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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
This action is in response to claim amendments filed 8/3/26. Claims 1, 3-4, 6, 9-11, and 14-15, 17-23 are pending and under examination.
Withdrawn Rejections
The objection to the claims is withdrawn in light of the amendments.
The 112b rejections are withdrawn in light of the amendments.
The 112d rejection is withdrawn; the baseline is established in a sample from the subject, which is a further limitation of claim 1.
The enablement rejection of claim 16 is withdrawn; claim 16 has been canceled.
The written description requirement of claims 3, 6, and 17 is withdrawn in light of the amendments.
Maintained Rejections and New Rejections Necessitated by Amendment
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 1, 3-4, 6, 9-11, 14-15, and 17-23 are rejected under 35 U.S.C. 101 because:
Step 1: It must first be determined if the claim is to a statutory category and, if so, proceed to step 2A prong 1. The claims are a method and fall within the statutory category of a process.
Step 2A, prong 1: Prong 1 requires the Examiner to evaluate whether the claim recites a judicial exception and, if so, proceed to prong 2. In this case, the claims recite “assessing fatigue in the subject based on the measured level of CRP, IL-6, and/or IL-10, wherein a decrease in the measured level relative to a baseline level is indicative of an improvement in one or more symptoms of fatigue”. The claim therefore recites (is drawn to) the correlation between certain biomarker levels and fatigue, which is a natural correlation/phenomenon.
Step 2A, prong 2: Prong 2 requires the Examiner to evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception and, if not, proceed to step 2B. In order to integrate the recited judicial exception into a practical application, the claim will apply, rely on, or use the judicial exception that imposes a meaningful limit such that the claim is more than a drafting effort to monopolize the judicial exception. Examiners evaluate integration by identifying additional elements in the claim beyond the judicial exception and evaluating those elements individually and in combination to determine whether they integrate the exception in to a practical application. Examples that have been found by the Courts in which the exception was not integrated into a practical application include:
Mere instructions to implement an abstract idea on a computer
Adding generic instructions that the judicial exception should be used ("apply it")
Adding insignificant extrasolution activity to the exception ("mere data gathering")
Generally linking the use of the exception to a particular technological environment or field of use
In this case, for claim 1, the measurement of CRP, IL6 or IL10 are part of the data gathering step and so represent “mere data gathering”. Once gathered, these values are “indicative” of an improvement in fatigue. Therefore, observing these naturally occurring values indicates fatigue improvement, which meets the limitations of “assessing fatigue”. These purely mental steps are not a practical application of the judicial exception but rather merely informs a relevant audience as to the existence of the judicial exception.
Regarding claims 3-4, 6, 15 these claims indicate where the phenomenon may be observed (in which subjects) but does not add any additional steps and so does not practically apply the exception as above.
Regarding claim 9, this claim is also directed to the data gathering step, e.g., gathering the necessary data for the baseline comparison. This is not a practical application because, as above, the whole of the claim is still directed to no more than observing the phenomenon and making mental conclusions (being informed of the phenomenon).
Regarding claim 10, this claim has been amended to include embodiments where the judicial exception is not used. Previously, while the claim was indefinite, the claim nevertheless required using the gathered data to make an active treatment decision, i.e., keep treating or altering treatment. In both cases, the active step of treatment was still employed but the nature of the treatment changed based on the gathered data (excepting the overlap which was previously noted), which is a practical application and not routine and conventional as discussed previously. However, as amended, claim 10 only contains a single “if” clause: if the biomarkers are within 10% of the baseline, the antibody treatment is altered. This therefore includes the embodiment where if the biomarkers are not within 10% of baseline, nothing happens. The claim does not require continuing treatment or any other practical application of the judicial exception.
Regarding claim 11, these limitations are directed to when the treatment is being altered, i.e., when levels are within 10% of the baseline. This claim further limits the way the treatment is altered but does not appear to require that the treatment is actually altered, i.e., claim 11 does not appear to overrule the “if” statement in claim 10.
Regarding claim 14, “monitoring” is also an abstract observation that does not depend on the judicial exception itself. This step, recited at a high level of generality, occurs no matter what the levels of biomarker are and therefore do not practically apply the judicial exception.
Regarding claims 17-23, these claims are directed to the antibody treatment the subject is already receiving. This does not represent a change in the treatment and does not practically apply the judicial exception. Rather, similar to claims such as 3 and 6, this claim describes the subject in which to observe the phenomenon.
Step 2B: Where a claim does not integrate the exception, a claim may nevertheless be patent eligible, for example where additional elements are “significantly more” than the exception such that the additional elements were unconventional in combination. Considerations include whether or not the claim adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
In this case, the claims measure CRP, IL-6 or IL-10 by any possible means, which is recognized by the Courts to be well-understood and routine (MPEP 2106; Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)). Administering an anti-C1s antibody was also routine and conventional. See:
Roth (first Roth citation on IDS 7/26/23, NPL, no citation number provided)
Roth (second Roth citation on IDS 7/26/23, NPL, no citation number provided)
Van Vlasselaer (US 9074004; IDS 7/26/23, US Patent documents, no citation number provided)
Rosenthal (US20160326237; IDS 7/26/23, US Patent documents, no citation number provided)
Rosi (US 20200140533; effective filing date 11/2/18; previously cited)
As these two steps (administering C1s antibody and measuring IL6/IL10) were routine and conventional, they do not make the claim patent eligible. While the combination of steps may make a claim eligible, this is not the case where those steps “simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception”. The newly added step of the levels of these biomarkers being “indicative” of an improvement in fatigue and assessing fatigue “based on” these levels is a description of the judicial exception itself and so cannot provide “significantly more”. Claims describing the subject or the treatment the subject was already receiving is also a description of where to observe the judicial exception and so cannot provide significantly more. Claims 10 and 11, in some embodiments, require the data to be applied to effect a change in treatment. As noted in the previous action, this is considered to meet the criteria for eligibility. However, as also noted in the previous action, where no steps are taken in response to observing the phenomenon, the claims are not eligible. In this case, the claim has been amended to include “do nothing” (where levels are not within 10% of the baseline), which does not make the claim eligible for the reasons set forth previously; see the discussion of the previous level overlap where the results are not relevant to the treatment decision.
Therefore, claims 1, 3-4, 6, 9-11, 14-15, and 17-23 are not patent eligible.
With respect to claim 10, the Examiner wishes to clarify that the previous statements regarding eligibility was based on the previous claim language still existing in some form. In other words, while using these biomarkers to make treatment decisions was not conventional, this on its own is just a description of the judicial exception. To be eligible, there must still be a practical application of this exception. Applicant has amended claim 10 to no longer require the data being used to make a treatment decision, i.e., where the measured biomarkers are not within 10% of a baseline. Amending the claims such that an active treatment step is required based on the gathered data would likely overcome the rejection. The examiner makes the following suggestions while recognizing that these are not the only ways to overcome the instant rejection:
Placing the limitations of claim 10 into the independent claim and amending the claim such that all data values result in an active treatment step based on those values. This could include “if level is more than 10% higher than the baseline” and “if level is more than 10% lower than the baseline” where these two are accompanied by effecting a particular treatment regimen. This version of a claim would require that, no matter what value is observed, the value is being actively used to apply a treatment, which is a practical application.
Placing the limitations of claim 10 into the independent claim and amending the claim to require a certain value is gathered, such as “wherein a value within 10% of the baseline level is obtained and where the method further comprises altering” the treatment. This version requires a certain level is obtained, excluding from the claim the observation of other values while still being used to practically apply a treatment.
It is further noted that the subject must already be one receiving the anti-C1s antibody (newly amended claim 1). This treatment is considered to provide specificity for altering the treatment, including those in claim 11, to rise to a practical application when using the gathered data to apply said treatment. Finally, Applicant is reminded that the Examiner has not evaluated any of the suggested language for, e.g., new matter and the precise language used remains the purview of Applicant.
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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-4, 6, 9-11, 14-15, 17-19, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vlasselaer (WO2018170145; IDS 7/26/23, no citation number provided) in view of Ulvestad (previously cited).
Regarding claim 1, Vlasselaer teaches inhibiting complement activation in an individual (subject) (abstract) by administering an anti-C1s antibody (abstract). Vlasselaer teaches this administration to treat cold agglutinin disease (CAD; figure 1; paragraph 346).
Vlasselaer does not teach measuring IL-6 levels.
Ulvestad teaches that, in patients with CAD, an increase in IL-6 leads to hemolysis (abstract). Ulvestad states “haemolysis in CAD is controlled by the availability of early classical pathway complement molecules and that hemolysis following acute phase response occurs as a consequence of increased complement synthesis” (abstract). Ulvestad also teaches that IL-6—a proinflammatory cytokine—“plays a major role in fever induction” and that the acute production of proinflammatory cytokines leads to the complement-mediated hemolysis (p.241 C2).
It would have been obvious to one of ordinary skill in the art at the time of filing to administer an anti-C1s antibody to the subject and measure IL-6 in a sample of a subject, arriving at the instant claim. Ulvestad teaches that increased IL-6 is indicative of pathology (hemolysis) in CAD and teaches methods of measuring this biomarker. Vlasselaer teaches anti-C1s is a known therapy for CAD and one which inhibits complement activation, which would be further desirable given that Ulvestad teaches increased complement synthesis leads to hemolysis. The combination of these two—administering a therapeutic and measuring a biomarker—would have led to the predictable outcome of the disease being treated and the IL-6 levels being measured; see KSR rationale A. The only difference between the instant claim and the prior art is the actual combination of the two steps, yet their combination does no more than perform the same function as each step does separately and the results would have been predictable.
With respect to the claim limitations “assessing fatigue in the subject based on the measured level of CRP, IL-6, and/or IL-10, wherein a decrease in the measured level relative to a baseline level is indicative of an improvement in one or more symptoms of fatigue”, there does not appear to be any active step for this assessment other than measuring the biomarker. IL-6 “indicates” an improvement in fatigue whether or not this was recognized at the time. The BRI of assessment include solely measuring the IL-6 levels, which would have been obvious as above.
Regarding claim 3, CAD is a complement mediated disease.
Regarding claim 4, Vlasselaer teaches the treatment of CAgD (cold agglutinin disease) with the anti-C1s antibody acts to “improve fatigue” (paragraph 345). In evaluating the efficacy of the antibody, one of the secondary endpoints was evaluating the mean change in fatigue using the FACIT-F scale (paragraph 479). One of the inclusion criteria was presence of fatigue as a CAgD (CAD)-related symptom (paragraph 481). Thus, Vlasselaer teaches fatigue is a symptom of the disease to be treated (CAD), was a desirable symptom for a subject to be experiencing prior to treatment with the anti-C1s antibody and provides a reason to expect the C1s treatment will ameliorate the fatigue. This would have made it obvious to one of ordinary skill in the art at the time of filing to include a subject having fatigue.
Regarding claim 6, the subject having a complement mediated disease, such as CAD, would have been obvious as discussed above regarding claim 3. Further, Vlasselaer teaches explicitly that fatigue is a symptom of CAD as noted above. Thus, claim 6 would have been obvious for the same reasons.
Regarding claim 9, any subject necessarily has a “baseline” level prior to the treatment. As Vlasselaer treats the subject, whatever level the subject had prior to that treatment is the baseline. Further, Ulvestad measures IL-6 in the subjects as described above. Since Ulvestad does not teach these subjects had been administered an anti-C1s antibody, this measurement meets the instant limitations of a baseline prior to such administration. Neither claim 1 nor claim 9 require actually making a comparison to the baseline but rather describes a property of the value: it is decreased relative to a baseline, which is a property whether or not one makes such a comparison.
Regarding claim 10, as described above, Ulvestad teaches increased IL-6 is seen in subjects with CAD which leads to hemolysis. Further, the antibody of Vlasselaer is meant to inhibit the complement-mediated pathway. It would have been obvious to one of ordinary skill in the art that if a known biomarker of disease—IL-6—is improving (is reduced), then the therapeutic is having the intended treatment effect and should be continued. See MPEP 2141(II)(C): "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. This applies to when the measured value is more than 10% reduced and so the limitations of claim 10 would not apply.
Regarding claim 11, Vlasselaer teaches the treatment can reduce fatigue associated with CAD as discussed above. Thus, where a specific dosing regimen of the anti-C1s antibody results in “fatigue [in] the subject is maintained or worsens relative to baseline”, it would have been within the ordinary skill and inferences of the ordinary artisan to adjust the dosing or frequency, such as by increasing the therapeutic amount, or by including “further treatment of the subject to improve fatigue”. This latter category is not limited to any particular treatment and so it would have been within the ordinary skill in the art to include an additional therapeutic to improve fatigue upon observing that fatigue was not improving as desired. Moreover, Vlasselaer teaches adding additional pharmaceutically active compounds (paragraph 269). Vlasselaer also teaches various dosages and frequencies (starting at paragraph 286). Thus, Vlasselaer recognizes dosing as a result-effective variable and, if therapeutic outcomes such as fatigue improvement are not being realized, the person of ordinary skill in the art would have found it obvious to adjust these variables to optimize the outcome. See MPEP 2141(II)(C): "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. See also: “it is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions” (MPEP §2144.05(II)(A)).
Regarding claim 14, Ulvestad measures IL-6 over a period of time (table 1), making such a step obvious. Moreover, given the role of IL-6 described by the art in the disease pathway, a person of ordinary skill in the art would have recognized that these levels are indicative of the disease state and could be monitored during therapy (Id. at 418, 82 USPQ2d at 1396).
Regarding claim 15, the subject in Ulvestad received a blood transfusion for the hemolysis (p.240 C1). Thus, blood transfusions were a known treatment for hemolysis in a subject with CAD. It would have been obvious to one of ordinary skill in the art that receiving a blood transfusion previously would not be expected to alter the efficacy of the anti-C1s antibody and so one would have found it obvious to perform the method as described above on a subject with CAD even when they had previously undergone a blood transfusion. Moreover, Vlasselaer teaches administration of the antibody to subjects “who have a recent history of blood transfusion” (example 6).
Regarding claims 17-19, Vlasselaer teaches the antibody has the heavy chain sequence of SEQ ID NO: 22, which is identical to instant SEQ ID NO: 1 (claim 19). Vlasselaer also teaches the antibody has a light chain sequence of SEQ ID NO: 23, which is identical to instant SEQ ID NO: 2 (claim 19). As instant claim 19 depends from claim 18 which depends from claim 17, the sequences in claims 17 and 18 are also in the Vlasselaer antibody.
Regarding claim 23, Vlasselaer teaches the exemplary antibody BIVV009, which has the above sequences, is the IgG4 isotype (paragraph 387).
Therefore, claims 1, 3-4, 6, 9-11, 14-15, 17-19, and 23 would have been obvious.
Claim(s) 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vlasselaer/Ulvestad as applied to claims 1, 3-4, 6, 9-11, 14-15, 17-19, and 23 above, and further in view of Panicker (WO2018071676; IDS 7/26/23, no citation number provided).
The teachings of Vlasselaer and Ulvestad are discussed above and incorporated herein. Neither teaches the antibody of instant claims 20-22.
Like Vlasselaer, Panicker is also concerned with administering an anti-C1s antibody to inhibit the complement pathway and treat cold agglutinin disease (abstract; paragraph 243). Panicker teaches the anti-C1s antibody comprising SEQ ID NO: 29, which is identical to instant SEQ ID NO: 11 (claim 22). Panicker also teaches the antibody has a light chain sequence of SEQ ID NO: 30, which is identical to instant SEQ ID NO: 12 (claim 22). As instant claim 22 depends from claim 21 which depends from claim 20, the sequences in claims 20 and 21 are also in the Panicker antibody.
It would have been obvious to make a simple substitution for one known anti-C1s antibody which treats CAD (Vlasselaer) with another (Panicker) because the antibodies were both known in the art, both known to possess the same therapeutic function, both known to bind the same target, and one could have made the substitution with an expectation of achieving the same predictable result.
Therefore, claims 20-22 would have been obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-4, 6, 9-11, 14-15, and 17-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10450382 in view of Vlasselaer (WO2018170145), Ulvestad, and Panicker (WO2018071676).
The reference claims are directed to an anti-C1s antibody with the same CDRs as instant claim 17 and within the scope of instant claim 1. Where a reference document is directed to a composition of matter, the specification may be inspected for the uses of that composition when making a double patenting determination. See the decisions in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353 supporting the Office’s use of disclosed utilities of compositions when applying double patenting rejections to method claims.
In this case, C13 describes the antibodies inhibition of CAD-associated hemolysis in subjects with CAD and describes administering the antibody to treat CAD (C86). This disclosed utility therefore represents an obvious variation/anticipates the instant methods of instant claims 1, 3, 6, 9, 17, and 23 with respect to administering (“treating the subject with”) the anti-C1s antibody. The teachings of Ulvestad are discussed above and incorporated herein, which address the obviousness of including the claimed IL-6 assessment. The remaining instant claims represent an obvious variation of the claimed composition and disclosed utilities in the reference document as set forth in the §103 rejection above regarding the teachings of Vlasselaer, Ulvestad, and Panicker, which are incorporated herein. To sum, the reference invention is an anti-C1s antibody which treats CAD, which is also the invention of instant claim 1. The remaining limitations represent obvious variations of the reference claims.
Claims 1, 3-4, 6, 9-11, 14-15, and 17-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 8877197 in view of Vlasselaer (WO2018170145), Ulvestad, and Panicker (WO2018071676).
The reference claims are directed to an anti-C1s antibody with the same CDRs as instant claim 17 and within the scope of instant claim 1. Where a reference document is directed to a composition of matter, the specification may be inspected for the uses of that composition when making a double patenting determination. See the decisions in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353 supporting the Office’s use of disclosed utilities of compositions when applying double patenting rejections to method claims.
In this case, C13 describes the antibodies inhibition of CAD-associated hemolysis in subjects with CAD and describes administering the antibody to treat CAD (C86). This disclosed utility therefore represents an obvious variation/anticipates the instant methods of instant claims 1, 3, 6, 9, 17, and 23 with respect to administering (“treating the subject with”) the anti-C1s antibody. The teachings of Ulvestad are discussed above and incorporated herein, which address the obviousness of including the claimed IL-6 assessment. The remaining instant claims represent an obvious variation of the claimed composition and disclosed utilities in the reference document as set forth in the §103 rejection above regarding the teachings of Vlasselaer, Ulvestad, and Panicker, which are incorporated herein. To sum, the reference invention is an anti-C1s antibody which treats CAD, which is also the invention of instant claim 1. The remaining limitations represent obvious variations of the reference claims.
It is noted that Applicant has filed numerous patent applications covering the C1s antibodies and their use in treating complement mediated diseases including specifically CAD. The Examiner has endeavored to discover such documents. However, it is noted for the record that where Applicant or a shared inventor is listed on a pending US application or US Patent that claims an anti-C1s antibody, such document would serve as the basis for a non-statutory double patenting rejection for essentially the same reasons as listed above. The following documents were discovered and the rejection headers provided; however, the body of the rejection is not reiterated as it is essentially duplicative of the two recited above and should be considered incorporated therein, as either the reference documents claim an anti-C1s antibody as a composition and disclose the utility of treating CAD or else claim a method of administering an anti-C1s antibody to a subject. The inclusion of the IL-6 or IL-10 assessment represents an obvious variation as discussed, particularly with respect to Ulvestad, and the symptoms of the disease (e.g., assessing fatigue) or the particular C1s antibody would have been obvious as discussed, particularly with respect to Vlasselaer and Panicker.
Claims 1, 3-4, 6, 9-11, 14-15, and 17-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of U.S. Patent No. 8945562 in view of Vlasselaer (WO2018170145), Ulvestad, and Panicker (WO2018071676).
Claims 1, 3-4, 6, 9-11, 14-15, and 17-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9074003 in view of Vlasselaer (WO2018170145), Ulvestad, and Panicker (WO2018071676).
Claims 1, 3-4, 6, 9-11, 14-15, and 17-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9074004 in view of Vlasselaer (WO2018170145), Ulvestad, and Panicker (WO2018071676).
Claims 1, 3-4, 6, 9-11, 14-15, and 17-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9206259 in view of Vlasselaer (WO2018170145), Ulvestad, and Panicker (WO2018071676).
Claims 1, 3-4, 6, 9-11, 14-15, and 17-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9562092 in view of Vlasselaer (WO2018170145), Ulvestad, and Panicker (WO2018071676).
Claims 1, 3-4, 6, 9-11, 14-15, and 17-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 35-36, 38-40, 42-43, 48, 57-58, 60-61, 69, 74-76, 80 of copending Application No. 19068758 in view of Vlasselaer (WO2018170145), Ulvestad, and Panicker (WO2018071676).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-4, 6, 9-11, 14-15, and 17-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8-9, 11-12, 14-15, 17, 19, 21-25, 27-29, 31, 33, 36-40, 42, 45 of copending Application No. 18334567 in view of Vlasselaer (WO2018170145), Ulvestad, and Panicker (WO2018071676).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-4, 6, 9-11, 14-15, and 17-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18919489 in view of Vlasselaer (WO2018170145), Ulvestad, and Panicker (WO2018071676).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-4, 6, 9-11, 14-15, and 17-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-16, 18, 20, 22, 24, and 27 of copending Application No. 18477981 in view of Vlasselaer (WO2018170145), Ulvestad, and Panicker (WO2018071676).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 8/3/26 have been fully considered but they are not persuasive.
Regarding the §101 rejection, Applicant argues the claims have been amended to incorporate the Examiner’s suggestions. This is not persuasive because the amendments to claim 10 have removed embodiments of treatment and now encompass embodiments where there is no practical application of the biomarkers and where the biomarkers are not used to make any treatment decisions. Thus, even where the measuring informing a treatment decision is not conventional as indicated, Applicant has amended the claims such that the measurement does not inform said decisions and are ineligible for the reasons set forth.
Further, previous claim 1 was not rejected under §101 because the previous claim did not recite a judicial exception. Applicant’s amendments now explicitly recite a judicial exception in claim 1 and so the new rejection of claim 1 and dependent claims thereof were necessitated by the amendment.
Regarding the §103 rejection, Applicant argues the present claims are based in part on the discovery that anti-C1s antibody treatment shows a decrease in inflammatory cytokines and improvement in fatigue. Applicant argues the instant application was the first to recognize a direct link between inflammatory markers like IL-6 and symptoms of fatigue and so there was no reasonable expectation that fatigue could be assessed based on these biomarkers.
This is not persuasive. As set forth in the rejection, Vlasselaer teaches the antibody treatment inhibits complement activation and Ulvestad teaches IL-6 (a proinflammatory cytokine) leads to complement-mediated hemolysis. Thus, as set forth in the rejection, it would have been obvious that IL-6 is a biomarker of CAD and that treatment would have been expected to reduce these levels via the inhibition discussed. Further, Vlasselaer teaches that the antibody treatment acts to “improve fatigue”, providing a reasonable correlation between decreasing negative biomarkers (IL-6) and improved fatigue. The instant claims “assess” fatigue at such a high level of generality that the BRI includes merely measuring the biomarkers.
Applicant notes that Vlasselaer teaches improved fatigue with antibody treatment and that Ulvestad reports hemolytic episodes are associated with increased IL-6. The Examiner agrees and this supports the Examiner’s position.
Applicant argues improved fatigue is only one possible outcome of the treatment. The prior art is available for all that it teaches and Applicant does not point to other outcomes that would undermine the reasonable expectation articulated by the rejection. Applicant argues the cited art fails to provide motivation for making the “specific selections” among many possibilities or had a reasonable expectation of doing so. This is not persuasive. With respect to reasonable expectation of success, Applicant makes this assertion without providing any objective evidence as to why the combination would not be expected to succeed. Applicant is reminded that “arguments of counsel cannot take the place of factually supported objective evidence" (MPEP§2415). With respect to motivation to make specific choices, 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, the rejection of record articulates the rationale for combining the references and, other than Applicant’s assertion, Applicant makes no specific argument as to why the references could not be combined or why the person of ordinary skill in the art would not have recognized the implications of the teachings relied upon.
Regarding the double patenting rejections, Applicant relies on the same arguments against Vlasselaer and Ulvestad, which are not persuasive for the reasons above.
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 ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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/Adam Weidner/Primary Examiner, Art Unit 1675
