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
Summary
This is the Final Office Action based on application 17/816076 RCE response filed 06/12/2026.
Claims 1, 3, 5-6, & 8-17 & 19-21 have been examined and fully considered.
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 1, 3, 5-6, & 8-17 & 19-21 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.
With respect to Claims 16 (but also for Claim 1 as shown in the last line of this rejection), it is unclear if the administration step always happens or not, or if instead it only happens “when,” the identification conditions in the claimed “identifying,” steps occurs. Therefore the claim is unclear. To clear up the claim, applicant could recite instead of how the claimed identifying and measuring steps, “measuring a level of IL-15 (Interleukin-15) and MCP-1(monocyte chemoattractant protein-1) in a blood sample of the patient using synthetic probes that is higher than a corresponding reference level, and thereby identifying the patient as being likely to experience toxicity.” This also applies to the similar limitations in Claim 1.
Further with respect to Claim 16, the claimed step of “measuring viability of cells used in the cell therapy,” is unclear as it is not clear if applicant means the immune cells already referred to in the claim or not. Either way- clarification is required as no “the,” is used before “cells,” in the “measuring viability of cells used in the cell therapy step.” This also applies to Claim 19 and the similar limitations in Claim 1.
Further with respect to Claim 16, “the cytokine release syndrome,” fails to have proper antecedent basis as “cytokine release syndrome,” is not referred to priorly in the claim.
Even further for Claim 16, it is unclear why applicant claims a reference level for IL-15, but not for MCP-1.
Claims 3, 5-6, & 8-15, 17 & 19-21 are rejected by virtue of their dependency on Claims 1 & 16.
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.
Claims 1, 3, 5-6, & 8-17 & 19-20 are rejected under 35 U.S.C. 101 as the claimed invention is directed to a natural correlation and abstract idea, both which are judicial exceptions without significantly more. The claim(s) recite(s) a judicial exception which is a natural correlation. The 101 analysis is shown below:
Step 1, Prong One: Are the claims directed to a statutory category of invention?
Yes, independent claims 1 & 16 are directed towards a method.
Yes, independent Claim 21, is directed to a kit, which is a device.
Step 2A, Prong One: Identify the judicial exception. Is it a law of nature/natural phenomenon/abstract idea?
Independent Claim 1 recites a “method for treating a patient experiencing toxicity following a cell therapy”.
This is done by measuring a level of at least one of IL-15 and MCP-1 in a blood sample of a patient and comparing it to a reference. This is a natural correlation (level of biomarker= presence of disease or condition which in this case is likelihood of toxicity after cell therapy)—which is a natural phenomena or law of nature judicial exception.
Further- “identifying,” as claimed is an abstract idea/mental process. Therefore, though the claims do not use the word “diagnosis,” and the preamble itself is not directed to the judicial exception, due to the substance of the rest of the claim even if the judicial exception is not explicitly claimed (biomarker present= “diagnosed,” condition which is the likelihood of toxicity), it is still implicitly in Claim 1 and those which depend therefrom.
Independent Claim 16, the preamble is drawn towards “a method for preventing or treating toxicity,” however includes the same steps and the same judicial exception as in Claim 1 which are analyzed the same way in that the judicial exception is still implicitly in the claims. Claim 16 includes an extra step from what is in Claim 1, and this is analyzed below.
See USPTO subject matter eligibility examples 29 & 43.
Claim 21 is drawn towards a kit or package, which is a device, as claimed. The only thing required in the kit is a “synthetic probe.” This does not encompass or tie up a judicial exception, when claimed by itself. Therefore, Claim 21 is not included in the 101 rejection.
Step 2A Prong Two: Has the judicial exception--natural correlation or abstract idea been integrated into a particular practical application?
For both Claims 1 & 16, the answer is no.
The “measuring,” as claimed is claimed without any particularity or specificity. No particular processing or measurement method is claimed. As amended 01/23/2026, applicant has added that a “synthetic probe,” is added and that the measurement is “based on,” the synthetic probe. Even with this added, the measuring is just a data pull/data gathering to perform the natural correlation judicial exception. Data gathering to be used in an abstract idea (or natural correlation) is insignificant extra-solution activity, and not a particular practical application. This also applies to the claimed “measuring viability of cells used in cell therapy,” as nothing is done dependent on the determination of the cell viability measurement. See MPEP 2106.05(g).
The same also applies the claimed, “administering a cell therapy….wherein the cell therapy comprises immune cells,” as claimed in Claims 1 & 16. This step occurs prior to any other step in the claimed, and it is performed again to gather data and accomplish the judicial exception--- like the measuring step. The claimed treatment is not with the immune cells is not practically applying the judicial exception as it occurs before the judicial exception occurs in the claim. (Though not claimed this way, the same thing would be accomplished if a patient was already treated with immune cells prior to the claimed method starting, and then the claimed measurement steps are taken.) Therefore- the claimed treatment with immune cells is considered extra-solution activity which is performed to then accomplish the judicial exception.
Further- at the level generality claimed, comparison to a reference is also used for this data pull and is part of the judicial exception itself. Further, “identifying,” / “comparing,” as claimed is an abstract idea/mental process which is another judicial exception.
For Claims 1, & 16—the claimed treatments, “administering an agent selected from the group consisting of….” in Claim 1 and 16, and “administering and agent to the patient that prevents or treats cytokine release syndrome, NE, or combination of,” and then recites a reference level for only MCP-1 in Claim 1 and in Claim 16 there is only a reference level for IL-15. This is not considered to be particular or specific treatment.
As claimed, the “when,” clause indicates that the treatment is conditional and is not administered in all instances for which the claim is read. If applicant can instead limit the claim to a treatment as claimed (using the specific treatment claimed), it is likely the 101 rejection will be overcome.
See MPEP 2106.04 (d)(2)(a).
Also see Vanda memorandum about particular and specific treatment.
Therefore, the independent claims 1 & 16 do not practically apply the claimed judicial exceptions.
Step 2B: Do the claims recite any elements which are significantly more than the natural correlation or abstract idea?
Here, we look to the elements other than the natural correlation and abstract idea to see if there is significantly more.
For Claims 1 & 16, it requires “measuring,” in a “blood sample of the patient”. As amended 01/23/2026, applicant has added that a “synthetic probe,” is added and that the measurement is “based on,” the synthetic probe. All of these steps however as claimed however are well understood, routine and conventional (WURC) in the art, even using “synthetic probes,” at the level of generality claimed.
For Claim 16 & 1 the administration of an “agent selected from the group consisting of,” is also not claimed particularly and significantly more since this is only done conditionally “when”.
Further, biomarkers in blood, and administering “agents,” to patients and comparison to a reference, and also the claimed administration of immune cells to “patients,” are well understood routine and conventional (WURC) in the art and therefore are not significantly more than the claimed judicial exceptions, especially at the level of generality claimed.
This is evidenced by SCHETTINI in US 20150301058 in view of ALBERTSON in US 20200352998.
Specifically, ALBERTSON teaches of detecting whether a patient will develop severe CRS by detecting pretreatment and post-treatment levels of two cytokines including MCP-1 (paragraph 0058, 0376, 0429, 0440, 0693). Further, ALBERTSON teaches that this can be measured after administration of immune cells as the cell therapy (paragraph 0032 & 0050-0052) (toxicity can develop a few days after administration of cell therapy and that this can cause a fever and that further a patient with the fever can be admitted and then further treated with a treatment that reduces neurotoxicity).
SCHETTINI teaches of using a probe which is synthetic (paragraph 0430).
See MPEP 2106.05 (d) for “The courts have recognized the following laboratory techniques as well understood routine and conventional.”
Therefore, for Claims 1 & 16, nothing is added which is significantly more than the judicial exceptions.
The dependent claims undergo a similar analysis.
Claim 3 claims “treating,” with things such as NSAIDs. This is not particular to toxicity, so there is no practical application and also is a WURC treatment. Therefore, this does not practically apply nor does it add significantly more to the natural correlation judicial exception.
Claim 4 claims “treating,” and claims what appears to be a long list of steroids. At the level of generality claimed this does not appear to be particular to specific so is not a practical application, and all these claimed compounds especially at the level of generality are WURC. This step does not seem to be done as a result of the judicial exception, so there is no practical application. Therefore, this not practically apply nor does it add significantly more to the natural correlation judicial exception.
Claims 5-6 specify what the “immune cells,” are engineered to express CAR. In Claim 1 are however--- this seems to be extra-solution activity since cell therapy does not actually occur within the boundaries of Claim 1 and those which depend therefrom. Therefore, this not practically apply nor does it add significantly more to the natural correlation judicial exception.
Claims 8-9 specify that the blood sample is obtained prior to cell therapy (which reduces lymphocytes), however this is still not a claiming of cell therapy. The natural sample is part of the judicial exception itself. Therefore, this not practically apply nor does it add significantly more to the natural correlation judicial exception.
Claims 10-11 specify that the toxicity that the patient had/condition they might experience is a specific type of toxicity. This is still a condition/disease and part of the judicial exception itself.
Claim 12 specifies that the toxicity occurs within a certain amount of days. This is still a condition/disease and the timing doesn’t change that and part of the judicial exception itself.
Claim 13 specifies that the reference levels are determined from patients who have toxicity and patients who don’t. This doesn’t do anything after determination of the correlation. Further, using these types of references is WURC. Therefore, this not practically apply nor does it add significantly more to the natural correlation judicial exception.
Claim 14 specifies that another generic “measuring,”/measurement is taken for cell viability however does not detail any specifics and doesn’t do anything after the measurement to practically apply. Further this is WURC. Therefore, this not practically apply nor does it add significantly more to the natural correlation judicial exception.
Claim 15 specifies that further generic baseline measurements are taken however does not detail any specifics and doesn’t do anything after the measurement to practically apply. Further this is WURC. Therefore, this not practically apply nor does it add significantly more to the natural correlation judicial exception.
Claim 17 claims “treating,” with things such as NSAIDs. This is not particular or specific to toxicity, and also is a WURC treatment. Therefore, this does not practically apply nor does it add significantly more to the natural correlation judicial exception.
Claim 18 claims “treating,” and claims what appears to be a long list of steroids. At the level of generality claimed this does not appear to be particular to specific so is not a practical application, and all these claimed compounds especially at the level of generality are WURC. This step does not seem to be done as a result of the judicial exception, so there is no practical application. Therefore, this not practically apply nor does it add significantly more to the natural correlation judicial exception.
Claim 19 specifies that another generic “measuring,”/measurement is taken for cell viability however does not detail any specifics and doesn’t do anything after the measurement to practically apply. Further this is WURC. Therefore, this not practically apply nor does it add significantly more to the natural correlation judicial exception.
Claim 20 specifies that further generic baseline measurements are taken however does not detail any specifics and doesn’t do anything after the measurement to practically apply. Further this is WURC. Therefore, this not practically apply nor does it add significantly more to the natural correlation judicial exception.
All pending claims, aside from Claim 21 are rejected under 101.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5-6, & 8-17, 19-21 are rejected under 35 U.S.C. 103 as being obvious over SCHETTINI in US 20150301058 in view of ALBERTSON in US 20200352998 and further in view of JAMES in US 20150098940 and further in view of ANDERSON in US 20170059582.
With respect to Claims 1 & 16, SCHETTINI teaches of a method for assessing biomarkers for diagnostic, therapy-related or prognostic methods (abstract).
SCHETTINI teaches of detecting biomarkers such as MCP-1 which is also known as CCL2 (paragraph 0037, 0048), and that the biomarkers can be used to determine toxicity (paragraph 0364). SCHETTINI teaches that the biomarkers and vesicles can be related to diseases and disorders such as immune cells (paragraph 0287). SCHETTINI teaches of using a probe which is synthetic to detect these compounds (paragraph 0430) and of measuring/detecting the levels of the biomarkers based on the probe (paragraph 0246, 0430) and of comparing the measured levels to a reference level (paragraph 0292, 0405, 0407, 0709).
Further, SCHETTINI teaches assessing that the biomarkers can be present or absent, increased or reduced based on the selection of the desired target sample and comparison of the target sample to the desired reference sample. Non-limiting examples of target samples include: disease; treated/not-treated; different time points, such as a in a longitudinal study; and non-limiting examples of reference samples are: non-disease; normal; different time points; and sensitive or resistant to candidate treatment(s) (paragraph 0141, 0289, 0500).
SCHETTINI further teaches that the biosignature including the biomarkers can be used to determine or predict whether a subject is responding to a treatment (paragraph 0365, 0364).
SCHETTINI further teaches of using the biosignature of biomarkers to provide feedback on how to optimize treatment regimens (paragraph 0394), and also of using the method to prevent adverse drug reactions (paragraph 0395). Through broadest reasonable interpretation--- toxicity is an adverse drug reaction.
SCHETTINI does not teach specifically of treating with immune cells/administering them prior to detection of the toxicity that can be detected by the claimed biomarkers, or of specifically treating with an agent that influence toxicity post detection. SCHETTINI also does not teach of administration of an agent specifically for CRS or neurologic event (Claim 16), or of using one of the claimed agents. SCHETTINI also does not teach of measuring cell viability.
ALBERTSON is used to remedy this and more specifically teaches of a method for predicting and treating toxicity related to cell therapy and specifically of identifying if the subject is at risk or likely to develop a toxicity following administration of cell therapy (abstract).
Specifically, ALBERTSON teaches of detecting whether a patient will develop severe CRS by detecting pretreatment and post-treatment levels of two cytokines including MCP-1 (paragraph 0058, 0376, 0429, 0440, 0693). Further, ALBERTSON teaches that this can be measured after administration of immune cells as the cell therapy (paragraph 0032 & 0050-0052) (toxicity can develop a few days after administration of cell therapy and that this can cause a fever and that further a patient with the fever can be admitted and then further treated with a treatment that reduces neurotoxicity).
ALBERTSON also teaches of comparing the levels of the cytokine IL-5 to pretreatment levels (which can be considered the reference level) (paragraph 0363) and of determining the severity of CRS is determined from these measurements and that an increase/max fold change of at least 75 compared to pre-treatment levels is indicative of severe CRS/toxicity (paragraph 0363). CRS is cytokine release syndrome which is related to toxicity (abstract).
ALBERSTON further teaches of analyzing/measuring the viability or function of cells (paragraph 0228, 0400).
ALBERTSON also further teaches of treating with an agent’s capable of treating toxicity which includes inhibitors and cytokine receptor of MCP-1 (paragraph 0058, 0367, 0429). So- though detection of MCP-1 for toxicity detection is already taught by SCHETTINI, since ALBERSTON teaches that treatment of toxicity can be performed with an antagonist of inhibitor of MCP-1, they are still acknowledging that MCP-1 plays a role in toxicity (paragraph 0058) and therefore one would have reasonable expectation of success in combining ALBERTSON with SCHETTINI.
ALBERTSON teaches of treating the toxicity/CRS (abstract, paragraph 0005, & 0011-0013). ALBERTSON further teaches of treating the patient with NSAID (non-steroidal anti-inflammatory drug) (paragraph 0367). ALBERTSON even further teaches of treating with tocilizumab (paragraph 0381).
ALBERTSON also teaches of measuring and comparing the levels of the cytokine IL-5 to pretreatment levels (which can be considered the reference level) (paragraph 0363) and of determining the severity of CRS is determined from these measurements and that an increase/max fold change of at least 75 compared to pre-treatment levels is indicative of severe CRS/toxicity (paragraph 0363). CRS is cytokine release syndrome which is related to toxicity (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to monitor the toxicity of immune cells treatments and then further treat the toxicity as is done in ALBERTSON in the method of SCHETTINI due to the need in the art for increased safety and reduced toxicity of cell therapy (ALBERSTON, paragraph 0004).
SCHETINI and ALBERTSON do not teach of the claimed reference levels of IL-5 and MCP1.
JAMES is used to remedy this and teach of biomarkers for diseases which include inflammatory flares (abstract). JAMES further teaches of detecting the level for IL-5 flare at 108.61 pg/ml and the non-flare level (SNF) (paragraph 0023) as being 43.84 pg/m and further that the MCP-1 flare level is 143.85 and the non flare SNF level being 16.23(Table 3). Therefore JAMES teaches above about 43 pg/ml which is in between 20=50 pg/ml there is a flare and treatment for inflammatory disease is needed as claimed. JAMES further teaches of measuring viability (paragraph 0299).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect and diagnose a flaring condition as is done in JAMES in the methods of SCHETINI and ALBERTSON due to the need in the art for better methods of determining and controlling disease flares (paragraph 0008).
If it’s unclear JAMES teaches of the reference level as claimed for MCP-1, ANDERSON is used to remedy this.
ANDERSON teaches of a method for detecting another inflammatory disease (abstract) and further of detecting MCP-1 at a level of 313 pg/ml which can read on the claimed “about 600 pg/ml” through broadest reasonable interpretation (Table 2) and also of MCP-1 of 484 pg/ml and 3362 pg/ml(paragraph 0301).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect inflammatory conditions using the reference levels as is done in ANDERSON in the method of JAMES, SCHETINI and ALBERTSON due to the need in the art for better methods of correctly diagnosing diseases and conditions and due to the need in the art to compare pre treatment and post treatment levels of compounds (paragraph 0301, 0002).
With respect to Claim 3, SCHETTINI teaches of the claims as shown above, but does not call out specific treatments for toxicity. ALBERTSON teaches of treating the patient with NSAID (non-steroidal anti-inflammatory drug) (paragraph 0367). See reason for combination from Claim 1.
With respect to Claim 5, SCHETTINI teaches of the claims as shown above, but does not call out specific immune cell treatment claimed. ALBERSTON teaches of the immune cell treatment being using a chimeric antigen receptor, CAR (paragraph 0004, 0062). See reason for combination from Claim 1.
With respect to Claim 6, SCHETTINI teaches of the claims as shown above, but does not call out specific immune cell treatment claimed. ALBERTSON teaches of the CAR having specific binding specificity to CD19 (paragraph 0622-0623, 0706). See reason for combination from Claim 1.
With respect to Claim 8, SCHETTINI teaches of the claims as shown above, but does not call out specific immune cell treatment claimed, so doesn’t teach of immune cell treatment before taking the blood sample. ALBERTSON also teaches of the sample being a blood sample which is serum (paragraph 0006, 0043) and that it can be taken at a time when treatment is still being considered or after a treatment is performed (so before treatment) (paragraph 0067-0068). ALBERTSON also teaches of preconditioning prior to cell therapy (or taking/measurement of the sample) (paragraph 0310-0311). See reason for combination from Claim 1.
With respect to Claim 9, See Claim 8 rejection. ALBERTSON teaches of preconditioning subjects by lymphodepleting (paragraph 0310-0311). See reason for combination from Claims 1 & 8.
With respect to Claim 10, SCHETTINI teaches of the claims as shown above, but does not call out the specific claimed toxicity. ALBERTSON teaches of comparing the levels of the cytokine IL-5 to pretreatment levels (which can be considered the reference level) (paragraph 0363) and of determining the severity of CRS is determined from these measurements and that an increase/max fold change of at least 75 compared to pre-treatment levels is indicative of severe CRS/toxicity (paragraph 0363). CRS is cytokine release syndrome which is related to toxicity (abstract). See Claim 1, reason for combination on why it would be obvious to measure toxicity.
With respect to Claim 11, SCHETTINI teaches of the claims as shown above, but does not call out the specific claimed toxicity ALBERSTON teaches of the toxicity being early toxicity which can start from 3 to 7 days after administration of the cell therapy (paragraph 0531-0532). See Claim 1, reason for combination on why it would be obvious to measure toxicity.
With respect to Claim 12, See Claim 11 rejection. ALBERSTON teaches of the toxicity being early toxicity which can start from 3 to 7 days after administration of the cell therapy (paragraph 0531-0532). See Claim 1 & 11, reason for combination on why it would be obvious to measure toxicity.
With respect to Claim 13, SCHETTINI teaches assessing that the biomarkers can be present or absent, increased or reduced based on the selection of the desired target sample and comparison of the target sample to the desired reference sample. Non-limiting examples of target samples include: disease; treated/not-treated; different time points, such as a in a longitudinal study; and non-limiting examples of reference samples are: non-disease; normal; different time points; and sensitive or resistant to candidate treatment(s) (paragraph 0141, 0289, 0500).
With respect to Claim 14, SCHETTINI teaches of testing the viability (paragraph 0299). ALBERTSON also teaches of comparing the levels of the cytokine IL-5 to pretreatment levels (which can be considered the reference level and this can be of “healthy,” subject with no toxicity or ones instead with toxicity as claimed) (paragraph 0363) and of determining the severity of CRS is determined from these measurements and that an increase/max fold change of at least 75 compared to pre-treatment levels is indicative of severe CRS/toxicity (paragraph 0363). CRS is cytokine release syndrome which is related to toxicity (abstract). ALBERTSON also teaches of determining resulting cell viability (paragraph 0400).
With respect to Claim 15, SCHETTINI teaches of making baseline measurements (paragraph 0294), but does not teach of the claimed specific baseline measurements. ALBERTSON teaches of measuring tumor burden (paragraph 0331, 0480, 0360, 0355). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to measure baseline tumor burden as is done in ALBERTSON in the method of SCHETTINI since tumor burden is shown to be correlate with toxicity (ALBERTSON, abstract).
With respect to Claim 17, SCHETTINI teaches of the claims as shown above, but does not call out specific treatments for toxicity. ALBERTSON teaches of treating the patient with NSAID (non-steroidal anti-inflammatory drug) (paragraph 0367). See reason for combination from Claim 1.
With respect to Claim 19, SCHETTINI teaches of testing the viability (paragraph 0299). ALBERTSON also teaches of comparing the levels of the cytokine IL-5 to pretreatment levels (which can be considered the reference level and this can be of “healthy,” subject with no toxicity or ones instead with toxicity as claimed) (paragraph 0363) and of determining the severity of CRS is determined from these measurements and that an increase/max fold change of at least 75 compared to pre-treatment levels is indicative of severe CRS/toxicity (paragraph 0363). CRS is cytokine release syndrome which is related to toxicity (abstract). ALBERTSON also teaches of determining resulting cell viability (paragraph 0400).
With respect to Claim 20, SCHETTINI teaches of making baseline measurements (paragraph 0294), but does not teach of the claimed specific baseline measurements. ALBERTSON teaches of measuring tumor burden (paragraph 0331, 0480, 0360, 0355). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to measure baseline tumor burden as is done in ALBERTSON in the method of SCHETTINI since tumor burden is shown to be correlate with toxicity (ALBERTSON, abstract).
With respect to Claim 21, SCHETTINI teaches of using a kit provided with reagents to carry out the methods taught above in SCHETTINI for Claim 1 and the other dependent claims in which reagents or antigens are used (paragraph 0046). More specifically, SCHETTINI teaches of using a probe which is synthetic (paragraph 0430).
ALBERTSON also teaches of a kit to determine the condition as taught in claim 1 (also paragraph 0058), which includes antibodies or antigens specific for detecting IL-5 or probes (paragraph 0058, 0478, 0361-0363).
Response to Arguments
Applicant's arguments filed 06/12/2026 have been fully considered but they are not persuasive.
With respect to the 101 rejection—please see the 101 rejection itself for the significantly amended claims as shown above. It is noted that if applicant gets rid of the conditional “when,” statement in the claim and clears the claim/s up, while keeping the substance of the claims, it is likely the 101 rejection will be overcome.
The examiner notes a 112 rejection was added to the office action due to amendments made 06/12/2026.
With respect to the prior art, applicant has significantly amended the claims and thus the examiner has added additional prior art references to read on the claims as shown above. Therefore, applicant’s arguments are not commensurate in scope with the instant rejection made.
All claims remain rejected.
Conclusion
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 REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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