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
Applicant’s submission filed on 11/08/2024 is duly acknowledged.
Claims 1-18 as presented are pending in this application, and have been examined (for “A process of biologically producing hydrogen gas….”) on their merit in this action hereinafter.
Priority
This application is a CON of 17/763,761 (filed on 03/25/2022, now PAT 12139738), which is a 371 of PCT/US2020/052812 (filed on 09/25/2020), which has a US PRO 62/906,261 (filed on 09/26/2019).
Claims and Objection to Specification
The phrase “without intentional additions of bacteria to the organic waste” in claim 1 (lines 5-6) has been interpreted as “without external additions of bacteria to the organic waste” in light of the instant disclosure of record (see parent application SPEC 17/763761, paragraphs [0008], [0012], for instance).
Specification of record is objected to because it does not provide for the basis of the phrase or proviso “without intentional additions of bacteria to the organic waste” per se. Appropriate correction and/or explanation is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 (as currently presented) are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites the following:
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Claim 1 recites the limitations “performing anaerobic fermentation of the organic waste in the reactor tank without intentional additions of bacteria to the organic waste” (see lines 5-6), which is renders the claim ambiguous and confusing. Irrespective of the fact whether the addition of bacteria is being done with or without “intentions” to do so (akin to knowingly or unknowingly added), the reaction mix in the fermentation reactor tank would comprise the “externally” added bacteria in the organic waste. Therefore, it is unclear as to what exactly the “intentions” of such addition of a component has to do with the process as claimed, especially if it does not change the fermentation reaction mixture. Does it mean that one can add “externally” certain bacteria to the fermentation reactor “unintentionally” in the process as claimed ? The metes and bounds of the claimed process does not appear to be properly defined. Also, none of the dependent claims clarify this specific issue, and therefore they are also rejected as being indefinite for the same reasons of record. Appropriate correction is required.
NOTE: 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-15, 17 and 18 (as currently presented) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kramer et al (US 2014/0157777A1; US-PGPUB cited as ref. [A] on PTO 892 form).
Claim 1 as currently presented is reproduced below:
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It is noted that instant claim 1 does not specify any particular yeast strain as “a first yeast strain”, and is open to “un-intentional additions of bacteria to the organic waste”.
See also limitations of dependent claims 4-15, 17 and 18, as currently presented.
Kramer et al (2014), teach a modular renewable energy system comprising: a solar collector system for generating heat energy; a bioreactor including a chamber for fermenting organic waste, and one of a fuel cell and a heat engine in gaseous communication with the bioreactor; wherein (regarding instant claim 1) anaerobic fermentation of organic waste in the chamber generates hydrogen gas, the hydrogen gas being directed to the one of a fuel cell and a heat engine, and wherein heat energy effective for sterilization is applied to the organic waste subsequent to fermentation, the heat energy being generated by the solar collector system, wherein studies have been conducted using microorganisms to generate hydrogen from fermentation of a variety of substrates, and wherein some studies used single species cultures of bacteria, such as species of Bacillus, Clostridium, and Enterobacter, while others used mixed cultures that originated from sludge, animal wastes, sewage, compost, soil, food waste, etc. (i.e. “without intentional additions of bacteria” to the organic waste material; see Kramer et al, claims l, 10, 17; Summary of the Invention, [0006]-[0010] on p. 1, and p. 3, [0035]-[0036], [0038]-[0039], for instance). Heat treated organic waste is the introduced into the bioreactor, where it is allowed to ferment. The bioreactor includes a controller for controlling the temperature, pH, pressure, water content, and flow rate for the bioreactor. The bioreactor may be a batch or continuous bioreactor. Dry Distillers Grain plus Solubles (DDGS) produced as a byproduct of ethanol production includes carbohydrates as well as hydrogen-producing yeast (see Kramer et al, [0039], regarding instant claims 15, 18). Kramer et al disclose the process for producing hydrogen gas from organic waste, including food waste (regarding instant claim 17) using anaerobic fermentation in the bioreactor (regarding instant claim 4-9; that includes a controller for regulating temperature, pressure, pH, water content, and flow rate for the bioreactor; see Kramer et al, [0039]) that uses DDGS produced as a byproduct of ethanol production (regarding instant claim 15), and has been known to include “hydrogen-producing yeast” (i.e. “at least a first yeast strain”, it is noted that the specific strain of yeast has not been recited in instant claim 1 per se), wherein results indicated that yeast remaining in the DDGS after fermentation is able to robustly produce hydrogen under anaerobic conditions (see Kramer et al, p. 5, [0053], for instance); wherein the anaerobic fermentation of food waste is performed at a “controlled elevated temperature” between 35 degree C to 45 degree C (see [0050], for instance), and at an elevated temperature of 37 degree C (see Kramer et al, [0058], for instance; wherein the controlled pH range is between pH of 4.5 to 6.5, with initial pH of about 6 (see Kramer et al, [0052], for instance), and the test fermentation pH is maintained at 5.5 (see Kramer et al, [0058], for instance); wherein it was found that “increased hydrogen content is obtained by controlling pH below 6.0”, wherein “maintaining a pH in the range of 4.5-6.5, or in the range of 5-6, or about 5.75, over the duration of fermentation is preferred” (see Kramer et al, [0055], in particular)); wherein the pH is controlled with addition of a base such as sodium hydroxide (regarding instant claim 10; see Kramer et al, p. 5, [0052]); wherein the gas produced by the bioreactor is “approximately 25% hydrogen with the remainder being nitrogen and carbon dioxide” (see Kramer et al, p.6, [0028], [0064]; Figure 8, in particular), wherein carbon dioxide produced was measured in the headspace using a computer controlled automated device in a separate channel of the GC equipped with a suitable column and carrier gas (see Kramer et al, p. 4, [0046]); wherein Kramer et al disclose that the hydrogen production rate increased with increasing substrate concentrations up to 120 g/L tested, and that by increasing the agitation it was possible to “decrease the time to first hydrogen production” (regarding instant claim 11; see page 6, [0061], [0063], for instance); and wherein (regarding instant claims 12-14) the gaseous products comprise mainly hydrogen and carbon dioxide in about equal concentrations in the head space, wherein “a majority of the hydrogen gas of the gaseous product is produced within a 24-hour period” (i.e. about 50% each, where most of hydrogen gas is produced within first 24 hours; see Kramer et al, paragraph [0055], and Figure 8). Kramer et al also disclose that “After an initial small concentration of oxygen in the head space that is believed to be associated with the addition of the DDGS to the system, the dissolved oxygen levels remain at substantially zero throughout the production period” (see [0056]-[0057], in particular).
Thus, the disclosure provided by Kramer et al reasonably meets all the limitations of instant claims 1, 3-15, 17 and 18, as currently presented.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
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.
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 1-18 (as currently presented) are rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al (US 2014/0157777A1; US-PGPUB cited as ref. [A] in view of Battista et al (2016; NPL cited in applicant’s IDS dated 11/08/2024, citation no. 9).
Claims 1, 4-15, 17 and 18 have been discussed above in relation to the prior art disclosure for the biological process of producing hydrogen gas via anaerobic fermentation, as taught by Kramer et al 2014, and the detailed teachings and/or suggestions are further relied upon in the same manner hereinafter.
Claims 2 and 16 have been reproduced as follows:
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However, the process for producing hydrogen gas from anaerobic fermentation of organic waste- (1) “wherein the anaerobic fermentation is performed in the reactor tank at a pressure above atmospheric pressure but not greater than 12 Pa…” (instant claim 2); and (2) wherein “the first yeast strain is Saccharomyces cerevisiae or one or more species of the genus Schizosaccharomyces” (instant claim 16), have not been explicitly disclosed by the cited prior art of Kramer et al, as discussed above (however, they do disclose the fact that “yeast remaining in DDGS after fermentation is able to robustly produce hydrogen under anaerobic conditions”; see disclosure in paragraph [0053], for instance).
Battista et al (2016) discloses a method for producing hydrogen and ethanol using anaerobic fermentation of organic waste derived from olive oil production by addition of yeast stain such as Saccharomyces cerevisiae (abstract, section “Materials and methods”, sections 2.1 and 2.2); wherein the fermentation process is carried out in an apparatus comprising two glass bottles and a plastic vessel, connected by pipes, and wherein agitation is provided via a rotary shaker. The feedstock is either pre-treated or left untreated, and the fermentation is performed at under anaerobic conditions by sparging the headspace of the bottle with nitrogen. They demonstrate various pre-treatments that were tested and found to improve the hydrogen and bioethanol produced from a mixture of olive mill waste materials (see page 406, section 4 “Conclusions”, and Table 3, for instance); wherein the basic and ultrasonic pretreatments resulted in the best bioethanol and hydrogen production (see Abstract, for instance) as the “ultrasonic pretreatment likely contributes to the destruction of complex chemical structures (lignin, cellulose) within the OP, and potentially increases the surface area available for bacterial degradation, thus enhancing the mass transfer phenomena”, thus directly eluding to the important role bacteria play in the entire fermentation process (see Battista et al, p. 405, right column, 2nd paragraph, Table 3, for instance). Although, the focus of Battista et al was on the effects of pretreatments in order to improve the yield of bioethanol and hydrogen, they nevertheless disclose the fact that yeast strains can be used for production of hydrogen under anaerobic fermentation conditions using food or sugar-containing waste materials such as olive mill waste materials.
Thus, given the teachings and/or suggestions from Battista et al as discussed above, to an artisan of ordinary skill in the art it would have been obvious to employ a well-known and used strain of yeast such as Saccharomyces cerevisiae in the process for production of hydrogen gas from food waste materials using anaerobic fermentation conditions that have already been disclosed and/or suggested by the process disclosed by Kramer et al. Given the detailed teachings from Kramer et al, the specific limitations of anaerobic fermentation reactor controlled conditions and/or parameters for specific range of pressure, levels of oxygen, temperature, pH, substrate concentration, etc., would have been obvious and/or fully contemplated by an artisan in the art as result effective variables (known in the art of anaerobic fermentation) that can be suitably optimized for increased production of hydrogen over carbon dioxide over a given period of time, as already discussed above for the cited prior art of Kramer et al (see for instance, [0031], [0039], [0046], [0050], [0055], and [0061]-[0065]), unless evidence/data provided on record to the contrary.
In addition, it is to be noted to applicants that the scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data (see parent specification 17/763761, [0019], in particular for “narrow ranges of processing parameters” in order to provide the intended result) is not commensurate in scope with the degree of protection sought by the independent claim 1 as currently presented.
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
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.
1. Claims 1-18 (as presented) are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 12,139,738 B2 (issued on Nov. 12, 2024 to common inventors and assignee; from the parent US application 17/763761 from which instant application has been derived as a CON). Although the claims at issue are not identical, they are not patentably distinct from each other because issued claim 1 of the patent ‘738 is also directed to essentially the same process for biological production of hydrogen gas using anaerobic fermentation of organic waste using at least one yeast strain. The issue claim 1 of ‘738 patent has been reproduced as follows:
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It is clear that the issue claim 1in the ‘738 patent is an species of the generically recited claims in this application under examination (i.e. in genus-species relationship), and therefore, an ODP rejection is deemed proper.
2. Claims 1-18 (as presented) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of copending Application No. 18/504,690 (reference application; filed by common inventors and assignee as a CIP of 17/763,761 on 11/08/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the copending application ‘690 is also directed to essentially the same process for biological production of hydrogen gas using anaerobic fermentation of organic waste using at least one strain of yeast. Claim 1 of copending application ‘690 is reproduced hereinbelow:
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It is clear that the copending claim 1 (as currently amended) is an species of the generically recited claims of instant application under examination (i.e. in a genus-species relationship; see instant claim 1, in particular), and therefore, an ODP rejection is deemed proper.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3. Claims 1-18 (as currently presented) are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 9,506,084 B2 (issued on 11/29/2016 to common inventors and assignee; from application 13/891,435 published as US-PGPUB 2014/0157777 A1 filed on June 12, 2014). Although the claims at issue are not identical, they are not patentably distinct from each other because issued claim 1 is directed to a species of the instantly claimed process for a method for producing hydrogen gas by anaerobic fermentation of "organic waste", wherein the hydrogen produced is directed to "one of a fuel cell and a heat engine"; and wherein the disclosure of the issued patent provides that the organic waste contains active "yeast" that helps in production of hydrogen and almost equal amounts of carbon dioxide during anaerobic fermentation (see also issued claims 2 and 5, and column 9, 4th and 5th paragraphs). Since, instant claim 1 is deemed generic to the species already issued in patent '084, an ODP rejection is deemed proper.
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
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