Ex Parte YUN et alDownload PDFPatent Trial and Appeal BoardAug 30, 201812888172 (P.T.A.B. Aug. 30, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/888, 172 09/22/2010 93726 7590 09/04/2018 EPA - Bozicevic Field & Francis LLP Bozicevic, Field & Francis 201 REDWOOD SHORES PARKWAY SUITE 200 REDWOOD CITY, CA 94065 FIRST NAMED INVENTOR ANTHONY JOONKYOO YUN 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. P AL0-003CIPCON 3904 EXAMINER BORGEEST, CHRISTINA M ART UNIT PAPER NUMBER 1649 NOTIFICATION DATE DELIVERY MODE 09/04/2018 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): docket@bozpat.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ANTHONY JOONKYOO YUN and PATRICK YUARN-BOR LEE Appeal2017-005964 Application 12/888, 172 Technology Center 1600 Before ULRIKE W. JENKS, RYAN H. FLAX, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL Appellants 1 submit this appeal under 35 U.S.C. § 134 involving claims to a multi-dose active agent package. The Examiner rejected the claims for lack of patent-eligible subject matter and for obviousness. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM. 1 Appellants identify the Real Party in Interest as Palo Alto Investors. App. Br. 3. Appeal2017-005964 Application 12/888, 172 STATEMENT OF THE CASE According to the Specification, "[t]here are a variety of disease conditions that are known to increase in severity and/or occurrence during certain times of the day." Spec. ,r 2. Similarly, the Specification explains, "[t]here are also multiple disease conditions which have been shown to vary in occurrence or severity depending on the particular season of the year." Id. The Specification describes "[ m ]ulti-dose active agent packages and methods for using the same for treating a subject for a condition." Spec. ,r 4. "The subject invention ... includes multi-dose active agent packages for use in methods for treating a subject for a condition that has seasonal variations by modulating at least a portion of the autonomic nervous system during at least one predetermined season of the year." Id. ,r 138. According to the Specification, the "multi-dose active agent package of the subject invention can be a seasonal package that includes daily discrete or continuous unit doses" and further "[ t ]he seasonal package may be a two or more stage pharmaceutical pack, e.g., containing at least about 90 daily unit doses in two stages." Id. ,r,r 142, 143; see also id. at Figs. 1-3 (showing various seasonal and yearly multi-dose packages). The Specification explains that the multi-dose package may include first and second active agents. Id. ,r 145. Further, "[t]he first and second active agents may differ in one or more respects, e.g., they may be different active agents ( different types), they may be the same active agent but may differ in dose of active agent, etc." Id. According to the Specification, "[ m ]ultiple dosage units of one or more pharmacological agents may be packaged in a single container, e.g., a single blister pack, tube, bottle," etc. 2 Appeal2017-005964 Application 12/888, 172 or the dosage units "may be individually packaged and/or individually labeled such that certain packages may have more than one container of a pharmacological agent or of different pharmacological agents." Id. ,r 147. 2 The "multi-dose active agent package can have any suitable shape, e.g., a rectangular or square box, a cylindrical tube, a rectangle, square, or circular blister package, etc." Id. ,r 148. Claims 27, 28, 31-36, 38, and 51-57 are on appeal. Claim 27, the only independent claim on appeal, is illustrative and is reproduced below: 27. A multi-dose active agent package comprising: a first unit dosage of an active agent that is formulated into a pharmaceutical composition that comprises a pharmaceutically acceptable carrier; and a second unit dosage of the same active agent that is formulated into a pharmaceutical composition that comprises a pharmaceutically acceptable carrier; wherein the active agent is selected to treat a subject for a condition, wherein the active agent comprises an anti-coagulant, and the amount of the active agent in the first unit dosage is different from the amount of the active agent in the second unit dosage, and a package, wherein the package holds each of the first unit dosage and the second unit dosage in a separate section. App. Br. 17 (Claims App.). 2 The Specification lists numerous "[r ]epresentative pharmacological agents ... that may be used" including, inter alia, beta-blockers, angiotensin converting enzyme (ACE) inhibitors, statins, antihistamines, calcium channel blockers, and anti-coagulants. Spec. ,r 69. The Specification discloses that "[ d]osages for a given pharmacological agent are readily determinable by those of skill in the art by a variety of means." Id. ,r 67. 3 Appeal2017-005964 Application 12/888, 172 The claims stand rejected as follows: I. Claims 27, 28, 31-36, 38, and 51-57 under 35 U.S.C. § 101 for claiming patent ineligible subject matter ("Rejection I"). II. Claims 27, 28, 31-33, 35, 36, 38, 51, and 53-57 under 35 U.S.C. § I03(a) as obvious over Galler, 3 D' Angelo, 4 Theofanous, 5 and ten Berg6 ("Rejection II"). III. Claim 34 under 35 U.S.C. § I03(a) as obvious over Galler, D'Angelo, Theofanous, ten Berg, and the '212 patent7 ("Rejection III"). IV. Claim 52 under U.S.C. § I03(a) as obvious over Galler, D' Angelo, Theofanous, ten Berg, and Gerraty8 ("Rejection IV"). V. Claims 27, 28, 31-36, 38, and 51-57 underU.S.C. § I03(a) as obvious over ten Berg and Hermelin9 ("Rejection V"). 3 Galler, US 6,087,332, issued July 11, 2000. 4 D' Angelo et al., US 5,756,117, issued May 26, 1998. 5 Theofanis G. Theofanous et al., Multiple-Dose Kinetics of Oral Anticoagulants: Methods of Analysis and Optimized Dosing, 62 J. PHARM. SCI. 261---66 ( 1973 ). 6 Jurrien M. ten Berg et al., Oral Anticoagulant Therapy During and After Coronary Angioplasty: The Intensity and Duration of Anticoagulation Are Essential to Reduce Thrombotic Complications, 103 CIRCULATION 2042--47 (2001). 7 D'Angelo et al., US 5,614,212, issued Mar. 25, 1997 ("the '212 patent"). 8 R. P. Gerraty, Stroke Prevention: what's new?, 33 INTERNAL MEDICINE JOURNAL 177-81 (2003). 9 Hermelin et al., US 6,375,956 Bl, issued Apr. 23, 2002. 4 Appeal2017-005964 Application 12/888, 172 Appellants identify the following related and co-pending appeals: Appeal No. 2017-005980 (US Appl. No. 13/169,897) and Appeal No. 2017- 006039 (US Appl. No. 12/761,297). App. Br. 3. Like the claims in the present appeal, the Examiner entered rejections for lack of patent-eligible subject matter and obviousness in these related appeals. Decisions in these related appeals are being mailed concurrently with this Decision. I. SUBJECT MATTER ELIGIBILITY In analyzing patent eligibility under 35 U.S.C. § 101, the Supreme Court has set forth a "framework for distinguishing patents that claim [patent-ineligible] laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bank Int'!, 134 S. Ct. 2347, 2355 (2014) (internal citation omitted). According to that framework, first "we determine whether the claims at issue are directed to one of those patent-ineligible concepts." Id. "If so, we then ask, ' [ w ]hat else is there in the claims before us?"' Id. ( quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 78 (2012)). To answer this second question, we consider the elements of each claim both individually and as an ordered combination to determine whether the additional elements transform the nature of the claim into a patent-eligible application. . . . [The Supreme Court has] described step two of this analysis as a search for an inventive concept - i.e., an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself. Id. (internal citations and quotation marks omitted). 5 Appeal2017-005964 Application 12/888, 172 The Examiner rejected all the pending claims under § 101 as being directed to a product of nature. Ans. 3-7, 17-26; see also Final Act. ( dated Feb. 25, 2016) 2--4; Funk Brothers Seed Co. v. Kala Inoculant Co., 333 U.S. 127, 130-31 (1948) (holding claims to a composition of different bacterial strains was directed to "the work of nature" and, thus, patent ineligible). According to the Examiner, claim 27 is "directed to nature-based products" and, more particularly, to anticoagulants such as heparin, warfarin, and streptokinase, "all of which are natural products that are not markedly different in structure from naturally occurring products." Ans. 3--4 ( citing Spec. ,r 69). As for the required pharmaceutically acceptable carrier, the Examiner finds the carrier may simply be water; so, even with the anti- coagulant, the Examiner finds the claims "encompass a mixture of naturally occurring products" with no change in structure or function of the active agent. Id. at 5---6. The Examiner acknowledges claim 27's recitation of a "package" that "itself is not naturally occurring," yet the Examiner states that "it does not impart markedly different characteristics to the recited active agent(s)." Id. at 18. Appellants argue "the claims are not directed to a product of nature." Reply Br. 2. To the contrary, Appellants contend, claim 27 is "directed to a package with two different dosages of an anti-coagulant in different locations of the package," which "package does not occur in nature, but is instead man-made." Id.; App. Br. 5-7. Moreover, Appellants argue, "the multi-dose package system of the claimed invention is not a generic container" and instead requires "separate sections that hold different dosage 6 Appeal2017-005964 Application 12/888, 172 units of an active agent and a structural element of the system for structurally distinguishing between the different dosage units." App. Br. 6. At step one of the Alice/Mayo analysis, we ask whether claim 27 is directed to patent-ineligible subject matter. Because all inventions, at some level, embody or apply laws of nature, abstract ideas, etc., "we tread carefully in construing this exclusionary principle lest it swallow all of patent law." Alice, 134 S. Ct. at 2354. Hence, we must "ensure at step one that we articulate what the claims are directed to with enough specificity to ensure the step one inquiry is meaningful." Thales Visionix Inc. v. US., 850 F.3d 1343, 1347 (Fed. Cir. 2017). We are unpersuaded that claim 27 is directed to a patent-ineligible product of nature. The dispute between the Examiner and Appellants is largely one of emphasis. The Examiner emphasizes the active agent in claim 27. Ans. 3-7. Appellants emphasize the claimed package with separate sections for holding different dosage units of the active agent. On this record, Appellants have the better position. True, claim 27 requires an anti- coagulant. And, as the Examiner explains, some anti-coagulants (e.g., streptokinase) are naturally occurring. Ans. 4. But, as the Federal Circuit has confirmed, "[ a ]t step one, ... it is not enough to merely identify a patent-ineligible concept underlying the claim; [the Board] must determine whether ... [the] patent-ineligible concept is what the claim is 'directed to."' Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1050 (Fed. Cir. 2016). Reading the claims in light of the Specification, we find that the claimed invention is, on balance, directed to the multi-dose package. Spec. 7 Appeal2017-005964 Application 12/888, 172 ,r,r 4, 13 8--49; see also id. at Figs. 1-3 ( depicting packages) and ,r,r 214--217 (Examples). The package is described as providing an alleged improvement in dosing of the active agent to account for temporal ( e.g., seasonal) variations of a condition - it keeps separate a plurality of different unit dosages of the same active agent, so that more or less of the agent can be taken depending on the condition's severity, such as with package-included cues like color-coding or identification of the day, week, month, etc., when particular dosages should be taken. Id. The active agent itself is, in material respects, secondary to the multi-dose package as evidenced by the fact that the Specification provides a roughly six-page laundry list of pharmacological agents (generically and specifically described) that can be used in combination with the package for treating a likewise generic list of conditions ( e.g., cardiovascular conditions, inflammatory conditions, gastrointestinal conditions, menstrual related disorders, pain, bacterial infections, and so on). Spec. ,r 69. Tellingly, yet unsurprisingly, the active agents (known categories of drugs, like ACE inhibitors, beta blockers, antihistamines, and anti-coagulants) are not described as being the invention. We thus conclude that claim 27 is directed to a multi-dose package having separate sections that respectively hold a plurality of unit dosage forms with different dosages of an active agent, which agent here happens to comprise an anti-coagulant. To be sure, the features of the package are in many ways broadly recited. Whether the package and those features are new or nonobvious is not the issue. The issue, for purposes of this rejection, is whether a package with the structural features recited in claim 27 is merely directed to nature's handiwork. It is not. 8 Appeal2017-005964 Application 12/888, 172 The answer to the first question of the Alice/ Mayo analysis is "no" - we are unpersuaded claim 27 is directed to a product of nature. 10 Because the answer at step one is "no," the inquiry is over and moving to step two is unnecessary. Thales, 850 F.3d at 1349 ("Because we find the claims are not directed to an abstract idea, we need not proceed to step two."). Accordingly, for the reasons above, the rejection of claim 27 (and its dependent claims) under § 101 is reversed. II. OBVIOUSNESS a. Galler, D' Angelo, Theofanous, and ten Berg (Rejection II) The Examiner rejected claims 27, 28, 31-33, 35, 36, 38, 51, and 53- 57 as obvious over Galler, D' Angelo, Theofanous, and ten Berg. Final Act. 4--8; Ans. 8-10, 26-43. The bases of the rejection are described below. Appellants do not argue the rejected claims separately. We, thus, choose claim 27 as representative. 37 C.F.R. § 4I.37(c)(l)(iv). The Examiner finds that Galler teaches treatment of thrombolytic disorders with anti-coagulants (i.e., streptokinase and derivatives). Ans. 8. The Examiner further finds that Galler teaches that the dosages administered depend on several factors, such as the particular subject, the condition treated, and the type of concurrent treatment. Id. ( citing Galler 17:3-12); see also Galler 16:37--47. According to the Examiner, Galler teaches that the active agent can be administered in multiple doses and that the agent can be delivered by, inter alia, transdermal means. Ans. 8; see Galler 17:32-36, 17:48-50. 10 Whether claim 27 is patent ineligible under§ 101 for other potential reasons (e.g., abstract idea) is not an issue before us in this appeal. 9 Appeal2017-005964 Application 12/888, 172 Because the Examiner finds that "Galler does not explicitly teach a multi-dose package comprising two different dosages of the active agent," the Examiner turns to D' Angelo, Theofanous, and ten Berg. Ans. 8. The Examiner finds that D' Angelo teaches a "multi-dose transdermal delivery system (package) capable of delivering medicaments in varying dosages over an extended treatment period." Id. at 9; D' Angelo Abstract, 2:53---67, Figs. 1---6. The Examiner finds Theofanous evidences that "it was well- established in the art that chronic anticoagulant therapy had to be highly individualized," teaching, for example, that effects vary widely among treated individuals and that there is no "universal response to a fixed dose of these [anticoagulant] agents." Ans. 9--10; Theofanous 261 ("This fact, as well as a need to readjust therapeutic levels of activity during therapy[], obviously necessitates patient individualization of dosing regimens for these drugs."). The Examiner finds that ten Berg teaches "administration of varying doses of multiple anticoagulants ( aspirin, coumarin) for a period of at least 6 months," thus further evidencing a "need for extended treatment with anticoagulants ... in which dosages are adjusted as well as the combined use of two different agents." Ans. 10; ten Berg 2043 ("Medication" section). 11 11 As explained by the Examiner, ten Berg teaches, inter alia, "a trial in which aspirin (an anticoagulant) was administered at a loading dose of 300 mg followed by 100 mg/day." Ans. 29. According to the Examiner, ten Berg further teaches "that acenocoumarol (also known as Sintrom) was administered at 6 mg on the first day, 4 mg on the second day and 2 mg on the third day and thereafter until intervention ( 6-12 months)" and another treatment involving "administration of ticlodipine at a loading dose of 500mg followed by 250 mg twice daily for 4 weeks." Id.; see also id. at 31- 10 Appeal2017-005964 Application 12/888, 172 The Examiner concludes it would have been obvious to modify Galler' s teachings by using the prior art transdermal system as taught by D' Angelo. Ans. 9--10. The Examiner reasons such a system "would be useful to patients who require varying doses of anticoagulants over an extended treatment period," as suggested by Theofanous and ten Berg. Id. We agree with and adopt the Examiner's findings concerning the scope and content of Galler, D'Angelo, Theofanous, and ten Berg, the Examiner's reasoning on the motivation to combine the prior art, and the Examiner's conclusion of obviousness as to claim 27. Final Act. 4--8; Ans. 7-10, 26-43. The combined teachings of the art evidence that anti- coagulant therapy is highly individualized (see, e.g., Galler 17:3-36; Theofanous 261 ), and that effective anti-coagulant therapy may be provided by administering different dosage units of the active agent over time (see, e.g., ten Berg 2043). Ans. 29 ("In ten Berg ... , there was a teaching in which fixed dosing regimens of anticoagulants were varied with higher or loading doses at the start of treatment followed by daily [lower] maintenance doses."). And, on this record, we agree it would have been obvious to provide such therapy in multi-dose packaging, such as described in D' Angelo, to make it easy for the subject to take the drugs, and follow such a therapeutic schedule over an extended period of time. Ans. 7-10, 26-43. Appellants argue that the cited references "fail[] to teach or suggest wherein the amount of the active agent in the first unit dosage is different from the amount of the same active agent in the second unit dosage," as 32 (discussing ten Berg's teaching of a dosing schedule of Sintrom (6 mg, 4 mg, then 2 mg) that "resulted in ideal anticoagulation"). 11 Appeal2017-005964 Application 12/888, 172 recited in claim 27. App. Br. 8. Appellants contend Galler does not disclose administering varying dosage amounts of an active agent. Id. According to Appellants, "Galler is instead directed towards a dosing protocol procedure for repeatedly administering an identical. proper dosage of therapeutic agents which is tailored for an individual subject." Id. at 8-9 (citing Galler 17:7-8). Appellants' argument is unpersuasive. Galler discloses optimizing dosages for the particular individual based on their particular condition, age, health and other factors. Galler 16:37-53, 17:3-36. But even assuming Appellants are correct, and Galler' s aim is to determine a single dosage amount for treatment purposes, Appellants do not account persuasively for at least ten Berg, which the Examiner relies upon as teaching and providing a reason for giving active agents that comprise anti-coagulants in differing dosage amounts. ten Berg 2043; Ans. 27-28. As the Examiner noted, "[t]he rejection was made under 35 USC 103 over a combination of references." Ans. 27; In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986) ("Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references"). Appellants contend D' Angelo "fails to remedy the deficiencies of Galler" and that Theofanous "is completely silent about administering different amounts of the same active agent." App. Br. 9-10. Here again, these arguments do not account for ten Berg's teachings and the full combination of the references. As such, Appellants' contentions are unpersuasive. 12 Appeal2017-005964 Application 12/888, 172 Turning to ten Berg, Appellants argue "ten Berg is completely silent regarding a multi-dose package" containing differing unit dosages of the active agent. App. Br. 10. The Examiner did not rely upon ten Berg as teaching the package. See, e.g., Ans. 28-29. That teaching comes from D' Angelo, and the Examiner is proposing to modify that package to include differing dosages of an anti-coagulant as suggested by ten Berg. Id. at 30 ("The patent by D 'Angelo was relied upon for a teaching of the multi-dose package"). Appellants contend ten Berg is a clinical report and "concludes that stable anti-coagulation with coumarins achieved the best result." App. Br. 10. According to Appellants, the skilled artisan "would not be motivated to administer different unit dosages" based on ten Berg's results. Id.; see also id. at 11 (contending ten Berg's "dosage regimens settled on a single maintenance dose that was used to maintain the desired level of anticoagulation"). Appellants contend ten Berg's disclosure of "initial loading" dosages followed by maintenance dosages does not provide a motivation to administer different dosages to a subject. Id. at 11 ("A clinical study that tests different dosages does not suggest a packaged product with different dosages, since the clinical study was performed to find the single dosage to use."). We remain unpersuaded. The Examiner rebutted Appellants on these points and, on this record, we agree with the Examiner. As the Examiner noted: The fact that ten Berg et al. concluded that their results "suggest that stable anticoagulation with coumarins (i.e. Sintrom) is more effective than unfractionated, intravenous heparin" does not 13 Appeal2017-005964 Application 12/888, 172 constitute a teaching away from the instantly claimed multi-dose package. This result suggests that oral coumarins are more effective than intravenous heparin. Since ten Berg et al. teach that acenocoumarol, (also known as Sintrom) was administered at 6 mg on the first day, 4 mg on the second day and 2 mg on the third day and thereafter until intervention ( 6-12 months), the variable anticoagulant dosage regimen was successful. Ans. 31. As further highlighted by the Examiner, ten Berg "teach[ es] a dosing schedule of anticoagulants in which there is a first unit dosage, second unit dosage and third unit dosage of oral anticoagulant [e.g., Sintrom ], which resulted in optimal anticoagulation. Optimal anticoagulation is a positive finding and an explicit teaching of a successful outcome." Ans. 35; see also id. at 32-33 ("optimal anticoagulation was achieved with Sintrom in a 6mg/4mg/2mg dosing schedule suggest[ing] to one of ordinary skill in the art that optimal anticoagulation is achieved through a dosing schedule that makes use of starting (i.e., loading) doses followed by long term maintenance doses."). The Examiner further points out that "[ t ]he concept of loading and maintenance doses is well known in the art," as evidenced by at least ten Berg. Ans. 33. And, the Examiner explains, Appellants' claim 27 "encompass[es] a package comprising a starting (first unit) dosage and a maintenance (second unit) dosage of an anticoagulant." Id. Appellants provided insufficient persuasive argument or evidence to the contrary. On this record, as already explained, we agree with the Examiner that it would have been obvious to provide loading and maintenance dosages of an anticoagulant (like taught in ten Berg) in an easy-to-use multi-dose package. For the reasons above, the preponderance of the evidence on this record supports the Examiner's conclusion that claim 27 would have been 14 Appeal2017-005964 Application 12/888, 172 obvious over Galler, D' Angelo, Theofanous, and ten Berg. Claims 28, 31- 33, 35, 36, 38, 51, and 53-57 have not been argued separately and therefore fall with claim 27. b. Galler, D'Angelo, Theofanous, ten Berg, and the '212 patent (Rejection III) The Examiner rejected claim 34 as obvious over Galler, D' Angelo, Theofanous, ten Berg, and the '212 patent. Ans. 11, 26-43. We agree with and adopt the Examiner's findings concerning the scope and content of Galler, D'Angelo, Theofanous, ten Berg, and the '212 patent, the Examiner's reasoning on the motivation to combine the prior art, and the Examiner's conclusion of obviousness. Appellants provide no separate argument for Rejection III, arguing only that the '212 patent "fails to remedy the deficiencies in the teachings of Galler, D' Angelo, Theofanous and ten Berg." App. Br. 12. We are unpersuaded that the art is deficient as explained above regarding Rejection II. Accordingly, Rejection III is affirmed. c. Galler, D' Angelo, Theofanous, ten Berg, and Gerraty (Rejection IV) The Examiner rejected claim 52 as obvious over Galler, D' Angelo, Theofanous, ten Berg, and Gerraty. Ans. 12-13, 26-43. We agree with and adopt the Examiner's findings concerning the scope and content of Galler, D' Angelo, Theofanous, ten Berg, and Gerraty, the Examiner's reasoning on the motivation to combine the prior art, and the Examiner's conclusion of obviousness. 15 Appeal2017-005964 Application 12/888, 172 Appellants provide no separate argument for Rejection IV, arguing only that Gerraty "fails to remedy the deficiencies in the teachings of Galler, D' Angelo, Theofanous, and ten Berg." App. Br. 12. We are unpersuaded that the art is deficient as explained above regarding Rejection II. Accordingly, Rejection IV is affirmed. d. ten Berg and Hermelin (Rejection V) The Examiner rejected claims 27, 28, 31-36, 38, and 51-57 as obvious over ten Berg and Hermelin. Ans. 13-17, 43--47. The bases of the rejection are described further below. Appellants do not argue the rejected claims separately. Claim 27 is representative. 3 7 C.F .R. § 41.3 7 ( c )( 1 )(iv). The Examiner finds ten Berg teaches administration of a single bolus of heparin, followed by administration of oral anticoagulants (acenocoumarol or Sintrom) at a dose of 6 mg, followed by 4 mg, then 2 mg for a period of at least 6 months. Ans. 13-14. Thus, the Examiner finds, ten Berg "teach[ es] a dosage regimen comprising a single anticoagulant drug administered in multiple different unit dosages for an extended period," meeting claim 27's limitations. Id. at 14. According to the Examiner, ten Berg "does not teach that the anticoagulants are contained within a multi- dose package as recited in the claims." Id. So, the Examiner cites Hermelin as "teach[ ing] a disposable drug dispenser capable of supplying [a] complex and varying dosing regimen or unevenly dosed components in a single, shelf stable user-friendly package." Id.; see Hermelin Abstract, 1 :21--40, claim 1, 16 Appeal2017-005964 Application 12/888, 172 Figs. 2-3. 12 According to the Examiner, Hermelin teaches that the package may contain different unit dosages of the same drug. Ans. 14; Hermelin 8 :29---61, claim 3 5. The Examiner concludes it would have been obvious to modify the teachings of ten Berg "by organizing the anticoagulant dosages into a pharmaceutical package in which the first and second unit dosages are stored in a separate section, in the form of a monthly package." Ans. 15-16. The Examiner reasons that Hermelin "teach[ es] that simultaneous administration of [a] complex treatment regimen often result in poor patient compliance," and, thus, the skilled artisan would have been motivated to modify the prior art as proposed - incorporating the anticoagulant dosages described in ten Berg in a multi-dose package of Hermelin - "because such would simplify the dosing and increase patient compliance." Id. at 16. We agree with and adopt the Examiner's findings concerning the scope and content of ten Berg and Hermelin, the Examiner's reasoning on the motivation to combine the prior art, and the Examiner's conclusion of obviousness. Ans. 13-17, 43--47. Appellants' arguments parallel their arguments related to ten Berg as described above for Rejection II. App. Br. 13-14; Reply Br. 4--5. Appellants contend "ten Berg does not disclose that multiple doses of the same active agent are administered to a patient in a varying dosage amount." App. Br. 13. Appellants contend ten Berg provides an initial starting or 12 See also Hermelin 10:38-50 (defining "[b]iologically active substance[s]," usable in Hermelin's packages), 10:56---65 (defining "[u]neven dosing" of the biologically-active substances). 17 Appeal2017-005964 Application 12/888, 172 loading dose "and thereafter, the initial loading dose was reduced into providing a maintenance dose for an extended period of time." Id. Appellants also contend ten Berg "discloses that an 'optimal' level of anti- coagulation was reached when administering a patient[] a recurring, identical dosage of 2 mg over an extended treatment period." Id. Finally, Appellants argue, Hermelin does not make up for ten Berg's deficiency. Id. at 13-14. Appellants' contentions are unpersuasive for reasons explained above regarding Rejection II. Furthermore, contrary to Appellants' argument, ten Berg does teach administration of multiple, different doses of the same active agent (e.g., Sintrom according to a 6 mg, 4 mg, and 2 mg dosing regimen). ten Berg 2043; Ans. 44--45. Appellants provide insufficient persuasive argument or evidence demonstrating that the first and second unit dosages as claimed do not encompass the starting and maintenance dosages of anticoagulants described in ten Berg, which ten Berg indicates provided optimal anticoagulation. Ans. 44. And the Examiner has persuaded us, on this record, that claim 27 does not exclude such dosages. Id. at 45--46. ten Berg's teachings are not limited to only the allegedly optimal maintenance dosage (e.g., 2 mg) as Appellants' argument suggests. Ans. 47. Appellants do not account for ten Berg's starting doses (e.g., 6 mg and 4 mg), and the Examiner has provided sufficient reasoning to explain why the skilled person would have been motivated to include both the starting and maintenance dosages in a multi-dose package like described in Hermelin. Ans. 15-16. Accordingly, ten Berg is not deficient as argued by Appellants. 18 Appeal2017-005964 Application 12/888, 172 For the reasons above, the preponderance of the evidence on this record supports the Examiner's conclusion that claim 27 would have been obvious over ten Berg and Hermelin. Claims 28, 31-36, 38, and 51-57 have not been argued separately and therefore fall with claim 27. SUMMARY We reverse the rejection for patent-ineligible subject matter, but affirm the rejections for obviousness on appeal. 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 19 Copy with citationCopy as parenthetical citation