DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 11/04/2025 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant contends that it would not have been obvious to one of ordinary skill in the art to have modified the device of Etling to comprise a threading on the working stem “a” configured to mate with a corresponding threading of an axially-movable stop element, as disclosed by and incorporated from the teachings of Metzger.
Applicant contends that the reasoning for this inclusion of “providing a translatable stop element configured to adjust and limit the amount the working tip may be inserted into the ear canal” does not provide any articulated reasoning and merely describes the resulting structural combination. No reasoning has been provided as to why a skilled artisan would have been motivated to include the translatable stop element into the device of Etling. The examiner respectfully disagrees. Metzger’s devices is configured to be used to clean out an ear canal (analogous and similar in function to the device of Etling), wherein a stop element that is able to translate along the length of a working tip would allow a user to adjust, based on the size and shape of the target use area, the penetration depth of the distal working tip by moving the stop element along the length of the working tip to a desired location. This provides a clear benefit to a device configured to be used in the ear canal in proving a stop element configured to be adjusted based on the shape and size of a target-use area to limit the penetration depth of the distal working tip.
Applicant further contends that one of ordinary skill in the art would not have combined the device of Etling with the teachings of Metzger on the grounds that Etling discloses wherein “a piece of cloth, soft leather of the like is stretched over and around the thickened front of the stem, the free ends of the cloth being held in place by the clamping ring” which Applicant contends is “the defining feature” of the device of Etling and any modification to alter the texture of the stem would destroy the principle operation of the device of Etling. Therefore, should a user modify the stem of Etling to comprise an axial threading along the length thereof to receive an axially-translatable stop (i.e., from the teachings of Metzger), the cloth covering of the stem would be removed and the core functional element of Etling would be destroyed. The examiner respectfully disagrees with the contention that the cloth covering is the “defining feature” of the device of Etling. While Etling does provide a disclosure that a piece of cloth is stretched over the stem of the device, the examiner cannot find any description of implication that the cloth serves a functional purpose in the use of the device. The working tip is configured to be introduced to the outer ear canal for cleaning, but there is no evidence that the cloth provides any benefit to this function. Given the lack of function or criticality given by Etling to the cloth covering, one of ordinary skill in the art would not have considered this to be a core feature of the device and would have modified the stem of Etling to comprise the threading of Metzger to achieve the disclosed benefit of providing a translatable and adjustable stop element to variable limit penetration depth of the distal working tip of the device.
Applicant contends that none of either Etling or Metzger expressly disclose the amended limitations of “a flat, disc-shaped stopped” on the grounds that the stopper of Metzger is “cylindrical”. The examiner respectfully disagrees. As there appears to be no special definition for the term “disc” provided in the instant specification, the examiner turns to a dictionary definition of a disc as “a round, flat structure”. Looking to the stop of Metzger, the cylindrical shape fits this description due to its configuration as a round (i.e., circular) flat (i.e., not having any bumps of protrusions) structure.
Applicant contends that Etling does not disclose the amended limitations of “a length of the stopper engagement section is less than a length of the elongated, rod-shaped handle”. While the examiner agrees that Etling does not provide any description of the relative dimensions of the stem and handle, the examiner contends it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the stem of Etling et al, to have an a length that is less than a length of the elongated rod-shaped handle since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the stem and/or handle of Etling et al. would not operate differently with the claimed relative dimensions since, so long as the a user is able to grip the handle and the stem is sized to be introducer to a nasal passage, Etling does not disclose any further criticality to their relative dimensions. Further, Applicant appears to have placed no criticality on the recited dimensions as Para. [0026] of the Specification recites wherein the stopper engagement section may be located only partially along the length of the handle or may extend along an entire length of the handle, indicating the relative lengths are not a critical feature to the claimed invention, leading to a lack of criticality in the claimed limitations that serve no specific patentable or novel function over the prior art.
Applicant contends that Etling does not disclose the amended limitations of “a length of the stopper engagement section is less than a length of the elongated, rod-shaped handle”. While the examiner agrees that Etling does not provide any description of the relative dimensions of the stem and handle, the examiner contends it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the stem of Etling et al, to have an a length that is less than a length of the elongated rod-shaped handle since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the stem and/or handle of Etling et al. would not operate differently with the claimed relative dimensions since, so long as the a user is able to grip the handle and the stem is sized to be introducer to a nasal passage, Etling does not disclose any further criticality to their relative dimensions. Further, Applicant appears to have placed no criticality on the recited dimensions as Para. [0026] of the Specification recites wherein the stopper engagement section may be located only partially along the length of the handle or may extend along an entire length of the handle, indicating the relative lengths are not a critical feature to the claimed invention, leading to a lack of criticality in the claimed limitations that serve no specific patentable or novel function over the prior art.
Applicant’s arguments with respect to claim(s) 1 and 12 pertaining to the amended limitations of “an elongated, rod-shaped handle…having a uniform cross-section that extends between a distal end and a proximal end”, “the handle comprising a polypropylene material”, “the working tip of the stopper engagement section configured comprising a silicone material”, “the stopper configured to rest against an outside of a nose of a user below the nasal cavity to limit a depth of insertion of the working tip into the nasal cavity” and “the stopper comprising a polypropylene material” have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites, “road-shaped” which should be corrected to recite “rod-shaped”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Etling (US 1693581 A)(previously of record) in view of Metzger (US 1138967 A)(previously of record), further in view of Lee (US 2010/0064457 A1), further in view of Begun (US 2001/0001828 A1), further in view of Kruglick (US 5632756 A).
Regarding claim 1, Etling discloses:
A device (see Fig. 1) configured for removing a substance from a nasal cavity (the device of Fig. 1 is used to remove wax from an ear (see Col. 1, Lines 1-3) and thus is therefore understood to be sized such as to be capable of removing a substance from a nasal cavity), comprising:
an elongated, rod-shaped handle (handle “f”, see Fig. 1) configured to be gripped by a user (handle “f” is configured to be gripped by a user due to its designation as the “handle” of the device);
a shoulder at the distal end of the handle (ring “d”, see Fig. 1);
a stopper engagement section (stem “a”, see Fig. 1) extending distally from the shoulder (see Fig. 1), the stopper engagement section comprising a substantially uniform cross-section (see Fig. 1 showing wherein stem “a” has a “substantially uniform” cross-section);
a working tip (working tip “b”, see Fig. 1) at the distal end of the stopper engagement section (see Fig. 1) and configured to be inserted into a nasal cavity (working tip “b” is sized so as to be capable of being inserted into a nasal cavity due to its ability to operate within the ear of a patient);
wherein the distal end of the handle is free from any working tips (see Fig. 1 showing wherein the distal end of the handle “f” is free and spaced apart from tip “b”) and comprises a rounded end (see Fig. 1 showing wherein the entirety of the body of the handle “f” is cylindrical, which is a rounded shape).
However, while Etling discloses wherein the handle may be formed from “any appropriate material” (see Col. 1, Line 20), Etling does not expressly disclose:
Wherein the elongated, rod-shaped handle comprises a substantially uniform cross-section that extends between a distal end and a proximal end;
Wherein the handle comprises a polypropylene material;
Wherein the stopper engagement section comprises helical threads;
Wherein the working tip comprising a silicone material;
A flat, disc-shaped stopper movably connected to the stopper engagement section and movable between the shoulder and the working tip, the shoulder configured to provide a stop to limit an amount that the stopper can be moved along the stopper engagement section in a distal direction, the stopper including a size that is greater than an opening to the nasal cavity, the stopper configured to rest against an outside of a nose of a user below the nasal cavity to limit the depth of insertion of the working tip into the nasal cavity, the stopper comprises a polypropylene material;
Wherein the stopper is rotatable about the helical threads of the stopper engagement section to increase and decrease a distance between the working tip and the stopper to prevent the working tip from penetrating too deeply into the nasal cavity; and
wherein an outer diameter of the stopper is greater than an axial thickness of the stopper, the axial thickness of the stopper extending along a length of the stopper engagement feature; and
wherein a length of the stopper engagement section is less than a length of the elongated rod-shaped handle.
In the same field of endeavor, namely devices configured to be inserted into and clean an ear canal, Kruglick teaches wherein an ear cleaning device (see Fig. 3) comprising a distal working end (swab 40 and cage 28, see Fig. 3) and a handle (23, see Fig. 3), wherein the handle comprises a rigid, cylindrical shape (see Col. 5, Lines 40-45).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known handle shape for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having the handle of Etling comprise a cylindrical, substantially uniform shape as disclosed by Kruglick. Since Etling does not provide any express disclosure pertaining to a specific function of the current shape of the handle, one of ordinary skill in the art would have understood the handle shape to be a non-critical feature and would have thus expected the handle of Etling to function equally well with either the currently-presented shape, or a substantially cylindrical shape as disclosed by Kruglick. Since both devices are within the same field of endeavor (i.e., ear cleaning device), without an express benefit to the shapes of the handle, so long as a user is still capable of gripping the handle, one of ordinary skill would have been able to select from other known handle shapes within analogous art to be interchangeable with the handle of Etling without comprising overall functionality of the device.
In the same field of endeavor, namely ear cleaning devices, Metzger teaches wherein an ear cleaning device (see Fig. 1) having an elongate body (1, see Fig. 1) and comprising a flat, disc-shaped depth stopper (6, see Fig. 1 and Lines 82-89) that comprises an internal helical threading (7, see Fig. 2 – threading is understood to be “helical” to allow the stop to translate along the length of the body) configured to mate with a corresponding threading along the elongate body (see Fig. 2 and Lines 82-90) that permits the stopper translate along the length of the elongate body to adjust the distance the working tip may be inserted into an ear canal (see Lines 82-90) by acting as an enlarged barrier that is sized to be prevented from entering the ear canal.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stem “a” of Etling to comprise a threading thereon that is configured to mate with a corresponding threading of a flat, disc-shaped stop element configured to be moved along the length of the stem via the mating threading disposed thereon as taught and suggested by Metzger to, in this case, provide a translatable stop element configured to adjust and limit the amount the working distal tip may be inserted into an ear canal (see Metzger Lines 82-95), limited when the stop of Metzger abuts against the exterior of the canal (i.e., nasal or ear). As only the stem “a” is receiving the threading from the teachings of Metzger, the ring “d” would act as a barrier to prevent the stop of Metzger from translating further proximally beyond the length of the stem.
Regarding the limitations, “wherein an outer diameter of the stopper is greater than an axial thickness of the stopper, the axial thickness of the stopper extending along a length of the stopper engagement feature”, Metzger does not expressly disclose relative dimensions of the stop, as incorporated into the device of Etling.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the stop of Metzger et al, as incorporated into the device of Etling, to have an outer diameter that is larger than an axial thickness along the longitudinal length thereof since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the stop of Metzger et al. would not operate differently with the claimed relative dimensions since, so long as the stop maintains a cylindrical shape that prevents entry of said stop into the target area (i.e., the ear canal or nasal canal), Metzger does not disclose any further criticality to the relative dimensions of the stop. Further, Applicant appears to have placed no criticality on the recited dimensions as no express mention of these relative dimensions can be found described in the specification, leading to a lack of criticality in the claimed limitations that serve no specific patentable or novel function over the prior art.
Regarding the limitations, “wherein a length of the stopper engagement section is less than a length of the elongated rod-shaped handle”, Etling does not expressly disclose relative dimensions of the stem or handle.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the stem of Etling et al, to have an a length that is less than a length of the elongated rod-shaped handle since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the stem and/or handle of Etling et al. would not operate differently with the claimed relative dimensions since, so long as the a user is able to grip the handle and the stem is sized to be introducer to a nasal passage, Etling does not disclose any further criticality to their relative dimensions. Further, Applicant appears to have placed no criticality on the recited dimensions as Para. [0026] of the Specification recites wherein the stopper engagement section may be located only partially along the length of the handle or may extend along an entire length of the handle, indicating the relative lengths are not a critical feature to the claimed invention, leading to a lack of criticality in the claimed limitations that serve no specific patentable or novel function over the prior art.
In the same field of endeavor, namely surgical devices used within the nasal cavity, Lee, teaches a device used for cleaning within the nasal canals (nose cleaner 10, see Fig. 1 and Para. [0018]) comprising a handle (see Figs. 1 and 5) and a distal working tip (cleaning device 13, see Fig. 1) may be formed from, among other alternatives, polypropylene (see Para. [0029]) as a known material within the art.
Since Etling expressly discloses wherein the handle may be formed from “any appropriate material” (see Col. 1, Line 20), it would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to known materials used to form handles of similar devices within the available prior art and caused the handle of Etling to be formed from polypropylene as disclosed by Lee since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
In the same field of endeavor, namely surgical devices used within the nasal cavity, Lee teaches a device used for cleaning within the nasal canals (nose cleaner 10, see Fig. 1 and Para. [0018]) comprising a handle (handle 12, see Figs. 1) and a distal working tip (cleaning device 13, see Fig. 1) may be formed from, among other alternatives, Silicone (see Para. [0029]) as a known material within the art.
Since Etling does not expressly disclose a specific material used to form the distal working tip of the device, it would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to known materials used to form working tips of similar devices within the available prior art and caused the working tip of Etling to be formed from silicone as disclosed by Lee since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
In the same field of endeavor, namely surgical devices used within the nasal cavity, Begun teaches a device used for cleaning within ear canals (see Fig. 9A) comprising a handle (stem 94, see Fig. 9A), a distal working tip (loop 95, see Fig. 9A) and a stopper element (stopper 93, see Fig. 9A), wherein the entirety of the device may be formed from polypropylene (see Para. [0040]) which is a flexible, resilient material allowing for repeated bending without damage to the device (see Para. [0042]) as a known material within the art.
Since Metzger does not expressly disclose a specific material used to form stop, as incorporated into the device of Etling, it would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to known materials used to form stopper elements of similar devices within the available prior art and caused the stop of Etling, as incorporated from the device of Metzger, to be formed from polypropylene as disclosed by Begun since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Regarding claim 11, the combination of Etling, Metzger, Kruglick, Lee and Begun disclose the invention of claim 1, Etling further discloses wherein the working tip comprises a spoon, scraper, loop curette, flashlight, swab, rounded edge, square or linear edge, cotton tip, suction device, or a combination thereof (see Fig. 1 showing wherein the distal working tip “b” is in the form of a rounded scraper).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Etling (US 1693581 A)(previously of record) in view of Metzger (US 1138967 A)(previously of record), further in view of Lee (US 2010/0064457 A1), further in view of Begun (US 2001/0001828 A1), further in view of Kruglick (US 5632756 A), as applied to claim 1, further in view of Farzin (US 2015/0127036 A1), further in view of Banks (US 2010/0280544 A1).
Regarding claim 12, the combination of Etling, Metzger, Kruglick, Lee and Begun disclose all of the limitations of the invention of claim 1, Etling further discloses:
A method comprising:
adjusting a distance between the stopper and the working tip by rotating the stopper about the stopper engagement feature (see Metzger Lines 82-90 mentioning wherein the stopper positing is adjusted by rotating the stopper about the inner engagement tool until a desired stop depth is achieve).
However, Etling does not expressly disclose wherein the disclosed device is configured to be used within the nasal canal and thus does not expressly disclose the steps of:
Resting the working tip of the device according to claim 1 against the outside of the nose of the user with the stopper arranged below and against a nostril;
Wherein the step of adjusting the stopper about the stopper engagement feature takes place after resting the device according to claim 1 outside the nose of the user with the stopper arranged below the nostril; and
After the adjusting step, inserting the working tip of the device into the nasal cavity until the stopper contacts the nose in a region below an opening into the nasal cavity to prevent the working tip from penetrating too deeply into the nasal cavity.
In the same field of endeavor, namely devices configured to clean out a nasal canal, Farzin teaches wherein a device for cleaning out an ear canal (see Fig. 1 and Abstract and Para. [0009]) may also be used within a nasal passage to clean out mucus therefrom (see Abstract and Para. [0009]); wherein in said method for removing material from a nasal passageway, a working tip (loop 26 and bowl 18, see Fig. 1) is inserted into the nasal passageway until a stop (20, see Fig. 1) abuts against the exterior of the nose and prevents further insertion into the nasal passageway (see Para. [0023]-[0025] and Figs. 6-7).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the device of Etling, as modified by Metzger, within the nasal passage to clean out material therefrom as disclosed by Farzin to be a known alternative use for ear cleaning devices (see Farzin Para. [0009]); wherein in using the device of Etling, one of ordinary skill would have utilized the known method disclosed by Farzin and inserted the distal working tip of Etling into the nasal canal until the stop, as incorporated from the device of Metzger, abuts against the exterior of the nose, preventing further insertion into the nasal canal (see Farzin Para. [0023]-[0025] and Figs. 6-7).
In the same field of endeavor, namely device configured to remove material from a nasal canal, Banks discloses a device for removing material from a nasal canal (see Fig. 1 and 6; see also Para. [0031]), the device comprising a distal working end (distal ends 22 and 32, see Fig. 1) and an adjustable stop element (wing tabs 60 and 260, see Figs. 1 and 7-8) configured to limit the penetration depth of the distal working end into the nasal canal (see Para. [0037]); wherein a user may, before inserting the distal working ends into the nasal canal of a patient, adjust the location of the stop elements based on the depth of the patient’s nasal canal prior to insertion of the distal working ends into said nasal canal (see Para. [0037]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of being obvious to try (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of, prior to insertion of the distal working ends of the device of Etling, as modified by Metzger, adjusted the axial location of the stop member of Etling by resting the distal working end of the device against the exterior of a patient’s nose before sliding the stop element to a desired stop depth based on the relative length of the patient’s nose, when compared to the distal working end of the device. Since both Metzger and Banks disclose wherein the stop element is configured to be adjusted to limit penetration depth of a distal working end into an intended bodily cavity (i.e., a nasal canal), one of ordinary skill in the art would have selected from a finite number of possible ways to align the stop element with the length of a patient’s nasal canal. Since a measurement step of the intended use area would be required to ensure proper penetration depth of the stop element, it would have been obvious to one of ordinary skill to have performed this measurement step by aligning the device along the exterior of a patient’s nose to ensure proper placement of the stop element relative to the size of the patient’s nose.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2021/0378710 A1 to Hirschhorn, US 2021/0008356 A1 to Reo and US 2020/0338287 A1 to Chan which all disclose ear/nose cleaning device and/or having a stop member and accompanying method of use.
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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771