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 .
Claims 1-20 are pending in this application.
Election with traverse
Applicant's election with traverse of the invention of Group I, claims 2-5, in the reply filed on 5/26/2026 is acknowledged. Applicant traverses the restriction requirement with respect to Groups I to IV; Applicant does not traverse the restriction requirement with respect to Groups V and VI.
The traversal with respect to Groups I to III is on the ground(s) that Groups I, II, and III are all classified in the same classification, CPC A61M 31/002, and “no serious search burden exists that would justify maintaining the restriction between these groups.” Applicant argues that the three capsule types of Groups I, II, and III “all operate by the same fundamental mechanism and achieve the same result of electrically-induced capsule deformation and rupture,” and because “Groups I, II, and III share the same CPC classification and the same core inventive concept of electrophoretic rearrangement causing capsule deformation, a search for one group would necessarily uncover prior art relevant to the other groups” (emphases added). Applicant further adds with respect to Group IV, “incremental burden of examining the dependent claims across all groups is minimal, as the core inventive concept [claim 1] has already been addressed.”
This is not found persuasive because CPC classification is not the only evidence of serious search burden. A61M 31/00, under which A61M 31/002 is in classification hierarchy, is for “Devices for introducing or retaining media, e.g. remedies, in cavities of the body.” It must be noted that claim 1 and inventions of Groups I, II, III, and IV are much broader in that they are not limited to delivering active ingredients in the cavities of the body. Clearly, A61M 31/00 or 31/002 would not be a complete and exhaustive search field for any of the inventions. Furthermore, CPC A61M 3/002 is for delivering a drug, whereas the actives of claim 1 and all the invention groups could be any active, such as non-drug dyes, or any other conceivable substance that could have some active functionality. Consequently, a search in A61M 31/002 is merely the start, not the end, of search burden for each of the inventions I, II, III, or IV.
Each of the inventions I to IV would require a different field of search to evaluate the activation or actuation technology for each different type of capsules. The search field for Group IV would further require review of valve technologies. Therefore, a different field of search, which is not likely to result in finding art pertinent to the other inventions, would be required for each of the inventions I to IV.
The requirement is still deemed proper and is therefore made FINAL.
Linking claims 1, 6, and 16 will be examined to the extent that they read on the elected invention Group I, claims 2-5. Claims 7-15 and 17-20 are withdrawn from further consideration as being directed to non-elected subject matter.
Prior art-based grounds of rejection
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raghavan et al. (hereinafter, Raghavan).
Raghavan discloses that electrical responses can be induced even in nonconducting biopolymer-based materials. When microcapsules made from common, biocompatible polysaccharides like alginate with ionic complexation are placed in aqueous solution and subjected to an electric field of about 10 V/cm, the particles deform in about a minute and burst within about 5 minutes. Raghavan discloses the mechanism for electrical bursting as including “electrophoretic movement.” Such deformation and bursting can be used to release solutes loaded inside these structures.
Claim 1 requires a cationic and anionic component, and claim 2 specifies alginate as the anionic component. Raghavan discloses alginate, which is anionic, and ionic complexation, which would require a cation.
Claim 1 also requires a pair of electrodes at least partially submerged in the aqueous solution. Although Raghavan does not explicitly disclose the term “electrodes,” Raghavan’s aqueous solution is subjected to an electric field of about 10 V/cm, and such uniform electric field would require electrodes at least partially submerged in the aqueous solution.
Claim 1 further requires, “wherein the aqueous solution (402) causes an electrophoretic rearrangement of ions or polyelectrolyte chains in the electroresponsive biopolymer capsule [ ], thereby deforming the electroresponsive biopolymer capsule [ ].” Raghavan discloses the mechanism for electrical bursting as including “electrophoretic movement.” Further, the same alginate microcapsule with ionic complexation is used by Raghavan and subjected to electric field, so the same electrophoretic rearrangement and deformation would have been obtained as claimed herein.
Claim 6 requires an inner core and an outer shell. Raghavan discloses solutes loaded inside the alginate capsules, thereby teaching an inner core and an outer shell.
The claims are thereby anticipated.
Claims 1-4, 6, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kasak et al. (hereinafter, Kasak).
Kasak discloses microcapsule having a core of calcium ion and sodium alginate and a membrane of poly(methylene-co-guanidine) and cellulose sulfate (PMCG and CS), which swell and decrease mechanical properties under applied electric current. See abstract; pages 770-776, sections 2.1.1, 2.1.2, 2.1.3, Fig. 1, section 3.1. The microcapsules are in a 0.9 wt% NaCl solution with electrodes at least partially submerged in the solution (sections 2.2, 2.3.2, and 3.1; Figs. 2 and 3; Table 1). Under exposure to electric current, anisotropic swelling of the membrane was observed (page 774, left column). In the microcapsule, Ca+2 ions migrated to the cathode side and water from the solution entered the alginate gel (page 774, left column). Under exposure to electric current, Ca+2 ions also migrated from the microcapsule core to the microcapsule shell, which caused decline of mechanical properties and leaking of the microcapsule (page 774, right column).
The claims are thereby anticipated.
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.
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.
Claims 1-6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Raghavan in view of Kasak, Ping et al. (hereinafter, Ping), Chou et al. (US 596,310; hereinafter, Chou), and KR 20200051239.
Raghavan discloses that electrical responses can be induced even in nonconducting biopolymer-based materials. When microcapsules made from common, biocompatible polysaccharides like alginate with ionic complexation are placed in aqueous solution and subjected to an electric field of about 10 V/cm, the particles deform in about a minute and burst within about 5 minutes. Raghavan discloses the mechanism for electrical bursting as including “electrophoretic movement.” Such deformation and bursting can be used to release solutes loaded inside these structures.
Kasak discloses microcapsule having a core of calcium ion and sodium alginate and a membrane of poly(methylene-co-guanidine) and cellulose sulfate (PMCG and CS), which swell and decrease mechanical properties under applied electric current. See abstract; pages 770-776, sections 2.1.1, 2.1.2, 2.1.3, Fig. 1, section 3.1. The microcapsules are in a 0.9 wt% NaCl solution with electrodes at least partially submerged in the solution (sections 2.2, 2.3.2, and 3.1; Figs. 2 and 3; Table 1). Under exposure to electric current, anisotropic swelling of the membrane was observed (page 774, left column). In the microcapsule, Ca+2 ions migrated to the cathode side and water from the solution entered the alginate gel (page 774, left column). Under exposure to electric current, Ca+2 ions also migrated from the microcapsule core to the microcapsule shell, which caused decline of mechanical properties and leaking of the microcapsule (page 774, right column).
Ping discloses agarose-alginate hydrogel beads for cell encapsulation, transportation, and release (abstract). Combination of features of alginate and agarose produces hydrogels with better quality that are suitable for stem cell transportation (page 105). See also page 106.
Chou (US 596,310) discloses encapsulating sperm cells in a particle comprised of alginate, calcium, and agarose (Examples 2, 3, 8) for artificial insemination (claim 1).
KR 202000512391 discloses agarose-alginate-calcium hybrid capsules are different from conventional alginate capsules in terms of strength and water release (Production Examples 1 and 5 on pages 2-3, Experimental Examples 3-4). The water release was more sustained for the hybrid capsule, which is beneficial for plant growth (Experimental Examples 4-5). Control of amount and timing of water release by changing the components of capsules is taught (page 5, lines 2-8). .
Claim 1 requires a cationic and anionic component. Raghavan discloses alginate, which is anionic, and ionic complexation, which would require a cation. Claim 3 requires that the cationic component is the calcium ion, Ca2+. Kasak teaches calcium as the cationic component to the anionic alginate.
Claim 1 also requires a pair of electrodes at least partially submerged in the aqueous solution. Although Raghavan does not explicitly disclose the term “electrodes,” Raghavan’s aqueous solution is subjected to an electric field of about 10 V/cm, and such uniform electric field would require electrodes at least partially submerged in the aqueous solution. Additionally, Kasak teaches electrodes at least partially submerged in the aqueous solution.
Claim 1 further requires, “wherein the aqueous solution (402) causes an electrophoretic rearrangement of ions or polyelectrolyte chains in the electroresponsive biopolymer capsule [ ], thereby deforming the electroresponsive biopolymer capsule [ ].” Raghavan discloses the mechanism for electrical bursting as including “electrophoretic movement.” Further, Kasak teaches migration of Ca2+ to the cathode side and also from the core to the shell. Because the same alginate microcapsule with ionic complexation is used by Raghavan and subjected to electric field, the same electrophoretic rearrangement and deformation would have been obtained as claimed herein.
Claim 5 requires the polymer ion capsule to be “embedded” in an agarose gel. Raghavan does not disclose a polymer capsule made of two different biopolymers. However, Kasak discloses that “agarose spheres were least affected by the electric field compared to other gel beads like alginate and agar” (page 770, left column) and further discloses combination of alginate, PMCB, and CS to produce a microcapsule. Ping teaches suitability of alginate and agarose for encapsulation of stem cell for transportation and release. Chou teaches encapsulation of sperm cells in particles comprised of alginate, calcium, and agarose. KR 20200051239 teaches adjustability of release by combining alginate, calcium, and agarose in delivering and releasing encapsulated water. The ordinary skilled artisan would have found it obvious from these teachings that various actives can be encapsulated and its release modified by calcium crosslinked alginate embedded in agarose, as such encapsulation is known for delivering various active ingredients with different release characteristics when such difference is required for end use. The ordinary skilled artisan would have been motivated to adjust or fine tune the deformation of encapsulated actives by using agarose gel to embed alginate capsules and use such embedded capsules for delivering and releasing various actives.
Claim 6 requires an inner core and an outer shell. Raghavan discloses solutes loaded inside the alginate capsules, thereby teaching an inner core and an outer shell. Kasak further teaches an inner core and outer shell.
Claim 16 requires sodium chloride solution. Kasak teaches placing the alginate microcapsules in a sodium chloride solution with electrodes. It would have been obvious to the ordinary skilled artisan that sodium chloride in the aqueous solution would make the solution better at conducting electricity because the sodium chloride dissolves to provide sodium and chloride ions to carry electrical current through the solution.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because every element of the invention and the claimed invention as a whole have been fairly disclosed or suggested by the teachings of the cited references.
For these reasons, all claims under examination are rejected. No claim can be allowed at this time.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to JOHN PAK whose telephone number is (571)272-0620. The Examiner can normally be reached on Monday to Friday from 8:30 AM to 5 PM.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's SPE, Fereydoun Sajjadi, can be reached on (571)272-3311. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/JOHN PAK/Primary Examiner, Art Unit 1699
1 Machine translation is provided herewith. All page references are to the machine translation page numbers.
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