Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Non-Final Office Action
Priority (Bauman-Type Continuation or Divisional)
The instant application was identified on filing as a continuation of Application 17/145,002, which is an application for reissue of Patent 8,058,416 (which issued from application 12/273,296). See the Application Data Sheet (ADS) and the first paragraph of the specification, which were filed on 10/20/2023 as part of the original filing of the instant application.
The mere fact that an application purports to be a continuation or divisional of a parent reissue application does not make it a reissue application itself because it is possible to file a 35 USC 111(a) continuing application of a reissue application. See In re Bauman, 683 F.2d 405, 409, 214 USPQ 585, 589 (CCPA 1982) (a patentee may file a regular continuation of a reissue application that obtains the benefit of the reissue application’s filing date). Accordingly, in order for a continuation or divisional of a parent reissue application to be treated as a reissue application itself, there must be an identification, on filing, that the application is a “continuation reissue application” or a “divisional reissue application”, as opposed to a Bauman type continuing application. Indicia that a continuation or divisional reissue application is being filed are:
(1) A 37 CFR 1.175 reissue oath/declaration, which is not merely a copy of the parent’s reissue oath/declaration.
(2) A specification and/or claims in proper double column reissue format per 37 CFR 1.173.
(3) Amendments in proper format per 37 CFR 1.175.
(4) A 37 CFR 3.73 statement of assignee ownership and consent by assignee.
(5) A correct transmittal letter (Form PTO/AIA /50 is recommended) identifying the application as a reissue filing under 35 U.S.C. § 251.
(6) An identification of the application as being “a reissue continuation of application number [the parent reissue application]”, or "a continuation of application number [the parent reissue application] and an application for reissue of patent number [the patent for which reissue is sought]" or equivalent language, rather than being "a continuation of reissue application number [the parent reissue application]."1. The same applies for a divisional reissue application, with the word “divisional” substituted for “continuation”.
See MPEP 1451.
The instant application was not filed with any of the above-listed indicia of a continuation reissue application. Rather, the ADS and the first paragraph of the specification filed as part of the original application papers both identify the instant application as a continuation of reissue application 17/145,002, which is an application for reissue of Patent 8,058,416 (which issued from application 12/273,296). No reissue oath or declaration were filed, and the application does not contain an indication of the assignee’s consent to reissue. Neither the specification nor the claims were supplied in double-column format, and there are no claim amendments in accordance with 37 CFR 1.175. Thus, the instant application was not identified, on filing, as both a continuation and a reissue application. Accordingly, the instant application:
(a) Was processed as a 35 USC 111(a) continuing application of a reissue application. See the Filing Receipts mailed on 11/3/23 and 3/7/24 and the Electronic Acknowledgment Receipts dated 2/23/24, 3/4/24, 4/30/24, and 10/3/24.
(b) Will be examined as a Bauman type continuing application, i.e., a 35 USC 111(a) continuing application of a reissue application.
Again, see MPEP 1451.
As established by In re Bauman, a Bauman type continuing application:
(a) Receives the benefit of the actual filing date of the parent reissue application.
(b) Does not receive the benefit of the filing date of the patent sought to be reissued by the parent reissue application because the copendency requirement of 35 USC 120 is not met.
Therefore, the patent sought to be reissued by the parent reissue application is available as prior art under pre-AIA 35 USC 102(b) or AIA 35 USC 102(a)(1) with respect to the Bauman type continuing application if the parent reissue application was filed more than one year after the grant date of the patent.
Accordingly, the effective filing date of the instant Bauman type continuing application is 1/8/21, i.e., the actual filing date of the parent reissue application 17/145,002. Since the parent reissue application was filed more than one year after the publication date of Patent 8,058,416 (issued 11/15/11), the patent qualifies as prior art under pre-AIA 35 USC 102(b) or AIA 35 USC 102(a)(1) with respect to the instant Bauman type continuing application.
Prosecution History and Claim Status
On 11/15/2011: US Patent 8,058,416 issued to Prendergast et al. with claims 1-5.
On 1/8/2021: Applicants filed US Reissue Patent Application 17/145,002, which added new claims 6-8 for US Patent 8,058,416.
On 10/20/2023: Applicants filed the instant Bauman-type continuation of US Reissue Patent Application 17/145,002 with claims 1-19.
On 10/24/2023: US Patent RE49,708 issued to Prendergast et al. with claims 1-8.
Claims 1-19 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims in application 18/491,078.
Ongoing Duty To Disclose
Applicant(s) is/are reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent 8,058,416 is or was involved. These proceedings would include any trial at the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Application Data Sheet
The ADS is objected to because it appears to erroneously state that application 12/273,296 is a reissue of itself.
Information Disclosure Statement
References lined-through on the information disclosure statement(s) were not considered because they were not provided as required by 37 CFR 1.98.
Claim Objections
Claim 17 and 18 are objected to because of the following informalities:
A. The claim contains periods other than at the end of the claim and in abbreviations. MPEP § 608.01(m) states, “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations.”
B. Claim 17 recites “the IDO2 protein of claim 1” in both elements “a” and “b”. However, claim 1 is drawn to a nucleic acid encoding an IDO2 protein, not an IDO2 protein per se. Thus, claim 17 should refer to the IDO2 protein encoded by the nucleic acid of claim 1. Claim 18 should also be amended to recite the same terminology as claim 17 in place of “the IDO2 protein of step a” to maintain consistency with any amendment to claim 17.
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 17-18 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. Claims 17-18 are directed to a method of identifying a compound which modulates IDO2 activity comprising a) contacting the IDO2 protein of claim 1 with a test compound, and b) determining tryptophan catabolism activity of the IDO2 protein. The active steps in claim 17 depend on the natural process of tryptophan catabolism by IDO2. Further, determining the tryptophan catabolism activity of IDO2 was well-understood, routine, and conventional prior to the instant invention. As such, claim 17 as a whole represents an assay informed by a natural phenomenon, followed by interpretation of the data from the assay. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as set forth in the following analysis:
The claims are directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions).
Step 1: Is the claim to a process, machine, manufacture, or composition of matter? Yes, the claims are drawn to a method (i.e., a process).
Next, the claim as a whole is analyzed to determine if the claim recites a judicial exception.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea (i.e., a judicial exception)? Yes, the claim recites a judicial exception (i.e., a natural phenomenon) since the claimed process depends on the natural process of tryptophan catabolism by IDO2 (a natural human protein). Further, when viewed as a whole the eligibility of the claim is not self-evident. See MPEP 2106.04(b)(I). “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972). Judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (quoting Myriad, 569 U.S. at 589, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). MPEP 2106.04(I).
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? Instant claim 17 recites "A method for identifying a compound which modulates IDO2 activity comprising: a. contacting the IDO2 protein of claim 1 with a test compound; and b. determining tryptophan catabolism activity of the IDO2 protein". Simply adding an undefined test compound and then determining the tryptophan catabolism activity of IDO2 adds no significant features to the claim as determining the tryptophan catabolism activity of IDO2, is a well-understood, routine, and conventional procedure for those of skill in the art. Specifically, see US 2009/0158451 (at par. [0124]), US 2019/0160102 (at par. [0175]), and US 2019/0031665 (at par. [0004]).
Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is not eligible.
In Mayo v. Prometheus, the Court found that "[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Additionally, "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law". Flook, 437 U. S., at 590; see also Bilski, 561 U.S., at __ (slip op., at 14) ("[T]he prohibition against patenting abstract ideas 'cannot be circumvented by'.., adding 'insignificant post-solution activity'" (quoting Diehr, supra, at 191-192)). The Court summarized their holding by stating "[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately." Applicant's attention is also directed to PerkinElmer, Inc. v. Intema Ltd., 496 F. App'x 65 (Fed. Cir.16 2012) and the recent Report and Recommendation in Genetic Tech v. LabCorp and 23AndMe (D. Del. September 2014) available via url: < ded.uscourts.gov/sites/default/files/opinions/cjb/2014/september/12-1736.pdf> and MYRIAD GENETICS, INC., v. AMBRY GENETICS CORPORATION, CAFC, 2014.
Claim Rejections - 35 USC § 102
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-19 are rejected under 35 U.S.C. 102(b) as being anticipated by PRENDERGAST (US 8,058,416; Issued Nov. 15, 2011).
Prendergast discloses nucleic acid molecules encoding indoleamine 2,3-dioxygenase-2 (IDO2) (title; abstract). Prendergast teaches an isoform of IDO2 that corresponds exactly to instant SEQ ID NO: 2 (Fig. 1B; see SEQ ID NO: 2 of Prendergast). Prendergast teaches that nucleic acid sequences encoding the IDO2 proteins of the invention include cDNA clones (col. 13, lines 31-38; col. 14, lines 12-16; Example 2).
Regarding claim 6, Prendergast teaches vectors, including cDNA vectors (col. 14, lines 12-16; col. 27, lines 8-10; Example 2).
Regarding claim 7, Prendergast teaches a vector is a plasmid or virus vector (col. 8, lines 36-39).
Regarding claims 9-16, Prendergast teaches the same nucleotide sequences as instant SEQ ID NOs: 8 and 10 (see SEQ ID NOs: 8 and 10 of Prendergast). Specifically, Prendergast teaches that SEQ ID NO: 8 encodes SEQ ID NO: 1 (col. 3, lines 24-25) and that SEQ ID NO: 10 encodes SEQ ID NO: 3 (col. 3, lines 27-29). Prendergast teaches that nucleic acid sequences encoding the IDO2 proteins of the invention include cDNA clones (col. 13, lines 31-38; col. 14, lines 12-16; Example 2).
Regarding claims 17-18, Prendergast teaches methods of identifying compounds which modulate IDO2 activity which may be enzymatic or cell-based assays (col. 22, lines 1-37). The cell-based assays comprise transfecting cells with a plasmid expressing IDO2 and contacting the cells with a test compound (col. 22, lines 55-63). Subsequently, kynurenine can be assayed to determine tryptophan catabolism activity (col. 22, lines 24-27 and 61-63).
Regarding claim 19, Prendergast teaches that IDO2 can be assessed by measuring liver inhibitory protein (LIP) (col. 4, lines 6-14; col. 6, lines 30-47; Fig. 9B; col. 21, lines 4-10).
Conclusion
Claims 1-19 are rejected. No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin S Orwig, whose telephone number is (571)270-5869. The examiner can normally be reached Mon.-Fri. 8AM-5PM.
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Central Reexam Unit
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/Kevin S Orwig/
Patent Reexamination Specialist, Art Unit 3991
Conferees:
/LBD/ Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/ SPRS, Art Unit 3991
1 In contrast, a Bauman type continuing application is identified as “a continuation of reissue Application No. [the parent reissue application], or “a continuation of reissue Application No. [the parent reissue application], which is an application for reissue of Patent No. [the original patent sought to be reissued by the parent reissue application]”.