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 .
1. The Amendment filed November 13, 2025 in response to the Office Action of September 5, 2025, is acknowledged and has been entered. Claims 1, 2, and 4 are pending. Claim 3 is canceled. Claims 1 and 4 are amended. Claim 2 remains withdrawn. Claims 1 and 4 are currently being examined as drawn to the elected species of:
A. (i) LAG-3 inhibitor; and
B. (i) small molecule inhibitor.
The claims have been amended to add a “CD44 antagonist”.
New Rejections
(necessitated by amendments)
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.
2. Claims 1 and 4 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. This is a NEW MATTER REJECTION.
Claims 1 and 4 have been amended to recite “a CD44 antagonist” as part of the pharmaceutical composition with a small-molecule inhibitor that targets LAG3.
The limitation of “a CD44 antagonist” has no clear support in the specification and the claims as originally filed.
Applicants point to support for this amendment in the specification at p. 3, lines 25-26:
In addition, besides targeting LAG-3 alone, combined treatment with CD44, TIM-3, PD-1 or PD-L1 is also possible.
The cited support has been considered but has not been found persuasive because the cited support is not drawn to “a CD44 antagonist”. There is no mention of a CD44 antagonist anywhere in the specification and claims as originally filed. The specification neither states nor demonstrates a CD44 antagonist. The sentence in the specification on page 3, lines 25-26 that Applicants point to for support does not disclose an antagonist of CD44. The sentence discloses combined treatment with “CD44”, which is interpreted as the CD44 protein itself. Even if Applicants interpret the sentence to disclose combined targeting of LAG3 with targeting of CD44, the sentence does not disclose the targeting of CD44 functions as antagonistic, nor does the specification disclose a CD44 antagonist is combined with a LAG3 small molecule inhibitor in a composition, or that a CD44 antagonist is included in a composition configured to be used in the treatment of a metastatic small cell lung cancer.
The subject matter claimed in claims 1 and 4 alter the scope of the invention as originally disclosed in the specification.
3. Claims 1 and 4 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a WRITTEN DESCRIPTION rejection.
The claims are now drawn to a pharmaceutical composition comprising: (a) a small-molecule inhibitor that targets LAG-3; and (b) a CD44 antagonist, wherein the pharmaceutical composition is configured to be used in a treatment of a metastatic small cell lung cancer.
Dependent claim 4 recites the active ingredients in the pharmaceutical composition consist of (a) a small-molecule inhibitor that targets LAG-3; and (b) a CD44 antagonist. The instant specification does not disclose a single exemplary: (1) SMI that functions to target and inhibit LAG-3; and (2) CD44 antagonist, and wherein they both function to treat metastatic small cell lung cancer.
Thus, the claims identify the small-molecule inhibitor (SMI) of LAG3 by function only, where the function is to inhibit LAG-3 and target LAG-3, as well as function in the treatment of metastatic small cell lung cancer. No SMI structure is recited.
The claims identify the CD44 antagonist by function only, wherein the function is to antagonize CD44, as well as function in the treatment of metastatic small cell lung cancer. No antagonist structure is recited.
LAG-3 SMI:
The instant specification does not disclose a single exemplary SMI targeting and inhibiting LAG-3. The specification fails to disclose any structure required of an SMI to possess the function of inhibiting and targeting LAG-3.
In relevant art, the National Cancer Institute (NCI) defines “small molecule drug” as:
A drug that can enter cells easily because it has a low molecular weight. Once inside the cells, it can affect other molecules, such as proteins, and may cause cancer cells to die. This is different from drugs that have a large molecular weight, which keeps them from getting inside cells easily. Many targeted therapies are small-molecule drugs.
Therefore, the state of the art is such that a small molecule drug can broadly encompass any class of drug so long as it has a relatively low molecular weight to enter cells easily.
The claimed genus of SMI targeting and inhibiting LAG-3 broadly encompasses anything and any class of molecule that functions as claimed.
CD44 antagonist:
The instant specification does not disclose a single exemplary CD44 antagonist. The specification fails to disclose any structure required of a CD44 antagonist to possess the function of antagonizing CD44.
To provide adequate written description and evidence of possession of the claimed SMI and antagonist genus, the instant specification can structurally describe representative SMIs that function to inhibit and target LAG-3, and representative molecules that antagonize CD44, or describe structural features common to the members of the genus, which features constitute a substantial portion of the genus. Alternatively, the specification can show that the claimed invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics (see University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) and Enzo Biochem, Inc. V. Gen-Probe Inc.).
Although Applicants may argue that it is possible to screen for SMIs that inhibit/target LAG-3, and antagonists of CD44 that function as claimed, the court found in (Rochester v. Searle, 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. “As we held in Lilly, “[a]n adequate written description of a DNA … ‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions.” Knowledge of screening methods provides no information about the structure of any future SMIs and antagonists yet to be discovered that may function as claimed. The LAG-3 antigen provides no information about the structure of an SMI that inhibits and targets it. The CD44 antigen provides no information about the structure of an agent that antagonizes it.
The instant specification fails to describe structural features common to the members of the SMI and antagonist genus, which features constitute a substantial portion of the genus because the instant specification fails to disclose a single exemplary SMI and antagonist that functions as claimed. A definition by function does not suffice to define the genus because it is only an indication of what the SMI and antagonist do, rather than what they are. The specification fails to provide any structural features coupled to the claimed functional characteristics. The instant specification fails to describe a representative number of SMI and antagonist structures for the vast genus of SMIs and antagonists that function as claimed. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed SMI and antagonist genus.
Given the lack of representative examples to support the full scope of the claimed SMIs and antagonists, and lack of reasonable structure-function correlation with regards to the unknown SMI structure that provides LAG-3 inhibiting/targeting function, and unknown structure that provides the CD44 antagonist function, the present claims lack adequate written description. Thus, the specification does not provide an adequate written description of LAG-3 SMIs and CD44 antagonists that can function in the treatment of metastatic small cell lung cancer, that is required to practice the claimed invention.
Response to Relevant Arguments
4. Applicants argue that the instant specification provides adequate written descriptive support for LAG3 targeting and inhibiting SMIs. Applicants argue that the specification: (1) pinpoints the precise target (human LAG3 on T cells), (2) explains when and where the target is pathologically upregulated, and (3) teaches how inhibition is assayed. Applicants argue that those are classic, field-accepted identifying characteristics that a PHOSITA uses both to recognize and to confirm LAG-3 inhibition in development programs. Applicants argue the specification expressly lists the contemplated inhibitor species, including "small-molecule inhibitors targeting LAG-3 or TIM-3," along with antibodies, bispecifics, gene-silencing compositions, and antibody-mediated nanoparticles.
Applicants argue that the stat of the art prior to 2020 was such that “LAG-3 antagonists” were a recognized therapeutic class with moieties that include SMIs. Applicants point to the prior art cited by Examiner, Foy et al, arguing that Foy teaches inhibitors of LAG-3 include antibodies, antisense/siRNA, and SMIs and demonstrate in vivo antitumor efficacy for LAG-3/PD-1 blockade in combination immunotherapy. Applicants argue that a PHOSITA reading the instant application would understand that a small molecule LAG-3 inhibitor was known and pursued species within the recognized genus of LAG-3 antagonists.
Applicants argue that Examiner’s reliance on Lilly and Enzo are misplaced. Applicants state that Lilly was drawn to broad DNA sequences defined by function/result without providing the relevant sequence or identifying characteristics to show possession of the genus. Applicants argue the facts int eh instant application are different and their claims do not seek out to encompass every possible agent that treats cancer, nor do they claim a nucleic acid genus. Applicants argue the claims focus on a well-characterized receptor LAG-3 in a defined biological context and marrow the agent to a recognized modality – SMI – whose defining structural feature is target-binding complementarity to LAG-3 sufficient to block ligand engagement/signaling. Applicants argue that “binds LAG-3 and blocks its interaction with ligands” is not a naked functional aspiration, it is a structural/physiochemical definition by property that a PHOSITA translates into specific, testable pharmacophores using routine receptor-binding and cell-based readouts. Applicants argue that this is exactly the type of structure-function correlation the Federal Circuit’s jurisprudence permits to show possession when coupled with mature knowledge in the art.
Applicants argue that Enzo confirms written description may be satisfied by deposits or by other identifying characteristics that let a PHOSITA recognize the claimed material. Applicants argue that Enzo does not require a deposit or line-by-line structural recital is the only way to satisfy the written description requirement. Applicants argue that the instant disclosure supplies those identifying characteristics for the LAG-3 SMI species: target identity, disease-relevant cellular source, phenotypic and immunologic endpoints, and combination context (e.g., with PD-1/PD-L1), all of which were already correlated in the art with the structure and properties of LAG-3 antagonists, including SMIs.
Applicants argue that Examiner’s rationale that the claims are drawn to a genus defined by function only with structure unknown is incorrect and does not apply. Applicants argue the claims are limited to small molecule inhibitors that bind LAG-3 and inhibit it. Applicants argue that in drug discovery, binding-and-blocking a target us a structural limitation. Applicants argue that the claims do not encompass “any small molecule” and argue the art of LAG3 SMIs is mature.
Applicants argue that they do not rely on one to screen for SMIs to provide structural information. Applicants argue that the specification provides disease-specific biology (SCLC CSCs driving LAG-3/TIM-3 on T cells), assays and markers (which cell subsets, which markers, what direction of modulation), and therapeutic combinations tailored to that biology. Those identifying characteristics, taken with what the art already taught about LAG-3 antagonists-including small-molecule inhibitors expressly recognized as members of that antagonist class-are more than a plan; they show possession of the species and its use in the claimed indication.
Applicants disagree that there is no structure-function correlation. Applicants argue that in checkpoint pharmacology there is an established correlation: an agent that binds LAG-3 at or allosterically affecting the ligand-binding interface (e.g., MHC-II/FGL1) and blocks the inhibitory signaling will restore T-cell effector function-exactly the cellular effects the instant application measures in SCLC systems. Applicants argue that the target, mechanism, and assays together supply the correlation that Enzo contemplates as an acceptable basis for written description in a mature art.
Applicants argue that Examiner’s non-final office action confirms that PHOSITA would understand Applicants was in potion of the SMI species. Applicants appear to argue that Foy, Rudd, and Mason, cited in the previous office action as prior art for LAG3 SMIs, provide evidence that the art of LAG3 SMIs was mature at the time of filing and LAG3 SMIs were readily identifiable and well known.
5. The arguments have been carefully considered but are not persuasive. Examiner relied upon the precedential decisions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) (“Lilly”) and Enzo Biochem, Inc. V. Gen-Probe Inc. (Fed. Cir. 2002) (“Enzo”) as the standards for determining adequate written description of the instant claim. Contrary to arguments, these precedential decisions are relevant to determining if the written description requirements or standards have been satisfied for the instant claims. Examiner established that:
the claims define the SMI by function only without any chemical structure recited;
the specification fails to provide the critical or shared core structure correlated to, and responsible for, the LAG-3 targeting and inhibiting SMI function; and
the specification fails to provide a single representative species of SMI that functions to target and inhibit LAG-3.
In all of Applicant’s Remarks/Arguments provided, Applicants have not persuasively argued that the specification provides a single representative species of SMI chemical structure that performs the claimed functions. Per the standards in Lily, Applicants have not pointed to a single exemplary species of SMI structure that functions as claimed, and fail to provide a representative number of SMI species that function as claimed. Given the failure to identify a single representative SMI that functions as claimed, one cannot recognize or immediately envision members of the claimed genus of SMIs in order to make the claimed composition. Contrary to arguments, the decision in Lily is relevant to the instant claims and specification. As stated in the rejection: “As we held in Lilly, “[a]n adequate written description of a DNA … ‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions.” Knowledge of screening methods provides no information about the structure of any future SMIs and antagonists yet to be discovered that may function as claimed. Therefore, the decision in Lily has been applied to non-DNA inventions, and is relevant to the instant claims or the reasons of record.
In all of Applicant’s Remarks/Arguments provided, Applicants have not persuasively argued that the instant specification provides any chemical or molecular structure of an SMI critical to performing the claimed functions of targeting and inhibiting LAG-3. Per the standards in Enzo, Applicants have not pointed to a single recognizable, identifiable structure shared by the claimed genus of SMIs that is critical to performing the claimed functions of targeting and inhibiting LAG-3. Given the failure to identify a single representative SMI chemical or molecular structure that functions as claimed, one cannot recognize or immediately envision members of the claimed genus of SMIs in order to make the claimed composition.
Although Applicants argue that they do not rely on one to screen for SMIs to provide structural information on SMIs claimed, Applicants have not pointed to any disclosure in the specification providing identifiable structural information on SMIs or representative species of SMIs that function as claimed. Further, Applicants describe screening processes in their arguments (i.e., assaying for LAG-3 inhibition) as a method for identifying SMIs. Therefore, according to the instant specification and Applicant’s arguments, one of ordinary skill in the art would be required to screen for SMIs targeting LAG-3 in order to identify members of the claimed genus. Knowledge of screening methods provides no information about the structure of any future SMIs and antagonists yet to be discovered that may function as claimed. The LAG-3 antigen provides no information about the structure of an SMI that inhibits and targets it (See MPEP 2163).
Contrary to arguments, the genus of claimed SMIs is broadly drawn to “any small molecule inhibitor” that targets LAG-3 because there are no limiting structures recited to exclude any SMIs that function as claimed.
Contrary to arguments, the state of the prior art does not establish that genus of SMIs functioning to target and inhibit LAG-3 is well established and mature, such that one of ordinary skill in the art could readily envision members of the claimed genus without the instant specification disclosing a single representative species.
MPEP 2163 states that if the application does not provide sufficient evidence of possession include the 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, then patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art:
“Whether the specification shows that the inventor was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the 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 inventor was in possession of the claimed species is sufficient. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. The description needed to satisfy the requirements of 35 U.S.C. 112 "varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084. Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art. In most technologies which are mature, and wherein the knowledge and level of skill in the art is high, a written description question should not be raised for claims present in the application when originally filed, even if the specification discloses only a method of making the invention and the function of the invention.
In contrast, for inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.”
In the instant case, as stated above, the specification fails to provide sufficient evidence of possession, including the 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 SMI invention. The instant specification also fails to point to any prior art that demonstrates SMIs that function as claimed were readily known and established at the time of filing (April 10, 2020). The instant specification does not mention any of the SMIs recently discovered and invented by the prior art cited by Examiner in the Office Action mailed September 5, 2025: Mason 2019 and Rudd 2020. Rudd disclosed a single SMI SB415288 that functioned to treat metastasis melanoma in combination with a LAG-3 inhibiting antibody. This single SMI of LAG-3 fails to provide evidence that the genus of SMIs functioning to target and inhibit LAG-3 is well developed and that members of the genus were well known and recognizable by function. Mason disclosed a method for screening and identifying chemical compounds that function as SMIs of LAG-3, clearly indicating the art of identifying and recognizing members of the genus of SMIs inhibiting and targeting LAG-3 was developmental and unpredictable at the time of filing. US Patent Application Publication 2016/0271239, Foy et al, contemplates and teaches generalized antagonists of LAG-3 including small molecule inhibitors, but does not disclose a single representative species or chemical structure of an SMI that functions as claimed, therefore does not demonstrate that the art of SMIs targeting and inhibiting LAG-3 was mature at the time of filing. Thus, contrary to arguments, the prior art cited by Examiner fails to provide evidence that the genus of SMIs functioning to target and inhibit LAG-3 was well developed and that members of the genus were well known and recognizable by function only. Therefore, the art of making SMIs that target LAG-3 is an emerging and unpredictable technology, and more evidence is required to show possession of the claimed genus of SMIs targeting LAG-3.
MPEP 2163 states:
“Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021 ("A gene is a chemical compound, albeit a complex one, and it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it. Conception does not occur unless one has a mental picture of the structure of the chemical, or is able to define it by its method of preparation, its physical or chemical properties, or whatever characteristics sufficiently distinguish it. It is not sufficient to define it solely by its principal biological property, e.g., encoding human erythropoietin, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property. We hold that when an inventor is unable to envision the detailed constitution of a gene so as to distinguish it from other materials, as well as a method for obtaining it, conception has not been achieved until reduction to practice has occurred, i.e., until after the gene has been isolated." (citations omitted)). In such instances the alleged conception fails not merely because the field is unpredictable or because of the general uncertainty surrounding experimental sciences, but because the conception is incomplete due to factual uncertainty that undermines the specificity of the inventor’s idea of the invention. Burroughs Wellcome Co. v. Barr Labs. Inc., 40 F.3d 1223, 1229, 32 USPQ2d 1915, 1920 (Fed. Cir. 1994). Reduction to practice in effect provides the only evidence to corroborate conception (and therefore possession) of the invention. Id.”
In the instant case, the specification fails to provide a mental picture of the structure of the SMI targeting LAG-3. It is not sufficient to define the SMI solely by its principal biological property, e.g., targeting and inhibiting LAG-3. Therefore, an inventor is unable to envision the detailed constitution of an SMI that targets LAG-3 so as to distinguish it from other materials, as well as a method for obtaining it, and conception has not been achieved until reduction to practice has occurred. In this case, reduction to practice in effect provides the only evidence to corroborate conception (and therefore possession) of the invention. The instant specification has not produced a single exemplary SMI that targets LAG-3 as required by the claims.
Contrary to arguments, the claims do not recite an SMI that binds to LAG-3 and blocks the function of LAG-3 or blocks ligands from binding to LAG-3. The claims recite a small molecule inhibitor that targets LAG-3. Nowhere, do the claims require that the SMI actually bind to LAG-3 in order to target and inhibit LAG-3. Therefore, Applicants are arguing a limitation not recited in the claims. Regardless, adding another functional limitation of SMI binding to LAG-3 would still fail to satisfy the written description requirement for the reasons of record.
Contrary to arguments, the well-known characterization of an antigen (LAG-3) does not translate to the well-known characterization of SMIs that target and inhibit the antigen. For example, MPEP 2163 states (bold emphasis added):
For some biomolecules, examples of identifying characteristics include a sequence, structure, binding affinity, binding specificity, molecular weight, and length. Although structural formulas provide a convenient method of demonstrating possession of specific molecules, other identifying characteristics or combinations of characteristics may demonstrate the requisite possession. As explained by the Federal Circuit, "(1) examples are not necessary to support the adequacy of a written description; (2) the written description standard may be met … even where actual reduction to practice of an invention is absent; and (3) there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure." Falkner v. Inglis, 448 F.3d 1357, 1366, 79 USPQ2d 1001, 1007 (Fed. Cir. 2006); see also Capon v. Eshhar, 418 F.3d at 1358, 76 USPQ2d at 1084 ("The Board erred in holding that the specifications do not meet the written description requirement because they do not reiterate the structure or formula or chemical name for the nucleotide sequences of the claimed chimeric genes" where the genes were novel combinations of known DNA segments.). However, the claimed invention itself must be adequately described in the written disclosure and/or the drawings. For example, disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed. Cir. 2017)("knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies"); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed. Cir. 2011)(patent disclosed the antigen the claimed antibody was supposed to bind, but did not disclose any antibodies with the specific claimed properties).
In the instant case, even if the LGA-3 antigen is well characterized, this does not provide an adequate written description of SMIs that target and inhibit LAG-3. Further, Examiner maintains that the cited prior art (Foy, Rudd, and Mason) demonstrates that the production of LAG-3 SMIs was not routine or conventional in the prior art, and the art of LAG-3 SMIs was not mature at the time of filing.
6. All other rejections recited in the Office Action mailed September 5, 2025 are hereby withdrawn in view of amendments of the claims requiring a CD44 antagonist.
7. Conclusion: No claim is allowed.
Conclusion
8. 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.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA B GODDARD whose telephone number is (571)272-8788. The examiner can normally be reached Mon-Fri, 7am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Laura B Goddard/Primary Examiner, Art Unit 1642
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