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 .
Drawings
The drawings are objected to because the explanation of the changes to the drawings have not been provided. According to 37 C.F.R. 1.121, “All changes to the drawings shall be explained, in detail, in either the drawing amendment or remarks section of the amendment paper.” The Applicant has not explained any of the changes to the drawings. Since all the drawings have been replaced, it is assumed that there are more changes than simply addressing the objections to FIGS. 1 and 11 in the Office Action mailed on 10/20/2025.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the feature “wherein the second geometric layout includes a spiral layout in which a set of grooves curved lines are connected together at a center point of the collection tip, and each groove of the set of grooves extend from the center point of the collection tip across the collection tip” of claim 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim 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 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 1-5 and 8-20 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 recites “the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening” in lines 10-11, but it is not clear how the collection tip can extend laterally away from itself. That is, the collection tip is extending out yet is also the frame of reference for the extension. This contradiction renders claim 1 indefinite.
Claims 2-5 and 8-13 are rejected by virtue of their dependence from claim 1.
Claim 3 recites “wherein the inner cavity opening at the collection layer is exposed in response to decoupling the collection tip from the distal end of the elongated body” in lines 1-4, which is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claim 4 is rejected by virtue of its dependence from claim 3.
Claim 11 recites “in which a set of grooves curved lines are connected together at a center point of the collection tip” in lines 2-3, which is so grammatically awkward that its meaning is not clear.
Claim 14 recites “the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening” in lines 11-12, but it is not clear how the collection tip can extend laterally away from itself. That is, the collection tip is extending out yet is also the frame of reference for the extension. This contradiction renders claim 14 indefinite.
Claims 15-17 are rejected by virtue of their dependence from claim 17.
Claim 16 recites “wherein passageway the inner cavity opening at the collection layer is exposed in response to decoupling the collection tip from the distal end of the elongated body” in lines 1-4, which is so grammatically awkward that its meaning is not clear. Also, the recitation is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claim 17 is rejected by virtue of its dependence from claim 16.
Claim 17 recites “wherein the inner cavity opening exposes the inner cavity” in lines 1-2, which seems to contradict the recitation “the collection tip being configured to cover the inner cavity opening at the collection layer” of claim 14, lines 10-11. It is not clear how the inner cavity opening exposes the inner cavity when the collection tip covers the inner cavity opening. This contradiction renders claim 17 indefinite.
Claim 18 recites “the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening” in lines 9-11, but it is not clear how the collection tip can extend laterally away from itself. That is, the collection tip is extending out yet is also the frame of reference for the extension. This contradiction renders claim 18 indefinite.
Claims 19-20 are rejected by virtue of their dependence from claim 18.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 8-9, 11-12, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2021/0321991 (Elliott)(previously cited).
With respect to claim 1, Elliott teaches a swab for collecting samples in a nasal passageway, the swab comprising:
an elongated body (the handle portion 16 and the extension 30 of Elliott) having a distal end;
a collection layer proximate to the distal end of the elongated body, the collection layer having a first geometric layout (the protrusions 32 and apertures 34 of Elliott) and configured to collect the samples in the nasal passageway (paragraph 0006 of Elliott), the collection layer forming an inner cavity (the cavities formed by the apertures 34 and protrusions 32 of Elliot) configured to retain the samples from the nasal passageway, the inner cavity having an inner cavity opening (the tops of the cavities formed by the apertures 34 and protrusions 32 of Elliot); and
a collection tip (the sleeve 20 of Elliott) at the distal end of the elongated body,
the collection tip (the sleeve 20 of Elliott) having a second geometric layout and configured to collect the samples in the nasal passageway,
the collection tip configured to cover the inner cavity opening at the collection layer (the sleeve 20 covers the protrusions 32 and apertures 34 such that the sleeve necessarily covers the cavities formed by the apertures 34 and protrusions 32 of Elliot, including the tops of the cavities), and
the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening (the sleeve 20 extends laterally away from the point A of the sleeve 20 in the below annotated FIG. 13C and covers (and thereby extends laterally away from) the cavities formed by the apertures 34 and protrusions 32 of Elliot, including the tops of the cavities),
wherein the first geometric layout is different from the second geometric layout (the protrusions 32 and apertures 34 are different from the sleeve 20 of Elliott).
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Annotated FIG. 13C of Elliott
With respect to claim 2, Elliott teaches that the collection tip is removably coupled to the distal end of the elongated body (the protrusions 32 and apertures 34 are removably coupled to the sleeve 20 of Elliott; paragraphs 0019, 0032, 0059, and 0065 of Elliot).
With respect to claim 3, Elliott teaches that the inner cavity opening at the collection layer is exposed in response to decoupling the collection tip from the distal end of the elongated body (the cavities formed by the apertures 34 and protrusions 32 of Elliot, including the tops of the cavities would be exposed if the sleeve 20 was removed).
With respect to claim 4, Elliott teaches that the inner cavity is situated below an outer surface formed by the first geometric layout of the collection layer (the cavities formed by the protrusions 32 and apertures 34 are situated below the outer circumferential surface of the protrusions 32 of Elliott).
With respect to claim 5, Elliott teaches that the first geometric layout includes bristles (the protrusions 32 of Elliott).
With respect to claim 8, Elliott teaches that the collection layer is formed around a circumference of the elongated body (the protrusions 32 and apertures 34 are formed around the circumference of the extension 30 of Elliott), and wherein the first geometric layout of the collection layer forms pores configured to retain the samples from the nasal passageway (the apertures 34 of Elliott form pores).
With respect to claim 9, Elliott teaches that the pores are configured to facilitate capillary action to retain the samples from the nasal passageway (paragraphs 0024 and 0030 of Elliott).
With respect to claim 11, Elliott teaches that the second geometric layout includes a spiral layout in which a set of grooves curved lines are connected together at a center point of the collection tip, and each groove of the set of grooves extend from the center point of the collection tip across the collection tip (the sleeve 20 of Elliott has a spiral layout in FIGS. 10B-10J, 11A-11C, and 13A-13C of Elliott in which a set of grooves formed by the spiral layout are connected at a center point at the distal most point of the sleeve 20 (e.g., the point A of the sleeve 20 in the above annotated FIG. 13C)).
With respect to claim 12, Elliott teaches a proximate end of the elongated body (the handle portion 16 of Elliott), wherein the proximate end of the elongated body is configured to manipulate the swab for inserting the swab into the nasal passageway (the handle portion 16 and the extension 30 of Elliott have this ability).
With respect to claim 14, Elliott teaches a swab system for collecting samples in a nasal passageway, the system comprising:
an elongated body (the handle portion 16 and the extension 30 of Elliott) having a distal end;
a collection layer configured to couple proximate to the distal end of the elongated body, the collection layer having a first geometric layout (the protrusions 32 and apertures 34 of Elliott) and configured to collect the samples in the nasal passageway, the collection layer forming an inner cavity (the cavities formed by the apertures 34 and protrusions 32 of Elliot) configured to retain the samples from the nasal passageway, the inner cavity having an inner cavity opening (the tops of the cavities formed by the apertures 34 and protrusions 32 of Elliot); and
a collection tip (the sleeve 20 of Elliott) configured to couple at the distal end of the elongated body,
the collection tip (the sleeve 20 of Elliott) having a second geometric layout and configured to collect the samples in the nasal passageway,
the collection tip being configured to cover the inner cavity opening at the collection layer (the sleeve 20 covers the protrusions 32 and apertures 34 such that the sleeve necessarily covers the cavities formed by the apertures 34 and protrusions 32 of Elliot, including the tops of the cavities), and
the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening (the sleeve 20 extends laterally away from the point A of the sleeve 20 in the above annotated FIG. 13C and covers (and thereby extends laterally away from) the cavities formed by the apertures 34 and protrusions 32 of Elliot, including the tops of the cavities),
wherein the first geometric layout is different from the second geometric layout (the protrusions 32 and apertures 34 are different from the sleeve 20 of Elliott).
With respect to claim 15, Elliott teaches that the collection tip is removably coupled to the distal end of the elongated body (the protrusions 32 and apertures 34 are removably coupled to the sleeve 20 of Elliott; paragraphs 0019, 0032, 0059, and 0065 of Elliot).
With respect to claim 16, Elliott teaches that passageway the inner cavity opening at the collection layer is exposed in response to decoupling the collection tip from the distal end of the elongated body (the cavities formed by the apertures 34 and protrusions 32 of Elliot, including the tops of the cavities would be exposed if the sleeve 20 was removed).
With respect to claim 17, Elliott teaches that the inner cavity opening exposes the inner cavity (the tops of the cavities formed by the apertures 34 and protrusions 32 of Elliot exposes the cavities formed by the apertures 34 and protrusions 32 of Elliott).
With respect to claim 18, Elliott teaches a method of manufacturing a swab for collecting samples in a nasal passageway, the method comprising:
forming a collection layer at a distal end of an elongated body (forming the protrusions 32 and apertures 34 of Elliott at a distal end of the handle portion 16 and the extension 30 of Elliott) the collection layer having a first geometric layout (the protrusions 32 and apertures 34 of Elliott) and configured to collect the samples in the nasal passageway, the collection layer forming an inner cavity (the cavities formed by the apertures 34 and protrusions 32 of Elliot) configured to retain the samples from the nasal passageway, the inner cavity having an inner cavity opening (the tops of the cavities formed by the apertures 34 and protrusions 32 of Elliot); and
forming a collection tip at the distal end of the elongated body (forming the sleeve 20 of Elliott at the distal end of the extension 30 of Elliott),
the collection tip (the sleeve 20 of Elliott) having a second geometric layout and configured to collect the samples in the nasal passageway,
the collection tip being configured to cover the inner cavity opening at the collection layer (the sleeve 20 covers the protrusions 32 and apertures 34 such that the sleeve necessarily covers the cavities formed by the apertures 34 and protrusions 32 of Elliot, including the tops of the cavities), and
the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening (the sleeve 20 extends laterally away from the point A of the sleeve 20 in the above annotated FIG. 13C and covers (and thereby extends laterally away from) the cavities formed by the apertures 34 and protrusions 32 of Elliot, including the tops of the cavities),
wherein the first geometric layout is different from the second geometric layout (the protrusions 32 and apertures 34 are different from the sleeve 20 of Elliott).
Claims 1, 10, 12, 14, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Application Publication No. 2023/0404545 (Browka)(previously cited).
With respect to claim 1, Browka teaches a swab for collecting samples in a nasal passageway, the swab comprising:
an elongated body (the handle 131 of Browka) having a distal end;
a collection layer proximate to the distal end of the elongated body, the collection layer having a first geometric layout (the discs 710, the collection volumes 712, and the connecting links 713 of Browka) and configured to collect the samples in the nasal passageway (paragraph 0001 of Browka), the collection layer forming an inner cavity (the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka) configured to retain the samples from the nasal passageway, the inner cavity having an inner cavity opening (the outer openings of the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka); and
a collection tip (the distal end 708 of Browka) at the distal end of the elongated body, the collection tip having a second geometric layout (the distal flutes 709 of Browka) and configured to collect the samples in the nasal passageway,
the collection tip configured to cover the inner cavity opening at the collection layer (the distal end 708 of Browka covers the outer openings of the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka when viewed from the perspective of FIG. 7B), and
the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening (the distal flutes 709 extend laterally away from the base of the distal end 708 and the outer openings of the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka when viewed from the perspective seen in the below annotated FIG. 7C of Browka),
wherein the first geometric layout is different from the second geometric layout (the discs 710, the collection volumes 712, and the connecting links 713 are different from the distal flutes 709; see FIGS. 7A-7E of Browka).
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Annotated FIG. 7C of Browka
With respect to claim 10, Browka teaches that the collection layer is more flexible than the elongated body (paragraphs 0010 and 0117 of Browka teaches that the discs 710, the collection volumes 712, and the connecting links 713 are flexible relative to the handle 131).
With respect to claim 12, Browka teaches a proximate end of the elongated body (the end member 104 or the proximate portion of the handle 131 below the break point 105 in FIG. 7A of Browka), wherein the proximate end of the elongated body is configured to manipulate the swab for inserting the swab into the nasal passageway (the end member 104 or the proximate portion of the handle 131 below the break point 105 in FIG. 7A of Browka has this ability).
With respect to claim 14, Browka teaches a swab system for collecting samples in a nasal passageway, the system comprising:
an elongated body (the handle 131 of Browka) having a distal end;
a collection layer configured to couple proximate to the distal end of the elongated body, the collection layer having a first geometric layout (the discs 710, the collection volumes 712, and the connecting links 713 of Browka) and configured to collect the samples in the nasal passageway, the collection layer forming an inner cavity (the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka) configured to retain the samples from the nasal passageway, the inner cavity having an inner cavity opening (the outer openings of the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka); and
a collection tip (the distal end 708 of Browka) configured to couple at the distal end of the elongated body, the collection tip having a second geometric layout (the distal flutes 709 of Browka) and configured to collect the samples in the nasal passageway,
the collection tip being configured to cover the inner cavity opening at the collection layer (the distal end 708 of Browka covers the outer openings of the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka when viewed from the perspective of FIG. 7B), and
the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening (the distal flutes 709 extend laterally away from the base of the distal end 708 and the outer openings of the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka when viewed from the perspective seen in the above annotated FIG. 7C of Browka),
wherein the first geometric layout is different from the second geometric layout (the discs 710, the collection volumes 712, and the connecting links 713 are different from the distal flutes 709; see FIGS. 7A-7E of Browka).
With respect to claim 18, Browka teaches a method of manufacturing a swab for collecting samples in a nasal passageway, the method comprising:
forming a collection layer at a distal end of an elongated body (forming the discs 710, the collection volumes 712, and the connecting links 713 at a distal end of the handle 131 of Browka) the collection layer having a first geometric layout (the discs 710, the collection volumes 712, and the connecting links 713 of Browka) and configured to collect the samples in the nasal passageway, the collection layer forming an inner cavity (the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka) configured to retain the samples from the nasal passageway, the inner cavity having an inner cavity opening (the outer openings of the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka); and
forming a collection tip at the distal end of the elongated body (forming the distal end 708 of Browka at the distal end of the handle 131 of Browka),
the collection tip having a second geometric layout (the distal flutes 709 of Browka) and configured to collect samples in the nasal passageway,
the collection tip being configured to cover the inner cavity opening at the collection layer (the distal end 708 of Browka covers the outer openings of the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka when viewed from the perspective of FIG. 7B), and
the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening (the distal flutes 709 extend laterally away from the base of the distal end 708 and the outer openings of the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka when viewed from the perspective seen in the above annotated FIG. 7C of Browka),
wherein the first geometric layout is different from the second geometric layout (the discs 710, the collection volumes 712, and the connecting links 713 are different from the distal flutes 709; see FIGS. 7A-7E of Browka).
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 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Browka, in view of U.S. Patent Application Publication No. 2011/0179887 (Cobian)(previously cited).
Browka teaches a swab for collecting samples in a nasal passageway. Cobian teaches that such swabs may include an external layer (e.g., a coating) comprising a material that affords hydrophilic, hydrophobic, positively-charged, or negatively-charged surfaces to achieve desired sample acquisition characteristics (paragraph 0035 of Cobian). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a coating comprising a material that affords hydrophilic, hydrophobic, positively-charged, or negatively-charged surfaces to the discs 710, the collection volumes 712, the connecting links 713, and the distal flutes 709 of Browka since it permits the achievement of desired sample acquisition characteristics.
With respect to claim 19, the combination teaches or suggests applying a surface treatment to the collection layer and the collection tip, the surface treatment configured to positively charge the collection layer and the collection tip (the application of a coating comprising a material that affords positively-charged surfaces to the discs 710, the collection volumes 712, the connecting links 713, and the distal flutes 709 of the combination).
With respect to claim 20, the combination teaches or suggests applying a coating to the collection layer and the collection tip, the coating configured to bond to pathogenic material found in the samples that are located in the nasal passageway (the application of a coating comprising a material that affords hydrophilic, positively-charged, or negatively-charged surfaces to achieve desired sample acquisition characteristics surfaces to the discs 710, the collection volumes 712, the connecting links 713, and the distal flutes 709 of the combination).
Claims 1, 8-10, 12-14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2011/0179887 (Cobian).
Cobian teaches a swab for collecting samples in a nasal passageway, the swab comprising: an elongated body (the stem 12 of Cobian) having a distal end; a collection layer proximate to the distal end of the elongated body, the collection layer having a first geometric layout (the regions 130 of Cobian) and configured to collect samples in the nasal passageway (paragraph 0029 of Cobian); and a collection tip (the regions 128 of Cobian) at the distal end of the elongated body, the collection tip having a second geometric layout and configured to collect samples in the nasal passageway (FIG. 9 of Cobian). Cobain teaches that, in each the embodiments described herein, the stem 12 may define an inner lumen that is in fluid communication with the sample acquisition regions, regardless of whether the sample acquisition regions are defined by apertures or by projections (paragraph 0105 of Cobain). Cobain teaches that fluid communication between the sample acquisition regions and the lumen with apertures along the surface (paragraphs 0063-0064 of Cobian). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place apertures along the surface of regions 128 and 130 so that fluid communication can be established between the sample acquisition regions and the lumen, as suggested by Cobain.
With respect to claim 1, Cobian teaches or suggests a swab for collecting samples in a nasal passageway, the swab comprising:
an elongated body (the stem 12 of Cobian) having a distal end;
a collection layer proximate to the distal end of the elongated body, the collection layer having a first geometric layout (the regions 130 with the projections 126 of Cobian) and configured to collect the samples in the nasal passageway (paragraph 0029 of Cobian), the collection layer forming an inner cavity (the apertures along the surface of the regions 130 leading to the lumen in the stem 12 of Cobian) configured to retain the samples from the nasal passageway, the inner cavity having an inner cavity opening (the mouths of the apertures along the surface of the regions 130 leading to the lumen in the stem 12 of Cobian); and
a collection tip (the regions 128 with the projections 124 of Cobian) at the distal end of the elongated body,
the collection tip having a second geometric layout and configured to collect the samples in the nasal passageway (FIG. 9 of Cobian shows the second geometric layout),
the collection tip configured to cover the inner cavity opening at the collection layer (the regions 128 of Cobian cover the mouths of the apertures along the surface of the regions 130 leading to the lumen in the stem 12 when viewed from above the body 120 in FIG. 9 of Cobain), and
the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening (the projections 124 extend laterally away from the regions 128 and the mouths of the apertures along the surface of the regions 130 leading to the lumen in the stem 12 if the lateral direction is outward and/or upward in FIG. 9 of Cobain),
wherein the first geometric layout is different from the second geometric layout (the regions 130 are different from the regions 128 of Cobian).
With respect to claim 8, Cobian teaches or suggests that the collection layer is formed around a circumference of the elongated body (the regions 130 are formed around the circumference of the stem 12 of Cobian), and wherein the first geometric layout of the collection layer forms pores configured to retain the samples from the nasal passageway (the spacing between the projections 126 in the region 130 and/or the apertures along the surface of the regions 130 leading to the lumen in the stem 12 constitute pores; paragraphs 0063-0066 and 0105 of Cobian).
With respect to claim 9, Cobian teaches or suggests that the pores are configured to facilitate capillary action to retain the samples from the nasal passageway (the spacing between the projections 126 in the region 130 operate by capillary action and/or the apertures along the surface of the regions 130 leading to the lumen in the stem 12 operate by capillary action; paragraphs 0007, 0029, 0034, 0036, 0058, 0063-0066, 0087-0090, and 0105 of Cobian).
With respect to claim 10, Cobian teaches or suggests that the collection layer is more flexible than the elongated body (the stem is rigid (paragraph 0031 of Cobian) while the projections 126 of regions 30 are flexible (paragraph 0090 of Cobian)).
With respect to claim 12, Cobian teaches or suggests a proximate end of the elongated body (the stem 12 of Cobian), wherein the proximate end of the elongated body is configured to manipulate the swab for inserting the swab into the nasal passageway (the stem 12 of Cobian has this ability).
With respect to claim 13, Cobian teaches or suggests that the elongated body is cylindrical and wherein the elongated body includes a hollow tube for transporting the samples (the stem 12 of Cobian is cylindrical and has a lumen; paragraphs 0063-0064 and 0105 of Cobian).
With respect to claim 14, Cobian teaches or suggests a swab system for collecting samples in a nasal passageway, the system comprising:
an elongated body (the stem 12 of Cobian) having a distal end;
a collection layer configured to couple proximate to the distal end of the elongated body, the collection layer having a first geometric layout (the regions 130 with the projections 126 of Cobian) and configured to collect the samples in the nasal passageway (paragraph 0029 of Cobian), the collection layer forming an inner cavity (the apertures along the surface of the regions 130 leading to the lumen in the stem 12 of Cobian) configured to retain the samples from the nasal passageway, the inner cavity having an inner cavity opening (the mouths of the apertures along the surface of the regions 130 leading to the lumen in the stem 12 of Cobian); and
a collection tip (the regions 128 with the projections 124 of Cobian) configured to couple at the distal end of the elongated body,
the collection tip having a second geometric layout and configured to collect the samples in the nasal passageway (FIG. 9 of Cobian shows the second geometric layout),
the collection tip being configured to cover the inner cavity opening at the collection layer (the regions 128 of Cobian cover the mouths of the apertures along the surface of the regions 130 leading to the lumen in the stem 12 when viewed from above the body 120 in FIG. 9 of Cobain), and
the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening (the projections 124 extend laterally away from the regions 128 and the mouths of the apertures along the surface of the regions 130 leading to the lumen in the stem 12 if the lateral direction is outward and/or upward in FIG. 9 of Cobain),
wherein the first geometric layout is different from the second geometric layout (the regions 130 are different from the regions 128 of Cobian).
With respect to claim 18, Cobian teaches or suggests a method of manufacturing a swab for collecting samples in a nasal passageway, the method comprising:
forming a collection layer at a distal end of an elongated body (forming the regions 130 at a distal end of the stem 12 of Cobian) the collection layer having a first geometric layout (the regions 130 with the projections 126 of Cobian) and configured to collect the samples in the nasal passageway, the collection layer forming an inner cavity (the apertures along the surface of the regions 130 leading to the lumen in the stem 12 of Cobian) configured to retain the samples from the nasal passageway, the inner cavity having an inner cavity opening (the mouths of the apertures along the surface of the regions 130 leading to the lumen in the stem 12 of Cobian); and
forming a collection tip at the distal end of the elongated body (forming the regions 128 with the projections 124 of Cobian at the distal end of the stem 12 of Cobian),
the collection tip having a second geometric layout and configured to collect the samples in the nasal passageway (FIG. 9 of Cobain shows a second geometric layout),
the collection tip being configured to cover the inner cavity opening at the collection layer (the regions 128 of Cobian cover the mouths of the apertures along the surface of the regions 130 leading to the lumen in the stem 12 when viewed from above the body 120 in FIG. 9 of Cobain), and
the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening (the projections 124 extend laterally away from the regions 128 and the mouths of the apertures along the surface of the regions 130 leading to the lumen in the stem 12 if the lateral direction is outward and/or upward in FIG. 9 of Cobain),
wherein the first geometric layout is different from the second geometric layout (the regions 130 are different from the regions 128 of Cobian).
With respect to claims 19-20, Cobian teaches a swab for collecting samples in a nasal passageway (FIG. 9 of Cobian). Cobian teaches that such swabs may include an external layer (e.g., a coating) comprising a material that affords hydrophilic, hydrophobic, positively-charged, or negatively-charged surfaces to achieve desired sample acquisition characteristics (paragraph 0035 of Cobian). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a coating comprising a material that affords hydrophilic, hydrophobic, positively-charged, or negatively-charged surfaces to the regions 130 and 128 of Cobian since it permits the achievement of desired sample acquisition characteristics.
With respect to claim 19, Cobian teaches or suggests applying a surface treatment to the collection layer and the collection tip, the surface treatment configured to positively charge the collection layer and the collection tip (the application of a coating comprising a material that affords positively-charged surfaces to the regions 130 and 128 of Cobian).
With respect to claim 20, Cobian teaches or suggests applying a coating to the collection layer and the collection tip, the coating configured to bond to pathogenic material found in the samples that are located in the nasal passageway (the application of a coating comprising a material that affords hydrophilic, positively-charged, or negatively-charged surfaces to achieve desired sample acquisition characteristics surfaces to the regions 130 and 128 of Cobian).
Response to Arguments
The Applicant’s arguments filed 1/7/2026 have been fully considered.
Drawing objections
There are new grounds of drawing objections that were necessitated by the claim amendments filed on 1/7/2026.
Also, the replacement drawings are objected to because the explanation of the changes to the drawings, as required by 37 C.F.R. 1.121, has not been provided.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejections 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 1/7/2026.
Prior art rejection based on Elliott
The Applicant asserts that Elliott does not teach or suggest the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening. This argument is not persuasive.
First, as pointed out in the above 112 rejection, this recitation indefinite since it is not clear how the collection tip can extend laterally away from itself. That is, the collection tip is extending out yet is also the frame of reference for the extension.
Second, the Applicants asserts that “FIG. 1 illustrates an example of swab 100 that include a collection layer 120 and a collection tip 120 extending laterally away from the collection layer”. However, claim 1 does not recite the collection tip being configured to extend laterally away from the collection layer, but being configured to extend laterally away from the collection tip and the inner cavity opening. Thus, this position is not commensurate with the claim language.
The Applicant asserts:
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This argument is not persuasive. As previously mentioned, claim 1 does not recite the collection tip being configured to extend laterally away from the collection layer, but being configured to extend laterally away from the collection tip and the inner cavity opening. As such, the argument is not commensurate with the claim language.
Also, Elliott does teach the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening since the sleeve 20 extends laterally away from the point A of the sleeve 20 in the above annotated FIG. 13C and covers (and thereby extends laterally away from) the cavities formed by the apertures 34 and protrusions 32 of Elliot, including the tops of the cavities.
The rejections of claims 14 and 18 are proper for the same and/or analogous reason for why the rejection of claim 1 is proper.
The rejections of claims 2-5, 8-9, 11-12, and 15-17 are proper because the rejections of claims 1 and 14 are proper, as outlined above, and Elliott teaches the features of these claims, as outlined in the above rejections.
Prior art rejection based on Browka
The Applicant asserts that Browka does not teach or suggest the collection tip configured to cover the inner cavity opening at the collection layer, and the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening. In particular, the Applicant asserts:
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This argument is not persuasive. First, as pointed out in the above 112 rejection, this recitation indefinite since it is not clear how the collection tip can extend laterally away from itself. That is, the collection tip is extending out yet is also the frame of reference for the extension.
Second, Browka teaches the collection tip configured to cover the inner cavity opening at the collection layer in the form of the distal end 708 of Browka covering the outer openings of the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka when viewed from the perspective of FIG. 7B.
Third, Browka teaches the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening in the form of the distal flutes 709 extending laterally away from the base of the distal end 708 and the outer openings of the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka when viewed from the perspective seen in the above annotated FIG. 7C of Browka.
The rejections of claims 14 and 18 are proper for the same and/or analogous reason for why the rejection of claim 1 is proper.
The rejections of claims 10 and 12 are proper because the rejection of claim 1 is proper, and Browka teaches the features of these claims, as outlined in the above rejections.
The rejections of claims 19-20 based on Browka and Cobain are proper because the rejection of claim 18 based on Browka is proper and Browka and Cobain teach or suggest the features of these claims.
Prior art rejection based on Cobain
The Applicant asserts that Cobain does not teach or suggest the collection tip configured to cover the inner cavity opening at the collection layer, and the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening. In particular, the Applicant asserts:
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This argument is not persuasive. First, as pointed out in the above 112 rejection, this recitation indefinite since it is not clear how the collection tip can extend laterally away from itself. That is, the collection tip is extending out yet is also the frame of reference for the extension.
Second, there are new grounds of claim rejections that were necessitated by the claim amendments filed on 1/7/2026. In particular, Cobain teaches the collection tip configured to cover the inner cavity opening at the collection layer in the form of the regions 128 of Cobian covering the mouths of the apertures along the surface of the regions 130 leading to the lumen in the stem 12 when viewed from above the body 120 in FIG. 9 of Cobain. That is, the regions 128 do not seal the mouths of the apertures but are positioned over the entire longitudinal lengths of the apertures including each aperture’s mouth.
Third, Cobain teaches the collection tip being configured to extend laterally away from the collection tip and the inner cavity opening in the form of the projections 124 extending laterally away from the regions 128 and the mouths of the apertures along the surface of the regions 130 leading to the lumen in the stem 12 if the lateral direction is outward and/or upward in FIG. 9 of Cobain.
The rejections of claims 14 and 18 are proper for the same and/or analogous reason for why the rejection of claim 1 is proper.
The rejections of claims 8-10, 12-13, and 19-20 are proper because the rejections of claims 1 and 18 are proper, and Cobain teaches or suggests the features of these claims, as outlined in the above rejections.
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.
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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