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 .
Claims 1, 18, 19, 21-33, 35, 36, 38, and 40 are pending and currently under consideration.
Claim Interpretation
All pending claims depend on claim 1, which recites an isolated anti-Mycobacterium tuberculosis arabinomannan (anti-Mtb-AM) antibody or Mycobacterium tuberculosis arabinomannan-binding fragment (Mtb AM-binding fragment) thereof. Claim 1 further recites the anti-Mtb-AM antibody “or” Mtb AM-binding fragment thereof comprises a heavy chain variable region and a light chain variable region, wherein the regions each comprise CDR1, CDR2, and CDR3. Without stating whether the claimed anti-Mtb-AM antibody and/or Mtb AM-binding fragment thereof comprise CDR1H, CDR2H, CDR3H, CDR1L, CDR2L, or CDR3L regions, claim 1 recites each of CDR1H, CDR2H, CDR3H, CDR1L, CDR2L, and CDR3L comprise recited SEQ ID NOs. Claim 1 does not require claimed anti-Mtb-AM antibody or Mtb AM-binding fragment thereof to comprise both a heavy chain with a CDR1, a CDR2, and a CDR3 and light chain with a CDR1, a CDR2, and a CDR3 (due to recitation of “or” at line 3 of claim 1). Claim 1 does not require claimed anti-Mtb-AM antibody or Mtb AM-binding fragment thereof to comprise recited SEQ ID NOs (claim 1 does not recite the claimed anti-Mtb-AM antibody and/or Mtb AM-binding fragment thereof comprise CDR1H, CDR2H, CDR3H, CDR1L, CDR2L, or CDR3L with recited SEQ ID NOs). Rather, claim 1 broadly encompasses every imaginable isolated anti-Mycobacterium tuberculosis arabinomannan (anti-Mtb-AM) antibody and Mycobacterium tuberculosis arabinomannan-binding fragment (Mtb AM-binding fragment) thereof.
Claim Objections
Claim 23 is objected to because of an apparent typographical issue. Claim 23 recites “…wherein the heavy chain and light chain variable regions comprises a CDR1….” Because “regions” is plural, the term “comprises” should be replaced by “comprise”. In an effort to expedite prosecution, the following amendment is suggested to obviate this objection: “…wherein the heavy chain and light chain variable regions each comprise a CDR1….” Proper correction is required.
Claim Rejections - 35 USC § 112
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 27, 31-33 and 40 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 27 recites “…wherein the enzyme is….” There is insufficient antecedent basis for “the enzyme” in the claim.
Claim 31 is rejected for reciting: “…further comprising a fluid sample pad prior in sequential order to the first and second portions.” The metes-and-bounds of the claim are unclear because it is unclear what would, or would not, be considered a fluid sample pad “prior in sequential order” to the first and second portions.
Claims 32-33 are rejected because claim 32 recites: “…further comprising a control portion subsequent in sequential order to the first and second portions.” The metes-and-bounds of the claim are unclear because it is unclear what would, or would not, be considered a control portion “subsequent in sequential order” to the first and second portions.
Claim 40 recites “…administering to said subject the….” There is insufficient antecedent basis for “said subject” in the claim.
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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 18, 19, 21-33, 35, 36, and 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Achkar et al (WO 2019/200255 A1; 10/17/2019; 9/7/23 IDS).
Achkar et al teaches anti-Mycobacterium tuberculosis arabinomannan (anti-Mtb-AM) antibody and Mycobacterium tuberculosis arabinomannan-binding fragment (Mtb AM-binding fragment) thereof ([0005], in particular). Achkar et al further teaches said antibody and binding-fragment as being isolated ([0083], in particular). Achkar et al further teaches a method of reducing activity of Mtb AM in a subject comprising administering to said subject said antibody and binding-fragment ([0011], in particular). Achkar et al further teaches a method of treating Mtb infection in a subject comprising administering to said subject said antibody and binding-fragment ([0012], in particular). Achkar et al further teaches an assay device for selectively detecting one or more bacteria from the MTC group in a biological sample comprising (a) a first portion comprising a first plurality of said antibodies or binding fragment thereof attached to a reporting entity and (b) a second portion comprising a second plurality of anti-Mtb AM antibodies, or Mtb AM-binding fragments thereof, or anti-mycobacterial AM-antibodies ([0015], in particular). Achkar et al further teaches said anti-Mtb-AM antibodies include those with a VH domain comprising SEQ ID NO: 13 (which comprises instant SEQ ID NOs:17-19) and a VL domain comprising SEQ ID NO:15 (which comprises instant SEQ ID NOs:20-22). At [0016] and [0064], Achkar et al further teaches a lateral flow assay device for detecting Mtb in a biological sample comprising a first portion comprising a plurality of anti-Mtb AM antibodies comprises antibodies comprising a VH domain comprising SEQ ID NO: 13 (which comprises instant SEQ ID NOs:17-19) and a VL domain comprising SEQ ID NO:15 (which comprises instant SEQ ID NOs:20-22) attached to reporting entities and a second portion comprising a second set of anti-Mtb. Achkar et al further teaches such reporting entities include gold nanoparticles and enzymes such as horseradish peroxidase ([0066], in particular). Achkar et al further teaches said lateral flow assay device where in the second set of anti-Mtb are antibodies are, or are not, affixed to a solid support of the device ([0066]-[0067], in particular). Achkar et al further teaches said lateral flow assay device where in the solid support comprises nitrocellulose ([0069], in particular). Achkar et al further teaches said lateral flow assay device comprising “a fluid sample pad prior in sequential order to the first and second portions” ([0070], in particular) and/or “a control portion subsequent in sequential order to the first and second portions ([0071], in particular). Achkar et al further teaches said lateral flow assay device wherein the control portion comprises a third plurality of antibodies, immobilized on a solid support of the device, and which third plurality of antibodies are capable of binding the first plurality of virulent Mycobacterium tuberculosis antibodies each attached to their own reporting molecule ([0072], in particular). Achkar et al further teaches a method for detecting one or more bacteria from the MTC group in a biological sample comprising contacting the lateral flow device with a biological sample and observing if virulent Mycobacterium tuberculosis- bound antibodies bind to the second plurality of virulent Mycobacterium tuberculosis- binding antibodies, wherein if such antibodies bind then virulent Mycobacterium tuberculosis has been detected in the biological sample and wherein if no virulent Mycobacterium tuberculosis- bound antibodies bind to the second plurality of virulent Mycobacterium tuberculosis- binding antibodies then virulent Mycobacterium tuberculosis has not been detected in the biological sample ([0075], in particular). Achkar et al further teaches said method wherein the sample is urine or blood ([0077], in particular).
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception(s) (i.e., a law of nature, a natural phenomenon, and/or an abstract idea) without significantly more. The rationale for this determination is explained below:
Claim 1 is directed to natural phenomenon because the claim recites natural phenomenon (“Step 2A prong one”) and the judicial exception(s) is/are not integrated into a practical application (“Step 2A prong two”). The “natural phenomenon” is: anti-Mycobacterium tuberculosis arabinomannan antibody. Anti-Mycobacterium tuberculosis arabinomannan antibodies are antibodies that occur in nature in sera of subjects naturally exposed to Mycobacterium tuberculosis (page 1814 of Chen et al (JCI, 2020, 130(4): 1808-1822), in particular). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s). A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. In the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element that the recited antibodies are “isolated” is not “significantly more” (see “isolated” DNA of Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589-91, 106 USPQ2d 1972, 1978-79 (2013) discussed at MPEP 2106.04(b)). Claimed antibodies are not markedly different than those found in nature. (“Step 2B”)
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.
Claims 1, 18, 19, and 21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of U.S. Patent No. 11643455 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because patent claim 1 is drawn to a species of antibodies broadly encompassed by instant claim 1 and patent claim 8 is drawn to a method of administering said antibody encompassed by instant claims 18, 19, and 21.
Claims 1, 22, 24-33, 35, 36, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-13, and 15-19 of U.S. Patent No. 12202888 B2. Although the claims at issue are not identical, they are not patentably distinct from each other Patent claims require antibodies encompassed by the instant claims. Further, assay devices and methods of detection of patent claims are species of assay devices and methods of detection encompassed by the instant claims.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642