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 .
Applicants Amendment
Applicants amendment filed 4/13/2026 has bee received and entered. Claims 1-7, 9, 11, 12, 17, 19 have been amended, claims 16, 20 have been cancelled (both of which are incorporated into claim 1) and claim 21 has been added.
Claims 1-15, 17-19, 21 are pending.
Election/Restriction
Applicant’s election without traverse of Group III and the species of monocyte as cell type, coilin and nuclear protein and nusinersen as treatment in the reply filed on 9/9/2025 was acknowledged. In prosecution, in review of the claims of the elected invention, and upon initial search and review, it does not appear to be an undue burden to examine all the groups in view of the election. Accordingly, the restriction requirement between groups I-III and all the recited species, was withdrawn.
Newly added claim 21 depends on 2 and provides a specific range % of enucleated cells observed and is consistent with the examined invention.
Claims 1-15, 17-19, 21, drawn to a method of assessing the location of proteins associated with spinal atrophy for possible treatment for spinal muscular atrophy are currently under examination.
Priority
This application filed 3/11/2022 claims benefit to foreign application JP2021-040682 filed 3/12/2021 in Japan.
Receipt was acknowledged of certified copies of papers required by 37 CFR 1.55 (paper entered 4/18/2022 of electronically retrieved from WIPO).
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 1-15, 17-19 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn.
The amendments to the claims have addressed the issue of “SMN” and limitation of “acquiring an intracellular distance” between “bright” spots.
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 1-6, 10-15, 17-19 stand and newly added claim 21 is 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.
Claim analysis
Examiner note-claim 7 has been amended and provides for an additional step based on the observed SMN location, where treatment is assessed by observing changes in distances/location of the dyes in response to and in the absence of treatment. Given the additional element of measuring and lack of prior knowledge for the correlation of the change in distance, the claim as a whole appears to be a practical application of the abstract idea in the screening of potential compounds that affect SMN location as possible treatments.
Accordingly, the claims have been found patent eligible and removed from the basis of the rejection.
Claim 1 has been amended to incorporate the limitations of claims 16 and 20 and still are directed to analyzing fluorescence images which represent location of SMN proteins which were identified using two fluorescent dyes and measure the distance between the two detected labels. More specifically, given the guidance of the specification the analysis provides for the basis of differences in the distances when they exist can be interpreted to be correlated to be an indicator of spinal muscular atrophy affection. Claim 4 has been amended to provide the specific distance for a threshold value and provides for similar steps and correlations as claim 1.
For step 1 of the 101 analysis, the claims are found to be directed to a statutory category of a process.
For step 2A of the 101 analysis, the judicial exception of the claims are the steps of accessing image data. The step of assessing an image and measuring distance between to observable labels in an image are instructional steps. Further, once a distance is measured the measurement is used to correlate to a specific condition of spinal muscular atrophy, when the appropriate SMN proteins are detected and the correlation between the SMN is informative of spinal muscular atrophy. In view of the guidance of the specification, the claim requires assessing images and computing a distance of any observed label that can be observed. The judicial exception is a set of instructions for analysis of image data, and appear to be directed to Mathematical Concepts to the extent that distances are assessed and correlated to spinal muscular atrophy and also directed to Mental Processes, which are concepts performed in the human mind (including an observation, evaluation, judgment, opinion) for making the observation of an image. The breadth of “acquiring” encompasses non-transformative visual assessment of an individual image coupled with prior or known knowledge of the correlation of said distance with spinal muscular atrophy. This breadth does not impose a meaningful limit on the claim scope, such that all others are not precluded from using the natural principle of observing a biological process that represents the state of the cell and represents the presence of spinal muscular atrophy. Although the claims recite “fluorescence image’ this image can be physical and observable, but to the extent that it can be digital the courts have also identified limitations that did not integrate a judicial exception into a practical application; for example, merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f). Computing, constructing datasets and using statistical models was well understood, conventional, and routinely performed in the art at the time the application was filed. Furthermore, the limitation of the wherein clause that a distance is associated with a condition is simply informative and descriptive of what the image may represent. See MPEP § 2106.05(g) for a discussion on adding insignificant extra-solution (both pre-solution and post-solution) activity to the judicial exception. See also MPEP § 2106.05(h) for a discussion on generally linking the use of a judicial exception to a particular technological environment or field of use.
Recent guidance from the office requires that the judicial exception be evaluated under a second prong to determine whether the judicial exception is practically applied. In the instant case, the claims do not have an additional element beyond making observation and measuring ‘labels’ that can be measured. This judicial exception requires steps recited at high level of generality and are only stored on a non-transitory, and is not found to be a practical application of the judicial exception as broadly set forth.
For step 2B of the 101 analysis, each of the independent claims recites additional elements and are found to be the steps of obtaining image data. As such, the claims do not provide for any additional element to consider under step 2B. It is noted that in explaining the Alice framework, the Court wrote that "[i]n cases involving software innovations, [the step one] inquiry often turns on whether the claims focus on the specific asserted improvement in computer capabilities or, instead, on a process that qualifies as an abstract idea for which computers are invoked merely as a tool." The Court further noted that "[s]ince Alice, we have found software inventions to be patent-eligible where they have made non-abstract improvements to existing technological processes and computer technology." Moreover, these improvements must be specific -- "[a]n improved result, without more stated in the claim, is not enough to confer eligibility to an otherwise abstract idea . . . [t]o be patent-eligible, the claims must recite a specific means or method that solves a problem in an existing technological process.” As indicated in the summary of the judicial exception above and in view of the teachings of the specification, the steps are drawn to analysis of image data. While the instruction can be stored on a medium and could be implemented on a computer, together the steps do not appear to result in significantly more than a means to compare sequences. The judicial exception of the method as claimed can be performed by hand and in light of the previous claims to a computer medium and in light of the teaching of the specification on a computer. In review of the instant specification the methods do not appear to require a special type of processor and can be performed on a general purpose computer. Based upon an analysis with respect to the claim as a whole, claims 1-20 do not recite something significantly different than a judicial exception. Dependent claims set forth additional steps which are more specifically define the considerations and steps of calculating, and comparing, and do not add additional elements which result in significantly more to the claimed method for the analysis. In the instant case, the claims comprise steps of comparing image data and is considered the judicial exception. It is noted that while the claims set forth or imply information about the image being analyzed (that they are correlated to spinal muscular atrophy), this is only description of the data being analyzed and context and user defined. As such, the instant claims set forth an inventive concept that are drawn only to an abstract process that only manipulates data and, therefore, are not directed to statutory subject matter. No additional steps are recited in the instantly claimed invention that would amount to significantly more than the judicial exception. Without additional limitations, a process that employs mathematical algorithms (measuring distances) to generate additional information is not patent eligible. Furthermore, if a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is non-statutory. In other words, patenting abstract idea (designing probes to a target sequence) cannot be circumvented by attempting to limit the use to a particular technological environment or purpose and desired result.
Response to Applicants arguments
Applicants summarize the claim method steps are argue that the are not well understood or conventional, arguing that labeling SMN and measuring are physical steps that are not disclosed.
In response, examiner agrees that claim 7 recites and has these requirements and have been found patent eligible. However, claim 1 broadly provides for acquiring an image, and while the claim indicates what the image represents or steps that could have been performed to provide an image, the steps do not appear to be a requirement of the claims and are interpreted to be descriptive of what the acquired image provides. The remaining steps of measuring can be done by observation and assessed mentally by hand. Antibodies to SMN were known and used previously, as well as imaging cells after being labeled and the claims as a whole do not appear to provide for any new staining or imaging techniques which provide for limitations that make the claims patent eligible with respect to providing an image which is subsequently analyzed which is considered the judicial exception of the claims.
As noted previously, one way to overcome a rejection for non-patent-eligible subject matter is to persuasively argue that the claimed subject matter is not directed to a judicial exception. Another way for the applicants to overcome the rejection is to persuasively argue that the claims contain elements in addition to the judicial exception that either individually or as an ordered combination are not well understood, routine, or conventional. Another way for the applicants to overcome the rejection is to persuasively argue that the claims as a whole result in an improvement to a technology. Persuasive evidence for an improvement to a technology could be a comparison of results of the claimed subject matter with results of the prior art, or arguments based on scientific reasoning that the claimed subject matter inherently results an improvement over the prior art. The applicants should show why the claims require the improvement in all embodiments.
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.
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.
Claims 1-15, 17-19 rejected under 35 U.S.C. 103 as being unpatentable over Saito et al. (US 2017/0115297 (27 April 2017), Sapaly et al. (Small-molecule flunarizine increases SMN protein in nuclear Cajal bodies and motor function in a mouse model of spinal muscular atrophy. Scientific Reports. 8:2075 1-16 (01 February 2018)), Tucker et al. (Residual Cajal bodies in coilin knockout mice fail to recruit Sm snRNPs and SMN, the spinal muscular atrophy gene product The Journal of Cell Biology, Volume 154, Number 2, July 23, 2001) and AMNIS (Image Stream MkII imaging flow cytometers (2014)) is withdrawn.
Upon review of the amendments and teachings of references, it is agreed while SMN was analyzed with fluorophore antibodies and Saito et al. teach that a measured or quantitated decrease in SMN protein in the monocytes of the subject compared against measured or quantitated normal level of SMN protein of a healthy normal subject indicates the subject to have spinal muscular atrophy (SMA). Further, Sapaly provide evidence that SMN deficiency manifested as decrease in SMN protein levels resulting from SMA alters nuclear body formation and localization as detected by high resolution AMNIS imaging flow cytometry and that altered nuclear body (CB) localization of SMN protein is the hallmark of childhood SMA disease. However, there is no specific teaching for measuring or providing the specific threshold values required of the amended claims.
Conclusion
Claims 7-9 are allowed.
The art of record demonstrates that methods of analyzing survival motor neuron (SMN) protein in whole blood sample of a subject were known as evidenced by Saito et al. who teach that a measured or quantitated decrease in SMN protein in the monocytes of the subject compared against measured or quantitated normal level of SMN protein of a healthy normal subject indicates the subject to have spinal muscular atrophy (SMA). SMN protein has a specific localization in the nucleus, and is found specifically concentrated in the nuclear bodies and that altered nuclear body (CB) localization of SMN protein is the hallmark of childhood SMA disease and that mutations result in decrease in SMN protein levels and that SMN deficiency alters nuclear body or Cajal body (CB) formation as provided by Sapaly et al. However, the art fails to provide any importance to the distance of SMN proteins that could be observed or the correlation of a threshold distance associated with SMA.
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 Joseph T Woitach whose telephone number is (571)272-0739. The examiner can normally be reached Mon-Fri; 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz R Skowronek can be reached at 571 272-9047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Joseph Woitach/ Primary Examiner, Art Unit 1687
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