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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/25/26 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 7/15/2020 is acknowledged.
Claims 1-6 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventive group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/15/2020.
Claims 11-16 and 20 are examined on the merits and are free of the prior art of record.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objections
Specification
(Re-instated Objection) The disclosure is objected to because of the following informalities: The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser- executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See descriptions for Drawings 1 and 2 and page 23 for hyperlink recitations. Appropriate correction is required. Applicant’s amendment of 8/25/25 that attempted to correct this hyperlink was not entered into the record. Additionally, this amendment removed the previously inserted SEQ ID NO:s for the figure descriptions of figures 1 and 2 that were presented in the amendment of 7/29/24. It is suggested that applicant’s provide an updated amendment to these sections of the specification that remove an operable hyperlink and include the necessary SEQ ID NO:s.
(New Objection) Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 8/25/25 have been fully considered but they are not persuasive. See response in the maintained 35 USC 101 rejection below.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Prior Rejection Maintained) Claims 11, 13-16 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally-occurring element of nature 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) (hereafter “Myriad”).
Based upon an analysis with respect to the claims as a whole, claim(s) 11-16 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See “https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility)).
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes the claims are directed to an ineligible product/process as further detailed below.
In this case, claim(s) 11, 13-16 and 20 recite or are directed to a composition of matter (Step 1) and recite natural phenomenon(s) (in this case, an antibody and the encoding sequences were isolated from human PBMCs following a natural infection by Andes virus in said human) that are directed to a judicial exception (in this case, a natural phenomenon)(Step 2A). This process of isolating these antibody is detailed on pages 20-24 of the specification and summarized in Figure 2A of Garrido et al. (See citation below).
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Thus the claimed product is not markedly different from its naturally occurring counterpart (see Part I.A.3 of the Interim Eligibility Guidance; Example 2, p. 29). Thus the claims also read upon combining the antibody with a pharmaceutically acceptable carrier, however, a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
The claims thus recite a nature-based product limitation that does not exhibit markedly different characteristics from its naturally occurring counterpart, or is directed to a “product of nature” exception. While applicants have amended their claimed invention to require that the antibody is a recombinant antibody, since this reference to the antibody as recombinant does not alter the antibody in comparison with what occurs in nature, this amendment does not amount to the claims reciting additional elements that amount to significantly more than the judicial exception. In addition, the kit of claim 20 does not include additional elements that amount to significantly more than the interpretation of the instant invention as a product of nature. The presence of a pharmaceutically acceptable carrier does not impart any changes to the recombinant antibody or recombinant protein that would remove it from being a judicial exception since the presence of the carrier has not bee identified as having an effect/influence on the antibody/protein.
Further, in view of Step 2B and the “No” pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception. While the claimed invention also requires a pharmaceutically acceptable carrier to be added with the antibody, these additional limitations do not amount to significantly more than the judicial exception since the carrier does not provide any additional elements to change a property or function of the antibody.
As pursuant to the Office’s interpretation of the Myriad decision, a recitation of a naturally-occurring nucleic acid, protein, or any natural product of nature that does not have a substantial or marked difference from the natural product is not patent eligible subject matter. Therefore, claims 11, 13-16 and 20 as written, read upon a non-naturally occurring antibody that was found to have occurred naturally in nature without being subject to the "hand-of-man" and resulting in a substantial or markedly different product from that found in nature. Therefore, claim(s) 11, 13-16 and 20 do not recite eligible subject matter under 35 U.S.C. 101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter. This rejection is necessitated by expanded 35 USC §101 USPTO training in view of the USPTO’s interpretation of Myriad. Applicant is directed towards the USPTO memos, which support the analysis of the claims; please review the latest materials regarding 35 USC §101 rejections. It is suggested that applicant cancel the rejected claims, draw the rejected claims to read upon a non-naturally occurring antibody, recite specific steps that are non-routine/non-conventional, and/or recite products/processes which are substantially or markedly different from the judicial exceptions. Applicant is cautioned to amend the claims according to these suggestions utilizing limitations for which the application would have support.
Response to arguments:
Applicant presents the following arguments in traversal of the rejection:
Applicants point to monoclonal antibody JL16 (see claim 12) as an example of a non-naturally occurring recombinant that comprises the variable domains of SEQ ID NO:s 6 and 8. JL16 also comprises a heterologous IgG1 constant region. However, JL16 is not recited in claims 11, 13-16 and 20. Therefore, the claimed invention rejected herein remains drawn to a judicial exception (i.e., an naturally occurring antibody that comprises SEQ ID NO:s 6 and 8 and the encoding sequences, which were isolated from human PBMCs following a natural infection by Andes virus in said human). As discussed above and in the previous Office action, the recitation of “recombinant human antibody” does not alter the antibody in comparison with what occurs in nature, this amendment does not amount to the claims reciting additional elements that amount to significantly more than the judicial exception. Furthermore, applicant points to the Myriad supreme court decision (Assoc. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) that identified cDNA as being non-naturally occurring and therefore patent eligible, while DNA is naturally occurring and therefore, not patent eligible. cDNA is a complementary DNA sequence that lacks the introns of the DNA it was derived from. However, recombinant antibodies can take many forms and the claims and specification of the instant application do not establish a definition that differentiates recombinant monoclonal antibody from a naturally occurring monoclonal antibody. As a result, the instant invention is not patent eligible for reasons set forth above.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671