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 .
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, “a second guidewire lumen for a second guidewire” (claim 22) must be shown or the feature(s) canceled from the claim(s). 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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “penetration tool” and “blood bypass structure“ in claim 1 and 41.
Claim 1 and 41 recites the limitation of a “penetration tool”. The term “tool” is used as a substitute for “means” and is modified by functional language “for penetrating vessel walls of two adjacent blood vessels to form the fistula”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “penetration tool” is “a needle” or (Page 7, 14) or equivalents thereof.
Claim 1 recites the limitation of a “blood bypass structure”. The term “structure” is used as a substitute for “means” and is modified by functional language “for allowing blood to flow past the inflated balloon”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “blood bypass structure” is “may comprise a spiral channel on an outer surface of the balloon…. two or more spiral channels on the outer surface of the balloon…. a spiral ridge on an outer surface of the balloon…. two or more spiral ridges on the outer surface of the balloon…. multiple bumps on the surface of the inflatable balloon” (Page 3-5) or equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 39 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 39 is dependent on canceled claim 37. For examination purposes, the limitation will be seen as depending from claim 27.
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 39 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 39 depends from a canceled claim, thus fails to further limit the subject matter of the claim from which it depends. 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-3, 5, 7, 14, 16, 19, 21-23, 27-29, 31, 33, 39-40 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. (US 20050245788 A1) in view of Sardesai et al. (US 20210046291 A1).
Regarding claim 1, Gerber discloses a catheter system (10) for forming a fistula between two adjacent blood vessels ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.), the catheter system comprising:
a crossing catheter (30) for introduction into a blood vessel, the crossing catheter having a distal end section (32) and an inflatable balloon (38A) disposed in the distal end section for stabilizing the crossing catheter in the blood vessel (Figure 8-9; Paragraph 0043);
a penetration tool (72) for penetrating vessel walls of two adjacent blood vessels to form the fistula, wherein the penetration tool is disposed within the crossing catheter and is movable between a retracted position and an advanced position (Figure 8; Paragraph 0061) (As indicated above, the limitation “penetration tool” invokes 112(f). The corresponding structure in Gerber is a needle, which is equivalent to a needle, as disclosed in the present disclosure.),
wherein the crossing catheter has a penetration lumen (lumen of 30) for accommodating the penetration tool and a distal end of the penetration lumen ends in a penetration port (70) through which the penetration tool can exit the crossing catheter (Figure 8; Paragraph 0059), and wherein the penetration port is disposed at the distal end of the crossing catheter (Figure 8; Paragraph 0060).
Gerber fails to explicitly disclose wherein, in the inflated state, the inflatable balloon comprises at least one blood bypass structure for allowing blood to flow past the inflated balloon.
However, Sardesai is directed to a catheter system and teaches a balloon (109) with at least one blood bypass structure (801, 802, 803, 804) (Figure 8A-D; Paragraph 0067), which would be fully capable of allowing blood to flow past the inflated balloon (As indicated above, the limitation “blood bypass structure” invokes 112(f). The corresponding structure in Sardesai is serrations and/or projections, which is equivalent to ridges, channels, or bumps, as disclosed in the present disclosure.).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Gerber such that in the inflated state, the inflatable balloon comprises at least one blood bypass structure, as taught by Sardesai, which would allowing blood to flow past the inflated balloon, as both references and the claimed invention are directed to balloon catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gerber with the teachings of Sardesai by incorporating in the inflated state, the inflatable balloon comprises at least one blood bypass structure in order to enhance anchoring of the balloon (Sardesai Paragraph 0067).
Regarding claim 2, the combination of Gerber and Sardesai teaches the catheter system of claim 1, and Sardesai further teaches wherein the blood bypass structure comprises a spiral channel (801) on an outer surface of the balloon (Figure 8A; Paragraph 0067).
Regarding claim 3, the combination of Gerber and Sardesai teaches the catheter system of claim 2, and Sardesai further teaches wherein the spiral channel is formed by a wire wrapped in a spiral around the outer surface of the balloon (Paragraph 0067).
Regarding claim 5, the combination of Gerber and Sardesai teaches the catheter system of claim 1, and Sardesai further teaches wherein the blood bypass structure comprises a spiral ridge on an outer surface of the balloon (Figure 8A; Paragraph 0067).
Regarding claim 7, the combination of Gerber and Sardesai teaches the catheter system of claim 1, and Sardesai further teaches wherein the blood bypass structure comprises multiple bumps (projections) on the surface of the inflatable balloon (Figure 8A-D; Paragraph 0067).
Regarding claim 14, Gerber further discloses wherein the penetration port is disposed distally adjacent the inflatable balloon (Figure 8-9; Paragraph 0062).
Regarding claim 16, Gerber further discloses the penetration port comprises a lateral opening in the crossing catheter (Figure 8; Paragraph 0060).
Regarding claim 19, Gerber further discloses wherein a distal end of the penetration tool (distal end of 72) deflects laterally as the penetration tool is moved distally from the retracted position to the advanced position (Figure 8-9).
Regarding claim 21, Gerber further discloses the penetration tool comprises a guidewire lumen (lumen of 72), which is fully capable for accommodating a guidewire, wherein the guidewire lumen allows placement of the guidewire through the fistula formed by the penetration tool (needle 72 is configured to deliver an injectable substance and thus is fully capable of accommodating a guidewire) (Paragraph 0060).
Regarding claim 22, Gerber as modified by Sardesai teaches the catheter system of claim 21, but fails to explicitly disclose wherein the crossing catheter comprises a second guidewire lumen for accommodating a second guidewire.
However, Sardesai teaches a catheter (100) with a guidewire lumen (105) for accommodating a guidewire (108) (Figure 1; Paragraph 0053).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gerber with the teachings of Sardesai by incorporating wherein the crossing catheter comprises a guidewire lumen for accommodating a guidewire in order to allow the catheter to be inserted over the guidewire (Sardesai Paragraph 0053) and prevent entanglement of the guidewire with other elements in the catheter.
Regarding claim 23, the combination of Gerber and Sardesai teaches the catheter system of claim 1, but fails to explicitly disclose wherein the inflatable balloon is a first inflatable balloon, the crossing catheter further comprises a second inflatable balloon, wherein the second inflatable balloon, in the inflated state, comprises at least one blood bypass structure for allowing blood to flow past the inflated balloon.
However, Sardesai teaches wherein the inflatable balloon is a first inflatable balloon (501) the crossing catheter (100) further comprises a second inflatable balloon (502) (Figure 5; Paragraph 0062), wherein the second inflatable balloon, in the inflated state, comprises at least one blood bypass structure for allowing blood to flow past the inflated balloon (Figure 8A-D; Paragraph 0067).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gerber with the teachings of Sardesai by incorporating wherein the inflatable balloon is a first inflatable balloon, the crossing catheter further comprises a second inflatable balloon, wherein the second inflatable balloon, in the inflated state, comprises at least one blood bypass structure for allowing blood to flow past the inflated balloon in order to independent be able to inflate the balloons according to the orientation of the catheter to anchor it in multiple spots (Sardesai Paragraph 0062).
Regarding claim 42, Gerber discloses wherein the inflatable balloon is fully capable of being configured for expanding the size of the fistula when inflated while positioned within the fistula ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.).
Regarding claim 27, Gerber discloses a catheter system (10) for forming a fistula between two adjacent blood vessels ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.), the catheter system comprising:
a crossing catheter (30) for introduction into a blood vessel, the crossing catheter having a distal end section (32) and an inflatable balloon (38A) disposed in the distal end section for stabilizing the crossing catheter in the blood vessel (Figure 8-9; Paragraph 0043);
a needle (72) is fully capable for penetrating vessel walls of two adjacent blood vessels to form the fistula (Figure 8; Paragraph 0060), wherein the needle is disposed within the crossing catheter and is movable between a retracted position and an advanced position (Figure 8; Paragraph 0060),
wherein the crossing catheter has a penetration lumen (lumen of 30) for accommodating the needle and a distal end of the penetration lumen ends in a penetration port (70) through which the needle can exit the crossing catheter (Figure 8; Paragraph 0059), and wherein the penetration port is disposed at the distal end of the crossing catheter (Figure 8; Paragraph 0060).
Gerber fails to explicitly disclose wherein the inflatable balloon is adapted for allowing blood to flow past the inflated balloon.
However, Sardesai is directed to a catheter system and teaches a balloon (109) with serrations and/or projections (801, 802, 803, 804) (Figure 8A-D; Paragraph 0067), which would be fully capable of allowing blood to flow past the inflated balloon as per the present specification.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Gerber such that the inflatable balloon has projections and/or serrations, which would allow blood to flow past the inflated balloon, as taught by Sardesai, as both references and the claimed invention are directed to balloon catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gerber with the teachings of Sardesai by incorporating the inflatable balloon has projections and/or serrations in order to enhance anchoring of the balloon (Sardesai Paragraph 0067).
Regarding claim 28, the combination of Gerber and Sardesai teaches the catheter system of claim 27, and Sardesai further teaches wherein the inflatable balloon comprises a spiral channel (801)on an outer surface of the balloon for allowing blood to flow past the inflated balloon (Figure 8A; Paragraph 0067).
Regarding claim 29, the combination of Gerber and Sardesai teaches the catheter system of claim 28, and Sardesai further teaches wherein the spiral channel is formed by a wire wrapped in a spiral around the outer surface of the balloon (Figure 8A; Paragraph 0067).
Regarding claim 31, the combination of Gerber and Sardesai teaches the system of any of claim 27, and Sardesai further teaches wherein the inflatable balloon comprises a spiral ridge on an outer surface of the balloon for allowing blood to flow past the inflated balloon (Figure 8A; Paragraph 0067).
Regarding claim 33, the combination of Gerber and Sardesai teaches the catheter system of claim 27, and Sardesai further teaches wherein the inflatable balloon comprises multiple bumps (Protrusions) on the outer surface of the balloon (Figure 8A-D; Paragraph 0067).
Regarding claim 39, as best understood in view of the 112(b) issues above, Gerber further discloses wherein the penetration port comprises a lateral opening in the crossing catheter (Figure 8; Paragraph 0060).
Regarding claim 40, Gerber further discloses wherein a distal end of the needle deflects laterally as the needle is moved distally from the retracted position to the advanced position (Figure 8-9).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerber in view of Sardesai as applied to claim 1 above, and further in view of Deaton et al. (US 20210220616 A1).
Regarding claim 26, Gerber as modified by Sardesai teaches the catheter system of claim 1, but fails to explicitly disclose wherein the inflatable balloon is at least partly made from a woven or spun thread.
However, Deaton is directed to a balloon catheter and teaches a balloon (PTA balloon) comprising a woven mesh embedded in the polymer of the balloon (Paragraph 0382).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Gerber as modified by Sardesai such that the inflatable balloon is at least partly made from a woven thread, as taught by Deaton, as both references and the claimed invention are directed to balloon catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gerber as modified by Sardesai with the teachings of Deaton by incorporating the inflatable balloon is at least partly made from a woven thread in order to limit tearing of the balloon, which can inhibit or prevent balloon material from causing emboli (Paragraph 0382).
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heuser (US 20070203515 A1) in view of Sardesai.
Regarding claim 41, Heuser discloses a method of forming a fistula between two adjacent blood vessels (210, 220) using a catheter system (Paragraph 0007; 0053) comprising a crossing catheter (230) having a distal end section (234) and an inflatable balloon (250) disposed in the distal end section (Figure 13; Paragraph 0050; 0057), and a penetration tool (244) (Paragraph 0050) (As indicated above, the limitation “penetration tool” invokes 112(f). The corresponding structure in Heuser is a piercer, which is equivalent to a needle, as disclosed in the present disclosure.), the method comprising:
introducing the crossing catheter into a blood vessel (Paragraph 0054; 0056);
advancing the distal end of the crossing catheter to a predetermined point where the fistula is to be formed (Paragraph 0054; 0056);
stabilizing the crossing catheter by inflating the inflatable balloon (Paragraph 0057);
moving the penetration tool from a retracted position and an advanced position to form the fistula (Paragraph 0054).
Heuser fails to explicitly disclose wherein the inflatable balloon comprises at least one blood bypass structure for allowing blood to flow past the inflated balloon.
However, Sardesai is directed to a catheter system and teaches a balloon (109) with at least one blood bypass structure (801, 802, 803, 804) (Figure 8A-D; Paragraph 0067), which would be fully capable of allowing blood to flow past the inflated balloon (As indicated above, the limitation “blood bypass structure” invokes 112(f). The corresponding structure in Sardesai is serrations and/or projections, which is equivalent to ridges, channels, or bumps, as disclosed in the present disclosure.).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Heuser such that in the inflated state, the inflatable balloon comprises at least one blood bypass structure, which would allow blood to flow past the inflated balloon, as taught by Sardesai, as both references and the claimed invention are directed to balloon catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Heuser with the teachings of Sardesai by incorporating in the inflated state, the inflatable balloon comprises at least one blood bypass structure in order to enhance anchoring of the balloon (Sardesai Paragraph 0067).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J./Examiner, Art Unit 3771
/BRIGID K BYRD/Examiner, Art Unit 3771
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