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 .
Claims Status
The amendments and remarks filed 04/29/2026 are acknowledged.
Claims 157, 231, and 331-337 are pending.
Claims 157 and 231 are amended.
Claims 331-337 are new.
Applicant’s election without traverse of Group II in the reply filed on 04/29/2026 is acknowledged.
Claims 157, 231, and 331-337 are under examination.
Priority
The instant application is a continuation of PCT/US2022/024109 and claims priority to provisional application 63/172,782. Priority is given with the earliest effective filing date of 04/09/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/28/2024, 11/12/2024, 02/13/2025, and 04/29/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Claim Objections
Claim 157 is objected to because of the following informalities: Claim 157 recites the limitation “wherein the anti-venom antibody comprises a variable heavy (VH) complementarity-determining region 3 (CDR3) of SEQ ID NO: 12, a VH complementarity-determining region 1 (CDR1) of SEQ ID NO: 28, a VH complementarity determining region 2 (CDR2) of SEQ ID NO: 41.” For conventional terminology of reciting the CDRs in order (i.e. CDR1, CDR2, CDR3), the Examiner recommends amending the claim to recite “wherein the anti-venom antibody comprises a variable heavy (VH) complementarity-determining region 1 (CDR1) of SEQ ID NO: 28, a VH complementarity determining region 2 (CDR2) of SEQ ID NO: 41, a VH complementarity-determining region 3 (CDR3) of SEQ ID NO: 12.” Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 337 is 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.
Claim 337 recites the limitation “wherein the antivenom antibody neutralizes alpha-bungarotoxin (krait), alpha-elapitoxin (mamba), pseudonajatoxin (brown snake), alpha-cobra toxin (cobra), and toxin B (king cobra).” It is unclear if the snake names listed in parentheses are exemplary for where the toxin may come from or if the listed toxins can only come from the respective snake names listed in the parentheses. Therefore, the scope of this claim is indefinite.
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 157, 231, and 331-337 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claim 157 recites a broadly-neutralizing anti-venom composition comprising an anti-venom antibody that selectively binds to a plurality of different toxins, wherein the anti-venom antibody comprises a variable heavy (VH) complementarity-determining region 3 (CDR3) of SEQ ID NO: 12, a VH complementarity-determining region 1 (CDR1) of SEQ ID NO: 28, a VH complementarity determining region 2 (CDR2) of SEQ ID NO: 41, a variable light (VL) CDR1 of SEQ ID NO: 46, a VL CDR2 of SEQ ID NO: 80, and a VL CDR3 of SEQ ID NO: 101. Claim 231 adds the limitation wherein the anti-venom antibody comprises a VH of SEQ ID NO: 242 and a VL of SEQ ID NO: 273. The judicial exception is not integrated into a practical application because the claim(s) are directed to a naturally occurring antibody. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements recited.
MPEP 2106.04(b)(II) states “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". For example, the isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. 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 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
Step 1: It must first be determined if the claim is to a statutory category, and, if so
proceed to step 2A prong 1. The claims are directed a composition comprising an anti-venom antibody, and thus, this falls within the statutory category of a product.
Step 2A, prong 1: Prong 1 requires the Examiner to evaluate whether the claim recites a judicial exception and, if so, proceed to prong 2. In this case, the claims are drawn to the judicial exception of “an anti-venom antibody that selectively binds to a plurality of different toxins, wherein the anti-venom antibody comprises a variable heavy (VH) complementarity-determining region 3 (CDR3) of SEQ ID NO: 12, a VH complementarity-determining region 1 (CDR1) of SEQ ID NO: 28, a VH complementarity determining region 2 (CDR2) of SEQ ID NO: 41, a variable light (VL) CDR1 of SEQ ID NO: 46, a VL CDR2 of SEQ ID NO: 80, and a VL CDR3 of SEQ ID NO: 101”, “…wherein the anti-venom antibody comprises a VH of SEQ ID NO: 242 and a VL of SEQ ID NO: 273.” The antibody is a naturally occurring fully human antibody as disclosed by the instant specification. The instant specification states that the technology described in this application utilizes a novel, diverse immune library harvested from a middle-aged male who has been administering dose-escalating self-immunizations from the world’s most venomous snakes [0008; 293] and that the invention isolates and characterizes broadly neutralizing fully human anti-venom antibodies [0018]. The specification further discloses that the antibody Centi-D09 is a fully human, broadly neutralizing antibody against alpha-neurotoxin [0291] comprising the sequences of SEQ ID NOs: 28, 41, and 12 for the VH CDRs 1-3, respectively [see Tables 1-3 of the instant specification] and SEQ ID NOs: 46, 80, and 101 for the VL CDRs 1-3, respectively [see Tables 4-6 of the instant specification], SEQ ID NO: 242 for the VH [see Table 16] and SEQ ID NO: 273 for the VL [see Table 17], which is the antibody as claimed. The specification does not disclose that this antibody was altered in any way to make it distinct from its natural occurrence. Therefore, the claims recite a judicial exception (i.e. natural product).
Step 2A, prong 2: Prong 2 requires the Examiner to evaluate whether the claim
recites additional elements that integrate the exception into a practical application of
that exception and, if not, proceed to step 2B. In order to integrate the recited judicial
exception into a practical application, the claim will apply, rely on, or use the judicial
exception that imposes a meaningful limit such that the claim is more than a drafting
effort to monopolize the judicial exception. Examiners evaluate integration by identifying
additional elements in the claim beyond the judicial exception and evaluating those
elements individually and in combination to determine whether they integrate the
exception into a practical application. Examples that have been found by the Courts in
which the exception was not integrated into a practical application include:
Mere instructions to implement an abstract idea on a computer
Adding generic instructions that the judicial exception should be used (“apply
it”)
Adding insignificant extrasolution activity to the exception (“mere data gathering”)
Generally linking the use of the exception to a particular technological environment or field of use
In this case, claims 157 and 231 encompass a naturally occurring antibody and do not require anything beyond the product of this antibody. Claims 331-337 only further describe the judicial exception, and do not add any element that amounts to significantly more than the exception itself.
Step 2B: Where a claim does not integrate the exception, a claim may nevertheless be patent eligible, for example where additional elements are “significantly more” than the exception such that the additional elements were unconventional in combination. Considerations include whether or not the claim adds a specific limitation or combination of limitations that not well-understood, routine, conventional activity in
the field, which is indicative that an inventive concept may be present; or simply
appends 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 be present. In this case, the claims as a whole are not considered to recite any additional steps or elements that amount to significantly more and do not add something “significantly more” so as to render the claims patent-eligible because all the antibody is a product of nature.
As a whole, considering every step of the most recent guidelines for a proper
§101 analysis, claims 157, 231, and 331-337 do not provide significantly more than the recitation of the judicial exception and are thus not patent eligible.
In summary, the above analysis conducted in line with all current guidance
issued by the USPTO sets forth the rationale and evidence for deeming the above
claims patent ineligible. It is appreciated that all inventions at some level embody, use,
reflect, rest upon, or apply a law of nature, natural phenomenon, or abstract idea.
However, the instant claims do not improve another technology, apply the judicial
exception with any specific machine, transform the gathered data into a different state
or thing, include any limitations which use or apply the exception, add a limitation that is
anything more than what is well-understood, conventional, or routine in the field, or any
other meaningful limitation beyond generally linking the use of the exception to a
particular technological environment.
Therefore, claims 157, 231, and 331-337 are not patent eligible.
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 157, 231, and 331-337 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention.
Claim 157 is directed to a broadly-neutralizing anti-venom composition comprising an anti-venom antibody that selectively bind a plurality of different toxins, wherein the anti-venom antibody comprises a variable heavy (VH) complementarity-determining region 3 (CDR3) of SEQ ID NO: 12, a VH complementarity-determining region 1 (CDR1) of SEQ ID NO: 28, a VH complementarity determining region 2 (CDR2) of SEQ ID NO: 41, a variable light (VL) CDR1 of SEQ ID NO:46, a VL CDR2 of SEQ ID NO: 80, and a VL CDR3 of SEQ ID NO: 101. Claim 231 further limits claim 157 to wherein the anti-venom antibody comprises a VH of SEQ ID NO: 242 and a VL of SEQ ID NO: 273. Claims 331-337 only further describe the function of the antibody.
It is noted that the instant specification teaches that the technology described in this application utilizes a novel, diverse immune library harvested from a middle-aged male who has been administering dose-escalating self-immunizations from the world’s most venomous snakes [0008; 0293] and that the invention isolates and characterizes broadly neutralizing fully human anti-venom antibodies [0018]. The specification further discloses that the antibody Centi-D09 is a fully human, broadly neutralizing antibody against alpha-neurotoxin [0291] comprising the sequences of SEQ ID NOs: 28, 41, and 12 for the VH CDRs 1-3, respectively [see Tables 1-3 of the instant specification] and SEQ ID NOs: 46, 80, and 101 for the VL CDRs 1-3, respectively [see Tables 4-6 of the instant specification], SEQ ID NO: 242 for the VH [see Table 16] and SEQ ID NO: 273 for the VL [see Table 17], which is the antibody as claimed. The specification does not disclose that this antibody was altered in any way after being harvested from the middle-aged man.
Persson teaches that Steve Ludwin has self-administered weekly injections of venom from some of the world’s most venomous snakes for 25 years [page 2, first paragraph] and that an artificial library of antibodies, comprised of copies of antibodies generated by Ludwin’s immune system in response to injections with snake venom, has been completed [page 2, fourth paragraph] and is termed “The Ludwin Library” [page 5, first paragraph]. Persson also teaches that the library is now used to screen for antibodies that can neutralize individual toxins in venom [page 3, second paragraph] and that the library comprises human antibodies specifically targeting the snake toxins that Steve has used [page 5, fourth paragraph].
While Persson does not teach the specific structures of the antibodies comprised in “The Ludwin Library” it would be reasonable to conclude that the library comprises the antibody as claimed in instant claims 147 and 231 since this antibody was obtained from a “diverse immune library harvested from a middle-aged male who has been administering dose-escalating self-immunizations from the world’s most venomous snakes” [0008; 0293 of the instant specification] and the specification does not disclose that this antibody was altered in any way after being obtained.
Therefore, as evidenced by Persson, the antibody of the instant claim was in use before the effective filing date.
Claims 331-337 are included in this rejection because these claims describe properties of the claimed antibody. Since Persson teaches the antibody as claimed, the antibody must also have these characteristics since function flows from structure. See MPEP 2112.01(II). Additionally, these would be inherent properties of the antibody. Applicant is reminded that chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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