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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 159-161 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 159 recites the limitation "cultured microbiome". There is insufficient antecedent basis for this limitation in the claim, as a cultured microbiome has not been previously recited. Claims 160-161 recite “the cultured microbiome”. These claims depend from claim 157, which depends from claim 148. Neither claim 157 or 148 recites a cultured microbiome.
Claims 160-161 recite “the fecal sample”. There is insufficient antecedent basis for this limitation in the claim, as a fecal sample has not been previously recited. These claims depend from claim 157, which depends from claim 148. Neither claim 157 or 148 recites a fecal sample.
As it is not clear exactly what the recited elements “cultured microbiome” and “fecal sample” are referring to, it is unclear how to interpret these elements in the claims. How exactly do these elements fit into the method claims? Is the cultured microbiome the resulting product? An input product that is further cultured? Likewise is the fecal sample an input product or the product that is a result of the co-culturing?
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 148-158 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Lab Chip, 2012, cited in IDS filed on July 25, 2023) in view of Maier et al. (Nutrients, 2014).
The claims are directed to a method of culturing obligate anaerobes and parenchyma cells in a microfluidic device such that at least a portion of the obligate anaerobes and a portion of the parenchyma cells are in direct contact.
Kim et al. teaches a human gut-on-a-chip, an in vitro living cell-based model of the intestine that mimics the human gut. (entire doc, esp. abstract). The device has two microfluidic channels separated by a porous flexible membrane coated with extracellular matrix cells (ECM) and lined with human intestinal epithelial (Caco-2) cells; Lactobacillus rhamnosus GG is co-cultured on the luminal side of the cultured epithelium. (entire doc, abstract).
Kim et al. teaches culturing an anaerobe (Lactobacillus rhamnosus GG) in direct contact with parenchyma cells (human intestinal epithelial) in a microfluidic device. Lactobacillus rhamnosus GG is a facultative anaerobe microbe, not an obligate anaerobe, as the claims require.
Maier et al. teach that the model taught by Kim et al. could be modified to include the dual-environment conditions required to study the effects of obligate anaerobic bacteria on intestinal function, as dual-environment co-culture models have been developed and can be adapted. (pg. 62, 1st full para.).
It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have modified the gut-on-a-chip taught by Kim et al. to incorporate dual-environment conditions such that obligate anerobic bacteria could be directly cultured on the intestinal epithelial cells in place of or in addition to the Lactobacillus rhamnosus GG because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Incorporating this modification (as taught by Maier et al.) would have led to predictable results with a reasonable expectation of success because Maier et al. teaches exactly this modification.
With respect to claim 149, Kim et al. teach that Lactobacillus rhamnosus GG was originally isolated from the human gut (“contents of a cavity”). (pg. 2168, 2nd col., “Microbial studies”).
With respect to claim 150, Kim et al. teach human intestinal epithelial (Caco-2) cells. (abstract).
With respect to claim 151, Maier et al. teach that the dual-environment co-culture models will enable culturing of obligate anaerobic intestinal bacteria, which are abundant but our understanding of them remains limited, at least partly due to our inability to co-culture these bacteria. (Abstract). It would be obvious to, in addition to investigating the effects of the unstudied majority of intestinal microorganisms, to also identify some of the unstudied intestinal microorganisms, as many of them are unstudied because they are also currently unknown. (Abstract, pg. 46-47, “The Human Intestinal Microbiota”).
With respect to claim 152, Kim et al. teach flowing media at a flow rate. (Abstract).
With respect to claim 153, Kim et al. teach the microfluidic device has a second microchannel positioned below a first microchannel and separated by a membrane. (Abstract)
With respect to claim 154, Maier et al. teach dual-environment co-culture models where oxygenated medium flows through a second microchannel from external oxygenated medium reservoir. (Pg. 61, Fig. 2B).
With respect to claims 156-158, Kim et al. teach that culturing happens for greater than a week. (Abstract).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 148-158 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,807,871 (the ‘871 patent) in view of Kim et al. (Lab Chip, 2012, cited in IDS filed on July 25, 2023) in view of Maier et al. (Nutrients, 2014).
The ‘871 patent teaches a method for establishing a stable complex community of gut commensal microbes in vitro that including culturing intestinal epithelium and microbiota from a fecal sample with anaerobic and aerobic bacteria that are in direct and indirect contact with the epithelium, but does not teach the claimed microfluidic device.
Kim et al. teaches a human gut-on-a-chip, an in vitro living cell-based model of the intestine that mimics the human gut. (entire doc, esp. abstract). The device has two microfluidic channels separated by a porous flexible membrane coated with extracellular matrix cells (ECM) and lined with human intestinal epithelial (Caco-2) cells; Lactobacillus rhamnosus GG is co-cultured on the luminal side of the cultured epithelium. (entire doc, abstract).
Maier et al. teach that the model taught by Kim et al. could be modified to include the dual-environment conditions required to study the effects of obligate anaerobic bacteria on intestinal function, as dual-environment co-culture models have been developed and can be adapted. (pg. 62, 1st full para.).
It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by the ‘871 patent to include the gut-on-a-chip taught by Kim et al. with the dual-environment conditions such that obligate anerobic bacteria could be directly cultured on the intestinal epithelial cells in place of or in addition to the Lactobacillus rhamnosus GG (as taught by Maier et al.) because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Incorporating these modification (as taught by Kim et al. and Maier et al.) would have led to predictable results with a reasonable expectation of success because Kim et al. teaches the claimed microfluidic device and Maier et al. teaches exactly the modifications for enabling dual-environment co-culture to enable culturing of gut commensal microbes in vitro.
With respect to claim 149, Kim et al. teach that Lactobacillus rhamnosus GG was originally isolated from the human gut (“contents of a cavity”). (pg. 2168, 2nd col., “Microbial studies”).
With respect to claim 150, Kim et al. teach human intestinal epithelial (Caco-2) cells. (abstract).
With respect to claim 151, Maier et al. teach that the dual-environment co-culture models will enable culturing of obligate anaerobic intestinal bacteria, which are abundant but our understanding of them remains limited, at least partly due to our inability to co-culture these bacteria. (Abstract). It would be obvious to, in addition to investigating the effects of the unstudied majority of intestinal microorganisms, to also identify some of the unstudied intestinal microorganisms, as many of them are unstudied because they are also currently unknown. (Abstract, pg. 46-47, “The Human Intestinal Microbiota”).
With respect to claim 152, Kim et al. teach flowing media at a flow rate. (Abstract).
With respect to claim 153, Kim et al. teach the microfluidic device has a second microchannel positioned below a first microchannel and separated by a membrane. (Abstract)
With respect to claim 154, Maier et al. teach dual-environment co-culture models where oxygenated medium flows through a second microchannel from external oxygenated medium reservoir. (Pg. 61, Fig. 2B).
With respect to claims 156-158, Kim et al. teach that culturing happens for greater than a week. (Abstract).
Conclusion
No claims are allowed.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634