Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Application Status
This application is a 371 of PCT/US 2021/061860, filed on 05/25/2023.
Claims 1-20 are currently pending in this patent application.
In response to a previous Office action, a Non-Final Rejection Office action (mailed on 05/12/2026), Applicants filed a response and an amendment on June 23, 2026, amending claims 1-20 is acknowledged.
The Examiner is also acknowledged the filing of Affidavit/Declaration under 37 CFR 1.132.
Applicants' arguments filed on April 7, 2006, have been fully considered and are deemed persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claims 1-20 are present for examination.
Priority
Acknowledgement is made of applicants claim for priority of US Provisional applications 63/120,997, filed on 12/03/2020, and 63/196,509 filed on 06/03/2020.
Maintained-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.
The claimed invention is directed to a naturally-occurring nucleic acid or fragment thereof, whether isolated or not, that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., -- U.S. -- (June 13, 2013).
The previous rejection of Claims 1-20 under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter, s maintained. This rejection has been discussed at length in the previous Office Action, and the rejection is maintained as discussed previously and for the following reasons.
The instant rejection is issued because of recent "Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products", currently accessible from <http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf>.
In the instant case, when a claim is determined to recite or involve one or more judicial exceptions, the key inquiry becomes whether the claim as a whole recites something significantly different than the judicial exception. The Guidance provides weighing factors for determining whether a claim recites something that is significantly different than the judicial exception. If the totality of the relevant factors weighs toward eligibility, the claim qualifies as eligible subject matter. However, if the totality of the relevant factors weighs against eligibility, the claim should be rejected.
Based upon consideration of all of the relevant factors with respect to the claims as a whole, the factors weigh against something that is significantly different than a law or product of nature and therefore the claims do not qualify as eligible subject matter. The rationale for this determination is explained below:
Claim 1 is drawn to under Broadest Reasonable Interpretation (BRI) - An isolated bacterial strain Thiomonas isabelensis (ECOAUO 1), which has been designated Accession number NRRL No. B-67995, deposited in accordance with the Budapest Treaty at the Agricultural Research Service Culture Collection (USDA, ARS,1815 North University Street, Peoria, IL, 61064) on November 13, 2020.
Given the broadest reasonable interpretation (BRI), the claimed “An isolated bacterial strain Thiomonas isabelensis (ECOAUO 1), which has been designated Accession number NRRL No. B-67995, deposited in accordance with the Budapest Treaty at the Agricultural Research Service Culture Collection (USDA, ARS,1815 North University Street, Peoria, IL, 61064) on November 13, 2020, is to be a product/Law of nature. To be eligible, the claimed product is not markedly different in structure from a naturally occurring bacterial strain, In this case, the recited bacterial strain Thiomonas isabelensis (ECOAUO 1) is not markedly different from naturally occurring bacterial strain. See Association for Molecular Pathology v. Myriad
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Genetics Inc. 106 USPQ2d 1972 (U.S. Supreme Court 2013). As such, the claimed recited bacterial strain Thiomonas isabelensis (ECOAUO 1), is not markedly different in structure from naturally occurring bacterial strain, and thus, the claimed “bacterial strain Thiomonas isabelensis (ECOAUO 1) is not patent eligible subject matter.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Step 1) Are the claims directed to a process, machine, manufacture or composition of matter?
Yes, the claims are drawn to a composition of matter or manufacture (a product).
Step 2a, Prong 1) Does the claim recite an Abstract Idea, Law of Nature or Natural Phenomenon?
Yes, the claim 1 is drawn to a Natural Phenomenon and Law of Nature, bacterial strain Thiomonas isabelensis (ECOAUO 1) would meet the defined claim and render it non-patent eligible.
Step 2a, Prong 2) Does the claim recite additional elements that integrate the Judicial Exception into a Practical Application?
The answer is No. the claimed bacterial strain Thiomonas isabelensis (ECOAUO 1 doesn’t improve any technology or technical field, apply or use the JE to effect to a particular application or apply/use the JE in some other meaningful way.
Step 2B) Does the claim recite additional elements that amount to significantly more than the Judicial Exception?
The answer is No, therefore, the recited bacterial strain Thiomonas isabelensis (ECOAUO 1) is not patent eligible.
Claims 2-20 are also not patent eligible for the same reason as discussed above for claim 1.
Arguments: Applicants state that they provides the data in the accompanying Subject Matter Eligibility Declaration (SMED) to definitively show that the claimed recited bacterial strain Thiomonas isabelensis (ECOAUO 1), is indeed markedly different in structure from naturally occurrin' bacterial strain. As should be apparent from the data in the SMED, which supports and enhances the data presented in the original application was filed, the microbial strain recited in claim 1 possesses markedly higher amounts of important amino acids, which in turn contributes to the increase seen in gold recovery by the subject microbial strain vs. wild type.
Therefore, Applicant respectfully maintains that the claimed recited bacterial strain Thiomonas isabelensis (ECOAUO 1), is indeed markedly different in structure from naturally occurring bacterial strain, and therefore claim 1, as amended, recites patent eligible subject matter.
Response: Applicants arguments in the Remarks, and in the Declaration have been fully considered but are not deemed persuasive to overcome the rejection under 35 USC 101 because Applicants failed to distinguish the claimed strain from the natural counterpart. Applicants are advised to provide more clear information as per specification, and provide evidential information as per Rule 105. Of USPTO (see, MPEP).
Since, Applicants failed to prove that claimed strain is structurally different than natural one, and thus, the rejection is maintained.
Conclusion
Claims 1-20 stand/are rejected.
Applicants must respond to the objections/rejections in each of the sections in this Office action to be fully responsive in prosecution. 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 extension fee pursuant to 37 C.F.R. § 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 IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F from 9:00 AM-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Iqbal H. Chowdhury, Primary Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office (USPTO)
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
Prosecution Insights