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 .
Claim Objections
Claims 7 and 9 are objected to because of the following informalities: The preamble of each of claims 7 and 9 recite “The cleaning section of claim 1…” It is believed that this is a typographical error and that instead the applicant intended the preamble to recite “The cleaning device…” to be consistent with the other claims depending from claim 1. Appropriate correction is required.
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 19 December 2025 introduces a new limitation reciting “wherein at least the central portion comprises a substantially impermeable outer surface”. The originally filed disclosure fails to provide support for this subject matter and is considered new matter. It is noted that the specification paragraph [0058] states that “The device may include a coating that is hydrophobic.” However, impermeable is not defined the same as hydrophobic. According to www.merriam-webster.com “impermeable” is defined as “not permitting passage (as of a fluid) through its substance” and “hydrophobic” is defined as “lacking affinity for water” or “resistant to or avoiding wetting”. Also, paragraph [00207] discusses that the cleaning member “may comprise any material that absorbs biomatter, fluid or other debris…” which appears to contradict the language requiring the outer surface being “substantially impermeable.” Paragraph [00221] describes an outer surface (210) of a cleaning member (204) as being of a material that is “smooth enough to minimize or completely avoid creating any scratches or other defects in the surface of the lumen…” In this paragraph they describe endoscopes, not the cleaning member, as being resistant to water. Lastly, there is not any discussion in the specification of any specific type of material for specifically the outer surface of the “at least the central portion” of the cleaning member. For these reasons, 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 Leuthardt et al., US 2018/0014720.
Regarding claim 1, KR 200483788 discloses the claimed invention 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 (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)]
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KR 200483788 states that the cleaning member comprises urethane (fourth paragraph from the bottom on page 5 of English translation) and it is well known that many types of urethane are considered to be substantially impermeable and water resistant. However, KR 200483788 fails to disclose specifically wherein at least the central portion comprises a substantially impermeable outer surface.
Leuthardt et al. teach a cleaning ribbon (550) for cleaning endoscopes (Abstract). Regarding claim 1, Leuthardt et al. teach that the material of the cleaning ribbon (550) has a liquid-impermeable coating on its surface so that it wipes debris away without leaving excess moisture on the endoscope lens (paragraph [0039]).
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 substantially impermeable outer surface, as taught by Leuthardt et al., in order to prevent excess moisture being left behind on the surfaces of the endoscope during cleaning.
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 Leuthardt et al., US 2018/0014720 as applied to claim 1.
KR 200483788 and Leuthardt et al. 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 Leuthardt et al. 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) 1-9 and 11-14 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.
The applicant argues that the cleaning member described in KR 200483788 as a PVA sponge, and that it PVA is inherently absorbent. However, the cleaning member 220 of KR 200483788 can also be constructed of urethane (fourth paragraph from the bottom on page 5 of English translation). Urethane is known to be water resistant and substantially impermeable. KR 200483788 makes no mention of permeability of the cleaning member or material. As stated above, the examiner relies upon Leuthardt et al., US 2018/0014720 for its teaching of an endoscopic cleaner having an outer surface that is substantially impermeable. Further, the applicant’s amendment of 19 December 2025 introduces a new limitation reciting “wherein at least the central portion comprises a substantially impermeable outer surface” and the originally filed disclosure fails to provide support for this subject matter.
The applicant also argues that KR 200783788 does not have a shaped central portion that generates a controlled pressure gradient due to being formed by a sponge. The examiner respectfully disagrees. KR 200783788 may comprise a foam including PVA or urethane (see English translation) and the central portion retains a shape (see Figures). Depending on the diameter of the lumen and force applied by the cleaning device, the central portion of KR 200783788 is capable of creating a pressure gradient in the manner claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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.
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/LAURA C GUIDOTTI/Primary Examiner, Art Unit 3723
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