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 .
Status of the Claims
Claims 1-9 and 11-14 are pending. Claim 3 is canceled. Claims 1, 2, 4, 7, 9, 11, 12, and 14 are amended.
Claims 1-2, 4-9, and 11-14 are examined herein.
Withdrawn Rejections
The objection to the specification is withdrawn in view of abstract amendments.
The objections to claims 1, 2, 4, 5, 7, 9, 11, and 14 are withdrawn in view of claims amendments.
The objection to claim 3 is withdrawn in view of claim cancellation.
The rejection of claim 3 is withdrawn in view of claim cancellation.
The rejection of claim 9 under 35 U.S.C. §101 is withdrawn in view of claim amendments.
The rejection of claims 9 and 11-12 under 35 U.S.C. §102 is withdrawn in view of claims amendments.
Improper Markush Rejection
Claim 4 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of serum, urine, cerebrospinal fluid, saliva, and cysts is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: serum, urine, cerebrospinal fluid, and saliva are examples of biological fluids, while cysts are sac-like pockets of membranous tissue.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
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 14, 1, 2, 4-8, and 13 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 5 recites an antibody capable of binding to a target Putative lysine rich protein (PLRP) defined by SEQ ID NO:1 or an antigenic fragment thereof.
The claim is broadly drawn to any antibody capable of recognizing protein defined by SEQ ID NO:1 or an antigenic fragment thereof.
An original claim may lack written description support when a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc) (MPEP §2163.03.V).
“[T]he disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." (MPEP § 2163.II.A).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.") (MPEP § 2163).
In the instant case, claim 5 is directed to a broad genus of antibodies that specifically bind protein defined by SEQ ID NO:1 or an antigenic fragment thereof. The instant specification fails to disclose any antibodies by their structure. The teachings of the instant specification are insufficient to establish possession of antibodies required to practice the claimed invention consistent with the written description requirement of 35 U.S.C. § 112(a).
The teachings of the instant specification fail to demonstrate that Applicant had knowledge of the structural features common to members of the claimed genus, i.e., knowledge of the types of heavy and light chain CDRs that can perform the functions in the instant claim.
Claim 6 dependent from claim 5 recites an antibody by its function, but not the structure.
Claims 14, 1, 2, 4, 7-8, and 13 recite the use of the antibody that doesn’t have written description. Therefore, claims 14, 1, 2, 4, 7-8, and 13 are rejected under 35 U.S.C. 112(a) for failure to describe antibodies capable of recognizing protein defined by SEQ ID NO:1 or an antigenic fragment thereof by structure.
Claim 13 recites a method for treating Neurocysticercosis in a subject, comprising administering to the subject the antibody of claim 5. The specification fails to disclose that the protein defined by SEQ ID NO:1 has any function relevant to the disease progression or the pathogen growth, and that binding of the protein defined by SEQ ID NO: 1 to the antibody would have any therapeutic effect.
Based on the above findings, one of ordinary skill in the art would conclude that Applicant did not have possession of the claimed invention.
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 11-12 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 11 recites “A composition comprising the antigenic fragment sequences of claim 9”. It is unclear what is claimed - protein as matter or protein as sequence. Protein sequences cannot comprise a composition of matter because the sequences are information. A composition of matter claim requires material constitutive parts.
Claim 12 recites “The composition of claim 11, wherein the composition is a vaccine”. It is unclear what is claimed – the sequences comprising the composition of claim 9, which are information or a biological entity - vaccine.
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 9 and 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because a “antigenic fragment sequences” are not a process, a machine, a manufacture, or a composition of matter. The “antigenic fragment sequences” are information; therefore, they are not one of the statutory categories of invention.
Therefore, claims 9 and 11-12 are ineligible under 35 U.S.C. 101.
Subject Matter Free of the Prior Art
Claims 1, 2, 4-9, and 11-14 are free of the prior art.
The prior art neither teaches nor suggests a method for detecting PLRP protein using an anti-PLRP antibody, a kit for detecting PLRP protein, or SEQ ID NOs 2 and 3.
Response to Arguments
Applicant's arguments filed September 23, 2025 have been fully considered.
Applicant respectfully submits that the Applicant has submitted the access code for retrieving the priority document electronically by filing a corrected ADS on October 17, 2022 (Remarks, pg. 6, par. 3). The information is acknowledged. The Patent Office has retrieved the document electronically.
Abstract amendment is acknowledged (pg. 6, par. 4). The objection to the disclosure is withdrawn.
Applicant argues that “Claims 1-5, 7, 9, 11, and 14 are amended to overcome objections to the claims made in the OA” (pg. 6, par. 5). The argument is persuasive and the objections are withdrawn.
However, amended claim 4 reciting “the test sample is selected from serum, urine, cerebrospinal fluid, saliva and cysts” is rejected under Improper Markush Rejection (see details above). Briefly, the Markush grouping of serum, urine, cerebrospinal fluid, saliva, and cysts is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: serum, urine, cerebrospinal fluid, and saliva are examples of biological fluids, while cysts are sac-like pockets of membranous tissue.
Claims 14, 1, 2, 4-8, and 13 are rejected under 35 U.S.C. §112(a) for failing to comply with the written description requirement. Applicant respectfully traverses this rejection (pg. 6, par. 6). Applicant provides a lengthy argument (pg. 6, last par. – pg. 8, par. 2).
The argument is not persuasive because the written description requirement for antibodies claimed as a broad genus requires disclosure of a representative number of species with claimed binding specificity as was presented in 112(a) rejection: ““[T]he disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." (MPEP § 2163.II.A). A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.") (MPEP § 2163)” (non-final OA, June 23, 2025; pg. 4, par. 3-4).
The disclosure of SEQ ID NOs: 1, 2, and 3 and an approach how SEQ ID NOs 2 and 3 were selected (Remarks, pg. 7, par. 1-3) are not sufficient to overcome the rejection. The specification fails provide evidence that the claimed biological materials are: (1) known and readily available to the public; (2) reproducible from the written description; or (3) deposited in compliance with the criteria set forth in 37 CFR 1.801-1.809.
The instant specification fails to disclose antibodies by their structure, instead the antibodies are recited by their function of binding to protein of SEQ ID NO:1. As such, the teachings of the instant specification are insufficient to establish possession of antibodies required to practice the claimed invention consistent with the written description requirement of 35 U.S.C. § 112(a).
Claims 1-9, 11, 12, and 14 were rejected under 35 U.S.C. 112(b) (pg. 8, section “Rejection under 35 U.S.C. §112(b)”).
Presently made amendments and cancelation of claim 3 overcome 112(b) rejections for claims 1-9, and 14. The rejection of claims 1-9, and 14 under 112(b) are withdrawn.
However, amended claims 11-12 are rejected under 35 U.S.C. 112(b) because: (a) claim 11 recites “A composition comprising the antigenic fragment sequences of claim 9”. It is unclear what is claimed because protein sequences are information, but a composition of matter requires material constitutive parts; and (b) claim 12 recites “The composition of claim 11, wherein the composition is a vaccine”. It is unclear what is claimed – the sequences comprising the composition of claim 9, which are information or a biological entity - vaccine.
Applicant argues that “Applicant has cancelled the subject matter directed to SEQ ID NO: l from claim 9. Further, the Applicant has amended the language of claims 11 and 12 to comply with US patent practice” (pg. 8, section “Rejection under 35 U.S.C. §101”).
The argument is persuasive, however the amended claims 9 and 11-12 are still rejected under 35 U.S.C. §101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because a “antigenic fragment sequences” are not a process, a machine, a manufacture, or a composition of matter. The “antigenic fragment sequences” are information; therefore, they are not one of the statutory categories of invention. Therefore, claims 9 and 11-12 are ineligible under 35 U.S.C. 101 and the rejection stays.
Applicant argues that “claim 9, as amended herein, is not anticipated by UniProt entry
Q8MPE0. Claims 11 and 12 are also novel at least because of their dependence from claim 9. Accordingly, the Applicant respectfully requests withdrawal of the §102 rejection” (pg. 9, par. 2). The argument is persuasive and the rejection of claims 9 and 11-12 under 35 U.S.C. 102 is withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/ALEXANDER ALEXANDROVIC VOLKOV/Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677