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 filed 12/12/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Drawings
The drawings are objected to because as stated in MPEP 608.02V, sectional views require cross-hatching. 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 Objections
Claims 37-41 and 43 are objected to because of the following informalities: in claim 37, line 6, “stem placing the” should read --stem; placing the--. Appropriate correction is required.
Claims not specifically referenced are objected to as being dependent on an objected to base claim.
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 40 and 41 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.
Regarding claim 40, the limitation “or (ii) over molding a boot on the spring stanchion or (iii) over molding a boot onto the spring stanchion” is unclear and indefinite. It appears that limitation (ii) and (iii) of claim 40 are the same limitation.
Claim 41 recites the limitation "the gasket" in line 2 and “the lubricant” in line 5. There is insufficient antecedent basis for these limitations in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 15, 16, 17, 18, 19, 20, 23, 26, 37, 38, 39, 40, and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 56, 11, 13, 28, 28, 29, 30, and 1 of U.S. Patent No. 12,207,789. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 2, 3, 4, 56, 11, 13, 28, 28, 29, 30, and 1 of U.S. Patent No. 12,207,789 anticipates Application claims 15, 16, 17, 18, 19, 20, 23, 26, 37, 38, 39, 40, and 42. Accordingly, claims 15, 16, 17, 18, 19, 20, 23, 26, 37, 38, 39, 40, and 42 are not patentability distinct from claims 1, 2, 3, 4, 56, 11, 13, 28, 28, 29, 30, and 1 of U.S. Patent No. 12,207,789.
Differences between the claims are underlined.
Here, U.S. Patent No. 12,207,789 claim 1 requires:
A disposable valve assembly configured for use with an endoscope, the disposable valve assembly comprising: a stem comprising a proximal end and a distal end and a first opening disposed along a longitudinal axis of the stem and extending from the proximal end to the distal end of the stem, the stem comprising a thermoplastic material and a second opening transverse to and intersecting with the first opening, the second opening of the stem extending through the stem; a spring stanchion comprising an opening configured to receive the stem, the spring stanchion and/or a spring configured to allow movement of the stem in an upward and downward direction relative to the proximal and/or distal end; and the spring configured to contact the spring stanchion, wherein the disposable valve assembly comprises an umbrella valve disposed adjacent to the distal end and the umbrella valve has a convex shape concaving downward toward the distal end of the stem.
While Application claim 15 requires:
A disposable valve assembly configured for use with an endoscope, the disposable valve assembly comprising: a stem comprising a proximal end and a distal end and a first opening disposed along a longitudinal axis of the stem, the stem comprising a thermoplastic material and a second opening transverse to and intersecting with the first opening, the second opening of the stem partially extending through the stem; a spring stanchion comprising an opening configured to receive the stem, the spring stanchion and/or a spring configured to allow movement of the stem in an upward and downward direction relative to the proximal and/or distal end; and the spring configured to contact the spring stanchion.
Here, U.S. Patent No. 12,207,789 claim 28 requires:
A method for manufacturing a disposable air/water valve assembly configured for use with an endoscope, the method comprising: separately molding a valve stem, cap and spring stanchion, wherein the stem comprises a proximal end and a distal end and a first opening disposed along a longitudinal axis of the stem and extending from the proximal end to the distal end of the stem, the first opening facing the longitudinal direction at an end face of the distal end of the stem, the stem comprising a second opening transverse to and intersecting with the first opening, the second opening of the stem extending through the stem; placing the proximal end of the stem through a stem opening in the spring stanchion; placing the proximal end of the stem through the center of a spring; and attaching the cap onto the proximal end of the stem and securing with a stem insert, wherein the method further comprises disposing an umbrella valve adjacent to the distal end and the umbrella valve has a convex shape concaving downward toward the distal end of the stem.
While Application claim 37 requires:
A method for manufacturing a suction disposable valve assembly configured for use with an endoscope, the method comprising: separately molding a valve stem, cap and spring stanchion, wherein the stem comprises a proximal end and a distal end and a first opening disposed along a longitudinal axis of the stem, the stem comprising a second opening transverse to and intersecting with the first opening, the second opening of the stem partially extending through the stem; placing the proximal end of the stem through a stem opening in the spring stanchion; placing the proximal end of the stem through the center of a spring; attaching the cap onto the proximal end of the stem.
Thus, it is apparent that the more specific U.S. Patent No. 12,207,789 claims 1 and 28 encompass Application claims 15 and 37. Following the rationale in In re Goodman cited in the preceding paragraph, wherein Applicant has one been granted a patent containing a claim for the specific or narrower invention, Applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Note that since U.S. Patent No. 12,207,789 anticipates Application claims 15 and 37, and since anticipation is the epitome of obviousness, then Application claims 15 and 37 are obvious over U.S. Patent No. 12,207,789.
Similarly, claims 16, 17, 18, 19, 20, 23, 26, 38, 39, 40, and 42 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 2, 3, 4, 56, 11, 13, 28, 29, 30, and 1, respectively for the same reason set forth above.
Claims 24 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 28 of U.S. Patent No. 12,207,789 in view of Ishibiki (JP 2002/306405).
Regarding claim 24, U.S. Patent No. 12,207,789 does not recite (i) a plurality of gaskets disposed at the distal end of the stem; or (ii) dual gaskets disposed at the distal end of the stem.
Ishibiki teaches (i) a plurality of gaskets (59, 60b) disposed at a distal end of a stem 58; or (ii) dual gaskets disposed at the distal end of the stem.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified U.S. Patent No. 12,207,789 to provide (i) a plurality of gaskets disposed at the distal end of the stem; or (ii) dual gaskets disposed at the distal end of the stem, as taught by Ishibiki. Doing so would provide sealing through the valve assembly.
Regarding claim 43, U.S. Patent No. 12,207,789 does not recite wherein the stem comprises plastic material.
Ishibiki teaches wherein a stem comprises plastic material (see translation paragraph 0089).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified U.S. Patent No. 12,207,789 to provide wherein the stem comprises plastic material. Doing so would provide a rigid material for the stem (see translation paragraph 0089), as recognized by Ishibiki.
Claims 25, 27, and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 and 28 of U.S. Patent No. 12,207,789 in view Levey (U.S. 2009/0112064).
Regarding claims 25, 27, and 41 U.S. Patent No. 12,207,789 does not recite wherein the lubricant comprises an antimicrobial agent; wherein (i) the lubricant comprises silicone-based grease, non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant or a combination thereof.
Levey teaches an endoscope wherein a lubricant comprises an antimicrobial agent (see paragraph 0045); wherein (i) a lubricant comprises silicone-based grease, non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant or a combination thereof (see paragraph 0045).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified U.S. Patent No. 12,207,789 to provide wherein the lubricant comprises an antimicrobial agent; wherein (i) the lubricant comprises silicone-based grease, non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant or a combination thereof. Doing so would make the valve sterile (see paragraph 0045), as recognized by Levey.
Claim Rejections - 35 USC § 102
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.
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Annotated Figure 26 from Ishibiki.
Claim(s) 15, 16, 18, 20, 24, 37, 38, and 40-43, as best understood, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishibiki (JP 2002/306405).
Regarding claim 15, Ishibiki discloses:
A disposable valve assembly (Figure 26) configured for use with an endoscope (2), the disposable valve assembly (Figure 26) comprising: a stem (58) comprising a proximal end (top end) and a distal end (bottom end) and a first opening (see annotated figure above) disposed along a longitudinal axis of the stem (58), the stem (58) comprising a thermoplastic material and a second opening (48) transverse to and intersecting with the first opening (see annotated figure above), the second opening (48) of the stem partially extending through the stem 58 (see translation paragraph 0089); a spring stanchion (53) comprising an opening configured to receive the stem (58), the spring stanchion (53) and/or a spring (62) configured to allow movement of the stem (58) in an upward and downward direction relative to the proximal and/or distal end (see translation paragraph 0103); and the spring (62) configured to contact the spring stanchion 53 (see Figure 26)
Further regarding the limitation “the second opening of the stem partially extending through the stem”, the term partially does not exclude the second opening extending fully through the stem. An opening that extends fully through also extends partially through.
Regarding claim 16, Ishibiki discloses:
wherein the disposable valve assembly (Figure 26) is used to allow suction through the endoscope 2 (see translation paragraph 0041)
Regarding claim 18, Ishibiki discloses:
wherein the disposable valve assembly (Figure 26) further comprises a cap (66), the cap (66) configured to engage the stem 58 (see Figure 26)
Regarding claim 20, Ishibiki discloses:
wherein the disposable valve assembly (Figure 26) further comprises a boot (50) having a diameter greater than the spring stanchion (53) and configured to engage the spring stanchion 53 (see Figure 26; see translation paragraph 0104)
Regarding claim 24, Ishibiki discloses:
(i) a plurality of gaskets (59, 60b) disposed at a distal end (see annotated figure above) of a stem 58; or (ii) dual gaskets (59, 60b) disposed at the distal end (see annotated figure above) of the stem 58
Regarding claim 37, Ishibiki discloses:
A method for manufacturing a suction disposable assembly (Figure 26) configured for use with an endoscope (2), the method comprising: separately molding a valve stem (58), cap (66) and spring stanchion (53), wherein the stem (58) comprises a proximal end (see annotated figure above) and a distal end (see annotated figure above) and a first opening (see annotated figure above) disposed along a longitudinal axis of the stem (58), the stem (58) comprising a second opening (48) transverse to and intersecting with the first opening (see annotated figure above), the second opening (48) of the stem (58) partially extending through the stem 58 (see Figure 26); placing the proximal end (see annotated figure above) of the stem (58) through a stem opening in the spring stanchion 53 (see Figure 26); placing the proximal end (see annotated figure above) of the stem (58) through the center of a spring 62 (see Figure 26); and attaching the cap (66) onto the proximal end (see annotated figure above) of the stem 58 (see translation paragraph 0095, 0102, and 0105)
Further regarding the limitation “the second opening of the stem partially extending through the stem”, the term partially does not exclude the second opening extending fully through the stem. An opening that extends fully through also extends partially through.
Regarding claim 38, Ishibiki discloses:
Securing the cap (66) with a stem insert 46 (see translation paragraph 0095, 0102, and 0105)
Regarding claim 40, Ishibiki discloses:
comprising (i) over molding gaskets (60a, 60b) on the stem 58 (see translation paragraphs 0099 and 0100); (ii) over molding a boot (50) onto the spring stanchion 53 (see paragraph 0105)
Regarding claim 41, Ishibiki discloses:
wherein the stem (58) comprises gaskets (60a, 60b, 60c) to assure an air-tight seal within a suction port or the stem 58
Regarding claims 42 and 43, Ishibiki discloses:
wherein the stem (58) comprises a plastic material (see translation paragraph 0089)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
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) 17 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishibiki in view of Dorsey, III (U.S. Patent No. 5,522,796).
Regarding claims 17 and 39, Ishibiki discloses the invention as essentially claimed but fails to disclose wherein a lubricant is disposed on the stem, spring stanchion and/or the spring; wherein the method further comprises applying a lubricant onto the stem, spring and/or spring stanchion.
Dorsey, III teaches a medical valve wherein a lubricant is disposed on a stem, spring stanchion and/or a spring 26 (Col. 6, lines 42-62).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified Ishibiki to provide wherein a lubricant is disposed on the stem, spring stanchion and/or the spring, as taught by Dorsey, III. Doing so would ensure easy movement of the spring.
Claim(s) 19 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishibiki in view of Yamane (U.S. 2013/0138061).
Regarding claims 19 and 23, Ishibiki discloses the invention as essentially claimed but fails to disclose wherein the disposable valve assembly further comprises a cap having a fitting to snap fit with the stem; wherein the cap comprises a plurality of projections configured to receive a stem insert at one end and to snap fit onto the stem at the opposite end.
Yamane teaches an endoscope wherein a disposable valve assembly (103) further comprises a cap (25, 110) having a fitting to snap fit with a stem 105 (see paragraph 0072); wherein the cap (25, 110) comprises a plurality of projections (112, 113, 114) configured to receive a stem insert (107) at one end and to snap fit onto the stem (105) at the opposite end (see Figure 10).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified Ishibiki to provide wherein the disposable valve assembly further comprises a cap having a fitting to snap fit with the stem; wherein the cap comprises a plurality of projections configured to receive a stem insert at one end and to snap fit onto the stem at the opposite end. Doing so would ensure a smooth coupling of the elements (see paragraph 0072), as recognized by Yamane.
Claim(s) 25 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishibiki in view of Dorsey, III, in further view of Levey et al. (U.S. 2009/0112064).
Regarding claims 25 and 27, Ishibiki as modified teaches the invention as essentially claimed but fails to teach wherein the lubricant comprises an antimicrobial agent; wherein (i) the lubricant comprises silicone-based grease, non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant or a combination thereof.
Levey teaches an endoscope wherein a lubricant comprises an antimicrobial agent (see paragraph 0045); wherein (i) the lubricant comprises silicone-based grease, non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant or a combination thereof (see paragraph 0045).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified Ishibiki to provide wherein a lubricant comprises an antimicrobial agent; wherein (i) the lubricant comprises silicone-based grease, non-silicone based grease, or a combination thereof; and/or (ii) the antimicrobial agent is an antibiotic, an antiseptic, an antiviral agent, an antifungal agent, a disinfectant or a combination thereof. Doing so would make the valve sterile (see paragraph 0045), as recognized by Levey.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishibiki in view of Ishiguro et al. (U.S. Patent No. 5,871,441).
Regarding claim 26, Ishibiki discloses the invention as essentially claimed but fails to disclose wherein (i) the thermoplastic material comprises an antimicrobial agent; and/or (ii) the thermoplastic material has an antimicrobial agent coated thereon.
Ishiguro teaches an endoscope wherein (i) a thermoplastic material comprises an antimicrobial agent (Col. 1, lines 40-55); and/or (ii) the thermoplastic material has an antimicrobial agent coated thereon (Col. 1, lines 40-55).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified Ishibiki to provide wherein (i) the thermoplastic material comprises an antimicrobial agent; and/or (ii) the thermoplastic material has an antimicrobial agent coated thereon. Doing so would disinfect the valve (Col. 1, lines 40-55), as recognized by Ishiguro.
Allowable Subject Matter
Claims 21 and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Xu et al. (U.S. 2016/0143516) discloses a disposable valve assembly configured for use with an endoscope, the disposable valve assembly comprising: a stem comprising a proximal end and a distal end and a first opening disposed along a longitudinal axis of the stem, the stem comprising a material and a second opening transverse to and intersecting with the first opening, the second opening of the stem partially extending through the stem; a spring stanchion comprising an opening configured to receive the stem, the spring stanchion and/or a spring configured to allow movement of the stem in an upward and downward direction relative to the proximal and/or distal end; and the spring configured to contact the spring stanchion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY E CARY whose telephone number is (571)272-9427. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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/KELSEY E CARY/Primary Examiner, Art Unit 3753