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 .
Election/Restrictions
Applicant’s election without traverse of group II in the reply filed on 01/08/2026 is acknowledged. There being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/16/2023 and 01/08/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 13-14 and 16-33 are pending with claims 13-14 and 16-33 being examined. Claims 1-12 and 15 are canceled.
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.
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.
Claim limitation “insertion mechanism configured to move two portions apart to expand the container (cause the container to expand)” in claims 13 and 14 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “mechanism” coupled with functional language “to move two portions to expand the container” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term “mechanism” is merely a generic placeholder for the term “means.”
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claims 13 and 14 has/have been interpreted as a combination of guide slots and a descending mechanism” corresponding to structure described in the specification that achieves the claimed function, and equivalents thereof (Spec., [para 0196], Figs. 3B,C “the first and second ends of the container are slid into or secured to slots of the tool or the machine. The slots of the machines are apart from each other at a distance of a height of the container in the expanded configuration. The tool or the machine can change the container from the expanded configuration to the collapsed configuration (e.g., after the container is ready to be packaged, shipped, or stored) by decreasing the distance between the slots (e.g., a slot is controlled by a descending mechanism, reducing the distance between the slots”). See 35 USC 112(b) rejection 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 13, 14, and 16-33 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 13 recites “the insertion mechanism configured to move two portions apart to cause the container to expand”.
Claim 14 recites “the insertion mechanism secures the first container; moving the two portions apart to expand the first container”.
As mentioned above, claim limitation “insertion mechanism” 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.
In this case, applicant’s specification discloses “the first and second ends of the container are slid into or secured to slots of the tool or the machine. The slots of the machines are apart from each other at a distance of a height of the container in the expanded configuration. The tool or the machine can change the container from the expanded configuration to the collapsed configuration (e.g., after the container is ready to be packaged, shipped, or stored) by decreasing the distance between the slots (e.g., a slot is controlled by a descending mechanism, reducing the distance between the slots” (Spec., [para 0196], Figs. 3B,C).
“The tool or the machine” (i.e., “descending mechanism”) is illustrated in Figs. 3B,C of applicant’s drawings (see below):
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Figures 3B,C of applicant’s drawings.
It is recognized that, under proper circumstances, drawings may provide a written description of an invention as required by 35 U.S.C. 112. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1565, 19 USPQ2d 1111, 1118 (Fed. Cir. 1991) (see MPEP 2181(II)(A)). However, in this case, the type of actuator that performs movement of the upper slot to expand/collapse the container is not sufficiently clear from the written description and drawings.
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.
Claims 16-33 are rejected as being dependent on independent claims 13 and 14.
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.
Claims 13, 16-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Michaels (US 20080061064 A; hereinafter “Michaels”) in view of Kern (US 5362642; hereinafter “Kern”).
Regarding claim 13, Michaels teaches a method of manufacturing a cell culture solution container (Michaels; [0008] “invention related to a liner assembly) comprising:
providing a rigid first end (Michaels; fig. 1. 26);
providing a rigid second end (Michaels; fig. 1. 22);
providing a deformable middle portion (Michaels; fig. 1. 24);
attaching the deformable middle portion to the first end and second end (Michaels; fig. 1. 20), wherein the first end, second end, and middle portion enclose a region having a variable volume (Michaels; fig. 1. 28);
providing an inlet;
fluidly coupling the inlet to the region (Michaels; fig. 2. 56);
providing an outlet;
fluidly coupling the outlet to the region (Michaels; fig. 2. 54).
Michaels teaches an expandable container (Michaels; Title).
Michaels does not teach the container is configured to be accepted by an insertion mechanism comprising two portions configured to move apart, the container is further configured to be secured to the insertion mechanism after the insertion mechanism accepts the container, and the insertion mechanism is configured to move the two portions apart to cause the container to expand.
It would have been obvious to include an insertion mechanism comprising two portions configured to move apart to insert and secure the expandable container to the insertion mechanism and move the two portions apart to cause the container to expand as the modification allows to expand the container while holding the container secure while the container is being filled.
Michaels fails to teach loading cell culture solution powder in the region. However, Kern teaches the analogous art of a cell culture media (Kern; Title) that includes a mixing bag (deformable middle portion “region”) (Kern; fig. 1. 12) that includes loading cell culture solution powder in the region (Kern; Abstract).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Michaels region to include loading cell culture solution powder in the region as taught by Kern because Kern teaches a cell culture media (Kern; Title) that includes a mixing bag (deformable middle portion “region”) (Kern; fig. 1. 12) that includes loading cell culture solution powder in the region (Kern; Abstract).
The modification allows to the preparation of a cell culture media in the mixing bag.
Regarding claim 16, modified Michaels teaches the method of claim 13 (see above), wherein the providing the middle portion comprises providing a polyethylene bag or a polypropylene bag (Michaels; [0031] “materials for the bag include polyethylene”).
Regarding claim 17, modified Michaels teaches the method of claim 13, wherein one or more of the rigid first end, the rigid second end, and the middle portion comprise a recyclable material.
Modified Michaels teaches the one or more of the rigid first end, the rigid second end, and the middle portion can be made of polyethylene (see claim 16 above). It is known in the art that polyethylene is a recyclable material.
Regarding claim 18, modified Michaels teaches the method of claim 13 (see above), further comprising coupling a filter or a fitting configured to connect to a filter to the outlet (Michaels; fig. 5. 156). Examiner notes the port can be used to place a filter.
Regarding claim 21, modified Michaels teaches the method of claim 13 (see above), further comprising: configuring the container to be in a collapsed configuration (Michaels; fig. 1. 24 and [0032], and vacuum-sealing the middle portion of the container in the collapse configuration (Michaels; Abstract).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Michaels (US 20080061064 A; hereinafter “Michaels”), in view of Kern (US 5362642; hereinafter “Kern”) further in view of Larsen et al. (US 20130081995 A1; hereinafter “Larsen”).
Regarding claim 19, modified Michaels teaches the method of claim 13 (see above) to include first and second ends (see above).
Modified Michaels fails to teach the rigid first and second ends comprise at least one of polyethylene, poly lactic acid (PLA), and poly carpolactone (PCL).
However, Larsen teaches the analogous art of a manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043]) wherein the container has a body (Larsen; fig. 3. 120) that includes a rigid first end (Larsen; fig. 3. 134) and a second end (Larsen; fig. 3. 136) wherein the rigid first and second ends comprise at least one of polyethylene, poly lactic acid (PLA), and poly carpolactone (PCL) (Larsen; [0047] “body is comprised of polyethylene”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Michaels first and second ends to be made of polyethylene, poly lactic acid (PLA), and poly carpolactone (PCL) as taught by Larsen because Larsen teaches manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043]) wherein the container has a body (Larsen; fig. 3. 120) that includes a rigid first end (Larsen; fig. 3. 134) and a second end (Larsen; fig. 3. 136) wherein the rigid first and second ends comprise at least one of polyethylene, poly lactic acid (PLA), and poly carpolactone (PCL) (Larsen; [0047] “body is comprised of polyethylene”).
The modification allows to have an impermeable wall at each end (Larsen; [0047] ‘impermeable material such as polyethylene”).
Regarding claim 20, modified Michaels teaches the method of claim 13 (see above) to include a container (see above).
Modified Michaels fails to teach a volume of the container in an expanded configuration is 500L.
However, Larsen teaches the analogous art of a manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043) wherein the container has an expanded configuration of 50 (Larsen; [0053] the body can hold from about 10L to 2000 L).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Michaels container to have an expanded volume configuration of 500L as taught by Larsen because Larsen teaches manufacturing a cell culture solution within a container (Larsen; fig. 2. 112, and [0043] wherein the container has an expanded configuration of 500L (Larsen; [0053] the body can hold from about 10L to 2000 L).
Overlapping ranges are prima facie evidence of obviousness. It would have been obvious to one having ordinary skill in the art to have selected the portion of 500L that corresponds to the claimed range because it is a standard range for cell culture media preparation in batches. In re Malagari, 184 USPQ 549 (CCPA 1974).
Allowable Subject Matter
Claims 14 and claims 22-33 (as being dependent on claim 14) would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance:
Claim 14 recites, among other things a method of creating culture solution comprising: receiving, at an insertion mechanism of a dispenser, a first container in a collapsed configuration, wherein the insertion mechanism comprises two portions configured to move apart, and after receiving the first container, the insertion mechanism secures the first container; moving the two portions apart to expand the first container to an expanded configuration; while the first container is expanding or the first container is in the expanded configuration, injecting water into the first container, driving a stirrer in the first container and mixing, with the stirrer, a powder and the water in the first container to create the culture solution, and dispensing the culture solution into a second container, wherein the first container comprises a rigid first end, a rigid second end, a deformable middle portion attached to the first end and second end and enclosing, with the first and second ends, a region having a variable volume, the powder in the region, an inlet fluidly coupled to the region, and an outlet fluidly coupled to the region.
Hurst, the closest cited prior art of record, teaches a method of creating culture solution, comprising: a first container, the first container comprises a region that includes a powder in the region, while the first container is expanding or the first container is in the expanded configuration, injecting water into the first container, driving a stirrer in the first container, and mixing, with the stirrer, a powder and the water in the first container to create the culture solution.
However, Hurst fails to teach receiving, at an insertion mechanism of a dispenser, a first container; in a collapsed configuration, wherein: the insertion mechanism comprises two portions configured to move apart, and after receiving the first container, the insertion mechanism secures the first container; moving the two portions apart to expand the first container to an expanded configuration; while the first container is expanding or the first container is in the expanded configuration: injecting water into the first container; driving a stirrer in the first container; and mixing, with the stirrer, a powder and the water in the first container to create the culture solution; and dispensing the culture solution into a second container, wherein the first container comprises: a rigid first end; a rigid second end; a deformable middle portion attached to the first end and second end and enclosing, with the first and second ends, a region having a variable volume; an inlet fluidly coupled to the region; and an outlet fluidly coupled to the region, and there is no motivation to modify Hurst to provide these additional method steps.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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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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/A.R./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
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