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 .
Claim Interpretation
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“An evaluation unit for evaluating images” in claim 23, 24, and 26.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-26 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 1, this is a method claim, but there is not a clear series of steps to be performed, and the claim is missing any apparent transition phrase (e.g. “comprising”). In addition, "the particular coloring rounds" is recited in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Claim 1 earlier states that there are multiple coloring rounds. It is unclear which coloring rounds, "the particular coloring rounds" is referring to.
The term “the individual vector components” in line 14 lacks clear antecedent basis for what specific components are being projected.
Claim 1 is further indefinite because it is directed to a method but the limitations in the “wherein” clause (lines 11-18) do not clearly recite a sequence of acts. The claim recites relationships between data structures without specifying how or when the recited operations are performed during the method. It is unclear whether the projection and aggregation steps are performed for each coloring round, after all rounds, or in some other order.
Regarding claim 2, independent claim 1 recites “the individual vector components being projected onto a projection vector… and the projection vector… being sequentially aggregated onto an aggregation vector” lines 14-17, indicating that projection and aggregation are distinct operations. However, claim 2 recites “the aggregation for the aggregation vector is a principal axis transformation or a singular value decomposition (SVD)” lines 3-5. The specification describes principal axis transformation and singular value decomposition as techniques used for projection (Pg. 15, line 14). Accordingly, it is unclear whether the aggregation recited in claim 1 is a separate step or whether it corresponds to the projection step.
Regarding claim 5, “the omitted j components include in particular at least one of the following components … the last components” is recited in lines 8-11. “the last components” fails to specify how many components are encompassed and does not provide objective boundaries for determining which components are omitted. Accordingly, the scope of the claim is uncertain.
Regarding claim 12, "the particular coloring rounds" is recited in line 5. This is unclear in view of claim 1 above.
Regarding claim 22. It is unclear what the preamble is directed to. Claim 1 (a method) might be the parent claim here, but this seems to be a method of using a system by using a method of using a system to perform a method. (“training” “system” “using” “model” “carrying out” “method”. This doesn’t clearly fit into one of the statutory categories.
Regarding claims 24 and 26, the phrase “such as” is recited in lines 2 and 3 respectively. This renders the claim indefinite as it is unclear whether the following limitation is part of the claimed invention.
The remaining dependent claims inherit the deficiencies of their parent claim.
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 22 and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claim 22 is not clearly directed to either a machine or a method of using the machine or a method of making the machine.
Claim 25 does not fall within at least one of the four categories of patent eligible subject matter because claim 25 is directed to a "computer program product being in particular a computer readable memory medium". The broadest reasonable interpretation of the instant claim in light of the specification encompasses transitory signals. However, transitory signals are not within one of the four statutory categories (i.e. non-statutory subject matter). See MPEP 2106(I). Claims directed toward a non-transitory computer readable medium may qualify as a manufacture and make the claim patent-eligible subject matter. MPEP 2106(I). Therefore, amending the claims to recite a "non-transitory computer-readable medium" would resolve this issue.
The following claim is drafted by the examiner and considered to distinguish patentably over the art of record in this application. It largely corresponds to claim 1 and is presented to applicant for consideration:
A method for preparing data for identifying analytes comprising:
coloring one or more analytes with markers in multiple coloring rounds, the markers in each case being specific for a certain set of analytes;detecting multiple markers using a camera, which for each coloring round generates at least one image containing multiple pixels and color values assigned thereto, which may contain color information of one or more markers[,]; and
storing the color information of the multiple coloring rounds for evaluating the color information, the color information comprising: a data point in each case including one or more contiguous pixels in the images of the multiple coloring rounds that are assigned to the same location in a sample, wherein for each data point of a sample, the color value for one of n coloring rounds of an experiment is recorded in each case, and these color values in each case form a component of an output vector with the dimension m, and
after recording the corresponding color value, the are projected onto a projection vector with a dimension k that is smaller than m, and
the projection vector for each coloring round is sequentially aggregated onto an aggregation vector with the same dimension k as the projection vector, and the aggregation vector is stored.
Allowable Subject Matter
Claims 1-24 and 26 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. Claim 25 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, set forth in the Office action.
Conclusion
Pertinent Prior Art: Lahiani, A., Gildenblat, J., Klaman, I., Navab, N., & Klaiman, E. (2018). Generalizing multistain immunohistochemistry tissue segmentation using one-shot color deconvolution deep neural networks. ArXiv.org. https://arxiv.org/abs/1805.06958 Similar coloring round processing but does not perform projection or aggregation.
US 2017/0327876 A1, Khafizov et al., “METHODS FOR DETECTING TARGET NUCLEIC ACIDS IN A SAMPLE”, published 2017 Similarly uses color to detect nucleic acid by defining a color code. Does not perform projection or aggregation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A WAMBST whose telephone number is (703)756-1750. The examiner can normally be reached M-F 9-6:30 EST.
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, Gregory Morse can be reached at (571)272-3838. 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.
/DAVID ALEXANDER WAMBST/Examiner, Art Unit 2663
/GREGORY A MORSE/Supervisory Patent Examiner, Art Unit 2698