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 01/05/25 is acknowledged.
2. Claims 1-2,6-8,10,12,14,18,20,23-28,30,31,49,50 are pending.
Claims 23-28,30,31 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1-2, 6-8, 10-,12,14,18,20, 49 and 50 read on a method of delivering an antibody to CNS are under consideration in the instant application.
The following new ground of rejection is necessitated by the amendment filed on 01/05/25
4. 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.
5. Claims 1-2, 6-8, 10-,12,14,18,20, 49 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20160243192 in view of Walter et al ( J of Extracellular Vesicles , 2017,v.6 supp.1 pp29) and US Patent Application 20250122565 in view of newly cited US Patent Application 20210322327 and US Patent Application 20220088215
Applicant’s arguments filed on 01/05/25 have been fully considered but have not been found convincing.
Applicant assets that as amended the claims now recited that antibody is covalently conjugated to the surface of extracellular vesicles. None of the prior art references teaches said feature.
Newly cited US Patent Application’327 teaches an extracellular vesicles (exosomes ) wherein antibody covalently conjugated to said exosomes. US Patent Application’327 teaches that said exosomes can be used for various immunoassay and immunotherapy ( see entire document, paragraphs 0010, 0041, 0209, 0400
Newly cited US Patent Application’215 teaches an extracellular vesicles (exosomes ) wherein antibody covalently conjugated to said exosomes. US Patent Application’327 teaches that said exosomes can be used for various immunoassay and immunotherapy ( see entire document, paragraphs 0030, 0055, 0149 in particular)
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to covalently conjugate antibody to exosomes with a reasonable expectation of success because the prior art suggests that said exosomes can be used for various immunoassay and immunotherapy
As has been stated previously,
US Patent Application’192 teaches a method of delivery an antibody to specific location in a subject comprising administering to the subject an extracellular vesicle ( exosomes) loaded with antibody. US Patent Application’192 teaches that exosomes can be obtained from any cell capable of secreting exosomes ( see entire document, Abstract and paragraphs 0004,0008, 0013 in particular).
US Patent Application’192 does not explicitly teaches exosomes derived from neural cells or that antibody attached to the surface of exosomes by way of linker.
Walter et al., teach the use exosomes derived from neural progenitor cells for delivering therapeutic agent to the subject. ( see entire document)
US Patent Application’565 teaches a conjugate comprising antibody attached to the surface of exosome by way of linker that can be used for delivering antibodies to specific locations when administered to the subject ( see entire document, paragraphs 0122,0180,0220,0303
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 obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute exosomes taught by US Patent Application;192 with exosomes taught by Walter et al and attaches antibody to the surface of said exosomes by the way of linker with a reasonable expectation of success because the prior art suggests that : both types of exosomes can be used for delivering therapeutical agents (antibody) when administered to the subject and that antibody can be attached to the surface of said exosomes via linker.
Claims 14, 20, 49 and 50 are included because it would be conventional and within the skill of the art to : (i) identify an optimal means and linker to conjugate antibody to the surface of exosomes 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).
From the teachings of the references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
6. 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.
7. Claims 1-2, 6-8, 10-,12,14,18,20, 49 and 50 stand provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of US Patent Application 20230173094 A1 for the same reasons set forth in the previous Office Action, mailed on 09/03/26.
Applicant argument filed on 01/05/26 have been fully considered but have not been found convincing.
Applicant asserts that the claims of the pending Application’094 are directed to an ER comprising an exogenous binding agent that specifically binds to CELSR3.
Contrary to Applicant’s assertion it is noted that the claims of the pending Application’094 broadly recited an ER comprising an exogenous binding agent (i.e. antibody see claim 12 in particular) that specifically binds to a protein expressed by brain endothelial cells.
It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute an exogenous binding agent that specifically binds to a protein expressed by brain endothelial cells with any antibody broadly recited in the instant claims.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims 1 claims of US Patent Application 20230173094 A are drawn conjugate comprising extracellular vesicle and antibody that are used in the presently claimed methods, and wherein the presently claims methods are disclosed in the specification of the US Patent Application 20230173094
This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
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