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 OFFICE ACTION
This Office Action is in response to the papers filed on 16 September 2025.
APPLICANT’S ELECTION
Applicants’ election without traverse of Group I (Claims 1-3, 5-7,10-12, 14-19 and 21-23; drawn to a method for treating a subject suffering from a disease) in the reply filed on 16 September 2025 is acknowledged. Claims 28 and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
CLAIMS UNDER EXAMINATION
Claims 1-3, 5-7, 10-12, 14-19 and 21-23 have been examined on their merits.
PRIORITY
Provisional Application 62/991564, filed on 18 March 2020, is acknowledged.
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, 5-7, 10-12, 14-19 and 21-23 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter.
Based on the claims as a whole, claims 1-3, 5-7, 10-12, 14-19 and 21-23 are determined to be directed to a law of nature/natural principle. The rationale for the determination is explained below.
Claim 1 is directed to a method of treating a subject suffering from a disease.
Question 1: Is the claim to a process, machine manufacture or composition of matter? Yes, the invention recited in claim 1 is a process.
Question 2A Prong 1: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? Yes, claim 1 is directed to an abstract idea.
(a) The limitations in the claim that set forth the law of nature is:
The 2019 PEG explains that the abstract idea exception includes the following groupings of subject matter:
Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations;
Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
Claim 1 recites diagnosing a subject as suffering from a disease. The claim encompasses any disease. The specification does not define diagnosing. Therefore it includes visually looking at test results, and determining a patient has a disease based on a mental evaluation. Such mental observations and evaluations fall within the “mental processes” grouping of abstract idea set forth in the 2019 PEG. 2019 PEG Section I, 84 Fed. Reg. at 52.
The method recites verifying upregulation of CAMP in a subject. The specification does not define verifying. The specification discloses verifying can comprise measuring concentrations of an analyte in multiple samples from a patient and comparing the concentrations in the sample. These are mental observations and evaluations (judicial exceptions).
The claim recites upregulating the cathelicidin gene CAMP in the subject. The specification discloses this is the result of administering a composition (hence, a treatment) that upregulates cathelicidin (e,g, , the supplements curcumin, DHA, resveratrol, retinol, beta-carotene, cholecalciferol, and genistein) ([0013] of PG Pub).
While the claim recites administering a treatment, the claims do not require the treatment be performed in response to the verification step. The administration is considered insignificant extra-solution activity because it is a necessary data gathering step in order to make the verification.
Question 2A Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? No. The administration is considered insignificant extra-solution activity because the administration is not being done in response to the verification step, but is a necessary data gathering step in order to make the verification. The treatment is recited at such a high level of generality that it does not result in significantly more than the recited judicial exceptions.
Question 2B: Do the claims recite any additional elements? Yes.
With respect to Step 2B, limitations that were found to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
Improvements to another technology or technical field.
Improvements to the functioning of the computer itself.
Applying the judicial exception with, or by use of, a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application.
Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
With respect to Step 2B, limitations that were found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer
Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities previously known to the industry
Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea
Generally linking the use of the judicial exception to a particular technological environment or field of use.
Does the additional element result in the claim amounting to significantly more?
No.
Claims 2-3, 12 and 21-23 further limit the treatment. The claims do not require the treatment be performed in response to the verification step. The administration is considered insignificant extra-solution activity because it is a necessary data gathering step in order to make the verification.
Claims 5-7 and 10-11 recite limitations directed to verifying. The claims encompass measuring analyzes obtained from patient samples, comparing the samples and verifying if the measurements exceed a specific concentration. These are mental processes and evaluations (judicial exceptions).
Claims 14-19 recite compositions that are administered to upregulate cathelicidin. The administration is considered insignificant extra-solution activity because it is a necessary data gathering step in order to make the verification.
Therefore claims 1-3, 5-7, 10-12, 14-19 and 21-23 are not eligible subject matter under 35 USC 101.
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, 5-7, 10-12, 14-19 and 21-23 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 treating and diagnosing a subject “as suffering from a disease”. “Suffering” means to undergo distress or hardship. It is a relative term which renders the claim indefinite. The metes and bounds of the term are unclear. It is unclear if the claim means the patient is diagnosed with a disease. Appropriate correction is required. All dependent claims are included in this rejection.
Claim 12 recites “wherein infusing NK cells into the body of the subject…”. There is a lack of antecedent basis for infusing NK cells. The metes and bounds of the claim are unclear. Appropriate correction is required.
Claim 21 recites upregulation in the subject “occurs prior to infusing the NK cells into the body of the subject”. The base claim recites “Natural Killer (NK) cell therapy”. It is unclear if claim 21 is referring to the NK cell therapy recited in claim 2. There is a lack of antecedent basis for “infusing the NK cells into the body of the subject”. Appropriate correction is required.
Claim 22 recites upregulation in the subject “occurs subsequent to infusing the NK cells into the body of the subject”. The base claim recites “Natural Killer (NK) cell therapy”. It is unclear if claim 22 is referring to the NK cell therapy recited in claim 2. There is a lack of antecedent basis for “infusing the NK cells into the body of the subject”. Appropriate correction is required.
Claim 23 recites upregulation in the subject “occurs both prior to and subsequent to infusing the NK cells into the body of the subject”. The base claim recites “Natural Killer (NK) cell therapy”. It is unclear if claim 23 is referring to the NK therapy recited in claim 2. There is a lack of antecedent basis for “infusing the NK cells into the body of the subject”. Appropriate correction is required.
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.
Claim 23 is 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 23 recites upregulating CAMP before and after infusing the NK cells into the body of the subject. This is interpreted to mean CAMP is upregulated twice. The claim is not further limiting because claim 1 only recites one step of CAMP upregulation.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5 and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barron et al. (Polytherapy Modulating Cathelicidin Gene Expression Modulation For The Treatment Of Alzheimer’s Disease And Other Conditions. US20190015361 published 17 January 2019).
Barron teaches a method of treating Alzheimer’s disease in a subject (5XFAD mice [0128]). The art teaches aggressive amyloid beta accumulation pathology ([0128]). Therefore the subject has been diagnosed as suffering from a disease. Barron administers bexarofene, DHA and vitamin D3 (Table 2). Barron teaches Vitamin D3 induces CAMP gene expression ([0118]). Therefore it’s administration would inherently upregulate CAMP. The art teaches bexarofene and the RXR agonist DHA treat Alzheimer’s ([0119]). Therefore Barron diagnoses a subject suffering from a disease, upregulates cathelicidin and administers a treatment for the disease. Barron teaches the induction of camp cathelicidin in 5XFAD mice was able to enhance their cognitive function, where treated mice had memory equivalent to wild type mice ([0130]). Therefore the art is broadly interpreted to verify upregulation in treated subjects. Claim 1 is anticipated.
Barron teaches the synergistic combination of compounds cause expression of LL-37 peptide in the brain ([0132]). Therefore claim 5 is included in this rejection. Barron administers a composition that upregulates cathelicidin (supra). Therefore claim 14 is included in this rejection. The composition includes Vitamin D3, phenylbutyrate, bexarotene, DHA, curcumin and resveratrol. Therefore claims 15-18 are included in this rejection.
Therefore Applicant’s Invention is anticipated as claimed.
Claims 1 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Koon et al. (Cathelicidin as novel inflammatory bowel disease marker and therapy for colitis-associated intestinal fibrosis. US 2015/0293123).
Koon teaches a method of treating inflammatory bowel disease, Crohn's disease and ulcerative colitis (Abstract). Koon teaches administering a composition to increase the patient’s cathelicidin protein levels ([0033]). Koon teaches the composition is sodium butyrate ([0034] [0106] [0171]).
Koon teaches induction of endogenous cathelicidin by sodium butyrate administration significantly ameliorates dextran induced colitis in mice ([0080] [0063] [0163]). Therefore Koon diagnoses a subject with a disease (colitis) and administers a drug that induces expression of cathelicidin. Because the art teaches sodium butyrate induced endogenous cathelicidin expression in biopsied colons ([0163]), the art has verified expression is increased. Therefore claim 1 is anticipated. Koon teaches sodium butyrate upregulates cathelicidin (supra). Therefore claim 14 is rejected. The art teaches sodium butyrate (supra); Therefore claim 15 is included in this rejection.
Therefore Applicant’s invention is anticipated as claimed.
.
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.
Claims 5-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Koon et al.
Claim 1 is rejected on the grounds set forth above. The teachings of Koon are reiterated. Koon teaches butyrate induces endogenous cathelicidin.
Koon teaches LL-37 is the cathelicidin protein (hence, the product of the gene) ([0134]). LL-37 levels can be measured in patient biopsies ([0134]).
Koon also teaches serum LL-37 levels can be correlated to ulcerative colitis development ([0135]). Ulcerative colitis progression can be measured by taking measurements of the cathelicidin LL-37 protein ([0135]). The art teaches increased levels of LL-37 indicate a good prognosis, while lower levels indicate a bad prognosis ([0134]). Patients with high colonic cathelicidin LL-37 level have significantly lower disease development score compared to those with lower colonic cathelicidin LL-37 level ([0083]).
It would have been obvious to verify upregulation of LL-37 cathelicidin peptide. One would have been motivated to do so since Koon teaches LL-37 can be used as a marker for prognosis. One would measure its levels to verify expression is increased. One would have had a reasonable expectation of success since Koon teaches it can be measured in patient samples. Therefore claim 5 is rendered obvious.
Koon teaches the disclosed method and products can be used to monitor treatment ([0152]). Koon teaches measuring levels of proteins to monitor therapy ([0152]).
It would have been obvious to compare levels of LL-37 in patient samples before and after treatment. One would have been motivated to do so to monitor treatment in a patient. Because Koon teaches higher levels of LL-37 protein correlate with improved outcome, one would compare levels to determine whether treatment is effective. One would have had a reasonable expectation of success since Koon teaches monitoring protein levels in patients. Therefore claim 6 is rendered obvious.
Koon teaches if LL-37 levels were higher than 35 pg/ug protein, patients had a good prognosis of UC. If LL-37 levels were lower than 20 pg/ug protein ([0134]).
It would have been obvious to verify upregulation based on increased levels of Ll-37. One would have been motivated to do so since Koon teaches increased levels are associated with positive disease outcome. The skilled artisan would optimize the parameters for determining upregulation based on the desired disease outcome. Therefore claim 7 is included in this rejection.
Koon teaches LL-37 can be measured in a blood sample from a patient ([0118]). Therefore claim 10 is included in this rejection.
Koon teaches human peripheral blood monocytes can be used ([0163]). Therefore claim 11 is included in this rejection.
Therefore Applicant’s invention is rendered obvious as claimed.
Claims 1-3, 12 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Barron et al. in view of Liu et al. (Use of CAR-Transduced Natural Killer Cells in CD19-Positive Lymphoid Tumors. NEJM 05 February 2020. 382:545-553).
Barron teaches a polytherapy that synergistically modulates and induces the expression of the cathelicidin gene (CAMP), which encodes LL-37 (Abstract). The polytherapy can be used to treat medical conditions ([0002]). Barron teaches cathelicidin is required for NK cell-mediated suppression of tumor growth ([0043]). Barron teaches LL-37 has anti-cancer effects on gastric cancer ([0044]). Barron teaches it is beneficial to upregulate LL-37 expression in the context of blood cancers like B cell lymphoma and Jurkat T cell lymphoma [0044] [0046].
Barron does not teach treating cancer by administering NK cell therapy to a patient.
Liu teaches treating lymphoid tumors with Natural Killer cells (hence, NK cell therapy; see Methods section on page 545). Rapid response is seen within 30 days after infusion at all doses (see Results section on page 545).
It would have been obvious to combine the teachings of the prior art by administering NK cell therapy. Barron teaches upregulated CAMP expression is beneficial when treating lymphomas and Liu teaches administering NK cell therapy to treat lymphomas. The skilled artisan would administer both compositions to provide an enhanced effect. See MPEP 2144.06. One would have had a reasonable expectation of success since Barron teaches cathelicidin is required for NK cell-mediated suppression of tumor growth. One would have expected similar results since both references are directed to cancer treatment. Therefore claim 1 is rendered obvious. Administering NK cell therapy is rendered obvious on the grounds set forth above. Claim 2 is included in this rejection. Liu obtains NK cells from cord (umbilical) blood (see second paragraph of “Methods” on page 546). Therefore claim 3 is included in this rejection. Liu infuses modified NK cells into the body of ta subject (supra). The cells have been modified to expression an anti-CD19 (see Background on page 545). Therefore claim 12 is included in this rejection. The selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See MPEP 2144.04 IV. Therefore claims 21-23 are included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Mily et al.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Barron et al. as evidenced by Mily et al. (Oral intake of phenylbutyrate with or without vitamin D3 upregulates the cathelicidin LL-37 in human macrophages: a dose finding study for treatment of tuberculosis (BMC Pulm Med. 2013 Apr 16;13:23).
Barron teaches a therapy that synergistically modulates and induces the expression of the cathelicidin gene (CAMP) (supra). Barron teaches the synergistic induction of the CAMP gene by the combination of Vitamin D3 and Phenylbutyrate has been developed as a novel treatment for the treatment of tuberculosis ([0120]). Barron teaches phenylbutyrate upregulates CAMP (supra). Because Barron teaches administering phenylbutyrate, it would inherently upregulate camp expression.
It is noted the reference cited in [0120] is Mily et al. As evidenced by Mily, vitamin D3 induces mycobacterium killing (see page 6, left column, last paragraph). Barron teaches mycobacterium causes tuberculosis ([0023]). Therefore Vitamin D3 is interpreted to be a therapy for treating tuberculosis.
Barron teaches levels of cathelicidin can be measured by quantitative PCR of DNA extracted from white blood cells ([0124]). Therefore Barron teaches verifying upregulation.
Barron is deficient because it does not teach verifying upregulation in a single embodiment.
It would have been obvious to verify CAMP upregulation. Barron teaches induction of the CAMP gene treats tuberculosis. One would verify upregulation to confirm if the treatment is effective. One would have had a reasonable expectation of success since Barron teaches levels of cathelicidin can be measured in blood samples. Therefore claim 1 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Barron in view of Samperio et al. (Expression and Secretion of Cathelicidin LL-37 in Human Epithelial Cells after Infection by Mycobacterium bovis Bacillus Calmette-Guérin
September 2008 Volume 15 Issue 9).
Claim 1 is rejected on the grounds set forth above. The teachings of Barron are reiterated. Barron teaches a therapy that synergistically modulates and induces the expression of the cathelicidin gene (CAMP), which produces LL-37 protein (Abstract). Barron teaches a method of treating tuberculosis. The art does not teach administering BGC vaccine to upregulate CAMP.
Samperio et al. teach BCG is the world’s most widely used tuberculosis vaccine (Abstract). Treatment with BCG induced LL-37 expression in a dose dependent manner (Abstract).
It would have been obvious to combine the teachings of the prior art by administering BGC. One would have been motivated to do so since Barron teaches administering multiple compounds that increase cathelicidin expression and Samperio teaches BGC can increase cathelicidin expression. One would have expected similar results since both references are directed to treating tuberculosis. Therefore claim 19 is rendered obvious.
Therefore Applicant’s Invention is rendered obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-3,5-7,10-12,14-19 and 21-23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6, 9-10, 14, 18 and 20 of US Patent Application US2023/0134704 (Barron et al. A Method of Treating Cancer By Upregulating Cathelicidin Gene Expression and Infusing Natural Killer Cells. Application 17800903).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claim limitations of the Instant Application encompass claim limitations of the patent. This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Claim 1 of ‘903 recites a method of treating a subject suffering from cancer (a disease), comprising: diagnosing the subject as suffering from cancer (a disease);
upregulating the cathelicidin gene CAMP in the subject; obtaining Natural Killer (NK) white blood cells (a treatment for the disease); and infusing (administering) the NK cells into the body of the subject. Claim 3 of ‘903 recites verifying the upregulation of the cathelicidin gene CAMP in the subject. These limitations read on claim 1 of the instant application.
The ‘903 Application teaches NK cell (supra). This reads on claim 2 of the instant application.
Claim 2 of ‘903 Application recites the NK cells are obtained from umbilical cord blood. This reads on claim 3 of the instant application.
Claim 4 of the ‘903 application recites verifying the upregulation of at least one protein product of CAMP gene in the subject, wherein said at least one protein product is selected from the group consisting of hCAP-18 and LL-37 cathelicidin peptide. This reads on claim 5 of the instant application.
Claim 5 of the ‘903 application recites the upregulation of cathelicidin LL-37 is verified in the subject by (a) measuring the concentration of LL-37 in a first biological sample obtained from the subject prior to upregulating cathelicidin in the subject, (b) measuring the concentration of LL-37 in a second biological sample obtained from the subject after upregulating cathelicidin in the subject; and (c) comparing the concentration of cathelicidin in the first and second samples. This reads on claim 6 of the instant application.
Claim 6 of the ‘903 application recites wherein upregulation of LL-37 is verified in the subject only if the concentration of cathelicidin in the second sample is at least 3 times the concentration of cathelicidin in the first sample. This reads on claim 7 of the instant application.
Claim 9 of the ‘903 application recites verifying the upregulation by (a) obtaining a sample of blood from the subject, and (b) measuring the concentration of LL-37 in the blood sample. This reads on claim 10 of the instant application.
Claim 10 of the ‘903 application recites verifying the upregulation by (a) obtaining peripheral monocytes from the subject, and (b) measuring the levels of CAMP gene mRNA, or the concentration of LL-37 in the obtained peripheral monocytes. This reads on claim 11 of the instant application.
Claim 14 of the ‘903 application recites modifying the NK cells such that they target a specific surface marker present on cancer cells of the cancer the patient has been diagnosed with, thereby obtaining modified NK cells;
wherein infusing NK cells into the body of the subject includes infusing the modified NK cells into the body of the subject. This reads on claim 12 of the instant application.
Claim 18 of the ‘903 application recites upregulating cathelicidin in the subject includes administering a pharmaceutical composition to the subject that upregulates cathelicidin. This reads on claim 14 of the instant application.
Claim 20 of the ‘903 application recites the pharmaceutical composition includes at least one substance selected from the group consisting of butyrate, phenylbutyrate, bexarotene, curcumin, resveratrol, retinol, beta-carotene, cholecalciferol, entinostat, docosahexaenoic acid, caprylic acid, capric acid, lauric acid, and pharmaceutically acceptable salts thereof. This reads on claims 15-18 of the instant application.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 270-8439.
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/NATALIE M MOSS/ Examiner, Art Unit 1653