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 remarks as submitted in a communication filed on 4/1/2026 is acknowledged.
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 Claims 7-8, 17-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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(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 prior Office actions. They are maintained for the reasons of record and those set forth below.
Applicant argues that the claim language is definite and gives a skilled person sufficient guidance on what the claimed invention is. Applicant states that the Examiner’s views under this section are extraordinary when compared to the views in other jurisdictions. Applicant states that the Examiner has taken an unnecessary narrow and/or erroneous interpretation of the guidance in MPEP.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejections. The Examiner agrees with Applicant’s contention that the claim language is definite and that one of skill in the art would understand the scope of the claims. However, the issue in the instant case is the fact that the scope of the claims is not adequately described and enabled as currently presented.
With regard to the argument that the Examiner’s views under this section are extraordinary when compared to the views in other jurisdictions and that the Examiner has taken an unnecessary narrow and/or erroneous interpretation of the guidance in MPEP, Applicant is reminded that the examination of the instant application is being conducted under the laws and regulations of the United States of America. Contrary to Applicant’s assertions, the Examiner has not taken an unnecessary narrow and/or erroneous interpretation of the claims. As set forth in MPEP § 2111, the claims must be given their broadest reasonable interpretation in light of the specification. The claims as currently presented are directed to a method of producing a genus of biodegradable polymers comprising polyhydroxybutyrate using cannabis waste as a carbon source, wherein said method required culturing several naturally occurring microorganisms as well as recombinant microorganisms, namely E. coli, R. meliloti and P. putida. Applicant’s attention is directed to claim 1 that specifically requires in the preamble producing any biodegradable polymer that comprises culturing any one of the naturally occurring microorganisms recited in step (e) as well as a recombinant E. coli, a recombinant R. meliloti, and a recombinant P. putida as recited in step (e). Therefore, contrary to Applicant’s assertions, the Examiner has not interpreted the claims erroneously. It is abundantly clear that the claimed method is a method to make any biodegradable polymer that comprises polyhydroxybutyrate, including one that solely consists of polyhydroxybutyrate, wherein the method requires culturing the naturally occurring microorganisms as recited in step (e) of claim 1 as well as a recombinant E. coli, a recombinant R. meliloti and a recombinant P. putida.
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 (see step (e) of claim 1).
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.
Even if the argument is 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. 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 states that (i) Sandhya et al., Devi et al, and Kuglarz et al. using different feedstocks/biomass, (ii) Sandhya et al. teach different solvents without enzymatic degradation, Devi et al. uses only enzymatic degradation, Kuglarz et al. teach using both enzymatic and solvent degradation, (iii) Kuglarz et al. teach 10 minutes of pre-treatment, Sandhya et al. cites Chen 1984 and Chen 1985 as teaching seconds to up to 4 hours, and Devi et al. teach 30 minutes of pre-treatment, and (iv) the proposed temperature ranges in Sandhya et al., Devi et al, and Kuglarz et al. from 50 °C to 250 °C.
The Examiner acknowledges the teachings of the cited prior art. It is noted, however, that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that it is unknown if the combination of Kuglarz et al. and Devi et al. teach or suggest pretreat at 50 °C to 80 °C or 180 °C, use solvents or not and in what percentage, or pretreat for 30 minutes or 10 minutes. Applicant submits that it is unknown if the combination of Kuglarz et al. and Sandhya et al. teach or suggest pretreat at 70 °C to 250 °C or 180 °C, use solvents in high concentrations or only one in a much lower concentration, or use enzymatic degradation or not, and which enzymes. Applicant states that the claims are patentable because Applicant found a solution to process a relatively un-studied biomass in spite of confusing combinations of teachings.
With regard to the argument that is unknown if (a) the combination of Kuglarz et al. and Devi et al. teach or suggest pretreat at 50 °C to 80 °C or 180 °C, use solvents or not and in what percentage, or pretreat for 30 minutes or 10 minutes., and (b) the combination of Kuglarz et al. and Sandhya et al. teach or suggest pretreat at 70 °C to 250 °C or 180 °C, use solvents in high concentrations or only one in a much lower concentration, or use enzymatic degradation or not, and which enzymes, 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. Therefore arguments regarding unknown temperature ranges, use of solvents, enzymatic degradation, and identity of enzymes are completely irrelevant. 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. 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 et al. 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). As previously indicated, there is no evidence on the record or the specification that shows the criticality of these 5 minutes in the claimed process.
Applicant states that the sugar extraction process is only one of a series of steps in the multiphase procedure required to make Applicant’s plastic from cannabis waste. Applicant disagrees with the position that inventing an entirely new pretreatment step when using a unique biomass is not required for the entire process to be novel. Applicant refers to the Slater declaration and the Galega declaration previously presented and submits that the views in those declarations support the argument that the pretreatment process is efficient and streamlined and that the use of cannabis waste has not been done before. Applicant states that in the absence of expert declarations by the Examiner to rebut Applicant’s claims, the applicable threshold related to patentability has been met. Applicant is of the opinion that hindsight has been adopted by the Examiner when examining this application. Applicant states that the Examiner’s interpretation of the law on inventiveness in the United States is narrow and wrong.
With regard to the argument that the in the absence of expert declarations by the Examiner and taking into consideration the Slater and Galega declarations previously presented, the applicable threshold related to patentability has been met, it is reiterated herein that these declarations were fully considered as indicated in the Non Final action of 6/10/2024 and not found persuasive to overcome the instant rejection. The Examiner previously acknowledged the findings in the Galega affidavit with regard to the physical characteristics found in the biopolymer tested. However, the method as claimed is directed to the production of any biodegradable polymer comprising PHB, or any polyhydroxybutyrate. The claims do not require a particular structure or properties for the recited biodegradable polyhydroxyalkanoate polymer or polyhydroxybutyrate. As such, the Galega affidavit does not address the issue in the instant case, which is whether one of skill in the art would have reasonably expected the production of PHB by culturing the cells of Sandhya et al. or Devi et al. in a medium that comprises the glucose-rich hemp hydrolysate of Kuglarz et al. The Examiner also acknowledged the findings in the Slater affidavit regarding the advantages of using cannabis waste as a feedstock. However, it is reiterated herein that the prior art, as evidenced by Kuglarz et al., already discloses at least one advantage of using cannabis waste as a viable carbon source, namely the high glucose content of such waste. Therefore, taking into consideration the Slater and Galega declarations previously presented, the applicable threshold related to patentability has not been met.
With regard to the argument that that hindsight has been adopted by the Examiner when examining this application and that the Examiner’s interpretation of the law on inventiveness in the United States is narrow and wrong, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Furthermore, as previously indicated the claims have been interpreted in accordance with MPEP § 2111 and the obviousness rejection has been applied in accordance with MPEP § 2141. Therefore, it is not believed that the Examiner’s interpretation of the law on inventiveness in the United States is narrow and wrong,
Applicant argues that pretreatment is a costly and complicated process, one heavily influenced by the specific type of biomass selected citing specific teachings from Mosier 2025, Amin 2017, Okolie 2021, and Sjulander 2022. Applicant refers to Bakili 2025 in support of the argument that this publication teaches away from Applicant’s claimed temperature range. Applicant states that the task is not solely generating high sugar yields but also the potential of creating inhibitory byproducts such as furfural, citing specific teachings from Jonsson 2016, Guo 2022, and Jilani 2023. Applicant states that Kuglarz et al. acknowledged the risk of toxic byproducts such as formic acid and furfural which are detrimental to bacteria. Applicant states that pretreatment and the decision making processes associated with it still host many scientific uncertainties and dangers, citing specific teachings of Amin 2017, Kim 2018, Jonsonn 2016, Du 2022 and Sjulander 2022. Applicant states that Kuglarz et al. are not people reasonably skilled in the art of making biopolymers from cannabis waste. Applicant contends that the art relevant to the instant discussion is using cannabis as a carbon source to produce biodegradable plastic or more broadly, using plant biomass as a carbon source to produce biodegradable plastic.
The Examiner acknowledges the teachings of Mosier 2025, Amin 2017, Okolie 2021, Sjulander 2022, Bakili 2025, Jonsson 2016, Guo 2022, Kim 2018, Du 2022 , and Jilani 2023. However, it is noted that Kuglarz et al. teach cannabis waste and a treatment of said waste so that it can be used as a carbon source. With regard to the argument that Kuglarz et al. are not people reasonably skilled in the art of making biopolymers from cannabis waste, and that the art relevant to the instant discussion is using cannabis as a carbon source to produce biodegradable plastic or more broadly, using plant biomass as a carbon source to produce biodegradable plastic, it is noted that the instant rejection is not an anticipation rejection. It is the combination of references that render the claimed invention obvious. Applicant is reminded that the teachings of Kuglarz et al. were introduced to show that the treatment of cannabis waste to produce a hydrolysate that could be used as a carbon source for microbial fermentation was known in the art. The teachings of Devi et al. and Sandhya et al. were introduced to show the use of industrial waste as carbon source for the microbial production of PHA/PHB. As such, one of skill in the art would understand that Kuglarz et al. is not being cited as disclosing the production of a biodegradable plastic.
Applicant states that the claimed invention does not use enzymatic hydrolysis or steam explosion at the temperatures taught by Pan 2025. Applicant also states that Le Troedec 2008 teaches five different methods for treating dried bundles of hemp, which is different from Applicant’s claims. Applicant refers to the teachings of Kreuger 2011 in support of the argument that the claimed invention does not teach enzymatic pretreatment of hemp biomass and that creating fuel from hemp is different from creating plastic from hemp. Applicant states that producing biofuels and biopolymers are different arts. Applicant cites the teachings of Stevulova 2014 in support of the argument that the prior art teaches using hemp in the creation of plastic and other construction materials and that with the benefit of Kuglarz et al., Devi et al. and Sandhya et al., experts did not anticipate using cannabis biomass as a carbon source to create biodegradable plastic.
The Examiner acknowledges the teachings of Pan 2025, Le Troedec 2008, Kreuger 2011 and Stevulova 2014. However, it is noted that these references are irrelevant to the instant discussion because (a) Kuglarz et al. teach (i) a pre-treatment of cannabis waste which does not require enzymatic hydrolysis or steam explosion, and (ii) the use of cannabis waste as a carbon source for microbial fermentations, and (b) the use of cannabis waste to make PHB was found obvious in view of the combined references previously cited. Applicant is again reminded that the instant rejection is an obviousness rejection that results from the combination of the teachings of the prior art. As such, experts did not have to anticipate using cannabis biomass as a carbon source to create a biodegradable plastic.
With regard to the argument that producing biofuels and biopolymers are different arts, it has been held that a prior art reference must either be in the field of the inventor' s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the reference by Kuglarz et al. relates to a process for the treatment of cannabis waste to produce a hydrolysate that can be used as a carbon source for microbial fermentation. The instant application also relates to a process where cannabis waste is treated so that it can be used as a carbon source for microbial fermentation. While it is agreed that the product being made from the microbial fermentation of Kuglarz et al. is not a biodegradable polymer, both the biodegradable polymer and bioethanol are made by microbial fermentations. Therefore, it is believed that the reference by Kuglarz et al. is in the field of Applicant’s endeavor.
Applicant refers to the teachings of Li 2015 in support of the argument that a pretreatment process has been used to obtain furfural while Kuglarz 2015 teaches producing bioethanol from hemp using a different pretreatment process. Applicant cites the teachings Amin 2017, Baruah 2018 and Choi 2019 in support of the argument that the art teaches away from commercial scale use of techniques used by Applicant. Applicant states that it is possible that Kuglarz et al. findings were erroneous with regard to low furfural production based on all the evidence about conditions under which furfural is created most effectively. Applicant states that if Kuglarz et al. are incorrect, they cannot be credibly relied upon to anticipate Applicant’s claims.
The examiner acknowledges the teachings of Li 2015, Amin 2017, Baruah 2018 and Choi 2019. However, it is noted that while the production of a byproduct such as furfural has been disclosed in the prior art, none of these cited references show the production of a toxic byproduct in a method for treating cannabis waste to obtain a carbon-containing hydrolysate, such as the method of Kuglarz et al. As taught by Kuglarz et al., their pretreatment method show negligible concentrations of furfural and HMF, which are known to be toxic to microorganisms (page 239, right column, second full paragraph). While Applicant states that is possible that Kuglarz et al. findings were erroneous with regard to low furfural production based on all the evidence about conditions under which furfural is created most effectively, it is reiterated herein that none of the cited references relate to cannabis waste treated using the method of Kuglarz et al. Therefore, in the absence of evidence directly contradicting the specific results found by Kuglarz et al. through experiments carried out under the same conditions as those of Kuglarz et al., it is unclear as to how one could reasonably conclude that the findings of Kuglarz et al. regarding negligible amounts of furfural and HF are erroneous.
Applicant cites Okolie 2021 to indicate that this reference teaches making biopolymers from furfural and HMF. Applicant cites the teachings of Dulie 2021 to indicate that this reference teaches the production of furfural using sugarcane trash with a technique similar to that of Kuglarz et al. Applicant refers to the teachings of Du 2022 to indicate that they pretreated corn stover using conditions to minimize the production of toxins during pretreatment. Applicant refers to the teachings of Bakili 2025 indicating that this reference teachings various methods which are materially different from Applicant’s teachings and that they teach that enzymatic hydrolysis is another key technique used in furfural production, which is a process not used by Applicant.
The Examiner acknowledges the teachings of post filing references Okolie 2021, Dulie 2021, Du 2022 and Bakili 2025. However, it is noted that none of these references refer to the use of cannabis waste as a carbon source, let alone the formation of toxic compounds such as furfural in a method such as the method of Kuglarz et al., who teaches a method to treat cannabis waste to so that it can be used as a carbon source where negligible concentrations of furfural and HMF were found.
Applicant states that no Examiner in other jurisdictions have found conclusive evidence that any person of ordinary skill in the art thought of making biodegradable plastic using cannabis waste. Applicant states that a number of publications on pretreating biomass which were released after the filing of the instant application do not disclose making biodegradable plastic from cannabis waste.
With regard to the argument that no Examiner in other jurisdictions have found conclusive evidence that any person of ordinary skill in the art thought of making biodegradable plastic using cannabis waste and that there are several post filing publications on pretreating biomass that do not disclose making biodegradable plastic from cannabis waste, it is noted that this argument is irrelevant to the instant discussion because the instant claims have been found unpatentable as being obvious over specific references by the United States Patent and Trademark Office following US patent law and regulations. It should also be noted that it would be improper for the Examiner to comment on the prosecution of another application, let alone the prosecution of an application in a foreign patent Office.
Applicant states that the Examiner is incorrect in stating that Applicant cited the teachings of Khattab et al. in support of the argument that the state of the art taught away from processing hemp waste, and that the teachings of Khattab et al. would not have deterred one of skill in the art from using cannabis as a carbon source. Applicant states that, to the contrary, Applicant is alleging that Khattab et al. teaches the art of using cannabis waste as a carbon source for making PHA. Applicant states the post filing reference by Khattab et al. did not combine the references cited by the Examiner when given the opportunity. As such, Applicant is of the opinion that the rejection is based on a hypothetical. Applicant states that they cited Khattab et al. to show that the authors published because they thought their work was novel enough to research and publish. Applicant requests the Examiner to take an unequivocal possition on/ declaration about whether or not (i) Khattab and Dahman are individuals reasonably skill in the art of making PHAs, (ii) a work authored by Khattab & Dahman was published in 2019, (iii) the reference by Khattab et al. took place after Applicant’s priority date, (iv) it is commonplace for academics, researchers and others to research and attempt to publish work/findings known or are so obvious that their work would be of little/no value in their field, and (v) it is commonplace for academic journals to peer-review and publish works which document information known or obvious.
With regard to the argument that the Examiner is incorrect in stating that Applicant cited the teachings of Khattab et al. in support of the argument that the state of the art taught away from processing hemp waste, Applicant’s attention is directed to the statement provided in the response of 8/1/2025 shown below
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Since Applicant has specifically stated that the Khattab article indicates that the state of the art taught away from processing hemp waste, given hemp’s waste’s chemical complexity, it is unclear as to why the Examiner was incorrect in stating that Applicant cited the teachings of Khattab et al. in support of the argument that the state of the art taught away from processing hemp waste.
With regard to the argument that the Examiner was incorrect in stating that the teachings of Khattab et al. would not have deterred one of skill in the art from using cannabis as a carbon source, it is noted that the Examiner previously indicated that the teachings of Khattab et al. regarding the nature of hemp waste, which is background information that predates the reference by Khattab et al., is not evidence which would have deterred one of skill in the art to use hemp waste as a carbon source in view of the fact that Kuglarz et al. teach the use of hemp waste as a carbon source. Therefore, it is not believed that the Examiner’s statement is erroneous.
With regard to the argument that the post filing reference of Khattab et al. did not combine the references cited by the Examiner when given the opportunity, thus making the basis of rejection hypothetical, it is noted that whether the claimed invention was deemed obvious by others or not before Applicant is irrelevant to the issue of obviousness. As set forth in MPEP § 2141 (II), an invention that would have been obvious to a person of ordinary skill at the relevant time is not patentable. The term “would have been obvious” conveys a hypothetical situation or state. Please note that if others would have arrived to the claimed invention before Applicant by combining the teachings of the prior art, then the issue at hand would have been anticipation. Applicant is reminded that the issue at hand is obviousness and not anticipation.
With regard to Applicant’s request that the Examiner take an unequivocal position on/ declaration about whether or not (i) Khattab and Dahman are individuals reasonably skill in the art of making PHAs, (ii) a work authored by Khattab & Dahman was published in 2019, (iii) the reference by Khattab et al. took place after Applicant’s priority date, (iv) it is commonplace for academics, researchers and others to research and attempt to publish work/findings known or are so obvious that their work would be of little/no value in their field, and (v) it is commonplace for academic journals to peer-review and publish works which document information known or obvious, it is noted that it is unclear as to why the Examiner has to take an unequivocal position or provide a declaration as requested when it was Applicant who introduced the post filing reference by Khattab et al. in the response of 8/1/2025. Please note that the teachings of Khattab et al. are not part of the cited prior art which is the basis of the instant obviousness rejection. Therefore, issues related to the post filing reference by Khattab et al. are completely irrelevant to the instant discussion. Since Applicant discussed the teachings of Khattab et al. in the response of 8/1/2025 and in the response of 4/1/2026, one would have to conclude that Applicant is well aware that (i) Khattab and Dahman are individuals who made PHAs, (ii) a work authored by Khattab & Dahman was published in 2019, and (iii) the reference by Khattab et al. took place after Applicant’s priority date. With regard to an unequivocal position or a declaration about whether or not it is commonplace for academics, researchers and others to research and attempt to publish work/findings known or are so obvious that their work would be of little/no value in their field, and whether or not it is commonplace for academic journals to peer-review and publish works which document information known or obvious, Applicant is reminded that the Examiner’s role is to evaluate patentability with respect to inventions claimed in a patent application under the conditions for patentability set forth in Title 35 of the United States code. The Examiner is not a peer reviewer and it would be completely improper to make any comments regarding what a journal, researchers or others consider obvious, novel or valuable for publication.
Conclusion
No claim is in condition for allowance.
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 extension fee 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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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
July 11, 2026
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