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. In view of the Appeal Brief filed 05/04/26 PROSECUTION IS HEREBY REOPENED.
New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678
2. Claims 1-20 are pending.
3. Claims 1-20 read on an expanded TILs pharmaceutical composition are under consideration in the instant application.
4. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
5. This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
6. Claims 1-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over US Patent Application, 20120244133 (IDS), Dudley et al., ( J of Immunol. 2003, v.26, pages 332-342,IDS) , US Patent Application 20170081635(IDS) and newly cited US Patent 5,126,132 and US Patent Application 20170044496
US Patent Application’ 133 teaches an expanded therapeutically effective dosage of TIL from in a pharmaceutical composition for adoptive cell immunotherapy , wherein said TIL were expanding in the medium comprising IL-2 and OKT-3 ( see entire document, paragraphs 0002,0008, 0021, 0030, 0057 in particular).
US Patent Application’ 635 teaches an expanded therapeutically effective dosage of TIL from a mammal for adoptive cell immunotherapy , wherein said TIL were expanding in the medium comprising IL-2 and OKT-3 ( see entire document, paragraphs 0002, 0072, 0092 in particular).
Dudley et al., teach 133 teaches an expanded therapeutically effective dosage of TIL in a pharmaceutical composition for adoptive cell immunotherapy , wherein said TIL were expanding in the medium comprising IL-2 and OKT-3 ( see entire document, Materials and Method in particular) and administering a therapeutically effective dosage of said expanding TILs to the subject.
Newly cited US Patent ‘496 teaches a composition comprising an expanded TILs and cryopreservant and IL-2(6,000IU/ml). US Patent ‘496 teaches an increase production of IFN-gamma after 3 weeks of culturing and expanding of said TILs ( see entire document, paragraphs 0005, 0033, 0120 and 0164 in particular).
Newly cited US Patent’132 teaches a composition comprising effective amount of expanded TIL in a range of about 5x109 to 5x1011 cells and IL-2 in a range of 100 IU/ml to 1000IU/ml ( see entire document, paragraph 19, and claims 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 use cryopreservant and an effective amount of TIL in the range of about 5x109 to 5x1011 cells and IL-2 in a range of 100 IU/ml to 1000IU/ml taught by US Patent ‘496 and US Patent’132 for the expanded TILs taught by US Patent Application’ 133, US Patent Application’ 635 and Dudley et al., teach 133 with a reasonable expectation of success because the prior art suggests that said dosages were well know for the skilled in the art for more than 25 years and were routinely used.
Claims 3-7 and 14 and 15 are included because said structural and functional properties would be an inherent/obvious properties of the recited expanded TILs, because the recited and instantly claimed are the same expanded TIL and there is no evidence of record of structural/functional differences between claimed and recited expanded TIL.
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.
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.
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 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 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/process/file/efs/guidance/eTD-info-I.jsp.
7. Claims 1-20 are rejected, or provisionally rejected in the case where the reference is a pending application, on the ground of nonstatutory double patenting as being unpatentable over the claims of the U.S. Patents and copending applications listed below. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case they claim either:
Methods of expanding tumor infiltrating lymphocytes comprising successive culturing steps, wherein there are al least two consecutive steps of culturing in media for a total of 22 days or less, Cells and compositions comprising such cells made by those culturing methods, wherein the cells are suitable for treating cancer, and/or methods of treating subjects with cancer comprising administering such TILs or compositions.
To the extent that the claims in the conflicting patents or applications are drawn to methods of treatment, or methods of expanding TILs as opposed to the now-claimed expanded TILs cell cultured the underlying specifications disclose the same cells as instantly claimed. See MPEP 804(II)(B)(1).
To the extent that the claims in the conflicting patents or applications are drawn to methods of culturing cells as opposed to the now-claimed expanded TILs cell cultured the underlying specifications disclose the same cells as instantly claimed underlying specifications disclose that the cells made by such methods See MPEP 804(II)(B)(1).
Issued U.S. Patents
12104172
It is noted that Applicant argues that claims of US Patent’ 172 recite exposing TILs to transcriptional factors and/or other molecules capable of transiently altering protein expression.
It is noted that the instant claims are drawn to the product, i.e. expanded TIL not a method of producing said TIL. Applicant provided no evidences that the TILs recited in claims of US Patent’172 are structurally/functionally different from the instantly claimed.
U.S. Patent Applications
17053344
18551138
17290705
17771723
17610671
17290639
18984595
It is noted that Applicant argues that instant Application has the earliest effective filing date and if no other rejections are remain than the rejection should be withdrawn.
It is noted that the claims of the instant Application stay rejected under 35 U.S.C. 103(a) ( see above)
8. No claim is allowed.
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
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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