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 .
Response to Arguments
Applicant's arguments filed August 12, 2026, have been fully considered but they are not persuasive.
Applicant states:
“First, regarding the Office Action's allegation that the terms "pretreatment," "extraction," "pre-amplification," and "non-extraction" in claim 1 lack structural requirements, the Applicant respectfully submits that these terms serve as functional modifiers to distinguish different components based on their intended purposes within the system, rather than imposing mandatory structural limitations. Such usage is conventional and analogous to expressions like "first device" and "second device," which are routinely used in patent drafting to differentiate components. One skilled in the art would readily understand that these terms are for identification and differentiation purposes and, thus, do not render the claim indefinite.”
It is noted that as admitted by applicant the terms do not provide for any structural elements of the respective devices and holder. The terms are directed to intended use. The respective for clauses are also directed to intended use relative to further claimed structures and materials as indicated by the respective “for pretreating…”; “for holding…”; “for quantifying…”; “for preparing…”; “for moving…”; “for picking up”; and other similar clauses. There is no requirement for any pretreating, holding of anything, preparing, extracting, pre-amplification quantifying, moving, picking up, mixing , and transferring (nor any other process steps) of anything is ever required to be performed. The claims are not directed to method. Intended uses and process steps do not provide for structural elements of the claimed apparatus. Each of the respective devices and holders are not defined in the claim by any specific structures. There is no indication as to what is structurally required to structurally define each of the devices and holder. There is no unspecified sample claimed required to be present nor is any “pretreating” (not defined in the claim by any specific process steps, what is required to done to a sample to be considered as pretreating) of any sample required to be performed. Any structure capable of making a sample available is a “sample pretreatment device”. A simple container, tube, pipette, plate, substrate, etc. and various other known structures can be considered as such.
The extraction device is not defined as being and specific structure(s). Reciting that the device can utilize an unclaimed reagent container (that is not a structural element of the device) does not provide for any structure of the device. The claim does not specify how the device using the container (previously recited as “an extraction strip”) to perform any extraction. Any structure that can hold a structure that can be used for extraction and/or can be employed for holding a structure that can be used for extraction is an extraction device The same is applicable to the further broad, structurally undefined devices and holder.
There is no genetic material, solution, extraction pipette tip, and non-extraction pipette tip are claimed as elements of the invention.
The terms “extraction” and “non-extraction” do not provide for any structural distinctions. A device that can hold a non-extraction tip is not precluded from being structurally capable of holding an extraction tip. Although no pipette tip is positively claimed as a structural element of the invention, there is no structural distinction between an extraction pipette tip and a non-extraction pipette tip. Whether or not one chooses to use a pipette tip or not to extract (aspirate) and transfer any liquid is a matter of choice.
Applicant asserts that are “utilized solely to distinguish components by their respective operational paths in the system”. As stated above, no pipette tips are positively claimed as elements of the system. No pipette tips are required to be moved along any operational paths. The unclaimed pipette tips and “operational paths” not mentioned nor defined in the claim do not structurally define the claimed invention.
It is noted that although specification disclose and the claims previously recited “an automatic preparation system” applicant has now deleted the term “automatic” from the claims. However, it is noted that there is no indication description of the devices being structurally capable of performing the respective recited intended uses themselves. For example, the pipetting device cannot control, move itself to pick up any pipette tips and perform any mixing and transferring of any liquid.
As to claim 5 applicant states:
“Applicant respectfully submits that claim 5 depends from amended independent claim 1, which now recites sufficient structural limitations and layout for the system components.
Furthermore, the Applicant has clarified that the reference to a "sample" in claim 5 does not improperly inject non-structural process features into an apparatus claim; rather, it merely provides the functional environment and intended use for the claimed components. One skilled in the art would clearly understand the structural requirements of the components when cooperative with a sample. Accordingly, claim 5 is believed to satisfy § 112 for at least these reasons.”
The examiner disagrees. Neither claim 1 nor claim 5 has been amended to positively claim a sample as an element of the invention. The sample is not a component of the system. Therefore, it is unclear how any reference to the layout of the system components remedies the issue of claim 5. Claim 5 is directed to a sample that is not positively claimed as an element of the system. The sample is not required to be present. The sample is mentioned in terms of how a sample is intended to be used with the system. The sample does not further structurally define the system. Therefore, the 112 rejection is hereby maintained.
Applicant arguments directed to claim 7 are similar or same as that of claim 12. It is noted that the “operational environment” that applicant asserts claim 7 serves to define is not a structural element of the system nor structurally defined in the claim. However, it is unclear how such sample as recited in the claim defines such an operational environment. No operations of anything are required to be performed. The claim does not provide for any further structure of the system nor pipetting device. Claim 7 is directed to intended use of the pipette. The pipetting device can be said to have numerous possible uses. Reciting everything that the pipetting device can be used to mix and further possible uses of the pipetting device does not provide for any further structure of the pipetting device. There is no requirement for and mixing of any liquid to be performed by the pipetting device. Therefore, the rejection is hereby maintained.
As to claim 8, applicant asserts the claim has been amended to recite “a moving range”. The examiner disagrees. The only amendment to claim 8 is the deleting of the term “automatic”. Furthermore, the moving ranges are not clearly structurally defined in the claim. There is no recitation of how any structural layout and any of the positively claimed elements structurally define the moving ranges. Therefore, the rejection is hereby maintained. Furthermore, as stated above, there is no indication the pipetting devices can move themselves or perform any other actions.
Applicant’s arguments, see response, filed August 12, 2026, with respect to the rejection(s) of claim(s) 1-9 under 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the claims are directed to an apparatus defined by the positively claimed elements listed in the claims. It is noted that claims mention a sample, reagent container, genetic material, container, solution, extraction tip, non-extraction tip, liquid, reagent, prepared solution, container for the sample, container for the genetic material, label, and tag. All of the prior are articles and/or materials intended to be, can be worked upon, or used with the claimed apparatus.
It is noted that the claims are replete with “for…” clauses that do not provide for any further structural elements, but are directed to intended, possible uses of the claimed structures. The claims are directed to an apparatus not a process of use including any involving any of the unclaimed materials and articles that are not structural elements of the invention. There is no requirement of the system to be used to perform any process steps.
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.
It is noted that various “…device for…” and “holder for…” clauses are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
It is noted that that number of the respective positively claimed elements (sample pretreatment device, extraction device, sample holder, pre-amplification quantification device, amplification sample preparation device, pipetting device, image capturing unit, etc.) are not defined in the claims by, as be 1.
As stated above, the terms “pretreatment”, “extraction”, “pre-amplification”, and “non-extraction” do not provide for any further structure of any of the respective devices and holder. There is no requirement for any unspecified “treatment”, “amplification quantification” of any sample/genetic material, “amplification” and “preparation” of any sample/genetic material to be performed prior to anything, and not all. As noted above, the claims are directed to an apparatus, not process of use.
It is noted that the term “or” provides for alternative options, nor requirements.
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 5, and 7-9 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.
It is unclear what is further structurally required by claim 5 because the claim does not provide for any further structure, but is directed to the sample that is not positively claimed as an element of the invention. See also prior remarks above.
It is unclear what is further structurally required by claim 7 because the claim does not provide for any further structure, but is directed to a process of mixing the liquid that is not positively claimed as element of the invention. See also prior remarks above.
Claim 8 recites the limitations "the moving range of the first pipetting device" and “the moving range of the first pipetting device”. There is insufficient antecedent basis for these limitations in the claim. Furthermore, although no movement of any pipette device is required to be performed, it is unclear what constitutes such ranges because such ranges are not clearly structurally defined in the claim. It is noted that one can choose to move a pipetting device to where one desires.
Claim 9 recites the limitations "the container for the sample” and “the container for the genetic material." There is insufficient antecedent basis for these limitations in the claim. No such containers have been previously positively claimed as elements of the invention nor mentioned in claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-5, and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over BRU GIBERT; Rafael et al. US 2025/0298048.
Bru Gibert discloses systems and employing such systems in analysis methods. One such method includes transferring, by a pipettor system in an analyzer device, a nucleic acid to at least one primary reaction chamber in a polymerase chain reaction (PCR) cartridge inserted in the analyzer device (preamplification quantification device), performing a first amplification of the nucleic acid in the at least one primary reaction chamber, resulting in a first amplified product, and inserting a needle of the analyzer device through a septum of the at least one primary reaction chamber to remove the first amplified product. The method further includes dispensing a plurality of aliquots of the first amplified product to a plurality of secondary reaction chambers in the PCR cartridge through respective septums of the plurality of secondary reaction chambers, wherein each aliquot corresponds to a respective secondary reaction chamber, and wherein each secondary reaction chamber comprises a set of reagents for reacting with the respective aliquot of the first amplified product, and performing a second amplification of the aliquots of the first amplified product in the plurality of secondary reaction chambers (amplification sample preparation). (paragraph 0011).
It is noted that a number of the disclosed structures may be considered as a sample preparation treatment device, such as the sample preparation cartridge 114, analyzer 108, cartridge 117, etc.
FIG. 1 illustrates a diagram of a system 101 for performing pathogen identification, according to embodiments of the present disclosure. In some embodiments, the system 101 may be referred to herein as a pathogen identification system 101 or a polymerase chain reaction (PCR) system 101. The system 101 may comprise an analyzer 108, a sample tube 111 (sample holder, see also processing tube 113), sample preparation cartridge 114, PCR cartridge 117, processing device 116, and a plurality of databases 110 communicatively coupled via a network 112. (paragraph 0055).
In some embodiments, the spin column may perform extraction and purification of the nucleic acid from the portion of liquid. In some embodiments, the one or more reservoirs may be configured to store magnetic beads for nucleic acid extraction and purification. (extraction device; paragraph 0101, 102, 111, 129).
The first and second pipettors 202, 204 (pipetting device) may be configured to move elements, such as tubes, cartridges, or the like, within the housing 201 of the analyzer device 200. In particular, the first and second pipettors 202, 204 may each comprise a pipette tip holder (tip holders) that may attach to various components used in the analyzer device 200. (paragraph 0072).
The system comprises a housing 201 in which the devices above are located. The housing includes an opening, houses various components and modules for performing sample preparation, processing, and testing. (paragraph 0068, Figure 2).
However, Bru does not disclose that the respective devices and holder are arranged in the housing as recited in the last paragraph of claim 1.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
It would have been obvious to and within the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention to rearrange the holder and device within the housing as desired including that a claimed. Choosing rearrange elements of previously known system is not considered as novel and non-obvious, but is an obvious matter of design choice since it only requires placing structures in different locations within the housing of Bru.
As to claim 3-4, The system a processing tube and/or reagent tube (reagent holder, amplification sample holder (paragraphs 0025, 96). It is noted that any of the structures capable of holding a reagent/sample can be considered as such.
AS to claim 5, the sample is not a structural element of the invention. However, the system can be employed with various samples including blood. (paragraph 0002, 04, 07, 96).
The thermal cycler of the PCR subsystem 244 may control temperatures in a range of about 35° C. to 100° C. (paragraph 0085). In some embodiments, AST subsystem 250 may comprise a heater configured for incubation of samples in an AST cartridge 232 in the housing 201. (paragraph 0089).
As to claim 7-8, the first and second pipettors 202, 204 can be used as desired including for mixing and such pipettors can move to each of the various structures within the housing.
As to claim 9, the system comprises readers (image recognizers) in the drawers 210, 220, and 230 may be configured to scan identification codes, barcodes, or data matrices of corresponding sample tubes and/or cartridges. In some embodiments, the readers in the drawers 210, 220, and 230 may be barcode readers, quick response (QR) code readers, or the like. (paragraph 0078).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over BRU GIBERT; Rafael et al. US 2025/0298048 as applied to above, and further in view of Wasson; James et al.; US 10,012,664.
BRU GIBERT does not disclose an ultraviolet light sterilizer.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
Wasson discloses the fluid handling apparatus, and other device resources, can also be decontaminated, sterilized, or disinfected by a variety of other methods, including UV irradiation. (column 190, lines 47-50).
It would have been obvious to and within the common sense, knowledge and skill of one of ordinary skill in the art before the effective filing date of the invention to employ a UV sterilizer to disinfect/decontaminate the components of the system of BRU GIBERT to provide for a sterile environment and avoid contamination during use as taught by Wasson.
Conclusion
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 BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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