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 .
Priority
Receipt is acknowledged of certified copies of KR10-2020-0040944. A translation of the certified copy together with a statement that the translation of the certified copy is accurate was submitted on July 14, 2026.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. KR10-2020-0040944, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. KR10-2020-0040944 does not disclose that the composition is administered within one day before performing the chemotherapy. Instead, KR10-2020-0040944 discloses that the composition is administered within one day after chemotherapy (e.g. claim 7).
The earliest effective filing date of the claims is April 2, 2021.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 1, 5-6, 12, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mayo et al. (NPL 3; IDS 5/10/2024) in view of Choi et al. (WO 2019/066586 A1, published 4 April 2019; English language equivalent US 2020/0262888 A1), Sung et al. (US 2017/0362293 A1), Giorgino et al. (US 2016/0067311 A1). This rejection is modified to reflect the amendment filed July 14, 2026.
Determining the scope and contents of the prior art.
Mayo et al. teach a method of preventing or treating cancer chemotherapy-induced mucositis in a subject in need thereof comprising administering a therapeutically effective amount of a GLP-2 derivative (Table 1). Mayo et al. teach that subjects are pre- and post-treated with a GLP-2 analogue (p. 237, col 2, para 2). Mayo et al. teach GLP-2 treatment results in an increase in whole body weight and in intestinal wet weight, and in a number of improved intestinal histological parameters including crypt depth, villous height, crypt cell proliferation and crypt cell apoptosis, when compared with saline (p. 237, col 2, para 2).
Ascertaining the differences between the prior art and the claims at issue.
Mayo et al. do not teach that the GLP-2 derivative is of Chemical Formula I or is linked to an immunoglobin Fc domain.
Resolving the level of ordinary skill in the pertinent art.
The substituted GLP-2 derivatives and their functions were known in the prior art. Choi et al. teach the use of GLP-2 analogues for the treatment of intestinal disease including mucositis (para [0067]). Specifically, Choi et al. teach the long-acting conjugate CA-GLP-2 RK-PEG(3.4K)-immunoglobulin Fc, in which the CA-GLP-2 RK is covalently linked to the immunoglobulin Fc by the PEG (Examples 2 and 6-7; Table 3). This derivative corresponds to claimed Chemical Formula 1 wherein X is the GLP-2 derivative, L is the PEG(3.4K), and F is the immunoglobulin Fc. Choi et al. also teach more generally that the molecular weight of the PEG can be 3.4 kDa to 10 kDa, preferably 3.4 kDa (para [0217]). The reduction to practice shows that the long-acting GLP-2 conjugate comprising 3.4 KDa PEG exhibits an AUC and half-life (para [0289], Table 4) and effect on intestinal weight (para [0292]; Figure 4) that is significantly increased compared to the control teduglutide.
Choi et al. teach that the GLP-2 derivative is an amino acid sequence selected from the group consisting of SEQ ID NOS: 2 to 8 (Table 1), which includes the GLP-2 derivative instant SEQ ID NO: 4.
Choi et al. teach that L is a PEG linker with a molecular weight of 3.4 kDa (Example 2).
Choi et al teach that F is an immunoglobulin Fc region of human IgG4, which is the same as instant SEQ ID NO: 32 (claim 12, para [0038], [0203]-[0204]).
The long-acting GLP-2 derivatives of Choi et al. meet the structural requirements of claim 1.
Choi et al. teach the GLP-2 derivative may be amidated (para [0206]), as required by instant claim 5.
Choi et al. teach that the Fc region is a dimer (para [0199]), as required by instant claim 16.
In addition, the use of other long-acting GLP-2 derivatives to treat chemotherapy-induced mucositis has been reported in the prior art. For example, Sung et al. teach that a structurally distinct, long-acting GLP-2-Fc conjugate can prevent diarrhea caused by irinotecan in a mouse model (Example 3-10). Sung et al. teach in para. [0154] and Figure 16 that the group treated with the GLP-2-Fc conjugate showed a decrease in diarrhea score compared to the untreated group. In addition, Giorgino et al. teach that the GLP-2 derivative elsiglutide was effective at preventing chemotherapy-induced diarrhea (CID) in clinical trials for patients with colorectal cancer receiving 5-FU based chemotherapy (Example 2). Giorgino et al. teach in para. [0017] that the occurrence of CID is prevented or its severity is reduced by elsiglutide and that the elsiglutide provides a protective effect against CID that extends long after the elsiglutide is administered. Giorgino et al. teach that the protective effects of the GLP-2 are not limited to 5-FU based chemotherapy and can be used to reduce toxicity of a wide range of different chemotherapeutic agents, prodrugs of such chemotherapeutic agents, and chemotherapy regimens including docetaxel and cyclophosphamide (para [0047]).
In addition, the use of GLP-2 derivatives for the pretreatment of a subject having mucositis caused by chemotherapy has been reported in the prior art. Drucker et al. teach that pretreatment with a GLP-2 receptor activator followed by chemotherapy “improved cell survival, reduces bacteremia, attenuated epithelial injury, and inhibits cellular apoptosis” (abstract). Drucker et al. teaches that the protective effects of the GLP-2 receptor activator regress within about once week following final dosing and that the chemotherapy should begin on the day following the pretreatment regimen, e.g. within about 8-36 hours, preferably within about 12-24 following pretreatment (p. 12, lines 15-29). Drucker et al. teach that this protocol is not limited to a single type of chemotherapy and specifically applies for cyclophosphamide (p. 13, lines 8-12).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to substitute the GLP-2 derivatives in the method of treating cancer chemotherapy-induced mucositis taught by Mayo et al. with the GLP-2 derivatives taught by Choi et al., to apply the regimen to a broad array of chemotherapy agents, including docetaxel and cyclophosphamide, as taught by Giorgino et al. and Drucker et al., and to use the GLP-2 as a pretreatment, as taught by Drucker et al. The rationale for obviousness is some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (MPEP § 2143.01(G)). The relevant findings for this rationale are as follows.
(1) There was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings.
Mayo et al. identify short in vivo half-life as a limitation for GLP-2 drugs (emphasis added, citations removed; p. 237, col. 1, para. 1):
Normal actions of GLP-2, which act on GLP-2 receptors that are specifically located in the GIT, include aiding nutrient absorption via altering expression and activity of nutrient transporters, reducing GIT motility and intestinal epithelial permeability. These are vital actions of the peptide. Interestingly, however, GLP-2 is also known to stimulate crypt cell proliferation, increasing mucosal epithelium thickness in both the small and large intestines, whilst inducing anti-apoptotic pathways and increasing blood flow to select areas of the GIT. Naturally occurring GLP-2 is rapid acting and has a short half- life of only 7 min before degradation and metabolism. The metabolism of GLP-2 occurs via the enzyme dipeptidyl peptidase-IV (DPP-IV), which truncates the protein to its biologically inactive form by degradation from the N-terminus at the alanine in position 2. DPP-IV is abundant in the intestinal mucosa, potentially affecting the function of GLP- 2 before it enters circulation. The function of DPP-IV is very specific, and any changes to the N-terminus amino acids will alter the activity of DPP-IV and increase time before degradation and metabolism of this regulatory peptide. Research demonstrating the role of DPP-IV has shown that a deficiency of this enzyme in rats caused an increase in biologically active GLP-2 and an increased bowel weight.
Therefore, the primary reference Mayo et al. establishes that short in vivo half-life is a problem associated with the use of GLP-2 to treat gastrointestinal mucositis caused by cancer chemotherapy.
Choi et al. also teach that short in vivo half-life is a problem with GLP-2 as drug:
[0004] However, GLP-2 still has limitations in being developed into a commercial drug. Peptides such as GLP-2 can be easily denatured due to low stability, loses activity due to degradation by protease in the body, and are easily removed through the kidney due to their relatively small size. Therefore, in order to maintain optimal blood concentrations and titers of peptide drugs, there is a need to administer the peptide drug more frequently. However, most peptide drugs are administered in various types of injections, and frequent injections are required to maintain the blood concentration of the peptide drug, which causes severe pain in patients. In this regard, there have been many attempts to solve these problems, one of which has developed a method of increasing membrane permeability of a peptide drug, leading to the delivery of the peptide drug to the body by inhalation through an oral or a nasal. However, this method has a limitation of a low delivery efficiency of the peptide drug as compared with the injection thereof, and thus it still remains difficult to retain sufficient biological activity of the peptide drug for therapeutic use.
[0005] In particular, GLP-2 has extremely short in vivo half-life (7 minutes or shorter) due to its inactivation by dipeptidyl peptidase-IV (DPP IV) which cleaves between the amino acids at position 2 (Ala) and position 3 (Asp) of GLP-2
Choi et al. developed a solution to this problem, the conjugation of GLP-2 peptides to immunoglobulin Fc regions via PEG linkers. Choi et al. report the following advantageous effects of the long-acting GLP-2 conjugates:
[0073] Since the GLP-2 derivative and long-acting conjugate thereof of the present invention have a significantly high activity and a superior in vivo duration effect, these can be effectively used for the prevention, amelioration, and treatment of intestinal disease, intestinal injury, and gastrosia.
Here Choi et al. explicitly motivate one of ordinary skill in the art to use the long-acting conjugates in place of standard GLP-2 therapies for treating and preventing intestinal disease because doing so overcomes the art-recognized problem of short in vivo half-life.
One of ordinary skill in the art would understand the problem identified by Mayo et al., short in in vivo half-life of GLP-2 in an otherwise promising therapy for cancer chemotherapy-induced gastrointestinal mucositis based on the express teaching in that reference. One of ordinary skill in the art would recognize that Choi et al. provides a solution to the problem of short in in vivo half-life of GLP-2, based on the express teaching and evidence in that reference. One of ordinary skill in the art would be motivated to combine the references in order to use a solution in the prior art of Choi et al. to solve a problem identified in the prior art of Mayo et al.
One of ordinary skill in the art would not limit the solution to the types of chemotherapy taught by Mayo et al. but rather would understand in view of Giorgino et al. and Drucker et al. that GLP-2 derivatives can protect against mucositis caused by a wide variety of agents, including docetaxel and cyclophosphamide. One of ordinary skill in the art would be motivated to treat any patient experiencing chemotherapy-induced mucositis in order to improve treatment outcomes and compliance.
Finally, one of ordinary skill in the art would be motivated to use the GLP-2 as a pretreatment, as taught by Drucker et al., specifically within one day before performing the chemotherapy (p. 12, lines 15-29). One of ordinary skill in the art would be motivated by the teaching in Drucker et al. that pretreatment with a GLP-2 receptor activator followed by chemotherapy “improved cell survival, reduces bacteremia, attenuated epithelial injury, and inhibits cellular apoptosis” (abstract).
Therefore, there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings.
(2) There was reasonable expectation of success.
In addition to describing short in vivo half-life as a problem for treating cancer chemotherapy-induced gastrointestinal mucositis with GLP-2 peptides, Mayo et al. explicitly state that a long-acting GLP-2 derivative would improve treatment (p. 245, col. 1):
Analogues of GLP-2, which are longer-lasting and exert a potent effect on the GIT, are of particular interest, due to the likely benefits of potentially fast-tracking repair caused by chemotherapeutic agents like irinotecan.
This assertion is supported by Giorgino et al. which teaches that the long-acting GLP-2 derivative
elsiglutide was effective at preventing chemotherapy-induced diarrhea (CID) in clinical trials for patients with colorectal cancer receiving 5-FU based chemotherapy (Example 2). Giorgino et al. teach in para. [0017] that the occurrence of CID is prevented or its severity is reduced by elsiglutide and that the elsiglutide provides a protective effect against CID that extends long after the elsiglutide is administered.
In addition, Choi et al. provide evidence that the substitution would be beneficial. In Example 6, Choi et al. present a comparison between the GLP-2 conjugated to an Fc region and an unconjugated GLP-2 teduglutide. The data establish that both AUC and half-life of the long-acting conjugate of CA GLP-2 RK derivative were significantly increased compared to those of Teduglutide (¶ [0289], Figure 3, Table 4).
Therefore, one of ordinary skill in the art would predict that a long-acting GLP-2 of Choi et al. could be used to treat gastrointestinal mucositis caused by chemotherapy using anticancer drugs.
(3) Whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Example 3 demonstrates that a claimed GLP-2 conjugate administered prior to the chemotherapy caused significantly less weight loss of the small intestine in a mucositis model induced by chemotherapy and significantly greater weight gain of the small intestine during recovery compared to an unconjugated derivative taught in the prior art, teduglutide, and compared to simultaneous dosing.
MPEP § 716.02(c)(II) states: "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967)
In the instant case, the beneficial results evidenced in Example 3 of the specification are expected in view of the prior art.
First, Mayo et al. establish that GLP-2 derivatives with increased half-lives are expected to be effective at treating mucositis caused by chemotherapy (emphasis added, citations removed; p. 237, col. 1., para. 2 – col. 2, para. 1):
Following evidence that naturally occurring GLP-2 alters GI functions and can improve GI damage, pharmaceutical companies have begun to develop degradation- resistant forms of the peptide. Analogues of GLP-2 are being created with a change in amino acids at the N-terminus cleavage site to increase effect on the GI tract. These analogues, which increase the peptide biological function and half-life, have been suggested for use in improving diseases that severely damage the GI tract and alter its function. Teduglutide, a GLP-2 analogue which has an increased enzymatic degradation resistance of 2–3 h, has been implicated in improving a number of debilitating GI diseases, including short bowel syndrome (SBS), Crohn’s disease and ulcerative colitis, which are common inflammatory bowel diseases (IBDs) and share similar characteristics to GI mucositis.
The promising results of teduglutide and other GLP-2 analogues in these models of GI disease have sparked studies into their potential effects on GI mucositis. GLP-2 analogues, including teduglutide, have been used in models of chemotherapy-, targeted therapy- and radiotherapy-induced GI mucositis (Table 1). So far, studies have been examined rodent models with administered chemotherapeutic agents, targeted therapies or radiotherapy, which were also pre- and post-treated with a GLP- 2 analogue until animals were killed. These studies showed increased whole body weight, intestinal wet weight and a number of improved intestinal histological parameters including crypt depth, villous height, crypt cell proliferation and decreased crypt cell apoptosis, when compared with saline-treated rodents.
In summary, Mayo et al. teach that teduglutide was an early attempt to improve GLP-2 by increasing its half-life and that this GLP-2 analogue is effective in animal models of chemotherapy-, targeted therapy- and radiotherapy-induced GI mucositis.
Choi et al. provide a comparison to the teduglutide and demonstrate that the GLP-2 analogues conjugated to immunoglobulin Fc regions via PEG linkers have an improved in vivo half-life and an improved effect on intestinal weight in mice (¶ [0292], emphasis added):
As a result, in both Teduglutide and the long-acting conjugate of CA GLP-2 RK derivative, the weight of the small intestines was increased in a dose-dependent manner (FIG. 4(A)), and it could be derived that the increase of the weight of the small intestines is due to the increase in the length of the villi based on the fact that the increase of the intestinal weight is associated with the increase in the villi length (FIG. 4(B)). The high- dose administration group (15 nmol/kg/BID), which is known to exhibit the maximum efficacy of Teduglutide, was similar to the low-dose administration group (4.15 nmol/kg/Q2D) of the group administering the long-acting conjugate of the CA GLP-2 RK derivative, and it was confirmed that the long-acting conjugate of the CA GLP-2 RK derivative had an effect exceeding the maximum efficacy of Teduglutide in a dose- dependent manner. The result thereof is shown in FIG. 4(A) and FIG. 4(B).
Thus, the prior art of Choi et al. suggests that increasing in vivo half-life of GLP-2 leads to an increase in the therapeutic effect of the GLP-2. It follows then that the long-acting conjugates of Choi et al. would have an increase in therapeutic effect in the animal models of chemotherapy-, targeted therapy- and radiotherapy-induced GI mucositis taught by Mayo et al.
Finally, Drucker et al. emphasizes the use of GLP-2 derivates as a pretreatment (p. 12, lines 15-29).
The results shown in Example 3 are consistent with this prediction based on the prior art of Mayo et al., Choi et al., and Drucker et al. Therefore, the results in Example may be beneficial but they are expected beneficial results not unexpected beneficial results.
The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). Therefore, claims 1, 5, 16, and 19 are obvious over the cited art.
With respect to claim 6, Mayo et al. teach gastrointestinal mucositis (Table 1).
With respect to claim 12, Mayo et al. teach GLP2 treatment showed increased whole body weight, intestinal wet weight and a number of improved intestinal histological parameters including crypt depth, villous height, crypt cell proliferation and decreased crypt cell apoptosis, when compared with saline (p. 237, col 2, para 2).
Response to Arguments
Applicant's arguments filed July 14, 2026, have been fully considered but they are not persuasive.
(1) Choi et al. (WO 2019/066586 A1) was published 4 April 2019, which is more than one year prior to the earliest effective filing date of the instant claims, 2 April 2021. Therefore, Applicant’s statement of common ownership does not overcome the rejection. In addition, a declaration under 37 CFR 1.130(a) for attribution would not apply.
(A) The legal standard is acknowledged.
(2) (B) Applicant asserts that no reference teaches or suggests the 3.4 kDa PEG linker. This argument is not persuasive because Choi et al. teach and reduce to practice the 3.4 kDa PEG linker in Examples 2 and 6-7. See rejection above.
Applicant argues that the motivation in the rejection teaches away from the 3.4 kDa linker because the molecular weight 3.4 kDa being less than 10 kDa would be expected to have a shorter half-life. This argument is not persuasive because Choi et al. address this precise issue. Specifically, Choi et al. teach (para [0287]): “for the long-acting conjugate of CA GLP-2 RK (3.4K PEG) derivative, the half-life thereof was actually shortened due to the short PEG, but there was no significant difference in AUC. The result thereof is shown in FIG. 2 and Table 3.” In fact, Choi et al. selected the CA GLP-2 RK (3.4K PEG) derivative for further testing and show that the long-acting GLP-2 conjugate comprising 3.4 KDa PEG exhibits an AUC and half-life (para [0289], Table 4) and effect on intestinal weight (para [0292]; Figure 4) that is significantly increased compared to the control teduglutide.
(2)(C) Applicant asserts that no reference teaches or suggests mucositis induced by docetaxel and/or cyclophosphamide. This argument is not persuasive because Giorgino et al. teach that the protective effects of the GLP-2 are not limited to 5-FU based chemotherapy and can be used to reduce toxicity of a wide range of different chemotherapeutic agents, prodrugs of such chemotherapeutic agents, and chemotherapy regimens including docetaxel and cyclophosphamide (para [0047]). In addition, Drucker et al. teach that the use of GLP-2 as chemotherapy pretreatment is not limited to a single type of chemotherapy and specifically applies for cyclophosphamide (p. 13, lines 8-12).
(2)(D) Applicant assert that no applied references teach administration within one day before chemotherapy, and that timing was not recognized as a result-effective variable. This is not persuasive because of the teachings of Drucker et al. Drucker et al. teach that pretreatment with a GLP-2 receptor activator followed by chemotherapy “improved cell survival, reduces bacteremia, attenuated epithelial injury, and inhibits cellular apoptosis” (abstract). Drucker et al. teach that the protective effects of the GLP-2 receptor activator regress within about once week following final dosing and that the chemotherapy should begin on the day following the pretreatment regimen, e.g. within about 8-36 hours, preferably within about 12-24 following pretreatment (p. 12, lines 15-29).
(2)(E) Applicant asserts evidence of unexpected results. Applicant is correct that the amended claims are commensurate in scope with the evidence presented in the specification. However, the evidence presented is insufficient to overcome the rejection for two reasons. First, as explained above, the results are expected, not unexpected in view of the prior art. Second, the data does not fully support the assertion that prophylactic injection is more effective than concomitant injection. Figure 2(B) shows a significant difference between prophylactic injection and concomitant injection on days 1 and 2 but on day 3 there is no difference between the two groups. The burden is on Applicant to explain why this difference only on days 1 and 2 is of practical benefit.
For these reasons, the rejection is maintained.
The rejection of claims 1, 3-6, 8-12, and 15-19 under 35 U.S.C. 103 as being unpatentable over Sung et al. (US 2017/0362293 A1) in view of Choi et al. (WO 2019/066586 A1, published 4 April 2019; English language equivalent US 2020/0262888 A1) is withdrawn in view of the amendment filed July 14, 2026.
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 CHRISTINA M MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 8:30 am - 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINA M MARCHETTI BRADLEY/Primary Examiner, Art Unit 1654
Prosecution Insights