Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of 17/802,872
Claims 1-8, 10-15, and 45-49 are currently pending.
Priority
Instant application 17/802,872, filed 8/26/2022, claims priority as follows:
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The earlier filed provisional application contains support for the claims, and thus the effective filing date of the instant claims is 2/28/2020.
Information Disclosure Statement
All references from the IDS’s submitted on 11/21/2022 and 7/14/2025 have been considered unless marked with a strikethrough.
Response to Arguments/Amendments
The amendment filed 6/4/2026 has been entered. Claims 1-4, 12, 13, and 46 have been amended and claim 9 has been cancelled.
In the Non-Final dated 2/4/2026, the specification was objected to for embedded hyperlinks and/or other form of browser-executable codes. In response, Applicant has amended the specification to omit these hyperlinks, which overcomes this objection. Thus, this objection is withdrawn.
The drawings were objected to in the Non-Final dated 2/4/2026 for pixelated and illegible images. In response, Applicant has submitted replacement sheets with corrected drawings, which overcome the objection. The objection is withdrawn.
Claim 3 was objected to for minor grammatical informalities. In response, Applicant has changed the capitalized letters of the generic pharmaceuticals to lowercase letters, which overcomes the objection. Therefore, the objection is withdrawn.
In the Non-Final dated 2/4/2026, claims 1-3, 6, and 9-15 were rejected under 35 U.S.C. 112(b). In response, Applicant has struck through the term, “therapeutically effective amount”, has brought in the content from the tables and figures previously recited in the claims, and has provided arguments with respect to the definition and clarity of “cancer-specific antigen”, which overcomes the rejections. The rejections are withdrawn.
Claims 1-3, 6, and 9-14 were rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) in the Non-Final dated 2/4/2026. In response, Applicant has cancelled claim 9, and has amended instant claim 1 to include additional limitations with respect to the patient population. The addition of the requirement where the subject has an HLA allelic variation predicted to lead to an immune hypersensitivity reaction in the subject after administration of the HLA binding molecule in the method overcomes the rejection. Therefore, the rejection is withdrawn.
In the Non-Final dated 2/4/2026, claims 1, 14, and 15 were rejected under 35 U.S.C. 103. In response, Applicant amended instant claim 1 as stated above. The amendment overcomes the rejection of the Non-Final which is thus withdrawn.
However, Applicant’s amendments necessitated the new ground(s) of rejection presented in this Office Action.
Election/Restriction
Applicant’s election of Group I, claims 1-15, drawn to methods of administering a therapeutically effective amount of an HLA binding molecule to a subject in the reply filed 7/14/2025 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse. See MPEP § 818.01(a). Applicant’s election of abacavir as the species of HLA binding molecule and skin cancer as the species of cancer in the reply filed 9/30/2025, is also acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified in the Non-Final dated 2/4/2026. The 102 and 103 rejections of the Non-Final were overcome with amendments; however, additional art was identified to help teach the limitations of these amendments. See the 102 and 103 rejections below. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1-3, 6, and 10-15 read on the elected species. Claims 4-5, 7-8, and 45-49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
NEW REJECTIONS NECESSITATED BY AMENDMENT
Claim Interpretation
Claim 1 recites, “an HLA allelic variation that is predicted to lead to an immune hypersensitivity reaction in the subject after administration of the HLA binding molecule” in reference to the patient population to which the HLA binding molecule is administered. This phrase is not explicitly defined in the specification and it is not generally known to one of ordinary skill in the art; however, the instant disclosure does give an example of HLA allelic variant as the HLA-B*57:01 variant (page 4) and further states that abacavir, an HLA binding molecule, can have a significant risk of a hypersensitivity reaction if taken by an HLA-B*57:01 patient (page 10, last paragraph). Thus, the limitation is currently being interpreted as any HLA allelic variation that has been demonstrated to lead to a hypersensitivity reaction and the example of HLA-B*57:01 currently satisfies this limitation.
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 1-2, 6, and 10-15 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.
Claims 1 and 2 recite limitations that are not defined in the instant disclosure nor known to one of ordinary skill in the art. Specifically, the terms, “a sulfonamide agent”, “a nonsteroidal anti-inflammatory (NSAID) agent”, “an aminopenicillin agent”, “a cold medicine”, “a statin agent”, and “component of Cortalex” are indefinite, unclear, and not known in the art. Dependent claims 6 and 10-15 do not resolve this issue by claiming a specific HLA binding molecule and are thus also rejected. Appropriate correction is required.
Claim 1 contains the trademark/trade name “Cortalex” in reference to the HLA binding molecules. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an HLA binding molecule and, accordingly, the identification/description is indefinite. Dependent claims 6 and 10-15 do not resolve this issue by claiming a specific HLA binding molecule and are thus also rejected.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 6, and 10-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, the claims of the instant application embrace a method of administering an HLA binding molecule to a subject, wherein the HLA binding molecule is a small molecule selected from a large group recited in instant claim 1. The group includes molecules such as, “a sulfonamide agent”, “a nonsteroidal anti-inflammatory (NSAID) agent”, “an aminopenicillin agent”, “a cold medicine”, “a statin agent”, and “component of Cortalex”, which invoke the 112(a) rejection. Even a cursory calculation of the number of compounds embraced in the instant claims would result in thousands of compounds.
Level of skill and knowledge in the art
The level of skill and knowledge in the art is high.
Partial Structure
Compounds able to bind to HLA have been disclosed and some examples of compound species that would be within the general formula have been disclosed. However, as to the claimed sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex, no specific examples are given that would demonstrate possession or put the public in possession of all the sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex able to bind HLA.
It is generally accepted that sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex may vary by chemical formulae and may also differ in properties and the arrangement of atoms in the molecule.
Physical and/or chemical properties/functional characteristics
Compounds able to bind HLA, including sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex, are compounds which are allegedly useful in treatment of cancer. Although the art recognizes generally accepted definitions, the terms are not explicitly defined by the specification in such a way as to demonstrate that the inventor had possession of the sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex able to bind HLA.
A review of the prior art identifies the reference Shah (Shah, F. and Bell, I. M. J. Med. Chem. 2020, 63, 7447-7457), which analyzes cutaneous reactions after administration of sulfonamide-containing drugs (title, abstract). Shah teaches that though the mechanisms underlying hypersensitivity reactions are not fully understood, it is generally accepted that the terminal aniline on some sulfonamides produces metabolites that bind to proteins, leading to antigen presentation and immune response (page 7447, last paragraph). Thus, sulfonamides without this aniline, or differ by a substitution at this position, are not known to bind to the same proteins. In view of the teachings of Shah, it is unknown which sulfonamide agents will be active or inactive in inducing an immune hypersensitivity reaction in the subject. Further, one of ordinary skill in the art would not be able to predict which compounds, of the vast number that are claimed, will be active or inactive absent evidence. There is no structure/function correlation in the specification showing which agents would or would not be active in hypersensitivity reactions.
Since Applicant has not set forth compounds in the specification which Applicant considers sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex, it is not clear what compounds fall under these definitions. Applicant has not described which sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex have the ability to bind to HLA, and which do not. Stated differently, there is no structure/function correlation and no representative number of specific examples of sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex that demonstrate which compounds retain activity. Further, one of ordinary skill in the art would not be able to predict the biological activity of the claimed sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex.
Predictability of the art
Medicinal chemistry is an experimental science with a low predictability level. Small changes in the structure of a compound can lead to large differences in their pharmacological activity. Regarding sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex predicting if a certain claimed compound retains the activity and function of the original drug is filled with experimental uncertainty because sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex contain variation by chemical and physical properties of the molecules.
Method of making the claimed invention
No method for making all of the compounds, including the sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex, encompassed by the instant claims has been disclosed. Methods of synthesizing compounds are, in general, known to a person of ordinary skill; however, methods of making the myriad of compounds encompassed by the instant claims is beyond the skill of the artisan, particularly when certain elements, such as sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex are merely described partially.
As such, the instant specification and instant claims do not provide sufficient description such that one could anticipate what additional elements may be present in the sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex because the examples illustrated in the experimental section are limited to only the general terms.
Substantial and undue experimentation would be needed to practice Applicant’s invention because the specification lacks sufficient detail to show how to use the sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex of the instant invention. Further, there is no guarantee that all of the sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex embraced by the scope of the claims would be use in treatment of a cancer.
Even with the undue burden of experimentation, there is no guarantee that one would obtain the product of a desired sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex. Although some functional characteristics are disclosed or would be known to a person of ordinary skill in the art, in the absence of a disclosed structure, there can be no correlation between the function and structure of the claimed sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex in the instant application.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claim(s) are broad and generic with respect to all possible compounds encompassed by the claims: the possible structural variations are limitless to any sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex. In the instant case, however, the specification does not disclose a sufficient variety of species to reflect this variance in the genus. Specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims, for example, sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Dependent claims 3, 6, and 10-15 do not resolve the 112(a) written description rejections raised in claims 1 and 2, since those claims do not further limit or provide further structure of the sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex. Accordingly, these claims are also rejected. This rejection would be overcome by amending the claims to remove the terms, sulfonamide agents, NSAID agents, aminopenicillin agents, cold medicines, statin agents, and components of Cortalex.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-3 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mallal (Mallal, S. N. Engl. J. Med. 2008, 358(6), 568-579).
The reference Mallal discloses the administration of abacavir, which is an HLA binding molecule, to human patients in with the HLA-B*57:01 allele variation in the control group (page 570 and page 576, Table 4) and evaluated for hypersensitivity reactions. The Examiner notes according to the claim interpretation above, the HLA-B*57:01 allelic variation satisfies the limitation of HLA allelic variation that is predicted to lead to an immune hypersensitivity reaction in the subject after administration of the HLA binding molecule. Thus, Mallal anticipates instant claims 1-3 and 6.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mallal (Mallal, S. N. Engl. J. Med. 2008, 358(6), 568-579, cited in the IDS of 11/21/2022) in further view of Kyoto University (US 2016/0000796 A1, cited in the IDS of 11/21/2022, herein after “Kyoto”).
Determining the scope and contents of the prior art
The reference Mallal teaches as disclosed above, and at least those teachings are incorporated herein.
The reference Kyoto teaches methods of treating cancer with abacavir (abstract). Specifically, Kyoto discloses the administration of 100 μM of abacavir to a human adult t-cell leukemia/lymphoma (ATL) cell line to induce apoptosis (page 6, para [0099]-[0101] and Figure 11).
Regarding claim 10, the cancer cell line, the subject, is diagnosed as having cancer.
With respect to claim 11, Kyoto teaches that the pharmaceutical compositions of the present invention can be used for a cancer whose DNA repair system is impaired, and an example of a cancer whose DNA repair system is impaired is skin cancer.
Regarding claims 12 and 13, Kyoto teaches the killing of cancer cells in Figure 11, which slows the development, growth, and spread of cancer.
With respect to claim 14, Kyoto teaches that the pharmaceutical composition may be used in combination with a different therapeutic agent for cancer, and is preferably, but not limited to, a chemotherapeutic agent, immunotherapeutic agent, hormone therapy agent, or radiation therapy (page 3, para [0056]).
Ascertaining the differences between the prior art and the claims at issue
The reference Mallal fails to teach administration of abacavir to subjects diagnosed with cancer.
The reference Kyoto fails to teach the administration of abacavir to subjects with an HLA allelic variation that is predicted to lead to an immune hypersensitivity reaction in the subject after administration of the HLA binding molecule, such as HLA-B*57:01.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of methods of administration of abacavir. An artisan possess the technical knowledge necessary to make adjustments to the methods to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said methods of administration of abacavir and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious to one of ordinary skill in the art to combine the methods of administration of abacavir in patients with the HLA-B*57:01 allele variant found in Mallal with the administration of abacavir in human cancer cell lines in Kyoto to identify additional administration methods of abacavir in human patients. The artisan would be motivated before the effective filing date to combine patient populations of already successful abacavir administration methods to discover additional methods of use of abacavir, and would readily predict success in light of the teachings of Mallal and Kyoto.
Claims 1-3, 6, and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Mallal (Mallal, S. N. Engl. J. Med. 2008, 358(6), 568-579, cited in the IDS of 11/21/2022) in further view of Kyoto University (US 2016/0000796 A1, cited in the IDS of 11/21/2022, herein after “Kyoto”) and Suehiro (Suehiro, Y., et. al. British Journal of Haematology, 2015, 169, 356-367).
Determining the scope and contents of the prior art
The references Mallal and Kyoto teach as disclosed above, and at least those teachings are incorporated herein.
Suehiro teaches the administration of a vaccine to augment an immune response implicated in anti-Adult T cell leukemia/lymphoma (ATL) effects (abstract). Specifically, Suehiro teaches the administration of the Tax peptide-pulsed DC vaccine (page 361, first paragraph), which in turn decreased the number of ATL cells in peripheral blood (page 361, Figure 2A).
Ascertaining the differences between the prior art and the claims at issue
Mallal fails to teach an example of a method of administering abacavir to a subject diagnosed with cancer and a cancer specific antigen.
Kyoto fails to teach an example of a method of administering abacavir to a subject with an HLA allelic variation that is predicted to lead to an immune hypersensitivity reaction and a cancer specific antigen to a subject.
Suehiro fails to teach a method of administering a therapeutically effective amount of abacavir to a subject.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of methods of administration of abacavir. An artisan possess the technical knowledge necessary to make adjustments to the methods to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said methods of administration of abacavir and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious for one of ordinary skill in the art to combine the methods of administration of abacavir found in Mallal and Kyoto with the methods of administration of the anti-cancer vaccine found in Suehiro because one skilled in the art would expect the combination of pharmaceuticals known to treat the same diseases to maximize the effectiveness of treatment of the diseases. The artisan would be motivated before the effective filing date of the claimed invention to test combinations of pharmaceuticals taught for the same purpose to improve the overall activity of the compositions and would have readily predicted success in light of the teachings of Mallal, Kyoto, and Suehiro.
Conclusion
Claims 1-3, 6, and 10-15 are rejected. Claims 4-5, 7-8, and 45-49 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.N.H./ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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