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 .
Claims 1-20 are the current claims hereby under examination.
Claim Objections
Claim 20 is objected to for the word “evaluate” in line 6. The word should state “evaluates”.
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 1-20 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.
Claims 1 and 18-19 (and all its dependents) generates a combination of fluorophores for a biomolecule on a “basis of” a number of recited parameters, which has been deemed as vague and indefinite. It is unclear as to what relationship the term “basis of” creates or what steps are required for use in resulting in the generated list of fluorophores using the parameters recited. It is further unclear as to how the four different parameters (i.e. expression level category, brightness category, correlation information, and expression relationship information) are used together or what algorithm is used that is based on these parameters in order to result in the generated list of fluorophores. Clarification via clearer claim wording is required.
Claims 1 and 18-19 (and all its dependents) comprises one of the parameters used to generate the list of fluorophores as “an expression category” which is obtained by classifying a plurality of biomolecules used for analysis of a sample on a basis of an expression level in the sample. It is unclear as to what exactly an “expression category” refers and how it is obtained through the recited classification of biomolecules. It is further unclear as to how it used in combination with the other parameters to arrive at the generated combination list of fluorophores. Clarification via clearer claim wording is required.
Claims 1 and 18-19 (and all its dependents) further recites a parameter for generating a list of fluorophores “correlation information between the plurality of fluorophores,” which has been deemed as vague and indefinite. It is unclear as to exactly what type of information is considered “correlation information” and how it is obtained. Clarification via clearer claim wording is required.
Claims 1 and 18-19 (and all its dependents) further recites a parameter for generating a list of fluorophores “expression relationship information of the plurality of the plurality of biomolecules,” which has been deemed as vague and indefinite. It is unclear as to what type of information is considered “expression relationship information” and how it is obtained. Clarification via clearer claim wording is required.
Claims 1 and 18-19 (and all its dependents) further recites a final step of selecting a fluorophore from the combination list from the brightness category associated with an expression level category to which the biomolecule belongs, which has been deemed as vague and indefinite. It is unclear as to what exactly the term “associated with” means. The term fails to inform a person of ordinary skill in the art with reasonable certainty as to the metes and bounds of said term. The term does not establish a clear relationship or boundaries that are required between brightness category and expression level category. Additionally, the combination list is already generated “on a basis” of a combination of parameters, which include both brightness and expression level. It is unclear as to how this final is supposed to further filter the data to arrive at a selection of fluorophore when a list has been generated seemingly “on a basis” of the two required parameters and some type of additional relationship between them. Clarification via clearer claim wording is required.
Claim 20 recites the limitation wherein the processing unit executes an “evaluation,” which has been deemed as vague and indefinite. The evaluation is of “separation ability regarding a combination list of fluorophores for a biomolecule,” which is further deemed as vague and indefinite. It is unclear as to what occurs during the evaluation step or what is required or what it results in. The second step adds wherein the evaluation uses expression relationship information of the plurality of biomolecules, but this does not add any clarity as to what exactly is occurring. It is not clear as how the combination list is used, what the relationship is between the combination list and the assigned fluorophore is, what information exactly is encompassed by the term “expression relationship information of the plurality of biomolecules” and how that unknown scope of information is used in evaluating separation ability. It is further unclear as to what exactly is the scope of the term “separation ability” or what exactly is meant by the term. It is noted this last step of claim 20 is also recited in claim 2. As such, claim 2 is further deemed as vague and indefinite for the same reasons with regards to the use of expression relationship information being used to evaluate separation ability. Clarification via clearer claim wording is required.
Claim 5 recites wherein the expression relationship information has a “tree structure” which has been deemed as vague and indefinite. It is unclear as to what exactly is meant by the term “tree structure.” Clarification via clearer claim wording is required.
Claims 7 and 9 comprise the term “assumed to be acquired” which has been deemed as vague and indefinite. It is unclear as to exactly what is meant by the term “assumed to be acquired.” Clarification via clearer claim wording is required.
Claim 11 recites the limitation of “combination information regarding a combination of biomolecules’ which has been deemed as vague and indefinite. The term “combination information” fails to inform a person of ordinary skill in the art with reasonable certainty what the metes and bounds are of the type of information encompassed by the scope of “combination information.” Clarification via clearer claim wording is required.
Claim 14 comprises a step of “fluorescence separation simulation” which has been deemed as vague and indefinite. It is unclear as to what exactly is involved or how fluorescence separation using the combination list is simulated. Clarification via clearer claim wording is required.
Claim 15 is generally unclear as to what is exactly is being determined or what exactly is occurring or supposed to occur in the claim. It is unclear as to what the relationship is between the simulation data and the data related to stained particles and what the result is of what the processing unit uses the data or relationship between the data. Clarification via clearer claim wording is required.
Claim 19 recites in the preamble “an information processing apparatus,” but fails to recite any structural elements that define “an information processing apparatus” in the body of the claim. As such, the claim has been deemed as vague and indefinite. Clarification via clearer claim wording is required.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Claims 1, 18-19, and 20 is being interpreted under 35 USC 112 Sixth Paragraph because claims 1 and 20 use the non-structural phrase “processing unit” whereas claims 18-19 use the non-structural phrase “step of” with generic placeholding functional language of “that generates”, “that executes”, and “generating” where there is no specific structure identified in the specification to correspond to the claimed generic placeholding functional language of “that generates”, “that executes” of “generating” Furthermore, the non-structural term is not preceded by a structural modifier. The non-structural phrases “processing unit” “that executes” or “list generation step of” “generating” are not recognized as the name of a structure but merely a substitute for the term “means for” because the phrases are not modified by sufficient structure, material, or acts for achieving the specified function of evaluation of separation ability.
A consideration of the understanding of one skilled in the art in no way relieves the patentee of adequately disclosing sufficient structure in the specification for such means plus function. For the instant indefiniteness analysis it is asked first whether a structure is described in the specification, and, if so, whether one skilled in the art would identify the structure from the description. The inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing a structure. Accordingly, a bare statement that known techniques or methods can be used does not disclose structure. To conclude otherwise would vitiate the language of the statute requiring “corresponding structure, material, or acts described in the specification. Therefore, it is not enough to say one of ordinary skill in the art would know how to implement said means plus function, but the patentee must state a specific structure, which one of ordinary skill in the art would recognize as implementing said means.
A review of the specification does not appear to show a corresponding structure for the 35 U.S.C. 112, sixth paragraph limitation.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not wish to have the claim limitation treated under 35 U.S.C. 112, sixth paragraph, applicant may amend the claim so that it will clearly not invoke 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112, sixth paragraph.
For more information, see Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. § 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Regarding claim 1 the following means/step (or that executes) plus function limitation is vague and indefinite:
“that generates a combination list of fluorophores”
Regarding claim 18-19 the following means/step (or that executes) plus function limitation is vague and indefinite:
“generating a combination list of fluorophores”
Regarding claim 20 the following means/step (or that executes) plus function limitation is vague and indefinite:
“that executes evaluation of separation ability”
The specification as filed does not set forth specific structures for performing the means recited. The recited “that generates”, “that executes” or “generates” language lacks specific related structures in the specification. See MPEP § 2181 for guidance in determining whether an applicant has complied with the requirements of 35 U.S.C. 112, second paragraph, when 35 U.S.C. 112, sixth paragraph, is invoked. 35 U.S.C. 112, sixth paragraph states that a claim limitation expressed in means-plus-function language “shall be construed to cover the corresponding structure…described in the specification and equivalents thereof.” “If one employs means plus function language in a claim, one must set forth in the specification an adequate disclosure showing what is meant by that language. If an applicant fails to set forth an adequate disclosure, the applicant has in effect failed to particularly point out and distinctly claim the invention as required by the second paragraph of section 112.” In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (in banc).
Examiner’s Comment
In light of the claim rejections for indefiniteness under 35 U.S.C. 112 2nd paragraph, as set forth above, the Examiner was not able to perform a meaningful search of the prior art. Applicant is reminded that prior art rejections under 35 U.S.C. 102 and/or 35 U.S.C. 103 may be applied in the next Office action in light of applicant's amendments, and that the next Office action can properly be made "Final" if these rejections are necessitated by amendment. See MPEP 706.07.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
the claimed invention is directed to determining whether a fetus has a chromosomal aneuploidy or a generating a classification model for doing so without significantly more.
Analysis of independent claim 1:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a method and claim 19-20 are directed to information processing apparatus for performing the method, which describes one or more of the four statutory categories of patentable subject matter, i.e., a process/machine. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites an abstract idea. In particular, the claim recites the following:
a. generating a combination list of fluorophores using four parameters of data; and
b. selects a fluorophore to be assigned to a biomolecule.
These elements recited in claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper and/or they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations.
Step A involves the mental and/or mathematical step of using four parameters to generate a combination list of fluorophores, which can be performed mentally or using pen and paper. The generically recited step B of selecting a fluorophore to be assigned involves the mental of evaluating data and making a selection.
The identified abstract steps, recited at the high level of generality, do not suggest an undue level of complexity for a person with ordinary skill in the art to be practically performed in the human mind with the aid of pen and paper.
Prong Two: Claim 1 does not recite additional elements that integrate the exception into a practical application. Therefore, the claim is “directed to” the abstract idea.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements outside of the recognized JE. Therefore claim 1 does not recite limitations alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
In view of the above, the recited limitations do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Analysis of other independent claims 19-20:
Claim 19-20 have the same analysis as above, but with the addition of the method being carried out by a processing apparatus. Patenting abstract ideas cannot be circumvented by attempting to limit the use [the idea] to a particular technological environment. In the instant claims, the processing apparatus amount to mere instruction to implement an abstract idea. Any attempted hardware recited by the processing apparatus claims do not offer a meaningful limitation beyond generally linking “the use of the method to a particular technological environment,’ that is, implementation via computers.” see Alice Corp v. CLS Bank Int’l 573 U.S. (2014).
Analysis of the dependent claims:
Claims 2-17 depend from the independent claims. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely describe additional details of steps of generating the combination list, such as by evaluating separation ability or what other types of data are used for generating the combination list or the type of data that is output.
Conclusion
No claim is allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Sims, whose telephone number is (571)-272-7540.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Jonathan Moffat can be reached via telephone (571)-272-4390.
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the Central PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central PTO Fax Center number is (571)-273-8300.
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/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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