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 .
FINAL ACTION
Election/Restrictions
1. Applicant’s response to the Non-Final Action dated 8/13/25 is acknowledged (paper filed 1/13/26). In the amendment filed therein claims 18, 19, 28, 31, and 32 were modified. While claims 1-17 have been canceled without prejudice or disclaimer.
2. Currently claims 18-32 are pending and under consideration.
3. Rejections and/or objections of record not reiterated herein have been withdrawn.
Priority
4. The instant application has a priority date of June 21, 2019. The application is a 371 of International Patent Application No. PCT/SG2020/050343, filed June 19, 2020, which claims priority to Singapore Application No. 10201905757Q, filed June 21, 2019.
NEW GROUNDS OF REJECTIONS NECESSITATED BY AMENDMENTS
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.
5. Claims 18-32 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 pre-AIA the applicant regards as the invention.
A. Claim 18 is vague and indefinite because it is not clear as to what the method will encompass or measure. As recited the claim recites “wherein a change in the levels of the biomarkers as compared to a reference indicates the presence of lung cancer in the subject;”. However, the specification only identifies increased biomarker expression relative to a normal control as the means for determining NSCLC. See page 24 and figure 4. The measurement of any change in comparison to any reference is therefore ambiguous as to what parameters are being evaluated. In order to obviate this rejection, it is suggested that the claims clearly identify that the change is increased expression in NSCLC as compared to a normal control (healthy subject). Appropriate correction is required.
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.
6. Claims 18-32 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to a judicial exception or JE (i.e. natural phenomena-measuring biomarkers found in nature and abstract idea-comparison to a reference control) without significantly more.
The claim(s) recite(s): Claim 1. A method of treating a lung cancer in a subject, the method comprising (a) determining the levels of the biomarkers, surfactant protein B (SFTPB) and C-X-C motif chemokine receptor 4 (CXCR4), from a vesicle population isolated from a biological sample from said subject, wherein a change in the levels of the biomarkers as compared to a reference indicates the presence of lung cancer in the subject; and (b) administering an anti-cancer therapy to the subject determined to have lung cancer.
Claim 31. A method of detecting and treating lung cancer in a subject, the method comprising: (a) determining the levels of the biomarkers, SFTPB and CXCR4, in a vesicle population isolated from a biological sample from said subject, wherein a change in the levels of the biomarkers as compared to a reference indicates the presence of lung cancer in the subject, and (b) administering an anti-cancer therapy to the subject found to have lung cancer.
Claim 32. A method of treating a lung cancer in a subject, the method comprising (a) selecting a subject based on the levels of the biomarkers, SFTPB and CXCR4, in a vesicle population isolated from a biological sample from said subject, wherein a change in the levels of the biomarkers as compared to a reference indicates the presence of lung cancer in the subject; and b) administering an anti-cancer therapy to the subject found to have lung cancer.
The judicial exception (natural phenomena) is not integrated into a practical application because determining natural biomarkers (CAT, CXCR4, and SFTPB) in a biological sample, comparing data (reference control levels), and diagnosing lung cancer by merely thinking about the results does not practically apply the judicial exception. Although the methods recite a treatment or administering an anti-cancer therapy, the treatment is not necessarily performed.
In other words, there is no corresponding action with respect to the knowledge provided by the judicial exception. Step b in claims 18, 31, and 32 read on administering an anti-cancer therapy when the “protein level of SFTPB and CXCR4 demonstrates a change in comparison to a reference. The claims includes a conditional limitation because the treatment is not conducted if no change is observed; therefore the method reads on instances where the treatment does not occur (protein levels equal to reference levels).
Additionally, the method of claim 19 - provides a medical treatment if higher levels of the biomarkers are measured. This method encompasses non-treatment processes. Accordingly, the claims do not integrate the JE into a practical application.
Examiner directs Applicant to the case law (Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F. 3d 1117) and PTO guidance emphasizing that method of treatment claims can be found to satisfy 35 USC § 101 at the first step of an Alice/Mayo analysis, without requiring a showing of “non-routine or unconventional steps’.
Unlike Vanda’s claims, where administering is required for all populations of patients, in instant case, the broadest reasonable interpretation of the claimed scope is that the treatment steps or therapy are not necessarily performed. The steps of “determining and comparing” in claims 18, 31,and 32 do not actually require an active wet step but encompasses abstract ideas and are insufficient to make an otherwise ineligible claims patent eligible, the claims are ineligible subject matter under 35 U.S.C. 101. (Alice Corporation Pty. Ltd. v. CLS Bank International, et al.).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the determining, comparing, and administering steps do not transform the method into an inventive process. The additional steps do not amount to significantly more than the judicial exception.
Based upon an analysis with respect to the claims as a whole, the claims are determined to be directed to a law of nature/natural principle (natural phenomena). The rationale for this determination is explained below:
A claim that focuses on use of a natural principle (method merely identifying or determining the natural compositions of CAT, CXCR4, and SFTPB) must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966.
To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. The analysis turns on whether the claim has added enough to show a practical application. See id. at 1968.
Specifically the claim cannot cover the natural principle itself such that it is effectively standing alone. A bare statement of a naturally occurring correlation, albeit a newly discovered natural correlation or very narrowly confined correlation, would fail this inquiry. See id. at 1965, 1971.
Claims 18-32, as currently recited encompass measurements in individuals with or without lung cancer, who will not receive treatment. It is not necessary that every recited element or step integrate or relate to the natural principle as long as it is applied in some practical manner. However, there must be at least one additional element or step that applies, relies on or uses the natural principle so that the claim amounts to significantly more than the natural principle itself.
Along with integration, the additional steps must be sufficient to ensure that the claim amounts to significantly more than the natural principle itself by including one or more elements or steps that limit the scope of the claim and do more than generally describe the natural principle with generalized instructions to “apply it.” See id. at 1965, 1968.
The additional elements or steps must narrow the scope of the claim such that others are not foreclosed from using the natural principle (a basic tool of scientific and technological work) for future innovation.
Elements or steps that are well-understood, purely conventional, and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular technological environment (field-of-use), would not be sufficiently specific. See id. at 1968.
In the present case, the claims are directed to a naturally occurring correlation, namely the natural composition of CAT, CXCR4, SFTPB; naturally found in an individual; and measuring differential expression in lung cancer. See claims 18-32.
The combination of steps recited in the claims, taken as a whole, is not sufficient to qualify as a patent-eligible practical application because the steps are not sufficiently specific to ensure that the claims amount to significantly more than the natural principle itself. Rather, in this case the claims would cover every substantial practical application of the correlation.
In particular, the “determining, comparing, and administering an anti-cancer therapy are recited at a high level of generality and is not sufficient to ensure that the claims amount to significantly more than the naturally occurring correlation itself.
This is because every application of the correlation would require determining; and also because the “determining, comparing to a reference control, and initiating” steps do not relate to the natural principle in a significant way to impose a meaningful limit on the claim scope.
Limitations that are necessary for all practical applications of the natural principle, such that everyone practicing the natural principle would be required to perform those steps or every product embodying that natural principle would be required to include those features, would not be sufficient to confer patent eligibility.
In addition, appending conventional steps, specified at a high level of generality, to a natural principle does not make the claim patent-eligible.
Steps that amount to instructions that are well-understood, routine, conventional activity, previously engaged in by those in the field add nothing specific to the natural principle that would render it patent-eligible.
In this case, it was known to measure CAT, SFTPB, and CXCR4 in lung cancer patients and treat said lung cancer. See for example the reference to Spetzler et al. (WO2012/115885A1)) which discloses a method for diagnosis, prognosis (i.e. cancer progression) or theragnosis (i.e. responder/non-responder status to anti-cancer treatment) for lung cancer comprising the detection of the levels of vesicle or exosome associated biomarkers of CXCR4, superoxide dismutase (SOD) and SFTPB (pro) and comparing these levels to that of corresponding reference group.
While Gold et al. discloses CAT and superoxide dismutase (SOD) as a lung cancer biomarkers used in distinguishing between benign nodule versus NSCLC, with CAT used individually or as a panel of biomarkers to provide better specificity and sensitivity (Tables 1, 30, 34, 39).
The instantly claimed invention when given its broadest reasonable interpretation (BRI) reads on a method (claims 18, 31, and 32) measuring CAT, CXCR4, SFTPB with or without additional biomarkers in a test sample wherein the detection of lung cancer is not measured. The step of determining is therefore insufficient to render the claim patent eligible, since it represents well-understood, routine, and conventional activity that was previously engaged in by those in the field.
Furthermore, the additional elements set forth in the dependent claims also represent well-understood, routine, conventional activity that was previously engaged in by those in the field.
In other words, CAT, CXCR4, SFTPB with additional biomarkers are naturally occurring products and the claimed methods identifying them merely amount to routine activity that is not patent eligible.
In summary, the claims do not include additional elements/steps or a combination of elements/steps that are sufficient to ensure that the claims amount to significantly more than a natural principle itself. This is because (1) the claims would cover every substantial practical application of the correlation and (2) the additional steps recited in the claim were previously taken by those in the field.
When the claims are considered as a whole, the steps taken together amount to no more than recognizing the law of nature itself. A claim setting forth the relationship between naturally occurring CAT, CXCR4, SFTPB with additional biomarkers levels in patients would require additional steps that do significantly more to apply this principle than conventional marker testing or general diagnostic activity based on such testing. Such additional steps could involve, for example, a testing technique or treatment steps that would not be conventional or routine.
Additionally Claim(s) 18-32 are also directed to abstract ideas as independent claims 18, 31, and 32 recite “comparing the detected marks to a reference control” (reading on mental processes). Comparing information regarding a sample or test subject to a control or target data reads on “An Idea ‘Of Itself’” as when given its broadest reasonable interpretation, such a comparison would read on a mental process that could be performed in the human mind, or by a human using pen and paper. See July 2015 Update, Quick Reference Guide.
Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and comparing known information in Classen, or comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC.
The specific information that is being compared (CAT, CXCR4, SFTPB with additional biomarkers) merely narrows the abstract idea, which does not make the comparison step less abstract and is not sufficient to provide eligibility on its own. Please see the 2019 Guidance on Patent Subject Matter Eligibility.
101 Analysis – Claims 18, 31, and 32
Step 1: – Is the claim to a process, machine, manufacture or composition of matter?
YES. The claims recite a step or act, i.e. method of diagnosing lung cancer by measuring CAT, CXCR4, SFTPB in a biological sample comprising a vesicle population to determine lung cancer and administer an anti-cancer therapy. Thus, the claim is directed to a process.
Step 2A Prong 1: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea?
Yes. The claim recites a step of determining, comparing, and administering treatment based on CAT, CXCR4, and SFTPB biomarkers levels. This reads on comparing or mental activities that are abstract ideas (JE). The steps of comparing (determining presence or level) is recited a high level of generality that merely requires a comparison of two pieces of information and imposes no limits on how the comparison is performed. In Myriad CAFC, the court round this step of comparing to be an abstract idea. When applying the 2014 IEG and interpreting the claim during examination, it is apparent that the step of comparing (determining presence or level) could be performed by a human using mental steps or basic critical thinking.
Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and comparing known information in Classen, or comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC.
The specific information that is being compared (CAT, CXCR4, and SFTPB) merely narrows the abstract idea, which does not make the comparison step less abstract and is not sufficient to provide eligibility on its own.
Thus, the claim is directed to an abstract idea. The claim is drawn to an abstract ideas in what they are directed to a method for collecting and comparing information regarding a sample or test subject to a control or target data (Ambry/Myriad CAFC).
Step 2A Prong 2: Is the JE integrated into a practical application?
No, there is not action on the JE. The method merely requires thinking about the information or results obtained (comparison and possibly administering a treatment) reading on instances wherein the JE is not physically acted on.
Step 2B: Does the claim as a whole amount to significantly more than the judicial exception, i.e. the product of nature, law of nature, natural phenomenon, or abstract idea? Inventive concept
The claim as a whole is analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the abstract idea. The claim recites steps of measuring CAT, CXCR4, and SFTPB biomarkers and including antibody specific binding partners are all well understood, routine and conventional procedures. Accordingly, the claims as a whole do not amount to significantly more than the abstract idea of comparing/determining information (evaluating data). The claim is not patent eligible.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The method of claims 18-32 are generally directed to collecting information and comparing the data to determine lung cancer. The use of conventional, well understood, and routine activities previously known to the industry, specified at a high level of generality, had been held NOT to be enough to qualify as “significantly more” when recited in a claim with a judicial exception.
Determining whether CAT, CXCR4, and SFTPB biomarkers are present in a sample merely instructs a scientist to use any detection technique. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or transformation of a particular article, in this step that distinguishes it from well-understood, routine and conventional data gathering activity engaged in by scientist prior to applicant’s invention, and at the time the application was filed. Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)).
For all of the reasons above, at least claims 18-32 fails to include additional elements that are sufficient to amount to significantly more than the judicial exception(s).
Claims 18-32 are directed to the additional step of measuring by known routine assay techniques. As such, claims 18-32 fail to include additional elements that are sufficient to amount to significantly more than the judicial exception.
Response to Arguments
Applicant contends that claims 18, 31, and 32 have been amended such that treatment of the lung cancer subjects is necessarily performed. This argument was carefully considered but not found persuasive because the method remains directed to mental processes and abstract ideas. The determining step for CAT, CXCR4, and SFTPB biomarkers are present in a sample merely instructs a scientist to use any detection technique. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or transformation of a particular article, in this step that distinguishes it from well-understood, routine and conventional data gathering activity engaged in by scientist prior to applicant’s invention, and at the time the application was filed.
Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)). In Myriad CAFC, the court round this step of comparing to be an abstract idea. When applying the 2014 IEG and interpreting the claim during examination, it is apparent that the step of comparing (determining presence or level) could be performed by a human using mental steps or basic critical thinking.
Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and comparing known information in Classen, or comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC. The specific information that is being compared (CAT, CXCR4, and SFTPB) merely narrows the abstract idea, which does not make the comparison step less abstract and is not sufficient to provide eligibility on its own.
Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 102
7. 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. Claim(s) 18-26, 31, and 32 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Spetzler et al. (WO2012/115885 A1).
Spetzler et al. discloses, explicitly or implicitly, a method for diagnosis, prognosis (i.e. cancer progression) or theragnosis (i.e. responder/non-responder status to anti-cancer treatment) for lung cancer comprising the detection of the levels of vesicle or exosome associated biomarkers of CXCR4, superoxide dismutase (SOD) and SFTPB (pro) and comparing these levels to that of corresponding reference group. The vesicle population used can be isolated and/or detected using for example, an anti-CD9 antibody, anti-CD63 antibody and anti-CD81 antibody.
Moreover, Spetzler discloses the selection of an anti-cancer treatment for the cancer patient based on responsiveness for a treatment.
It demonstrates a downregulation in circulating protein levels based on plasma-derived circulating microvesicles (cMVs) in the non-small cell lung cancer (NSCLC) subjects as compared to healthy controls, where it includes patients with early stage (stage |) NSCLC (D1: para. [0019], [0022], [0028], [0032], e.g. altered levels of the biomarkers relative to a reference provide a determination whether the cancer is responding to therapeutic treatment, where in elevated levels of one or more biomarker in the sample compared to the reference can indicate the likelihood of a more advanced cancer in the sample, [00169], e.g. closely aligning with or no change compared to non-responder group means subject is a non-responder, or closely aligning with a responder group means subject is a responder, [00190], [00195], [00247], [00329], [00331]-[00334], [00398], [00403], [00434], [00786], [001035], [001077], [001082], [001098], [001205]-[001207], [001620];
Table 5 on page 96, see vesicle markers, bridging section on pages 101-102, see row on Lung cancer, Table 9 on pages 215-216; Example 83 and Table 909: claims 1 25 11 12 59*)
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spetzler et al. (WO2012/115885 A1) in view of Gold et al. (WO 2010/030697 A1).
Please see Spetzler et al. as set forth above.
Spetzler et al. differ from the instant invention in not specifically teaching the detection of the CAT protein biomarker in their procedures.
However, Gold et al. discloses CAT and superoxide dismutase (SOD) as a lung cancer biomarkers used in distinguishing between benign nodule versus NSCLC, with CAT used individually or as a panel of biomarkers to provide better specificity and sensitivity (Tables 1, 30, 34, 39).
Absent evidence to the contrary including known biomarkers such as CAT in lung cancer measurements is deemed an obvious design choice previously taught by the prior art.
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960); Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Gold et al. taught that CAT can be utilized individually or as a panel of biomarkers to provide better specificity and sensitivity in NSCLC detections. (Tables 1, 30, 34, 39)
Therefore it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the CAT biomarker taught by Gold et al. in the biomarker panel exemplified by Spetzler et al. as a routine design choice/binding reagent taught the prior art that provided better specificity and sensitivity to NSCLC detection assays.
Response to Arguments
Applicant's arguments filed 13 January 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning.
But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, prior are has disclosed the biomarkers in the measurement of lung cancer. In fact, Applicant has disclosed “that surfactant protein B (SFTPB), is a lung specific protein that is only expressed in lung tissues”. See page 23. It is obvious to combine known reagents to generate the expected result taught by the prior art.
In response to the argument that the instant invention has surprisingly shown more accurate detection of NSCLC when biomarkers (SFTPB, CXCR4, and CAT) are measured in combination, it is noted that synergism has no magic status in rendering otherwise obvious subject matter patentable. The prior art has demonstrated that the biomarkers are useful in determining lung cancer. The Supreme Court in KSR reaffirmed the familiar framework for determining obviousness as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), but stated that the Federal Circuit had erred by applying the teaching-suggestion-motivation (TSM) test in an overly rigid and formalistic way. KSR, 550 U.S. at 404, 82 USPQ2d at 1391. Specifically, the Supreme Court stated that the Federal Circuit had erred in four ways: (1) "by holding that courts and patent examiners should look only to the problem the patentee was trying to solve " (Id. at 420, 82 USPQ2d at 1397); (2) by assuming "that a person of ordinary skill attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem" (Id.); (3) by concluding "that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘obvious to try’" (Id. at 421, USPQ2d at 1397); and (4) by overemphasizing "the risk of courts and patent examiners falling prey to hindsight bias" and as a result applying "[r]igid preventative rules that deny factfinders recourse to common sense" (Id.). See also Novartis Pharms. Corp. v. West-Ward Pharms. Int'l Ltd., 923 F.3d 1051, 1059, 2019 USPQ2d 171676 (Fed. Cir. 2019); Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1047-48, 120 USPQ2d 1400, 1410 (Fed. Cir. 2016); and Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324, 1332, 102 USPQ2d 1445, 1449 (Fed. Cir. 2012). Thus the combination of known parameters (SFTPB, CXCR4, and CAT) to access a known disease (lung cancer) is obvious. The fact that a claimed method or composition is more effective than anticipated is not persuasive of unobviousness where what is claimed would flow naturally from the teachings of the prior art. In re Adams et al. (CCPA 1960) 284 F2d 525, 128 USPQ 116.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
11. For reasons aforementioned, no claims are allowed.
12. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Remarks
13. Prior art made of record and not relied upon is considered pertinent to theapplicant's disclosure:
A. Shoshan-Barmatz (US Patent No. 11,408,887) discloses biomarkers for detecting lung cancer wherein NSCLC, AC, and SCC are distinguished. See abstract and col. 2 line 40 through col. 3 line 24.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Cook whose telephone number is 571-272-0816. The examiner works a flexible schedule but can normally be reached on Monday, Thursday, and Friday from 9am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached at telephone number 571-270-3505. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lisa V. Cook
Patent Examiner
Art Unit 1642
Remsen
571-272-0816
5/14/26
/LISA V COOK/Primary Examiner, Art Unit 1642
Prosecution Insights