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 .
Election/Restrictions
The Applicant’s elections without traverse of species B1 and B2 in the reply filed on 11/12/2025 are acknowledged. Claims 7-8 and 19 are withdrawn from consideration.
Information Disclosure Statement
The information disclosure statement filed 1/8/2024 fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. Reference no. 2 under the section “U.S. Patents” is not a correctly listed since the Patent Number does not match the Issue Date or the Name of the Patentee. This reference has not been considered since it is not clear what the reference is.
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
Claims 1, 14, and 17 are objected to because of the following informalities:
in claim 1, line 8: “there are” should be “there is”;
in claim 1, line 10: “the diameter of the apertures is” should be “diameters of the apertures are”;
in claim 14, line 2: “SAM” should be “synthetic absorbent/adsorbent matrix (SAM)”; and
if “the apertures” of claim 17 are the same as “the plurality of apertures” of claim 1, lines 8-9 (see the below 112 rejection of claim 16): “have a diameter of 0.2 µm to 100 µm” in claim 17, line 2 should be “wherein the apertures are circular and the diameters of the apertures range from 0.2 µm to 100 µm”.
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 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 is indefinite because it contains the following recitations in which there are insufficient antecedent bases in this claim:
“the respiratory tract” in line 2;
“the upper gastrointestinal tract” in line 2;
“the distal end” in line 5;
“the internal diameter” in lines 10-11;
“the pressure in the interior cavity” in line 12; and
“the pressure outside the catheter” in line 13.
Claim 1 recites “a sample fluid” in line 11, but it is not clear if this recitation is the same as, related to, or different from “a sample of mucosal lining fluid” of claim 1, line 1. If they are the same, “a sample fluid” in line 11 should be “the sample of mucosal lining fluid”. If they are different, their relationship should be made clear, they should be clearly distinguished from each other, and it should be made clear how the sample fluid is obtained since claim 1 does not refer to the sample fluid except in line 1.
Claims 2-6, 9-18, and 20 are rejected by virtue of their dependence from claim 1.
Claim 2 recites “the proximal end of the sampling tube” in line 2 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites “the external diameter of the sampling tube” in lines 1-2 in which there is insufficient antecedent basis for this limitation in the claim.
Claims 4-6 are rejected by virtue of their dependence from claim 3.
Claim 4 recites “the internal diameter of the catheter lumen” in lines 1-2, which renders the claim indefinite. In particular, it is not clear if “the catheter lumen” is the same as, related to, or different from “a lumen” of claim 1, line 4. If they are the same, “the catheter lumen” should be “the lumen”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other. Also, if they are different, there are insufficient antecedent bases for “the catheter lumen” and “the internal diameter” of the catheter lumen in the claim.
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 9 recites “optionally all or part of the sampling tube” having a helical form in line 2, which renders the claim indefinite because it is unclear whether the limitations following the phrase “optionally” are part of the claimed invention.
Claim 13 recites “such as polyester (PE), poly(lactic acid) (PLA), poly(lactic-co-glycolic acid) (PLGA), poly(methyl acrylate) (PMA) and ε-caprolactone” in lines 2-4. The phrase “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 16 recites “10 to 500 apertures” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a plurality of apertures” of claim 1, lines 8-9. If they are the same, “wherein the sampling head comprises 10 to 500 apertures” in line 16 should be “wherein the plurality of apertures comprises 10 to 500 apertures”. If they are different, their relationship should be made clear, 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), and subsequent recitations of the apertures (such as in claim 17, line 1; claim 18, line 1; and claim 20, line 1) should make it clear which recitation is being referred to.
Claims 17-18 and 20 are rejected by virtue of their dependence from claim 16.
Claim 18 recites “the aperture” in line 3, but it is not clear if this recitation is referring to one aperture or every aperture of the “apertures” of claim 18, line 1. Also, as previously mentioned, it is not clear if “the apertures” of claim 18, line 1 is referring to “10 to 500 apertures” of claim 16, line 2 and/or “a plurality of apertures” of claim 1, lines 8-9. Clarification is required.
Claim 18 recites “the aperture is the aperture is set in a recess in the outer surface of the wall of the sampling head” in lines 5-6, which is so grammatically awkward that its meaning it not clear. Also, it is not clear if “the aperture” in line 5 (both occurrences) is referring to one aperture or every aperture of the “apertures” of claim 18, line 1. Further, as previously mentioned, it is not clear if “the apertures” of claim 18, line 1 is referring to “10 to 500 apertures” of claim 16, line 2 and/or “a plurality of apertures” of claim 1, lines 8-9. Clarification is required.
Claim 18 recites “the outer surface” in line 5 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites “the whole surface of the sampling head” in line 2 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites “for example in a spiral pattern” in line 2. The phrase “for example” renders the claim indefinite because it is unclear whether the limitation following the phrase “for example” is part of the claimed invention. See MPEP § 2173.05(d).
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, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/084945 (Hata)(cited by Applicant) in view of U.S. Patent Application Publication No. 2015/0209535 (Cole). Citations to Hata will refer to the English machine translation that accompanies this Office Action.
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 catheter (the suction catheter of Hata) for obtaining a sample of mucosal lining fluid from a sampling region in the respiratory tract or the 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 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 the 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 are 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 diameter of the apertures is substantially smaller than the internal diameter of the lumen and is such that a sample fluid can pass through the apertures into the interior cavity only when the pressure in the interior cavity is reduced compared to the pressure outside the 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 the proximal end of the sampling tube (FIG. 1 and page 2 of Hata).
With respect to claim 3, the combination teaches or suggests that the 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 the internal diameter of the catheter 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 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 such as polyester (PE), poly(lactic acid) (PLA), poly(lactic-co-glycolic acid) (PLGA), poly(methyl acrylate) (PMA) and ε-caprolactone (the polyester of Hata for the hollow fiber(s) 64 of Hata).
With respect to claim 16, the combination teaches or suggests that the sampling head 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 apertures are circular and have a diameter of 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 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 the aperture is set in a recess in the 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 the 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), for example in a spiral pattern (this optional recitation is not required).
Claims 9-12 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). Citations to Hata will refer to the English machine translation that accompanies this Office Action.
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 and optionally all or part of the sampling tube have 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).
Claims 13-14 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). Citations to Hata will refer to the English machine translation that accompanies this Office Action.
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 such as polyester (PE), poly(lactic acid) (PLA), poly(lactic-co-glycolic acid) (PLGA), poly(methyl acrylate) (PMA) and ε-caprolactone (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 SAM (the polyester in a synthetic absorbent matrix 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).
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).
Conclusion
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.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791