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 .
Status of Claims
This office action is in response to the patent application 18/397,649 originally filed on December 27, 2023. Claims 1-16 were originally presented for examination.
In the Preliminary Amendment filed December 27, 2023, claims 1-4, 7-12, and 14-16 were amended. Claim 17 is new. Claims 1-17 are now pending examination. Claim 1 is independent.
Claim Objections
Claims 1-17 are objected to because of the following informalities: bullets or hyphens.
Claims 1, and substantially similar limitations in claims 15 and 16, are objected to because the limitations contain hyphens which make the claims difficult to examine. For the purpose of examination, the Examiner will reasonably interpret the claim limitations without the hyphens. Appropriate correction is required. Claims 2-17 are also objected to based on their respective dependencies to claim 1. Claim 17 is also objected to based on its dependency to claim 16.
Claims 14, 16, and 17 are objected to because of the following informalities: typographical errors.
Claims 14 is objected to because of the following informalities: typographical errors.
Claim 14 recites the limitation “wherein each glass is stirred.” The Examiner reasonably believes this is a typographical error and should be corrected to “wherein each glass reactor is stirred.” Appropriate correction is required.
Claim 16 recites the limitation “vii) Innoculating intestinal microbiota.” The Examiner reasonably believes this is a typographical error and should be corrected to “vii) inoculating intestinal microbiota.” Appropriate correction is required. Claim 17 is also objected to based on its dependency to claim 16.
Claims 16 and 17 are objected to because of the following informalities: claims containing more than one period.
Claim 16 is objected to because steps “a”, “b”, “c,” and “d,” each have a period after them. These periods should be removed, or substituted with a “)”, as each claim can only have one period. Per MPEP 608.01(m), each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995). Appropriate correction is required. Claim 17 is also objected to based on its dependency to claim 16.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. § 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-17 are rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites the limitation “at least one glass reactor, said glass reactor containing a lid.” The limitation is originally introduced earlier in claim 1. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “ at least one glass reactor containing a lid”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 1. Therefore, claim 1 is rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 2-17 are also rejected under 35 U.S.C. § 112(b), based on their respective dependencies to claim 1.
Claim 7, and substantially similar limitations in claims 8 and 14, the terms “continuously,” “semi-continuously,” and “in continuous fashion” in claims 7, 8, and 14, respectively, are relative terms which renders the claim indefinite. The variations of the term “continuously” regard a degree of duration, but are not defined by the claims, and the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, what is the technical difference between performing an action “continuously,” “semi-continuously,” “in continuous fashion,” or performing the action without explicitly specifying that it is performed “continuously”? Given the lack of a definite scope of these limitations, they will be interpreted in this office action using the broadest reasonable interpretation in light of the specification.
Claim Rejections - 35 USC § 103
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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (hereinafter “Chen,” Foreign Publication CN 104851346 A) in view of Yu et al. (hereinafter “Yu,” Foreign Publication CN 101665758 B), and further in view of Decker et al. (hereinafter “Decker,” US 4,095,859).
Regarding claim 1, Chen discloses a digestive system simulator apparatus, comprising at least one mobile rack with at least two levels (see Chen Fig. 2, showing a frame with two levels) … , each cabinet comprising:
- at least one support for accessories, wherein said accessories comprise at least one bottle of acid solution and at least one bottle of alkaline solution, and wherein said support for accessories further comprises at least one recess configured to allow the fitting of said bottles (see Chen Fig. 1 and Chen page 8, “the platform 5 is formed with at least one reagent bottle installation position (37) and pipe channel 10. the reagent bottle 4 is filled with acid/alkali/enzyme reagent”);
- at least one light indicator (Chen page 10, “each function module in a electronic or mechanical elements needed to finish the task module, comprising… indicator light”);
…
- at least one peristaltic pump (Chen page 4, “starting the peristaltic pump, injection of diluted alkali liquor or acid in the reaction vessel so as to reach the target value, stopping the peristaltic pump”); and
… and in its lower part at least one heating bath with demand (Chen page 11, “one 37 degrees centigrade water bath heat preservation”).
Chen does not explicitly teach every limitation of the mobile rack with at least two levels configured to support up to five cabinets each, with at least one glass reactor on each level … at least one glass reactor, said glass reactor containing a lid on its upper part … and at least one distribution block for reactor heating.
However, Yu discloses the mobile rack with at least two levels configured to support up to five cabinets each, with at least one glass reactor on each level … at least one glass reactor, said glass reactor containing a lid on its upper part … and at least one distribution block for reactor heating (see Yu Figs. 1 and 2, showing five sets of glass reactors, each glass reactor having a lid on its upper part. A distribution block can be seen behind the glass reactors in Yu Fig. 2).
Yu is analogous to Chen, as both are drawn to the art of simulating biological processes. It would be obvious to try by one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method as taught by Chen, to include the mobile rack with at least two levels configured to support up to five cabinets each, with at least one glass reactor on each level … at least one glass reactor, said glass reactor containing a lid on its upper part … and at least one distribution block for reactor heating, as taught by Yu, since it would have combined prior art elements of having five distinct interconnected glass reactors according to known methods to yield predictable results (i.e. a similar setup could be accomplished by connecting five cabinets of Chen side by side and using a glass reactor instead of reactor tanks). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Chen in view of Yu does not explicitly teach wherein said mobile rack comprises in its upper part at least one backup peristaltic pump … at least one means of locomotion.
However, Decker discloses wherein said mobile rack comprises in its upper part at least one backup peristaltic pump … at least one means of locomotion (Decker col. 1 lines 45-59, “the present invention is directed to such a cart which houses eye examination instruments and is provided with an electrical power source including automatic on and off switches for those instruments which are electrically operated, as well as storage areas for convenient location of ophthalmic drugs and examination supplies, small instruments accessories, spare lamps and parts, patient record charts, and other miscellaneous items, and which is small, can easily fit between two hospital beds, is provided with retractable covers to secure and protect instruments and supplies, and preferably which is provided with large wheels for traversing door frames without danger of tipping over,” the cart carries spare parts and has wheels for locomotion).
Decker is analogous to Chen in view of Yu, as both are drawn to the art of scientific testing workspaces. It would be obvious to try by one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method as taught by Chen in view of Yu, to include wherein said mobile rack comprises in its upper part at least one backup peristaltic pump … at least one means of locomotion, as taught by Decker, since it uses known techniques of providing wheels for locomotion and providing areas for storing extra parts, to improve similar devices in the same way. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 2, Chen in view of Decker does not explicitly teach wherein each cabinet of the apparatus is configured to simulate a portion of the human digestive tract.
However, Yu discloses wherein each cabinet of the apparatus is configured to simulate a portion of the human digestive tract (see Yu page 2, “three glass tank further comprises colon part by Belgian Ghent University Research invention of human intestinal tract micro-ecology system simulator (ASON; of the Human SHIME Microbial Ecosystem, Ecosystem) in addition to stomach and small intestine simulated glass jar, ascending colon, transverse colon, descending colon,” each section has a reactor jar representing one part of the digestive system, such as stomach, small intestine, ascending colon, transverse colon, or descending colon).
Yu is analogous to Chen in view of Decker, as both are drawn to the art of simulating biological processes. It would be obvious to try by one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method as taught by Chen in view of Decker, to include wherein each cabinet of the apparatus is configured to simulate a portion of the human digestive tract, as taught by Yu, since it would have combined prior art elements of having five distinct interconnected glass reactors according to known methods to yield predictable results (i.e. a similar setup could be accomplished by connecting five cabinets of Chen side by side and using a glass reactor instead of reactor tanks). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 3, Chen in view of Decker does not explicitly teach wherein each cabinet is configured to operate a simulation of each portion of the gastrointestinal tract in parallel.
However, Yu discloses wherein each cabinet is configured to operate a simulation of each portion of the gastrointestinal tract in parallel (see Yu page 2, “three glass tank further comprises colon part by Belgian Ghent University Research invention of human intestinal tract micro-ecology system simulator (ASON; of the Human SHIME Microbial Ecosystem, Ecosystem) in addition to stomach and small intestine simulated glass jar, ascending colon, transverse colon, descending colon,” each section has a reactor jar representing one part of the digestive system, such as stomach, small intestine, ascending colon, transverse colon, or descending colon; also see Yu Fig. 2, showing the different parts operating in parallel).
Yu is analogous to Chen in view of Decker, as both are drawn to the art of simulating biological processes. It would be obvious to try by one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method as taught by Chen in view of Decker, to include wherein each cabinet is configured to operate a simulation of each portion of the gastrointestinal tract in parallel, as taught by Yu, since it would have combined prior art elements of having five distinct interconnected glass reactors according to known methods to yield predictable results (i.e. a similar setup could be accomplished by connecting five cabinets of Chen side by side and using a glass reactor instead of reactor tanks). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 4, Chen in view of Yu and Decker discloses wherein the lid of the bottles contains means of coupling configured to allow coupling of at least one hose to transfer acid solution and at least one hose for transportation of alkaline solution (see Chen Fig. 16 and page 10, “21 is alkaline buffer solution, 22 is the nitrogen outlet is acidic buffer solution”).
Regarding claim 5, Chen in view of Yu and Decker discloses wherein the alkaline solution in the bottle of alkaline solution is a sodium hydroxide (NaOH) solution (Chen page 5, “the reaction tank upper cover bottle opening is set several guide pipes for digestive juice, adding and taking out NaOH, HCl liquid. The stomach. small intestine and a large intestine microbial growth condition is different, the pH of the ascending colon, transverse colon and descending colon, by pH monitoring module adding the diluted HCl and NaOH is used for adjusting the current one reaction tank is added to the reaction solution in one reaction tank.”).
Regarding claim 6, Chen in view of Yu and Decker discloses wherein the acid solution in the bottle of acid solution is a hydrochloric acid (HCl) solution (Chen page 5, “the reaction tank upper cover bottle opening is set several guide pipes for digestive juice, adding and taking out NaOH, HCl liquid. The stomach. small intestine and a large intestine microbial growth condition is different, the pH of the ascending colon, transverse colon and descending colon, by pH monitoring module adding the diluted HCl and NaOH is used for adjusting the current one reaction tank is added to the reaction solution in one reaction tank.”).
Regarding claim 7, Chen in view of Yu and Decker does not explicitly teach wherein peristaltic pumps of cabinets with a 1500 mL reactor are configured to operate continuously. However, the Applicant’s use of a 1500 mL reactor is an obvious design choice. Applicant has not disclosed that a using a 1500 mL reactor instead of a different volume reactor solves any stated problem or is for any particular purpose. Moreover, it appears that any volume of reactor using the system of Chen in view of Yu and Decker or the Applicant would perform equally well. Therefore, it would have been prima facie obvious to modify Chen in view of Yu and Decker to obtain the device as specified in claim 7, because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Chen in view of Yu and Decker.
Regarding claim 8, Chen in view of Yu and Decker does not explicitly teach wherein peristaltic pumps of cabinets with a 500 mL reactor are configured to operate semi-continuously. However, the Applicant’s use of a 500 mL reactor is an obvious design choice. Applicant has not disclosed that a using a 500 mL reactor instead of a different volume reactor solves any stated problem or is for any particular purpose. Moreover, it appears that any volume of reactor using the system of Chen in view of Yu and Decker or the Applicant would perform equally well. Therefore, it would have been prima facie obvious to modify Chen in view of Yu and Decker to obtain the device as specified in claim 8, because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Chen in view of Yu and Decker.
Regarding claim 9, Chen in view of Yu does not teach wherein the means of locomotion of the mobile rack are selected from: wheels, rigid ball bearings, and transfer balls.
However, Decker discloses wherein the means of locomotion of the mobile rack are selected from: wheels, rigid ball bearings, and transfer balls (Decker col. 1 lines 45-59, “the present invention is directed to such a cart… which is provided with large wheels for traversing door frames without danger of tipping over,” the cart carries spare parts and has wheels for locomotion).
Decker is analogous to Chen in view of Yu, as both are drawn to the art of scientific testing workspaces. It would be obvious to try by one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method as taught by Chen in view of Yu, to include wherein the means of locomotion of the mobile rack are selected from: wheels, rigid ball bearings, and transfer balls, as taught by Decker, since it uses known techniques of providing wheels for locomotion to improve similar devices in the same way. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 10, Chen in view of Yu and Decker discloses wherein the glass reactors comprise a nutritional medium maintained in anaerobiosis by a daily injection of nitrogen (Chen page 15, “liquid level height control module contents in the reaction tank is transferred to the next one in the reaction tank. generating and food at each stage in order to simulate the coli flora of biochemical reaction; the whole model by filling nitrogen to keep anaerobic environment”).
Regarding claim 11, Chen in view of Yu and Decker discloses wherein the acid and alkaline solutions are added automatically to the glass reactor of each cabinet (Chen page 5, “the reaction tank upper cover bottle opening is set several guide pipes for digestive juice, adding and taking out NaOH, HCl liquid. The stomach. small intestine and a large intestine microbial growth condition is different, the pH of the ascending colon, transverse colon and descending colon, by pH monitoring module adding the diluted HCl and NaOH is used for adjusting the current one reaction tank is added to the reaction solution in one reaction tank,” pH monitoring module monitors pH levels; also Chen page 14, “the one reaction tank to the reaction liquid is added to one reaction tank, through the upper computer sends automatic transferring command to the lower computer realize reaction liquid by the peristaltic pump module,” the computers automatically control the pumps).
Regarding claim 12, Chen in view of Yu and Decker discloses wherein the daily injection of nitrogen into each glass reactor occurs for 1 minute to 2 hours (Chen pages 8 and 9, “detecting oxygen sensor of oxygen concentration information, if itis higher than the maximum value, automatically opening the electric control gas valve (relay control)for nitrogen, nitrogen blowing process is 30 seconds, blowing nitrogen after the work is finished, sampling and detecting, if the oxygen concentration is lower than the maximum value, the timing in sampling and detecting, if higher than the maximum. Ncu.m/h is repeated 3 times to work and if blowing work cannot make oxygen content returns to the normal value, the alarm 10 minutes under normal situation inquiry response once,” wherein nitrogen is injected for 30 seconds and repeated up to 3 times [for a total of 2 minutes]).
Regarding claim 13, Chen in view of Yu and Decker discloses wherein the mobile rack is made of at least one of the following metallic materials: iron, steel, carbon steel, stainless steel, aluminum, nickel, and titanium (Official Notice is taken that laboratory racks, carts, and surfaces are typically made of iron, steel, carbon steel, stainless steel, aluminum, nickel, or titanium).
Regarding claim 14, Chen in view of Yu and Decker discloses wherein each glass is stirred magnetically and/or mechanically in continuous fashion (Chen page 5, “the peristalsis of each reaction tank is stirring action simulation of the magnetic stirring module”).
Regarding claim 15, Chen in view of Yu and Decker discloses wherein the lid of each glass reactor comprises a plurality of inlets, said plurality of inlets being configured to allow the coupling of: -at least one pH sensor; -at least one temperature sensor; -at least one pressure sensor; -at least one volume sensor; -at least one oxygen level sensor; -at least one pipette; -at least one ammonia level sensor; -and at least one hose for fluid transfer (see Chen Fig. 16; also Chen page 8, “detecting the oxygen partial pressure in the container… detecting oxygen sensor of oxygen concentration information”; also Chen page 9, “detecting concentration of ammonium ion concentration in the reaction tank”; also Chen page 10, “bottle opening fitting by replacing the blue cap bottle and a temperature probe sensor is mounted… detect a contact type liquid level height (volume) in the pipe so as to realize measurement of the in layer tank body liquid volume… 26 is a pH sensor”; also Chen page 15, “liquid level height control module contents in the reaction tank is transferred to the next one in the reaction tank”; Official Notice is taken that a pipette is a common tool used in a scientific environment to dispense small controlled mounts of liquid).
Regarding claim 16, Chen in view of Yu and Decker discloses a process for operating the digestive system simulator apparatus as defined in claim 1, comprising: i) Cleaning of all reactors using: - hot water; - a solution of water and activated chlorine; - 70% isopropyl alcohol; - distilled water; ii) Cleaning all lids, hoses and connections using: 1. autoclave; 2. water and detergent; 3. 70% isopropyl alcohol; 4. distilled water; iii) Assembling the digestive system simulator apparatus after i) and ii); iv) Programming software for the digestive system simulator apparatus with all the parameters to automate the simulation; v) Calibrating the pumps; vi) Calibrating all pH sensors; vii) Innoculating intestinal microbiota in reactors simulating colon portions; viii) Feeding the apparatus with nutritional medium for 14 days; ix) Feeding the apparatus with pepsin, pancreatic juice and nutritional medium for 7 days; x) Feeding the apparatus with pepsin, pancreatic juice, nutritional medium and active ingredients, for up to 14 days; xi) Maintaining of anaerobiosis using a nitrogen generator; and xii) Removing of sample aliquots from the reactors (Official Notice is taken that cleaning laboratory equipment using hot water, activated chlorine, 70% isopropyl alcohol, distilled water, autoclave, and detergents, as well as reassembling equipment components after cleaning, are well known and common practices; also Chen page 11, “height control module module and liquid level for calibrating the pH: pH probe calibration initialization is finished, click value module, a 3 calibration button, which are respectively pH4, pH7.01, PH9.18. the pH probe to wash pH module, into pH4 standard buffer solution, clicking pH4 button, namely lockingpH4 voltage by the user, repeating the step, locking pH7.01 and 9.18 voltage, the real-time pH value is two-point or three-point connection is corresponding to the voltage value; the altimeter calibration after the initialization is finished,” showing calibration of equipment before use; also Chen page 11, “extracting and inoculating human fecal microbial”; also Chen page 5, “mode employs a liquid food component comprises arabinogalactan, starch, glucose, pectin, xylan, peptone, cysteine, yeast extract, mucus, gastric acid comprises hydrochloric acid and pepsin into small intestinal fluid comprises: cholate, pancreatin and ammonium bicarbonate;”; also Chen page 11, “filling nitrogen to keep anaerobic environment”; also Chen page 14, “taking the litter mixture 100 g, anaerobic conditions in the 1 L culture medium to culture, after 24 hours, the 100 mL culture by sterilizing gauze to remove large particulate matter is transferred to an anaerobic tank,” removing sample aliquots; also note that specific durations given are a matter of design choice that are dependent on the design of the simulation).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Yu and Decker, and in further view of Marzorati et al. (hereinafter “Marzorati,” US 2012/0058551).
Regarding claim 17, Chen in view of Yu and Decker does not explicitly teach wherein x) comprises feeding prebiotics, probiotics, postbiotics, or symbiotics.
However, Marzorati discloses wherein x) comprises feeding prebiotics, probiotics, postbiotics, or symbiotics (Marzorati [0162], “This adhesion module of the invention when implemented in the SHIME or the extended SHIME can be used for developing and testing probiotic, prebiotic or synbiotic foods and their effects on the gastrointestinal microflora in particular their effects on adhesion and the respective host cellular response”).
Marzorati is analogous to Chen in view of Yu and Decker, as both are drawn to the art of simulating biological processes. It would be obvious to try by one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method as taught by Chen in view of Yu and Decker, to include wherein x) comprises feeding prebiotics, probiotics, postbiotics, or symbiotics, as taught by Marzorati, since it uses a known technique of feeding to improve similar methods in the same way. Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Roughead et al. (US 2012/0269865) Nutritional composition for promoting gut microbiota balance and health
Daguet (US 2015/0306162) Use of a composition comprising Arabic gum (AG) for improving gut impermeability
Zhan et al. (US 2019/0228681) Visual bionic digestive system for human gastrointestinal tract model
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/STEPHEN ALVESTEFFER/Examiner, Art Unit 3715
