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 .
Election/Restrictions
Applicant’s election without traverse of the species Escherichia coli in the reply filed on 07/7/2025 is acknowledged.
Claims 1-14 are pending and under current examination.
All rejections not reiterated have been withdrawn.
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 1-14 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.
This is a new matter rejection. 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, the examiner is unable to locate support in the application, as filed, for a step where the lyophilized antigen is solubilized at ambient temperature. The application makes several references to incubating the antigen with the cationic nanoparticles at ambient; however, no step of solubilizing the antigen at ambient temperature is disclosed. Clarification is requested.
.Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the new matter concerns outlined above.
Claim Rejections - 35 USC § 103
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over De Miguel (FR 2803526; publication date: 07/13/2001; citing the English machine translation; cited in the IDS filed 01/10/2023) in view of Bauer et al. (US 8,236,522; issue date: 08/07/2012).
The claim are examined in view of the elected species of pathogen/antigen: Escherichia coli.
De Miguel discloses polysaccharide particles (abstract) formed from polysaccharides or oligosaccharides such as dextran, chitosan, starch, amylose, cellulose, polygalactose, polymannose and their derivatives (page 2) which can be crosslinked and are made charged by reaction with negatively or positively charged groups (page 3). To impart a positive charge to the polysaccharide particle, it can be reacted with, inter alia, quaternary ammonium compounds (page 3). The polysaccharides are useful for oral delivery of actives including antigens for a vaccine (page 4). The active may be introduced into the polymer matrices at different stages of manufacture, depending on charge and hydrophobicity (page 4).
With regard to instant claim 1, On pages 5-9, De Miguel discloses several example methods of forming the polysaccharide particles, loaded with active agent and/or negatively charged phospholipid. Examples 3, 6, and 9 altogether, describe amphotericin B combined with the cationic polysaccharide matrix particles. Example 3 describes preparation of submicron cationic hydrophilic matrices: Inter alia, maltodextrin is crosslinked with epichorohydrin then formed into particles that are combined with the quaternary ammonium compound glycidyltrimethylammonium. Particles thus formed are homogenized to a size of less than 100 and purified by filtration (page 5). In example 6 the submicron cationic amphiphilic matrices of example 3 are associated with anionic phospholipid (dipalmitoylphosphatidylglycerol; page 6). In example 9, an aqueous solution containing the particles formed in example 6 are stirred in a water bath (i.e. an aqueous solution comprising a cationic nanoparticle consisting of a porous cationic polysaccharide core is provided), and this is combined with a solution of amphotericin B followed by stirring for 2 hours (i.e. an active agent is added to the aqueous solution), which results in association of amphotericin B with the particles (page 8).
De Miguel does not disclose that the vaccine antigen has been lyophilized nor is the elected species of antigen, Escherichia coli, disclosed.
Bauer discloses a bacterial extract as a vaccine to reduce incidence of digestive or urinary tract infections cause by Escherichia coli (E. coli) that contain lysates of E. coli (title, abstract, col 1, lines 27-31) for oral delivery (col 9, lines 5-7). The lysate of E. coli is lyophilized then recovered (col 23, lines 30-60). Bauer then teaches oral administration of this lyophilizate (see e.g. col 27, lines 57-59).
It would have been prima facie obvious to formulate the lyophilized lysate of E. coli described by Bauer into De Miguel’s vehicle. The skilled artisan would have been motivated to do so in order to provide the advantages described by De Miguel of stability and protection from the surrounding environment as well as controlled delivery (page 4). The skilled artisan would have had a reasonable expectation of success because De Miguel indicates the vehicle to be suitable for antigens for a vaccine (page 4).
With regard to the limitation recited in instant claim 1, as amended, requiring “solubilizing the at least on lyophilized antigen at ambient temperature”, the examiner notes that in De Miguel’s examples, using highly hydrophobic drugs, the step of solubilizing the active substance is performed above room temperature. The examiner also points out that De Miguel teaches that the active agent is in solution when it is associated with the particles. Thus, the artisan having ordinary skill, a highly intelligent person with e.g. a Ph.D. degree, would have sought to ensure that the active agent is dissolved when it is combined with the particles in De Miguel’s method.
Bauer teaches that the E. coli lysates can be dissolved in water at room temperature: “the extracts were dissolved … in distilled water” (col 29, lines 7-9).
It would have been prima facie obvious to carry out the solubilizing step taught by Miguel at whatever temperature was required to solubilize the specific active agent in question. In the case of the E. coli extracts taught by Bauer, one having ordinary skill would have recognized that this step may be carried out at room temperature, and the heating step used to solubilize amphotericin or estradiol valerate because the E. coli lyophilizate is soluble in water at ambient temperature. For this reason, the examiner does not consider the requirement that the solubilizing step occur at ambient temperature to patentably define over the cited prior art. See also MPEP 2144.05(II): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to claim 2, upon addition of the freeze-dried E. coli lysate, noted above, the aqueous solution would contain an antigenic protein from E. coli.
With regard to claim 3, De Miguel discloses an example in which the polysaccharide is not crosslinked (see example 12).
With regard to claims 3, 4, and 6, as noted above an example polysaccharide core is formed with maltodextrin and the quaternary ammonium compound glycidyltrimethylammonium.
With regard to claims 4 and 5, as noted above, the polysaccharide is crosslinked with epichlorohydrin.
With regard to claims 7-9, in the example noted above, the particle is charged with dipalmitoylphosphatidylglycerol.
With regard to claim 10, in other examples the particles are not charged with lipid, see e.g. example 2. The examiner considers this an obvious variant of the procedure disclosed by De Miguel.
With regard to claims 11-14, the antigen in the method rendered obvious by De Miguel and Bauer is a lysate (i.e. an extract) of the bacterial pathogen, Escherichia coli.
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive.
On page 9, Applicant argues that the prior art does not teach the limitation recited in amended claim 1 requiring the solubilizing step to occur at ambient temperature.
Please see the rejection above, the examiner respectfully disagrees with this position. De Miguel teaches solubilizing the active agent and describes heating active agents that have very low water solubility. One having ordinary skill would have understood that the temperatures can vary (80C for amphotericin vs. 37C for estradiol valerate), and would have understood from Bauer that a heating step would not be needed in order for the E. coli lyophilizate to dissolve in water. Thus, it would have been obvious to solubilize the lyophilized antigen at ambient temperature.
On page 10, Applicant argues that De Miguel does not provide expectation of success that the lyophilized antigen may be solubilized in aqueous solution comprising a cationic nanoparticle etc., let alone to solubilize the lyophilized antigen at room temperature and that Bauer merely teaches that the extract may be lyophilized prior to formulating it for use an dis silent on how to formulate and solubilize the lyophilized extract let alone to solubilize the lyophilized extract at an ambient temperature.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding the allegation that the artisan of ordinary skill would have lacked reasonable expectation of success, see In re O’Farrell, 853 F.2d 894, 7 USPQ2d 1673 (Fed. Cir. 1988) and MPEP 2143: "Obviousness does not require absolute predictability of success.” In the instant case, as explained in the rejection, the artisan of ordinary skill would have been highly intelligent and experienced, and would have been able to draw from the combined teachings of De Miguel and Bauer that the E coli lysate could be dissolved in water at room temperature for the step of combining with the polymer particles. Further expectation of success is drawn from De Miguel who discloses that the method can be used to form vaccine formulations.
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.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-8 of U.S. Patent No. 6759060;
claims 1-29 of U.S. Patent No. 6342226;
claims 1-30 of U.S. Patent No. 6214621;
claims 1-48 of U.S. Patent No. 6017513;
claims 1-37 of U.S. Patent No. 6096291; and
claims 1-20 of U.S. Patent No. 9731005
in view of Miguel (FR 2803526; publication date: 07/13/2001; citing the English machine translation; cited in the IDS filed 01/10/2023) in view of Bauer et al. (US 8,236,522; issue date: 08/07/2012).
Inter alia, the claims of the cited patents embrace a particle for vaccine or biologically active agent delivery comprising a solid nanoparticle formed from a polysaccharide selected from dextran, a dextrin, and a maltodextrin and a cationic group such as a quaternary ammonium group and further associated with a negatively charged phospholipid.
The claims of the cited patents do not disclose a method for forming the solid particle component.
De Miguel discloses polysaccharide particles (abstract) formed from polysaccharides or oligosaccharides such as dextran, chitosan, starch, amylose, cellulose, polygalactose, polymannose and their derivatives (page 2) which can be crosslinked and are made charged by reaction with negatively or positively charged groups (page 3). To impart a positive charge to the polysaccharide particle, it can be reacted with, inter alia, quaternary ammonium compounds (page 3). The polysaccharides are useful for oral delivery of actives including antigens for a vaccine (page 4). The active may be introduced into the polymer matrices at different stages of manufacture, depending on charge and hydrophobicity (page 4). Thus, the particles are comparable to those of the cited patents.
On pages 5-9, De Miguel discloses several example methods of forming the polysaccharide particles, loaded with active agent and/or negatively charged phospholipid. Examples 3, 6, and 9 altogether, describe amphotericin B combined with the cationic polysaccharide matrix particles. Example 3 describes preparation of submicron cationic hydrophilic matrices: Inter alia, maltodextrin is crosslinked with epichorohydrin then formed into particles that are combined with the quaternary ammonium compound glycidyltrimethylammonium. Particles thus formed are homogenized to a size of less than 100 and purified by filtration (page 5). In example 6 the submicron cationic amphiphilic matrices of example 3 are associated with anionic phospholipid (dipalmitoylphosphatidylglycerol; page 6). In example 9, an aqueous solution containing the particles formed in example 6 are stirred in a water bath (i.e. an aqueous solution comprising a cationic nanoparticle consisting of a porous cationic polysaccharide core is provided), and this is combined with a solution of amphotericin B followed by stirring for 2 hours (i.e. an active agent is added to the aqueous solution), which results in association of amphotericin B with the particles (page 8).
It would have been prima facie obvious to form the solid polysaccharide core according to the method disclosed by De Miguel because this would have been simply combining prior art elements according to known methods to yield predictable results (see MPEP 2143(A)).
Neither the cited patents nor De Miguel disclose that the vaccine antigen to be combined with the particles has been lyophilized nor is the elected species of antigen, Escherichia coli, disclosed.
Bauer discloses a bacterial extract as a vaccine to reduce incidence of digestive or urinary tract infections cause by Escherichia coli (E. coli) that contain lysates of E. coli (title, abstract, col 1, lines 27-31) for oral delivery (col 9, lines 5-7). The lysate of E. coli is lyophilized then recovered (col 23, lines 30-60). Bauer then teaches oral administration of this lyophilizate (see e.g. col 27, lines 57-59).
It would have been prima facie obvious to formulate the lyophilized lysate of E. coli described by Bauer into De Miguel’s vehicle. The skilled artisan would have been motivated to do so in order to provide the advantages described by De Miguel of stability and protection from the surrounding environment as well as controlled delivery (page 4). The skilled artisan would have had a reasonable expectation of success because De Miguel indicates the vehicle to be suitable for antigens for a vaccine (page 4).
With regard to the limitation recited in instant claim 1, as amended, requiring “solubilizing the at least on lyophilized antigen at ambient temperature”, the examiner notes that in De Miguel’s examples, using highly hydrophobic drugs, the step of solubilizing the active substance is performed above room temperature. The examiner also points out that De Miguel teaches that the active agent is in solution when it is associated with the particles. Thus, the artisan having ordinary skill, a highly intelligent person with e.g. a Ph.D. degree, would have sought to ensure that the active agent is dissolved when it is combined with the particles in De Miguel’s method.
Bauer teaches that the E. coli lysates can be dissolved in water at room temperature: “the extracts were dissolved … in distilled water” (col 29, lines 7-9).
It would have been prima facie obvious to carry out the solubilizing step taught by Miguel at whatever temperature was required to solubilize the specific active agent in question. In the case of the E. coli extracts taught by Bauer, one having ordinary skill would have recognized that this step may be carried out at room temperature, and the heating step used to solubilize amphotericin or estradiol valerate because the E. coli lyophilizate is soluble in water at ambient temperature. For this reason, the examiner does not consider the requirement that the solubilizing step occur at ambient temperature to patentably define over the cited prior art. See also MPEP 2144.05(II): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to claim 2, upon addition of the freeze-dried E. coli lysate, noted above, the aqueous solution would contain an antigenic protein from E. coli.
With regard to claim 3, De Miguel discloses an example in which the polysaccharide is not crosslinked (see example 12). The examiner considers non-crosslinked particles to have been an obvious variant of the cited patents.
With regard to claims 3, 4, and 6, as noted above an example polysaccharide core is formed with maltodextrin and the quaternary ammonium compound glycidyltrimethylammonium.
With regard to claims 4 and 5, as noted above, the polysaccharide is crosslinked with epichlorohydrin.
With regard to claims 7-9, in the example noted above, the particle is charged with dipalmitoylphosphatidylglycerol.
With regard to claim 10, in other examples the particles are not charged with lipid, see e.g. example 2.
With regard to claims 11-14, the antigen in the method rendered obvious by De Miguel and Bauer is a lysate (i.e. an extract) of the bacterial pathogen, Escherichia coli.
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18251658 in view of Miguel (FR 2803526; publication date: 07/13/2001; citing the English machine translation; cited in the IDS filed 01/10/2023) in view of Bauer et al. (US 8,236,522; issue date: 08/07/2012).
Inter alia, the claims of the application embrace a particle for vaccine or biologically active agent delivery comprising a solid nanoparticle formed from a polysaccharide selected from dextran, a dextrin, and a maltodextrin and a cationic group such as a quaternary ammonium group and further associated with a negatively charged phospholipid.
The claims of the cited application do not disclose a method for forming the solid particle component.
De Miguel discloses polysaccharide particles (abstract) formed from polysaccharides or oligosaccharides such as dextran, chitosan, starch, amylose, cellulose, polygalactose, polymannose and their derivatives (page 2) which can be crosslinked and are made charged by reaction with negatively or positively charged groups (page 3). To impart a positive charge to the polysaccharide particle, it can be reacted with, inter alia, quaternary ammonium compounds (page 3). The polysaccharides are useful for oral delivery of actives including antigens for a vaccine (page 4). The active may be introduced into the polymer matrices at different stages of manufacture, depending on charge and hydrophobicity (page 4). Thus, the particles are comparable to those of the cited patents.
On pages 5-9, De Miguel discloses several example methods of forming the polysaccharide particles, loaded with active agent and/or negatively charged phospholipid. Examples 3, 6, and 9 altogether, describe amphotericin B combined with the cationic polysaccharide matrix particles. Example 3 describes preparation of submicron cationic hydrophilic matrices: Inter alia, maltodextrin is crosslinked with epichorohydrin then formed into particles that are combined with the quaternary ammonium compound glycidyltrimethylammonium. Particles thus formed are homogenized to a size of less than 100 and purified by filtration (page 5). In example 6 the submicron cationic amphiphilic matrices of example 3 are associated with anionic phospholipid (dipalmitoylphosphatidylglycerol; page 6). In example 9, an aqueous solution containing the particles formed in example 6 are stirred in a water bath (i.e. an aqueous solution comprising a cationic nanoparticle consisting of a porous cationic polysaccharide core is provided), and this is combined with a solution of amphotericin B followed by stirring for 2 hours (i.e. an active agent is added to the aqueous solution), which results in association of amphotericin B with the particles (page 8).
It would have been prima facie obvious to form the solid polysaccharide core according to the method disclosed by De Miguel because this would have been simply combining prior art elements according to known methods to yield predictable results (see MPEP 2143(A)).
Neither the cited application nor De Miguel disclose that the vaccine antigen to be combined with the particles has been lyophilized nor is the elected species of antigen, Escherichia coli, disclosed.
Bauer discloses a bacterial extract as a vaccine to reduce incidence of digestive or urinary tract infections cause by Escherichia coli (E. coli) that contain lysates of E. coli (title, abstract, col 1, lines 27-31) for oral delivery (col 9, lines 5-7). The lysate of E. coli is lyophilized then recovered (col 23, lines 30-60). Bauer then teaches oral administration of this lyophilizate (see e.g. col 27, lines 57-59).
It would have been prima facie obvious to formulate the lyophilized lysate of E. coli described by Bauer into the vehicle of the cited application. The skilled artisan would have been motivated to do so in order to provide the advantages described by De Miguel of stability and protection from the surrounding environment as well as controlled delivery (page 4). The skilled artisan would have had a reasonable expectation of success because De Miguel indicates the vehicle to be suitable for antigens for a vaccine (page 4).
With regard to the limitation recited in instant claim 1, as amended, requiring “solubilizing the at least on lyophilized antigen at ambient temperature”, the examiner notes that in De Miguel’s examples, using highly hydrophobic drugs, the step of solubilizing the active substance is performed above room temperature. The examiner also points out that De Miguel teaches that the active agent is in solution when it is associated with the particles. Thus, the artisan having ordinary skill, a highly intelligent person with e.g. a Ph.D. degree, would have sought to ensure that the active agent is dissolved when it is combined with the particles in De Miguel’s method.
Bauer teaches that the E. coli lysates can be dissolved in water at room temperature: “the extracts were dissolved … in distilled water” (col 29, lines 7-9).
It would have been prima facie obvious to carry out the solubilizing step taught by Miguel at whatever temperature was required to solubilize the specific active agent in question. In the case of the E. coli extracts taught by Bauer, one having ordinary skill would have recognized that this step may be carried out at room temperature, and the heating step used to solubilize amphotericin or estradiol valerate because the E. coli lyophilizate is soluble in water at ambient temperature. For this reason, the examiner does not consider the requirement that the solubilizing step occur at ambient temperature to patentably define over the cited prior art. See also MPEP 2144.05(II): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to claim 2, upon addition of the freeze-dried E. coli lysate, noted above, the aqueous solution would contain an antigenic protein from E. coli.
With regard to claim 3, De Miguel discloses an example in which the polysaccharide is not crosslinked (see example 12). The examiner considers non-crosslinked particles to have been an obvious variant of the cited application.
With regard to claims 3, 4, and 6, as noted above an example polysaccharide core is formed with maltodextrin and the quaternary ammonium compound glycidyltrimethylammonium.
With regard to claims 4 and 5, as noted above, the polysaccharide is crosslinked with epichlorohydrin.
With regard to claims 7-9, in the example noted above, the particle is charged with dipalmitoylphosphatidylglycerol.
With regard to claim 10, in other examples the particles are not charged with lipid, see e.g. example 2.
With regard to claims 11-14, the antigen in the method rendered obvious by De Miguel and Bauer is a lysate (i.e. an extract) of the bacterial pathogen, Escherichia coli.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive.
On pages 11 and 12, Applicant argues that De Miguel and Bauer do not teach the step of solubilizing the lyophilized antigen in the aqueous solution at ambient temperature.
This is not persuasive for the reasons set forth in the rejections and as described in greater detail in the Response to Arguments section following the obviousness rejection.
Conclusion
No claims are allowed.
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 KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617