DETAILED CORRESPONDENCE
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/17/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-19 are pending.
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: “mix up preventer for preventing mix-up” in claim 7.
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.
The specification discusses the mix-up preventer as the shape of the holder and corresponding bag/cartridge/storage in [76, 66, 105] and Fig. 4, 5, and also discusses an ID code on the storage/cartridge and a corresponding reader at/near the holder in [106] or also a marker/ID at both the storage/cartdrige and at the holder where an operator can perform verification [108].
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 1-19 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 pre-AIA the applicant regards as the invention.
As to claim 1, it is unclear what is or is not being positively recited. Line 2 recites a holder for detachably holding a liquid supplier, where the liquid supplier is not positively recited. However, lines 2-3 then state “including a storage…and an ejector…” where it is unclear if the holder includes these limitations or if the liquid supplier includes these limitations. If these are part of the liquid supplier, then the storage and ejector are not positively recited as part of the apparatus. If the storage and ejector are not part of the liquid supplier, then it is unclear what a liquid supplier is attempting to be defined by. As drafted, the claim appears to only positively recite a holder and the limitations of the storage and ejector are interpreted as part of the unclaimed liquid supplier and are therefore directed towards intended use.
Claims 2-19 are rejected based on further claim dependency.
As to claim 5, it is unclear what a product generated is attempting to recite. How is the product generated? There is no actual product being formed or created, and it is unclear what or how a product is generated. Further, it is unclear how the conveyor relates to the rest of the structure (i.e. the holder) since there is no nexus between the conveyor and the rest of the processing apparatus structure.
Regarding claim 6, it is unclear how the biological sample is processed. Specifically, claim 1 recites a liquid used for processing a sample, but there is not any further description of processing a sample. Therefore, it is unclear where the sample is and how it is processed, or processed in a continuous manner, without further clarification on what defines processing and also where the sample is located within the apparatus.
With respect to claim 7, it is unclear what is attempting to be claimed by the mix-up preventer. The mix-up preventer appears to not only relate to the holder, but also to the storage/cartridge itself. However, because the storage is not positively recited, then the claimed features are attempting to relate the claimed holder with respect to the unclaimed storage when in use. Therefore, it becomes unclear since there are claimed features being related to unclaimed features. A potential infringer would not understand whether a particular apparatus with a holder alone would meet the claims or not since the storage is not positively recited.
Regarding claim 12, it is unclear how the biological sample is processed. Specifically, claim 1 recites a liquid used for processing a sample, but there is not any further description of processing a sample. Therefore, it is unclear where the sample is and how it is processed without further clarification on what defines processing and also where the sample is located within the apparatus. Also, how is the processor detachable, and what does it process? How is the processor elated to the other features of the apparatus?
Regarding claim 13, it is unclear how the biological sample is processed and also unclear how processing creates waste. Specifically, claim 1 recites a liquid used for processing a sample, but there is not any further description of processing a sample or how this processing would create waste. Therefore, it is unclear where the sample is and how it is processed without further clarification on what defines processing and also where the sample is located within the apparatus.
Appropriate correction and/or clarification is required.
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 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.
(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.
Claims 1-6, 12, 13, 16-19 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Shiraiwa, H (US 20180044624; hereinafter “Shiraiwa”; already of record).
As to claim 1, Shiraiwa teaches a biological sample processing apparatus (As best understood, Shiraiwa teaches a processing device; abstract) comprising a holder for detachably holding a liquid supplier including a storage for storing a liquid used for processing a biological sample and an ejector for pushing the liquid out from inside the storage to eject the liquid directly to an ejection destination (As best understood, Shiraiwa teaches a holder on 110 that holds cartridge 200; Fig. 4, [80]. As best understood, the examiner notes that the storage is not positively recited and therefore limitations towards the storage do not further define the apparatus structure. Further, even if the storage was positively recited, what the storage is used to store is a matter of intended use that does not define the apparatus/storage beyond that of a capability. Shiraiwa teaches a liquid supplier as the cartridge 200 with liquid storage chamber 213/224 and ejector 221/212; [86, 88, 91, 101], Fig. 5).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”, “for…”, etc…). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Shiraiwa teaches the biological sample processing apparatus according to claim 1 (see above), wherein the storage is configured to store the liquid in an amount corresponding to one-time use (As best understood, the examiner notes that the storage is not positively recited and therefore limitations towards the storage do not further define the apparatus structure. Further, even if the storage was positively recited, what the storage is used to store is a matter of intended use that does not define the apparatus/storage beyond that of a capability. Shiraiwa teaches culture medium; [80, 86, 101]).
As to claim 3, Shiraiwa teaches the biological sample processing apparatus according to claim 1 (see above), wherein the storage is configured to store the liquid in an amount corresponding to multiple-time use (As best understood, the examiner notes that the storage is not positively recited and therefore limitations towards the storage do not further define the apparatus structure. Further, even if the storage was positively recited, what the storage is used to store is a matter of intended use that does not define the apparatus/storage beyond that of a capability. Shiraiwa teaches culture medium; [80, 86, 101]).
As to claim 4, Shiraiwa teaches the biological sample processing apparatus according to claim 1 (see above), further comprising a driver configured to drive the ejector to eject the liquid (Shiraiwa teaches a drive mechanism 249 that drives the valve 240/226; Fig. 5C, 7, [93, 97]).
As to claim 5, Shiraiwa teaches the biological sample processing apparatus according to claim 1 (see above), further comprising a conveyor for conveying a product generated during the processing (Shiraiwa teaches a transfer part 13/23/33, serving to transfer/convey the culture containers 75 in which the cells and culture medium are placed; [62, 66, 71], Fig. 2. Shiraiwa teaches that the culture containers are conveyed; [147]. Also, Shiraiwa teaches that the containers are conveyed/transported; Fig. 3, [58]).
As to claim 6, Shiraiwa teaches the biological sample processing apparatus according to claim 5 (see above), configured to continuously process the biological sample (As best understood, the examiner notes that how the sample is processed is a matter of intended use that does not define the apparatus/storage beyond that of a capability. Shiraiwa teaches continuously culturing the cells; [146]).
As to claim 12, Shiraiwa teaches the biological sample processing apparatus according to claim 1 (see above), further comprising a detachable processor used for the processing of the biological sample (As best understood, Shiraiwa teaches that the cartridge is detachable; [80]. Alternatively, Shiraiwa teaches that the analysis part 104/106 is a separate module, and this would be able to be detached; [79, 81, 107], Fig. 4).
As to claim 13, Shiraiwa teaches the biological sample processing apparatus according to claim 1 (see above), further comprising a waste disposer for disposing of waste generated by the processing (Shiraiwa teaches a waste disposer 105c; [110-111], Fig. 11).
As to claim 16, Shiraiwa teaches the biological sample processing apparatus according to claim 1 (see above), wherein the biological sample is blood for making an induced pluripotent stem cell, the processing includes separation of a blood cell in the blood, and the liquid is phosphate buffered saline (PBS) (As best understood, the examiner notes that the sample and liquid, and the corresponding processing are not positively recited and therefore limitations towards these features do not further define the apparatus structure. Further, what defines the sample, liquid, and processing is a matter of intended use that does not define the apparatus/storage beyond that of a capability. Shiraiwa teaches culture medium; [80]).
As to claim 17, Shiraiwa teaches the biological sample processing apparatus according to claim 1 (see above), wherein the biological sample is a peripheral blood mononuclear cell (PBMC) for making an induced pluripotent stem cell, the processing includes the introduction of a factor into the peripheral blood mononuclear cell, and the liquid is the factor (As best understood, the examiner notes that the sample and liquid, and the corresponding processing are not positively recited and therefore limitations towards these features do not further define the apparatus structure. Further, what defines the sample, liquid, and processing is a matter of intended use that does not define the apparatus/storage beyond that of a capability. Shiraiwa teaches culture medium and cells; [80, 104]).
As to claim 18, Shiraiwa teaches the biological sample processing apparatus according to claim 1 (see above), wherein the liquid is an intermediate product generated while an induced pluripotent stem cell is being made (As best understood, the examiner notes that the liquid is not positively recited and therefore limitations towards the liquid do not further define the apparatus structure. Further, what defines the liquid is a matter of intended use that does not define the apparatus/storage beyond that of a capability. Shiraiwa teaches culture medium and cells; [80, 104]).
As to claim 19, Shiraiwa teaches the biological sample processing apparatus according to claim 1 (see above), wherein the ejection destination is a filter or a storing container (As best understood, the examiner notes that the ejection destination is not positively recited and therefore limitations towards the ejection destination do not further define the apparatus structure. Further, what defines the ejection destination is a matter of intended use that does not define the apparatus/storage beyond that of a capability. Shiraiwa teaches ejection into a container 75; [88], Fig. 4-5).
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Shiraiwa, H (US 20180044624; hereinafter “Shiraiwa”; already of record) in view of Hamada et al (US 20110244558; hereinafter “Hamada”).
As to claim 7, Shiraiwa teaches the biological sample processing apparatus according to claim 1 (see above).
Shiraiwa does not teach a mix-up preventer. However, Hamada teaches the analogous art of a sample processing device (Hamada; abstract) with a holder for holding a liquid supply/storage, and a mix-up preventer for preventing mix-up of the liquid supplier (Hamada teaches a holder which holds a liquid supplier 200/300, where there is a reader to read a liquid supplier tag/code 260/360 to determine if the liquid supplier is appropriate, and also a label on the holder which can visually confirm the liquid supply, and when the code on the liquid supplier does not match the code on the holder then a user can be notified via the computer; Fig. 4-13, [55-65, 81, 111, 112]). It would have been obvious to one of ordinary skill in the art to have modified the processing device which enables placement of liquid suppliers in holder of Shiraiwa to have included the mix up preventer as in Hamada because Hamada teaches that reading the ID can help determine when an appropriate liquid has been provided and alert a user when inappropriate liquid is provided (Hamada; [111, 112]) and this would also allow a visual check confirmation via a user (Hamada; [81]).
As to claim 8, Shiraiwa teaches the biological sample processing apparatus according to claim 7 (see above), wherein the mix-up preventer is provided at the storage and includes an identification code for identifying the liquid and a reader for reading the identification code (The modification of liquid suppliers in holder of Shiraiwa to have included the mix up preventer as in Hamada has already been discussed above. Hamada; Fig. 4-13, [55-65, 81, 111, 112]).
As to claim 9, Shiraiwa teaches the biological sample processing apparatus according to claim 8 (see above), wherein the mix-up preventer further comprises a controller configured to determine whether or not a correct liquid supplier is attached to the holder based on a result of reading the identification code (The modification of liquid suppliers in holder of Shiraiwa to have included the mix up preventer as in Hamada has already been discussed above. Hamada; Fig. 4-13, [55-65, 81, 111, 112]).
As to claim 10, Shiraiwa teaches the biological sample processing apparatus according to claim 7 (see above), wherein the mix-up preventer comprises the holder to which only a corresponding liquid supplier is attachable (As best understood, the examiner notes that how the holder is used is a matter of intended use that does not define the apparatus/storage beyond that of a capability. The modification of liquid suppliers in holder of Shiraiwa to have included the mix up preventer as in Hamada has already been discussed above. Hamada; Fig. 4-13, [55-65, 81, 111, 112]).
As to claim 11, Shiraiwa teaches the biological sample processing apparatus according to claim 7 (see above), wherein the mix-up preventer is provided at each of the liquid supplier and the holder and includes an identification marker for identifying a correspondence relationship between the liquid supplier and the holder (The modification of liquid suppliers in holder of Shiraiwa to have included the mix up preventer as in Hamada has already been discussed above. Hamada; Fig. 4-13, [55-65, 81, 111, 112]).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Shiraiwa, H (US 20180044624; hereinafter “Shiraiwa”; already of record) in view of Angros et al (US 20110150725; hereinafter “Angros”).
As to claims 14-15, Shiraiwa teaches the biological sample processing apparatus according to claim 4 (see above), with a driver for moving and ejecting fluid (see above).
Shiraiwa does not teach the driver is a syringe pump, and the ejector comprises a piston configured to be driven by the syringe pump for movement. However, Angros teaches the analogous art of a liquid supplier with a syringe pump driver, and the ejector comprises a piston configured to be driven by the syringe pump for movement (Angros teaches liquid supplier reagent containers 14/40 through which a syringe pump 154 is driven to actuate a piston 44 to eject liquid; [146, 170, 172, 176], Fig. 2, 23, 24. Angros teaches that the reagent containers can be syringe-like, and therefore the pump 154 is considered a syringe pump; [140]). It would have been obvious to one of ordinary skill in the art to have modified the ejection of liquid from the liquid supplier via the driver of Shiraiwa to have ejected liquid via a syringe pump and piston as in Angros because Angros teaches that using an actuated piston is a known way to dispense reagents (Angros; [146, 170, 172, 176]), and because this would be simply substituting a known liquid ejection device of Angros for the known ejection device of Shiraiwa thereby achieving the same purpose and predictable result of ejecting fluids (See MPEP 2143 I. B).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Hatsuda et al (US 20260193580; hereinafter “Hatsuda”) teaches culture solution containers 21-26 where there is a pump in the container [59], and the amount can be for one production [111] where the size and shape of the containers can be different; Fig. 10-11, see also [107].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571) 272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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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/Benjamin R Whatley/Primary Examiner, Art Unit 1798
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