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 .
Applicants’ arguments, filed 06/21/2026, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Interpretation
Per the interpretation of “is stable and functioned” in the Office Action mailed 04/14/2026, “is functioned” is understood to mean that the antimicrobial peptide functioned as an antimicrobial peptide, i.e., “having antimicrobial properties”.
Claim Rejections - 35 USC § 103 – New by Amendment
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.
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.
1) Claim 1, 2, 4-7 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Carbohydrate Polymers, 2019, v. 223, 115115; cited in IDS 04/15/2024) in view of Hu et al. (Science of Food, 05/20/2023, vol. 7, no. 20) and Imperlini et al. (Antibiotics, 01/16/2023, v. 12, no. 184).
Li “explore[s] the protective effect of β-cyclodextrin (β-CD) on nisin and corresponding interactions involved” (i.e., structure lock components and antimicrobial peptide according to instant claims 4 and 5) [abstract]. Li discloses that the “environmental non-polarity of nisin was enhanced because of the increased hydrophobic interaction force with the combination of β-CD” (i.e., beta-CD and nisin have hydrophobic interactions; instant claim 2). Li further discloses that “the presence of β-CD in the nisin solution also resulted in a visible increase in fluorescence intensity. λmax occurs at a shorter wavelength indicating Trp residues were exposed to a more hydrophobic environment” (i.e., hydrophobic core of beta-CD interacts with the hydrophobic1 tryptophan residue of nisin) [p. 3, last line - p. 4, col. 1, line 3]. Li also discloses “that the combination of nisin and β-CD was an effective sanitizer for microbial decontamination in cooked pork meat” [p. 3, col. 1, last sentence]. Finally, Li teaches that loading nisin into nanoparticles is known to enhance the effectiveness of nisin [p. 1, col. 2, para. 1, lines 7-8].
The nisin:beta-cyclodextrin complex of Li maintains nisin “native conformation” as defined by the instant specification because it is able to perform its intended biological function effectively, i.e., antimicrobial. See the instant specification at paragraph 47:
“As used herein, the term "native conformation" pertains to the natural and biologically active three-dimensional structure of a molecule, such as a protein or peptide, in its unaltered state. It represents the specific arrangement of atoms and functional groups that enables the molecule to perform its intended biological function effectively.”
Li does not disclose a controlled release material.
Hu relates to the stabilization of nisin by a cyclodextrin carboxylate [abstract]. Hu discloses that such complexes have “great potential for improving its utilization as an
antibacterial agent in food or pharmaceutical formulations” [p. 6, col. 2, para. 1, penultimate sentence].
Imperlini relates to nanosystems for delivering antimicrobial peptides, such as nisin [title & p. 9, Table 1, row 10]. Imperlini discloses “antimicrobial peptides (AMPs) are a new potential alternative to conventional antibiotics, as they show a low risk of developing antimicrobial resistance, thus preventing MDR bacterial infections” [abstract]. Additionally, “solid lipid NPs and lipid nanocapsules have been employed to enhance AMP solubility and protect peptides from proteolytic degradation” (i.e., solid lipid encapsulation material; instant claim 6) [abstract]. Imperlini further teaches that solid lipid have high biocompatibility and biodegradation, and enhance bioavailability of the AMP [p. 2, last para, lines 9, 14-17].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the solid lipid nanoparticle of Imperlini with the cyclodextrin stabilized nisin of Li. One would have been motivated to apply the teachings of Imperlini to the stabilized nisin of Li because Imperlini discloses that antimicrobial peptides, such as nisin, can be used as a potential alternative to conventual antibiotics to prevent multidrug resistant bacterial infections. One would have had an expectation of success because Hu discloses nisin-cyclodextrin complexes have potential in pharmaceutical formulations. One would have been motivated to combine the solid lipid nanoparticles of Imperlini to further protect nisin, as desired by Li. One would have had an expectation of success because Li discloses loading nisin into nanoparticles was known. Finally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have encapsulated an antimicrobial peptide (nisin) bonded to a structure lock component (beta-cyclodextrin) in a encapsulation material (solid lipid). Wherein the beta-cyclodextrin and nisin interact non-covalently through hydrophobic interactions, and the beta-cyclodextrin binds to the hydrophobic residues (e.g., tryptophan) of nisin. Furthermore, because the prior art contains the cyclodextrin non-covalently bonded to nisin, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e., pH stability of instant claim 1, temperature stability of instant claim 1, antimicrobial effect of instant claim 7, nontoxic preservative of instant claim 20 and food additive of instant claim 21.
2) Claim 1, 2, 4-7 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (Science of Food, 05/20/2023, vol. 7, no. 20) in view of Imperlini et al. (Antibiotics, 01/16/2023, v. 12, no. 184).
Hu discloses nisin “has good solubility, stability, and activity under acidic conditions, but it becomes less soluble, stable, and active when the solution pH exceeds 6.0, which severely restricted the industrial application range of nisin as antibacterial agent. In this study, we investigated the potential of complexing nisin with a cyclodextrin carboxylate, succinic acid-β-cyclodextrin (SACD), to overcome the disadvantages” (i.e., nisin and a cyclodextrin; instant claims 4 and 5) [abstract]. Hu also discloses that “[s]trong hydrogen bonding was shown between the nisin and SACD, promoting the formation of nisin-SACD complexes” (i.e., non-covalent bond according to instant claim 2) [abstract]. “These complexes exhibited good solubility under neutral and alkaline conditions, and good stability after being held at high pH values during processing with high-steam sterilization” [abstract]. Specifically, Hu discloses that the “complexation of nisin and SACD became stronger as the pH increased” [p. 4, col. 1, lines 10-11] and demonstrates stable complexes from a pH of 2 to a pH of 8 (see Figure 4 on page 5). Furthermore, Hu discloses the nisin-SACD complex exhibited strong antimicrobial activity which “can be attributed to the increased solubility and chemical stability of the nisin in the complexes” [sentence spanning pages 5-6, and the first full sentence of p. 6, col. 1]. Hu also discloses that “[t]he cyclic nature of CDs [cyclodextrins] leads to the creation of molecules that have a hydrophobic core and a hydrophilic exterior” [p. 1, col. 2, para. 2] and that “β-CD displays low cost and strong binding affinity to hydrophobic guest substances among the commonly used cyclodextrins in food industry” (i.e., cyclodextrins bind to the hydrophobic regions of nisin) [p. 1, col. 2, para. 3]. Hu discloses that such complexes have “great potential for improving its [nisin] utilization as an antibacterial agent in food or pharmaceutical formulations” [p. 6, col. 2, para. 1, penultimate sentence]. Finally, Hu discloses that nano-delivery systems are known to improve the stability of nisin [p. 1, col. 2, first sentence].
Hu does not disclose the complexes are encapsulated by a controlled release encapsulation material.
Imperlini relates to nanosystems for delivering antimicrobial peptides, such as nisin [title & p. 9, Table 1, row 10]. Imperlini discloses “antimicrobial peptides (AMPs) are a new potential alternative to conventional antibiotics, as they show a low risk of developing antimicrobial resistance, thus preventing MDR bacterial infections” [abstract]. Additionally, “solid lipid NPs and lipid nanocapsules have been employed to enhance AMP solubility and protect peptides from proteolytic degradation” [abstract]. Imperlini further teaches that solid lipid have high biocompatibility and biodegradation, and enhance bioavailability of the AMP [p. 2, last para, lines 9, 14-17].
First, regarding the complex of Hu, the instant claims do not require an antimicrobial peptide in the native conformation. Rather, the claims only recite a structure-lock component “to maintain the antimicrobial peptide in its native conformation” which is an intended use. MPEP 2111.02 (II) states “To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997). In the present case, according to instant claim 5, the succinic acid-β-cyclodextrin (SACD) would have been capable of fulfilling the intended use because it is a cyclodextrin.
Furthermore, the instant specification defines native conformation at paragraph 47:
“As used herein, the term "native conformation" pertains to the natural and biologically active three-dimensional structure of a molecule, such as a protein or peptide, in its unaltered state. It represents the specific arrangement of atoms and functional groups that enables the molecule to perform its intended biological function effectively.”
Thus according to the instant definition, the prior art maintains native conformation because the nisin performs its intended biological function effectively, i.e., antimicrobial action.
Second, one would have expected the nisin-SACD complex of Hu to function at a pH range of 4-10. Hu attributes the antimicrobial properties of the complex to the increased solubility and chemical stability and discloses the complexation of nisin and SACD was stable at a pH of 8 became stronger as the pH increased. Additionally, Hu discloses that the purpose of complexing the nisin with the SACD is to overcome the disadvantage of reduced antimicrobial action when nisin is present at a pH above 6. Thus, a skilled artisan would have expected the nisin-SACD complexes to demonstrate similar stability and solubility at pH values above a pH of 8, and therefore to have exhibited antimicrobial properties over the instantly claimed pH range.
Finally, in regards to the encapsulation material, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the solid lipid nanoparticle of Imperlini with the cyclodextrin stabilized nisin of Hu. One would have been motivated to apply the teachings of Imperlini to the stabilized nisin of Hu because Imperlini discloses that antimicrobial peptides, such as nisin, can be used as a potential alternative to conventual antibiotics to prevent multidrug resistant bacterial infections. One would have had an expectation of success because Hu discloses nisin-cyclodextrin complexes have potential in pharmaceutical formulations. Finally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have encapsulated an antimicrobial peptide (nisin) non-covalently bonded to a structure lock component (a cyclodextrin) in an encapsulation material (solid lipid). Wherein the cyclodextrin binds to the hydrophobic residues of nisin. Wherein the nisin functions at pH value range of 4-10. Wherein the cyclodextrin and nisin interact non-covalently through hydrogen bonding. Furthermore, because the prior art contains cyclodextrin stabilized nisin, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e., antimicrobial effect of instant claim 7, nontoxic preservative of instant claim 20 and food additive of instant claim 21.
Technological Background
The prior art made of record is considered pertinent to applicant's disclosure. Khemaissa et al, Tryptophan, an Amino-Acid Endowed with Unique Properties and Its Many Roles in Membrane Proteins, 2021, Crystals, v. 11, no. 1032. Khemaissa is pertinent for teaching tryptophan has hydrophobic character.
Response to Arguments
1) On page 8 of their Remarks, Applicant argues that Li uses the beta-cyclodextrin to improve physicochemical properties, not as a “structure-lock” component as instant claimed.
This argument is not persuasive. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the present case, the prior art recognizes the protective advantages of cyclodextrins on nisin.
2) On page 8 and 9 of their Remarks, Applicant argues that Li and Hu do not disclose an antimicrobial peptide maintained in its native conformation. Specifically, Applicant argues that Li discloses structural perturbations of nisin and therefore cannot read on the instantly claimed composition.
This argument is not persuasive. As discussed above, the instant claims do not limit the structure to the native conformation. Rather the instant claims recite an intended use for the “structure-lock” component. Thus, any structure capable of maintaining the antimicrobial peptide in the native conformation fulfils this limitation. See MPEP 2111.02 (II).
Furthermore, the instant specification defines “native conformation” to mean “the specific arrangement of atoms and functional groups that enables the molecule to perform its intended biological function effectively” [0047]. Therefore, an antimicrobial peptide that performs its intended biological function effectively (i.e., antimicrobial function) is understood to be in its “native conformation.” Accordingly, the prior art discloses antimicrobial nisin in its native conformation because the cyclodextrin-nisin complexes of the prior art demonstrate antimicrobial activity.
This interpretation is supported by instant specification’s disclosure the inventive examples which demonstrate structural perturbations. See Example 2 on pages 13-15 of the specification as originally filled, specifically paragraphs 92 and 94:
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Here the specification teaches that even though the peptide:structure lock complexes demonstrates different twisting angles (i.e., different structural conformations), they are nevertheless suitable for the present invention.
Finally, "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). See MPEP2112 (V).
In the present case, the prior art discloses beta-cyclodextrin-nisin samples were prepared by “[f]irstly, 0.2% Nisin, 0.4% β-CD and 0.6% trypsin solution were prepared with 0.02 mol/L HCl (pH 7.5 adjusted by NaOH) as the solvent. […] Finally, the antimicrobial solutions were freshly prepared before using: […] samples treated with 0.05% nisin and 0.1% β-CD;” [p. 2, col. 1, para. 4]. On the other hand, in regard to the inventive examples the instant specification discloses “[t]he procedure for preparing nisin-cyclodextrin solutions in different pH environments is as follows: 1 g of nisin and 1 g of cyclodextrin [e.g., beta-cyclodextrin; [0095], Table 3, row 3] are dissolved in 98 mL of deionized water, and the mixture is stirred overnight” [0093]. Given the components of the prior art and the components of the inventive examples are the same, and the preparation methods are so similar, a skilled artisan would have expected the prior art compositions to exhibit the same properties as instantly recited (see MPEP 2112.01 (II)). Thus the burden is on applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. Additionally, applicant has not satisfactorily demonstrated that prior art complexes are different from those instantly claimed in view of the instant definition for “native conformation” and the structural perturbations of nisin allowed in the instant examples, as discussed above.
3) On page 8 of their Remarks, Applicant argues that Li's beta-CD system exists as a simple inclusion complex in solution and that Li does not teach or suggest selectively capping, locking, or stabilizing hydrophobic residues of an antimicrobial peptide to preserve the peptide structure across a broad pH range or under thermal stress.
This argument is not persuasive. The instant claims only recite “wherein the structure-lock component bind to hydrophobic residues of the antimicrobial peptide”. This limitation is addressed by the prior art as discussed above. Specifically, Li teaches the hydrophobic core of beta-CD interacts with the hydrophobic tryptophan residues on nisin (see this Office Action at page 4 and Li at [p. 3, last line - p. 4, col. 1, line 3]). Additionally, Li discloses the same combination of elements as instantly claimed and so they would have been expected to exhibit the same properties as instantly claimed. “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” MPEP2112.01 (II).
4) On page 9 of their Remarks, Applicant argues that Imperlini does not relate to Li and Hu because it does not disclose cyclodextrin-peptide complexes.
This argument is not persuasive. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Li, Hu, Imperlini and the instant application all relate to stabilizing antimicrobial peptides.
5) On page 9 of their Remarks, Applicant argues the combination of Imperlini with Li amounts to hindsight reasoning. Applicant further argues that one would not have had an expectation of success in combining these prior art references.
This argument is not persuasive. 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). Briefly, in the present case, Imperlini discusses encapsulating antimicrobial peptides to protect them [abstract] while Li relates to stabilizing antimicrobial peptides and teaches that loading nisin into nanoparticles is known to enhance the effectiveness of nisin [p. 1, col. 2, para. 1, lines 7-8]. Therefore, as discussed above, the prior art would have motivated a skilled artisan to combine, and provided an expectation of success in combining, the prior art elements discussed above.
6) On page 10 of their Remarks, Applicant argues the instantly claimed compositions provides unexpected results. Namely, a synergistic improvement in antimicrobial performance across multiple stress conditions, including acidic environments, alkaline environments, elevated temperatures, and biological degradation conditions.
This argument is not persuasive. Overcoming a rejection based on unexpected results requires the combination of three different elements: (i) the results must fairly compare with the prior art, (ii) the results must truly be unexpected and (iii) the claims must be commensurate in scope. MPEP §716.02. The burden rests with Applicant to establish results are unexpected and significant. MPEP §716.02(b). Applicant's showing of allegedly unexpected results does not satisfy any of these requirements.
(i) Applicant has not compared the inventive examples to the closes prior art. The closest prior art is the beta-cyclodextrin:nisin complex disclosed by Li and discussed above.
(ii) Regarding the alleged synergy, ““Synergism, in and of itself, is not conclusive of unobviousness in that synergism might be expected.” Jn re Kollman, 595 F.2d 48, 55 fn. 6 (CCPA 1979). Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991). In the present case, the prior art teaches improved stability, solubility and antimicrobial action of nisin complexed with a cyclodextrin (e.g., See Hu at Figures 4, 5 and 6) as compared to nisin. Therefore a skilled artisan would have expected the “structure-lock” components of the instant invention to improve antimicrobial properties of a antimicrobial peptide, as compared to the antimicrobial peptide alone (i.e., the alleged synergy). Additionally, the instant application lacks examples demonstrating antimicrobial action over the entire temperature range recited in the claims. The maximum temperature tested is 90 deg. C at Examples 9, paragraph 137. Accordingly, the examiner cannot determine the alleged synergy across all claimed parameters.
(iii) The "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support" (see MPEP 716.02(d) quoting In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)). In the present case, the claims are not commensurate in scope for the following reasons. The claims do not recite propolis extract, an antibacterial compound (see instant specification at [0111]) which is included in the composition cited to support the unexpected results. Additionally, the narrow showing of allegedly unexpected results from a composition comprising specific amounts of nisin, alpha-cyclodextrin, poly-L-lysine and honokiol does not support the broadly claimed any amount of any antimicrobial peptide, any structure lock component and any encapsulation material.
Furthermore, the data does not support the antimicrobial functionality across the broad temperature range instantly claimed. In fact, the Examiner will respectfully note that the data only supports antimicrobial functionality after heat treatment as opposed to the instant claims which recite an antimicrobial peptide having antimicrobial function at temperatures from 0-120 deg. C. See Example 9 starting at paragraph 9. Example 9 discloses antimicrobial action after a 15 minute heat treatment of 90 deg. C.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.T.W./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
1 Khemaissa et al, Crystals, 2021, v. 11, no. 1032.
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