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 .
Response to Amendment
Applicant’s amendments filed on 10/02/2025 has been fully considered. Claims 52, 55, 57-63, 65, 68-69, and 71-77 are pending in this application. Claims 52, 63, and 71 are amended. Claim 73-77 are newly added. Claims 1-51, 53-54, 56, 64, 66-67, and 70 are cancelled.
Response to Arguments
Applicant’s arguments with respect to amended claim 52 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 77 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 77 recites the limitation “an internal bore extending from the proximal open end" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. In an effort compact prosecution, the limitation is interpreted as “an internal bore having a proximal open end”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 52, 55, 57-63, and 75-76 are rejected under 35 U.S.C. 103 as being unpatentable over Carpenter (Publication No. US 2011/0087174 A1) in view of Graham (Patent No. US 5,484,070 A) and Utterberg (Patent No. US 5,071,413 A).
Regarding claim 52, Carpenter teaches an adapter for injecting a volume of irrigation fluid into a nasal passage (cap 2 dispenses fluid into the nose for irrigation; Paragraph 0029; Figure 2-3), the adapter comprising:
an outer wall configured to form a liquid seal with a nostril (cap 2 has an outer wall that fits sealingly against the user’s nostril; Paragraph 0030; Figure 2-3);
a fluid transfer channel defining an inner wall within the outer wall (nipple extension 8 is defined by an inner wall within outer wall of cap 2; Paragraph 0031; Figure 2-3), the fluid transfer channel terminated at its distal end by a discharge port which extends through the outer wall (nipple extension 8 terminates at the distal end at the nipple orifice 7; Figure 2-3; Paragraph 0031);
a female coupler (opposing end of nipple extension 8 that connects to tube 3 is the female coupler; Figure 2-3; Paragraph 0031); and
an inner hollow between the outer wall and the fluid transfer channel (inner hollow is between the outer wall of cap 2 and the nipple extension 8; Figure 2-3; Paragraph 0031);
wherein:
a proximal end of the outer wall extends proximally beyond a proximal end of the female coupler (proximal end of outer wall of cap 2 extends proximally past the proximal end of the proximal end of the nipple extension 8 that connects to the tube 3; Figure 2-3; Paragraph 0031).
Carpenter does not teach the adapter for injecting a volume of irrigation fluid from a syringe, the female coupler comprising a frustoconical interior bore extending at least 7.5 mm from a coupler opening in a 6% narrowing taper, the coupler opening having a diameter in a range from 4.270 mm to 4.315 mm; and the outer wall is configured to avoid interference with a collar of a standard male luer lock connector attached to the coupler; and an external surface of the coupler comprises a lug or an external helical thread.
However, Graham teaches the adapter for injecting a volume of irrigation fluid from a syringe (Figure 7), and the outer wall is configured to avoid interference with a collar of a standard male luer lock connector attached to the coupler (closure has an annular side wall 44 of Figure 7 is configured to avoid interference of the collar of a male luer-lock when attached to the coupler of Figure 7; Column 6, lines 25-39 and Column 6, line 65 to Column 7, line 9); and an external surface of the coupler comprises a lug or an external helical thread (Figure 7; coupler has flange/lug on the external surface to connect to a luer-lock; Column 4, lines 43-55 and Column 6, line 65 to Column 7, line 9).
Carpenter and Graham are considered to be analogous to the claimed invention because they are in the field of fluid dispensing devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carpenter to incorporate the teachings of Graham and have the device of Carpenter to have the female coupler of Graham with the outer wall of Carpenter sized to avoid the collar of a luer lock connector, as taught by Graham. This allows for the fitting of the closure when not in use and the fitting of the coupler with the luer lock syringe when in use (Graham; Column 6, line 65 to Column 7, line 18).
The combination of Carpenter in view of Graham does not teach the female coupler comprising a frustoconical interior bore extending at least 7.5 mm from a coupler opening in a 6% narrowing taper, the coupler opening having a diameter in a range from 4.270 mm to 4.315 mm.
However, Utterberg teaches that a universal luer connection (connector that is able to connect with female luer connectors; Abstract) comprises a frustoconical interior bore extending at least 7.5 mm from a coupler opening in a 6% narrowing taper, the coupler opening having a diameter in a range from 4.270 mm to 4.315 mm (Column 3, line 45 to Column 4, line 2). Additionally, Carpenter teaches that the diameter of the proximal end of the nipple extension may be between 2 to 7 mm (Paragraph 0033).
Carpenter in view of Graham and Utterberg are considered to be analogous to the claimed invention because they are in the field of medical fluid connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carpenter in view of Graham to incorporate the teachings of Utterberg and have the device of Carpenter in view of Graham to have the attachment mechanism/coupler of Carpenter in view of Graham to be dimensioned, as taught by Utterberg. This allows for the connector to connect with a large number of female luer connections so that the connector can be conveniently used with a variety of different medical components (Utterberg; Column 1, lines 53-66).
Regarding claim 55, Carpenter in view of Graham and Utterberg teaches the adapter of claim 52. The combination of Carpenter in view of Graham and Utterberg further teaches wherein the coupler is configured to removably connect to each of a luer-Lock connector and a luer-slip connector (Graham; coupler is designed to fit to a standard syringe tip, luer-lock or non-luer lock; Column 4, lines 43-67; Utterberg; connector sized to fit a variety of luer-shaped components; Column 1, lines 53-66; see rejection of claim 52 above).
Regarding claim 57, Carpenter in view of Graham and Utterberg teaches the adapter of claim 52. Carpenter further teaches wherein the outer wall comprises a tapered geometry wherein a distal portion of the outer wall being narrower than a proximal portion (distal portion of cap 2 is narrower than proximal portion of cap 2 to form tapered geometry; Figure 2-3).
Regarding claim 58, Carpenter in view of Graham and Utterberg teaches the adapter of claim 52. Carpenter further teaches wherein the outer wall comprises a rounded bulb and a frustoconical base (cap 2 has shape with top rounded bulb and frustoconical base; Figure 2-3) .
Regarding claim 59, Carpenter in view of Graham and Utterberg teaches the adapter of claim 52. Carpenter further teaches wherein the outer wall, the fluid transfer channel, and the coupler are each coaxial (outer wall of cap 2, nipple extension 8, and proximal end of nipple extension 8 are coaxial; Figure 2-3).
Regarding claim 60, Carpenter in view of Graham and Utterberg teaches the adapter of claim 52. Carpenter further teaches wherein the inner wall defined by the fluid transfer channel is cylindrical (inner wall of nipple extension 8 is cylindrical; Figure 2-3).
Regarding claim 61, Carpenter in view of Graham and Utterberg teaches the adapter of claim 52. Carpenter further teaches wherein the outer wall and the inner wall of the fluid transport channel are integrally formed from a single constituent material (outer wall of cap 2 and nipple extension is made of a singular material/one-piece; Figure 2-3).
Further, making the outer wall and the inner wall of the fluid transport channel integral is an obvious matter of engineering design choice well within the ordinary skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.").
Regarding claim 62, Carpenter in view of Graham and Utterberg teaches the adapter of claim 52. Carpenter further teaches wherein the discharge port has a diameter of 0.5 mm or greater (nipple orifice 7 can be 2 to 7 mm in diameter; Paragraph 0033; Figure 3).
Regarding claim 63, Carpenter teaches a positive pressure nasal irrigation system comprising (Figure 2-3):
an adapter (cap 2 dispenses fluid into the nose for irrigation; Paragraph 0029; Figure 2-3) comprising:
an outer wall configured to form a liquid seal with a nostril (cap 2 has an outer wall that fits sealingly against the user’s nostril; Paragraph 0030; Figure 2-3);
a fluid transfer channel defining an inner wall within the outer wall (nipple extension 8 is defined by an inner wall within outer wall of cap 2; Paragraph 0031; Figure 2-3), the fluid transfer channel terminated at its distal end by a discharge port which extends through the outer wall (nipple extension 8 terminates at the distal end at the nipple orifice 7; Figure 2-3; Paragraph 0031); and
an inner hollow between the outer wall and the fluid transfer channel (inner hollow is between the outer wall of cap 2 and the nipple extension 8; Figure 2-3; Paragraph 0031). Carpenter does not teach a plunger syringe comprising a male luer-lock connector and the female coupler comprising a frustoconical interior bore extending at least 7.5 mm from a coupler opening in a 6% narrowing taper, the coupler opening having a diameter in a range from 4.270 mm to 4.315 mm; wherein: the outer wall is configured to avoid interference with a collar of the male luer-lock connector; and an external surface of the female coupler comprises a lug or an external helical thread.
However, Graham teaches a plunger syringe comprising a male luer-lock connector (Column 6, lines 25-39 and Column 6, line 65 to Column 7, line 9), and the outer wall is configured to avoid interference with a collar of a standard male luer lock connector attached to the coupler (closure has an annular side wall 44 of Figure 7 is configured to avoid interference of the collar of a male luer-lok syringe when attached to the coupler of Figure 7; Column 6, lines 25-39 and Column 6, line 65 to Column 7, line 9); and an external surface of the coupler comprises a lug or an external helical thread (Figure 7; coupler has flange/lug on the external surface to connect to a luer-lok; Column 4, lines 43-55 and Column 6, line 65 to Column 7, line 9).
Carpenter and Graham are considered to be analogous to the claimed invention because they are in the field of fluid dispensing devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carpenter to incorporate the teachings of Graham and have the device of Carpenter to have the female coupler of Graham with the outer wall of Carpenter sized to avoid the collar of a luer lock connector, as taught by Graham. This allows for the fitting of the closure when not in use and the fitting of the coupler with the luer lock syringe when in use (Graham; Column 6, line 65 to Column 7, line 18).
The combination of Carpenter in view of Graham does not teach the female coupler comprising a frustoconical interior bore extending at least 7.5 mm from a coupler opening in a 6% narrowing taper, the coupler opening having a diameter in a range from 4.270 mm to 4.315 mm.
However, Utterberg teaches that a universal luer connection (connector that is able to connect with female luer connectors; Abstract) comprises a frustoconical interior bore extending at least 7.5 mm from a coupler opening in a 6% narrowing taper, the coupler opening having a diameter in a range from 4.270 mm to 4.315 mm (Column 3, line 45 to Column 4, line 2). Additionally, Carpenter teaches that the diameter of the proximal end of the nipple extension may be between 2 to 7 mm (Paragraph 0033).
Carpenter in view of Graham and Utterberg are considered to be analogous to the claimed invention because they are in the field of medical fluid connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carpenter in view of Graham to incorporate the teachings of Utterberg and have the device of Carpenter in view of Graham to have the attachment mechanism/coupler of Carpenter in view of Graham to be dimensioned, as taught by Utterberg. This allows for the connector to connect with a large number of female luer connections so that the connector can be conveniently used with a variety of different medical components (Utterberg; Column 1, lines 53-66).
Regarding claim 75, Carpenter in view of Graham and Utterberg teaches the adapter of claim 52. Carpenter further teaches wherein the fluid transfer channel comprises an internal bore having a proximal open end, the internal bore terminated at its distal end by a discharge port which extends through the outer wall (nipple extension 8 terminates at the distal end at the space/internal bore having a proximal open end and a distal end that is adjacent to the nipple orifice 7; Figure 2-3; Paragraph 0031). A “bore” is interpreted to be a channel or a space within a lumen/conduit.
Regarding claim 76, Carpenter in view of Graham and Utterberg teaches the adapter of claim 75. Carpenter further teaches wherein the fluid transfer channel consists of the open internal bore having a proximal open end, and terminated at its distal end by the discharge port which extends through the outer wall (nipple extension 8 terminates at the distal end at the space/internal bore having a proximal open end and a distal end that is adjacent to the nipple orifice 7; Figure 2-3; Paragraph 0031).
Claim(s) 65 and 68-69 are rejected under 35 U.S.C. 103 as being unpatentable over Carpenter (Publication No. US 2011/0087174 A1) in view of Graham (Patent No. US 5,484,070 A), and Utterberg (Patent No. US 5,071,413 A), as applied to claim 63 above, and further in view of Martin (Patent No. US 5,788,683 A).
Regarding claim 65, Carpenter in view of Graham and Utterberg teaches the system of claim 63. The combination of Carpenter in view of Graham and Utterberg does not teach wherein the plunger syringe has a volume of at least 15 mL (about 50 mL of saline; Column 5, lines 40-46).
Martin and Carpenter in view of Graham and Utterberg are both considered to be analogous to the claimed invention because they are in the field of fluid delivery systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carpenter in view of Graham and Utterberg to incorporate the teachings of Martin and have the plunger syringe of Carpenter in view of Graham and Utterberg be a volume of at least 15 mL, as taught by Martin. This allows for the device to irrigate the first nostril and obtain the mucopurulence from the second nostril (Martin; Column 5, lines 31-60).
Regarding claim 68, Carpenter in view of Graham and Utterberg teaches the system of claim 63. The combination of Carpenter in view of Graham and Utterberg does not teach wherein the plunger syringe is pre-filled with a sterile saline solution.
However, Martin teaches wherein the irrigation fluid source is prefilled with a sterile saline solution (Abstract; Column 5, lines 41-60).
Martin and Carpenter in view of Graham and Utterberg are both considered to be analogous to the claimed invention because they are in the field of fluid delivery systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carpenter in view of Graham and Utterberg to incorporate the teachings of Martin and have the plunger syringe of Carpenter in view of Graham and Utterberg be pre-filled with a sterile saline solution, as taught by Martin. This allows for the device to irrigate the nasal cavity of the patient while insuring a sterile environment for the patient during treatment (Martin; Column 5, lines 41-60).
Regarding claim 69, Carpenter in view of Graham and Utterberg teaches the system of claim 63. The combination of Carpenter in view of Graham and Utterberg further teaches a method of flushing a nasal passage with an irrigation fluid (Abstract), the method comprising: a) applying the device to a first nostril (Carpenter; Paragraph 0048).
However, Martin teaches b) compressing the nasal irrigation system so that at least 15 mL of the irrigation fluid floods the first nostril of the patient, and fills the nasal passage (apply device by pressing syringe to nostril and irrigate the first nostril with at least about 50 mL; Column 5, lines 41-49); and c) applying a continual force to the nasal irrigation system such that at least 15 mL of irrigation fluid flows out through a second nostril (simultaneously apply force with saline to collect fluid from second nostril; Column 5, lines 41-49).
Martin and Carpenter in view of Graham and Utterberg are both considered to be analogous to the claimed invention because they are in the field of nasal irrigation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carpenter in view of Graham and Utterberg to incorporate the teachings of Martin and have at least 15 mL of irrigation fluid flood the first nostril and apply continual force to the nasal irrigation system to have at least 15 mL flows out through a second nostril. This allows for the device to irrigate the first nostril and obtain the mucopurulence from the second nostril (Martin; Column 5, lines 31-60).
Claim(s) 71, 73-74, and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Carpenter (Publication No. US 2011/0087174 A1) in view of Utterberg (Patent No. US 5,071,413 A).
Regarding claim 71, Carpenter teaches an adapter for injecting a volume of irrigation fluid from an irrigation fluid source into a nasal passage (cap 2 dispenses fluid into the nose for irrigation; Paragraph 0029; Figure 2-3), the adapter comprising:
an outer wall configured to form a liquid seal with a nostril (cap 2 has an outer wall that fits sealingly against the user’s nostril; Paragraph 0030; Figure 2-3);
a fluid transfer channel defining an inner wall within the outer wall (nipple extension 8 is defined by an inner wall within outer wall of cap 2; Paragraph 0031; Figure 2-3), the fluid transfer channel comprising an internal bore having a proximal open end terminated at its distal end by a discharge port which extends through the outer wall (nipple extension 8 terminates at the distal end at the space/internal bore having a proximal open end and a distal end that is adjacent to the nipple orifice 7; Figure 2-3; Paragraph 0031); and
a female coupler (opposing end of nipple extension 8 that connects to tube 3 is the female coupler; Figure 2-3; Paragraph 0031);
wherein the discharge port has a diameter in a range from 0.5 mm to 2.1 mm (nipple orifice 7 can be 2 to 7 mm in diameter; Paragraph 0033; Figure 3). Carpenter does not teach the female coupler comprising a frustoconical interior bore extending at least 7.5 mm from a coupler opening in a 6% narrowing taper, the coupler opening having a diameter in a range from 4.270 mm to 4.315 mm.
However, Utterberg teaches that a universal luer connection (connector that is able to connect with female luer connectors; Abstract) comprises a frustoconical interior bore extending at least 7.5 mm from a coupler opening in a 6% narrowing taper, the coupler opening having a diameter in a range from 4.270 mm to 4.315 mm (Column 3, line 45 to Column 4, line 2). Additionally, Carpenter teaches that the diameter of the proximal end of the nipple extension may be between 2 to 7 mm (Paragraph 0033).
Carpenter and Utterberg are considered to be analogous to the claimed invention because they are in the field of medical fluid connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carpenter in view of Graham to incorporate the teachings of Utterberg and have the device of Carpenter to have the attachment mechanism/coupler of Carpenter to be dimensioned, as taught by Utterberg. This allows for the connector to connect with a large number of female luer connections so that the connector can be conveniently used with a variety of different medical components (Utterberg; Column 1, lines 53-66).
Regarding claim 73, Carpenter in view of Utterberg teaches the adapter of claim 71. Carpenter further teaches further comprising an inner hollow between the outer wall and the fluid transfer channel (inner hollow is between the outer wall of cap 2 and the nipple extension 8; Figure 2-3; Paragraph 0031).
Regarding claim 74, Carpenter in view of Utterberg teaches the adapter of claim 71. Carpenter further teaches wherein a proximal end of the outer wall extends proximally beyond a proximal end of the female coupler (proximal end of outer wall of cap 2 extends proximally past the proximal end of the proximal end of the nipple extension 8 that connects to the tube 3; Figure 2-3; Paragraph 0031).
Regarding claim 77, Carpenter in view of Utterberg teaches the adapter of claim 71. Carpenter further teaches wherein the fluid transfer channel consists of an internal bore extending from the proximal open end, and terminated at its distal end by the discharge port which extends through the outer wall (nipple extension 8 terminates at the distal end at the space/internal bore having a proximal open end and a distal end that is adjacent to the nipple orifice 7; Figure 2-3; Paragraph 0031).
Claim(s) 72 is rejected under 35 U.S.C. 103 as being unpatentable over Carpenter (Publication No. US 2011/0087174 A1) in view of Utterberg (Patent No. US 5,071,413 A), as applied to claim 71 above, and further in view of Graham (Patent No. US 5,484,070 A).
Regarding claim 72, Carpenter in view of Utterberg teaches the adapter of claim 71. The combination of Carpenter in view of Utterberg does not teach wherein an external surface of the coupler comprises a lug or an external helical thread.
However, Graham teaches wherein an external surface of the coupler comprises a lug or an external helical thread (Figure 7; coupler has flange/lug on the external surface to connect to a luer-lok; Column 4, lines 43-55 and Column 6, line 65 to Column 7, line 9).
Carpenter and Graham are considered to be analogous to the claimed invention because they are in the field of fluid dispensing devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Carpenter to incorporate the teachings of Graham and have the device of Carpenter to have the female coupler of Graham. This allows for the fitting of the coupler with the luer lock syringe when in use (Graham; Column 6, line 65 to Column 7, line 18).
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781