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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5 June 2026 has been entered.
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:
“elongate member configured for advancement” in claim 1 (corresponds to a pushing and pulling element, a navigation element (paragraph 0023), the navigation element can include wire or tube (paragraph 0160))
“cleaning member” in claim 1 (corresponds to sponge-like material, sponges of any shape and size (paragraphs 0053-0054))
“centering element” in claim 11 (corresponds to a shaped element that keeps the device centered, paragraph 0041)
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 and 11-14 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.
The applicant’s amendment of 5 June 2026 introduces a new limitation reciting “wherein at least the central portion comprises a non-absorbent surface configured to direct fluid flow between the cleaning member and the lumen of the device”. The originally filed disclosure fails to provide support for this subject matter and is considered new matter. The cleaning member, that includes the central portion, comprises “…any material that absorbs biomatter, fluid or other debris, such as a polymer foam, sponge, bamboo, hemp, microfibers, cotton or other absorbable fabric or the like” (paragraph [00207]). It is noted that the specification paragraph [0058] states that “The device may include a coating that is hydrophobic” but does not specify that the coating is part of a central portion of the cleaning member. The remainder of the applicant’s originally filed disclosure is silent as to any other material absorbencies for any embodiment. For these reasons, claim 1 contains new matter.
The applicant’s remarks of 5 June 2026 provides statements showing support for the amendment reciting “a non-absorbent surface configured to direct fluid flow between the cleaning member and the lumen of the device.” The examiner does not agree that there is sufficient support in the originally filed disclosure for the amendment of claim 1. The applicant argues that (1) the specification explicitly distinguishes the variable pressure region from absorbent materials; (2) the described geometry inherently requires a non-absorbent surface; (3) the described hydrodynamic mechanism requires fluid to flow across, not be absorbed into, the central portion; (4) the quantified pressure performance confirms a non-absorbent surface; and (5) the term “non-absorbent” is supported as the converse of the specification’s express disclosure. The examiner respectfully disagrees. First, it is again noted that the specification describes the cleaning element with the central portion as comprising “…any material that absorbs biomatter, fluid or other debris, such as a polymer foam, sponge, bamboo, hemp, microfibers, cotton or other absorbable fabric or the like” (paragraph [00207]). It is also noted that any mention of “the central portion” specifically, does not describe any specific material. The central portion is represented by reference number “508” in Figure 10. In this embodiment of the cleaning device (500) is not discussed specifically as being constructed of any material or material property (paragraph [00170]). The examiner does not agree with the applicant’s statements of support (1)-(5). With regards to point (1), the applicant points to paragraph [0053] that discusses that the cleaning device may have one or more absorbent sponges positioned in front or at the end of the cleaning device, that the sponges are distinct. The examiner does not find that it would have been obvious to conclude that this distinct structure is of a different type of material, such as a non-absorbent material. With regards to point (2), the examiner does not find that the geometry of the cleaning device would inherently lead to the material being non-absorbent. There may be at least a small degree of absorbency that would allow the cleaning device to function as recited geometrically. With regards to points (3)-(4), the applicant points to many passages describing the venturi, other fluid flow, or fluid pressure across the surfaces of the cleaning device as a entirety. Note, none of these passages refer specifically to the central portion. It is not clear how the motion of the fluid or pressure performance of the fluid determines or would lead one of ordinary skill in the art to conclude that the central portion of the cleaning device is inherently non-absorbent. Again, there may be at least a small degree of absorbency that would allow the cleaning device, fluid and pressure to occur. With regard to point (5), the applicant states the specification describes materials distinct from the variable pressure cleaning member. The applicant states that the passage that includes mentioned paragraph [0207] is a different component and not a variable pressure cleaning member. The examiner recognizes that the application includes numerous embodiments, however this is the only passage that describes the material of a cleaning member. There is no indication that other embodiments of cleaning devices or members are constructed of different materials or absorbencies, and paragraph [0225] states that “features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments.” For these reasons, the examiner does not find support in the originally filed disclosure and concludes that claim 1 contains new matter.
Claim Rejections - 35 USC § 103
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 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.
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, 4-5, and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 200483788 (see also computer generated English translation) in view of Kritzler, US 6,699,331.
Regarding claim 1, KR 200483788 discloses the claimed invention of a cleaning device including an elongate member (100) configured for advancement through a lumen (Abstract), at least one cleaning member removably coupled to a portion of the elongate member (200, Figure 1; the cleaning member is removably coupled to the elongate member, see English translation, page 4 third paragraph), wherein the cleaning member comprises distal and proximal end portions (distal and proximal end portions are 210) and a central portion between the distal and proximal end portions configured to direct fluid flow between the cleaning member and lumen of the device (central portions comprise 220 or 220 and 222, see Figures 1-5), and wherein the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion (Figures 1-5; in that the central portion is a smaller diameter than the end portions and is shaped to achieve a pressure gradient during use), wherein the central portion of the cleaning member comprises a contraction section coupled to the proximal end portion, a diffusion section coupled to the distal end portion, and a throat section coupling the diffusion and contraction sections (see annotated Figure below), wherein the throat section has a diameter less than the diameter of the proximal and distal end portions and greater than a diameter of the diffusion and contraction sections (see annotated Figure below). Regarding claim 4, the contraction section increases in diameter from the proximal end portion to the throat section and the diffusion section decreases in diameter from the throat section to the distal end portion (see annotated Figure below). Regarding claim 5, the throat section is substantially cylindrical (on its own, it is substantially cylindrical, see annotated Figure below). Regarding claim 12, there are second and third cleaning members (also 200, see Figures 1-5), the second cleaning member coupled to a second portion of the elongate member and the third cleaning member coupled the second cleaning member (Figures 1-5), wherein first and second cleaning members each comprise distal and proximal end portions and a central portion between the distal and proximal end portions (see Figures 1-5) wherein the central portion is shaped to create a pressure gradient along the central portion from the distal end portion to the proximal end portion (Figures 1-5; in that the central portion is a smaller diameter than the end portions to achieve a pressure gradient during use). Regarding claim 13, the proximal end portion of the second cleaning member is coupled to the distal end portion of the first cleaning member (Figures 1-5).
[AltContent: ][AltContent: textbox (cleaning member)][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: ][AltContent: ][AltContent: arrow][AltContent: textbox (distal end portion)][AltContent: textbox (proximal end portion)]
PNG
media_image1.png
187
404
media_image1.png
Greyscale
[AltContent: textbox (throat section)]
[AltContent: textbox (contraction section)]
[AltContent: textbox (diffusion section)]
KR 200483788 states that the cleaning member comprises urethane (fourth paragraph from the bottom on page 5 of English translation) and fails to disclose specifically wherein at least the central portion comprises a non-absorbent surface.
Kritzler teaches an endoscope cleaning device (Title) with an elongate member configured for advancement through a lumen within a device (1) and at least one cleaning member (apparatus 4 with cleaning members 5, see Figures). Regarding claim 1, Kritzler teaches that the material of the cleaning member, including its central portion, has a non-absorbent surface (column 8 lines 51-52). The material of the cleaning member is formed inexpensively from an extruded or molded polymer that form fins to efficiently remove contamination (column 4 lines 37-50) and it is also important that the material does not score the inner surface of the lumen (column 4 line 63 to column 5 line 2).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer surface of at least the central portion of the cleaning member of KR 200483788 so that it comprises a non-absorbent surface, as taught by Kritzler, that does not scratch or score the inner surface of the lumen and is of an appropriate and inexpensively formed material sufficient in removing debris from the inner surface of the lumen.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR 200483788 (see also computer generated English translation) and Kritzler, US 6,699,331 as applied to claim 1.
KR 200483788 and Kritzler disclose all elements previously mentioned above. KR 200483788 is silent that the pressure gradient specifically causes an increase in relative velocity between the cleaning member and fluid within the lumen as the cleaning member is advanced through the lumen or the pressure gradient causes an increase in shear stress between fluid in the lumen and an internal wall of the lumen. The cleaning member of KR 200483788 is shaped so that when it is advanced through a lumen that there is a pressure gradient along the central portion (see annotated Figure described previously, there is a pressure gradient across cleaning member 200). The Applicant describes in the Specification at paragraph 00113 that in the present application there is a venturi effect created between the cleaning element/member and the walls of the endoscope channel as the cleaning element is moved through the lumen. As a result, when there is cleaning fluid flowing across the variable pressure area that the fluid flow transfers from an area of high pressure to an area of low pressure and then back to another area of high pressure, this directs the fluid with an increased velocity and force. Applicant’s specification in paragraph 00116 continues to describe that the shape is inverted, partial venturi, parabolic, or a variable slope shape. The shape of the cleaning member/element of KR 200483788 is shaped as the cleaning member shape is described in the Applicant’s specification. Also, the claims are directed towards “a cleaning device for use with an endoscopic instrument” and does not positively recite a lumen or fluid. KR 200483788 is again silent as to a velocity or shear stress between fluid in a lumen and internal walls of a lumen.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure gradient of KR 200483788 and Kritzler so that it achieves an increase in a relative velocity between the cleaning member and fluid within the lumen as the cleaning member is advanced and so that the pressure gradient causes an increase in shear stress between fluid in the lumen and an internal wall of the lumen in order to advance the cleaning device and clean the endoscopic instrument.
Allowable Subject Matter
6. Claims 15-21 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: None of the prior art made of record discloses, teaches, or suggests the invention of claims 15-21. In particular regards to claims 6-9, 11, and 14-21 (claims 6-9, 11, and 14 are currently rejected under 35 USC 112(a)), KR 200483788 does not disclose that the contraction section defines an angle with the throat portion that is about 4 degrees to about 85 degrees, that the diffusion section defines an angle with the throat portion that is about 4 degrees to 85 degrees, that the diffusion section defines an angle with the throat portion that is about 15 degrees to about 30 degrees, that the cleaning member comprises at least one cylindrical centering element positioned on an end of the cleaning member, one or more cylindrical elements sized to contact a wall of the lumen and being positioned on a trailing end of the first and second cleaning members, or wherein the central portion is shaped to increase a force applied by a fluid against an internal wall of the lumen, wherein the force creates a pressure of at least about 100 Pa in at least one area between the distal end proximal end portions of the cleaning element, or wherein the pressure gradient causes an increase in shear stress between fluid in the lumen and an internal wall of the lumen.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5 and 12-13 as rejected under 35 USC 103 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Please note that the examiner responded to the applicant’s statements regarding amended claim 1 in the 35 USC 112(a) discussion of this office action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. JP 3406081 B2 describes a cleaning device comprising an elongate member configured for advancement through a lumen within a device (see English translation, 2) and at least one cleaning member (3) that is constructed of a non-absorbent material (see English translation, discussion relating to the “non-liquid-absorbing elastic body”).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Laura C Guidotti whose telephone number is (571)272-1272. The examiner can normally be reached typically M-F, 6am-9am, 10am-4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Posigian can be reached at 313-446-6546. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAURA C GUIDOTTI/Primary Examiner, Art Unit 3723
lcg
Prosecution Insights