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
The preliminary amendment filed on 12/22/2023 amended claims 2-4, 6-9, 12, 13, and 15. The preliminary amendment filed on 08/18/2025 amended claim 10. There are no claims withdrawn and no claims cancelled. Claims 1-15 are pending and will be examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on 12/22/2023 and 05/19/2025 have been considered. Signed copies are enclosed.
Claim Interpretation
In claim 1, the phrase "for use in the treatment and/or alleviation of inflammation and/or symptoms caused by inflammation" is part of the claim preamble, thus is considered intended use under MPEP 2111.2, and therefore does not hold patentable weight.
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 3, 4, 6, 8, 9, and 14 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.
Regarding claims 3, 4, 8, and 9, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 6 and 14, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 3 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In claim 1, the phrase "for use in the treatment and/or alleviation of inflammation and/or symptoms caused by inflammation" does not hold patentable weight (see claim interpretation above). As the limitations of claims 2 and 3 only apply to this intended use, which does not hold patentable weight, they are not considered to further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-13 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) 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. This judicial exception is not integrated into a practical application because these claims are drawn to an organism, not a method. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the organism is not noticeabl.
The following analysis is laid out in accordance with MPEP 2106.
Step 1: Is the Claim directed to a process, machine, article of manufacture, or composition of matter?
Yes – the claims are directed to a composition of matter, a yeast cell.
Step 2A: Is the claim directed to a law of nature, natural phenomenon, natural product, or an abstract idea?
Yes – the claims are directed to a naturally occurring organism.
2A prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon (natural product)?
Yes – the claims recite a natural product, a yeast cell that has not been substantially altered from its original state.
2A prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No – the claim does not recite any methods or steps; only the yeast cell and a composition containing the yeast cell.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No – all additional elements are also natural products. Claims 4-8 describe a yeast cell treated by a process. Claim 10 recites a composition comprising a yeast cell and an excipient and/or a carrier. Claim 11 recites that the composition of 10 further comprises a at least one vitamin and/or at least one mineral. Claims 2-3 recite an intended use for the yeast cell, claim 9 recites a limitation on the species of yeast cell, and claims 12-15 recite limitations on the form of the composition of 10, including the formulation of the composition as a liquid or a powder. As the additional physical elements are all naturally occurring as well, these claims do not add significantly more to the judicial exception. Claim 10 recites an excipient and/or a carrier; water reads on both an excipient and a carrier, and water is a naturally occurring product. Claim 11 recites a vitamin and/or a mineral; however, both vitamins and minerals are naturally occurring. Claims 2, 3, 9, 12, 13, and 15 do not add any elements or substantially alter the natural product.
Claims 4-8 describe the treatment of the yeast stated in claim 1. However, the specification does not provide support that this treatment materially changes the yeast cell in any way. The specification states, on page 3 line 30, that the yeast cell has not been genetically modified. Therefore, it is a naturally occurring yeast cell. The specification states, on page 14 line 12, that the effect of the treatment is shown in Fig. 1. The only effect shown is on the population growth of the yeast culture – the yeast culture experiences a step-wise growth curve, as opposed to an exponential curve, possibly indicating synchronicity of the cell cycles of the yeast cells within the culture. As this is the only effect of the treatment on the yeast that is shown, it is apparent that the effect of the treatment is on a culture of cells. No support is provided that shows the treatment alters the cellular biology of an individual yeast cell, as claimed. All experimentation data provided in the specification is from the result of treatment with a culture of yeast cells, and no data is provided as to the effect of a single yeast cell on the inflammatory state of the cells. Therefore, there is no support in the specification of the effects of the treatment at the individual cell level, i.e. “a yeast cell” as in claim 1, that would render the yeast cell materially different from its natural counterpart. Therefore, claims 1-9, drawn to a yeast cell, are drawn to a natural product, as interpreted in light of the support presented in the specification. Additionally, claims 10-13 and 15, which are drawn to a composition containing ‘at least one yeast cell according to claim 1’, are also drawn to this natural product, as they do not require any components that are not natural products, and the specification does not support that this ‘at least one yeast cell’ is materially different from its naturally occurring counterpart. Therefore, claims 1-13 and 15 are drawn to the judicial exception of natural phenomenon.
Claim Rejections - 35 USC § 102
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.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Archer et al., J Immuno Allerg; 2020:1(1):1-13 (hereinafter Archer).
The instant claims are drawn to 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. As stated above, the intended use of “for use in the treatment and/or alleviation of inflammation and/or symptoms caused by inflammation” stated in the preamble does not hold patentable weight, nor do claims 2 and 3. Claims 4 and 5 further limit the range of the waves, ultimately to about 45-60 GHz. Claims 6-8 limit the power density, frequency modulation, and exposure time for the treatment. Therefore, claims 1-8 are all product-by-process claims (see MPEP 2113). Claim 9 further limits the yeast cell species. Claim 10 is drawn to a composition comprising at least one yeast cell 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.
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. The use of this yeast for treatment and/or alleviation of allergy would meet the limitations of instant claims 1-3, if the intended use were to be given patentable weight, as allergy symptoms are often caused by inflammation (see introduction, page 2).
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 and 5. 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. Archer discloses a treatment time of 20-120 minutes, which meets the limitations of instant claim 8. 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. 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.
Therefore, claims 1-13 are anticipated by Archer, 2020.
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 10 and 13-15 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).
Claim 10 is drawn to a composition comprising at least one yeast cell treated with electromagnetic waves in the range of 1 GHz to 300 GHz, or grown from a yeast cell treated as such, and an excipient and/or carrier. Claims 13-15 further modify the composition of claim 10, with claim 13 identifying the composition as a liquid, Claim 14 further limiting the yeast concentration in the liquid composition of claim 13, stating ‘the yeast cell in an amount of from 10x106 CFUs/ml to 50x106 CFUs/ml’, and claim 15 stating the composition is in the form of a powder.
Archer discloses a suspension of treated yeast in a growth medium such as wort, meeting the limitations of the composition of claim 10 and 13.
Archer does not disclose a culture with the concentration of yeast cells in an amount of from 10x106CFUs/ml to 50x106CFUs/ml. Archer does not disclose the composition of claim 10 in the form of 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 10x106 CFUs/ml to 50x106 CFUs/ml, it would be obvious to stop the growth of the cells of Archer at the desired concentration of 10x106 - 50x106 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 10x106 - 50x106 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.
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 1-15 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. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of claim 15 of '678 does not require any more than the yeast of instant claim 1 or the composition of instant claim 10.
The instant claims are drawn to 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. As stated above, the intended use of “for use in the treatment and/or alleviation of inflammation and/or symptoms caused by inflammation” stated in the preamble does not hold patentable weight, nor do claims 2 and 3. Claims 4 and 5 further limit the range of the waves, ultimately to about 45-60 GHz. Claims 6-8 limit the power density, frequency modulation, and exposure time for the treatment. Therefore, claims 1-8 are all product-by-process claims (see MPEP 2113). Claim 9 further limits the yeast cell species. Claim 10 is drawn to a composition comprising at least one yeast cell according to claim 1 and an excipient and/or carrier. Claims 11-15 all 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, claim 13 identifying the composition as a liquid and claim 14 further limiting the yeast concentration in the liquid composition of claim 13, and claim 15 stating 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 and 5. ‘678 claims 6-8 and 11-12 recite the limitations of instant claims 6-8; 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 claim 9. 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 claim 14. ‘678 claim 18 recites the composition as a powder, as in instant claim 15.
Moreover, while instant claims 2 and 3 do not hold patentable weight as they are further limiting an intended use, the alleviation of allergy symptoms is still the alleviation of symptoms caused by inflammation (as commonly known in the art and stated in the specification, see column 1, background), and therefore the method of ‘678 claim 15 could be used for the intended use of instant claims 2. Moreover, as the product-by-process claimed treated yeast cell of claim 1 is identical to that of instant claim 15, the treated yeast cell used in the method of ‘678 would be able to treat the conditions listed in instant claims 2 and 3.
Therefore, claims 1-15 of the instant application are anticipated by the claims 1 and 4-19 of ‘678.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amelia C Stephens whose telephone number is (571)272-1006. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA STEPHENS/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645