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
The claim amended set filed 11/24/2025 is acknowledged.
Claims 13, 15-25, 27-61 are cancelled.
Claims 1-12, 14, 26, and 62-63 will be examined on the merits herein.
Claim Objections
Claim 2 recites such has, this is an apparent typographical error. In the interest of compact prosecution, the examiner will interpret this as such as.
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 1-12, 14, and 26, are rejected as they refer to Tables 3 and 4. The claim incorporates limitations from the specification rather than reciting the claimed subject matter, a person having ordinary skill in the art would need to references the specification thus the metes and bounds of the claim itself are uncertain. Where possible, claims are to be complete in themselves. 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); see MPEP 2173.05(s).
Claim 2 is indefinite as it uses exemplary language “such as” preceding the list of biological fluids, it is not clear if the list of biological fluids are limitations or not. Exemplary embodiments should be disclosed in the specification only.
Claim 4 recites the limitation “determining a change in helminth antigen levels as compared to the first assay” this is dependent on claim 1 which recites a method of “detecting a parasitic worm” and does not refer to helminth antigens. It is unclear if the applicants wish to introduce a different antigen here or refer to the same antigen from the parasitic worm. There is insufficient antecedent basis for this limitation in the claim.
In the interest of compact prosecution, the examiner will interpret the helminth antigen as referring to the parasitic worm antigen and the 2 may be used interchangeably throughout this office action.
It noted that filarial nematodes are threadlike worms and they are parasites, examples are the species such as Wuchereria bancrofti and Brugia malayi, instant specification p.1 par.2.
The applicant can overcome this rejection by consistently using parasitic worm instead of helminth in claim 4.
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.
Abstract Idea Rejection
Claim 4 is rejected under 35 U.S.C. § 101 because the claimed invention is directed to an abstract idea without significantly more. See MPEP § 2106 for analysis framework.
Regarding claim 4, the claim recites “The method of claim 1, further comprising performing steps (a) and (b) a second time and determining a change in helminth antigen levels as compared to the first assay.” This claim is a process which is statutory category of matter (Step 1: YES).
The claim is drawn to repetition of claim 1 and comparing the results of the first and second assay. These steps could be performed by a human using mental steps or basic critical thinking using the output of such a computer or program, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Thus, the claim is directed to at least one exception, which may be termed as an abstract idea (Step 2A, Prong 1: YES)
This judicial exception is not integrated into a practical application because the claim does not recite any additional elements beyond comparing the results the first assay to the second assay (Step 2A, Prong 2: NO). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements beyond the comparison of the two assay results that amount to significantly more (Step 2B: NO).
Natural Product Rejection
Claims 26 and 62-63 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Regarding claim 26, the claim recites “the antibody or antigen-binding fragment thereof comprises clone-paired heavy and light chain CDR sequences from Tables 3 and 4, respectively” This claim is a composition of matter (Step 1: YES). The instant specification discloses that the inventor analyzed seven subjects with a clinical history of lymphatic filariasis, loiasis, or onchocerciasis, two diagnosed with tropical pulmonary eosinophilia (TPE) and collected samples which were cryopreserved. IgE-secreting human hybridomas were generated from the cryopreserved PBMCs obtained from subjects. The antibodies were sequenced and are the source of the instant specification’s antibodies from table 3 and 4.
See MPEP 2106.04(c): “In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. … The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977 ("Myriad's patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 (describing how would-be infringers could not avoid the scope of Myriad’s claims). In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions.”
The instant specification does not disclose any properties of the antibodies that are markedly different as a result of the isolation. Therefore, it appears that, like in Myriad, the antibodies are different due to isolation but not markedly different and therefore the claim recites a product of nature exception. (Step 2A, Prong 1: YES)
This judicial exception is not integrated into a practical application because the claim does not recite any additional elements beyond the antibodies that might integrate the judicial exception into a practical application (Step 2A, Prong 2: NO). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements beyond the antibodies that might amount to significantly more (Step 2B: NO).
Regarding claim 62, the claim recites “A vaccine composition comprising one or more parasitic worm antigens selected from SXP-1” as well as others. This claim is a composition of matter (Step 1: YES). The instant specification discloses SXP-1 are proteins from W. bancrofti, B. malayi and D. immitis. Therefore, SXP-1 is a naturally occurring protein.
The instant specification does not disclose any properties of SXP-1 that are markedly different. Therefore, it appears that, like in Myriad, the protein is different due to inclusion in a vaccine but not markedly different and therefore the claim recites a product of nature exception. (Step 2A, Prong 1: YES)
This judicial exception is integrated into a practical application because the claim recites the additional element of integrating the protein into a vaccine (Step 2A, Prong 2: YES). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements beyond the vaccine that might amount to significantly more as vaccines are routine and conventional and the natural protein itself is sufficient to be used as vaccine (Step 2B: NO).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-10, and 26 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as anticipated by application US 20190353661 A1 ( published 11/21/2019 ) hereinafter 661.
Regarding claim 1, 661 discloses a method of detecting a parasitic worm antigen in a sample comprising contacting a sample with an antibody named 11H12 in a western blot of helminth lysate Fig.3, in which lane 3 is the antibody 11H12 par.36. The antibody 11H12 binds to the antigens of the helminth in the lysate and is detected by the presence of bands on a gel, the details of western blotting are disclosed in par.497-501.
It noted that filarial nematodes are threadlike worms and they are parasites, and the terms will be used interchangeably, instant specification p.1 par.2.
661 discloses the antibody 11H12 with identical heavy (SEQ ID NO: 77) and light (SEQ ID NO: 78) chains p.34 table B, to the instant application heavy (SEQ ID NO: 79) and light (SEQ ID NO: 80) chains, and the same name (11H12), instant specification p.97 table 2. Alignments of the sequences are provided below. These sequences comprise the CDRs in tables 3 and 4 as indicated by the label 11H12 p.99 table 3 and p.101 table 4.
Instant SEQ ID NO: 79 alignment to 661 SEQ ID NO: 77.
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770
1494
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Instant SEQ ID NO: 80 alignment to 661 SEQ ID NO: 78
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761
1526
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In addition, the examiner has provided screen shots of the CDRs from the tables below to demonstrate they are the same.
Heavy CDRs from instant p.99 table 3:
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61
614
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Heavy CDRs from 661 p.36 table C:
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77
650
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Light CDRs from instant p.101 table 4:
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47
626
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Light CDRs from 661 p.36 table D:
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71
702
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Regarding claim 2, the lysate is a biological fluid 661 par.36.
Regarding claim 3, the detection comprises a western blot 661 par.36.
Regarding claim 5, claim 5 is drawn to a nucleotide sequence encoding the antibody as defined in table 1. The nucleotide sequences of instant 11H12 are encoded by SEQ ID NO: 41 (heavy chain) and SEQ ID NO: 42 (light chain). The nucleotide sequences encoding 11H12 of 661 are encoded by SEQ ID NO: 25 (heavy chain) and SEQ ID NO: 26 in table A p.30. The examiner has provided an alignment demonstrating both sequences are identical to the instant applications sequences below.
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556
656
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569
661
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Regarding claim 6, the rejection of claim 5 demonstrates the nucleotide sequence is more than 70% identical.
Regarding claim 7, the rejection of claim 5 demonstrates the nucleotide sequence is more than 95% identical.
Regarding claim 8, the rejection for claim 1 demonstrates the protein sequences are 100% identical.
Regarding claim 9, the rejection for claim 1 demonstrates the protein sequences are more than 70% identical.
Regarding claim 10, the rejection for claim 1 demonstrates the protein sequences are more than 95% identical.
Regarding claim 26, the antibody 11H12 referenced in the rejection for claim 1 anticipates claim 26 (a).
Claims 62-63 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Wang et al. ( Evaluation of recombinant chitinase and SXP1 antigens as antimicrofilarial vaccines. Am J Trop Med Hyg. 1997 Apr;56(4):474-81. doi: 10.4269/ajtmh.1997.56.474. PMID: 9158061).
Regarding claim 62, Wang discloses a vaccine composition comprising one or more parasitic worm antigens SXP-1 p.474 title. Wang teaches filarial nematodes such as Brugia malayi and Wuchereria infect nearly 80 million people, thus they are parasitic worms p.474 par.1. Wang discloses Jirds were immunized with recombinant parasite antigens including filarial SXP1 p.474 Antigens paragraph, and 5 p.g of recombinant protein emulsified in Freund's complete adjuvant (FCA) or alum, and given a booster immunization with antigen in Freund's incomplete adjuvant (HA) or alum via the same route p.474 immunizations paragraph. This is a vaccine composition.
Regarding claim 63, Wang discloses a method of immunization a subject against a parasitic worm infection, specifically Wang discloses Mongolian jirds, 6-8-months old, were immunized intraperitoneally (ip) or by subcutaneous (sc) injection in the hind leg p.474 Immunizations paragraph. Wang discloses immunization with SXP1 reduced microfilaremia levels up to four months after infection.
Claim Rejections - 35 USC § 103
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.
Claims 4, 11, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over 661 as applied to claim 1 above in the 35 U.S.C. 102 rejection.
Regarding claim 4, as indicated above 661 teaches claim 1 however the above rejection does not address the method of claim 4, further comprising performing steps (a) and (b) a second time and determining a change in helminth antigen levels as compared to the first assay.
661 teaches a method of detecting IgE antibodies with binding affinity toward a helminth antigen in a subject, the method may further comprise performing steps (a) and (b) a second time and determining a change in antibody levels as compared to the first assay par.13. The above method is directed toward detecting IgE antibodies rather than antigens; however, the method involves binding of antibodies to antigens in order to detect the IgE antibodies as indicated by the recitation “detecting IgE antibody with binding affinity for helminth antigen in said sample by measuring the reduction of binding to helminth antigen by the test antibody”. This assay also uses the same antibodies from table C and D as in the rejection of claim 1 above.
It would have been obvious to a person having ordinary skill in the art to take the teaching of 661 and substitute the method of detecting IgE antibodies in a sample with the method of detecting antigens in order to arrive at a method of detecting a parasitic worm antigen in a sample further comprising performing steps (a) and (b) a second time and determining a change in helminth antigen levels as compared to the first assay. A person having ordinary skill in the art would have been motivated to determine if a helminth infection is becoming worse or better over time.
There would have been reasonable expectation of success because 661 taught both methods in the same disclosure and both methods use the same antibodies directed at the same antigens.
Claim 11 as indicated above 661 teaches claim 1 however the above rejection does not address the method of claim which is drawn to the use of scFv (single chain fragment variable) in the detection method of claim 1.
661 teaches “the antibody fragment may be a recombinant scFv (single chain fragment variable) antibody” when referring to the use of antibodies to helminth antigens par.18.
It would have been obvious to a person having ordinary skill in the art to use an scFv in a detection method such as a western blot because they are smaller. A person having ordinary skill in the art would have been motivated to use antibodies that area smaller and cheaper to produce and can access smaller spaces to bind antigens in a sample.
There would have been reasonable expectation of success because they are well known in the art and 661 contemplated their use.
Regarding claim 12, the above rejection of claim 1 details the anticipation of the antibody of tables 3 and 4, however this is directed toward detection of parasitic worm antigens. The above rejection does not address a method of detecting IgE anti-parasitic worm antigen antibodies in a sample.
661 teaches “A method of detecting a IgE antibody with binding affinity/specificity for a helminth antigen in a subject par.13, the helminth antigen is a parasitic worm antigen.
661 teaches the method comprising (a) providing a test antibody or fragment thereof having clone paired heavy and light chain CDRs from Tables C and D par.13, which comprise one of the same antibodies of instant Tables 3 and 4.
661 teaches (b) contacting the test antibody or fragment thereof with an antibody-containing sample from said subject in the presence of a helminth antigen par.13, which is the same as claim 12 step (a). 661 teaches a step (c) detecting IgE antibody with binding affinity for helminth antigen in said sample by measuring the reduction of binding to helminth antigen by the test antibody or fragment thereof as compared to the binding of the test antibody or fragment thereof in the absence of said sample par.13, which is essentially the same as claim 12 step (b), detecting competition for binding would include a reduction in binding.
Therefore, it would have been obvious to complete the same steps taught by 661 in par.13 thus arriving at the method of claim 12.
There would have been reasonable expectation of success because 661 teaches both the specific antibodies and the method in the same embodiment of par.13.
Regarding claim 14, the above rejection of claim 1 details the anticipation of the antibody of tables 3 and 4, however this is directed toward detection of parasitic worm antigens. The above rejection does not address a method of preventing or treating parasitic worm infection in a subject comprising delivering to said subject an IgE antibody or antibody fragment.
661 teaches the adaptive aspect of the human anti-helminth immune response is directed through the generation of specific IgE par.5. 661 teaches Passive transfer of antibodies, known as artificially acquired passive immunity, generally will involve the use of intravenous or intramuscular injections, and passive immunity provides immediate protection, this may be referring to IgG antibodies or it may be ambiguous, par.460. 661 teaches it will be understood that IgE monoclonal antibodies will have several applications. These include treating parasitic worm infections. par.68.
It would have been obvious to a person having ordinary skill in the art to combine the disclosure of 661 antibodies in Tables 3 and 4 with teaching of 661 for using IgG antibodies in passive immunity in order to arrive at a method of preventing or treating parasitic worm infection in a subject by swapping the IgG antibodies with the IgE antibodies sequences from Tables 3 and 4, respectively and delivering them to said subject. A person having ordinary skill in the art would have been motivated to provide immediate protection rather than waiting for antibodies to be produced by the immune system by a vaccine and to use IgE antibodies which are involved in parasitic immunity.
There would have been reasonable expectation of success because 661 teaches both the specific antibodies and both of the methods in the same disclosure.
Conclusion
No claims are allowed.
Inquiry Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUDOLPH E. SLOUP Jr. IV Ph.D. whose telephone number is (571)272-7899. The examiner can normally be reached Monday to Friday, 9am to 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUDOLPH E. SLOUP Jr. IV Ph.D./
Examiner, Art Unit 1645
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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