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 .
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, 5, 6, 8-15, 33, and 34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claims recite an antibody which binds the receptor-binding domain of the spike protein of SARS-CoV-2 and comprises the CDRs of SEQ ID NOs: 59-64 or 119-124, a kit or a pharmaceutical composition comprising the antibody, nucleic acids encoding the antibody, or a host cell comprising the nucleic acid.
The anti-SARS-CoV-2 antibody, as recited in claims 1, 2, 5, 6, 8-12, 33, and 34, is taught in the Specification as being obtained from blood samples of patients with naturally acquired infections of SARS-CoV-2; see Example 1. Human SARS-CoV-2 spike protein-specific IgG-positive B cells were isolated by FACS; see Example 5. Initially, Examiner misunderstood the phrase “minor modifications” on pages 52 and 53 to indicate modifications made to the sequences of the antibodies. However, upon further evaluation Examiner understands “minor modifications” refers to modifications of the procedures referenced by citation. Thus, the anti-SARS-CoV-2 antibodies as claimed are indistinguishable from the naturally occurring human antibodies following naturally acquired infection. Moreover, claims 5, 6, and 8, being drawn to inherent properties of the human anti-SARS-CoV-2 antibodies do not distinguish from the product of nature.
Claims 13 and 14 recite a pharmaceutical composition comprising the antibody and a pharmaceutically acceptable excipient or a pharmaceutical composition which is a vaccination composition for a human and/or animal subject. There is no limiting definition of excipient in the Specification, but one of ordinary skill in the art would understand excipient to be a vehicle for the antibody. This encompasses the antibody found in sera, which is a product of nature. The Specification defines a vaccination composition as “a pharmaceutical composition comprising at least one antibody or antigen-binding portion thereof of the present invention which is capable of providing active and/or passive immunity.” Again, an antibody in sera would be capable of providing immunity.
This judicial exception is not integrated into a practical application because there are no additional structures nor steps which apply the product of nature into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because while claim 15 does recite a kit, which while lacking a definition in the Specification, may comprise vials and/or syringes, this is routine and conventional; see the ‘How Supplied’ sections of the Prescribing Information for Humira (Published: August 2018), the Prescribing Information for Zenapax (Published: September 2010), and the Prescribing Information for Rituxan (Published: February 2020).
Thus, claims 1, 2, 5, 6, 8-15, 33, and 34 are drawn to a product of nature without significantly more
Allowable Subject Matter
Claims 29-32 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.
The following is an examiner’s statement of reasons for allowance: Although the antibody appears to be a product of nature and, thus, not a statutory category of invention, the prior art does not teach an antibody comprising the CDRs of SEQ ID NOs: 59-64 or 119-124.
The closest prior art is Shi et al. (Nature. 584: 120-124: Published Online: May 26, 2020) teaches a neutralizing anti-SARS-CoV-2 antibody which binds to the receptor-binding domain of the spike protein of SARS-CoV-2. The reference does not teach that the antibody comprises the instantly claimed CDRs.
Because claim 32 is drawn to a method of in vitro expression of the antibody, claim 32 would be allowable as indicated with the objection above.
Claims 29 and 30, which are drawn to a nucleic encoding the antibody which comprises the CDRs of SEQ ID NOs: 59-64 or 119-124 and an expression vector comprising the nucleic acid encoding the antibody which comprises the CDRs of SEQ ID NOs: 59-64 or 119-124, are interpreted as a single nucleic acid or expression vector comprising the CDRs of both the heavy and light variable chains. Claim 31 recites a host cell comprising “the nucleic acid according to claim 29” (a singular nucleic acid).
It is noted that vector defined as “a nucleic acid molecule capable of transporting another nucleic acid to which it has been linked” (see page 25 of the instant disclosure) encompasses chromosomal DNA being transported through mitotic division. And an expression vector defined as “certain vectors [which] are capable of directing the expression of genes to which they are operatively linked” (see page 25 of the instant disclosure), does not delineate from naturally occurring DNA which comprises promotors thereby directing expression. Given that nucleic acids encoding the heavy and light variable regions of antibodies are naturally present on different chromosomes, the presence of both regions on a single nucleic acid molecule is distinct from the naturally occurring nucleic acid molecules encoding the human antibody; see McBride et al. (Journal of Experimental Medicine. 155(5): 1480-1490; Published: May 1, 1982).
Moreover, while a single nucleic acid molecule encoding both the heavy and light variable regions is distinct from the naturally occurring nucleic acid molecules encoding the human antibody, the antibody which would result from the expression of such a single nucleic acid molecule is not distinct from the naturally occurring human antibody unless, for example, recitation of such an antibody were restricted to non-naturally occurring antibody formats which can be expressed from a single nucleic acid molecule (e.g. scFv). Similarly, more than one nucleic acid molecule encoding both the heavy and light variable domains would be out of scope of claims 29 and 30, and a host cell comprising more than one nucleic acid molecule encoding both the heavy and light variable domains would be out of scope of claim 31. It is noted that a naturally occurring B cell comprising the nucleic acid molecules encoding the antibody are encompassed in both of these aforementioned out-of-scope products and would be considered products of nature.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE ANN HOLTZMAN whose telephone number is (571)270-0252. The examiner can normally be reached Monday - Friday 7:30am - 5:00pm.
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/KATHERINE ANN HOLTZMAN/Examiner, Art Unit 1646
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644