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 Amendment
The amendment filed 1/2/26 has been entered and fully considered.
Claims 1-2, 5-8 remain pending, of which claims 7-8 were previously withdrawn.
The previous objection to the drawings has been withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/2/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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: stirring device and fastening part in claim 1.
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 1-2, 5-6 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.
Claim limitation “stirring device” 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 present disclosure and drawing of Fig. 1 contains no description or definition of what structures provide the stirring function, nor how such stirring device would be located in the bioreactor. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
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 1-2, 5-6 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 “stirring device” 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 present disclosure and drawing of Fig. 1 contains no description or definition of what structures provide the stirring function, nor how such stirring device would be located in the bioreactor. 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.
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 § 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) 1-2, 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over BISHOP (US 2018/0229241) in view of MAGGIORE (US 2017/0335268) further in view of EVERETT (US 2010/0209966).
Regarding claim 1, fastening part is interpreted under 35 USC 112f as stated above to be a flange connector as per Fig 2 and 0041 of the specification, and functional equivalents thereof.
BISHOP discloses a cell culture system comprising a bioprocess container 30 or 54/56 containing culture media 34 (medium storage tank), a culture apparatus 10 (bioreactor) which can have a stirrer and be made of a single use disposable material (bag) (0086) that receives media from the bioprocess container (0054), a cell culture linking tube 32 (medium transfer line) configured to introduce a medium from the bioprocess container to the culture apparatus 10, (0066)(Fig 2, 6),
Wherein the linking tube 32 includes a leak proof flange (fastening part) formed at one end of the tube 32 (discharge line) connected to the bioprocess container and a bioprocess tube (SU disposable tube) welded (connected) to the tube 32 using the leak proof flange at one end and connected with the culture apparatus at the other end, in which the tubes are made of thermoplastic elastomers (single use and disposable) (0061-0069, Fig 2, 4-5).
BISHOP discloses the reactor of the system may be stainless steel or single use depending on need (0086) but does not explicitly disclose the bioprocess container (medium storage tank) is made of stainless steel. However, it would have been obvious to one of ordinary skill in the art to modify the bioprocess container of BISHOP to be made of steel in order to be reusable and provide structural rigidity and also it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
BISHOP does not explicitly disclose a vent filter provided on the tube 18 connected to the bioreactor. However, MAGGIORE discloses a dispensing system from biological products comprising a tube 54 (SU disposable tube) that can be connected to a bioreactor (Fig 6), in which the tube is provided with a vent filter 62 (Fig 1A) to properly vent the tubing as material moves through (0049).
It would have been obvious to one of ordinary skill in the art to modify the tubing of BISHOP to include the integrated vent filter as taught by MAGGIORE because it allows the fluid to properly move through the tube when it fills with fluid subjected to an external force (0049).
BISHOP discloses another tube (steam trap) is branched from the weld connection in a Y shape (Fig 6) and the tube includes a flow stop device 36 (0060) but does not explicitly disclose what the flow stop device is. However, EVERETT discloses aseptic bioreactor system in which culture containers were connected to bags via their tubes with aseptic connectors 34 (fastening parts), the transfer tubes having a pinch clamp to seal it (0051, Fig 1B).
It would have been obvious to one of ordinary skill in the art to modify the flow stop device of BISHOP to be a pinch clamp as taught by EVERETT, because it would’ve been a simple substitution of one known element for another for the same purpose of stopping fluid flow in a tube and therefore would’ve obtained predictable results.
Regarding claim 2, BISHOP discloses the line and tube connection can be inclined at a predetermined angle (Fig 6).
Regarding claim 5, BISHOP discloses the tubes can be connected by welding (0065).
Regarding claim 6, BISHOP discloses the system can be used for manufacturing antibodies (0084). Regarding the contents of the container, the examiner has given the limitation its appropriate weight. This limitation does not afford patentability to the apparatus or system because they are not defining any structural features of said apparatus but merely defining the contents used in the claimed apparatus during its use. It has been well established that it is fundamental that an apparatus claim defines the structure of the invention and not how the structure is used in a process, or what materials the structure houses in carrying out the process. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP 2114 and 2115. Further, it has been held that "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." It is further noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. The system of BISHOP meets the claimed structural limitations of the device and additionally discloses use for antibody manufacture (0084) and is therefore considered capable of being used to manufacture any of the claimed antibody pharmaceuticals.
Response to Arguments
Applicant's arguments filed 1/2/26 have been fully considered but they are not persuasive.
In response to applicant’s arguments regarding the 35 USC 112(a) & (b) rejections, the examiner respectfully disagrees. While it is true that stirring devices are often used in the bioprocessing field, there is no “standard component” that is used for stirring. Rather, the function of stirring can be performed with a large variety of options that all have different modes of operation and constructional details required. Not all known stirring devices could be simply inserted in every bioprocessing system as each system will have different requirements. Therefore the rejection is maintained as the present disclosure and drawings contains no description or definition of what structures provide the stirring function, nor how such stirring device would be located in the bioreactor. As such the meets and bounds of the claim cannot be determined.
In response to applicant's argument that the Y connection of BISHOP does not connect tubes used for the claimed fluids, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. It is further noted that the contents used in or worked on by a device do not lend patentability to the claimed structure. In the case of BISHOP, all the tubes connected in the Y configuration are used for transporting liquid materials (0075-76) and therefore are considered capable of discharging steam condensate. Applicant is encouraged to distinguish any structural differences in the tubes between the prior art and instant invention, rather than the contents of the tubes during use of the device.
In response to applicant’s argument that the cited reference do not teach or suggest a medium storage tank made of a stainless steel material, the examiner respectfully disagrees. While the embodiments disclosed by BISHOP are made of single use containers and paragraph [0002] does state this is generally the case, these do not constitute a teaching away from modifying the tank material. As stated in the above rejection, BISHOP discloses there are a variety of known suitable materials for constructing the containers of the system (0086). It is disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments. M.P.E.P. 2123. See, also, M.P.E.P. 2131.05. Therefore the examiner maintains it would have been obvious to one of ordinary skill in the art to modify the bioprocess container of BISHOP to be made of steel in order to be reusable and provide structural rigidity and also it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
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 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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