DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant's submission filed on 8/20/2026 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 18 are objected to because of the following informalities:
in claim 1, line 17: “a center” should be “the center”;
in claim 14, line 18: “a center” should be “the center”; and
in claim 18, line 17: “a center” should be “the center”.
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 1-2, 4-5, 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 center of the collection tip” in lines 15-16 in which there is insufficient antecedent basis for this limitation in the claim.
Claims 2, 4-5 and 8-13 are rejected by virtue of their dependence from claim 1.
Claim 13 recites “the spacing” in line 1, but it is not clear if this recitation is referring to one of the spacings of claim 1, line 17 or all of them. Clarification is required.
Claim 14 recites “the center of the collection tip” in lines 16-17 in which there is insufficient antecedent basis for this limitation in the claim.
Claims 15-17 are rejected by virtue of their dependence from claim 17.
Claim 18 recites “the center of the collection tip” in lines 15-16 in which there is insufficient antecedent basis for this limitation in the claim.
Claims 19-20 are rejected by virtue of their dependence from claim 18.
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, 4-5, 8, and 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2023/0404545 (Browka)(previously cited), in view of U.S. Patent Application Publication No. 2018/0126343 (Wiles).
Browka teaches a swab for collecting samples in a nasal passageway, the swab comprising: an elongated body (the handle 131 of Browka); a collection layer (the discs 710, the collection volumes 712, and the connecting links 713 of Browka) configured to collect the samples in the nasal passageway (paragraph 0001 of Browka); and a collection tip (the distal end 708 of Browka) at the distal end of the elongated body.
The distal end 708 comprises distal flutes 709 (paragraph 0117 of Browka). The distal flutes 709 create recesses between each flute, whereas these recesses provides additional collection volume (paragraph 0117 of Browka). Wiles teaches an alternative in the form of a helical formation at the tip (FIG. 5D of Wiles). The tip also has a center hole 501 encircled with the helical formation 502 (paragraph 0043 of Wiles). The helical formation provides deeper recesses that facilitate better sample collection and retention (paragraph 0043 of Wiles). 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 helical formation of Wiles in place of the distal flutes of Browka since (1) it is a simple substitution of one known element for another to obtain predictable results and/or (2) the helical formation of Wiles that provides deeper recesses that facilitate better collection and retention.
With respect to claim 1, the combination teaches or suggests a swab for collecting samples in a nasal passageway, the swab comprising:
an elongated body (the handle 131 of Browka) having a distal end, the elongated body extending in a first direction;
a collection layer (the discs 710, the collection volumes 712, and the connecting links 713 of Browka) proximate to the distal end of the elongated body, the collection layer having protrusions (the discs 710 of Browka) extending in a second direction perpendicular to the first direction, the collection layer being 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; and
a collection tip (the helical formation of Wiles at the distal end of Browka) at the distal end of the elongated body, the collection tip having a plurality of spirals protruding from the collection tip in the first direction, the plurality of spirals being configured to collect the samples in the nasal passageway, wherein each spiral of the plurality of spirals is radially arranged about the center of the collection tip, and wherein, at a given radius from a center of the collection tip, spacings between adjacent spirals of the plurality of spirals are uniform (FIG. 5D of Wiles shows this formation).
With respect to claim 4, the combination teaches or suggests that the inner cavity (the cavities formed by the discs 710, the collection volumes 712, and the connecting links 713 of Browka) is situated below an outer surface formed by the protrusions (the outer surface formed by the discs 710 of Browka) of the collection layer (see FIG. 7C of Browka).
With respect to claim 5, the combination teaches or suggests that the plurality of spirals forms a circular pattern at the collection tip and wherein the plurality of spirals are radially symmetrical (FIG. 5D of Wiles shows this formation).
With respect to claim 8, the combination teaches or suggests that the collection layer is formed around a circumference of the elongated body (see FIG. 7C of Browka), and wherein the protrusions form pores configured to retain the samples from the nasal passageway (the entrances of the cavities formed by the discs 710 and the connecting links 713 of Browka are considered to be pores).
With respect to claim 10, the combination teaches or suggests that the collection tip has a first surface extending in the second direction, the first surface containing each spiral of the plurality of spirals (FIG. 5D of Wiles shows this formation).
With respect to claim 11, the combination teaches or suggests that each spiral of the plurality of spirals has an apex pointing away from the collection layer (FIG. 5D of Wiles shows this formation).
With respect to claim 12, the combination teaches or suggests that the first surface has a circumferential edge (FIG. 5D of Wiles shows this edge).
With respect to claim 13, the combination teaches or suggests that the spacing decreases as the plurality of spirals extends radially inward toward the center of the collection tip (FIG. 5D of Wiles shows this decreasing spacing).
With respect to claim 14, the combination teaches or suggests 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, the elongated body extending in a first direction;
a collection layer configured to couple proximate to the distal end of the elongated body, the collection layer having protrusions (the discs 710 of Browka) extending in a second direction perpendicular to the first direction, the collection layer being 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; and
a collection tip (the helical formation of Wiles at the distal end of Browka) configured to couple at the distal end of the elongated body, the collection tip having a plurality of spirals protruding from the collection tip in the first direction, the plurality of spirals being configured to collect the samples in the nasal passageway, wherein each spiral of the plurality of spirals is radially arranged about the center of the collection tip, and wherein, at a given radius from a center of the collection tip, spacings between adjacent spirals of the plurality of spirals are uniform (FIG. 5D of Wiles shows this formation).
With respect to claim 15, the combination teaches or suggests that the collection tip has a first surface extending in the second direction, the first surface containing each spiral of the plurality of spirals, and the first surface having a circumferential edge (FIG. 5D of Wiles shows this formation).
With respect to claim 16, the combination teaches or suggests that each spiral of the plurality of spirals has an apex pointing away from the collection layer, the apex being situated at the circumferential edge of the collection tip (FIG. 5D of Wiles shows this formation).
With respect to claim 17, the combination teaches or suggests that each spiral of the plurality of spirals has a slope that increases toward the circumferential edge (FIG. 5D of Wiles shows this slope).
With respect to claim 18, the combination 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 discs 710, the collection volumes 712, and the connecting links 713 at a distal end of the handle 131 of Browka) that extends in a first direction, the collection layer having protrusions (the discs 710 of Browka) extending in a second direction perpendicular to the first direction, the collection layer being 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; and
forming a collection tip at the distal end of the elongated body (forming the helical formation of Wiles at the distal end of the handle 131 of Browka), the collection tip having a plurality of spirals protruding from the collection tip in the first direction, the plurality of spirals being configured to collect the samples in the nasal passageway, wherein each spiral of the plurality of spirals is radially arranged about the center of the collection tip, and wherein, at a given radius from a center of the collection tip, spacings between adjacent spirals of the plurality of spirals are uniform (FIG. 5D of Wiles shows this formation).
Claims 2, 9, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2023/0404545 (Browka)(previously cited), in view of U.S. Patent Application Publication No. 2018/0126343 (Wiles), and further in view of U.S. Patent Application Publication No. 2011/0179887 (Cobian)(previously cited).
With respect to claim 2, the combination teaches or suggests an elongated body (the handle 131 of Browka); a collection layer having a first geometric layout (the discs 710, the collection volumes 712, and the connecting links 713 of Browka); and a collection tip (the helical formation of Wiles at the distal end of the handle 131 of Browka). Cobian teaches that the collection segment may be couplable to its handle or integral to its handle (paragraph 0072 of Cobain). 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 handle and the collection layer/collection tip couplable to each other since it permits interchangeability and/or it is a simple substitution of one known element for another to obtain predictable results. Thus, the combination teaches or suggests that the collection tip is removably coupled to the distal end of the elongated body (the discs 710, the collection volumes 712, and the connecting links 713 of Browka and the helical formation of Wiles are couplable to the handle 131 of Browka).
With respect to claim 9, the combination teaches or suggests that the protrusions form pores configured to retain the samples from the nasal passageway (the entrances of the cavities formed by the discs 710 and the connecting links 713 of Browka are considered to be pores). Cobain teaches that such structures my receive sample particles by capillary force (paragraphs 0007, 0029, 0034, 0036, 0058, 0063-0066, 0087-0090, and 0105 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 make the entrances of the cavities formed by the discs 710 and the connecting links 713 of Browka support capillary action so as to better collect the samples. Thus, the combination teaches or suggests that the pores are configured to facilitate capillary action to retain the samples from the nasal passageway (paragraphs 0007, 0029, 0034, 0036, 0058, 0063-0066, 0087-0090, and 0105 of Cobian).
With respect to claims 19-20, 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 of Browka and the helical formation of Wiles 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 of Browka and the helical formation of Wiles ).
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 of Browka and the helical formation of Wiles ).
Response to Arguments
The Applicant’s arguments filed 8/20/2026 have been fully considered.
Drawing objections
The drawing objections have been withdrawn.
Claim objection
There are new grounds of claim objections.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 8/20/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn. However, there are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Prior art rejection based on Elliott
The Applicant’s arguments with respect to the rejection of claims 1-2, 4-5, and 8-20 have been considered but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of prior art rejections.
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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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
