Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
Summary
This is the Non-Final Office Action based on application 19/187629 response filed 01/30/2026.
Claims 1, 3-4, 9-10, 12-15 & 18-26 are pending and have been fully examined.
Claims 2, 5-8, 11, 16-17 are cancelled.
Claims 18-26 are newly added.
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.
The claimed invention of claims 1, 3-4, 9-10, 12-15 & 18-26 are directed to a natural correlation without significantly more.
Through 101, inquiry analysis:
Is the claim directed to a statutory category of invention?
Yes, independent Claim 1 and the claims depending therefrom are drawn towards a method of assaying for one or more biomarkers.
Yes, independent Claim 20 and the claims depending therefrom are drawn towards a method for detecting IL19 and PI3.
Step 2A, Prong One: Identify if there is a law of nature/natural phenomenon/abstract ideas.
For independent Claims 1 & 20, they recite, “assaying.” “Assaying,” as claimed through broadest reasonable interpretation can be interpreted as a mental process of assaying. Mental processes are abstract idea judicial exceptions. In Claim 20, the preamble includes that “detecting,” is done, but within the claim body what is claimed is “assaying,” which again is a mental process and it is noted that the claim body is what matters for the claim as preambles are not always limiting, especially when they do not tie into the claimed method/claim body steps. Comparison to a control as claimed for claim 20, is also a mental process which is an abstract idea.
Step 2A Prong Two: Has the judicial exception been integrated into a particular practical application?
The judicial exception is not integrated into a practical application in independent claims 1 or 20.
Claims 1 & 20 includes the main step which is, “assaying a biological sample,” for levels of IL19 and PI3. “Assaying,” as broadly claimed can be read through broadest reasonable interpretation as an abstract idea/mental process. That the biological sample is from a patient, “at risk of having hidradenitis suppurativa,” does not change matters as any patient can be interpreted as “at risk,” through broadest reasonable interpretation. Further, taking a biological sample does nothing to practically apply the abstract idea.
Even further- the claimed “assaying,” if is in fact actual detection (though not claimed aside from in the preamble and no detection device is claimed) is merely done to pull data to perform the judicial exception. Note that data gathering to be used in an abstract idea or with the claimed natural correlation, is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g).
In addition, nothing further is done with the data gathered after the claimed “assaying,” or detection. Therefore, the judicial exceptions are not integrated into a practical application as no steps are performed after the detection to integrate into a practical application. This could include things like a particular and specific treatment which always occurs in the boundaries of the claims.
Step 2B: Do the claims recite any elements which are significantly more than the law of nature/natural correlation?
Independent Claims 1 & 20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no particularity or specificity of measurement, detection or treatment that makes the claims significantly more than the claimed natural correlation.
In addition to the judicial exceptions Claims 1 & 20 require that the biological sample is obtained from a subject “having or at risk of having hidradenitis suppurativa.” Through broadest reasonable interpretation any patient can be interpreted as the above. Further obtaining biological samples to measure biomarkers is well-understood, routine and conventional activity (WURC) for those in the field of diagnostics. This is evidenced by the fact that prior art teaches of them, and is especially true at the level of generality claimed.
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 (or natural correlation) (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)).
Further MPEP 2106.04 for examples of laboratory techniques that have been shown to be routine and conventional. “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…”
The dependent claims undergo a similar analysis.
Claim 3 does not change the matters above. It indicates that multiple protein levels of biomarkers or specific biomarkers are detected. These biomarkers are still part of the judicial exception itself which is assayed as described for Claim 1 rejection above.
Claim 4 does not change the matters above. It indicates that multiple mRNA levels of biomarkers or specific biomarkers are detected. These biomarkers are still part of the judicial exception which is assayed as described for Claim 1 rejection above.
Claim 9 specifies that the treatment is performed, “if,” a condition is met in comparison to a normal control. However, this still leaves the claims open to the condition not being met within the boundaries of the claims and therefore no treatment. Therefore, the claimed treatment is not a practical application of the judicial exception and does not change the matters above. See Vanda memorandum.
Claim 10 specifies further what the treatment is however again though the claims are still left open to no treatment occurring. Therefore, this is not a particular practical application.
Claim 12 specifies that the treatment is however again though the claims are still left open to no treatment occurring and uses an “if,” clause indicating treatment only occurs sometimes. Therefore, this is not a particular practical application. See Vanda memorandum.
Claim 13 specifies further what the treatment is however again though the claims are still left open to no treatment occurring. Therefore, this is not a particular practical application.
Claim 14, specifies that the treatment is however again though the claims are still left open to no treatment occurring and uses an “if,” clause indicating treatment only occurs sometimes. Therefore, this is not a particular practical application. See Vanda memorandum.
Claim 15, specifies further what the treatment is however again though the claims are still left open to no treatment occurring. Therefore, this is not a particular practical application.
Claims 18 & 26, specify that the “assaying,” includes one or more of the claimed biomarkers. This is still part of the claimed judicial exception, of “assaying,” which this claim still reads on and does not add anything to practically apply nor to add significantly more.
Claim 19 specifies that the blood sample is lesional skin or blood. As shown for the independent claims, obtaining biological samples, including lesional skin or blood is WURC, so does not add significantly more, nor does it do anything to practically apply.
Claim 21 does not change the matters above. It indicates that multiple protein levels of biomarkers or specific biomarkers are detected. These biomarkers are still part of the judicial exception itself which is assayed as described for Claim 1 rejection above.
Claim 22 does not change the matters above. It indicates that multiple mRNA levels of biomarkers or specific biomarkers are detected. These biomarkers are still part of the judicial exception which is assayed as described for Claim 1 rejection above.
With respect to Claim 23, it claims that the subject was previously treated, however this does not occur within the boundaries of the claim and therefore doesn’t have an affect on the claimed, “assaying,” in claim 20 from the standpoint of practically applying or adding significantly more.
Claims 24-25, specify that the treatment is however again though the claims are still left open to no treatment occurring and uses an “if,” clause indicating treatment only occurs sometimes. Therefore, this is not a particular practical application. See Vanda memorandum.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1, 3-4 & 18-19 are rejected under 35 U.S.C. 102 (a)(1) and 102 (a)(2) as being anticipated by SHANMUGAM in US 20200109453.
With respect to Claim 1, SHANMUGAM teaches of methods of detecting and treating hidradenitis suppurativa by calculation of differential gene expression (abstract, paragraph 0018, 0022, 0122, Table 3). SHANMUGAM further teaches of detecting/assaying for expression of IL19 (paragraphs 0082-0085, Table 11), and the expression of PI3 (paragraph 0083-0085, Table 11). To do this, a biological sample is taken from a subject who either has or is suspected or at risk for having hidradenitis suppurativa (any patient/ sample can be considered “at risk,” of having the claimed disease through broadest reasonable interpretation) (paragraph 0007, 0010-0011, 0014). This can be done by a chemical assay (paragraph 0028), though through broadest reasonable interpretation, the claimed assaying can be a mental process.
With respect to Claim 3, SHANMUGAM teaches the expression level being the protein expression level (paragraphs 0020-0022, 0026-0028). Also, see Claim 1 rejection.
With respect to Claim 4, SHANMUGAM teaches the expression level being the mRNA expression level (paragraphs 0020-0022, 0026-0028, 0145). Also, see Claim 1 rejection.
With respect to Claim 18, SHANMUGAM further teaches of detecting expression of CXCR4, CD86, CD247, CD3D, HLA-DMA, HLS-DMB, IL6, IL4R, CD79A, CCL27, dermcidin, IL-37 or a combination thereof in a biological sample of a human subject; b) characterizing HS severity by comparing the subject's gene expression levels of S100A7, S100A8, S100A9, STAT1, NFATC3, BTK, CXCR4, CD86, CD247, CD3D, HLA-DMA, HLS-DMB, IL6, IL4R, CD79A, CCL27 (paragraph 0007), among other biomarkers. Also, see Claim 1 rejection.
With respect to Claim 19, SHANMUGAM further teaches of hidradenitis skin containing lesions/being lesional (paragraph 0022, 0023), and of taking biological samples of these (paragraph 0010).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
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.
Claims 9-10, 12-15 & 20-26 are rejected under 35 U.S.C. 103 as being obvious over SHANMUGAM in US 20200109453 in view of MARTORELL in Present and future trends of biologic therapies and small molecules in hindradenitis suppurativa (as cited in prior action).
With respect to Claims 9, 12 & 14, SHANMUGAM teaches of methods of detecting and treating hidradenitis suppurativa by calculation of differential gene expression (abstract, paragraph 0018, 0022, 0122, Table 3). SHANMUGAM further teaches of detecting/assaying for expression of IL19 (paragraphs 0082-0085, Table 11), and the expression of PI3 (paragraph 0083-0085, Table 11). To do this, a biological sample is taken from a subject who either has or is suspected or at risk for having hidradenitis suppurativa (any patient/ sample can be considered “at risk,” of having the claimed disease through broadest reasonable interpretation) (paragraph 0007, 0010-0011, 0014). This can be done by a chemical assay (paragraph 0028), though through broadest reasonable interpretation, the claimed assaying can be a mental process.
SHANMUGAM further teaches that the levels of the biomarkers are measured in comparison to a control sample for differential analysis to determine if they are different from what is found in a control (paragraph 0029). SHANMUGAM does not teach specifically of the treatment being an IL-17 A or IL-17 F inhibitor.
MARTORELL is used to remedy this and more specifically teaches of a method for investigating biologic and small molecule treatments for hidradenitis suppurativa abstract). MARTORELL further teaches of using the drug sonelokimab which is specific to IL-17A and IL-17F (Page 13, column 2, last two paragraphs and Page 14, column 1, first two paragraphs). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use sonelokimab which is specific to IL-17A and IL-17F as an inhibitor as is done in MARTORELL in the method of SHANMUGAM due to the advantage that these drugs have showed for similar conditions (Page 13, column 2, last two paragraphs and Page 14, column 1, first two paragraphs).
With respect to Claims 10, 13 & 15 see claim 9 rejection. MARTORELL is used to remedy this and more specifically teaches of a method for investigating biologic and small molecule treatments for hidradenitis suppurativa abstract). MARTORELL further teaches of using the drug sonelokimab which is specific to IL-17A and IL-17F (Page 13, column 2, last two paragraphs and Page 14, column 1, first two paragraphs). See reason for combination from Claim 9.
With respect to Claim 20, SHANMUGAM teaches of methods of detecting and treating hidradenitis suppurativa by calculation of differential gene expression (abstract, paragraph 0018, 0022, 0122, Table 3). SHANMUGAM further teaches of detecting/assaying for expression of IL19 (paragraphs 0082-0085, Table 11), and the expression of PI3 (paragraph 0083-0085, Table 11). To do this, a biological sample is taken from a subject who either has or is suspected or at risk for having hidradenitis suppurativa (any patient/ sample can be considered “at risk,” of having the claimed disease through broadest reasonable interpretation) (paragraph 0007, 0010-0011, 0014). This can be done by a chemical assay (paragraph 0028), though through broadest reasonable interpretation, the claimed assaying can be a mental process.
SHANMUGAM further teaches that the levels of the biomarkers are measured in comparison to a control sample for differential analysis to determine if they are different from what is found in a control (paragraph 0029) and that the control is a healthy source (paragraph 0016-0017, 0122, 0129, 0135). SHANMUGAM does not teach of the sample being from a peripheral source.
MARTORELL is used to remedy this and more specifically teaches of a method for investigating biologic and small molecule treatments for hidradenitis suppurativa abstract). MARTORELL further teaches of using peripheral tissues (Which include blood) (page 16, column 1, 3 paragraphs from bottom).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to use peripheral blood samples as is done in MARTORELL in the method of SHANMUGAM due to the need in the art for better methods of detecting, diagnosing and treating hidradenitis suppurativa (MARTORELL, pages 8-10, columns of writing).
With respect to Claim 21, SHANMUGAM teaches the expression level being the protein expression level (paragraphs 0020-0022, 0026-0028). Also, see Claim 1 rejection.
With respect to Claim 22, SHANMUGAM teaches the expression level being the mRNA expression level (paragraphs 0020-0022, 0026-0028, 0145). Also, see Claim 1 rejection.
With respect to Claim 23, SHANMUGAM teaches that the treatment can includes administration of one or more home remedies, one or more pharmaceutical compositions, one or more radiological therapies, one or more surgical procedures, or a combination thereof (which means a treatment can include treatment on a patient who was previously treated) (paragraph 0086).
With respect to Claim 24, SHANMUGAM teaches of methods of detecting and treating hidradenitis suppurativa by calculation of differential gene expression (abstract, paragraph 0018, 0022, 0122, Table 3). SHANMUGAM further teaches of detecting/assaying for expression of IL19 (paragraphs 0082-0085, Table 11), and the expression of PI3 (paragraph 0083-0085, Table 11). To do this, a biological sample is taken from a subject who either has or is suspected or at risk for having hidradenitis suppurativa (any patient/ sample can be considered “at risk,” of having the claimed disease through broadest reasonable interpretation) (paragraph 0007, 0010-0011, 0014). This can be done by a chemical assay (paragraph 0028), though through broadest reasonable interpretation, the claimed assaying can be a mental process.
SHANMUGAM further teaches that the levels of the biomarkers are measured in comparison to a control sample for differential analysis to determine if they are different from what is found in a control (paragraph 0029). SHANMUGAM does not teach specifically of the treatment being an IL-17 A or IL-17 F inhibitor.
MARTORELL is used to remedy this and more specifically teaches of a method for investigating biologic and small molecule treatments for hidradenitis suppurativa abstract). MARTORELL further teaches of using the drug sonelokimab which is specific to IL-17A and IL-17F (Page 13, column 2, last two paragraphs and Page 14, column 1, first two paragraphs). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use sonelokimab which is specific to IL-17A and IL-17F as an inhibitor as is done in MARTORELL in the method of SHANMUGAM due to the advantage that these drugs have showed for similar conditions (Page 13, column 2, last two paragraphs and Page 14, column 1, first two paragraphs).
With respect to Claim 25, see claim 24 rejection. MARTORELL is used to remedy this and more specifically teaches of a method for investigating biologic and small molecule treatments for hidradenitis suppurativa abstract). MARTORELL further teaches of using the drug sonelokimab which is specific to IL-17A and IL-17F (Page 13, column 2, last two paragraphs and Page 14, column 1, first two paragraphs). See reason for combination from Claim 24.
With respect to Claim 26, SHANMUGAM further teaches of detecting expression of CXCR4, CD86, CD247, CD3D, HLA-DMA, HLS-DMB, IL6, IL4R, CD79A, CCL27, dermcidin, IL-37 or a combination thereof in a biological sample of a human subject; b) characterizing HS severity by comparing the subject's gene expression levels of S100A7, S100A8, S100A9, STAT1, NFATC3, BTK, CXCR4, CD86, CD247, CD3D, HLA-DMA, HLS-DMB, IL6, IL4R, CD79A, CCL27 (paragraph 0007), among other biomarkers. Also, see Claim 1 rejection.
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive.
With respect to the 101 rejection, applicant argues that the instant claims do not recite a judicial exception. The examiner disagrees as the instant claims now recite an abstract idea. Therefore, the 101 rejection is maintained. This is explained further for the significantly amended claims as shown in the above 101 rejection.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is further noted that the instant claims have been amended significantly necessitating a new grounds of rejection.
Notably, a new primary reference SHANMUGAM is used as shown above and the priorly used NAVRAZHINA reference is no longer used.
Applicant only argues about MARTORELL to say they think it does not cure the deficiencies of NAVRAZHINA, which is no longer used as a reference. OKUN also is no longer used as a reference.
All claims remain rejected.
Conclusion
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 REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758