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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7 in the reply filed on 3/5/26 is acknowledged.
Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/5/26.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/27/23, 1/21/25, 1/21/25 and 8/21/25 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: proliferation detection unit 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 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, 5 is 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.
Regarding Claim 1 it is unclear whether the gas permeable member is required or not. The gas permeable member is in the preamble as an intended use of the culture system and is not positively recited, but the detection algorithm appears to require permeability of the gas permeable member. Therefore, it seems unclear whether a sensor alone, in use, would infringe on the limitations or whether a gas permeable member is required.
Regarding claim 5, the term "type" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "type"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) a proliferation detection unit, which is interpreted under 35 USC 112f as stated above to be a computer configured to calculate a proliferative property, specifically via the formula of Claim 2 [Spec 0011, 0065, 0082].
101 Analysis:
Step 1:
Is the claim to a process, machine, manufacture or composition of matter?
Yes, claims 1-7 are drawn towards a statutory category (a machine).
Step 2A, Prong 1:
Does the claim recite a judicial exception?
Yes, Claim 1 and its dependents are drawn towards a system with a unit (computer) that performs a calculation via a formula. The formula is a mathematical concept which is one of the enumerated groupings of abstract ideas as per MPEP 2106.04(a).
Step 2A, Prong 2:
Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, in addition to the abstract idea stated above, claim 1 requires a generic computer to perform the calculation and an oxygen concentration sensor.
The judicial exception is not integrated into a practical application because the claim is directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a generic computer. See MPEP 2106.04(d) and MPEP 2106.05(b). Also, once the proliferative property is calculated/detected no action is taken and there is no application at all. The use of the sensor is also gathering data, and data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g).
Step 2B:
Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the only other positively recited element of claim 1 is an oxygen concentration sensor. This sensor is an insignificant extra-solution component as it is a generic type of sensor that merely collects raw data. Such sensors collecting oxygen concentration are well-understood, routine, and conventional in the cell culture art as evidenced by US7289836 provided by applicant on the IDS dated 1/21/25 and US6730471 provided by applicant on the IDS dated 8/21/25.
Evaluation of Dependent claims:
Claims 3-4: specifies where values input into the formula are obtained without reciting any further structural limitations of the system. They represent data gathered to make use of the judicial exception, are just further defining the abstract idea and therefore do not practically apply or add significantly more.
Claims 5-7: specifies the type of oxygen sensor and its means of attachment and also the material the attachment and vessel are made from. These limitations do not add significantly more as they are well understood, routine and conventional in the art as evidenced by US7289836 and US6730471.
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) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over VERA (US 2015/0175966) in view of ENGLER (US 2019/0218492) both as supplied by applicant on the IDS dated 4/27/23.
Regarding claim 1-2, VERA discloses a static gas permeable culture device (cell culture system for statically culturing cells with a culture vessel, the vessel being at least partially formed of a gas permeable member) [Fig 6, 22a-d] comprising:
a means for measuring a component of the media such as glucose (sensor) that measures glucose concentration in a vicinity of a culture surface inside the vessel; and
a means of calculating population growth by cell count (proliferative property) normalized for surface density (count of cells per unit area) based on a formula that uses predetermined values and the measured glucose concentration [0194-228, Figs 19a-f].
VERA does not explicitly disclose an oxygen concentration sensor measuring oxygen as the component of the media nor a computer to carry out the calculation of cell count based on the data from the oxygen sensor.
However, ENGLER discloses a self-regulating bioreactor comprising a dissolved oxygen concentration sensor 104 to measure the oxygen concentration within the bioreactor and a controller that can be a hardware or software device (computer, proliferation detection unit) in communication with the dissolved oxygen concentration sensor, in which the controller solves an equation using the data from the sensor to determine oxygen consumption rate which then is used to estimate cell proliferation within the bioreactor apparatus [0071, 0081-88].
It would have been obvious to one of ordinary skill in the art when the invention was filed to modify the system of VERA to include the property measurement being by an oxygen concentration sensor that measures oxygen concentration with a controller (computer, proliferation detection unit) that detects the proliferation by estimating cell count based on a formula incorporating known factors and the measured oxygen concentrations as taught by ENGLER because measuring a change in glucose will provide information about thee level of metabolic activity in the cells whereas changes in oxygen consumption rate can be used to estimate cell proliferation or degradation (proliferative property of the cells) [0086] and the oxygen consumption can be tracked continuously in real time [0066].
It is noted that neither the manner of operating a disclosed device does not limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. 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. See MPEP 2114 and 2115.
Regarding claim 3-4, these claims do not recite additional structural components nor further limit any structural components previously recited. Rather they define values that are input into the formula calculated by the computer. It is noted that neither the manner of operating a disclosed device does not limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. 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. See MPEP 2114 and 2115. As the above combination of VERA and ENGLER disclose the apparatus of a computer programmed with a formula to perform the claimed determination, it is considered capable of performing with input values as claimed.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over VERA (US 2015/0175966) in view of ENGLER (US 2019/0218492) as applied above, further in view of COLVIN (US 2006/0149143).
Regarding claim 5-7, ENGLER discloses the sensor can be selected from a group including optical dissolved oxygen probes [0008] but does not explicitly disclose the oxygen concentration sensor is a fluorescent type.
However, COLVIN discloses an optical based sensing device for measuring oxygen [0079] which operates based on the fluorescence of fluorescent indicator molecules (fluorescent type) [0073], the sensor can be secured to the tissue (culture surface) using a porous material (perforated resin member) made of polyethylene (type of resin) [0083].
It would have been obvious to one of ordinary skill in the art when the invention was filed to modify the system of modified VERA with ENGLER to include the sensor being a fluorescent type sensor, secured using a perforated resin member made of polyethylene as disclosed by COLVIN because it provides a totally self-contained sensor [0010] that is encased in a biocompatible material to allow optimal growth [0083].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The references cited on the attached PTO 892 are listed as they relate to the current state of art of the present invention.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
Prosecution Insights