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 .
Priority
The instant application was filed 10/16/2023. This application claims benefit to foreign application EP 22461622.7, filed 10/15/2022; however, the priority document has not been received. Hence, the effective filing date is the filing date of the instant application, 10/16/2023, until the foreign priority is perfected.
Information Disclosure Statement
No information disclosure statement has been received for this application. The specification lists 14 references on pp. 10-12. This does not constitute an information disclosure statement. The references should be listed on an IDS and submitted for consideration of the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “an subtype” in line 9 which should be “a subtype”.
Additionally, there is a space before the period at the end of the claim which should be removed.
Appropriate correction of both is required.
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 1-12 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.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: step (b).
The method of claim 1, stating “characterised in that said method comprises the following steps:” comprises step (a), step (c) and step (d) but no step (b). Dependent claims 4-9 all reference step (b) which is not listed in claim 1. Claims 2-12 depend from claim 1 and do not resolve the indefiniteness; hence, claims 1-12 are rejected under 35 U.S.C. 112(b) as being indefinite.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “the sample is treated with a solution of an aldehyde”, and the claim also recites “preferably glutaraldehyde” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claims 2-12 depend from claim 1 and do not resolve the indefiniteness; hence, claims 1-12 are rejected under 35 U.S.C. 112(b) as being indefinite.
Undefined abbreviations of materials recited in the claims renders the claim indefinite. Abbreviations such as “ALL” recited in line 9 of claim 1, line 2 of claim 10 and line 1 of claim 12 and “PBS” recited in line 2 of claim 4 should be spelled out upon their first occurrence. Hence, claims 1, 4, 10 and 12 are rejected under 35 U.S.C. 112(b) as being indefinite.
Claims 10-12 contain the phrase “it relates to” (“wherein at step (a) it relates to biological material” in claim 10, “wherein at step (a) it relates to lymphoblasts” in claim 11 and “wherein it relates to identifying ALL cells” in claim 12) which is indefinite. Simply stating what the limitation is that is being modified and how it is modified would overcome the indefiniteness, such as “wherein the sample comprises biological material...” in place of “wherein at step (a) it relates to biological material”.
Claims 1-10 and 12 have antecedent basis issues, detailed below, mainly due to limitations in the claims preceded by the word “the” which, in patent claims, indicates that the limitation has been previously set forth, i.e., has an antecedent. Many of the antecedent basis rejections below can be resolved by rewording the claims to avoid the antecedence issue.
Claim 1 recites the limitations "the blood or bone marrow" in lines 3-4, “the diagnosed patient” in line 4, “the Raman spectra” in line 6, “the clinical samples”, “the integral intensities ratio” in line 7, “the value obtained for a sample from a healthy patient” in lines 8-9 and “the identification of an subtype of ALL” in line 9. There is insufficient antecedent basis for these limitations in the claim because the claim does not previously recite “blood or bone marrow”, “diagnosed patient” or any patient or subject, “Raman spectra”, “clinical samples”, “integral intensities ratio”, “value obtained for a sample from a healthy patient”, or “identification of an subtype of ALL”.
Claim 2 recites the limitation "the patient" in line 2. There is insufficient antecedent basis for this limitation in the claim because claim 2 depends from claim 1 and neither claim 1 nor claim 2 recite a patient (claim 1 recites “diagnosed patient” not patient).
Claim 3 recites the limitations " the Raman imaging" in line 1 and “the number of blasts” in line 2. There is insufficient antecedent basis for this limitation in the claim because claim 3 depends from claim 1 and neither claim 1 nor claim 3 recite Raman imaging or number of blasts.
Claim 4 recites the limitation "in step (b)" in line 1. There is insufficient antecedent basis for this limitation in the claim because claim 4 depends from claim 1 and neither claim 1 nor claim 4 recite a step (b).
Claim 5 recites the limitation "from step (b)" in line 1. There is insufficient antecedent basis for this limitation in the claim because claim 5 depends from claim 1 and neither claim 1 nor claim 5 recite a step (b).
Claim 6 recites the limitation "in step (b)" in line 1. There is insufficient antecedent basis for this limitation in the claim because claim 6 depends from claim 1 and neither claim 1 nor claim 6 recite a step (b).
Claim 7 recites the limitations "at stage (b)" in line 2 and “the fingerprint range” in line 2. There is insufficient antecedent basis for these limitations in the claim because claim 7 depends from claim 1 and neither claim 1 nor claim 7 recite a stage (b) or a fingerprint range.
Claim 8 recites the limitations "in step (b)" in line 1, “the presence of KMT2A gene rearrangement” in line 2, “the band intensity” in line 3 and “the band ratio” in line 3. There is insufficient antecedent basis for these limitations in the claim because claim 8 depends from claim 1 and neither claim 1 nor claim 8 recite a step (b), presence of KMT2A gene rearrangement, band intensity or band ratio.
Claim 9 recites the limitation "in step (b)" in line 1, “the presence of KMT2A-r” in line 2 and “the calculated average value” in line 2. There is insufficient antecedent basis for these limitations in the claim because claim 9 depends from claim 1 and neither claim 1 nor claim 9 recite a step (b), presence of KMT2A-r, or calculated average value.
Claim 10 recites the limitation "the time of ALL diagnosis" in line 2. There is insufficient antecedent basis for this limitation in the claim because claim 10 depends from claim 1 and neither claim 1 nor claim 10 recite time of ALL diagnosis.
Claim 12 recites the limitation " the presence of a rearrangement within the KMT2A gene" in line 2. There is insufficient antecedent basis for this limitation in the claim because claim 12 depends from claim 1 and neither claim 1 nor claim 12 recite presence of a rearrangement within the KMT2A gene.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites “The method according to claim 1, wherein in step (a) the lymphoblasts are isolated from blood or bone marrow obtained from the patient” and claim 11 recites “The method according to claim 1, wherein at step (a) it relates to lymphoblasts isolated from blood or bone marrow”; however, claim 1 already recites “(a) providing a sample containing lymphoblasts isolated from the blood or bone marrow of the diagnosed patient”; hence, claims 2 and 11 do not further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more.
Claims 1-12 are drawn to methods comprising a mental step, i.e., a judicial exception.
The first question in the subject matter eligibility determination is “Is the claim to a process, machine, manufacture or composition of matter?” (Step 1)
Yes, claims 1-12 are drawn to methods, i.e., a process.
The second question (Step 2A, prong 1) in the subject matter eligibility determination asks “Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)?"
Yes, the claimed processes of claims 1-12 are drawn to processes comprising an abstract idea (mental step; judicial exception) and well understood, conventional and routine laboratory steps.
Regarding claims 1-12, the processes are drawn to treating lymphoblasts isolated from the blood or bone marrow of a patient with an aldehyde, recording Raman spectra of the lymphoblasts and calculating the ratio of 1040/1008 cm-1 ± 3 cm-1 wherein an increase in the ratio compared to that of a healthy patient indicates a subtype of ALL with KMT2A-r, i.e., a mental step, which is an abstract idea or intangible relationship, which is a judicial exception.
Step 2A, prong 2 asks does the claim recite additional elements that integrate the judicial exception into a practical application?
Regarding claims 1-12, no, the claims do not integrate the judicial exception into a practical application because the claims do not recite any practical steps to be taken upon making the mental step of identifying whether the ALL is a subtype with KMT2A-r.
The final question (Step 2B) in the subject matter eligibility determination to be asked is “Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No, claims 1-12 do not recite additional elements that amount to significantly more than the judicial exception.
Regarding claims 1-12, contacting lymphoblasts isolated from blood or bone marrow of a patient with aldehyde, collecting Raman spectra of the fingerprint region (~500-1800 cm-1) with excitation of a 532 nm laser and identifying the subtype of ALL from the spectra is well-understood, routine and conventional as demonstrated in Leszczenko et al., 2021 (cite U, attached PTO-892) and Manago et al., 2018 (cite V, attached PTO-892)
These well-understood, routine, conventional activities are not part of a specific transformative method, but rather represent generalized method steps which are executed solely for the production of data for the mental step. Accordingly, claims 1-12 do not amount to significantly more than the judicial exceptions and are not patent eligible.
Thus, claims 1-12 are rejected under U.S.C. 101 as not being drawn to patent eligible subject matter.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651