Ex Parte Epshtein et alDownload PDFPatent Trial and Appeal BoardJan 17, 201710522651 (P.T.A.B. Jan. 17, 2017) 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. 10/522,651 01/22/2005 Oleg Iliich Epshtein 841/007 7491 83336 7590 01/19/2017 PFRPtAMFNT fr r’FPFDA T T P EXAMINER 163 Madison Ave., PAK, MICHAEL D Suite 220-036 Morristown, NJ 07960 ART UNIT PAPER NUMBER 1646 NOTIFICATION DATE DELIVERY MODE 01/19/2017 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): mcepeda@ pergamentcepeda. com lmacqueen@pergamentcepeda.com sshankar@pergamentcepeda.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte OLEG ILICH EPSHTEIN, EVGENY DANILOVICH GOLDBERG, and ALEXANDR MIKHAILOVICH DYGAY1 Appeal 2014-006750 Application 10/522,651 Technology Center 1600 Before TAWEN CHANG, RACHEL H. TOWNSEND, and DEVON ZASTROW NEWMAN , Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to a homeopathically potentized form of tumor necrosis factor alpha (TNF-a), which have been rejected as being directed to nonstatutory subject matter, indefinite, lacking in written description, not enabled, and anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. We designate the affirmance of the written description rejection as a new ground of rejection. 1 Appellants identify the Real Party in Interest as Dr. Oleg Epstein. (Appeal Br. 2.) We note that Appellants use both Epshtein and Epstein to refer to the inventor Dr. Oleg Epstein. We refer to the inventor throughout as Epshtein. Appeal 2014-006750 Application 10/522,651 STATEMENT OF THE CASE Treating autoimmune diseases by introducing antibodies to various cytokines, which regulate the course of inflammatory processes, such as antibodies to the tumor necrosis factor alpha (TNF-a), is a well-known practice. (Spec. 1.) “The therapeutic effect... is based on cytokine binding (inactivating).” (Id.) According to the Specification, Appellants’ “invention is directed at ... the treatment of inflammatory, including autoimmune, diseases, . . . ensuring the anti-inflammatory effect by modification rather than by binding (inactivation) of a cytokine.” (Id.) Further according to the Specification, the treatment employs “an activated form of ultra-low doses of [antibodies to the tumor necrosis factor alpha] . . . prepared by multiple consecutive dilutions and by exposure to external factors.” (Id.) Claims 3 and 5—10 are on appeal. Claim 3 is representative and reads as follows: 3. A medicament effective in correcting a pathologic immune reaction, said medicament comprising a homeopathically potentized form of at least one monoclonal polyclonal or natural antibody to a recombinant human or heterologous tumor necrosis factor alpha (TNF-a), wherein said homeopathically potentized form of antibody is prepared by homeopathic methodology that includes multiple consecutive dilutions. (Appeal Br. 14.) The following grounds of rejection by the Examiner are before us on review: 1. Claims 3 and 5—10 under 35 U.S.C. § 101 as being directed to nonstatutory subject matter. 2 Appeal 2014-006750 Application 10/522,651 2. Claims 3 and 5—10 under 35U.S.C. § 112, second paragraph as being indefinite. 3. Claims 3 and 5—10 under 35U.S.C. § 112, first paragraph as containing subject matter which was not described in the specification. 4. Claims 3 and 5—10 under 35U.S.C. § 112, first paragraph as not being enabled. 5. Claims 3 and 5—10 under 35 U.S.C. § 102 as being anticipated over Le.2 (Appeal Br. 3.) DISCUSSION §101 The Examiner finds that the claims are directed to a homeopathically potentized form of a naturally occurring antibody which is limited by a particular process of making it, namely dilution of the antibody. (Non-Final 4—5; Ans. 9.)3 The Examiner contends that “[wjhatever is the structural form [of the naturally occurring antibody] after the series of dilution[, it] is a naturally occurring form from the naturally occurring antibody originally used.” (Ans. 9.) Regarding the method of creating this form, the Examiner finds that the “steps relating to the dilution of antibody are well-understood” and amounts to “instructions that are well-understood, routine, conventional activity, previously engaged in by those in the field” and, thus, “add nothing 2 Le et al., US 5,698,195, issued Dec. 16, 1997. 3 Although Appellants appeal from a non-final rejection, the pending claims have been rejected at least twice. Consequently, the Appeal is properly filed. 35 U.S.C. § 134(a). 3 Appeal 2014-006750 Application 10/522,651 specific to the natural principle that would render it patent-eligible.” (Ans. 4.) We agree with the Examiner’s factual findings and conclusion that claim 3 is directed to nonstatutory subject matter. Appellants’ argument that the claimed antibodies are not nonstatutory subject matter because “[i]t is well established that claims to antibodies are patentable” and that the process of multiple dilutions “is not a natural process” (Reply Br. 2) is not well founded. Determination of subject matter eligibility involves a two-step test. First, one must determine if the claimed subject matter is directed to a judicially recognized exception, such as a product of nature, i.e., natural phenomenon. Mayo Collaborative Serves, v. Prometheus Lab., Inc. 132 S.Ct. 1289, 1293, 1297 (2012); Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107, 2116 (2013). If it does, the next step is to determine if the claims recite additional elements that transform the nature of the claim. Genetic Tech. Ltd. v. Merial LLC, 888 F.3d 1369, 1374 (Fed. Cir. 2016) We disagree with Appellants’ blanket statement that “claims to antibodies are patentable.” The Supreme Court has clearly indicated that naturally occurring material that is isolated from its natural environment is unpatentable. See Myriad, 133 S.Ct. at 2118 (finding claims to isolated DNA unpatentable). Antibodies that are unaltered by genetic or chemical manipulation are naturally occurring. Claim 3 recites a composition that can be “a homeopathically potentized form” of a “natural antibody to a recombinant human or heterologous tumor necrosis factor alpha (TNF-a).” (Claim 1.) Appellants’ 4 Appeal 2014-006750 Application 10/522,651 Specification does not specifically define the term “homeopathically potentized form.” However, it does disclose that “homeopathic potentisation technology” provides “ultra low or low doses” of antibody by “consecutive multiple dilutions and [subjecting them] to an external mechanical factor” such as “vertical shaking.” (Spec. 2.) In light of this, we determine that the broadest reasonable interpretation consistent with the Specification of the term “homeopathically potentized form” as would be understood by one of ordinary skill in the art is that the claimed form refers to an antibody that is present in an ultra low or low dose prepared at least by consecutive multiple dilutions. Appellants do not disagree; indeed they confirm as much in their brief, noting that the claimed “form of antibody is prepared by multiple consecutive dilution of the initial antibody until potentization is achieved.” (Appeal Br. 4.) Such an antibody is altered less than the nucleic acid in Myriad, it is chemically unchanged: there is no chemical bond severing such as was done to release the nucleic acid from the chromosome in Myriad, but simply separation of the antibody from its natural environment and subsequent dilution to low dose or ultra low dose. Appellants argue that in the process for making the claimed antibody “to TNF-alpha, the inventor raises polyclonal antibodies in rabbit” and then “the inventor does multiple consecutive dilution in accordance with homeopathic technology.” (Reply Br. 2.) Regardless of whether the Specification describes raising polyclonal antibodies in rabbit (Spec. 2), Claim 3 recites a composition that can be “a homeopathically potentized form” of a “natural antibody.” (Claim 3.) A natural antibody is a product of nature. The fact that it is present in the 5 Appeal 2014-006750 Application 10/522,651 formulation in a low or ultra low dose is analyzed under the second step in the subject matter eligibility determination. We note that in addition to reciting that the natural antibody to TNF- alpha is present in a “homeopathically potentized form,” claim 3 recites a process step by which the homeopathically potentized form of the natural antibody must be made, i.e., “multiple consecutive dilutions.” (Claim 3.) That process step does not add anything to transform the nature of the antibody of claim 3.4 Indeed, it is nothing more than an explicit recitation of one step the Specification teaches is used to create the low or ultra low dose of antibody that is the “homeopathically potentized form.” There is no argument made that the dilution of an antibody creates a new structural form of the antibody or alters the natural antibody in any structural way, nor is it a novel step in preparing antibodies for use in therapeutics, as the Examiner found (Ans. 4). Thus, isolating the natural antibody to TNF-a and subjecting it to “multiple consecutive dilution” to achieve a low or ultra low 4 At oral argument, Appellants’ representative asserted that the potentization process results in there being no antibodies left in the diluent but which diluent has a new activity. (Oral Hearing Tr. 4:20-5:7 (“you take a serum with antibodies, and you dilute it until there is no more antibodies left in that. You create a new activity by this process. . . . This solvent obtains new property”).) This is a new argument, which we do not consider, see e.g., Ex parte Borden, 93 USPQ2d 1473, 1473-74 (BPAI 2010) (“informative”) (absent a showing of good cause, the Board is not required to address argument in Reply Brief that could have been presented in the principal Brief), except to note that it is inconsistent with the teachings in the Specification that homeopathic potentization technology provides for a low or ultra low dose of antibody and that “this procedure gives the required dose (potency)” (Spec. 2). 6 Appeal 2014-006750 Application 10/522,651 dose of the antibody is not found to result in an inventive concept that transforms the natural phenomenon of the natural antibody to TNF-a into a patentable invention. Claims 5—10 have not been argued separately and therefore fall with claim 3. 37 C.F.R. § 41.37(c)(l)(iv). § 112, second paragraph The Examiner finds that the term “homeopathically potentized form” is “ambiguous and confusing because the metes and bounds of the term is not clear [in that] [i]t is not clear when a compound is [a] homeopathically potentized form.” (Ans. 5; Final Action 6.) The Examiner further notes, citing Goldacre,5 that “[i]t is not clear to all skilled in the art that such form is clear” in light of the art indicating that “homeopathy produced no statistically significant benefit over placebo” and “it is not clear what the product is that is giving the placebo effect.” (Ans. 10; Final Action 7.) The Examiner further finds that the methodology of creating the homeopathically potentized form recited does not make clear the metes and bounds because “it is not clear when a compound becomes homeopathically potentized since the dilution of Le . . . does not appear to be a homeopathically potentized [form] when diluted” and “Goldacre was not able to determine the metes and bounds of a homeopathically potentized [form] from his studies.” (Ans. 10—11.) In short, according to the 5 Goldacre et al., Comment: Benefits and risks of homeopathy, 370 Lancet 1672-73 (Nov. 17, 2007) 7 Appeal 2014-006750 Application 10/522,651 Examiner, while the claim language may make “clear the genesis of the claimed ‘homeopathically potentized form’ of antibody,” “it is not clear when such homeopathic methods are used what is the product which is acting on the placebo effect that is being claimed” and Appellant “has not defined what the product is when the product is in ‘homeopathically potentized form.’” (Final Action 7—8). Appellants argue that evidence of record provided by the second Declaration of Dr. Epshtein (dated Feb. 4, 2012), including results of clinical trials establishes that the claimed form of antibodies to TNF-a have a biological effect different from placebo, and thus the Examiner’s reliance on Goldacre is improper. (Appeal Br. 5—6; Reply Br. 3.) Appellants further argue that the excerpt of the German Homeopathic Pharmacopeia6 provided during prosecution specifically refers to formulations that are obtained by “potentization” and “describes standard homeopathic preparation technologies for various known homeopathic preparations” and for each described method indicates “the necessary potentization methodology,” thereby establishing that “the meaning of the term homeopathic potentization or activation was well defined to one skilled in the art at the time of filing of the application.” (Appeal Br. 6.) Appellants also note that the first Declaration of Dr. Epshtein (dated Nov. 12, 2009) and the Declaration ofNikolayev, (dated Nov. 12, 2009) both filed during prosecution, state unequivocally “that the term ‘homeopathic potentization’ has a well-defined meaning in the homeopathic art,” and support a finding 6 German Homeopathic Pharmacopeia (GHP), Translation of the 5th Supplement (1991) to the 1978 edition, pp. 23, 31—38. 8 Appeal 2014-006750 Application 10/522,651 that the term is known to those of skill in the art. (Appeal Br. 6—7.) According to Appellants, that meaning is “that the homeopathically potentized form of the antibody of the application on appeal are prepared by homeopathic methodology that includes multiple consecutive dilutions.” (Appeal Br. 7.) The Supreme Court explained that the standard for determining whether a claim is indefinite is whether the claim “inform[s] those skilled in the art about the scope of the invention with reasonable certainty.” Nautilus, Inc. v. Biosig Instruments, 134 S. Ct. 2120 (2014). We agree with the Examiner that claim 3 is indefinite. The Specification explains that one of ordinary skill in the art can make ultra low or low doses of TNF- a antibody through “homeopathic potentisation technology” and that this “technology” “gives rise to a uniform decrease in the concentration” of the antibody “through consecutive dilution of 1 volumetric part of the initial matter (antibodies) in 9 volumetric parts (for decimal dilution, D) or in 99 volumetric parts (for centesimal dilution, C) of a neutral solvent with multiple vertical shaking of each solution.” (Spec. 2.) This is consistent with the discussion in the GHP and Appellants’ argument that the GHP describes homeopathic preparation technologies. However, a discussion as to how one prepares the claimed homeopathically potentized form of the antibody does not describe the boundaries of what that form of the antibody is with reasonable certainty. “The indefmiteness inquiry is concerned with whether the bounds of the invention are sufficiently demarcated, not with whether one of ordinary skill in the art may find a way to practice the invention.” ePlus, Inc. v. Lawson Software, Inc., 700 F.3d 509, 519 (Fee. 9 Appeal 2014-006750 Application 10/522,651 Cir. 2012). One of ordinary skill in the art is not informed by the description in the Specification or the GHP with reasonable certainty what the attributes of the homeopathically potenitzed form of TNF-a antibody are as compared to any other diluted TNF-a antibody such as is taught by Le so as to be able to distinguish a homeopathically potentized form from any other diluted form of TNF- a antibody. In other words, that the Specification may identify a method of making an ultra low dose or low dose of an antibody by dilution methods known to those of ordinary skill in the homeopathic art is insufficient to inform one of ordinary skill in the art with reasonable certainty the metes and bounds of what is a homeopathically potentized form of TNF-a antibody. The statement by declarant Epshtein that “homeopathic potentization” has a well-defined meaning to one of skill in the art because potentization is known to refer to dilution technology used in homeopathy (Epshtein Declaration dated Nov. 12, 2009, ^6—10), and the statement by declarant Nikolayev that “[hjomeopathic potentization” “is generally understood as ‘creating the desired homeopathic potency’ th[r]ough homeopathic technology” (Nikolayev Declaration dated Nov. 12, 2009 17) also do not establish that one of ordinary skill in the art would be reasonably certain of the metes and bounds of the claimed homeopathically potentized form of TNF-a antibody. Both statements simply indicate that serial dilution is the known methodology by which homeopathic preparations are made; neither statement is sufficient to provide information as to what one of ordinary skill in the art would have understood with reasonable certainty as being a homeopathically potentized form of TNF-a antibody. 10 Appeal 2014-006750 Application 10/522,651 At oral argument, Appellants’ representative indicated that the only way to know when one has “something that’s been diluted enough to be a potentized form” “is to dilute and test the material in the biological — in the biologically acceptable model.” (Oral Hearing Tr. 8.) Appellants’ representative noted that for every medical compound, there is a threshold concentration below which the compound will not be biologically active, and that if one had a dilution that is above the threshold concentration and the antibody achieved a therapeutic effect it would not be a homeopathic potentized form. (Oral Hearing Tr. 16.) Even if true, Appellants have not provided sufficient evidence establishing there is such a biologically acceptable model for determining positive homeopathic results in treating pathologic immune reaction. And in any event, the pertinent issue is whether the Specification discloses to one of ordinary skill in the art adequate standards for determining the boundaries of the claim. The Specification does not provide a standard for evaluating whether a given dilution of TNF-a antibody has reached the stage of homeopathic potentization, i.e. the requisite ultra low or low dose. As the Examiner noted, “one skilled in the art has the technology to measure the quantity of TNF-alpha antibody by a number of methods whereas the specification does not use known techniques to determine the concentration of the antibody.” (Ans. 10.) While it is true that “patentable inventions cannot always be described in terms of exact measurements, symbols and formulae,” it is nevertheless also true that “[i]f the subject matter of the patent is such that the patentee ... is incapable of ascribing reasonable limits to his claims, 11 Appeal 2014-006750 Application 10/522,651 regardless of intrinsic merit[,] his invention cannot be patented.” Georgia- Pacific Corp. v. United States Plywood Corp., 258 F.2d 124, 136 (2d Cir.) In light of the foregoing, we affirm the Examiner’s rejection of claim 3 under 35 U.S.C. § 112, second paragraph. Claims 5—10 have not been argued separately and therefore fall with claim 3. 37 C.F.R. § 41.37(c)(l)(iv). § 112, first paragraph: Written Description According to the Examiner, “[i]f one skilled in the art cannot envision the generic claim from the specific example then it lacks written description.” (Final Action 9; Ans. 5—6.) The Examiner contends that “the essential feature of the invention is not clear because the structure which makes an antibody homeopathically potentized is not disclosed.” (Final Action 8.) The Examiner further contends that “[hjomeopathically potentized antibody cannot be envisioned by one skilled in the art” and “[t]he nexus between the method of making the product and resulting product which is ‘homeopathically potentized form’ is not disclosed in a manner that one of skilled in the art can determine what is the product claimed.” (Final Action 9.) We agree with the Examiner’s conclusion that the Specification fails to adequately describe the claimed invention, but for slightly different reasons. Consequently, we designate our affirmance as a new ground of rejection. “[T]he test for sufficiency [of the written description] is whether the disclosure of the application relied upon reasonably conveys to those skilled 12 Appeal 2014-006750 Application 10/522,651 in the art that the inventor had possession of the claimed subject matter as of the filing date.” AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Identifying the structure of a claimed compound is not the only way to establish possession, as Appellants note (Appeal Br. 7). The written description requirement can be met by “showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ... i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of characteristics.” Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316, 1324 (Fed. Cir. 2002). But, while Appellants have provided (a) preparation of “potentiated” antibodies to TNF-a by homeopathic technology including starting materials (e.g., at page 2, 3rd and 4th paragraph), (b) administration of the activated or potentiated form of the antibody to TNF-a to patients (e.g., Examples 3 and 4 ), and (c) biological effects of such administration in an animal model (e.g., Examples 1 and 2) (Appeal Br. 7), there is no disclosure of sufficient relevant identifying characteristics of the claimed homeopathically potentiated form of TNF-a antibody. There is no identification of the structure or any physical properties of the claimed form. To the extent any chemical properties are deemed to be described because biological effects are shown, there is no indication of any known or determined structure to function/activity relationship regarding any observed biological effects. Thus, not only have Appellants not provided the structure of the claimed antibody, Appellants 13 Appeal 2014-006750 Application 10/522,651 have also not provided any other sufficiently detailed, relevant identifying characteristics. We therefore affirm the rejection of claim 3 under 35 U.S.C. § 112, first paragraph as not being adequately described in the Specification. Claims 5—10 have not been argued separately and therefore fall with claim 3. 37C.F.R. §41.37(c)(l)(iv). § 112, first paragraph: Enablement The Examiner finds that the Specification does not reasonably enable the skilled artisan to make and use the claimed homeopathically potentized form of antibody without undue experimentation. (Final Action 11—13.) The Examiner contends that The state of the art is such that one skilled in the art prior to the time of the invention found that homeopathically potentized form are no better than placebo (Goldacre (Lancet, 2007)). Goldacre (Lancet, 2007) disclose that homeopathy produced no statistically significant benefit over placebo. The amount of direction provided in the specification is limited to diluting TNF antibodies. One skilled in the art cannot discern where the product is produced which results in a treatment which is different from placebo. One skilled in the art would require empirical experimentation in order to determine the difference between placebo effect and the treatment due to the potentized homeopathically form. In view of the extent and the unpredictability of the experimentation required to practice the invention as claimed, one skilled in the art could not make the invention without undue experimentation. (Id.) We agree with the Examiner’s factual findings and conclusion that that the invention recited in claim 3 is not enabled. Like Appellants (Appeal 14 Appeal 2014-006750 Application 10/522,651 Br. 10), we understand the Examiner’s enablement rejection to focus on the lack of an enabling disclosure as to how to use the claimed composition for effective correction of a pathologic immune reaction. Appellants contend that “office has not provided any evidence showing that the homeopathically potentized forms of antibodies of the present invention are not useful for correcting pathological immune reaction” and that enablement is established by clinical trial evidence submitted in the second Declaration of Dr. Epshtein (dated Feb. 4, 2012) and a 2010 article by Dr. Montagnier. (Appeal Br. 10-11.) In particular, Appellants note that the file wrapper contains evidence that the homeopathically potentized form of antibodies to TNF-alpha has biological activity different from placebo. See Epstein Declaration II and Exhibits submitted with the Declaration. The study described in the Epshtein Declaration II is double-blind, placebo-controlled study clearly demonstrating that the effect of Artrofoon is not a placebo effect. In contrast to the information in the Goldacre article, the information in the Epshtein Declaration II pertains directly to the specific homeopathically potentized form of the application on appeal. (Appeal Br. 10.) Appellants note further that the article by Dr. Luc Montagnier makes reference to his experimental research that confirms that homeopathic medicine that uses doses of substances that undergo sequential dilution with vigorous shaking in-between each dilution has biological effects. (Appeal Br. 11.) Appellants contend that the article by Goldacre is insufficient to countermand the foregoing “un-contradicted evidence.” (Appeal Br. 10.) 15 Appeal 2014-006750 Application 10/522,651 As the Examiner notes, however, “[n]o evidence has been presented that the data presented in [the second] Epstein Declaration is representative of [a] model for placebo effect.” (Ans. 14.) One of the studies relied upon in Goldacre to render the conclusion that “homoeopathy produced no statistically significant benefit over placebo” was “Comparative study of placebo-controlled trials of homeopathy and allopathy.” (Goldacre 1673 n. 5.) The Examiner thus has presented evidence to countermand Appellants’ position that the claimed invention is necessarily more than a placebo effect because clinical trial evidence was provided that “morning stiffness and the total intensity of pain were significantly reduced” in patients with Reiter disease and because there were accompanying “positive dynamics of laboratory indicators: the CRP has significantly decreased by the third month of treatment [and a] significant decrease of TNF-a [and] downward trend of IL-ip were observed by the sixth month” in those treated for arthritis (Appeal Br. 5—6). For this reason, we disagree with Appellants that “there is no requirement” for “empirical experimentation in order to determine the difference between placebo effect and the treatment due to homeopathically potentized form” of the claimed antibody (Reply Br. 5). As the Examiner noted, “[w]ithout such control data, the experiment is unpredictable as to the effect of the homeopathically potentized effect as taught by Goldacre (Lancet, 2007) which had placebo effect.” (Ans. 14.) Furthermore, Appellants do not contest the Examiner’s position that the animal model “is not [a] predictable model that one skilled in the art can replicate.” (Ans. 14.) Nor do Appellants contest that the control requires a low dose dilution of the TNF-a antibody but one that is not homeopathically 16 Appeal 2014-006750 Application 10/522,651 potentized in order to appropriately assess placebo effects. (Id.) As one commentator has noted: “A randomised trial of ‘solvent only’ versus ‘infinite dilutions’ is a game of chance between two placebos.” Jan P Vandenbroucke, 350 Lancet 824 (Sept. 20, 1997). That is, some fraction of patients will improve without any treatment, and this improvement does not evidence efficacy of the compound but simply represents the natural healing ability of the human body. Appellants’ reliance on the Montagnier article is also unavailing as the article does not discuss therapeutic results; nor does it indicate what level of dilution is referred to, but rather simply states that “we cannot go further than a 10'18 dilution” without losing the electromagnetic signals. Montagnier 1733. We therefore affirm the rejection of claim 3 under 35 U.S.C. § 112, first paragraph as not being not enabled. Claims 5—10 have not been argued separately and therefore fall with claim 3. 37 C.F.R. § 41.37(c)(l)(iv). §102 The Examiner finds that Le “disclose[s] anti-TNF antibodies used for treatment of rheumatoid arthritis [and] teach[es] numerous method[s] of therapeutic administration with different dosages.” (Final Action 15; Ans. 8.) According to the Examiner, these dosages involve dilution of the antibody. (Ans. 16.) Thus, the Examiner concludes that “Le . . . uses the TNF-alpha antibody and functions to treat rheumatoid arthritis [the] same as claimed.” (Ans. 16.) 17 Appeal 2014-006750 Application 10/522,651 For reasons stated above, we cannot determine the scope of claim 3 and 5—10 on appeal. Before a proper review of the rejection can be performed, the subject matter encompassed by the claims on appeal must be reasonably understood without resort to speculation. See In re Steele, 305 F.2d 859, 862-63 (CCPA 1962); In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970). Accordingly, we reverse pro forma the prior art rejection of claim 3. Cf. Ex parte Gutta, 93 USPQ2d 1025, 1036 (Bd. Pat. App. & Int. 2009) (precedential). This is a technical reversal rather than one based upon the merits of the Section 102 rejection. SUMMARY We affirm the following rejections: 1. Claims 3 and 5—10 under 35 U.S.C. § 101 as being directed to nonstatutory subject matter. 2. Claims 3 and 5—10 under 35 U.S.C. § 112, second paragraph as being indefinite. 3. Claims 3 and 5—10 under 35 U.S.C. § 112, first paragraph as containing subject matter which was not described in the specification. 4. Claims 3 and 5—10 under 35 U.S.C. § 112, first paragraph as not being enabled. Because our reasoning regarding the rejection for lack of written description differs to some degree from the Examiner’s, we designate our affirmance of this rejection as New Grounds of Rejection. We reverse the rejection of claims 3 and 5—10 under 35 U.S.C. § 102 as being anticipated over Le. 18 Appeal 2014-006750 Application 10/522,651 TIME PERIOD FOR RESPONSE 37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record. . . . 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. 37 C.F.R, $ 41.50(b) 19 Copy with citationCopy as parenthetical citation