DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed July 16, 2025. Currently, claims 19-25 are pending.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow.
This action is FINAL.
Any objections and rejections not reiterated below are hereby withdrawn.
The new matter rejection has been withdrawn in view of the amendments to the claims to remove the calibrator or control gene and/or protein language.
The 102 rejections have been withdrawn in view of the amendments to the claims to require analysis of both/each of TSPYL5 and HOXA1.
Election/Restrictions
Applicant's election without traverse of TSPYL5 and HOXA1in the paper filed July 28, 2021 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority as a DIV of 15/694,300, filed September 1, 2017 which claims priority to 62/383,165, filed September 2, 2016.
Drawings
The drawings are acceptable.
Information Disclosure Statement
It is noted that the IDS filed July 16, 2025 contains an extremely large number of references for consideration by the Examiner. It is noted Applicant has filed more than 150 PAGES of IDS for consideration.
If the Applicant and/or Applicant and/or Applicant's representative are aware of any particular reference or portion of a reference in the extensive list which the examiner should pay particular attention to, it is required that it be specifically pointed out in response to this Office action.
Applicant is reminded that "burying" relevant references in a lengthy IDS is discouraged. See, e.g., Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823, 1831 (Fed. Cir. 1995) The court concluded that, by “burying” Wagenseil in a multitude of other references, Hirsh and Smith intentionally withheld it from the PTO becausethis manner of disclosure was tantamount to a failure to disclose. Citing Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F.Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff'd, 479 F.2d 1328, 178 USPQ 577 (5th Cir.), cert. denied, 414 U.S. 874 (1973), the court stated that Hirsh's and Smith's failure to highlight Wagenseil in light of their knowledge of Whitson's actions in the foreign prosecutions violated their duty of candor to the PTO. Citing our precedent, Textron asserts that Smith's and Hirsh's conduct is “inexcusable, fraudulent, and cannot operate to cure Whitson's inequitable conduct.” See Rohm & Haas Co. v. Crystal Chem. Co., 722 F.2d 1556, 220 USPQ 289(Fed.Cir. 1983), cert. denied, 469 U.S. 851 (1984) (where intentional material misrepresentations have been made, a “cure” through voluntary efforts during prosecution must be demonstrated by clear, unequivocal, and convincing evidence).
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 23 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II.
Based upon consideration of the claims as a whole, as well as consideration of elements/steps recited in addition to the judicial exception, the present claims fail to meet the elements required for patent eligibility.
Question 1
The claimed invention is directed to a process that involves an abstract idea.
Question 2A Prong I
The claims are taken to be directed to an abstract idea.
Claim 23 is directed to “a method for measuring a methylation level” and TSPYL5 and HOXA1 is increased compared to a sample that does not have HCC.
Claim 19 is directed to a process that involves the judicial exceptions of an abstract idea (i.e. the abstract steps of a comparison step to make the determination of increased methylation level compared to a control).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow.
Herein, claim 23 involves the patent-ineligible concept of an abstract process. Claim 23 recites a comparison between the methylation level and a reference marker to determine an increased methylation level (see MPEP 2106.04(a)(2)(III)(A); • claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014)).
Question 2A Prong II
The exception is not integrated into a practical application of the exception. The claims do not recite any additional elements that integrate the exception into a practical application of the exception. While the claim recites extracting DNA, treating and amplifying, this is not an integration of the exception into a practical application. Instead, these elements are data gathering required to perform the method. Thus, the claim is “directed to” the exception.
Accordingly, the claims are directed to judicial exceptions.
Question 2B
The second step of Alice involves determining whether the remaining elements, either in isolation or combination with the other non patent ineligible elements, are sufficient to “’transform the nature of the claim’ into a patent eligible application” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
The claims are not sufficiently defined to provide a method which is significantly more from a statement of a natural principle for at least these reasons:
The claims do not include applying the judicial exception, or by use of, a particular machine. The claims do not tie the steps to a “particular machine" and therefore do not meet the machine or transformation test on these grounds. The use of machines generally does not impose a meaningful limit on claim scope.
The claims also do not add a specific limitation other than what is well-understood, routine and conventional in the field. The extracting DNA, treating DNA with bisulfite and amplifying DMR to evaluate mutation status are mere data gathering step that amounts to extra solution activity to the judicial exception. It merely tells the users of the method to determine the methylation level of a sample without further specification as to how the sample should be analyzed. The claim does not recite a new, innovative method for such determination. The extracting DNA, treating DNA with bisulfite and amplifying DMR essentially tells users to determine the markers through whatever known processes they wish to use.
The step was well known in the art at the time the invention was made. The steps are recited at a high level of generality. The claim merely instructs a scientist to use any methylation analysis method. The claim does not require the use of any particular non-conventional reagents. When recited at this high level of generality, there is no meaningful limitation that distinguishes this step from well understood, routine and conventional activities engaged in by scientists prior to applicant’s invention and at the time the application was filed.
Additionally, the teachings in the specification demonstrate the well understood, routine, conventional nature of additional elements because it teaches that the additional elements were well known. Specifically, the specification teaches analyzing changes in methylation patterns involves a PCR based process and cites numerous known methods (see pages 3-4). Thus, methods of methylation specific PCR, methylation sensitive DNA restriction enzyme analysis and bisulfite sequencing PCR were well known in the art at the time the invention was made.
It is noted Claims 21 and 22 that require particular primers of SEQ ID NO: 1-2 and 28-29 have not been included in the instant rejection because the primers of SEQ ID NO: 1-2 and 28-29 are not well understood routine and conventional.
Further it is noted 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.
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
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)
For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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.
Claims 19-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Clin Cancer, Res, Vol. 15, No. 3, pages 812-820, 2009) and Shen et al. (BMC Medical Genomics, DOI 10.1186/s12920-01-0105-1, “Integrative epigenomic and genomic filtering for methylation markers in hepatocellular carcinoma, June 10, 2015) or Zheng Fang (CN104762301A, cited in 1/20/2022 IDS) in further view of Iyer et al. (Experimental and Molecular Pathology, Vol. 88, No. 1 pages 107-111, Feb 2010).
Lee teaches a method of measuring a methylation level for CpG island hypermethylation analysis of hepatocellular carcinoma and nonneoplastic liver tissues. Lee teaches extracting genomic DNA, performing Methylight analysis. Methylight analysis relies upon PCR amplification. Lee teaches performing Methylight analysis on liver samples from hepatocellular carcinoma. Lee teaches the reaction primers and probes for the Methylight reaction for HOXA1 are:
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Lee identified HOXA1 as the number one methylated CpG island loci (see page 814, col. 2, para 1).
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Lee does not teach analysis of methylation levels for TSPYL5 in blood samples from subjects suspected of having HCC.
However, Shen teaches highly consistently DNA methylation for TSPYL5 in hepatocellular carcinomas (abstract).
Additionally, Fang teaches detection methylation level of liver cancer risk gene TSPYL5. Fang teaches methylation of TSPYL5 may be analyzed by quantitative PCR methods, such as MSRE-qPCR (see abstract). Fang teaches particular primers for use in the amplification of TSPY5.
Iyler teaches a concordance of DNA methylation pattern in plasma and tumor DNA of Egyptian hepatocellular carcinoma patients. Iyler teaches while liver biopsy is the gold standard for methylation studies, plasma analysis was concordant with tissue for all 5 genes studied. In particular, Iyler teaches analysis of tumor methylation of 5 tumor suppressor genes in tissues and plasma to test the concordance between the two types of specimens for the same HCC patients (abstract). Iyler concludes that plasma DNA, i.e. a blood sample, can be reliable for testing methylation profile in liver cancer patients (abstract).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art to have modified the methods taught by Lee analyzing HOXA1 so as to have also amplified TSPYL5 in bisulfite treated samples as taught by Shen or Fang, since both Lee, Fang and Shen teach their markers will be relevant potential biomarkers for the detection of hepatocellular cancer. The ordinary artisan would have been motivated to have used blood samples that are less invasive and more amenable to tracking over time because Iyler teach blood samples are concordant with tissue samples. Since having aberrant methylation in either one of these genes would be indicative of hepatocellular cancer, the skilled artisan would been motivated to measure methylation of both of them since they were both implicated in hepatocellular cancer. It would have been obvious to measure the methylation using Methylight, as taught by Lee. It is prima facie obvious to combine two elements taught by the prior art to be useful for the same purpose in order to form a third to be used for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art as associated with hepatocellular carcinoma. MPEP 2144.06.
With respect to Claim 23, Lee, Fang and Shen teach comparison analysis to subjects without HCC.
With respect to Claim 24, Lee teaches the HOXA1 CpG was in the promoter, i.e. regulatory region.
With respect to Claims 10, 12, the particular primers of SEQ ID NO: 1 and 2 and 28 and 29, the primers are directed to the promoter regions of the recited genes. It would have been obvious to have modified the sequence of the primers taught by Lee, Shen and Fang to design equivalent primers for amplifying the promoter region to detect methylation. Thus, absent unexpected results, the instant primers are obvious in view of the primers taught in the art.
Response to Arguments
The response filed July 16, 2025 is substantially identical to the previous responses filed. The arguments have been considered but are not persuasive.
The response traverses the rejection. Mr. Taylor filed a Declaration on February 29, 2024. The Declaration and the arguments have been fully considered but does not place the case in condition for allowance.
The response filed November 22, 2024 argues the claimed invention requires combining two markers (consisting of TSPYL5 and HOXA1) from the vast number of markers disclosed in the cited art. This argument has been reviewed but is not considered persuasive. The claims are limited to analysis of only TSPYL5 and HOXA1, as argued by the response. Lee identified HOXA1 as the number one methylated CpG island loci (see page 814, col. 2, para 1). Shen identifies two genes with a highly consistent DNA hypermethylation in the abstract with TSPYL5 having the greater underexpression and percentage. Thus, Shen identifies TSPYL5 as the candidate gene with the best results (see abstract). Fang teaches analysis of a single gene TSPYL5. Thus, there is no picking or choosing required for Fang. As provided in MPEP 2144.08, to selected the claimed subgenus from the disclosed prior art genus would have been obvious. Selecting the number one methylated CpG island loci from Lee and the best or only gene from Shen and Fang for determining methylation in HCC would have been obvious. The size of the genus’ provided in Lee and Shen are extremely small and one skilled in the art would envisage each member of the genus. The prior art also expressly teaches a reason to selected the claimed species. Even more, the prior art teaches the genes each have similar properties and uses. Thus, selecting the two genes TSPYL5 and HOXA1 would have been obvious to the ordinary artisan at the time the invention was made with a reasonable expectation of success.
The Declaration filed February 29, 2024 and the response argue that it would not have been obvious to one of ordinary skill in the art to combine the detection of methylated HOXA1 as disclosed with the detection of methylated TSPYL5 as disclosed with Shen/Feng for assessing HCC within a blood sample. The Declaration and the response argue the data in Iyler is incomplete; the study design is flawed and the conclusion of “concordance” between plasma and tumor DNA is unsubstantiated. The Declaration and the response states Iyler fails to disclose the sequences of the PCR primers and any gels required to demonstrate that the bands detected accurately reflect the methylation profiles. The response also argues that it is unclear if any positive or negative controls were used and the p-values are not explained. The Declaration and the response argue the primary data is not available and one of ordinary skill in the art is incapable of assessing its veracity or accuracy. This argument has been reviewed but is not persuasive. MPEP 2143(I)(B), Example 2 provides “Obviousness does not require absolute predictability of success.” In re O’Farrell, 853 F.2d 894, 7 USPQ2d 1673 (Fed. Cir. 1988). Obviousness only requires a reasonable expectation of success. Iyler teaches a concordance of DNA methylation pattern in plasma and tumor DNA of Egyptian hepatocellular carcinoma patients. Iyler teaches while liver biopsy is the gold standard for methylation studies, plasma analysis was concordant with tissue for all 5 genes studied. In particular, Iyler teaches analysis of tumor methylation of 5 tumor suppressor genes in tissues and plasma to test the concordance between the two types of specimens for the same HCC patients (abstract). Iyler concludes that plasma DNA, i.e. a blood sample, can be reliable for testing methylation profile in liver cancer patients (abstract). The primer pair sequences, the gels and other experimental results are not required to expect a concordance between blood and tumor tissues because Iyler explicitly teaches and illustrates in Figure 1 a concordance exists. The standard for obviousness only requires a reasonable expectation of success, not absolute predictability. Here the level of skill in the art is quite high and contains detailed methodology, thus, there is a reasonable expectation of success for determining methylation patterns in blood samples. It would have been obvious to have tried the known method for detecting methylation in blood samples with a reasonable expectation of success.
Further, Shen discusses using blood as a surrogate for tissue samples. Shen suggests performing routine experimentation to determine which markers are associated with HCC and Iyler teaches there is a reasonable expectation of success that markers would be concordant in HCC tissue and blood samples.
The Declaration filed February 29, 2024 and the response next assert Iyer is directed to matched samples. The response cites post-filing date Kisiel, from 2019, that uses unmatched tissue and plasma samples. The response argues, without evidence that is much easier and less statistically relevant to find concordance between tissue and plasma samples if the samples are obtained from the same HCC patient. This argument has been reviewed but is not persuasive. The presence of two possible methods for establishing concordance between blood and tissue samples does not indicate that the paired sample method of Iyler is not reliable. The use of paired studies would provide a reasonable expectation of success for analyzing blood and tumor samples for methylation. Again, the claims are merely directed to assessing methylation in a blood sample and does not require any particular result.
The response cites two additional post filing date references to discuss the state of the art. It is noted that the instant filing date is 2016 and the Pelizzaro reference is five years later. The response also cites Ng filed in 2018. This is not “around the time of the present application”. The response argues that Pelizzaro clearly discloses to one of ordinary skill in the art that there is more likely than not a lack of concordance in DNA methylation between tumor tissue samples and plasma samples from HCC patients. Pelizzaro is one reference that demonstrates three of 11 genes shared the same methylation pattern between HCC tumor tissue and plasma samples. The response argues Ng teaches not all HCC tumors with p15/p16 methylation were associated with the equivalent methylation status in the plasma/serum DNA. The sentence before this sentence states “all cases with evidence of p15/p16 methylation in the plasma/serum DNA also showed evidence of methylation in the corresponding tumors”. This demonstrates there were not false positives by detecting methylation patterns in the plasma/serum for “all cases” analyzed by Ng. Additionally, the art provides numerous additional examples of concordance between tumor tissue and plasma samples from HCC patients. Yin et al. (Disease Markers, Vol. 2016, Article ID 1427849) teaches “many studies have shown that the majority of methylated genes can be detected in the circulatory system of HCC patients and the cfDNA methylation profiled showed good consistency with methylation profile in tumor tissues”. Therefore, the totality of the evidence of record demonstrates that it would have been obvious to try to determine whether DNA methylation patterns found in tumor samples from HCC patients were consistent with plasma samples.
The Declaration argues “only a small proportion of cfDNA from plasma is capable of representing the patterns of DNA methylation. The Declaration also discusses early-stage cancer patients and the smaller fraction of tumor-derived DNA. These arguments have been fully reviewed, but are not persuasive. The claims are not directed to early-stage cancer patients or any particular timepoint for detection. Therefore, the Declaration is arguing limitations not found in the claims.
The Declaration concludes identifying methylated DNA markers that will be useful for the development of a robust blood-based assay for HCC requires a significant amount of experimental validation. This argument is directed to the unpredictability or enablement of the method. This argument has been thoroughly reviewed but is not deemed persuasive. MPEP 2164.06 provides ‘The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed.’" In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Here, the art teaches the analysis of tumor and plasma for methylation patterns was merely routine. The art is also replete with guidance with respect to how the experimentation should proceed. Therefore, it is not unpredictable to test blood and tissue tumors for methylation.
There is a reasonable expectation of success that the assessment of methylation HOXA1 and TSPYL5 in a blood-based assay would be a useful indicator of HCC based upon the disclosure of the markers in HCC tissue samples. A reasonable expectation of success does not require an absolute expectation of success.
The response cites post-filing Chalasani as demonstrating unexpected results for the instant combination of two markers. It is noted the instant claims do not require any particular result. The instant claims do not even require predicting liver cancer or any prognostic method. Further, the teachings in Chalasani states an “algorithm was developed for the mt-HBT, which incorporates methylation biomarkers (HOXA1, TSPYL5 and B3GALT6), AFP and sex. The instant claims are not limited to these three genes, AFP nor sex. Thus, the claims are not commensurate in scope with the alleged unexpected results.
The response argues that the analysis in Chalasani showed levels of methylation of TSPYL5 in plasma is not elevated compared to controls but HOXA1 is different between controls and HCC. The response concludes that HOXA1 would be an effective methylated DNA marker but TSPYL5 would not. The Declaration filed provides sensitivity and specificity values for methylated HOXA1 andTSPYL5 individually and in combination. The response argues this demonstrates unexpected results.
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This argument has been reviewed but is not persuasive. The response argues that when used in combination the % sensitivity increases “substantially”. Looking at the results of the data provided a change from about 59% and about 57% to 63% does not appear to be a substantial increase. As provided in 716.02(a) the results must show unexpected results. It is not unexpected or surprising that when you combine two markers known to be associated with a disease that you will get better results than the markers individually. The prior art is replete with studies that analyze single genes and combination of genes and see that combination of methylation of genes provides much more sensitivity (see Hua et al. Experimental and Molecular Pathology Vol. 91, No. 1, pages 455-460, August 2011).
Additionally, a change from about 71% and 70% to about 77% does not appear to be a substantial increase. MPEP 716(a) requires that the unexpected results are of a significant, practical advantage. Here, the increases do not appear to be substantial or significant. The response and the evidence do not provide any statistical analysis that an increase from 71% and 70% to about 77% is significant and is a practical advantage. The response filed November 22, 2024; page 4 reiterates that Dr. Bruinsma’s declaration provides evidence of unexpected results. The response states 467,346 patients were diagnosed in 19 years and would results in additional 32,714 HCC patients positively identified beyond those identified by each methylated marker individually. There sheer increase in number of cases identified does not suggest this is not expected that using two genes instead of one is unpredictable or rises to the level of unexpected results.
The response argues nothing in the art at the time of filing suggested the combination of HOXA1 with TSPYL5 would result in the increased in sensitivity demonstrate in the results above. This argument has been reviewed but is not persuasive. The prior art teaches TSPYL5 and HOXA1 are individually associated in tissue of HCC cancer patients. The prior art teaches blood is a surrogate for methylation profiles in HCC tissue. The prior art teaches two markers provides increased sensitivity over single markers and demonstrates examples. MPEP 2143.02 provides that the expectation of success need only be reasonable. Obviousness does not require absolute predictability. As provided in MPEP 2143, “A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
The response filed February 29, 2024 cites to passages in Chalasani that provides the mt-HBT showed higher early stage sensitivity compared with AFP and GALAD. MPEP 716.02(b) provides the burden is on Applicant to provide evidence of unexpected properties in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. Here, a comparison of the AFP and GALAD is not the closest prior art. The art cited here was directed to the particularly claimed biomarkers.
Applicant submitted a declaration under 37 C.F.R. 1.132 by Dr. Hatim Allawi on September 21, 2022. The Declaration reviews the three cited references and provides his opinion and beliefs about the teachings of the references. Dr. Allawi then provides his opinion about the obviousness of selecting HOXA1 and TSPYL5 from the cited references. MPEP 716.01(c) provides “factual evidence is preferable to opinion testimony; such testimony is entitled to consideration and some weight so long as the opinion is not on the ultimate legal conclusion at issue. While an opinion as to a legal conclusion is not entitled to any weight, the underlying basis for the opinion may be persuasive. In re Chilowsky, 306 F.2d 908, 134 USPQ 515 (CCPA 1962)”. Here, Declarant’s opinion as to the obviousness conclusion is the ultimate legal conclusion is not persuasive.
During the interview with Applicant’s attorney on January 13, 2023, the Examiner suggested comparing the DMR regions analyzed in the instant application to the DMR regions of the prior art to distinguish the references from the instant invention. The response does not appear to avail them of this opportunity.
The response previously argued that Lee discloses HOXA1 among 23 CpG island loci that were significantly methylated but does not explicitly teach the marker would be useful for prognostication. The response focuses on Lee’s statement that SYK and CRABP7 hypermethylation may serve as useful tumor markers for prognostication of hepatocellular carcinoma patients. This argument has been reviewed but is not persuasive. The text of Lee unequivocally states that HOXA1 showed the highest statistical significance (“in descending order of statistical significance”).
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Lee specifically lists HOXA1 as the highest in the order of statistical significance as a CpG site associated with hepatocellular carcinoma (see page 814, col. 2).
Even if one could argue that HOXA1 is not preferred marker (which seems unlikely given the explicit statement in Lee), the MPEP makes it clear that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments (see MPEP 2123).
The response argues that the combination of the instant genes is hindsight. However, “[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.” In re McLaughlin 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). Applicants may also argue that the combination of two or more references is “hindsight” because “express” motivation to combine the references is lacking. However, there is no requirement that an “express, written motivation to combine must appear in prior art references before a finding of obviousness.” See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004). See MPEP § 2141 and § 2143 for guidance regarding establishment of a prima facie case of obviousness. Here, the Examiner has done just this. There is absolutely no reference to the instant specification in order to teach or suggest any element of the claimed invention. Rather, the obviousness case was very clearly built on “only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made.”
Thus, for the reasons above and those already of record, the rejection is maintained.
Conclusion
No claims allowable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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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.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682 July 28, 2025