DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant's election with traverse of the species of methods of detecting expression of CSRs by detecting nucleic acids and the CSR of TREM2 in the reply filed on 08 June 2026 is acknowledged. The traversal is on the ground(s) that the cited Poulsen and Hong references do not teach the “guidance” provided in the final “wherein” clause of “"wherein the anticancer agent is preferentially administered systemically to the subject when it does not bind to a CSR on the surface of a cell from a healthy organ or tissue, and wherein the anticancer agent is preferentially administered locally to a tissue or organ of the subject when it does bind to a CSR on the surface of a healthy organ or tissue." Applicant concludes that this is a special technical feature linking the recited species. This is not found persuasive because the information in the “wherein” clause is not an active step of administering the agents, but only a property of how one could administer the agents depending on their binding activity. Further, the language of “preferentially administered” indicates that this is a preferred characteristic and not a required characteristic of the claimed method. The “guidance” provided in the wherein clauses does not materially distinguish the claimed method over the prior art and does not constitute a special technical feature over the prior art. The response argues that the different detection methods are alternative ways to establish CSR expression. However, it is maintained that the species of detecting expression by detecting nucleic acids involves performing different steps and using different reagents. The species lack the same or corresponding technical feature for the reasons of record. The response states “(t)he fact that claims 1-10 are generic with respect to the CSR species undermines the basis for requiring a CSR election.” However, while the claims are currently generic to the CSR, the specification discloses hundreds of different CSRs which each have a different nucleotide sequence, and which encode for proteins having a different functional activity and effect. The recited CSRs do not share a common structure essential to a common activity as required to establish that they are of a ‘similar nature.’ If the claims are amended during prosecution to recite particular CSRs, the election will apply to such claims.
The requirement is still deemed proper and is therefore made FINAL.
However, it is noted that the species of methods of detecting the CSR by detecting a protein has been rejoined with the species of methods of detecting the CSR by detecting a nucleic acid.
Claim Status
3. Claims 1-10 are pending and have been examined herein.
Information Disclosure Statement
4. The information disclosure statement filed 31 January 2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Note that the IDS size fee and size fee assertion went into effect on 19 January 2025. See url: <uspto.gov/sites/default/files/documents/quick-reference-guide-to-the-information-disclosure-statement-ids.pdf>.
Claim Rejections - 35 USC § 101
5. 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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a law of nature / natural phenomenon, and/or an abstract idea without significantly more. The judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow.
Applicant' s attention is directed to MPEP 2106 “Patent Subject Matter Eligibility” which discusses the Alice/Mayo two-part test for evaluating subject matter eligibility.
Regarding Step 1 of the subject matter eligibility test set forth at MPEP 2106III, the claims are directed to the statutory category of a process.
Regarding Step 2A, prong one, the claims recite the judicial exception of
an abstract idea and particularly mental processes.
MPEP 2106.04(a) states that the enumerated groupings of abstract ideas include:
“1) Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP § 2106.04(a)(2), subsection I);…
3) Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).”
The claims require performing the step of “establishing” which CSRs are on the surface of cancer tissue and on normal tissue; “determining” which CSRs are differentially expressed; “confirming” differential expression; and “identifying” anti-cancer agents that target the CSRs that are differentially expressed. Neither the specification nor the claims set forth a limiting definition for the “establishing,” "determining," “confirming” and “identifying” steps and the claims do not set forth how these steps are accomplished. The broadest reasonable interpretation of the establishing,” "determining," “confirming” and “identifying” steps is that these steps may be accomplished by critical thinking processes. For instance, a practioner can read information in a database or report to thereby ascertain the level of expression of a CSR in a cancer tissue and in a normal tissue of a subject; mentally compare the expression levels to determine which CSRs are differentially expressed; review these results to confirm the differential expression; and then read reports or information in the literature to mentally identify agents that target the differentially expressed CSR. Such establishing,” "determining," “confirming” and “identifying” thereby encompass processes that may be performed mentally and thus is an abstract idea.
Further, the “identifying” may be accomplished verbally. Such verbal communication is also abstract, having no particular concrete or tangible form.
With respect to claim 10 and to any extent that the “wherein” clause of claim 1 is intended to encompass a step of selecting an anticancer agent with the recited features, such selecting is also a step that may be accomplished mentally or verbally and constitutes the judicial exception of an abstract idea.
Regarding Step 2A, prong two, having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application.
Herein, the claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). The claims as broadly written do not recite any active, transformative process steps - i.e., steps that are not a judicial exception of an abstract idea. While claim 2 recites a step of providing any organ or tissue sample collected from the subject for use in step (i), the claim does not set forth how the organ is used in step (i) to establish CSR levels, particularly in a cancerous organ or tissue. Note that claims 3 and 4 define how the CSR can be established by measuring but do not require performing an active step of measuring. To any extent that the claims intend to require performing a step of measuring CSR levels in a cancerous organ or tissue sample obtained from a subject (and in a healthy portion of the same organ or tissue), such a measuring step is part of the data gathering process necessary to observe the judicial exception. This step does not practically apply the judicial exception.
Further, it is noted that the final “wherein” clauses in claim 1 do not constitute an active step of administering an anti-cancer agent to the subject. At most, the “wherein” clauses provide guidance regarding how an anti-cancer agent can be administered.
Regarding such guidance, “prescribing” or “suggesting” or “selecting” therapy that is to be administered in a particular manner is not a practical application of the judicial exception.
See MPEP 2106.04(d)(2):
Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.
Moreover, the present claims are drawn to a method of identifying an anti-cancer agent and are not drawn to a method of treating cancer in a subject by administering the identified anti-cancer agent.
To any extent that the claims may be amended to recite an active step of administering the identified anti-cancer agent, such agents are recited at a very high level of generality and do not constitute a practical application of the judicial exception. Rather, such an administering step would be merely an “apply it” limitation. Note that the claims encompass any anti-cancer agent that targets any CSR, wherein the agent may be any type of agent, including any polynucleotide, protein, peptide or small molecule (claim 5).
Regarding specific treatments, see MPEP 2106.04(d)(2):
When determining whether a claim applies or uses a recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, the following factors are relevant.
a. The Particularity Or Generality Of The Treatment Or Prophylaxis
The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). The claim also recites "administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype." This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and "administering a suitable medication to a patient." This administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application….
b. Whether The Limitation(s) Have More Than A Nominal Or Insignificant Relationship To The Exception(s)
The treatment or prophylaxis limitation must have more than a nominal or insignificant relationship to the exception(s). For example, consider a claim that recites a natural correlation (law of nature) between blood glucose levels over 250 mg/dl and the risk of developing ketoacidosis (a life-threatening medical condition). The claim also recites "treating a patient having a blood glucose level over 250 mg/dl with insulin". Insulin acts to lower blood glucose levels, and administering insulin to a patient will reduce the patient’s blood glucose level, thereby lowering the risk that the patient will develop ketoacidosis. Thus, in the context of this claim, the administration step is significantly related to the recited correlation between high blood glucose levels and the risk of ketoacidosis. Because insulin is also a "particular" treatment, this administration step integrates the law of nature into a practical application. Alternatively, consider a claim that recites the same law of nature and also recites "treating a patient having a blood glucose level over 250 mg/dl with aspirin." Aspirin is not known in the art as a treatment for ketoacidosis or diabetes, although some patients with diabetes may be on aspirin therapy for other medical reasons (e.g., to control pain or inflammation, or to prevent blood clots). In the context of this claim and the recited correlation between high blood glucose levels and the risk of ketoacidosis, administration of aspirin has at best a nominal connection to the law of nature, because aspirin does not treat or prevent ketoacidosis. This step therefore does not apply or use the exception in any meaningful way. Thus, this step of administering aspirin does not integrate the law of nature into a practical application.
Also note that the language of “preferentially administered’ indicates that this is a preferred embodiment but not a required embodiment of the claimed method.
Regarding Step 2B, the next question is whether the remaining elements/steps – i.e., the non-patent-ineligible elements/steps - either in isolation or combination, amount to significantly more than the judicial exception.
Herein, the claims as a whole are not considered to recite any additional steps or elements that amount to significantly more than routine and conventional activity and do not add something “significantly more” so as to render the claims patent-eligible. The claims do not require performing any specific, non-conventional transformative active process steps. To any extent claims 3 and 4 may intend to include a step of measuring CSR levels by performing a microarray, SAGE, blotting, RT-PCR, sequencing or quantitative PCR assay, these assays for measuring mRNA transcript levels were well-known, routine and conventional in the prior art. This finding is evidenced by the teachings in the specification. For instance, the specification (para [0009]; paragraph numbering herein is with respect to the published application) states “It will be appreciated that the mRNA transcript level may be measured by any technique for measuring mRNA levels that are known in the art. Preferably, the mRNA levels will be measured by a technique selected from the group consisting of microarray, SAGE, blotting, RT-PCR, sequencing or quantitative PCR.”
See also MPEP 2106.05(d) II which states that:
The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
iii. Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
iv. Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011);
v. Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
vi. Freezing and thawing cells, Rapid Litig. Mgmt. 827 F.3d at 1051, 119 USPQ2d at 1375;
vii. Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014); and
viii. Hybridizing a gene probe, Ambry Genetics, 774 F.3d at 764, 113 USPQ2d at 1247.
In Mayo v. Prometheus, the Supreme Court stated: "[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately."
This is similar to the present situation wherein the additional steps and elements are recited at a high degree of generality and are all routine, well understood and conventional in the prior art. The recited steps and elements do not provide the inventive concept necessary to render the claims patent eligible. See also Genetic Technologies Ltd. v. Merial L.L.C. 818 F.3d at 1377, 1379 (Fed. Cir. 2016).
For the reasons set forth above, when the claims are considered as a whole, the claims are not considered to recite something significantly more than a judicial exception and thereby are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
6. 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.
Claim 10 is 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 10 is indefinite over the recitation of “the anticancer agent is selected” because it is not clear as to how this recitation relates back to the remainder of the claim. The claim is drawn to a method for identifying an anti-cancer agent and step (vii) recites identifying one or more anticancer agents. It is unclear as to whether the selecting step in claim 10 is intended to further limit the “identifying” at step (vii) or is intended to be a separate embodiment or step, such as a step of “selecting” one of the identified anticancer agents based on the specificity to which the anticancer agent binds to the differentially expressed CSR.
Claim Rejections - 35 USC § 103
7. 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.
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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al (Oncotarget. Cell-surface marker discovery for lung cancer. 2017. 8(69): 113373-113402 and Supplementary Materials and Supplementary Table 34, 105 pages total).
Cohen teaches methods for identifying therapeutic agents that target cell-surface markers / receptors to treat lung cancer and thereby “improve outcomes and enable personalized care” (see abstract). The method of Cohen comprises: (i) identifying cell surface receptors (CSR's) on the surface of a cell from a cancerous organ or tissue -i.e., lung cancer tissue - obtained from a subject (e.g., p. 113375 “Cell-surface marker identification” and “Confirmation of marker protein expression” at p. 113377); (ii) determining if an identified CSR occurs on the surface of a cell from a healthy part of the same organ or tissue in (i) (e.g., p. 113374, col. 2 final para and p. 113375 “Cell-surface marker identification”; and “Confirmation of marker protein expression” at p. 113377); (iii) determining which of the CSR's are differentially expressed in the cancerous organ or tissue compared to healthy organ or tissue (e.g., p. 113374, col. 2 final para; p. 113375 “Cell-surface marker identification” at col. 2 and Table 2; and “Confirmation of marker protein expression” at p. 113377); (iv) identifying the differentially expressed CSR's as targets for anticancer therapy (e.g., abstract); (vi) confirming that the differentially expressed CSR's are expressed at a higher level on the cancer cells as compared to the cells from the healthy part of the same organ or tissue in the subject or as compared to their expression in other healthy organs or tissues in the subject (e.g., abstract; p. 113375 “Cell-surface marker identification”; Table 1 and Figure 1; “Confirmation of marker protein expression” at p. 113377; and Table 8); and (vii) identifying one or more anticancer agents which target one or more of the differentially expressed CSR's from the cancerous organ or tissue, which anticancer agents do not target cells from a healthy part of the same organ or tissue, wherein the anticancer agent preferentially binds to the differentially expressed CSR on the surface of a cell from the cancerous organ or tissue (e.g., p. 113388, col. 1, second para to col. 2 first para).
Cohen teaches that “(t)umor marker expression is often reported for only a small set of patient samples, only in tumor cell lines, or only reported for tumors without consideration of expression in surrounding normal tissues or normal tissues of concern for agent clearance or toxicity. Each of these concerns can lead to inadequately informed decisions about targets to pursue for development of targeted agents for a given application” (p. 113381, col. 2)). To address this issue, Cohen teaches: “In addition to higher expression in tumor samples relative to normal lung samples, expression in other tissues associated with toxicity and clearance, e.g. liver, kidney, heart, etc., was also considered and markers that were expressed in these tissues were de-emphasized” (p. 113375, col. 2).
Cohen also states (p. 113389, col. 2): “We identified 208 potential cell-surface markers specifically overexpressed in some lung tumors, but not in normal lung. We further demonstrated that 10 of these targets were detectable by immunohistochemistry and therefore good candidates for the development of novel targeted therapeutics. Some of our candidates are already being targeted in this way.” See also supplementary materials.
To the extent that steps (ii) and (vi) are intended to be distinct, separate steps, Cohen does not teach this limitation. Rather, Cohen teaches combining mRNA expression datasets for lung cancer tissue and normal lung tissue obtained from the same patient, normalizing the samples and comparing the mRNA expression levels in the lung cancer samples to the normal lung tissue samples (see “Tissue data and analyses” beginning at p. 113388, col. 2). Cohen teaches confirming the mRNA expression results by immunohistochemistry of tissue microarrays of “of lung tumor samples and adjacent normal lung samples, as well as several other control tissues (liver, spleen, and lymph node)” (see p. 113377 “Confirmation of marker protein expression”; p. 113391, col. 1 and Figures 3 and 4).
Cohen also teaches that there was variation in the level of mRNA expression between the different lung tumor samples and normal samples (Table 1 and Supplementary Tables 2-11; p. 113375, col. 2). Cohen further notes that “(s) ince mRNA expression does not always translate to protein, we needed to confirm protein expression of the selected markers” (p. 113377, col. 1).
In view of the teachings of Cohen of comparing protein expression levels between lung tumor cancer samples and adjacent normal lung tissue and the goal of the method of Cohen of providing a personalized approach to selecting a targeted therapy for a cancer patient, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Cohen so as to have also directly compared mRNA levels present in a lung cancer sample of the patient to adjacent normal lung tissue samples of the patient. One would have been motivated to have done so in order to have ensured that the selection of the anticancer agent was based on the specific mRNA (and protein) expression profile of the patient, thereby providing a highly personalized therapeutic approach to treating the patient.
Regarding the recitation of “wherein the anticancer agent is preferentially administered systemically to the subject when it does not bind to a CSR on the surface of a cell from a healthy organ or tissue, and wherein the anticancer agent is preferentially administered locally to a tissue or organ of the subject when it does bind to a CSR on the surface of a healthy organ or tissue,” this recitation indicates only a property of the anticancer agent and does not constitute an active process step of administering the anticancer agent to the patient. Moreover, the language of “is preferentially administered” indicates that this is a preferred embodiment and not a required embodiment. Further, the claims do not specifically require that the method is one in which the anticancer agent binds to CSRs on the surface of a healthy organ or tissue since the claims define the anticancer agent as one “which anticancer agents do not target cells from a healthy part of the same organ or tissue, wherein the anticancer agent preferentially binds to the differentially expressed CSR on the surface of a cell from a cancerous organ or tissue.” Accordingly, the recitations of how the anticancer agent can preferentially be administered do not distinguish the claimed method over that of Cohen.
Regarding claim 2, Cohen teaches providing an organ or tissue sample collected from a subject for use in performing immunohistochemistry to detect protein expression levels of the CSRs (e.g., p. 113391, col. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have also provided a lung tissue sample and adjacent normal lung tissue sample, as well as other normal tissue samples from a patient to perform mRNA analysis of the expression levels of the CSRs.
Regarding claim 3, as discussed above, modification of the method of Cohen as stated above results in a method in which mRNA transcript levels of the CSRs are measured in cancer cells and normal cells of the patient.
Regarding claim 4, Cohen teaches measuring mRNA transcript levels by performing microarray analysis (e.g., abstract, Figure 1 and p. 113390, col. 1).
Regarding claim 5, Cohen teaches that the anticancer agent can be an antibody (e.g., p. 113387, col. 2 and p. 113388, col. 1), and thereby a protein.
Regarding claims 6 and 7, Cohen teaches identifying CSRs that are expressed at a log2 fold increase in the lung tumor tissue as compared to the normal lung tissue and which were expressed in a healthy organ or tissue of the subject at a level below a log2 fold difference of 2. (e.g., p. 113390). Regarding the recitation of “wherein when the differentially expressed CSR is expressed at a log-fold difference of between 1 and 2 as compared to a cell from a healthy organ or tissue the anticancer agent is an anticancer agent which would be suitable for local administration to the cancerous organ or tissue, and wherein when the differentially expressed CSR is expressed on a cancerous cell at a log-fold difference of greater than 2 as compared to its expression on a cell from a healthy organ or tissue the anticancer agent is an anticancer agent which would be suitable for systemic administration to a subject,” this constitutes a property of an anticancer agent per se and does not materially distinguish the claimed method over that of Cohen.
Regarding claim 8, in the method of Cohen, the subjects were human subjects (e.g., abstract, p. 113391 and Supplementary Table 34).
Regarding claim 9, it is a property of the CSRs on the surface of the lung cancer cell and absence on a healthy lung tissue that it is a suitable target for the anticancer agent (e.g., abstract; p. 113388, col. 1).
Regarding claim 10, the anticancer agent is selected so that it selectively binds a CSR that is differentially expressed (e.g., abstract; [/ 113375; and p. 113388, col. 1).
8. Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al (Oncotarget. Cell-surface marker discovery for lung cancer. 2017. 8(69): 113373-113402 and Supplementary Materials and Supplementary Table 34, 105 pages total) in view of Rosenblum et al (Nature Communications. Progress and challenges towards targeted delivery of cancer therapeutics, 2018. 9: 1410. 12 pages).
The following rejection applies to the claims to the extent that the claims may intend to include a step of preferentially administering the anticancer agent systemically to the subject when the agent does not bind to a CSR on the surface of a cell from a healthy organ or tissue, or preferentially administering the anticancer agent locally to a tissue or organ of the subject when the agent does bind to a CSR on the surface of a healthy organ or tissue.
The teachings of Cohen are presented above. Cohen does not teach a step of preferentially administering the anticancer agent systemically to the subject when the agent does not bind to a CSR on the surface of a cell from a healthy organ or tissue, and preferentially administering the anticancer agent locally to a tissue or organ of the subject when the agent does bind to a CSR on the surface of a healthy organ or tissue.
However, as discussed above, Cohen teaches that increased toxicity and reduced effectiveness is associated with systemic administration of anticancer agents that target cell surface markers / receptors when the cell surface markers / receptors are present on normal, non-cancerous tissues (e.g., abstract p. 113374, col. 2, second para; p. 113375, col. 1; and p. 113381, final para). For instance, Cohen (p. 113375, col. 1) states “targeted therapeutic agents can deliver cytotoxic payloads or inhibit pathways that are important for normal cellular functions. Hence, marker discovery for targeted therapy requires evaluation of expression in tumor versus expression in a range of tissues that are of concern for systemic toxicity”.
Further, Rosenblum teaches that “Local delivery can significantly improve
pharmacological benefit at the disease site and reduce systemic toxicity compared to systemic administration” (p. 8, col. 2). However, Rosenblum also notes the “biological and technical barriers to the success of local drug delivery” and teaches conventional methods of systemic anticancer targeted therapy (e.g., abstract; Figure 5; p. 3, col. 2 to p. 4, col. 1; and p. 8 final para to p. 9, col. 1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a step in the method of Cohen of preferentially administering the identified anticancer agent locally in those instances in which the targeted cell surface marker / receptor was also present on normal, healthy tissues, while preferentially administering the anticancer agent systemically when the targeted cell surface marker was not present on normal, healthy tissues. One would have been motivated to have done so in order to have avoided systemic toxicity in those instances in which the targeted cell surface marker / receptor was present on normal, healthy cells, while permitting the use of more conventional anticancer agent delivery systemically in those instances in which systemic toxicity was less likely to occur, as suggested by the combined teachings of Cohen and Rosenblum.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLA J MYERS whose telephone number is (571)272-0747. The examiner can normally be reached M-Th 6:30-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached on 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CARLA J MYERS/Primary Examiner, Art Unit 1682
Prosecution Insights