Marc Stadler et al.

Patent Trials and Appeals Board

Jan 12, 2022

2021005269 (P.T.A.B. Jan. 12, 2022)

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. 14/124,429 02/12/2014 Marc Stadler 104093-37 KGB 7253 27384 7590 01/12/2022 Briscoe, Kurt G. Norris McLaughlin, PA 7 Times Square, 21st Floor New York, NY 10036-6524 EXAMINER WHEELER, THURMAN MICHAEL ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 01/12/2022 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): mgonzalez@norris-law.com nmanfredi@norris-law.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte MARC STADLER, JENS BITZER, BÄRBEL KÖPCKE, KATHRIN REINHARDT, and JANA MOLDENHAUER Appeal 2021-005269 Application 14/124,429 Technology Center 1600 ____________ Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL The Examiner rejected 25, 28, 31, and 32 under 35 U.S.C. § 101 as lacking patent eligibility. Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject the claims. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as IMD Natural Solutions GMB. Appeal Br. 1. Appeal 2021-005269 Application 14/124,429 2 STATEMENT OF THE CASE Claims 25, 28, 31, and 32 stand rejected by the Examiner in the Final Office Action under 35 U.S.C. § 101 as being “directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.” Final Act. 2-3. There are two independent claims on appeal, claim 25 and 28. Claim 28 is directed to a “purified compound consisting essentially of glycolipid and selected from” four recited structures labeled [1], [12], [13], and [18]. Claim 28 is directed to a “purified compound consisting essentially of glycolipid and having the formula I.” The “Claims Appendix” to the Appeal Brief discloses the structure of the compounds recited in the claims. Appeal Br. 21-24. Because the structures are not in dispute in the appeal, we have not reproduced them here. An oral hearing in this appeal was held December 15, 2021. A transcript of the hearing has been entered into the record. CLAIM INTERPRETATION Claim 25 is directed to a purified compound consisting essentially of glycolipid selected from a group of compounds having formula [1], [12], [13], or [18]. Claim 28 is directed to a purified compound consisting essentially of a glycolipid of formula I. The Specification discloses that the glycolipids are purified from the fungus family Dacrymycetaceae, especially Dacryopinax spathularia strain FU50088 (deposited as MUCL 53181). Spec. 7, 10, 134 (“B)”). Appeal 2021-005269 Application 14/124,429 3 PRINCIPLES OF LAW Under 35 U.S.C. § 101, an invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” However, not every discovery is eligible for patent protection. Diamond v. Diehr, 450 U.S. 175, 185 (1981). “Excluded from such patent protection are laws of nature, natural phenomena, and abstract ideas.” Id. The Supreme Court articulated a two-step analysis to determine whether a claim falls within an excluded category of invention. Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012). In the first step, it is determined “whether the claims at issue are directed to one of those patent-ineligible concepts.” Alice, 573 U.S. at 217. If it is determined that the claims are directed to an ineligible concept, then the second step of the two-part analysis is applied in which it is asked “[w]hat else is there in the claims before us?” Id. (alteration in original). The Court explained that this step involves 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.” Alice, 573 U.S. at 217-18 (alteration in original) (citing from Mayo, 566 U.S. at 75-77). Alice, relying on the analysis in Mayo of a claim directed to a law of nature, stated that in the second part of the analysis, “the elements of each claim both individually and ‘as an ordered combination’” must be considered “to determine whether the additional elements ‘transform the Appeal 2021-005269 Application 14/124,429 4 nature of the claim’ into a patent-eligible application.” Alice, 573 U.S. at 217. The PTO published guidance on the application of 35 U.S.C. § 101. See USPTO’s January 7, 2019 Memorandum, 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Eligibility Guidance”). This guidance provides additional direction on how to implement the two-part analysis of Mayo and Alice. See also Appendix 1 to the October 2019 Update: Subject Matter Eligibility Life Sciences & Data Processing Examples2 (see Example 44 (“Denveric Acid”). We follow this guidance below. DISCUSSION Step 1 In this part of the eligibility analysis, we determine whether the claim falls within a statutory category of invention. The claims are directed to a “purified glycolipid” which is a “composition of matter,” one of the statutory categories of patent-eligible subject matter under 35 U.S.C. § 101. Because the claim falls into one of the statutory categories of patent-eligible subject matter, following the first step of the Mayo/Alice analysis, we proceed to Step 2A, Prong One, of the Eligibility Guidance. Step 2A, Prong One In Step 2A, Prong One, of the Eligibility Guidance, the specific limitations in the claim are examined to determine whether the claim recites a judicial exception to patent eligibility, namely whether the claim recites an 2 https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_app1.pdf Appeal 2021-005269 Application 14/124,429 5 abstract idea, law of nature, or natural phenomenon. As explained in the October 2019 PEG Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Claim 1 recites a nature-based product limitation, namely a “glycolipid,” which a naturally- occurring a product of nature. The markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. Manual of Patent Examining Procedure § 2106.04(c)(I) (Ninth Edition, Revision 10.2019, Last Revised June 2020) (“MPEP”). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if the claimed composition has markedly different characteristics from the natural counterpart. MPEP § 2106.04(c)(II). The Specification discloses that the claimed glycolipids [1], [12], [13], and [18] are purified from the fungus family Dacrymycetaceae, especially Dacryopinax spathularia strain FU50088 (deposited as MUCL 53181). Spec. 7:15-16; 10; 134 (“B)”). Appellant did not dispute that such organisms are found in nature. The glycolipids from the naturally-occurring organisms are thus reasonably presumed to be naturally-occurring, as well. Appellant provided declarations by Jens Bitzer, Ph.D., a co-inventor of the application. Dr. Bitzer provided evidence of the properties of the claimed glycolipids, in an attempt to show that it is possesses “markedly different characteristics” than the glycolipid found in nature. See Bitzer 2018 Declaration (signed Dec. 6, 2018). The Bitzer 2018 Declaration describes the preparation of “purified glycolipid compounds” from Dacryopinax spathularia strain FU50088. 5.1. Appeal 2021-005269 Application 14/124,429 6 Bitzer 2018 Decl. § 5.1. According to Dr. Bitzer, the purified glycolipid components were prepared from fermentation broth as described in the Specification, in accordance with the preparation of extract [X1], to a purity of >93%. Id. Three types of samples were prepared: purified glycolipid components, culture broth, and supernatant. The purified glycolipids, referred to throughout the Bitzer declaration as the “purified glycolipid components,” do not comprise only one glycolipid, but rather are a mixture of glycolipids, only some of which are the claimed glycolipids. According to the Bitzer 2018 Declaration, the purified glycolipids was prepared in accordance with extract [X1] disclosed in the Specification. Bitzer 2018 Decl. § 5.1. Appellant, in the Reply Brief, states extract [X2] was prepared. Reply Br. 8. For discussion purposes, we will discuss the purified glycolipids used in Dr. Bitzer’s experiments as if they are those in extract [X2]. However, we note that Dr. Bitzer did not disclose the glycolipid profile of the purified glycolipid components tested in his declaration. Therefore, it has not been established on this record that the purified glycolipid components used in Dr. Bitzer’s experiments actually have the glycolipid profile of [X2] described in the Specification. Table 17 of the Specification (149-150) discloses that [X2] has the following glycolipid profile: Appeal 2021-005269 Application 14/124,429 7 Table 17 shows that extract [X2] (rightmost column) comprises at least 16 glycolipids in quantifiable amounts, including all four claimed glycolipids, [1], [13], [14], and [18] (table annotated by highlighting the claimed glycolipids). Glycolipid [1] is in the highest amount (29.8); unclaimed glycolipid [7] is in the second highest amount (25.1). Dr. Bitzer tested: 1) antifungal activity on agar plates (Bitzer 2018 Decl. § 6.1); 2) antifungal activity in apple juice (as a preservative) (id. § 6.2); 3) critical micelle concentration (CMC) (id. § 6.3); and 4) hydrophilic-lipophilic balance (HLB) (id. § 6.4). The amount of glycolipid in each of the purified glycolipid components, culture broth, and supernatant were adjusted to be the same (Bitzer 2018 Decl. § 6.1; Appeal Br. 7)). The experimental evidence showed Appeal 2021-005269 Application 14/124,429 8 that although the total glycolipid concentrations were the same in all three samples, the purified glycolipid components had more antifungal activity than the other two sample types in the agar and apple juice assays. Bitzer 2018 Decl. 6 (Tables 1 and 2). Dr. Bitzer stated that “the culture broth, although including the same amount of glycolipid components, only maintains 7.5% of the antifungal performance of the purified glycolipid components” when measured by the agar assay. Id. § 7.1. Dr. Bitzer further stated in his declaration that “the antifungal activity as well as beverage application as preservative of purified glycolipid components, purified at >93%, is far superior to the culture broth provided by nature, although it includes the same amount and concentration of glycolipid components.” Id. Dr. Bitzer stated that the purified glycolipid components “are about 15 times more anti-microbially potent compared to the culture broth, as provided by nature, although it includes the same amount and concentration of glycolipid components.” Id. The CMC value was only determined for purified glycolipid components. Dr. Bitzer concluded, based on its CMC value, that it has “rather strong surfactant properties.” Id. § 7.2. The HLB value, for suitability as a detergent and cleansing agent, was only determined for purified glycolipid components. Dr. Bitzer concluded, based on its HLB value, that it has “high suitability as detergent and cleansing agent.” Id. § 7.3. Based on the experiments, Dr. Bitzer concluded: As a consequence it becomes obvious that the glycolipid components in the culture broth provided by nature are different in nature compared to the purified glycolipid component generated in the course of the isolation process as described in . . . [the Specification]. While I do not wish to be bound by Appeal 2021-005269 Application 14/124,429 9 theory, the above experimental results give evidence for a physical chemical change in conformation of the glycolipid components in the culture broth provided by nature compared to the purified glycolipid compot1ents obviously determined by the strong surfactant properties; this change in physical- chemical stage may be influencing other properties such as the desired anti-microbial efficacy. Id. § 7.4. Dr. Bitzer testified in his declaration that the “findings are surprising and unexpected in my view, being neither taught nor rendered obvious before.” Id. § 7.4 The Examiner did not find this data to be sufficiently persuasive to demonstrate that the purified glycolipid components has markedly different properties from the naturally-occurring product, for example as it occurred in the culture both or supernatant collected from the medium in which the fungal cells were cultured. As explain in more detail below, we agree with the Examiner’s determination about the inadequacy of the data. We summarize the Examiner’s arguments as follows: (1) The Examiner finds that the enhanced antifungal activity of the purified glycolipid components “is dependent” upon its higher purity. Ans. 13. The Examiner finds that Dr. Bitzer did not establish that the purified glycolipid components “provide antimicrobial properties that are distinguishable from the glycolipids of the culture broth and supernatant since the glycolipids of culture broth and supernatant perform the identical antimicrobial function as the purified glycolipid components, while differing only by degree (amount) of activity.” Id. at 17-18. (2) With respect to Dr. Bitzer’s statement that the “experimental results give evidence for a physical chemical change in conformation of the Appeal 2021-005269 Application 14/124,429 10 glycolipid components in the culture broth provided by nature compared to the purified glycolipid components” and this change “in physical-chemical stage may be influencing other properties such as the desired anti-microbial efficacy,” the Examiner finds that one of ordinary skill in the art would not know “if the difference in activity is the result of all of the glycolipids in the mixture of glycolipids that make up the purified glycolipid components or just some of the glycolipids in the mixture of glycolipids undergo a change of conformation.” Ans. 18. The Examiner also finds that one of ordinary skill in the art would not know “how much of each glycolipid that actually did change its conformation, e.g., equilibrium mixture between the glycolipid that has changed its conformation (i.e., proposed different compound) and the identical glycolipid that has not changed its conformation that exists in nature.” Id. at 18-19. The Examiner finds that Dr. Bitzer did not “prove that the change in conformation of a glycolipid would provide a complete conversion of the glycolipid that [exists] in nature to a completely different compound.” Id. at 19. (3) The Examiner also finds that Dr. Bitzer “fails to identify the specific glycolipids that make up the purified glycolipid components that are reasonable expected enhance the antimicrobial activity, wherein the purified glycolipid components contains a mixture of glycolipids.” Ans. 19. The Examiner explains that the enhanced activity (and conformational changes) “may be the result of merely a portion of the glycolipids contained in purified glycolipid components,” and not necessarily of all of those which are claimed. Id. (4) The Examiner finds that the claims do not require a conformational or structural change that differs from nature. Ans. 23. Appeal 2021-005269 Application 14/124,429 11 With respect to the Examiner’s arguments that the properties of the three tested sample types are the same, but only the degree of activity is different and thus does not make the purified glycolipid components markedly different, Appellant argues that “purity” can be the basis for markedly different properties and that the difference in activity rises to the level of being markedly different. Reply Br. 5. Appellant also argues “that its task was only to show that the claimed compounds exhibit markedly different properties compared to the natural counterparts, i.e., the compounds in the culture broth” and were not “tasked with showing that other unclaimed compounds present in the culture broth along with the claimed compound are not themselves also transformed along with the claimed compounds by the act of purification.” Id. at 6. Appellant does not persuasively demonstrate that the Examiner erred. First, neither claim 25 nor claim 28 is directed to a mixture of glycolipids. Each of these claims is directed to a “purified compound,” not a mixture of compounds. All of the experiments described in the Bitzer 2018 Declaration involved a mixture of glycolipids, four of which are the claimed compounds [1], [12], [13], and [18], along with at least 12 other glycolipids. Appellant has not shown the properties of any single compound which is claimed. Secondly, we agree with the Examiner that the increased antifungal potency of purified glycolipid components as compared to culture broth is not necessarily a markedly different property. The increase in potency could be simply a result of increasing the amount of certain glycolipids in the purified glycolipid components which have higher antifungal potencies. For example, in Dr. Bitzer’s declaration filed in 2016, he showed that Appeal 2021-005269 Application 14/124,429 12 glycolipids [1] and [13] were more potent than glycolipids [6] and [7]. Bitzer 2016 Decl. § 6.1 (signed Oct. 24, 2016). Glycolipid [1] is present in the highest concentration in [X2] (see Table 17 supra at 6). Dr. Bitzer did not show how much glycolipid [1] is present in the culture broth to which the purified glycolipid components were compared. If the concentration of [1] is higher in the purified glycolipid components as compared to the unpurified culture broth, then it would be reasonably expected to confer high potency on the purified components because it is present in higher amounts. This is simply a dose-response relationship: a higher dose gives a greater response. Consistently, Appellant admits the claimed glycolipids are present in higher amounts. Reply Br. 8 (“[I]n view of this high amount of compounds [1], [12], [13], and [18] and their high antifungal effectivity, one can reasonably exclude the likelihood that the observed enhanced activity of the product is derived from any other unclaimed glycolipid”). Dr. Bitzer did not address this issue in his declaration. Appellant states that “the record establishes that the glycolipids in the purified glycolipid component are present therein in the same quantity and type as they are in the culture broth.” Reply Br. 10. The glycolipid content as a whole is the same, but this does not mean that individual glycolipids in the samples are in the same amounts. We have not been directed to any showing in the record that the claimed glycolipids [1], [12], [13], and [18] are present in the same amounts in the culture broth and in the purified glycolipid components. An increase in the amount of any of the claimed glycolipids could account for the increased activity as would be apparent to the ordinary skilled worker familiar with a dose-response relationship. Appellant’s statement to the contrary appears to ignore this basic pharmacological Appeal 2021-005269 Application 14/124,429 13 property and instead attributes it to the compounds being markedly different.3 It also be due to the removal of inhibitory compounds resulting in higher apparent activity. Appellant also argues that the claimed glycolipids have unexpected advantages because of their antifungal properties against various filamentous fungi and yeast. Reply Br. 8-9. However, the antifungal property is just an inherent property of the claimed glycolipids that would be present in the naturally-occurring compound in the same qualitative way. Concentrating the amount of the compound by purifying it does not make the property any different from the property as it exists in nature, there is simply more of it. As held in In re Papesch, 315 F.2d 381, 391 (CCPA 1963), “[f]rom the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” Dr. Bitzer discussed in his declaration that there could be a physical chemical change in the conformation of the purified glycolipid components that “may be influencing other properties such as the desired anti-microbial efficacy.” Bitzer 2018 Decl. § 7.4. The Examiner, as explained above, did not find this data persuasive. We agree. While it may be true that changing the physical state of a compound by changing its conformation may be sufficient to show a markedly different characteristics4 in some 3 “What is more likely, and what the Examiner refuses to acknowledge, is that the claimed glycolipids, which show superior antimicrobial activity when individually isolated from the purified glycolipid component, are responsible for the enhanced antimicrobial activity when the culture broth is purified to the purified glycolipid component.” Reply Br. 11. 4 See “Nature-Based Products,” December 16, 2014, “4. Purified Proteins,” pp. 4-7 Appeal 2021-005269 Application 14/124,429 14 circumstances, this has not been demonstrated here. The CMC and HLB values were only obtained for the purified glycolipid components. No comparison was made between the purified glycolipid component and the culture broth or supernatant. The individually claimed glycolipids were not even tested. Therefore, there is inadequate evidence that the “physical- chemical” change described by Dr. Bitzer is unique to the purified glycolipid components and makes them markedly different from unpurified glycolipids. Moreover, as discussed by the Examiner (Ans. 18-19 as summarized above), Dr. Bitzer did not establish that all the glycolipids exhibited the asserted physical-chemical changes and that such changes are responsible for the activity observed. For example, the so-called changes could leave the glycolipids with less or no activity, and all the observed activity is due to the unchanged, naturally-occurring form. Dr. Bitzer’s statement is speculation and not supported by sufficient objective evidence. As pointed out by the Examiner (Ans. 24, (4) above), the claims do not even require the purified glycolipid to have a conformation or structure that differs from nature. Dr. Bitzer, because he did not test any individual glycolipid, did not establish that purification necessarily is associated with the asserted physical- chemical change. See In re American Academy of Science Tech Center, 367 F.3d 1359, 1370 (Fed. Cir. 2004) (“[T]he Board is entitled to give such weight to declarations as it deems appropriate.”) Because we find that the Examiner correctly found that claims 25 and 28 recite a naturally-occurring compound, the claimed glycolipid falls into the product of nature exception to patent eligibility. Association for (https://www.uspto.gov/sites/default/files/documents/mdc_examples_nature- based_products.pdf). Appeal 2021-005269 Application 14/124,429 15 Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two. Step 2A, Prong Two Prong Two of Step 2A under the 2019 Eligibility Guidance asks whether there are additional elements that integrate the exception into a practical application. We must look at the claim elements individually and “as an ordered combination” to determine whether the additional elements integrate the recited abstract idea into a practical application. “A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” Eligibility Guidance, 84 Fed. Reg. 54. Integration into a practical application is evaluated by identifying whether there are additional elements individually, and in combination, which go beyond the judicial exception. Id. at 54-55. In this case, the claims are directed to purified compounds. There are no additional elements recited in the claim beyond the judicial exception. Accordingly, the purified compound is not integrated into a practical application. Step 2B Because we determined that the judicial exception is not integrated into a practical application, we proceed to Step 2B of the Eligibility Guidelines, which asks whether there is an inventive concept. In making this Appeal 2021-005269 Application 14/124,429 16 Step 2B determination, we must consider whether there are specific limitations or elements recited in the claim “that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present” or whether the claim “simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, indicative that an inventive concept may not be present.” Eligibility Guidance, 84 Fed. Reg. 56. There are no additional elements recited in the claim. As explained under Step 2A, Prong Two, the claimed glycolipids are indistinguishable from the compound as they are found in nature, and the properties described in Dr. Bitzer’s 2018 Declaration for the claimed glycolipids are simply inherent and inseparable from the compounds, themselves. Dependent claims 31 and 32 were not argued separately and fall with claims 25 and 28. 37 C.F.R. 41.37(c)(1)(iv). CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 25, 28, 31, 32 101 Patent eligibility 25, 28, 31, 32 TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).