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 06/17/2024 and claims priority from provisional application 63521696 , filed 06/18/2023.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 5, 11, 18 are objected to because of the following informalities:
Claim 5 is objected to as it recites “i.p.” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Claim 11 is objected to as it recites “i.p.” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Claim 18 is objected to as it recites “i.p.” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Appropriate correction 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 1-19 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 recites “responsive to radiation therapy.” The recitation of responsive suggests there is non-responsive and thus is a relative term. Review and searching of the specification did not provide a standard to differentiate responsive from non-responsive. Thus the metes and bounds are unclear.
Claim 1 recites, “specifically hybridizing. “The recitation of specifically hybridizing suggests there is non- specifically hybridizing and thus is a relative term. Review and searching of the specification did not provide a standard to differentiate specifically hybridizing from non- specifically hybridizing. Thus the metes and bounds are unclear.
Claim 7 recites, “capable of specifically hybridizing. “The recitation of capable of specifically hybridizing suggests there is incapable of specifically hybridizing and thus is a relative term. Review and searching of the specification did not provide a standard to differentiate capable of specifically hybridizing from incapable of specifically hybridizing. Thus the metes and bounds are unclear
Claim 14 recites, “capable of specifically hybridizing. “The recitation of capable of specifically hybridizing suggests there is incapable of specifically hybridizing and thus is a relative term. Review and searching of the specification did not provide a standard to differentiate capable of specifically hybridizing from incapable of specifically hybridizing. Thus the metes and bounds are unclear
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 -19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation / mental step or abstract idea without significantly more of determining responsiveness to radiation therapy . This judicial exception is not integrated into a practical application because if CCL5 is not integrated. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims not provide no specific reagents or steps which are significantly more.
Claim analysis
The instant claim 2 is directed A method of treating cancer in a subject in need thereof comprising administering a radiation therapy to the subject, where the subject has been determined to be responsive to the radiation therapy comprising: (a) contacting a sample from the subject comprising one or more nucleic acid molecules with a device comprising a single-stranded nucleic acid molecule capable of specifically hybridizing with nucleotides of a CCL5 gene; (b) detecting a level of expression of the CCL5 gene by performing microarray analysis or quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) of the sample; and (c) determining that the CCL5 gene is expressed in the subject.
The recitation of “where the subject has been determined to be responsive to the radiation therapy comprising “ dependent on CCL5 expression is a natural correlation or phenomena.
Claim 7 is drawn to a method of treating a cancer in a subject in need thereof comprising: (a) contacting a sample from the subject comprising one or more nucleic acid molecules with a device comprising single-stranded nucleic acid molecules capable of specifically hybridizing with nucleotides of a CCL5 gene; (b) detecting a level of expression of the CCL5 gene by performing microarray analysis or quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) of the sample; (c) determining that the CCL5 gene is expressed in the subject; and (d) administering a therapy to the subject thereby providing the method of treating the cancer.
Claim 7 is treating cancer based on the natural correlation of CCL5 expression and response to therapy.
Claim 14 is drawn to A method of treating a cancer in a subject in need thereof comprising: (a) contacting a sample from the subject comprising one or more nucleic acid molecules with a device comprising single-stranded nucleic acid molecules capable of specifically hybridizing with nucleotides of a CCL5 gene; (b) detecting a level of expression of the CCL5 gene by performing microarray analysis or quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) of the sample; (c) determining that the CCL5 gene is expressed in the subject; and (d) administering a radiation therapy to the subject thereby providing the method of treating the cancer, where the radiation therapy is administered in a dosage between: a lower limit of approximately 1 Rad / day; and an upper limit of approximately 100 Rad / day.
Claim 14 is treating cancer based on the natural correlation of CCL5 expression and response to therapy.
The contacting step is considered to be an active step requiring the analysis of a sample.
The detecting and determining step broadly encompass reading a report and thus is a mental step or abstract idea.
Dependent claims set forth further limitations with respect to administering IFH type I. and radiation therapy.
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, abstract idea and law of nature or natural phenomena.
With regards to claim 1, the claim recites, “where the subject has been determined to be responsive to the radiation therapy.” This is an abstract idea or mental step or natural correlation or natural phenomenon.
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is no as in the absence of a CCL5 no additional steps.
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No, the claims provide no limitations which are specific and provide for significantly more.
The claim requires a single active step of contacting.
Liao (Research Square Pages 1-22, (Mach 10, 2020) demonstrates this is routine and conventional.
Thus the claim does not provide additional steps which are significantly more.
Dependent claims are routine and conventional in view of Mowat (J. Exp. Med. 2021 Vol. 218 No. 9 e20210108) and He (Cell Death and Disease (2020) 11:44)
GSE60331 teaches IFN is detected in samples
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.
Claim(s) 1, 6-7, 12-14, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liao (Research Square Pages 1-22, (Mach 10, 2020) and Krishnamurthi (CLINICS IN COLON AND RECTAL SURGERY/VOLUME 20, NUMBER 3 200, 167-181)
With regards to claim 1, 7, 13-14 Liao teaches analysis of Affymetrix microarray data (data source) Liao teaches, “downregulation of Chemokines 13(CXCL13) and Chemokines 5(CCL5) might be the potential biomarkers of the radiotherapy resistance of rectal cancer” (abstract).
Liao does not specifically teach CCL5 detection as a marker of response to radiation therapy.
However it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims, if down regulation of CCL5 is a marker of radiation therapy resistance, increased CCL5 expression is indicative of response to radiation therapy and treating patients with radiation therapy. The artisan would be motivated as Liao teaches, “downregulation of Chemokines 13(CXCL13) and Chemokines 5(CCL5) might be the potential biomarkers of the radiotherapy resistance of rectal cancer.” The artisan would have a reasonable expectation of success as the artisan is merely applying a known correlation.
Liao does not specifically teach specific radiation doses or 1 Rad.day to 100Rad/day.
However, Krishnamurthi teaches treatment with 25 to 50 Rad.
MPEP 2144.05 III states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to treat rectal cancer at 1 to 100rad/day. The artisan would be motivated as Krishnamurthi provides radiation dosing for rectal cancer. The artisan would have reasonable expectation of success as the artisan is merely using known radiation doses.
Claim(s) 2-5, 8-11, 15- 18 is/are rejected under 35 U.S.C. 103 as being unpatentable Liao (Research Square Pages 1-22, (Mach 10, 2020) and Krishnamurthi (CLINICS IN COLON AND RECTAL SURGERY/VOLUME 20, NUMBER 3 200, 167-181) as applied to claims 1, 6-7, 12-14, 19 above, and further in view of Mowat (J. Exp. Med. 2021 Vol. 218 No. 9 e20210108) and He (Cell Death and Disease (2020) 11:44)
The teachings of Liao are set forth above.
While Liao teaches CCL5 and radiation therapy, Lia does not specifically teach treatment with interferon type I.
However, Mowat teaches, “In the current study, we used an orthotopic model with isogenic CRC cells differing in their MMR capacity to study how loss of the DNA mismatch repair gene MLH1 regulates antigen independent activation and recruitment of CD8+ Tcells.This was driven by overexpression of the IFN-dependent chemokines CCL5 and CXCL10, which led to preferential recruitment and retention of systemic, not local, CD8+ T cells into the tumor epithelium. While activation of this immunogenic gene signa ture is endogenous in dMMR CRCs, it can be exogenously induced in CIN CRCs via treatment with type I IFN or DNA damaging chemo- and radiotherapies.” (page 2, 1st column, 2nd paragraph)
He teaches IP injection of IFN.
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to stimulate CCL5 by intraperitoneal injection of IFN with radiation. The artisan would be motivated as Lia teaches CCL5 is a biomarker or responsiveness to radiation therapy. The artisan would be motivated to inject IFN prior to, after and/or during radiation therapy to determine if there was a temporal response. The artisan would have a reasonable expectation of success as the artisan is using a known reagent and known methods of treating.
Summary
No claims are allowed
Conclusion
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/Steven Pohnert/ Primary Examiner, Art Unit 1683
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