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
The amendment filed on 06/11/2026 amended claims 1 and 3-15, cancelled claim 2, and added new claims 16-20. Claims 1 and 3-20 are pending and will be examined on the merits.
Response to Amendment
The amendment filed 06/11/2026 in response to the office action mailed 02/04/2026 is acknowledged. The rejections set forth under 35 USC §112(b), 101, and 102 are withdrawn for the following reasons:
The rejection of claims 3, 4, 6, 8, 9, and 14 under 35 USC §112(b) as being indefinite due to the use of “such as” and/or “preferably” have been withdrawn in light of the amendments to the claims.
The rejection of claims 2 and 3 under 35 USC §112(d) has been withdrawn due to the cancellation of claim 2 and the amendments to the claims.
The rejection of claims 1-15 under 35 USC §101 has been withdrawn in light of the amending of the claims to recite a method of treating.
The rejection of claims 1-13 under 35 USC §102 over Archer et al. is withdrawn in light of the amendment to the claims reciting a method of treating and/or alleviating inflammatory bowel disease or irritable bowel syndrome.
Maintained or modified rejections are set forth below, as necessitated by the amendments. Responses to arguments follow.
New 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 19 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 19 recites improper Markush group language. A proper Markush group should recite “selected from the group consisting of…” and the list should recite “and” at the end of the recited options. Claim 19 reads “[t]he method according to claim 9, wherein said yeast cells are selected from the group consisting of Saccharomyces carlsbergensis or Saccharomyces cerevisiae”. Examiner suggests amending the claim to recite “Saccharomyces carlsbergensis and Saccharomyces cerevisiae” to be consistent with proper Markush group terminology (see MPEP §2117).
Maintained Claim Rejections - 35 USC § 103 - Modified as Necessitated by Claim Amendments
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 3-20 are rejected under 35 U.S.C. 103 as being unpatentable over Archer et al., J Immuno Allerg; 2020:1(1):1-13 (hereinafter Archer) in view of Kotlyar et al., World J Gastroenterol; 2014: 20(32): 11023-11032.
The instant claims are drawn to a method of treating and/or alleviating inflammation and/or symptoms of inflammation, wherein the inflammation is inflammatory bowel disease or irritable bowel syndrome, including administering to a subject in need thereof a plurality of yeast cells, wherein the yeast cells have been treated with electromagnetic waves in the range of 1 GHz to 300 GHz, or said yeast cells have been grown from a yeast cell treated with electromagnetic waves in the range of 1 GHz to 300 GHz. Claim 3 further limits the inflammatory bowel disease to Crohn’s disease or ulcerative colitis (UC). Claims 4, 5, and 16 further limit the range of the waves, ultimately to about 45-60 GHz. Claims 6-8 and 17-18 limit the power density, frequency modulation, and exposure time for the treatment. Claims 9 and 19 further limit the yeast cell species. Claim 10 is drawn to administering a composition comprising yeast cells according to claim 1 and an excipient and/or carrier. Claims 11-13 further modify the composition of claim 10, with claim 11 stating that the composition further comprises at least one vitamin and/or at least one mineral, claim 12 indicating the composition is formulated for oral consumption, and claim 13 identifying the composition as a liquid. Claims 14 and 20 further limit the yeast cell concentration in the liquid composition of claim 13 to ‘from 20x106 CFUs/ml to 40x106 CFUs/ml’, and claim 15 states the composition is in the form of a powder.
Archer discloses the use of a treated yeast cell in the treatment and/or alleviation of allergy. This treated yeast cell has been treated with electromagnetic waves in the range of 1 GHz to 300 GHz, as stated in instant claim 1. Archer discloses the treatment of the yeast cell with electromagnetic waves in the range of 35 to about 65 GHz, thereby meeting the limitations of instant claims 4, 5, and 16. Archer also discloses electromagnetic waves with a power density below 1 mW/cm2, with a smaller range limitation of 0.004 – 0.2 mW/cm2 and specifically, 0.1 mW/cm2, meeting the limitations of instant claim 6 and 17. Archer discloses a treatment time of 20-120 minutes, which meets the limitations of instant claim 8 and 18. While the instant specification does not explicitly disclose what characteristics the treatment of instant claims 1-8 imposes on the yeast cell, the treatment process disclosed by Archer is similar enough to the instant claims that the yeast cell of Archer is assumed to have the same properties as that of the instant application, and would therefore be able to treat inflammation in a similar manner to the claimed yeast cell, thereby also meeting the limitations of claims 1-8. Archer discloses that the yeast cell is S. cerevisiae, or Saccharomyces cerevisiae (see page 4), meeting the limitations of claim 9 and 19. Archer discloses a suspension of treated yeast in a growth medium such as wort, meeting the limitations of the composition of claim 10. Wort is derived from barley or other plants, and therefore contains vitamins and minerals, meeting the limitations of claim 11. As this composition in Archer is administered as a drink, it is both suitable for oral intake and is a liquid, meeting the limitations of claims 12 and 13.
Archer does not explicitly disclose a culture with the concentration of yeast cells in an amount of from 10x106CFUs/ml to 50x106CFUs/ml, or the composition of claim 10 as a powder.
To reach a desired concentration of cells, such as in instant claim 14, one of ordinary skill in the art would need to identify when the yeast cells reach a desired concentration and abort the growth of the cells. Detecting CFU/mL is a common technique in the art, as is the process to halt growth, i.e., one simply must remove the cells from the optimal growing conditions. On page 5, when addressing the preparation of the liquid wort and yeast, Archer teaches “…growth may be aborted at any time, when a desired cell concentration is achieved.” Therefore, as the growth of the composition of Archer can be stopped by one of ordinary skill in the art when the concentration of yeast cells is 20x106 CFUs/ml to 40x106 CFUs/ml, it would be obvious to stop the growth of the cells of Archer at the desired concentration of 20x106 - 40x106 CFUs/ml for use in the composition of claim 14. One would be motivated to do so, as this is known in the art as a typical mid-log phase concentration of cells, and there is nothing in the instant specification to indicate that there is an advantage to this particular concentration of cells. There would be a reasonable expectation of success, as detecting CFU/mL is a common technique in the art, as is the process to halt growth. Therefore, to one of ordinary skill in the art, before the effective filing date of the invention, it would have been obvious to stop the growth of the yeast cells in the composition of Archer when the cells reached the desired concentration of 20x106 - 40x106 CFUs/ml, thereby meeting the limitations of claim 14.
Finally, Archer discloses “[o]ther forms of [the yeast composition], more amenable to pharmaceutical handling” (see page 11). One of ordinary skill in the art of pharmaceutical compositions would understand that a powder is the most common form of pharmaceutical substances, and thus most amenable to handling. One skilled in the art of pharmaceutical compositions would know how to convert a liquid composition into a powder. One would be motivated to do so, as Archer teaches, to improve pharmaceutical handling of the composition. There would be reasonable expectation of success, as conversion of a liquid to a powder is common in the art of pharmaceutical handling, and the invention does not disclose any special considerations on creating the powder (e.g., the yeast cells must be alive). Therefore, to one of ordinary skill in the art, before the effective filing date of the invention, it would have been obvious to convert the liquid composition of Archer into a powder composition to improve pharmaceutical handling, thereby meeting the limitations of instant claim 15.
As such, Archer discloses all limitations of the instant claims apart from the use of the yeast cells to treat and/or alleviate inflammation and/or symptoms of inflammation, wherein the inflammation is inflammatory bowel disease or irritable bowel syndrome. Instead, Archer teaches a method of administering the same yeast cells to treat and/or alleviate allergy.
Kotlyar et al. teach that clinical and pathophysiological similarities exist between the inflammatory responses of IBD and allergy, including commonalities in histamine, mast cell, and IgE responses (see abstract, whole document). Additionally, Kotlyar et al. recite that probiotics, including Saccharomyces species, are recommended for use in both IBD and allergy (see Tables 1-3, page 11025). Finally, Kotlyar et al. describe similarities in the inflammatory mechanisms behind IBD and intestinal allergic phenomena, such as maladaptive TH2-like responses, T regulatory cells, and upregulation of specific cytokines, which are also similar to those seen in chronic rhinosinusitis, another condition associated with allergy (see page 11028, right column).
Taken together, one of ordinary skill in the art of treating inflammation with probiotics would know that there are known similarities between the inflammatory responses of IBD and allergy. This overlap in etiologies would motivate one to repurpose a treatment for inflammation due to allergy as a treatment for inflammation due to inflammatory bowel disease. One would have a reasonable expectation of success, as the oral composition of Archer reaches the gastrointestinal tract and would therefore encounter the tissues affected by IBD inflammation. Additionally, one would have reasonable expectation of success as similar probiotics have been used to treat both allergy and IBD (See Table 1 of Kotlyar et al.). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the treatment method of Archer to individuals with IBD in order to alleviate inflammation from IBD. Thus, Archer in view of Kotlyar et al. renders the instant invention obvious.
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive. Applicant argues that Archer is limited to the treatment of allergy, and there is no teaching, suggestion, or motivation that EM treated yeast cells may be used to treat IBD or IBS, which are complex gastrointestinal disorders involving distinct mechanisms that differ fundamentally from allergic responses. Applicant also argues that even if Archer discloses anti-inflammatory effects in the context of allergy, it does not follow that such effects would translate to gastrointestinal inflammatory diseases. Applicant argues that the application demonstrates the modulation of cytokines relevant to inflammatory conditions, particularly to IBD and IBS, that are not disclosed by Archer in the context of IBD or IBS, and so the claimed methods represent more than the routine application of a known treatment to a new indication. Finally, Applicant argues that the assertion that it would be obvious to use the EM treated yeast cells to treat any inflammatory condition relies on hindsight, and that the prior art provides no teaching, suggestion, or motivation to apply Archer’s disclosure to IBD or IBS, nor does it provide a reasonable expectation of success in doing so.
In response to Applicant’s arguments that Archer does not disclose a method of treating or alleviating IBD or IBS, Examiner notes that the previous set of claims, filed 08/18/2025 and addressed in the office action mailed on 02/04/2026, did not disclose a method of treating or alleviating IBD or IBS, but were instead drawn to a yeast cell with an intended use of treating or alleviating inflammation from IBD or IBS, which was not given patentable weight (see page 2, paragraph 5, page 7, paragraph 15, and page 13, paragraph 21). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The rejection has been modified to address the amended claims, which recite a method of treating and/or alleviating inflammation and/or symptoms of inflammation wherein the inflammation is IBD or IBS. See paragraph 7 above for the modified rejection in view of the claim amendments.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Maintained Double Patenting - Modified as Necessitated by Claim Amendments
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 1 and 3-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-19 of U.S. Patent No. 12,239,678 in view of Kotlyar et al., World J Gastroenterol; 2014: 20(32): 11023-11032.
The instant claims are drawn to a method of treating and/or alleviating inflammation and/or symptoms of inflammation, wherein the inflammation is inflammatory bowel disease or irritable bowel syndrome, including administering to a subject in need thereof a plurality of yeast cells, wherein the yeast cells have been treated with electromagnetic waves in the range of 1 GHz to 300 GHz, or said yeast cells have been grown from a yeast cell treated with electromagnetic waves in the range of 1 GHz to 300 GHz. Claim 3 further limits the inflammatory bowel disease to Crohn’s disease or ulcerative colitis (UC). Claims 4, 5, and 16 further limit the range of the waves, ultimately to about 45-60 GHz. Claims 6-8 and 17-18 limit the power density, frequency modulation, and exposure time for the treatment. Claims 9 and 19 further limit the yeast cell species. Claim 10 is drawn to administering a composition comprising yeast cells according to claim 1 and an excipient and/or carrier. Claims 11-13 further modify the composition of claim 10, with claim 11 stating that the composition further comprises at least one vitamin and/or at least one mineral, claim 12 indicating the composition is formulated for oral consumption, and claim 13 identifying the composition as a liquid. Claims 14 and 20 further limit the yeast cell concentration in the liquid composition of claim 13 to ‘from 20x106 CFUs/ml to 40x106 CFUs/ml’, and claim 15 states the composition is in the form of a powder.
‘678 claim 1 recites “A method of treatment and/or alleviation of allergy and/or symptoms caused by allergy, comprising administering to a subject in need thereof, a yeast cell, wherein the yeast cell has been treated with electromagnetic waves in the range of 1 GHz to 300 GHz, or said yeast cell has been grown from a yeast cell treated with electromagnetic waves in the range of 1 GHz to 300 GHz, thereby treating and/or alleviating allergy and/or symptoms caused by allergy in the subject.” The yeast cell of ‘678 claim 1 is identical to the yeast cell of instant claim 1. ‘678 claims 4, 5, and 10 limit the range of electromagnetic waves to 1-200 GHz and a group of 40-65 GHz, ranges that are identical to or included in instant claims 4, 5, and 16. ‘678 claims 6-8 and 11-12 recite the limitations of instant claims 6-8 and 17-18; that is, a power density of below 1 mW/cm2, or between 0.004 mW/cm2 and 0.2 mW/cm2, modulation of the frequency within a given range, and treatment time of 10-240 minutes or 20-120 minutes. ‘678 claim 9 recites the limitation of Saccharomyces as the yeast, and ‘959 claim 13 recites the yeast as Saccharomyces carlsbergensis or Saccharomyces cerevisiae, as in instant claims 9 and 19. Claim 14 of ‘678 recites “wherein the yeast cell is present in a composition further comprising an excipient and/or a carrier,” identical to the composition of instant claim 10. ‘An excipient and/or carrier’ is broad, and reads on a vitamin or mineral, thereby meeting the limitations of instant claim 11. ‘678 claims 15 and 16 identify the composition as suitable for oral intake, and in the form of a liquid, as in instant claims 12 and 13. ‘678 claim 17 and 19 recite a CFU range for the composition of 16, identical to ranges presented by instant claims 14 and 20. ‘678 claim 18 recites the composition as a powder, as in instant claim 15.
As such, ‘678 discloses all limitations of the instant claims apart from the use of the yeast cells to treat and/or alleviate inflammation and/or symptoms of inflammation, wherein the inflammation is inflammatory bowel disease or irritable bowel syndrome. Instead, ‘678 teaches a method of administering the same yeast cells to treat and/or alleviate allergy.
Kotlyar et al. teach that clinical and pathophysiological similarities exist between the inflammatory responses of IBD and allergy, including commonalities in histamine, mast cell, and IgE responses (see abstract, whole document). Additionally, Kotlyar et al. recite that probiotics, including Saccharomyces species, are recommended for use in both IBD and allergy (see Tables 1-3, page 11025). Finally, Kotlyar et al. describe similarities in the inflammatory mechanisms behind IBD and intestinal allergic phenomena, such as maladaptive TH2-like responses, T regulatory cells, and upregulation of specific cytokines, which are also similar to those seen in chronic rhinosinusitis, another condition associated with allergy (see page 11028, right column).
Taken together, one of ordinary skill in the art of treating inflammation with probiotics would know that there are known similarities between the inflammatory responses of IBD and allergy. This overlap in etiologies would motivate one to repurpose a treatment for inflammation due to allergy as a treatment for inflammation due to inflammatory bowel disease. One would have a reasonable expectation of success, as the oral composition of ‘678 reaches the gastrointestinal tract and would therefore encounter the tissues affected by IBD inflammation. Additionally, one would have reasonable expectation of success as similar probiotics have been used to treat both allergy and IBD (See Table 1 of Kotlyar et al.). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the treatment method of Archer to individuals with IBD in order to alleviate inflammation from IBD. Therefore, claims 1 and 3-20 of the instant application are obvious over claims 1 and 4-19 of ‘678 in view of Kotlyar et al.
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive. Applicant argues that the claims of ‘678 are directed to a method of treating or alleviating allergy, as opposed to a method of treating or alleviating IBD or IBS. Applicant argues the disease states are distinct and involve different physiological systems and underlying mechanisms. Applicant argues that nothing in the ‘678 patent suggests the treated yeast cells would be effective in the treatment of IBD or IBS, and a person of ordinary skill in the art would not have had a reasonable expectation that treatment for allergy would be effective for gastrointestinal disorders.
In response to Applicant’s arguments that ‘678 does not disclose a method of treating or alleviating IBD or IBS, Examiner notes that the previous set of claims, filed 08/18/2025 and addressed in the office action mailed on 02/04/2026, did not disclose a method of treating or alleviating IBD or IBS, but were instead drawn to a yeast cell with an intended use of treating or alleviating inflammation from IBD or IBS, which was not given patentable weight (see page 2, paragraph 5, page 7, paragraph 15, and page 13, paragraph 21). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The rejection has been modified to address the amended claims, which recite a method of treating and/or alleviating inflammation and/or symptoms of inflammation wherein the inflammation is IBD or IBS. See paragraph 11 above for the modified rejection in view of the claim amendments.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amelia Stephens whose telephone number is (571)272-1006. The examiner can normally be reached M-F 8-5 EST.
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/AMELIA STEPHENS/Examiner, Art Unit 1645
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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