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 .
Receipt is acknowledged of Applicant’s Restriction Requirement Response filed on 12/22/2025; and IDS filed on 06/07/2023.
Claims 1-21 are pending in the instant application.
Claims 9-21 are withdrawn from consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-8) in the reply filed on 12/22/2025 is acknowledged.
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 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/010,219 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-application recites a core-shell microparticle comprising a biodegradable polymer with at least two or more surface cavities for use in the treatment of vascular disease, wherein the shell further comprises one or more drugs (see claim 1), wherein the shell comprises one or more anti-inflammatory drugs (see claim 4), wherein at least one anti-inflammatory drug is a steroid, preferably dexamethasone (see claim 5), wherein the biodegradable polymer is selected from an aliphatic polyester, aromatic copolyester, polyamide, poly(ester-amide), polyurethane, polyanhydride, polysaccharide, and blends or copolymers thereof (see claim 7), wherein the biodegradable polymer is poly(lactic-co-glycolic acid) (see claim 8).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 6, 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MOHAMED et al (PLGA microcapsules with novel dimpled surfaces for pulmonary delivery of DNA. International Journal of Pharmaceutics 311 (2006) 97–107).
MOHAMED teaches poly(lactic-co-glycolic acid)(“PLGA”) microcapsules with dimpled surfaces (see title; abstract; and pg. 102, Fig. 5), which reads on two or more cavities. The microparticles were prepared using PLGA, poly(vinylalcohol)(“PVA”) and dichloromethane (DCM) to form water-in-oil-water (w/o/w) double emulsion-solvent evaporation technique (see pg. 98, 2nd col – pg. 99, 1st col), which appears to be the same ingredients and method used by Applicant (see Applicant’s specification at [0166]), and would have a hollow core and shell (see pg. 103, Fig. 6). Additional disclosures include: 3-5um and >8 um diameter (see pg. 98, 1st col), such as 10um (see pg. 101, Table 2).
Note, MOHMED’s composition would be capable of being used as an ultrasound contrast agent, because MOHMED’s composition has the same ingredients as claimed by Applicant. Especially, when PLGA are well-known to be ultrasound detectable.
Claim(s) 1-4, 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SHIM et al (Fabrication of hollow porous PLGA microspheres using sucrose for controlled dual delivery of dexamethasone and BMP2. Journal of Industrial and Engineering Chemistry 37 (2016) 101–106).
SHIM teaches hollow porous PLGA microspheres for dual delivery of drugs (see title), which reads on hollow core and shell, wherein pores formed on the surface (see pg. 102, 2nd col), which reads on cavities. Additional disclosures include: the microspheres are produced by W/O/W double emulsion solvent evaporation method (see pg. 102, 2nd col), which appears to be the same method used by Applicant (see Applicant’s specification at [0166]); dexamethasone (DEX) is encapsulated in the PLGA shell (see pg. 103, Scheme 1), which reads on a hydrophobic chemical, such as dexamethasone (see Applicant’s specification at [0020]); bone morphogenetic protein-2 (BMP2) and type I collagen (Col1) drug are in the core (see pg. 103, Scheme 1), which reads on hydrophilic drug, such as proteins (see Applicant’s specification at [0021]).
Note, SHIM’s composition would be capable of being used as an ultrasound contrast agent, because SHIM’s composition has the same ingredients as claimed by Applicant. Especially, when PLGA are well-known to be ultrasound detectable.
Claim(s) 1-3, 5, 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WHEATLEY et al (US 2009/0028797).
WHEATLEY teaches hollow (see [0062]) microcapsules and nanocapsules (see [0006]) for ultrasound (see title) comprise of: poly(lactide)(“PLA”) or copolymer of poly(lactide) and poly(glycoside)(“PLGA”) (see [0099]) using PVA as a stabilizing agent (see [0105), wherein the microcapsules are indented (see [0148]), which reads on cavities. Additional disclosures include: peptide antibiotics can be encapsulated in the microcapsules (see [0065]), which reads on the core comprises a hydrophilic drug, such as peptides (see Applicant’s specification at [0020]).
Additional disclosures include: particle size can be controlled by the concentration of PVA (see [0164]) and raw droplet size formed during the emulsification stage (see [0165]).
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.
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) 1-3, 6-8 are is/are rejected under 35 U.S.C. 103 as being unpatentable over MOHAMED et al (PLGA microcapsules with novel dimpled surfaces for pulmonary delivery of DNA. International Journal of Pharmaceutics 311 (2006) 97–107).
As discussed above, MOHAMED teaches poly(lactic-co-glycolic acid)(“PLGA”) microcapsules with dimpled surfaces (see title; abstract; and pg. 102, Fig. 5), which reads on two or more cavities. The microparticles were prepared using PLGA, poly(vinylalcohol)(“PVA”) and dichloromethane (DCM) to form water-in-oil-water (w/o/w) double emulsion-solvent evaporation technique (see pg. 98, 2nd col – pg. 99, 1st col), which appears to be the same ingredients and method used by Applicant (see Applicant’s specification at [0166]), and would have a hollow core and shell (see pg. 103, Fig. 6). Additional disclosures include: 3-5um and >8 um diameter (see pg. 98, 1st col), such as 10um (see pg. 101, Table 2). Note, MOHMED’s composition would be capable of being used as an ultrasound contrast agent, because MOHMED’s composition has the same ingredients as claimed by Applicant. Especially, when PLGA are well-known to be ultrasound detectable.
The reference does not specifically teach the average diameter range as claimed by Applicant. The average diameter of a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, such as optimal size to be delivered to the target area. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Claim(s) 1-3, 5-8 are is/are rejected under 35 U.S.C. 103 as being unpatentable over WHEATLEY et al (US 2009/0028797).
As discussed above, WHEATLEY teaches hollow (see [0062]) microcapsules and nanocapsules (see [0006]) for ultrasound (see title) comprise of: poly(lactide)(“PLA”) or copolymer of poly(lactide) and poly(glycoside)(“PLGA”) (see [0099]) using PVA as a stabilizing agent (see [0105), wherein the microcapsules are indented (see [0148]), which reads on cavities. Additional disclosures include: peptide antibiotics can be encapsulated in the microcapsules (see [0065]), which reads on the core comprises a hydrophilic drug, such as peptides (see Applicant’s specification at [0020]). Additional disclosures include: particle size can be controlled by the concentration of PVA (see [0164]) and raw droplet size formed during the emulsification stage (see [0165]).
The reference does not specifically teach the average diameter range as claimed by Applicant. The average diameter of a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, such as optimal size to be delivered to the target area. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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