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 without traverse of Species I directed to Figs. 1-2 to include the stabilizing tool with radially-inward projections and a ramp located inside the lumen, in reply filed 05/17/2022 is acknowledged.
Acknowledgment of Amendment
The amendment filed 08/19/2025 has been entered. Claims 1,3-4,15,21-22,24-28,30-31,33-34 and 38-42 are pending in the application with claims 1, 21, 22, 25-27, 33, 40, and 42 amended. Claims 2, 5-14, 16-20, 23, 29, 32, and 35-37 are canceled.
Response to Arguments
Applicant’s arguments, dated 08/19/2025, with respect to claims 1, 3-4, 15, 21-22, 24-28, 30-31, and 39-42 have been fully considered and are persuasive. Therefore the rejections within the final office action dated 05/19/2025 have been withdrawn.
Applicant’s arguments, dated 08/19/2025, with respect to claims 33, 34, and 38 have been fully considered but are moot because Applicant has amended independent claim 33 with a newly added limitation stating, “…a stabilizer coupled to a distal end of the scope, the stabilizer including a ring-shaped support secured within the first lumen, the stabilizer including at least two radially extending projections extending into the first lumen and defining a circle-shaped opening of the first lumen at a distal end of the stabilizer|[:]], wherein a size of the circle-shaped opening is less than a size of the first lumen, wherein a distal surface of the stabilizer is positioned at a distalmost face of the scope, wherein each of the at least two radially extending projections has a free end,
Such amendments change the scope of the claims. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made in view of the amendments to the claims.
Please section 35 U.S.C §102 and 35 U.S.C §103 below for further explanation.
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:
Member in claim 24, which has structural support on page 8 of Applicant’s specification stating, “Scope 100 may be any suitable endoscopic member, such as, e.g., an endoscope, a ureteroscope, a nephroscope, a colonoscope, a hysteroscope, a uteroscope, a bronchoscope, a cystoscope, a duodenoscope, a sheath, or a catheter. Scope100 may include one or more additional lumens configured for the passage of a variety of therapeutic or diagnostic equipment, including, but not limited to, imaging devices and tools for irrigation, vacuum suctioning, biopsies, and drug delivery.”[emphasis added].
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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 33 and 38 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated Ouchi Teruo (JP2000342516A) hereinafter Ouchi.
Regarding Claim 33, Ouchi discloses a system, comprising:
a scope (Fig. 3 endoscope 10) having a plurality of lumens (Figs. 2, 4, 16 channel 20, lumen of illumination window 16, lumen of observation window 15), including a first lumen (Figs. 2, 4, 16 channel 20), the first lumen(Figs. 2, 4, 16 channel 20) having a central longitudinal axis (see annotated Fig. 16); and
a stabilizer (see annotated Fig. 13) coupled to a distal end (Fig. 16 distal end main body 13) of the scope (Fig. 3 endoscope 10), the stabilizer (see annotated Fig. 13) including a ring- shaped support (see annotated Figs. 13 and 16) secured within (via engagement portions 132) the first lumen (Figs. 2, 4, 16 channel 20), the stabilizer (see annotated Fig. 13) including at least two radially extending projections (see annotated Figs. 13 and 16) extending into the first lumen (Figs. 2, 4, 16 channel 20) and defining a circle-shaped opening (see annotated Fig. 16, Also Fig. 4 shows outlet opening 20a is circular) of the first lumen (Figs. 2, 4, 16 channel 20) at a distal end of the stabilizer (see annotated Figs. 13 and 16),
wherein a size of the circle-shaped opening (see annotated Fig. 16) is less than a size (engagement portions is inside channel 20, [0035-0036]) of the first lumen (Figs. 2, 4, 16 channel 20),
wherein a distal surface (see annotated Figs. 13 and 16) of the stabilizer (see annotated Figs. 13 and 16) is positioned at a distalmost face (see annotated Fig. 16) of the scope (Fig. 3 endoscope 10),
wherein each of the at least two radially extending projections (see annotated Figs. 13 and 16) has a free end (see annotated Fig. 16);
wherein a connected end (see annotated Fig. 16) of each of the at least two radially extending projections (see annotated Figs. 13 and 16) is connected to the ring-shaped support (see annotated Figs. 13 and 16),
wherein the free end (see annotated Fig. 16) of each of the at least two radially extending projections (see annotated Figs. 13 and 16) is nearer to the central longitudinal axis (see annotated Fig. 16) than the connected end (see annotated Fig. 16) of each of the at least two radially extending projections (see annotated Figs. 13 and 16) is to the central longitudinal axis (see annotated Fig. 16), and
wherein the free end (see annotated Fig. 16) of each of the at least two radially extending projections (see annotated Figs. 13 and 16) extends radially inward towards the circle-shaped opening (see annotated Fig. 16).
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Regarding Claim 38, Ouchi discloses the system of claim 33, wherein distal surfaces (see annotated Fig. 16) of each of the at least two radially extending projections (see annotated Figs. 13 [above] and 16 [below]) are perpendicular to the central longitudinal axis (see annotated Fig. 16).
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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 34 is rejected under 35 U.S.C. 103 as being unpatentable over Ouchi in view of St. Onge et al. (US2011/0124960) hereinafter St. Onge.
Regarding Claim 34, Ouchi discloses the system of claim 33, wherein each of the at least two radially extending projections (Ouchi - see annotated Fig. 16) includes a ramp (Ouchi - see annotated Fig.16) that extends from a proximal end (Ouchi - see annotated Fig.16) toward a distal end (Ouchi - see annotated Fig.16) , and tapers in a radial dimension from the distal end (Ouchi - see annotated Fig.16) to the proximal end (Ouchi - see annotated Fig.16) wherein the ramp (Ouchi - see annotated Fig.16) extends into the first lumen (Figs. 2, 4, 16 channel 20), but is silent as to wherein the radial dimension of the ramp increases within the first lumen from the proximal end toward the distal end.
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However St. Onge, in the same field of endeavor teaches, the radial dimension of the ramp (St. Onge – Fig. 7a barrier 34) increases within the first lumen (St. Onge – working channel 31) from the proximal end (St. Onge – Fig. 7a near reference numeral 22) toward the distal end (St. Onge – Fig. 7a near reference numeral 22b) (St. Onge – [0066] “…barrier 34 can be formed of a rigid or semi-rigid material. A rigid barrier 34 could include one or more spring elements configured to deflect when a force is applied. These spring elements could be surfaces which deflect when instruments are passed. Further, other spring mechanisms such as leaf or coil springs could deflect one or more instruments or be deflected by one or more instruments.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Ouchi with the teachings of St. Onge to have the radial dimension of the ramp increase within the first lumen from the proximal end toward the distal end for the benefit of controlling the deflection of one or more instruments at the distal end of the lumen ([St. Onge – 0066]).
Allowable Subject Matter
Claims 1,3-4,15,21-22,24-28,30-31, and 39-42 are allowed over the prior art of record.
The following in an examiner’s statement of reasons for allowance:
The prior art fails to reach, among other features, an a system, comprising: a scope having two or more lumens, the two or more lumens including a first lumen; a stabilizer secured within the first lumen and positioned in alignment with a distalmost face of the scope, wherein the stabilizer includes
(a) a ring-shaped support defining a first opening and
(b) at least two radially extending projections circumferentially spaced apart from one another:
each of the at least two radially extending projections including a fixed end at the ring-shaped support and a free end within the first opening, the at least two radially extending projections defining a second opening at a distal end of the first lumen;
a cross-sectional area of the second opening is less than a cross-sectional area of the first lumen; and
the free end of each of the at least two radially extending projections is configured to flex distally away from the distalmost face of a distal end of the scope to extend distally beyond the ring-shaped support,
wherein each of the at least two radially extending projections is a ramp having a proximal end and a distal end, wherein the distal end extends from the proximal end of the ramp toward the distal end of the first lumen, and has an increasing radial dimension extending from the proximal end of the ramp toward the distal end of the ramp.
Komi Shuji (JPH05146397) teaches the above system except for a stabilizer secured within the first lumen and positioned in alignment with a distalmost face of the scope.
Masterson et al. (US5392766) teaches the above system except for wherein each of the at least two radially extending projections is a ramp having a proximal end and a distal end, wherein the distal end extends from the proximal end of the ramp toward the distal end of the first lumen, and has an increasing radial dimension extending from the proximal end of the ramp toward the distal end of the ramp.
Tsutomu Okada (US2009/0043154) teaches the above system except for the free end of each of the at least two radially extending projections is configured to flex distally away from the distalmost face of a distal end of the scope to extend distally beyond the ring-shaped support.
The prior art also fails to reach, among other features, a system, comprising: a member including a lumen and a distalmost end, the lumen having a cross-sectional area and having a central longitudinal axis; and a stabilizer coupled to the distalmost end of the member, the stabilizer including
(a) a ring-shaped support defining a first opening and secured within the lumen at a distalmost end of the lumen and
(b) two radially extending projections,
wherein each of the two radially extending projections includes a connected end at the ring-shaped support and a free end within the first opening, wherein distal surfaces of the two radially extending projections are perpendicular to the central longitudinal axis, the two radially extending projections defining a second opening at the distalmost end of the lumen,
wherein a cross-sectional area of the second opening is less than the cross-sectional area of the lumen, and
wherein the free end of each of the two radially extending projections is nearer to the central longitudinal axis than the connected end of each of the two radially extending projections is to the central longitudinal axis, wherein the first opening is non-coaxial with the second opening.
Komi Shuji (JPH05146397) teaches the above system except for a stabilizer secured within the first lumen and positioned in alignment with a distalmost face of the scope.
Ueda et al. (US12121213) and Yamamoto et al. (US6059719) separately teach the above system except for wherein the free end of each of the two radially extending projections is nearer to the central longitudinal axis than the connected end of each of the two radially extending projections is to the central longitudinal axis, wherein the first opening is non-coaxial with the second opening.
Therefore, there is no reason or suggestion provided in the prior art to modify the above prior art to have the additional features as claimed above, and the only reason to modify the references would be based on Applicant’s disclosure, which is impermissible hindsight reasoning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN E MONAHAN whose telephone number is (571)272-7330. The examiner can normally be reached Monday - Friday, 8am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached on (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN ELIZABETH MONAHAN/Examiner, Art Unit 3795