DETAILED ACTION
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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Culture of Regulatory T-cells.
Claim Rejections - 35 USC § 112
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 2 and 9 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.
Regarding claim 2, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “a population of Tregs”, and the claim also recites “particularly a population of CD4+CD25+Tregs” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 9, broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “at least about 15 minutes”, and the claim also recites “at least about 30 minutes to about 90 minutes” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 9, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 12, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation “at least about 6 hours”, and the claim also recites “about 12 to about 72 hours”; “about 12 to about 60 hours”; “about 36 to about 60 hours”: and about 48 hours”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 12, the phrase "for example", used multiple times in the claims, renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 12 also recites, “at least about 6 hours”. “At least” specifies that the lower end of the range cannot go below 6 hours”. However, “about” implies that the number of the lower end of the range can be some small degree lower than 6 hours. As such, reciting “about” with “at least” renders the recitation indefinite because “about” contradict the statement of “at least”. In other words, it is not apparent if the lower end of the range is cut of at 6 hours or can be less than 6 hours.
Claim 16 recites, “less than about 25 nM”. “Less than” sets the upper limit of the range of 25nM”. However, “about” indicates that the range can be above 25nM to some degree. As such, the metes and abouts of the range are not apparent because it is not apparent if the upper part of the range is cut off at 25nM or could be more than 25nM.
Claim 16 also recites, “at least about 6 hours”. “At least” specifies that the lower end of the range cannot go below 6 hours”. However, “about” implies that the number of the lower end of the range can be some small degree lower than 6 hours. As such, reciting “about” with “at least” renders the recitation indefinite because “about” contradict the statement of “at least”. In other words, it is not apparent if the lower end of the range is cut of at 6 hours or can be less than 6 hours.
Regarding claim 16, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation “at least about 6 hours”, and the claim also recites “about 12 to about 72 hours”; “about 12 to about 60 hours”; and “about 36 to about 60 hours”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation “at least about 6 days”, and the claim also recites “about 8 days to about 36 days” and “about 10 days to about 14 days” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 16 also recites, “at least about 6 hours”. “At least” specifies that the lower end of the range cannot go below 6 hours”. However, “about” implies that the number of the lower end of the range can be some small degree lower than 6 hours. As such, reciting “about” with “at least” renders the recitation indefinite because “about” contradict the statement of “at least”. In other words, it is not apparent if the lower end of the range is cut of at 6 hours or can be less than 6 hours.
Regarding claim 16, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 19, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 19 recites the broad recitation “introducing a heterologous nucleic acid”, and the claim also recites “transducing a viral vector comprising the heterologous nucleic acid”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 19, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 20 is dependent upon claim 19 and therefore has the indefinite subject matter of claim 19.
Regarding claim 20, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 20 recites the broad recitation “at least about 6 hours”, and the claim also recites “about 12 to about 72 hours”; “about 12 to about 60 hours”; and “about 36 to about 60 hours”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 20 also recites, “at least about 6 hours”. “At least” specifies that the lower end of the range cannot go below 6 hours”. However, “about” implies that the number of the lower end of the range can be some small degree lower than 6 hours. As such, reciting “about” with “at least” renders the recitation indefinite because “about” contradict the statement of “at least”. In other words, it is not apparent if the lower end of the range is cut of at 6 hours or can be less than 6 hours.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 20 recites the broad recitation “at least about 6 days”, and the claim also recites “about 8 days to about 36 days” and “about 10 days to about 14 days” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 20 also recites, “at least about 6 hours”. “At least” specifies that the lower end of the range cannot go below 6 hours”. However, “about” implies that the number of the lower end of the range can be some small degree lower than 6 hours. As such, reciting “about” with “at least” renders the recitation indefinite because “about” contradict the statement of “at least”. In other words, it is not apparent if the lower end of the range is cut of at 6 hours or can be less than 6 hours.
Regarding claim 20, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 23 recites, “less than about 25 nM”. “Less than” sets the upper limit of the range of 25nM”. However, “about” indicates that the range can be above 25nM to some degree. As such, the metes and abouts of the range are not apparent because it is not apparent if the upper part of the range is cut off at 25nM or could be more than 25nM.
Regarding claim 26, broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 26 recites the broad recitation “about 8 days to about 36 days”, and the claim also recites “about 8 days to about 22 days” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 26, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 27 is rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more.
According to the 2019 Revised Patent Subject Matter Eligibility Guidelines (2019PEG), the claim is first analyzed to determine if it is directed to one of the acceptable statutory categories of invention (i.e. process, machine, manufacture, or composition of matter). Claim 27 recites, “a product”. Thus claim 27 is drawn to a composition of matter comprising a population of Treg cells. Thus claim 27 meets the requirements for step 1 of the analysis.
Second, the claim is assessed to determine if it is directed to a judicial exception under step 2A. Under 2019PEG, “directed to” is determined via a two-prong inquiry: (1) Does the claim recite a law of nature, a product of nature, a natural phenomenon, or an abstract idea; and (2) Does the claim recite additional element(s) that integrate the judicial exception into a practical application. The phrase, “integration of a practical application”, requires the presence of an additional claim element(s) or a combination thereof to apply, rely on or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception, such that the claim does not monopolize the judicial exception. (See MPEP § 2106.05 for examples of integration of practical application).
Regarding the first prong (1), claim 27 is directed to “a product” comprising a population of Tregs. Treg cells are found in body of humans and other animals. A such, the claimed product is a product of nature and thus a judicial exception.
Regarding the second prong (2), claim 27 recites the additional element of “obtained by and/pr obtainable by the method of claim 1”. This language is product by process language and does not impart any practical application. As such, the claim does not integrate the claimed judicial exception into a practical application.
Thus, claim 27 meets the requirement of step 2A as being directed to a judicial exception with no integration into a practical application.
Third, if a judicial exception is present in the claim, it is further assessed to determine if the claim recites any additional elements or steps that are sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception. The additional element provides for a method steps that culture the population. While the end product is Tregs in culture, the product itself does not require the Treg population to be in isolated form and thus can be one that reintroduced into the host animal. As such, the method of obtaining the Treg population does not impart any distinction from the natural Treg counterpart found in an animal or human.
Even if one interpreted the method of obtaining limitations as limiting the product to an isolated Treg population an isolated but otherwise unchanged cell population would not be markedly different from its natural counterpart in vivo.
Under the holding of Myriad, an isolated but otherwise unchanged nucleic acid was not patent eligible subject matter because it was not different enough from what exists in nature to avoid improperly tying up the future use and study of naturally occurring nucleic acid. The isolated Treg population of the claim is analogous to the isolated nucleic acid in Myriad. The claimed in vitro culture of a Treg population can be interpreted as being an isolated Treg population that is otherwise an unchanged. Thus, similar to the isolated nucleic acid, the isolated Treg population is not patent eligible subject matter because it is not different enough from Treg populations that exists in nature to avoid improperly tying up the future use and study of the naturally occurring Treg population.
Thus, as a whole, generic nature of the process does not impart any structural or functional distinctions to the claimed Treg cell population product that would distinguish it from a Tregcell population found in nature. As such, claim 27 does not meet the requirements of step 2B of the 2019PEG because the isolated nature of the claimed Treg cell population do not impart a significant distinction to the claimed Treg cell population to distinguish it from its natural Treg population counterpart.
In conclusion, claim 27 does not meet all the requirements of the 2019PEG and therefore is deemed patent ineligible.
Claim Rejections - 35 USC § 102
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.
(1) Claim(s) 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Attias (Attias et al. Clinical and Experimental Immunology, 197: 36–51, 2019).
Attias discloses Treg cell populations (see abstract).
(2) Claim(s) 1-3, 10-11, and 26-27 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Winqvist (US 2009/0311228 pub date:12/17/2009 effectively filed:8/22/2006).
Regarding claim 1, Winqvist discloses according to a third preferred aspect of the invention regulatory T cells in an activated state or a non-activated state are collected from lymph nodes draining bowel segments with or without IBD, respectively, and expanded in vitro. Expansion may be continuous or in intervals, such as in phases interrupted by resting phase(s). The expanded regulatory T cells are activated (stimulated) with cytokine(s) in combination with an antigen extract from an inflammatory bowel segment. Alternatively the regulatory T cells collected from lymph nodes draining bowel segments with or without IBD are activated (stimulated) in such manner prior to expansion or between expansion phases. One cytokine, preferably two or more cytokines selected from IL-2, IL-7, IL-10, TGF-.beta., TSLP, such as a cytokine cocktail comprising IL-2, IL-7, IL-10, TGF-.beta., in particular TGF-.beta.1, TSLP, are used in combination with the antigen extract from the inflammatory bowel segment to obtain Treg activation. It is also preferred to provide for additional Treg activation by use of anti-CD3, anti-CD28 and rapamycin ([0014])
As such, Winqvist discloses a culture of Tregs that has multiple expansion phases and that activation ours between expansion phases with rapamycin being additionally used during expansion phases. A such multiple rounds would mean that at least in the second round of expansion, the Tregs would have been exposed to the mTOR , rapamycin, prior to the second activation step, meeting the limitations of step (a) as claimed. The Tregs would be subjected to the second round of activation, meeting the limitations of step (b) of the claim. Finall the Tregs would be cultured in the presence of the rapamycin following the second activation step, meeting the limitations of step (c). As such, the Winqvist discloses all of the limitations of claim 1.
Regarding claim 2, Winqvist discloses the invention is provided a method of isolating regulatory T cells from a sentinel lymph node draining a bowel segment with IBD, comprising exerting a pressure on the lymph node, collecting the cell suspension thereby expelled from the node, and isolating regulatory T cells from the suspension ([0020]). Winqvist discloses isolating CD4+CD25+ Treg cells ([0034]). Thus Winqvist discloses all the limitations of claim 2.
Regarding claim 3, Winqvist discloses rapamycin treatment in (a) and/or (c) as discussed above.
Regarding claims 10-11, Winqvist discloses activating with the TCR/CD3 activator, anti-CD3, and/or the TCR co-stimulator anti-CD28 as discussed above ([0014]).
Regarding claim 13, the rounds of activation and expansion disclose by Winqvist (and described above) encompass the limitations of step c occurring concurrently or immediately after step b.
Regarding claim 26, Winqvist discloses isolating the CD4+/CD25+ Tregs by cells sorting ([0034]. The claim does not specify when the Tregs are harvested and further harvest limitations are recited in a “wherein” clause and thus is not an active step. Thus these disclosure from Winqvist meet the limitations of claim 26.
Regarding claim 27, Winqvist discloses a Treg population obtained by the method above as claimed.
In conclusion, the prior art of Winqvist anticipates the claims.
Claim Rejections - 35 USC § 103
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.
(1) Claim(s) 5-9, 12, 14, 16, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Winqvist (US 2009/0311228 pub date:12/17/2009 effectively filed:8/22/2006).
Regarding claim 5, Winqvist teaches the limitations of the method as discussed above. Winqvist is silent as to whether the rapamycin is removed prior to step b or c. However, an artisan of ordinary skill would predictably be able to determine if rapamycin needs to be removed in step b or c through routine optimization to predictable arrive at the limitations of claim 5. Further it is noted that the lack of removing limitations is recited in a wherein clause and therefore is not an active step in the method. Given the end results of the method is in vitro culturing of Tregs and Wingvist successfully results in in vitro culture of Tregs, the wherein clause is not limiting and can be interpreted as optional. See MPEP 2111.04(I).
Regarding claim 6, Winqvist is silent as to a washing step prior to step (b) or (c). However, determining the need for a washing step in a culture of Tregs has long been established in the art. As such, it would be a matter of routine optimization to determine that a washing step does not occur as claimed. Further it is noted that the lack of washing limitations is recited in a wherein clause and therefore is not an active step in the method. Given the end results of the method is in vitro culturing of Tregs and Winqvist successfully results in in vitro culture of Tregs, the wherein clause is not limiting and can be interpreted as optional. See MPEP 2111.04(I).
Regarding claim 7, Winqvist is silent as to whether the rapamycin is present throughout step a-c as claimed. However, determining the need for a continuous culture in the presence of the same rapamycin through step a-c of Tregs has long been established in the art. Further Winqvist teaches that rapamycin can be used in activation of Tregs ([0014]) and further teaches that rapamycin can be used to obtain optimal expansion and functionality of the IBD Tregs ([0053]). As such, the ordinary artisan would see no counter-indication that rapamycin can be used throughout all steps. Therefore it would have been a matter of routine experimentation and one of a finite number of options (i.e. the presence of rapamycin in all three steps versus only in steps a and c) to try to arrive at the limitations of claim 7 with a reasonable expectation of success.
Regarding claim 8, Winqvist does not teach the claims concentration ranges for the mTOR inhibitor. However, determining concentrations of rapamycin to support the function of Treg activation and/or expansion would be routine optimization and predictable at the time of effectively filing. As such, an obvious variant of Winqvist.
Regarding claims 9, 12, and 14, these claims recite different timing of applying the mTOR inhibitor in different step. However, determining timing of application of rapamycin to support the function of Treg activation and/or expansion would be routine optimization and predictable at the time of effectively filing. As such, an obvious variants of Winqvist.
Regarding claims 16 and 23, the claim specifies reducing mTOR inhibitor or removing mTOR inhibitor for a period of time. Again concentrations and timings of applying modulatory agents to a Treg cells population are well within routine optimization and thus obvious variants of Wingvist.
(2) Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Winqvist (US 2009/0311228 pub date:12/17/2009 effectively filed:8/22/2006) as applied to claims1-3, 5-14, 16, 23, 26, and 27 above, and further in view of Guillonneau (WO2019/012024 pub date 1/17/2019; effectively filed 7/13/2017; of record in IDS).
Regarding claim 19 Winqvist discloses the limitations as discussed above Winqvist does not disclose that the method further comprises introducing heterologous nucleic acid into the Tregs.
However before the time of effective filing Guillonneau teaches a method of expanding Treg populations by culturing in the presences of a rapamycin compound (p. 2, lines 5-11). Guillonneau further teaches the Tregs can be genetically modified to include a nucleic acid encoding various biologically active products. A prefer nucleic acid would be a TCR or CAR to specific antigens. Human Tregs cells can act more specifically and efficiently on effector T cells to inhibit immune responses in a patient in need thereof. Further, Guillonneau teaches that the basic principles of CAR design and introduction have been expressly described (p. 5, lines 18-31).
As such, it would have been obvious to an artisan at the time of effective filing to add a step of introducing a heterologous nucleic acid encoding a TCR or a CAR to Tregs, as taught by Gillonneau, to the Treg culture method of Winqvist to predictably arrive at the limitations of claim 19. An artisan would have a reasonable expectation of success because Gillonneau teaches that the basic principles of CAR design and introduction have been expressly described and can be applied to method of culturing and expanding Tregs with rapamycin. Further, the artisan would be motivated to introduce a nucleic acid encoding a TCR or CAR to the Tregs of Winqvist because human Tregs cells can act more specifically and efficiently on effector T cells to inhibit immune responses in a patient in need thereof, as taught by Gillonneau. Thus Winqvist in view of Gillonneau render claim 19 obvious.
Regarding claim 20, Gillonneau teaches introduction of a nucleic acid encoding a CAR is an obvious variant as discussed above. Additional embodiments in the claim specify the duration of nucleic acid introduction and duration of culturing/expansion. Gillion teaches that means of CAR introduction was well described in the prior art as discussed above as would be the durations of introduction. As such, Wingvist in view of Gillonneau render claim 20 obvious.
Regarding claim 21, Wingvist teaches timings of reducing or removing rapamycin as discussed above. Gillonneau also teaches timing of heterologous nucleic acids as discussed above. As such, Wingvist in view of Gillonneau teach the limitations of claim 21 for reasons discussed above and thus render it obvious.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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