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 .
1. Claims 1, 3, 6, 12, 15-17, 22, 26, 31, 32, 36, 38, 39, 43 and 46 are pending in the instant patent application.
Claims 1, 3, 6, 12, 15-17, 22, 26, 31, 32, 36, 38, 39, 43 and 46 are under examination.
Claim Objections
2. Claims 1, 17, 22, 26 and 32 are objected to because of the following informalities:
The claims recite “ARIA-H” and “ARIA-E” without first providing the full name of the terms. It is suggested that the terms be spelled out at their first use and in all independent claims so that it is clearly understood what they stand for. Appropriate correction is suggested.
Specification
3. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see p. 21, for example. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
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.
4. Claims 1, 3, 6, 12, 15, 22, 26, 31, 32, 36, 38, 39, 43 and 46 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
5. Claim 1 is vague and ambiguous in sections (B) (a)-(d). Specifically, section (B), which follows the step of administering an anti-beta-amyloid antibody to the subject under treatment, recites steps (a) as monitoring for ARIA, (b) wherein […], (c) monitoring, and (d) wherein […]. It is not obvious and cannot be determined from the claim or the specification as filed if the “wherein” limitation is a separate step or it follows steps (a) and (c). This renders the claim indefinite.
6. Claim 32 is indefinite as being directed to a method of treating Alzheimer’s disease while expressly requiring treatment to be administered to “a population of human subjects,” and it is not obvious if a group therapy is a part of the inventive concept.
7. Applicant is advised that one of the purposes of the 112, second paragraph is to provide a clear warning to others as to what constitutes infringement of the patent (see, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). The test for definiteness under 35 U.S.C. § 112, second paragraph, is whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F .2d 1565 (Fed. Cir. 1986) (citations omitted).
In precedential decision Ex parte Kenichi Miyazaki, Appeal 2007-330, BPAI stated “In particular, rather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amendable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph.”
Further, the federal Circuit stated in Halliburton Energy Servs.:
When a claim limitation is defined in purely functional terms, the task of determining whether that limitation is sufficiently definite is a difficult one that is highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area). We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiner demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.
Halliburton Energy Servs. V. M-ILLC 514 F .3d 1244, 1255 (Fed. Cir. 2008) (emphasis added).
8. Claims 3, 6, 12, 15, 22, 26, 31, 36, 38, 39, 43 and 46 are indefinite for being dependent from indefinite claims.
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.
9. Claims 1, 3, 6, 12, 15-17, 22, 26, 31, 32, 36, 38, 39, 43 and 46 are 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, or an abstract idea) without significantly more. Method claim(s) 1, 3, 6, 12, 15-17, 22, 26, 31, 32, 36, 38, 39, 43 and 46, directed to monitoring and assessing efficacy of treatment of Alzheimer’s disease, set forth laws of nature by reciting relationship between changes in the levels of naturally occurring factors and the pathology itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for reasons that follow.
The subject matter eligibility under 35 U.S.C. 101 of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products) was confirmed by the U.S. Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. , 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. , 132 S. Ct. 1289, 101 USPQ2d 1961 (2012). "[L]aws of nature, natural phenomena, and abstract ideas" are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. (2010). "Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work." Gottschalkv. Benson, 409 U. S. 63, 67 (1972).
In brief, in Prometheus, a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder is the focus. This method comprises a) administering 6-thioguanine to patients and b) determining the level of 6-thioguanine in the patients and c) correlate the level of 6-thioguanine, i.e. a certain level/red blood cells, with the decision whether a need for increase or decrease the amount of 6-thioguanine treatment in said patients.
In Prometheus, the Court found that "[i]f a law of nature is not patentable, neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Additionally, "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law." Flook, 437 U. S., at 590; see also Bilski, 561 U. S., ("[T]he prohibition against patenting abstract ideas 'cannot be circumvented by'.., adding 'insignificant post-solution activity'" (quoting Diehr, supra, at 191-192)).
The Court also summarized their holding by stating "[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately."
Thus, if the claim recites or involves a judicial exception, such as a law of nature/natural principle or natural phenomenon (e.g., the law of gravity, F=ma, sunlight, barometric pressure, etc.), and/or something that appears to be a natural product (e.g., a citrus fruit, uranium metal, nucleic acid, protein, etc.), then the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself.
In the instant case, based upon an analysis with respect to the claim as a whole, claims 1, 3, 6, 12, 15-17, 22, 26, 31, 32, 36, 38, 39, 43 and 46 are determined to be directed to a judicial exception without significantly more. The rationale for this determination is explained below in view of controlling legal precedent set forth in 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618) dated December 16, 2014 and 2019 Revised Patent Subject Matter Eligibility Guidance (84 FR 50) dated January 07, 2019.
The instant claims 1, 3, 6, 12, 15-17, 22, 26, 31, 32, 36, 38, 39, 43 and 46 encompass a process. (Step 1: Yes).
Next, Step 2, is the two-part analysis from Alice Corp. (also called the Mayo test) to determine whether the claim is directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions). (In Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014) the Supreme Court sets forth a two-step test for determining patent eligibility. First, determine if the claims encompass a judicial exception (a natural phenomenon/law of nature/abstract idea). If so, then ask whether the remaining elements/steps, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to ‘“transform the nature of the claim’ into a patent-eligible application.” Id. at 2355 (quoting Mayo, 132 S. Ct. at 1297). Put another way, there must be a further “inventive concept” to take the claim into the realm of patent eligibility. Id. at 2355. In the recent Myriad v Ambry case, the CAFC found claims (drawn to methods comprising obtaining tissue samples, analyzing sequences of cDNA and comparing germline sequences of a gene to wild-type sequences) to encompass the abstract mental processes of ‘comparing’ and ‘analyzing’. Recitation of specific techniques (in Myriad claims 7 and 8 further recited hybridization and PCR) were deemed not “enough” to make the claims patent-eligible since the claims contained no otherwise new process. The elements/steps recited in addition to the judicial exception did nothing more than spell out what practitioners already knew). The instant claims 1, 3, 6, 12, 15-17, 22, 26, 31, 32, 36, 38, 39, 43 and 46 encompass changes that occur during treatment of Alzheimer’s disease by administration of anti-beta-amyloid antibody, such as development of edema, ARIA-E, or hemosiderin deposition, ARIA-H, the process that is governed by a law of nature, and thus is a judicial exception. The reaction to administration of anti-beta-amyloid antibody during treatment of Alzheimer’s pathology occurs naturally, it exists in principle and is a consequence of the ways anti-beta-amyloid antibodies are metabolized by the body, entirely natural process, a natural phenomenon, and thus a judicial exception (Step 2A/1: Yes). Next, prong two of Step 2A requires identifying whether there are additional elements recited in the claim beyond the judicial exception(s) and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. “Integration in to a practical application” requires an additional element or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such as the claim is more than a drafting effort designed to monopolize the exception. In the instant case, the claims do not recite any additional elements to integrate the judicial exception into a practical application because all the steps of the claimed methods are limited to only those that assess naturally occurring reaction(s) during a treatment of a naturally occurring pathology. The instant situation is similar to the one in Mayo, wherein the claims recited method of administering drugs to a patient and measuring the levels of certain metabolites in the blood, wherein the level of metabolites indicates whether to adjust the dosage. The Supreme Court held that the claims recited a natural law and did not “include any “additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.” Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S., 132 S. Ct. 77, 101 USPQ2d 1961 (2012). (Step 2A/2: No).
Finally, claims 1, 3, 6, 12, 15-17, 22, 26, 31, 32, 36, 38, 39, 43 and 46 do not recite any elements, or combinations of elements to ensure that the claim as a whole amounts to significantly more than the judicial exception because the active steps of the claims—applying a well-known imaging tool of MRI—represent routine steps that encompass well-understood and purely conventional routine techniques in the art. (Step 2B: No).
Thus, for reasons fully explained above, claims 1, 3, 6, 12, 15-17, 22, 26, 31, 32, 36, 38, 39, 43 and 46 do not satisfy the requirement of 35 U.S.C. 101 and are therefore rejected.
Claim Rejections - 35 USC § 103
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.
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.
10. Claim(s) 1, 3, 6, 12, 15-17, 22, 26, 31, 32, 36, 38, 39, 43 and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/211827 document, cited within IDS submitted on 03/05/2-24 as reference B2.
Claims 1, 3, 6, 12, 15-17, 22, 26, 31, 32, 36, 38, 39, 43 and 46 are drawn to a process of administering multiple doses of an anti-beta-amyloid antibody to a subject as a treatment for Alzheimer’s disease in cases when the subject develops an Amyloid Related Imaging Abnormality, ARIA. The WO 2017/211827 document fully teaches treatment by administration of the same antibody as exemplified by the instant invention, BIIB037, delivered in multiple doses, wherein the doses are adjusted based on the results obtained by MRI to monitor an adverse reaction to the treatment, such as development of edema or hemosiderin deposition, see the whole document and claims 1-41 specifically. The WO 2017/211827 patent does not disclose specific details of the protocol of the dose or regimen adjustment, as in current claims; however, it fully describes the inventive concept supporting the method of the instant claims.
It would have been obvious for one of ordinary skill in the art at the time of filing of the instant patent application to implement the method of adjusting the dose and frequency of treatment of AD by administration of anti-beta-amyloid antibody based on the results of MRI, which is performed during the treatment to assess any of abnormality associated with the treatment. One of ordinary skill in the art would have been motivated to do so because the WO 2017/211827 document fully discloses the rationale behind the inventive concept of the treatment by administration of an antibody that binds to pathological amyloid plaques and provides solid working examples to support the method. This makes the instant claimed invention obvious over the cited prior art.
Conclusion
11. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
July 29, 2026
Prosecution Insights