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/Restrictions
Applicant’s election of Species C, readable on claims 1-7, 10-12, 14, 15, 18 and 20 in the reply filed on 2/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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:
“a compression device” in Claims 10 and 18
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.
Claims 5-6 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 5 recites the limitations “the proximal end” and “the distal end” in Line 4 in which it’s unclear if the claim is referring the proximal and/or distal end of the tube (as defined in Claim 1) or the proximal and distal end of the plurality of channels (defined in Claim 5). Claim 6 is also rejected due to its dependency on claim 5. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-7, 10-12, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lamport et al. (US Patent No. 5,681,328, hereinafter Lamport).
In regard to claim 1, Lamport discloses a delivery device (18, Figs. 1,2) comprising:
a tube (40,50) having a proximal end, a distal end, and a lumen (passage within wall (40)) extending from the proximal end to the distal end, wherein the proximal end of the tube is mountable to a distal tip of a medical device via the lumen (Fig. 1 illustrates the device mounted to tubular housing (14)), and the tube includes:
an inner wall (40) defining the lumen (Figs. 2,3),
an outer wall (50) coupled to the inner wall at the proximal end and the distal end (Figs. 2,3);
a cavity formed from the coupled inner wall and outer wall, the cavity configured to hold a deliverable substance (via interior space between walls (40,50) which holds ligation band (30), Fig. 3); and
a plurality of openings connected to the cavity and positioned on a distal-facing surface of the distal end (distal-facing surface of the outer wall (50) defines notches (i.e. openings) between fingers (52), Figs. 2,3)
wherein at least a portion of the inner wall or the outer wall is a flexible wall (fingers (52) of the outer wall) that transitions between a first configuration and a second configuration to cause delivery of the deliverable substance (30) from the cavity to a treatment site through the plurality of openings when a force is applied to the flexible wall (the fingers (52) of the outer wall (50) flex between a state in which the ligation band (30) is retained within a cavity and a state in which the ligation band projects distally beyond the fingers (52)).
In regard to claim 2, Lamport teaches wherein the tube further comprises a plurality of protrusions (via fingers (52), Fig. 2) extending distally from the distal-facing surface (Fig. 2).
In regard to claim 3, Lamport teaches wherein the plurality of protrusions are positioned along one or both of an outer circumference of the distal-facing surface and an inner circumference of the distal-facing surface (the fingers (52) are positioned via along the outer surface of the outer wall, Fig. 2).
In regard to claim 4, Lamport teaches wherein the tube further comprises a plurality of channels (Fig. 2 illustrates channels extending along an interior surface of the fingers connecting the notches/openings on the distal-facing surface of the fingers to the cavity) connecting the plurality of openings to the cavity.
In regard to claim 5, Lamport teaches wherein each of the plurality of channels includes a proximal end connected to the cavity and a distal end connected to a respective one of the plurality of openings (Fig. 2), and wherein each of the plurality of channels is a tapered channel that gradually narrows from the proximal end toward the distal end (the opening extends along the distal (the openings extend along the radially outer surface to the distal-facing surface, wherein the openings taper inward towards the distal end, Fig. 2).
In regard to claim 6, Lamport teaches wherein each of the plurality of openings are configured to form a seal, and wherein the seal breaks when the force is applied to the flexible wall (the openings allow the fingers (52) to radially deflect and therefore allow the fingers to seal the ligating band within the dispenser and allow the fingers to radially expand to release the ligating band).
In regard to claim 7, Lampart teaches wherein a configuration of the lumen prevents obstruction of components at the distal tip of the medical device when the tube is mounted to the medical device, the components including at least one of distal openings of one or more working channels, one or more illumination devices, or one or more visualization devices (Fig. 2 illustrates the dispenser (18) mounted on a medical device would still allow for working channels, illumination devices and/or visualization devices to be unobstructed).
In regard to claim 10, Lampart teaches wherein at least the portion of the outer wall is the flexible wall (via fingers (52)), and the delivery device further comprises: a compression device (60) surrounding a portion of the tube and configured to move from a first position to a second position along the tube (Fig. 3 shows the compression device surrounding the inner wall), wherein the force applied to the flexible wall to cause the delivery of the deliverable substance is a movement of the compression device from the first position to the second position along the tube (Figs. 3,7).
In regard to claim 11, Lampart teaches wherein at least the portion of the outer wall transitions between a convex configuration and a straight configuration, and wherein, in the convex configuration, an outermost diameter of at least the portion of the outer wall is greater than an inner diameter of the compression device, causing at least the portion of the outer wall to transition from the convex configuration to the straight configuration as the compression device is moved from the first position to the second position (Figs. 8 and 9 illustrates the fingers (52) configured to transition between a straight state (Fig. 9) and a radially expanded state (Fig. 8)).
In regard to claim 12, Lampart teaches further comprising: an actuation device (24); and
one or more actuators (48) connected to the compression device and extended to the actuation device, wherein actuation of the one or more actuators via the actuation device moves the compression device from the first position to the second position (Figs. 8-9).
In regard to claim 14, Lampart teaches further comprising: a flange (84) attached to the proximal end of the tube and including one or more through holes (via central lumen of cap (80)), wherein the one or more actuators extend from the compression device via the one or more through holes to the actuation device (Fig. 2 shows the actuator extending through the central lumen of the cap); and one or more outer tubes (14, 80) coupled to the flange and enclosing the one or more actuators from a proximal surface of the flange to the actuation device (Figs. 1-2).
In regard to claim 15, Lamport teaches wherein: the tube is formed from an assembly comprised of at least a first assembly component (40) and a second assembly component, the first assembly component includes the inner wall and a proximal-facing surface of the proximal end, and the second assembly component (50) includes the outer wall and the distal-facing surface of the distal end (Figs. 2-3).
Allowable Subject Matter
Claims 18 and 20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 18 recites the limitation “wherein when the one or more actuators are actuated, at least the portion of the outer wall transitions from the convex configuration to the substantially straight configuration as the compression device is moved from the first position to the second position, the transition compressing the cavity and causing delivery of the deliverable substance from the cavity to a treatment site through the plurality of openings” wherein the prior art does not teach of the outer wall transitioning from a convex configuration to a straight configuration thereby compressing the cavity to deliver a substance through the plurality of openings. The prior art of Lamport (US 5,681,328) teaches the outer wall transitioning between a straight configuration to a radially expanded configuration to deliver a ligation band to a body cavity, but fails to disclose compressing the cavity in order to deliver the ligation band (i.e. substance) through the openings to the body cavity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 April 4, 2026
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