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 .
Claim Status
Claim listing filed on March 4, 2026 is pending. Claims 2-4, 9-10, 12-16, and 21-22 are canceled. Claims 1, 5, 11, and 17 are amended. Claims 23-29 are new. Claims 5, 7, 17, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species. Claims 1, 6, 8, 11, 18, 20, and 23-29 are examined upon their merits.
Withdrawn Objections and Rejections
Applicant’s cancelation of Claims 9 and 21-22 have rendered all previous rejections directed to these claims moot.
The objection to Claim 11 is withdrawn in view of Applicant’s amendments. Specifically, the claim no longer repeats “chimeric antigen.”
The rejection of Claims 1, 6, 8, 11, 18, and 20 under 35 U.S.C. 112(b) for indefiniteness is withdrawn in view of Applicant’s amendments. In particular, Claims 1 and 11 now recite “every three weeks.”
Claim Rejections - 35 USC § 112 (New, necessitated by amendment)
Claims 1, 6, 8, 11, 18, 20, and 23-29 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 1 recites “a method of chronic treating HBV infection.” There is no definition of “chronic treating” in the specification, and three doses over 42 days is not understood as “chronic treatment” in the state of the art prior to filing. For the purpose of compact prosecution, Claim 1 is interpreted as “a method of treating chronic HBV” which is defined in the specification (paragraph [0049]).
Claim 24 recites “wherein an IFN-γ production increases by at least two-fold,” and Claim 26 recites “wherein alanine aminotransferase levels do not increase more than 1.5-fold relative to baseline.” These limitations recite indefinite relative terminology, specifically the term “increase” (MPEP § 2173.05(b)). It is interpreted that the IFN-γ and alanine aminotransferase levels are measured in the host by means understood in the art prior to filing; however, it is unclear to what values the increases are being compared. In Claim 24, what is the two-fold increase in IFN-γ production in comparison to? In Claim 26, the 1.5-fold increase in alanine aminotransferase is relative to “baseline,” but “baseline” is not defined in the specification and its meaning is unclear. Is baseline the level of alanine aminotransferase in a healthy subject, a subject with HBV that does not receive the treatment of Claim 1, or an alternative control value? The relative language is indefinite, and Claims 24 and 26 are rejected.
Claims 23-26 are rejected for recitation of intended results/effects that do not confer some structural, material, or manipulative difference on the scope of the parent claim. Claim 23 recites wherein the method induces an immune response; Claim 24 recites wherein an IFN-γ production increases by at least two-fold; Claim 25 recites wherein the method does not induce hepatotoxicity; and Claim 26 recites wherein alanine aminotransferase levels do not increase more than 1.5-fold relative to baseline. None of these claims recite active method steps. It is unclear whether or not assessing immune response and/or hepatotoxicity is required for infringement because these claims add no steps over those of the parent claim, Claim 1. Thus, absent method steps, it is unclear how these claims further limit the scope of the parent claim. MPEP 2173.05(g) states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim” (emphasis added). Since the claims fail to meet all (3) criteria set forth in MPEP 2173.05(g), then Claims 23-26 are rejected.
Note, “chronic HBV infection characterized by immune tolerance” as recited in Claim 27 is not defined in the specification and is interpreted as chronic HBV wherein the host’s immune system does not attack the virus, resulting in unchecked viral application and high viral load.
Claim Rejections - 35 USC § 103 (Modified, necessitated by amendment)
Claims 1, 6, 11, 18, 23-27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Rajan et al. US 8,025,873 (of record) in view of Dando et al. Drugs. 2003 (of record) and Yin et al. PLoS One. 2011.
In regard to Claim 1, Rajan teaches treating chronic HBV by administering chimeric antigens that comprise Hepatitis B Core protein coupled to a xenotypic Fc fragment (col. 8, lines 1-39, Figure 1b, and Example 7). Rajan teaches that it is advantageous to include at least one antiviral therapeutic in addition to the chimeric antigen, and a preferred antiviral therapeutic is dipivoxil (col. 29, lines 32-56). Note, “dipivoxil” is the abbreviated name for adefovir dipivoxil which is a prodrug of the nucleotide analogue adefovir and a well-known treatment for HBV (Dando et al. Drugs. 2003; abstract). The chimeric antigen and the antiviral agent can be administered concurrently (col. 31, lines 50-54). In a specific example, DHBV-infected ducks were treated with either 40µg/dose or 19.9 µg/dose HBV core chimeric antigen every other week until week 22 in combination with 20mg/kg lamivudine b.i.d until week 12 at which point the lamivudine was increased to 40mg/kg b.i.d (col. 58, lines 1-17). Note, both lamivudine and adefovir dipivoxil are antiviral nucleotide analogues understood to treat chronic HBV. Rajan teaches that the diseased “host” receiving the treatment can be a human (col. 16, lines 46-50).
In regard to Claim 6, Rajan teaches that HBV is routinely treated by two forms of antiviral therapies, antiviral compounds such as nucleoside analogues and immune modulators such as interferons (col. 5, lines 5-15). Rajan specifically recites “It is reasonable to assume that combining the antiviral effect of one drug with a second agent promoting immune modulation may improve the response rate beyond that seen with either agent alone” (col. 5, lines 51-55). As stated above, Rajan teaches that is it advantageous to include at least one antiviral therapeutic in addition to the chimeric antigen (col. 29, lines 32-56; emphasis added) which anticipates combining both an antiviral compound and an immune modulator with the chimeric antigen since both types of treatment are routine in HBV therapy.
In regard to Claims 11 and 18, Rajan teaches that the therapeutic compositions can be manufactured in a kit comprising package inserts with instructions for use (col. 36, lines 1-11). The chimeric antigen and the antiviral agents (including dipivoxil) can be administered concurrently and can optionally be formulated in the same pharmaceutical composition (col. 31, lines 50-54 and col. 29, lines 32-57). Note, MPEP 2112.01.III states: Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.").
In regard to Claims 23-24, Rajan teaches that there was an elevation of serum anti-core antibody levels in core-chimeric antigen treated DHBV-ducks compared to the control groups which suggests a humoral response to the vaccination with the chimeric antigen in a chronic virus-infected animal model (col. 58, lines 28-37). While not in humans, DHBV-ducks are an accepted animal model for studying HBV (col. 2, lines 20-24). Fig. 28 shows that administration of the xenotypic Fc fragment alone (termed TBD), even without the additional presence of the core protein, is able to increase the percent of IFN-γ+ CD3+ cells by at least two-fold as compared to untreated controls.
In regard to Claims 25-26, Rajan teaches that no local reaction to the injections of the core-chimeric antigen vaccine in the DHBV-ducks was observed and no other adverse reactions were noticed (col. 58, lines 18-20). Rajan does not teach wherein the treatment method causes hepatotoxicity or increased levels of alanine aminotransferase. To the contrary, Rajan teaches that the immune mechanism of action of the chimeric antigen could minimize the toxicity of antiviral agents by permitting lower doses of the antiviral agent to be administered over a shorter period of time (col. 32, lines 7-11).
In regard to Claim 27, the presence of persistent viremia was verified in the DHBV-ducks at week four before the start of treatment (col. 57, lines 43-49) wherein viremia is the presence of virus in the bloodstream. Therefore, the duck models of chronic HBV were characterized by immune tolerance (see above 112(b) section for interpretation of “characterized by immune tolerance”).
In regard to Claim 29, the pharmaceutical compositions are preferably delivered by parental routes such as subcutaneous or intradermal administration (col. 26, lines 61-67).
Rajan teaches administering the HBV core chimeric antigen every two weeks for 22 weeks but does not explicitly teach administering treatment every 3 weeks for a total of three doses wherein treatment is no longer administered after Day 42 (Claim 1), administering the HBV core chimeric antigen at a dose of 0.498 mg per human subject (Claim 1), or administering the adefovir dipivoxil at a dose of 0.0705 mg/kg to 0.0767 mg/kg based on a body weight of the human subject (Claim 1).
However, Rajan does teach that the dosage of the chimeric antigen for a human typically ranges from about 500 ng to about 50,000 µg per 70kg subject, and specific effective amounts will depend on the manner of administration, the composition administered, the stage of the disease being treated, the weight and general state of health of the subject, and the judgement of the prescribing physician (col. 26, lines 9-20). Administration should continue until at least clinical symptoms or laboratory tests indicate that the condition has been slowed or eliminated, and the dosages, routes of administration, and dose schedules are adjustable in accordance with methodologies known in the art (col. 26, lines 24-29). Dando teaches that adefovir dipivoxil Is approved in the US for chronic HBV infection at a dose of 10 mg/day (page 2219). Yin teaches the administration of HBV core protein immunizations in mice every two weeks for a total of three doses, and the treated mice were able to clear HBV faster than control untreated mice (page 6 and Fig. 4). Even though the art does not teach the specific drug concentrations recited in Claim 1, Rajan and Dando teach effective concentrations of the chimeric antigen and adefovir dipivoxil, respectively, and it is clear from the teachings of Rajan that specific dose concentrations can be routinely determined by a prescribing physician. Similarly, the art does not teach the specific treatment schedule of Claim 1 (i.e. every 3 weeks for a total of three doses); however, it is clear from the teachings of Yin that HBV core protein immunizations can have an effective antiviral effect after only three doses. Rajan teaches that administration should continue until the condition has been slowed or eliminated, and specific treatment schedules are routinely adjusted in the art.
Dosages and administration periods are results-effective variables which can be optimized. In the case of administering the chimeric antigen and adefovir dipivoxil, one of skill in the art would clearly recognize that doses must be timed sufficiently to maintain the efficacy of the drug in vivo and that the timing of dosages can be variable and could easily be optimized by a treating physician based on the needs and physiology of an individual patient. As such, the duration of treatment and the dosages would amount to nothing more than routine experimentation that can be optimized on an individual patient basis. MPEP § 2144.05 teaches that differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929). As dosage and treatment schedule optimization is routine in the art of medicine and pharmacology, the claims are considered to be prima facie obvious.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention that the number of treatment cycles and the dosages of the HBV core chimeric antigen and adefovir dipivoxil are a result of routine optimization. Rajan teaches administering an HBV core chimeric antigen in combination with an HBV antiviral agent to treat HBV and makes clear that the exact treatment schedule and dosages can be achieved through optimization strategies known in the art. Rajan teaches that there is motivation to adjust the treatment schedules and dosages depending on the stage of the disease being treated, the weight and general state of health of the subject, and the discretion of the prescribing physician to maximize therapeutic effects for each patient. While Rajan teaches a more prolonged treatment schedule (every 2 weeks until week 22), Yin teaches that HBV core protein immunizations can have an effective antiviral effect after only three doses administered every 2 weeks. In light of MPEP § 2144.05 on routine optimization, it is clear that differences in treatment schedules and dosages are directed to changes in form, proportions, and degrees which are differences that do not support patentability. Therefore, Claims 1, 6, 11, 18, 23-27, and 29 are obvious over the teachings of Rajan in view of Dando and Yin.
Applicant's arguments filed March 4, 2026 have been fully considered but they are not persuasive. Applicant argues that Rajan teaches a prolonged bi-weekly administration continuing until week 22 wherein the instant method is directed to a finite, defined, and cessation-based regimen with a defined stopping rule. It is of record and reiterated above that Rajan teaches that administration should continue until at least clinical symptoms or laboratory tests indicate that the condition has been slowed or eliminated, and the dose schedules are adjustable in accordance with methodologies known in the art. Yin supports that shorter treatment regimens (three doses of HBV core protein immunizations) can effectively treat HBV in mice which provides support that the treatment regimen of Rajan could be shortened with a reasonable expectation of success in treating HBV. Further, Rajan teaches that the combination of the chimeric antigen with an antiviral agent could reduce the length of time to achieve a sustained response and could reduce the chances of developing drug-resistant viral mutants normally induced by antiviral agents, especially nucleoside analogue antiviral agents, when used alone in long-term therapy (col. 32, lines 7-15). Therefore, Rajan provides motivation for shortening the length of treatment time to avoid development of drug-resistance. In summary, Rajan teaches that treatment schedules only need to continue until the condition is slowed or eliminated (i.e. 22 weeks is not required for efficacy), and shorter treatment schedules are preferable. Yin provides support that effective anti-HBV responses can be achieved after only 3 doses of HBV core protein immunizations. From the cited art, one of ordinary skill could arrive at the specific treatment schedule of Claim 1 by routine optimization.
Applicant argues that Rajan does not teach the specific dosages required when the chimeric antigen is used in combination with adefovir dipivoxil. It is of record that Rajan teaches treating DHBV-infected ducks with either 40µg/dose or 19.9 µg/dose HBV core chimeric antigen every other week until week 22 in combination with 20mg/kg lamivudine b.i.d until week 12 at which point the lamivudine was increased to 40mg/kg b.i.d (col. 58, lines 1-17). Note, both lamivudine and adefovir dipivoxil are antiviral nucleotide analogues understood to treat chronic HBV, so this teaching of Rajan provides dosages for the chimeric antigen when administered in combination with a nucleotide analogue. Further, it is of record that Dando teaches that adefovir dipivoxil Is approved in the US to treat chronic HBV infection at a dose of 10 mg/day. From the cited art, one of ordinary skill could arrive at the specific dosages of Claim 1 by routine optimization. It is well-understood in the art of medicine and pharmacology that dosages and administration periods are routinely optimized simultaneously. For example, higher doses can be administered less frequently or lower doses can be administered more frequently to maximize in vivo efficacy and minimize potential toxicity.
Applicant argues that the DHBV-duck models cannot provide a reasonable expectation of success for reversing immune tolerance in humans because it lacks key immunopathological features including sustained T-cell dysfunction and HBx-mediated immune suppression. While animal models are imperfect, it is understood in the art that they provide enabling guidance on treatments that can be further optimized in human clinical trials. It is of record that Rajan teaches that DHBV-ducks are an accepted animal model for studying HBV (col. 2, lines 20-24). Even the instant specification teaches that ducks infected with DHBV have served as an animal model for the study of the mechanism of viral replication and screening for antiviral agents since 2004 (paragraph [0057]), and congenitally DHBV-infected ducks remain chronically infected for life (paragraph [0062]). MPEP § 2107.03.IV teaches that human clinical data is not necessary to establish utility for an invention related to treatment of human disorders, and as such, the instant specification only teaches examples of treating animal models in ducks (Example 1) and mice (Example 2). Because these animal models are sufficient to enable to instant method of treatment, the DHBV-duck experiments taught by Rajan provide sufficient evidence in an animal model to inform human treatment.
Applicant argues that the routine optimization doctrine is inapplicable to the present Application. MPEP § 2144.05.III teaches that in response to a prima facie case of obviousness by routine optimization, Applicants can rebut by (A) showing that the range is critical, (B) showing that the prior art teaches away, (C) showing that the claimed parameter was not recognized as “result-effective”; or (D) showing that a claimed parameter is disclosed in a very broad range in prior art. Applicant rebuts using option (A) that the parameters are critical to achieving the technical effects observed in specification Example 2, specifically (1) breaking HBV-specific immune tolerance; (2) inducing significantly enhanced cellular immune responses; (3) exhibiting no toxicity throughout the entire process; and (4) producing a significant synergistic enhancement effect when administered in combination. It is of record that the combination of the chimeric antigen and lamivudine in Rajan did break immune tolerance by inducing an immune response with no observed toxicity (see rejection above). One of ordinary skill would expect similar results substituting adefovir dipivoxil for lamivudine as they are both understood in the art to be anti-HBV nucleotide analogues, and Rajan teaches that they are both preferred antiviral agents (of record). Applicant claims that the instant specification teaches “a significant synergistic enhancement effect when administered in combination”; however, synergy is an interaction where the combination of two drugs produces a therapeutic effect that is greater than the sum of their individual effects, and the individual effect of adefovir dipivoxil was not quantified in Example 2 (see Table 1 treatment conditions). Therefore, a synergistic effect cannot be quantified or claimed. Even if drug synergy is present, this effect is not critical to the claimed parameters as this effect was anticipated by Rajan which teaches: “The use of a chimeric antigen in combination with an antiviral agent, such as a nucleoside analogue, may prove to be highly efficacious in inducing sustained responses in the treatment of subjects suffering from chronic hepatitis B. The mechanisms of action of the two agents used in combination may produce synergistic effects in treatment of hepatitis B subjects. While not being limited to a particular therapy, a nucleoside analogue, for example, would reduce the number of viral particles circulating in the blood and hence reduce the antigenic load that the immune system must eliminate, and the chimeric antigen would induce a highly specific cellular immune response that would eliminate cells that harbor virus, viral antigens and viral DNA/RNA. In addition, the chimeric antigen would induce a humoral immune response that would neutralize and remove circulating viral particles” (col. 31, line 59 to col. 32, line 7). Therefore, Rajan teaches that the technical effects of the instant method are not critical to the dosages and treatment schedule of Claim 1, because Rajan achieves the same technical effects with different dosages and treatment schedules. Further, Applicant provides no evidence wherein the technical effects are lost when the dosages and/or treatment schedules are varied. Therefore, it is not persuasive that the technical effects are critical to the dosages and treatment schedule of Claim 1, and the prima facie case of obviousness by routine optimization is maintained.
Applicant’s arguments have been considered but are not persuasive, and the rejection is maintained.
Claims 1, 6, 8, 11, 18, 20, and 23-29 are rejected under 35 U.S.C. 103 as being unpatentable over Rajan et al. US 8,025,873 (of record) in view of Dando et al. Drugs. 2003 (of record) and Yin et al. PLoS One. 2011 as applied to Claims 1, 6, 11, 18, 23-27, and 29 above, and further in view of Tzeng et al. PLoS One 2012 (of record).
The teachings of Rajan in view of Dando and Yin as they apply to Claims 1, 6, 11, 18, 23-27, and 29 are outlined in the rejection above. Rajan teaches further administering an immune modulatory agent in combination with the chimeric antigen (see above), and specifically teaches that the additional agent can be administered either concurrently or sequentially with the chimeric antigen (col. 31, lines 50-54). Rajan does not teach wherein the immune modulatory agent is specifically a PD1 immune checkpoint inhibitor (Claims 8, 20, and 28).
Tzeng teaches that PD1 blockage reverses immune dysfunction and viral persistence in HBV mouse models (abstract). Tzeng concludes that anti-PD1 antibodies are therapeutic candidates for HBV infection (abstract).
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to adapt the method of treating HBV by administering an immune modulator as taught by Rajan to specifically comprise the immune modulator anti-PD1 as taught by Tzeng. Rajan teaches that immune modulators are important in the treatment of HBV because they stimulate an immune system into mounting a response against the viral infection (col. 5, lines 11-15). Similarly, Tzeng teaches that anti-PD1 treatment mounted an immune response by reversing T-cell exhaustion to induce an anti-HBV therapeutic response (abstract). Rajan teaches that the antiviral immune modulating agent can be administered sequentially with the chimeric antigen which reads on instant Claim 28. Therefore, it would be obvious to one of ordinary skill to substitute the generic immune modulator taught by Rajan with the specific anti-PD1 immune modulator as taught by Tzeng because the anti-PD1 therapy effectively treated HBV. Further, it would be obvious to manufacture the anti-PD1 therapy in a kit as taught by Rajan to improve convenience for both patients and physicians.
Applicant's arguments filed March 4, 2026 have been fully considered but they are not persuasive. Applicant argues that Tzeng and Dando fail to remedy the deficiencies of Rajan. The alleged deficiencies of Rajan are addressed in the rejection above.
Double Patenting (New)
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.
1. Claims 11 and 18 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over Claims 1 and 13 of U.S. Patent No. 8,007,805 in view of Rajan et al. U.S. Patent No. 8,025,873 (published September 27, 2011; referenced as “Rajan”).
The instant claims are directed to a kit comprising an HBV Core-Xenotypic Fc fragment chimeric antigen, adefovir dipivoxil, and a package insert or label with directions to the method of Claim 1 (Claim 11). Claim 18 recites wherein the kit further comprises an immune modulatory agent. Note, MPEP 2112.01.III states: Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.").
The patented claims are directed to a chimeric antigen for eliciting an immune response against HBV wherein the chimeric antigen comprises a HBV Core polypeptide and a xenotypic Fc antibody fragment (Claim 1), and an article of manufacture comprising the chimeric antigen and instructions for administering the chimeric antigen to a subject in need thereof (Claim 13).
The patented claims do not teach wherein the kit or article of manufacture further comprises adefovir dipivoxil and/or an immune modulatory agent.
Rajan teaches that HBV is routinely treated by two forms of antiviral therapies, antiviral compounds such as nucleoside analogues and immune modulators such as interferons (col. 5, lines 5-15). Rajan further teaches that it is advantageous to include at least one antiviral therapeutic in addition to the chimeric antigen, and a preferred antiviral therapeutic is dipivoxil (col. 29, lines 32-56; emphasis added) which anticipates combining both an antiviral compound and an immune modulator with the chimeric antigen since both types of treatment are routine in HBV therapy. Note, the chimeric antigen of Rajan is the same as the chimeric antigen of the Patented claims (Rajan col. 8, lines 1-39, Figure 1b, and Example 7). Rajan teaches that the therapeutic compositions can be manufactured in a kit comprising package inserts with instructions for use (col. 36, lines 1-11). The chimeric antigen and the antiviral agents (including dipivoxil) can be administered concurrently and can optionally be formulated in the same pharmaceutical composition (col. 31, lines 50-54 and col. 29, lines 32-57).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the article of manufacture as taught by the Patented claims to further comprise adefovir dipivoxil and/or an immune modulatory agent as taught by Rajan. Rajan teaches that the chimeric antigen of the Patented claims can be administered with adefovir dipivoxil and/or an immune modulatory agent wherein the additional agents can be administered concurrently and/or formulated in the same pharmaceutical composition. It would be obvious to further comprise the additional agents in the Patented article of manufacture to improve convenience for both patients and physicians. Thus, the kit of the instant claims is either anticipated and/or rendered obvious by the Patented claims in view of Rajan.
Conclusion
No claim is allowed.
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/SARAH COOPER PATTERSON/ Examiner, Art Unit 1675
/JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675
Prosecution Insights