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 .
DETAILED ACTION
Information Disclosure Statement
The information disclosure statements (IDS) filed on 06/16/2026 and 08/13/2026 have been considered here.
Status of Claims
The arguments filed on 06/16/2026 are acknowledged and have been fully considered. Claims 14-32 are now pending. Claims 1-13 are canceled; claims 16-17 and 21-23 are withdrawn.
Claims 14-15, 18-20, and 24-32 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112: Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14-15, 18-20, 24-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating Alzheimer’s disease in a subject, the method comprising: administering to the subject a composition comprising at least one bacterioruberin, does not reasonably provide enablement for a method for treating and preventing any and all diseases involving deregulation in protein aggregation in any and all subjects, wherein the disease is a neurodegenerative disease selected from those listed in claims 14 and 29 using any and all methods of administration. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The enablement requirement is considered based on the following eight Wands factors (MPEP 21.64.01(a)): (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims: The scope of the instant claims are broad and read on types of bacterioruberin and all routes of administration.
The nature of the invention: The claim invention is directed to a method of treating or preventing a neurodegenerative disease through the administration of at least one bacterioruberin.
The state of the prior art and The level of predictability in the art: As taught in Ram Shristi (2020; as submitted on IDS of 06/14/2023), it is known that singlet O2 species and free radicals are accountable for a wide spectrum of conditions such as Alzheimer’s and dementia (see paragraph bridging pages 7-8). It is taught that carotenoids, such as bacterioruberin (see page 3, 6. Carotenoid production from bacteria: its scope and significance), are known as antioxidants and evading the damaging effects of oxidative stress (see paragraph bridging pages 7-8). There is no support in the instant specification that all delivery routes/types will result in the same outcome with absolute predictability, as a result one of ordinary skill in the art would have to result to trial-and-error experimentation in order to practice the invention commensurate in scope with the claims. Based on all the data presented in the references above, the Examiner deems the art as highly unpredictable since it is unknown if any and all bacterioruberin will treat or prevent any and all types of neurodegenerative diseases as listed in the instant claims via any and all types/routes of administration.
The amount of direction provided and The existence of working examples: There is no evidence in the specification that the instant invention is capable of working or used with any and all of types of administration with any and all types of bacterioruberin to prevent any and all of the neurodegenerative diseases as listed in the claims. There is no mention or examples using different bacterioruberins, other than a mixture of alpha-bacterioruberin, monoglycosylated bacterioruberin, and diglycosylated bacterioruberin, showing that the bacterioruberin is able to treat or prevent all of the listed neurodegenerative diseases, except for Alzheimer’s disease. The only guidance and working example provided by the inventor comprises alpha-bacterioruberin, monoglycosylated bacterioruberin, and diglycosylated bacterioruberin being administered to cells that mimic Alzheimer’s disease while monitoring neural network integrity and hyperphosphorylation of tau protein, which are used as indications of Alzheimer’s disease (see Example III in the instant specification as filed).
The quantity of experimentation needed to make or use the invention: Given the breadth of the claims and the data presented above, one of ordinary skill would have to undertake a burdensome amount of research to show how each and every bacterioruberin would achieve the same functions when administered via each and every route of administration to different subjects for treating and preventing the claimed neurodegenerative diseases. It is not clear what specific embodiments would be required in order for one of ordinary skill in the art to practice the instant invention commensurate in scope with the claims.
The level of one of ordinary skill: The level of one of ordinary skill is high, i.e. advanced education and training.
Response to Arguments
Applicant's arguments filed 06/16/2026 have been fully considered but they are not persuasive.
In regards to applicant’s arguments and declaration, it is first noted that the declaration of Isabelle Benoit is appreciated. While the data presented in the declaration and arguments is helpful in showing that the composition of the instant claims is enable for the treatment of Alzheimer’s disease, it is not enough to establish that the bacterioruberin is able to prevent all of the neurodegenerative diseases in the claims. There is no showing of that the bacterioruberin prevent the diseases in a susceptible subject. Further it is not established how the diseases are predicted to be in a subject in order to be prevented. In another way, if the bacterioruberin is administered to a healthy subject (that may or may not get the disease), how can it be said that the disease has been prevented from occurring (when it might not occurred at all). As such, the data presented is not enough to establish that the specification is enabled for the prevention of all the diseases listed in claim 14 through any and all routes of administration to a subject in need thereof.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 14-15, 18-20, and 24-32 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20130337068 A1 (Petyaev, 2012) in view of Silva et al. (2019) and Ram Shristi (2020; as submitted on IDS of 06/14/2023).
In regard to claims 14, 19, 25-27, 29 and 32, Petyaev teaches an orally administered tablet or capsule composition (see Petyaev, paragraphs 0100-0102) comprising a carotenoid, such as bacterioruberin (see Petyaev, paragraph 0015), for treating Alzheimer’s disease (see Petyaev, paragraph 0120-0122). The composition is taught to be a food additive or dietary supplement (i.e., a food supplement) (see Petyaev, paragraph 0055).
In regard to claim 28, it is taught that the carotenoid compound is used in an amount from 1 to 10 mg in the composition (see Petyaev, paragraph 0027). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Petyaev is silent on the use of a mixture of monoglycosylated and diglycosylated bacterioruberin.
In regard to claims 14-15, 18, 20, 29-31, Silva teaches that bacterioruberin monoglucoside and bacterioruberin diglucoside (i.e., monoglycosylated and diglycosylated bacterioruberin) were present in an extracted mixture from A. agilis (see Silva, page 421, Carotenoid Identification; Table 4) with high antioxidant activity (see Silva, page 424; Antioxidant Capacity).
In regard to claim 24, while Silva does not teach that the composition is essentially free of non-glycosylated forms of bacterioruberin, it is taught that the monoglucoside and diglucoside bacterioruberin have different properties, such as phototoxicity, solubility, and bioavailability than the non-glucoside bacterioruberin (see Silva, paragraph bridging pages 426-427). As such, it is noted as these properties of the compounds are variables that can be modified, among others, by adjusting amount of non-glycosylated bacterioruberin and glycosylated bacterioruberin, the properties changing as amount of non-glycosylated bacterioruberin is changed, the amount of non-glycosylated bacterioruberin would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed amount of non-glycosylated bacterioruberin cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, amount of non-glycosylated bacterioruberin in Silva to obtain the desired balance between the properties as taught by Silva (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
In regards to claims 14-15, 18-20, and 24-32, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Petyaev and Silva as it is known that singlet O2 species and free radicals are accountable for a wide spectrum of conditions such as Alzheimer’s and dementia (see Ram Shristi, paragraph bridging pages 7-8) and that carotenoids, such as bacterioruberin (see page 3, 6. Carotenoid production from bacteria: its scope and significance), are known as antioxidants and evading the damaging effects of oxidative stress (see Ram Shristi, paragraph bridging pages 7-8). As the monoglucoside and diglucoside bacterioruberin mixture is known to have antioxidant properties, it would be within the purview of one with ordinary skill in the art to use the teachings of Petyaev and Silva to formulate a composition for treating Alzheimer’s disease using known antioxidants. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One with ordinary skill in the art would be motivated to combine the glycosylated bacterioruberins of Silva and the teachings of Ram Shristi with the composition of Petyaev according to the known method of treating Alzheimer’s disease using bacterioruberin (see Petyaev, paragraphs 0015 and 120-122) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Response to Arguments
Applicant's arguments filed 06/16/2026 have been fully considered but they are not persuasive.
In regards to applicant’s arguments that the art of record does not teach that the bacterioruberins possess a chaperone-like protein-stabilizing interaction that would mitigate protein denaturation/aggregation and the rejection is rooted in carotenoids as antioxidants/dietary supplement components for Alzheimer’s disease, however it is pointed out that as the combination of teachings of Petyaev, Silva, and Ram Shrista would yield an identical composition used for treating Alzheimer’s disease as instantly claimed, the properties, such as the chaperone-like protein stabilizing interaction, of the composition would be the same. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art teaches an identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Further, the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the instant case, one with ordinary skill in the art would understand that the bacterioruberins of Petyaev, Silva, and Ram Shrista would behave in a way that is identical to the instantly claimed invention, even if it is not necessarily taught in the art. Applicant also notes that Silva does not teach using bacterioruberins to treat Alzheimer’s disease, however the rejection is made in view of all the references together. Silva teaches that bacterioruberin monoglucoside and bacterioruberin diglucoside (i.e., monoglycosylated and diglycosylated bacterioruberin) were present in an extracted mixture from A. agilis (see Silva, page 421, Carotenoid Identification; Table 4) with high antioxidant activity (see Silva, page 424; Antioxidant Capacity). Ram Shristi teaches that singlet O2 species and free radicals are accountable for a wide spectrum of conditions such as Alzheimer’s and dementia (see Ram Shristi, paragraph bridging pages 7-8) and that carotenoids, such as bacterioruberin (see page 3, 6. Carotenoid production from bacteria: its scope and significance), are known as antioxidants and evading the damaging effects of oxidative stress (see Ram Shristi, paragraph bridging pages 7-8). As the monoglucoside and diglucoside bacterioruberin mixture is known to have antioxidant properties, it would be within the purview of one with ordinary skill in the art to use the teachings of Petyaev and Silva to formulate a composition for treating Alzheimer’s disease using known antioxidants.
Further, applicant argues that Petyaev teaches that the bacterioruberins are taught as delivery vehicles and not the active, there is nothing in the claims that limits the use of bacterioruberins to not be a delivery vehicle. The only requirement of the claim is that the composition that is administered to a subject comprises bacterioruberin, which is taught in the cited art.
Applicant argues that, in respect to claim 24, the non-glycosylated forms of the bacterioruberin are taught to be most favorable in terms of phototoxicity and as such the routine optimization argument is an impermissible extrapolation, it is pointed out that the teachings of Silva are drawn towards sunscreen usage (i.e., topical) but evaluation for oral administration (i.e., feed or food supplement) is taught to have not been performed yet (see Silva, page 427, column 2, second paragraph) and as such, it would be within the purview of one with ordinary skill in the art to undergo routine experimentation to optimize the amounts of the monoglucoside and diglucoside for their different properties, such as phototoxicity, solubility, and bioavailability than the non-glucoside bacterioruberin.
In regard to applicant’s presentation of data, applicant is reminded that whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In the instant case, the data presented does not show exactly which bacterioruberins are used, rather just teaches the extract (SBE) in an specific amount. Further, the claims teach a composition comprising bacterioruberin broadly without an amount which is not enough to establish unexpected results as the data is not commensurate with the scope of the data. For example would one molecule of bacterioruberin be enough to show the alleged unexpected results for the treatment of Alzheimer’s disease? Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e). See In re Blondel, 499 F.2d 1311, 1317, 182 USPQ 294, 298 (CCPA 1974) and In re Fouche, 439 F.2d 1237, 1241-42, 169 USPQ 429, 433 (CCPA 1971) for examples of cases where indirect comparative testing was found sufficient to rebut a prima facie case of obviousness.
As such the claims remain rejected.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 14-15, 18-20, and 24-32 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-18, 21, 24, and 28-33 of copending Application No. 18257526 (reference application) in view of Ram Shristi (2020; as submitted on IDS of 06/14/2023).
The reference application teaches a composition comprising at least one glycosylated bacterioruberin, selected from monoglycosylated and diglycosylated bacterioruberin among others, in a therapeutic or food supplement composition (see reference claim 1). Reference claims 17-18, 24, and 28 further narrow the amount and type of glycosylated bacterioruberin. Reference claim 21 specifies that there is no non-glycosylated bacterioruberin in the composition. Claims 29-33 are drawn to a method of preventing oxidative stress by administering at least one glycosylated bacterioruberin.
The reference application is silent on treating a neurodegenerative disease such as Alzheimer’s disease.
The teachings of Ram Shristi have been described supra.
In regards to claims 14-15, 18-20, and 24-32, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of the reference application and Ram Shristi as it is known that bacterioruberins have antioxidative capabilities and are used to treat Alzheimer’s disease (see Ram Shristi, paragraph bridging pages 7-8; page 3, 6. Carotenoid production from bacteria: its scope and significance). It would be obvious to one with ordinary skill in the art to combine the teachings of the reference application with the teachings of Ram Shristi according to the known method of preventing oxidative stress as taught by the references to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 06/16/2026 have been fully considered but they are not persuasive.
As the arguments presented against the prior art have been rebutted above, the double patenting rejections are maintained.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYAAN A ALAM whose telephone number is (571)270-1213. The examiner can normally be reached M-F 8-5 EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
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