DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of a composition comprising (i) oxygen-scavenging membrane fragments and/or membrane vesicles derived from bacteria Escherichia coli; and (ii) succinic acid as a hydrogen donating substance in the reply filed on May 19, 2025 is acknowledged.
Claim(s) 4 and 13 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 19, 2025.
Claim(s) 1-3, 5-12, and 14-18 are currently under examination.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Specification and Claim Objections
The disclosure is objected to because of the following informalities:
The specification contains the term “Escherichia coli” which should be italicized according to conventional scientific notation for genus and species names (e.g. Specification [0066]-[0067]). Corrections should be made in each instance in the specification and claims.
The specification contains the terms “OXYRASE” (e.g. Specification, paragraphs [0012], [0024] and [0066]-[0069], Examples 1-4) and "Tween” (e.g. Specification, paragraph [0088]) which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim 11 recites “the method of claim 10, wherein the cryoprotectant is s glycerol”. Appropriate correction is required.
Please note the above are considered necessary grammatical corrections; however, it is not exhaustive of all possible informalities, as examination is not made for the purpose of securing grammatical perfection (See MPEP 601.01(g)). Appropriate correction is required.
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.
Claim 8 is 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 8 contains the trademark/trade name “OXYRASE.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the composition comprising oxygen-scavenging membrane fragments and/or membrane vesicles, and, accordingly, the identification/description is indefinite.
Claim Rejections – 35 USC § 102/103
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 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.
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) 1-3, 5, 8-12, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Copeland, J. (US 2020/0353017 A1).
MPEP § 2112 provides guidance as to the Examiner' s burden of proof for a rejection of claims under 35 U.S.C. 102 or 103 based upon the express, implicit, and inherent disclosures of a prior art reference. The case law clearly states that something which is old does not become patentable upon the discovery of a new property.
The instant claims are as of record, drawn broadly to a method of treating a disease or condition associated with gut inflammation comprising administering to a patient in need thereof a therapeutically effective amount of a composition comprising oxygen-scavenging membrane fragments and/or membrane vesicles.
Copeland, J. broadly teaches method(s) and composition(s) for inhibiting or reducing tumor metabolism, growth and/or proliferation (i.e. broadly inclusive of polyps, cancer and diverticulitis), through administration of a composition comprising oxygen scavenging membrane fragments (e.g. Oxyrase™) and cryoprotectant (e.g. glycerol) (Specification, paragraph(s) [0005] and [0035]), as required in the instant claim(s) 1-3, 5, 8-12, and 14-15.
Copeland, J. broadly teaches oxygen reducing membrane fragments are believed to create an anaerobic environment within the tumor which inhibits growth and/or results in cell death (Specification, paragraph [0005]). Copeland, J. further teaches the tumor treated by these methods can comprise colon tumors (Specification, paragraph(s) [0013]; claim 10), as required in the instant claim 1 and claims dependent thereto.
Copeland, J. teaches the oxygen scavenging membrane fragments can be derived from bacterial membranes (e.g. Escherichia coli, Salmonella typhimurium, Acetobacter, et al.) (Specification, paragraph(s) [0010] & [0041]), as required in the instant claim(s) 2 and 3.
Copeland, J. further teaches the composition can further comprise a hydrogen donating substance (e.g. lactic acid, succinic acid, formic acid, et al.) (Specification, paragraph(s) [0011] & [0040]), as required in the instant claim(s) 12, 14.
Copeland, J. teaches the composition may be in the form of an injection, solution, suspension or emulsion (Specification, paragraph [0012]), as required in the instant claim 15.
Copeland, J. teaches the composition may contain oxygen-scavenging membrane fragments in an amount of about 0.01 units/mL to about 100 units/mL, or from about 0.01 units/mL to about 10 units/mL, or from about 0.3 unit/mL to about 10 units/mL, or from about 0.3 unit/mL to about 10 units/mL, or from about 1 unit/mL to about 10 units/mL (Specification, paragraph(s) [0012]) as required in the instant claim 5. Copeland further teaches the term “about” may refer to plus or minus 10% of the indicated number (Specification, paragraph [0034]).
Copeland, J. teaches the composition may include glycerol or polyethylene glycol as a cryoprotectant to enhance stability of the composition. (Specification, paragraph [0016]), as required in the instant claim 10. Copeland, J. further teaches the cryoprotectant may contain cryoprotectant in an amount of about 15% by weight to about 65% by weight, or from about 50 wt % to about 65 wt %. (Specification, paragraph [0016]), as required in the instant claim 11.
The cited art taken as a whole demonstrates that Copeland, J. is either identical or sufficiently similar to the claimed method that whatever differences exist, they are not patentably significant.
The cited reference discloses method(s) (and compositions relating thereto) of inhibiting or reducing tumor metabolism, growth and/or proliferation (i.e. broadly inclusive of polyps, cancer and diverticulitis), through administration of a composition comprising oxygen scavenging membrane fragments (e.g. Oxyrase™), which appears to be identical to the presently claimed method(s) and composition(s) for treating a disease or condition associated with gut inflammation (e.g. broadly inclusive of colon cancer, polyp(s), diverticulitis) since it is formulated and/or obtained from the same component materials and is administered/administrable to a subject. Consequently, the claimed method(s) appear to be anticipated by the reference. In the alternative, even if the method(s) (and compositions relating thereto) are not identical to the referenced method, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics as of in the claimed process, particularly in view of the similar characteristics which they have been shown to share (e.g. similar step(s), component materials/formulations and the same broad administration). Thus, the claimed method and compositions relating thereto would have at least been obvious to those of ordinary skill in the art within the meaning of 35 U.S.C. § 103(a).
Claim(s) 6, 7 and 16-18 is/are rejected under 35 U.S.C. 103 as obvious over Copeland, J. (US 2020/0353017 A1), as applied to claim(s) 1-3, 5, 8-12, and 14-15 above, in view of Terzic, et al. “Inflammation and Colon Cancer” Gastroenterology, Volume 138, Issue 6, 2101 - 2114.e5.
The instant claims and teaching of Copeland, et al. are of record above.
Although Copeland, J. broadly teaches each of the step(s) in the claimed method(s) (and composition(s) relating thereto), the reference is silent regarding the composition is administered as a parabiotic to prevent inflammatory bowel disease development (instant claim 6) and to maintain microbiome diversity (instant claim 7) and the methods of administration being orally, rectally and/or intracolonically (instant claim(s) 16-18).
Terzic, et al. broadly teaches there is a well-established connection between gut inflammation and tumorigenesis (see Abstract). Terzic, et al. teaches Inflammatory Bowel Disease (IBD) and inflammation generally is likely to be involved with colon and other forms of gut cancers. (see Whole document). Terzic, et al. further teaches that under certain conditions, anti-inflammatory agents may be effective in treating Colitis-associated cancer (CAC) (see page 2112). Moreover, Terzic, et al. teaches that growth and progression of colorectal tumors and colitis-associated tumors depends on the quality and quantity of intestinal microflora. (page 2103, Table 1).
Thus, it would have been obvious to one of ordinary skill in the art to apply the method(s)/composition(s) of Copeland, J. to treat diseases/disorders associated with gut inflammation (broadly, prophylactically administer the instant composition as a parabiotic to prevent IBD (as required in instant claim 6) and to maintain microbiome diversity (as required in instant claim 7)) based on the teachings of Terzic, et al., that gut inflammation is coextensive with tumors (i.e. broadly colon cancer). One of ordinary skill in the art would have been motivated to combine these teachings particularly where the instant is a single-step method of administering oxygen scavenging membrane fragments to treat a tumor and/or cancer (i.e. a disease and/or disorder associated with gut inflammation, e.g. colon cancer), and thus the properties of the oxygen scavenging membrane fragments themselves are inherent, especially in the absence of evidence to the contrary (See MPEP §§ 2112-2112.02), as required in claims 6 and 7.
Copeland, J. and Terzic, et al. are relied upon the reasons discussed above. If not expressly taught by the references, based upon the overall beneficial teaching provided by these references with respect to the ingredients of the composition(s) and the method(s) of making and/or using disclosed therein, including the routine selection of routes of administration being orally, rectally and/or intracolonically (instant claim(s) 16-18), is/are deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Moreover, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In this particular case, for treatment of diseases and/or disorders associated with gut inflammation, there are a finite number of alternative routes of administration that are direct and/or indirect, including oral, rectal and intracolonic administration, as required in the instant claim(s) 16-18. There is no evidence to suggest the route of administration is critical and/or produces an unexpected result. Thus, absent some demonstration of unexpected results or criticality from the claimed parameters, this optimization would have been obvious before the effective filing date of applicant’s claimed invention.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within the processes thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Relevant Art
The relevant art and/or prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure, including the following:
Fábrega, et al., (“Intestinal Anti-inflammatory Effects of Outer Membrane Vesicles from Escherichia coli Nissle 1917 in DSS-Experimental Colitis in Mice.” Front Microbiol. 2017 Jul 11;8:1274.), considered relevant for broadly teaching a method of treating mucosal injury and gut inflammation (e.g. colitis) using outer membrane vesicles (OMVs) from bacteria (i.e. Escherichia coli Nissle 1917 (EcN)).
Conclusion
Currently no claim(s) are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vani G. Verkhovsky whose telephone number is (571)272-3777. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm EST.
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/V.G.V./Examiner, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655