Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-13 and species: dosage for CD40 agonist: 20 to about 800 ug per kg body weight, 30 to about 600 ug per kg body weight, 40 to about 300 ug per kg body weight in the reply filed on 09/05/2025 is acknowledged. The traversal is on the ground(s) that the prior art used to break unity of invention does not teach all the limitations of the instant claims. This is not found persuasive because the prior art used to break unity of invention describes the dosages recited in the claims, even if the reference does not use the exact terminology of the claims. Additionally, the instant claims are interpreted using the broadest reasonable interpretation and as such, teaches the invention of the instant claims as using a combination of an IL-15 protein and an agonist of CD40 to treat pancreatic cancer.
Claim 14 is withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 09/05/2025. Claims 1-13 are now under consideration in the instant Office Action.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-2 and 4-13 have been amended.
Claims 15-18 are newly added.
Claim 3 has been cancelled.
Claim 14 have been withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 01/16/2026.
Claims 1-2, 4-13, and 15-18 are under consideration.
Withdrawn Objections
Objections to claims 4-13 as being in improper form because a multiple dependent claim cannot depend from another multiple dependent claim are hereby withdrawn in view of amendments to the claims.
Modified Rejections Necessitated by Amendment
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 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.
The term “subtherapeutic dose” in instant claims 1-2 is a relative term which renders the claim indefinite. The term “subtherapeutic dose” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no “standard” therapeutic dose in the claim provided to base a “subtherapeutic” dose from.
Instant claims 1-2 recite “wherein at least one of said IL-15 and CD40 agonist are used in a subtherapeutic dose”. It is unclear which of the proteins in the claimed combination of IL-15 or CD40 agonist is to be administered at a subtherapeutic dose, whether it be the total combination of both to be administered at a subtherapeutic dose overall or if one of the components in the combination is to be administered at a reduced dose.
Response to Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive.
Applicant argues “that the term “subtherapeutic dose” is explicitly defined in the instant specification” on page 7, lines 34-38 and this is sufficient to ascertain what is encompassed within the instant claims. This is not found persuasive.
While the specification defined the term “subtherapeutic dose” as an amount “that would be below an accepted therapeutically effective amount”, this broad limitation is not read into the instant claims. The rejected claims do not recite a therapeutic dose value from which a “subtherapeutic dose” can be derived from. Applicant is reminded that the claims are to be fully encompassing and that limitations from the instant specification are not read into the instant claims.
As such, the rejection has been modified in view of amendments to the claims.
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, 4-13, and 15-18 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 claim(s) 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.
Claim 1-2, 4-13, and 15-18 are directed to any agonistic antibody that binds CD40. As such, the claim is directed to an antibody defined entirely by function (binding). See MPEP §2163(I)(A) which states:
"The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.”
In this case, antibodies generally share certain characteristics such as Fc regions or hinge regions. However, these structures are not correlated with the binding function of the antibody. The hyper variable regions (HVRs), i.e., complementarity determining regions (CDRs) of an antibody, are well established in the art as the portion of the binding region which imparts the specificity of an antibody. However, there is no way to a priori look at an antigen sequence (CD40) and envisage the combination of six CDRs that will bind that antigen. First, even highly related CDRs may not bind the same target. See for example Kussie (instant PTO-892) who demonstrates that a single amino acid change in the heavy chain of an antibody which binds p-axophenylarsonate (Ars) completely abrogates the ability of the antibody to bind Ars but adds the functionality of binding the structurally related p-azophenylsulfonate (e.g., abstract). Second, even when provided with several related antibodies that bind the desired target, this does not represent the astronomical and potentially unknowable breadth of all possible amino acid sequences which will result in the desired binding properties. This is exemplified by the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014)), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (p.7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor’s antibodies which bound the same target but shared only 50% sequence similarity (see table on page 11).
Thus, the art recognizes that the CDRs define the binding properties of an antibody and that even single amino acid changes to this region can completely abrogate the binding specificity of an antibody. As a further example, see Chen et al., 1995 (instant PTO-892) which demonstrates single amino acid changes in the VH CDR2 sequence can increase binding, decrease binding, destroy binding, or have no effect on binding when compared to the wild-type antibody.
See also Koenig 2017 (instant PTO-892), which provides a large mutation analysis study where every amino acid in both variable regions are substituted with every other amino acid. Looking at figure 1 of Koenig, the bottom half of each section (labeled VEGF) relates to the ability of the mutant to bind the original target, with blue meaning a reduced affinity and black meaning a complete loss of binding ability. In VH-CDR2, for example, mutating any given residue to cysteine, which is encompassed by the instant claims, resulted in reduced binding at 12 residues and a complete loss of binding at 5 residues. That is, at 100% of the positions, mutation to cysteine reduced or ablated the antibody’s ability to bind the target. Looking at a specific position, in 100% of the mutations of residue 55, binding was reduced (15/19) or eliminated (4/19). While residues 56-65 appear more tolerant of change, residues 50-55 are generally intolerant of change.
It is appreciated that Koenig is studying one specific antibody and there is no evidence that the instant antibodies would react in the same way. However, this is part of the problem. It is entirely unclear from the specification which residues of Applicant’s CDRs are tolerant or intolerant to change, and whether those tolerant positions are only tolerant to conservative mutations. The fact that some residues might tolerate mutation does not convey to the skilled artisan that Applicant knew which of the claimed residues were tolerant of such, i.e., does not convey that Applicant was in possession of those sequences which are mutated yet preserve the claimed function. In other words, the specification fails to convey possession of an invention commensurate in scope with what is now claimed and therefore fails to meet the written description requirement. Looking at Koenig figure 2A, ~200 mutations in the CDR region of the VH chain completely abrogates any binding. While 2B appears to indicate that the CDRs of VL are more tolerant of change than the heavy chain CDRs, still over half of the mutations reduce binding compared to the parent.
Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions.
The specification discloses only six antibodies identified by name which comprise: Selicrelumab, APX005M, ChiLob7/4, ADC-1013, SEA-CD40, and CDX-1140. However, as discussed above, without any way to determine how broad the genus of such antibodies are, there is no way to determine if these antibodies represent the full breadth of what is claimed. The disclosure of these specific antibodies would not convey to the artisan that Applicant was in possession of the full genus of all antibodies which possess the required functions nor does it allow the skilled artisan to envisage the specific structure of such antibodies.
Further note the decision in Amgen v. Sanofi 2017, where the Court supported previous decisions (Centocor 2011; Abbvie 2014) that defining an antibody solely by what it binds does not satisfy the written description requirement, stating that this would allow patentees to “claim antibodies by describing something that is not the invention, i.e., the antigen”. This decision has precipitated guidance to the Office instructing that the portion of MPEP 2163 regarding the “newly characterized antigen test” (indicating a well-characterized antigen is sufficient to satisfy written description for antibodies which bind that antigen) should no longer be used and that contrary materials should not be relied upon as reflecting the current state of the law.
It is appreciated that certain claims do include at least one structure, e.g., claim 9 which requires one of the six recited antibodies from the specification. However, the rest of the instant claims recite a broad genus of agonistic anti-CD40 antibodies including any variant, a variant being defined as noted above to include no particular structure so long as the function is retained.
However, as above, arbitrarily altering any amino acid in the CDR of an antibody is unpredictable and the specification does not convey possession of any CDRs other than those of the disclosed antibodies. Further, it is well-known in the art that specificity of an antibody stems from the interaction of six CDRs. Moreover, CDRs are not generally recognized as interchangeable, such that using one CDR from one antibody would not be reasonably expected to confer the same binding properties or even the same binding target when combined with two to five CDRs from other antibodies. For example, WO 2008068048 (instant PTO-892) discloses an antibody with a heavy chain comprising three CDRs (SEQ ID NO: 2) that binds secreted aspartyl protease from Candida sp. US 20170355756 (instant PTO-892) describes the same three CDRs in the heavy chain (C10-VH3) combined with a different light chain that binds human TDP-43. There is no evidence in the instant specification that a single CDR placed in the context of two to five other CDRS, regardless of what those other CDRs are, would result in the required function, nor that a single chain is correlated to the required function when combined with any other chain. As such, the specification fails to set forth a structure-function correlation sufficient to claim all possible antibodies defined by function and one-three CDRs or alterations thereof.
As such, the disclosure of six antibody sequences does not convey possession of other antibodies with the same binding properties; possession of the precisely defined sequence of six CDRs is required.
With respect to product claims 1-2, 4-14, and 15-18, it is recognized that information which is well known in the art need not be described in detail in the specification (MPEP §2163(II)(A)(2)). See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. MPEP §2163(II)(A)(3)(a) also discusses Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004), where a method of using a PGHS-2 inhibitor did not meet the written description as the inhibitor itself was not sufficiently described, clearly indicating that written description of the compound is still required in a method of using that compound. In this case, it is clear from the specification that the invention is in a new antibody, or at the least disclosure of a new antibody that could not have been envisaged from the prior art indicates that the prior art was not in possession of all “CD40 antibodies”. Thus, the prior art cannot provide sufficient written description of this genus of compounds and the specification as filed, disclosing one antibody, does not sufficiently describe the genus either as there is an unknown amount of structurally distinct antibodies in this genus (see Amgen and Centocor decisions discussed above).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Vas-Cath, Inc., v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. An antibody described only by functional characteristic, such as antibody that binds CD40 or one of the claimed epitopes, without any known or disclosed correlation between that function and the structure of the sequence, is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest. In re Bell, 991 F.2d 781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993). In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995). In the instant case, the specification provides insufficient direction or guidance concerning the relationship between the structure of the possible antibody to demonstrate possession of the breadth of the genus of CD40 antibodies encompassed by the instant claims, especially in view of the unpredictability of such an endeavor. The prior art as evidenced by Edwards et al., 2003 (instant PTO-892) teaches there is a substantially huge antibody diversity produced to one single antigen target. Edwards provides evidence that over 1000 antibodies, all different amino acid sequences, were generated towards one single protein antigen target (see abstract). Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Without this guidance or direction the skilled artisan would not consider applicant to be in possession of the claimed genus of antibodies because the skilled artisan recognizes that even seemingly minor changes made without guidance or direction as to the relationship between the particular amino acid sequence of the instantly claimed antibody and its ability to bind antigen, can dramatically affect antigen-antibody binding.
Applicant has not described the claimed invention sufficiently to show they had possession of the claimed genus of an antibody that binds CD40. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004).
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.
To provide adequate written description and evidence of possession of the claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factors present in the claims are a recitation of one generic, broad genus that encompassed a diverse and huge number of possible antibodies that bind the disclosed epitope. The specification does not provide a consistent structure for all of the possible antibodies and fails to provide a representative number of species for the claimed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that they invented what is claimed.” (See Vas-Cath at page 1116).
With the exception of specifically disclosed antibodies with specific CDRs, the skilled artisan cannot envision the detailed chemical structure of all of the encompassed antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Therefore, claims 1-2, 4-13, and 15-18 do not meet the written description requirement.
Response to Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive.
Applicant argues “a skilled artisan would know the structure of IL-15, which is a known "cytokine that regulates the activation and proliferation of T cells and natural killer (NK) cells” and “with respect to the claimed CD40 agonist, there is no requirement that applicants must provide structural descriptions of all molecules or compounds that increases CD40 activity. Nevertheless, in any case, the specification clearly defines "CD40 agonist" as "a molecule which specifically binds to the subject's CD40 molecule." See id. at page 7, lines 1-3. Such definition therefore already includes a structural component (i.e., specific binding to CD40)”. This is not found persuasive.
As noted by the Applicant, aspects of the rejection drawn to the IL-15 protein have been amended out of the instant rejection as they have persuasively shown that the IL-15 structure is well known in the art. However, despite these amendments, the instant claims still encompass a functional description of the CD40 agonist which can be an antibody (claim 1). The scope of the instant claims include any anti-CD40 antibody that retains agonistic functions. The specification on page 3 recites a list of well-known antibodies that bind to CD40; however, this is not sufficient to fully cover what is encompassed within the instant claims. There are numerous, structurally discrete antibodies that can bind to CD40 and have agonistic functions, and Applicant has not fully described all the possibilities of structures that fall into this category that is also encompassed by the claims. Applicant is encouraged to amend the claims to align in the scope with the description provided in the disclosure.
As such, the rejection has been modified in view of amendments to the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Audenaerde et al., 2018 (“PO-417 Antitumoral effects of IL-15 and CD40 stimulations as a novel combination immunotherapy for pancreatic cancer”, in IDS filed 08/30/2022).
Van Audenaerde et al. teaches that within the tumour microenvironment of pancreatic cancer cells, a strong desmoplastic reaction occurs and is held responsible for the formation of a protective shield and how tackling this stromal shield is needed to overcome treatment resistance. Van Audenaerde et al. argue that CD40 stimulation has already demonstrated moderate anti-tumour responses in pancreatic cancer, including some anti-stroma effects, see Introduction.
Van Audenaerde et al. teaches that interleukin (IL)−15 stimulated NK cells are capable of tackling both tumour as well as the surrounding desmoplastic stroma and thus explore a novel combination immunotherapy consisting of the combination of an agonistic anti-CD40 monoclonal antibody and IL-15 in two mouse models of pancreatic cancer, see Introduction. Van Audenaerde et al. discovered that the combination treatment of IL-15 and anti-CD40 caused a distinct reduction of tumour growth rates in comparison with single agent treatments. Moreover, mice receiving the combination treatment showed significantly increased survival, with 60%–80% of the mice being completely tumour free. Depletion studies revealed both CD8+ T cells and NK cells are mechanistically involved in the anti-tumour effect of this novel treatment, see Results and discussions. Van Audenaerde et al. also found that the combination of treatments exhibited a profound anti-tumor response in mouse models of pancreatic cancer resulting in prolonged survival and even total eradication of >60% of pancreatic cancer cells, see Conclusion.
Therefore, claims 1-2 are rejected as anticipated by Van Audenaerde et al.
Response to Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive.
Applicant argues “the Office provides no evidence that Van Audenaerde teaches subtherapeutic dosages of either IL-15 and/or a CD40 agonist” and the instant invention results in “synergistic effects between the CD40 agonist and IL-15”. This is not found persuasive.
As discussed above, the limitation regarding “subtherapeutic doses” in the instant claims is not clearly ascertained. It is also unclear how a subtherapeutic dose, which Applicant defines as one “that would be below an accepted therapeutically effective amount”, could be effective against disease. The instant claims simply intend to encompass any value larger than 0, up to those that are deemed therapeutically effective without retaining the proper disclosure showing evidence that Applicant has conceived of a specific “subtherapeutic dose”. The instant claims have been amended, yet still do not recite what the “therapeutic dosage” is or what constitutes as a subtherapeutic dosage. Given that the prior art teaches the same combination of IL-15 and CD40 administered to pancreatic tumors and showed a distinct reduction of tumour growth rates in comparison with single agent treatments, one of ordinary skill in the art would expect that the combination of treatments would result in an additive effect. The disclosure of Van Audenaerde reveals this in “mice receiving the combination treatment showed significantly increased survival, with 60%–80% of the mice being completely tumour free. Depletion studies revealed both CD8+ T cells and NK cells are mechanistically involved in the anti-tumour effect of this novel treatment”, see Results and discussions. Since the prior art discloses that a therapeutically effective amount is needed to treat the cancer, Applicant is required to show what the subtherapeutic dosage they have determined is their inventive concept is and provide the necessary disclosure showing the results of this in order to overcome the art rejection.
Additionally, Applicant’s assertion of synergistic or unexpected results must be commensurate in scope with the claimed invention (see MPEP §716.02(d)). Additionally, the instant claims are drawn to a product, which is fully described in the prior art. Therefore, the products of the prior art will produce the same results as the instantly claimed products since one is administering the same products. MPEP 2145(II) states: “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)” (“The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.”).
There is no unexpected result since the prior art already taught that the claimed products, which had similar effects and one would expect that combining both of the treatments would produce a better result, as shown in Marshal. Please see MPEP 7106.0 (a), I, which states that “a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (Evidence showing greater than additive sweetness resulting from the claimed mixture of saccharin and L-aspartyl-L-phenylalanine was not sufficient to outweigh the evidence of obviousness because the teachings of the prior art lead to a general expectation of greater than additive sweetening effects when using mixtures of synthetic sweeteners.).“ The evidence provided by applicant of unexpected results falls into the additive sweetness combination example and does not show a greater than expected outcome and therefore, the instant invention is obvious over the combination of references.
Conclusion
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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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675