DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/10/2026 has been entered.
Claims Pending
Applicant’s addition of claim 35, in the response filed 08/10/2026, and previous cancellation of claims 1, 4, 7-9, 14-17, and 20-24, 27, and 28 is acknowledged.
Claims 2-3, 5-6, 10-13, 18-19, 25-26, and 29-35 are the current claims hereby under examination.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: legs – 3062a, 3062b (Par. 94-95 of applicant’s spec.). 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. 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 Objections
Applicant is advised that should claim 12 be found allowable, claim 31 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 32: The claim limitation “first exterior leg and the second exterior leg are configured to be deflected inwardly toward the center leg to expel fluid contained within the first gap and the second gap” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “leg” coupled with functional language “configured to be deflected inwardly toward the center leg to expel fluid contained within the first gap and the second gap” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “configured to be deflected inwardly toward the center leg to expel fluid contained within the first gap and the second gap”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Legs of a material that include “PTE, polyethylene, polypropylene, silicone and the like. Furthermore, the handle portion 14 may be formed from the same or other materials such as, but not limited to, wood, PTE, polyethylene, polypropylene, silicone, and the like”, “a first material (e.g. a thermosplastic elastomer, polyethylene, polypropylene, silicone, and the like) is injected into the cavity to form a monolithic part including both the swab head 6008 and swab handle 6004”, or equivalents thereof, as described on Par. 54 and 96, respectively, of the disclosure filed on 04/02/2021. (Examiner's Note: Interpreted as the material of the leg being responsible for the indicated function)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102 – Previously Withdrawn
Applicant’s arguments, filed 03/28/2025, have been fully considered, and the previous rejection withdrawn.
The applicant’s argument, that Fig. 6A of McMillan does not have a center leg and instead has two retention means -34 with a central gap due to the presence of the stacked vertical line markings on each retention means -34 in Fig. 6A that indicate shading, has been fully considered and deemed as persuasive.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMillan (US Pat. No. 4951684) hereinafter McMillan.
Regarding claim 18, McMillan discloses A swab for collecting biological samples (Abstract), the swab comprising:
a handle having a first end (Fig. 12, shaft – 70 (the first end is considered to be the left end with collection means 71)) and a second end opposite the first end;
a head (Fig. 12, collection means – 71) coupled to the handle at the first end thereof (Fig. 12, (observable that the collection means 71 is connected to the shaft -70)), wherein the head defines a first gap (Fig. 12, (observable gap between retention means 74 and the first leg as indicated in modified Fig. 12 below)), and wherein the first gap is open to the exterior of the head in at least one location (Fig. 12, (observable gap between retention means 74 and the first leg as indicated in modified Fig. 12 below, and is between the tip and base of collection means - 71)) (Fig. 12,12A, trailing edge – 73 (observable that trailing edge – 73 is exposed to the environment)) (Fig. 12, 12A (observable that the above indicated first gap is exposed to the trailing edge – 73, which faces the above indicated first and second gaps)); and
wherein the head includes at least one location on the exterior having a first roughness and at least one location on the exterior having a second roughness different than the first roughness (Fig. 12A, (one side with scraping means – 76 and the other without))(Col. 7, lines 58-59) (Col. 8, lines 55-65).
McMillan fails to explicitly disclose a handle having a second end opposite the first end (Examiner's Note: McMillan fails to explicitly indicate the structure on the opposite end of shaft – 70).
However, McMillan does teach in an alternate embodiment a handle having a second end (Fig. 1 (distal end -22)) opposite the first end (Col. 6, lines 17-24) (Fig. 1 (proximal end -23)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan with an alternate embodiment of McMillan to include a handle having a second end opposite the first end through the combination of embodiments as differing shaft structures are known (McMillan (Col. 4, lines 36-49) (Col. 6, lines 17-24)) and it would have yielded the predictable result of explicitly providing a location to grasp the device.
Claim(s) 11, 5, 10, 12, 19, 29-31, 34-35, 32, 25-26, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMillan, and further in view of Olson (US Pat. No. 9278030) hereinafter Olson.
Regarding claim 11, McMillan discloses a swab for collecting biological samples (Abstract), the swab comprising:
a handle having a first end (Fig. 12, shaft – 70 (the first end is considered to be the left end with collection means 71));
a head (Fig. 12, collection means – 71) coupled to the handle at the first end thereof (Fig. 12, (observable that the collection means 71 is connected to the shaft -70)), wherein the head includes:
a base proximate the first end of the handle (Fig. 12, collection means – 71 (the base of the collection means 71 is the right end of the collection means towards the shaft – 70)),
a tip spaced a distance from the base opposite the handle (Fig. 12 (the tip is considered to be the very left end of the collection means 71 furthest from the shaft – 70)), and
a plurality of legs each extending between the base and the tip (Fig. 12, (first and second leg as indicated in modified Fig. 12 below), retention means – 74) each extending between the base and the tip (Fig. 12, (observable that the first and second legs as indicated in modified Fig. 12 below and retention means 74 extend between the tip and base of collection means 71)); and
wherein the plurality of legs includes a center leg (Fig. 12, retention means -74), a first exterior leg (Fig. 12, (first leg as indicated in modified Fig. 12 below)), and a second exterior leg (Fig. 12, (second as indicated in modified Fig. 12 below)),
wherein the head defines a first gap between the center leg and the first exterior leg (Fig. 12, (observable gap between retention means 74 and the first leg as indicated in modified Fig. 12 below)), and a second gap between the center leg and the second exterior leg (Fig. 12, (observable gap between retention means 74 and the second leg as indicated in modified Fig. 12 below)),
wherein the first gap is enclosed by the center leg, the first exterior leg, the base, and the tip (Fig. 12, (observable gap between retention means 74 and the first leg as indicated in modified Fig. 12 below, and is between the tip and base of collection means - 71)),
wherein the second gap is enclosed by the center leg, the second exterior leg, the base, and the tip (Fig. 12, (observable gap between retention means 74 and the second leg as indicated in modified Fig. 12 below, and is between the tip and base of collection means - 71)),
wherein the head includes an exterior (Fig. 12,12A, trailing edge – 73 (observable that trailing edge – 73 is exposed to the environment)), and wherein both the first gap and the second gap are open to the exterior of the head in at least one location (Fig. 12, 12A (observable that the above indicated first and second gaps are exposed to the trailing edge – 73, which faces the above indicated first and second gaps)).
McMillan fails to explicitly disclose a handle having a second end opposite the first end. (Examiner's Note: McMillan fails to explicitly indicate the structure on the opposite end of shaft – 70)
However, McMillan does teach in an alternate embodiment a handle having a second end (Fig. 1 (distal end -22)) opposite the first end (Col. 6, lines 17-24) (Fig. 1 (proximal end -23)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan with an alternate embodiment of McMillan to include a handle having a second end opposite the first end through the combination of embodiments as differing shaft structures are known (McMillan (Col. 4, lines 36-49) (Col. 6, lines 17-24)) and it would have yielded the predictable result of explicitly providing a location to grasp the device.
Modified McMillan fails to explicitly disclose wherein the center leg extends, in a direction measured perpendicular to the first exterior leg and the second exterior leg, beyond the first exterior leg and the second exterior leg in both directions.
However, Olson teaches wherein the center leg (Fig. 3-4, longitudinal wall – 30) extends, in a direction measured perpendicular to the first exterior leg (Fig. 3-4, longitudinal wall- 32) and the second exterior leg (Fig. 3-4, (structure – 33)) (Fig. 4, (three observable longitudinal walls)), beyond the first exterior leg and the second exterior leg in both directions (Fig. 3-4, longitudinal wall – 30, 32, structure – 33 (observable that longitudinal wall – 30 extends further than wall 32 and structure – 33 in both directions)) (Abstract (“The bulbous cleaner has two or more spaced, longitudinal walls disposed outward of the inner core that are configured to remove debris with turning of the ear cleaning device about a longitudinal axis of the device”)) (Col. 4, lines 5-23 (longitudinal walls)) (Fig. 4, (three observable longitudinal walls)).
(Examiner's Note: As there is no indication within the claim as to any type of common plane between the first and second exterior legs, this limitation is given its broadest reasonable interpretation.)
McMillan and Olson are considered to be analogous art to the claimed invention as they are both involved with collection of biological materials.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan with that of Olson to include wherein the center leg extends, in a direction measured perpendicular to the first exterior leg and the second exterior leg, beyond the first exterior leg and the second exterior leg in both directions through the combination of references as it would have yielded the predictable result of providing additional edges for sample collection (Olson (Col. 3, lines 17-35)).
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McMillan Modified Fig. 12A
Regarding claim 5, modified McMillan fails to explicitly disclose the limitations of the claim.
However, Olson further teaches wherein the head portion and the handle portion are molded together during a single molding step (Olson (Col. 2-3, lines 66-3) (Col. 8, lines 5-9, “The ear cleaning device 10 can be made from a variety of materials such as plastic, steel, wood, and paper pulp-fibrous. The device 10 can be made of one or more materials. In one form, the ear cleaning device 10 is made of plastic and formed using an injection molding procedure.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan and Olson with that of Olson to include wherein the head portion and the handle portion are molded together during a single molding step through the combination of references as differing material compositions are known in the art and it would have yielded the same or similar results (Olson (Col. 8, lines 5-9)).
Regarding claim 10, modified McMillan further discloses wherein the head includes at least one protrusion extending radially outwardly therefrom (McMillan (Fig. 12A, members – 76)(Col. 7, lines 58-59) (Col. 8, lines 55-65)).
Regarding claims 12 and 31, modified McMillan fails to explicitly disclose the limitations of the claim.
However, Olson further teaches wherein the handle and the head are formed from a single piece of material (Olson (Col. 2-3, lines 66-3) (Col. 8, lines 5-9, “The ear cleaning device 10 can be made from a variety of materials such as plastic, steel, wood, and paper pulp-fibrous. The device 10 can be made of one or more materials. In one form, the ear cleaning device 10 is made of plastic and formed using an injection molding procedure.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan and Olson with that of Olson to include wherein the handle and the head are formed from a single piece of material through the combination of references as differing material compositions are known in the art and it would have yielded the same or similar results (Olson (Col. 8, lines 5-9)).
Regarding claim 19, modified McMillan further discloses wherein at least one leg of the plurality of legs includes a protrusion extending therefrom (McMillan (Fig. 12A, (the scraping means 76 are on the external surface of the section of collection means 71))(Col. 7, lines 58-59) (Col. 8, lines 55-65)).
Regarding claim 29, modified McMillan fails to explicitly disclose the limitations of the claim. However, Olson further teaches wherein the center leg (Olson (Fig. 3-4, longitudinal wall – 30)), first exterior leg (Olson (Fig. 3-4, longitudinal wall- 32)), and second exterior leg (Olson (Fig. 3-4, (structure – 33)) (Fig. 4, (three observable longitudinal walls))) lie on a first reference plane oriented parallel to the handle (Olson (Abstract (“The bulbous cleaner has two or more spaced, longitudinal walls disposed outward of the inner core that are configured to remove debris with turning of the ear cleaning device about a longitudinal axis of the device”)) (Col. 4, lines 5-23 (longitudinal walls)) (Fig. 4, (three observable longitudinal walls))), and wherein a rib extends inwardly from the first leg and the second leg in a direction parallel to the plane (Olson (Fig. 2-3, (lateral wall – 50 extends on the lateral plane)) (Col. 3, lines 25-35))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan and Olson with that of Olson to include wherein the center leg, first exterior leg, and second exterior leg lie on a first reference plane oriented parallel to the handle; and wherein a rib extends inwardly from the first leg and the second leg in a direction parallel to the plane through the combination of references as it would have yielded the predictable result of improving sample collection by providing additional edges (Olson (Col. 3, lines 17-35)).
Regarding claim 30, modified McMillan further discloses further comprising one or more gullets formed into at least one of the first exterior leg and the second exterior leg (McMillan (Fig. 12A, (members – 76 form gullets between each member))(Col. 7, lines 58-59) (Col. 8, lines 55-65)).
Regarding claim 34, modified McMillan fails to explicitly disclose the limitations of the claim. However, Olson further teaches wherein the center leg (Olson (Fig. 3-4, longitudinal wall – 30)), first exterior leg (Olson (Fig. 3-4, longitudinal wall- 32)), and second exterior leg (Olson (Fig. 3-4, (structure – 33)) (Fig. 4, (three observable longitudinal walls))) lie on a first reference plane oriented parallel to the handle (Olson (Abstract (“The bulbous cleaner has two or more spaced, longitudinal walls disposed outward of the inner core that are configured to remove debris with turning of the ear cleaning device about a longitudinal axis of the device”)) (Col. 4, lines 5-23 (longitudinal walls)) (Fig. 4, (three observable longitudinal walls))), and wherein a rib extends outwardly from the first leg and the second leg in a direction parallel to the plane (Olson (Fig. 2-3, (lateral wall – 50 extends on the lateral plane)) (Col. 3, lines 25-35))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan and Olson with that of Olson to include wherein the center leg, first exterior leg, and second exterior leg lie on a first reference plane oriented parallel to the handle; and wherein a rib extends outwardly from the first leg and the second leg in a direction parallel to the plane through the combination of references as it would have yielded the predictable result of improving sample collection by providing additional edges (Olson (Col. 3, lines 17-35)).
Regarding claim 35, modified McMillan fails to explicitly disclose the limitations of the claim.
However, Olson further teaches wherein the center leg is substantially planar (Olson (Fig. 3-4, longitudinal wall – 30)(Fig. 4, (longitudinal walls))(Abstract (“The bulbous cleaner has two or more spaced, longitudinal walls disposed outward of the inner core that are configured to remove debris with turning of the ear cleaning device about a longitudinal axis of the device”)) (Col. 4, lines 5-23 (longitudinal walls))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan and Olson with that of Olson to include wherein the center leg is substantially planar through the combination of references as it would have yielded the predictable result of improving sample collection by providing additional edges (Olson (Col. 3, lines 17-35)).
Regarding claim 32, McMillan discloses a swab for collecting biological samples (Abstract), the swab comprising:
a handle having a first end (Fig. 12, shaft – 70 (the first end is considered to be the left end with collection means 71));
a head (Fig. 12, collection means – 71) coupled to the handle at the first end thereof (Fig. 12, (observable that the collection means 71 is connected to the shaft -70)), wherein the head includes:
a base proximate the first end of the handle (Fig. 12, collection means – 71 (the base of the collection means 71 is the right end of the collection means towards the shaft – 70)),
a tip spaced a distance from the base opposite the handle (Fig. 12 (the tip is considered to be the very left end of the collection means 71 furthest from the shaft – 70)), and
a plurality of legs (Fig. 12, (first and second leg as indicated in modified Fig. 12 below), retention means – 74) each extending between the base and the tip (Fig. 12, (observable that the first and second legs as indicated in modified Fig. 12 below and retention means 74 extend between the tip and base of collection means 71)); and
wherein the plurality of legs includes a center leg (Fig. 12, retention means -74), a first exterior leg (Fig. 12, (first leg as indicated in modified Fig. 12 below)), and a second exterior leg (Fig. 12, (second as indicated in modified Fig. 12 below)),
wherein the head defines a first gap between the center leg and the first exterior leg (Fig. 12, (observable gap between retention means 74 and the first leg as indicated in modified Fig. 12 below)), and a second gap between the center leg and the second exterior leg (Fig. 12, (observable gap between retention means 74 and the second leg as indicated in modified Fig. 12 below)),
wherein the first gap is enclosed by the center leg, the first exterior leg, the base, and the tip (Fig. 12, (observable gap between retention means 74 and the first leg as indicated in modified Fig. 12 below, and is between the tip and base of collection means - 71)),
wherein the second gap is enclosed by the center leg, the second exterior leg, the base, and the tip (Fig. 12, (observable gap between retention means 74 and the second leg as indicated in modified Fig. 12 below, and is between the tip and base of collection means - 71)),
wherein the head includes an exterior (Fig. 12,12A, trailing edge – 73 (observable that trailing edge – 73 is exposed to the environment)), and wherein both the first gap and the second gap are open to the exterior of the head in at least one location (Fig. 12, 12A (observable that the above indicated first and second gaps are exposed to the trailing edge – 73, which faces the above indicated first and second gaps)),
wherein the first gap (Fig. 12, (observable gap between retention means 74 and the first leg as indicated in modified Fig. 12 below)) and the second gap (Fig. 12, (observable gap between retention means 74 and the second leg as indicated in modified Fig. 12 below)) pass completely through the head (Fig. 12, (observable that the indicated gaps between retention means -74 and the indicated legs pass through the head)).
McMillan fails to explicitly disclose a handle having a second end opposite the first end. (Examiner's Note: McMillan fails to explicitly indicate the structure on the opposite end of shaft – 70)
However, McMillan does teach in an alternate embodiment a handle having a second end (Fig. 1 (distal end -22)) opposite the first end (Col. 6, lines 17-24) (Fig. 1 (proximal end -23)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan with an alternate embodiment of McMillan to include a handle having a second end opposite the first end through the combination of embodiments as differing shaft structures are known (McMillan (Col. 4, lines 36-49) (Col. 6, lines 17-24)) and it would have yielded the predictable result of explicitly providing a location to grasp the device.
Modified McMillan fails to explicitly disclose wherein the center leg, first exterior leg, and second exterior leg lie on a first reference plane oriented parallel to the handle; wherein the center leg extends beyond at least one of the first exterior leg and the second exterior leg in a direction measured perpendicular to the first reference plane.
However, Olson teaches wherein the center leg (Fig. 3-4, longitudinal wall – 30), first exterior leg (Fig. 3-4, longitudinal wall- 32), and second exterior leg (Fig. 3-4, (structure – 33)) (Fig. 4, (three observable longitudinal walls)) lie on a first reference plane oriented parallel to the handle (Abstract (“The bulbous cleaner has two or more spaced, longitudinal walls disposed outward of the inner core that are configured to remove debris with turning of the ear cleaning device about a longitudinal axis of the device”)) (Col. 4, lines 5-23 (longitudinal walls)) (Fig. 4, (three observable longitudinal walls)); wherein the center leg extends beyond at least one of the first exterior leg and the second exterior leg in a direction measured perpendicular to the first reference plane (Fig. 3-4, longitudinal wall – 30, 32, structure – 33 (observable that longitudinal wall – 30 extends further than wall 32 and structure – 33)) (Abstract (“The bulbous cleaner has two or more spaced, longitudinal walls disposed outward of the inner core that are configured to remove debris with turning of the ear cleaning device about a longitudinal axis of the device”)) (Col. 4, lines 5-23 (longitudinal walls)) (Fig. 4, (three observable longitudinal walls)).
McMillan and Olson are considered to be analogous art to the claimed invention as they are both involved with collection of biological materials.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan with that of Olson to include wherein the center leg, first exterior leg, and second exterior leg lie on a first reference plane oriented parallel to the handle; and wherein the center leg extends beyond at least one of the first exterior leg and the second exterior leg in a direction measured perpendicular to the first reference plane through the combination of references as it would have yielded the predictable result of providing additional edges for sample collection (Olson (Col. 3, lines 17-35)).
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McMillan Modified Fig. 12
Regarding claim 25, modified McMillan fails to explicitly disclose the limitations of the claim. However, Olson further teaches wherein the center leg has a first dimension measured perpendicular to the first reference plane (Olson (Fig. 4, (the length of center leg 30 that extends from the perimeter of the circle, including support shaft 62, and extends to the opposite side of the circle))) and a second dimension measured parallel to the first reference plane (Olson (Fig. 4, (the width of center leg 30 that extends from the perimeter of the circle, including support shaft 62, and extends to the opposite side of the circle, where the width is taken in the Left to right direction))), and wherein the first dimension is larger than the second dimension (Olson (Fig. 4, (as the first dimension extends the entire diameter of the circle, whereas the second dimension does not, the first dimension is larger than the second))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan and Olson with that of Olson to include wherein the center leg has a first dimension measured perpendicular to the first reference plane and a second dimension measured parallel to the first reference plane, and wherein the first dimension is larger than the second dimension through the combination of references as it would have yielded the predictable result of providing edges for sample collection (Olson (Col. 3, lines 17-35)).
Regarding claim 26, modified McMillan fails to explicitly disclose the limitations of the claim. However, Olson further teaches wherein the handle and the head are formed from a single piece of material (Olson (Col. 2-3, lines 66-3) (Col. 8, lines 5-9, “The ear cleaning device 10 can be made from a variety of materials such as plastic, steel, wood, and paper pulp-fibrous. The device 10 can be made of one or more materials. In one form, the ear cleaning device 10 is made of plastic and formed using an injection molding procedure.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan and Olson with that of Olson to include wherein the handle and the head are formed from a single piece of material through the combination of references as differing material compositions are known in the art and it would have yielded the same or similar results (Olson (Col. 8, lines 5-9)).
Regarding claim 33, modified McMillan fails to explicitly disclose the limitations of the claim. However, Olson further teaches wherein the center leg extends beyond both the first exterior leg and the second exterior leg in a direction measured perpendicular to the first reference plane (Olson (Fig. 3-4, longitudinal wall – 30, 32, structure – 33 (observable that longitudinal wall – 30 extends further than wall 32 and structure – 33 in two directions)) (Abstract (“The bulbous cleaner has two or more spaced, longitudinal walls disposed outward of the inner core that are configured to remove debris with turning of the ear cleaning device about a longitudinal axis of the device”)) (Col. 4, lines 5-23 (longitudinal walls)) (Fig. 4, (three observable longitudinal walls))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan and Olson with that of Olson to include wherein the center leg extends beyond both the first exterior leg and the second exterior leg in a direction measured perpendicular to the first reference plane for the reasoning as indicated in claim 32 above.
Claim(s) 2-3 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMillan in view of Olson as applied to claim 12 and 11 above, and further in view of Frandsen (US Pub. No. 20220054317) hereinafter Frandsen.
Modified McMillan and Olson teach the device of claim 12 above.
Regarding claim 2, modified McMillan fails to explicitly disclose the limitations of the claim.
However, Frandsen teaches wherein the single piece of material includes medical-grade polypropylene (Frandsen (Par. 56 (Thermoplastic elastomers))).
McMillan, Olson, and Frandsen are considered to be analogous art to the claimed invention as they are involved with swabs.
Therefore, it would have been further obvious to modify the device of McMillan and Olson with that of Frandsen to include wherein the single piece of material includes medical-grade polypropylene through the combination of references as varying thermoplastics are known in the art and it would have yielded the predictable result of improving the resiliency of the swab (Frandsen (Par. 57)).
Regarding claim 3, modified McMillan fails to explicitly disclose the limitations of the claim.
However, Frandsen teaches wherein the single piece of material is a non-fibrous and non-foam type material (Frandsen (Par. 56 (Thermoplastic elastomers))).
Therefore, it would have been further obvious to modify the device of McMillan and Olson with that of Frandsen to include wherein the single piece of material is a non-fibrous and non-foam type material through the combination of references as varying thermoplastics are known in the art and it would have yielded the predictable result of improving the resiliency of the swab (Frandsen (Par. 57)).
Modified McMillan and Olson teach the device of claim 11 above.
Regarding claim 13, modified McMillan fails to explicitly disclose the limitations of the claim.
However, Frandsen teaches wherein the handle and the head are formed separately (Par. 57).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan and Olson with that of Frandsen to include wherein the handle and the head are formed separately through the combination of references as forming the handle and head separately and together are known manufacturing variations and it would have yielded predictable results of improving reusability (Frandsen (Abstract)(Par. 57)).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over McMillan in view of Olson as applied to claim 11 above, and further in view of Olsen (US Pub. No. 20130338533) hereinafter Olsen.
Modified McMillan and Olson teach the device of claim 11 above.
Regarding claim 6, modified McMillan fails to explicitly disclose wherein the handle portion includes a grip portion and a neck portion extending from the grip portion,
However, McMillan does teach in an alternate embodiment wherein the handle portion includes a grip portion (McMillan (Col. 6, lines 21-24) (Fig. 1, means – 17)) and a neck portion extending from the grip portion (McMillan (Fig. 1 (unlabeled area of shaft – 10 between the means 17 and collection means -11))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan and Olson with an alternate embodiment of McMillan to include wherein the handle portion includes a grip portion and a neck portion extending from the grip portion through the combination of embodiments as differing shaft structures are known (McMillan (Col. 4, lines 36-49) (Col. 6, lines 17-24)) and it would have yielded the predictable result of explicitly providing a location to grasp the device.
Modified McMillan fails to explicitly disclose wherein the grip portion has a greater area moment of inertia than the neck portion.
However, Olsen teaches wherein the grip portion (Par. 47, handle - 2 (handle body)) has a greater area moment of inertia than the neck portion (Par. 47, handle – 2 (neck portion)).
McMillan, Olson, and Olsen are considered to be analogous art as they are both involved with biological sample collection.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan and Olson with that of Olsen to include wherein the grip portion has a greater area moment of inertia than the neck portion through the combination of references as it would have yielded the predictable result of improving the grip and rotational control (Olsen (Par. 47)).
Response to Arguments
Applicant’s arguments, filed 08/10/2026, regarding the previous 103 rejection, have been fully considered and deemed as not persuasive.
The applicant’s arguments, regarding claim 11, that McMillan and Olson do not teach the indicated limitations of the claim have been fully considered and deemed as not persuasive. As indicated in the 103 rejection above, Olson teaches wherein the center leg (Fig. 3-4, longitudinal wall – 30) extends, in a direction measured perpendicular to the first exterior leg (Fig. 3-4, longitudinal wall- 32) and the second exterior leg (Fig. 3-4, (structure – 33)) (Fig. 4, (three observable longitudinal walls)), beyond the first exterior leg and the second exterior leg in both directions (Fig. 3-4, longitudinal wall – 30, 32, structure – 33 (observable that longitudinal wall – 30 extends further than wall 32 and structure – 33)) (Abstract (“The bulbous cleaner has two or more spaced, longitudinal walls disposed outward of the inner core that are configured to remove debris with turning of the ear cleaning device about a longitudinal axis of the device”)) (Col. 4, lines 5-23 (longitudinal walls)) (Fig. 4, (three observable longitudinal walls)). As such, Olson teaches the added limitation to the claim.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to a person of ordinary skill in the art to modify the device of McMillan with that of Olson to include wherein the center leg extends, in a direction measured perpendicular to the first exterior leg and the second exterior leg, beyond the first exterior leg and the second exterior leg in both directions through the combination of references as it would have yielded the predictable result of providing additional edges for sample collection (Olson (Col. 3, lines 17-35)). Additionally, the examiner respectfully disagrees with the applicant’s assertion that McMillan teaches away from the above combination.
The applicant’s arguments regarding the dependent claims, rely on the arguments related to the independent claim, and as such are also deemed as not persuasive.
The applicant’s argument, regarding claim 18, that McMillan does not teach the indicated limitations of the claim, has been fully considered and deemed as not persuasive. As the applicant’s claims are given their broadest reasonable interpretation, the claim itself recites “wherein the head includes at least one location on the exterior having a first roughness and at least one location on the exterior having a second roughness different than the first roughness”, where “roughness” is defined as “the quality or state of being rough” (Merriam-Webster dictionary), and “rough” is defined as “marked by inequalities, ridges, or projections on the surface” (Merriam-Webster dictionary). As such, under the broadest reasonable interpretation, the prior art need only teach a location having a first roughness of any amount and a location having a second roughness of any amount that is different from the first roughness. As indicated in the 103 rejection above, McMillan discloses wherein the head includes at least one location on the exterior having a first roughness and at least one location on the exterior having a second roughness different than the first roughness (Fig. 12A, (one side with scraping means – 76 and the other without))(Col. 7, lines 58-59) (Col. 8, lines 55-65). As such, McMillans one side with scraping means -76 and another without the scraping means reads on the indicated limitations of the claim.
The applicant’s argument, regarding claim 32, that the prior art does not teach the added limitations to claim 32, have been fully considered and deemed as not persuasive. As the limitation was not previously addressed, the limitation has been addressed in the 103 rejection as indicated above. Additionally, the added limitation invokes 112f as indicated in the 112f interpretation above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ARI S PADDA/Examiner, Art Unit 3791
/RENE T TOWA/Primary Examiner, Art Unit 3791
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