DETAILED ACTION
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Examiner have withdrawn objection to the claims and 112 (b) and 112 (d) rejection on record.
Examiner is maintaining 112(a) lack of written description and 103 rejection on record.
Applicant’s cancelled claims for non-elected group II, hence restriction requirement of 12/16/2024 is withdrawn.
Applicants did not provide a compliant species election, therefore examiner elects, paracetamol (acetaminophen) as species of drug without traverse.
Examiner found 103 prior art on the elected species. Therefore, Markush search was not extended to the full scope of independent claim 1,16 and 21. Thus election requirement in office action of 12/16/2024 is maintained.
Elected species reads on claims 1, 16,19-22, and 33-42.
Claims 2-3 and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/23/2025.
Claims 1, 16, 19-22 and 33-42 are examined.
Current Status of 17/607,352
This Office Action is in response to the amended claims of 11/05/2025.
Claim 22 is original; claims 2-3 and 32 are withdrawn; claims and 19-20, 33 and 35-40 are previously presented; claims 1, 16, 33 are currently amended; and claims 41-42 are new.
The amended claims 1, 16, 19-22 and 33-42 examined in this office action.
Priority
Effected filing date is 5/28/2018 based on PCT/US19/34227.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 03/12/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks of 11/05/2025. Examiner have reviewed these remarks and amendments.
Applicant did present new claim 42 mentioned in the remarks of 11/05/2025 in the claim set of 11/05/2025.
Regarding claim objection of claims 1 and 32 applicant replacing “Ioperaminde” with “Loperaminde” and deleted “Docolax”, rendering moot the claim objection. Thus Claim objection is withdrawn.
Regarding 112 (b) indefinite rejection, applicant
amended claims 16 and 21 to incorporated Table 1.
Amended claim 1 by deleting trademarked names.
Amended claim 34 by deleting reference to canceled claim 6 and deleted the phrase “similar”
Thus, rendering moot 112(b) indefinite rejections. 112(b) rejection is withdrawn.
Regarding 112 (d) e rejection, applicant
Amended claim 34 by deleting reference to canceled claim 6
Thus, rendering moot 112(d) rejections. 112(d) rejection is withdrawn.
Regarding 112 (a) lack of written description possession,
Applicant argues:
Applicant provided numerous synthesis of biomass-based compounds. A patent needs not teach and preferably omits what is well known in the art in the art.
Examiner’s response:
Examiner does not find applicant’s arguments convincing. Providing numerous examples of compounds synthesized from biomass does not indicate the applicant have actually possessed the compounds or have done experiments to indicate the compounds have been administered to patients.
Applicant merely conducted a survey asking consumer if they are more likely to be compliant with bio-based medicine. Specification does not provide evidence or follow up survey if the consumer has been treated with bio-based medicine. A survey is not a scientific invention and is not patentable.
Written description under 35 USC 112(a) is a statutory requirement to make sure Applicants disclose they were in possession (emphasis) of the subject matter of the claims (herein: “compounds derived from plant materials and comprise at least 50 mass% bio-based carbons”) at the time of filing.
Therefore 112(a) lack of written description possession rejection is maintained.
Regarding 103 rejections:
Applicant argues:
Applicant surprisingly discovered that biobased medication would increases compliance by 45% to 67%.
Examiner’s response
Independent claims 1 and 16 are not directed to patient compliance to biobased medication. Therefore, applicant argument for surprising discovery due to answers in a patient survey is not relevant. Thus 103 rejection is maintained.
Regarding independent claim 21. Applicant claims of surprising and unexpected results is not convincing. Applicant merely conducted a survey asking consumer if they are more likely to be compliant with bio-based medicine. Specification does not provide “objective evidence” (surveys are not “objective evidence”) for follow up survey if the patients have been treated with bio-based medicine. A survey is not evidence of surprising/unexpected results. See MPEP 716.02(d) and explanation, below.
True surprising/unexpected results must be documented in the Specification (or via Affidavit/Oath) and clearly show a contrast between an exemplary teaching in the prior art and how Applicants’ claims are unexpected/surprising (emphasis). See MPEP 716.02(d), which speaks to need for Applicants to provide “objective evidence”. A survey result (Applicants’ Specification) is not “objective evidence”. Therefore 103 rejection is maintained.
Claim Interpretation
Claim 1 is interpreted as method of treating diseases with pharmaceutically effective amount of compounds where compounds are sourced or synthesized from bio-based material.
Claim Rejections - 35 USC § 112 (maintained)
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.
Claim 1, 16, 19-22 and 33-42 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention This is a written description rejection.
MPEP 2163(I) states “The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.”
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include: (a) Actual reduction to practice; (b) Disclosure of drawings or structural chemical formulas; (c) Sufficient relevant identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional characteristics when coupled with a known or disclosed correlation between function and structure; (d) Method of making the claimed invention; (e) Level of skill and knowledge in the art and (f) Predictability in the art. While all of these factors are considered, a sufficient number for a prima facie case are discussed below.
The instant claims are drawn very broadly to the method of treating disease with compounds derived from biomass (instant claims 1, 16, 19-22 and 33-41) but the specification does not disclose possession of the synthesized compounds such as paracetamol from biomass or administration of compounds derived from biomass to a patient. Applicant merely state the starting material can be obtained from biomass but does not demonstrate the possession of the synthesized compounds recited in the instant claims from biomass.
Applicant merely conducted a survey asking population if the population is likely to complaint with taking bio-based medicine. Specific does not provide evidence for follow up survey if the population have actually received bio-based medication synthesized. A survey is not a scientific invention and is not patentable Therefore, specification does not provide support for applicant’s instant claims 1, 16, 19-22 and 33-42.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claim Rejections - 35 USC § 103 (maintained)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 16, 19-22, and 33-42 are rejected under 35 U.S.C. 103 as being unpatentable over
Joncour et.al. (Green Chem., 2014,16, 2997-3002)
In view of
Candeias et.al. (Eur. J. Org. Chem. 2016, 3856-3861)
In further view of
Fang et. al. (Ind. Eng. Chem. Res. 2012, 51, 4759−4763)
1. Determining the scope and contents of the prior art.
Joncour et.al use of hydroquinone as starting material for the synthesis of paracetamol from hydroquionone and ammonium acetates.
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Candeias et.al. discloses synthesis of hydroquinone (aromatic group where carbon atoms are between 10%-90%, claims 36 and 38) from biomass.
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(Scheme 1, page 3857). Candeias further teaches there is an effort to minimize waste and use less toxic and/or hazardous reagents to develop safer and greener processes for developing high volume aromatic compounds (page 3856). Partially teaching independent claims 1,16 and 21.
Fang et.al. discloses a production of acetic acid from biomass
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(page 4760 scheme 1)
2. Ascertaining the differences between the prior art and the claims at issue.
Joncour does not source synthesis of paracetamol from starting material from biomass.
Cadeisas teaches production of hydroquinone from biomass but do not show the synthesis of paracetamol.
Fang teaches the production of acetic acid from biomass but do not show the synthesis of paracetamol.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in organic synthesis and looking to synthesize pharmaceuticals from renewable source (green chemistry).
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
One skilled in the art would be motivated to use the teaching of Joncour for the synthesis of paracetamol (acetaminophen) (Joncour et.al. page 2998, scheme 3) using hydroquinone (Candeias et.al., Scheme 1, page 3857) and ammonium acetate (ammonium acetate is generally produced by adding ammonia to acetic acid(Fang et. al. page 4760 scheme 1)) synthesized from biomass. Therefore, paracetamol can be derived entirely (claim 33) from biomass (at least 10-90 % of carbon is renewable source, teaching claims 33 and 36-38) to reduce the dependency on fossil fuel starting material (non-renewable source), by the combined teaching of Joncour et.al., Candeias et.al., and Fang et.al (teaching claim 33).
Paracetamol derived from biomass is expected to treat disease state in a similar way as paracetamol that’s derived from fossil oil. Moreover, starting material for the synthesis of paracetamol, sourced form biomass, is expected to have less toxic and hazardous material (Cadeias et. al. page 3856) than sourced from nonrenewable resources (fossil fuel). Furthermore, paracetamol synthesized from renewable resources is expect to improve patient compliance, because it is expected to be more “green”, among patient with knowledge of renewable source of paracetamol (claims 19-20 and 39-42) thus all the elements of independent claims 1, 16 and 21.
Regarding claim 35, paracetamol is generally available in oral dosage which requires excipients; therefore, it would be obvious for paracetamol derived from biomass to have excipients, thus teaching claim 35.
Claim 22 is directed to dosage. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Regarding claims 19-20, 39-40 and 42. Claims are directed to % compliance Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. Generally compliance will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Regarding claim 34 14C:12C isotopic ratio in paracetamol sourced from renewable resource is similar to 14C:12: isotopic ration of a living organism Examine interprets these as inherent properties of composition of base claim 1. Therefore, it will not support patentability of the claim. When the structure or method recited in the prior art references is substantially identical to that of the claim, claimed properties are presumed inherent. See MPEP 2112.01(I). Thus, teaching claim 34.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Conclusion
No Claims are allowable as written.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625