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 .
DETAILED ACTION
1. Applicant's amendment, filed 12/23/25
is acknowledged.
Claims 1-4, 6-14, 17-32 are pending.
Claims 1-4, 6-14, 17-32 read on a method of treating acute respiratory distress syndrome (ARDS) or cytokine storm syndrome (CSS) in a subject comprising administering negatively charges particles are under consideration in the instant application.
2. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following new ground of rejection is necessitated by the amendment filed on 12/23/25.
3. 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.
4. Claim(s) 1-4, 6-14, 17-32 are rejected under 35 U.S.C. 103 as obvious over Yu et al. ( J of Nanobiotech, 2020, v.18, pp 1-16, IDS) WO 2017/075053 and WO2016057909 (IDS) in view of US Patent Application 20220257768
Applicant argument s filed on 12/23/25 have been fully considered but have not been found convincing.
Applicant asserts that: (i) as amended the claims now recited PLGA negative zeta particles. Yu et al. do not describe the use of said particles. (ii) WO’053 and WO’909 do not teach or suggest the used of PLGA having a negative zeta for treating ARDS or CSS
Newly cited US Patent Application 20220257768 teaches the use of PLGA having a negative zeta potential between -80mv to -30 mv and a diameter from 05mm to 3 mM for treating lung related injury and/or inflammations ( see entire document, paragraphs 0005 , 0014-0018, 0021 in particular.
Yu et al., teach a method of treating ARDS or CSS comprising administering negatively charged nanoparticles. Yu et al., teach that ARDS or CSS are result of direct lung-injury or lung inflammation. ( see entire document, Abstract and pages 2, 7 and Table 1 in particular ) .
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute negatively charge particles taught by Yu et al., with a PLGA having a negative zeta potential taught by US Patent’ 786 reasonable expectation of success because the prior art suggests that both types of particles can be used for treating lung-injury or lung inflammation that causes ARDS or CSS .
With regards to Applicant’s statement that “ WO’053 and WO’909 do not teach or suggest the used of PLGA having a negative zeta for treating ARDS or CSS”
It has been recently stated that KSR forecloses the argument that a specific teaching, suggestion, or motivation are required to support a finding of obviousness See Board decision ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
As has been sated previously, WO’ 053 teaches a method of treating inflammation disorders caused by viral or bacterial infection, that can result in CSS and/or ARDS in a subject comprising administering a negatively charges particles. WO’ 053 teaches that said negative particles comprises PLGA ( see entire document, Abstract and paragraphs, 0009, 0054, 00115 in particular).
WO’ 909 teaches a method of treating inflammation disorders caused by filovirus infection that can result in CSS and/or ARDS in a subject comprising administering a negatively charges particles. WO’ 909 teaches that said negative particles comprises PLGA ( see entire document, Abstract and paragraphs, 0013,0014 in particular).
Applicant provided no evidences or Declarations why it would not been obvious to one skied in the art to use teaching of WO’ 053 and WO’ 909 treat ARDA or CSS that is the result of rapid onset of inflammation disorder as indicated by Applicant ( see Applicant’s response page 7 in particular)
Claims 7-14, 20-26, 29 are included because it would be conventional and within the skill of the art to : (i) identify the type of virus or bacteria that induce ARDA or CSS (ii) identify the cause of ARDA or CSS; or (iii) determine the optimum composition and negative zeta potential said negative particles. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
Thus the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
5. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.131(c). 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. 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 filing date of the application will determine what form 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 https://www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
6. The claims 1-4, 6-14, 17-32 stand rejected on the grounds of nonstatutory double patenting of the claims 1-28 of US Patent 11,045492
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-28 of US Patent 11,045492 recited a method of treating a cancer in a subject , comprising administering to the subject a therapeutically effective amount of negatively charges particles. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that cancer can result in CSS and/or ARDS.
Applicant’s arguments and the Examiner’s rebuttable are essentially the same as set forth above for rejection under 103.
7. The claims 1-4, 6-14, 17-32 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application Nos 18/840232; 17/631277
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims of copending Application Nos 18/840232; 17/631277 recited a method of treating a cancer in a subject , comprising administering to the subject a therapeutically effective amount of negatively charges particles. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that cancer can result in CSS and/or ARDS.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
It is noted that Applicant requested to hold that provisional double patenting rejection in abeyance until allowable subject matter is identified.
8. No claim is allowed.
9. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). 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 extension fee 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644