DETAILED ACTION
Claims 2-3, 5-9, 11-16, and 18-20 are pending and under consideration on the merits.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/24/2026 has been entered.
Status of the Rejections
The 101 rejection is maintained.
The double patenting rejections are maintained.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 2-3, 5-9, 11-16, and 18-20 are rejected under 35 U.S.C. 101 as being drawn to a nature-based product.
Claims 2-3, 5-9, 11-16, and 18-20 are drawn to processes, which are one of the four categories of statutory subject matter. Therefore, whether the claims lack utility is determined by whether the claims are directed to a judicial exception, and, if so, whether the claims include additional elements that are sufficient to amount to significantly more than the judicial exception, using the Step 2A Prong One, Step 2A Prong Two, and Step 2B analysis. See MPEP 2106.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon?
This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II), a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
Claim 2 is directed to a method of promoting immune system health in a human in need thereof. The method comprises an oral administration step. The step is the oral administration of an effective amount of a composition comprising beta-1,3-glucan from Euglena heterotrophically grown using fermentation and dried to contain less than 10% moisture, said beta-1,3-glucan having no beta- 1,6-glyco-sidic bonds, wherein the effective amount of the composition comprises between 0.1 mg beta-1,3-glucan/kg body weight and 100 mg beta-1,3-glucan/kg body weight. As noted in claims 2 and 6 the beta-1,3,-glucan have a natural origin from Euglena. The present specification teaches that the composition administered by claim 2 is a natural product produced by Euglena and recovered in its natural form using a natural fermentation process (see, e.g., paragraphs 4, 27, 92-93, 98, 117). Thus, the instant process is focused on the administration of naturally occurring components.
Since the process is focused on the administration of naturally-occurring components, the claim is ‘directed to’ a nature-based product. Since the claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). 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 it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring fermented beta-1,3, glucan from Euglena. There is no indication that the general oral administration steps, would change the structure, function or other characteristics of the individual components in any way. Rather, it is expected that fermented beta-1,3, glucan would retain its naturally-occurring structure and function.
Therefore, claim 2 recites a product of nature exception. Association for 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.
Base claim 8 recites a method of modulating an autoimmune response in an individual in need thereof. The step is the administration of an effective amount of a composition comprising beta-1,3-glucan from Euglena heterotrophically grown using fermentation and dried to contain less than 10% moisture, said beta-1,3-glucan having no beta- 1,6-glyco-sidic bonds, wherein the effective amount of the composition comprises between 0.1 mg beta-1,3-glucan/kg body weight and 100 mg beta-1,3-glucan/kg body weight. As noted in claims 8-10 and 12 the beta-1,3,-glucan have a natural origin from Euglena. The present specification teaches that the composition administered by claim 2 is a natural product produced by Euglena and recovered in its natural form using a natural fermentation process (see, e.g., paragraphs 4, 27, 92-93, 98, 117). Thus, the instant process is focused on the administration of naturally occurring components.
Since the process is focused on the administration of naturally-occurring components, the claim is ‘directed to’ a nature-based product. Since the claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). 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 it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring fermented beta-1,3, glucan from Euglena. There is no indication that the general oral administration steps, would change the structure, function or other characteristics of the individual components in any way. Rather, it is expected that fermented beta-1,3, glucan would retain its naturally-occurring structure and function.
Therefore, claim 8 recites a product of nature exception. Association for 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.
Base claim 15 recites a method of modulating inflammation in a human in need thereof. The method comprises an oral administration step. The step is the administration of an effective amount of a composition comprising beta-1,3-glucan from Euglena heterotrophically grown using fermentation and dried to contain less than 10% moisture, said beta-1,3-glucan having no beta- 1,6-glyco-sidic bonds, wherein the effective amount of the composition comprises between 0.1 mg beta-1,3-glucan/kg body weight and 100 mg beta-1,3-glucan/kg body weight. As noted in claims 15-17 and 19, the beta-1,3-glucan have a natural origin from Euglena. The present specification teaches that the composition administered by claim 2 is a natural product produced by Euglena and recovered in its natural form using a natural fermentation process (see, e.g., paragraphs 4, 27, 92-93, 98, 117). Thus, the instant process is focused on the administration of naturally occurring components.
Since the process is focused on the administration of naturally-occurring components, the claim is ‘directed to’ a nature-based product. Since the claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). 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 it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring fermented beta-1,3, glucan from Euglena. There is no indication that the general administration steps would change the structure, function or other characteristics of the individual components in any way. Rather, it is expected that fermented beta-1,3, glucan would retain its naturally-occurring structure and function.
Therefore, claim 15 recites a product of nature exception. Association for 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: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d)II.
Claim 2 recites an additional element beyond the natural component of fermented beta-1,3-glucan in that the component is part of a method of promoting immune system health in a human in need thereof and the component is orally administered. The process steps of administration are written at a high level of generality and do not provide any specific limitation as to how the oral administration is done or any specific dosage but a large range between 0.1 mg/kg body weight to 100 mg/kg of body weight as described above, the process of orally administering the components does not impart any distinct qualities or characteristics to the components. The claim preamble of a “method of promoting immune system health in a human in need thereof” merely indicates the result of the method but does not provide any further limit to the administration step. Thus, the active steps of the claim are merely limited as “orally administering” which is broad and routine. The step of “orally administering” does not provide a technical improvement that clearly defines a practical application of the natural products and does not distinguish the invention from any purely natural phenomenon. Thus, the process steps of claim 2 are routine and conventional in the art and do not integrate the product of nature exception into a practical application and the claim is therefore directed to the judicial exception.
Claim 8 recites an additional element beyond the natural component of fermented beta-1,3-glucan in that the component is part of a method of modulating an autoimmune response in a human in need thereof and the component is administered to the human. The process steps of administration are written at a high level of generality and do not provide any specific limitation as to how the oral administration is done or any specific dosage but a large range between 0.1 mg/kg body weight to 100 mg/kg of body weight as described above, the process of administering the components does not impart any distinct qualities or characteristics to the components. The claim preamble of a “method of modulating an immune response in a human in need thereof” merely indicates the result of the method but does not provide any further limit to the administration step. Thus, the active steps of the claim are merely limited as “administering” which is broad and routine. The step of “administering” does not provide a technical improvement that clearly defines a practical application of the natural products and does not distinguish the invention from any purely natural phenomenon. Thus, the process steps of claim 8 are routine and conventional in the art and do not integrate the product of nature exception into a practical application and the claim is therefore directed to the judicial exception.
Claim 15 recites an additional element beyond the natural component of fermented beta-1,3-glucan in that the component is part of a method of modulating inflammation in an individual in need thereof and the component is administered to the individual. The process steps of administration are written at a high level of generality and do not provide any specific limitation as to how the administration is done or any specific dosage but a large range between 0.1 mg/kg body weight to 100 mg/kg of body weight as described above, the process of administering the components does not impart any distinct qualities or characteristics to the components. The claim preamble of a “method of modulating inflammation in an individual in need thereof” merely indicates the result of the method but does not provide any further limit to the administration step. Thus, the active steps of the claim are merely limited as “administering” which is broad and routine. The step of “administering” does not provide a technical improvement that clearly defines a practical application of the natural products and does not distinguish the invention from any purely natural phenomenon. Thus, the process steps of claim 15 are routine and conventional in the art and do not integrate the product of nature exception into a practical application and the claim is therefore directed to the judicial exception.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As discussed with respect to Step 2A Prong Two, the process step of claims 2, 8, and 15 are broad and routine and readily available to one of ordinary skill in the art and do not result in an alteration of the natural components. Therefore, claims 2, 8, and 15 do not include any additional element which would amount to ‘significantly more’ than the judicial exception itself and thus the claims as a whole do not amount to significantly more than the judicial exception.
Conclusion: Claim 2 which is directed toward a process of promoting immune system health in a human in need thereof, and is focused on the oral administration of natural products, is not markedly different in structure or function as compared to the closest naturally-occurring counterpart. Subsequently, claim 2 is directed toward a judicial exception under 35 USC 101. Claims 3- and 5-7 do not recite any element which would be considered to provide ‘significantly more’ than the judicial exception.’
Claim 8 which is directed toward a process of modulating an autoimmune response in a human in need thereof, and is focused on the administration of natural products, is not markedly different in structure or function as compared to the closest naturally-occurring counterpart. Subsequently, claim 8 is directed toward a judicial exception under 35 USC 101. Claims 9-14 do not recite any element which would be considered to provide ‘significantly more’ than the judicial exception.’
Claim 15 which is directed toward a process of modulating inflammation in an individual in need thereof, and is focused on the administration of natural products, is not markedly different in structure or function as compared to the closest naturally-occurring counterpart. Subsequently, claim 15 is directed toward a judicial exception under 35 USC 101. Claims 16 and 18-20 do not recite any element which would be considered to provide ‘significantly more’ than the judicial exception.
Response to Applicant’s Arguments
Applicant continues to argue that the previously submitted copy of a Patent Trial and Appeal Board decision in U.S. Pat. Appl. No. 13,773,971, which reversed a 101 rejection, is highly relevant to the present case. Applicant states that the Board found that the previously submitted Horst declaration persuasively established that the claimed subject matter was markedly different from what is found in nature because Euglena found in nature does not grow by fermentation and has not been dried to contain less than 10% moisture and to have more than 20 wt% beta-1,3-glucan. Applicant states that the Board made it clear that it is the Examiner’s burden to show otherwise, and found that the Office did not point to any evidence of a species of Euglena having more than 20 wt% of beta-1,3-glucan as it occurs in nature. Applicant argues that the same reasoning should apply in the present case, because claim 2 recites that the composition comprises beta-1,3-glucan with no beta-1,6-glycosidic bonds, which implies that the glucan polymer is 100% comprised of beta-1,3 linkages, which far exceeds the 20% threshold that the Board has already recognized as being non-natural.
In response, Applicant’s argument seems to be based on a misunderstanding of the use of the phrase “greater than 20 weight %” in Application 13/773,971. This application issued as US Pat. No. 10,265,340, and contains the following language in claim 1:
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The language in the above claim 1 is stating that the Euglena comprises a beta-(1,3)-glucan in an amount that is greater than 20% by weight of the Euglena. Therefore, the phrase “greater than 20 weight %” is NOT referring to the percentage of 1,3-glycosidic bonds in a glucan polymer produced by Euglena, but rather to the amount of a 1,3-glucan polymer with respect to the weight of the Euglena. The Board held that the Office failed to show that Euglena which produces an amount of a 1,3-glucan polymer in an amount of greater than 20 wt% is found in nature.
The Board’s holding is NOT on point to the present case because the present claims do not recite administering Euglena itself, but rather recite administering a composition comprising a beta-1,3-glucan that is obtained from Euglena. Therefore, the question under 35 USC 101 is not whether Euglena that produces an amount of a 1,3-glucan polymer in an amount of greater than 20 wt% is found in nature (in fact no such limitation can be found in the present claims), but rather whether a 1,3-glucan polymer produced by Euglena and within the scope of the claims is found in nature. The skilled artisan would recognize that the answer to this question is “yes,” because Euglena is known to produce paramylon, which is a beta-1,3-glucan polymer, as evidenced by Feuzing et al. (Carbohydrate Polymers 288 (2022) 119181).
The Abstract of Feuzing states as follows:
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Additionally, Section 3 of Feuzing states as follows:
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Therefore, Feuzing evidences that there exists in nature a glucan polymer which comprises beta-1,3-glycosidic bonds but no beta-1,6-glycosidic bonds, such that it is within the scope of claim 2.
For the foregoing reasons, the rejection is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-3, 5-9, 11-16, and 18-20 are rejected on the ground of nonstatutory double patenting as unpatentable over claims 1-25 of U.S. Patent No. 10,912,794 and in view of Johansen et al. (US Pat. Pub. 2011/0008476; of record) where indicated below.
Johansen discloses a method of treating a condition such as inflammatory bowel disease, Crohn’s disease, or colitis (i.e., diseases related to immune health)(paragraphs 1, 75) in a human (paragraph 16), the method comprising administering a composition comprising an effective amount of beta-1,3-glucan obtained from yeast fermentation as the active (paragraphs 14-16 and claim 22 of Johansen), wherein the administration may be oral or via injection (paragraphs 17 amd 65).
Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims recite a method of treating hyperlipidemia, metabolic syndrome, inflammatory bowel disease, colitis, or Crohn’s disease in a human by oral administration of a composition comprising beta-1,3-glucan having no beta-1,6 glycosidic bonds in the form of paramylon that is purified from heterotrophically grown Euglena gracilis using fermentation, and in the amount of 0.1-100 mg/kg of body weight which is administered daily as a single dose.
Although the reference claims do not recite that the composition is administered via injection, it would have been prima facie obvious to do so in light of Johansen’s teaching that when beta-1,3-glucan is administered as an active, it may be administered via injection.
Claims 2-3, 5-9, 11-16, and 18-20 are rejected on the ground of nonstatutory double patenting as unpatentable over claims 1-19 of U.S. Patent No. 11,744,847.
Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims recite a method of alleviating intestinal inflammation (i.e., a disease related to immune health) by oral administration or injection of a composition comprising beta-1,3-glucan having no beta-1,6 glycosidic bonds in the form of paramylon that is purified from heterotrophically grown Euglena gracilis using fermentation, and in the amount of 0.1-100 mg/kg of body weight which is administered daily as a single dose. It is noted that the ‘847 method represents a species (with regards to type of disease/disorder) within the scope of the instantly claimed genus. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cor. 1993). Thus, the instant claims and the application claims are obvious variants.
Response to Applicant’s Arguments
Applicants’ request to hold a rejection in abeyance is not a proper response to a rejection [Remarks: p 6]. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Accordingly, the rejection will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejection.
Conclusion
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617
