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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/01/26 has been entered.
Claim Interpretation
Applicant’s claims recite that the uronic acid polymer having a backbone of repeating uronic acid units that is esterified. The examiner is interpreting that any degree of esterification of the backbone uronic acid units reads on the instant claims.
Applicants use of consisting of as the transitional phrase has prompted all new grounds of rejection under 112 presented herein.
Claim Rejections - 35 USC § 112
Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for stimulating growth of plant roots and thereby increasing plant biomass with low doses of glyphosate on specific crops because this use of low doses of glyphosate on specific crop plants (corn and soybean) was already known in the art at the time of the instant filing as is taught by Velini et al. to accomplish this (Pest Mgmt. Sci., 2008, 64, 489-496; see entire document; abstract; Table 1 and 3; results and discussion sections). However, the specification does not reasonably provide enablement for using any herbicide or pre-emergent on any plant species in any amount with the blend comprising the uronic acid polymer that is esterified and wherein the solution containing these components is applied to plant roots and gels on the plant root to increase thickness, etc. as claimed. 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 use the invention commensurate in scope with these claims because herbicides and pre-emergent herbicides by definition are for killing plants/damaging plants not for stimulating the growth of plant roots and increasing plant biomass as is the intended function of the instantly claimed method. The examiner notes that it was already known in the art to use particularly low doses of glyphosate to improve plant growth and biomass in specific crops (soybeans and corn), which includes root biomass which means root growth was improved (See Velini sections cited above), and applicant’s own specification does not actually disclose or demonstrate any other herbicides or pre-emergent(s) which are useful in the claimed method of improving plant root growth, etc. as claimed and by definition herbicides and pre-emergent (herbicides) are agents used to destroy or inhibit plant growth (See merriam webster definition at www.merriam-webster.com/dictionary/herbicide).
This rejection is based on the absence of an enabling disclosure for any herbicides or pre-emergent(s) leading to the claimed increase in root growth and biomass except for the low dosages of glyphosate which was known in the art prior to applicant’s invention. In determining whether Applicant’s claims are enabled, it must be found that one of skill in the art at the time of invention by Applicant would not have had to perform “undue experimentation” to make and/or use the invention claimed.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404: “Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
MPEP § 2164.04 states: “[W]hile the analysis and conclusion of a lack of enablement are based on the factors discussed in MPEP § 2164.01(a) and the evidence as a whole, it is not necessary to discuss each factor in the written enablement rejection.” When given their broadest reasonable interpretation, in view of the as filed specification, the claims encompass any herbicide or pre-emergent in any amount for the claimed intended purpose of improving/increasing plant root growth, etc. as claimed. However, the specification does not provide any enabling disclosure for any herbicides or pre-emergent agents which accomplish this intended use of the method.
The instant specification discloses no specific herbicides or pre-emergent agents. The guidance provided by the specification amounts to an invitation for the skilled Artisan to try and follow the broad disclosure to make a composition of the claimed invention which exhibits effects that applicants have not even demonstrated/shown is even possible especially since the intended use of the method is contrary to the known definition of herbicides beyond the specific low dosages of glyphosate which were already known in the art to lead to these effects. The specification appears to disclose no experiments where they used any herbicides and led to the intended use/effect of increased root growth, etc. as claimed.
Thus, the detail of the disclosure provided by Applicant, in view of the prior art, must encompass a wide knowledge, so that the Artisan of skill would be able to practice the invention as claimed by Applicant, without undue burden being imposed on such Artisan. This burden has not been met because it would require undue experimentation to make the compositions for use in the claimed methods to achieve the required increase in root growth, etc. as claimed. Therefore, in view of the art recognized high level of unpredictability for which herbicides and pre-emergent agents would even lead to improved root growth since these effects are completely contrary to the definition of what a herbicide does.
Thus, because of the large quantity of research required to define these unpredictable variables, and the lack of guidance provided in the specification regarding which herbicides/pre-emergents are useful for improving root growth, etc. when this is contrary to the art known definition of herbicides (with exception of glyphosate at low doses which was already known in the art), it is the position of the examiner that it would require undue experimentation for one of skill in the art to practice the scope of the invention as broadly claimed. Hence, absent a strong showing by Applicant, in the way of specific guidance and direction, and/or working examples demonstrating the same, such invention as claimed by Applicant is not enabled.
Claims 1 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for using milk or calcium salts for instance as a source of polyvalent cations, does not have support for using polyvalent cations alone not in a salt form as a component of their blend for use in the claimed method because polyvalent cations do not exist alone on their own, they are in salt forms. However, applicants use of consisting of does not allow for the polyvalent cations to be in salt form as it claims only the polyvalent cations. Thus, the specification does not reasonably provide enablement for using any polyvalent cation (e.g. for instance Ca2+ in the form of the cation with no counterion because that is what a polyvalent cation is) in any amount with the blend comprising the uronic acid polymer that is esterified and wherein the solution containing these components is applied to plant roots and gels on the plant root to increase thickness, etc. as claimed. 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 use the invention commensurate in scope with these claims because polyvalent cations do not exist on their own as is instantly claimed. I.e. one cannot buy Ca2+ and calcium metal Ca0 when reacted with water forms calcium hydroxide which is a form of Ca2+ which exists as the salt (Ca(OH)2). The examiner notes that it was already known in the art to use calcium salts for instance in the form of milk as was previously noted in the previous office action by Scott ((https://web.archive.org/web/20160727222151/http://www.underwoodgardens.com/milk-molasses-magic-garden/, from IDS) to improve plant biomass, root growth etc. (See entire document; see also comment by Stephen on 06/21/16; More gardening recipes section; milk as soil food section; molasses feeds micro-organisms section), and applicant’s own specification does not actually disclose or demonstrate any polyvalent cations being used in their compositions and they specifically state that the calcium source e.g. the source of the calcium/ions can be milk, but milk contains a lot more than just polyvalent calcium and as such does not read on the claims because of the current consisting of transitional phrase. Further they state that any source of the ions can be used such as a salt. But again a salt is not a polyvalent cation as is specifically claimed, it is a source of polyvalent cations but it also contains the counterions which are not allowed as per applicant’s use of consisting of. Thus, applicant’s blend cannot exist as claimed with a free polyvalent cation as is now claimed because free polyvalent cations are not stable enough to just exist on their own as is now claimed in applicant’s claims with the use of the consisting of transitional phrase. Additionally the examiner notes that if for instance the presence of polyvalent ion such as calcium is in the presence of glyphosate they will complex which could theoretically be a source of calcium ions and a herbicide which might lead to the intended root growth effects, the claimed blend comprising a calcium glyphosate likely would not function to gel as claimed because calcium is known to react with glyphosate to form insoluble chelated complexes which tie up both the calcium and glyphosate and as such this would tie up the calcium which gels the uronic acid polymers to form the gels which protect the roots in the instantly claimed method. See Thelen www.cambridge.org/core/journals/weed-science/article/abs/basis-for-the-hardwater-antagonism-of-glyphosate-activity/1B115821F1CAFEB89F926BBB1CE66810; see abstract, etc.)
This rejection is based on the absence of an enabling disclosure for having a blend which contains a free polyvalent cation as is instantly claimed and which leads to pre-emergent(s) leading to the claimed increase in root growth and biomass. In determining whether Applicant’s claims are enabled, it must be found that one of skill in the art at the time of invention by Applicant would not have had to perform “undue experimentation” to make and/or use the invention claimed. Especially since polyvalent cations do not exist freely as claimed due to applicant’s consisting of language.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404: “Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
MPEP § 2164.04 states: “[W]hile the analysis and conclusion of a lack of enablement are based on the factors discussed in MPEP § 2164.01(a) and the evidence as a whole, it is not necessary to discuss each factor in the written enablement rejection.” When given their broadest reasonable interpretation, in view of the as filed specification, the claims encompass a blend consisting a carboxylic acid ester, herbicide, uronic acid polymer, and polyvalent cation (that is to say no salts which would be a source of the cations are allowed as per the consisting of language). As discussed above and herein, the specification does not provide any enabling disclosure for compositions which only consist of the claimed components, specifically wherein the compositions contain a free polyvalent cation as claimed.
The instant specification discloses no sources or examples which have the polyvalent cation as claimed or examples of compositions consisting of the claimed components as claimed. The guidance provided by the specification amounts to an invitation for the skilled Artisan to try and follow the broad disclosure to make a composition of the claimed invention which contains polyvalent cations as a separate component. The specification appears to disclose no experiments which utilize polyvalent cations as claimed the examples use sources of polyvalent cations such as milk or salts which are sources of polyvalent cations but are not polyvalent cations themselves which is what is now claimed because polyvalent cations have a clear definition in the art, they are ions which have multiple charges, e.g. Ca2+, Fe3+, etc.
Thus, the detail of the disclosure provided by Applicant, in view of the prior art, must encompass a wide knowledge, so that the Artisan of skill would be able to practice the invention as claimed by Applicant, without undue burden being imposed on such Artisan. This burden has not been met because it would require undue experimentation to make the compositions for use in the claimed methods to achieve the required increase in root growth, etc. as claimed. Therefore, in view of the art recognized high level of unpredictability for how polyvalent cations can be incorporated into their compositions to form the claimed blends which gel without utilizing known sources of the polyvalent cations, e.g. salts which are not allowed with applicants use of consisting of as the transitional phrase.
Thus, because of the large quantity of research required to define these unpredictable variables, and the lack of guidance provided in the specification to form the claimed blends for use in the claimed methods, it is the position of the examiner that it would require undue experimentation for one of skill in the art to practice the scope of the invention as broadly claimed. Hence, absent a strong showing by Applicant, in the way of specific guidance and direction, and/or working examples demonstrating the same, such invention as claimed by Applicant is not enabled.
Claims 1 and 11 are also rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), because the specification, while being enabling for preservative compositions comprising polyglycerol esters and a preservative agent from those listed in the claimed weight ratios. However, the specification as originally filed does not reasonably provide enablement for an increase in biocidal activity that is greater than the additive effect of the preservative agent and polyglycerol ester each alone as is required by the instant claims. 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. The examiner notes that it was already known in the art to combine the claimed preservative agents with the claimed polyglycerol esters as taught by Richardson et al. (WO2011017367) which teaches 1 to 99% wt organic acids with 0.5-10 wt% surfactant, wherein the surfactants are/include the claimed decaglyceryl monocaprylate/polyglyceryl-1-caprylate/caprate (claims, etc.) and do not disclose that this/the instant claimed combination exhibits the required increase in biocidal activity that is greater than the additive effect of the preservative agent and polyglycerol ester each alone. Further, applicant’s own data presented in the specification does not actually demonstrate that their combinations are actually greater than the additive of the polyglycerol ester and the preservative alone. The prior art, Brennan-Krohn et al. (Clinics In Laboratory Med. 2019 39(3), 345-358; https://pmc.ncbi.nlm.nih.gov/articles/PMC6686866/#:~:text=Aliquots%20are%20removed%20from%20each,alone%2C%20the%20combination%20is%20synergistic.&text=If%20the%20colony%20count%20at,the%20combination%20is%20also%20bactericidal.&text=It%20should%20be%20noted%20that%20the%20nature%20of%20the%20assessment,combination%20than%20its%20constituent%20drugs?%E2%80%9D) teaches that if the colony count at 24 hours from the combination tube/treatment is ≥2 log10 less than the count from the tube containing the most active drug alone, the combination is synergistic. If the colony count at 24 hours from the combination tube is ≥2 log10 less than the count from the tube containing the most active drug alone, the combination is synergistic (See 1st paragraph time-kill assay section). None of applicants combinations are ≥2 log10 different from the most active drug alone as for instance there aren’t even clear values for PGE control and Benzoic acid, as they could both be 2.919 for the PGE control and 2.849 for benzoic acid both of which fall within the values claimed and the value obtained from the addition of the combination is/would be greater than the 4.12 achieved in applicants results. Further, if applicants are defining their synergy to be greater than additive result of the polyglycerol ester and the preservative each applied/used alone, then the examiner needs an actual value in order to see if there is actual synergy, as it does not appear to the examiner that applicants have any actual true synergy for any of the claimed combinations as reported in Table 2.
This rejection is based on the absence of an enabling disclosure for any of the claimed preservative compositions leading to the claimed increase in biocidal activity that is greater than the additive effect of the preservative agent and polyglycerol ester each alone as is required by the instant claims (i.e. synergistic combinations). In determining whether Applicant’s claims are enabled, it must be found that one of skill in the art at the time of invention by Applicant would not have had to perform “undue experimentation” to make and/or use the invention claimed.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404: “Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
MPEP § 2164.04 states: “[W]hile the analysis and conclusion of a lack of enablement are based on the factors discussed in MPEP § 2164.01(a) and the evidence as a whole, it is not necessary to discuss each factor in the written enablement rejection.” When given their broadest reasonable interpretation, in view of the as filed specification, the claims encompass preservative combinations comprising polyglycerol esters and at least one preservative agent from those disclosed in applicants claims and wherein the polyglycerol ester and preservative agent are present in specific weight ratios and which must exhibit an increase in biocidal activity that is greater than the additive effect of the preservative agent and polyglycerol ester each alone (i.e. synergistic biocidal activity). However, the specification does not provide an enabling disclosure for any claimed combinations which actually exhibit the required increase in biocidal activity that is greater than the additive effect of the preservative agent and polyglycerol ester each alone (synergistic biocidal activity).
The instant specification discloses combinations of a few specific preservatives and one specific polyglycerol ester which lead to increased biocidal activity over the preservative alone but none of the increases actually appear to be synergistic, specifically wherein the increase in biocidal activity that is greater than the additive effect of the preservative agent and polyglycerol ester each alone or as recognized by the prior art having a greater than or equal to a 2 log increase in reduction of P. aeruginosa counts over the most active single component of the combination as discussed above. The guidance provided by the specification amounts to an invitation for the skilled Artisan to try and follow the disclosed experiments to make a composition of the claimed invention having synergy which applicants have not even demonstrated with their own data is even possible, since none of the examples in Table 2 have exhibited any synergy based on applicants claimed increase in biocidal activity that is greater than the additive effect of the preservative agent and polyglycerol ester each alone as is required by the instant claims. The specification appears to disclose no experiments in which synergistic results were obtained with their claimed combinations which means that there is little to no direction or guidance and no working examples wherein the claimed combinations actually provide the required increase in biocidal activity that is greater than the additive effect of the preservative agent and polyglycerol ester each alone.
Thus, the detail of the disclosure provided by Applicant, in view of the prior art, must encompass a wide knowledge, so that the Artisan of skill would be able to practice the invention as claimed by Applicant, without undue burden being imposed on such Artisan. This burden has not been met because it would require undue experimentation to make the claimed compositions to achieve the required increase in biocidal activity that is greater than the additive effect of the preservative agent and polyglycerol ester each alone. Therefore, in view of the art recognized high level of unpredictability for synergy especially since applicants own specification does not appear to actually support their claims that their preservative compositions exhibit the claimed increase in biocidal activity that is greater than the additive effect of the preservative agent and polyglycerol ester each alone.
Thus, because of the large quantity of research required to define these unpredictable variables, and the lack of guidance provided in the specification regarding such synergy, it is the position of the examiner that it would require undue experimentation for one of skill in the art to practice the scope of the invention as broadly claimed. Hence, absent a strong showing by Applicant, in the way of specific guidance and direction, and/or working examples demonstrating the same, such invention as claimed by Applicant is not enabled.
Written Description
Claims 1 and 11 are also 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. Specifically, upon further consideration, with applicant’s use of consisting of language applicants do not have support for the blends comprising polyvalent cations. The specification states at [0058] that some compositions comprise a source of a cation, a source of a cation is not a polyvalent cation existing on its own as is now claimed/required with the use of the consisting of language because polyvalent cations do not exist on their own, they are in salt forms, even the calcium in milk is provided via a salt form of CaHPO4 which is the source of the Ca2+ polyvalent cations in milk but these sources of the polyvalent cations are not allowed in applicant’s claimed because the consisting of closes the blend to the counter ions of the salts, etc. But nowhere in the specification is their support for a composition consisting of the claimed agents and a free polyvalent cation as is now required due to the consisting of language which excludes everything except that which is expressly disclosed in the claim to be part of the blend, e.g. applicants do not have the source for the polyvalent cations in the composition being free polyvalent cations as is now claimed due to the consisting of language.
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 and 11 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.
Applicants have amended claim 1 to recite that the blend consists of the listed components. Consisting of language is closed language and as such nothing else can be added to the blend with applicant’s use of consisting of. Applicant’s blend is to contain a polyvalent cation, e.g. Ca2+ or Fe 2+, e.g. a polyvalent cation by definition is and ion/atom having more than 1 positive charge, e.g. Ca2+ or Fe 2+. However, applicants exemplified polyvalent cations in their specification include sodium and potassium which only exist as monovalent cations. As applicants never specifically defined polyvalent cation contrary to its known definition by being their own lexicographer, in light of the examples of polyvalent cations in applicants specification the scope of what applicants are intending to encompass with this term is completely unclear to the examiner.
Response to Arguments/Remarks
Applicant’s amendments to the claims have overcome the previous 112, 103, and double patenting rejections because applicant’s claims now use consisting of language which excludes any sources of calcium which contain anything beyond the polyvalent cation, e.g. salts, milk, etc. However, applicant’s amendments have prompted the new grounds of rejection under 112(a) and (b) which are presented herein.
As applicant’s arguments are pertinent to the previous grounds of rejection which are no longer pertinent and as such these arguments are not further addressed herein at this time.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin E Hirt whose telephone number is (571)270-1077. The examiner can normally be reached 10:30-7:30 ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN E HIRT/Primary Examiner, Art Unit 1616
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