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 .
Claims 1-3, 7-14, 19 and 23-24 are pending and will be examined on the merits.
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Note: the polylysine components of the lipopeptides of claim 8 (e.g., -SKKKK, -CSKKKK, etc….) as well as in the Specification (e.g., p 19, lines 11-16) are all enumerations of four or more contiguous amino acids and, as such, require sequence identifiers.
Note: The objection to the Specification as well as the objection to claim 8 are because of this issue.
Claim Rejections - 35 USC § 112
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.
Claim 23-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of treating a cancer, does not reasonably provide enablement for methods of preventing a cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue include, but are not limited to: 1) nature of the invention, 2) state of the prior art, 3) relative skill of those in the art, 4) level of predictability in the art, 5) existence of working examples, 6) breadth of claims, 7) amount of direction or guidance by the inventor, and 8) quantity of experimentation needed to make or use the invention. In re wands, 858 F.2d 731, 737.8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The instant claims are drawn to a method for preventing, ameliorating or treating a cancer in a subject in need thereof, said method comprising administering to said subject a composition comprising the collection of all of the TAA peptides identified in claims 23 and 24, either with a lipopeptide adjuvant (claim 24) or without (claim 23).
When given the broadest reasonable interpretation, “a subject in need thereof” includes humans and non-experimental animals.
The Merriam-Webster definition of the word “prevent”—“to keep from happening or existing”. Thus, the broadest reasonable interpretation of the claim is that the method comprising the administration of the instant claimed combination of immunogenic TAA peptides described in the preceding paragraph prophylactically prevents cancer from occurring by killing every cancer cell present or stopping every healthy cell from becoming cancerous.
The skilled artisan recognized that before any method of preventing a particular cancer could be practiced with any level of predictability, some method of identifying subjects predisposed to the particular cancer must be available. While the art has advanced in recent years, it is still highly unpredictable not only which individuals will develop a particular cancer, but also when a “preventative” therapy will be helpful.
Breast cancer illustrates the difficulties associated with detecting and preventing cancer. The skilled artisan generally recognized symptoms of breast cancer to include changes in the breast such as the presence of a lump, nipple discharge, or other changes in the shape or texture of the breast. However, such symptoms are non-specific and have multiple other potential causes. Even detection of a breast mass by mammography is only an early step in the diagnosis of breast cancer. As noted in a 2014 article in the World Journal of Clinical Oncology, following an abnormal mammographic finding exam, biopsy is required for a diagnosis (cancer vs. benign lesion) and staging is required to determine appropriate treatment (Shah, et al. World J Clin Oncol 2014 August 10; 5(3): 283-298, Table 1).
Further, even in individuals judged to have a twofold increased risk of developing breast cancer, prevention with tamoxifen was incomplete. Briefly, high risk women were given either tamoxifen or a placebo and the occurrence of breast cancer was monitored for 20 years. The placebo group had a breast cancer rate of 12.3% and the treatment group had a breast cancer rate of 7.8 %. (Cuzick, et al Lancet Oncol 2015 Jan; 16(1) 67-75, Results, page 4). While tamoxifen did reduce the risk of the occurrence of breast cancer, it did not completely prevent it. It should be noted that the Specification is not enabling for prevention of any type of cancer.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 9-11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Both claims 7 and 11 are dependent on claim 2. Claim 2 recites the composition of claim 1, further comprising an adjuvant consisting of a lipopeptide and an immunoactive substance. Both claims 7 and 11 attempt to further limit claim 2 by reciting that the adjuvant of claim 2 comprises the lipopeptide of claim 2 as well as a liposome.
Please note that claim 2 recites that the adjuvant consists of a lipopeptide. The translational phrase “consisting of” excludes any element, step or ingredient not specified in the claim and that a claim which depends from a claim that “consists of” the recited elements or steps cannot add an element or step (See MPEP § 2111.03(II)). The “consisting of” language of claim 2 with respect to the adjuvant of claim 2 excludes any and all design elements not recited in claim 2. As such, claims 7 and 11 do not contain all of the limitations of claim 2 because claim 2 recites that the adjuvant is a lipopeptide and nothing else besides the lipopeptide, but claims 7 and 11 attempt to add design elements to the adjuvant other than the lipopeptide of claim 2
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-3, 8, 12-14, 19 and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barner (Barner, et al., WO 2009/046738; Published 4/16/2009) in view of Dobeel (Dobeel, et al., WO 2009/072767 A2; Published 6/11/2009), Eriksen (Eriksen, et al., WO 02/070679 A2; Published 11/12/2002), Saito (Saito, et al., US 2009/0136572; Published 3/28/2009), Wang (Wang, et al., WO 2018/166298 A1; Published 9/20/2018), Chen (Chen, et al., WO 03/038047 A2; Published 5/8/2003), Straten (Straten, et al., WO 2004/067023 A2; Published 8/12/2004) , Fikes (WO 01/41741-A1; Published 6/14/2001), FikesII (Fikes , et al., WO 01/42267-A1; Published 6/14/2001), Wang, R (Wang, R., et al., WO 02/064057; Published 8/22/2002), Chiang (Chiang, et al., US 9,181,302 B2; Issued 11/10/2015) and Sugiyama (Sugiyama, et al., US 2008/0070835 A1; Pub 3/20/2008).
Barner teaches on the subject of immunostimulatory compositions comprising mRNA encoding multiple antigenic sequences as well as methods of treating non-small cell lung cancer (NSCLC), said methods comprising administering the immunostimulatory compositions of Barner to a subject in need thereof (Barner, Abstract). Barner teaches that the immunostimulatory composition of Barner is used in the treatment of lung cancer (Barner, p 5, lines 25-30). Barner teaches that the immunostimulatory composition of Barner comprises RNA encoding at least two (preferably different) antigens selected from the group of: hTERT, WT1, MAGE-A2, 5T4, MAGE-A3, MUC1, Her-2/neu, NY-ESO-1, CEA, Survivin, MAGE-C1 and MAGE-C2 and that combinations of antigens selected from the aforementioned efficiently stimulates the immune system to allow for treatment of NSCLC (Barner, p 6, line 1-27). Regarding claims 2 and 8, Barner teaches that the multi-antigen NSCLC vaccine of Barner further includes adjuvants that are lipopeptides that are Pam3Cys (Barner, claim 19). Regarding claim 19, Barner teaches that the multi-antigen NSCLC vaccine of Barner is aqueous (Barner, p 43, lines 11-20). Regarding claims 23-24, Barner teaches methods of treating NSCLC, said methods comprising administering the multi-antigen NSCLC vaccine of Barner to a patient in need thereof (Barner, p 48, lines 9-26).
Barner does not teach that the multi-antigen NSCLC vaccine of Barner comprises: 1) hTERT peptides of SEQ ID NOs: 1, 2, 3 and 4, 2) survivin peptides of SEQ ID NO: 5, 3) MAGE-A3 peptides of SEQ ID NOs: 8 and 9, 4) MUC1 peptide of SEQ ID NO: 12 and 4) WT-1 peptides of SQ ID NOs:15 and 16. Barner does not teach that the multi-antigen NSCLC vaccine of Barner comprises the lipopeptide Pam3Cys-SKKKK and 50-5,000 bp poly(I:C) at a lipopeptide to poly(I:C) ratio of 1.25:1 – 2:1.
Dobeel teaches on the subject of vaccine adjuvants comprising a lipopeptide and poly I:C (Dobeel, Abstract)
Dobeel teaches that the poly I:C of Dobeel is between 50-2000 bp (Dobeel, p 7, lines 1-2). Dobeel teaches that, in an in vivo antibody titer experiment using influenza as a model, 20 ug Pam3Cys-SKKKK mixed with 20 ug poly I:C demonstrated a strong synergistic effect with respect to HA antibody titer compared to 20 ug Pam3Cys-SKKKK alone or 20 ug poly I:C, with Pam3Cys-SKKKK+PolyIC generating a titer of 3.0 * 106, poly I:C alone generating 8.6 *105 and Pam3Cys-SKKKK alone generating a 6.8 * 105 titer (Dobeel, p 13 lines 5-38)
Eriksen teaches on the subject of of anti-cancer peptide vaccines (Eriksen, Abstract). Eriksen teaches the immunogenic peptides are hTERT fragments comprising REEILAKFLHWLMSVYVVEL (Eriksen, p 27, line 28 – p 28, line 10), with the 5th from the top peptide of p 29 of Eriksen comprising 100% of instant SEQ ID NO: 1 (Eriksen, p 29, line 5).
Saito teaches of cancer immunotherapeutics comprising cancer antigen peptide(s) emulsified and administered as a cancer vaccine (Saito, ¶ 0001). Saito teaches that SEQ ID NO: 48 of Saito is a hTERT cancer antigen peptide identical to instant SEQ ID NO: 2 (Saito, ¶ 0065).
Wang teaches of an hTERT tumor associated epitopic peptide of Wang’s SEQ ID NO: 7 that is identical to instant SEQ ID NO: 3.
Chen teaches on the subject of MHC-II hTERT restricted tumor-associated epitopes and their administration for the treatment of hyperproliferative diseases. Chen teaches one of the immunogenic hTERT peptides of Chen is a peptide of Chen’s SEQ ID NO: 20, which is identical to instant SEQ ID NO: 4 (Chen, p 63, Table 1, entry 4)
Straten teaches on the subject of survivin-derived MHC Class I restricted survivin epitopes capable of binding HLA Class I molecules (Straten, Abstract). Straten teaches that survivin was identified as one of the top genes invariably upregulated in man types of cancer, but is undetectable in normal tissue, rendering it a suitable tumor associated antigen (TAA) (Straten, p 3, line 39, p 40, line 9). Straten teaches that one of the survivin-derived epitopic peptides of Straten is Straten’s SEQ ID NO: 2 which is identical to instant SEQ ID NO: 5 (Straten, p 8, lines 20-24).
Fikes teaches that the peptide epitopes of Fikes are useful in stimulating an immune response to tumor associated antigens (TAAs) and therefore could be administered to individuals expressing one or more of the TAAs in the treatment of various cancers (Fikes, p 4, lines 1-15). Fikes teaches SEQ ID NO 20 of Fikes, which was an identified MAGEA3 CTL epitope for vaccination and is identical to instant SEQ ID NO: 8 (Fikes, p 69, table 6, third entry from bottom).
FikesII teaches that the peptides of FikesII are epitope-based vaccines directed toward tumor associated antigens (TAAs) for use in methods of treatment of cancers (FikesII, p 3, lines 1-6). FikesII teaches one of the epitopic peptides identified was a MAGEA3 peptide of sequence IMPKAGLLI (same ass instant SEQ ID NO: 9) (FikesII, p 158, Table XXVIa; entry 18)
Wang, R teaches that the peptide STAPPVHNV(same as instant SEQ ID NO: 12) is a HLA I A2 tumor associated antigen derived from MUC 1 (Wang, R, p 18, entry 7th from top).
Chiang teaches on the subject of compositions comprising cancer antigen peptides derived from WT1 (Chiang, Abstract). Chiang teaches that one of the WT1 cancer antigen peptides of Chiang is Chiang’s SEQ ID NO: 2 (identical to instant SEQ ID NO: 15) (Chiang, Col.5, line 43).
Sugiyama teaches on the subject of WT1-derived HLA-DRB1*0405-binding antigen peptides derived from WT1 as well as the use of such peptides in enhancing the efficacy of cancer vaccines (Sugiyama, ¶ 0006). Sugiyama teaches that one of the DRB1*0405-binding antigenic peptides derived from WT1 was Sugiyama’s SEQ ID NO: 24 (identical to instant SEQ ID NO: 16) was shown to specifically induce CD4-positive T cells to the antigen (Sugiyama, ¶ 0181-0182).
It would be prima facie obvious to one of ordinary skill in the art to combine the method of treating NSCLC taught by Barner comprising administering mRNA encoding antigens from hTERT, survivin, MAGEA3, MUC1 and WT1 coupled a Pam3Cys adjuvant with: 1) the antigenic, tumor associated hTERT peptides taught by Eriksen, Saito Wang and Chen, 2) the antigenic, tumor associated survivin peptide taught by Straten, 3) the antigenic, tumor associated MAGEA3 peptides taught by Fikes and Fikes II, 4) the antigen, tumor associated MUC1 peptide taught by Wang, R and 5) the antigenic, tumor associated WT1 peptides taught by Chiang and Sugiyama to form a method of treating NSCLC, said method comprising administering to a patient in need thereof a vaccine comprising a Pam3Cys adjuvant and: 1) the antigenic, tumor associated hTERT peptides taught by Eriksen, Saito Wang and Chen, 2) the antigenic, tumor associated survivin peptide taught by Straten, 3) the antigenic, tumor associated MAGEA3 peptides taught by Fikes and Fikes II, 4) the antigen, tumor associated MUC1 peptide taught by Wang, R and 5) the antigenic, tumor associated WT1 peptides taught by Chiang and Sugiyama. One of ordinary skill in the art would be motivated to do this in order to better treat NSCLC. One of ordinary skill in the art would have a reasonable expectation of success forming a method of treating NSCLC, said method comprising administering to a patient in need thereof a vaccine comprising a Pam3Cys adjuvant and: 1) the antigenic, tumor associated hTERT peptides taught by Eriksen, Saito Wang and Chen, 2) the antigenic, tumor associated survivin peptide taught by Straten, 3) the antigenic, tumor associated MAGEA3 peptides taught by Fikes and Fikes II, 4) the antigen, tumor associated MUC1 peptide taught by Wang, R and 5) the antigenic, tumor associated WT1 peptides taught by Chiang and Sugiyama because: A) Barner teaches the idea of treatment of NSCLC via simultaneously targeting tumor-associated antigens selected from amongst hTERT, survivin, MAGEA3, MUC1 and WT1 as well as the a Pam3Cys adjuvant, B) Eriksen, Saito, Wang and Chen teach hTERT antigens identical to instant SEQ ID NOs: 1, 2, 3, and 4, respectively, with each peptide being taught to be antigenic and tumor-associated, C) Straten teaches a survivin antigen identical to instant SEQ ID NO: 5 that is antigenic and tumor-associated, D) Fikes and FikesII teach MAGEA3 antigens identical to instant SEQ ID NOs:8 and 9, respectively, with each peptide being taught to be antigenic and tumor-associated E) Wang, R teaches a MUC1 antigen identical to instant SEQ ID NO: 12 that is antigenic and tumor-associated, F) Chiang and Sugiyama teach WT1 antigens identical to instant SEQ ID NOs:15 and 16, and G) one of skill in the art would reasonably deduce that the resultant combination of antigenic peptides would be likely to have an anti-NSCLC effect because each individual component peptide is individually taught in the prior art by the respective author as antigenic and cancer- associated and each one of the peptides is selected from the selection of anti-NSCLC vaccine antigens taught by Barner.
It would be prima facie obvious to modify the collective method treating NSCLC collectively taught by Barner, Eriksen, Saito, Wang, Chen, Strate, Fikes, FikesII, Wang, R, Chiang and Sugiyama described in the preceding paragraph to comprise the Pam3Cys-SKKKKK and 50-2000 bp poly (I:C) immunoactive agent of Dobeel. One of ordinary skill in the art would be motivated to do this in order to enhance the adjuvant effect in the NSCLC vaccine described above. One of ordinary skill in the art would have a reasonable expectation of success using Pam3Cys-SKKKK and 50-2000 bp poly I:C as adjuvants in the multi-antigen NSCLC vaccine collectively taught by Barner, Eriksen, Saito, Wang, Chen, Strate, Fikes, FikesII, Wang, R, Chiang and Sugiyama because Dobeel teaches that the adjuvant effect of Pam3Cys-SKKKK is strongly synergistic and thus likely to be an improvement on the Pam3Cys adjuvant of Barner.
It would be further prima facie obvious to one of ordinary skill in the art to start with the adjuvant comprising a1:1 Pam3Cys-SKKK to poly I:C wt/wt ratio taught by Dobeel and arrive at an adjuvant comprising a 1.25:1 Pam3Cys-SKKKK to Poly I:C in the adjuvant via routine optimization. One of ordinary skill in the art would be motivated to do this in order to optimize the lipopeptide: poly I:C ratio in the adjuvant. Dobeel show3d that mixing 20 ug of Poly I:C with 20 ug of Pam3Cys-SKKKK produced a profound synergistic adjuvant effect compared to 20 ug of either component alone. Dobeel’s data naturally invite routine optimization of Pam3Cys-SKKKK to poly I:C mass ratio because Dobeel demonstrates that at a 1:1 mg/mg ratio of Pam3Cys-SKKKK to poly I:C is much higher than either component alone. Dobeel’s data show that there are minima with respect to adjuvant activity when the mass fraction of either component is 0 and a maximum with respect to adjuvant activity when the mass fractions are equal. This naturally gives rise to the idea of varying the mass ratios of the components and observing changes in adjuvant activity (that is to say, to engage in routine optimization; See MPEP § 2144.05 (II)). One of ordinary skill in the art would have a reasonable expectation of success starting with the adjuvant comprising a1:1 Pam3Cys-SKKK to poly I:C wt/wt ratio taught by Dobeel and arriving at an adjuvant comprising a 1.25:1 Pam3Cys-SKKKK to Poly I:C in the adjuvant via routine optimization because: 1) Dobeel teaches that a mass ratio of 1:1 Pam3Cys-SKKKK to poly IC produced a profound synergistic adjuvant effect (corresponding to a maximum) when compared to Pam3Cys-SKKKK or poly I:C alone, 2) this creates a mass fraction vs adjuvant activity curve comprising a maximum (at mass fraction of either component = 0.5) flanked by two minima (when the mass fraction of either is 0) and 2) it is within the purview of one of ordinary skill in the art to realize there must be some mass/mass ratio within this range corresponding to the absolute maximum adjuvant activity and to vary parameters (in this case mass ratio/ mass fraction) and observe the effects.
Conclusion
Claims 1-3, 7-14, 19 and 23-24 are rejected.
Claim 8 is objected to.
The Specification is objected to.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sydney Van Druff whose telephone number is (571)272-2085. The examiner can normally be reached 10 am - 6 pm.
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/SYDNEY VAN DRUFF/ Examiner, Art Unit 1643
/JULIE WU/ Supervisory Patent Examiner, Art Unit 1643