Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 37, 40-5 and 54-58 are under consideration in the instant Office Action.
Withdrawn Rejections
The rejection of claims 37 and 40-58 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of the newly amended claim 37 which now requires diabetic retinopathy and inhibitory anti-sortilin antibodies.
The rejection of claims 37, 40-54 and 58 under 35 U.S.C. 102(a)(1) as being anticipated by Rosenthal et al., WO2016/164637 (IDS) is withdrawn in view of the newly amended claim 37 which now requires diabetic retinopathy.
The rejection of claims 37 and 40- 58 under 35 U.S.C. 103 as being unpatentable over Rosenthal et al., WO2016/164637 are as applied to claims 37, 40-54 and 58 above, and further in view of Yamada et al., 2016 is withdrawn in view of the newly amended claim 37 which now requires diabetic retinopathy.
Modified and New Rejections Necessitated by 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 37, 40-50 and 54-58 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.
Independent claim 37 is directed to a method claim that requires the treatment of diabetic retinopathy in a therapeutic manner by administering an inhibitory anti-sortilin antibody or an antigen binding fragment thereof. Note that an antigen binding fragment of an antibody still reads on an antibody. As such, the claim is directed to an antibody defined entirely by function.
See MPEP §2163(I)(A) which states:
"The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.”
The specification fails to describe to the public the full genus of “inhibitory anti-sortilin antibody or an antigen binding fragment thereof”, as recited in newly amended claim 37. While certain embodiments such as antibodies are exemplified in the specification, the full genus of inhibitory anti-sortilin antibody or an antigen binding fragment thereof, which can be of any generic antibody with the required function, has not been described. Because there is not an art-established correlation between structure (i.e., specific molecules or sequences) and function (therapeutic, inhibitory and treatment of eye diseases), and because the specification fails to disclose a reasonable number of antibodies that are representative of the full genus of such required antibodies, one skilled in the art cannot visualize the specific inhibitory anti-sortilin antibody or an antigen binding fragment structure which therapeutically treats eye diseases like diabetic retinopathy through an inhibitory effect that involve the retina, choroid or optic nerve. Further, the limitation of an inhibitory anti-sortilin antibody or an antigen binding fragment thereof reads any antibody that binds any epitope in sortilin protein as in SEQ ID NOs: 1-12 and TGL, as disclosed in the instant claims 45-46 which further fails the written description requirement.
In this case, antibodies without any specific structure are not correlated with the binding function of the antibody. The hyper variable regions (HVRs), i.e., complementarity determining regions (CDRs) of an antibody, are well established in the art as the portion of the binding region which imparts the specificity of an antibody. However, there is no way to a priori look at an antigen sequence or the general target protein and envisage or describe the structural combination of six CDRs that will bind that antigen/general target protein or what antibody will specifically meet all functional limitations of the instant claims. First, even highly related CDRs may not bind the same target. See for example Kussie et al., 1994 (5/5/2025 PTO-892) who demonstrates that a single amino acid change in the heavy chain of an antibody which binds p-axophenylarsonate (Ars) completely abrogates the ability of the antibody to bind Ars but adds the functionality of binding the structurally related p-azophenylsulfonate (e.g., abstract). Second, even when provided with several related antibodies that bind the desired target, this does not represent the astronomical and potentially unknowable breadth of all possible amino acid sequences which will result in the desired binding properties. This is exemplified by the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (p.7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor’s antibodies which bound the same target but shared only 50% sequence similarity (see table on page 11 of Abbvie decision).
Thus, the art recognizes that the CDRs define the binding properties of an antibody and that even single amino acid changes to this region can completely abrogate or alter the binding specificity of an antibody. As a further example, see Chen et al., 1995 (5/5/2025 PTO-892) which demonstrates single amino acid changes in the VH CDR2 sequence can increase binding, decrease binding, destroy binding, or have no effect on binding when compared to the wild-type antibody. Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions. As the specification does not provide sufficient guidance to the skilled artisan to allow such a reasonable expectation of success, it would require undue experimentation on the part of the skilled artisan to make and test each combination of CDRs and mutations to determine for themselves which antibodies meet the claim limitations.
The specification discloses one specific antibody, goat polyclonal anti-sortilin antibody (aka AF2934) in their example 3 (see page 21) and nonspecific sortilin antibodies in their example 5 (see page 25) and points to different antibody companies as possible sources of antibodies for the anti-sortilin antibody (see page 26 of the instant specification). As discussed above, without any way to determine how broad the genus of such antibodies are, there is no way to determine if these antibodies represent the full breadth of what is claimed. The disclosure of specific antibodies would not convey to the artisan that Applicant was in possession of the full genus of all antibodies which possess the required functions. The instant specification calls for screening methods to determine the best inhibitory sortilin antibodies but fails to teach which are the appropriate set of antibodies and only claims a generic genus that may be capable of performing the required function (see pages 25 and 26). As discussed above, one cannot predict how the binding affinity and antibodies may compete while not binding any common residues, such as through steric hindrance when binding spatially proximate epitopes of a protein. The specification does not convey possession of such antibodies nor does it allow the skilled artisan to envisage the specific structure of such antibodies. As above, arbitrarily altering any amino acid in the CDR of an antibody is unpredictable and the specification does not convey possession of any CDRs other than those of the disclosed antibodies. Further, it is well-known in the art that specificity of an antibody stems from the interaction of at least three (in the case of single-domain antibodies) and usually six (for single-chain and full antibodies) CDRs.
Further note the decision in Amgen v. Sanofi 2017, where the Court supported previous decisions (Centocor 2011; Abbvie 2014) that defining an antibody solely by what it binds does not satisfy the written description requirement, stating that this would allow patentees to “claim antibodies by describing something that is not the invention, i.e., the antigen”.
With respect to method claims, it is recognized that information which is well known in the art need not be described in detail in the specification (MPEP §2163(II)(A)(2)). See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. MPEP §2163(II)(A)(3)(a) also discusses Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004), where a method of using a PGHS-2 inhibitor did not meet the written description as the inhibitor itself was not sufficiently described, clearly indicating that written description of the compound is still required in a method of using that compound. In this case, it is clear from the specification that the invention is in a new antibody, or at the least disclosure of a new antibody that could not have been envisaged from the prior art indicates that the prior art was not in possession of all “therapeutic inhibitory anti-sortilin antibodies”. Thus, the prior art cannot provide sufficient written description of this genus of compounds and the specification as filed, disclosing one antibody, does not sufficiently describe the genus either as there is an unknown amount of structurally distinct antibodies in this genus (see Amgen and Centocor decisions discussed above).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Vas-Cath, Inc., v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. An antibody described only by functional characteristic, such as an inhibitory antibody that binds sortilin, without any known or disclosed correlation between that function and the structure of the sequence, is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest. In re Bell, 991 F.2d 781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993). In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995). In the instant case, the specification provides insufficient direction or guidance concerning the relationship between the structure of the possible antibody and its capability of binding sortilin and treating diabetic retinopathy to demonstrate possession of the breadth of the genus of anti-sortilin antibody or an antigen binding fragment thereof encompassed by the instant claims, especially in view of the unpredictability of such an endeavor. The prior art as evidenced by Edwards et al., 2003 (5/5/2025 PTO-892) teaches there is a substantially huge antibody diversity produced to one single antigen target. Edwards provides evidence that over 1000 antibodies, all different amino acid sequences, were generated towards one single protein antigen target (see abstract). Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Without this guidance or direction the skilled artisan would not consider applicant to be in possession of the claimed genus of antibodies because the skilled artisan recognizes that even seemingly minor changes made without guidance or direction as to the relationship between the particular amino acid sequence of the instantly claimed antibody and its ability to bind antigen, can dramatically affect antigen-antibody binding.
Applicant has not described the claimed invention sufficiently to show they had possession of the claimed genus of an anti-sortilin antibody or an antigen binding fragment thereof. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004).
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.
To provide adequate written description and evidence of possession of the claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factors present in the claims are a recitation of one generic, broad genus that encompassed a diverse and huge number of possible antibodies that bind the disclosed epitopes. The specification does not provide a consistent structure for all of the possible antibodies and fails to provide a representative number of species for the claimed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that they invented what is claimed.” (See Vas-Cath at page 1116).
With the exception of specifically disclosed antibodies, the skilled artisan cannot envision the detailed chemical structure of all of the encompassed the therapeutic antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Therefore, claims 37, 4-50 and 54-58 do not meet the written description requirement.
Response to Arguments
Applicant's arguments filed 8/4/2025 have been fully considered but they are not persuasive. Applicant argues that the newly amended claims that now specifically require the treatment of diabetic retinopathy by administering inhibitory anti-sortilin antibodies and that one of ordinary skill in the art would recognize that anti-sortilin antibodies are well known in the prior art. Applicant argues that one of ordinary skill in the art could readily obtain anti-sortilin antibodies from these commercial sources since their example 6 in the instant speciation describes how to screen for inhibitory anti-sortilin antibodies. Applicant argues that they do not have to disclose all antibodies to meet the written description since they are not claiming a new antibody and there is enough antibodies to screen for in the prior art and commercial resources. This is not found persuasive because the instant claims are not just towards a product genus of inhibitory anti-sortilin antibodies but rather for a method that requires a specific effect, a therapeutic effect, and therefore claiming a generic inhibitory anti-sortilin antibody is not sufficient to show that the applicant actually is in possession of the required antibodies that are needed to produce the required effective, therapeutic treatment in a specific patient population of diabetic retinopathy. This is merely a plan to screen for the required inhibitory anti-sortilin antibody. The specification discloses one specific antibody, goat polyclonal anti-sortilin antibody (aka AF2934) in their example 3 (see page 21) and nonspecific sortilin antibodies in their example 5 (see page 25) and points to different antibody companies as possible sources of antibodies for the anti-sortilin antibody (see page 26 of the instant specification). As discussed above, without any way to determine how broad the genus of such antibodies are, there is no way to determine if these antibodies represent the full breadth of what is claimed and capable of producing the required effect. The disclosure of specific antibodies would not convey to the artisan that Applicant was in possession of the full genus of all antibodies which possess the required functions to be able to achieve the required method treatment.
New Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 37, 40-41, 45-48, 54, 56-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petersen et al., US2011/0160439 (instant PTO-892).
Petersen teaches treating humans with medicaments comprising inhibitors of sortilin induced apoptosis (see paragraphs [0304-0306]) and reads on instant claims 37 and 54. Petersen teaches that the diseases and disorder involving retina to be treated include diabetic retinopathy, macular degeneration and glaucoma (see paragraph [0320]) and reads on instant claim 37. Petersen teaches that their antibodies bind SEQ ID NO: 1 and binding site 3 of SEQ ID NO: 1 and inhibits ligand binding or targets receptors (see paragraphs [0401-407] and claim 172) and reads on instant claims 37 and 45-46 since Petersen’s SEQ ID NO: 1 is the same as instant SEQ ID NO:1 which is a human sortilin protein. Petersen teaches that the antibody includes polyclonal, monoclonal, a humanized antibody and single chain antibodies (see paragraphs [0417-418], [0514] and claims 173 and 175) and reads on instant claims 40-41 and 47-48. Petersen teaches routes of administration that include administration to the eye and topical administration (see paragraphs [0325-326]), drops (see paragraphs [0333], [0344]) and a gel (see paragraphs [0335], [0346]) and reads on instant claims 56-58.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 37, 40-50 and 54-58 are rejected under 35 U.S.C. 103 as being unpatentable over Petersen et al., US2011/0160439 (instant PTO-892) are as applied to claims 37, 40-41, 45-48, 54, 56-58 above, and further in view of Rosenthal et al., WO2016/164637 (IDS) and Yamada et al., 2016 (5/5/2025 PTO-892).
See Petersen as discussed above. Petersen teaches treating diabetic retinopathy with inhibitory anti-sortilin antibodies but fails to teach the cell-penetrating peptide of claims 49-50 and intravitreal administration of instant claim 55.
Rosenthal teaches methods of treating individuals in need thereof with compositions that include antibodies that are monoclonal, chimeric, humanized antibodies and antibody fragments that bind one or more epitopes within a sortilin protein (see abstract and paragraphs 15-16) as in instant claims 37, 41, 45 and 47-48. Rosenthal teaches using anti-sortilin antibodies to treat individuals with retinal dystrophy, age-related macular degeneration, retinitis pigmentosa, retinal degeneration and glaucoma (see paragraphs 10, 13 and 420) which is the same field of endeavor, retinal disease. Rosenthal teaches that the anti-sortilin antibodies are human antibodies, humanized antibodies, monoclonal antibodies and conjugated antibodies (see paragraph 16) as in instant claims 41-42, 48-49. Rosenthal teaches that the cell penetrating conjugate includes TAT (see bottom of paragraph 16) as in instant claims 49-50. Rosenthal teaches that the antibody fragments include , Fab, Fab’, Fab’-SH, F(ab’)2, Fv and scFv (see bottom of paragraph 16) as in instant claim 47. Rosenthal teaches that the anti-sortilin antibody has an IgG isotype that can be human or mouse (see paragraphs 31, 38) as in instant claims 42 and 44. Rosenthal teaches that anti-sortilin antibodies include goat polyclonal antibodies (see paragraph 53) as in instant claims 40 and 43. Rosenthal teaches that the anti-sortilin antibodies have epitopes that have 5-30 or more amino acid residues from the sortilin protein of their SEQ ID NO: 1 which is the same sequence as the instant SEQ ID NO: 1 of instants claim 45-46 (see paragraphs 37 and 128) since the SEQ ID NO: teaches at least one amino acid of the TGL peptide. Rosenthal teaches that the individual includes mammals and humans (see paragraph 79) as in instant claim 54. Rosenthal teaches formulations for therapeutic administrations comprising antibodies to include ointments, solutions, injections and gels (see paragraph 351) and meets the gel requirement of instant claim 58.
While Rosenthal teaches different administration routes, Rosenthal fails to specifically teach intravitreal injections, eye drops and topical administration to the eye as required in instant claims 55-57 and fails to specifically teach treating diabetic retinopathy as now required in instant claim 37.
Yamada teaches that there are multiple routes of administration of therapies to the eye and retina that include topical administration that include topical drug delivery, eyedrops and intravitreal delivery (see abstract and page 72, bottom of 2nd column; page 73, Figure 1; page 74, 2nd column; page 78, 1st column) to treat diseases like age-related macular degeneration (AMD; see page 73, 2nd column page 74, 2nd column) as in instant claims 55-57. Yamada teaches using antibodies in these types of eye treatment routes but fails to specifically teach anti-sortilin antibodies.
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of Petersen, Rosenthal and Yamada. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because Petersen and Rosenthal teach using the inhibitory anti-sortilin antibodies to treat eye diseases including diabetic retinopathy and one of ordinary skill would use the known and accepted routes of administration as taught by Yamada to administer the antibody treatment to the eye and retina with a reasonable expectation of success. The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Response to Arguments
Applicant's arguments filed 8/4/2025 have been fully considered but they are not persuasive in view of the new primary reference Petersen et al., US2011/0160439 (instant PTO-892). The new reference, Petersen, either anticipated or obviates all of the required limitations. As discussed above, Petersen makes up for the deficiencies of both Rosenthal not teaching the patient population as diabetic retinopathy patients and Yamada’s failure to teach the instantly claimed inhibitory anti-sortilin antibodies. The combination of all three references, as set forth above in the new 103 obvious rejection, make the instant claims obvious. Therefore, all instant claims are still considered obvious and are rejected over the prior art of record.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675