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 .
Amended claims 1, 3-4, 7-8, (9/23/2026), and new claim 28, (9/23/2026), are under consideration by the Examiner.
Claims 9-27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 2, 5-6, have been canceled.
Receipt of Applicant's arguments and amendments filed on 9/23/2026 is acknowledged.
Claim objections
Claim 7 objected to under 37 CFR 1.75 as being a substantial duplicate of claim 8. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 101
5. 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.
5a. Claims 1, 3-4, 7-8, and 28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more.
This rejection is maintained for reasons of record set forth at pages 3-6 of the previous action dated 5/26/2026.
Applicant argues that claim 2 has been cancelled, and claim 1 has presently been amended in order to incorporate the subject matter of original claims 5 and 6, which were not rejected under § 101. However, contrary to Applicant’s arguments, claims 5-6 were not treated on the merits because claims 4-8 were objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only and cannot depend from any other multiple dependent claim. See MPEP § 608.01(n).
Since Applicant has failed to demonstrate the error in this 35 U.S.C. 101 rejection by the Examiner, this rejection is maintained for reasons of record.
Claim Rejections - 35 USC § 112(a), lack of written description
6. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6a. Claims 1, 3-4, 7-8, 28, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection is maintained for reasons of record set forth at pages 6-11 of the previous action dated 5/26/2026.
Applicant argues that claim 1 has presently been amended, to incorporate the subject matter of original claims 5 and 6, which were not rejected under § 112. However, contrary to Applicant’s arguments, claims 5-6 were not treated on the merits because claims 5-6 were objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only and cannot depend from any other multiple dependent claim. See MPEP § 608.01(n).
Furthermore, Applicant argues that techniques for measurement of CXCL13 in a biological fluid from a patient is known among those skilled in the art, and the Pierson reference1 that the Office cited pursuant to the rejection under 35 U.S.C. § 102 discloses measurement of CXCL13, among other biomarkers. However, contrary to Applicant’s arguments, each application is examined on its own merits, and the claims specifically recite “comparing the amount of CXCL13 in a biological fluid” without reciting how the amount of CXCL13 is measured.
Additionally, Applicant argues that claim 1 has been amended in order to specify that the response to treatment in the subject is assessed in terms of whether there is a deviation of about 15% or greater (i.e., by a specific amount) relative to the amount of CXCL13 in the biological fluid obtained from the subject prior to commencement of the treatment, and the amended claims do not encompass correlating any measured value with respect to treatment. However, contrary to Applicant’s arguments, the new limitation “downward deviation of about 15% or greater” is unclear and therefore, there is no demonstration that the various methods for obtaining the amount of CXCL13 encompassed in the method of independent claim 1 are correlated with the recited response to treatment with a iMCD therapy. Therefore, in view of all of the above, artisans would reasonably conclude that Applicant was not in possession of the invention as presently claimed at the time the instant application was filed.
Claim Rejections - 35 U.S.C. § 112 second paragraph
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6a. Claims 1, 3-4, 7-8, 28, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
This rejection is maintained for reasons of record set forth at pages 11-13 of the previous action dated 5/26/2026.
Amended claim 1, line 10, is vague and indefinite because it recites “of about 15% or greater” and it is unclear if this limitation encompasses “5%, 10% or even 14%”.
Claim 1, lines 3, 5, 7, 9-10, 12, 14, 17 are vague and indefinite for the recitation of “treatment” and it is unclear what and which treatment is encompassed by the claim. Is the treatment by siRNA, antibody, or a chemical, and what does the therapy comprise? The metes and bounds of the claim are unclear. This rejection can only be obviated by reciting the specific treatment for which there is a basis in the specification and in claim 4.
Similarly, claims 3, 7-8, and 28 are rejected as vague and indefinite for the recitation of “treatment”.
Claim 7, lines 3, 5, is vague and indefinite because it recites “significant downward deviation” which is a subjective limitation. It is unclear what the term “significant” encompasses. Is the “significant downward deviation” 5%, 10% or 25%? This rejection can be obviated by reciting the specific deviation for which there is a basis in the instant specification.
Claim 7, lines 3, 5, is vague and indefinite because it recites “significant downward deviation” which is a subjective limitation. It is unclear what the term “significant” encompasses. Is the “significant downward deviation” 5%, 10% or 25%? This rejection can be obviated by reciting the specific deviation for which there is a basis in the instant specification.
Claim 8, lines 3, 5, is vague and indefinite because it recites “significant downward deviation” which is a subjective limitation. It is unclear what the term “significant” encompasses. Is the “significant downward deviation” 5%, 10% or 25%? This rejection can be obviated by reciting the specific deviation for which there is a basis in the instant specification.
Claim 7, line 5, is vague and indefinite because it recites “of about 17% or greater” and it is unclear if this limitation encompasses “5%, 10% or even 14%”. This rejection can be obviated by reciting the specific deviation for which there is a basis in the instant specification.
Claim 8, line 5, is vague and indefinite because it recites “of about 17% or greater” and it is unclear if this limitation encompasses “5%, 10% or even 14%”. This rejection can be obviated by reciting the specific deviation for which there is a basis in the instant specification.
Claim 28, line 2, is vague and indefinite because it recites “about one week” and it is unclear if this limitation encompasses “6 days, 8 days or even 10 days”.
Claim 4 is rejected as vague and indefinite insofar as it depends on rejected claim 1 for its limitations.
Claim rejections-35 U.S.C. 102
7. 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 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.
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.
7a. Claims 1, 3-4, and 7-8, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Pierson et al. (2018).
This rejection is maintained for reasons of record set forth at pages 13-14 of the previous action dated 5/26/2026.
Pierson et al disclose a method for assigning a subject having idiopathic multicentric Castleman disease (iMCD) to a group having a higher or lower probability (based on CXCL13 levels) of responding to treatment for iMCD (siltuximab is the monoclonal IL-6 antibody administered for treatment) (See abstract; page 903, columns 1-2). The reference also discloses that seven days after siltuximab was first administered, 9 proteins were significantly different between responders and non-responders: CXCL13 being one of the proteins (page 904, column 1). The reference discloses that CXCL13 was recently discovered as a key cytokine in iMCD, and the early and significant decline of CXCL13 in responders versus non-responders (See Figure 2B-2D). Prior to treatment, CXCL13 was significantly higher in this cohort of iMCD patients than in a group of age-matched healthy donors, and by day 64, CXCL13 levels in siltuximab responders decreased to levels approaching the healthy donor range but remained-elevated in non-responders. Therefore, the prior art method discloses all the limitations of the instant claims encompassing assigning a subject having iMCD to a group having a higher or lower probability of responding to iMCD treatment by comparing the amount of CXCL13 in a biological fluid obtained from the subject following commencement of the treatment (with the anti-IL-6 monoclonal antibody siltuximab), to the amount of CXCL13 in a biological fluid obtained from the subject prior to commencement of the treatment, about one week following commencement of the treatment with siltuximab (page 904, columns 1-2). Therefore, the method disclosed in the reference anticipates claims 1, 3-4, 7-8, 28.
Applicant argues that amended claim 1 incorporates the subject matter of original claims 5 and 6, which were not rejected under § 102. However, contrary to Applicant’s arguments, claims 5-6 were not treated on the merits because claims 5-6 were objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only and cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Furthermore, contrary to Applicant’s arguments, Pierson explicitly discloses assigning a subject having iMCD to a group having a higher or lower probability of responding to iMCD treatment by comparing the amount of CXCL13 in a biological fluid obtained from the subject about one week following commencement of the treatment (with the anti-IL-6 monoclonal antibody siltuximab), to the amount of CXCL13 in a biological fluid obtained from the subject prior to commencement of the treatment (page 904, colums 1-2; page 905, column 1, last 2 lines; column 2, lines 1-6; page 905, Figures 2B-2D). Therefore, the Pierson et al reference anticipates claims 1, 3-4, 7-8, 28.
Conclusion
No claim is allowed.
Claims 1, 3-4, 7-8, and 28 are rejected.
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.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876. The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm.
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1674
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