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
The Amendment filed March 03, 2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the Specification and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed December 05th, 2025. Examiner acknowledges applicant’s assertion that the claim language does not invoke 112(f) claim limitation found in claim 11 and 12 and examiner withdraws the claim objection.
Drawings
The replacement drawings were received on March 03, 2026. These drawings are accepted.
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 1rejected 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. Claim 1 has been amended to include the term “straight”. The term “straight” is not recited in the specification, and does not appear to be supported by the original disclosure. Claim 1 recites "straight" longitudinal struts, however amended drawing recites "the shading line of the longitudinal strut 111 is curved indicating that the ends are curved radially outward" therefore, it remains unclear the degree to which the strut is considered to be straight based on the originally filed disclosure.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, 8 and 10 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being unpatentable over US 5,827,321 (hereinafter, "Roubin et al.") .
Regarding claim 1, Roubin et al. discloses a stent frame (Fig. 3, stent, 40, col. 5, lines 24-28) comprising
a plurality of expandable structures (Fig 4a/b, left and right strut arm, 42 and 44 in combination with connecting member 48, col. 6 lines 3-5);
wherein each expandable structure comprises one or more straight longitudinal struts (Fig 4a/b, longitudinal components 42, 44 are straight, see also col. 6, line 3-5);
wherein the plurality of expandable structures are coupled together to from a stent ring (see below, annotated Figs 4A/B and Fig 6A/B see also, col. 5, lines 41-42, annular element);
wherein the stent ring comprises a first longitudinal length (see below, annotated Fig 4A, 6A, D2, D4) when in a radially compressed state (see below, annotated Fig 4B, 6B, stent in compressed state); and
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wherein the stent ring comprises a second longitudinal length (see below, annotated Fig 4A/B, D1, D3) equivalent to the first longitudinal length (Fig 6A/B, D3 is equal to D4, D1 is equal to D2, see also col. 6, lines 24-29) when in a radially expanded state (see below, annotated Fig 4A/6A, see annotated image, stent in expanded state).
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Regarding claim 2, Roubin et al. further discloses: wherein the first and second longitudinal lengths are equivalent to a length of the longitudinal strut (Fig. 6A/6B, stent, 40, see also col. 6, lines 25-29).
Regarding claim 3, Roubin et al. further discloses: wherein each of the plurality of expandable structures comprises:
the longitudinal strut comprising a first end (see below, annotated Fig 4A, E1) and a second end (see below, annotated Fig 4A, E2, see also col. 5, lines 43-44);
a first strut arm (see below, annotated Fig 4A, S1, left strut arm, 42) coupled to the first end of the longitudinal strut and extendable in a first direction (see below, annotated Fig 4A, L2) relative to the longitudinal strut;
a second strut arm (see below, annotated Fig 4A, S3, right strut arm, 44) coupled to the first end of the longitudinal strut and extendable in a second direction (see below, annotated Fig 4A, L3) opposite of the first direction relative to the longitudinal strut;
a third strut arm (see below, annotated Fig 4A, S2) coupled to the second end of the longitudinal strut and extendable in the first direction relative to the longitudinal strut (see below, annotated Fig 4A, see annotated image, L2); and
a fourth strut arm (see below, annotated Fig 4A, S4) coupled to the second end of the longitudinal strut and extendable in the second direction (see below, annotated Fig 4A, see annotated image, L3) relative to the longitudinal strut.
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Regarding claim 4, Roubin et al. further discloses:
wherein the first strut arm is coupled to the second strut arm of a first adjacent expandable structure (see above, annotated Fig 4A, S1 in combination with L2);
wherein the second strut arm is coupled to the first strut arm of a second adjacent expandable structure (see above, annotated Fig 4A, S3 in combination with L3);
wherein the third strut arm is coupled to the fourth strut arm of the first adjacent expandable structure (see above, annotated Fig 4A , S2 in combination with L2);
wherein the fourth strut arm is coupled to the third strut arm of the second adjacent expandable structure (see above, annotated Fig 4A, S4 in combination with L3).
Regarding claim 8, Roubin further discloses wherein the plurality of expandable structures comprise any one of a shape memory metal alloy, stainless steel, cobalt-chrome, or titanium (stent, struts and connecting members, 40, 42, 44, 48, col. 8, line 43-49).
Regarding claim 10, Roubin further discloses wherein each of the plurality of expandable structures is laser cut from a tubular blank (stent, 40, col 9, line 19-27).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 5- 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over US 5,827,321 (hereinafter, "Roubin et al.") in view of US 10,357,384 (hereinafter, “Lord et al.”) .
Regarding claim 5, Roubin et al. does not disclose the angular details of the strut arms.
Lord et al. teaches a stent (Fig. 1, stent, 100, col. 6 lines 14-19) discloses wherein each expandable structure.
Lord et al. discloses a radially expandable stent including a ring (Fig 1 and 5, stent, col. 7, lines 26-27) and strut arms (see below, annotated Fig. 6, strut arms T1, T2, T3, T4) and a longitudinal strut (see below, annotated Fig. 3, LS1):
wherein when the ring is in the radially expanded state, the first strut arm is disposed at angle ranging from zero degrees to 90 degrees (see below, annotated Fig 3, A1, see also col. 11, lines 21-29) relative to the longitudinal strut;
the second strut arm is disposed at angle ranging from zero degrees to 90 degrees (see below, annotated Fig 3, A2, see also col. 11, lines 21-29) relative to the longitudinal strut;
the third strut arm is disposed at angle ranging from zero degrees to 90 degrees (see below, annotated Fig 3, A3, see also col. 11, lines 21-29) relative to the longitudinal strut;
and the fourth strut arm is disposed at angle ranging from zero degrees to 90 (see below, annotated Fig 3, A4, see also col. 11, lines 21-29) relative to the longitudinal strut.
Therefore, before the effective filing date of the present invention it would have been obvious to a person of ordinary skill in the art to allow for angle variability, as taught by Lord et al. in the stent device disclosed by Roubin et al. since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
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Regarding claim 6, modified Roubin et al. does not disclose the details of the joints. Lord et al. further discloses:
wherein a first flexible joint (see below, annotated Fig. 1, B1, bending elements, 130; see also col. 7, lines 26-35) is disposed between the first strut arm and the second strut arm of the first adjacent expandable structure;
wherein a second flexible joint (see below, annotated Fig 1, B2, bending elements, 140; see also col. 7, lines 26-35) is disposed between the second strut arm and the first strut arm of the second adjacent expandable structure;
wherein a third flexible joint (see below, annotated Fig 1, B3, bending elements, 150; see also col. 7, lines 26-35) is disposed between the third strut arm and the fourth strut arm of the first adjacent expandable structure.
Lord et al. does not disclose that a fourth flexible joint is disposed between the fourth strut arm and the third strut arm of the second adjacent expandable structure. However, including a fourth joint would merely involve repeating the structure provided for the previous joints. Courts have found that where a modification merely combines prior art elements according to known methods to yield predictable results, there is support for a conclusion of obviousness. Before the effective filing date of the present invention, it would have been obvious to a person of ordinary skill in the art to modify the stent disclosed by Roubin et al. to include flexible joints between the strut arms, as taught by Lord et al., including up to four or more flexible joints, depending on the number of arms, since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
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Regarding claim 7, modified Roubin further discloses: wherein the first, second, third, and fourth flexible joints comprise an omega shape (see below, annotated Fig 9, spiral pattern, 47, see also col. 7, line 7-15).
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Regarding claim 9, modified Roubin et al. does not explicitly disclose the detail wherein one or more of the first end and the second end of the longitudinal strut is bent radially outward relative to a central portion of the longitudinal strut.
However, Lord et al. further teaches both outward and inward bends of the previously disclosed bending elements to allow for radial expansion (col. 7, lines 26-35). Therefore, before the effective filing date of the present invention, it would have been obvious to a person of ordinary skill in the art to modify the stent disclosed by Roubin et al. to include a radial bend as taught by Lord et al. to allow for radial compression/expansion to withstand anatomical delivery forces (col. 7 lines 30-38)
Claims 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 5,827,321 (hereinafter, "Roubin et al.") further in view of US 2021/0322189 (hereinafter “Schwartz et al.”).
Regarding claim 11, Roubin et al. discloses a stent comprising:
compromising a plurality of expandable structure coupled together (see below, annotated Fig 10, see also col. 3, line 1-10 );
wherein each expandable structure comprises one or more longitudinal struts (see below, annotated Fig 10, S1 see also col. 3, line 1-10).
Roubin does teach tubular coupling member (see comment) and change the rejection to cite to Roubin
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Modified Roubin et al. does not explicitly teach a plurality of discrete stent rings, wherein the plurality of the discrete stent rings are separate from each other. However, Schwartz et al. teaches a stent frame (Fig. 1, multi-element stent, 200, para 0056), wherein the stents are comprised of multiple, cylindrical stent segments, which are separate from one another (see below, annotated Fig. 2B, DSR 1-3, para 0051). Therefore, before the effective filing date of the present invention it would have been obvious to a person of ordinary skill in the art to modify the stent frame of Roubin et al. with the multiple stent frames of Schwartz et al. to yield a desired strength and provide flexibility of placement (para 0052).
Regarding claim 17, modified Roubin et al. does not disclose wherein the plurality of discrete stent rings are disposed along a length of the coupling member.
Schwartz et al. further teaches the plurality of discrete stent rings (see above, annotated Fig. 2B, DSR 1-3, para 0051) are disposed along a length of the tubular coupling member (Fig. 2A, inflatable balloon, 203, para 0056). Therefore, before the effective filing date of the present invention it would have been obvious to a person of ordinary skill in the art to modify the stent frame of Roubin et al. with the multiple stent frames and inflatable balloon of Schwartz et al. to provide device deployment while maintaining the ability to treat and maintain bends in skeletal motion (para 0056).
Claim(s) 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Roubin in view of Schwartz et al as applied to claim 11 above, and further in view of US 2021/0299415 ("Moffarah et al.")..
Regarding claim 12, modified Roubin et al. does not disclose the use of a tube. Lord et al. further discloses a coupling member, where the tubular coupling member is a tube (Fig. 2, 260, balloon, col 10. Lines 36-40),
wherein the plurality of discrete stent rings are disposed along a length of and surround the tube (Fig. 15, col. 5, lines 46-49)
and wherein each of the longitudinal struts is coupled to the tube (Fig. 15, col. 5, lines 46-49, see also Fig. 19A, 20A, and 21A). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent disclosed by Roubin et al. to include a tube as taught by Lord et el. in order to advance the stent to the desired anatomical location (Lord et al, col 1 lines 52-55).
Roubin et al. in view of Lord et al. does not explicitly disclose the use of a polymeric tube. However, Moffarah et al. discloses a medical balloon (equivalent to a polymeric tube, para 0003-0004) and teaches the use of polymer reinforced composite balloons (para 0009). Therefore, before the effective filling date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent disclosed by Roubin et al. in view of Lord et al. to include a polymeric tube as taught by Moffarah et al. in order to reinforce balloons to “advantageously sustain high pressures, provided precise shape control, and are highly resistant to tear and puncture” (Moffarah et al, see para 0010).
Regarding claim 13, modified Roubin et al. does not disclose the number of strut arms coupled to the tube. Lord et al. further teaches a configuration wherein one or more of first, second, third, and fourth strut arms of each of the plurality of expandable structures are coupled (Fig 13, col 19, lines 32-34, see also col 21, lines 57-59) to the tube. Therefore, before the effective filing date of the present invention it would have been obvious to a person of ordinary skill in the art to couple the stent device disclosed by Roubin et al. to the plurality of strut arms as taught by Lord et al. in order to advance the stent to the desired anatomical location (Lord et al, col 1 lines 52-55).
Roubin et al. in view of Lord et al. does not disclose the use of a polymeric tube. However, Moffarah et al. discloses an inflatable medical balloon and teaches the use of polymer reinforced composite balloons (para 0009). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent disclosed by Roubin et al. to include a tube as taught by Lord et al. to be polymeric as taught by Moffarah et al. for “enhanced trackability, while still maintaining its ability to withstand high pressures, provide precise shape control, and have highly controlled tear properties” (Moffarah et al., para 0011).
Regarding claim 14, modified Roubin et al. in view of Lord et al. does not explicitly disclose that the polymeric tube comprises one or more of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene, and silicone, however Moffarah et al. further teaches that the polymeric tube comprises one are more of these materials, specifically silicone (para 0006), in the example of a high compliance construction (para 0003-0004, teaching that it is suitable for medical application). Therefore, before the effective filing date of the present invention, it would have been obvious to a person of ordinary skill in the art to modify the stent disclosed by Roubin et al. coupled to the balloon disclosed by Lord et al to include a polymeric tube as taught by Moffarah et al. for “enhanced trackability, while still maintaining its ability to withstand high pressures, provide precise shape control, and have highly controlled tear properties” (Moffarah et al., para 0011).
Regarding claim 15, modified Roubin et al. does not explicitly disclose the use of elongate filaments for the tubular coupling member. However, Lord et al. further discloses:
wherein the plurality of discrete stent rings are disposed along a length of the coupling member (Fig 3, 305, col. 11 lines 15-17, see also Fig 5, col. 11, lines 35-40), and
and wherein the longitudinal struts are coupled to the coupling member (Fig 3 5, 355, col. 11, lines 35-40). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent disclosed by Roubin et al. to include the coupling member as taught by Lord et al in order to advance the stent to the desired anatomical location (Lord et al, col. 1 lines 52-55).
Roubin et al. in view of Lord et al. does not disclose that the coupling member comprises a plurality of elongate filaments, however Moffarah et al. further discloses a coupling member, balloon, comprising a plurality of elongate filaments (see Fig 1, para 0030-0034 for embodiments and para 0035 for material listings). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent disclosed by Roubin et al. in view of Lord et al with the use of elongate filaments as taught by Moffarah et al., in order to generate a “fiber-reinforced device, such as a balloon, that can be manufactured quickly and easily, with a low profile and enhanced trackability, while still maintaining its ability to withstand high pressures, provide precise shape control, and have highly controlled tear properties” (Moffarah et al., para 0010).
Regarding claim 16, modified Roubin et al. in view of Lord et al. does not explicitly disclose the plurality of elongate filaments comprise poly-paraphenylene terephthalamide, however Moffarah et al. further discloses the application use of poly-paraphenylene terephthalamide (Kevlar) in similar application (see Fig 1, para 0030-0034 for embodiments and para 0035 for material listings). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent disclosed by Roubin et al. in view of Lord et al to include poly-paraphenylene terephthalamide as taught by Moffarah et al., in order to generate a fiber reinforced device with a ”enhanced trackability, while still maintaining its ability to withstand high pressures, provide precise shape control, and have highly controlled tear properties” (Moffarah et al., para 0010).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over US 5,827,321 (hereinafter, "Roubin et al.") and US 10,357,384 (hereinafter, “Lord et al.”) further in view of US 2021/0322189 (hereinafter “Schwartz et al.”).
Regarding claim 18, modified Roubin et al. further discloses a method of manufacturing a stent, compromising:
laser cutting a plurality of discrete stent rings from a tubular blank (Fig. 3, stent, 100, see also col. 9, line 21-25).
Roubin et al. does not explicitly disclose the details of the laser cut structure, however Lord et al. further teaches:
wherein each discrete stent ring comprises a plurality of expandable structures (Fig. 3, linking arms, 355, see also col. 11, lines 41-46) and
wherein each expandable structure comprises a longitudinal strut (see above, annotated Fig 10, S1 see also col. 3, line 1-10);
disposing the plurality of discrete stent rings along a length of a coupling member (Fig 10, annular element, col. 3, lines 1-5); and
coupling the longitudinal struts to the tubular coupling member (crimping, col 1, lines 55-58, see also Fig 2, 260).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to manufacture the stent disclosed by Roubin et al. through the technique of laser cutting and couple the stent to a coupling member as taught by Lord et el. since the claimed invention is merely a combination of old elements, an in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (see MPEP 2143).
Modified Roubin et al. does not explicitly teach a plurality of discrete stent rings, wherein the plurality of the discrete stent rings are separate from each other.
However, Schwartz et al. teaches a stent frame (Fig. 1, multi-element stent, 200, para 0056), wherein the stents are comprised of multiple, cylindrical stent segments, which are separate from one another (see below, annotated Fig. 2B, DSR 1-3, para 0051). Therefore, before the effective filing date of the present invention it would have been obvious to a person of ordinary skill in the art to modify the stent frame of Roubin et al. with the multiple stent frames of Schwartz et al. to yield a desired strength and provide flexibility of placement (para 0052).
Claim 19-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Roubin et al, Lord et al., Schwartz et al, and further in view of US 2021/0299415 ("Moffarah et al.").
Regarding claim 19, modified Roubin et al. does not disclose the use of a tube. Lord et al. further discloses a tubular coupling member where the coupling member is a tube (Fig 2. 260, balloon, col 10. Lines 36-40). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent disclosed by Roubin et al. to include a tube as taught by Lord et el. in order to advance the stent to the desired anatomical location (Lord et al, col 1 lines 52-55). However, Roubin et al. in view of Lord et al. does not disclose polymeric tube.
Moffarah et al. further teaches the use of polymer reinforced composite balloons (para 0009). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent disclosed by Roubin et al. in view of Lord et al. to include a polymeric material for compliant reinforcement as taught by Moffarah et el. in order to adapt the ballon for medical procedures predicated on balloon shape reliability (Moffarah et al., see para 007-0010).
Regarding claim 20, modified Roubin et al. does not explicitly disclose the tubular coupling member comprises a plurality of filaments. Lord et al. further discloses a coupling member
where the coupling member is a tube (Fig 2. 260, balloon, col 10. Lines 36-40). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the stent disclosed by Roubin et al. to include a tube as taught by Lord et el. in order to advance the stent to the desired anatomical location (Lord et al, col 1 lines 52-55). However, Roubin et al. in view of Lord et al. does not disclose the plurality of filaments.
Moffarah et al. further teaches a device wherein the coupling member comprises a plurality of filaments (see para 0043-0045). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the method of manufacture disclosed by Roubin et al. in view of Lord et al. to include a plurality of filaments as disclosed by Moffarah et al. in order to adapt the ballon for medical procedures predicated on balloon shape reliability (Moffarah et al., see para 0003-0004) with enhanced trackability, while still maintaining its ability to withstand high pressures, provide precise shape control, and have highly controlled tear properties (Moffarah et al., para 0011).
Response to Arguments
Applicant's arguments filed March 03, 2026 have been fully considered but they are not persuasive.
In response to applicant's arguments that Roubin et al. does not teach a straight longitudinal strut, it is noted that Roubin teaches longitudinal components 42, and 44 which are straight (see col. 6 lines 3-5). Alternatively, if applicant’s argument is that the connecting member of Roubin is not straight, Roubin teaches various embodiments wherein the connecting member is straight (see below, annotated Fig. 7 and 8, connecting member 48a/b, col. 6, lines 40-50). In addition, applicant describes that the longitudinal strut of the claimed invention is curved at the ends (Remarks, B, Amended Drawings). Therefore, it is reasonable in interpretation to cite to prior art with an embodiment of alternating straight segments.
Applicant’s arguments with respect to claims 11 and 18 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.
Regarding the combination of Roubin et al. in view of Lord et al. with respect to claims 11 and 18, The Examiner respectfully disagrees and maintains the rejection based on the prior art outlined in section 103.
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 JICHELE MONIQUE SANDERS whose telephone number is (571)272-2240. The examiner can normally be reached M-Thu 6:30-5:15.
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/J.M.S./Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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