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 .
Status of the Claims
Applicant’s response filed March 16, 2026 has been received and entered into the application file. Applicant’s arguments and amendments to the claims have been fully considered.
Applicant filed amendments on March 16, 2026. As such, claims 22-24, 26, and 69-78 of the claim set filed March 16, 2026 are pending. Claims 25, and 27-68 are cancelled.
Objection(s)/Rejection(s) Withdrawn
Double Patenting
RE: Claims 22-23 and 70-71 are rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,022,405 in view of Lu (WO 2020081869 A1, published April 23, 2020; PTO 892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4 of U.S. Patent No. 10,022,405, in view of Lu, make obvious claims 22-23 and 70-71 of the instant application.
Applicant amended claim 22 to now state:
A method of reducing the number of tumor cells or cancer burden in a subject in need thereof and/or for treating a subject with cancer or an increased risk of cancer, comprising administering to the subject a therapeutically effective amount of an isolated cell, a transduced cell, a population of cells, a whole cell vaccine or a composition, wherein
the isolated cell or transduced cell is a cell line which secretes
IL-12 and
at least one of IL-18 and/or IL-21 which in combination is at the or above a therapeutically effective threshold level, and wherein the individual secretion level of IL- 12, and IL-18 and/or IL-21 is below an individual therapeutically effective threshold level,
the population of cells comprises at least 0.1 to 50% of the isolated cell or transduced cell of A),
the whole cell vaccine comprises the isolated cell or transduced cell of A) or the population of cells of B),
the composition comprises the isolated cell, the transduced cell, the population of cells, or the whole cell vaccine.
Examiner notes Applicant remarks were extremely helpful in deciphering the differences between ‘405 and the instant application. In particular, Applicant remarks noting ‘405 teaches cell lines secreting high levels of IL-12 (20,000 pg/mL/10^6 cells/2hrs) conferred protection in 80% of mice even if they represented only 0.5% of the total number of leukemia cells injected, whereas cell lines secreting lower amounts of IL-12 (2,000 pb/mL/10^6 cells/2hrs) failed to confer protection even if they represented 10% of the injected cells. Accordingly, ‘405 teaches that the therapeutic effect of IL-12 producing cells depends at least in part on the level of IL-12 produced by individual cells in the population rather than the total amount of IL-12 secreted by the bulk population of cells administered to the subject. I.e., the skilled person would understand that a smaller number of cells expressing higher levels of IL-12 could be expected to provide better protection than a larger number of cells expressing lower levels of IL-12. Thus, ‘405 differs fundamentally from the instant application.
Therefore, in light of Applicant remarks and Applicant amendment to claim 22, the previously filed rejections are withdrawn.
Claim Interpretation
RE: Claims 22, 70, and 71 use the term “optionally” and claims 23, 26, 70, and 71 use the term “preferably”. Examiner notes that said terms do not further limit claims 22, 23, 26, and 70-71.
Applicant amended to remove “optionally” and “preferably” from said claims. As such, the previously applied claim interpretation is no longer necessary.
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.
RE: Claims 22-24, 26, and 69-71 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lu (WO 2020081869 A1, published April 23, 2020; PTO 892).
Applicant amended claim 22 to now state:
A method of reducing the number of tumor cells or cancer burden in a subject in need thereof and/or for treating a subject with cancer or an increased risk of cancer, comprising administering to the subject a therapeutically effective amount of an isolated cell, a transduced cell, a population of cells, a whole cell vaccine or a composition, wherein
the isolated cell or transduced cell is a cell line which secretes
IL-12 and
at least one of IL-18 and/or IL-21 which in combination is at the or above a therapeutically effective threshold level, and wherein the individual secretion level of IL- 12, and IL-18 and/or IL-21 is below an individual therapeutically effective threshold level,
the population of cells comprises at least 0.1 to 50% of the isolated cell or transduced cell of A),
the whole cell vaccine comprises the isolated cell or transduced cell of A) or the population of cells of B),
the composition comprises the isolated cell, the transduced cell, the population of cells, or the whole cell vaccine.
Lu does not teach the newly amended limitations and as such, the previously filed rejections are withdrawn.
Objection(s)/Rejection(s) Maintained and Updated for Amendment
&
Response to Applicant Remarks
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
RE: Claim 22 and dependent claims 23-24, 26, and 69-71 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. Dependent claims 23-24, 26, and 69-71 are rejected by virtue of their dependency on claim 22 and for not remedying the issue at hand.
Applicant amended claim 22 to now state:
A method of reducing the number of tumor cells or cancer burden in a subject in need thereof and/or for treating a subject with cancer or an increased risk of cancer, comprising administering to the subject a therapeutically effective amount of an isolated cell, a transduced cell, a population of cells, a whole cell vaccine or a composition, wherein
the isolated cell or transduced cell is a cell line which secretes
IL-12 and
at least one of IL-18 and/or IL-21 which in combination is at the or above a therapeutically effective threshold level, and wherein the individual secretion level of IL- 12, and IL-18 and/or IL-21 is below an individual therapeutically effective threshold level,
the population of cells comprises at least 0.1 to 50% of the isolated cell or transduced cell of A),
the whole cell vaccine comprises the isolated cell or transduced cell of A) or the population of cells of B),
the composition comprises the isolated cell, the transduced cell, the population of cells, or the whole cell vaccine.
In regards to the previously filed rejection and the issues in regards to the method claimed, Examiner notes Applicant amended to remove “and/or inducing or enhancing an immune response or a memory immune response in a subject, optionally with cancer or an increased risk of cancer.” However, Examiner respectfully notes the scope of the claim as a whole is still very broad. Claim 22, as currently written, still encompasses a method for reducing the number of tumor cells or cancer burden in ANY subject in need (e.g., a subject with glioblastoma multiform, pancreatic cancer, melanoma, etc.), as well as for treating ANY subject with an increased risk of cancer (i.e., said subject does not currently have cancer).
Examiner notes Applicant remarks state a skilled person would have a reasonable expectation of success in applying similar methods to other cancer types, including glioblastoma, pancreatic cancer, etc. Examiner respectfully disagrees. As is evidenced by Boldt (Boldt, Clayton PHD, UT MD Anderson (2020), retrieved from the internet 5/19/2026 from https://www.mdanderson.org/cancerwise/why-doesnt-immunotherapy-work-for-everyone.h00-159385101.html; PTO 892) immunotherapy has become a viable treatment option for many cancer patients (1st paragraph). However, immunotherapy does not work yet for everyone. Certain cancers, including pancreatic cancer, prostate cancer, and glioblastoma have been especially resistant to this approach. The idea that these agents work for some patients but not for others is a huge research question that is still trying to be understood (4th -5th Paragraphs). Per the instant specification, the invention of claim 22 is drawn to cytokines which have been candidates for use in anti-cancer immunotherapy protocols [0004]. Thus, Examiner respectfully notes Boldt teaches immunotherapy (and thus the instant application) not working for ANY type of cancer treatment.
In regards to the previously filed rejection and the issues regarding the claimed administering, Examiner notes Applicant amended to state “a therapeutically effective amount” of an isolated cell, a transduced cell, a population of cells, a whole cell vaccine or a composition to be administered. However, Examiner respectfully notes the claim remains broad in scope in regards to ANY route of administration. Examiner notes Applicant remarks state a skilled person could readily determine a suitable route of administration. However, Examiner respectfully notes the specification does not teach of ANY route of administration but rather teaches of the specific route of administering via injection [00188], [00214]. Further, Examiner respectfully notes Roland (Roland, James Healthgrades, retrieved from the internet 5/19/2026 from https://resources.healthgrades.com/right-care/cancer/how-early-injectable-immunotherapy-for-cancer-can-benefit-outcomes; PTO 892) teaches injectable immunotherapy works quicker and is more effective than IV or oral medications (How cancer immunotherapy works).
Thus, for the reasons discussed above, the previously filed rejections are maintained and updated below for Applicant amendment.
Claim 22 and dependent claims 23-24, 26, and 69-78 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. Dependent claims 23-24, 26, and 69-71 are rejected by virtue of their dependency on claim 22 and for not remedying the issue at hand.
Applicant amended claim 22 to now state:
A method of reducing the number of tumor cells or cancer burden in a subject in need thereof and/or for treating a subject with cancer or an increased risk of cancer, comprising administering to the subject a therapeutically effective amount of an isolated cell, a transduced cell, a population of cells, a whole cell vaccine or a composition, wherein
the isolated cell or transduced cell is a cell line which secretes
IL-12 and
at least one of IL-18 and/or IL-21 which in combination is at the or above a therapeutically effective threshold level, and wherein the individual secretion level of IL- 12, and IL-18 and/or IL-21 is below an individual therapeutically effective threshold level,
the population of cells comprises at least 0.1 to 50% of the isolated cell or transduced cell of A),
the whole cell vaccine comprises the isolated cell or transduced cell of A) or the population of cells of B),
the composition comprises the isolated cell, the transduced cell, the population of cells, or the whole cell vaccine.
To satisfy the written description aspect of 35 U.S.C. 112, first paragraph, Applicants must show that they are in possession of the invention being claimed. Possession of an invention may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings, structural chemical formulas or sequences that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998).
The application is considered to lack written description for the full genus of the above written method.
Issues in regards to the method claimed:
In regards to the claimed method, a review of the specification shows Applicant does not provide sufficient written description for:
A method:
of reducing the number of tumor cells or cancer burden in a subject in need thereof; and/or
for treating a subject with cancer or an increased risk of cancer.
Examiner notes the scope of the claimed method is overly broad. The application contains written description, in the form of proof-of-concept (Figures 1-5), to the single species of a method for treating a subject with leukemia. Examiner notes IL-12, IL-21 and IL-18 have been studied in regards to their therapeutic effects on different types of cancer. However, Applicant is claiming a very broad genus of method and such a broad genus needs sufficient written description to show Applicant is in possession of the genus claimed.
Applicant has not provided sufficient written description for the claimed method. Applicant has provided data showing an increase in survival in a murine leukemia model when mice are transduced with either LV12:LV21 or LV12:LV18. Applicant has not provided data that the claimed method reduces the number of tumor cells or cancer burden in ANY subject in need (e.g., a subject with glioblastoma multiform, pancreatic cancer, melanoma, etc), nor does Applicant provide data for treating ANY subject with an increased risk of cancer (i.e., said subject does not currently have cancer). As is evidenced by Boldt (Boldt, Clayton PHD, UT MD Anderson (2020), retrieved from the internet 5/19/2026 from https://www.mdanderson.org/cancerwise/why-doesnt-immunotherapy-work-for-everyone.h00-159385101.html; PTO 892), and discussed supra, immunotherapy has become a viable treatment option for many cancer patients (1st paragraph). However, immunotherapy does not work yet for everyone. Certain cancers, including pancreatic cancer, prostate cancer, and glioblastoma have been especially resistant to this approach. The idea that these agents work for some patients but not for others is a huge research question that is still trying to be understood (4th -5th Paragraphs).
Per the instant specification, the invention of claim 22 is drawn to cytokines which have been candidates for use in anti-cancer immunotherapy protocols [0004]. Thus, Examiner respectfully notes Boldt teaches immunotherapy (and thus the instant application) not working for ANY type of cancer treatment.
Thus, Applicant has not disclosed a representative number of species within the claimed genus to demonstrate Applicants were in possession of the full genus as claimed. The data provided in Figures 1-5 are not representative of the broad genus claimed.
Issues in regards to administering to the subject:
In regards to the claimed administering, a review of the specification shows Applicant has not provided sufficient written description for the claimed genus of: administering to the subject, ANY therapeutically effective amount of IL-12 and at least one of IL-18 and/or IL-21, below an individual therapeutically effective threshold level, which in combination is at the or above a therapeutically effective threshold level, and through ANY route of administration.
In regards to written description and the claims, Examiner respectfully notes:
(a) there is not a specified amount of the isolated cell, a transduced cell, a population of cells, a whole cell vaccine or a composition to be administered
(b) there is not a specified range of cytokine secretion level or a specific, specified amount of cytokine secretion level reading on “below an individual therapeutically effective threshold level” “which in combination is at the or above a therapeutically effective threshold level” to be administered
(c ) there is not a specified ratio of IL-12 to IL-18 and/or IL-21 to be administered.
Applicants have not disclosed a representative number of species within the claimed genus to demonstrate that Applicants were in possession of the full genus as claimed.
Examiner respectfully notes the language of claim 22 as currently written encompasses administering in ANY manner, ANY level of cytokine secretion/cell amount/ratio of cytokine that is “below an individual therapeutically effective threshold level”, “which in combination is at the or above a therapeutically effective threshold level”.
Fig 1C teaches injecting 10^5 cells of double producer LV12+LV21 (p11, lines 31-33). Fig 2C teaches injecting 10^5 cells of double producer LV12+LV18. The specification teaches, “as demonstrated in the Examples, when 100% but not 10% of administered cells are secreting IL-12 at about 1000 pg/10^6 cells/ml/hr, animals are protected from co-administered untransduced leukemic cells (Fig 1A, 2A, and 3A). Similarly, when 100% but not 10% of administered cells are secreting IL-21 at about 250pg/10^6/cells/ml/hr, animals are protected from co-administered untransduced leukemic cells or when 100% but not 10% of administered cells are secreting IL-18 at about 5pg/10^6 cells/ ml/hr, animals are protected from co-administered untransduced leukemic cells. A lower secretion of IL-12 can be used with increased benefit when cells are secreting both IL-12 and either IL-18 or IL-21. For example, when 10% of administered cells are secreting IL-12 at about 1000 pg/10^6 cell/ml/hr and also secreting either IL-21 or IL-18, animals are protected from co-administered untransduced leukemic cells (Fig 1C and 2C).” (p40, [00254].
Thus, the instant application contains written description for when 10% of administered cells are secreting IL-12 at about 1000 pg/10^6 cell/ml/hr and also secreting either IL-21 or IL-18, animals are protected from co-administered untransduced leukemic cells. Examiner notes however it is unclear in this scenario what the secretion level is of IL-21 and/or IL-18.
Accordingly, said claims are considered to lack sufficient written description and are properly rejected.
Claim Rejections - 35 USC § 112(b)
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.
RE: Claim 22 and dependent claims 23-24, 26, and 70-71 are rejected under 35 U.S.C. 112(b), 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.
RE: In regards to claim 22, the phrase “threshold level” is a relative term which renders the claim indefinite.
Applicant amended claim 22 to state: “the isolated cell or transduced cell is a cell line which secretes i) IL-12 and ii) at least one of IL-18 and/or IL-21 which in combination is at the or above a therapeutically effective threshold level, and wherein the individual secretion level of IL- 12, and IL-18 and/or IL-21 is below an individual therapeutically effective threshold level”. Examiner respectfully notes said amendment does not clarify the metes and bounds of the claim. The claim is still indefinite as to what exactly the threshold level is in regards to “below an individual therapeutically effective threshold level” “which in combination is at the or above a therapeutically effective threshold level”.
Applicant remarks state the “threshold level” is “a quantity sufficient to … effect beneficial or desired results”, depending on the context in which it is applied. Applicant states, in the context of treating cancer, a “therapeutically effective threshold level” would be understood to be a level sufficient to achieve a treatment response as compared to the response obtained without treatment or as to a control”.
Examiner respectfully notes Applicant remarks have been considered but have not been found persuasive. The claims stand rejected and are updated below for amendment.
Claim 22 and dependent claims 23-24, 26, and 70-78 are rejected under 35 U.S.C. 112(b), 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.
In regards to claim 22, the phrase “below an individual therapeutically effective threshold level” “which in combination is at the or above a therapeutically effective threshold level” is a relative phrase which renders the claim indefinite.
The phrase “below an individual therapeutically effective threshold level” “which in combination is at the or above a therapeutically effective threshold level” is not defined by the claims, 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.
Examiner notes the specification teaches: [00181] “In one aspect, methods for expressing IL-12 and one or more of IL-21 or IL-18 in cells above a threshold level, within a selected range or at a selected ratio are provided. For example, the threshold level, range and/or ratio can be determined by identifying the level of expression that for the cytokine of interest (e.g. IL -12) produces an incomplete immunity (i.e., below an individual therapeutically effective threshold level) when administered to mice at a 1:10 ratio with untransduced cells but produces complete immunity when administered at 10% when further expressing either IL-21 or IL-18 (i.e., which in combination is at the or above a therapeutically effective threshold level ) as described in the examples.” Additionally, the specification teaches: [00311] “and analyzed for the required level of expression (e.g., above a threshold level, within a selected range and/or at a selected ratio)”. However, Applicant has not stated what the specific range and/or ratio of expression is required for said “below an individual therapeutically effective threshold level” “which in combination is at the or above a therapeutically effective threshold level” and thus the metes and bounds of the claim cannot be determined.
The claims are considered indefinite because there is a question or doubt as to how to quantitatively measure the “below an individual therapeutically effective threshold level” “which in combination is at the or above a therapeutically effective threshold level”.
Thus, the claims are properly rejected.
New Ground(s) of Rejection, Necessitated by Amendment
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 22 and dependent claims 23-24, 26, and 69-78 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not reasonably provide enablement for the genus of a method of reducing the number of tumor cells or cancer burden in a subject in need thereof and/or for treating a subject with cancer or an increased risk of cancer, comprising administering to the subject a therapeutically effective amount of an isolated cell, a transduced cell, a population of cells, a whole cell vaccine or a composition, wherein
the isolated cell or transduced cell is a cell line which secretes
IL-12 and
at least one of IL-18 and/or IL-21 which in combination is at the or above a therapeutically effective threshold level, and wherein the individual secretion level of IL- 12, and IL-18 and/or IL-21 is below an individual therapeutically effective threshold level,
the population of cells comprises at least 0.1 to 50% of the isolated cell or transduced cell of A),
the whole cell vaccine comprises the isolated cell or transduced cell of A) or the population of cells of B),
the composition comprises the isolated cell, the transduced cell, the population of cells, or the whole cell vaccine.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with this claim. Dependent claims 23-24, 26, and 69-78 either depend directly from claim 22, or incorporate the product of claim 22.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” See MPEP § 2164. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill:
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples;
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Breadth of the claims:
With respect to the breadth of the claims, the claims as currently drafted encompass the genus of a method of reducing the number of ANY tumor cells or ANY cancer burden in ANY subject in need thereof and/or for treating ANY subject with ANY cancer or an increased risk of cancer (i.e., said subject does not currently have cancer) and further, the claimed genus encompasses treating the above subject via ANY route of administration with an unspecified amount of cells expressing an unspecified secretion level in an unspecified ratio of cytokine. Consequently, the breadth of the claims is expansive.
Nature of the invention:
The invention is in the field of immunotherapy for cancer treatment.
The state of the prior art and predictability in the art:
With respect to the state of the prior art, and predictability of the art, at the time of filing the instant invention, the use of cytokines for the immunotherapeutic treatment of cancer was known. (Please see the previously filed OA 102 rejection.)
However, as discussed supra, as is evidenced by Boldt (Boldt, Clayton PHD, UT MD Anderson (2020), retrieved from the internet 5/19/2026 from https://www.mdanderson.org/cancerwise/why-doesnt-immunotherapy-work-for-everyone.h00-159385101.html; PTO 892) immunotherapy does not work yet for everyone. Certain cancers, including pancreatic cancer, prostate cancer, and glioblastoma have been especially resistant to this approach. The idea that these agents work for some patients but not for others is a huge research question that is still trying to be understood (4th -5th Paragraphs).
Consequently, there is reason to conclude that there would be a high degree of unpredictability in the claimed method of treating ANY type of cancer via immunotherapy, as is claimed in claim 22.
Guidance of the Specification/Workinq Examples:
Applicants have not provided working examples encompassing the genus of the claimed method as discussed above. Applicants have provided a working example for the species of a method of treating leukemia.
Further, and as discussed above in regards to the written description rejection, Fig 1C teaches injecting 10^5 cells of double producer LV12+LV21 (p11, lines 31-33). Fig 2C teaches injecting 10^5 cells of double producer LV12+LV18. The specification teaches, “as demonstrated in the Examples, when 100% but not 10% of administered cells are secreting IL-12 at about 1000 pg/10^6 cells/ml/hr, animals are protected from co-administered untransduced leukemic cells (Fig 1A, 2A, and 3A). Similarly, when 100% but not 10% of administered cells are secreting IL-21 at about 250pg/10^6/cells/ml/hr, animals are protected from co-administered untransduced leukemic cells or when 100% but not 10% of administered cells are secreting IL-18 at about 5pg/10^6 cells/ ml/hr, animals are protected from co-administered untransduced leukemic cells. A lower secretion of IL-12 can be used with increased benefit when cells are secreting both IL-12 and either IL-18 or IL-21. For example, when 10% of administered cells are secreting IL-12 at about 1000 pg/10^6 cell/ml/hr and also secreting either IL-21 or IL-18, animals are protected from co-administered untransduced leukemic cells (Fig 1C and 2C).” (p40, [00254]. Examiner notes however it is unclear in this scenario what the secretion level is of IL-21 and/or IL-18. Examiner further notes it is unclear what the ratio is of IL-12 to IL-18 and/or IL-21.
The Quantitation of Experimentation Required:
Undue experimentation would be required to practice the invention as claimed due to the amount of experimentation necessary because of the expansive breadth of the claims, the state of the prior art and its lack of predictability, and the lack of guidance in the form of working examples in the specification.
Examiner respectfully notes that the claim language of claim 22, as currently written, does not require a specific ratio of IL-12 to IL-18 and/or IL-21, nor does it require a specific amount of cells to be administered, nor does it recite a specific secretion level of the cytokines. Thus, undue experimentation would be required to practice the invention as claimed.
MPEP §2164.01(a), provides that “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1157, 1562; 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
After applying the Wands factors and analysis to claim 22 and dependent claims 23-24, 26, and 69-78, in view of the Applicant’s entire disclosure, it is concluded that the practice of the invention as claimed in claim 22 and dependent claims 23-24, 26, and 69-78, would not be enabled by the written disclosure. Therefore, claim 22 and dependent claims 23-24, 26, and 69-78 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to make the invention commensurate in scope with the claims.
Conclusion
No claims are allowable.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE R SMALL whose telephone number is (703)756-4783. The examiner can normally be reached Monday - Friday 8:30am-4pm.
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/KATHERINE R SMALL/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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