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 .
The status identifier in the amended claims appears to be incorrect, and all claims were labeled as withdrawn. This does not preclude examination of the application because the claims are now directed to the originally examined invention, however appropriate correction of the claim identifiers is required.
Applicant previously canceled claims 6-7, 16-17 and 31. Claims 1-5, 8-15, 18-30 and 32-35 are currently pending. Claims 14-15, 18-30 and 32-34 remain withdrawn as being drawn to a nonelected invention. Claims 1-1-5, 8-13 and 35 are currently under examination.
Any objection or rejection of record in the previous Office Action, which is not addressed in this action has been withdrawn in light of Applicant’s amendments and/or arguments. This action is FINAL.
Information Disclosure Statement
The Information Disclosure Statement filed July 09, 2025 has been considered.
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 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions (i.e., product of nature, a law of nature, a natural phenomenon, or an abstract idea) without significantly more. This rejection is maintained.
The claims recite a method for estimating performance of a bioprocess material when used in a bioprocess system the bioprocess material comprising at least two ingredients, each having data properties, wherein the method comprises: i) obtaining the data properties for the at least two ingredients used to produce the bioprocess material, ii) defining procedures to produce the bioprocess material, iii) processing the at least two ingredients according to the defined procedures to obtain at least one product, iv) measuring data properties of each product, v) calculating data properties of each product based on the measured data properties of each product and/or data properties from the at least two ingredients, and vi) if the product is the bioprocess material, processing the measured and calculated data properties to estimate the impact of the bioprocess material on a target product in the bioprocess system, or vii) if the product is not the bioprocess material, treating the product as an intermediate material and repeating steps iii)-vi) with each product as one of the at least two ingredients, based at least in part on estimating, obtaining data properties, defining procedures, processing and calculating (i.e., abstract idea abstract idea exception that corresponds to mental processes and/or an idea ‘of itself’)
These judicial exceptions are not integrated into a practical application because claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Every claimed invention must be examined to determine whether the claimed invention complies with 35 U.S.C. 101, particularly whether the claimed invention falls within a 35 U.S.C. 101 judicial exception of non-patentable subject matter (e.g. an abstract idea, law of nature, natural phenomenon, natural product etc.). Phenomena of nature, though just discovered, natural products, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work. See MPEP 2106. As per the “2019 Revised Subject Matter Eligibility Guidance” (Federal Register Vol. 84, No. 4, available 01-07-2019), claims drawn to a process, machine, manufacture or composition of matter are further analyzed according to a two-part process to determine if A) the claim(s) is/are “directed to” a judicial exception because the claims(s) recite(s) a judicial exception (i.e. prong one) that is not integrated into a practical application (i.e. prong two) and, if so, if B) the claim(s) provide(s) an inventive concept, i.e. recite(s) additional elements that amount to significantly more than the judicial exception.
Subject Matter Eligibility Test for Products and Processes
Step 1 - Is the Claim to a Process, Machine, Manufacture or Composition of Matter? YES.
The instant claims are directed to a method for estimating performance of a bioprocess material when used in a bioprocess system the bioprocess material comprising at least two ingredients, each having data properties, wherein the method comprises: i) obtaining the data properties for the at least two ingredients used to produce the bioprocess material, ii) defining procedures to produce the bioprocess material, iii) processing the at least two ingredients according to the defined procedures to obtain at least one product, iv) measuring data properties of each product, v) calculating data properties of each product based on the measured data properties of each product and/or data properties from the at least two ingredients, and vi) if the product is the bioprocess material, processing the measured and calculated data properties to estimate the impact of the bioprocess material on a target product in the bioprocess system, or vii) if the product is not the bioprocess material, treating the product as an intermediate material and repeating steps iii)-vi) with each product as one of the at least two ingredients. Thus, the claims are directed to a statutory category (e.g., a process).
Step 2A, Prong One — Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? YES.
Abstract ideas have been identified by the courts by way of example, including fundamental economic practices, certain methods of organizing human activities, an idea ‘of itself,’ and mathematical relationships/formulas. The instant claims are directed to methods for estimating performance of a bioprocess material when used in a bioprocess system. The claims recite multiple “mental” judicial exceptions: 1) The “mental” process of estimating performance based on obtaining data properties of which corresponds to the concepts identified as an abstract idea by the courts; and 2) The “mental” processes of defining procedures to produce the bioprocess material which corresponds to “an abstraction”; an idea having no particular concrete or tangible form. 3) The “mental” process of calculating data properties of each product and 4) The “mental” process of processing the measured and calculated data properties to estimate the impact of the bioprocess material, which corresponds to the concepts identified as an abstract idea by the courts.
Thus, the claimed invention describes judicial exceptions, which correspond to abstractions (ideas, having no concrete tangible form).
Step 2A, Prong Two — Does the Claim Recite an Additional Elements that Integrate the
Judicial Exception into a Practical Application? NO.
The Supreme Court has long distinguished between principles themselves, which are not patent eligible, and the integration of those principles into practical applications, which are patent eligible. However, absent are any additional elements recited in the claim beyond the judicial exceptions which integrate the exception into a practical application of the exception. The “integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. The claim analysis continues with identifying additional elements beyond the judicial exceptions that might evidence integration of the judicial exceptions into a practical application. The steps or elements in addition to the judicial exceptions are: “the bioprocess material comprising at least two ingredients, processing the at least two ingredients according to the defined procedures to obtain at least one product; if the product is the bioprocess material, processing the measured and calculated data properties to estimate the impact of the bioprocess material on a target product in the bioprocess system, or if the product is not the bioprocess material, treating the product as an intermediate material and repeating steps iii)-vi) with each product as one of the at least two ingredients wherein the calculated data properties in step v) and the measured data properties in step iv) are the data propertied for each product used as one of the at least two ingredients; the procedures in step ii) further comprises any combination of the group: filtration, reacting, cooling, activation, mixing, diluting, sieving, washing, grinding and heating; and further comprise retrieving information of the manufacturing process of the target product in the bioprocess system and mapping the estimated performance of the bioprocess material on the manufacturing process to estimate the impact of the bioprocess material on a target product.”, which is not indicative of integration into a practical application. These steps, recited at a high level of generality, comprise routine data gathering, which is considered an insignificant extra-solution activity. This data gathering is required for using the judicial exceptions. (See MPEP 2106.05(g)). The claim limitations are considered simply a recitation of a “mental” process for obtaining data properties, defining procedures and calculating data properties of each product based on the measured data properties of each product and/or data properties from the at least two ingredients. There are no further/additional steps which applies either the identified judicial exception into practical application. Thus, a careful evaluation of the claim as a whole fails to reveal the practical application of the judicial exception to, e.g., effect an improvement to the functioning of a computer or other technology/technical field, effect a particular treatment or prophylaxis for a disease or medical treatment, implement a particular machine that is integral to the claim, or effect a transformation or reduction of a particular article to a different state or thing, or to apply the judicial exception in another meaningful way beyond generally linking its use to a particular technological environment. Accordingly, the claims do not integrate the judicial exception(s) into a practical application and is therefore directed to a judicial exception.
Step 2B - Does the Claim Recite Additional Elements that Amount to Significantly More than the Judicial Exception? NO.
The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to “significantly more” than the judicial exception(s) itself. The claims as a whole are analyzed to determine whether any additional element/step, or combination of additional elements/steps, in addition to the identified judicial exception(s) is sufficient to ensure that the claim amounts to “significantly more” than the exception(s).
The eligibility analysis proceeds with identifying any additional elements or limitations, separate from the judicial exceptions, that might potentially render the claims directed to a judicial exception patent eligible. To render the claims patent-eligible, these elements must comprise meaningful limitations that add to or transform the judicial exception to the effect that it amounts to significantly more than the natural correlation or abstract idea itself - i.e. provide an “inventive concept’. The elements of claims that are in addition to the judicial exception comprise the bioprocess material comprising at least two ingredients, processing the at least two ingredients according to the defined procedures to obtain at least one product; if the product is the bioprocess material, processing the measured and calculated data properties to estimate the impact of the bioprocess material on a target product in the bioprocess system, or if the product is not the bioprocess material, treating the product as an intermediate material and repeating steps iii)-vi) with each product as one of the at least two ingredients wherein the calculated data properties in step v) and the measured data properties in step iv) are the data propertied for each product used as one of the at least two ingredients; the procedures in step ii) further comprises any combination of the group: filtration, reacting, cooling, activation, mixing, diluting, sieving, washing, grinding and heating; and further comprise retrieving information of the manufacturing process of the target product in the bioprocess system and mapping the estimated performance of the bioprocess material on the manufacturing process to estimate the impact of the bioprocess material on a target product and “wherein the calculated data properties in step v) and the measured data properties in step iv) are the data propertied for each product used as one of the at least two ingredients;" does not add something more to the judicial exception in that it does not describe how it solves the particular problem within the field of bioprocessing but merely describes limitations for the two ingredients used in the bioprocess. When considered separately and in combination, these elements do not add significantly more to the judicial exception. The steps of the bioprocess material having at least two ingredients and processing the at least two ingredients according to the defined procedures to obtain at least one product, the procedures being any combination of filtration, reacting, cooling, activation, mixing, diluting, sieving, washing, grinding and heating; and further comprise retrieving information of the manufacturing process of the target product in the bioprocess system and mapping the estimated performance of the bioprocess material on the manufacturing process to estimate the impact of the bioprocess material on a target product are well-understood, routine and conventional activities in the field (e.g., see Gledson E. J. et al. "Predicting Mab Product Yields from Cultivation Media Components, Using Near-Infrared and 2D-Fluorescence Spectroscopies", Biotechnology Progress, Vol. 27, No. 5, Pages 1339-1346, published May 26, 2011, cited on the IDS filed May 04, 2023 and Latham et al. WO2014/145744 A1, published September 18, 2014 and Skudas United States Patent US9149738 B2, published October 06, 2015). Simply appending routine and conventional activities previously known to the industry specified at a high level of generality to the judicial exception and/or generally linking the use of the judicial exceptions to a particular technological environment or field of use, are not found to be enough to qualify as “significantly more.”
Thus, when viewed both individually and as an ordered combination, the claimed elements/steps in addition to the identified judicial exceptions are found insufficient to supply an inventive concept because the elements/steps are considered conventional and specified at a high level of generality. The claim limitations do not transform the abstract idea that they recite into patent- eligible subject matter because “the claims simply instruct the practitioner to implement the abstract idea with routine, conventional activity.”
Accordingly, the instant claims do not qualify as patent-eligible subject matter.
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 (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 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 1-5, 8-13 and 35 are rejected under 35 U.S.C. 102 (a)(1) and 102 (a)(2) as being anticipated by Skudas (United States Patent US 9,149,738 B2, published October 06, 2015). This rejection is maintained.
Regarding claim 1, Skudas teaches a method for estimating performance of a bioprocess material when used in a bioprocess system (Column 15, Lines 17-20, Column 17, Lines 58-67 –Column 18, Lines 1-17 and Column 25, Lines 58-67 –Column 26, Lines 1-3). Skudas teaches the bioprocess material comprising at least two ingredients, each having data properties (Examples 1 and 2). Skudas teaches obtaining the data properties for the at least two ingredients used to produce the bioprocess material (Column 4, Lines 10-15, Examples 1-2 and Tables 1-5). Skudas teaches defining procedures to produce the bioprocess material (Column 3, Line 35—Column 5, Line 10 and Examples 1 and 2). Skudas teaches processing the at least two ingredients according to the defined procedures to obtain at least one product (Examples 1 and 2). Skudas teaches measuring data properties of each product (Figs. 8 and 12). Skudas teaches calculating data properties of each product which are different from the measured data properties of each product based on the measured data properties of each product and data properties from the at least two ingredients (Column 1, Line 55—Column 2, Line 32). Skudas teaches if the product is the bioprocess material, processing the measured and calculated data properties to estimate the impact of the bioprocess material on a target product in the bioprocess system (Fig. 8 and Examples 1 and 2). Skudas teaches if the product is not the bioprocess material, treating the product as an intermediate material and repeating steps iii)-vi) with each product as one of the at least two ingredients, wherein the calculated data properties in step v) and the measured data properties in step iv) are the data properties for each product used as one of the at least two ingredients (Example 1).
Regarding claim 2, Skudas teaches the data properties of at least one ingredient and/or each product comprise morphological data properties (Column 15, Lines 24-29).
Regarding claim 3, Skudas teaches obtaining, for at least one ingredient, a particle size distribution (Column 15, Lines 24-29 and Column 17, Lines 49-54).
Regarding claim 4, Skudas teaches obtaining at least data properties related to, particle size distribution and/or porosity and/or flow rate of each intermediate material (Column 15, Lines 24-29, Column 17, Lines 49-54, Column 31, Lines 30-35).
Regarding claim 5, Skudas teaches the procedures in step ii) further comprises any combination of the group: filtration, reacting, cooling, activation, mixing, diluting, sieving, washing, grinding and heating (Column 27, Lines 4-6, Column 29, Lines 5-7 and Column 30, Lines 52-56).
Regarding claim 8, Skudas teaches the batches differ from each other with respect to one or more morphological data properties (Column 17, Lines 41-57).
Regarding claim 9, Skudas teaches each ingredient comprises at least one substance, and the method further comprises selecting the data properties of each ingredient to comprise, lot number, supplier of the ingredient and data characterizing the at least one substance (Columns 7, Lines 4-13, Column 6, Lines 5-8, Fig. 8 and Example 2)
Regarding claim 10, Skudas teaches for ingredients with at least two substances, selecting the data properties of each ingredient to further comprise the ratio between the at least two substances (Column 2, Lines 26-32 and Column 3, Lines 19-32).
Regarding claim 11, Skudas teaches the bioprocess material is selected to be chromatography resin (Column 2, Lines 33-56, and Examples 1-4).
Regarding claim 12, Skudas teaches the bioprocess material is selected to be cell culture media (Column 8, Lines 25-37).
Regarding claim 13, Skudas teaches retrieving information of the manufacturing process of the target product in the bioprocess system, and mapping the estimated performance of the bioprocess material on the manufacturing process to estimate the impact of the bioprocess material on a target product (Column 1, Line 56—Column 2, Line 15, Figs. 8-14 and Example 4).
Regarding claim 35, Skudas teaches the at least two ingredients are different batches of the same material, and wherein said batches differ from each other with respect to one or more data properties (Examples 1 and 2).
Response to Arguments
Applicant’s arguments and amendments filed February 20, 2025, with respect to the rejection under U.S.C. § 101 have been fully considered but are not deemed to be persuasive.
Applicant asserts that the amended claims recite a bioreactor or chromatography system configured to estimate performance of a bioprocess material according to a series or steps and that the claims are now directed to an article of manufacture rather than a method. However, due to the claims being amended to be consistent with the original elected invention, the claims are still drawn to a method of estimating performance of a bioprocess system and the claims simply instruct the practitioner to implement the abstract idea with routine, conventional activity as discussed above.
Applicant’s arguments and amendments filed February 20, 2025, with respect to the rejection under U.S.C. § 102 have been fully considered but are not deemed to be persuasive.
Applicant asserts Skudas does not disclose or suggest a bioreactor or chromatography system configured to estimate performance of a bioprocess material as required by Applicant's amended claims. Since the claims have been amended to be consistent with the originally elected invention, drawn to a method for bioprocessing comprising estimating performance of a bioprocess material this argument is considered to be not persuasive.
Applicant asserts Skudas does not disclose a system capable of “obtaining data properties for the at least two ingredients used to produce the bioprocess material” and “Nowhere does Skudas disclose that the chromatography system is capable of obtaining this data”. Applicant asserts “Skudas also does not disclose a system capable of measuring data properties of one or more reaction products, and/or calculating data properties of each product, which are different from the measured data properties of each product based on the measured data properties of each product and data properties from the at least two process ingredients.
However, the instant specification describes data properties may be purity, size exclusion, titration data, pore size, process performance (productivity and/or product recovery), as well as binding capacity (see, Page 7, Lines 7-11 and Page 5, Lines 1-13). The instant claims additionally discloses that “data properties” may be a particle size distribution and/or flow rate (see Claims 3-4). Skudas discloses obtaining for at least two batches (ingredients), titration information, binding capacity as well as purity in at least Examples 1-3 and Tables 1-5. Skudas additionally and specifically discloses that pore size can be measured by the inversive size exclusion chromatography (Column 18, Lines 4-5). Skudas teaches obtaining a flow rate that is suitable for chromatography (Column 21, Lines 29-34 and column 31, Lines 30-35) as well as obtaining an average particle (and pore) size distribution suitable for use as chromatographic sorbent (Colum 17, Lines 51-67—Column 18, Lines 1-20). Skudas discloses calculating the productivity, product loss/recovery, binding capacities and purity (Examples 1-3 and Tables 1-5), which are different from the measured pores size and titration information.
Applicant asserts “Skudas therefore also does not disclose or suggest the subsequent step of “defining procedures to produce the bioprocess material based on the obtained data properties” as recited by Applicant’s amended claims”. Since the claims have been amended to be consistent with the originally elected invention, the amended claim 1, now only includes the limitation of “defining procedures to produce the bioprocess material”. As discussed above Skudas teaches defining procedures to produce the bioprocess material (Column 3, Line 10—Column , Line 10 as well as, Examples 1-2).
Therefore, for all these reasons, and those listed above Skudas is deemed to render the instant invention anticipated.
Conclusion
THIS ACTION IS MADE FINAL. 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 JESSICA DANIELLE PARISI whose telephone number is (571)272-8025. The examiner can normally be reached Mon - Friday 7:30-5:00 Eastern with alternate Fridays off.
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/JESSICA D PARISI/Examiner, Art Unit 1675
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684