DETAILED ACTION
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 .
Claim Status
Claims 2, 4-13, 15-41, 45-47, 49, and 52-55 have been cancelled; claims 1, 14, 42, 44, 48, and 51 have been amended; and claims 56-59 have been newly added, as requested in the amendment filed on 04/13/2026. Following the amendment, claims 1, 3, 14, 42-44, 48, 50-51, and 56-59 are pending in the instant application.
Claims 1, 3, 14, 42-44, 48, 50-51, and 56-59 are under examination in the instant office action.
Claim Rejections - 35 USC § 101 - Withdrawn
Claims 14, 29, 31, 41, 44-47, 49, 51, and 53-54 were rejected under 35 U.S.C. 101 because the claimed invention was directed to a judicial exception (i.e., a law of nature/a natural phenomenon) without significantly more.
It is noted that claims 29, 31, 41, 45-47, 49, and 53-54 have been cancelled, rendering their rejection moot. Regarding claims 14, 44, and 51, it is noted that the independent claims from which they depend have been amended to recite a specific treatment of an anti-integrin blocking antibody comprising an antigen binding domain of anti-ITGA4/B7 blocking antibody Vedolizumab or an antigen binding domain of anti-ITGB7 blocking antibody Etrolizumab; thus claims 14, 44, and 51 are also directed to the above-recited specific treatments. Furthermore, it is noted that claims 14, 44, and 51 address the second population of patients identified as unsuitable for treatment. As such, the rejection of claims 14, 41, 44-47, 49, 51, and 53-54 under 35 U.S.C. 101 because the claimed invention was directed to a judicial exception (i.e., a law of nature/a natural phenomenon) without significantly more is withdrawn.
Claim Rejections - 35 USC § 112 - Withdrawn
Claims 1, 3, 14, 29, 31, and 41 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
Claims 29, 31, and 41 have been cancelled, rendering their rejection moot. It is noted that Applicant has amended independent claim 1 such that the claim now recites treating a suitable subject with an anti-integrin blocking antibody comprising an antigen binding domain of anti-ITGA4/B7 blocking antibody Vedolizumab or an antigen binding domain of anti-ITGB7 blocking antibody Etrolizumab. As such, the instantly claimed methods are correlated to a different drug than that of the cited prior art reference US 2010/0069256 A1 (previously cited on PTO-892; herein after referred to as "Baribaud"). In view of the now amended claims correlating the recited molecules to a different treatment than that of Baribaud (i.e., an anti-TNF antibody), the rejection of claim 1, and subsequently dependent claims 3, 14, 29, 31, and 41, under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn.
Claim Rejections - 35 USC § 103 - Withdrawn
Claims 42-43, 45, and 47 were rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0069256 A1 (previously cited on PTO-892; herein after referred to as "Baribaud").
Claims 46, 48-50, and 53 were rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0069256 A1 (previously cited on PTO-892; herein after referred to as "Baribaud") in further view of non-patent literature by Park and Jeen (World J. Gastroenterol., May 2018, 24(17) 1868-1880; previously cited on PTO-892; herein after referred to as “Park”).
Claim 44 was rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0069256 A1 (previously cited on PTO-892; herein after referred to as "Baribaud") in further view of non-patent literature by Knowlden and Georas (J. Immunol., 2014, 192(3), 851-857; previously cited on PTO-892; herein after referred to as "Knowlden") and non-patent literature by Benesch et. al (Journal of Lipid Research, 2015, 56, 1134-1144; previously cited on PTO-892; herein after referred to as "Benesch").
Claims 51 and 54 were rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0069256 A1 (herein after referred to as "Baribaud") in further view of non-patent literature by Park and Jeen (World J. Gastroenterol., May 2018, 24(17) 1868-1880; previously cited on PTO-892; herein after referred to as “Park”), non-patent literature by Knowlden and Georas (J. Immunol., 2014, 192(3), 851-857; previously cited on PTO-892; herein after referred to as "Knowlden"), and non-patent literature by Benesch et. al (Journal of Lipid Research, 2015, 56, 1134-1144; previously cited on PTO-892; herein after referred to as "Benesch").
With regard to the above-listed claim rejections under 35 U.S.C. 103, it is noted that claims 41, 45-47, 49, and 53-54 have been cancelled, rendering their rejection(s) moot. Furthermore, Applicant has amended independent claims 1, 42, 48 such that the claim now recites treating a suitable subject with an anti-integrin blocking antibody comprising an antigen binding domain of anti-ITGA4/B7 blocking antibody Vedolizumab or an antigen binding domain of anti-ITGB7 blocking antibody Etrolizumab after determining a subject as suitable for treatment by measuring at least one of the recited molecules in a sample and comparing said measurement(s) to a predetermined threshold. As such, the instantly claimed methods are correlated to a different drug than that of the cited prior art reference US 2010/0069256 A1 (previously cited on PTO-892; herein after referred to as "Baribaud"). In view of the cancelled and now amended claims correlating the recited molecules to a different treatment than that of Baribaud (i.e., an anti-TNF antibody), the above-listed claim rejections under 35 U.S.C. 103 are withdrawn.
Claim Objections - New as Necessitated by Amendment
Claims 14, 44, and 51 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 56 is objected to because of the following informalities: line 1 of the claim currently reads “comprising measuring is said sample”, but should read “comprising measuring in said sample”. Appropriate correction is required.
Claim Rejections - 35 USC § 101 - Maintained
Claims 1, 3, 42-43, 48, and 50 stand as rejected, and new claims 56-59 are newly rejected, under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature/a natural phenomenon) without significantly more.
The claim(s), as amended, recite(s) a method for determining suitability of a subject suffering from inflammatory bowel disease to be treated with an anti-integrin blocking antibody comprising an antigen binding domain of anti-ITGA4/B7 blocking antibody Vedolizumab or an antigen binding domain of anti-ITGB7 blocking antibody Etrolizumab, and treating a suitable subject, comprising providing a gut/peripheral blood sample; measuring at least one of (i) LPA levels, (ii) expression of at least one of SLC22A4, METTL9, AGPAT3, MBOAT2, ATX, and CREB1, (iii) at least one molecule that regulates LPA expression, or (iv) expression of ATX; determining suitability by comparing the measured level/expression of the above-listed molecules/proteins to a predetermined threshold (levels/expression in gut/peripheral blood samples from subjects suffering from inflammatory bowel disease that do not respond to said therapeutic agent); and (1) not administering any therapeutic agent to said subject not likely to respond or (2) administering said therapeutic agent to said subject likely to respond.
Thus, the claims are directed to the judicial exception of the levels of LPA and the expression of various naturally occurring proteins.
In outcome (1), this judicial exception is not integrated into a practical application because the claims recite only the detection or observation of a naturally occurring phenomenon/law of nature, which is data gathering to observe the naturally occurring phenomenon/law of nature without applying the data to a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite use of routine laboratory procedures (i.e., providing gut or peripheral blood samples and in said sample(s) “measuring LPA levels” or “measuring expression” of one of various recited proteins. The steps of measuring LPA levels and/or measuring protein expression, are considered known, routine steps and are typically taken by those in the field to perform testing of a sample and are not elements that are sufficient to amount to significantly more than the judicial exception (see MPEP 2106.05(d)). For example, US Patent Application Publication 2010/0069256 A1 demonstrates practicing routine measurement of expression levels of various proteins in both gut and blood samples. Routine data gathering in order to observe a natural phenomenon/natural principle does not add a meaningful limitation to the method as it would be routinely used by those of ordinary skill in the art in order to observe the natural phenomenon/natural principle, and it fails to narrow the scope of the claims such that others are not foreclosed from using the law of nature/natural phenomenon. Methods of detecting natural phenomenon preempt all practical uses of it as others must use/detect the natural phenomenon to apply it to any other correlations, diagnosis, prognosis, therapeutic response, monitoring, etc.
To obviate the rejection, there must be at least one additional element or physical step that applies, relies on, or uses the natural principle so that the claim amounts to significantly more than the judicial exception itself. The claimed method(s) currently fail(s) to provide a practical application of the judicial exception as pertains to outcome (1) above and fails to add any elements that amount to significantly more than the judicial exception.
Response to Arguments - 35 USC § 101
Applicant's arguments filed 04/13/2026 (herein after referred to as "Remarks") have been fully considered but they are not persuasive.
At Pages 12-13 of Remarks, Applicant argues the following:
Claims 1, 42, and 48 have been amended to limit the therapeutic agent to an anti-integrin blocking antibody comprising an antigen binding domain of anti-ITGA4/B7 blocking antibody Vedolizumab or an antigen binding domain of anti-ITGB7 blocking antibody Etrolizumab.
Claims 1, 42, and 48 have been amended to recite in the preamble that the method is a method determining suitability and “treating a suitable subject”; thus Applicant argues that the claims make clear that only instances when a suitable subject is being treated are claimed.
Claims 14, 44, and 51 further recite a step of treating a non-suitable subject, and as such the claims recite methods where both suitable and unsuitable subjects are treated (the unsuitable subjects after being made suitable) and as such the claims recite more than the judicial exception.
With regard to the first and third arguments, it is noted that the independent claims now recite a specific and particular treatment, and as such dependent claims 14, 44, and 51 require the specific and particular treatment and they address both patient populations (i.e., suitable patients and unsuitable patients); as such the rejection of claims 14, 44, and 51 under 35 USC § 101 has been withdrawn.
With regard to the second argument, it is specifically noted that, even as amended, independent claims 1, 42, and 48 do not require limiting the subject being tested (i.e., the subject undergoing testing for suitability) as having to be identified as being suitable for treatment; there is a second population of patients in the instantly claimed methods which are identified as not suitable for treatment, and this patient population is not addressed by the independent claims themselves and as such there is an outcome/patient population in the independent claims wherein the judicial exception (i.e., natural phenomenon) is not incorporated into a practical application because the claimed methods with regard to this particular patient population are drawn only to detecting natural phenomenon which preempts all practical uses of it as others must use/detect the natural phenomenon to apply it to any other correlations, diagnosis, prognosis, therapeutic response, monitoring, etc. This particular secondary outcome regarding unsuitable patients is readily apparent from dependent claims 14, 44, and 51, which sufficiently incorporate the judicial exception into a particular treatment comprising making the unsuitable subjects suitable for treatment and subsequently treating the now suitable subjects with the specific and particular treatment.
In view of the above, the rejection of previously presented claims 1, 3, 42-43, 48, and 50, and new claims 56-59 which depend from claims 1 or 42, under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature/a natural phenomenon) without significantly more is deemed proper and is maintained.
Conclusion
Claims 1, 3, 14, 42-44, 48, 50-51, and 56-59 are pending. Claims 1, 3, 42-43, 48, 50, and 56-59 are rejected. Claims 14, 44, and 51 are objected to. No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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/ALYSSA RAE STONEBRAKER/Examiner, Art Unit 1642
/Laura B Goddard/Primary Examiner, Art Unit 1642
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