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 .
Response to Amendment
The response filed on 6/1/2026 is not in conformance with the Office's rules and regulations regarding claim amendments. In particular, the withdrawn claims do not include their text, which is improper. 37 C.F.R. 1.121(c) provides “Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application”.
Also, claim 18 does not properly show the deleted text of this claim (the text “the aperture” before “the aperture is set…”) via strikethrough font. Rather, claim 18 simply removes the deleted text from the claim, which is improper. 37 C.F.R. 1.121(c)(2) provides "The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. ". In an effort to continue prosecution, the amendments have been entered, but the Applicant should be mindful of the proper format for making amendments.
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.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 1 is objected to because of the following informalities:
in claim 1, line 10: “the diameters of the apertures” should be “diameters of the apertures”.
Appropriate correction is required.
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 1-6, 9-18, and 20-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein the diameters of the apertures substantially smaller than an internal diameter of the lumen and is such that the sample of mucosal lining fluid can pass through the apertures into the interior cavity when… ” which is so grammatically awkward that its meaning is not clear.
Claims 2-6, 9-18, and 20-23 are rejected by virtue of their dependence from claim 1.
Claim 4 recites “an internal diameter of the lumen” in lines 1-2, but it is not clear if this recitation is the same as, related to, or different from “an internal diameter of the lumen” in lines 10-11. If they are the same “an internal diameter of the lumen” in claim 4 should be “the internal diameter of the lumen”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claims 5-6 are rejected by virtue of their dependence from claim 4.
Claim 5 recites “the internal diameter of the sampling head” in lines 1-2 in which there is insufficient antecedent basis for this limitation in the claim.
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 1-6, 13, 16-18, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/084945 (Hata)(previously cited) in view of U.S. Patent Application Publication No. 2015/0209535 (Cole)(previously cited). Citations to Hata will refer to the English machine translation that accompanied the Office Action dated 1/30/2026.
Hata teaches that the suction catheter can be applied to any surgical method that involves discharging a liquid (page 8 of Hata). Cole teaches a catheter for the removal of fluid from a sampling region in the respiratory tract or the upper gastrointestinal tract (paragraph 0019 of Cole). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the suction catheter of Hata as the catheter for the removal of fluid from a sampling region in the respiratory tract or the upper gastrointestinal tract, as suggested by Cole, since Hata teaches that the suction catheter can be applied to any surgical method that involves discharging a liquid and Cole teaches one such surgical method.
Hata teaches a series ranges for various dimensions including:
the outer diameter of the catheter shaft 16 (which appears to also be the outer diameter of the tubular portion 62 as seen in FIG. 7) is 1 to 30 mm (page 4 of Hata);
the total length of the catheter shaft 16 is 5 to 1000 cm (page 4 of Hata);
the thickness of the inner layer 22 in the radial direction is 1 to 99 mm (page 4 of Hata);
the length of the inner layer 22 is 0.1 to 10 cm (page 4 of Hata);
the length of the portion 24 in FIG 2 (which is a comparable component of the tubular portion 62 in FIG. 7) is 0.1 to 10 cm (page 4 of Hata);
the thickness of the portion 24 in FIG 2 (which is a comparable component of the tubular portion 62 in FIG. 7) is 30 to 200 microns (page 4 of Hata); and
the pores 22a range from 50-700 microns while the holes 61 of Hata are smaller than that (pages 4 and 8 of Hata).
Additionally, Hata teaches that the dimensions of the system will be selected according to the site in the living body in which it is used (page 4 of Hata). From these teachings, the physical dimensions of the catheter components are subject to change. The physical dimensions of the catheter components would depend upon the site in the living body where the catheter is used, materials, ease of use, and designer preferences. As such, the physical dimensions of the catheter components are results-effective variables that would have been optimized through routine experimentation based on the site in the living body where the catheter is used, materials, ease of use, and designer preferences. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the physical dimensions of the catheter components, using the dimensions of Hata as a starting point, so as to obtain the desired factors of the site in the living body where the catheter is used, materials, ease of use, and designer preferences.
With respect to claim 1, the combination teaches or suggests a sampling catheter (the suction catheter of Hata) for obtaining a sample of mucosal lining fluid from a sampling region in a respiratory tract or an upper gastrointestinal tract (the use of removing mucosal lining fluid from a sampling region in the respiratory tract or the upper gastrointestinal tract as suggested by Cole), wherein the sampling catheter comprises:
i. a sampling tube (the catheter shaft 16 of Hata) having a lumen (the lumen 16a of Hata); and
ii. a sampling head (the inner layer 22 and/or the tubular portion 62 of Hata) at a distal end of the sampling tube,
wherein the sampling head comprises an interior cavity (the cavity were the hollow fiber(s) 64 is located in FIG. 7 of Hata) in fluid connection with the lumen and a permeable material (the hollow fiber(s) 64 of Hata) within the interior cavity;
wherein the sampling head (the inner layer 22 and/or the tubular portion 62 of Hata) is closed by an exterior wall in which there is a plurality of apertures (the pores 22a and/or the holes 61 of Hata),
wherein the permeable material is in contact with the exterior wall and the apertures (the hollow fiber(s) 64 are in physical contact with the tubular portion 62 and in fluid contact with the inner layer 22 of Hata; FIG. 7 of Hata) and
wherein the diameters of the apertures substantially smaller than an internal diameter of the lumen and is such that the sample of mucosal lining fluid can pass through the apertures into the interior cavity only when a pressure in the interior cavity is reduced compared to a pressure outside the sampling catheter (the pores 22a range from 50-700 microns while the holes 61 of Hata are smaller than that (pages 4 and 8 of Hata) and/or the optimization of the pore and hole sizes using the ranges of Hata as a starting point).
With respect to claim 2, the combination teaches or suggests a suction device (the suction device 14 of Hata) connected to a proximal end of the sampling tube (FIG. 1 and page 2 of Hata).
With respect to claim 3, the combination teaches or suggests that an external diameter of the sampling tube is from 1 mm to 6 mm (the catheter shaft 16 has an outer diameter of 1 to 30 mm (page 4 of Hata) and/or the optimization of the outer diameter of the catheter shaft 16 using the ranges of Hata as a starting point).
With respect to claim 4, the combination teaches or suggests that an internal diameter of the lumen is from 0.1 mm to 1.5 mm (the catheter shaft 16 has an outer diameter of 1 to 30 mm while its thickness seems comparable to the thickness of the portion 24 in FIG. 2 (which is in the range of 30 to 200 microns)(page 4 of Hata) and/or the optimization of the outer diameter of the catheter shaft 16 and the thickness of the catheter shaft 16 using the ranges of Hata as a starting point).
With respect to claim 5, the combination teaches or suggests that the internal diameter of the sampling head is from 0.5 mm to 5 mm (the outer diameter of the catheter shaft 16 (which appears to also be the outer diameter of the tubular portion 62 as seen in FIG. 7) is 1 to 30 mm (page 4 of Hata) while the thickness of the portion 24 in FIG 2 (which is a comparable component of the tubular portion 62 in FIG. 7) is 30 to 200 microns (page 4 of Hata) and/or the optimization of the outer diameter of the tubular portion 62 and the thickness of the tubular portion 62 using the ranges of Hata as a starting point).
With respect to claim 6, the combination teaches or suggests that the sampling catheter is from 0.2 m to 3 m in length (the total length of the catheter shaft 16 is 5 to 1000 cm (page 4 of Hata) and/or the optimization of catheter length using the ranges of Hata as a starting point).
With respect to claim 13, Hata teaches that the constituent material of the liquid absorbent portion 18 can be made from a variety of materials including polyester (page 4 of Hata). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use polyester as the material for the hollow fiber(s) 64 since a material is required and Hata teaches suitable materials for such components. Thus, the combination teaches or suggests that the permeable material is formed from an electrospun polymer (the polyester of Hata for the hollow fiber(s) 64 of Hata).
With respect to claim 16, the combination teaches or suggests that the plurality of apertures comprises 10 to 500 apertures (the number of the pores 22a and/or the holes 61 of Hata is shown in FIG. 7 of Hata).
With respect to claim 17, the combination teaches or suggests that the plurality of apertures are circular and the diameters of the plurality of apertures range from 0.2 µm to 100 µm (the pores 22a have diameters (implying circular shapes) that range from 50-700 microns while the holes 61 of Hata having diameters (implying circular shapes) that are smaller than that (pages 4 and 8 of Hata) and/or the optimization of the pores 22a and the holes 61 using the ranges of Hata as a starting point).
With respect to claim 18, the combination teaches or suggests that the each of the plurality of apertures have one or more of the features: i. the aperture is surrounded by an annular groove having a straight or bevelled edge; ii. the aperture is set in a recess in an outer surface of the wall of the sampling head (the holes 61 are set in a recess (the lumen of the inner layer 22) in the outer surface of inner layer 22 of Hata; see below altered FIG. 7 of Hata).
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Altered FIG. 7 of Hata
With respect to claim 20, the combination teaches or suggests that the apertures are arranged around a whole surface of the sampling head (the pores 22a and/or the holes 61 are arranged around the whole surface of the inner layer 22 and/or the tubular portion 62 of Hata).
With respect to claim 22, Hata teaches that the constituent material of the liquid absorbent portion 18 can be made from a variety of materials including polyester (page 4 of Hata). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use polyester as the material for the hollow fiber(s) 64 since a material is required and Hata teaches suitable materials for such components. Thus, the combination teaches or suggests that the electrospun polymer is at least one of polyester (PE), poly(lactic acid) (PLA), poly(lactic-co-glycolic acid) (PLGA), poly(methyl acrylate) (PMA) and s-caprolactone (the polyester of Hata for the hollow fiber(s) 64 of Hata).
Claims 9-12, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hata in view of Cole, and further in view of U.S. Patent Application Publication No. 2023/0083848 (Aboufares)(previously cited). Citations to Hata will refer to the English machine translation that accompanied the Office Action dated 1/30/2026.
The combination teaches or suggests a suction catheter for the removal of fluid from a sampling region in the respiratory tract or the upper gastrointestinal tract. Aboufares teaches that such suction catheters may have distal ends that are straight or helical (paragraph 0034 of Aboufares). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the distal end of the suction catheter of Hata be helical in configuration since (1) it is a simple substitution of one known element for another to obtain predictable results, (2) it inhibits large numbers of holes from being obstructed, and/or (3) it permits a greater coverage for fluid removal.
With respect to claim 9, the combination teaches or suggests that the sampling head has a helical form (the helical formation of the suction catheter of Hata).
With respect to claim 10, the combination teaches or suggests a non-helical outer sleeve (the sheath 40 of Hata) surrounding the sampling head and sampling tube.
With respect to claim 11, the combination teaches or suggests that the sampling tube and sampling head are movable relative to the outer sleeve (the catheter shaft 16 and the inner layer 22 and/or the tubular portion 62 move relative to the sheath 40 of Hata).
With respect to claim 12, the combination teaches or suggests that the sampling head is from 30 mm to 150 mm in length (the length of the inner layer 22 is 0.1 to 10 cm (page 4 of Hata); the length of the portion 24 in FIG 2 (which is a comparable component of the tubular portion 62 in FIG. 7) is 0.1 to 10 cm (page 4 of Hata); the optimization of the lengths of the inner layer 22 and the tubular portion 62 using the ranges of Hata as a starting point).
With respect to claim 21, the combination teaches or suggests that all or part of the sampling tube has a helical form (the helical formation of the suction catheter of Hata).
With respect to claim 23, the combination teaches or suggests that the apertures are arranged around the whole surface of the sampling head in a spiral pattern (the pores 22a and/or the holes 61 are arranged around the whole surface of the inner layer 22 and/or the tubular portion 62 of Hata and, since the suction catheter of Hata has a helical formation, the pores 22a and/or the holes 61 necessarily have a spiral pattern).
Claims 13-14 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Hata in view of Cole, and further in view of U.S. Patent Application Publication No. 2007/0196817 (Broom)(previously cited). Citations to Hata will refer to the English machine translation that accompanied the Office Action dated 1/30/2026.
Hata teaches a permeable material in the form of hollow fiber(s) 64. Hata also teaches that the constituent material of the liquid absorbent portion 18 can be made from a variety of materials including polyester (page 4 of Hata). Further, Broom teaches that such fibrous material may be a synthetic absorbent matrix (paragraph 0053 of Broom). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use polyester in a synthetic absorbent matrix as the material for the hollow fiber(s) 64 since a material is required and Hata and Broom teach suitable materials for such components.
With respect to claim 13, the combination teaches or suggests that the permeable material is formed from an electrospun polymer (the polyester in a synthetic absorbent matrix for the hollow fiber(s) 64 of Hata).
With respect to claim 14, the combination teaches or suggests that the permeable material is a synthetic absorbent/adsorbent matrix (SAM) (the polyester in a synthetic absorbent matrix for the hollow fiber(s) 64 of Hata).
With respect to claim 22, the combination teaches or suggests that the electrospun polymer is at least one of polyester (PE), poly(lactic acid) (PLA), poly(lactic-co-glycolic acid) (PLGA), poly(methyl acrylate) (PMA) and s-caprolactone (the polyester of Hata for the hollow fiber(s) 64 of Hata).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hata in view of Cole, and further in view of U.S. Patent Application Publication No. 2012/0078169 (Tani)(previously cited). Citations to Hata will refer to the English machine translation that accompanied the Office Action dated 1/30/2026
The combination teaches or suggests that the sampling head is attached to the sampling tube (the inner layer 22 and/or the tubular portion 62 of Hata is coupled to the distal end of the catheter shaft 16; page 7 of Hata). Tani teaches that tips may be removably attached to the sampling tube so as to be replaceable (paragraphs 0018, 0069-0070, and 0072 of Tani). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the inner layer 22 and/or the tubular portion 62 of Hata releasably attached to the distal end of the catheter shaft 16 so that the inner layer 22 and/or the tubular portion 62 can be replaced. Thus, the combination teaches or suggests that the sampling head is releasably attached to the sampling tube (the inner layer 22 and/or the tubular portion 62 of Hata is releasably coupled to the distal end of the catheter shaft 16; page 7 of Hata; paragraphs 0018, 0069-0070, and 0072 of Tani).
Response to Arguments
The Applicant's arguments filed on 6/1/2026 have been fully considered.
Claim objections
In view of the claim amendments filed on 6/1/2026, the previous claim objections are withdrawn with the exception of “the diameters of the apertures” in claim 1, line 10. This claim objection has not been addressed by amendment or argument. The Examiner cannot find a reason to withdraw this claim objection.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 6/1/2026.
Also, the Applicant has not addressed, by amendment or by argument, the indefiniteness issue with respect to “the internal diameter of the sampling head” in claim 5, lines 1-2 in which there is insufficient antecedent basis for this limitation in the claim. The Examiner cannot find a reason to withdraw this claim rejection.
Prior art rejections
The Applicant asserts that Hata and Cole relate to removing liquids, but not sampling fluids. The Applicant also asserts that sampling fluids and removing fluids are not interchangeable or equivalent concepts. For example, the Applicant asserts:
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These arguments are not persuasive. A sample is merely “a small part of anything, intended as a representative of the whole” (see page 2 of the definition from dictionary.com that accompanies this Office Action). Thus, there is no structural difference between the material being removed from the patient in the combination and the material being removed by the device of claim 1. It is simply biological material. The difference that it seems that the Applicant is relying on lies in the intent of the operator after the material is collected. This intent does not create a structural difference in the claimed device relative to the combination.
Also, the nature of the use of the material after it is collected does not impact the structure of the combination as it reads on the claimed device. That is, the subsequent analysis of the material is merely intended use that does not impact the structure of the collecting device. If the combination and the claimed device were simply sitting on a shelf, there is no structural distinction from each other.
Alternatively or additionally, a portion of “unwanted or undesirable fluid” is still a sample even if it does not undergo further analysis since it is a part of the fluid which is representative of the fluid at the target area (regardless of what is done with the collected fluid).
The Applicant asserts:
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This argument is not persuasive since there is no physical distinction between the combination and the claimed device. The term “sampling region” is a mere region of collection of biological material. Whatever is done with the biological material after collection does not change the nature or structure of the region from which the material was collected. Alternatively or additionally, the region of collection of the combination is a sampling region since it is the region to which a sample of waste fluid is collected (even if the waste fluid is not subject to further analysis).
The Applicant asserts:
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This argument is not persuasive since there is no physical distinction between the combination and the claimed device. Also, sampling a fluid is removing a fluid. The actions are the same. The only difference is in the intent of the use of the collected material, which does not create a structural difference.
The Applicant asserts:
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These arguments are not persuasive. Hata teaches a series of ranges for various dimensions including: the outer diameter of the catheter shaft 16 (which appears to also be the outer diameter of the tubular portion 62 as seen in FIG. 7) is 1 to 30 mm (page 4 of Hata); the total length of the catheter shaft 16 is 5 to 1000 cm (page 4 of Hata); the thickness of the inner layer 22 in the radial direction is 1 to 99 mm (page 4 of Hata); the length of the inner layer 22 is 0.1 to 10 cm (page 4 of Hata); the length of the portion 24 in FIG 2 (which is a comparable component of the tubular portion 62 in FIG. 7) is 0.1 to 10 cm (page 4 of Hata); the thickness of the portion 24 in FIG 2 (which is a comparable component of the tubular portion 62 in FIG. 7) is 30 to 200 microns (page 4 of Hata); and the pores 22a range from 50-700 microns while the holes 61 of Hata are smaller than that (pages 4 and 8 of Hata). Additionally, Hata teaches that the dimensions of the system will be selected according to the site in the living body in which it is used (page 4 of Hata). From these teachings, the physical dimensions of the catheter components are subject to change. The physical dimensions of the catheter components would depend upon the site in the living body where the catheter is used, materials, ease of use, and designer preferences. As such, the physical dimensions of the catheter components are results-effective variables that would have been optimized through routine experimentation based on the site in the living body where the catheter is used, materials, ease of use, and designer preferences. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the physical dimensions of the catheter components, using the dimensions of Hata as a starting point, so as to obtain the desired factors of the site in the living body where the catheter is used, materials, ease of use, and designer preferences.
From these above considerations, the claimed structure would have been obvious in view of the teachings of Hata. As can be seen in the rejections of claims 3-6 and 17, the dimensions of the external diameter of the tube (1 mm to 6 mm), the internal diameter of the lumen (0.1 mm to 1.5 mm), the internal diameter of the head (0.5 mm to 5 mm), the catheter length (0.2 m to 3 m), and the diameters of the plurality of apertures range (0.2 µm to 100) overlap with the same dimensions as those in Hata, which means Hata contemplated the values of the claimed device. Thus, the dimensional ranges (including the diameters of the apertures and the internal diameter of the lumen) of the claimed device would have been obvious. As such, Hata teaches or suggests that the diameters of the apertures substantially smaller than an internal diameter of the lumen and is such that the sample of mucosal lining fluid can pass through the apertures into the interior cavity only when a pressure in the interior cavity is reduced compared to a pressure outside the sampling catheter since Hata suggests the same dimensions or such dimensions would have been obvious regardless of whether the condition (the sample of mucosal lining fluid can pass through the apertures into the interior cavity only when a pressure in the interior cavity is reduced compared to a pressure outside the sampling catheter) exists or not. That is, the combination has the capability of the claimed device because it has the same dimensional ranges as the claimed device.
Additionally or alternatively, the condition “the sample of mucosal lining fluid can pass through the apertures into the interior cavity only when a pressure in the interior cavity is reduced compared to a pressure outside the sampling catheter” is a condition that fluid flow must meet anyway. There is no fluid flow if there is no pressure differential (no matter how small the pressure differential is). For either the combination or the claimed device to cause collection, there must be a pressure differential.
The Applicant asserts:
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These arguments are not persuasive. The term “exterior wall” does not necessarily convey “the outermost surface of the device”. Rather, the term “exterior wall” merely means a wall that is exterior relative to some other frame of reference, for example, the hollow fiber 64 or the lumen 16a. As such, the combination has the claims structure since the inner layer 22 and/or the tubular portion 62 of Hata are external walls relative to the hollow fiber 64 or the lumen 16a. Additionally, the pores 22a and the holes 61 are apertures in the inner layer 22 and tubular portion 62, respectively. Thus, the combination has the claimed apertures.
In view of the above, the combination teaches or suggests all the features of claim 1 and the rejection of claim 1 is proper.
The rejections of the dependent claims are proper since the rejection of claim 1 is proper and the prior art teaches or suggests the features of these claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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