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. Claims 1,2, 6,10,11, 12,20,27, 32, 35-37,40,44-46,54,61-63,71,72 and 74 are pending.
2. Applicant's election with traverse of Group I, claims 1,2, 6,10,11, 12,20,27, 32 ,in the reply filed on 11/07/25 is acknowledged. Applicant traverse the Restriction Requirement on the grounds that the search of Groups I-II together would not constitute a serious search burden on the examiner and that search of the claims of Group I would provide useful information for the claims of Group II
This is not found persuasive because the MPEP 803 (August 2001) states that “For purposes of the initial requirement, a serious burden on the examiner may be prima facie shown if the examiner shows by appropriate explanation either separate classification, separate status in the art, or a different field of search”. The Restriction Requirement enunciated in the previous Office Action meets this criteria and therefore establishes that serious burden is placed on the examiner by the examination of more than one Group. The Inventions are distinct for reasons elaborated in paragraphs 3-5 of the previous Office Action and above
The requirement is still deemed proper and is therefore made FINAL.
3. Claims 35-37,40,44-46,54,61-63,71,72 and 74 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1,2, 6,10,11, 12,20,27, 32 read on a method for treating B-cell hyperproliferative disorder and a subject are under consideration in the instant application.
Prior of setting art rejection it is noted that during patent examination, the pending claims must be "given the broadest reasonable interpretation consistent with the specification." See MPEP 2100.
Thus, when claim 1 is given its broadest reasonable interpretation , it can read on a method for treating a B-cell hyperproliferative disorder in a subject with CD19 targeted therapy and one of the agents recited in step ( a) of claim 1.
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, 6,10,11, 12,20,27, 32 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20190336504 in view of US Patent Application 20180104354 and US Patent Application 20250109194
US Patent Application’504 teaches a method of treating a B-cell hyperproliferative disorder in a subject using CD19-targeting therapy. US Patent Application’504 teaches that said CD19-targeting therapy comprises administering anti-CD19 CAR-T cells. US Patent Application’504 teaches that said therapy should be done in combination with other CD19 targeting therapy ( see entire document, paragraphs 006, 0008, 0017, 0026, 0033 in particular.
Us Patent’504 does not explicitly teach administering one of the agents as recited in claim 1 step (a )
US Patent Application’354 teaches a method of treating B-cell hyperproliferative disorder ( CLL or ALL) comprising administering combination immunotherapy including administering anti-CD19 antibody ( see entire document, paragraphs 0004, 0005 , 0008, 0011 in particular).
US Patent Application’194 teaches a method of treating B-cell hyperproliferative disorder ( cancer) comprising administering combination immunotherapy including administering bispecific antibody. US Patent Application’194 teaches that said bispecific antibody comprising a first binding domain having affinity to CTLA-4 ( immune checkpoint surface protein) and a second binding domain, having an affinity to PLXDC1 ( non-CD19 pericyte surface protein) ( see entire document, paragraphs 0012, 0154, 0160, 0324 0346 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 combine CD19-targeting therapy taught by US Patent Application 20190336504 together with anti- CD19 antibody or bispecific antibody taught by US Patent Application 20180104354 and US Patent Application20250109194 with a reasonable expectation of success because the prior art teaches that each of said treatment was successful used in combination therapy for treating of B-cell hyperproliferative disorder.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
Claims 10 is included because it would be conventional and within the skill of the art to : (i) determine the optimum means of administration of the agent. 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).
Claim 27 is included because the administered agents of the prior are the same as instantly claimed it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories 58 USPQ2d 1508 (CAFC 2001). “{i}t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable”. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious.
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
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.
The claim is provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application No. 17/149541 in view of in view of US Patent Application 20180104354 and US Patent Application20250109194.
Claims of copending Application No. 17/149541 recited a method of treating cancer expressing CD19 in a subject ( B-cell hyperproliferative disorder) comprising administering CD-targeted therapy comprisng anti-CD19 CAR-T cells ( see pending claims 34, 36 in particular)
Claims of copending Application No. 17/149541 do not explicitly teach administering one of the agents as recited in instant claim 1 step (a )
US Patent Application’354 teaches a method of treating B-cell hyperproliferative disorder ( CLL or ALL) comprising administering combination immunotherapy including administering anti-CD19 antibody ( see entire document, paragraphs 0004, 0005 , 0008, 0011 in particular).
US Patent Application’194 teaches a method of treating B-cell hyperproliferative disorder ( cancer) comprising administering combination immunotherapy including administering bispecific antibody. US Patent Application’194 teaches that said bispecific antibody comprising a first binding domain having affinity to CTLA-4 ( immune checkpoint surface protein) and a second binding domain, having an affinity to PLXDC1 ( non-CD19 pericyte surface protein) ( see entire document, paragraphs 0012, 0154, 0160, 0324 0346 in particular).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to combine CD19-targeting therapy taught by claims of copending Application No. 17/149541 together with anti- CD19 antibody or bispecific antibody taught by US Patent Application 20180104354 and US Patent Application20250109194 with a reasonable expectation of success because the prior art teaches that each of said treatment was successful used in combination therapy for treating of B-cell hyperproliferative disorder.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
7. No claim is allowed.
8. 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, Daniel Kolker can be reached on 571/ 272-3181
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