach or suggest that iron may be used to treat ADHD patients" (Br. 5; see FF 7; Ans. 8). Thus, we find that Goldman fails to make up for the deficiencies in the combination of Bruner and Y ehuda. Similarly, Examiner fails to establish that Arnold's conclusion "that iron supplementation may be particularly relevant for ADHD women of menstruation, whose iron stores are often compromised" makes up for the foregoing deficiencies in the combination of Bruner, Y ehuda, and Goldman (see FF 8; see also Ans. 8-9 an dlO; see generally Br. 5-6). The same is true of Examiner's reliance on Beguin, which, as Appellant explains, "does not teach or suggest that iron 9 Appeal2018-007451 Application 10/559,293 administration may be used to treat ADHD in children" (Br. 6; see FF 9; Ans. 11). Thus, for the foregoing reasons, we find that Examiner failed to establish an evidentiary basis on this record to support a conclusion that the combination of Bruner, Yuhdua, Goldman, Arnold, and Beguin makes obvious Appellant's claimed invention. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) ("[E]xaminer bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability."); see also In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) ("[R ]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness."). Re} ection II: Based on the combination of Bruner, Y ehuda, Goldman, Arnold, Beguin, and Barton Examiner concludes that, at the time Appellant's invention was made, "[i]t would have been [prima facie] obvious to ... supplement individuals with iron dextran who have iron deficiency [because] Barton ... [discloses] iron dextran to be safe and effective treatment for iron deficiency" (Final Act. 10). We are not persuaded because Examiner failed to establish that Barton makes up for the foregoing deficiency in the combination of Bruner, Y ehuda, Goldman, Arnold, and Beguin (see Br. 7). 10 Appeal2018-007451 Application 10/559,293 Rejection III: Based on the combination of Bruner, Y ehuda, Goldman, Arnold, Beguin, and Pineda, Examiner concludes that, at the time Appellant's invention was made, it would have been prima facie obvious "to use iron bis-glycinate for the treatment of iron deficiency [because] Pineda ... [disclose] that ferrous bis-glycinate chelate was absorbed or retained 3, 4 times greater than ferrous sulfate making it the iron of choice for treatment" (Final Act. 11 ). We are not persuaded because Examiner failed to establish that Pineda makes up for the foregoing deficiency in the combination of Bruner, Y ehuda, Goldman, Arnold, and Beguin (see Br. 7). Re} ection IV: Based on the combination of Bruner, Y ehuda, Goldman, Arnold, Beguin, and Horvath, Examiner concludes that, at the time Appellant's invention was made, it would have been prima facie obvious "to select tardyferon as the source of ferrous sulfate and thus produce the instantly claimed invention because Bruner et al. already teaches administration of ferrous sulfate" and Horvath discloses the use of "tardyferon for controlling iron deficiency in children and infants" (Final Act. 13). We are not persuaded because Examiner failed to establish that Horvath makes up for the foregoing deficiency in the combination of Bruner, Y ehuda, Goldman, Arnold, and Beguin (see Br. 8). CONCLUSION The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. 11 Appeal2018-007451 Application 10/559,293 Rejection I, the rejection of claims 1, 5, 6, 9, 23, and 24 under 35 U.S.C. § 103(a) as unpatentable over the combination of Bruner, Yehuda, Goldman, Arnold, and Beguin, is reversed. Rejection II, the rejection of claim 7 under 35 U.S.C. § 103(a) as unpatentable over the combination of Bruner, Y ehuda, Goldman, Arnold, Beguin, and Barton, is reversed. Rejection III, the rejection of claim 8 under 35 U.S.C. § 103(a) as unpatentable over the combination of Bruner, Y ehuda, Goldman, Arnold, Beguin, and Pineda, is reversed. Rejection IV, the rejection of claim 25 under 35 U.S.C. § 103(a) as unpatentable over the combination of Bruner, Y ehuda, Goldman, Arnold, Beguin, and Horvath, is reversed. REVERSED 12 Copy with citationCopy as parenthetical citation