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 .
Priority
The present application is a § 371 National Stage Entry of PCT/EP2023/058376 (filed on 03/30/2023) and claims priority to foreign applications EP22191719.8 (filed on 08/23/2022) and EP22166139.0 (filed on 03/31/2022).
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 09/30/2024 and 12/13/2024 are in compliance with the provisions of 37 C.F.R. 1.97. All references cited in these IDSs have been fully considered.
Claim Status
Claims 1-5, 9-12, 14-15, and 20-24 are currently pending and have been examined on their merits.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the dyed materials as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
Specifically, because the claimed invention is directed to a red dye (see, for example, the description of Figure 7 which describes a “Bordeaux” or “Barbados cherry” color), it is considered that a color drawing is the only practical medium by which to disclose in a printed utility patent the subject matter to be patented.
Petition for Colored Drawings
It is suggested that applicant file a petition for color drawings under 37 CFR 1.84(a)(2).
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Alternative Solution
Alternatively, applicant must amend the description of each of the photographs such that they no longer refer to specific colors.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/patents-application- process/filing-online/legal-framework-efs-web), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item (1)(a)(iii) above. Specifically, the incorporation by reference
paragraph recites the size of the sequence listing in kilobytes (“3 kilobytes”). Compliant sequence listing file sizes must be presented in bytes, rather than kilobytes.
Required response - Amendment of the SEQUENCE LISTING paragraph of the specification to recite the size of the sequence listing file in bytes.
Claim Objections
Claim 1 is objected to because it contains unitalicized taxonomic names (Fusarium solani). In general, the names of taxonomic genera and species should be italicized.
Claims 4-5, 10, 12, 15, and 24 are objected to because they contain periods (.) in the body of the claim. See MPEP § 608.01(m) which states that “[e]ach claim begins with a capital letter and ends with a period” and “[p]eriods may not be used elsewhere in the claims except for abbreviations”. Accordingly, it is recommended that the period following the Roman Numerals be amended to “)”.
Claim 5 is objected to because it contains markup from the previous amendment (“[[4]]”) and because the conjunction “and” should be inserted after “6.7”.
Claim 9 is objected to because the abbreviation “HSL” should be fully defined when first used in the claim. For example, the claim may be amended to read “…according to the Hue, Saturation, and Lightness (HSL) color model”.
Claim 12 is objected to because a comma should be inserted after “6.7” and the conjunction “and” should be inserted before “under” in line 3.
Claim 20 is objected to because a comma should be inserted after “6.7” and the conjunction “and” should be inserted before “under” in line 3.
Claim 21 is objected to because the parentheses around “m/v” should be deleted.
Claim 22 is objected to because the text should be double spaced.
Appropriate correction is required.
Claim Interpretation
Claim 1 refers to a deposit number (“DSM 34187”). Deposit numbers are arbitrary accession numbers assigned by depositories. Accordingly, these numbers do not impart any structure on the claim other than identifying the specific strain deposited under this number. That is to say, a Fusarium solani strain “deposited under the number DSM 34187” is indistinguishable from the same strain deposited elsewhere, deposited under a different DSM number, or not deposited at all. Accordingly, for the purpose of applying prior art, the claims have been considered for the Fusarium solani strain identified by this deposit number irrespective of whether the prior art also uses this deposit number.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
(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.
Claims 1-5, 9-12, 14-15, and 20-24 are rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement.
The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification lacks complete deposit information for the deposit of Fusarium solani said strain being deposited under accession number DSM 34187. Because it is not clear that the properties of these strains are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of this specific strain, a suitable deposit for patent purposes is required.
It is noted that the deposited strain was deposited on 02/24/2022 (Specification, p. 3, lines 16-19). It is not clear whether this deposit was made under the provisions of the Budapest Treaty.
If the deposit has been made under the provisions of the Budapest Treaty, the deposit requirement may be fulfilled by filing an affidavit or declaration by applicants or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number averring that:
the deposit was made under the Budapest treaty and “all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent”.
This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring that:
“during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request”;
“all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application”;
“the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest”; and
“the deposits will be replaced if they should become non-viable or non-replicable”.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR § 1.801-1.809 for further information concerning deposit practice.
Claim 2-3, 5, 9, 12, 14, 20, and 22-24 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 2 is rejected as being an impermissible “Use” claim. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b). Although it is acknowledged that applicant believes this claim to comply with 112(b)(04/30/2026 Remarks, p. 6), the claims nonetheless are indefinite because they do not set forth any active, positive steps delimiting how this use is actually practiced (MPEP § 2173.05(q)).
Specifically, the claim only recites that the fungus of claim 1 is used “for dyeing a substrate”.
Claim 3 is rejected as an impermissible “Use” claim because it merely limits the type of substrate and therefore does not introduce an active, positive step delimiting how the use is practiced.
Claim 4 is rejected because it recites a step of “contacting the substrate with the cultivation medium…until the desired color is obtained”. Neither this claim nor the claim from which it depends recites “a desired color”. Accordingly, the claim is indefinite. In the interest of compact prosecution, it is recommended that applicant amend “the” to “a”.
Claim 5 is rejected because depends from claim 2 but limits the “pre-cultivating” step. Claim 2 does not recite a “pre-cultivating” step. Accordingly, there is insufficient antecedent basis for this limitation.
Examiner’s Note: It is noted that this claim erroneously contains the double bracketed deletion markup from the previous claim set. For the purpose of examination, this markup has not been considered. However, it is also noted that claim 4 is the claim which introduces the “pre-cultivating” step. Accordingly, this claim has been examined for prior art purposes as if it depends from claim 4, which is the first claim to introduce the step.
Claim 9 is rejected as indefinite because it requires the method to “further comprise” the step of contacting the substrate with FeCl3. Although it is acknowledged that this is an active, positive, step, as discussed above, claim 2 does not contain any steps and it is therefore unclear where the “contacting” step occurs because there is currently no step which uses a substrate (claim 2 merely recites the purpose of the method).
Claim 12 is rejected because it is unclear what is meant by “red/purple”. Specifically, it is not clear if this limitation means “red or purple”, “red and purple”, or a blend of “red and purple”.
Claim 12 is further considered to be indefinite because it requires cultivation “until a red/purple color is detected”. It is unclear how this “detection” is performed. For example, does this claim encompass merely observing a red/purple color or does it require the use of an instrument such as a spectrophotometer?
Claim 14 is rejected because it requires the addition of FeCl3 but it is not clear how the FeCl3 can be included in an amount of 0%. In other words, it is unclear if methods which do not include FeCl3 also read on this claim.
Claim 20 is rejected because it inherits the indefinite language of claims 2 and 4 and does not further clarify the claim.
Claim 22 is rejected because it inherits the indefinite language of claim 12 and does not further clarify the meaning.
Claim 23 is rejected because it recites “preferable” limitations which render the scope of the claim indefinite. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. Specifically, it is unclear if ethanol and ethyl acetate are required by the claim.
Claim 24 is rejected because it inherits the indefinite language of claims 2 and 4 and does not further clarify the claim.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
The instant claims recites laws of nature and natural phenomena. These judicial exceptions (JEs) are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A): Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
The Markedly Different Characteristics Analysis
The first step in the analysis is to select the appropriate counterpart to the nature-based product. When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. See MPEP § 2106.04(c)(II)(A).
The second step in the analysis is to identify appropriate characteristics to compare. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673. See MPEP § 2106.04(c)(II)(B).
The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. See MPEP § 2106.04(c)(II)(C).
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP § 2106.05(a);
Applying the judicial exception with, or by use of, a particular machine. See MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP § 2106.05(c);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP § 2106.05(d);
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.05(e).
Step (2B). If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step (1)(direction to a process, machine, manufacture, or composition of matter):
Claim 1 is directed to a composition of matter, which is a statutory category.
Therefore, the answer to this step for claim 1 is yes.
Step (2A) Prong 1 (recitation of a law of nature, natural phenomenon, or an abstract idea):
Claim 1 recites an isolated fungus belonging to the species Fusarium solani. There is no evidence of record that the isolated is modified in any way.
Accordingly, the claim recites a product of nature.
The next relevant question is whether the Fusarium solani recited in claim 1 is markedly different from its natural counterpart (e.g., in structure, property, or function). There is no evidence that the Fusarium solani is markedly different from Fusarium solani in nature.
Therefore, the answer to this prong for claim 1 is yes.
Step (2A) Prong 2 (recitation of additional elements that integrate the JE into a practical application):
Claim 1 recites the fungus per se. Accordingly, it does not recite an additional element that integrates the JE into a practical application.
Therefore, the answer to this prong for claim 1 is no.
Step (2B)(recitation of additional elements that amount to significantly different than the JE such that they provide an inventive concept):
Claim 1 recites the fungus per se. Accordingly, the claim is not significantly different such that it provides an inventive concept.
Therefore, the answer to step (2B) for claim 1 is no.
Conclusion
Claim 1 is directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. § 101.
Pertinent Prior Art
The closest prior art is Menezes et al. (AMB Express, 2020, Vol. 10(117), pages 1-12; cited in IDS filed on 12/13/2024). Menezes et al. teaches the production of natural red pigments by Fusarium solani BRM054066 (abstract). Although Menezes et al. teaches that Fusarium solani strains such as BRM054066 are capable of producing natural dyes, there is no teaching or suggestion of the existence of Fusarium solani deposited under DSM 34187. Accordingly, the prior art does not teach or suggest the claimed isolated fungus (claim 1) or the methods of using said isolated fungus (claims 2-5, 9-12, 14-15, and 20-24).
Conclusion
No claim is allowed.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRANT C CURRENS/
Examiner, Art Unit 1651
Prosecution Insights