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
Claims 2-3, 7-8, 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/22/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/11/2023, 11/08/2024, 09/25/2025, and 03/11/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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, 4-6, and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The limitations, under their broadest reasonable interpretation, cover mental process (concept performed in a human mind, including as observation, evaluation, judgment, opinion). The claims recite a method of checking and determining the quality of documents. This judicial exception is not integrated into a practical application because the steps do not add meaningful limitations to be considered specifically applied to a particular technological problem to be solved. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of the claimed invention can be done mentally and no additional features in the claims would preclude them from being performed as such.
According to the USPTO guidelines, a claim is directed to non-statutory subject matter if:
• STEP 1: the claim does not fall within one of the four statutory categories of invention (process, machine, manufacture or composition of matter), or
• STEP 2: the claim recites a judicial exception, e.g., an abstract idea, without reciting additional elements that amount to significantly more than the judicial exception, as determined using the following analysis:
o STEP 2A (PRONG 1): Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
o STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the
judicial exception into a practical application?
o STEP 2B: Does the claim recite additional elements that amount to significantly more
than the judicial exception?
Using the two-step inquiry, it is clear that claims 1 and 10 are directed to an abstract idea as shown below:
STEP 1: Do the claims fall within one of the statutory categories?
YES. Claim 1 is directed to a method, i.e., process.
STEP 2A (PRONG 1): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea?
YES, the claims are directed toward a mental processes (i.e., abstract idea).
With regard to STEP 2A (PRONG 1), the guidelines provide three groupings of subject matter that are considered abstract ideas:
• Mathematical concepts – mathematical relationships, mathematical formulas or equations,
mathematical calculations;
• Certain methods of organizing human activity – fundamental economic principles or
practices (including hedging, insurance, mitigating risk); commercial or legal interactions
(including agreements in the form of contracts; legal obligations; advertising, marketing or sales
activities or behaviors; business relations); managing personal behavior or relationships or
interactions between people (including social activities, teaching, and following rules or
instructions); and
• Mental processes – concepts that are practicably performed in the human mind (including an
observation, evaluation, judgment, opinion).
The method in claim 1 comprise a set of evaluations on a population of stem cells that can be done by a human.
Claim 1 recites:
A production method for a therapeutic agent for arthrosis, comprising: imaging a population including a plurality of mesenchymal stem cells being cultured, to acquire a cell image; analyzing the cell image to derive density information on the mesenchymal stem cells in the cell image; detecting colonies, which are formed by the mesenchymal stem cells in the population, based on the density information; and sorting the population based on at least one of an average colony size or a colony forming unit, which is derived from the detected colonies.
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
NO, the claims do not recite additional elements that integrate the judicial exception into a practical application.
With regard to STEP 2A (prong 2), whether the claim recites additional elements that integrate the judicial exception into a practical application, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application:
• an additional element reflects an improvement in the functioning of a computer, or an
improvement to other technology or technical field;
• an additional element that applies or uses a judicial exception to affect a particular treatment
or prophylaxis for a disease or medical condition;
• an additional element implements a judicial exception with, or uses a judicial exception in
conjunction with, a particular machine or manufacture that is integral to the claim;
• an additional element effects a transformation or reduction of a particular article to a different
state or thing; and
• an additional element applies or uses the judicial exception in some other meaningful way
beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to
monopolize the exception.
While the guidelines further state that the exemplary considerations are not an exhaustive list and that there may be other examples of integrating the exception into a practical application, the guidelines also list examples in which a judicial exception has not been integrated into a practical application:
• an additional element merely recites the words “apply it” (or an equivalent) with the judicial
exception, or merely includes instructions to implement an abstract idea on a computer, or
merely uses a computer as a tool to perform an abstract idea;
• an additional element adds insignificant extra-solution activity to the judicial exception; and
• an additional element does no more than generally link the use of a judicial exception to a
particular technological environment or field of use.
Claims 1, 4-6, and 9 do not recite any of the exemplary considerations that are indicative of an abstract idea having been integrated into a practical application.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
With regard to STEP 2B, whether the claims recite additional elements that provide significantly more than the recited judicial exception, the guidelines specify that the pre- guideline procedure is still in effect. Specifically, that examiners should continue to consider whether an additional element or combination of elements:
• adds a specific limitation or combination of limitations that are not well-understood, routine,
conventional activity in the field, which is indicative that an inventive concept may be present; or
• simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
With regard to (2b) the Guidance provided the following examples of limitations that may be enough to qualify as “significantly more" when recited in a claim with a judicial exception:
• Improvement to another technology or technical field
• Improvement to functioning of computer itself and/or applying the judicial
exception with, or by use of, a particular machine
• Effecting a transformation or reduction of a particular article to a different state or
thing.
• Adding a specific limitation other that what is well understood, routine and
conventional in the field, or adding unconventional steps that confine the claim to
a particular useful application
• Meaningful limitation beyond generally linking the use of an abstract idea to a
particular technological environment.
The Guidance further set forth limitations that were found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
• Adding words to “apply it” (or an equivalent) with the judicial exception or mere
instructions to implement abstract ideas on a computer
• Simply appending well-understood, routine and conventional activities previously
known to the industry specified at a high level of generality to the judicial
exception, e.g. a claim to an abstract idea requiring no more than a generic
• Computer to perform generic computer functions that are well -understood,
routine and conventional activities previously known to the industry.
• Adding insignificant extra-solution activity to the judicial exception, e.g. mere data
gathering in conjunction with a law of nature or abstract idea
• Generally linking the use of the judicial exception to a particular technological
environment or field of use.
Claims 1, 4-6, and 9 do not recite any additional elements that are not well-understood, routine or conventional.
Thus, since Claim 1 is: (a) directed toward an abstract idea, (b) do not recite additional elements that integrate the judicial exception into a practical application, and (c) do not recite additional elements that amount to significantly more than the judicial exception, claim 1 is not eligible subject matter under 35 U.S.C 101. Similar analysis is made for the dependent claims 4-6, and 9 and the dependent claims are similarly identified as: being directed towards an abstract idea, not reciting additional elements that integrate the judicial exception into a practical application, and not reciting additional elements that amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 5-6, and 9 is/are rejected under 35 U.S.C. 102(a) as being unpatentable over Sekiya et al. (US Patent Number 2010/0178274-A1, hereinafter “Sekiya”)
Regarding claim 1, Sekiya teaches: A production method for a therapeutic agent for arthrosis, comprising: ([0039], "Therefore, the method of the present invention aims to provide a method for treating a disease associated with defects of cartilage or meniscus. Specifically, the method for treating a disease associated with defects of cartilage or meniscus provided in the present invention comprises at least the following steps"; [0049], "The autologous synovium-derived MSCs isolated from the patient suffering from defects of cartilage or meniscus are cultured ex vivo without prior induction by differentiation medium (such as .alpha.MEM without supplementing TGF-.beta.3, dexamethasone, or BMP2). The proliferated, undifferentiated synovium-derived MSCs are then transplanted back to the patient from whom the synovium-derived MSCs are derived. To efficiently cure the cartilage defect site or meniscal defect site using the proliferated MSCs, it is necessary to apply at least 5.times.10.sup.7 undifferentiated MSCs, more preferably, at least 1.times.10.sup.8 MSCs, per cartilage defect site or meniscal defect site about the area of 10 cm.sup.2 for the efficient treatment of the cartilage defect site or meniscal defect site using MSCs.")
imaging a population including a plurality of mesenchymal stem cells being cultured, to acquire a cell image; ([0085], "The adipogenic cultures were subsequently stained with Crystal Violet, and the number of total cell colonies was counted (Sekiya, I, et al., 2004, J Bone Miner Res. 19:256-64). Adipocyte colonies were shown in red (FIG. 3C) and higher magnification of Oil Red-O-positive cells is also shown in FIG. 3D (Bar: 25 .mu.m).")
analyzing the cell image to derive density information on the mesenchymal stem cells in the cell image; ([0136], "Then, the cells were harvested after treatment with 0.25% trypsin and 0.02% EDTA, counted using a hemocytometer, and replated at 50 cells/cm.sup.2.")
detecting colonies, which are formed by the mesenchymal stem cells in the population, based on the density information; ([0083], "Three dishes were stained for 5 minutes with 0.5% Crystal Violet in methanol. The cells were washed twice with distilled water and the number of colonies per dish was counted to assess the colony-forming efficiency (FIG. 3A). Colonies less than 2 mm in diameter and faintly stained colonies were ignored. The total number of cells was counted from 3 other dishes and the cell number per colony was calculated to assess the proliferation activity (Sakaguchi et al., 2004, Blood. 104:2728-35).")
and sorting the population based on at least one of an average colony size or a colony forming unit, which is derived from the detected colonies. ([0084],"Larger dense colonies consisted of spindle cells as observed in FIG. 3B (Bar: 50 .mu.m). The colony forming unit efficiency of the cells at Passage 1 was 60.+-.5% (mean.+-.SD, n=3) and the cell number per colony was 6774.+-.437 cells.")
Regarding claim 5, Sekiya teaches: The production method for a therapeutic agent for arthrosis according to claim 1, wherein the mesenchymal stem cells are obtained by treating a biological tissue with an enzyme. ([0070], "Harvested rabbit synovium was digested in a 3 mg/ml collagenase D solution (Roche Diagnostics, Mannheim, Germany) in .alpha.MEM (Invitrogen, Carlsbad, Calif., USA) at 37.degree. C. After 3 hours digestion, digested cells were filtered through a 70-.mu.m nylon filter (Becton Dickinson, Franklin Lakes, N.J., USA) and the remaining tissues were discarded.")
Regarding claim 6, Sekiya teaches: The production method for a therapeutic agent for arthrosis according to claim 5, wherein in the treatment of the biological tissue with an enzyme, an enzyme mixture containing at least one kind of collagenase and at least one kind of neutral protease is used. ([0048], "Synovium tissue to be cultured ex vivo is harvested under anesthesia from a non-load-bearing portion of the joint. The excised synovium tissue is digested by protease(s) (such as collagenase and trypsin) and digested cells are filtered through a mesh filter (such as a 70-.mu.m nylon filter). Nucleated cells isolated by the above method are used as synovium-derived MSCs in the present invention. In the case of using autologous serum, for example, the surgeon may obtain the patient's blood at the same time as obtaining the synovium tissue from the patient, or at another time."; [0105], "Synovium tissue was harvested from left knee and digested in a 3 mg/ml collagenase D solution in HBSS at 37.degree. C. After 3 hours, digested cells were filtered through a 70-.mu.m nylon filter and the remaining tissues were discarded. Nucleated cells were plated in 3 dishes (150 mm diameter) and cultured in .beta.-MEM supplemented with antibiotics and 10% autologous rabbit serum or 20% fetal bovine serum. Fourteen days after plating the cells, the cells were harvested as MSCs with 0.25% trypsin and 1 mM EDTA for 5 minutes at 37.degree. C. and counted with a hemocytometer to determine the number of the cells.")
Regarding claim 9, Sekiya teaches: The production method for a therapeutic agent for arthrosis according to claim 1, wherein the mesenchymal stem cells are a synovium-derived cell. ([0036], "In this study, the inventors isolated MSCs from the synovium.")
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jinsu Hwang whose telephone number is (703)756-1370. The examiner can normally be reached Mon-Thu 10am-8am EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella can be reached at (571) 272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JINSU HWANG/Examiner, Art Unit 2667
/MATTHEW C BELLA/Supervisory Patent Examiner, Art Unit 2667
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