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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-15, drawn to an intravascular blood pump and introducer.
Group II, claim(s) 16, drawn to a kit for placing an intravascular blood pump.
Group III, claim(s) 17-20, drawn to a method for placing an intravascular blood pump.
Group IV, claim(s) 21-22, drawn to an alternate method for placing an intravascular blood pump.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-IV lack unity of invention because even though the inventions of these groups require the technical feature of an intravascular blood pump generically, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Aboul-Hosh et al. (US 7,022,100 B1). Aboul-Hosh teaches an intravascular blood pump (Fig. 2, at elements 12 and 14). Therefore, this technical features does not make a contribution over the prior art and is not considered a special technical feature.
During a telephone conversation with Richard Botos on 11/4/25 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-22 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the impeller must be shown or the feature(s) canceled from the claim(s). The impeller is mentioned in the specification but also includes a note stating it is not shown. However, structure of the impeller is claimed and therefore should be shown in the drawings. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(a)
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.
Claim 5 and all dependents thereof 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. Claim 5 recites an anchoring structure formed as a neck-and-head structure which is shown in embodiment of Fig. 28a-c). However, Claim 5 depends on claim 2 which recites limitations towards an anchoring structure of a different embodiment (hook or loop of Fig. 24a-c). These two embodiments appear to be separate from one another and not used in combination. The specification does not provide support for both the neck-and-head structure to be used in combination with the loop. Therefore there is an impermissible combination of embodiments. It appears that the dependency of claim 5 was incorrect and the claim should depend on claim 1. For purposes of examination, claim 5 is being interpreted to depend on claim 1.
Claim Rejections - 35 USC § 112(b)
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 4 and all dependents thereof are 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 4 recites “an atraumatic distal extension” in line 2. However, an atraumatic distal extension is already recited in claim 3 from which claim 4 depends. Therefore, it is unclear whether the structure in claim 4 is different or the same as the one in claim 3. For purposes of examination, the structure in claim 4 is being interpreted to be the same as the one claim 3.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 appears to recite limitations that are the same as those in claim 3 from which claim 4 depends. Therefore, claim 4 does not appear to narrow the scope of the claims. Amendment or change in dependency is suggested to correct the issue. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aboul-Hosh et al. (US 7,022,100 B1).
With regard to claim 1, Aboul-Hosh discloses An intravascular blood pump (Fig. 2 and 3) for percutaneous insertion into a patient's vasculature, the intravascular blood pump comprising a pumping device (12) and a supply line (32), wherein the pumping device (12) comprises a pump section (14) having a blood flow inlet (40/42), a blood flow outlet (38) and an impeller (48) rotatable about an axis of rotation for conveying blood from the blood flow inlet to the blood flow outlet (Col 9, lines 30-55), and a drive section (12) connected to the pump section (14) and adapted to drive the impeller Col 9, lines 5-29), and wherein the supply line (32) is adapted to supply energy for driving the impeller, and wherein an anchoring structure (22) is provided at a distal end region of the intravascular blood pump (element 22 is considered an anchoring structure under broadest reasonable interpretation because it is used to position pumping device in place within the heart and there is considered to help “anchor” or place the device, Col 7, lines 30-54. Further structure or definition for the anchoring structure would needed to overcome the rejection).
With regard to claim 14, Aboul-Hosh discloses wherein the anchoring structure (22) comprises at least one anchor (structure 22 is considered the anchor) adapted to anchor the intravascular blood pump in a wall of a patient's blood vessel element (22 is considered an anchoring structure under broadest reasonable interpretation because it is used to position pumping device in place within the heart and there is considered to help “anchor” or place the device, Col 7, lines 30-54. Further structure or definition for the anchoring structure would needed to overcome the rejection).
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.
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aboul-Hosh et al. (US 7,022,100 B1) in view of Corbett et al. (US 2015/0328383 A1).
With regard to claim 2, Aboul-Hosh discloses the anchoring structure but fails to disclose the anchoring structure is a hook or loop.
Corbett teaches an intravascular blood pump device (Fig. 8, element 801) also using an impeller (803) and further teaches that an anchoring structure (806) can be provided at the distal end region of the intravascular blood pump (see Fig. 8) and comprises a loop (806 is a pig-tail loop) at an axial end of the distal end region (see Fig. 8).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchoring structure of Aboul-Hosh with a loop as taught by Corbett for the purpose of assisting with stabilizing and position the blood pump assembly in the correct position in the left ventricle of the heart ([0036]).
With regard to claim 3, Aboul-Hosh discloses the claimed invention except for a loop.
Corbett teaches wherein the loop (806, Fig. 8) is made from a soft, elastic material ([0037], soft flexible material) and forms an atraumatic distal extension at the axial end of the intravascular blood pump ([0037], “pigtail extension 806 provides an atraumatic tip for contact with the ventricle wall and to allow for guidewire loading”).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchoring structure of Aboul-Hosh with a loop as taught by Corbett for the purpose of assisting with stabilizing and position the blood pump assembly in the correct position in the left ventricle of the heart ([0036]).
With regard to claim 4, Aboul-Hosh discloses the claimed invention except for a loop.
Corbett teaches wherein the loop (806) is provide at an atraumatic distal extension of the intravascular blood pump ([0037], “pigtail extension 806 provides an atraumatic tip for contact with the ventricle wall and to allow for guidewire loading”).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchoring structure of Aboul-Hosh with a loop as taught by Corbett for the purpose of assisting with stabilizing and position the blood pump assembly in the correct position in the left ventricle of the heart ([0036]).
Claim(s) 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aboul-Hosh et al. (US 7,022,100 B1) in view of Pfeffer et al. (US 2020/0129683 A1).
With regard to claim 5, Aboul-Hosh discloses the claimed invention except for an anchoring structure that is a head and neck structure.
Pfeffer teaches a blood pump (Fig. 1 and 2) having at it’s a distal end an anchoring structure (10, Fig. 2) wherein the anchoring structure comprises a neck (10.2, Fig. 3) and head (10.1, Fig. 3) structure at an axial end of the distal end region (see Fig. 1 and 2, showing element 10 at the distal end of the blood pump device).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchoring structure of Aboul-Hosh with the neck and head structure as taught by Pfeffer for the purpose of providing an atraumatic tip to protect the heart muscle ([0057]).
With regard to claim 6, Aboul-Hosh disclose the claimed invention except for the head and neck structure.
Pfeffer teaches wherein a connecting surface (see annotated Fig below) between a head (10.1) a neck (10.2) of the neck and head structure is inclined by 90 degrees relative to a longitudinal axis of the intravascular blood pump.
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Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchoring structure of Aboul-Hosh with the neck and head structure as taught by Pfeffer for the purpose of providing an atraumatic tip to protect the heart muscle ([0057]).
With regard to claim 7, Aboul-Hosh discloses the claimed invention except for the neck and head structure.
Pfeffer teaches wherein the neck and head structure (10) is formed in a recess of the end region (Fig. 2, see element 8.1 which includes lumen within considered to be a recess and to which the neck and head structure is formed and attached).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchoring structure of Aboul-Hosh with the neck and head structure as taught by Pfeffer for the purpose of providing an atraumatic tip to protect the heart muscle ([0057]).
With regard to claim 8, Aboul-Hosh discloses the claimed invention except for the neck and head structure.
Pfeffer teaches wherein the neck-and-head structure (10, Fig. 2) is formed at an end of an atraumatic distal extension (8.1 is considered an atraumatic distal extension because it is made of a elastic flexible material that can bend when being inserted into the body and thus not damage the heart tissue, [0058], [0059]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchoring structure of Aboul-Hosh with the neck and head structure and atraumatic distal extension as taught by Pfeffer for the purpose of providing an atraumatic tip to protect the heart muscle ([0057]).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aboul-Hosh et al. (US 7,022,100 B1) in view of Corbett et al. (US 2015/0328383 A1) and in further view of Kermode et al. (US 2011/0098525 A1).
With regard to claim 9, Aboul-Hosh discloses an introducer set comprising an intravascular blood pump (Fig. 2 and 3) for percutaneous insertion into a patient's vasculature, the intravascular blood pump comprising a pumping device (12) and a supply line (32), wherein the pumping device (12) comprises a pump section (14) having a blood flow inlet (40/42), a blood flow outlet (38) and an impeller (48) rotatable about an axis of rotation for conveying blood from the blood flow inlet to the blood flow outlet (Col 9, lines 30-55), and a drive section (12) connected to the pump section (14) and adapted to drive the impeller Col 9, lines 5-29), and wherein the supply line (32) is adapted to supply energy for driving the impeller.
However, Aboul-Hosh does not disclose the anchoring structure to be used with a connector of a connector catheter.
Corbett teaches an intravascular blood pump device (Fig. 8, element 801) also using an impeller (803) and further teaches that an anchoring structure (806) can be provided at the distal end region of the intravascular blood pump (see Fig. 8) and comprises a loop (806 is a pig-tail loop) at an axial end of the distal end region (see Fig. 8) which would be adapted to be used with a connector of a connecting catheter.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchoring structure of Aboul-Hosh with a loop as taught by Corbett for the purpose of assisting with stabilizing and position the blood pump assembly in the correct position in the left ventricle of the heart ([0036]).
However, Aboul-Hosh/Corbett does not teach a connecting catheter with a connector for connecting with the anchoring structure.
Kermode teaches the use of a connecting catheter (retrieval catheter Fig. 23a-23e) which comprises a connector (hook 2304) adapted to connect to the anchoring structure of the intravascular blood pump ([0110] this limitation is considered a functional limitation and therefore only the structure of the connecting catheter and connector must be taught by the prior art and simply need to be capable of performing the recited function. In this case the hook 2304 is capable of engaging the medical implant, or the pigtail loop taught in Corbett above in order to pull the device through the body).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the set of Aboul-Hosh/Corbett with the connecting catheter as taught by Kermode for the purpose of assisting in removing or moving the implanted medical device ([0110]).
With regard to claim 10, Aboul-Hosh/Corbett teach the claimed invention except for the connector.
Kermode teaches wherein the connector (2304) comprises a hook ([0110]) adapted to hook into the anchoring structure of the intravascular blood pump ([0110], hook of Kermode is considered to be adapted to or capable of hooking onto an anchoring structure, such as the loop taught by Corbett above, because the hook of Kermode is able to be used to grasp a medical implant as taught in [0110]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the set of Aboul-Hosh/Corbett with the connecting catheter and connector as taught by Kermode for the purpose of assisting in removing or moving the implanted medical device ([0110]).
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aboul-Hosh et al. (US 7,022,100 B1) in view of Corbett et al. (US 2015/0328383 A1) and in further view of Kermode et al. (US 2011/0098525 A1) and Bonde et al. (US 2015/0306291 A1).
With regard to claim 11, Aboul-Hosh/Corbett/Kermode teach the claimed invention except for a gripper having a first and second grip.
Bonde teaches a connecting catheter ([0057], retrieval device) similar in use as that of Kermode above alternative to the a hook can have forceps ([0057], considered the gripper of the claims) which would inherently having a first and second grip (by definition forces have two parts that are used to pinch or grip an object) adapted to close or grip around the anchoring structure of the intravascular blood pump (this limitation is functional and therefore the first and second grip must only need to be capable of closing or gripping the anchoring structure of the intravascular blood pump. [0057] of Bonde teaches that forces are used to retrieve an implanted medical device by grasping onto the frame of the device. Therefore, the first and second grip would be capable of grasping the loop anchoring structure taught by Corbett above in claim 9).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the set of Aboul-Hosh/Corbett/Kermode with the first and second grip as taught by Bonde for the purpose of providing an alternative means of retrieving the implanted medical device as is well-known in the art as a substitute to a hook ([0057]).
With regard to claim 12 and 13, Aboul-Hosh/Corbett/Kermode teach the claimed invention except for a gripper.
Bonde teaches the use of a gripper ([0057], retrieving forceps) which would inherently having two gripping surfaces on each of the first and second grip in order to pinch or grasp the medical device. While Bonde does not explicilyt disclose the angle at which the gripping surface is made, whether by 90 degrees or more than 90 degrees, it would be prima facie obvious to optimize the gripping surface angle as doing so would not alter the overall function of the device ([0057]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the set of Aboul-Hosh/Corbett/Kermode with the first and second grip as taught by Bonde for the purpose of providing an alternative means of retrieving the implanted medical device as is well-known in the art as a substitute to a hook ([0057]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aboul-Hosh et al. (US 7,022,100 B1) in view of Foster (US 2011/0124950 A1).
With regard to claim 15, Aboul-Hosh discloses the claimed invention except for spikes.
Foster teaches a similar intravascular blood pump (fig. 1, element 1 and 5) further teaching the anchor (14) comprises spikes (legs 14) that are expandable and collapsible ([0034], legs 14 expand radially outward but can be inwardly compressible for insertion).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the set of Aboul-Hosh with the spikes as taught by Foster for the purpose of centralizing the pump within the heart walls without causing damage ([0034]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783