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 .
DETAILED ACTION
Claims 26, 30-33 and 37-45 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 26, 30-33, and 37-39, and the species of Pediococcus sp., Myxococcus sp., and Clostridium sp., claims 26 and 30-32 in the reply filed on 9/8/2025 is acknowledged.
Claims 33 and 37-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/8/2025.
Claims 26 and 30-32 are examined herein.
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 31-32 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 31 recites the pharmaceutical composition further comprises an excipient comprising water, NaCl, normal saline solutions, lactated Ringer’s, normal sucrose, normal glucose, or a combination thereof. There is no definition for normal sucrose or normal saline provided within the specification. Unlike normal saline, which is 0.9% NaCl, or lactated Ringer’s, which has an art-recognized composition (see Rout, 2025 website; “Lactated Ringer Solution”), there is no art-recognized definition for normal sucrose or normal glucose. Therefore, the person of ordinary skill in the art would have been unable to ascertain the metes and bounds of the claim.
Claim 32 is rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 26 and 30-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a product of nature without significantly more.
A flowchart has been established to determine subject matter eligibility under 35 U.S.C. 101. See MPEP 2106 part (III) and 2106.04 part (II)(A). The flowchart comprises answering: Step 1) Is the claim to a process, machine, manufacture or composition of matter? Step 2A Prong One) Does the claim recite an abstract idea, law of nature or natural phenomenon? Step 2A Prong Two) Does the claim recite additional elements that integrate the judicial exception into a practical application? Step 2B) Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.
Claim 26 is drawn to a pharmaceutical composition comprising Pediococcus pentosaceus, Myxococcus xanthus, and Clostridium hiranonis. Claim 26 is a composition of matter, which is one of the four statutory categories of invention (Step 1: Yes). Claim 26 recites the judicial exception of a product of nature because each of the bacteria are naturally occurring. For example, strains of Myxococcus xanthus are isolated from soil (BacDive1, Title), strains of Peptacetobacter hiranonis (synonym for Clostridium hiranonis) are isolated from human feces (BacDive2, Title), and strains of Pediococcus pentosaceus are isolated from barley (BacDive3, Title). There is no evidence of record to support that the combination has markedly different characteristics than a product of nature because genotypes of the bacteria in combination are unchanged as compared to their individual counterparts as they occur in nature (Step 2A Prong One: Yes). The claim does not recite additional elements that integrate the judicial exception into a practical application (Step 2A Prong Two: No). The preamble recites “a pharmaceutical composition,” but this is purely an intended use and does not meaningfully limit the judicial exception. There are no additional elements recited within the claim besides the judicial exception (Step 2B: No).
The same analysis applied to claim 26 above (Step 1: Yes, Step 2A Prong One: Yes, Step 2A prong Two: No) also applies to dependent claims 30-32. Step 2B is analyzed below for each claim.
Claim 30 recites that the composition further comprises an auxiliary agent comprising lubricants, preservatives, stabilizers, buffers, coloring, or a combination thereof. There is no evidence of record to support that the addition of the auxiliary agent alters the properties of the composition such that the composition has markedly different characteristics than a product of nature, so the analysis for Step 2A Prong One is unchanged. Furthermore, the auxiliary agent may also be a product of nature (e.g. naturally-occurring coloring). See Chaudhari et al. (Int J Adv Pharm Biol Chem 1.1 (2012): 21-34; Excipients based on their origin, pages 21-22: Animal source, vegetable source, mineral source). Each of these components is recited at a high level of generality and is well-understood, routine, and conventional in the pharmaceutical sciences (see Chaudhari et al.; Classification of excipients based on their functions, left column), so the additional elements do not amount to significantly more than the judicial exception (Step 2B: No).
Claim 31 recites that the composition further comprises an excipient comprising water, NaCl, normal saline solutions, lactated Ringer’s, normal sucrose, normal glucose, or a combination thereof. There is no evidence of record to support that the addition of any of the excipients alters the properties of the composition such that the composition has markedly different characteristics than a product of nature, so the analysis for Step 2A Prong One is unchanged. Each of these components is well-understood, routine, and conventional in the pharmaceutical sciences (Step 2B: No). See Pramanick et al. (Pharma Times 45.3 (2013): 65-77l the Excipients column in the Table spanning pages 66-68, which includes sodium chloride, and Table 1 on page 66, which includes both sucrose and glucose).
Claim 32 recites that the pharmaceutical composition is a capsule or a suspension. Desiccated bacteria exist naturally as powders and the presence of the capsule merely serves as a container for the judicial exception. Likewise, bacteria occur naturally in liquids as a suspension. Furthermore, these elements are well-understood, routine, and conventional in the pharmaceutical sciences (Step 2B: No). Therefore, the embodiments in which the pharmaceutical composition is a capsule or a suspension are ineligible under 35 U.S.C. 101. However, the embodiment in which the pharmaceutical composition is a tablet is eligible under 35 U.S.C. 101 because bacteria do not naturally exist in a tablet and formulation of bacteria as a tablet requires transformation of the bacteria into a different physiological state.
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 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.
Claims 26 and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Cook (WO 2015/095241 A2) in view of Jonganurakkun et al. (Journal of Bioscience and Bioengineering 106.1 (2008): 69-73) and Ruiz et al. (Microbiology 131.8 (1985): 2035-2039).
Cook teaches a pharmaceutical composition for the treatment, inhibition or prevention of immune disorders such as allergies and asthma comprising Clostridium hiranonis (Abstract and [0059]). In some embodiments, the composition comprises Pediococcus pentosaceus ([0062]). Cook teaches that the bacteria are provided as purified populations ([0084]). Cook teaches that the composition reduces or inhibits inflammation associated with allergic disease ([0068]).
Cook does not exemplify a composition comprising both Clostridium hiranonis and Pediococcus pentosaceus. Cook does not teach that the composition further comprises Myxococcus xanthus.
Jonganurakkun teaches that Pediococcus pentosaceus NB-17 inhibits allergies (Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Jonganurakkun’s Pediococcus pentosaceus NB-17 with the composition of Cook in order to inhibit allergies. The composition of Cook inhibits allergies and so does Jonganurakkun’s Pediococcus pentosaceus NB-17, so both compositions are art-recognized equivalents for the same purpose. See MPEP 2144.06(I): combining equivalents known for the same purpose.
Cook and Jonganurakkun do not teach that composition further comprises Myxococcus xanthus.
Ruiz teaches that administering myxospores of Myxococcus xanthus causes non-specific modulation of humoral and cellular immune responses in laboratory animals (Abstract). In contrast with Gram-negative bacteria, Ruiz teaches that Myxococcus xanthus do not induce a rapid or potent inflammatory response (Discussion paragraph 2 on page 2039). Furthermore, delayed-type hypersensitivity to sheep erythrocytes (measured as footpad swelling) is also suppressed in mice after intraperitoneal injection (Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Ruiz’s Myxococcus xanthus with the composition of Cook and Jonganurakkun in order to further improve the composition by increasing its anti-inflammatory properties. The person of ordinary skill in the art would have been motivated by the teaching of Ruiz, which suggests that Myxococcus xanthus suppresses delayed-type hypersensitivity (a type of delayed inflammatory response to an antigen). The person of ordinary skill in the art would have had a reasonable expectation of success in the combination given that Ruiz teaches that Myxococcus xanthus reduces inflammation when administered intraperitoneally.
Regarding claim 30, Cook teaches that the pharmaceutical composition may further comprise a stabilizer or a preservative, ([0082]), coloring ([0091]), buffer ([0096]), or a lubricant ([0090] on page 36).
Regarding claim 31, Cook teaches liquid preparations of the bacteria comprising glucose (0090]). Cook also teaches the composition may further comprise water ([0087]).
Regarding claim 32, Cook teaches the composition is a capsule or a tablet ([0090]) or a suspension ([0091]).
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 26 and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-18 of U.S. Patent No. 12,018,327 (‘327) in view of Cook (WO 2015/095241 A2).
Claims 1 and 18 of ‘327 are drawn to a method of treating atopy (genetic predisposition to develop allergic conditions caused by an overactive immune system) or reducing the likelihood of atopy in a subject in need thereof comprising: (f) administering an effective amount of at least one of a (iv) Myxococcus xanthus and (v) Pediococcus pentosaceus. Claims 2-17 of ‘327 further limit the method of claim 1.
Claims 1-18 of ‘327 do not recite that the bacteria are purified. However, since the composition is intended to be administered to a subject in need thereof, it would have been obvious to purify the bacterial population in order to avoid introducing contaminants into the subject, as suggested by Cook [0084]. The person of ordinary skill in the art would have had a reasonable expectation of success in purifying the bacteria.
Claims 1-18 of ‘327 do not recite that the composition further comprises Clostridium hiranonis.
Cook teaches a pharmaceutical composition for the treatment, inhibition or prevention of immune disorders such as allergies and asthma comprising Clostridium hiranonis (Abstract and [0059])) In some embodiments, the composition comprises Pediococcus pentosaceus ([0062]), although Cook does not exemplify a composition with both C. hiranonis and P. pentosaceus. Cook teaches that the bacteria are provided as purified populations ([0084]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Cook’s Clostridium hiranonis with the composition of claims 1-18 of ‘327. The composition of claims 1-18 of ‘327 prevents allergies and so does the composition of Cook, so both compositions are art-recognized equivalents for the same. See MPEP 2144.06(I): combining equivalents known for the same purpose
Regarding claim 30, claims 1-18 of ‘327 do not recite that the pharmaceutical composition further comprises a stabilizer, preservative, coloring, buffer, or lubricant.
Cook teaches that the pharmaceutical composition may further comprise a stabilizer or a preservative, ([0082]), coloring ([0091]), buffer ([0096]), or a lubricant ([0090] on page 36).
Regarding claim 31, claims 1-18 of ‘327 do not recite that the pharmaceutical composition further comprises water or glucose.
Cook teaches liquid preparations of the bacteria comprising glucose (0090]). Cook also teaches the composition may further comprise water ([0087]).
Regarding claim 32, claims 1-18 of ‘327 do not recite that the pharmaceutical composition is a capsule, tablet, or suspension.
Cook teaches the composition is a capsule or a tablet ([0090]) or a suspension ([0091]).
It would have been further obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the composition of claims 1-18 of ‘327 with any of the excipients taught by Cook (a stabilizer, a preservative, coloring, a buffer, a lubricant, water or glucose) and to formulate the composition as a capsule, tablet, or suspension, as taught by Cook. The person of ordinary skill in the art would have been motivated to apply the teachings of Cook because Cook also teaches a composition comprising bacteria for the prevention of allergies. Thus, the person of ordinary skill in the art would have had a reasonable expectation of success.
Claims 26 and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,033,588 (‘588) in view of Cook (WO 2015/095241 A2), Jonganurakkun et al. (Journal of Bioscience and Bioengineering 106.1 (2008): 69-73) and Ruiz et al. (Microbiology 131.8 (1985): 2035-2039).
Claim 1 of ‘588 is drawn to a pharmaceutical composition, comprising: a purified bacterial population comprising a strain of Lactobacillus sp., Faecalibacterium sp., and Akkermansia sp., wherein the purified bacterial population is present in an effective amount for reducing the incidence of allergic inflammation in a subject in need thereof, and wherein the pharmaceutical composition is in the form of a suspension. Claims 2-19 of ‘588 further limit the method of claim 1 of ‘588.
Claim 12 of ‘588 requires composition comprises a pharmaceutically acceptable excipient.
Claim 13 of ‘588 requires that the pharmaceutically acceptable excipient comprises saline solution, glycerin, or a combination thereof.
Claims 1-19 of ‘588 do not recite that the composition comprises Pediococcus pentosaceus, Myxococcus xanthus, and Clostridium hiranonis.
Cook teaches a pharmaceutical composition for the treatment, inhibition or prevention of immune disorders such as allergies and asthma comprising Clostridium hiranonis (Abstract and [0059])) In some embodiments, the composition comprises Pediococcus pentosaceus ([0062]), although Cook does not exemplify a composition with both C. hiranonis and P. pentosaceus. Cook teaches that the bacteria are provided as purified populations ([0084]). Cook teaches that the composition reduces or inhibits inflammation associated with allergic disease ([0068]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the composition of Cook comprising Clostridium hiranonis with the composition of claims 1-19 of ‘588. Both compositions are art-recognized equivalents for the same purpose because they both reduce or inhibit inflammation associated with allergic disease. See MPEP 2144.06(I): combining equivalents known for the same purpose.
Claims 1-19 of ‘588 do not recite and Cook does not teach that the composition further comprises Pediococcus pentosaceus.
Jonganurakkun teaches that Pediococcus pentosaceus NB-17 inhibits allergies (Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Jonganurakkun’s Pediococcus pentosaceus NB-17 with the composition of claims 1-19 of ‘588 modified by Cook because of the strain’s property to inhibit allergies, which would also have been desirable in a composition intended to inhibit allergic inflammation. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination of compositions both beneficial for the treatment of allergies.
Claims 1-19 of ‘588 do not recite and Cook and Jonganurakkun do not teach that the composition further comprises Myxococcus xanthus.
Ruiz teaches that administering myxospores of Myxococcus xanthus causes non-specific modulation of humoral and cellular immune responses in laboratory animals (Abstract). In contrast with Gram-negative bacteria, Ruiz teaches that Myxococcus xanthus do not induce a rapid or potent inflammatory response (Discussion paragraph 2 on page 2039). Furthermore, delayed-type hypersensitivity to sheep erythrocytes (measured as footpad swelling) is also suppressed in mice after intraperitoneal injection (Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Ruiz’s Myxococcus xanthus with the composition of claims 1-19 of ‘588 modified by Cook and Jonganurakkun in order to further improve the composition by increasing its anti-inflammatory properties. The person of ordinary skill in the art would have been motivated by the teaching of Ruiz, which suggests that Myxococcus xanthus suppresses delayed-type hypersensitivity (a type of delayed inflammatory response to an antigen). The person of ordinary skill in the art would have had a reasonable expectation of success in the combination given that Ruiz teaches that Myxococcus xanthus reduces inflammation when administered intraperitoneally.
Regarding claim 30, claims 1-19 of ‘588 do not recite that the composition comprises a stabilizer, a preservative, coloring, or a buffer.
Cook teaches that the pharmaceutical composition may further comprise a stabilizer or a preservative, ([0082]), coloring ([0091]), or a buffer ([0096]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the composition of claims 1-19 of ‘588 modified by Cook, Jonganurakkun, and Ruiz with any of the agents taught by Cook (a stabilizer, a preservative, coloring, or a buffer). Each of these agents has an obvious use (stabilizes, preserving, coloring, and maintaining pH) that would have been beneficial to the pharmaceutical composition. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Regarding claim 31, claim 12 of ‘588 requires that the composition comprises a pharmaceutically acceptable excipient. Claim 13 of ‘588 requires that the pharmaceutically acceptable excipient comprises saline solution (synonym for NaCl), glycerin, or a combination thereof.
Regarding claim 32, claim 1 of ‘588 requires that the composition is a suspension.
Claims 26 and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 and 26 of U.S. Patent No. 10,668,118 (‘118) in view of Cook (WO 2015/095241 A2), Jonganurakkun et al. (Journal of Bioscience and Bioengineering 106.1 (2008): 69-73) and Ruiz et al. (Microbiology 131.8 (1985): 2035-2039).
Claim 1 of ‘118 is drawn to a method of treating or reducing the incidence of allergic inflammation, the method comprising administering a bacterial population comprising isolates of at least: Lactobacillus sp., Faecalibacterium sp., and Akkermansia muciniphila to a subject in need thereof, wherein the bacterial population is present in an effective amount for treating or reducing the incidence of allergic inflammation in the subject. Claims 2-24 and 26 further limit the method of claim 1 of ‘118.
Claims 1-24 and 26 of ‘118 do not recite that the composition comprises Pediococcus pentosaceus, Myxococcus xanthus, and Clostridium hiranonis.
Cook teaches a pharmaceutical composition for the treatment, inhibition or prevention of immune disorders such as allergies and asthma comprising Clostridium hiranonis (Abstract and [0059])) In some embodiments, the composition comprises Pediococcus pentosaceus ([0062]), although Cook does not exemplify a composition with both C. hiranonis and P. pentosaceus. Cook teaches that the bacteria are provided as purified populations ([0084]). Cook teaches that the composition reduces or inhibits inflammation associated with allergic disease ([0068]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the composition of Cook comprising Clostridium hiranonis with the composition of claims 1-24 and 26 of ‘118. Both compositions are art-recognized equivalents for the same purpose because they both reduce or inhibit inflammation associated with allergic disease. Therefore, both compositions are art-recognized equivalents for the same purpose. See MPEP 2144.06(I): combining equivalents known for the same purpose.
Claims 1-24 and 26 of ‘118 do not recite and Cook does not teach that the composition further comprises Myxococcus xanthus.
Jonganurakkun teaches that Pediococcus pentosaceus NB-17 inhibits allergies (Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Jonganurakkun’s Pediococcus pentosaceus NB-17 with the composition of claims 1-24 and 26 of ‘118 modified by Cook because of its property to inhibit allergies, which would also have been desirable in a composition intended to inhibit allergic inflammation. The person of ordinary skill in the art would have had a reasonable expectation of success in the combination.
Claims 1-24 and 26 of ‘118 do not recite and Cook and Jonganurakkun do not teach that the composition further comprises Myxococcus xanthus.
Ruiz teaches that administering myxospores of Myxococcus xanthus causes non-specific modulation of humoral and cellular immune responses in laboratory animals (Abstract). In contrast with Gram-negative bacteria, Ruiz teaches that Myxococcus xanthus do not induce a rapid or potent inflammatory response (Discussion paragraph 2 on page 2039). Furthermore, delayed-type hypersensitivity to sheep erythrocytes (measured as footpad swelling) is also suppressed in mice after intraperitoneal injection (Abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Ruiz’s Myxococcus xanthus with the composition of claims 1-24 and 26 of ‘118 modified by Cook and Jonganurakkun in order to further improve the composition by increasing its anti-inflammatory properties. The person of ordinary skill in the art would have been motivated by the teaching of Ruiz, which suggests that Myxococcus xanthus suppresses delayed-type hypersensitivity (a type of delayed inflammatory response to an antigen). The person of ordinary skill in the art would have had a reasonable expectation of success in the combination given that Ruiz teaches that Myxococcus xanthus reduces inflammation when administered intraperitoneally.
Regarding claim 30, claims 1-24 and 26 of ‘118 do not recite that the composition comprises a stabilizer, a preservative, coloring, a buffer, or a lubricant.
Cook teaches that the pharmaceutical composition may further comprise a stabilizer or a preservative, ([0082]), coloring ([0091]), buffer ([0096]), or a lubricant ([0090] on page 36).
Regarding claim 31, claims 1-24 and 26 of ‘118 do not recite that the composition comprises glucose or water.
Cook teaches liquid preparations of the bacteria comprising glucose (0090]). Cook also teaches the composition may further comprise water ([0087]).
Regarding claim 32, claims 1-24 and 26 of ‘118 do not recite that the composition is a capsule, a tablet, or a suspension.
Cook teaches the composition is a capsule or a tablet ([0090]) or a suspension ([0091]).
It would have been further obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the composition of claims 1-24 and 26 of ‘118 with any of the excipients taught by Cook (a stabilizer, a preservative, coloring, a buffer, a lubricant, water or glucose) and to formulate the composition as a capsule, tablet, or suspension, as taught by Cook. The person of ordinary skill in the art would have been motivated to apply the teachings of Cook because Cook also teaches a composition comprising bacteria for the prevention of allergies. Thus, the person of ordinary skill in the art would have had a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657