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 .
DETAILED ACTION
Summary
This is the initial Office action on the 18/754402 application filed on 6/26/24.
Claims 1-11 are pending and have been fully considered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/26/24, 7/23/24 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 incorporated monument must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The disclosure is objected to because of the following informalities: the related applications section of the first paragraph should be updated to include issued patent numbers for all applications listed.
Appropriate correction is required.
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: incorporated monument in claim 1, cold thermal assembly in claim 4.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claim limitation “incorporated monument” does not appear to be a well-known or standard term in the art; therefore it has been interpreted as a generic placeholder under 35 USC 112(f). The claims, specification and drawings lack any further description of what structure is defined by the term.
Claims 2-11 depend from claim 1 and therefore incorporate the same deficiency.
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 1-11 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 limitation “incorporated monument” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The claim limitation “incorporated monument” does not appear to be a well-known or standard term in the art; therefore it has been interpreted as a generic placeholder under 35 USC 112(f). The claims, specification and drawings lack any further description of what structure is defined by the term. Based on the lack of further description, it is unclear what the meets and bounds of the claim limitation should be. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claims 2-11 depend from claim 1 and therefore incorporate the same deficiency.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4 are rejected under 35 U.S.C. 102a2 as being anticipated by KEI (US 2019/0049343) with evidence of PATIL (pub 2015).
With respect to claim 1, KEI discloses a cell support system (cell culture system) with a cooling unit for supporting the specimen rack 342 (culture cassette), the rack having 96 wells which are capable of being used to contain cells for growth (bioreactor module) and fluid reagents (reagents fluid reservoir);
the system comprising a cooler 351 that uses a general Peltier element (thermoelectric device to pump heat from a cold side to hot side);
the cooler having heat insulation member 353 and cover 354 (thermal insulation) to inhibit heat from returning to the cold side;
the cooler having a heat transfer member 352 (incorporated monument) adjacent to the cooler (cold sink) and providing a conductive path for heat to travel from the cold sink to the thermoelectric device. Additionally it is clear from Fig 5 of Patil that a Peltier thermoelectric cooler, such as that disclosed by KEI, inherently has conductive pathways between the cold side sink and the hot side sink. Therefore the disclose of KEI inherently meets all positively recited claim structure.
When reading the preamble in the context of the entire claim, the recitation “for receiving and operationally supporting an automated cell culture cassette for biological processes, the cell culture cassette comprising a bioreactor module and a reagents fluid reservoir” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention's limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See MPEP § 2111.02. Furthermore the limitation regarding the heat pumped being a sum of heat, this limitation does not recite any further structural limitations, but rather is directed to how the device operates during use, and therefore does not add patentable weight to the apparatus claim. MPEP 2114-2115.
With respect to claim 2, KEI does not detail the structure of the thermoelectric device. From the evidence of PATIL it can be seen that the basic structure of a peltier cooler has a plurality of cold sink fins (cold sink array) compressed with the Peltier device to a hot sink (Fig 5).
With respect to claim 3, KEI discloses the cooler provides a cold zone that is capable of circulating a cold airflow path around the tips (reservoirs). It is noted that the claim does not recite any structure required to create the cold airflow nor what structure allows the airflow path to circulate. Therefore the disclosure of KEI teaches all positively recited structures of the claim and is therefore considered capable of operating as claimed. MPEP 2114-2115.
With respect to claim 4, cold thermal assembly is being interpreted under 35 USC 112f as stated above to be a cold sink array substantially as recited in present claim 2 (See original claims of the specification #30). KEI does not detail the structure of the thermoelectric device. From the evidence of PATIL it can be seen that the basic structure of a Peltier cooler has a plurality of cold sink fins (cold sink array) compressed with the Peltier device to a hot sink (Fig 5).
With respect to claim 10, KEI does not detail the structure of the thermoelectric device. From the evidence of PATIL it can be seen that the basic structure of a Peltier cooler has a hot side fan (hot sink fan) (Fig 5).
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(s) 5-7, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over KEI (US 2019/0049343) with evidence of PATIL (pub 2015) as applied above,
With respect to claim 5, KEI does not detail the cold thermal assembly, however, the evidence of a basic structure of a Peltier cooler of PATIL shows the cold side has a fan (Fig 5). Neither reference explicitly disclose the fan is configured to be uncoupled from the cold sink, however, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the fan separable in order to perform maintenance of the cooler, or to aid in shipping, additionally it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. MPEP 2144.04.
With respect to claim 6-7, KEI does not explicitly disclose a condensation control mechanism. However, PATIL discloses it was known to use a water distribution line to move moisture in a Peltier cooler system (Fig 4). It would have been oblivious to one of ordinary skill in the art to modify the system of KEI to include the water distribution line for condensation control of PATIL because it can improve the cooling operation (Section IV, A).
With respect to claim 11, Neither KEI nor PATIL explicitly disclose the hot sink fan is configured to be withdrawn upwardly and away via hinges. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the fan separable via a well-known connector such as a hinge in order to perform maintenance of the cooler, or to aid in shipping, additionally it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. MPEP 2144.04.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over KEI (US 2019/0049343) with evidence of PATIL (pub 2015) as applied above, in view of TSURUTA (US 2006/0194193).
With respect to claims 8-9, KEI does not explicitly disclose a warm zone configured to circulate a warm airflow path wherein a heating assembly is provided to generate the warm airflow directed at the bioreactor module. However, TSURUTA discloses a biological sample culturing system comprising a well plate (bioreactor module) (0087) in an incubator housing in which a warm air is supplied (heating assembly generates warm zone configured to circulate warm airflow path) (0270, 0315, 318, Fig 41), a supply device comprising a refrigerator/freezer that cold stores culture solution, waste solution and reagents (cold zone configured to circulate a cold airflow path surrounding reagents fluid reservoir) (0114, 0121, Fig 1). At the time the invention was filed it would have been obvious to one of ordinary skill in the art to modify the system of KEI to include the warm zone with heating assembly as taught by TSURUTA because it allows for better control of the temperature in order to provide the optimal environment for the cells contained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
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, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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