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 .
The supplemental claim amendments dated 12/23/2024 are under consideration.
Priority
The present application is a 371 national stage entry of PCT/CA2022/051694 (filed 11/16/2022); which claims foreign priority to CANADA 3139296 (filed 11/16/2021).
Priority to the CANADA 3139296 application is not recognized. First, it is noted that the body of the present specification is 10 pages longer than the entire certified copy of the foreign priority document, which includes fewer drawings and cover page documents. The CANADA 3139296 application does not disclose “total telomere length” or “average telomere length” as “telomere parameters”. The CANADA 3139296 application also does not disclose a “classification model” consisting of “a) nuclear telomere distribution, a/c ratio, and total telomere length; b) a/c ratio and telomere numbers; c) a/c ratio and nuclear telomere distribution, or d) a/c ratio and telomere aggregates”.
The present claims are given the earliest effective PCT/CA2022/051694, which is 11/16/2022.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
Drawings
The drawings are objected to because the 5/15/2024 drawings include references to colors, in particular Fig. 1; however, no color copies are provided. It is unclear if applicant intends the application to include color figures.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: the amendments dated 12/23/2024 are objected to because they are redundant in view of the same amendments filed 5/15/2024. The 12/23/2024 amendments are not entered.
Appropriate correction is required.
Claim Objections
Claim 48 is objected to because of the following informalities: the claim recites “the at least telomere”, which is a typographical error. Appropriate correction is required.
Claim 49 is objected to because of the following informalities: the claim recites “the sample” rather “the test sample”. Appropriate correction is required.
Claim Interpretation
The claims include the element that are introduced as “optional”. Claim scope is not limited by claim language that makes optional but does not require elements as part of the claims. MPEP 2111.04.
Terms in parentheticals, such as “3D”, are interpreted as being abbreviations for the preceding term.
In claim 41, the claim states “”the plurality of plasma cells previously obtained from a test sample from a subject having smoldering multiple myeloma (SMM)”. The language is interpreted as not requiring an active method step of “obtaining the plurality of plasma cells”, but rather put forth the source of the plasma cells.
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 41,42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59 and 60 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions without significantly more.
The claims are drawn to methods, one of the four statutory categories.
The claim(s) recite(s):
“applying a classification model to the 3D telomere organization sample signature to obtain an output classification of stable SMM or high-risk SMM, the classification model consisting of the telomere parameters: a) nuclear telomere distribution, a/c ratio, and total telomere length; b) a/c ratio and telomere numbers; c) a/c ratio and nuclear telomere distribution, or d) a/c ratio and telomere aggregates” (claim 41);
“providing the clinical outcome prognosis or the diagnosis to the subject according to the output classification, the clinical outcome prognosis or the diagnosis being an increased likelihood of stable SMM or an increased likelihood of high-risk SMM, wherein the subject with increased likelihood of high-risk SMM is likely to progress to multiple myeloma (MM) within 2 years and the subject with increased likelihood of stable SMM is not likely to progress to MM within 5 years” (claim 41);
“comparing the 3D telomere organization monitoring signature to a 3D telomere organization signature obtained from a previous sample from the subject” (claim 55);
“providing an updated clinical outcome prognosis or an updated diagnosis to the subject having an increased likelihood of stable SMM” (claim 55);
“providing the subject the personalized treatment plan to be administered to the subject when the subject has an increased likelihood of high-risk SMM or monitoring the subject when the subject has an increased likelihood of stable SMM determined according to the method of claim 41” (claim 58);
“applying a classification model to the 3D telomere organization sample signature to obtain an output classification of stable SMM or high-risk SMM” (claim 60); and
“providing the clinical outcome prognosis or the diagnosis to the subject according to the output classification (claim 60).
The “applying” steps broadly encompass an abstract idea as they relate to the consideration of a two or three pieces of data. This amount of data may be considered by the human mind.
The “providing” steps broadly encompass an abstract as it coordinates human behavior relating to conveying medical information between individuals.
The “comparing” steps broadly encompass an abstract idea as it involves the consideration of a limited amount of data that may be considered by the human mind.
The judicial exceptions are not integrated into a practical application because the claims do not involve:
improvements to the functioning of a computer or to any other technology or technical field;
applying or using the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition;
applying the judicial exception with, or by use of, a particular machine; or
effecting a transformation or reduction of a particular article to a different state or thing.
The claimed limitations add insignificant extra-solution activity to the judicial exceptions. While claims 52-54 further comprises treating a subject, the treating is conditioned on the type of diagnosis or prognosis. None of the claims require treating a patient in some manner across all embodiments. For example, claim 52 focuses on subjects having high-risk SMM, but requires nothing be done to subjects with stable SMM. Furthermore, the treating of claim 54, which is “subsequently monitored” is not an active method step that is a particular treatment or prophylaxis that integrates a judicial exception.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims encompass the use of well-known assays as described in paragraphs 226-235 of the instant specification.
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.
Claims 41,42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59 and 60 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.
Regarding claim 41, the claims recites “the 3D telomere organization sample signature comprising at least one telomere parameter selected from total telomere length, average telomere length, telomere numbers, telomere aggregates, a/c ratio, nuclear volume, and nuclear telomere distribution”. The claim also recites “applying a classification model to the 3D telomere organization sample signature to obtain an output classification of stable SMM or high-risk SMM, the classification model consisting of the telomere parameters: a) nuclear telomere distribution, a/c ratio, and total telomere length; b) a/c ratio and telomere numbers; c) a/c ratio and nuclear telomere distribution, or d) a/c ratio and telomere aggregates”. It is unclear if the “applying” step is intended to further limit the scope of “at least one telomere parameter” to including at least one combination of “a) nuclear telomere distribution, a/c ratio, and total telomere length; b) a/c ratio and telomere numbers; c) a/c ratio and nuclear telomere distribution, or d) a/c ratio and telomere aggregates”. If not, the claim is incomplete as it does not require collecting all of the information required for the classification model.
Claims 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59 and 60 depend from claim 41 and are rejected for the same reason.
Regarding claim 41, the claim recites “the clinical outcome prognosis or the diagnosis being an increased likelihood of stable SMM or an increased likelihood of high-risk SMM” and is based on the “output classification” obtained through the “applying” step. The recitation of “an increased likelihood of stable SMM or an increased likelihood of high-risk SMM” lacks proper antecedent basis as the “output classification” is for generic “stable SMM or high-risk SMM”.
Claims 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59 and 60 depend from claim 41 and are rejected for the same reason.
Regarding claim 43, the claim recites “the prognosis or the diagnosis is provided to the subject or the subject's medical professional at time of SMM diagnosis”. It unclear how a prognosis or diagnosis is to be provided at the time of SMM diagnosis when the sample is “from a subject having smoldering multiple myeloma (SMM)”. In order to practice the “assaying” step the subject must have SMM. In other words, the subject would have to be known to have SMM, i.e., be diagnosed, with SMM prior to carrying out the method. If it is unknown whether a patient has SMM at the time of the method, it is unclear how one knows if they are infringing the method until after they have completed.
Regarding claim 48, the claim recites “the one or more of…telomere parameter”. The recitation lacks proper antecedent basis.
Regarding claim 50, the claim recites the at least one telomere parameter of the classification model is selected to have a particular accuracy of distinguishing between stable SMM and high-risk SMM. It is unclear what is the scope of the telomere parameters having the different claimed accuracies. For example, it is unclear what is the scope of telomere parameters having an accuracy of at least 75% versus the scope of telomere parameters that have an accuracy of 100%. It is further unclear what, if any additional elements, are required by the classification model in order to achieve any of the recited accuracies.
Regarding claim 55, the claims states “assaying the plurality of plasma cells according to the assaying step of claim 41”. The assaying step of claim 41 obtains a “3D telomere organization sample signature”. It is unclear a “3D telomere organization monitoring signature” is obtained from a process that generates “3D telomere organization sample signature”.
Regarding claim 59, the claim recites “the clinical outcome prognosis or the diagnosis being an increased likelihood of stable SMM or an increased likelihood of high-risk SMM” and is based on the “output classification” obtained through the “applying” step. The recitation of “an increased likelihood of stable SMM or an increased likelihood of high-risk SMM” lacks proper antecedent basis as the “output classification” is for generic “stable SMM or high-risk SMM”.
Regarding claim 60, the claim recites “the clinical outcome prognosis or the diagnosis being an increased likelihood of stable SMM or an increased likelihood of high-risk SMM” and is based on the “output classification” obtained through the “applying” step. The recitation of “an increased likelihood of stable SMM or an increased likelihood of high-risk SMM” lacks proper antecedent basis as the “output classification” is for “stable SMM or high-risk SMM”.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 57-59 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mateos (N Engl J Med. 2013. 369:438-447).
Regarding claims 57, 58 and 59, Mateos teaches treating patients classified as high-risk SMM with a personalized regimen of lenalidomide and dexamethasone (Fig. 1).
The Mateos reference and claim 58 and 59 treat the same patients, i.e., high-risk SMM patients. It is noted that the claim does not require performing the method of claim 41 but rather treating patients that have high-risk SMM. Mateos teaches treating the same classification of patients and there is no indication that the high-risk SMM patients of Mateos are distinguishable from those of claim 58 classified based on the method of claim 41.
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.
Claim(s) 41-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rangel-Pozzo (Cancers. 2021. 13:1969, 16 pages).
Regarding claims 41, 56 and 60, Rangel-Pozzo teaches assaying plasma cells from SMM subjects using a 3D telomere FISH protocol and analyzed for 3D images (p. 3 of 16, 2.1. Sample Acquisition and Patient Population, 2.2. Sample Preparation, 2.3. Immunostaining and Telomere Hybridization, 2.5. Image Acquisition and Nuclear Architecture Analysis). The parameters of the telomeres assayed include telomere numbers, telomere aggregates, a/c ratio, etc. (Table 2).
Rangel-Pozzo teaches:
“In the SMM patient group, five different telomere parameters identified patients with stable or progressive disease and allowed us to stratify this group of SMM patients into high-risk SMM versus low-risk SMM. Similar results were observed for MM patients. This risk stratification has the potential to guide evidence-based treatment decisions of SMM patients with a high risk of progression or MM patients with active disease.” (p. 13 of 16).
It is noted that high-risk SMM versus low-risk SMM as described by Rangel-Pozzo is based on:
“Fifteen of the 20 SMM patients remained stable for 5 years, while five progressed to full stage multiple myeloma within 1 to 3 years from the point of diagnosis. They were stratified as indolent SMM (stable SMM) and high-risk SMM (SMM progression), respectively”.
It would have been prima facie obvious to have applied a “classification model” to the telomeric data obtained from plasma cells to provide a clinical outcome or diagnosis of the subject in view of the notion of classifying and risk stratification of SMM subjects based on the teachings of Rangel-Pozzo. It would have been prima facie obvious to have selected one or more of the parameters from Table 2 with the most significant p values, including telomere numbers, a/c ratio and/or total telomere intensity (which is proportional to telomere length, p. 8 of 16). One would recognize that combining parameters provides more information regarding the plasma cells and would increase the accuracy of a prognosis and/or diagnosis of high-risk SMM versus low-risk/stable SMM.
Regarding claim 42, Rangel-Pozzo teaches the plasma cells are from bone marrow (p. 3 of 16, 2.1. Sample Acquisition and Patient Population).
The claim does not require obtaining a sample of bone marrow or obtaining plasma cells bone marrow. There is no indication that plasma cells from the blood versus bone marrow are structurally different in the context of SMM.
Regarding claim 43, it would have been obvious that at the time of diagnosing SMM to have also performed the above assaying step in order to also provide a prognosis or diagnosis of the type of SMM the patient has (e.g., stable SMM or high-risk SMM).
Regarding claim 44, Rangel-Pozzo teaches the steps of claim 44 as described on p. 3 of 16, sections 2.2. Sample Preparation, 2.3. Immunostaining and Telomere Hybridization, 2.5. Image Acquisition and Nuclear Architecture Analysis.
Regarding claim 45, Rangel-Pozzo further teaches staining cell samples for CD138 and/or CD56 (p. 3 of 16, 2.3. Immunostaining and Telomere Hybridization).
Regarding claim 46, Rangel-Pozzo teaches the 3D imaging of claim 46 as described on p. 3 of 16, section 2.5. Image Acquisition and Nuclear Architecture Analysis.
Regarding claim 47, Rangel-Pozzo teaches the cells analyzed are interphase cells (p. 3 of 16, 2.5. Image Acquisition and Nuclear Architecture Analysis).
Regarding claim 48, Rangel-Pozzo teaches the telomere parameters are averages or ratios (p. 3 of 16, 2.5. Image Acquisition and Nuclear Architecture Analysis).
Regarding claim 49, Rangel-Pozzo teaches the samples are bone marrow plasma cells from subjects as noted above, which is broadly encompassed by a “diagnostic sample” in view of paragraph 103 of the instant specification.
Regarding claim 50, Rangel-Pozzo teaches a number of telomere parameters as describes above and as encompassed by the claim.
Regarding claim 51, one would readily recognize that the subjects of Rangel-Pozzo are humans.
Regarding claims 52-54 and 57, Rangel-Pozzo teaches patients with SMM are not treated but monitored (p. 13 of 16). Rangel-Pozzo further teaches their technique can guide treatment decisions for those with a high risk of progression (p. 13 of 16). Thus it would have been obvious to have monitored those with stable SMM and to treat those at risk of progressing to MM with one or more known treatments for MM in view of Rangel-Pozzo.
Regarding claim 55, Rangel-Pozzo renders obvious the method of claim 41 as described above. It would have been prima facie obvious to have repeated the method at later time points to determine if patients still had stable SMM or were at high risk of MM or if the risk level decreased, for example as a result of treatment.
Regarding claim 58, it would have been prima facie obvious to have provided a personal treatment plan of monitoring to individuals identified with the method of Rangel-Pozzo of having stable SMM.
Regarding 59, Rangel-Pozzo renders obvious the method of claim 41 as described above. The method of claim 41 is encompassed by claim 59.
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.
Claim 41-60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 23 (7/30/2025) of copending Application No. 18/861,552 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are of sufficient breadth so as to encompass the pending claims of the ‘552 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
-
-
Conclusion
No claims allowed.
-
-
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
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, Wu-Cheng Winston Shen can be reached at 5712723157. 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.
/JOSEPH G. DAUNER/ Primary Examiner, Art Unit 1682
Prosecution Insights