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
In the response filed on 13 March 2026, the following has occurred: claims 1, 3-12 and 14-15 have been amended; claim 16 is newly added.
Now claims 1-16 are pending.
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 14-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite system method and system for determining a patient’s response to a treatment at a particular time. The limitations of:
Claim 1, which is representative of claims 14 and 15
determining a qualitative response value of a response to treatment of a patient with multiple myeloma, comprising: [… collect …] results of a series of predefined consecutive tests on the patient, and determining a qualitative response value at time t as a function of a test result of the time t and a subsequent test result of a time t+ 1, wherein, to assign the qualitative response value of a partial response (PR), each test of the series of predefined consecutive tests is based on a following criteria: exclusion of a bone marrow biopsy; exclusion of one or more imaging results; and reduction in either serum M-protein levels or urine M-protein levels.
, as drafted, is a process that under its broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions) via human interaction with generic computer components. That is, other than reciting a computer (claims 1 and 14) a processing device (claim 15), the claimed invention amounts to managing personal behavior or interaction between people, the Examiner notes as stated in in 2106.04(a)(2), “certain activity between a person and a computer… may fall within the “certain methods of organizing human activity” grouping”. For example, via human interaction with a computer (claims 1 and 14) a processing device (claim 15), the claim encompasses collection of test results performed on a patient and organizing the collected data to make a response to be used by a human user to determine a response to a treatment in the treatment of multiple myeloma. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The claims are also abstract as a mental process, the steps of “determining…” and “to assign…” are recited at a high level of generality and amounts to no more than mere instructions to apply the exception using a computer (claims 1 and 14) a processing device (claim 15), as such the claim is also a mental process.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of a computer (claims 1 and 14) a processing device (claim 15). The computer (claims 1 and 14) a processing device (claim 15) is recited at a high-level of geniality (i.e., general purpose computers; see Applicant’s specification Figure 5 and paragraph [0110]-[0115]) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claims recite the additional element of “providing…”. The “providing…” steps are recited at a high-level of generality (i.e., as a general means of receiving/transmitting data) and amounts to the mere transmission and/or receipt of data, which is a form of extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a computer (claims 1 and 14) a processing device (claim 15) to perform the noted steps amounts to no more than mere instructions to apply the exception using generic hardware components. Mere instructions to apply an exception using a generic hardware component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “providing…” were considered generally linking the abstract idea to particular technological environment. The “providing…” steps have been re-evaluated under the “significantly more” analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in MPEP 2106.05(d)(II)(i) “Receiving or transmitting data over a network” is well-understood, routine, and conventional. Well-understood, routine, and conventional elements/functions cannot provide “significantly more.” As such the claim is not patent eligible.
Claims 2-13 and 16 are similarly rejected because either further define the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible.
Claims 2-3, 7, further describe the types of measurements (i.e., the labels of data), however the claims do not recite any additional elements are therefore cannot provide a practical application and/or significantly more.
Claims 4, 9-12 and 16 further describes various types responses, however the claims do not recite any additional elements are therefore cannot provide a practical application and/or significantly more.
Claim 5, recites an algorithm however this is so generic that it amounts to mere organization of data, which is not an additional element, as such the claim does not recite any additional elements are therefore cannot provide a practical application and/or significantly more.
Claim 7 is directed at mathematical concepts as it recites formulas.
Claim 13, recites a time range, however the claims do not recite any additional elements are therefore cannot provide a practical application and/or significantly more
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 nonobviousness.
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.
Claim(s) 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 20160024595 hereafter (“Alsobrook”), in view of W.O. Patent Pub. No. 2013009890 hereafter (“Giusti”).
Regarding (Currently Amended) claim 1, Alsobrook teaches a computer-implemented method of determining a qualitative response value of response to treatment of a patient with multiple myeloma (Alsobrook: paragraph [0044], “the methods are useful for monitoring the progression of melanoma in a subject… determining the effectiveness of melanoma treatment in a subject. For example, by comparing the molecular signature prior to treatment with the molecular signature after treatment”, paragraph [0046], “a direct quantitative and qualitative assessment of a molecular signature”), comprising:
providing results of a series of predefined consecutive tests on the patient (Alsobrook: paragraph [0021], “the biological sample is a first biological sample obtained from the subject at a first time point. In some embodiments, the method further comprises determining an expression profile of the one or more genes of the gene classifier by assaying the gene expression products from a second biological sample obtained from the subject having melanoma at a second time point; comparing the expression profile from the first time point to the second time point; and assessing the progression of melanoma in a subject”, paragraph [0158], “Once disease and/or pigmented skin lesion characterization is established and a treatment protocol is initiated, the methods of the disclosure, in some instances, is repeated on a regular basis to monitor the molecular signature of the genes or gene expression products of interest in the subject. The results obtained from successive assays may be used to show the efficacy of treatment over a period ranging from several days to months”, paragraph [0168], “skin samples are obtained at any number of time points, including 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or more time points”), and
determining a qualitative response value at time t as a function of a test result of the time t and a subsequent test result of a time t+1 (Alsobrook: paragraph [0021], “comparing the expression profile from the first time point to the second time point; and assessing the progression of melanoma in a subject; provided”, paragraph [0044], “determining the effectiveness of melanoma treatment in a subject. For example, by comparing the molecular signature prior to treatment with the molecular signature after treatment”, paragraph [0046], “a direct quantitative and qualitative assessment of a molecular signature”, paragraph [0158], “The results obtained from successive assays may be used to show the efficacy of treatment over a period ranging from several days to months”. The Examiner notes the molecular signature reads on what is required on a test result under the broadest reasonable interpretation),
wherein, to assign the qualitative response value […], each test of the series of predefined consecutive tests is based on a following criteria: exclusion of a bone marrow biopsy; […] (Alsobrook: paragraph [0006], “the biological sample is a tissue, blood, serum, plasma or urine sample”), and/or the tests exclude a bone marrow biopsy of the patient, and/or the response is determined without test results of a bone marrow biopsy of the patient (Alsobrook: paragraph [0022], “assaying the gene expression products in the biological sample from the at least one target gene at a second time point… performing a biopsy if the melanoma progressed from the first time point to the second time point”, paragraph [0046], “provided herein is a non-invasive method for collecting skin cells comprising cellular materials useful for obtaining a molecular signature of a subject… the non-invasive method provides information regarding cells of the outermost layers of the skin that may not be obtained using biopsy samples. The non-invasive method is also far less traumatic than a biopsy”, paragraph [0177], “tape stripping is useful in the care of patients with multiple pigmented lesions where it is unpractical to biopsy each and every lesion”. The Examiner notes that “to assign the qualitative response value” is an intended use of the determining that is not required to occur. This feature has been fully considered by the Examiner; however, the limitation does not provide patentable distinction over the cited prior art because it is an intended use or result of the determining. The Examiner notes a bone marrow biopsy is excluded in the measurements of test results and only performed after determination of a result, and therefore teaches what is required of the drafted claim under the broadest reasonable interpretation).
Alsobrook may not explicitly teach (underlined below for clarity):
wherein, to assign the qualitative response value of a partial response (PR), each test of the series of predefined consecutive tests is based on a following criteria: exclusion of a bone marrow biopsy; exclusion of one or more imaging results; and reduction in either serum M-protein levels or urine M-protein levels.
Giusti teaches wherein, to assign the qualitative response value of a partial response (PR), each test of the series of predefined consecutive tests is based on a following criteria: exclusion of a bone marrow biopsy; exclusion of one or more imaging results; and reduction in either serum M-protein levels or urine M-protein levels (Giusti: paragraph [0073], “the International Working Group on Myeloma (IMWG) recommendation”, paragraph [0333], “Treatment responses can be ranked as Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease, or Progressive Disease.”, Table: 9, “PR”, “>50% reduction of serum M-protein and reduction in 24-hour urinary M- protein by 290% or to <200 mg/24 h… If serum and urine M-protein are not measurable, and serum free light assay is also not measureable, >50% reduction in bone marrow plasma cells is required in place of M-protein”, paragraph [0334], “CR, sCR, VGPR, PR, and SD categories can also require no known evidence of progressive or new bone lesions if radiographic studies were performed”. The Examiner notes this appears to be the standard guidelines for PR under IMWG recommendation, which is explicitly taught, and additionally, looking to at least Table 9 and paragraph [0334] it can be seen exclusion of radiographic images (i.e., imaging results), exclusion of bone marrow biopsy and use of reduction in M-protein levels in serum or urine for determination of PR is taught such that a person of ordinary skill in the art would find it prima facie obvious under the broadest reasonable interpretation).
One of ordinary skill in the art before the effective filing date would have found it obvious to include using assigning of a PR as taught by Giusti within the determination of a qualitative response as taught by Alsobrook with the motivation of “support disease research, drive drug development, and/or improve treatment efficacy” (Giusti: paragraph [0021]).
Regarding (Original) claim 2, Alsobrook and Giusti teach the limitations of claim 1, and further teach wherein each test comprises at least one predefined type of quantitative measurement of the patient or a combination of at least two predefined types of quantitative measurements of the patient (Alsobrook: paragraphs [0008]-[0010], “the gene expression products are nucleic acid molecules… the amplification products are quantified using real-time quantitative PCR… assaying the gene expression products in the biological sample comprises quantifying the cDNA molecules. In some embodiments, the cDNA molecules are quantified using real time quantitative PCR to determine the gene expression profile. In some embodiments, a cDNA molecule is quantitated”, paragraph [0015], “calculating a score based on the gene expression profile of the biological sample”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 3, Alsobrook and Giusti teach the limitations of claim 1, and further teach wherein the qualitative response value comprises a plurality of increasing qualitative response levels (Alsobrook: paragraph [0046], “a direct quantitative and qualitative assessment of a molecular signature”, paragraph [0059], “the molecular signature is indicative of the putative effectiveness of a given treatment for melanoma; wherein a subject with a specific molecular signature is more or less likely to respond positively to a given treatment”, paragraph [0162], “expression of a target gene product, gene sequence, or protein sequence can predict a level of response to treatment, for example partial or temporary response to treatment versus a full response”. Also see, Giusti: paragraph [0073], Table 9).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 4, Alsobrook and Giusti teach the limitations of claim 3, and further teach wherein the plurality of increasing qualitative response levels comprise: the PR, a very good partial response (VGPR), a complete response (CR), and a stringent complete response (SCR) (Giusti: paragraph [0073], “the International Working Group on Myeloma (IMWG) recommendation”, paragraphs [00333]-[00334, “Treatment responses can be ranked as Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease, or Progressive Disease… All response categories (CR, sCR, VGPR, and PD) can require two consecutive assessments made at any time before the institution of any new therapy; CR, sCR, VGPR, PR, and SD categories can also require no known evidence of progressive or new bone lesions if radiographic studies were performed”. Also see, Table 9. The Examiner notes sCR is explicitly taught by the IMWG and table 9, under the broadest reasonable interpretation).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 5, Alsobrook and Giusti teach the limitations of claim 1, and further teach wherein the qualitative response value and/or a response level at time t is determined as a function of the test result of time t using a predefined algorithm, and/or the subsequent test result of time t+1 is used to confirm the qualitative response value and/or a determined response level at time t (Alsobrook: paragraph [0021], “comparing the expression profile from the first time point to the second time point; and assessing the progression of melanoma in a subject; provided”, paragraph [0044], “determining the effectiveness of melanoma treatment in a subject. For example, by comparing the molecular signature prior to treatment with the molecular signature after treatment”, paragraph [0246], “generate a prediction model from the training dataset”, paragraph [0261], “algorithm was applied to training dataset”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 6, Alsobrook and Giusti teach the limitations of claim 1, and further teach wherein in case the subsequent test result of time t+1 is worse than the test result of time t, a determined response level at time t is decreased as a function of the subsequent test result and/or is decreased to a response level corresponding to the subsequent test result (Alsobrook: paragraph [0021], “comparing the expression profile from the first time point to the second time point; and assessing the progression of melanoma in a subject; provided”, paragraph [0044], “determining the effectiveness of melanoma treatment in a subject. For example, by comparing the molecular signature prior to treatment with the molecular signature after treatment”, paragraph [0059], “the molecular signature is indicative of the putative effectiveness of a given treatment for melanoma; wherein a subject with a specific molecular signature is more or less likely to respond positively to a given treatment”, The Examiner notes less likely reads on a decreased level under the broadest reasonable interpretation).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 7, Alsobrook and Giusti teach the limitations of claim 1, and further teach wherein individual tests include different types of measurements that comprise at least one of: measurement of the serum M-protein levels associated with the patient, measurement the urine M-protein levels associated with the patient, measurement an absolute difference in free light chain (FLC) associated with the patient and defined as |FLC lambda - FLC kappa|, and measurement an FLC ratio associated with the patient and defined as FLC kappa/PLC lambda (Giusti: Table 9, “serum M-protein… urinary M- protein”, paragraph [0189], “free light chain (FLC) levels”.
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 8, Alsobrook and Giusti teach the limitations of claim 4, and further wherein teach the PR and/or the VGPR are determined as a function of serum M-protein levels or the urine M-protein levels, and an absolute difference in free light chain (FLC) associated with the patient (Giusti: paragraph [0073], “the International Working Group on Myeloma (IMWG) recommendation”, Table: 9, “VGPR… Serum and urine M-protein detectable… >90% decrease in the difference between involved and uninvolved FLC levels is required… PR… >50% reduction of serum M-protein and reduction in 24-hour urinary M- protein by 290% or to <200 mg/24 h… If serum and urine M-protein are not measurable, and serum free light assay is also not measureable”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 9, Alsobrook and Giusti teach the limitations of claim 4, and further teach wherein the PR, is determined as a function of: a reduction of more than 50% of the serum M-protein levels, or a reduction of the urine M-protein levels by more than 90% in 24 hours or to less than 200 mg in 24 hours, or if the serum and urine M-protein levels are unmeasurable, a more than 50% decrease in a difference between involved and uninvolved free light chain (FLC) levels (Giusti: paragraph [0333], “Treatment responses can be ranked as Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease, or Progressive Disease.”, Table: 9, “PR”, “>50% reduction of serum M-protein and reduction in 24-hour urinary M- protein by 290% or to <200 mg/24 h”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 10, Alsobrook and Giusti teach the limitations of claim 1, and further teach wherein the VGPR, is determined as a function of: a detectability of serum and urine M-protein by immunofixation but not on electrophoresis, or a reduction of more than 90% in the serum M-protein levels in combination with the urine M-protein level being less than 100 mg in 24 hours (Giusti: paragraph [0333], “Treatment responses can be ranked as Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease, or Progressive Disease.”, Table: 9, “VGPR”, Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h.”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 11, Alsobrook and Giusti teach the limitations of claim 4, and further teach wherein the CR and/or the SCR are determined as a function of the serum M-protein levels being less than 1 g/dL and the urine M-protein levels being less than 200mg during 24 hours (Giusti: paragraph [0314], “a. Serum M protein ≥ 1g/dl b. Urine M protein ≥ 200 mg/24 hrs”, paragraph [0333], “Treatment responses can be ranked as Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease, or Progressive Disease.”, Table: 9, “Serum M-component (the absolute increase must be ≥0.5 g/dL) and/or Urine M-component (the absolute increase must be ≥200 mg/24 h)”. The Examiner notes one of ordinary skill in the art would find it prima facie obvious that these values are a function of CR or sCR).
The motivation to combine is the same as in claim 8, incorporated herein.
Regarding (Currently Amended) claim 12, Alsobrook and Giusti teach the limitations of claim 4, and further teach wherein the CR, is determined as a function of: a negative immunofixation on serum and urine (Giusti: paragraph [0073], “the International Working Group on Myeloma (IMWG) recommendation”, Table 9, “sCR… CR as defined below plus… normal FLC ratio… CR… Negative immunofixation of serum and urine”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Original) claim 13, Alsobrook and Giusti teach the limitations of claim 1, and further teach wherein at least one of the times t and t+ 1, or each of the times t, t+ l, ... , t +n of the series defines a time range (Alsobrook: paragraph [0158], “The results obtained from successive assays may be used to show the efficacy of treatment over a period ranging from several days to months”, paragraphs [0165]-[0168], “over a period of time… skin samples are obtained at any number of time points, including 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or more time points”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 14, Alsobrook teaches a computer program product comprising computer-readable instructions on an non-transitory computer readable medium which when executed by a data processing system cause the data processing system to carry out the method of claim 1 (Alsobrook” paragraph [0061], “The detection of the labeled probes may be visual or may be performed and analyzed using a software program or module on a computer”, paragraph [0083], “a statistical software program or module performed on a computer processor is used to determine whether a statistically significant difference or correlation in gene expression is observed”. Also see claim 1, incorporated herein).
REGARDING CLAIM(S) 15
Claim(s) 15 is/are analogous to Claim(s) 1, thus Claim(s) 15 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 1.
Regarding (New) claim 16, Alsobrook and Giusti teach the limitations of claim 4, and further teach wherein the SCR is determined as a function of: a negative immunofixation on serum and urine, and a free light chain (FLC) ratio being in a predefined normal range (Giusti: paragraph [0073], “the International Working Group on Myeloma (IMWG) recommendation”, Table 9, “sCR… CR as defined below plus… normal FLC ratio… CR… Negative immunofixation of serum and urine”).
The motivation to combine is the same as in claim 1, incorporated herein.
Response to Arguments
Applicant's arguments filed on 13 March 2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed herein below in the order in which they appear in the response filed on 13 March 2026.
Rejections under 35 U.S.C. § 101
Regarding the rejection of claims 1-15, the Examiner has considered the Applicant’s arguments but does not find them persuasive. The Examiner has attempted to address all of the arguments presented by the Applicant; however, any arguments inadvertently not addressed are not persuasive for at least the following reasons:
Applicant argues
Amended claim 1 addresses a problem described in the specification… Paragraphs [0005]-[0006] of the published application… Amended claim 1 recites the technical features described in paragraph [0096] of the published application of excluding bone marrow biopsies, which "makes the method less laborious compared to a convention[al] method" as well as establishes a reliable test despite missing data
The Examiner respectfully disagrees.
It is respectfully submitted, Applicant’s specification does not describe a technical problem rooted in computer hardware technology, the problem of assessment of a patient’s response to a treatment is not a problem rooted in computer hardware technology, and is at best a doctor/patient problem (i.e., a human activity problem), which may improve upon the abstract idea, nevertheless, an improved abstract idea is still an abstract idea. The amended limitations amount to rules and are not additional elements, none of the claimed additional elements solve a technical problem recited in Applicant’s specification, and therefore the claims are not subject matter eligible.
Rejections under 35 U.S.C. § 103
Regarding the rejection of claims 1-15, the Examiner has considered the applicant’s arguments; however, the arguments are not persuasive as addressed herein. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons:
Applicant argues
The cited portions of Alsobrook fail to teach or suggest… the examiner states that these features are disclosed in paragraph [0002] of Califano. Applicant respectfully disagrees. At most, paragraph [0002] of Califano states… Califano fails to teach or suggest
The Examiner respectfully disagrees.
It is respectfully submitted, in view of the amended limitations new portions of Giusti have been applied which teach the argued limitation, in particular Giusti explicitly teaches use of Internation myeloma working group recommendations (see above but at least paragraph [0073]), which one of ordinary skill in the art would find prima facie obvious to use for a PR determination with the motivation of “support disease research, drive drug development, and/or improve treatment efficacy” (Giusti: paragraph [0021])., and further explicitly recites the argued limitations (see above but at least table 9), therefore in view of the new grounds of rejection as necessitated by amendment, the argument is not persuasive.
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.
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/A.E.L./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
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