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 .
Status of the Claims
Pursuant to the amendment dated 08/25/2025, claim 27 has been cancelled. Claims 17, 28, 29, 31134, 36-38, 40, and 41 were cancelled previously. Claims 1-16, 18-26, 30, 35 and 39 are pending. Claim 39 stands withdrawn with traverse.
Election of the following species was made without traverse:
Species A: pyroglutamyl apelin-13 ([pyr1]-apelin-13) as the species of biologically active peptide.
Species B: an anti-diabetic agent as the species of additional therapeutic agent.
Claims 1-16, 18-26, 30, and 35 are under current examination.
The objection to the specification for lack of compliance with nucleotide and/or amino acid sequence rules is hereby withdrawn in view of Applicant’s remarks on page 7 of the response filed 08/25/2025.
All rejections not reiterated have been withdrawn.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62801250, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The full scope of claims 1-16, 18-27, 30, and 35 is not supported in the provisional application. Claims 1-16, 18-27, 30, and 35 are therefore afforded the priority date of PCT/US2020/016867: 02/05/2020.
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 1-16, 18-26, 30, and 35 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, there is not support in the application, as filed, for the terms “guar gum” and “oat milk”. The examiner notes that these terms resemble the terms “gara gum” and “oak milk” present in the as filed application; however, no evidence exists that these terms were misspellings of guar gum and oat milk. Clarification of support is required.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16, 18-27, 30, and 35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 recites the limitation "PEG 8000" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation "the non-solvent components" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Response to Arguments
Applicant's arguments filed 08/25/2025 with respect to the indefiniteness rejections of claims 23 and 24 have been fully considered but they are not persuasive.
In the case of claim 23, the claim does not recite that a PEG is present in the lipid-based nanoparticle prior to recitation of the phrase “…a weight percentage of PEG 8000…” Amending claim 23, line 3 to recite “…wherein the lipid-based nanoparticle further comprises PEG and comprises a weight percentage of the apelin…” is one example for how the rejection could be overcome.
In the case of claim 24, as further explanation, the phrase “non-solvent components” embraces more than the non-solvent substances expressly recited in the claim and there are no solvent substances expressly recited in the claim; however, the claim does not have antecedent basis for the general category “non-solvent components”.
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 1-16, 18-26, 30, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Rajadas (WO2018/075822; publication date: 04/26/2018; cited in the IDS filed 04/22/2022) in view of Hennink et al. (US 6,395,302; issue date: 05/28/2002) and Lee et al. (International Journal of Biological Macromolecules Vol 42, pages 178-184; publication year: 2008).
The claims are examined in view of the following species elections:
Species A: [Pyrl]-apelin-13
Species B: anti-diabetic agent
With regard to claims 1, 5, 8-16, 18-20, 22, and 23, Rajadas discloses a therapeutic agent encapsulated in a liposome comprising an amount of at least one poloxamer, DSPC, DPPC, and PEG. In some embodiments, the composition comprises about 25 wt% of an apelin peptide (therapeutic agent), about 17 wt% poloxamer 188, about 25 wt% DSPC, about 25 wt% DPPC, and about 8 wt% PEG 8000. In other embodiments, the composition comprises about 45 wt% of an apelin peptide, about 15 wt% poloxamer 188, about 10 wt% DSPC, about 10 wt% DPPC, about 15 wt% PEG 8000, and about 5 wt% cholesterol (0015). The apelin peptide used in example compositions is [Pyrl]-apelin-13 (Table 2, page 11). Cholesterol is also present in example compositions at 5% (Table 2, page 11).
Rajadas discloses further that the composition may be formulated for oral delivery (0077) but does not disclose a plurality of particles wherein each particle comprises carbohydrate matrix having lipid-based nanoparticles embedded therein.
Hennink discloses that peptides, proteins and proteinaceous products generally cannot be administered orally because they are chemically and physically unstable in the digestive tract and have a short residence time in the body, although it would be preferrable to be able to orally administer medicine (col 1, lines 26-39). The invention of Hennink is a patient friendly delivery system for protein drugs that is safe and biodegradable and possesses well controllable delivery kinetics and high degree of loading (col 4, lines 49-60). Hennink discloses that their system has good controlled release behavior comprising microencapsulated colloidal systems, specifically microencapsulated liposomes designed for delivery of active ingredients (col 1, lines 10-17) and particularly protein drugs which otherwise cannot be administered orally (col 1, lines 27-30). The microparticles that encapsulate the liposomes are crosslinked polymer particles having pores that are smaller than the releasable entity (i.e. the liposome containing the protein therapeutic) (col 5, lines 45-67). The particle size is controllable and generally ranges from 100 nanometers to 100 micrometers (col 6, lines 1-10). The examiner notes that if the polymer particles are crosslinked, they contain a crosslinking agent as required by instant claim 1. The microparticles are formed from carbohydrate polymers such as dextrans, starches, or celluloses (col 7, lines 17-24).
It would have been prima facie obvious to encapsulate the liposomes disclosed by Rajadas in the microparticle system disclosed by Hennink. The artisan of ordinary skill would have been motivated to do so in order to be able to orally deliver the active agent contained therein. The skilled artisan would have had a reasonable expectation of success because Hennink’s protocol merely requires suspending preformed liposomes followed by forming the polymer microparticles (see protocol in col 10-11).
Neither Rajadas nor Hennink disclose any of the polysaccharides recited in instant claim 1, pectin, guar gum, or oat milk carbohydrate.
Lee discloses that calcium pectin gels (i.e. a pectin polysaccharide crosslinked by calcium ion crosslinking agents) can entrap liposomes for extended release delivery of active agents (abstract).
It would have been prima facie obvious to use a pectin gel crosslinked by calcium ions (Ca2+) as the polysaccharide in the nanoparticles of Rajadas/Hennink because one having ordinary skill in the art would have recognized this as a suitable crosslinked polysaccharide to entrap a liposome. See MPEP 2144.07.
With regard to claims 2-4, the apelin peptides disclosed by Rajadas are identical to those disclosed in the instant application and are therefore considered to have the properties claimed in instant claims 2-4.
With regard to claims 5-7, the liposomes of the instant invention are made by substantially the same method as that disclosed by Rajadas, therefore the examiner considers the [Pyrl]-apelin-13 to adopt a thermodynamically favorable distribution in both cases, wherein hydrophobic regions of the polypeptide will associate with hydrophobic regions of the liposome and hydrophilic regions of the polypeptide will affiliate with hydrophilic regions of the liposome.
With regard to claim 21, the composition can contain at least one additional therapeutic agent including an anti-diabetic agent (0064).
With regard to claim 24, Hennink discloses that the microparticles can encapsulate 10% or more of the lipid nanoparticle (col 9, lines 33-35), this leaves the remainder of the particle as the crosslinked polymer which contains the carbohydrate polymers such as dextran, starch, or cellulose that have been crosslinked with a crosslinking agent. Thus, Hennink implicitly discloses an amount of carbohydrate ranging from at least as high as 90% but lower in the event that the liposomes are present at greater than 10% of the particle. Hennink also discloses that the degree of crosslinking (i.e. the amount of crosslinking agent) can be used to control release of the liposome (col 5, lines 57-60: the crosslinking is carried out to such a degree that the pores (meshes) in the crosslinked structure eventually formed are substantially smaller than the size of the releasable entity). Thus, each of the ranges required by instant claim 24 for carbohydrate matrix, crosslinking agent, and lipid-based nanoparticle is taught by the prior art to be optimizable. See MPEP 2144.05(II)(A): 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 25, as noted above, Hennink discloses a range in particle size that overlaps with the range required by the instant claims. See MPEP 2144.05(I).
With regard to claim 26, as noted above, the microparticles disclosed by Hennink contain pores.
With regard to claim 30, as noted above, Lee discloses that the pectin gel is formed by binding to calcium (Ca2+), i.e. the divalent metal ion, calcium, is the cross-linking agent.
With regard to claim 35, as noted above, Rajadas contemplates formulations for oral delivery and Hennink’s formulation is intended for oral delivery.
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 1-16, 18-26, 30, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,400,049 in view of Hennink et al. (US 6,395,302; issue date: 05/28/2002) and Lee et al. (International Journal of Biological Macromolecules Vol 42, pages 178-184; publication year: 2008).
Inter alia the claims of the ‘049 patent embrace a liposome falling entirely within the scope of the lipid-based particle required by the instant claims having [Pyrl]-apelin-13 contained in a liposome formed from DSPC, DPPC, cholesterol, PEG, and poloxamer.
The claims of the ‘049 patent do not recite any limitation requiring a plurality of particles wherein each particle comprises a carbohydrate matrix comprising a polysaccharide and a crosslinking agent and containing a liposome.
Hennink discloses that peptides, proteins and proteinaceous products generally cannot be administered orally because they are chemically and physically unstable in the digestive tract and have a short residence time in the body, although it would be preferrable to be able to orally administer medicine (col 1, lines 26-39). The invention of Hennink is a patient friendly delivery system for protein drugs that is safe and biodegradable and possesses well controllable delivery kinetics and high degree of loading (col 4, lines 49-60). Hennink discloses that their system has good controlled release behavior comprising microencapsulated colloidal systems, specifically microencapsulated liposomes designed for delivery of active ingredients (col 1, lines 10-17) and particularly protein drugs which otherwise cannot be administered orally (col 1, lines 27-30). The microparticles that encapsulate the liposomes are crosslinked polymer particles having pores that are smaller than the releasable entity (i.e. the liposome containing the protein therapeutic) (col 5, lines 45-67). The particle size is controllable and generally ranges from 100 nanometers to 100 micrometers (col 6, lines 1-10). The examiner notes that if the polymer particles are crosslinked, they contain a crosslinking agent as required by instant claim 1. The microparticles are formed from carbohydrate polymers such as dextrans, starches, or celluloses (col 7, lines 17-24).
It would have been prima facie obvious to encapsulate the liposomes embraced by the ‘049 claims in the microparticle system disclosed by Hennink. The artisan of ordinary skill would have been motivated to do so in order to be able to orally deliver the active agent contained therein. The skilled artisan would have had a reasonable expectation of success because Hennink’s protocol merely requires suspending preformed liposomes followed by forming the polymer microparticles (see protocol in col 10-11).
Neither the claims of the ‘049 patent nor Hennink disclose any of the polysaccharides recited in instant claim 1, pectin, guar gum, or oat milk carbohydrate.
Lee discloses that calcium pectin gels (i.e. a pectin polysaccharide crosslinked by calcium ion crosslinking agents) can entrap liposomes for extended release delivery of active agents (abstract).
It would have been prima facie obvious to use a pectin gel crosslinked by calcium ions (Ca2+) as the polysaccharide in the nanoparticles of ‘049 patent/Hennink because one having ordinary skill in the art would have recognized this as a suitable crosslinked polysaccharide to entrap a liposome. See MPEP 2144.07.
With regard to claim 24, Hennink discloses that the microparticles can encapsulate 10% or more of the lipid nanoparticle (col 9, lines 33-35), this leaves the remainder of the particle as the crosslinked polymer which contains the carbohydrate polymers such as dextran, starch, or cellulose that have been crosslinked with a crosslinking agent. Thus, Hennink implicitly discloses an amount of carbohydrate ranging from at least as high as 90% but lower in the event that the liposomes are present at greater than 10% of the particle. Hennink also discloses that the degree of crosslinking (i.e. the amount of crosslinking agent) can be used to control release of the liposome (col 5, lines 57-60: the crosslinking is carried out to such a degree that the pores (meshes) in the crosslinked structure eventually formed are substantially smaller than the size of the releasable entity). Thus, each of the ranges required by instant claim 24 for carbohydrate matrix, crosslinking agent, and lipid-based nanoparticle is taught by the prior art to be optimizable. See MPEP 2144.05(II)(A): 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 25, as noted above, Hennink discloses a range in particle size that overlaps with the range required by the instant claims. See MPEP 2144.05(I).
With regard to claim 26, as noted above, the microparticles disclosed by Hennink contain pores.
With regard to claim 30, as noted above, Lee discloses that the pectin gel is formed by binding to calcium (Ca2+), i.e. the divalent metal ion, calcium, is the cross-linking agent.
With regard to claim 35, as noted above, Hennink’s formulation is intended for oral delivery.
Claims 1-16, 18-26, 30, and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 7-10, 12, 13, 15-22, 25, 28, and 32 of copending Application No. 17914714 in view of Hennink et al. (US 6,395,302; issue date: 05/28/2002).
Inter alia the claims of the ‘714 application embrace a liposome falling entirely within the scope of the lipid-based particle required by the instant claims having [Pyrl]-apelin-13 contained in a liposome formed from DSPC, DPPC, cholesterol, PEG, and poloxamer.
The claims of the ‘714 application do not recite any limitation requiring a plurality of particles wherein each particle comprises a carbohydrate matrix comprising a polysaccharide and a crosslinking agent and containing a liposome.
Hennink discloses that peptides, proteins and proteinaceous products generally cannot be administered orally because they are chemically and physically unstable in the digestive tract and have a short residence time in the body, although it would be preferrable to be able to orally administer medicine (col 1, lines 26-39). The invention of Hennink is a patient friendly delivery system for protein drugs that is safe and biodegradable and possesses well controllable delivery kinetics and high degree of loading (col 4, lines 49-60). Hennink discloses that their system has good controlled release behavior comprising microencapsulated colloidal systems, specifically microencapsulated liposomes designed for delivery of active ingredients (col 1, lines 10-17) and particularly protein drugs which otherwise cannot be administered orally (col 1, lines 27-30). The microparticles that encapsulate the liposomes are crosslinked polymer particles having pores that are smaller than the releasable entity (i.e. the liposome containing the protein therapeutic) (col 5, lines 45-67). The particle size is controllable and generally ranges from 100 nanometers to 100 micrometers (col 6, lines 1-10). The examiner notes that if the polymer particles are crosslinked, they contain a crosslinking agent as required by instant claim 1. The microparticles are formed from carbohydrate polymers such as dextrans, starches, or celluloses (col 7, lines 17-24).
It would have been prima facie obvious to encapsulate the liposomes embraced by the ‘714 claims in the microparticle system disclosed by Hennink. The artisan of ordinary skill would have been motivated to do so in order to be able to orally deliver the active agent contained therein. The skilled artisan would have had a reasonable expectation of success because Hennink’s protocol merely requires suspending preformed liposomes followed by forming the polymer microparticles (see protocol in col 10-11).
Neither the claims of the ‘714 application nor Hennink disclose any of the polysaccharides recited in instant claim 1, pectin, guar gum, or oat milk carbohydrate.
Lee discloses that calcium pectin gels (i.e. a pectin polysaccharide crosslinked by calcium ion crosslinking agents) can entrap liposomes for extended release delivery of active agents (abstract).
It would have been prima facie obvious to use a pectin gel crosslinked by calcium ions (Ca2+) as the polysaccharide in the nanoparticles of ‘714 application/Hennink because one having ordinary skill in the art would have recognized this as a suitable crosslinked polysaccharide to entrap a liposome. See MPEP 2144.07.
With regard to claim 24, Hennink discloses that the microparticles can encapsulate 10% or more of the lipid nanoparticle (col 9, lines 33-35), this leaves the remainder of the particle as the crosslinked polymer which contains the carbohydrate polymers such as dextran, starch, or cellulose that have been crosslinked with a crosslinking agent. Thus, Hennink implicitly discloses an amount of carbohydrate ranging from at least as high as 90% but lower in the event that the liposomes are present at greater than 10% of the particle. Hennink also discloses that the degree of crosslinking (i.e. the amount of crosslinking agent) can be used to control release of the liposome (col 5, lines 57-60: the crosslinking is carried out to such a degree that the pores (meshes) in the crosslinked structure eventually formed are substantially smaller than the size of the releasable entity). Thus, each of the ranges required by instant claim 24 for carbohydrate matrix, crosslinking agent, and lipid-based nanoparticle is taught by the prior art to be optimizable. See MPEP 2144.05(II)(A): 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 25, as noted above, Hennink discloses a range in particle size that overlaps with the range required by the instant claims. See MPEP 2144.05(I).
With regard to claim 26, as noted above, the microparticles disclosed by Hennink contain pores.
With regard to claim 30, as noted above, Lee discloses that the pectin gel is formed by binding to calcium (Ca2+), i.e. the divalent metal ion, calcium, is the cross-linking agent.
With regard to claim 35, as noted above, Hennink’s formulation is intended for oral delivery.
This is a provisional nonstatutory double patenting 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617