DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous office action has been withdrawn pursuant to 37 CFR 1.114. MPEP 706.07(h) pertains.
Rejoining claims and canceling the restriction requirement
The 3/31/2025 species restriction requirement is canceled and claims 18, 28, 35-40, 42-43 and 45 are rejoined. No claims remain withdrawn; no restriction requirements remain in effect.
In view of the cancelation of the restriction requirement as to the rejoined inventions, if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application. Once the restriction requirement is canceled, the provisions of 35 U.S.C. 121 are no longer applicable. (MPEP 804.01 pertains.)
Status of claims
Canceled:
2, 5-7, 10, 13-15, 17, 21, 23, 25-27, 29, 31, 41, 44
Pending:
1, 3-4, 8-9, 11-12, 16, 18-20, 22, 24, 28, 30, 32-40, 42-43 and 45-47
Withdrawn:
none
Examined:
1, 3-4, 8-9, 11-12, 16, 18-20, 22, 24, 28, 30, 32-40, 42-43 and 45-47
Independent:
1 and 46
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
x
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 12/14/2021 filing receipt, this application claims priority to as early as 2/19/2019. All claims have been interpreted as being accorded this priority date.
Withdrawal / revision of objections and/or rejections
In view of the amendment and remarks:
The objections to the claims are withdrawn, however new objections are applied.
The 112/b rejections are withdrawn, except as noted below, however new rejections are applied.
The 112/a rejection is withdrawn.
Rejections and/or objections not maintained from previous office actions are withdrawn. The following rejections and/or objections are either maintained or newly applied. They constitute the complete set applied to the instant application.
Claim objections
Claims 35 and 39 are objected to because of the following informalities. Appropriate correction is required. In each objection the claims are definite with respect to the issues cited here because interpretation would have been sufficiently clear to PHOSITA, but nonetheless the claims are objected to for consistency among the claims or as otherwise indicated. With regard to any suggested amendment below to overcome an objection, in the subsequent examination it is assumed that each amendment is made. However, equivalent amendments also would be acceptable. Any amendments in response to the following objections should be applied throughout the claims, as appropriate. For compact prosecution and examination, and planning for eventual allowance, the withdrawn claims also may be amended in order to keep them current with the rest of the claims.
The following issues are objected to:
Claim
Recitation
Comment
35
...allele and the...
Comma needed between grammatically independent clauses
39
...comprises...
Colon needed after "comprises"
Claim rejections - 112/b
The following is a quotation of 35 USC 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.
Claims 1, 3-4, 8-9, 11-12, 16, 18-20, 22, 24, 28, 30, 32-40, 42-43 and 45-47 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. For compact prosecution and examination, and planning for eventual allowance, the withdrawn claims also may be amended in order to keep them current with the rest of the claims. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment (suggestions in bold)
1
In claim 1, the relationship is unclear between the "wherein" clauses interpreted as part of step (b), before step (c), at least for lack of a grammatical article, e.g. "or," "and," etc. before the last "wherein" clause. The "and" after the last "wherein" clause at the end of step (b) is interpreted as defining the list of steps (a-c), a separate list from that referenced above within step (b). Claim 46 is rejected similarly.
18
the recipient-specific
nucleic acid or the donor-specific nucleic acid
Requires but lacks clear antecedent. Possibly should recite "one or more"
39
...into recipient homozygous group and recipient heterozygous group...
Grammatical articles are needed before "recipient homozygous group" and "recipient heterozygous group," possibly "a" in each instance.
39
(i)... a reference allele or an alternate allele
The relationship is unclear between these instances and those recited in claim 1.
39
(ii)... recipient homozygous groups
The relationship is unclear between this instance those previously recited.
39
(iii)... one or more polymorphic nucleic acid targets
The relationship is unclear between this instance the instance in claim 32.
46
(a)... after transplantation
In step (a), a grammatical article is needed before the noun "transplantation," noting that the previous instance of "transplantation" in the preamble was an adjective. The same issue recurs in step (b).
46
(c)... the transplant status
Requires but lacks antecedent
Nonstatutory double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.).
In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional.
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b).
Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly.
Double patenting rejections of instant claims
Instant claims 1, 3-4, 8-9, 11-12, 16, 18-20, 22, 24, 28, 30, 32-40, 42-43 and 45-47 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference patent 12,637,714 (application 17/268,732) in view of Woodward (as cited on the 4/28/2025 IDS), Ma (as cited on the 11/18/2025 form 892), Rava (as cited on the attached form 892) and Umbarger (as cited on the 11/18/2025 form 892).
The reference patent as well as the instant application recite claims which involve determining transplant status using similarly specified SNPs.
Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims.
It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art.
Conclusion
No claim is allowed.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
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The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
