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 .
2. Applicant’s amendment filed on 09/11/2023 is acknowledged.
3. Claims 1-3, 5-15, 17-18 and 21 are pending and under consideration for their full scope.
4. Applicant’s IDS document filed on 09/11/2023 has been considered.
Claim Objections
5. Claim 1 is objected to because of the following informalities:
A. Claim 1 does not recite the full name of the claimed proteins prior to abbreviating them.
B. Claim 2 recites detecting two times in a row in the first and second lines.
Appropriate correction is required.
6. 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.
7. Claims 1-3, 5-15, 17-18 and 21 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.
A. Claim 1 recites the limitation "a proliferation marker" in line 4, but the term should be “the proliferation marker” because the term was already introduced in line 1.
B. In claim 1 it is unclear how the antigen and the proliferation marker are related and what each term refers to in the claim. The claim recites detecting IgA to the proliferation marker and not to the antigen.
C. Claims 2-3 recites “in serum obtained from a feline patient” in lines 3 and 4, respectively. It is unclear if this is the serum from the first patient and if so it should recite “the serum from the feline patient”
D. Claim 2 it is unclear how “the OmpC corresponds to an OmpC from a feline microbiome.” The Examiner is not at all sure what this is supposed to mean.
E. Claims 2-3 recite “a labeled antibody which binds feline IgA” and this term has already been used so it should recite “the labeled antibody which binds feline IgA
F. Claims recite “endogenous IgA to” and it is unclear what this means. It is suggested that the claim recite “endogenous IgA specific for” instead.
G. Claim 6 should recite “affixing the feline Ki67 antigen and/or the feline TK1 antigen” in line 2
H. Claim 6 recites “the substrates” in line 4. There is insufficient antecedent basis for this limitation in the claim. There is only one recited substrate.
I. Claim 9 recites “a substrate for the enzyme” in line 1 but the term “a substrate” has already been used.
J. Claims 11 and 14-15 recites a fusion protein “and comprising any one or more of SEQ ID NO. 13-17” and it is unclear what is encompassed by this recitation since the recitation in claims 12-13 recite “further comprising any one or more of SEQ ID NO. 13-17” so it is unclear how they are different.
K. Claims 17-18 recite “OmpC (ACA), Ki67 (AKiA), integrin (AINTA) and keratin (AKERA)” and it is entirely unclear how what is recited in parentheses relates to the molecule name recited before that.
Correction is required.
8. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
9. Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 is a product claim and it cannot properly depend upon method claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
11. 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.
17. Claims 1-3, 5-15, 17-18 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for : a method of detecting endogenous antibodies to polypeptides selected from the group consisting of SEQ ID NOs 1-12 and 18-22 and patients with endogenous antibodies to SEQ ID NOs 1-12 and 18-22 for treatment, the specification does not reasonably provide enablement for: a method of detecting endogenous antibodies to Ki67, TK1, feline Ki67 antigen, feline TK1 antigen, OmpC corresponding to an OmpC from a feline micobiome, feline integrin, feline keratin, an antigenic portion of a marker for wound repair or inflammation selected rom feline integrin antigen, feline keratin, type I cytoskeletal 18, polymorphonuclear leukocytes (PMN), calprotectin, lactoferrin, c-reactive protein, food sensitivity antigens, OmpC (ACA), Ki67 (AKiA), integrin (AINTA) and keratin (AKERA) in a patient. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. The specification disclosure does not enable one skilled in the art to practice the invention without an undue amount of experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The specification has disclosed the specific peptides of SEQ ID NOs 1-12 and 18-22 for use in the claimed invention. One of ordinary skill in the art would not know how to make and use the following terms Ki67, TK1, feline Ki67 antigen, feline TK1 antigen, OmpC corresponding to an OmpC from a feline micobiome, feline integrin, feline keratin, an antigenic portion of a marker for wound repair or inflammation seleted rom feline integrin antigen, feline keratin, type I cytoskeletal 18, polymorphonuclear leukocytes (PMN), calprotectin, lactoferrin, c-reactive protein, food sensitivity antigens, OmpC (ACA), Ki67 (AKiA), integrin (AINTA) and keratin (AKERA). There is no indication of what is encompassed by any of these terms other than the specific sequences of SEQ ID NOs 1-12 and 18-22. Additionally the claims encompass any polypeptide comprising one or more of the instant recited peptides in addition to any number of amino acids added onto the N-and/or C-terminus or variant thereof so long as they are encompassed by the terms terms Ki67, TK1, feline Ki67 antigen, feline TK1 antigen, OmpC corresponding to an OmpC from a feline micobiome, feline integrin, feline keratin, an antigenic portion of a marker for wound repair or inflammation selected from feline integrin antigen, feline keratin, type I cytoskeletal 18, polymorphonuclear leukocytes (PMN), calprotectin, lactoferrin, c-reactive protein, food sensitivity antigens, OmpC (ACA), Ki67 (AKiA), integrin (AINTA) and keratin (AKERA).
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
18. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
19. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
20. Claims 1, 6-10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over LaPorte et al. (PTO-892; Reference U) in view of WO 2018030946 (PTO-892; Reference N) as evidenced by the attached sequence alignment.
LaPorte et al. teaches:
“One of the foremost problems in cancer is lack of a convenient, early detection method. Often malignancies are discovered too late, at stages that are so evolved that treatment becomes painful, expensive, or ineffective. Thymidine Kinase 1 (TK1) is an important nucleotide salvage pathway enzyme involved in DNA synthesis and repair. It has been shown that TK1 levels increase under normal cellular conditions typically during cell proliferation. However under malignant conditions, TK1 is over-expressed both in the cytosol of cancer cells and the serum of cancer patients. Consequently, serum TK1 levels (sTK1) are often used in cancer diagnosis and prognosis. We hypothesized that there may be autoantibodies against sTK1 in cancer patients because TK1 is generally intercellular and usually sequestered from the immune system. In order to investigate this hypothesis, we developed an ELISA in a 96 well plate format specifically to detect and measure the presence of autoantibodies against sTK1. Using purified TK1 as a capture antigen, we added serum from both pre-treatment cancer patients and age matched normal patients to detect any autoantibodies that interact with sTK1. Using two different types of primary, HRP conjugated antibodies, (Goat Anti-Human-HL & Goat Anti-Human-Fc) we were able to determine that there are antibodies to TK1 in the serum of both cancer and non-cancer patients. We eliminated the possibility that we were only detecting fragments of autoantibodies that were not true autoantibodies since our GAH-Fc antibody is specific to only intact antibodies. Furthermore, when we added TCEP (A common reducing agent which we used to remove the antibodies from the serum) to the serum, we saw a measurable signal reduction. Preliminary data suggest there are autoantibodies to TK1 in both cancer serum and normal serum.” (In particular, whole document).
The claimed invention differs from the prior art in the recitation of a kit comprising an antigen comprising a sequence selected from SEQ ID NO:18 and a labeled antibody which binds feline IgA of claim 21.
WO 2018/030946 teaches a clinically acceptable technique for measuring TK1 protein levels in non-human mammal subjects for oncology studies to detect cancer in animals including cats. The reference teaches an ELISA for determining the level of TK1 protein in a sample from a cat wherein the feline TK1 protein is reference SEQ ID NO:9 (which comprises instant SEQ ID NO:18).
It would have been obvious to one of ordinary skill in the art at the time of invention to have made a kit comprising a protein comprising instant SEQ ID NO:18 with an antibody that binds to feline IgA to detect TK1 autoantibodies in cats in view of the teachings of La Porte et al which teaches that autoantibodies against TK1 in cancer patients were detected and measured with an ELISA using purified TK1 as a capture antigen. It would have been obvious to have performed the method using the feline TK1 capture antigen of WO 2018/030946 of reference SEQ ID NO:9 in the method. It would have been obvious to one of ordinary skill in the art to measure all autoantibodies to the feline TK1 antigen, including IgA autoantibodies.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
21. No claim is allowed.
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. 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.
June 26, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
Prosecution Insights