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 .
Claim Status
2. Claims 5-8, 10-12, 14-17, 22, 24-25, 29 and 34-35 are cancelled.
Claims 1-4, 9, 13, 18-21, 23, 26-28, 30-33 and 36-37 are currently pending and under exam herein.
Claims 1-4, 9, 13, 18-21, 23, 26-28, 30-33 and 36-37 are rejected.
Priority
3. The priority claim to U.S. Provisional Application No. 63/027,294, filed 19 May 2020 is acknowledged. In this action, all claims are examined as though they had an effective filing date of 19 May 2020. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further analysis of the disclosure(s) of the priority application(s).
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on 11 July 2023 is being considered by the examiner.
Drawings
5. The drawings submitted on 18 November 2022 are accepted and being considered by the examiner.
Claim Interpretation
6. Terms in the claims are interpreted under broadest reasonable interpretation. ‘Determining a performance characteristic’ is interpreted to be determining any characteristic of a product including determining the osmolarity or pH of a medium. ‘Preparing a formulation’ is interpreted to include making and packaging a formulation, which can involve calculations. ‘Preparing a specification’ is interpreted to include preparing the features of a product or an order, which could include listing units of measure, storage requirements, shipping requirements, packaging, and/or ingredients of a medium. An ‘affordance’ is interpreted to mean an attribute.
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.
7. Claims 36 and 37 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 claims 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 inventors, at the time the application was filed, had possession of the claimed invention.
Claim 36 claims an electronic device comprising a display, a processor, a memory and a program, which when executed by the processor performs the claimed method (lines 1-7) and claim 37 claims a non-transitory computer-readable medium storing instructions that, when executed by one or more processors, cause the one or more processors to execute the claimed method (lines 1-3). However, the claimed method includes ‘providing ingredients’ (line31 of claim 36 and line 26 of claim 37) and ‘mixing the ingredients’ (line 35 of claim 36 and line 30 of claim 37). A processor alone is not capable of providing ingredients or mixing the ingredients. These steps would require an automated system and the components of such to do so, which were not disclosed in the specification. Therefore, the specification does not provide the necessary written description to support for the full breadth of the asserted claims (see MPEP 2101.01(I)).
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.
8. Claims 1-4, 9, 13, 18-21, 23, 26-28, 30-33 and 36-37 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 19 recites the limitations "receiving cost and fill time rates at the selected grade for a selected quantity” and “cost and fill time rates at the selected packaging for the selected quantity”. There is insufficient antecedent basis for these limitations in the claim because a selected grade and a selected quantity have not be introduced in the claim or the claim from which Claim 19 depends. For the purpose of examination, claim 19 will be considered to depend on claim 30, which recites ‘a selected grade-type’ (but not a ‘selected packaging’).
Claims 1, 36 and 37 recite “the selection” in lines 15, 20, and 15 respectively. Claims 4, 9, 18, and 20 also recite the term “the selection.” However, claims 1, 36, and 37 recite two different receiving a selection steps (in lines 4 and 12, lines 10 and 18 and lines 6 and 13, respectively) before the reference to “the selection”. Therefore, it’s unclear which ‘selection’ is being referenced. For the purpose of examination and with broadest reasonable interpretation, ‘the selection’ will be considered to refer to the selection disclosed at either of the receiving steps. Claims 2-4, 9, 13, 18-21, 23, 26-28 and 30-33, which depend from claim1, are similarly rejected as they do not resolve the indefiniteness issue.
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.
9. Claims 36 and 37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 2A, Prong 1
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claims 36 and 37 recite: in response to receiving the selection: identifying the candidate cell culture media formulation
Claims 36 and 37 recite: in response to receiving the selection: identifying, by the computer, a selected cell culture media formulation
Claims 36 and 37 recite: estimating a production cost of the selected cell culture media formulation based on the received properties
Claims 36 and 37 recite: selecting a subset of the plurality of ingredients based on the selected cell culture media formulation
The limitation regarding ‘estimating a production cost’ (which can involve calculating osmolality of components) is a verbal equivalent that describe a mathematical calculation that is performed as the limitation and is so simple that it could be performed in the human mind or with pen and paper. Therefore, this limitation fall under the "Mathematical concepts" and "Mental processes" groupings of abstract ideas.
The remaining limitations for ‘identifying the/a formulation’, ‘selecting ingredients’ are generically recited data analysis steps that can be practically performed in the human mind because the human mind is capable of identifying relevant information, comparing values, and determining information from other values.
The limitations directed to ‘estimating a production cost’ also falls into the “certain methods of organizing human activity” grouping of abstract ideas because it involves commercial interactions (sales activities or behaviors and business relations).
While claims 36 and 37 recite performing some aspects of the analysis with a computer, there are no additional limitations that indicate that this processor requires anything other than carrying out the recited mental process or mathematical concept in a generic computer environment. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then if falls within the "Mental processes" grouping of abstract ideas. As such, claims 36 and 37 recite an abstract idea (Step 2A, Prong 1: YES).
Therefore, claims 36 and 37 explicitly recite elements that, individually and in combination, constitute one or more judicial exceptions.
Step 2A, Prong 2
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further
analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception in some other meaningful way. Rather, the instant claims recite additional elements that amount to mere instructions to implement the abstract idea in a generic computing environment or insignificant extra-solution activity. Specifically, the claims recite the following additional elements:
Claim 36 recites: an electronic device, comprising: a display for displaying user interfaces,
Claim 36 recites: a processor, a memory; and a program, wherein the program is stored in the memory and configured to be executed by the processor, the program comprising instructions for performing a method
Claim 37 recites: a non-transitory computer-readable medium
Claim 37 recites: storing instructions that, when executed by one or more processors, cause the one or more processors to execute a method
Claims 36 and 37 recite: providing, by a computer a user interface with at least one affordance corresponding to a plurality of candidate cell culture media formulations
Claims 36 and 37 recite: receiving, by a computer a selection, via the at least one affordance, of a candidate cell culture media formulation
Claims 36 and 37 recite: providing, by the computer, a user interface based on the identified candidate cell culture media formulation, the user interface comprising a plurality of affordances corresponding to different media attributes of the identified candidate cell culture media formulation
Claims 36 and 37 recite: receiving, by the computer, a selection of at least one of the plurality of affordances corresponding to different media attributes of the identified candidate cell culture media formulation
Claims 36 and 37 recite: receiving properties of the selected cell culture media formulation
Claims 36 and 37 recite: transmitting, by the computer, the estimated production cost of the selected cell culture media formulation
Claims 36 and 37 recite: in response to receiving a confirmation: transmitting, by the computer, the selected cell culture media formulation
Claims 36 and 37 recite: receiving, at a location remote from the computer, the selected cell culture media formulation
Claims 36 and 37 recite: providing a plurality of ingredients combinable into a plurality of cell culture media formulations
Claims 36 and 37 recite: preparing the selected cell culture media formulation using the subset of the plurality of ingredients
The limitations directed to ‘receive a selection’, ‘receive properties’ and ‘receive the formulation’, merely serve to gather data that is used an input for the judicial exception. The limitations directed to providing affordances or recommendations (including grade type, cell use, or media type) merely serve to output data from the judicial exception. Therefore, these limitations are mere data gathering and outputting activities. As set forth in MPEP 2106.05(g), mere data gathering and outputting activities have been identified by the courts as insignificant extra-solution activity that does not provide a practical application.
The limitations directed storing instructions (using non-transitory computer readable medium), transmitting data (including a production cost or formulation), providing a ‘user interface’ and using a display, equate to routine computer/network activity related to performing the judicial exception or data gathering/output activities in a networked computing environment. Additionally, there are no limitations that indicate that the claimed processor, memory or program require anything other than a generic computing system and there is no information that the transmitting of data is anything more than merely communicating the information in a generic way using standard networked computers. As set forth in MPEP 2106.05(h), these limitations do nothing more than generally link the judicial exception to a particular technological environment. The courts have stated that mere instructions to implement the abstract idea on a generic computer does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
The limitations in claims 36 and 37 directed to ‘providing a plurality of ingredients’ and ‘preparing the selected cell culture media formulation’ using the ingredients pertain to a physical manufacture of a composition using the selected formulation. However, the claims as a whole fail to integrate the judicial exception into a practical application because the claimed system (including the display, processor, memory and program) and the claimed computer readable medium cannot actually perform the steps to make the formulation (i.e. provide the ingredients and prepare the selected cell culture media formulation). Therefore, preparing the formulation does not meaningfully limit the claim and is not sufficient to integrate the exception into a practical application.
Together, the above recited additional elements do not provide a practical application of the
recited judicial exception. As such, claims 36 and 37 are directed to an abstract idea (Step 2A, Prong 2: NO).
Step 2B
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic computing environment or well-understood, and conventional activity.
As discussed above, there are no additional limitations to indicate that the transmitting steps or the claimed computer, processor, display, user interface or memory require anything other than generic computer components and generic computer communication functions in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
Limitations that merely add an insignificant extra-solution activity (i.e. the data gathering and outputting limitations that were claimed at high level of generality), do not amount to an inventive concept, particularly when the activities are well-understood and conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978).
In addition, the following activities have been demonstrated to be well-understood, routine and conventional activities when claimed in a generic manner:
Storing medical data and retrieve information in memory (recognized by Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93) and recording a customer’s order (recognized by Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1244, 120 USPQ2d 1844, 1856 (Fed. Cir. 2016)
Transmitting data over a network (recognized by Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362)
Providing ingredients and preparing cell culture media (evidenced by Freshney (p. 99-114) (Culture of Animal Cells: A Manual of Basic Technique and Specialized Applications, Sixth Edition, 2010 ,John Wiley & Sons, Inc., chapter 8 Defined Media and Supplements, p. 99-114))
As such, the combination of additional elements recited in the claims is well- understood, routine and conventional.
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 36 and 37 are not patent eligible.
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.
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.
10. Claims 1-4, 13, 20, 27-28, 32-33 and 36-37 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Unger et al. (WO 2007016421 A2). The italicized text corresponds to the instant claim limitations.
Regarding claims 36 and 37, Unger et al. teaches a method and system including a system for online marketing of solid or liquid reagents or products to a plurality of users, including a server computer, central processing unit, software storage media and software effective to provide a user-interactive graphical user interface (GUI) (para. 00048; a display for displaying user interfaces, a processor; memory; and a program, wherein the program is stored in the memory and configured to be executed by the processor, the program comprising instructions for performing the method (claim 36); a non-transitory computer-readable medium storing instructions that, when executed by one or more processors, cause the one or more processors to execute the method (claim 37).
Regarding claims 1, 36 and 37, Unger et al. teaches a method and system for online marketing of solid or liquid reagents or products to a plurality of users. The disclosed system includes a server computer configured to provide a user-interactive graphical user interface (GUI) with users' computers. Unger et al. teaches any number of solid or liquid products including cell culture media and serum are part of the system and methods with a variety of affordances (e.g. serum may one of several types of bovine serum including for example heat inactivated bovine serum, donor bovine serum, donor bovine serum with iron, fetal bovine serum, US certified fetal bovine serum etc. and media may contain base medium eagle (BME), GJb medium, Brinster’s BMOC-3 Medium, CMRL Medium, Dulbecco’s Modified Eagle Media (D-MEM) etc.). Affordances include product specifications (e.g. low glucose), volume, or price of media and sera (para. 00029-00033, 00046, 00048, 000150; providing, by a computer, a user interface with at least one affordance corresponding to a plurality of candidate cell culture media formulations).
Regarding claims 1, 36 and 37, Unger et al. discloses that the user may also access one or more product or service descriptions such as searchable catalogs with a space can be provided for user input of search terms or an indicator for a product to be ordered. For example, a user may enter "Blue 29" and that color and number are an indicator for a desired product. The order for the product associated with Blue 29 would then be stored in a temporary memory, often referred to as a "shopping cart" while further orders are entered. The color and number correspond to various aspects (affordances) of the selected medium. For example, color can represent subfamilies such as Dulbecco's Modified Eagle Medium (DMEM) and the number represents various formulations and volumes of DMEM (e.g. low glucose, 500mL) (para. 00046, 000184; receiving, by the computer, a selection, via the at least one affordance, of a candidate cell culture media formulation).
Regarding claims 1, 36 and 37, Unger et al. discloses an administration that includes an order department, which receives input in the form of an order for a product from customer. Unger et al. further discloses that the order department then provides output in the form of instructions to shipping department to fill the order. Unger et al. further discloses custom ordering (Fig. 19, para. 00017, 000151; in response to receiving the selection: identifying the candidate cell culture media formulation).
Regarding claims 1, 36 and 37, Unger et al. discloses that a customer may browse the product descriptions first by keyword, or by product family. For example, a user may enter the term "Blue" into a search engine and would receive a page with all products in the family designated as "Blue", which are in the same media family. Each product listing can include product description, volume, and price, and would provide a tick box for ordering a particular product, or a box for entering a number of pieces of that product to be added to the shopping cart. The color is the candidate cell culture media formulation (e.g. DMEM) and after selecting a color, other attribute (affordances) appear to be selected (such as volume and glucose concentration or subclass of media with different compositions). Unger et al. further discloses that customers may order custom medium formulations with specific ingredient percentages (para. 00046, 000164, 000181, 000184; providing, by the computer, a user interface based on the identified candidate cell culture media formulation, the user interface comprising a plurality of affordances corresponding to different media attributes of the identified candidate cell culture media formulation).
Regarding claims 1, 36 and 37, Unger et al. disclose that upon completion of the order (i.e. after selection of desired media and specifications), the user can be directed to checkout where billing information is entered or confirmed, including shipping address, purchase order number, or other information to complete the order. The website provides a button to submit the order that is selected and confirmed by the user. The order is then electronically forwarded to a database that is accessible by the shipping and billing departments for completion. Unger et al. further discloses that one or more departments can also be notified by email or other means that an order has been received. Unger et al. further discloses a billing department that provides a bill to the customer as appropriate. Unger et al. further discloses that when the product is shipped, an invoice is either included in the package or can be sent by separate cover. Unger et al. further discloses that departments are connected by a communication network that can receive input from the customer. Unger et al. further discloses custom orders with custom medium ingredients and percentages and custom billing (para. 00046-00047, 000164, 000151, 000153, 000181, 000184; receiving, by the computer, a selection of at least one of the plurality of affordances corresponding to different media attributes of the identified candidate cell culture media formulation; in response to receiving the selection: identifying, by the computer, a selected cell culture media formulation, receiving properties of the selected cell culture media formulation, estimating a production cost of the selected cell culture media formulation based on the received properties, and transmitting, by the computer, the estimated production cost of the selected cell culture media formulation).
Regarding claims 1, 36 and 37, Unger et al. discloses that the website provides a button to submit the order that is selected and confirmed by the user. Unger et al. further discloses an administration that includes an order department which receives input in the form of an order for a product from the customer, and then provides instructions to the shipping department to fill the order (para. 00047, 000151; in response to receiving a confirmation: transmitting, by the computer, the selected cell culture media formulation).
Regarding claims 1, 36 and 37, Unger et al. discloses that the order is electronically forwarded to a database that is accessible by the shipping and billing departments for completion (para. 00047; receiving, at a location remote from the computer, the selected cell culture media formulation).
Regarding claims 1, 36 and 37, Unger et al. discloses that the method includes preparation of products, which can involve acquiring materials and parts from sources outside of an organization (e.g., a supplier) and used to prepare products, such as color coded labeled and capped bottles of DMEM. Unger et al. discloses that other components can be prepared within an organization (using acquired ingredients) (para. 000158; providing a plurality of ingredients combinable into a plurality of cell culture media formulations; selecting a subset of the plurality of ingredients based on the selected cell culture media formulation; and preparing the selected cell culture media formulation using the subset of the plurality of ingredients).
Regarding claim 2, Unger et al. discloses that a customer may browse the product descriptions in the user interface by keyword, or by product family. For example, a user may enter the term "Blue" into a search engine and would receive a page with all products in the family designated as "Blue." The color can be the candidate cell culture media formulation (e.g. blue is DMEM) and after selecting a color, other attributes (affordances) appear as options that can be selected (such as volume and glucose concentration). After selecting the base medium (e.g. Basal Medium Eagle (BME)), other affordances can be selected within the medium family (e.g. BGJB medium, improved MEM Zn++ medium etc.) (para. 00046, 000181, 000184 The method of claim 1, wherein providing a user interface with at least one affordance corresponding to a plurality of candidate cell culture media formulations comprises providing a plurality of affordances corresponding to the plurality of candidate cell culture media formulations).
With respect to claim 3, Unger et al. discloses that a customer may browse the product descriptions in the user interface by keyword, or by product family and after selecting the base medium (e.g. Basal Medium Eagle (BME)), other affordances can be selected within the medium family (e.g. BGJB medium, improved MEM Zn++ medium etc.). Unger et al. further teaches that the method may include maintaining an electronic catalog on a computer system that is accessible by customers (as for example a webpage) and in which at least some products are identifiable and searchable by the color code and numbers or other indicator. Unger et al. also discloses that a customer may also browse the product descriptions by keyword, or by product family and that a space can be provided for user input of search terms or an indicator for a product to be ordered (i.e. a search bar) (para. 00044-00046, 000181, 000184; the method of claim 1, wherein providing a user interface with at least one affordance corresponding to a plurality of candidate cell culture media formulations comprises providing a search bar).
Pertaining to claim 4, Unger et al. discloses that the method includes custom ordering, such as a medium with specific ingredient percentages and specific billing. Unger et al. discloses that disclosures are made to the customer including description of products, methods of using the products, instructions for practicing the methods and or using the products. Unger et al. discloses a customer service department that can receive input from the customer in the form of request for technical information and provide output in the form of information. Unger et al. further discloses a confirmation page during the online check out/ordering process that confirms the content of the order and specifications of the products. Unger et al. also discloses that the customer can additionally request confirmation that the requested product can be output to the customer. Unger et al. further discloses that departments and customer are connected by a network such as an internet (para. 00047, 000152-000156, 000163-000164; Fig. 19; the method of claim 1, wherein in response to receiving the selection, the method further comprising: preparing, by the computer, a specification of the selected cell culture media formulation, and transmitting, by the computer, the specification, and wherein the confirmation comprises a confirmation of the specification).
Pertaining to claim 13, Unger et al. discloses that the customer service department also can receive input from a customer in the form of requested technical information, for example, for confirming that instructions of the disclosure can be applied to the particular need of customer, and can provide output to customer in the form of a response to the requested technical information. Unger et al. further discloses that this communication can be done by a communication network such as an intranet, and can be further configured to receive input from customers via the internet (para. 000152 - 000153; the method of claim 1, further comprising: in response to receiving the selection of at least one of the plurality of affordances: estimating a performance characteristic of the selected cell culture media formulation; and transmitting, by the computer, the revised estimate of the performance characteristic).
Regarding claim 20, Unger et al. discloses that there is substantial ergonomic benefit to the user by decreasing the amount of vertical motion the user must employ to introduce the pipette into the opening. Unger et al. further disclose that containers and bottles used are designed to increase efficiency in the lab, decrease the likelihood of spills and contamination or more efficient packaging. Unger et al. further discloses that advertisements with product descriptions and one or more aspects of the disclosure are emailed to customers including ergonomic comfort (para. 00015, 000166, 000169; 000188, Table 1; the method of claim 1, further comprising: in response to receiving the selection: estimating an environmental impact of the selected cell culture media formulation based on the received properties, and transmitting, by the computer, the estimated environmental impact).
Regarding claim 27, Unger et al. discloses that in certain embodiments the products are packages of liquid products, such as products for use in the biological sciences and in certain embodiments, products such as cell culture media or sera (para. 00032 The method of claim 1, wherein preparing the selected media formulation using the subset of the plurality of ingredients comprises preparing a liquid media formulation.
Regarding claim 28, Unger et al. discloses that in certain embodiments the disclosure is directed to packages or containers for and/or containing solid products. Such solid products may be powder or crystalline products for example, and may include dry powders, such as dry cell culture media products, or they may comprise a dry form of cell culture media in a granular format (para. 00031; the method of claim 1, wherein preparing the selected media formulation using the subset of the plurality of ingredients comprises preparing a powdered media formulation).
Pertaining to claim 32, Unger et al. discloses, maintaining an electronic catalog on a computer system that is accessible by customers and in which products are identifiable and searchable by color and number indicators or by key word. The customer accesses the electronic catalog over an internet connection and searches for product on a webpage Each product listing includes product description , a volume and price (also custom pricing is available) and a tickbox for ordering a particular product and the quantity required. The customer checks out The website provides a button to submit the order that is selected and confirmed by the user (i.e. confirms the details of the order including specific media components). Unger et al. further discloses providing custom products (including medium with specific ingredient percentages and preparation of specific labeling and bottles (para. 00044-00048, 000164; the method of claim 1, further comprising: providing, by a computer, a plurality of media-type affordances corresponding to a plurality of candidate media types; receiving, by the computer, a selection of at least one of the plurality of media-type affordances; and in response to receiving the selection of at least one of the plurality of media-type affordances: performing the step of providing, by the computer, the user interface with at least one affordance corresponding to a plurality of candidate cell culture media formulations).
Pertaining to claim 33, Unger et al. discloses storage and/or containment systems for solid or liquid material products, wherein a container includes a color code associated with a family of products and a number is associated with a product within that family or group. In certain embodiments, the disclosed systems can include containers having labels attached to one or more sides of the container and optionally wherein the container further includes a cover, or cap, and wherein the color and/or the identification code are prominently displayed on the labels on one or more sides of the container and also optionally prominently displayed on the cover, as well as on systems that include such containers. (para. 00017-00018, 000164; the method of claim 1, further comprising receiving, at the computer, a selection of a packaging configuration).
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.
11. Claims 9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Unger et al. (WO 2007016421 A2) as applied to claims 1-4, 13, 20, 27-28, 32-33 and 36-37 above. The italicized text corresponds to the instant claim limitations.
Unger et al. teaches the limitations of claims 1-4, 13, 20, 27-28, 32-33 and 36-37 above.
Regarding claim 9, Unger et al. teaches that multiple orders can be placed and that data regarding the amount of money owed is tracked and the customer is billed. Unger et al. further teaches two-way communication between billing and the customer and between the customer service department and the customer (para. 000152-000153, 000161, Fig. 19; the method of claim 1, further comprising: receiving, by the computer, a second selection of at least one of the plurality of affordances corresponding to different media attributes of the identified candidate cell culture media formulation; and in response to receiving the selection: estimating a revised production cost; and transmitting, by the computer, the revised estimate of the production cost).
Unger et al. does not explicitly teach making a second selection that would revise a production cost, but this is inherent to the method as the customer can make multiple purchases and is billed for the purchases. Additionally, there is two-way communication with the customer and the customer service department, thus a second product could be added by a customer to an existing order and the cost could be revised accordingly. Thus revising a cost based on a second purchase is inherent to the method. The invention is therefore prima facie obvious.
Regarding claim 21, Unger et al. discloses taking custom orders from a customer for medium with specific percentages of ingredients and then billing the customer for the order after it is shipped. Unger et al. further discloses that the media can be supplied as a solid/powder media or dry cell culture products (thus in these cases, percentage would reflect a mass concentration). Unger et al. further discloses obtaining materials and parts from a source outside of the organization and that the media can be prepared within the organization (para. 000131, 000158, 000164; Fig. 19; the method of claim 1, wherein receiving, by the computer, a selection of at least one of the plurality of affordances comprises receiving a selected mass concentration of the selected cell culture media formulation, wherein estimating a production cost of the selected cell culture media formulation comprises receiving a cost of each of the ingredients at the selected mass concentration and estimating a total cost of the selected cell culture media formulation based on the cost of each of the ingredients at the selected mass concentration.
Unger et al. does not explicitly teach ‘receiving a cost for each of the ingredients’ in a custom media order, but given that the method includes providing custom orders to customers and billing them for the custom order, calculating the order based in part on ingredients used to make the medium (for example from the external supplier) is an obvious step in the method of determining the cost of the product. The invention is therefore prima facie obvious.
12. Claims 18, 23, 26 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Unger et al. (WO 2007016421 A2), as applied to claims 1-4, 9, 13, 20-21, 27-28, 32-33 and 36-37 above in view of Fike et al. (US2008/0019883A1). The italicized text corresponds to the instant claim limitations.
Unger et al. teaches the limitations of claims 1-4, 9, 13, 20-21, 27-28, 32-33 and 36-37 above.
With respect to claim 18, Unger et al. discloses methods for providing information to customers regarding the availability of products (para. 000161-000162; The method of claim 1, further comprising: in response to receiving the selection: estimating a production timeline of the selected cell culture media formulation based on the received properties; and transmitting, by the computer, the estimated production timeline.
Regarding claim 26, Unger et al. disclose that formulations of media include choice of specific parameters including volume (e.g. 500 mL), glucose content (e.g. low glucose), number of items, packaging (i.e. single bottle versus a package containing 10 bottles). Unger et al. also discloses custom ordering of specific media ingredient percentages and specific color-coded labels and bottles containing the medium. Unger et al. further discloses providing choice of a number of different packaging options including various containers to suit different needs (such as interlocking containers or stackable containers and containers with various color and number coding). Unger et al. further disclose selling fetal calf serum and concentrated solutions of amino acids for media (para. 00017-00026, 000164, 000184, 00046, 000173, 000183; the method of claim 1, wherein providing a user interface based on the identified cell culture media formulation comprises providing affordances associated with material grade, media format, media testing, glucose content, amino acids, serum, quantity, osmolality; and packaging.
Pertaining to claim 31, Unger et al. discloses a customer service department that can receive input from a customer in the form of requested technical information, for example, for confirming that instructions of the disclosure can be applied to the particular need of customer, and can provide output to customer in the form of a response to the requested technical information (para. 000152; the method of claim 1, further comprising: providing, by the computer, a plurality of cell-use affordances; receiving, at the computer, a selected cell-type; determining whether the selected cell-type conflicts with the selected cell culture media formulation; and in response to determining that the selected cell-type conflicts with the selected cell culture media formulation: providing a recommendation based on the selected cell culture media formulation.
Regarding claims 18, 23, 26, and 31 Unger et al. does not teach the specific methods of: estimating a production timeline of the selected cell culture media formulation based on the received properties (claim 18); wherein the step of receiving, by the computer, a selection of the candidate cell culture media formulation and the step of preparing the selected cell culture media formulation using the subset of the plurality of ingredients are separated by 12 weeks or less (claim 23); the method of claim 1, wherein providing a user interface based on the identified cell culture media formulation comprises providing affordances associated with material grade, and osmolality (claim 26); and determining whether the selected cell-type conflicts with the selected cell culture media formulation; and providing a recommendation based on the selected cell culture media formulation (claim 31). However, these limitations were known in the art at the time of the effective filing date of the invention as taught by Fike et al.
Regarding claims 18, Fike et al. discloses methods of production of cell culture products wherein media, media supplement, media subgroup and buffer formulations may be prepared on an as needed basis using "just in time" production techniques which reduce inventory, storage and labor costs. Fike et al. further discloses that the time required for the preparation and shipping of the media, media supplement, media subgroup and buffer formulations may be reduced from 6-8 weeks to as little as one day (para. 0344; The method of claim 1, further comprising: in response to receiving the selection: estimating a production timeline of the selected cell culture media formulation based on the received properties; and transmitting, by the computer, the estimated production timeline).
Pertaining to claim 23, Fike et al. discloses methods of production and distribution of cell culture products wherein media, media supplement, media subgroup and buffer formulations may be prepared on an as needed basis using "just in time" production techniques which reduce inventory, storage and labor costs. Fike et al. further discloses that the time required for the preparation and shipping of the media, media supplement, media subgroup and buffer formulations may be reduced from 6-8 weeks to as little as one day (para. 0344; The method of claim 1, wherein the step of receiving, by the computer, a selection of the candidate cell culture media formulation and the step of preparing the selected cell culture media formulation using the subset of the plurality of ingredients are separated by 12 weeks or less).
Regarding claim 26 Fike et al. discloses that pH and osmolality and nutrient formulations are important parameters in selecting commercially available cell culture media and that the osmolality of their media formulations are known (para. 0006, 0010, 0279-0280).
Regarding claim 31, Fike et al. discloses that their media powders are each optimized for certain cell types and that kits including cells with matched culture media are made available to customers (para. 0043, 0098, 0247, 0337).
An invention would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention if some motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. Fike et al. taught that a significant problem in cell culture media production is elimination of infectious agents (para. 0018). Fike et al. further taught that their powdered media formulations are presterilized after packaging of the powder by irradiation of the packaged powder with gamma rays and only require water for reconstitution, thus controlling contamination (para. 0031). Fike further teaches that this powdered formulation approaches significantly reduces production and shipping times (para. 0344). Therefore, one of ordinary skill in the art would have been motivated to utilize the powdered media formulation and distribution taught by Fike et al. in the culture media production and distribution method and system taught by Unger et al. in order to control contamination and decrease production and shipping times in commercial media formulations. Furthermore, one of ordinary skill in the art would predict that the media production and distribution approach taught by Fike et al. could be readily added to the method and system of Unger et al. with a reasonable expectation of success because they both pertain to cell culture media production and distribution to customers. The invention is therefore prima facie obvious.
13. Claims 30 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Unger et al. (WO 2007016421 A2), as applied to claims 1-4, 9, 13, 20-21, 27-28, 32-33 and 36-37 above, in view of Wamaitha et al. (Nature Communications, Feb. 2020, vol. 11, p. 1-16), as evidenced by StemCell Technologies 1 (mTesr1, Version 02; document 10000003789, 2019, p. 1-2) and StemCell Technologies 2 (TeSR-E8, Version 02, document 10000003508, 2019, p. 1-2). The italicized text corresponds to the instant claim limitations.
Unger et al. teaches the limitations of claims 1-4, 9, 13, 20-21, 27-28, 32-33 and 36-37 above.
Pertaining to claim 30, Unger et al. is silent to providing a grade-type affordance in the online ordering system (i.e. the method of claim 1, further comprising: providing, by the computer, a grade-type affordance; receiving, at the computer, a selected grade-type; determining whether the selected grade-type is an FDA grade; in response to determining that the selected grade-type is an FDA grade: preparing a GMP specification of the selected cell culture media, wherein the step of preparing a specification of the selected cell culture media comprises preparing the GMP specification; and in response to determining that the selected grade-type is not an FDA grade: preparing a non-GMP specification of the selected cell culture media, wherein the step of preparing a specification of the selected cell culture media comprises preparing the non-GMP specification). However, these limitations were known in the art at the time of the effective filing date of the invention as taught by Wamaitha et al.
Regarding claim 30, Wamaitha et al. teaches that both GMP and non-GMP media were commercially available at the time of the effective filing date. In a study of stem cell self-renewal, Wamaitha et al. discloses that they used mTesr1 medium from StemCell Technologies for culturing human embryonic stem cells, and TeSR-E8 medium from StemCell Technologies for fibroblast cell maintenance (p. 11, col. 2, para. 2-5). As evidenced by the StemCell Technologies 1, mTser1 medium is cGMP certified (footer at bottom of p. 2), but as evidenced by StemCell Technologies 2, TeSR-E8 medium is research use only (and not indicated as cGMP compliant) (footer at bottom of p. 2).
An invention would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention if some motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. Wamaitha et al. taught that the commercial availability of both GMP and non-GMP media yielded successful interrogation of lineage-specific gene expression patterns directly in the human blastocyst to understand the role of signaling in the embryo (p. 11, col. 1, para. 2). Wamaitha et al. further taught that the high cost of commercially available media can be prohibitive to doing research (p. 9, col. 2, para. 3). Therefore, one of ordinary skill in the art would have been motivated to make both GMP and non-GMP media commercially available (as was available at StemCell technologies) in the production and distribution method taught by Unger et al. in order to do research in the area of stem cell signaling taught by Wamaitha et al. Furthermore, having a choice of purchasing either GMP or non-GMP, enables the use of GMP media only when necessary, which can reduce the overall cost of commercially-sourced media making research more affordable. Furthermore, one of ordinary skill in the art would predict that the having commercial availability of both GMP and non-GMP media taught by Wamaitha et al. could be readily added to the media distribution method of Unger et al. with a reasonable expectation of success because they both pertain to production and commercial sale of cell culture media. The invention is therefore prima facie obvious.
With respect to claim19, Unger et al. discloses a network of electronic information involving communication between customer and various departments after a product is ordered, including communication with customer service, which can provide output in the form of feedback or information to the customer. Unger et al. further discloses that customer service can provide output to any other component of the organization including the order department, including output related to product inventory management, providing information regarding availability of a product and the acquisition of materials and parts from a source outside or within the organization (i.e. fill time rates). Unger et al. discloses that products can be culture media, media components, as well as packaging (i.e. media containers, bottles and/or labels). Unger et al. discloses that these types of communication are shown with arrows between departments in Fig. 19 and two-way arrows between distributor and billing department, customer and customer services, and between customer and billing. Unger et al. further discloses that product listings contain description, volume and price and that special pricing can be provided (para. 00044-00046; para. 000151-0000162, Fig. 19) the method of claim 1, wherein receiving properties of the subset of the plurality of ingredients comprises receiving (1) cost and fill time rates at the selected grade for a selected quantity and (2) cost and fill time rates at the selected packaging for the selected quantity.
Conclusion
14. No claims are allowed.
Claims 1-4, 9, 13, 18-21, 23, 26-28 and 30-31 were analyzed for subject matter eligibility under 35 U.S.C. 101 and were found to contain eligible subject matter at step 2A prong 2 because the limitation of claim 1 directed to “preparing the selected cell culture media formulation using the subset of the plurality of ingredients” was considered to be a practical application.
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/J.J.S./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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