DETAILED ACTION
Claims 1-18 are currently pending. Claims 1-13 are currently under examination.
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 .
Examiner’s Note
Applicant's amendments and arguments filed 03/10/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Maintained Rejections:
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4,663,286 in view of WO 2019/240219 (Furusako, IDS filed 6/26/23) as evidenced by English equivalent EP 3 808 783.
For ease of examination citations to Furusako are directed to locations in EP 3 808 783, which is an English language equivalent of WO 2019/2404219.
Regarding claims 1 and 12, the limitation of a structure comprising a core layer comprising a pharmaceutically ingredient imbedded in an alginate, a cationic polymer layer coating the core layer and an anionic polymer layer coating the cationic polymer layer is met by the ‘286 patent teaching a core material such as viable cells is encapsulated by telling an alginate polymer with a polyvalent cation to form a shape reacting gelled masses containing the core material. Polymer cationic polymer is taught as formed over the capsule. A second membrane layer may be formed by contacting the capsules with a second polymer cationic polymer. The second membrane may be coated with a polyanionic polymer such as an alginate (abstract).
Regarding claim 6, the limitation of wherein an anionic polymer forming the anionic polymer layer is alginic acid is met by the ‘286 patent teaching a coating of a polyanionic polymer such as alginate (abstract) wherein the polyanionic polymers are taught to include an acidic polysaccharide, such as an alginate salt (claims 10-13).
Regarding claims 7-8, the limitation of wherein the pharmacological ingredient embedded in a chemically crosslinked alginic acid in the core layer is a cell is met by the ‘286 patent teaching the core contains viable cells (abstract) wherein the cell growth is permitted and antibody production within the intracapsular volume is taught (column 7, lines 15-25).
Regarding claim 9, the limitation of wherein a cationic polymer forming the cationic polymer layer is poly-L-ornithine is met by the ‘286 patent teaching polyornithine (claims 13 and 25) or poly L-lysine (example 1).
Regarding claim 10, the wherein the shape of the structure is a bead, a sheet or a fiber is met by the ‘286 patent teaching capsules (column 9, lines 60-67) which read on beads.
Regarding claim 11, the limitation of wherein the structure being intended to be used in the living body is met by the ‘286 patent teaching designing the capsules for implantation (column 9, lines 60-67).
The ‘286 patent does not specifically teach a chemically crosslinked alginic acid (claim 1) with the specifically chemically modified alginic acid represented by Formula (H-I) and formula (H-H) (claim 2) specifically the elected
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(claims 3-5).
The ‘286 patent does not specifically teach the medical material is used as a cell transplantation substrate (claim 13).
Furusako teaches alginic acid derivatives represented by formula I and formula II and novel crosslinked alginic acid obtained by carrying out a Huisgen reaction using alginic acid derivatives of formula (I) and alginic acids of formula (II) proving a novel crosslinked alginic acid (abstract).
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Alginic acid is taught to be the acidic polysaccharide form ([0002], [0035]). The crosslinked alginic acid is taught to be molded into a bead which is highly stable and could be used to prepare a gel having a permeability more suited to the purpose then comparison with conventional gels [0018]. The structure is a bead or nearly spherical gel ([12]-[13]). The gel properties of the crosslinked product can be adjusted to adjust the substance permeability [0027]. The structure of formula I is taught to be
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wherein the right of the wavy line in the formula is excluded (page 16-17, [0306]). Formula II is preferably the structure of
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(page 27, [C114], [0225]). The alginic derivatives can be used in medicine, specifically medical materials such as wound dressings, postoperative adhesion prevention materials, sustained release materials and cell transplant substrates [0188]. When used as medicinal material, the crosslinked alginic acid structure may be in the form of a tube, fiber, bead, gel or like [0189].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the crosslinked alginic acid as taught by Furusako in the capsules taught by the ‘286 patent because Furusako teaches specific crosslinked alginic acid material to be used in implantable beads and the ‘286 patent teaches core material which comprise alginate gelled polymers. It would have been prima facie obvious to one of ordinary skill in the art to use the crosslinked materials of Furusako for the core taught by the ‘286 patent because Furusako teaches molded into a bead which is highly stable and could be used to prepare a gel having a permeability more suited to the purpose then comparison with conventional gels and the ‘286 patent teaches conventional gel alginates to form the core, thus providing a motivation. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Furusako and the ‘286 patent are directed to alginate gels forming a bead material to be used cells. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use exemplified alginate derivatives that fall within formulas I and II as taught by Furusako as Furusako specifically exemplifies
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of formula I and
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of formula II and Furusako specifically teaches the use of compounds of formula I and formula II to form the crosslinked alginate.
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 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/269,705 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘705 publication and the instant claims are directed to multilayer structures comprising a cell embedded in an alginate gel, wherein the alginate gel is comprised of crosslinked alginate derivatives of Formula I and Formula II (Formula H-I and Formula H-II). The crosslinked alginate core has a cationic polymer layer comprising poly-L-ornithine and an anionic layer over the cationic layer. The ‘705 application claims a gel fiber anticipating the fiber in the instant claim. The ‘705 application teaches the same structure as the instant claims, directed to multilayer structures comprising a cell embedded in an alginate gel, wherein the alginate gel is comprised of crosslinked alginate derivatives of Formula I and Formula II (Formula H-I and Formula H-II). The crosslinked alginate core has a cationic polymer layer comprising poly-L-ornithine and an anionic layer over the cationic layer, and thus would be capable of use in the body and as a wound dressing. Thus instant claims 1-13 are anticipated by the ‘705 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13 directed to an invention not patentably distinct from claims 1-8 of commonly assigned Application No. 18/269,705 Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned applications, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,312,574 in view of US 4,663,286.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘574 patent and the instant claims are directed to multilayer structures comprising a cell embedded in an alginate gel, wherein the alginate gel is comprised of crosslinked alginate derivatives of Formula I and Formula II (Formula H-I and Formula H-II). The crosslinked alginate core has a cationic polymer layer comprising poly-L-ornithine. The ‘574 claims teach a fiber meeting the limitations of claim 10, directed to a fiber. The ‘574 claims teach multilayer structure comprising a cell embedded in an alginate gel, wherein the alginate gel is comprised of crosslinked alginate derivatives of Formula I and Formula II (Formula H-I and Formula H-II) and cationic polymer layer and thus is capable of being used in a living body and for a wound dressing material. The ‘574 claims do not recite an anionic polymer layer coating the cationic polymer layer. This deficiency is made up for in the teachings of ‘286.
The ‘286 patent teaching a core material such as viable cells are encapsulated by telling an alginate polymer with a polyvalent cation to form a shape reacting gelled masses containing the core material. Polymer cationic polymer is taught as formed over the capsule. A second membrane layer may be formed by contacting the capsules with a second polymer cationic polymer. The second membrane may be coated with a polyanionic polymer such as an alginate (abstract). The use of a polyanionic coating over the cationic polymer coating layer is taught as desirable for implantation for physiological compatibly. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a polyanionic coating such as alginate over the cationic coating taught by the ‘574 patent because the ‘286 patent teaches it is known to use an anionic coating as the outer layer for physiological compatibility in an implantable composition.
Claims 1-13 directed to an invention not patentably distinct from claims 1-20 of commonly assigned U.S. Patent No. 12,312,574Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned patent, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: the ‘286 patent in view of the ‘219 publication (Furusako)
Applicant argues the ‘286 patent states the second membrane may be coated with polyanionic polymer such as alginate, suggesting the second polycationic polymer may be replaced with a polyanionic polymer. This point appears only in the abstract and not disclosed elsewhere in the specification. The ‘286 patent further discloses that after formation of the membrane it is preferable to reliquefy the capsule contents and that alginate gel masses crosslinked by multivalent cations may be redissolved by reaction with chelating agents. The ‘219 publication discloses chemically crosslinked alginic acid that cannot reliquefy. The combination cannot change the principle of operation of the primary reference and since the chemically crosslinked alginic acid of the ‘219 publication cannot be reliquefied, one of ordinary skill in the art would not replace alginate constituting the shape retaining gelled mases of the ‘286 patent with that of the ‘219 publication.
In response, a membrane is taught as formed around the gelling core material by contacting alginate with polycationic polymer, wherein the gelled membrane in the core may be liquified (abstract, column 5, lines 50-65). Thus, the capsule forming membrane which is additionally coated by a second membrane layer is not taught as dissolved and thus is not taught away from. Furusako teaches alginic acid derivatives where the crosslinked alginic acid is taught to be molded into a bead which is highly stable and could be used to prepare a gel having a permeability more suited to the purpose then comparison with conventional gels [0018]. It would have been prima facie obvious to one of ordinary skill in the art to use the crosslinked materials of Furusako for the core taught by the ‘286 patent because Furusako teaches molded into a bead which is highly stable and could be used to prepare a gel having a permeability more suited to the purpose then comparison with conventional gels and the ‘286 patent teaches conventional gel alginates to form the core, thus providing a motivation. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Furusako and the ‘286 patent are directed to alginate gels forming a bead material to be used cells. It would have been obvious to one of ordinary skill in the art to use the crosslinked alginates of Furusako to form the interior alginate membrane as the ‘286 patent teaches the core dissolves wherein the membrane is maintained and further coated.
Double Patenting:
Applicant requests the double patenting rejection be held in abeyance.
In response, Applicant has presented no substantive arguments thus the rejections are maintained for reasons of record.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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