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 .
Claim Status
Applicant’s amendments and remarks, filed 11/26/2025, are acknowledged.
Claims 2, 7-9, and 26 are amended.
Claim 27 is new.
Claims 1-27 are pending.
As such, claims 1-27 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/26/25 has been entered.
Withdrawn Rejections
Applicant’s arguments, see pages 6-8, filed 11/26/2025, with respect to claims 2, 5, 7, 9, 12-14, 17, and 26 rejected under 35 USC 112(b) as allegedly being indefinite have been fully considered and are persuasive. The issue regarding the claims comprising indefinite language have been sufficiently addressed through amendments to the claims. As such, the rejection under 35 USC 112(b) is withdrawn.
Applicant’s arguments, see pages 18-22, filed 11/26/2025, with respect to claim1-26 rejected under 35 USC 112(a) as allegedly lacking enablement for the claimed method, especially the genus of gene editing active agents altering the genome of an embryo or gametes have been fully considered and are persuasive. The issue regarding the specification failing to provide enablement for the claimed invention have been sufficiently addressed through Applicant’s arguments. Further, Examiner acknowledges that the claimed gene editing agents are known to alter genomes for a method of treating various diseases; thus, it is enabling for altering genomes in embryos or gametes. As such, the scope of enablement rejection under 35 USC 112(a) is withdrawn.
Applicant’s remarks, see pages 22-24, filed 11/26/2025, with respect to claims 1-2, 7, 9-20, 23, and 25 rejected under 35 USC 102 as allegedly anticipated by Ricciardi et al (NATURE COMMUNICATIONS (2018) 9:2481, published online: 06/26/2018; provided in IDS filed 06/27/2022) have been fully considered and are persuasive. Examiner acknowledges that the art teaches of in utero nanoparticle delivery for site-specific genome editing and does not explicitly teach of contacting embryos or gametes at the time of fertilization in vitro. As such, the rejection of claims 1-2, 7, 9-20, 23, and 25 under 35 USC 102 is withdrawn.
Applicant’s remarks, see pages 25-33, filed 11/26/2025, with respect to claims 1-26 rejected under 35 USC 103 as allegedly being unpatentable over Ricciardi et al over Jukam et al (Developmental Cell 42(4):316-332; August 21, 2017; provided in IDS filed 06/27/2022) have been fully considered and are persuasive. Examiner acknowledges that Ricciardi teaches of in utero nanoparticle delivery for site-specific genome editing, and neither Ricciardi nor Jukam explicitly teach of contacting embryos or gametes at the time of fertilization in vitro. As such, the rejection of claims 1-26 under 35 USC 103 is withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 112(a) Written Description
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 1-26 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. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Claim 1 is drawn to a method comprising contacting an embryo, male and female gametes at the time of fertilization, or a combination thereof in vitro with an effective amount of non-enzymatic gene editing active agent(s) selected from the group consisting of triplex-forming molecules, donor oligonucleotides, pseudocomplementary oligonucleotides, small fragment homologous replacement compositions, single-stranded oligodeoxynucleotide-mediated gene modification compositions, and combinations thereof to induce at least one alteration in the genome of the embryo, male gametes, female gametes, or combination thereof.
Claim 2 is drawn to the method of claim 1, wherein the effective amount of non-enzymatic gene editing active agent(s) is encapsulated, entrapped, or dispersed in polymeric particles.
Claim 3 is drawn to the method of claim 1, wherein the embryo is 1, 2, 4, 8, or 16 cells.
Claim 4 is drawn to the method of claim 1, wherein the embryo is a zygote, morula, or blastocyst.
Claim 5 is drawn to the method of claim 2, wherein the embryo, male gametes, female gametes, or a combination thereof is contacted with the particles on culture days 0-6 during or following in vitro fertilization.
Claim 6 is drawn to the method of claim 5, wherein the in vitro fertilization comprises co- incubation of male and female gametes on or prior to culture day 0.
Claim 7 is drawn to the method of claim 1, wherein the embryo and/or gametes are in liquid media, and contacting comprises adding the active agents to the liquid media.
Claim 8 is drawn to the method of claim 1, comprising contacting the embryo, wherein the embryo is a single cell embryo.
Claim 9 is drawn to the method of claim 1, wherein the alteration corrects a mutation that causes a genetic disease or disorder.
Claim 10 is drawn to the method of claim 9, wherein the genetic disease or disorder is a monogenic disease or disorder.
Claim 11 is drawn to the method of claim 9, wherein the disease or disorder is a hemophilia, a hemoglobinopathy, cystic fibrosis, xeroderma pigmentosum, a lysosomal storage disease, Huntington's disease, Duchenne muscular dystrophy or Alzheimer's disease.
Claim 12 is drawn to the method of claim 2, wherein the particles are selected from the group consisting of nanoparticles, microparticles, and mixtures thereof.
Claim 13 is drawn to the method of claim 12, wherein the nanoparticles, microparticles, and mixtures thereof are formed of a polymer, copolymer or polymer blend selected from the group consisting of poly(lactic acid) (PLA), poly(glycolic acid) (PGA), poly(lactide-co-glycolide) (PLGA), polyesters, polyanhydrides, poly(ortho)esters, poly(butic acid), poly(valeric acid), poly(caprolactone), poly(hydroxyalkanoates), poly(lactide-co-caprolactone), poly(beta-amino) esters (PBAEs) and poly(amine-co-ester) polymers (PACE).
Claim 14 is drawn to the method of claim 2, wherein the particles are nanoparticles comprising PLGA.
Claim 15 is drawn to the method of claim 1, wherein the gene editing active agent(s) comprises a peptide nucleic acid (PNA) tail clamp that enhances recombination of a donor oligonucleotide in the embryonic genome relative to the donor oligonucleotide alone.
Claim 16 is drawn to the method of claim 15, wherein the gene editing active agent(s) further comprises the donor oligonucleotide.
Claim 17 is drawn to the method of claim 15, wherein the PNA tail clamp comprises at least one PNA oligomer.
Claim 18 is drawn to the method of claim 17, wherein the at least one PNA oligomer of the PNA tail clamp is a modified PNA oligomer comprising at least one modification at a gamma position of a backbone carbon.
Claim 19 is drawn to the method of claim 18, wherein the modified PNA oligomer comprises at least one diethylene glycol (“miniPEG”) modification at a gamma position of a backbone carbon.
Claim 20 is drawn to the method of claim 1, further comprising transferring the embryo into the uterus of a female.
Claim 21 is drawn to the method of claim 20, wherein the contacting occurs with the embryo after the maternal-to-zygotic transition (MZT), and the transferring occurs after the contacting and before or during the blastocyst stage.
Claim 22 is drawn to the method of claim 20, wherein the contacting occurs with the embryo during the one cell stage, and the transferring occurs after the contacting and before or during the blastocyst stage.
Claim 23 is drawn to the method of claim 1, wherein the embryo is a mammalian embryo.
Claim 24 is drawn to the method of claim 23, wherein the mammal is a human.
Claim 25 is drawn to the method of claim 1, wherein the embryo is an embryo of a domesticated, agricultural, or wild animal.
Claim 26 is drawn to the method of claim 25, wherein the agricultural animal is a horse, cow, bull, pig, sheep, rabbit, chicken, or goat.
The specification disclose of synthetic nanoparticle delivery to mouse embryos for site-specific genome editing (see Example 1). The specification disclose of using nanoparticles fabricated from a biodegradable polymer, PLGA, which has been used in humans for over 40 years (see pg. 129, lines 21-23). To achieve gene correction, two active agents are loaded into the nanoparticles: a triplex-forming peptide nucleic acid (PNA) that induces recombination at a specific, targeted site on a chromosome and a short donor DNA molecule that contains the desired gene sequence; once administered, PLGA nanoparticles (NPs) are taken up by cells where they degrade, releasing the loaded PNA and DNA (see pg. 129, lines 24-29). Once inside a cell, the engineered PNA binds to a specific genomic target site, forming a triplex, which induces DNA repair mechanisms that stimulate the recombination of the short, single stranded donor DNA molecule containing the correct sequence, resulting in site-specific gene correction (see pgs. 129-130). In Example 1, IVS2-654 β-thalassemia mice were used and single cell fertilized embryos were obtained from these mice (see pg. 130, lines 5-15). Mini-PEG γPNA monomers were prepared from Boc-(2-(2-methyoxyethoxy)ethyl)-L-serine as a starting material by a series of multistep synthetic procedures including reduction, mitsunobu reaction, nucleobase (A,C,G and T) conjugation and then ester cleavage (see pg. 131, lines 2-5). Applicant indicates the sequence of γPNA used in this study is H-KKK-JTTTJTTTJTJT-OOO-TCTCTTTCTTTCAGGGCA-KKK-NH2 (SEQ ID NO: 66), wherein the underlined indicates γPNA residues; K, lysine; J, pseudoisocystosine; O, 8-amino-2,6,10-trioxaoctanoic acid linkers connecting the Hoogsteen and Watson-Crick domains of the tcPNA (see pg. 131, lines 18-23). The specification disclose that the PLGA used for these studies is as follows: 50:50 ester-terminated, 0.95-1.2 g dl-1 (LACTEL absorbable polymers; Birmingham, AL) (see pg. 132, lines 2-3). PNA/DNA PLGA NPs were formulated using a double-emulsion solvent evaporation technique modified to encapsulate PNA and DNA oligomers (see pg. 132, lines 17-19).
The specification also discloses that embryos can be effectively reimplanted (see Example 2). Embryos were treated for one hour with PLGA PNA/DNA NPs and then cultured for varying time-points before transfer to surrogate moms; all pregnancies resulted in fetuses that appeared healthy and exhibited normal morphology, and neonates were healthy with no visible defects and normal growth and development (see pg. 140, lines 7-11; Figs. 3A and 3B). Treated embryos reimplanted at the single-cell and two-cell stage had a development rate after reimplantation similar to that expected for untreated embryos; 64 of 139 embryos treated at either the one or two cell stage successfully implanted and developed (46%) compared to 27 of 53 of untreated single-cell reimplanted embryos (51%) (see pg. 140, lines 12-14 and 17-19). Embryos reimplanted at varying stages of development also exhibit normal growth and morphology with little to no embryo loss due to treatment, making PNA/DNA NP treatment an effective and gentler alternative to CRISPR microinjections; however, embryos reimplanted at the single-cell stage show low levels of editing (see pg. 143, lines 20-25).
Lastly, the specification discloses that naked PNA and donor DNA have an effect, but that NPs with the same PNAs and DNA are more effective (see Example 3). Embryos were treated at the single-cell stage with naked PNA and/or DNA oligonucleotides, which were delivered by pipetting directly onto embryo culture media (see pg. 144, lines 27-29). Naked oligonucleotides were given at the maximum theoretical dose of oligonucleotides encapsulated in PLGA NPs, (assuming 100% encapsulation efficiency) and embryos were analyzed by ddPCR at the blastocyst stage (see pg. 144, lines 29-32). Naked PNA alone does not result in any editing; editing is significantly improved with administration of NPs with PNA/DNA encapsulated over naked DNA or naked PNA and DNA alone (see Fig. 4A and Table 4). Survival of embryos to the blastocyst stage is shown in Fig. 4C.
However, the specification fails to disclose that Applicant was in possession of the claimed method. Specifically, the specification fails to disclose that Applicant was in possession of contacting embryos, male gametes, female gametes, or a combination thereof with an effective amount of any non-enzymatic gene editing active agent(s) to induce at least one alteration in the genome of the embryos, male gametes, female gametes, or a combination thereof. The specification fails to disclose of the claimed method wherein the embryo is 4, 8, or 16 cells. The specification fails to disclose the vast genus of mutations associated with a genetic disease or disorder and the corresponding alterations that corrects these mutations. Specifically, the specification fails to disclose that Applicant was in possession of the extraordinarily broad genus of “gene editing active agents” and the corresponding vast genus of diseases or disorders recited in claim 11. The specification fails to disclose that Applicant was in possession of the claimed method wherein the particles are formed of a polymer, copolymer or polymer blend selected from the group recited in claim 13, excluding PLGA. Lastly, the specification fails to disclose of contacting occurring with the embryo after the MZT as recited in claim 21.
Although the specification discloses transferring PNA/DNA encapsulated in nanoparticles fabricated from PLGA to β-thalassemia mice and single cell fertilized embryos, the claims are not limited to this disease, embryo, or non-enzymatic gene editing active agent(s), and are inclusive of any species of embryo, male or female gametes, or a combination thereof; any non-enzymatic gene editing active agent(s); and, any mutation associated with any genetic disease or disorder. This indicates that there are hundreds, if not thousands, of possible methods of comprising contacting an embryo, male gametes, female gametes, or a combination thereof in vitro with an effective amount of non-enzymatic gene editing active agent(s) to induce at least one alteration in the genome of the embryo, male gametes, female gametes, or combination thereof encompassed by the claims. Thus, the claims encompass a vast genus of disease-gene editing agents that have the claimed functions. However, the specification provides limited guidance on the structure and steps required for maintaining the claimed function(s). Therefore, the specification does not provide adequate written description to identify the broad and variable genus of non-enzymatic gene editing active agent(s) because, inter alia, the specification does not disclose a correlation between the necessary structure of the active agent(s) and the function(s) recited in the claims; and thus, the specification does not distinguish the claimed genus from others, except by function. Further, the specification fails to provide method steps that result in inducing at least one alteration in the genome of the embryos, male gametes, female gametes, or combination thereof. Accordingly, the specification does not define any structural features commonly possessed by the members of the genus, because while the description of an ability of the claimed substance may generically describe the molecule’s function, it does not describe the substance itself. A definition by function does not suffice to define the genus because it is only an indication of what the substance does, rather than what it is; therefore, it is only a definition of a useful result rather than a definition of what achieves the result. In addition, because the genus of substances is highly variable (i.e. each substance would necessarily have a unique structure, See MPEP 2434), the generic description of the substance is insufficient to describe the genus. Thus, the specification does not provide substantive evidence for possession of this large and variable genus, encompassing a potentially massive number of non-enzymatic gene editing active agents claimed only be a functional characteristic(s) and/or partial structure.
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 sufficient identifying characteristics for written description purposes, even when accompanied by a method of obtaining the agent. The specification does not adequately describe the correlation between the chemical structure and function of the genus, such as structural domains or motifs that are essential and distinguish members of the genus from those excluded. Thus, the genus of non-enzymatic gene editing active agents has no correlation between their structure and function.
MPEP § 2163.03(V) states:
While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed, In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. “Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Applicant has not shown possession of a representative number of species of diseases or non-enzymatic gene editing active agent(s). 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 gen[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).
The instant claims do not fully describe the structure of the non-enzymatic gene editing active agent(s) to achieve the required function. Accordingly, the specification also does not provide adequate written description to identify the broad genus of non-enzymatic gene editing active agent(s), claimed only by a function characteristic(s) and not structures per se, 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 non-enzymatic gene editing active agent(s) 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 non-enzymatic gene editing active agent(s) claimed only by a partial structure and functional characteristic(s). Thus the non-enzymatic gene editing active agent(s) described by the instant claims encompasses an overly broad genus and the functional outcome.
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), it is noted that to show invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358). Also, it is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361). An adequate written description must contain enough information about the actual makeup of the claimed products — “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361). Most significant to the present case, the Court held that "knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies" (Amgen at 1361). The idea that written description of an antibody can be satisfied by the disclosure of a newly-characterized antigen “flouts basic legal principles of the written description requirement” as it “allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen... And Congress has not created a special written description requirement for antibodies” (Amgen at page 1362).
Abbvie v. Centocor (Fed. Cir. 2014) is also relevant to the instant claims. In Abbvie, the Court held that a disclosure of many different antibodies was not enough to support the genus of all neutralizing antibodies because the disclosed antibodies were very closely related to each other in structure and were not representative of the full diversity of the genus. The Court further noted that functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support especially in technology fields that are highly unpredictable where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus.
The instant case has many similarities to AbbVie above. First, the claims clearly attempt to define the genus of non-enzymatic gene editing active agent(s) by the function of inducing at least one alteration in the genome of the embryo, male gametes, female gametes, or combination thereof. Additionally, the claims attempt to define the genus of non-enzymatic gene editing active agent(s) entirely by their functions. As noted by AbbVie above, functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description. Second, there is no information in the specification based upon which one of skill in the art would conclude that the disclosed species for which applicant has identified as having the recited functions would be representative of the entire genus. The specification discloses no structure to correlate with the function. Therefore, the specification provides insufficient written description to support the genus encompassed by the claim.
Furthermore, regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 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.)
Further, the skilled artisan cannot envision the detailed chemical structure of the encompassed non-enzymatic gene editing active agent(s), 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.
Finally, 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.
Regarding the encompassed non-enzymatic gene editing active agent(s) that are proteins and peptides, protein chemistry is one of the most unpredictable areas of biotechnology. This unpredictability prevents prediction of the effects that a given number or location of mutation will have on a protein (such as TNF or a cytokine) as taught by Skolnick et al. (Trends Biotechnol. 2000 Jan;18(1):34-9; previously submitted with the Office Action mailed on 09/24/2024), sequence-based methods for predicting protein function are inadequate because of the multifunctional nature of proteins (see e.g. abstract). Further, just knowing the structure of the protein is also insufficient for prediction of functional sites (see e.g. abstract). Sequence to function methods cannot specifically identify complexities for proteins, such as gain and loss of function during evolution, or multiple functions possible within a cell (see e.g. page 34, right column). Skolnick advocates determining the structure of the protein, then identifying the functionally important residues since using the chemical structure to identify functional sites is more in line with how a protein actually works (see e.g. page 34, right column).
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; previously submitted with the Office Action mailed on 09/24/2024) who teach that replacement of a single lysine reside 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; previously submitted with the Office Action mailed on 09/24/2024) 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.
Further, Miosge (Proc Natl Acad Sci U S A. 2015 Sep 15;112(37):E5189-98; previously submitted with the Office Action mailed on 09/24/2024) teach that Short of mutational studies of all possible amino acid substitutions for a protein, coupled with comprehensive functional assays, the sheer number and diversity of missense mutations that are possible for proteins means that their functional importance must presently be addressed primarily by computational inference (see e.g. page E5189, left column). However, in a study examining some of these methods, Miosge shows that there is potential for incorrect calling of mutations (see e.g. page E5196, left column, top paragraph). The authors conclude that the discordance between predicted and actual effect of missense mutations creates the potential for many false conclusions in clinical settings where sequencing is performed to detect disease-causing mutations (see e.g. page E5195, right column, last paragraph). The findings in their study show underscore the importance of interpreting variation by direct experimental measurement of the consequences of a candidate mutation, using as sensitive and specific an assay as possible (see e.g. page E5197, left column, top paragraph). Additionally, Bork (Genome Research, 2000,10:398-400; previously submitted with the Office Action mailed on 09/24/2024) clearly teaches the pitfalls associated with comparative sequence analysis for predicting protein function because of the known error margins for high-throughput computational methods. Bork specifically teaches that computational sequence analysis is far from perfect, despite the fact that sequencing itself is highly automated and accurate (p. 398, column 1). One of the reasons for the inaccuracy is that the quality of data in public sequence databases is still insufficient. This is particularly true for data on protein function. Protein function is context dependent, and both molecular and cellular aspects have to be considered (p. 398, column 2). Conclusions from the comparison analysis are often stretched with regard to protein products (p. 398, column 3). Further, although gene annotation via sequence database searches is already a routine job, even here the error rate is considerable (p. 399, column 2). Most features predicted with an accuracy of greater than 70% are of structural nature and, at best, only indirectly imply a certain functionality (see legend for table 1, page 399). As more sequences are added and as errors accumulate and propagate it becomes more difficult to infer correct function from the many possibilities revealed by database search (p. 399, paragraph bridging columns 2 and 3). The reference finally cautions that although the current methods seem to capture important features and explain general trends, 30% of those features are missing or predicted wrongly. This has to be kept in mind when processing the results further (p. 400, paragraph bridging cols 1 and 2).
One key issue is the prediction of protein function based on sequence similarity, which could be one way to identify the functional proteins that are useful in the instant claims. Kulmanov et al (Bioinformatics, 34(4), 2018, 660–668; previously submitted with the Office Action mailed on 09/24/2024), teach that there are key challenges for protein function prediction methods (see e.g. page 661, left column). These challenges arise from the difficulty identifying and accounting for the complex relationship between protein sequence structure and function (see e.g. page 661, left column). Despite significant progress in the past years in protein structure prediction, it still requires large efforts to predict protein structure with sufficient quality to be useful in function prediction (see e.g. page 661, left column). Another challenge is that proteins do not function in isolation. In particular higher level physiological functions that go beyond simple molecular interactions will require other proteins and cannot usually be predicted by considering a single protein in isolation (see e.g. page 661, left column). Due to these challenges it is not obvious what kinds of features should be used to predict the functions of a protein and whether they can be generated efficiently for a large number of proteins, such as the vast genus of proteins and peptides that may be encompassed by the instant claims (see e.g. page 661, left column).
The state of the art regarding the structure-function correlation cannot be relied upon because functional characteristics of any peptide/protein are determined by its structure as evidenced by Greenspan et al. 1999 (Defining epitopes: It's not as easy as it seems; Nature Biotechnology, 17:936-937; previously submitted with the Office Action mailed on 09/24/2024). Greenspan et al. teach that as little as one substitution of an amino acid (e.g. alanine) in a sequence results in unpredictable changes in the 3-dimenstional structure of the new peptide sequence which, in turn, results in changes in the functional activity such as binding affinity of the peptide sequence (page 936, 1st column). Greenspan et al. teach that contribution of each residue (i.e. each amino acid) cannot be estimated with any confidence if the replacement affects the properties of the free form of the molecule (page 936, 3rd column).
Given not only the teachings of Skolnick et al., Lazar et al., Burgess et al., and Greenspan et al., but also the limitations and pitfalls of using computational sequence analysis and the unknown effects of alternative splicing, post translational modification and cellular context on protein function as taught by Bork, the claimed non-enzymatic gene editing active agent(s) could not be predicted based on sequence identity. Clearly, it could not be predicted that a polypeptide or a variant that shares only partial homology with a disclosed protein or that is a fragment of a given SEQ ID NO. will function in a given manner.
Regarding non-enzymatic gene editing active agent(s) that are small molecules of a particular protein target, the prediction of binding to a target, much less the inhibitory activity, is highly unpredictable. According to Guido et al. (Curr Med Chem. 2008;15(1):37-46; previously submitted with the Office Action mailed on 09/24/2024), accurately predicting the binding affinity of new drug candidates remains a major challenge in drug discovery (see page 37). There are a vast number of possible compounds that may bind any particular target, many of which have likely not been discovered. Relying on virtual screening also lends unpredictability to the art regarding identification of molecules that would be capable of the required functions of the instant claims. Guido et al. teach that there are two main complex issues with predicting activity for a small molecule: accurate structural modeling and/or correct prediction of activity (see page 40). As taught by Clark et al. (J. Med. Chem., 2014, 57 (12), pp 5023–5038; previously submitted with the Office Action mailed on 09/24/2024), even when guided by structural data, developing selective structure-activity relationships has been challenging owing to the similarities of the enzymes (see page 5028). Therefore, it is impossible for one of skill in the art to predict that any particular encompassed small molecule therapeutic would function to inhibit a particular protein, especially a particular protein family member, or treat disease.
Regarding non-enzymatic gene editing active agent(s) that are nucleic acid-based therapeutics, the efficacy of any possible DNA or RNA based therapeutic modality is highly unpredictable. This unpredictability stems from an inability to predict the effects of any particular sequence the expression or function of any target. As taught by Aagaard et al. (Advanced Drug Delivery Reviews 59 (2007) 75–86; previously submitted with the Office Action mailed on 09/24/2024), the development of RNAi based therapeutics faces several challenges, including the need for controllable or moderate promoter systems and therapeutics that are efficient at low doses (see page 79), the ability of an unpredictable number of sequences to stimulate immune responses, such as type I interferon responses (see page 79), competition with cellular RNAi components (see page 83), the side effect of suppressing off targets (see page 80), and challenging delivery (see page 83). The success of antisense strategies, including anti-RNA and anti-DNA strategies are also highly unpredictable. Warzocha et al. (Leukemia and Lymphoma (1997) Vol. 24. pp. 267-281; previously submitted with the Office Action mailed on 09/24/2024) teach that the efficacy of antisense effects varies between different targeted sites of RNA molecules and three-dimensional RNA structures (see page 269), while DNA-targeting strategies have numerous problems including a restricted number of DNA sequences that can form triple helices at appropriate positions within genes and the inaccessibility of particular sequences due to histones and other proteins (see page 269). These references demonstrate that variation in RNA or DNA based therapeutics will often dramatically affect the biological activity and characteristics of the intended therapeutic. McKeague et al. (J Nucleic Acids. 2012;2012:748913. Epub 2012 Oct 24; previously submitted with the Office Action mailed on 09/24/2024) teach that aptamers have particular challenges because unlike antibodies or molecular imprinted polymers, their tertiary structure is highly dependent on solution conditions and they are easily degraded in blood. Further, they have less chemical diversity than other antagonist molecules (see page 2), and have issues associated with determining the Kd measurements for a given molecule (see page 13).
Given the teachings of Aagaard et al, Warzocha et al, and McKeague et al, the claimed nucleic acid therapeutics could not be predicted based on the targets selected or similarities to the disclosed example therapeutics. Therefore, it is impossible for one of skill in the art to predict that any particular encompassed nucleic acid based therapeutic, such as oligonucleotide aptamers, RNAi molecules and antisense oligonucleotides, would function to decrease expression or function of a target gene or protein, or treat disease.
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 (see MPEP 2163). A patent specification must set forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what is claimed. In the case of DNA, an adequate written description 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 (see Lilly, 119 F.3d at 1566 (quoting Fiers, 984 F.2d 15 1171 ). Because the specification does not describe the amino acid sequences nor any core structures for potentially numerous different antibody amino acid sequences which would have the recited dissociation constant, one of skill in the art would reasonably conclude that applicant was not in possession of the claimed genus of all non-enzymatic gene editing active agent(s).
A key role played by the written description requirement is to prevent “attempt[s] to preempt the future before it has arrived.” Ariad at 1353, (quoting Fiers v. Revel, 984 F.2d at 1171). Upholding a patent drawn to a genus of antibodies that includes members not previously characterized or described could negatively impact the future development of species within the claimed genus of antibodies.
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." Lizard tech 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 claimed non-enzymatic gene editing active agent(s). 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).
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 methods of comprising contacting an embryo, male and female gametes at the time of fertilization, or a combination thereof in vitro with an effective amount of non-enzymatic gene editing active agent(s) to induce at least one alteration in the genome of the embryo, male gametes, female gametes, or combination thereof as claimed. 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 respectfully requests the withdrawal of the rejection under 35 USC 112, written description.
At its core, the Examiner's rejection is insufficient, because it does not establish why Applicant's results in the model system are not representative results that would be recognized by one of ordinary skill in the art as extending to the well disclosed and claimed alternatives. The Examiner appears to rely primarily on a conclusion that the working examples are not sufficient to entitle Applicant to the breadth of the claimed alternatives, but the reliance is based on a generic conclusion that gene editing can be unpredictable, and some alleged support that specific examples of gene editing are variable and sometimes fail. This is not sufficient. The Examiner must provide facts to establish why the exemplified model system and results would not reasonably extend to the claimed substitutes in the context of what was already known in based on the prior art…
With respect to the timing of contacting the embryos, in response to Applicant's previously submitted arguments, the Examiner alleged "[t]he 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). Thus, based on the information provided in the specification, one of skill in the art would not understand that the 'contacting' can be delayed beyond the 2-cell stage nor that Applicant was in possession of the claimed invention beyond the 2-cell stage. Further, while the teachings of Jukam et al may provide motivation to administer NPs when the embryo is 4 cells for humans or 2 cells for mice, the art does not provide support for 8 or 16 cells as such the art nor the specification provide support for the claimed invention." Office Action at paragraph bridging pages 32-33.
However, these are a combination of facts from Jukum and conclusory statements, and do not establish why the specification lacks written description for this element (i.e., why one of skill in art would not understand why the invention as-claimed is not sufficiently disclosed).
The Examiner appears to be suggesting that this is because only 1 and 2 cell embryos were tested in the working examples. However, lack of working examples is not the legal standard for written description, and more importantly, the Examiner has not established why Applicant's working examples in combination with the state of the art is insufficient to entitle Applicant to the expressly disclosed time points.
As introduced above, the gene editing reagents are not the "invention." The invention is a new method of using the known gene editing reagents. For the reasons described above, Applicant needed not describe them in detail. The Examiner cites to Amgen Inc. v. Sanofi, Abbvie v. Centocor, Vas-Cath Inc. v. Mahurkar, and University of California v. Eli Lilly and Co., and others to support a lack of written description regarding claimed gene editing compositions, alleging the composition are not described in sufficient structural detail. However, the reliance on these cases is misplaced. The cited cases stand for the proposition that limited disclosure (e.g., a species) of the invention can be insufficient to support a genus or generic claim or a composition claimed by function, when the thing that is insufficient is the invention. In the instant case the gene editing composition and/or targeted mutation is not the invention. The invention is a method using these technologies, which were already known at the time of filing.
For illustration, the Examiner's attention is drawn to U.S. Patent No. 12,473,354, which issued on November 18, 2025.
Claim 1 recites "A method for treating a solid cancer in a patient in need thereof, the method comprising the steps of: (a) selecting a patient that has a blood level of human GDF-15 (hGDF-15) that is more than 1.2 ng/ml; and (b) administering an immune checkpoint blocker to the patient, wherein the immune checkpoint blocker is selected from the group consisting of an anti-PD-1 antibody, an anti-CTLA4 antibody, an anti-PD-L1 antibody, and combinations thereof." Emphasis added.
Even though there are a number of anti-PD-1, anti-CTLA4, and anti-PD-L1 antibodies that have failed to show efficacy for the treatment of solid tumors, the Patent Office did not require limitation of this "method of treatment" to specific functional antibodies, or otherwise require their structure in the claims. Put another way, one of skill in the art knowns that there are many, many, PD-1 antibodies in the prior art that can inhibit PD-1 and further that others that have been developed for this purpose but have failed. Furthermore, specific solid tumors/cancers are not required by the claims, even though surely Applicant did not test all solid tumors, In fact, even effective anti-PD-1 antibodies are well known not work for all cancers in all patients. Nonetheless, these claims do not fail the test for written description or enablement because the art is well established in the area of PD-1 antibodies, and the invention is not the antibody per se, but rather new uses of known antibodies.
When the technology is well known, Applicant may use generic terminology or functional language without running afoul of the cited cases law.
Returning to the instant case, the claimed non-nuclease based gene editing technologies include, but are not limited to, triplex-forming, pseudocomplementary oligonucleotides, small fragment homologous replacement (e.g., polynucleotide small DNA fragments (SDFs)), single- stranded oligodeoxynucleotide-mediated gene modification (e.g., ssODN/SSOs) and other described in Sargent, Oligonucleotides, 21(2): 55-75 (2011)). Design features of these technologies are discussed in the specification as-filed and known in the art. The instantly claimed gene editing technologies are not new. These are all well-known technologies, whose mechanism of action is based at least in-part on recombination of nucleic acids with a target sequence based on sequence identity and/or complementarity. Based on knowledge of the target mutation and the design parameters of these technologies, one of skill in the art knows the "structure" of each target-specific composition.
Support is found in the very MPEP section cited by the Examiner. Specifically, "the amino acid sequence of a protein along with knowledge of the genetic code might put an inventor in possession of the genus of nucleic acids capable of encoding the protein," See MPEP § 2163 (I)(A) citing In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993). Such is the case here. The target gene sequences and technology for targeting them, based on those sequences, are known. Applicant need not provide an exhaustive list of all possible sequence-specific gene editing reagents for modifying each particular target nucleic acid.
Nonetheless numerous examples of triplex-forming oligonucleotides, PNAs, and donor oligonucleotides linked to correct of specific monogenic diseases are expressly provided in the specification. For example, the Examiner further alleges "Applicant has supplied a single species of gene editing active agents, which comprises SEQ ID NO: 66 encapsulated in nanoparticles fabricated from PLGA to β-thalassemia." Pg. 34, first full paragraph. This is not true. See the specification at pages 96-125 which provides dozens of specific sequences that target at least four different specific diseases. These are not new sequences. They are established in the art, including the very references cited by the Examiner in the prior art rejections discussed in more detail below.
Similar support for various preferred nanoparticle formulations are provided on, for example, pages 18-36.
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive (see pages 8-17 of the Remarks).
The Examiner respectfully disagrees with Applicant’s assertion that the written description rejection is insufficient. As stated in the rejection, the Examiner specifically indicates that the issue is regarding Applicant’s possession of the claimed method (i.e., contacting embryos of a certain time or gametes with a broad genus of non-enzymatic gene editing active agents). A description of function alone does not suffice to define the genus because it is only an indication of what the substance does, rather than what it is; therefore, it is only a definition of a useful result rather than a definition of what achieves the result. In addition, because the genus of substances is highly variable (i.e. each substance would necessarily have a unique structure, See MPEP 2434), the generic description of the substance is insufficient to describe the genus. While Applicant is entitled to use functional language in the description of claimed agents, according to MPEP 2163, an invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. This matches the facts here. The claims require specific functionality for the gene editing active agents, but neither the instant disclosure, nor the art, provide description of the corresponding structure for that functionality or a representative number of species for the agents. For example, the gene editing active agent is defined by its ability to induce at least one alteration in the genome. In both the base claims and the dependent claims, for at least one agent/component in each claim, the claims only describe what the agent/component does, not what the agents/components are. Even when given possible sequences from which to select a gene editing active agent that would correct a mutation associated with a genetic disease or disorder, the question remains about which one(s) of the encompassed gene editing active agents would actually perform the claimed function. While methods to identify the gene editing active agents with the required function may be routine in the art, the fact that any experimentation is required to figure out exactly what is encompassed necessarily means that applicant has not sufficiently described the claimed subject matter. There are thousands of possible gene editing active agents encompassed by the instant claims. One of skill in the art could not immediately envisage the encompassed species in each genus from the guidance provided in the instant specification and claims. The claims require that the practitioner first select a disease or disorder, then identify any possible mutation that could be associated with said disease or disorder, then perform experimentation to identify the specific non-enzymatic gene editing active agent that would perform the functions according to the instant claims. The need for experimentation to discover the encompassed agents demonstrates the lack of written description for the claimed method. Therefore the claims encompass an extremely broad genus of gene editing active agents with a specific function, for which no correlating structure is provided.
Further, Applicant’s argument that the “invention” is a new method of using the known gene editing reagents, and not the gene editing reagents itself, is incorrect. The invention is the totality of the language within the claims (see 35 USC 100(j)); as such, the gene editing reagents are also included as the invention of the application. 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 biological composition 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. Further, as cited by Applicant, MPEP § 2163 (I)(A) citing In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993) states “the amino acid sequence of a protein along with knowledge of the genetic code might put an inventor in possession of the genus of nucleic acids capable of encoding the protein,". The claims do not provide the structure of any of the gene editing active agents recited, thus one would not be apprised that Applicant was in possession of the genus of gene editing agents.
Furthermore, with respect to Applicant citing U.S. Patent No. 12,473,354, Applicant is reminded that applications are examined on a case-by-case basis and the findings of one application may not reflect the same for another. In that particular case, while there are several species of anti-PD-1, anti-CTLA-4, and anti-PD-L1 antibodies, the base claim is limited to treating solid cancers in a specific demographic of patients (i.e., a patient with a blood level of hGDF-15 that is more than 1.2 ng/ml) which narrows the scope of the invention. That is not the case here. As stated previously, the claims broadly describe various components of the invention and nothing further. 35 U.S.C. § 112(a) requires adequate written description of the biological composition itself even when preparation of such a composition would be routine and conventional. Amgen Inc., v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). A key role played by the written description requirement is to prevent “attempt[s] to preempt the future before it has arrived.” Ariad at 1353, (quoting Fiers v. Revel, 984 F.2d at 1171). Upholding a patent drawn to a genus of agents that includes members not previously characterized or described could negatively impact the future development of species of agents that can be used within the claimed method. In the instant application, neither the art nor the specification provide a sufficient representative number of gene editing active agents or a sufficient structure-function correlation to meet the written description requirements.
With respect to the examples of gene editing active agents and nanoparticle formulations cited by Applicant, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims as indicated in MPEP 2145. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims are not limited to the gene editing active agents described in the arguments, and instead encompass a large genus of admixtures, for which the components are not adequately described.
As such, the written description rejection is maintained.
Conclusion
Claim 27 is allowable.
Claims 1-26 are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Das et al (Human Reproduction Update, Vol.22, No.5 pp. 588–619, 2016) teach of potential toxicity of engineered nanoparticles in mammalian germ cells and developing embryos: treatment strategies and anticipated applications of nanoparticles in gene delivery.
Bisht and Rupenthal (PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, 2018, VOL. 23, NO. 4, 324–333; published online 11/3/2016) teach of PLGA nanoparticles for intravitreal peptide delivery.
Walter and Merkle (Journal of Drug Targeting, 2002 Vol. 10 (1), pp. 11–21) teach of microparticle-mediated transfection of non-phagocytic cells in vitro.
Little et al (Journal of Controlled Release 107 (2005) 449–462) teach of formulation and characterization of poly (beta amino ester) microparticles for genetic vaccine delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
