DETAILED ACTION
Election/Restrictions
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
This Office Action is in response to the paper filed on 6/29/2026. Claims 1-10 are pending (claim set as filed on 6/29/2026). Claims 1 and 7 are amended. Claims 5-6 are withdrawn due to a restriction/election requirement. Claims 9-10 are new. Claims 1-4 and 7-10 are under examination.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN202211269196.5, filed on 10/17/2022 which finds full support for the instant claims. Therefore, the effective filing date of the application is 10/17/2022. Receipt is acknowledged of certified copies required by 37 CFR 1.55.
Withdrawal of Rejections
Rejection of claims 7-8 under 35 U.S.C. 112(b) (pre-AIA ) for being indefinite is withdrawn as the amendments to claim 7 have rendered the rejection moot. As claim 8 was rejected for depending on claim 7, the rejection is rendered moot as well and the rejection is withdrawn.
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.
Claims 1-4 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Rudi (Rudi et al., “Accumulation and Effect of Silver Nanoparticles Functionalized with Spirulina platensis on Rats”, 2021 Nov 7, Nanomaterials, 11, pgs. 1-14) and further in view of Alven (Alven et al., “Efficacy of Polymer-Based Nanocarriers for Co-Delivery of Curcumin and Selected Anticancer Drugs”, 2020 Aug 8, Nanomaterials, 10, pgs. 1-28).
Rudi’s general disclosure relates to a silver-spirulina nanoparticle complex administered to rats and wherein the silver nanoparticles have a wide application in medicine for antibacterial, antifungal, antiviral, anti-inflammatory, anti-angiogenic, and anticancer purposes (see abstract and pg. 1, ¶ 1).
Regarding claims 1 and 7, Rudi teaches a composition comprising silver nanoparticles loaded onto a spirulina biomass (see abstract), and wherein the silver nanoparticles are coated by a surface modifier chitosan (see pg. 11, ¶ 4). The composition was administered orally to the rat subjects (see abstract).
However, Rudi does not teach the composition further comprised an anti-radiation drug.
Alven’s general disclosure relates to a nanocarrier to deliver curcumin anti-radiation drugs (see abstract), and of which curcumin acts as an anti-inflammatory and anti-cancer therapeutic (see pg. 2, ¶ 1).
Regarding claims 1 and 7, Alven teaches a nanocarrier loaded with curcumin (see Alven pg. 2, ¶ 1). The instant specification exemplifies curcumin as a type of anti-radiation drug (see specification [0006]).
Regarding claims 1 and 7, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add the anti-radiation drug curcumin taught in Alven to the microalgae-nanoparticle composition as taught in Rudi. One would have been motivated to do so because Alven teaches curcumin offers several therapeutic effects such as anti-inflammatory properties and has been reported as an effective anti-cancer drug when combined with nanoparticles (see Alven pg. 2, ¶ 1). This would be advantageous to Rudi’s disclosure which states the silver-spirulina nanoparticles can be used for similar therapeutic purposes such as anti-inflammation and anti-cancer agents (see Rudi pg. 1, ¶ 1). Thus the ordinary artisan would have had a reasonable expectation of success in adding curcumin to the nanoparticle complex in Rudi as it is known in the art that curcumin-nanoparticle complexes are effective cancer therapeutics.
Regarding claim 2, modified-Rudi-Alven teaches the composition comprised curcumin (see Alven pg. 2, ¶ 1). The instant specification states that curcumin is a type of anti-radiation drug which is capable of preventing and/or treating radiation-induced cell, tissue, or organ damages (see specification [0006]).
Regarding claims 3 and 9, modified-Rudi-Alven teaches the nanoparticle was a poly (lactic-co-glycolic) (PLGA) nanoparticle (see Alven pg. 7, ¶ 1).
Regarding claims 4 and 10, modified-Rudi-Alven teaches the composition further comprises a surface modifier of chitosan which covers the nanoparticles (see Rudi pg. 11, ¶ 4).
Regarding claim 8, modified-Rudi-Alven teaches the composition further comprises a stabilizing excipient polyethylene glycol (see Rudi pg. 9, ¶ 4).
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 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17-18 of Application No. 18/606,877 in view of Rabiee (Rabiee et al., “Diatoms with Invaluable Applications in Nanotechnology, Biotechnology, and Biomedicine: Recent Advances”, 2021 Jun 21, ACS Biomaterials Science and Engineering, 7, pgs. 3053-3068).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims are directed towards:
an oral anti-radiation microalgae-nanoparticle compound preparation with a surface modifier (claim 1-2, 4, and 7)
the compound further comprising a pharmaceutically acceptable excipient (claim 8)
Co-pending Application No. 18/606,877 claims are directed towards:
pharmaceutical complex for radioprotection, comprising amifostine and natural microalgae (claim 1)
the pharmaceutical complex further comprising at least one active component such as amifostine and at least one pharmaceutically acceptable additive such as adhesives or excipients (claims 17-18)
Although the preambles are different, both sets of claims are directed to an anti-radiation composition comprising an anti-radiation drug, microalgae, and additives like adhesives (such as a surface modifier) and excipients. Co-pending Application No. 18/606,877 does not recite:
the compound further comprising a nanoparticle
Rabiee teaches a nanoparticle (see pg. 3058, ¶ 3).
It would have been obvious to one of ordinary skill in the art to add the nanoparticle as taught in Rabiee to the radioprotective pharmaceutical complex as taught in ‘877. The ordinary artisan would have been motivated to do so because Rabiee teaches that the nanoparticle encapsulation improves delivery of water insoluble drugs (see Rabie pg. 3058, ¶ 2). Therefore, such use of the nanoparticles would be considered an advantage in ‘877 which describes a drug delivery model for water-soluble compounds but not water-insoluble ones (see ‘877 [0007]).
Response to Arguments
Applicant's arguments filed on 6/29/2026 have been fully considered but are moot because the new ground of rejection based on the amendments of 6/29/2026. The pertinent arguments directed to any reference applied previously will be addressed below.
In response to the applicant’s amendments to claim 1 and the introduction of new claims 9-10, new art and grounds of rejections have been applied to claims 1-4 and 7-10.
In response to applicant’s arguments:
Rejections Under 35 U.S.C. § 102
As noted in the 103 rejection above, the amendment to claim 1 necessitated the addition of new prior art references Rudi and Alven which teach the amended limitations of a spirulina microalgae, a PLGA nanoparticle, and a chitosan surface modifier. Thus the argument that neither Rabiee nor Losic teach the drug-loading capabilities of porous silica diatoms is moot. It should be noted however that the applicant acknowledges that “diatoms inherently possess intrinsic biosilica frustules that provide naturally porous structures for drug loading and delivery” (see pg. 2, ¶ 4), which renders the argument moot as well. Applicant’s arguments with respect to claims 1-4 and 7-8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The argument that neither Rabiee nor Losic teach that the microalgae is Spirulina is moot as the combined teachings of Rudi and Alven teach the entirety of claim 1 and its dependent claims.
Double Patenting
In response to applicant’s request to hold the provisional non-statutory double patenting rejections of claims 1-8 in abeyance, they are advised to review MPEP 804(I)(B)(1). The applicant did demonstrate that the pending claims are patentably distinct from the reference claims, nor was a terminal disclaimer filed in accordance with 37 CFR 1.321 in the pending application. Thus the double patenting rejections still stand.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds 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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.R.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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