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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/5/2026 has been entered.
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.
The following claim limitations
“a sensing device” in claim 1
“a first sensing device” in claim 5
“a second sensing device” in claim 5
“a sensing device” in claim 20
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
“device” is a generic placeholder in the limitation “a sensing device” of claim 1
“device” is a generic placeholder in the limitation “a first sensing device” of claim 5
“device” is a generic placeholder in the limitation “a second sensing device” of claim 5
“device” is a generic placeholder in the limitation “a sensing device” of claim 20
coupled with functional language
“sensing” and “configured to detect a property of fluid within the inner the inner passage”
ii. “sensing” and “configured to detect a property of fluid within the inner the inner passage”
iii. “sensing” and “configured to detect a property of fluid within the inner the inner passage”
iv. “sensing” and “configured to detect a property of fluid within the inner the inner passage”
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1-10 and 20 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
For all four limitations the structure appears to be described in instant paragraph [0028] “pH paper or other material or device”, or in instant paragraph [0037] as “immunochromatographic paper”
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 lines 2 and 10 recite “the sensing device is a first sensing device”. It is unclear if there are two “first sensing devices” or if line 10 is referencing the same “first sensing device” as introduced in line 2. For purposes of examination it is interpreted that line 10 is referencing the same “first sensing device” introduced in line 2.
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.
Claim(s) 1-4, 6 and 8-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Babb et al. (US Patent 5291879 hereinafter “Babb”).
Regarding Claim 1, Babb teaches (Figs 4-6) a device comprising:
a housing (82, 90, 92) defining an outer surface (outer surface of 82), a first end (94), and a second end (96), the housing comprising an inner passage (inner passage defined by walls 124) that extends from the first end of the housing to the second end of the housing, wherein the outer surface comprises a curved planar surface (see annotated Fig 6) that curves inward towards the inner passage, wherein the curved planar outer surface defines an aperture (see annotated Fig 6; aperture is opening in passage towards 112) in fluid communication with a portion of the inner passage (passage defined by walls 124);
a stylet (See Col 13 line 65 – Col 14 line 3 teaching how an airway hose is attached; this is interpreted to be a stylet) coupled to the first end (94) of the housing, the stylet defining a channel (Channel is lumen of the hose as described in Col 13 line 65-Col 14 line 3) in fluid communication with the inner passage (passage defined by walls 124); and
a sensing device (102, 104, 112) configured to be placed on the curved planar surface of the housing and cover the aperture (see annotated Fig 6; the sensing device partially covers the aperture and is placed on the curved planar surface), the sensing device being configured to detect a property of fluid within the inner passage (See Col 16 line 65 – Col 17 line 2 teaches how the sensing device detects CO2 within the fluid of the inner passage 124).
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Annotated Fig 6 (Babb)
Regarding Claim 2, Babb teaches the device of claim 1, further comprising a cover (86) that retains the sensing device (102, 104, 112) against the aperture (See annotated Fig 6; also see Fig 4).
Regarding Claim 3, Babb teaches the device of claim 1, wherein the curved planar surface (See annotated Fig 6) is curved inward towards the inner passage (see annotated Fig 6) in a direction from the first end (See annotated Fig 6.2) to the second end (See annotated Fig 6.2) such that a cross section of the housing at the first end is larger than a cross section of the housing at the aperture defined by the curved planar surface (See annotated Fig 6.2)
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Annotated Fig 6.2 (Babb)
Regarding Claim 4, Babb teaches the device of claim 1, wherein the inner passage (passage defined by walls 124) curves outward from a central axis of the housing to approach the outer surface and the aperture (see Fig 6, passage curved outwards towards 112, where the aperture and outer surface is located; also see Col 16 line 65 – Col 17 line 2 teaching how 124 diverts flow towards the sensor).
Regarding Claim 6, Babb teaches the device of claim 1, wherein the inner passage (passage defined by 124) is defined by one or more inner walls of the housing (See Fig 6, passage is also defined by inner wall 124 which is considered a part of the housing).
Regarding Claim 8, Babb teaches the device of claim 1, wherein the sensing device comprises pH paper (See Col 10 line 66 teaching pH sensitive indicators are used in the device; this is considered a pH paper).
Regarding Claim 9, Babb teaches the device of claim 1, wherein the housing (92, 90, 82) comprises a cylindrical shape (See 92 and 90 in Fig 4, both are cylindrical portions), and wherein a portion (90, 92) of the outer surface (outer surface of 92, 90, 82) separate from the curved planar surface (See annotated Fig 6) defines the cylindrical shape (See Figs 4-6; portions 92 and 90 are the cylindrical shape, sperate from the outer curved portion annotated in Fig 6 which is part of 82).
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Babb (US Patent Pub. 5291879) in view of Gilbert (US Patent 9173602 hereinafter “Gilbert”)
Regarding Claim 7, Babb teaches all elements of claim 1 as described above. Babb does not specify the device wherein the housing comprises one or more tubes disposed within an inner wall of the housing, and wherein the one or more tubes define the inner passage.
Gilbert teaches (Fig 82) a housing (8210) with a tube (conduit 8212) disposed within an inner wall of the housing (8210) defining the inner passage (see Col 51 lines 36-39 “The body 8210 defines an interior lumen or conduit 8212 extending from a first end fluid opening 8218 second end fluid opening 8220, allowing fluid flow therethrough from one of the ends to the other.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner passage of Babb with a tube as shown in Gilbert. One of ordinary skill in the art would recognize this as another structure that allows for the same result of fluid flow from one end to the other (Gilbert Col 51 lines 36-39).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Babb (US Patent Pub. 5291879) in view of Brown (US Patent 5259399)
Regarding Claim 10, Babb teaches all elements of claim 1 as described above. Babb does not specify the device wherein the stylet is configured to be inserted into a tube of a gastrostomy button, the stylet being more rigid than the tube of the gastrostomy button.
Brown teaches a hollow stylet (13) configured to be inserted into a gastrostomy tube (2), wherein the stylet is more rigid than the tube (Brown Col 6 lines 1-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stylet of Babb such that it could be inserted into a gastrostomy tube as taught by Brown. One of ordinary skill in the art would have been motivated to do so in order to use this device in a procedure located in the stomach.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Babb (US Patent Pub. 5291879) in view of Gilbert (US Patent Pub. 20110077495) hereinafter “Gilbert ‘495”).
Regarding Claim 20, Babb teaches (Figs 4-6) a system comprising:
a device (fig 4) comprising:
a housing (82, 90, 92) defining an outer surface (see annotated Fig 6), a first end (94), and a second end (96), the housing comprising an inner passage (inner passage defined by walls 124) that extends from the first end (94) of the housing to the second end (96) of the housing, wherein the outer surface comprises a curved planar surface (see annotated Fig 6) that curves inward towards the inner passage, wherein the curved planar outer surface defines an aperture (see annotated Fig 6; aperture is opening in passage towards 112) in fluid communication with a portion of the inner passage (passage defined by walls 124) the aperture disposed in a curved portion of the curved planar surface (See annotated fig 6);
a stylet (See Col 13 line 65 – Col 14 line 3 teaching how an airway hose is attached; this is interpreted to be a stylet) coupled to the first end (94) of the housing, the stylet defining a channel (Channel is lumen of the hose as described in Col 13 line 65-Col 14 line 3) in fluid communication with the inner passage (passage defined by walls 124); and
a sensing device (102, 104, 112) configured to be placed on the curved planar surface of the housing and cover the aperture (see annotated Fig 6; the sensing device partially covers the aperture and is placed on the curved planar surface), the sensing device being configured to detect a property of fluid within the inner passage (See Col 16 line 65 – Col 17 line 2 teaches how the sensing device detects CO2 within the fluid of the inner passage 124).
Babb does not specify a syringe configured to couple to the second end of the housing, wherein the syringe is configured to withdraw fluid through the inner passage and to the aperture in response to withdrawal of a plunger within the syringe.
Gilbert ‘495 teaches a system comprising: a device comprising:
a housing (5502) defining an outer surface, a first end (5540), and a second end (5550), the housing (5502) comprising an inner passage (5506, 5514, 5518, 5520) that extends from the first end (5540) of the housing to the second end (5550) of the housing, wherein the outer surface defines an aperture (5508, 5510) in fluid communication with a portion (5506, 5514) of the inner passage (5506, 5514, 5518, 5520);
a sensing device (5504, 5530) configured to cover the aperture (see [0208] "The detection indicator 5504 is configured to abut the detection opening to provide the contact between the fluid and the detection indicator 5504. In one example, the detection indicator 5504 is configured to provide a seal against the detection opening to prevent leakage of the fluid to an exterior of the housing 5502."; also see [0216] and [0217]), the sensing device (5504, 5530) configured to detect a property of fluid within the inner passage (see [0205] "The detection indicator 5504 in one example is analogous to the chemical-property indicating medium or indicating elements described above. For example, the detection indicator is configured to change from a first visual indication to a second visual indication upon contact with a fluid or fluid sample based on a characteristic of the fluid."); and
a syringe (see [0215] “In a further implementation, the housing 5502 comprises a second opening 5550 configured to removably engage with a fluid retrieval component 5802 (e.g., a syringe, suction pump, wall suction or vacuum system) for retrieving the fluid from a distal end of the lumen into the interior chamber 5506.”) configured to couple to the second end (5550) of the housing (5502), wherein the syringe is configured to withdraw fluid through the inner passage and to the aperture in response to withdrawal of a plunger within the syringe (see [0213] In a further implementation, the housing 5502 comprises a second opening 5550 configured to removably engage with a fluid retrieval component 5802 (e.g., a syringe, suction pump, wall suction or vacuum system) for retrieving the fluid from a distal end of the lumen into the interior chamber 5506.”; also see Fig 61 showing an example of a possible a syringe with a plunger that could be used).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Babb such that it includes a syringe configured to couple to the second end of the housing, wherein the syringe is configured to withdraw fluid through the inner passage and to the aperture in response to withdrawal of a plunger within the syringe as taught by Gilbert ‘495. One of ordinary skill in the art would have been motivated to do so in order to retrieve fluid into the passageway of the system (See Gilbert ‘495 [0213]).
Allowable Subject Matter
Claim 5 is 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.
As to Claim 5, Babb teaches all elements of claim 4 as described above. Babb does not specify the device wherein: the aperture is a first aperture, the sensing device is a first sensing device, and the portion of the inner passage is a first portion, the inner passage comprises the first portion that curves outward in a first direction from the central axis of the housing to approach a first portion of the outer surface and the first aperture, and wherein the inner passage comprises a second portion that curves outward in a second direction from the central axis of the housing to approach a second portion of the outer surface and a second aperture in fluid communication with the second portion of the inner passage, the sensing device is a first sensing device and the property of the fluid is a first property of the fluid, and the device comprises a second sensing device configured to cover the second aperture and detect a second property of the fluid within the second portion of the inner passage. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Babb to satisfy these limitations.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 20 have been considered but are moot because the new ground of rejection takes into consideration the amendments filed on 6/5/2026 and provides a new interpretation and annotated figure of Babb.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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