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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed March 5, 2025 is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because Fig. 3D appears to show arrows representing the air flow when the valve is in the open configuration, which is when the air escape hole 304 is unblocked, air passing through the valve shaft 308 from the top end 310 to the bottom end 312 and into the suction source passage 332 as described in the specification ([0052]). Arrows in applicant’s Fig. 3D show air flow moving from the working passage 334 to the top end 310, which does not align with the description of Fig. 3D. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Morton et al. (US2025/0072719) in view of Sueyasu (US2017/0079514) and Lee et al. (US2025/0143716).
Regarding claim 1, Morton discloses a valve assembly for a medical device (suction valve 26 for endoscope 2 [0090]), comprising: a valve body having a suction source passage (Fig. 2 & 3: valve body 42 comprises outlet 40 [0095]; outlet 40 is connected to vacuum port 32 [0093]; vacuum port 32 is connected to hose 34 to a suction pump P [0090]) and a working passage (Fig. 2 & 3: valve body 42 comprises inlet 38 which connects to suction channel 30 [0093]); a valve cap positioned above the valve body (Fig. 2: suction button 28 [0090]; Fig. 2: button portion 58 and suction button 28 appear to point to the same feature, positioned above valve body 42); a spring member positioned between the valve cap and the valve body such that (Fig. 3: valve spring 50 is positioned between the button portion 58 and valve body 42), when the valve cap is pushed downward relative to the valve body, the spring member applies upward force against the valve cap (spring 50 is preloaded in the closed state of the suction valve as shown in Fig. 4 [0108]); and a valve shaft connected to the valve cap (stem 56 is attached to the button portion 58 [0100]), the valve shaft comprising a side wall having a side opening (side wall of stem 56 comprises through hole 76 [0104]), the valve shaft configured to translate within the valve body between an upper position and a lower position (Fig 4: stem 56 in upper position and closed state; Fig. 5: stem 56 in lower position and open state), the valve stem made entirely of a degradable material (valve stem are preferably made from thermoplastic polymer, such as biodegradable polypropylene [0059]).
Morton fails to disclose wherein the valve stem comprises a top opening and a bottom opening. In the same field of endeavor, Sueyasu teaches a medical valve comprising a valve body having a suction source passage and a working passage (Fig. 2A: fluid plug unit 70 comprising cylinder 71 having suction conduit portion 63 and suction conduit portion 61 [0073]); a valve cap positioned above the valve body (pushing portion 391b [0073]); a spring member positioned between the valve cap and the valve body such that, when the valve cap is pushed downward relative to the valve body, the spring member applies upward force against the valve cap (urging member 77 disposed between the pushing portion 391b and cylinder 71, wherein the urging member 77 has an urging force to urge the pushing portion 391b upward [0087]); and a valve shaft connected to the valve cap (Fig. 2A: piston 73 is connected to pushing portion 391b [0087]), the valve shaft configured to translate within the valve body between an upper position and a lower position (piston 73 can be pressed downward to a lower position, the leakage suppression state, as seen in Fig. 2B, and an upper position, the suction state, as seen in Fig. 2A). Sueyasu further teaches the valve shaft comprising a top opening and bottom opening and a sidewall comprising a side opening (Fig. 2A: vent hole portion 73a, piston 73 comprises an opening on the bottom, the center of the bottom opening intersecting the center axis C, suction passage portion 90 is a side opening in the sidewall of the piston 73). In view of Sueyasu, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that the configuration of the openings of a valve stem vary amongst valve design, that the openings on the valve stem of Sueyasu are a widely-known suction valve arrangement, and that the suction valve of Sueyasu is an alternative equivalent to the suction valve of Morton configured to accomplish the same task of controlling suction flow in a medical instrument.
While Morton discloses the valve stem being formed of a degradable material such as biodegradable polypropylene, Morton fails to further disclose potential materials to form the valve stem such as magnesium, zinc, iron, or other biodegradable polymers. In the same field of endeavor, Lee teaches an endoscopic instrument (instrument or system 100 [0061]) for use in connection with a clip (clip 10 [0061]), wherein the clip may be formed from biodegradable material, wherein the biodegradable material may be a biodegradable polymer such as biodegradable polypropylene, but also may be formed of multiple types of metal alloys and multiple other types of biodegradable polymer ([0020, 0060]). In view of Lee, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that the metal alloys and various biodegradable polymers mentioned by Lee are an equivalent alternative biodegradable material to be used to manufacture parts of medical instruments.
Regarding claim 2, Morton, modified by Sueyasu and Lee, discloses the valve assembly of claim 1. Lee further teaches wherein the degradable material is pure Mg or an alloy of Mg with a higher degradation rate than pure Mg (clip may be formed of magnesium alloy [0060]).
Regarding claim 3, Morton, modified by Sueyasu and Lee, discloses the valve assembly of claim 1. Lee further teaches wherein the degradable material is pure Zn or an alloy of Zn with a higher degradation rate than pure Zn (clip may be formed of zinc alloy [0060]).
Regarding claim 4, Morton, modified by Sueyasu and Lee, discloses the valve assembly of claim 1. Lee further teaches wherein the degradable material is an alloy of Fe with a higher degradation rate than pure Fe (clip may be formed of iron alloy [0060]).
Regarding claim 5, Morton, modified by Sueyasu and Lee, discloses the valve assembly of claim 1. Lee further teaches wherein the degradable material is a polymer with a higher degradation rate than polycarbonate (it is commonly known that polycarbonate is not biodegradable, thus it is very likely the biodegradable polymers of Lee [0060] would have a higher degradation rate than polycarbonate).
Regarding claim 6, Morton, modified by Sueyasu and Lee, discloses the valve assembly of claim 5. Lee further teaches wherein the polymer is polylactic acid, polyglycolic acid, polylactic-co-glycolic acid, polycaprolactone, or polyhydroxyalkanoate (polymer may be formed of polylactic acid [0060]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Morton in view of Sueyasu, Lee and Un et al. (US2024/0315544).
Regarding claim 7, Morton, modified by Sueyasu and Lee, discloses the valve assembly of claim 1, but fails to disclose wherein the degradable material may also be wood pulp coated with a degradable polymer. In the same field of endeavor, Un teaches an otoscope, wherein the entirety or each component comprising the otoscope can be produced from biodegradable, compostable or recyclable materials, including wood pulp coated with a degradable polymer (compostable material may originate from cellulose or paper, biodegradable plastics such as polylactic acid, polyhydroxyalkanoates, and polycaprolactone [0087-0088]). In view of Un, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included various other biodegradable materials, including the cellulose or paper and biodegradable plastics as taught by Un, to form any part of a valve assembly of a medical device, as it is known in the art that manufacturing products from biodegradable, compostable or recyclable materials is an environmentally friendly alternative that naturally break down over time, reducing pollution and waste accumulation [0087].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Morton in view of Sueyasu, Lee and Trovato (US2009/0306633).
Regarding claim 8, Morton, modified by Sueyasu and Lee, discloses the valve assembly of claim 1, but fails to explicitly disclose wherein the spring member is made entirely of a degradable material. In the same field of endeavor, Trovato teaches an ingestible capsule comprising an outer housing, a medicament reservoir for storing medicament, and an electronically controlled valve for dispensing the medicaments stored in the medicament reservoir ([0050]). Trovato further teaches the ingestible capsule comprising a spring member to act as a pressure mechanism to ensure that the medicament is directed toward the valve ([0068]), wherein the spring member is made of a degradable material (pressure mechanism 116 is preferable a biodegradable spring [0068]). In view of Trovato, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the spring member from a degradable material, as it is known in the art, and is beneficial for the environment and promotes sustainability.
Claims 9, 12-14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Morton in view of Sueyasu, Trovato, and Lee.
Regarding claim 9, Morton discloses a valve assembly for a medical device, comprising: a valve body having a suction source passage (Fig. 2 & 3: valve body 42 comprises outlet 40 [0095]; outlet 40 is connected to vacuum port 32 [0093]; vacuum port 32 is connected to hose 34 to a suction pump P [0090]) and a working passage (Fig. 2 & 3: valve body 42 comprises inlet 38 which connects to suction channel 30 [0093]); a valve cap positioned above the valve body (Fig. 2: suction button 28 [0090]; Fig. 2: button portion 58 and suction button 28 appear to point to the same feature, positioned above valve body 42); a spring member positioned between the valve cap and the valve body such that (Fig. 3: valve spring 50 is positioned between the button portion 58 and valve body 42), when the valve cap is pushed downward relative to the valve body, the spring member applies upward force against the valve cap (spring 50 is preloaded in the closed state of the suction valve as shown in Fig. 4 [0108]); and a valve shaft connected to the valve cap (stem 56 is attached to the button portion 58 [0100]), the valve shaft comprising a side wall having a side opening (side wall of stem 56 comprises through hole 76 [0104]), the valve shaft configured to translate within the valve body between an upper position and a lower position (Fig 4: stem 56 in upper position and closed state; Fig. 5: stem 56 in lower position and open state).
Morton fails to disclose wherein the valve stem comprises a top opening and a bottom opening. In the same field of endeavor, Sueyasu teaches a medical valve comprising a valve body having a suction source passage and a working passage (Fig. 2A: fluid plug unit 70 comprising cylinder 71 having suction conduit portion 63 and suction conduit portion 61 [0073]); a valve cap positioned above the valve body (pushing portion 391b [0073]); a spring member positioned between the valve cap and the valve body such that, when the valve cap is pushed downward relative to the valve body, the spring member applies upward force against the valve cap (urging member 77 disposed between the pushing portion 391b and cylinder 71, wherein the urging member 77 has an urging force to urge the pushing portion 391b upward [0087]); and a valve shaft connected to the valve cap (Fig. 2A: piston 73 is connected to pushing portion 391b [0087]), the valve shaft configured to translate within the valve body between an upper position and a lower position (piston 73 can be pressed downward to a lower position, the leakage suppression state, as seen in Fig. 2B, and an upper position, the suction state, as seen in Fig. 2A). Sueyasu further teaches the valve shaft comprising a top opening and bottom opening and a sidewall comprising a side opening (Fig. 2A: vent hole portion 73a, piston 73 comprises an opening on the bottom, the center of the bottom opening intersecting the center axis C, suction passage portion 90 is a side opening in the sidewall of the piston 73). In view of Sueyasu, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that the configuration of the openings of a valve stem vary amongst valve design, that the openings on the valve stem of Sueyasu are a widely-known suction valve arrangement, and that the suction valve of Sueyasu is an alternative equivalent to the suction valve of Morton configured to accomplish the same task of controlling suction flow in a medical instrument.
Morton also fails to disclose wherein the spring member is made entirely of degradable material, however, in the same field of endeavor, Trovato teaches an ingestible capsule comprising an outer housing, a medicament reservoir for storing medicament, and an electronically controlled valve for dispensing the medicaments stored in the medicament reservoir ([0050]). Trovato further teaches the ingestible capsule comprising a spring member to act as a pressure mechanism to ensure that the medicament is directed toward the valve ([0068]), wherein the spring member is made of a degradable material (pressure mechanism 116 is preferable a biodegradable spring [0068]). In view of Trovato, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the spring member from a degradable material, as it is known in the art, and is beneficial for the environment and promotes sustainability.
While Morton discloses the valve stem being formed of a degradable material such as biodegradable polypropylene, Morton fails to further disclose potential materials to form the valve stem such as magnesium, zinc, iron, or other biodegradable polymers. In the same field of endeavor, Lee teaches an endoscopic instrument (instrument or system 100 [0061]) for use in connection with a clip (clip 10 [0061]), wherein the clip may be formed from biodegradable material, wherein the biodegradable material may be a biodegradable polymer such as biodegradable polypropylene, but also may be formed of multiple types of metal alloys and multiple other types of biodegradable polymer ([0020, 0060]). In view of Lee, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that the metal alloys and various biodegradable polymers mentioned by Lee are an equivalent alternative biodegradable material to be used to manufacture parts of medical instruments.
Regarding claim 12, Morton, modified by Sueyasu, Trovato, and Lee, discloses the valve assembly of claim 9. Lee further teaches wherein the degradable material is pure Mg, an alloy of Mg with a higher degradation rate than pure Mg, pure Zn, an alloy of Zn with a higher degradation rate than pure Zn, or an alloy of Fe with a higher degradation rate than pure Fe (clip may be formed of magnesium alloy, zinc alloy or iron alloy [0060]).
Regarding claim 13, Morton, modified by Sueyasu, Trovato, and Lee, discloses the valve assembly of claim 9. Lee further teaches wherein the degradable material is a polymer with a higher degradation rate than polycarbonate (it is commonly known that polycarbonate is not biodegradable, thus it is very likely the biodegradable polymers of Lee [0060] would have a higher degradation rate than polycarbonate).
Regarding claim 14, Morton, modified by Sueyasu, Trovato, and Lee, discloses the valve assembly of claim 13. Lee further teaches wherein the polymer is polylactic acid, polyglycolic acid, polylactic-co-glycolic acid, polycaprolactone, or polyhydroxyalkanoate (polymer may be formed of polylactic acid [0060]).
Regarding claim 16, Morton, modified by Sueyasu, Trovato, and Lee, discloses the valve assembly of claim 9. Morton further discloses wherein the valve shaft is made entirely of a degradable material (valve stem are preferably made from thermoplastic polymer, such as biodegradable polypropylene [0059]).
Regarding claim 17, Morton, modified by Sueyasu, Trovato, and Lee, discloses the valve assembly of claim 16. Morton discloses wherein the valve shaft is formed of a biodegradable polypropylene ([0059]). Trovato teaches wherein the spring member is made from a biodegradable material but does not specify the biodegradable material ([0068]). Both Morton and Trovato fail to teach wherein the spring member and the valve shaft are formed of the same material. However, since the valve shaft and spring member are formed of degradable materials to reduce the environmental impact of disposing the valve, one of ordinary skill in the art would recognize that the valve shaft and spring member formed of two different biodegradable material would still provide the predictable result of being biodegradable and reducing environmental impact when disposed. The specific biodegradable material, where there is no disclosed significance to which biodegradable material is used for manufacturing the valve shaft and spring member, is a design consideration within the skill of the art. Since Applicant has not disclosed that manufacturing the valve shaft and the spring member from the same degradable material provides an advantage or solves a stated problem, one of ordinary skill would expect a valve comprising a valve shaft and stem formed of the same degradable material to perform just as well as a valve comprising a valve shaft and stem formed of two different degradable materials, since the two different biodegradable materials would degrade similarly to the one degradable material. Therefore, it would have been an obvious matter of design choice to form the valve shaft and spring member from the same degradable material.
Regarding claim 18, Morton, modified by Sueyasu, Trovato, and Lee, discloses the valve assembly of claim 16. Trovato teaches wherein the spring member is made of a first degradable material (biodegradable spring [0068]) and Morton teaches wherein the valve shaft is made of a second degradable material (valve stem preferably formed from biodegradable polypropylene [0059]) and wherein the spring member is elastic (valve spring is made from elastic material such as rubber [0050]). While Morton and Trovato fails to explicitly teach wherein the second degradable material is of higher rigidity than the first degradable material, since the spring member is intended to elastically expand and shrink, and the valve shaft appears to maintain its shape while an external force presses down on the valve shaft and the spring member, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the spring member is formed of a material that is less rigid than the material of the valve shaft. Further, Applicant has not disclosed that manufacturing the valve shaft of a second degradable material more rigid than the first degradable material of the spring member provides an advantage or solves a stated problem, thus one of ordinary skill could expect that a spring member formed of a first degradable material and a valve shaft formed of a second degradable material, wherein the second degradable material has a higher rigidity than the first degradable material, would perform its function within the valve and similarly degrade naturally as a spring member and valve shaft formed of the first degradable material and second degradable material, respectively, wherein the first degradable material has a higher rigidity than the second degradable material.
Regarding claim 19, Morton, modified by Sueyasu, Trovato, and Lee, discloses the valve assembly of claim 16. Lee further teaches wherein the valve shaft is made entirely of a polymer with a higher degradation rate than polycarbonate (it is commonly known that polycarbonate is not biodegradable, thus it is very likely the biodegradable polymers of Lee [0060] would have a higher degradation rate than polycarbonate).
Regarding claim 20, Morton, modified by Sueyasu, Trovato, and Lee, discloses the valve assembly of claim 19. Lee further teaches wherein the polymer is polylactic acid (PLA), polyglycolic acid (PGA), polylactic-co-glycolic acid (PLGA), polycaprolactone (PCL), or polyhydroxyalkanoate (PHA) (polymer may be formed of polylactic acid [0060]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Morton in view of Sueyasu, Trovato, Lee and Millius (US2022/0368195).
Regarding claim 10, Morton, modified by Sueyasu, Trovato, and Lee, discloses the valve assembly of claim 9, but fail to disclose wherein the spring member is a spring lever. In the same field of endeavor, Millius teaches a fluid valve comprising a biasing member to bias the valve toward a closed position, further teaching wherein the biasing member may be a spring, lever, or compressible substance ([0086]). In view of Millius, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized the spring member of Morton may be substituted with equivalent alternatives such as the lever or compressible substance as taught by Millius, as it is known in the valve art that such biasing members are capable of performing the same task of biasing the valve to the closed position.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Morton in view of Sueyasu, Trovato, Lee and Narasimhan et al. (US2023/0258060).
Regarding claim 11, Morton, modified by Sueyasu, Trovato, and Lee, discloses the valve assembly of claim 9, but fail to disclose wherein the spring member is a wavy washer stack or a disc washer stack. In the same field of endeavor, Narasimhan teaches a fluid valve comprising a biasing member to bias the valve toward a closed position, further teaching wherein the biasing member may be a wave spring, disk washers, and/or wave springs ([0040-0043]), which may be stacked ([0042]). In view of Narasimhan, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized the spring member of Morton may be substituted with equivalent alternatives such as the disk washer or wave springs as taught by Narasimhan, as it is known in the valve art that such biasing members are capable of performing the same task of biasing the valve to the closed position.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Morton in view of Sueyasu, Trovato, Lee and Un.
Regarding claim 15, Morton, modified by Sueyasu, Trovato, and Lee, discloses the valve assembly of claim 9, but fails to disclose wherein the degradable material is wood pulp coated with a degradable polymer. In the same field of endeavor, Un teaches an otoscope, wherein the entirety or each component comprising the otoscope can be produced from biodegradable, compostable or recyclable materials, including wood pulp coated with a degradable polymer (compostable material may originate from cellulose or paper, biodegradable plastics such as polylactic acid, polyhydroxyalkanoates, and polycaprolactone [0087-0088]). In view of Un, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included various other biodegradable materials, including the cellulose or paper and biodegradable plastics as taught by Un, to form any part of a valve assembly of a medical device, as it is known in the art that manufacturing products from biodegradable, compostable or recyclable materials is an environmentally friendly alternative that naturally break down over time, reducing pollution and waste accumulation [0087].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See referenced cited in PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5.
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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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/LI-TING SONG/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
6/19/26
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