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 .
Status of Claims
This action is in reply to the application filed on 04/11/2025.
In a preliminary amendment, claims 1-20 were cancelled. Claims 21-42 were added.
Claims 21-42 are currently pending and has been examined.
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: (a) a plurality of analytical modules and associated analytical submodules, and a plurality of pre-analytical modules and associated pre-analytical submodules in claim 22.
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.
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 obviousness-type 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 Omum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 21-42 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,308,097.
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 21-42 of the instant pending application omits certain steps of claims 1-20 in the 12,308,097 patent. Therefore, claims 21-42 are prima facie obvious of claims 1-20 because it would have been obvious to omit certain steps with the motivation of providing for processing biological samples in a batch type manner and efficiently performing biological assays.
Claims 21-42 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,887,703.
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 21-42 of the instant pending application omits certain steps of claims 1-20 in the 11,887,703 patent. Therefore, claims 21-42 are prima facie obvious of claims 1-20 because it would have been obvious to omit certain steps with the motivation of providing for processing biological samples in a batch type manner and efficiently performing biological assays.
Claims 21-42 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,581,089.
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 21-42 of the instant pending application omits certain steps of claims 1-28 in the 11,581,089 patent. Therefore, claims 21-42 are prima facie obvious of claims 1-28 because it would have been obvious to omit certain steps with the motivation of providing for processing biological samples in a batch type manner and efficiently performing biological assays.
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 21-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 21-42: Step 1
Claims 21-33 are drawn to an electronic system for performing biological assays, which is within the four statutory categories (i.e. machine). Claim 34-42 is drawn to a method for performing biological assays, which is within the four statutory categories (i.e. process).
Claims 21-42: Step 2A Prong One
Claim 34 recites receiving one or more assay instructions for processing one or more biological samples, determining a plurality of assays that need to be performed for each sample of the one or more biological samples based on the one or more assay instructions, determining an order to perform each assay in the plurality of assays to maximize one or more performance metrics, assembling the plurality of assays into one or more batches, wherein each batch comprises a subset of the plurality of assays which require the same assay resources, and performing the one or more batches of assays based on the determined order to maximize the efficiency of performing the plurality of assays. Claim 21 recites similar limitations.
These limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing personal behavior by manually following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity. But for the recitation of generic computer components, these limitations encompass a user receiving one or more assay instructions for processing one or more biological samples, determining a plurality of assays that need to be performed for each sample of the one or more biological samples based on the one or more assay instructions, determining an order to perform each assay in the plurality of assays to maximize one or more performance metrics, assembling the plurality of assays into one or more batches, wherein each batch comprises a subset of the plurality of assays which require the same assay resources, and performing the one or more batches of assays based on the determined order to maximize the efficiency of performing the plurality of assays. These steps could be carried out manually by a user following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity. Claim 21 recites similar limitations.
Claims 22-33 and 35-42 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea, but for the recitation of generic computer components. For example, but for the recitation of generic computer components, Claim 22 further defines the plurality of electronic instruments. Claims 23, 25, 36 and 37 further define the one or more performance metrics. Claim 24 further defines one or more pre-determined conditions. Claims 26, 27, 38 and 39 further define determining the order. Claims 28 and 29 further define further programming. Claim 30 and 35 further defines maximizing one or more performance metrics. Claims 31 and 40 further define allocating assay resources. Claims 32 and 41 further define deallocating assay resources. Claims 33 and 42 further define determining an updated order to perform the assays. Therefore, these claims are similarly drawn to Certain Methods of Organizing Human Activity.
Claims 21-42: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas along with insignificant, extra-solution data gathering activity, and adding limitations similar to adding the words “apply it” to the abstract idea.
Claims 21-42, directly or indirectly, recite the following generic computer components: “memory”, “processors,” “electronic system” and “analysis system” which are similar to adding the words “apply it” to the abstract idea. The written description discloses that the recited computer components encompass generic components including “Analyzer computer devices 236a1, 236a2 may also each include a processor and memory“ (see at least Paragraph [0061]), “Memory includes data that may be retrieved, manipulated or stored by the processor. The memory may be of any non-transitory type capable of storing information accessible by the processor, such as a hard-drive, memory card, ROM, RAM, DVD, CD-ROM, write-capable, and read-only memories” (see at least Paragraph [0069]), and “The one or more processors implemented by each of communication interfaces 232, 236a1, and 236a2 may be any conventional processors, such as a commercially available CPU” (see at least Paragraph [0072]). Although the additional elements limit the identified judicial exceptions, this type of limitation merely confines the use of the abstract idea to a particular technological environment, and thus fails to add an inventive concept to the claims. See MPEP 2106.05 (h). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 “merely include[ing] instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Claims 21-42: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”). As explained above, the generic computer components are at best the equivalent of merely adding the words “apply it” to the judicial exception.
Receiving and transmitting data over a network (i.e. receiving and communicating data or signals) has been recognized as well-understood, routine, and conventional activity of a general-purpose computer (see MPEP 2106.05(d) and buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014)).
Gathering and analyzing information using conventional techniques and displaying the result has also been found to be insufficient to show an improvement to technology, (see MPEP 2106.05(a) and TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48).
Insignificant, extra solution, data gathering activity has been found to not amount to significantly more than an abstract idea (see MPEP 2106.05(g) and Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)). Therefore, the high-level recitation of an output of results also fails to include additional elements that are sufficient to amount to significantly more than the judicial exception.
Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
The most remarkable prior art of record is as follows:
Denton: U.S. Patent Application Publication U.S. 2008/0312893 A1, Clinical Diagnostic Analyzer Performance Estimator
Dority et al.: U.S. Patent Application Publication U.S. 2017/0021356 A1, Molecular Diagnostic Assay System
Crafts, Jr. et al. : U.S. Patent Application Publication U.S. 2017/0124263 A1, Workflow And Interface Manager For A Learning Health System
Clark et al.: U.S. Patent U.S. 5,575,978, Sample Container Segment Assembly
Anonymous, “Laboratory Information Management System”, Wikipedia, October 25, 2017, Pages 1-8
Guder et al., “Glossary” in Diagnostic Samples: From The Patient To The Laboratory: The Impact Of Preanalytical Variables On The Quality Of Laboratory Results, December 31, 2009, Pages 102-107
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joy Chng whose telephone number is 571.270.7897. The examiner can normally be reached on Monday-Friday, 9:00am-5:00pm.
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/Joy Chng/
Primary Examiner, Art Unit 3686
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