DETAILED ACTION
Claims 19-28 are currently pending. Claims 19-23, 25 and 27-28 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 .
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 09/23/2026 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Specification
The specification amendments submitted 08/21/2026 are entered as correcting typographical errors.
Withdrawn Rejection
The objection over claim 27 is withdrawn based on Applicant’s amendment to conform with lowercase for all polymer names.
The 112(b) rejection of claim 21 for antecedent basis is withdrawn based on Applicant’s claim amendments to refer back to the first polymer.
Examiner’s Note
Applicant's amendments and arguments filed 05/21/2026 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed 05/21/2026, it is noted that claims 19, 21 and 27 are amended and claim 28 is newly added. No new matter or claims have been added.
Modified Rejection:
The following rejections are modified based on Applicant’s claim amendments and newly added claim.
Claim Rejections - 35 USC § 112 (b)
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 19-23, 25 and 27-28 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 19 recites “first polymer selected from the group consisting of” wherein specific polymers are named. The claim additionally recites “first charges generated at a surface of the delivery layer”. The polymeric layer additionally recites “a second polymer having an uncharged backbone” and “second charges generated at a surface of the polymeric layer”. It is unclear if the polymer is uncharged or just a specific part of the polymer is uncharged or if the pendant groups such as sulfate groups count as the “surface charge”. The specification provides no clarification and does not contain any mention of “uncharged backbone”. Therefore, the metes and bounds of “uncharged backbone” and the first polymer selected from a specific list with “charges generated at the surface” are unclear as to whether they may be part of the polymer or the polymer is uncharged and only charges are generated on the surface and not incorporated into the polymer through additional pendant groups, grafted groups or other polymeric chains in a copolymer. For examination purposes charges which are part of the polymer will be deemed to meet the instant claim limitation. Claims 20-23, 25 and 27-28 are further rejected as not clarifying the ambiguity of claim 19.
Claim 21 recites the limitation "the film forming material" in second line. There is insufficient antecedent basis for this limitation in the claim. Instant claims 19 is directed to delivery layer including a first polymer. Claim 19, from which claim 21 depends, does not include a recitation of “film forming material”.
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) 19-23, 25 and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0254095 (IDS dated 05/22/2023) in view of US 2014/0093575 (IDS dated 05/22/2023) and US 2013/0052134 (previously applied).
Regarding claim 19, the limitation of a pulsatile delivery device comprising a stack of at least two bilayer structures, each bilayer structure including a delivery layer including a first polymer having an uncharged backbone selected from the group including heparin sulfate, heparin and alginate and a predetermined substance dispersed through the first polymer; first charges generated at a surface of the delivery layer, and a polymeric layer including a second polymer having an uncharged backbone selected from the group including PLLA, and a sealant partially surrounding the stack so that one of the polymeric layer of the stack is exposed is met by the ‘095 publication teaching a delivery device includes a hollow container and a plurality of biodegradable and/or erodible polymeric layer establishing in the container, a layer including a predetermined substance is established between each of the plurality of polymeric layer, whereby degradation of the polymer layer and release of the predetermined substance occur intermittently (abstract, Figure 1E&F, [0008]). The advantageously be tailored for specific needs [0019]. The mold is printed in a layer by layer fashion [0023]. The material includes PLLA which is suitable for its mechanical properties and biodegradability [0025]. PEG may be added to the polymer layer for degradability [0028]. The layer containing the predetermined substance is taught to include heparin sulfate, dextran and alginate [0031], wherein sulfate has a negative charge. Suitable substances are taught to include hormones (e.g. PTH) [0033].
Regarding claims 21-23, the limitation of wherein the polymeric layer is polyanhydride, the predetermined substance is parathyroid hormone and the film forming material is alginate is met by the ‘095 publication teaching the polymer layer may be anhydride [0028], the active may be PTH [0033] and the delivery layer polymer may be alginate [0031].
Regarding claim 27, the limitation of wherein the sealant is selected from the group consisting of polycaprolactone, poly(glycolide-co-caprolactone) is met by the ‘095 publication teaching polycaprolactone [0025].
The ’095 publication does not specifically teach second charges generated at a surface of the polymeric layer in a direction opposite that of the first charges, than the second polymer; wherein the first and second charges are opposite each other and are electrostatically attached to each other (claim 19) wherein the positive charges are on the polymeric layer and the negative charges are on the delivery layer (claim 25).
The ’575 publication teaches a layer by layer film (abstract). The layer by layer film includes one or more therapeutic or other agents in at least one of its layers [0004] wherein the layers have alternating charges [0007] wherein the charges interact [0092], thus leading to electrostatic attachment which would necessarily eliminate air gaps between he bilayers (claim 20) as claimed as the structure and electrostatic interaction is taught. The LBL films are one or more distinct sets of layers including bilayer [0091]. LBL films can include alternating layer of opposite charge that is anionic and cationic layers. Anionic groups include sulphate groups that are pendant form the backbone [0092] which include carboxymethyldextran, alginic acids and hyaluronic acids [0094], reading on claims 19, 21 and 28. Positive charged include cationic groups containing cationic groups such as poly(lysine) [0093]. Polyelectrolyte films may include PLA as copolymers, mixture and adducts of these polymers may be employed to make the LBL films amenable to use in vivo [0099]. Hormones are taught as an active agent [0102]. Releasable agents can thus be gradually and controllably released from the LbL film [0098].
The ‘134 publication teaches the PEG-PLGA-PLL polymer is taught which may be cationic polymer and a carrier for an active agent (abstract, [0001]). The degradable polymer poly(lactic-co-glycolic acid) (PLGA) may be slowly degraded in vivo, allowing the drug to be slowly released with the material degradation, thereby achieve the curative effect for a long time. The cationic polymer poly-L-lysine (PLL) has good biodegradability and is degradation product is the amino acid required for the human body. PLL compound still bears the positive charge with flexible and stable structure and the polymer skeletons may be modified by introducing side chains [0044], wherein the PLLA compound reads on “second charges generated at a surface of the polymeric layer.
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 cationic and anionic polymers for the film layers taught by the ‘095 publication because the ‘095 publication teaches alternating layers wherein drug releasing layer include lactide polymers and polymer layers includes heparin sulfate, dextran or alginate and the ‘575 publication teaches the use of alternating cationic and anionic layers for drug release wherein the anionic layers include heparin and sulfate groups, carboxymethyldextran and anionic alginate and positive charges groups include PLL and can include lactide polymers, with the ‘134 publication teaching specifically PEG-PLGA-PLL cationic polymers for drug release. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use cationic and anionic layers for the film taught by the ‘095 publication because the ‘575 publication teaches alternating bilayer structures for drug release in the form of LBL films and the ‘095 publication teaches the use of layer by layer formation of the coating film. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘095 publication, the ‘575 publication and the ‘134 teach overlapping polymers used for drug release in the body. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success in using anhydride polymers and alginate or carboxymethyldextran as the ‘095 publication teaches anhydrides polymers and alginate or dextran and the ‘575 publication teaches anionic polymers include alginic acid and carboxymethyldextran and polymers may include polyanhydrides. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to modify the polymers of the ‘095 publication to obtain charged polymers for LbL assembly because the ‘575 publication teaches there are several advantages to LbL assembly including mild conditions, flexibility to coat objects of any size, shape or surface chemistry thus leading to versatility in design options [0109].
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 19-23 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,571,389. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘389 patent teaches a pulsatile delivery device comprising a stack of bilayers wherein the deliver layer is a film forming material which is negatively charged polymer including alginate including PHT and the polymer layer is positively charged including anhydride polymers and a sealant partially surrounding the stack of the polymer layers so that one of the sealant partially surrounding the attack is exposed, thus reading on the instant claims.
Claims 19, 22 and 25 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-15 of U.S. Patent No. 8,623,397 in view of US 2014/0093575 (previously applied). The ‘397 patent teaches a delivery device comprising a hollow container, a solid polymer layer including PLLA and a solid layer including the predetermined substance and formed of alginate or heparin sulfate (anionic) and wherein the active agent includes hormones. The ‘397 patent does not specifically teach a positively charged polymeric layer containing charges on the surface.
The ’575 publication teaches a layer by layer film (abstract). The layer by layer film includes one or more therapeutic or other agents in at least one of its layers [0004] wherein the layers have alternating charges [0007] wherein the charges interact [0092], thus leading to electrostatic attachment which would necessarily eliminate air gaps between the bilayers (claim 20) as claimed as the structure and electrostatic interaction is taught. The LBL films are one or more distinct sets of layers including bilayer [0091]. LBL films can include alternating layer of opposite charge that is anionic and cationic layers. Anionic groups include sulphate groups that are pendant form the backbone [0092] which include alginic acids and hyaluronic acids [0094]. Positive charged include cationic groups containing cationic groups such as poly(lysine) [0093]. Polyelectrolyte films may include PLA as copolymers, mixture and adducts of these polymers may be employed to make the LBL films amenable to use in vivo [0099]. Hormones are taught as an active agent [0102]. Releasable agents can thus be gradually and controllably released from the LbL film [0098]. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to add positive charges to the polymeric layer of the ‘397 patent because the ‘397 patent teaches layered drug delivery wherein the drug delivery layer has a negative charge and the ‘095 publication teaches alginate sulfate and cationic layer to obtain a layered drug delivery structure, wherein one would be motivated to do so because the ‘575 publication teaches there are several advantages to LbL assembly including mild conditions, flexibility to coat objects of any size, shape or surface chemistry thus leading to versatility in design options [0109], thus motivating one of ordinary skill in the art to use a positively charged polymeric modification to the PLLA or polyanhydride polymeric layer.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
112(b):
Applicant argues the phrase “having an uncharged backbone” relative to the first polymer has been removed.
In response, the metes and bounds of “uncharged backbone” and the first polymer selected from a specific list with “charges generated at the surface” are unclear as to whether they may be part of the polymer or the polymer is uncharged and only charges are generated on the surface and not incorporated into the polymer through additional pendant groups, grafted groups or other polymeric chains in a copolymer. For examination purposes charges which are part of the polymer will be deemed to meet the instant claim limitation.
103: The ‘095 publication (Ma), the ‘575 publication (Hammond) and the ‘134 publication (Duan)
Applicant argues the instant specification describes pulsatile delivery device consisting of alternating polymer layers and delivery layer, wherein the charge is generated on the surface including PTFE and glass slide. Applicant points to figures 7B and 8B demonstrating specific surface potential. Amended claim 19 recites first charges generated at a surface of the delivery layer such that a surface potential of the delivery layers greater, in either a positive direction or a negative direction than the first polymer.
In response, Applicant is arguing limitations not present in the instant claims. The instant claims do not contain limitations directed to the specific potential on the surface, nor the method of obtaining said surface charge. The instant claims do not clearly convey how the surface potential on the layer, wherein the claim limitations read on the polymer being modified by additional copolymers, grafted monomers or pendant groups, which would result in the charge being distributed throughout the polymeric layer including on the surface.
Applicant argues while the ‘575 publication includes alternating layer of opposite charge is does not disclose that layers exhibit a more positively charged or more negatively charged surface than the original form of the respective polymer used to form the respective layer. The ‘575 publication does not teach or suggest additional charged being generated at respective surface of the alternating layers. At most it discloses where an LBL film is made of a first layer that is positively charged polyelectrolyte with a first adjacent layer is biotin end functionalized PEG. The ‘575 publication states poly-L-lysine was functionalized to NHS-activated iminobotin or NHS-activated biotin on primary amine side groups. Polymer charges introduced groups can be oppositely charged. This is very different than charged generated at the respective surfaces.
In response, Applicant argues limitations that are not present in the claimed. The claims are directed to a charged surface compared to the first polymer or the second polymer. This however is not limited to a surface charge being added to an otherwise uncharged polymer, and reads on a base polymer being modified through pendant groups or additional monomers. The ‘095 publication teaches the use of heparin sulfate [0031], reading on heparin with an additional sulfate group reading on heparin with charge generated on the first polymer. The ‘095 publication teaches the use of degradable polymers including PLGA and polycaprolactone [0029] and the ‘575 publication teaches anionic groups include sulphate groups that are pendant form the backbone [0092] which include carboxymethyldextran, alginic acids and hyaluronic acids [0094], reading on claims 19, 21 and 28. Positive charged include cationic groups containing cationic groups such as poly(lysine) [0093]. Polyelectrolyte films may include PLA as copolymers, mixture and adducts of these polymers may be employed to make the LBL films amenable to use in vivo [0099]. The ‘134 publication teaches PLL compound still bears the positive charge with flexible and stable structure and the polymer skeletons may be modified by introducing side chains [0044], wherein the PLLA compound reads on “second charges generated at a surface of the polymeric layer. The ‘575 publication teaches the use of alternating cationic and anionic layers for drug release wherein the anionic layers include heparin and sulfate groups, carboxymethyldextran and anionic alginate and positive charges groups include PLL and can include lactide polymers, with the ‘134 publication teaching specifically PEG-PLGA-PLL cationic polymers for drug release.
Applicant argues the ‘134 publication does not supply the noted deficiencies of the ‘095 publication and the ‘575 publication.
In response, Applicant’s arguments regarding the ‘095 publication and the ‘575 publication are addressed above as first presented.
Double Patenting:
Applicant argues the amendments overcome the rejection.
In response, Applicant is referred to the modified rejections above. Applicant has presented no specific arguments and thus the rejection is maintained for reasons or records.
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.
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.
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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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