Ex Parte YunDownload PDFPatent Trials and Appeals BoardMay 13, 201914303492 - (D) (P.T.A.B. May. 13, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/303,492 06/12/2014 93726 7590 05/15/2019 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. PAL0-029 6191 EXAMINER BORGEEST, CHRISTINA M ART UNIT PAPER NUMBER 1649 NOTIFICATION DATE DELIVERY MODE 05/15/2019 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): 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 Appeal 2018-001128 Application 14/303,492 Technology Center 1600 Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and TA WEN CHANG, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a method of improving a sympathetic bias associated autonomic nervous system associated condition in a subject. The Examiner rejected the claims as failing to comply with the enablement and written description requirements. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellant identifies the Real Party in Interest as Palo Alto Investors (App. Br. 3). 2 We have considered the Specification of June 12, 2014 ("Spec."); Non- Final Office Action of May 20, 2016 ("Non-Final Act."); Final Office Action of Nov. 16, 2016 ("Final Act."); Appeal Brief of May 11, 2017 ("App. Br."); Examiner's Answer of Sept. 14, 2017 ("Ans."); and Reply Brief of Nov. 14, 2017 ("Reply Br."). Appeal 2018-001128 Application 14/303,492 Statement of the Case Background "The hypothalamus is a portion of the brain that is located below the thalamus and above the brain stem that functions to maintain homeostasis in a subject" (Spec. 6: 10-12). "[T]he hypothalamus functions to maintain homeostasis" of factors including "blood pressure, body temperature, fluid and electrolyte balance and body weight" based on "information from vagus, spinal cord, retina, and limbic and olfactory systems" by sending "neural signals to the autonomic system or endocrine signals to the pituitary" (Spec. 6: 13-21 ). The Examiner explains that the term "autonomic nervous system" is sometimes used to refer to both the parasympathetic and sympathetic nervous systems" (Ans. 3). The Examiner explains that the sympathetic nervous system is "the part of the autonomic nervous system that contains chiefly adrenergic fibers and tends to depress secretion, decrease the tone and contractility of smooth muscle, and increase heart rate" (Ans. 3). The Specification addresses approaches for "at least partially restoring normal function of a central nervous system endocrine gland in a manner sufficient to improve the condition in the subject" (Spec. 2: 10-12). According to the Specification, "[i]n some instances, the autonomic nervous system associated condition is a sympathetic bias associated condition" (Spec. 3:11-12). The Claims Claims 1-10, 12-15, and 21 are on appeal. Independent claim 1 is representative and reads as follows: 1. A method of improving a sympathetic bias associated autonomic nervous system associated condition in a subject, the method comprising: 2 Appeal 2018-001128 Application 14/303,492 at least partially restoring normal function of the hypothalamus in a manner sufficient to modulate autonomic function to equalize the sympathetic/parasympathetic activity ratio to improve the condition in the subject, wherein the at least partially restoring normal function of the hypothalamus comprises electrical stimulation of the hypothalamus; wherein the electrical simulation comprises increasing activity in the anterolateral hypothalamic region or inhibiting activity in the posteromedial hypothalamic region. The Issues 3 A. The Examiner rejected claims 1, 2, 4, 5, 12, 13, and 18 under 35 U.S.C. § 112, first paragraph, as failing to comply with the enablement requirement (Final Act. 4--12). B. The Examiner rejected claims 1, 2, 4, 5, 12, 13, and 16-18 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement (Final Act. 12-20). A. 35 U.S.C. § 112,first paragraph, enablement The Examiner finds that "in light of the complexity of the art, the specification does not provide guidance to the skilled artisan as to the electrical stimulation parameters ( e.g., intensity, frequency, pulse duration, electrode positioning, and application time) necessary to elicit stimulation of the parasympathetic and inhibition of the sympathetic nervous systems" (Final Act. 12). 3 We note that claims 21 and 23-28 were cancelled in an After-Final Amendment filed Jan. 17, 2017 that was entered by the Examiner in the Advisory Action Mailed Feb. 22, 2017. 3 Appeal 2018-001128 Application 14/303,492 The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner's conclusion that the claims fail to comply with the enablement requirement? Findings of Fact Breadth of Claims 1. Claim 1 is broadly drawn to "improving a sympathetic bias associated autonomic nervous system associated condition in a subject." 2. The Specification teaches that "[c]onditions that are caused by a sympathetic bias include, but are not limited to aging related diseases ( e.g., cardiovascular disease, cancer, arthritis, cataracts, osteoporosis, type 2 diabetes, hypertension; shy dragers, multi-system atrophy, age related inflammation conditions and diabetes)" (Spec. 10: 17-20). 3. The Specification further expands the list of treatable conditions, teaching that: Aging-associated conditions include, but are not limited to, cardiovascular disease, cancer, arthritis, cataracts, osteoporosis, type 2 diabetes, hypertension; shy dragers, multi- system atrophy, age related inflammation conditions and diabetes. In some instances, the condition is a cardiovascular condition. Cardiovascular conditions include, but are not limited to, cardiovascular disease, e.g., atherosclerosis, coronary artery disease, hypertension, hyperlipidemia, eclampsia, pre-eclampsia, cardiomyopathy, volume retention, congestive heart failure, QT interval prolongation, aortic dissection, aortic aneurysm, arterial aneurysm, arterial vasospasm, myocardial infarction, reperfusion syndrome, ischemia, sudden adult death syndrome, arrhythmia, fatal arrythmias, coronary syndromes, coronary vasospasm, sick sinus syndrome, bradycardia, tachycardia, thromboembolic disease, deep vein thrombosis, coagulopathy, disseminated intravascular coagulation ("DIC"), mesenteric ischemia, syncope, venous thrombosis, arterial thrombosis, malignant 4 Appeal 2018-001128 Application 14/303,492 hypertension, secondary hypertension, primary pulmonary hypertension, secondary pulmonary hypertension, raynaud's, paroxysmal supraventricular tachycardia, and the like. In certain embodiments, the subject method is for the treatment of a cancer. Cancers include, but are not limited to, bladder cancer, breast cancer, colon cancer, rectal cancer, endometrial cancer, kidney cancer, leukemia, lung cancer, melanoma, non-Hodgkin lymphoma, pancreatic cancer, prostate cancer and thyroid cancer, and the like. In some instances, the subject method is for the treatment of arthritis. Arthritic diseases include, but are not limited to, osteoarthritis, rheumatoid arthritis, gout, pseudo-gout, septic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis and Still' s disease. (Spec. 32:17 to 33:11). Presence of Working Examples 4. There are no working examples for any of the specific diseases listed (Ans. 6). Amount of Direction or Guidance Presented 5. The Specification provides generic teaching that "[b ]y 'electrically modulating at least a portion of a subject's autonomic nervous system' is meant altering or changing at least a portion of an autonomic nervous system by electrical means to provide a change, alteration or shift in at least one component or aspect of the function of the central nervous system endocrine gland" (Spec. 25: 14--18). 6. The Specification does not, however, provide any details whatsoever regarding specific electrical stimulation protocols including voltage, amperage or electrical frequency, nor does Appellant direct us to such a protocol. The Specification also does not provide details on the time 5 Appeal 2018-001128 Application 14/303,492 frame for electrical stimulation or how often the therapy should be administered (Spec. generally). 7. The Specification lists prior art devices "for applying electrical energy to a subject and which may be adapted for use in the subject invention are described, e.g., in U.S. Pat. Nos.: 7,149,574; 7,711,430; and 7,363,076; as well as U.S. Patent Application Serial No. 11/592,027; the disclosures of which are herein incorporated by reference" (Spec. 26: 1-5). State of the Prior Art and Unpredictability of the Art 8. Sironi4 teaches regarding electrical stimulation of the brain that "there are still many unresolved technical and ethical problems, concerning the identification of the targets for each disease, the selection of the patients and the evaluation of the results" (Sironi 1, abstract). 9. Sironi teaches that stimulation with different electrical frequencies yield different results, teaching that "while 'low-frequency stimulation' ( 5-10 Hz) could enhance tremor and other correlated symptoms, 'high-frequency stimulation' (50-100 Hz) resulted in a reduction of symptoms" (Sironi 2, col. 2). 10. Gubellini 5 teaches "[ s ]ize, shape and area of the microelectrode can affect the spatial distribution of the current density on the electrode surface and the electric field generated within the brain tissue, and overall affect brain tissue reactivity and potential neural damage" (Gubellini 86, col. 2). The Specification provides no guidance regarding electrode design. 4 Sironi, Origin and evolution of deep brain stimulation, 5 Frontiers in Integrative Neuroscience 1-5 (2011). 5 Gubellini et al., Deep brain stimulation in neurological diseases and experimental models: From molecule to complex behavior, 89 Progress in Neurology 79123 (2009). 6 Appeal 2018-001128 Application 14/303,492 11. Gubellini teaches "electrode material and its possible degradation, charge density (that depends on electrode surface), and duration and waveform of stimuli can have a significant impact not only on the effect and the efficacy of DBS, but also on the safety of this method" (Gubellini 88, col. 2). The Specification provides no guidance on charge density, waveform, or duration of stimulation. 12. Krack6 teaches, regarding DBS in the brain, that the "functional outcome of these complex putative mechanisms of action is uncertain and is probably variable, depending on the specific anatomophysiological arrangements of each target region" (Krack 477, col. 1 ). 13. Mahmud7 teaches: As a matter of fact, understanding how excitatory and inhibitory neurons respond to extracellular electrical stimulation is still an open challenge. A particularly intriguing and clinically relevant aspect is their response to sinusoidal stimuli, such as those employed in tACS, and how it varies by tuning stimulus intensity and over the frequency range. (Mahmud 2, col. 2). 14. Mahmud further teaches further elaboration will be necessary to assess the real potential of the approach in clinics. First of all, an unknown contribution will exist from fibers stimulation by the electric field ... Second, synaptic plasticity phenomena may also influence network dynamics upon sinusoidal stimulation ... Finally, it 6 Krack et al., Deep brain stimulation:from neurology to psychiatry?, 33 Trends in Neuroscience 474--84 (2010). 7 Mahmud et al., Differential Modulation of Excitatory and Inhibitory Neurons during Periodic Stimulation, IO Frontiers in Neuroscience 1-12 (2016). 7 Appeal 2018-001128 Application 14/303,492 will be crucial to precisely estimate the transmembrane potential in neurons during tACS, taking into account the impedence of the neuronal membrane and its shunting influence at higher frequencies. In fact, despite technical advances to strengthen stimulation ... the transmembrane potential modulation caused by tACS may tum out to be too weak to control E/I for clinical usage (Mahmud 10, col. 1; internal citations omitted). 15. Medtronic8 teaches "(FDA) approval of Medtronic Deep Brain Stimulation (DBS) Therapy for use in people with Parkinson's disease of at least four years duration and with recent onset of motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication" (Medtronic 1 ). 16. Leone9 teaches "that acute hypothalamic stimulation is ineffective as a treatment for CH [ cluster headache]" while "several weeks of continuous stimulation are required before the attacks are markedly reduced or eliminated" (Leone 189, col. 1-2). 1 7. Leone teaches the "latency of chronic stimulation and inefficacy of acute stimulation suggest that the mechanism of hypothalamic stimulation is complex and not the result of simple inhibition of hypothalamic neurons" (Leone 193, col. 1 ). 18. Reeves 10 teaches 8 Medtronic Press Release, FDA Approves Medtronic Deep Brain Stimulation for People with Parkinson's Disease with Recent Onset of Motor Complications (2016). 9 Leone et al., Hypothalamic deep brain stimulation in the treatment of chronic cluster headache, 3 Therapeutic Advances in Neurological Disorders 187-95 (2010). 10 Reeves et al., The Effects of Trans cutaneous Electrical Nerve Stimulation on Experimental Pain and Sympathetic Nervous System Response, 5 Pain Medicine 150-61 (2004). 8 Appeal 2018-001128 Application 14/303,492 The results of the present experiment failed to show any differences among the High-Frequency TENS, Low-Frequency TENS, and Sham TENS conditions with respect to SNS activity during baseline, SNS activity during TENS stimulation periods, and pre-TENS to post-TENS changes in the magnitude of the elicited SNS response in anticipation of painful shock. (Reeves 157, col. 1 ). 19. Reeves teaches "no support was found for high-frequency/low- intensity TENS or low-frequency/high-intensity TENS having any effect on elicited SNS responses or pain perception when compared with a credible sham TENS control condition" (Reeves 159, col. 2). 20. Stein 11 teaches: The results of this investigation suggests that low frequency TENS [ transcutaneous electrical nerve stimulation] may be a noninvasive, non-pharmacological approach to reduce sympathetic modulation. We recognize one limitation of the present study: we did not perform direct measurements of sympathetic nervous system by assessment of muscle sympathetic nerve or by evaluation of plasma catecholamine, which should be conducted to clarify the effects of TENS on sympathetic outflow. This might be a good target for future research to explore possible clinical uses of TENS in the field of rehabilitation, especially for patients who present sympathetic hyperactivity, by studying the biochemical mechanisms involved in this modulation. (Stein 207, col. 2). 21. Franco teaches that the "results of clinical effectiveness from different TENS frequencies on the hemodynamic response are controversial. 11 Stein et al., Transcutaneous electrical nerve stimulation at different frequencies on heart rate variability in healthy subjects, 165 Autonomic Neuroscience: Basic and Clinical 205-8 (2011). 9 Appeal 2018-001128 Application 14/303,492 For healthy subjects, low-frequency TENS reduced sympathetic and increased parasympathetic modulation; however, at high frequencies, these results were the opposite" (Franco 416, col. 1 ). 22. Franco teaches it should be emphasized that the different hemodynamic responses are related to other parameters (intensity, frequency, pulse duration, electrode positioning, and application time) of TENS application, as well as to different types of populations studied. Therefore, the results of this study, regarding frequency, differ from each other and must be analyzed according to the context in which they were carried out. (Franco 416, col. 1; internal citations omitted). Quantity of Experimentation 23. Krack teaches that "efficacy can be tested in randomized, double-blind, controlled clinical trials" (Krack 474, col. 2), which require significant investment of resources and effort. 24. The Examiner finds that a "large quantity of experimentation [ would have been] necessary to adapt the teachings of the prior art in order to be capable of carrying out the recited effects of modulating autonomic function so that the sympathetic/parasympathetic bias of the subject is closer to that of a healthy 25 year old" (Ans. 9). Skill in the Art 25. The cited art, replete with papers from medical doctors and neurophysiologists, suggests that the skill in the art is high (cf FF 8-22) and that the skilled worker knew how to implement electrical stimulation to the brain and understood its limitations and complexity. Principles of Law 10 Appeal 2018-001128 Application 14/303,492 Factors to be considered in determining whether a disclosure would require undue experimentation ... include ( 1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, ( 4) the nature of the invention, ( 5) the state of the prior art, ( 6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). Analysis The analytical framework for determining whether claims fail to satisfy the enablement requirement balances the Wands factors to determine if undue experimentation would have been required to perform the reasonable scope of the claimed method at the time of filing of the Specification. Claim 1 is a method broadly encompassing the treatment of many of the diseases to which humankind is susceptible ranging from aging to cancer (FF 1-3). The Specification not only lacks any working examples (FF 4), but also provides no guidance regarding the electric characteristics of any stimulation, the precise location of stimulation, the time frame of stimulation, or the frequency of stimulation therapy (FF 5-7). As to unpredictability, the cited prior art is replete with statements that treatment with electrical stimulation of various diseases is "uncertain and is probably variable, depending on the specific anatomophysiological arrangements of each target region" (FF 12). Sironi evidences that different stimulation parameters give different results (FF 9) while Gubellini explains that the shape of the electrode also effects the treatment (FF 10), as does the waveform of the stimuli itself (FF 11 ). Leone also shows that hypothalamic 11 Appeal 2018-001128 Application 14/303,492 stimulation is ineffective as an acute treatment for chronic headache (FF 16) and even if effective in long-term treatment, the "mechanism of hypothalamic stimulation is complex" (FF 17). Reeves found no support for stimulation as "having any effect ... when compared to credible sham TENS control" (FF 19). Franco also demonstrated the unpredictability in using electrical stimulation because "different hemodynamic responses are related to other parameters (intensity, frequency, pulse duration, electrode positioning, and application time) of TENS application, as well as to different types of populations studied" (FF 22). As to quantity of experimentation, the evidence supports the Examiner's finding that a significant quantity of experimentation would have been required to carry out the claimed method (FF 24 ). Stein teaches a need "for future research to explore possible clinical uses of TENS" (FF 20) while Mahmud explains that as of 2016, after the filing date of the instant application, "further elaboration will be necessary to assess the real potential of the approach in clinics" (FF 14). Krack teaches that "efficacy can be tested in randomized, double-blind, controlled clinical trials" (FF 23), which require significant investment of resources and effort. Indeed, even the showing by Medtronic that a particular regimen and device was approved, post-filing, for deep brain stimulation of Parkinson's disease evidences that very large quantity of experimentation would have been necessary to demonstrate efficacy for one condition (see FF 15), much less for the full scope of claim 1. A preponderance of the evidence therefore supports the Examiner's finding that 12 Appeal 2018-001128 Application 14/303,492 the complexity and lack of predictability in the prior art concerning the effects of hypothalamic DBS combined with the sparse guidance provided in the instant specification, represent an invitation to the skilled artisan to experiment to find the ideal intensity, frequency, pulse duration, electrode positioning, application time and nerve target to carry out the required functions of autonomic function modulation. (Ans. 26-27). The Examiner has "set forth a reasonable basis for finding that the scope of the appealed claims is not enabled by the specification. Consequently, the burden shifted to [Appellants] to present persuasive arguments, supported by suitable proofs where necessary, that the appealed claims are truly enabled." In re Wright, 999 F.2d 1557, 1562 (Fed. Cir. 1993). Here, where there is not even a single working example or description of a detailed treatment procedure, as well as significant evidence of unpredictability and the need for large amounts of experimentation, Appellants fail to meet this burden. Appellant points to generic descriptions of treatment in the Specification and general teachings of devices that apply electrical energy to subjects (see App. Br. 4--5) to conclude that "one of ordinary skill in the art could reasonably practice the instantly claimed method without undue experimentation" (App. Br. 5). We find these arguments unpersuasive because, as noted above, the Specification lacks the sort of detail necessary to guide the ordinary artisan in performing the treatment. While the ordinary artisan is presumed to be familiar with the prior art, Appellant has not identified teachings in the prior art that disclose the required components of intensity, frequency, pulse duration, electrode positioning, application time and nerve target necessary 13 Appeal 2018-001128 Application 14/303,492 to carry out the required functions of autonomic function modulation recited by claim 1. Appellant points to Sironi as showing "an ordinary skilled artisan would understand how to apply DBS in both excitatory and inhibitory stimulation approaches" (App. Br. 7), and similarly cite Gubellini, Krack, Mahmud as demonstrating "an ordinary skilled artisan would be readily aware of how to differentially modulate (i.e., with excitatory or inhibitory stimulation) areas of the brain using, e.g., high or low frequency DBS" (App. Br. 8). We find this argument unpersuasive because, while these references do discuss deep brain stimulation, they do not provide support for treatment of the entire scope of claim 1, including treatment of diseases ranging from aging to cancer and from atherosclerosis to Raynaud' s disease as recited in the Specification and reasonably encompassed by claim 1 (FF 3). Indeed, Sironi points to "unresolved technical and ethical problems" (FF 8), Krack to uncertain functional outcomes (FF 12), and Mahmud states the response to "electrical stimulation is still an open challenge" (FF 13). Thus, rather than supporting Appellant's position, these references underline how unpredictable and uncertain electrical treatment is even in context where it is currently being applied, much less in novel treatments of diseases such as cancer or atherosclerosis or arthritis for which Appellant provides no evidence of efficacy whatsoever. Appellant contends that the Examiner disregarded the prior art, pointing out specific general teachings in the prior art such as Gubellini' s teaching that "' [ d]eep brain stimulation (DBS) is now widely utilized as a 14 Appeal 2018-001128 Application 14/303,492 functional surgical strategy for the treatment of a variety of neurological and psychiatric disorders'" (App. Br. 12). We find this argument unpersuasive because the Examiner does not disregard the prior art, addressing these references extensively (see Ans. 24-- 33). We adopt the position of the Examiner entirely, and particularly agree with the Examiner's analysis of these references. As the Examiner pointed out, these references were not properly submitted during prosecution and therefore were not properly part of the record but "[i]n spite of this, the Examiner addressed the references, noting that they teach treatment of different diseases and targeting brain structures distinct from the hypothalamus and are further silent upon the effects on the sympathetic/ parasympathetic activity ratio or restoring endocrine function to that of a healthy human 25 year old" (Ans. 32). Indeed, as already noted, we find these references support, rather than refute, the Examiner's enablement position. We find that the balance of the Wand factors, including the large quantity of experimentation necessary, the minimal guidance in the Specification, the absence of any working examples, the lack of any nexus for the breadth of disease treatments and the electrical stimulation treatment, the unpredictability of the art regarding electrical stimulation with the limited set of diseases tested, and the extreme breadth of the claims, weighed against a high skill level in the art, support the Examiner's conclusion that undue experimentation would have been required to enable the full scope of the instantly claimed invention. Conclusions of Law 15 Appeal 2018-001128 Application 14/303,492 The evidence of record supports the Examiner's conclusion that the claims fail to comply with the enablement requirement. B. 35 U.S. C. § 112, first paragraph, written description The Examiner finds "in the absence of sufficient recitation of distinguishing identifying characteristics (i.e., steps), the specification does not provide adequate written description of the claimed genus of applying electrical energy" (Non-Final Act. 11 ). The Examiner specifically points out that as noted at p. 6 of Applicant's remarks filed 1/15/2016, the PGPUB 2004/0249416 "does not ... describe restoring normal endocrine function using electrical stimulation of central nervous system endocrine glands and is in fact silent to electrical stimulation of central nervous system endocrine glands, let alone doing so to restore endocrine function." This sentence raises an issue under written description, because it indicates that the patent disclosed as providing description for carrying out the claimed invention (i.e., 7,149 ,57 4/ 2004/0249416), is in fact, inadequate for the purpose of written description. Further, the passage at p. 25 of the instant specification provides evidence that prior art methods must first be "adapted for use" in the instant invention. (Non-Final Act. 12). Appellant contends the Examiner "has failed to sufficiently demonstrate by a preponderance of evidence why a person skilled in the art would not recognize in Applicant's disclosure a description of the method defined by the claims" (App. Br. 19). Appellant contends "the specification describes accomplishing the modulation by applying excitatory or inhibitory electrical energy to at least a portion of a subject's central nervous system endocrine gland (see e.g., pg. 25, lines 9-22)" (App. Br. 20). Appellant 16 Appeal 2018-001128 Application 14/303,492 contends that prior art supports possession, noting that "Yun [US 7,149,574] extensively describes additional components of electrostimulatory devices and the parameters and characteristics of each component present in such devices even identifying a specific exemplary device available commercially and referencing other art that provides further detailed descriptions of particular components" (App. Br. 21 ). Appellant similarly contends that other prior art teaches DBS applied as either inhibitory or excitatory to the thalamus (see App. Br. 22). Appellant contends that "a patent need not teach, and preferably omits, what is well known in the art" (App. Br. 23, citing various cases including In re Buchner, 929 F.2d 660, 661 (Fed. Cir. 1991)). We agree with the Examiner. "[I]t is the specification itself that must demonstrate possession. And while the description requirement does not demand any particular form of disclosure, ... or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement" Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010). The instant Specification does not evidence possession of any specific steps, including details of electrical stimulation protocols, necessary to treat the genus of sympathetic bias associated autonomic nervous system associated conditions encompassed by claim 1. As discussed above regarding enablement, the Specification lacks any working examples or even prophetic examples (FF 4). More importantly as to possession, the Specification provides no evidence of any particular stimulation protocols, including parameters such as electrical waveform, electrode material, 17 Appeal 2018-001128 Application 14/303,492 electrode location in the brain, electrical frequency, intensity, voltage, current, or other parameters necessary to perform the method. Without any link between the general concept of electrical stimulation of the hypothalamus and specific treatment parameters that result in some therapeutic effect on the extensive list of diseases encompassed by claim 1 (FF 3), it is not sufficient to state that prior art (or post-filing date art) treated other conditions using particular devices and parameters and, in a limited set of cases, obtained positive results. We find this situation analogous to Fujikawa, where the court found an "application contained no blazemarks as to what compounds, other than those disclosed as preferred, might be of special interest. In the absence of such blazemarks, simply describing a large genus of compounds is not sufficient to satisfy the written description requirement as to particular species or sub-genuses." Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Similarly here, there are no blazemarks in the Specification to any particular electrical waveforms, frequencies, electrodes, or other parameters that yield therapeutic effects on the hypothalamus sufficient to treat the immense genus of diseases including cancer and cardiovascular conditions generally, as well as arthritis, diabetes, age-related inflammation, cataracts, and other diseases (FF 3). Appellant has not provided sufficient evidence to establish that they conceived and described sufficient representative species encompassing the breadth of the genus and therefore have "only a research plan, leaving it to others to explore the unknown contours of the claimed genus." AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014). 18 Appeal 2018-001128 Application 14/303,492 To the extent that Appellant relies upon the prior art to describe specific details of electrical devices, electrodes, waveforms and other elements that might be obvious to apply to the particular disease conditions encompassed by claim 1, Appellant does not establish that the prior art does, in fact, render these details obvious. Appellant certainly does not establish that the prior art anticipated the instant claims. Moreover, even if the prior art did suggest all of the elements necessary to perform the method of claim 1, "a description that merely renders the invention obvious does not satisfy the [written description] requirement" Ariad, 598 F.3d at 1352. We, therefore, conclude that Appellant has not satisfied the written description requirement. SUMMARY We affirm the rejection of claims 1, 2, 4, 5, 12, 13, and 16-18 under 35 U.S.C. § 112, first paragraph, as failing to comply with the enablement requirement. We affirm the rejection of claims 1, 2, 4, 5, 12, 13, and 16-18 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. 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