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
Priority
This application is a 35 U.S.C. § 371 National Stage filing of International Application No. PCT/US2022/022822, filed March 31, 2022, which claims the benefit of priority to U.S. Provisional Application No. 63/168,460, filed on March 31, 2021 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 03/22/2024 is acknowledged. Claims 73-95 are pending and under examination.
Information Disclosure Statement
There was no information disclosure statement (IDS) submitted at the time of this Office action.
Drawings Objections
The drawings are objected to because Figure 21 illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 91-94 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
MPEP 2106.03: 35 U.S.C. 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these "four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of § 101 even if the subject matter is otherwise new and useful." In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007).
The Supreme Court in Mayo laid out a framework for determining whether an applicant is seeking to patent a judicial exception itself, or a patent-eligible application of the judicial exception. See Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961). The first part of the Mayo test is to determine whether the claims are directed to an abstract idea, a law of nature or a natural phenomenon (i.e., a judicial exception). Id. If the claims are directed to a judicial exception, the second part of the Mayo test is to determine whether the claim recites additional elements that amount to significantly more than the judicial exception. Id. citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). The Supreme Court has described the second part of the test as the "search for an 'inventive concept'". Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
STEP 1: Claims 91-94 are drawn to a “method for predicting” the protective efficacy of a dengue vaccine candidate, which is one of the four statutory categories of invention (MPEP § 2106, subsection III, Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? (Step 1: YES).
STEP 2A: MPEP § 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s "framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217-18, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
Regarding claims 91-94, (MPEP § 2106, subsection III, Step 2A Prong One of the eligibility analysis asks: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? (Step 2A, Prong One: YES).
Regarding claims 91-94, (MPEP § 2106, subsection III, Step 2A Prong Two of the eligibility analysis asks: Does the claim recite additional elements that integrate the judicial exception into a practical application? (Step 2A, Prong Two: NO). The claims are limited to the appreciation of the natural correlation between immune response parameters and protective efficacy to make a prediction. and data gathering steps required in order to apply the natural correlation; and do not recite any specific treatment or prophylaxis.
Claim 91 is directed to a method for predicting the protective efficacy of a dengue vaccine candidate comprising determining the presence and/or amount of at least two immune response parameters selected from the group consisting of complement-fixing antibodies and high affinity antibodies against dengue virus in a blood sample from a subject vaccinated with the dengue vaccine candidate, and predicting the dengue vaccine candidate to provide protective efficacy if the presence of at least two immune response parameters selected from the group consisting of complement-fixing antibodies and high affinity antibodies against dengue virus is determined in the blood sample. Claim 92 is directed to the method according to claim 91 further determining the presence and/or amount of neutralizing antibodies, serotype specific antibodies, cross-reactive neutralizing antibodies, dengue total binding antibodies, and/or antibodies against dengue non-structural protein. Claim 93 is directed to the method for predicting the protective efficacy according to claim 92, wherein the dengue structural protein is dengue E protein and/or the dengue non-structural protein is dengue NS1 protein. Claim 94 is directed to the method for predicting the protective efficacy according to claim 91, wherein the immune response parameters are determined by a method for characterizing the immune response of a subject to a tetravalent dengue virus composition administered to said subject, comprising performing with a serum sample from said subject a method (f) and a method (e), wherein method (f) selected from a method (i) and a method (ii), wherein a method (i) for determining affinity, binding kinetics and/or concentration of an antibody or of an antibody mixture specific for a virus comprising the following steps: a) providing a virus-like particle (VLP) attached to a biosensor, wherein said VLP comprises structural proteins from said virus; b) contacting the VLP attached to the biosensor with a first solution containing the antibody or antibody mixture specific for the virus such that the antibody or antibody mixture binds to the VLP attached to the biosensor and measuring the association of the binding complex; c) contacting the VLP attached to the biosensor having bound the antibody or antibody mixture with a second solution lacking the antibody or antibody mixture such that the antibody or antibody mixture dissociates from the VLP attached to the biosensor and measuring the dissociation of the binding complex, wherein the measuring in steps b) and c) are performed by surface plasmon resonance (SPR) or biolayer interferometry (BLI) ; and d) calculating the affinity, binding kinetics and/or concentration of the antibody or the antibody mixture specific for the virus from the measurement data in steps b) and c); or a method (ii) for determining affinity, binding kinetics and/or concentration of an antibody or of an antibody mixture specific for a virus comprising the following steps: a) providing a live virus or an inactivated virus attached to a biosensor; b) contacting the live virus or inactivated virus attached to the biosensor with a first solution containing the antibody or antibody mixture specific for the virus such that the antibody or antibody mixture binds to the live virus or inactivated virus attached to the biosensor and measuring the association of the binding complex; c) contacting the live virus or inactivated virus attached to the biosensor having bound the antibody or antibody mixture with a second solution lacking the antibody or antibody mixture such that the antibody or antibody mixture dissociates from the live virus or inactivated virus attached to the biosensor and measuring the dissociation of the binding complex, wherein the measuring in steps b) and c) are performed by SPR or BLI; and d) calculating the affinity, binding kinetics and/or concentration of the antibody or the antibody mixture specific for the virus; and wherein method (e) is a method to determine the presence and/or amount of flavivirus- reactive complement-fixing antibodies in said sample.
The claims read on methods comprising a product of a viral protein consisting of a naturally occurring virus (i.e. Dengue virus) in a subject being contacted by a ligand (e.g. antibody) specific to the viral protein. Further, the recitation of "calculating the affinity, binding kinetics and/or concentration of the antibody or the antibody mixture specific for the virus from the measurement data" is a natural principle. The method steps do not impose meaningful limits on the claim scope. The steps are drawn to performing an immunoassay of a Dengue virus sample and are not considered meaningful limits because it does not narrow the claim so that others are not substantially foreclosed from using the judicial exception. The instant claims are reciting this natural process accompanied by no more than an instruction to apply the natural process using well known and routine techniques (e.g., immunoassay) to carry out the natural process. The steps of making a correlation between the detection of virus and antibody affinity and/or concentration are at a high level of generality, and are necessary data gathering steps required in order to apply the natural correlation. While it takes a human action to trigger a manifestation of the natural process, the natural process exists in principle apart from any human action. See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 10, 132 S.Ct. 1289, 101 USPQ2d 1961 (2012). Specifically, the steps of performing immunoassay reading for a dengue virus protein does not add a feature that is more than well-understood, purely conventional or routine in the relevant field.
STEP 2B: MPEP § 2106, subsection III, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s "framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts." Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)).
Regarding claims 91-94, (MPEP § 2106, subsection III, Step 2B of the eligibility analysis asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? (Step 2B: NO).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because the claims recite methods that are making use of a natural correlation. Claims 91-94 are a recital of a natural correlation accompanied by additional steps that must be taken to apply the natural correlation (e.g., the step of taking a sample to test for a naturally occurring correlation). Adding steps to a natural biological process/natural correlation that only recite well-understood, routine, conventional activity previously engaged in by researchers in the field are not sufficient to render the claims patentable.
Claim Rejections - 35 USC § 112 / 35 USC § 101
A. 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.
Claims 73 and 94 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 73 and 94 requires performing method (f) and (e), whereby method (f) recites “determining affinity, binding kinetics and/or concentration of an antibody or of an antibody mixture”, but does not appear to recite any steps to actually perform (e). Claims 73 and 94 method (e require determining “the presence and/or amount of flavivirus-reactive complement-fixing antibodies in said sample” without delineating how to perform the method. Thus, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
B. 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 73 and 94 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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.
Claims 76 and 79 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 76 and 79 recite “preferably”. The term "preferably" is a relative term which renders the claim indefinite. The term "preferably" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the claim is rendered indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 73-95 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sunita et al. “Sunita” (Journal of Pharmaceutical and Biomedical Analysis, 2010, 52(2):255-259) as applied to claim 73 above, in view of Tsuji et al. “Tsuji” (Journal of Infectious Diseases, Feb. 2021, 225(9):1533-1544).
The claims are directed to a method for characterizing the immune response of a subject to a tetravalent dengue virus composition administered to said subject, comprising performing with a serum sample from said subject a method (f) and a method (e), wherein method (f) selected from a method (i) and a method (ii), wherein a method (i) for determining affinity, binding kinetics and/or concentration of an antibody or of an antibody mixture specific for a virus comprising the following steps:
a) providing a virus-like particle (VLP) attached to a biosensor, wherein said VLP comprises structural proteins from said virus;
b) contacting the VLP attached to the biosensor with a first solution containing the antibody or antibody mixture specific for the virus such that the antibody or antibody mixture binds to the VLP attached to the biosensor and measuring the association of the binding complex;
c) contacting the VLP attached to the biosensor having bound the antibody or antibody mixture with a second solution lacking the antibody or antibody mixture such that the antibody or antibody mixture dissociates from the VLP attached to the biosensor and measuring the dissociation of the binding complex, wherein the measuring in steps b) and c) are performed by surface plasmon resonance (SPR) or biolayer interferometry (BLI) ; and
d) calculating the affinity, binding kinetics and/or concentration of the antibody or the antibody mixture specific for the virus from the measurement data in steps b) and c); or
a method (ii) for determining affinity, binding kinetics and/or concentration of an antibody or of an antibody mixture specific for a virus comprising the following steps:
a) providing a live virus or an inactivated virus attached to a biosensor;
b) contacting the live virus or inactivated virus attached to the biosensor with a first solution containing the antibody or antibody mixture specific for the virus such that the antibody or antibody mixture binds to the live virus or inactivated virus attached to the biosensor and measuring the association of the binding complex;
c) contacting the live virus or inactivated virus attached to the biosensor having bound the antibody or antibody mixture with a second solution lacking the antibody or antibody mixture such that the antibody or antibody mixture dissociates from the live virus or inactivated virus attached to the biosensor and measuring the dissociation of the binding complex, wherein the measuring in steps b) and c) are performed by SPR or BLI; and
d) calculating the affinity, binding kinetics and/or concentration of the antibody or the antibody mixture specific for the virus; and
wherein method (e) is a method to determine the presence and/or amount of flavivirus-reactive complement-fixing antibodies in said sample.
Regarding claims 73-80 and 83-87, Sunita discloses “Surface plasmon resonance (SPR) is a promising tool in sensor technology for biomedical applications. An SPR based immunosensor was established for label free and real time assay for the serological diagnosis of dengue virus infection employing the dengue virus antigen as the sensing element. The dengue virus antigen conjugated with bovine serum albumin is covalently immobilized on a gold sensor chip via activated self-assembled monolayer (SAM) of 11-mercaptoundecanoic acid, by amide coupling. Surface morphology of the biosensor was recorded using atomic force microscopy. Presence of dengue virus specific IgM antibodies in dengue positive sera was monitored by increase in resonance angle in direct immunoassay, whereas the principle of indirect competitive inhibition immunoassay was used to detect presence of dengue virus for early detection of the onset of dengue viral infection in clinical diagnostics” and “The proposed biosensor being simple, effective and based on utilization of natural antigen–antibody affinity, our study presents an encouraging scope for development of biosensors for diagnosis of dengue and dengue hemorrhagic fever (DHF)” (Abstract). Sunita discloses the sensor surface was enriched with covalently anchored antigen-BSA, the analyte dengue virus specific IgM antibodies were injected over it page 256 second column second and third para). Sunita also discloses the SPR based biosensor is suitable for detention of dengue virus specific IgM antibodies in serum/plasma or CSF in a direct immunoassay as well as for detection of dengue virus antigen using indirect competitive inhibition immunoassay, employing den-Mab in human serum; a SPR response for the immunoreaction of den-antigen-BA conjugate with den-Mab in the absence and in the presence of dengue virus antigen (page 258 second column third para, Figure 5).
Sunita does not explicitly disclose the dengue virus is a tetravalent dengue virus VLP.
Tsuji, however, discloses an avidity assay employing biolayer interferometry (BLI) and dengue virus-like particles. “After validation using anti-dengue monoclonal antibodies, the assay was used to assess avidity of antibody responses to a tetravalent dengue vaccine candidate (TAK-003) in children, adolescents, and adults during two phase 2 clinical trials conducted in dengue-endemic regions. Vaccination increased avidity index and avidity remained high through 1-year postvaccination. Neutralizing antibody titers and avidity index did not correlate overall; however, a correlation was observed between neutralizing antibody titer and avidity index in those subjects with the highest degree of antibody affinity maturation. Therefore, vaccination with TAK-003 stimulates polyclonal affinity maturation and functional antibody responses, including neutralizing antibodies” (Abstract). Tsuji also discloses “As expected, all 4 dengue VLPs contained E, prM, and M proteins, as determined by sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) (Figure 1A). Antigenicity of dengue VLPs was evaluated using a panel of anti-dengue monoclonal antibodies (Figure 1B and 1C). Cross-reactive fusion loop-specific monoclonal antibodies 4G2, WNV-E60, and 1M7 bound to VLPs of all serotypes. Serotype-specific neutralizing antibodies DENV1-E106 for DENV-1, 2D22 for DENV-2, 5J7 for DENV-3, and DV4-75 for DENV-4 recognize quaternary epitopes. Each serotype-specific antibody bound the corresponding dengue VLP and did not bind to VLPs of the other 3 serotypes. Therefore, we concluded that, unlike soluble E protein, dengue VLPs retain DENV quaternary epitopes (page 1535 first column first full para; Figure 1).
Accordingly, it would have been obvious to one of ordinary skill in the art to generate a method for characterizing the immune response of a subject to a dengue virus composition by determining the affinity, binding kinetics and/or concentration of an antibody or of an antibody mixture specific for a virus as disclosed by Sunita, whereby the method incorporates the use of tetravalent dengue virus VLPs as disclosed by Tsuji. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the teachings of Sunita utilizing SPR and that Tsuji teaches “antibody affinity maturation is a critical step in development of functional antiviral immunity; however, accurate measurement of affinity maturation of polyclonal serum antibody responses to particulate antigens such as virions is challenging” and they demonstrate an “avidity assay employing biolayer interferometry and dengue virus-like particles” whereby “After validation using anti-dengue monoclonal antibodies, the assay was used to assess avidity of antibody responses to a tetravalent dengue vaccine candidate (TAK-003) in children, adolescents, and adults during two phase 2 clinical trials conducted in dengue-endemic regions. Vaccination increased avidity index and avidity remained high through 1-year postvaccination” (Abstract of Tsuji) (instant claims 73-80 and 83-87). Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claims 79-80, Sunita discloses biotinylated flavivirus cross-reactive monoclonal antibody (den-Mab) supplied in the kit “A ‘dengue-IgM capture ELISA’ kit was procured from National Institute of Virology, Pune, India” (page 256 first column last para).
Regarding claim 81, Sunita discloses the biosensor having an amine-reactive surface “hydroxysuccinimide (NHS)” and “ethanolamine (EA)” (page 256 first column last para).
Regarding claims 82, Sunita discloses the contacting and removing of the den-Mab mixture allowing association and dissociation of the mixture (page 256 second column second full para).
Regarding claims 88 and 91-94, Sunita does not disclose a microsphere complex coupled to a flavivirus antigen to allow binding of the complement-fixing antibodies in the sample.
Tsuji, however, discloses an avidity assay employing BLI and dengue virus-like particles. For the avidity assay, anti-dengue polyclonal antibodies are purified from serum by protein G Sepharose and immobilized to the biotinylated VLP-captured biosensor for 1800 seconds and then the sensor is incubated with dissociation buffer for 1200 seconds. Avidity index is than calculated by response/Koff. The method is used for determining antibody avidity after vaccination in serum samples. Tsuji shows that avidity increased significantly after vaccination, with the highest avidity antibodies to DENV-1, -2 and -3, and lower DENV-4 (page 1534 second column 4 para; page 1536 second column second para to page 1538 second column third para). Tsuji also discloses “As expected, all 4 dengue VLPs contained E, prM, and M proteins, as determined by sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) (Figure 1A). Antigenicity of dengue VLPs was evaluated using a panel of anti-dengue monoclonal antibodies (Figure 1B and 1C). Cross-reactive fusion loop-specific monoclonal antibodies 4G2, WNV-E60, and 1M7 bound to VLPs of all serotypes. Serotype-specific neutralizing antibodies DENV1-E106 for DENV-1, 2D22 for DENV-2, 5J7 for DENV-3, and DV4-75 for DENV-4 recognize quaternary epitopes. Each serotype-specific antibody bound the corresponding dengue VLP and did not bind to VLPs of the other 3 serotypes. Therefore, we concluded that, unlike soluble E protein, dengue VLPs retain DENV quaternary epitopes (page 1535 first column first full para; Figure 1).
Accordingly, it would have been obvious to one of ordinary skill in the art to generate a method for characterizing the immune response of a subject to a tetravalent dengue virus composition by determining the affinity, binding kinetics and/or concentration of an antibody or of an antibody mixture specific for a virus as discloses by Sunita, whereby the method incorporates the steps of a microsphere complex with a flavivirus antigen with the sample to allow binding of the flavivirus-reactive complement-fixing antibodies and contacting an amount of complement component 1q (C1q) with the complement-fixing antibodies; contacting an amount of a reporter antibody with the C1q bound to the antibodies and detecting a signal from the reporter antibody as disclosed by Tsuji. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the teachings of Sunita utilizing SPR and that Tsuji demonstrates the method can be achieved utilizing an avidity assay employing BLI for determining antibody avidity after vaccination in serum samples.
Regarding claims 89-90, with respect to the tetravalent dengue virus comprising live, attenuated virus strains comprising the serotypes (i) thru (iv), it is not inventive and considered routine and obvious to one of ordinary skill in the art to utilize the method as outlined in claim 73 with dengue virus strains that are well-known to one of ordinary skill in the art such as the dengue serotypes as well as the chimeric serotypes. A skilled artisan has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. A skilled artisan would have had a reasonable expectation of success, because the method would have yielded predictable results (i.e. a method of characterizing an immune response of a subject to a tetravalent dengue virus composition utilizing SPR or BLI) in improving the effects of vaccination) to one of ordinary skill in the art at the time of the invention.
Regarding claim 95, the claim recites a process for producing the composition (i.e. method for preparing a vaccine formulation) of claim 91. According to the MPEP (2113), PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009).
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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