15DETAILED 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 .
Claim Status
Claims 1-2, 5-11, and 13-16 are under consideration in this office action.
Withdrawn Objections/Rejections
Any objection or rejection of record pertaining to cancelled claims 3-4 is rendered moot by applicant’s cancellation of said claims.
The objection of claim 5 is withdrawn in view of applicant’s amendment.
The rejection of claims 1, 6-11, and 13-16 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of applicant’s amendment.
The rejection of claims 1-2, 6-11, and 13-16 under 35 U.S.C. 112(a) as failing to comply with the written description requirement, for reasons as set forth in the Nonfinal office action mailed June 3, 2026, is withdrawn in view of applicant’s amendment to limit the antibody to two specific embodiments comprising specific HCDR1-3 and LCDR1-3 amino acid sequences.
Claim Interpretation
Claim 6 recites “human antibodies”. Based on this language, the antibodies of claims 1-2 and 6 are interpreted to be isolated from a human and are, therefore, a natural product.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112(d)
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 15 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. Claim 15 depends from claim 1, which is drawn to two specific antibodies or antigen-binding fragment comprising (1) HCDR1-3 of HCVR of SEQ ID NO: 30 and LCDR1-3 of LCVR of SEQ ID NO and (2) HCDR1-3 of HCVR of SEQ ID NO: 46 and LCDR1-3 of LCVR SEQ ID NO: 48. However, claim 15 further recites that the antibody is a nanobody, a single-domain antibody, or anti-idiotype antibody, which is inconsistent with the antibody of claim 1. Nanobody and single-domain antibodies are only comprised of three CDRs and do not require the six CDRs of the claim 1 antibodies. An anti-idiotype antibody recognizes another antigen binding domain; as such, the antibody of claim 15 binds to a target that is not the spike protein of claim 1. Claim 15 is broader is scope than claim 1. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Modified Rejections Necessitated by Amendment
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 1-2, 6, and 10-11 are rejected under 35 U.S.C. 101 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 drawn to a naturally occurring human antibody, which is a natural product. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they claim human framework regions and CDRs from a human immunoglobulin against SARS-CoV-2 spike protein. This human antibody is isolated from a human and is therefore a product produced by nature, the applicant has merely isolated it.
Guidance effective December 16, 2014 sets out a series of steps and factors for determining subject eligibility in light of recent court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc., Mayo Collaborative Services v. Prometheus Laboratories, Inc., and Alice Corporation Pty. Ltd. v. CLS Bank International, et al. See gpo.gov/fdsys/pkg/FR-2014-12-16/pdf/2014-29414.pdf.
The first step under this guidance is determining if the claim is directed to one of the four statutory categories (process, machine, manufacture, or composition of matter). In this case, the claims are directed to a composition of matter.
The second step is determining if the claims recite or involve judicial exceptions, such as laws of nature, natural phenomena, or natural products. In this case, the claims involve natural products, the fully human antibodies that bind to SARS-CoV-2 spike protein comprise of HCDR1-3 of SEQ ID NO: 30 or 46 and LCDR1-3 of SEQ ID NO: 32 or 48. The amended claims are limited to an “isolated recombinant antibody”, and although this phraseology does not explicitly appear within the specification as filed, the disclosure teaches an “isolated antibody” [0029] and “recombinant antibodies” [0052]. As such, there is implicit support for this new limitation.
In the next step, it must be determined if the claim as a whole amounts to something significantly more than the judicial exception. The claims do not include additional elements that distinguish the product from the judicial exception. The new limitation drawn to an “isolated recombinant antibody” fails to meet this metric, as the antibodies are identical to those found in nature. Naturally occurring anti-SARS-CoV-2 spike protein antibodies have been described in the art; see Cao et al, published July 9 2020 (PTO-892 from 6/3/2026), which teaches that autoantibodies to SARS-CoV-2 spike protein have been isolated from the B cells of convalescent COVID-19 patients (see abstract). Because the claimed CDR sequences are naturally occurring and the claims are not limited to antibody structures that are markedly different from the antibody isolated from humans, claims 1-2 and 6 are directed to a natural product. The pharmaceutical composition of claim 10 and the kit of claim 11 do not include any additional elements that give the antibody a markedly different characteristic. For example, the pharmaceutical composition is not comprised of a new combination of active ingredients that would alter the characteristics possessed by the natural antibody.
In the absence of the hand of man, naturally occurring products are considered nonstatutory subject matter. Specifically, the claims, as written, do not sufficiently distinguish over the antibodies that exist naturally because the claims do not particularly point out any non-naturally occurring differences between the claimed products and the naturally occurring products. There is no specific limitation in the instant claims that would distinguish the claimed antibodies from the naturally occurring antibodies. Humanized antibodies and recombinant antibody fragments are examples of a human intervention while human antibodies are still a natural product because the intervention is only isolation, which does not significantly change or manipulate the naturally occurring product.
The instant claims only require the naturally occurring antibody characteristics, which do not further limit or distinguish the antibodies from those found in nature. The instant claims do not recite any elements in addition to the natural products that impose meaningful limits on the claim scope and would substantially foreclose others from using these natural products.
Therefore, claims 1-2, 6, and 10-11 are not patent eligible.
Response to Arguments
Applicant's arguments filed June 3, 2026 regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered, but they are not persuasive.
Applicant asserts that a claim is directed to a judicial exception only if it recites a mathematical concept, mental process, or certain methods of organizing human activity as its focus and that claim 1 does not fall within any of these categories (remarks, pg 10). This section of the MPEP 2106.04(a) is for the judicial exception abstract idea. The claims, however, are drawn to a product of nature. Applicant is directed to MPEP 2106.04(b) for a discussion of Laws of Nature, Natural Phenomena, and Products of Nature. The law of nature and natural phenomenon exceptions reflect the Supreme Court's view that the basic tools of scientific and technological work are not patentable, because the "manifestations of laws of nature" are "part of the storehouse of knowledge," "free to all men and reserved exclusively to none." Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948).
Applicant points out that the antibodies of amended claim 1 “do not exist in nature in large numbers” (pg 11), and that they are produced by human intervention and not a natural product (pg 11). Applicant acknowledges then that the claimed antibodies are naturally occurring antibodies; applicant has merely isolated them by routine methods. The finding that these antibodies exhibit high neutralizing activity is not sufficient under prong 2 because there is no integration of the product in a practical application. Notably, claim 14, which is drawn to a method of treating, is not included in this rejection because the method steps integrate the exception into a practical application. Also, the polynucleotides, vectors, and cells comprising the antibody are not rejected under 101, because these claims recite additional elements beyond the judicial exception.
Applicant states that the antibodies are recombinant, indicating that the product is obtained through in vitro genetic-engineering operations, including codon optimization, vector construction, and forced expression in CHO293 cells (pg 14). These methods, however, do not transform the antibody to something different than the naturally occurring antibody. The method to isolate the antibody are routine and conventional methods, and even if these steps were claimed, they would not be sufficient to add more to the judicial exception. See MPEP 2106.04(a): 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). Also, it is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible."). Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g., In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 130-132, 60 USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.
Therefore, the antibodies of claims 1-2, 6, and 10-11 are natural products, and the rejection under 35 U.S.C. 101 is maintained.
Allowable Subject Matter
Claims 5, 7-9, 13-14, and 16 are 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.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
