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 .
Terminal Disclaimer
The terminal disclaimer filed on 08/18/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Patent Application #18/052,998 on 11/07/2022 and #18/175,392 on 02/27/2023, has been reviewed and is accepted. The terminal disclaimer has been recorded.
Priority
2. Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 05/24/2023, 08/28/2023, and 07/12/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, this submission of the information disclosure statements is being considered by the examiner.
Response to Amendment
4. The amendment filed 08/18/2025 has been entered. Currently, claims 1-17, and 19-28 remain pending in the application. Independent claim 1 was amended without the addition of new matter to include further narrowing limitations. Additionally, claims 1, 4, 9, 17, and 25 were amended and claim 18 was cancelled to correct previous claim objections and 35 USC 101, 35 USC 112(B) rejections that were set forth in the Non-Final Office Action mailed 05/16/2025. Lastly, a pending claim objection to claim 10 remains.
Response to Arguments
5. Applicant’s amendment to independent claim 1 is sufficient to overcome the previous 35 USC § 102 and 103 rejections recited in the Non-Final Office Action mailed 05/16/2025.
Applicant’s arguments, see Remarks on Pages 8-9, filed 08/18/2025, with respect to the rejection under 35 USC § 102 and 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, the amended claims have changed the scope of the claims and upon further consideration, a new grounds of rejection is made in view of new and current prior art of record: Hindmarsh et al. (U.S. Patent Pub. No. 20230248219), Takahashi et al. (WO 2015022972 A1), Czajka et al. (U.S. Patent Pub. No. 20120222687), Roe et al. (CN 1144472 A), Jakub (U.S. Patent No. 5062159), Merrill (U.S. Patent Pub. No. 20200178628), Inoue et al. (JP 2011245017 A), Shaw (U.S. Patent No. 6357445), Schultz (U.S. Patent Pub. No. 20130296739), Khapchik (U.S. Patent Pub. No. 20140259263).
Claim Objections
Claims 10, 13-14 and 17 are objected to because of the following informalities:
In claim 10, rephrase “the sheet” to read –the planar sheet--.
In claim 13, rephrase “wherein at least one of the first or second fluid suppression member has at least a first porous member in which a first slit parallel to an insertion direction of the insertion part is formed” to read --wherein the first fluid suppression member has at least the first porous member in which the first slit parallel to an insertion direction of the insertion part is formed and/or the second fluid suppression member has at least a first porous member in which a first slit parallel to an insertion direction of the insertion part is formed—
In claim 14, rephrase “a second porous member in which a second slit parallel to the insertion direction and intersecting the first slit is formed” to read –the first fluid suppression member has the second porous member in which a second slit parallel to the insertion direction and intersecting the first slit is formed and/or the second fluid suppression member has a second porous member in which a second slit parallel to the insertion direction and intersecting the first slit is formed--.
In claim 17, rephrase “wherein of the first or second fluid suppression member, one has at least a first porous member in which a first slit parallel to an insertion direction of the insertion part is formed and the other has a second porous member in which a second slit parallel to the insertion direction and intersecting the first slit is formed, and” to read --wherein the first fluid suppression member has at least the first porous member in which the first slit parallel to an insertion direction of the insertion part is formed and the second porous member in which the second slit parallel to the insertion, and/or the second fluid suppression member has at least a first porous member in which a first slit parallel to an insertion direction of the insertion part is formed and/or a second porous member in which a second slit parallel to the insertion--.
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 limitations are: “second suppression member” in claims 3, and 12; “contractable member” in claim 5; “holding member” in claim 11; and “fixing member” in claim 12.
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. The term “member” followed by functional language is a generic placeholder for “means for”. For examination purposes, “suppression member” is interpreted as a porous slit (Specification, Paragraph 39); “contractable member” is interpreted as a gathering, elastic, or string (Paragraph 53); “holding member” is interpreted as a constraint such as a paper tape, a rubber band (Paragraph 111); “fixing member” is interpreted as a frame member and tubular member (Paragraphs 72-73)
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 § 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.
Claims 1-5, 7, 13-15, 21, 25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Hindmarsh et al. (U.S. Patent Pub. No. 20230248219) in view of Takahashi et al. (WO 2015022972 A1).
Regarding claim 1, Hindmarsh discloses an examination garment 72 (Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, garment 72 for colonoscopy comprising covering transparent material 73 covering patient body part with a hollow tube 2 therethrough forming an insertion port 7 for receiving inserted endoscope 4 and the insertion port 7 having fluid suppression valve 32,33 therein) for endoscopy, comprising: a covering portion 2,73 that is configured to cover a subject and that has an insertion port 7 into which an insertion part of an endoscope 4 is inserted; and a first fluid suppression member32,33 (Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, fluid suppression valves 32,33 having porous members) that is provided in the insertion port 7 and that suppresses passage of a fluid in the insertion port 7, wherein the first fluid suppression member 32,33 has at least a first porous member 32 (Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, fluid suppression valve 32,33 with first porous member 32 forming slit for insertion) in which a first slit is formed, and second porous member 33 (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a) in which a second slit is formed.
However, Hindmarsh fails to explicitly disclose the first porous member having three first slits formed, the second porous member having three second slits formed, one of the first slits is disposed to be perpendicular to one side of the first porous member, one of the second slits is disposed to be perpendicular to one side of the second porous member, and the first porous member and the second porous member are attached to the covering portion in a state in which the second slit is overlayed at a position rotated by 180° around a central axis parallel to the insertion direction with respect to the first slit.
Takahashi teaches the analogous first porous member (Page 4/37, Paragraph 4 and Figure 11B, upper half depth of valve 33 with three slits 55 being perpendicular to a circumferential side of the valve 33 ) having three analogous first slits 55 formed, the analogous second porous member (Page 4/37, Paragraph 4 and Figure 11B, lower half depth of valve 33 with three slits 57 being perpendicular to a circumferential side of the valve 33 and being rotated 180 degrees relative to slits 55) having three analogous second slits 57 formed, one of the analogous first slits 55 is disposed to be perpendicular to one side of the analogous first porous member, one of the analogous second slits 57 is disposed to be perpendicular to one side of the analogous second porous member, and the analogous first porous member and the analogous second porous member are attached to the analogous covering portion 13 (Page 4/27, Paragraph 2, hollow tube 13 defined as a covering portion because it forms an insertion port) in a state in which the analogous second slit 57 is overlayed at a position rotated by 180° around a central axis parallel to the analogous insertion direction with respect to the analogous first slit 55.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the first and second slit of the first and second porous members of Hindmarsh, so that there is the first porous member having three first slits formed, the second porous member having three second slits formed, one of the first slits is disposed to be perpendicular to one side of the first porous member, one of the second slits is disposed to be perpendicular to one side of the second porous member, and the first porous member and the second porous member are attached to the covering portion in a state in which the second slit is overlayed at a position rotated by 180° around a central axis parallel to the insertion direction with respect to the first slit, as taught by Takahashi, in order to provide an improved examination garment with enhanced first and second porous members that are oriented on one another with corresponding flipped slits so that sealing is effective prior and during instrument insertion (Takahashi, Page 4/37, Paragraph 4).
Regarding claim 2, the combination of Hindmarsh in view of Takahashi discloses the invention as described above. Hindmarsh further discloses wherein the covering portion 2,73 has a suction tube port 13 (Paragraph 100 and Figure 5a, suction tube port 13 with duckbill valve fluid suppression 16 on hollow tube 2 of covering portion 73 for receiving suction tube) into which a suction tube is inserted.
Regarding claim 3, the combination of Hindmarsh in view of Takahashi discloses the invention as described above. Hindmarsh further discloses a second fluid suppression member 16 (Paragraph 100 and Figure 5a, duckbill valve fluid suppression 16; this is the structure as defined by the 35 USC 112f analysis above) that is provided in the suction tube port 13 and that suppresses the passage of the fluid in the suction tube port 13.
Regarding claim 4, the combination of Hindmarsh in view of Takahashi discloses the invention as described above. Hindmarsh further discloses wherein the covering portion 2,73 (Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, pants 73) is a pants-shaped covering portion including a torso hole (Paragraph 171 and Figure 15a, torso hole with airtight torso seal 74) through which a torso portion of the subject passes and a thigh hole (Paragraph 171 and Figure 15a, left and right thigh hole with respective airtight left and right thigh seal 75,76) through which a thigh portion passes.
Regarding claim 5, the combination of Hindmarsh in view of Takahashi discloses the invention as described above. Hindmarsh further discloses wherein the covering portion 2,73 has a contractible member 75,76 (Paragraphs 158, 171 and Figure 15a, left and right thigh hole with respective airtight left and right thigh seal 75,76 is formed of neoprene rubber or silicone rubber, which are elastic contactable materials; this is the structure as defined by the 35 USC 112f analysis above), which contracts the thigh hole, provided around the thigh hole.
Regarding claim 7, the combination of Hindmarsh in view of Takahashi discloses the invention as described above. Hindmarsh further discloses wherein the contractible member75,76 (Paragraphs 158, 171 and Figure 15a, left and right thigh hole with respective airtight left and right thigh seal 75,76 is formed of neoprene rubber or silicone rubber gathering elastic contactable materials) is a gathering that is disposed around the thigh hole.
Regarding claim 13, the combination of Hindmarsh in view of Takahashi discloses the invention as described above. Hindmarsh further discloses wherein the first fluid suppression member 32,33 has at least a first porous member 32 (Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, fluid suppression valve 32,33 with first porous member 32 forming slit for insertion) in which a first slit parallel to an insertion direction of the insertion part is formed.
Regarding claim 14, the combination of Hindmarsh in view of Takahashi discloses the invention as described above and further discloses a second porous member (Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, fluid suppression valve 32,33 with second porous duckbill valve 33 forming slit for insertion; Takahashi, Page 4/37 and Figure 11B, bottom half depth of valve 33 with three slits 57 that intersect the slits 55) in which a second slit parallel to the insertion direction and intersecting the first slit is formed.
Regarding claim 15, the combination Hindmarsh in view of Takahashi discloses the invention as described above. Hindmarsh further discloses wherein the second fluid suppression member 16 (Paragraph 100 and Figure 5a, duckbill valve fluid suppression 16 attached to port 2 of covering member 2,73 forming first porous member 16) has a first porous member 16 (Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, fluid suppression valve 32,33 with first porous member 32 forming slit for insertion) in which a slit is formed.
However, the combination of Hindmarsh in view of Takahashi fails to explicitly disclose the first porous member of the second fluid suppression member has three first slits, and a second porous member in which three second slits are formed.
Takahashi further teaches an analogous first porous member (Page 4/37, Paragraph 4 and Figure 11B, upper half depth of valve 33 with three slits 55 being perpendicular to a circumferential side of the valve 33 ) of the analogous fluid suppression member 33 has three first slits 55, and a second porous member (Page 4/37, Paragraph 4 and Figure 11B, lower half depth of valve 33 with three slits 57 being perpendicular to a circumferential side of the valve 33 and being rotated 180 degrees relative to slits 55) in which three second slits 57 are formed.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the second fluid suppression member of Hindmarsh in view of Takahashi, so that the first porous member of the second fluid suppression member has three first slits, and a second porous member in which three second slits are formed, as taught by Takahashi, in order to provide an improved examination garment with enhanced second fluid suppression member having the first porous member and a second porous member that are oriented on one another with corresponding flipped slits so that sealing is effective prior and during instrument insertion (Takahashi, Page 4/37, Paragraph 4). Thereby, this second fluid suppression member matches the effective fluid suppression similarly to the first fluid suppression member.
Regarding claim 21, the combination of Hindmarsh in view of Takahashi discloses the invention as described above. Hindmarsh further discloses wherein the covering portion 2,73 is formed of a transparent member (Paragraph 45, transparent flexible sheet material 73).
Regarding claim 25, the combination of Hindmarsh in view of Takahashi discloses the invention as described above. Hindmarsh further discloses wherein in a case where the covering portion 2,73 has covered a periphery of a torso hole (Paragraph 171 and Figure 15a, torso hole with airtight torso seal 74 formed by gathering of neoprene rubber or silicone rubber elastic contactable materials), a gathering is provided at a point located on a torso portion of the subject.
Regarding claim 27, the combination of Hindmarsh in view of Takahashi discloses the invention as described above. Hindmarsh further discloses wherein the covering portion 2,73 has a cleaning liquid injection port 22 (Paragraph 106, 111, and Figure 3, cleaning liquid injection port 22 for injecting cleaning liquid 26 thereinto) for injecting a cleaning liquid 26 thereinto.
Claims 1-3 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Czajka et al. (U.S. Patent Pub. No. 20120222687) in view of Hindmarsh et al. (U.S. Patent Pub. No. 20230248219) and in further view of Takahashi et al. (WO 2015022972 A1).
Regarding claim 1, Czajka discloses an examination garment (Paragraphs 34-35 and 42 and Figure 6, garment capable of being used during endoscopy comprising covering drape 200 covering patient body part, with a fenestration 201 for a providing a port for a surgical/medical procedure therethrough as well as a separate suction port 600 outside of fenestration area 201) for endoscopy, comprising: a covering portion 200 that is configured to cover a subject and that has an insertion port 201.
However, Czajka fails to explicitly disclose (1) an insertion part of an endoscope is inserted into the insertion port; and a first fluid suppression member that is provided in the insertion port and that suppresses passage of a fluid in the insertion port; (2) the first porous member having three first slits formed, the second porous member having three second slits formed, one of the first slits is disposed to be perpendicular to one side of the first porous member, one of the second slits is disposed to be perpendicular to one side of the second porous member, and the first porous member and the second porous member are attached to the covering portion in a state in which the second slit is overlayed at a position rotated by 180° around a central axis parallel to the insertion direction with respect to the first slit.
Hindmarsh teaches an analogous examination garment 72 (Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, garment 72 for colonoscopy comprising covering transparent material 73 covering patient body part with a hollow tube 2 therethrough forming an insertion port 7 for receiving inserted endoscope 4 and the insertion port 7 having fluid suppression valve 32,33 therein) wherein an insertion part of an endoscope is inserted into the analogous insertion port 7; and a first fluid suppression member 32,33 (Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, fluid suppression valves 32,33 having porous members) that is provided in the analogous insertion port 7 and that suppresses passage of a fluid in the analogous insertion port 7.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the insertion port of Czajka, so that an insertion part of an endoscope is inserted into the insertion port; and a first fluid suppression member that is provided in the insertion port and that suppresses passage of a fluid in the insertion port, as taught by Hindmarsh, in order to provide an improved examination garment with an enhanced insertion port having an endoscope dimension as well as suppression valves for preventing fluid backflow and maintaining sterility throughout the medical endoscopy procedure (Hindmarsh, Paragraphs 76, 117-119, 170-178).
However, the combination of Czajka in view of Hindmarsh fails to explicitly disclose (2) the first porous member having three first slits formed, the second porous member having three second slits formed, one of the first slits is disposed to be perpendicular to one side of the first porous member, one of the second slits is disposed to be perpendicular to one side of the second porous member, and the first porous member and the second porous member are attached to the covering portion in a state in which the second slit is overlayed at a position rotated by 180° around a central axis parallel to the insertion direction with respect to the first slit.
Takahashi teaches the analogous first porous member (Page 4/37, Paragraph 4 and Figure 11B, upper half depth of valve 33 with three slits 55 being perpendicular to a circumferential side of the valve 33 ) having three analogous first slits 55 formed, the analogous second porous member (Page 4/37, Paragraph 4 and Figure 11B, lower half depth of valve 33 with three slits 57 being perpendicular to a circumferential side of the valve 33 and being rotated 180 degrees relative to slits 55) having three analogous second slits 57 formed, one of the analogous first slits 55 is disposed to be perpendicular to one side of the analogous first porous member, one of the analogous second slits 57 is disposed to be perpendicular to one side of the analogous second porous member, and the analogous first porous member and the analogous second porous member are attached to the analogous covering portion 13 (Page 4/27, Paragraph 2, hollow tube 13 defined as a covering portion because it forms an insertion port) in a state in which the analogous second slit 57 is overlayed at a position rotated by 180° around a central axis parallel to the analogous insertion direction with respect to the analogous first slit 55.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the first and second slit of the first and second porous members of Czajka in view of Hindmarsh, so that there is the first porous member having three first slits formed, the second porous member having three second slits formed, one of the first slits is disposed to be perpendicular to one side of the first porous member, one of the second slits is disposed to be perpendicular to one side of the second porous member, and the first porous member and the second porous member are attached to the covering portion in a state in which the second slit is overlayed at a position rotated by 180° around a central axis parallel to the insertion direction with respect to the first slit, as taught by Takahashi, in order to provide an improved examination garment with enhanced first and second porous members that are oriented on one another with corresponding flipped slits so that sealing is effective prior and during instrument insertion (Takahashi, Page 4/37, Paragraph 4).
Regarding claim 2, the combination of Czajka in view of Hindmarsh in view of Takahashi discloses the invention as described above. Czajka further discloses wherein the covering portion 200 (Paragraphs 34-35, 42, 53 and Figure 6, covering drape 200 covering patient body part, with a fenestration 201 for a providing a port for a surgical/medical procedure therethrough as well as a separate suction port 600 outside of fenestration area 201) has a suction tube port 600 into which a suction tube is inserted (Paragraph 53).
Regarding claim 3, the combination of Czajka in view of Hindmarsh in view of Takahashi discloses the invention as described above but fails to explicitly disclose a second fluid suppression member that is provided in the suction tube port and that suppresses the passage of the fluid in the suction tube port.
Hindmarsh further teaches a second fluid suppression member 16 (Paragraph 100 and Figure 5a, duckbill valve fluid suppression 16; this is the structure as defined by the 35 USC 112f analysis above) that is provided in the analogous suction tube port 13 (Paragraph 100 and Figure 5a, suction tube port 13 with duckbill valve fluid suppression 16 on hollow tube 2 of covering portion 73 for receiving suction tube) and that suppresses the passage of the fluid in the analogous suction tube port 13.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the suction tube port of Czajka in view of Hindmarsh in view of Takahashi, so that a second fluid suppression member is provided in the suction tube port and that suppresses the passage of the fluid in the suction tube port, as taught by Hindmarsh, in order to provide an improved examination garment with an enhanced suction tube port that directly controls fluid flow through the port to prevents undesirable leakage and maintain sterility (Hindmarsh, Paragraph 100).
Regarding claim 13, the combination of Czajka in view of Hindmarsh in view of Takahashi in discloses the invention as described above and further discloses wherein the first fluid suppression member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a: suppression members 32,33; Takahashi, Page 4/37 and Figure 4: top half depth and bottom half depth of valve 33) has at least a first porous member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, fluid suppression valve 32,33 with first porous member 32 forming slit for insertion; Takahashi, Page 4/37 and Figure 4: top half depth with three first slits 55) in which a first slit parallel to an insertion direction of the insertion part is formed.
Regarding claim 14, the combination of Czajka in view of Hindmarsh in view of Takahashi discloses the invention as described above and further discloses a second porous member (Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, fluid suppression valve 32,33 with second porous duckbill valve 33 forming slit for insertion; Takahashi, Page 4/37 and Figure 11B, bottom half depth of valve 33 with three slits 57 that intersect the slits 55) in which a second slit parallel to the insertion direction and intersecting the first slit is formed.
Regarding claim 15, the combination Czajka in view of Hindmarsh in view of Takahashi discloses the invention as described above. Hindmarsh further discloses wherein the second fluid suppression member 16 (Paragraph 100 and Figure 5a, duckbill valve fluid suppression 16 attached to port 2 of covering member 2,73 forming first porous member 16) has a first porous member 16 (Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, fluid suppression valve 32,33 with first porous member 32 forming slit for insertion) in which a slit is formed.
However, the combination of Czajka in view of Hindmarsh in view of Takahashi fails to explicitly disclose the first porous member of the second fluid suppression member has three first slits, and a second porous member in which three second slits are formed.
Takahashi further teaches an analogous first porous member (Page 4/37, Paragraph 4 and Figure 11B, upper half depth of valve 33 with three slits 55 being perpendicular to a circumferential side of the valve 33 ) of the analogous fluid suppression member 33 has three first slits 55, and a second porous member (Page 4/37, Paragraph 4 and Figure 11B, lower half depth of valve 33 with three slits 57 being perpendicular to a circumferential side of the valve 33 and being rotated 180 degrees relative to slits 55) in which three second slits 57 are formed.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the second fluid suppression member of Czajka in view of Hindmarsh in view of Takahashi, so that the first porous member of the second fluid suppression member has three first slits, and a second porous member in which three second slits are formed, as taught by Takahashi, in order to provide an improved examination garment with enhanced second fluid suppression member having the first porous member and a second porous member that are oriented on one another with corresponding flipped slits so that sealing is effective prior and during instrument insertion (Takahashi, Page 4/37, Paragraph 4). Thereby, this second fluid suppression member matches the effective fluid suppression similarly to the first fluid suppression member.
14. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hindmarsh et al. (U.S. Patent Pub. No. 20230248219) in view of Takahashi et al. (WO 2015022972 A1), as applied to claim 5, in view of Merrill (U.S. Patent Pub. No. 20200178628)
Regarding claim 6, the combination Hindmarsh in view of Takahashi discloses the invention as described above. Hindmarsh further discloses wherein the contractible member 75,76 is an elastic member (Paragraphs 158, 171 and Figure 15a, left and right thigh hole with respective airtight left and right thigh seal 75,76 is formed of neoprene rubber or silicone rubber, which are elastic contactable materials).
However, the combination Hindmarsh in view of Takahashi fails to explicitly disclose the elastic member is doubly wrapped around the thigh hole.
Merill teaches an analogous thigh hole (Paragraph 63, 86, and 90 and Figure 19, garment shorts thigh hole with cuff having elastic cord 1901 that is double looped) with an analogous contractible member 1901 formed by an analogous elastic member 1901 that is doubly wrapped around the analogous thigh hole.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the elastic contractable member of Hindmarsh in view of Takahashi, so that there is a double-wrap around the thigh hole, as taught by Merill, in order to provide an improved examination garment with an enhanced elastic member forming a double looped cord for desirable contraction, flexibility, and operability (Merill, Paragraph 63, 86, and 90).
15. Claims 8-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Czajka et al. (U.S. Patent Pub. No. 20120222687) in view of Hindmarsh et al. (U.S. Patent Pub. No. 20230248219) in view of Takahashi et al. (WO 2015022972 A1), as applied to claim 1, and in further view of Jakub (U.S. Patent No. 5062159)
Regarding claim 8, the combination of Czajka in view of Hindmarsh in view of Takahashi discloses the invention as described above. Czajka further discloses wherein the covering portion 200 is formed of a planar sheet 200 (Paragraphs 34-35 and 42 and Figure 6).
However, the combination of Czajka in view of Hindmarsh in view of Takahashi fails to explicitly disclose the planar sheet capable of being wrapped around the subject.
Jakub teaches an analogous garment 14 (Col. 2, lines 50-55 and Figure 4, hospital gown with lower body garment 14 formed of rectangular planar sheet 16 wrapped around body) formed of analogous planar sheet 16 is capable of being wrapped around the subject.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a dimension and donning of the planar sheet of Czajka in view of Hindmarsh in view of Takahashi, so that the planar sheet is capable of being wrapped around the subject, as taught by Jakub, in order to provide an improved examination garment that is formed of a lower body rectangular conforming shape for quick and easy user wrapping on and off with fastening for sealing both sides together (Jakub, Col. 2, lines 50-55).
Regarding claim 9, the combination of Czajka in view of Hindmarsh in view of Takahashi in view of Jakub discloses the invention as described above and further discloses wherein the planar sheet 200 (Czajka, Paragraphs 34-35 and 42 and Figure 6)has a quadrangular outer shape (Jakub, Col. 2, lines 50-60) in a case where the planar sheet is brought into an unfolded state.
Regarding claim 11, the combination of Czajka in view of Hindmarsh in view of Takahashi in view of Jakub discloses the invention as described above and further discloses a holding member 20A,20B (Jakub, Col. 2, lines 50-60, hook and loop fastener 20 for fastening both sides wrapped around legs; this is an equivalent structure as defined by the 35 USC 112f analysis above) that holds a state in which the covering portion 200 (Czajka, Paragraphs 34-35 and 42 and Figure 6) is wrapped around the subject.
15. Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Czajka et al. (U.S. Patent Pub. No. 20120222687) in view of Hindmarsh et al. (U.S. Patent Pub. No. 20230248219) in view of Takahashi et al. (WO 2015022972 A1), as applied to claim 1, and in further view of Roe et al. (CN 1144472 A)
Regarding claim 8, the combination of Czajka in view of Hindmarsh in view of Takahashi discloses the invention as described above. Czajka further discloses wherein the covering portion 200 is formed of a planar sheet 200 (Paragraphs 34-35 and 42 and Figure 6).
However, the combination of Czajka in view of Hindmarsh in view of Takahashi fails to explicitly disclose the planar sheet capable of being wrapped around the subject.
Roe teaches an analogous garment 20 (Page 5/99, Paragraph 4 and Figure 1A, disposable diaper garment 20 formed of T-shaped planar sheet wrapped around body) formed of analogous planar sheet is capable of being wrapped around the subject.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a shape and dimension of the planar sheet of Czajka in view of Hindmarsh in view of Takahashi, so that the planar sheet is capable of being wrapped around the subject, as taught by Roe, in order to provide an improved examination garment that is formed of a T-shaped for quick and easy user wrapping on and off by themselves (Roe, Page 5/99, Paragraph 4).
Regarding claim 10, the combination of Czajka in view of Hindmarsh in view of Takahashi in view of Roe discloses the invention as described above and further discloses wherein the planar sheet 200 (Czajka, Paragraphs 34-35 and 42 and Figure 6)has a T-shaped outer shape (Roe, Page 5/99, Paragraph 4 and Figure 1A) in a case where the planar sheet is brought into an unfolded state.
16. Claims 12, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Czajka et al. (U.S. Patent Pub. No. 20120222687) in view of Hindmarsh et al. (U.S. Patent Pub. No. 20230248219) in view of Takahashi et al. (WO 2015022972 A1), as applied to claim 3, and in further view of Inoue et al. (JP 2011245017 A).
Regarding claim 12, the combination of Czajka in view of Hindmarsh in view of Takahashi discloses the invention as described above but fails to explicitly disclose a fixing member that attaches at least one of the first or second fluid suppression member to the covering portion.
Inoue teaches an analogous examination garment (Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-7, and Figure 1, endoscopy garment/dressing/drape covering portion with opening port having a tubular port frame 4 therein with suppression member 12a,12b therein. These suppression member 12a,12b and tubular port frame 4 are held by first fixing frame member 3 on user-facing surface of garment and second fixing frame member 6,7 on non-user facing surface of garment) a fixing member 3, 4, 6,7 (Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-6, and Figure 1, frame members 3, 6,7 and tubular member 4; these are the structures as defined by the 35 USC 112f analysis above) that attaches the analogous fluid suppression member 12A,12B (Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-6, and Figure 1) to the analogous covering portion (Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-6, and Figure 1).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the covering portion with the first and second fluid suppression member of Czajka in view of Hindmarsh in view of Takahashi, so that there is a fixing member that attaches the first and second fluid suppression member to the covering portion, as taught by Inoue, in order to provide an improved examination garment with an enhanced covering portion forming a tight seal with the fluid suppression member therein by a fixing frame on the lower and upper surface of the covering portion that also seals and tightens the port opening (Inoue, Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-6).
Regarding claim 17, the combination of Czajka in view of Hindmarsh in view of Takahashi in view of Inoue discloses the invention as described above and further discloses wherein the first fluid suppression member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a: suppression members 32,33; Takahashi, Page 4/37 and Figure 4: top half depth and bottom half depth of valve 33) has at least the first porous member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, fluid suppression valve 32,33 with first porous member 32 forming slit for insertion; Takahashi, Page 4/37 and Figure 4: top half depth with three first slits 55) in which the first slit parallel to an insertion direction of the insertion part is formed and the second porous member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, second porous member 33; ; Takahashi, Page 4/37 and Figure 4: bottom half depth of valve 33 with three second slits 57) in which the second slit parallel to the insertion, and wherein the first fluid suppression member or second fluid suppression member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a: suppression members 32,33; Takahashi, Page 4/37 and Figure 4: top half depth and bottom half depth of valve 33) is attached to the covering portion 200 (Czajka, Paragraphs 34-35 and 42 and Figure 6) with a first porous member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a: first porous member 32; ; Takahashi, Page 4/37 and Figure 4: top half depth of valve 33 with three first slits 55) and a second porous member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, second porous member 33; ; Takahashi, Page 4/37 and Figure 4: bottom half depth of valve 33 with three first slits 55).
However, the combination of Czajka in view of Hindmarsh in view of Takahashi in view of Inoue fails to explicitly disclose the first porous member and the second porous member are laminated.
Inoue further teaches the analogous first porous member 12a (Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-7, and Figure 1) and the analogous second porous member 12B (Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-7, and Figure 1) are laminated.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a positioning of the first and second porous members of Czajka in view of Hindmarsh in view of Takahashi in view of Inoue, so that the first porous member and the second porous member are laminated, as taught by Inoue, in order to provide an improved examination garment with an enhanced first and second porous member formed of laminated layers with aligned and orthogonal slits for increased sealing properties and tightening of the valve against the inserted endoscope for desirable increased stability as well as sterility (Inoue, Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-7).
Regarding claim 19, the combination of Czajka in view of Hindmarsh in view of Takahashi in view of Inoue discloses the invention as described above and further discloses wherein the fixing member 3, 4, 6,7 (Inoue, Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-6, and Figure 1, frame members 3, 6,7 and tubular member 4) includes a tubular member (Czajka, Paragraphs 44, 53 and Figures 6-7, suction ports 600 with fixing tubular member 701 that extends outwardly from non-skin facing surface of covering portion 200 to couple with a medical tube device such as an endoscope or yankauer; Inoue, Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-6, and Figure 1, tubular member 4 extends out of upper surface of covering dressing) that extends to an outside of the covering portion 200 (Czajka, Paragraphs 34-35 and 42 and Figure 6) in a case where the covering portion 200 (Czajka, Paragraphs 34-35 and 42 and Figure 6) has covered the subject.
Regarding claim 20, the combination of Czajka in view of Hindmarsh in view of Takahashi in view of Inoue discloses the invention as described above and further discloses wherein the first fluid suppression member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, first fluid suppression valves 32,33 having porous slits within insertion port; Inoue, Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-6, and Figure 1, convex circular outer shape fluid suppression 12A,12B that protrude on outer non skin facing surface of covering dressing) has a convex portion that protrudes to the outside of the covering portion in a case where the covering portion 200 (Czajka, Paragraphs 34-35 and 42 and Figure 6) has covered the subject.
17. Claims 12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hindmarsh et al. (U.S. Patent Pub. No. 20230248219) in view of Takahashi et al. (WO 2015022972 A1), as applied to claim 3 and 13, in view of Inoue et al. (JP 2011245017 A).
Regarding claim 12, the combination Hindmarsh in view of Takahashi discloses the invention as described above but fails to explicitly disclose a fixing member that attaches at least one of the first or second fluid suppression member to the covering portion.
Inoue teaches an analogous examination garment (Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-7, and Figure 1, endoscopy garment/dressing/drape covering portion with opening port having a tubular port frame 4 therein with suppression member 12a,12b therein. These suppression member 12a,12b and tubular port frame 4 are held by first fixing frame member 3 on user-facing surface of garment and second fixing frame member 6,7 on non-user facing surface of garment) a fixing member 3, 4, 6,7 (Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-6, and Figure 1, frame members 3, 6,7 and tubular member 4; these are the structures as defined by the 35 USC 112f analysis above) that attaches the analogous fluid suppression member 12A,12B (Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-6, and Figure 1, to the analogous covering portion (Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-6, and Figure 1).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the covering portion with the first or second fluid suppression member of Hindmarsh in view of Takahashi, so that there is a fixing member that attaches the first or second fluid suppression member to the covering portion, as taught by Inoue, in order to provide an improved examination garment with an enhanced covering portion forming a tight seal with the fluid suppression member therein by a fixing frame on the lower and upper surface of the covering portion that also seals and tightens the port opening (Inoue, Page 2/15, last 5 paragraphs, Page 3/15, Paragraphs 1-6).
Regarding claim 17, the combination of Hindmarsh in view of Takahashi discloses the invention as described above and further discloses wherein the first fluid suppression member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a: suppression members 32,33; Takahashi, Page 4/37 and Figure 4: top half depth and bottom half depth of valve 33) has at least the first porous member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, fluid suppression valve 32,33 with first porous member 32 forming slit for insertion; Takahashi, Page 4/37 and Figure 4: top half depth with three first slits 55) in which the first slit parallel to an insertion direction of the insertion part is formed and the second porous member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a, second porous member 33; ; Takahashi, Page 4/37 and Figure 4: bottom half depth of valve 33 with three second slits 57) in which the second slit parallel to the insertion, and wherein the first fluid suppression member or second fluid suppression member (Hindmarsh, Paragraphs 76, 117-119, 170-178 and Figures 5a and 15a: suppression members 32,33; Takahashi, Page 4/37 and Figure 4: top half depth and bottom half depth of valve 33) is attached to the covering portion 200 (Czajka, Paragraphs 34-35 and 42 and Figure 6) with a first porous member (Hindmarsh, Paragraphs 76,