DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's amendment and remarks, filed 5/7/26, are acknowledged.
Claims 109, 111, 115, 119-120, 126 have been amended.
Claims 109-120, 122-131 are pending.
Claims 112 and 130-131 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 109-111, 113-120, 122-129 are being acted upon.
In view of Applicant’s claim amendments, the previous grounds of rejection are withdrawn.
The following are new grounds of rejection necessitated by Applicant’s claim amendments.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 109-111, 113-120, and 122-129 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Step d) of claim 109 is unclear and indefinite for several reasons. The claim requires expanding the third population of T cells in a third culture medium comprising a third concentration of the peptide antigen, wherein expanding further comprises gradually increasing concentration of the peptide antigen in the third cell culture medium relative to the third consecration of the peptide antigen in the third cell culture medium by sequentially adding two or more pulses of the peptide antigen during the expansion, and wherein a concentration of the peptide antigen in the third culture medium increases at least 1.1 fold with each addition. This is understood to require expanding the third population, wherein the third population is placed in a third culture medium comprising a certain concentration of the peptide antigen (i.e. comprising a third concentration of the peptide antigen), and then adding two or more additional pulses of the peptide antigen to said third culture medium. However, the timeframe of the addition and the particular concentration of peptide required to be added is unclear and indefinite. The claims require “gradually” increasing concentration by “sequentially adding two or more pulses”. However, gradual is a relative term and the specification does not define the term or provide a standard for assessing the requisite degree. In the examples of the specification, the sequential pulses are added one day apart. However, it is unclear what other timeframes would meet this limitation. Would pulsing 3 min apart be considered gradual or not, for example? Regarding the limitation that the concentration of peptide antigen increases at least 1.1 fold with each addition, it is not clear what is encompassed. For example, if the third T cell population is expanded in a third culture medium with a 1 um third concentration of the peptide antigen, would adding a 0.2 uM peptide pulse be within the scope? In this case the overall concentration of peptide in the culture could be 1.2 uM (1 uM added in the first step, and an additional 0.2 uM added in the pulse). This would be 1.2 fold higher that the initial concentration of 1 uM. However, requiring a certain concentration of the peptide antigen “in the third cell culture medium” after multiple pulses at any time period is unclear, since there is no way to know the concentration remaining, since peptides would be degraded in the culture, depending on the time period of the gradual addition. For example, a culture initiated with addition of 1uM of peptide, after a day, would still have some amount of peptide left, while some (unknown amount) could be degraded in the culture. How would one know what amount could be added such that the concentration “in the third cell culture medium increases at least 1.1 fold”. Or do the claims intend that the amount added in each pulse is 1.1 higher that what was added in the prior culture step. It is noted that in the examples, the method involves adding 100 nM peptide on day 15 (the third culture), then pulsing by adding 400 nM peptide on day 16, and adding 1000 nM peptide on day 17, which is referred to as exponential peptide stimulation (see paragraph 686, in particular). Thus, based on the examples, it appears that the claims may be intending to require adding an amount of peptide in each pulse that is at least 1.1 times the amount added in the prior pulse. For example, if the third concentration of the peptide antigen in the third cell culture medium was 1uM, would the claims then require adding at least a 1.1uM peptide pulse to the culture during the first sequential pulsing step? The scope of the claims is unclear and indefinite.
Claim 120 is indefinite in that it recites limitations further defining the sequential third culture step with gradually increasing the peptide over a time period of about 10 days to expand the third population, “followed by” further expanding the third population of T cells in the presence of “a fourth concentration of the peptide antigen” followed by expanding the third population of T cells in the presence of a “fifth concentration of the peptide antigen”. It is unclear if the reference to the fourth and fifth concentration refer to the at least 2 additional pulses added in claim 109 (which would technically involve culturing the third population of T cells in the presence of a fourth and fifth concentration of the peptide antigen that is provided after each addition of peptide in the pulsing step). Or are the fourth and fifth pulse reference in claim 120 performed after the at least 2 pulses in claim 109? Does claim 120 limit the 2 or more pulses in claim 109 to 3, and then the fourth and fifth come after the three of claim 109? Would claim 120 encompass performing 4 pulses in step d) of claim 109, and then the “fourth” and “fifth” concentration would refer to addition of peptide antigen after the first, second, third and fourth addition in claim 109? The scope of the claim is unclear and indefinite.
The term “about” in claim 120 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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