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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first fluid circuit”, “second fluid circuit”, “control unit” in claims 1 and 15, “at least one filter membrane” in claims 1 and 12, “a pipetting robot” in claim 14 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: filter membrane 28 in Figs. 3a, 3b (see para [0105] of applicant’s corresponding US 2024/0100528; hereinafter “’528”) or “control unit” capable of managing the selectable connection of the at least first fluid circuit and the second fluid circuit”. The control unit is shown in the figures as reference number 20. However, the reference number 20 is disclosed in para [0081] and shown in the figures as an “evacuation channel”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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. “an evacuation system” found in at least claim 1, has been interpreted by the examiner as a pump (see para [0022] of ‘528) or structural equivalents thereof.
b. “control unit” in claims 1 and 15, looking applicant’s specification, it is not clear what the “control unit” corresponds to structurally, see below.
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 1-16 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.
Claim 1 recites “the thermoregulating fluid circuit being selectively connectable to the at least first fluid circuit and the second fluid circuit” and “control unit” configured to manage the selectable connection of the at least first fluid circuit and the second fluid circuit”. Similarly, claim 15 recites the step of selectively activating and disactivating (interpreted to mean deactivating) over time, by means of the control unit, the first and second fluid circuits. However, the control unit is not shown or described as corresponding to any particular structure, but for the reference number 20 which appears to be an “evacuation channel”, not a control unit. The control unit is recited as merely configured to manage the selectable connection of the at least two fluid circuits to the internal thermoregulating fluid circuit in order to regulate and control the temperature inside the at least one well. However, the control unit does not include any elements that would provide for the functional/process of the managing selectable connection (i.e., valve) or control the temperature inside of the well (i.e., temperature sensor). Thus, the scope of the claim cannot be determined.
Claim 1 also recites “a reaction plate comprising at least one well configured to receive a reaction solution or a reaction tube”. Claim 15 depends from claim 1. Claim 15 recites “a reaction tube”. It is not clear if applicant is referring to the same reaction tube or an additional reaction tube. For examination purposes, it will be assumed by the examiner these are referring to the same reaction tube. Nevertheless, clarification in the claim is requested.
Claims 10 and 11 refer to a thermocycling multistep reactions device, wherein "the first fluid circuit defines a first predetermined temperature" and "the second fluid circuit defines a second predetermined temperature", respectively. However, this wording, in particular, the word "defines", does not clearly define in which way the first and second fluid circuits "define" the first and second predetermined temperatures. In particular, it is unclear, whether the fluid within the circuits are set at the predetermined temperature or whether the fluid circuits lead to another fluid outside the fluid circuits to have a predetermined temperature. Thus, the scope of these claims are unclear.
Claim 12 recites “the device comprises one filter membrane for each of the at least one well, each filter membrane connecting its corresponding well to the evacuation system. It is not clear whether this is referring to the same or an additional filter than the filter membrane previously recited. For examination purposes, it will be assumed by the examiner these are referring to the same filter membrane. Clarification is requested.
Claim 15, last step, “recovering the reaction product”. First, the reaction product lacks antecedent basis. Second, it is unclear how the membrane holds captive the reaction product if it is in the reaction tube. This appears to only work if the reaction wells include a reaction solution. Also, it is unclear how the membrane holds captive the reaction product (e.g., it is not clear properties hold the unknown reaction product within the membrane). Looking to applicant’s ‘528 specification, para [0201] recites, “[i]n any of the above embodiment, and depending on the reaction carried out, the reaction product may be recovered either in the well 14 as it remains captive from the membrane 28 after the activation of the evacuation system 18, or it can be recovered from the collector, if it is the remaining reaction solution which is held captive from the membrane 28. This is the case when the reaction inside the well 14 includes some cell culture or some bigger molecule degradation in order to obtain a smaller molecule of interest.” However, this recitation in the specification is vague and unclear. How does a cell culture or “bigger molecule degradation” (in the membrane?) capture some unknown reaction solution or product? Claim 15 does not include any properties of the membrane to accomplish this capture of the reaction product or reaction solution. This is vague and indefinite. This reasoning also applies to claim 16.
Also, claim 15 recites “filling the fluid circuits…and activating them”, “selectively activating and disactivating over time, the first fluid circuit and the second circuit according to a predetermined reaction protocol” and “activating the evacuation system when all reaction steps according to the reaction protocol are completed”. It is not clear what applicant means by “activating” the fluid circuits and “activating” the evacuation system. Looking to the specification for clarity, the specification of ‘528 recites “[w]hen activated, the evacuation system 18 enables to empty the wells 14 by evacuating the reaction solution. The evacuation system 18 may be activated by a vacuum pump (not represented) creating a vacuum sucking of the reaction solution out of the wells 14 into the evacuation channel 20 towards a collector (not shown)”. It is not clear how the evacuation pump would “activate and deactivate” the fluid circuits according to a predetermined reaction protocol since it appears to only create a vacuum for sucking the reaction solution out the wells. Also, it is unclear what applicant means by “all the reaction steps” included in the “predetermined protocol”. The phrase “all of the reaction steps” is vague and indefinite. In addition, “all the reaction steps” lacks antecedent basis.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-12 and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dutertre et al., (US 5,161,609; hereinafter “Dutertre”)
Regarding claim 1, Dutertre discloses a thermocycling multistep reactions device comprising:
a reaction plate 20 comprising at least one well 12 configured to receive a reaction solution or a reaction tube,
a first fluid circuit and a second fluid circuit each one configured to maintain a fluid at a predetermined temperature (heat source or cool source S; see col. 7, line 1 et seq.),
at least one internal thermoregulating fluid circulation circuit (22; see col. 5, line 15 et seq.) configured to be arranged in direct contact with the at least one well 12, the thermoregulating fluid circuit being selectively connectable to the at least first fluid circuit and the second fluid circuit (see col. 2, line 63 et seq.),
an evacuation system (pump 28 for controlling flow),
a control unit configured to manage the selectable connection of a first fluid circuit and the second fluid circuit to the internal thermoregulating fluid circuit in order to regulate and control the temperature inside the at least one well (see col. 3, line 35 et seq.), wherein each of the at least one well is connected to the evacuation system by means of at least one filter membrane (see col 6, line 11 et seq.), and
wherein the thermoregulating fluid circuit is made of a heat conducting material (see col. 2, line 22 et seq.) while the reaction plate is made of a polymerous material (see col. 6, line 51 et seq.), the reaction plate 24, 26 at least partially enclosing the thermoregulating fluid circuit in order to at least partially isolate said thermoregulating fluid circuit from the external environment.
Regarding claim 2, Dutertre discloses each of the at least one well 12 and the internal thermoregulating fluid circulation circuit are comprised in a same plane, said plane being defined by the reaction plate (see Fig. 4).
Claim 3 is directed to functional/process or intended result limitations which the prior art would inherently be capable of doing, the only distinction between applicant’s claims and the prior art is recited functional/process/intended result language. It is incumbent upon Applicant to show that the application disclosed by the prior art is not actually capable of performing such functions. See In re Ludtke, 169 USOQ 563 (CCPA 1971).
Regarding claim 4, Dutertre discloses the reaction plate further encloses the evacuation system in order to at least partially isolate said evacuation system from the external environment (see col. 3, line 4 et seq.)
Regarding claim 5, Dutertre discloses each of the at least one well displays an internal and an external surface, the external surface of each of the at least one well 12 being in direct contact with the thermoregulating fluid circuit (see Fig. 3).
Regarding claim 6, Dutertre discloses the external surface of each of the at least one well 12 is defined within the reaction plate, the reaction plate (12) thus comprising the external surface of each of the at least one well (see Fig. 2).
Regarding claim 7, Dutertre discloses each of the at least one well is defined within the thermoregulating fluid circuit, the thermoregulating fluid circuit thus comprising the an external surface of each of the at least one well (see Fig. 3).
Claim 8 is directed to functional/process or intended result limitations which the prior art would inherently be capable of doing, the only distinction between applicant’s claims and the prior art is recited functional/process/intended result language. It is incumbent upon Applicant to show that the application disclosed by the prior art is not actually capable of performing such functions. Dutertre discloses any heat diffusion between each of the at least one well 12 and the thermoregulating fluid circuit is a direct diffusion (see col. 1, line 29 et seq.)
Regarding claim 9, Dutertre discloses wherein the reaction plate, the evacuation system (pumps) and the thermoregulating fluid circuit (pipes) are separable from each other (see Fig. 4).
Regarding claim 10, Dutertre discloses the first fluid circuit defines a first predetermined temperature ranging from about 90 to about 110°C (see col. 2, line 55 et seq.)
Regarding claim 11, Dutertre discloses the second fluid circuit defines a second predetermined temperature ranging from about -150 to about 20°C (see col. 2, line 55 et seq.)
Regarding claim 12, Dutertre discloses one filter membrane for each of the at least one well 12, each filter membrane connecting its corresponding well to the evacuation system (pump), see col. 4, line 1 et seq.)
Regarding claim 14, Dutertre discloses a pipetting robot configured to fill or refill in an independent and automated way each of the at least one wells (14) of the thermocycling multistep reactions device (see col. 7, line 5 et seq.)
Regarding claim 15, Dutertre discloses filling the fluid circuits with one or several heat transfer fluid and activating them, filling each of the at least one well 12 with either a reaction solution or a reaction tube comprising the reaction solution, selectively activating and disactivating over time, by means of the control unit, first fluid circuit and the second fluid circuit according to a predetermined reaction protocol (see col. 1, line 18 et seq), activating the evacuation system (pump) when all the reaction steps according to reaction protocol are completed, and recovering the reaction product hold held captive in the membrane or collected in the collector (see col. 7, line 5 et seq.).
Regarding claim 16, Dutertre discloses inserting a reaction tube 12 inside the at least one well and positioning the at least one filter membrane between the at least one well and the evacuation system, wherein the inserting occurs after the filling of the fluid circuits and prior to the filling of each of the at least one well (see col. 3, line 49 et seq.)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Dutertre. Dutertre discloses the invention substantially as claimed except the dimensions of the device comprising a height 14 cm or less. However, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to determine the desired the dimensions of the device through routine experimentation in an effort to determine the desired throughput. Furthermore, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
a. Ouyang et al., (US 2023/0400506) which disclose a temperature control system and a temperature control method for an electronic device-testing apparatus. The temperature control system mainly includes a test socket, a temperature-controlling fluid supply device and a temperature-controlling fluid recovery device. A temperature-controlling fluid is supplied to a chip slot of the test socket by the temperature-controlling fluid supply device and drawn from the chip slot by the temperature-controlling fluid recovery device. In the present invention, the temperature-controlling fluid is forced to flow through the chip slot loaded with an electronic device so as to forcibly exchange heat with the electronic device and components in the chip slot, thereby achieving the constant temperature test. After the test is completed, the temperature-controlling fluid can be effectively recovered so that the contamination of the electronic device or the testing apparatus can be avoided; and
b. Lee et al., (US 2022/0080426) which disclose a gene amplification module including: a heat block in which a reaction container accommodation space is defined; a heating part provided below the heat block; a cooling part provided below the heating part; and a fluid supply part provided to face one side of the heat block, the fluid supply part being configured to supply a cooling fluid to the heat block, wherein sidewalls defining a circumference of the heat block are provided on the heat block, and one or more supply holes configured to supply the cooling fluid are defined in the sidewalls.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached between 9:30am-7pm EST.
Examiner interviews are available via telephone 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.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on 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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/P. Kathryn Wright/Primary Examiner, Art Unit 1798