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 .
The amendment and remarks filed 12/12/25 are acknowledged. Claims 8-11 have been canceled. Claims 25-44 have been added. Claims 1-7 and 12-44 are pending.
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/5/25.
Claims 1-7 and 16-44 are under examination as they read on the elected species.
Withdrawn Objection and Rejections
The objection to the specification for sequences appearing in the specification that are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c), is withdrawn in light of Applicant’s amendment thereto. See paragraph 6, page 3 of the previous Office action.
The rejection of claims 1-7 and 16-23 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a masked IL12 protein comprising the full length IL12, a PEG masking moiety, and a dienophile compound selected from 2.3, 2.5, 2.7, 2.9, and 2.14, does not reasonably provide enablement for all masked IL12 protein dienophile conjugates, is withdrawn in light of Applicant’s persuasive arguments. See paragraph 9, page 12 of the previous Office action.
New Rejections Necessitated by Applicant’s Amendment
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.
Claims 1-7 and 16-44 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
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, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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 Applicants were in possession of the claimed genus.
The instant claims are drawn to a masked IL12 protein, or a salt, hydrate, or solvate of said masked IL12 protein wherein at least one lysine residue of the masked IL 12 protein has a structure according to Formula (1):
PNG
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222
194
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wherein the wiggly lines indicate bonds to other amino acid residues of the masked IL12 protein; wherein the Trigger is a dienophile or a tetrazine; the dienophile or the tetrazine is linked to the s-amine of the lysine residue of Formula (1) via a bond CA. the dienophile comprises an eight-membered non-aromatic cyclic mono- alkenylene moiety comprising at least one allylic carbon, and optionally comprising one or more heteroatoms; the at least one allylic carbon is (a) directly linked to the s-amine of the lysine residue via a moiety MR selected from the group consisting of -OC(O)-, -OC(S)-, -SC(O)-, and -SC(S)-, forming a carbamate, thiocarbamate or dithiocarbamate moiety together with said s-amine and CA; or (b) directly linked to a first end of a self-immolative linker via a cleavable moiety MB selected from the group consisting of carbamate, thiocarbamate, carbonate, thiocarbonate, ether, ester, amine, amide, thioether, thioester, sulfoxide, and sulfonamide; and a second end of the self-immolative linker is directly linked to the s-amine of the lysine residue via a moiety MR that is part of the self-immolative linker, forming a carbamate, thiocarbamate or dithiocarbamate moiety together with said s-amine and CA.
The specification teaches that the masked IL12 comprises an IL12 protein or subunit thereof, and a masking moiety, e.g., a polyethylene glycol masking domain. The specification teaches that the masked IL12 protein can have various formulas comprising different combinations of an IL12 polypeptide [A], one or more masking moieties [B], one of more chemically cleavable linkers [L], and one or more chemical or polypeptide linkers/spacers that is typically noncleavable [S], and one or more half-life extension elements [H]. The specification teaches that the IL-12 polypeptide [A] can further be defined by its molecular subunits: [A1] IL12 p35 subunit polypeptide, and [A2] IL12 p40 subunit polypeptide. The specification teaches that the masked IL-12 protein can further include a targeting agent such as a small molecule, peptide, aptamer, DARPin, antibody, or antibody fragment, binding a target expressed in the target location. The specification discloses the amino acid sequence of human and mouse IL-12 p35 in SEQ ID NOs: 1 and 14, respectively. The specification discloses the amino acid sequence of human IL-12 p40 and variants thereof in SEQ ID NOs: 2-13. The specification discloses a masked IL12 proteins comprising the full length IL12 protein conjugated to TCO-PEG2 and TCO-PEG1K (See example 9), TCO-PEG8-keto (See example 15), and TCO-PEG-keto-peptide (See example 16).
The issue with regards to the written description provision of 112(a) is that the claims encompass a genus of masked IL12 proteins that are not fully described. Although the instant claims are inclusive of the fully described masked IL12 proteins exemplified in the specification (i.e., a masked IL12 protein comprising the full length IL12, a PEG masking moiety, and a dienophile compound selected from 2.3, 2.5, 2.7, 2.9, and 2.14), the claims also include masked IL12 proteins comprising a subunit or variant of IL12 and dienophiles other than those specifically disclosed in the specification. The IL12-dienophile conjugate in addition to the IL12 and dienophile also comprise a masking moiety that is not defined, one or more cleavable linkers between the two, and one or more spacers, all which bear various reactive groups, chemically incompatible groups, susceptible groups as substituents groups that can participate in conjugate addition inverse-electron Diels-Alder reaction and IL12-dienophile conjugate hydrolysis reaction.
Given the choices of variable group definitions, the genus of the masked IL12 proteins encompassed by claim 1 is vast, and would exceed trillions and trillions of compounds if not more. The specification does not provide support, as noted above, for such a large genus of compounds. There is no support for the process generically encompassed by the claims that would lead to the desired IL12-dienophile conjugate and subsequent release of the drug by interaction of the conjugate with the diene. A representative number of species of such a structurally diverse compounds generically encompassed by the claims has not been made or shown to possess in vitro activity much less in vivo uses claimed herein. The instant genus of compounds encompasses compounds bearing a plethora of structural cores and with substituents diverse functional groups and other groups permitted at instant variable groups noted above. There is no reasonable basis for assuming that the myriad of compounds embraced by the claims can be made and will all share the same activity profile since they are so structurally dissimilar as to be chemically non-equivalent and there is no basis in the prior art for assuming the same. Therefore, only a few species have been described and this is not considered to be representative of the breadth of the genus.
MPEP §2163 states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance (as in the instant case), the disclosure must describe a sufficient variety of species to reflect the variation within that genus. Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number to adequately describe a broad genus. The courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus (e.g., see In re Gostelli, 872, F. 2d at 1012, 10 USPQ2d at 1618).
Further, the disclosure of only one or two species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the genu[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.") (MPEP 2163). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when… the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
Accordingly, the specification also does not provide adequate written description to identify the broad genus of the claimed because inter alia, it does not describe a sufficient number and/or a sufficient variety of representative species to reflect the breadth and variation within the claimed genus. Consequently, based on the lack of information within the specification, there is evidence that a representative number and a representative variety of the numerous IL12 masked proteins had not yet been identified and thus, the specification represents little more than a wish for possession. Therefore, one of skill in the art would not conclude that Applicant was in possession of the broad and highly variable genus of proteins claimed only by a partial structure and functional characteristic(s).
Vas-Cath Inc. v. Mahurkar, 19 U5PQ2d 1111, makes clear 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 [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of the fully described IL12 masked protein (e.g., the full length IL12 conjugated to TCO-PEG2, TCO-PEG1K, TCO-PEG8-keto, or TCO-PEG-keto-peptide), the skilled artisan cannot envision the detailed chemical structure of the encompassed proteins, 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 for isolating it. The nucleic acid and/or protein itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481,1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc., 107 F.3d 1565,1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
Protein chemistry is probably one of the most unpredictable areas of biotechnology. Consequently, the effects of sequence dissimilarities upon protein structure and function cannot be predicted. Bowie et al. (Science, 1990, 247:1306-1310) teach that an amino acid sequence encodes a message that determines the shape and function of a protein and that it is the ability of these proteins to fold into unique three-dimensional structures that allows them to function and carry out the instructions of the genome and further teaches that the problem of predicting protein structure from sequence data and in turn utilizing predicted structural determinations to ascertain functional aspects of the protein is extremely complex (column 1, page 1306). Bowie et al. further teach that while it is known that many amino acid substitutions are possible in any given protein, the position within the protein's sequence where such amino acid substitutions can be made with a reasonable expectation of maintaining function are limited. Certain positions in the sequence are critical to the three dimensional structure/function relationship and these regions can tolerate only conservative substitutions or no substitutions at all (column 2, page 1306). The sensitivity of proteins to alterations of even a single amino acid in a sequence are exemplified by Burgess et al. (J. Cell Biol. 111:2129-2138,1990) who teach that replacement of a single lysine residue at position 118 of acidic fibroblast growth factor by glutamic acid led to the substantial loss of heparin binding, receptor binding and biological activity of the protein and by Lazar et al. (Mol. Cell. Biol., 8:1247-1252,1988) who teach that in transforming growth factor alpha, replacement of aspartic acid at position 47 with alanine or asparagine did not affect biological activity while replacement with serine or glutamic acid sharply reduced the biological activity of the mitogen. These references demonstrate that even a single amino acid substitution will often dramatically affect the biological activity and characteristics of a protein.
Additionally, Whisstock et al. (Quarterly Reviews in Biophysics. 36(3):307-340, 2007) teach that the prediction of protein function from sequence and structure is a difficult problem (See abstract). Although many families of proteins contain homologues with the same function, homologous proteins often have different functions as the sequences progressively diverge (See page 309). Whisstock et al. teach that assigning a function to an amino acid sequence based upon similarity becomes significantly more complex as the similarity between the sequence and a putative homologue falls. Whisstock et al. teach that while it is hopeful that similar proteins will share similar functions, substitution of a single, critically placed amino acid in an active-site may be sufficient to alter a protein’s role fundamentally (See pages 321-323). Given not only the teachings of Bowie et al., Lazar et al. and Burgess et al. but also the limitations and pitfalls of assigning a function to an amino acid sequence based upon similarity as taught by Whisstock, the claimed proteins could not be predicted. Therefore, the state of the art supports that even the skilled artisan requires guidance on the critical structures of the agent per se and thereby does not provide adequate written description support for which structural features of any given polypeptide would predictably retain their functional activities.
Accordingly, one of skill in the art would conclude that the claimed invention encompasses a plurality of polypeptides defined solely in terms of their function that may not have the biological functions recited in the claims. Based on the teachings of the instant specification and the prior art, one of skill in the art would not conclude that Applicant was in possession of the claimed genus of proteins.
While “examples explicitly covering the full scope of the claim language” typically will not be required, a sufficient number of representative species must be included to “demonstrate that the patentee possessed the full scope of the [claimed] invention.” Lizardtech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005).
In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus. 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, Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1895 (Fed. Cir. 2004); accord Ex Parte Kubin, 2007-0819, BPAI 31 May 2007, opinion at p. 16, paragraph 1). The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed (see Vas-Cath at page 1116).
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).
Applicant’s Arguments
Applicant argues that the examiner treats the claims as if they are drawn to a Markush genus of chemical compounds, requiring Applicant to demonstrate possession of representative species across all possible combinations of IL-12 protein variants, dienophile structures, tetrazine structures, masking moieties, and linkers and spacers. Applicant argues that this is incorrect because it dissects the claimed subject matter into its individual component parts and evaluates each part in isolation, rather than recognizing the novel and non-obvious combination of known elements. Applicant argues that the inventive concepts of the claims relate to the judicious insight that IL-12 protein can be deactivated if one or more of its lysine residues is modified with a bioorthogonal Trigger and then be reactivated via inverse electron-demand Diels-Alder (IEDDA) click chemistry. Applicant argues that specifically, the specification discloses the surprising finding that even a small Trigger moiety is able to significantly lower IL-12 activity. Applicant argues that while the component parts of the claims are all known: IL-12 proteins are known in the art, dienophiles and tetrazines are known in the art, IEDDA reactions are known in the art, and masking moieties and linkers are known in the art and are not individually inventive, the combination according to the claims are novel and non-obvious.
Applicant argues that the specification discloses representative species across the genus: (1) IL-12 proteins - human wild-type p35 and p40 (SEQ ID NOs: 1-2), stable p40 variants (SEQ ID NOs: 3-13), mouse p35 (SEQ ID NO: 14), and specific lysine positions (K122, K128, K168, K170 for p35; K58, K195, K197 for p40); (2) Dienophiles - General Formula (3b), synthesis methods, and exemplified compounds (2.3, 2.5, 2.7, 2.9, 2.14); (3) Tetrazines - General Formula (2), synthesis methods, and exemplified compounds (7.5, 7.8, 7.9, 8.5); (4) Masking moieties - PEG (extensively exemplified at various molecular weights), polysarcosine, PLA, PLGA, peptides (SEQ ID NOs: 16-32), and antibodies; and (5) Linkers - self-immolative linkers extensively described, carbamate linkages (preferred and exemplified), and various spacer chemistries. Applicant argues that a person of ordinary skill in the art (POSITA), reading the specification, would understand that: (1) the masking mechanism is general - blocking lysine residues disrupts IL-12 activity regardless of which IL-12 variant is used; (2) the bioorthogonal chemistry is well-established - IEDDA reactions are thoroughly documented; (3) extension to variants is routine - given working examples with full-length wild-type IL-12, a POSITA would recognize that variants with high sequence similarity would behave similarly; and (4) selection of appropriate masks is predictable - the specification provides assays to test masking efficiency.
Response to Arguments
Applicant’s arguments have been fully considered but they are not persuasive.
It is acknowledged that the claims encompass a combination of elements. However, it is the Office’s position that the specification does not adequately describe the genus of masked IL12 proteins. The structure of the complete masked IL12 protein is not provide in the claims, as written. The claims, rather, describe the masked IL12 protein by partial structures and/or function. Some claims embodiments do not recite any structure for the IL12 protein, and in other claim embodiments, the IL12 protein comprises a variant that shares at least 80% sequence similarity with the sequences set forth in SEQ ID NOs: 1-14. The claims also recite a particle structure for the dienophile trigger. The claims recite numerous variable groups for the dienophile trigger. The masked IL12 also comprises a masking moiety that is not defined, one or more cleavable linkers between the two, and one or more spacers, all which bear various reactive groups, chemically incompatible groups, susceptible groups as substituents groups.
As explained in the rejection, one of skill in the art would not be apprised of the full structure of the masked IL12 without adequate description of its component parts or overall makeup. The generically claimed IL12, dienophile, masking moiety, and linkers and spacers do not impart enough structural information to permit one of ordinary skill in the art to reasonably recognize or understand that Applicant was in possession of the full scope of the masked IL12 proteins as recited in the claims, as written. Without knowing the structure of the claimed IL12, dienophile, masking moiety, and linkers and spacers, one would not be able to adequately describe the claimed masked IL12 protein construct.
Applicant has provided little or no descriptive support beyond the mere presentation of generic or partially named structures to enable one of ordinary skill in the art to determine the actual structural composition of the claimed genus of masked IL12 protein. Although the prior art outlines art-recognized procedures for producing and screening for the component parts of the proitein, this is not sufficient to impart possession of the genera of masked IL12 proteins to Applicant. Even if a few structurally identifiable composition components were described in the specification, they may not be sufficient, as the ordinary artisan would not necessarily immediately recognize how to put them together in such a way as to form a completely constructed masked IL12 protein such that one would be able to distinguish it from the proteins of the prior art. Without an adequate structural description of the claimed components and descriptive support on how to put them together, one of ordinary skill in the art would not be reasonably apprised that Applicant was in possession of the genus of recombinant proteins as claimed. While "examples explicitly covering the full scope of the claim language" typically will not be required, a sufficient number of representative species must be included to "demonstrate that the patentee possessed the full scope of the [claimed] invention." Lizardtech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005).
In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus. 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, Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886,1895 (Fed. Cir. 2004); accord Ex Parte Kubin, 2007-0819, BPAI 31 May 2007, opinion at p. 16, paragraph 1). The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed (see Vas-Cath at page 1116). Applicant is reminded that although the claims are read in light of the specification, limitations in the specification cannot be read into the claims. The claims must stand on their own.
In response to Applicant’s argument that the specification provides a representative number of species, the species provided in the specification (i.e., a masked IL12 protein comprising the full length IL12, a PEG masking moiety, and a dienophile compound selected from 2.3, 2.5, 2.7, 2.9, and 2.14) are not commensurate in scope with the claims. As noted above, the claims encompass potentially thousands, if not millions, of masked IL12 protein given the generic description provided for the IL12 protein, dienophile, masking moiety, and linkers and spacers. The few species disclosed do not represent the genus because the species do not reflect the variation of the genus.
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.
Claim 26 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 26 recites the limitation "the polyethylene glycol" in 1. There is insufficient antecedent basis for this limitation in the claim. Claim 26 depends from claim 42, and claim 42 does not recite a polyethylene glycol. Clarification and/or correction is required.
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.
Claim 26 is 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. Although claim 26 recites a further limitation, the claim does not refer to a preceding claim. 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 Status
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA CARTER whose telephone number is (571)272-2932. The examiner can normally be reached 8:00-5:00 pm.
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/SANDRA CARTER/ Examiner, Art Unit 1674
/VANESSA L. FORD/ Supervisory Patent Examiner, Art Unit 1674