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 Action
Further consideration of applicants claim scope in light of the specification as originally filed has prompted this second non-final office action. It appears that the examiner accidentally read limitations from the specification into the claims and was not reading the claims as broadly as they are plainly written on further consideration.
Election/Restriction
Applicant’s election without traverse of Group I, claims 1-6 and 13-14 in the reply filed on 03/25/25 is acknowledged. Claims 8-12 were previously withdrawn as being directed to a non-elected invention. It appears that this paragraph did not save in the previous action and/or was inadvertently deleted from the action when posting and as such this acknowledgement has been added to this action. Thus, claims 1, 3-6, 13-14 are being examined in this office action. Claims 8-12 remain withdrawn.
Claim Objections
Claim 13 is objected to because of the following informalities: the claim recites “a lamellicolic anhydride” however the claim depends from claim 14 which discloses the lamellicolic anhydrides claimed in claim 13. The claim should instead recite “the lamellicolic anhydride…claim 14”. Appropriate correction is required.
Duplicate Claim
Applicant is advised that should claim 4 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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, 3-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a culture of Verticillium lamellicola without significantly more because as evidenced by/taught by McRitchie the claimed lamellicolic anhydride which is a compound of applicant’s formula (I) wherein R1, R3, and R4 are all H, R2 is methyl and R5 and R6 are both H as is a major component contained in known active antimicrobial extract from this naturally occurring organism/cultures of this organism and as such is a naturally occurring metabolite along with the naturally occurring active agrochemical/antimicrobial compound that is contained in this extract fraction which is also naturally occurring. The claim(s) recite(s) a composition comprising any amount of applicant’s compound of formula (I) and any amount of an agricultural active which includes any compounds exhibiting any degree of antimicrobial activity. This judicial exception is not integrated into a practical application because the claims as currently written read on naturally occurring product. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims fail to incorporate the natural product/naturally occurring biologically active extract without significantly more. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed compositions of the product of nature, specifically the extract comprising the claimed compound of formula (I) and an agriculturally active compound, do not require anything else in the composition, and do not structurally limit or change the naturally occurring product/extract.
Instant claims 1, 3-6 recite and/or claim/include in the scope of claimed compounds of formula I, specifically for example the compound wherein R1, R3, R4 are all H, R2 is methyl and R5 and R6 are both hydrogen, with any agriculturally active compound in any amount/ratio which is all that is required by applicant’s claims and this composition/extract is known in the art to be naturally occurring as per McRitchie. The recited compositions of the claims, are not markedly different from their naturally occurring form as an extract/metabolite of the naturally occurring V. because both naturally occurring and recited in the instant claims has the same structure. This judicial exception is not integrated into a practical application because additional element, fails to integrate the judicial exception into a practical application. This is because merely composition of the product of nature in water does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim, and is nothing more than an attempt to generally link the product of nature to a particular technological environment.
Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012), the Supreme Court set forth a two-step framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts. The first step looks to determine whether claims are directed to a patent-ineligible concept. Mayo, 132 S. Ct. at 1297. If they are, the second step is to consider whether the additional elements recited in the claim “transform the nature of the claim” into a patent eligible application by reciting an “inventive concept” that is “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.” Id. at 1294.
Claim 1 of U.S. Patent No. 6,355,623 in the Mayo dispute is reproduced here for applicant’s convenience:
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8.times.10.sup.8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8.times.10.sup.8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
In addition, the court in Arisosa Diagnostics, Inc v. Sequenom, Inc., No. 2014-1139, Fed. Cir. June 12, 2015 found ineligible claims drawn to a method of detecting paternally inherited cell free fetal DNA (cffDNA) in serum or blood. It is determined that the natural phenomenon in the claims is the cffDNA found in serum or blood.
The PTO guidance for determining subject matter eligibility under 35 U.S.C. 101 may be found in the Federal Register notice/ Subject Matter Eligibility update,” hereafter referred to as the “Guidance.” The Guidance supersedes the factor-based analysis of the “Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, and/Or Natural Products” from March of 2014.
The Guidance provides a test for determining subject matter eligibility under 35 U.S.C. 101 that comprises the following steps:
1) Is the claim to a process, machine, manufacture, or composition of matter? If the answer to this question is “no,” then the claim is not eligible subject matter under 35 U.S.C. 101. If the answer to this question is “yes,” then the analysis proceeds to the second step.
2) Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? If the answer to this question is “no,” then the claim is eligible subject matter under 35 U.S.C. 101. If the answer to this question is “yes,” then the analysis proceeds to the third step.
3) Does the claim recite additional elements that amount to significantly more than the judicial exception? If the answer to this question is “no,” then the claim is not eligible subject matter under 35 U.S.C. 101. If the answer to this question is “yes,” then the claim is eligible subject matter under 35 U.S.C. 101. Applicant is also directed to Section III of the Guidance (“Sample Analyses”), in particular, Example 5, Mayo v. Prometheus (U.S. Patent No. 6,355,623).
In the instant case, the claims are drawn to one of the statutory categories, i.e., a composition of matter, so the analysis proceeds to the second step. With respect to the second step, the claims are deemed to be directed to a judicially recognized exception, i.e., a product of nature, because, claims 1, 3-6 are drawn to a naturally occurring extract as discussed above and below in the 103 rejection. Specifically, an extract of the naturally occurring V. lamellicola, specifically a compound of formula (I) wherein R1, R3, R4 are all H, R2 is methyl and R5 and R6 are both hydrogen product, and at least one agrochemical active because as evidenced by McRitchie this extract is bioactive and has antifungal and antibacterial activity. The discovery of this extract does not, by itself, render the instant claims as patent eligible. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 2117 (2013) (“Myriad”). As a result, the answer to the second question is deemed to be “yes,” and the analysis proceeds to the third step. As indicated above, the third step asks whether the claim recites elements or steps in addition to the claimed judicial exception that amount to significantly more than the judicial exception. As indicated above, the instant claims are drawn to naturally occurring active composition/extract from the naturally occurring fungi V. lamellicola comprising a compound of applicant’s formula (I) wherein R1, R3, R4 are all H, R2 is methyl and R5 and R6 are both hydrogen, and at least one agrochemical active or any type. Thus, the claims recite a nature-based product, because there is no indication in the record that the claimed composition and/or concentrate is different in any way from its naturally occurring counterpart.
As a result, it is the Examiner’s position that the instant claims inform a relevant audience about a naturally existing composition/extract as is taught by McRitchie. Thus, the claims do not amount to significantly more than the product of nature, and accordingly, the claimed invention is not directed to patent eligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
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.
Claim 13 is 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. Specifically claim 13 has been amended to depend from claim 14 which is not a claim previously set forth as required by the statute above. 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 § 102
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.
Claim(s) 1, 3-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McRitchie (https://theses.gla.ac.uk/78634/1/11017941.pdf, 1973 doctoral thesis “Lamellicolic Anhydride and other polyketides…“).
Regarding claims 1, and 3-6, McRitchie teaches a crude active fraction extract/composition comprising compound of applicant’s formula (I) wherein R1, R3, R4 are all H, R2 is methyl and R5 and R6 are both hydrogen and wherein this extract contains components which exhibit antimicrobial activity which reads on the claimed at least one agrochemical active (see McRitchie compound (53) (unnumbered page before pg. 10), pgs. 10-19 of thesis, including unnumbered pgs.), and it also reads on/anticipates the concentrate formulation of claim 6 because the concentrate also need only comprise the compound of formula (I) and an agrochemical active agent in any amount as is claimed in claim 1.
Thus, McRitchie teaches all limitations of the claims and thereby anticipates the claims.
Allowable Subject Matter
Claim 14 is allowed.
Response to Arguments/Remarks
Applicant’s amendments have overcome the previous 112(b), 102(a)(1), and 103 rejections. Updated searching and consideration of applicant’s claims and disclosure has prompted the new grounds of rejection under 101 and 102(a)(1) in this second non-final office action.
Conclusion
Claim 14 is allowed. Claims 1, 3-6, and 13 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin E Hirt whose telephone number is (571)270-1077. The examiner can normally be reached 10:30-7:30 ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN E HIRT/Primary Examiner, Art Unit 1616