DETAILED ACTION
Status of the Application
Claims 1-3, 5-8, 17-26 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment of claims 1 and 5, and cancellation of claim 4 as submitted in a communication filed on 8/1/2025 is acknowledged.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/1/2025 has been entered.
As indicated in a prior Office action, claim 1 has been amended so that it is no longer a generic linking claim but rather a Markush claim. Claims 7-8, 17-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/12/2023. Claims 1-3, 5-6 are at issue and will be examined only to the extent they encompass the elected invention (i.e., a method of producing a biodegradable polymer using cannabis waste as the carbon source using R. meliloti).
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
Claims 4-6 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. In view of the cancellation of claim 4, this rejection is hereby withdrawn.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
Claims 1-3, 5-6 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-3, 5-6 remain 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 for producing polyhydroxybutyrate from cannabis waste as a carbon source, wherein said method requires culturing (a) a naturally-occurring R. meliloti or C. necator or (b) a R. meliloti or C. necator cell that has a disrupted endogenous gene encoding a polyhydroxybutyrate depolymerase, does not reasonably provide enablement for a method for producing a biodegradable polymer that comprises polyhydroxybutyrate, from cannabis waste as a carbon source, wherein said method requires culturing (a) microorganisms which are (i) naturally occurring and can produce any biodegradable polymer that comprises polyhydroxybutyrate, or (ii) modified by any means to produce a biodegradable polymer comprising polyhydroxybutyrate. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
These rejections have been discussed at length in the prior Office action. They are maintained for the reasons of record and those set forth below.
Applicant argues that paragraph [21] of the specification gives the skilled person in the art all the information needed to make an use the claimed invention. Applicant states that the Examiner appears to believe that the enablement requirement would only be met with the disclosure of examples in the specification. Applicant states that US case law pre-supposes that some degree of experimentation is permitted so long as it is not undue or unreasonable. Applicant submits that the present disclosure does not lack operative embodiments or require undue experimentation. Applicant states that the present disclosure directs the skilled person in the art to a finite list of specific bacterial strains. Applicant then concludes that the subject matter recited in the claims is enabled.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejections. The Examiner acknowledges the sections of the MPEP cited by Applicant as well as the teachings of the specification and the recitation of specific strains in claim 1. However, the Examiner disagrees with Applicant’s contention that the entire scope of the claims is adequately described and enabled.
With regard to the argument that the Examiner believes that enablement would only be met by disclosing examples in the specification, it is noted that the issue is not whether examples are present or not in the specification. Instead, the issue is whether the information provided fully describes and enables the entire scope of the claims. With regard to the argument that paragraph [21] gives one of skill in the art all the information needed to make and use the invention, it is noted that this paragraph simply states that suitable microorganisms for producing biodegradable polymers include naturally occurring or engineered strains selected from of a list of microorganisms. It is reiterated herein that the while the claims require producing any type of biodegradable polymer that comprises PHB (see the preamble of claim 1), it is unknown if the “naturally-occurring” strains recited in claim 1 can produce a biodegradable polymer, let alone any biodegradable polymer that comprises PHB. Furthermore, even if one assumes that all the naturally-occurring microorganisms recited in claim 1 are able to endogenously produce a biodegradable polymer that comprises PHB, the claims also encompass recombinant E. coli, R. meliloti and P. putida strains modified by any means to produce any biodegradable polymer comprising PHB.
As previously indicated, while the specification in the instant application discloses a C. necator (also known as A. eutrophus or R. eutropha) that endogenously produces polyhydroxybutyrate and the prior art discloses a limited number of naturally occurring (e.g., R. meliloti) and recombinant microorganisms that have been transformed with known genes encoding enzymes of the polyhydroxybutyrate biosynthetic pathway which are able to produce polyhydroxybutyrate, the specification is silent with regard to (a) which of the naturally-occurring microorganisms recited in claim 1 endogenously produce biodegradable polymers that comprise polyhydroxybutyrate, and (b) the genetic mutations required in engineered strains of E. coli, R. meliloti and P. putida so that they can produce polyhydroxybutyrate.
While the argument can be made that any microorganism can be transformed with nucleic acids encoding enzymes of the polyhydroxybutyrate biosynthetic pathway so that said microorganism can produce polyhydroxybutyrate, the specification fails to disclose the structural features required in any nucleic acid encoding an enzyme associated with the synthesis of any polyhydroxybutyrate-containing biopolymer. No disclosure of a structure/function correlation has been provided which would allow one of skill in the art to recognize which genes encode enzymes associated with the biosynthesis of a polyhydroxybutyrate-containing biopolymer. While Applicant states that the present disclosure does not lack operative embodiments or require undue experimentation, it is unclear if the naturally occurring strains recited in claim 1 can endogenously produce a biopolymer that comprises polyhydroxybutyrate because the specification fails to provide that information. Therefore, without experimentation, one of skill in the art cannot reasonably conclude that all the naturally occurring microorganisms recited can endogenously produce a biopolymer as required. With regard to the recombinant strains recited in claim 1, while methods of generating or isolating nucleic acids and enzymatic assays were known in the art at the time of the invention, it was not routine in the art to screen by a trial and error process for (i) an essentially infinite number of nucleic acids to find those that encode proteins that are associated with the biosynthesis of any polyhydroxybutyrate-containing biopolymer, and (ii) an essentially infinite number of genetic modifications so that E. coli, R. meliloti or P. putida can produce the recited biopolymer. In the absence of (i) a rational and predictable scheme for selecting those proteins and genetic modifications most likely to yield the desired functional effect, and/or (ii) a correlation between structure and activity, one of skill in the art would have to test an essentially infinite number of nucleic acids, proteins and modifications to determine which ones have the desired functional characteristics. This is not deemed routine experimentation. Therefore, for the reasons of record and those set forth above, one cannot reasonably conclude that the entire scope of the claims is adequately described and enabled by the teachings of the specification and/or the prior art.
Claim Rejections - 35 USC § 103 (AIA )
Claim 1 remains rejected under 35 U.S.C. 103 as being unpatentable over Sandhya et al. (Int. J. Environ. Sci. Technol. 10:47-54, 2013) in view of Kuglarz et al. (Bioresource Technology 163:236-243, 2014).
Claims 2-3 remain rejected under 35 U.S.C. 103 as being unpatentable over Sandhya et al. (Int. J. Environ. Sci. Technol. 10:47-54, 2013) in view of Kuglarz et al. (Bioresource Technology 163:236-243, 2014), Ienczak et al. (J. Ind. Microbiol. Biotechnol. 40:275-286, 2013), Mohammadi et al. (Environmental Engineering Science 29(8):783-789, 2012) and further in view of Choi et al. (Biotechnology and Bioengineering 62(5):546-552, 1999).
Claims 1-3, 5-6 remain rejected under 35 U.S.C. 103 as being unpatentable over Devi et al. (Biocatalysis and Agricultural Biotechnology 1:80-84, 2012) in view of Kuglarz et al. (Bioresource Technology 163:236-243, 2014), Ienczak et al. (J. Ind. Microbiol. Biotechnol. 40:275-286, 2013), Mohammadi et al. (Environmental Engineering Science 29(8):783-789, 2012), Choi et al. (Biotechnology and Bioengineering 62(5):546-552, 1999), and further in view of Trainer et al. (BMC Microbiology 10:92, pages 1-10, 2010) as evidenced by Tombolini et al. (Microbiology 141:2553-2559, 1995).
These rejections have been discussed at length in prior Office actions. They are maintained for the reasons of record and those set forth below.
Applicant argues that in addition to the reasons provided in previous responses, the combination of the cited prior art references does not teach or suggest heating the cannabis waste in a mineral acid solution for at least 25 minutes at a temperature of at least 121 °C to produce an aqueous mixture comprising mineral acid and cannabis. Applicant states that Sandya et al., Kuglarz et al., Devi et al., and Mohammadi et al. fail to teach a combination of heating for at least 25 minutes at a temperature of at least 121 °C, and asserts that Ienczak et al., Choi et al., Trainer et al. and Tombolini et al. are silent on any steps required to treat a feedstock. Applicant states that the cited prior art teaches or suggests either (a) high temperature for short duration, or (b) low temperature for long duration. Applicant states that the recited conditions are outside of what is recited in the prior art and that 5 minutes can make all the difference. Applicant states that Kuglarz et al. actually teaches steam treating the mixture at 180 °C for 10 minutes and that 5 is 50% of 10 minutes. Applicant states that the cited prior art is not relevant to the processing of cannabis feedstocks. Applicant cites a post-filing reference by Khattab et al. (Bioprocess and Biosystems Engineering 42:1115-1127, 2019; cited in the IDS) in support of the argument that the state of the art taught away form processing hemp waste, and that the chemical composition of hemp fibers is different from other agriculture biomasses. Applicant states that it would be improper to apply the teachings that may be applicable to other agriculture biomasses or assume that such teachings would apply to cannabis waste.
Applicant also argues that the cited prior art references does not teach or suggest mixing the filtrate with a mineral salt medium in a ratio of between 1:1 and 1:2 by volume to produce a production medium. Applicant states that Sandya et al., Kuglarz et al., Devi et al., Ienczak et al., and Tombolini et al. do not teach or suggest the sequential order of claim 1 and do not teach the mixing of a mineral salt medium with a filtrate. Applicant submits that Mohammadi et al., Choi et al., and Trainer et al. appear to be silent on the use of mineral salt media. Applicant points out that counterpart applications in Australia, Brazil, India, Israel, Japan, and South Korea have all proceeded to grant.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejections. The Examiner acknowledges the teachings of the cited prior art as well as the teachings of Khattab et al. However, the Examiner disagrees with Applicant’s contention that the claimed invention is not obvious over the references of record.
With regard to the argument that Sandya et al., Kuglarz et al., Devi et al., and Mohammadi et al. fail to teach a combination of heating for at least 25 minutes at a temperature of at least 121 °C, it is reiterated herein that Kuglarz et al. teach exposing chopped hemp to a sulfuric acid solution (mineral acid solution) to create a mixture which was then exposed to steam at 140 °C or 180 °C for 20 minutes. The only difference between the method of Kuglarz et al. and that of the claims is a mere 5 minutes. As previously indicated above and in prior Office actions, as set forth in MPEP § 2144.05, a prima facie case of obviousness exist where the claimed ranges or amounts do not overlap with the prior art but are merely close. Therefore, it is not believed that MPEP § 2144.05 does not contemplate optimization outside of what is disclosed in the prior art, particularly because the prior art in In re Aller disclosed a temperature of 100 °C and an acid concentration of 10% and the courts found that a temperature between 40-80 °C and an acid concentration between 25% and 70% was obvious. As stated in MPEP § 2144.05 “In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)”.
It is reiterated herein that a difference of 5 minutes between what is required by the claims and the teachings of the prior art is very small. As previously stated, Kuglarz et al. teach that the higher the heating temperature, the least amount of heating time required (page 237, right column, lines 1-5), thus suggesting that one could vary the temperature and heating time and obtain the same result. One of skill in the art would reasonably conclude based on the teachings of Kuglarz that if uses a temperature which is less than 140 °C, the heating time would be greater than 20 minutes. Therefore, it is considered that the heating times of Kuglarz et al. can be readily modified by routine experimentation. It is well settled that routine optimization is not patentable even if it results in significant improvement of the prior art. See MPEP § 2144.05 (II). While Applicant argues that 5 minutes can make all the difference, it is noted that the specification has not provided any evidence to show that 5 minutes can make all the difference, and there is no evidence on the record that shows the criticality of these 5 minutes in the claimed process.
With regard to the argument that the teachings of Khattab et al. are evidence to show that the prior art taught away from processing hemp waste and that the chemical composition of hemp fibers is different from other agriculture biomasses, it is noted that the teachings of Kuglarz et al. are evidence to show that cannabis waste as a carbon source has been previously used in the art. Moreover, the teachings of Kuglarz et al. show why one of skill in the art would have been highly motivated to replace the hydrolyzed straw of Sandhya et al. with the hemp (cannabis) hydrolysate of Kuglarz et al., namely the high level of glucose present in hemp biomass. Therefore, contrary to Applicant’s assertions, the teachings of Khattab et al. regarding the nature of hemp waste is not evidence which would have deterred one of skill in the art to use hemp waste as a carbon source.
With regard to the argument that Sandya et al., Kuglarz et al., Devi et al., Ienczak et al., and Tombolini et al. do not teach or suggest the sequential order of claim 1 and do not teach the mixing of a mineral salt medium with a filtrate, it is reiterated herein that Sandya et al. teach making a culture medium that is a modified mineral salt media that comprises the hydrolyzed straw (page 49, left column, Bacterial growth in defined media). In order to obtain their media, they had to mix the hydrolyzed straw and the mineral salt media to obtain their modified mineral salt media. Moreover, to obtain their modified mineral salt media, Sandya et al. had to start their method by first making the hydrolyzed straw. Similarly, Devi et al. teach making a PP medium which was the inoculum medium further comprising the fresh rice bran hydrolysate (RBH), wherein the inoculum medium was a mineral containing medium (page 81, left column, Materials and methods). Therefore, contrary to Applicant’s assertions, Sandya et al. and Devi et al. teach a sequence of steps where the hydrolyzed waste was first made, followed by mixing the hydrolyzed waste with a mineral salt containing medium to produce a production medium. Applicant is reminded that the instant rejections are obviousness rejections. In the instant case, it is the combination of the teachings of Sandya et al. and Kuglarz et al., or the combination of the teachings of Devi et al. and Kuglarz et al., that result in a sequence of steps that include producing a hydrolysate obtained from cannabis waste that include processing the cannabis waste by mechanic disruption, heating the cannabis waste in a mineral acid solution, cooling, filtering and neutralizing the pH of the solution that contains the cannabis waste to produce a filtrate, and mixing said filtrate with a mineral salt medium.
It is reiterated herein that the only difference between the method of Kuglarz et al. to deconstruct biomass and that of the claims is five additional minutes of heating. As previously indicated, Kuglarz et al. teach exposing chopped hemp to a sulfuric acid solution (mineral acid solution) to create a mixture which was then exposed to steam at 140 °C or 180 °C for 20 minutes. As previously indicated above and repeatedly stated in prior Office actions, as set forth in MPEP § 2144.05, a prima facie case of obviousness exist where the claimed ranges or amounts do not overlap with the prior art but are merely close. It is reiterated herein that a difference of 5 minutes between what is required by the claims and the teachings of the prior art is very small. There is absolutely no evidence teaching or suggesting the criticality of these 5 minutes. More importantly, the teachings of Kuglarz et al. disclose that the higher the heating temperature, the least amount of heating time required (page 237, right column, lines 1-5). Therefore, the teachings of Kuglarz et al. clearly suggest that one could readily adjust the temperature and heating time via routine experimentation. It is well settled that routine optimization is not patentable.
With regard to the argument that counterpart applications in Australia, Brazil, India, Israel, Japan, and South Korea have all proceeded to grant, this is deemed irrelevant to the prosecution of the instant application, which is being examined by the United States Patent and Tradermark Office following US patent law and regulations.
Conclusion
No claim is in condition for allowance.
Applicant is advised that any Internet email communication by the Examiner has to be authorized by Applicant in written form. See MPEP § 502.03 (II). Without a written authorization by Applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Sample written authorization language can be found in MPEP § 502.03 (II). An Authorization for Internet Communications in a Patent Application or Request to Withdraw Authorization for Internet Communications form (SB/439) can be found at https://www.uspto.gov/patent/forms/ forms-patent-applications-filed-or-after-september-16-2012, which can be electronically filed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DELIA M RAMIREZ, Ph.D., whose telephone number is (571) 272-0938. The examiner can normally be reached on Monday-Friday from 8:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B. Mondesi, can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/DELIA M RAMIREZ/Primary Examiner, Art Unit 1652
DR
November 26, 2025