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 .
DETAILED ACTION
Claims 26-44 are pending in the instant application.
Priority
This application is a continuation of 17058446 (now U.S. Patent No. 11851479), filed on 11/24/2020 which claims priority to PCT/US2019/037618 filed on 6/18/2019, and the provisional applications 62/829802 filed on 4/5/2019 and 62/686412 filed on 618/2018.
Information Disclosure Statement
The information disclosure statement (IDS) dated 11/15/2023 complies with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Claim Interpretation
“Detectable agent” in claims 33 and 39 has been interpreted as an imaging agent, contrast agent, or fluorescent probe in accordance with the instant specification. (See instant spec pg 19, para 4).
Objections to the Claims
Claim 26, line 5, lacks transitive words in the phrase “thereof immunologically”. Please replace “thereof immunologically” with “thereof that is immunologically”.
Correction is required. See MPEP § 608.01(m).
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.
Claims 26-44 are 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 26
Claim 26 is drawn to a method of “diagnosing a subject as having a Bordetella pertussis infection” wherein there are no active steps relating the antibody described to the immunoassay, thus it amounts as a “use” claim. The method of claim 37 lacks any positive steps towards completing the claimed method (e.g. lacks a “contacting” step of the sample and the antibody). Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: “[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). See MPEP § 2173.05(q). Dependent claims 27-44 fail to cure these deficiencies, thus are also rendered indefinite.
Claim 29-30, 44
Claim 29-30 and 44 refers to acronyms of amino acid sequences of antibodies that are translated in Fig 11A-11I. In particular, claim 30 states the antibody “comprises all six” CDRs from 14D12 … or 3E6, however, it is unclear if one could mix and match CDRs from this list (e.g. take HCDR1 from 14D12 and HCDR2 from 3E6) thus adding confusion to what is claimed. Where possible, claims are to be complete in themselves and because the sequences referred to have designated SEQ ID NOs, these need to be included into the claims, directly. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). See MPEP § 2173.05(s). In the instant case, these alternative names for sequences would be better represented by their SEQ ID NOs instead of the associated acronym, without confusion.
Claim 35
Claim 35 comprises two conjunctions, thus it is unclear how the list of options should be interpreted. The beginning phrase One of skill in the art would not be able to know if the adjective “nasopharyngeal” applies solely to “swab” or also applies to “aspirate” and/or “wash”. Alternatively both “nasal and nasopharyngeal” may apply to swab, aspirate, and wash. Because it is unclear what applicant is trying to claim, this claim is rendered indefinite. To reduce ambiguity, if an adjective is to be applied to all the list items, it is best to repeat that adjective before each list item instead of introducing a secondary conjunction.
Claim 36-37
Claim 36-37 is drawn to a method of “further comprises detecting respiratory syncytial virus (RSV)” wherein there are no active steps relating the antibody described in claim 37 to the method described in claim 36, thus it amounts as a “use” claim. The method of claim 37 lacks any positive steps towards completing the claimed method (e.g. lacks a “contacting” step of the sample and the antibody). Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: “[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). See MPEP § 2173.05(q).
Claim 44
Claim 44 could not be meaningfully interpreted. It is unclear which antibodies are being referred to in the method and where they are located. The location of these antibodies on the test strip has not been introduced in a previously set forth claim, adding considerable confusion as to what is intended to be claimed, especially in light of the antibodies all binding the same target. What claim 44 meaningfully achieves could not be determined. A conjugated antibody that “binds the same epitope as 10B1” is introduced, whereas a secondary and tertiary antibody are introduced as residing on the test site (binding 14D12 and 13E11, respectively). Because all of these antibodies bind TcfA, it is unclear what consequences this spatial differentiation achieves regarding the diagnosis of Pertussis. As a result, this claim is rendered indefinite.
Claim Rejections – 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 26-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 26-28, 40-44
Claims 26-28 and 40-44 are drawn to an immunoassay comprising the genus antibody that binds tracheal colonization factor A (TcfA). The specification as filed fails to provide an adequate written description of this genus. Even when provided with several related antibodies that bind the desired target, this does not represent the astronomical and potentially unknowable breadth of all possible amino acid sequences which will result in the desired binding properties. This is exemplified by the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014)), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (p.7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor’s antibodies which bound the same target but shared only 50% sequence similarity. Furthermore, note in the decision in Amgen v. Sanofi 2017, where the Court supported previous decisions (Centocor 2011; Abbvie 2014) that defining an antibody solely by what it binds does not satisfy the written description requirement, stating that this would allow patentees to “claim antibodies by describing something that is not the invention, i.e., the antigen.” Because applicant cannot meet the written description via a representative number of species, applicant must thus provide the core structure responsible for binding TcfA. Instant claims 26-28 and 40-44 describe the antibody solely by what it binds, thus fail to meet the written description requirement. Dependent claims 29-39 fail to cure these deficiencies, thus are also rendered indefinite.
Claim 29-32
Claims 29-32 are drawn to an immunoassay comprising an antibody that has a variable number of CDRs specified, e.g. a sequence comprising only one CDR of SEQ ID NO: 25, or a sequence comprising only three CDRs of the VL domain of SEQ ID NO: 23. The art recognizes that a complete set of six CDRs comprise the binding region of antibody (Sela-Culang 2013), and that even single amino acid changes to this region can completely abrogate the binding specificity of an antibody (Kussie 1994 and Chen 1995). Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions. Thus applicant has failed to meet the written description of antibodies that are able to bind TcfA that comprise less than the full set of six CDRs and failed to meet the written description of antibodies comprising at least 1 CDR from 14D12, 23F8, 18B2, 20F4, 14G11, 13E11, 10B1, 7E11, or 3E6 that are capable of binding TcfA.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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 reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
US1181479
Claims 26-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 1181479. Although the claims at issue are not identical, they are not patentably distinct from each other as described in the claim-by-claim analysis below.
Regarding instant claim 26, the reference claims a method of detecting Bordetella pertussis in a sample comprising contacting the sample with an antibody that binds TcfA within an immunoassay (claim 7, 14).
Regarding instant claims 27-28 and 40-43, the reference claims the antibody binds residues 139-150 of TcfA and the same epitope as the antibody 13E11 (claims 14-22). Because the structure of the instantly claimed antibodies and that of the reference are identical, the antibodies must bind the same epitopes. “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP §2112.01(II). Regarding instant claim 29, the reference claims the antibody binds the same epitope as 13E11 (claim 22). Regarding instant claim 30, the reference claims the antibody comprises the same CDRs as 13E11 (claim 1). Regarding instant claim 31, the reference claims the antibody comprises the HCDR of SEQ ID NO: 24 (claim 1). Regarding instant claim 32, the reference claims the antibody comprises the VH of SEQ ID NO: 22 (claim 3). Regarding instant claim 33-34, the reference claims the antibody is conjugated to a detectable agent, such as a gold nanoparticle (claim 5). Regarding instant claim 35, the reference claims the sample is a nasal sample (claim 9).
Regarding instant claims 36-37: To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. If claims to the compound’s use and the compound were subject to a restriction requirement, and the compound was elected, a nonstatutory double patenting rejection may not be appropriate in a divisional application claiming the restricted compound’s use. See MPEP § 804.01. However, subject matter disclosed in the reference patent or application that does not fall within the scope of a reference claim cannot be used to support a nonstatutory double patenting rejection as this would effectively be treating the reference patent or application as prior art. See MPEP § 804(B)(1).
The specification of this reference describes adding an antibody that detects for RSV into the immunoassay (col 17, para 3). At the time of filing, the method of treating detecting both pertussis and RSV was a known use, thus rendering obvious the method of “further comprises detecting respiratory syncytial virus (RSV)” in the instant application.
Regarding instant claim 38-39, the reference claims the immunoassay is a lateral flow immunoassay that comprises a test strip comprising a test site (claim 13).
Relevant Prior Art
Finn et al. (doi: 10.1111/j.1365-2958.1995.tb02425.x) teaches detecting Bordetella pertussis infection via using a nucleic acid probe to detect TcfA. While Finn also teaches polyclonal anti-sera can be generated towards fusion proteins comprising TcfA and maltose-binding protein (pg 628, col 2, para 2), this is considered a separate invention from that instantly claimed, because the instantly claimed invention is directed towards antibodies that detect TcfA and not TcfA fusion proteins.
Allowable Subject Matter
A method of detecting Bordetella pertussis infection comprising contacting an anti-TcfA antibody with a sample was found allowable over the prior art. The first reference of this method was described in applicant’s academic paper (doi: 10.1038/s41598-020-72092-6).
Regarding the antibody sequences, the closest prior art is that of Lacy et al. (US20160002324), who teaches a VH resembling that of instant SEQ ID NO: 106 (a.k.a. antibody 7E11). The CDR regions of instant SEQ ID NOs: 108-109 have been underlined.
instant_106 EVQLQQSGAELVKPGASVKLSCTASGFNIKDTYIHWVKQRPEQGLEWIGRIDPANGNIIY 60
Lacy_14 EVQLQQSGAELVKPGASVKLSCTASGFNIKDTYIYWVKQRPEQGLEWIGRIDPANGNTIY 60
**********************************:********************** **
instant_106 ASKFQGEATITADTSSNTAYMQLSSLTSGDTAVYYCSAM---DYWGQGTSVTVSS 112
Lacy_14 ASKFQGKATITADTSSNTAYMQLSSLTSGDTAVYYCAGYGYYAYWGQGTTLTVSS 115
******:*****************************:. ******::****
Lacy also teaches part of the VL of instant SEQ ID NO: 107, as shown below. The CDR regions of instant SEQ ID NO: 111-113 have been underlined.
instant_107 DVVMTQTPLTLSLTIGQPASISCKSSQSLLHSNGKTYLNWLLQRPGQSPKLLIYLVSKLD 60
Lacy_175 DIVMTQTPLSLPVTPGEPASISCRSSQSILHSNGNTYLEWYLQKPGQSPQLLIYRVSNRF 60
*:*******:* :* *:******:****:*****:***:* **:*****:**** **:
instant_107 SGVPDRFSGSGSGTDFTLKISRVEAEDLGVYYCLQATHFPHTFGSGTKLEIK- 112
Lacy_175 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCFQGAHVPFTFGQGTKLEIKR 113
***************************:*****:*.:*.*.***.*******
It is understood in the art that changes to CDRs are unpredictable, thus there was no guidance to arrive at the specific CDR' s recited, given the art of record.
Conclusion
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/
Supervisory Patent Examiner, Art Unit 1675
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