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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 24 February 2026 has been entered.
DETAILED ACTION
Applicant’s amendment filed on 24 February 2026 is entered. Claims 11, 18, and 33 are amended, claim 31 is canceled, and claim 45 is new. Claims 1-3, 5, 8-9, 11-13, 15, 18-19, 26-27, 29-30, 33, 35, 38, and 44-45 are pending. Claims 19, 35, 38, and 44 remain withdrawn.
Claims 1-3, 5, 8-9, 11-13, 15, 18, 26-27, 29-30, 33, and 45 are examined.
Claim Objections
Claims 18 and 45 are objected to because of the following informalities:
Claim 18. The species name “cepacia” is misspelled as “cepacian” in the bacteria “Pseudomonas cepacian” and “Burkholderia cepacian”.
Claim 45 is missing a period.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-3, 5, 8-9, 11-13, 15, 18, 26-27, 29-30, 33, and 45 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.
Claim 1 recites a prokaryotic cell having a coating comprising metal-phenolic networks (MPNs) and one or more cryoprotectants. One embodiment of the claim includes prokaryotic cells with cryoprotectants incorporated into the coating. Claim 45 recites a composition comprising lyophilized prokaryotic cells having a coating comprising MPNs and one or more cryoprotectants, wherein the composition is substantially free of additional cryoprotectants external to the coated prokaryotic cells.
The instant disclosure lacks sufficient written description to describe a prokaryotic cell having a coating that comprises cryoprotectants. The coating procedure for the prokaryotic cells provided on pg. 15 of the specification does not include any step or indication that a cryoprotectant is coated onto the prokaryotic cells, but rather only describes the MPN assembly and coating procedures. The lyophilization protection testing provided on pg. 17 of the specification and Figs. 4a and 10 of the drawings only describe a cryoprotectant (trehalose) as a compound added to the phosphate or phosphate citrate buffers prior to lyophilization, but does not describe any procedure of coating the prokaryotic cells with cryoprotectants, nor does it indicate that the MPN coatings comprise a cryoprotectant. Therefore, one of ordinary skill in the art would be required to turn to the prior art for description of a prokaryotic cell comprising a coating comprising an MPN and a cryoprotectant.
Guo (CN108841756A, published November 20, 2018) teaches a bacterial (prokaryotic) probiotic cell encapsulated by a polyphenol-metal ion complex, or metal-phenolic network (MPN) (Guo claim 1). However, Guo does not teach the prokaryotic cell’s coating comprises one or more cryoprotectants. Reddy (Role of Cryoprotectants on the Viability and Functional Properties of Probiotic Lactic Acid Bacteria during Freeze Drying, Food Biotechnology, 23:243–265, 2009) teaches prokaryotic bacterial cultures comprising one or more cryoprotectants (Reddy Table 1 and Fig. 1), but does not describe or provide any indication that the cryoprotectants are coated onto the prokaryotic cells. Reddy discloses the cryoprotectant was added to the cell suspension to form a feed solution for lyophilization (Reddy pg. 247). However, Reddy does not provide any written description of a coating comprising a cryoprotectant, just that the prokaryotic cell can be protected from the potential harmful effects of lyophilization by incorporating a cryoprotectant into the feed solution prior to performing the lyophilization procedures.
Therefore, both the instant disclosure and the prior art lack sufficient written description for a prokaryotic cell having a coating comprising both a metal-phenolic networks (MPNs) and one or more cryoprotectants. The disclosure lacks sufficient written description to reasonably convey to one skilled in the art that the inventors were in possession of the claimed invention at the time of filing.
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 1-3, 5, 8-9, 11-13, 15, 18, 26-27, 29-30, 33, and 45 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.
Regarding claim 1, it is unclear if the one or more cryoprotectants are a component integrated within the coating comprising metal-phenolic networks (MPN)s, or if the cryoprotectants are a separate component from the cell having a coating comprising MPNs.
Regarding claim 18, it is unclear whether the contents of the parenthetical phrases “(i.e., Burkholderia cepacia)” and “(i.e. Brevundimonas vesicularis)” are part of the claim limitations and intended to be limiting, or if the contents of the parenthetical phrases are merely exemplary and thus not required.
Regarding claim 45, the claim recites the prokaryotic cells have a coating comprising MPNs and one or more cryoprotectants, but then later recites that the composition is substantially free of cryoprotectants external to the coated prokaryotic cells. It is unclear if the contradictory limitation “substantially free of additional cryoprotectants external to the coated prokaryotic cells” is to exclude cryoprotectants external to the coating surrounding the prokaryotic cells, or to exclude cryoprotectants external to the cells themselves. Additionally, since the coating is external to the prokaryotic cells, it is unclear how these prokaryotic cells can comprise an external coating comprising cryoprotectants, but also be substantially free of external cryoprotectants.
Claims 2-3, 5, 8-9, 11-13, 15, 18, 26-27, 29-30, and 33 are dependent on claim 1, so are indefinite for the same reasons.
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.
Claims 1-2, 5, 8-9, 11-13, 15, 26, 29-30 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. (CN108841756A, published November 20, 2018) in view of Reddy et al. (Role of Cryoprotectants on the Viability and Functional Properties of Probiotic Lactic Acid Bacteria during Freeze Drying, Food Biotechnology, 23:243–265, 2009).
Regarding claims 1 and 15, Guo teaches a bacterial (prokaryotic) probiotic cell encapsulated by a polyphenol-metal ion complex, or metal-phenolic network (MPN) (Guo claim 1). Guo teaches the bacterial probiotic cells are Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus lactis, Streptococcus lactis, and Escherichia coli (Guo claim 6).
However, Guo does not teach the prokaryotic cell having an MPN coating comprises one or more cryoprotectants.
Reddy teaches prokaryotic bacterial cultures comprising one or more cryoprotectants (Reddy Table 1 and Fig. 1). The survival and viability rates of the lyophilized prokaryotic bacterial cultures comprising cryoprotectants were significantly enhanced as compared to a control group without cryoprotectants (Reddy Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to modify Guo’s prokaryotic probiotic cell encapsulated by a MPN to further comprise Reddy’s cryoprotectants. One of ordinary skill in the art would have been motivated to do so in order to enhance the survivability of Guo’s MPN encapsulated prokaryotic cells upon lyophilization. One of ordinary skill in the art would have had a reasonable expectation of success because Reddy teaches that survival and viability rates of lyophilized prokaryotic bacterial cultures comprising cryoprotectants are significantly enhanced as compared to a control.
Regarding claim 2, Guo teaches MPN that encapsulates the probiotic bacteria (Guo Page 2 Last sentence), and one of ordinary skill in the art would understand that “encapsulation” means a complete coating over the entire cell surface since the general meaning of “encapsulates” is enclose.
Regarding claim 5, Guo teaches a thickness of MPN in the range of 10 to 30nm (Guo claim 2), and that the coating comprises a single metal ion component and a single phenolic component (Guo claim 1 and Pg. 5 Example 1 para. 2).
Regarding claims 8-9 and 11-13, Guo teaches the metal cation component of the complex, which can be Al, Fe (including Fe3+), Zn, Cu, Mn, Ni, Co, or V (Guo claim 3 and Pg. 5 Example 1 para. 2). Guo teaches the polyphenol component to be tannic acid, epicatechin, epigallocatechin gallate, catechin gallate, ellagic acid, waxberry tannin, black tree tannin, anthocyanin, or catechin (Guo claim 5). Guo teaches that each of these metal cations and polyphenol components are complexed together into a MPN (Guo claim 1 and Pg. 5 Example 1 para. 2).
Regarding claim 26, Guo teaches lyophilization (or freeze-drying) of the MPN encapsulated bacterial probiotic cells (Guo claim 7).
Regarding claims 29, Guo teaches the encapsulation of a plurality of bacterial (prokaryotic) probiotic cells with a polyphenol-metal ion complex, i.e. metal-phenolic network (MPN) (Guo claim 1).
Regarding claims 30, Guo teaches that the MPN encapsulated bacterial probiotic cells are lyophilized (freeze-dried) (Guo claim 7).
Regarding claim 33, the encapsulated bacterial probiotic cells can be in powder form (Guo Page 3 Paragraph 5).
Claims 3 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Reddy as applied to claims 1-2, 5, 8-9, 11-13, 15, 26, 29-30 and 33 above, and further in view of Li et al. (Mussel Byssus-Like Reversible Metal-Chelated Supramolecular Complex Used for Dynamic Cellular Surface Engineering and Imaging, Adv. Funct. Mater. 2015, 25, 3775–3784).
Guo and Reddy do not teach the MPN coating to comprise 1-10 or more layers, nor the addition of one or more functional groups bound to the MPN encapsulation.
Regarding claim 3, Li teaches a prokaryotic bacterial cell comprising a metal-phenolic network (MPN) that uniformly coats the outside surface of the cell (Li Page 3779 paragraph 2 sentences 1, 4, and 6), and that additional layers of the MPN coating on the prokaryotic cell may be added by repeating the encapsulation method multiple times to create layers of MPN (Li Page 3781 paragraph 2 sentence 7).
Regarding claim 27, Li teaches the MPN of a cell is a convenient route for cell surface modification, including the addition of biomolecules to the MPN for improved biorecognition (Li Page 3777 Paragraph 3 sentences 4 and 8-9).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to add multiple MPN layers to the prokaryotic probiotic cell of Guo in view of Reddy, and to bind functional biomolecules to those MPN encapsulated prokaryotic probiotic cells. One of ordinary skill in the art would have been motivated to do so to provide additional protection to the MPN coated cells because Li teaches that MPNs protect the encapsulated cells from unfriendly environments, including UV light irradiation and reactive oxygen damage (Li Abstract). One of skill in the art would have had a reasonable expectation of success in adding multiple MPN layers to the prokaryotic probiotic cell of Guo in view of Reddy because Li taught multicoating cells with MPNs by performing the MPN assembly step repeatedly. One of ordinary skill in the art would have been motivated to bind functional biomolecules to the MPN encapsulated prokaryotic probiotic cells of Guo in view of Reddy because Li teaches the addition of biomolecules to the MPN surface improves biorecognition capabilities, and thus impart bio-targeting capabilities to the encapsulated prokaryotic probiotic cells of Guo. One of skill in the art would have had a reasonable expectation of success in binding functional biomolecules to the MPN encapsulated prokaryotic probiotic cells because Li teaches the possibility of modifying MPN surfaces with functional groups such as biomolecules.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Reddy as applied to claims 1-2, 5, 8-9, 11-13, 15, 26, 29-30 and 33 above, and further in view of Bertani et al. (Isolation and Characterization of Pseudomonas chlororaphis Strain ST9; Rhizomicrobiota and in Planta Studies, Plants 2021, 10, 1466, published 17 July 2021), Herrmann et al. (Challenges of formulation and quality of biofertilizers for successful inoculation, Appl Microbiol Biotechnol (2013) 97:8859–8873, published 15 September 2013), and Li et al. (Mussel Byssus-Like Reversible Metal-Chelated Supramolecular Complex Used for Dynamic Cellular Surface Engineering and Imaging, Adv. Funct. Mater. 2015, 25, 3775–3784).
Guo and Reddy do not teach MPN encapsulation of Applicant’s elected prokaryotic bacterial species, Pseudomonas chlororaphis.
Bertani teaches a plant-growth promoting rhizobacteria (PGPR) belonging to the Pseudomonas chlororaphis species, and further teaches that Pseudomonas chlororaphis acts as a plant probiotic due to its rhizosphere colonization abilities and plant associated beneficial phenotypes such as chemotaxis and motility, biofilm formation, phosphate solubilization, ACC deaminase, IAA production, and biocontrol (Bertani Pg. 2 first para.) Bertani teaches that Pseudomonas chlororaphis produces many antifungal compounds that inhibit the growth of various phytopathogens and protect plants such as maize and tomato (Bertani Pg. 2 first para.).
However, Guo, Reddy, and Bertani do not teach a motivation as to why one skilled in the art would encapsulate the PGPR Pseudomonas chlororaphis in a protective matrix, such as an MPN.
Herrmann teaches challenges associated with producing, distributing, and marketing bioinoculants (such as PGPR Pseudomonas chlororaphis), stating that there is a need to protect the cells during storage and transport because the bioinoculants are often stored in less than optimum conditions, such as high temperature and light exposure, and that those bioinoculants need to have an extended shelf life by being made to be robust or well protected to be able to survive in high numbers under harsh conditions (Herrmann Pg. 8860 paras. 2 and 6). Herrmann also teaches that the market potential for biofertilizer and bioinoculants is considerable in developed and developing countries (Herrmann Pg. 8860 para. 2).
However, Guo, Reddy, Bertani, and Herrmann do not teach that MPNs offer any long-term protective effect to the encapsulated cells.
Li teaches that MPNs can prolong cell viability over time and protect encapsulated cells from unfriendly environments, including UV light irradiation and reactive oxygen damage (Li Pg. 3777 para. 2 second column, Figs. 3b, 3c, and 7d, and Abstract).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to encapsulate the elected prokaryotic bacterial species Pseudomonas chlororaphis taught by Bertani with an MPN. One of ordinary skill in the art would have been motivated to do so because P. chlororaphis was known in the art to be a beneficial plant probiotic PGPR bacteria capable of growth promoting and protecting plants, including commercially relevant plants such as maize and tomatoes. There is a known need in the art to protect PGPR cells such as P. chlororaphis during storage and transport due to harsh conditions, such as high light exposure, and those cells need to have an extended shelf life and survive in high numbers during transport and storage. It is also known that there is a considerable market potential for high-performing, quality bioinoculants such as those comprising P. chlororaphis. It is also known in the art that encapsulating bacteria (such as P. chlororaphis) in an MPN prolongs cell viability over time and protects the cells from harsh environments such as UV light irradiation and reactive oxygen species. One of skill in the art would have had a reasonable expectation of success because Guo and Li teach MPN encapsulation methods useful on prokaryotic bacterial cells such as P. chlororaphis, and Li teaches that MPN encapsulations would prolong cell viability over time and protect the cells from harsh environments such as UV light irradiation and reactive oxygen species.
Response to Arguments
Applicant's arguments filed 24 February 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that claim 1 is not indefinite because one of ordinary skill in the art would understand the scope of the claimed invention with reasonable certainty when reading the claims in light of the specification (Remarks pg. 7-9), this 112(b) rejection is not questioning whether or not sufficient support is found within the specification for the different embodiments of the claim. Rather, the rejection is based on the indefinite claim limitation that leads to alternative interpretations. The claim does not make clear if the claim is limiting the one or more cryoprotectants to be a component integrated within the coating comprising metal-phenolic networks (MPN)s, or if the cryoprotectants are a separate component from the cell having a coating comprising MPNs.
Regarding Applicant’s arguments that Applicant’s use of the legal term “i.e.” within the parenthetical limitations reciting multiple species of bacteria in claim 18 is not indefinite, but rather clarifies the current scientific nomenclature to one of ordinary skill in the art by clearly indicating that, for example, Pseudomonas cepacia is identical to Burkholderia cepacia regardless of which nomenclature is encountered in the literature (Remarks pgs. 10-11), the incorporation of these alternative nomenclatures for the same organisms into a parenthetical phrase still renders the claim indefinite because it is not clear whether or not the contents within those parentheses are actually limiting the claim, or merely another way to describe the species. Applicant may amend the claim as they described in the remarks (pg. 11 para. 3) to overcome the rejection, or, if Applicant wishes to include both the new and old scientific nomenclature species names in the Markush group, both species names may be incorporated into the Markush group as separate alternative members. Even though both nomenclatures refer to the same physical entity, double inclusion within the same Markush group in this case is not indefinite. See MPEP 2173.05(o).
Regarding Applicant’s arguments that Guo and Reddy are directed to fundamentally different technological approaches, where Guo is directed to an MPN encapsulation technology, and Reddy is directed to traditional cryoprotection; thus, one of ordinary skill in the art would understand Guo’s MPN is an alternative approach to cell protection that does not require the traditional methods or cryoprotectants taught in Reddy, and that Guo does not suggest that additional cryoprotectants would be needed or beneficial, therefore the references operate under different technological spaces and addresses different problems using different solutions (Remarks pg. 12-14 point 1), Guo and Reddy do occupy the same technological space and address the same problem: cell preservation and survivability. Just because Guo teaches that their MPN coating is sufficient to protect the probiotic bacteria in an antibiotic environment and ensure normal growth of those probiotics does not mean that one of ordinary skill in the art would consider it to be alternative to the traditional methods of Reddy. In fact, if one of ordinary skill in the art would consider Guo to be alternative to Reddy, then that same person of ordinary skill in the art would reasonably conclude the two references share the same technological space and address the same problems. Additionally, Guo is not required to suggest that additional cryoprotectants may be needed or beneficial to encourage one of ordinary skill in the art to add a cryoprotectant upon lyophilization of the MPN-coated cells. When Guo is considered in combination with Reddy, one of ordinary skill in the art would reasonably understand that adding a cryoprotectant with an MPN-coated prokaryotic cell prior to lyophilization would not only protect the cells during lyophilization, but would also ensure their survivability after lyophilization.
Regarding Applicant’s arguments that there is no motivation to combine Guo and Reddy because Guo does not establish a problem with cell survivability during lyophilization (Remarks pg. 14 point 2(a)), as described above, Guo is not required to show that there is a problem with cell survivability during lyophilization to encourage one of ordinary skill in the art to add a cryoprotectant upon lyophilization of the MPN-coated cells. When Guo is considered in combination with Reddy, one of ordinary skill in the art would reasonably understand that adding a cryoprotectant with an MPN-coated prokaryotic cell prior to lyophilization would not only protect the cells during lyophilization, but would also ensure their survivability after lyophilization.
Regarding Applicant’s arguments that there is no motivation to combine Guo and Reddy because Guo’s MPN shell is presented as providing complete protection and that the Office Action relies solely on hindsight reasoning (Remarks pg. 15 point 2(b-c) and pg. 18 point 4), as Applicant pointed out previously Guo does not establish a problem with cell survivability during lyophilization; thus, one of ordinary skill in the art would not consider Guo to provide comprehensive protection to the cell during lyophilization at least because there is no data to show that Guo’s MPN enhances lyophilization protection. Reddy teaches that lyophilization can be detrimental to the survival of those lyophilized cells, thus one of ordinary skill in the art would reasonably conclude that Guo’s MPN coated cells would experience those same detrimental effects in the same situation. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, 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).
Regarding Applicant’s arguments that there is no motivation to combine Guo and Reddy because Reddy only teaches cryopreservation of unencapsulated cells, and that adding cryoprotectants to Guo’s system would add cost and complexity (Remarks pg. 15-16 point 2(d)), there is no presented evidence that demonstrates a cryoprotectant is detrimental to the structure of an MPN. In the absence of such evidence, one of ordinary skill in the art would have no convincing reason to believe that adding a cryoprotectant would interfere with the functionality of the MPN. Adding cost and complexity to a system is not, by itself, unmotivating. Considering the clear teachings of Reddy that the lyophilization procedure is hazardous to those cells, but that those negative effects can be mitigated with a cryoprotectant, one of ordinary skill in the art would reasonably find the benefits of adding a cryoprotectant to outweigh the increase in complexity.
Regarding Applicant’s arguments that the claimed invention demonstrates unexpected results, pointing to Figs. 4, 10, 13, and 17, asserting that the combination of an MPN coating and a cryoprotectant provides an unexpected synergistic effect providing superior protection to either approach alone (Remarks pgs. 16-18 point 3, pg. 23 paras. 1-2, and pg. 28 point 8), just because synergy allegedly exists does not mean that it would be unexpected to one of ordinary skill in the art. The resultant protection that Applicant asserts is unexpected actually aligns very well with the teachings of Reddy, which teaches that incorporating cryoprotectants into the feed solution comprising probiotic cells prior to lyophilization can protect those cells during and after the process. When Reddy’s teachings are combined with Guo’s, who also teaches beneficial effects of their MPN coating on the growth and survival of cells, one of ordinary skill in the art would expect MPN coated prokaryotic cells that were lyophilized in the presence of a cryoprotectant to have predictably better protection than either of the two approaches alone, especially absent any evidence to the contrary.
Regarding Applicant’s arguments that the specification provides evidence of secondary considerations that support nonobviousness, such as a long-felt but unmet need for improved protection of next-generation probiotics during processing, and a failure of others because the traditional approach of using cryoprotectants alone has been insufficient (Remarks pg. 18-19 point 5), arguments do not take place of evidence. See MPEP §2145(I). No evidence of these secondary conditions is presented in Applicant’s remarks.
Regarding Applicant’s arguments that Li’s multilayer MPN coating does not teach or suggest the addition of a cryoprotectant, and that Li teaches advantages of enhanced protection from UV light and ROS, and increased surface area for functionalization, which are not for cryoprotection (Remarks pg. 21-22 points 3-4), Li was not used in the rejection to teach addition of a cryoprotectant. That teaching was found in Reddy.
Regarding Applicant’s arguments that the combination of Guo, Reddy, and Li would require undue experimentation to determine how many MPN layers are optimal for cryoprotection, what type of functional groups are suitable for cryoprotection, how cryoprotectants react with multilayer MPN coatings, and what concentrations and formulations are needed (Remarks pg. 22 point 5), undue experimentation is not a factor for determining obviousness, but rather for determining the enablement of a disclosure. Regardless, the necessary procedures for performing each of these optimizations was known in the prior art, as seen in Guo, Reddy, and Li, so one of ordinary skill in the art would have all of the tools necessary to optimize their composition as necessary.
Regarding Applicant’s arguments that the claimed genus is broader than Pseudomonas chlororaphis, but the rejections focus narrowly on Pseudomonas chlororaphis, and the action has not established that MPN encapsulation with cryoprotectants would be obvious across this entire genus (Remarks pg. 28-29 bridging para.), Pseudomonas chlororaphis is the elected species. Examination of non-elected species is not required so long as the restriction is still in place, which it is.
Conclusion
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/Alexander M Duryee/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/ Supervisory Patent Examiner, Art Unit 1657
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