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 05/19/23 is acknowledged.
Claims 93-98,100-103,106,181-183 are pending.
Claims 93-98,100-103,106,181-183 read on a method for treating pro-inflammatory diseases comprising administering manufactured Treg are under consideration in the instant application.
2. 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 93 is given its broadest reasonable interpretation , it can read on administering the manufactured Treg obtained by the method disclosed in the instant specification. The instant Specification disclosed that manufactured Treg were obtained by incubating a population of de-differentiated T cells in the culture medium comprising anti-CD3/anti/CD28 beads in the presence of IL-2, IL-4 and TGF-β ( see paragraphs 0193-194 of the instant application).
3. 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.
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 93-98,100-103, 181-183 are rejected under 35 U.S.C. 102 (a) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US Patent Application 20260041688 and US Patent Application 20250114358.
US Patent Application’688 teaches a method of treating pro-inflammatory disease in a patient comprising administering to said patient an effective amount of manufactured Treg. US Patent Application’688 teaches that said Treg were obtained by stimulation of undifferentiated T cells in the culture medium comprising anti-CD3/anti/CD28 beads in the presence of IL-2, IL-4 and TGF-β. ( see entire document, paragraphs 0004, 0010, 0014, 0101, 0106, 0305 in particular).
US Patent Application’358 teaches a method of treating pro-inflammatory disease in a patient comprising administering to said patient an effective amount of manufactured Treg. US Patent Application’688 teaches that said Treg were obtained by stimulation of undifferentiated T cells in the culture medium comprising anti-CD3/anti/CD28 beads in the presence of IL-2, IL-4 and TGF-β. US Patent Application’358 teaches that said T regs can be administered together with administering lamivudine or pentostatin/cyclophosphamide or TNF-alpha therapy. ( see entire document, paragraphs 0015, 0017, 0022, 0023, 0028, 0039 in particular).
It is noted that US Patent Application’688 or US Patent Application 20250114358.
does not explicitly teach that manufactured T cells have the same functional/structural properties as claimed in the amended claim 93. However, the Treg cells recited in US Patent Application’688 were obtained by the same method as recited in the instant Specification, i.e. incubating a population of de-differentiated T cells in the culture medium comprising anti-CD3/anti/CD28 beads in the presence of IL-2, IL-4 and TGF-β , and thus would inherently have the same structural/functional properties as claimed. Since the office does not have a laboratory to test the reference Treg cells it is applicant’s burden to show that the reference Treg cells do not have the same functional/structural properties as recited in the claims. See In re Best, 195 USPQ 430, 433 (CCPA 1977); In re Marosi, 218 USPQ 289, 292-293 (Fed. Cir. 1983); In re Fitzgerald et al., 205 USPQ 594 (CCPA 1980).
Claims 94, 97, 98 ,103 and 183 are included because it would be conventional and within the skill of the art to : (i) identify an optimal dosage of administered Treg; (ii) optimal dosage and schedule of administered pentostatin and/or cyclophosphamide or lamivudine; (iii) and (iv) type of pro-inflammatory diseases to be treated. 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).
The reference teaching anticipates or , 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.
6. Claims 93, 96-98 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20260041688 in view of US Patent Application 20110130374.
The teaching of US Patent Application 20260041688 has been discussed supra.
US Patent’688 does not teach a method of treating pro-inflammatory diseases comprising administering pentostatin and/or cyclophosphamide.
US Patent Application’374 teaches a method of treating pro-inflammatory diseases in a subject comprising administering pentostatin and/or cyclophosphamide ( see entire document, paragraphs 0008, 0042, 0044 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 administered pentostatin and/or cyclophosphamide prior to administering Treg with a reasonable expectation of success because the prior art suggests that both agents can be used for treating pro-inflammatory diseases.
“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 97, 98 are included because it would be conventional and within the skill of the art to : (i) identify an optimal dosage of administered pentostatin and/or cyclophosphamide .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).
7. Claims 93, 100-103 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20260041688 in view of US Patent Application 20200188409
The teaching of US Patent Application 20260041688 has been discussed supra.
US Patent’688 does not teach a method of treating pro-inflammatory diseases comprising administering lamivudine.
US Patent Application’409 teaches a method of treating pro-inflammatory diseases in a subject comprising administering lamivudine ( see entire document, paragraphs 0009, 0029 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 administered lamivudine and Treg with a reasonable expectation of success because the prior art suggests that both agents can be used for treating pro-inflammatory diseases.
“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).
Claim 103 and is included because it would be conventional and within the skill of the art to : (i) identify optimal dosage and schedule of administered lamivudine. 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).
8. Claims 93, 106 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20260041688 in view of US Patent Application 20140010822
The teaching of US Patent Application 20260041688 has been discussed supra.
US Patent’688 does not teach a method of treating pro-inflammatory diseases comprising administering anti-TNF-alpha therapy
US Patent Application’822 teaches a method of treating pro-inflammatory diseases in a subject comprising administering anti-TNF alpha therapy( see entire document, paragraphs 0009, 0029 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 administered lamivudine and Treg with a reasonable expectation of success because the prior art suggests that both agents can be used for treating pro-inflammatory diseases.
“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).
From the combined teaching of the references, it is 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.
9. 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.
10. The claims 93-98,100-103, 181-183 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Applications 17/320891,18/913,444 in view of US Patent Application 20110130374, US Patent Application 20200188409, US Patent Application 20140010822
Claims of copending Applications 17/320891,18/913,444 each recited method of treating pro-inflammatory diseases in a subject comprising administering manufactured Treg.
US Patent Application’374 teaches a method of treating pro-inflammatory diseases in a subject comprising administering pentostatin and/or cyclophosphamide ( see entire document, paragraphs 0008, 0042, 0044 in particular).
US Patent Application’409 teaches a method of treating pro-inflammatory diseases in a subject comprising administering lamivudine ( see entire document, paragraphs 0009, 0029 in particular).
US Patent Application’822 teaches a method of treating pro-inflammatory diseases in a subject comprising administering anti-TNF alpha therapy( see entire document, paragraphs 0009, 0029 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 administered pentostatinand or cyclophosphamide, lamivudine and anti-TNF-alph therapy Treg with a reasonable expectation of success because the prior art suggests that each agents can be used for treating pro-inflammatory diseases.
“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).
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
11.No claim is allowed.
12. 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