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 .
Status of Claims
In the present application, Claims 1-13 are currently pending in the application.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claim 1 third limitation does not provided indention where new items are provided. Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). See MPEP 6.08.01(m).
Claim 6 recites the limitation “wherein each of the plurality of sealing valves comprises a ridge extending radially along the tubular housing and surfaces on both radial sides of the ridge.” Such limitation needs additional clarifying language to clarify the surfaces are in references to the plurality of sealing valves not where the ridge extends. It is suggested to amend the limitation as follows, “wherein each of the plurality of sealing valves comprises a ridge extending radially along the tubular housing and wherein each of the plurality of sealing valves comprises surfaces on both radial sides of the ridge.” Alternatively Applicant could amend the claim as follows, “wherein each of the plurality of sealing valves comprises a first surface, a second surface, and a ridge extending radially along the tubular housing, and wherein the first surface and the second surface are each opposite radial sides of the ridge.” Applicant has support for such amendments in paragraph [0043] of the specification.
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:
Scraping device, in claim 4, which has structural support in the specification in paragraph [0044], stating, “…a scraping device 19 for scraping the liquid or tissue on the distal end part 18 of the surgical instrument. The scraping device 19 includes a boss 20 and a scraper 21. The boss 20 protrudes proximally from the sealing valve9 and extends along the radial edge 35 of the sealing valve 9; and the scraper 21 protrudes proximally from the boss 20 and extends along the radial axis of the boss 20.”
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 4 and 9-11 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 4 recites the limitation "the sealing valve" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the at least one of the plurality of sealing valves.” Examiner is interpreting the limitation as such. Appropriate correction is required.
Claim 9 recites the limitation "the sealing valve" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the at least one of the plurality of sealing valves.” Examiner is interpreting the limitation as such. Appropriate correction is required.
Claim 10 recites the limitation "the sealing valve" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the at least one of the plurality of sealing valves.” Examiner is interpreting the limitation as such. Appropriate correction is required.
Claim 11 recites the limitation "the sealing valve" three times in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the at least one of the plurality of sealing valves.” Examiner is interpreting the limitation as such. 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 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peng et al. (CN216317505) hereinafter Peng.
Regarding Claim 1, Peng discloses an access assembly (Fig. 2) for a surgical instrument (Figs. 2-4 endoscope 300), comprising:
a tube member (Figs. 2-4 tubular body 200) structured to extend along a longitudinal axis (see annotated Fig. 2) of the access assembly (Fig. 2) and configured to receive the surgical instrument (Figs. 2-4 endoscope 300);
a proximal sealing device (Fig. 2 proximal piece 500) configured to connect the surgical instrument (Figs. 2-4 endoscope 300) to a proximal end (near reference numeral 730 of fig. 3a) of the tube member (Figs. 2-4 tubular body 200) in a sealed manner ([0017] “…the proximal end of the proximal piece 500 is sealingly mounted at the proximal end of the tubular body 200.” ;
a distal end member (Figs. 2-5 distal piece 400) connected with ([0017] “…the outer wall of the distal piece 400 is sealingly mounted to the inner wall at the distal end of the tubular body 200…”) the tube member (Figs. 2-4 tubular body 200), the distal end member (Figs. 2-5 distal piece 400) comprising:
a tubular housing (Figs. 2-5 housing of distal piece 400) structured to be connected with a distal end (near reference numeral 630 of Fig. 3a) of the tube member (Figs. 2-4 tubular body 200) ; and
a plurality of sealing valves (Fig. 5 sealing flaps 420) arranged at a distal end of the tubular housing (Figs. 2-5 distal end of housing of distal piece 400) and configured to be openable and closable to open and seal a distal end of the access assembly ([0040] “In one embodiment, such as with the embodiment of the distal end piece 400 shown in FIG. 5, stopping the first and second fluids can be accomplished automatically by bending the sealing flap 420 of the distal end piece 400 without It is necessary to operate the start and stop of the first fluid source or the second fluid source. In this case, when the distal end portion 320 of the endoscope 300 passes through the distal end piece 400 , the plurality of sealing flaps 420 gradually open against the outer wall of the endoscope 300 and bend radially outward, so that the sealing flaps 420 The flow passage between the upper orifice 412 and the fluid discharge port 630 is clamped and blocked, thereby stopping the discharge of the fluid. This simplifies the process of re-extending the distal end portion 320 of the endoscope 300 out of the distal end of the access assembly, shortens the overall operation time, and reduces the complexity of the medical personnel's operation.”)
at least one of the plurality of sealing valves (Fig. 5 sealing flaps 420) comprising a nozzle (Figs. 2-5 fluid discharge port 630) or ejecting a fluid ([0034-0037] “The physiological saline and the cleaning agent are mixed inside the three-way tube 100 into a uniform cleaning agent physiological saline solution, and are discharged from the fluid discharge port 630 to clean the distal end portion 320 of the endoscope 300.”), a fluid inlet (Figs. 2-5 fluid input port 610) for receiving the fluid ([0034-0037], and
a distal end member fluid channel (Figs. 2-5 near orifice 412 [0031] “…a flow passage (not shown) that fluidly connects the fluid outlet 620 to orifice 412). When the distal end piece 400 is installed and sealed to the distal end of the inner wall of the tubular body 200 of the access assembly, the orifice 412 is in fluid communication with the portion of the fluid conduit 620 formed on the tubular body 200 to receive the mixture fluid into the sealing flap 420”) for fluidly communicating the fluid inlet (Figs. 2-5 fluid input port 610) and the nozzle (Figs. 2-5 fluid discharge port 630);
wherein the nozzle (Figs. 2-5 fluid discharge port 630) is configured to eject the fluid towards a proximal direction (see annotated fig. 3a) of the access assembly directionally, and an ejection direction (see annotated fig. 3a) of the nozzle (Figs. 2-5 fluid discharge port 630) has an angle α (see annotated fig. 3a) with respect to a longitudinal axis (see annotated fig. 3a) of the distal end member (Figs. 2-5 distal piece 400);
a fluid supply passage (Figs. 2-4 three-way tube 100) configured to provide the fluid ([0034-0037] to the access assembly; and
a fluid discharge passage (Figs. 2-4 vacuum line 720) configured for the access assembly to discharge the fluid ([0022]), wherein the fluid discharge passage comprises an outlet (Figs. 2-4 vacuum port 710) and an inlet (Figs. 2-4 vacuum suction port 730), and the inlet (Figs. 2-4 vacuum suction port 730)of the fluid discharge passage (Figs. 2-4 vacuum line 720) is arranged at the proximal end (near reference numeral 730 of fig. 3a) of the tube member (Figs. 2-4 tubular body 200).
PNG
media_image1.png
788
1704
media_image1.png
Greyscale
Regarding Claim 2, Peng discloses the access assembly according to claim 1, wherein a value of the angle α (see annotated fig. 3a) is less than or equal to 60 degrees, preferably, the value of the angle α (see annotated fig. 3a) is less than or equal to 15 degrees.
PNG
media_image1.png
788
1704
media_image1.png
Greyscale
Regarding Claim 3, Peng discloses the access assembly according to claim 2, wherein the value of the angle α (see annotated fig. 3a) is equal to 15 degrees; and/or, the nozzle (Figs. 2-5 fluid discharge port 630) is directed to the inlet (Figs. 2-4 vacuum suction port 730) of the fluid discharge passage (Figs. 2-4 vacuum line 720).
PNG
media_image1.png
788
1704
media_image1.png
Greyscale
Regarding Claim 4, Peng discloses the access assembly according to claim 1, wherein a scraping device (see annotated fig. 5) for scraping ([0040] “During this process, the distal end piece 400 can scrape off excess liquid from the distal end portion
320 of the endoscope 300 and assist in forming a liquid film, thereby improving the anti-fogging performance of the lens and delaying the next fogging time.”) a distal end part of the surgical instrument (Figs. 2-4 endoscope 300) is arranged on the sealing valve (Fig. 5 sealing flaps 420), and the nozzle (Figs. 2-5 fluid discharge port 630) is arranged on at least one (see annotated fig. 5) of the plurality of sealing valves (Fig. 5 sealing flaps 420) away from the scraping device (see annotated fig. 5); the scraping device (see annotated fig. 5) is at least partially arranged at a central axis of the distal end member (Figs. 2-5 distal piece 400).
PNG
media_image2.png
345
413
media_image2.png
Greyscale
Regarding Claim 5, Peng discloses the access assembly according to claim 1, wherein a radial distance between a center point of the nozzle (see annotated fig. 5) and a central axis (see annotated fig. 5) of the distal end member (Figs. 2-5 distal piece 400) is greater than or equal to one quarter of an outer diameter of the tubular housing (Figs. 2-5 housing of distal piece 400).
PNG
media_image3.png
318
405
media_image3.png
Greyscale
Regarding Claim 6, Peng discloses the access assembly according to claim 1, wherein each of the plurality of sealing valves (Fig. 5 sealing flaps 420) comprises a ridge (see annotated Fig. 5) extending radially along the tubular housing (Figs. 2-5 housing of distal piece 400) and surfaces (see annotated Fig. 5) on both radial sides of the ridge (see annotated Fig. 5), the nozzle is arranged on one of a plurality of the ridges (see annotated Fig. 5), and the distal end member fluid channel (Figs. 2-5 near orifice 412 [0031] “…a flow passage (not shown) that fluidly connects the fluid outlet 620 to orifice 412). When the distal end piece 400 is installed and sealed to the distal end of the inner wall of the tubular body 200 of the access assembly, the orifice 412 is in fluid communication with the portion of the fluid conduit 620 formed on the tubular body 200 to receive the mixture fluid into the sealing flap 420”) extends in a plane bounded by the longitudinal axis (see annotated Fig. 5) of the distal end member (Figs. 2-5 distal piece 400) and the ridge (see annotated Fig. 5).
PNG
media_image4.png
322
405
media_image4.png
Greyscale
Regarding Claim 7, Peng discloses the access assembly according to claim 1, wherein a distance between an inner edge of the nozzle (see annotated Fig. 5) away from a central axis (see annotated Fig. 5) of the distal end member (Figs. 2-5 distal piece 400) and an outer wall of the tubular housing (Figs. 2-5 housing of distal piece 400) is greater than an inner diameter of the nozzle (see annotated Fig. 5).
PNG
media_image5.png
367
517
media_image5.png
Greyscale
Regarding Claim 8, Peng discloses the access assembly according to claim 4, wherein a distance between a proximal edge of the nozzle (see annotated Fig. 5) and a base of the distal end member (see annotated Fig. 5) is greater than a distance between a proximal edge of the scraping device (see annotated Fig. 5) and the base of the distal end member (see annotated Fig. 5).
PNG
media_image6.png
305
947
media_image6.png
Greyscale
Regarding Claim 9, Peng discloses the access assembly according to claim 4, wherein the scraping device (see annotated Fig. 5) protrudes proximally so that it can be in contact with the distal end part of the surgical instrument in a case where the surgical instrument passes through the sealing valve (Fig. 5 sealing flaps 420, 0040] “The distal side of 400, such as into the patient's body cavity, is shown by arrow F in Figure 3B. During this process, the distal end piece 400 can scrape off excess liquid from the distal end portion 320 of the endoscope 300 and assist in forming a liquid film, thereby improving the anti-fogging performance of the lens and delaying the next fogging time.”)
PNG
media_image2.png
345
413
media_image2.png
Greyscale
Regarding Claim 10, Peng discloses the access assembly according to claim 4, wherein the plurality of sealing valves (Fig. 5 sealing flaps 420) are arranged along a circumferential direction of the tubular housing (Figs. 2-5 housing of distal piece 400), each of the plurality of sealing valves (Fig. 5 sealing flaps 420) comprises two radial edges (see annotated Fig. 5) and one circumferential edge (see annotated Fig. 5), and the scraping device (see annotated Fig. 5) proximally protrudes from a surface of the sealing valve (Fig. 5 sealing flaps 420).
PNG
media_image7.png
317
328
media_image7.png
Greyscale
Regarding Claim 11, Peng discloses the access assembly according to claim 4, wherein the scraping device comprises at least one boss (see annotated Fig. 5) , which protrudes proximally from the sealing valve (Fig. 5 sealing flaps 420) and is arranged on the sealing valve (Fig. 5 sealing flaps 420). along at least one radial edge of the sealing valve (Fig. 5 sealing flaps 420), and the scraping device (see annotated Fig. 5) further comprises at least one scraper (see annotated Fig. 5), which protrudes proximally from a portion of the boss (see annotated Fig. 5) close to the longitudinal axis (see annotated Fig. 5) of the distal end member (Figs. 2-5 distal piece 400).
PNG
media_image8.png
316
323
media_image8.png
Greyscale
Regarding Claim 12, Peng discloses the access assembly according to claim 1, wherein the distal end member (Figs. 2-5 distal piece 400) at least is connected with one elastic piece (Fig. 5 side wall 410) , and the elastic piece (Fig. 5 sealing flaps 420) is structured to form, together with a part of the tube member (Figs. 2-4 tubular body 200) , at least part of the fluid supply passage (Figs. 2-4 three-way tube 100 [0027-0034]), and at least a distal end of the fluid supply passage (Figs. 2-4 three-way tube 100) is communicated with the distal end member fluid channel (Figs. 2-5 near orifice 412, [0030-0031] “the distal end piece 400 that implements the above functions may have a structure as shown in FIG. 5 . As shown in FIG. 5, the distal end piece 400 has a generally cylindrical side wall 410 with an aperture 412 therein for sealing at the distal end of the inner wall of the tubular body 200 of the access assembly. The distal piece 400 may also have a plurality of sealing flaps 420 at the distal end of the cylindrical sidewall 410 . The proximally facing surface of at least one of the plurality of sealing flaps 420 may have a fluid outlet 630 that accesses the fluid supply passage 600 of the assembly, and a flow passage (not shown) that fluidly connects the fluid outlet 630 to the orifice 412. ). When the distal end piece 400 is installed and sealed to the distal end of the inner wall of the tubular body 200 of the access assembly, the orifice 412 is in fluid communication with the portion of the fluid conduit 620 formed on the tubular body 200 to receive the mixture fluid into the sealing flap 420.”)
Regarding Claim 13, Peng discloses the access assembly according to claim 1, wherein the surgical instrument (Figs. 2-4 endoscope 3000) is an endoscope provided with a lens at a distal end part thereof.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Aluru et al. (US2021/0127963);
Henry Holsten (US2020/0163541); and
Christopher Tokarz (US2019/0069925).
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.
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, Michael Carey can be reached at (571) 270-7235. 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.
/MEGAN ELIZABETH MONAHAN/ Examiner, Art Unit 3795