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 .
Status of Claims
2. Claims 1-19 are pending and currently under consideration for patentability under 37 CFR 1.104.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). See also MPEP 211.05(I)(A)-(B).
The disclosure of the prior-filed application(s), Application No.’s 16/402,143, 16/431,631, 14/588,392, 62/011,591, and 61/922,791, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, none of these prior applications provide any support for:
“said head having a hollow cavity concentric with the primary axis through the center of the head face in an angular sweep motion; said patient applies a topical agent to said head into said hollow cavity” (claim 1, claim 10).
“said stem is located off center of said head and on the opposite side of said head surface” (claim 3, claim 13).
“said angular sweep motion is selected from the 90 degrees to 270 degrees if viewed from the face of the head” (claim 4, claim 14).
“said angular sweep motion speed is selected from 4,000 to 15,000 strokes/minute” (claim 5, claim 15).
“said head is made from thermoplastic elastomer and anti-infective agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents” (claim 7, claim 17).
“said head is made from silicone and anti-infective agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents” (claim 8, claim 18).
“a piezo electric mechanism that vibrates said head” (claim 10).
“wherein said piezo electric mechanism has a piezo electric frequency and said piezo electric frequency creates an ultrasonic motion” (claim 11).
Accordingly, claims 1-19 are not entitled to the benefit of these prior application(s).
The earliest potential priority for claims 1-2, 6, and 9 appears to be based upon app. 14/588,392 filed December 31, 2014.
The earliest potential priority for claims 7-8, 10, 12, and 16-19 appears to be based upon app. 62/835,868 filed April 18, 2019.
With respect to claims 3-5, 11, and 13-15, it is additionally noted that app. 16/852,829 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112.
The earliest potential priority for claims 3-5, 11, and 13-15 appears to be based upon instant app. 18/628,935 filed April 8, 2024.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
In the instant case, line 1of the abstract states “The invention relates generally to the field of medical devices and, more specifically to” which can be inferred, and should be deleted.
Claim Objections
Claims 1-19 are objected to because of the following informalities:
Claim 1, line 2 recites “patients eye” and the Examiner suggests --patient’s eye--.
Claim 1, line 4 recites “comprising of:” and the Examiner suggests --, the method comprising the steps of:-- to clarify.
Claim 1 recites a list of elements with “a.”, “b.”, … “j.” and the Examiner suggests --a)--, --b)--, … --j)-- because “periods may not be used elsewhere in the claims except for abbreviations” (see MPEP 608.01(m)).
Claim 2, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 1.
Claim 3, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 1.
Claim 4, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 1.
Claim 4, lines 2-3 recite “the 90 degrees” and the Examiner suggests deleting “the.
Claim 5, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 1.
Claim 6, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 1.
Claim 7, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 1.
Claim 8, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 1.
Claim 9, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 1.
Claim 9, line 2 recites “said topical agent selected” and the Examiner suggests --said topical agent is selected--.
Claim 10, line 2 recites “patients eye” and the Examiner suggests --patient’s eye--.
Claim 10, line 4 recites “comprising of:” and the Examiner suggests --, the method comprising the steps of:-- to clarify.
Claim 10 recites a list of elements with “k.”, “l.”, … “t.” and the Examiner suggests --a)--, --b)--, … --j)-- because “periods may not be used elsewhere in the claims except for abbreviations” (see MPEP 608.01(m)). Furthermore, the list should begin at “a)” rather than “k.”
Claim 11, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 10.
Claim 12, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 10.
Claim 13, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 10.
Claim 14, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 10.
Claim 14, lines 2-3 recite “the 90 degrees” and the Examiner suggests deleting “the.
Claim 15, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 10.
Claim 16, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 10.
Claim 17, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 10.
Claim 18, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 10.
Claim 19, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 10.
Claim 19, line 2 recites “said topical agent selected” and the Examiner suggests --said topical agent is selected--.
Appropriate correction is required.
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.
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 1-19 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, line 5 recites “said head” which lacks antecedent basis.
Claim 1, line 9 recites “the head face” which lacks antecedent basis. It is unclear if this is meant to refer to the previously recited --head surface--, or if it is a separate structure.
Claim 1, lines 10-11 recite “said head having a hollow cavity concentric with the primary axis through the center of the head face in an angular sweep motion” and it is unclear what the phrase “angular sweep motion” is referring to. Is this a movement? Does the hollow cavity have “an angular sweep motion”? Does the primary axis have on an “angular sweep motion”?
Claim 1, lines 13-14 recite “said topical agents” which is confusing because the claim only previously recites a singular “topical agent” (see line 12). Thus, it is unclear how many topical agent(s) are required by claim 1.
Claim 1, line 17 recites “said distal surface” which lacks antecedent basis. It is unclear what this is the distal surface of.
Claim 1, the third to last line recites “the axis of the head” which lacks antecedent basis. It appears this should potentially refer to --the primary axis of the head--.
Claim 4, lines 2-3 recite “said angular sweep motion is selected … if viewed from the face of the head” which is confusing because it appears that this is a conditional limitation. Is the angular sweep motion only selected between 90-270 degrees if it is viewed from the face of the head?
Claim 6, lines 2-3 recite “selected from the group comprising” which is confusing because the term “comprising” indicates that the group may include additional elements not listed. Thus, it is unclear what the metes and bounds of this group are. The Examiner suggests using Markush group language, --selected from the group consisting of--.
Claim 7, line 3 recites “selected from the group comprising of” which is confusing because the term “comprising” indicates that the group may include additional elements not listed. Thus, it is unclear what the metes and bounds of this group are. The Examiner suggests using Markush group language, --selected from the group consisting of--.
Claim 8, line 3 recites “selected from the group comprising of” which is confusing because the term “comprising” indicates that the group may include additional elements not listed. Thus, it is unclear what the metes and bounds of this group are. The Examiner suggests using Markush group language, --selected from the group consisting of--.
Claim 9, line 2 recites “selected from the group comprising of” which is confusing because the term “comprising” indicates that the group may include additional elements not listed. Thus, it is unclear what the metes and bounds of this group are. The Examiner suggests using Markush group language, --selected from the group consisting of--.
Claim 10, line 5 recites “said head” which lacks antecedent basis.
Claim 10, line 9 recites “the head face” which lacks antecedent basis. It is unclear if this is meant to refer to the previously recited --head surface--, or if it is a separate structure.
Claim 10, lines 10-11 recite “said head having a hollow cavity concentric with the primary axis through the center of the head face in an angular sweep motion” and it is unclear what the phrase “angular sweep motion” is referring to. Is this a movement? Does the hollow cavity have “an angular sweep motion”? Does the primary axis have on an “angular sweep motion”?
Claim 10, lines 13-14 recite “said topical agents” which is confusing because the claim only previously recites a singular “topical agent” (see line 12). Thus, it is unclear how many topical agent(s) are required by claim 10.
Claim 10, line 17 recites “said distal surface” which lacks antecedent basis. It is unclear what this is the distal surface of.
Claim 10, the third to last line recites “the axis of the head” which lacks antecedent basis. It appears this should potentially refer to --the primary axis of the head--.
Claim 14, lines 2-3 recite “said angular sweep motion is selected … if viewed from the face of the head” which is confusing because it appears that this is a conditional limitation. Is the angular sweep motion only selected between 90-270 degrees if it is viewed from the face of the head?
Claim 16, lines 2-3 recite “selected from the group comprising” which is confusing because the term “comprising” indicates that the group may include additional elements not listed. Thus, it is unclear what the metes and bounds of this group are. The Examiner suggests using Markush group language, --selected from the group consisting of--.
Claim 17, line 3 recites “selected from the group comprising of” which is confusing because the term “comprising” indicates that the group may include additional elements not listed. Thus, it is unclear what the metes and bounds of this group are. The Examiner suggests using Markush group language, --selected from the group consisting of--.
Claim 18, line 3 recites “selected from the group comprising of” which is confusing because the term “comprising” indicates that the group may include additional elements not listed. Thus, it is unclear what the metes and bounds of this group are. The Examiner suggests using Markush group language, --selected from the group consisting of--.
Claim 19, line 2 recites “selected from the group comprising of” which is confusing because the term “comprising” indicates that the group may include additional elements not listed. Thus, it is unclear what the metes and bounds of this group are. The Examiner suggests using Markush group language, --selected from the group consisting of--.
The remaining claims are rejected based on their dependence on a rejected base claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 and 9, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Rynerson et al. (2014/0214062) in view of Schwarz-Hartmann et al. (5,974,615), Hamburg (4,883,454), and La Bianco et al. (2004/0015139).
Regarding claim 1, Rynerson discloses a method of cleaning the eyelid margins and meibomian gland orifices of a patient and said patient having a patient's eye and said patients eye comprised of a lid portion and meibomian gland orifices and said cleaning cleans cellular and sebaceous debris from said meibomian gland orifices (See Figs. 5A-5B and para. [0038] “electromechanical device 10 operably drives the swab 14 to break the debris from either of the upper or lower eyelid margins 60, 62 … scrubbing, exfoliating, or buffing the eyelid margin or un-roofing a meibomian gland 66 with the swab 14”) comprising of:
a. said head (instrument 22 with swab 14, Fig. 1; 122, 14, Fig. 2. The head 122 is detachably connectable to the head receiver aperture 182, see Fig. 2) having a head stem (rigid member 116, Fig. 2) and a head surface (surface of swab 14, Fig. 1, Fig. 2);
b. said head surface (surface of swab 14) is located on the side of said head opposite said stem (see Fig. 2, the surface of swab 14 is opposite the stem 116);
c. attaching said head (the head 122 is detachably connectable to the head receiver aperture 182, see Fig. 2) to an eyelid care appliance (device 10, 110, Figs. 1-2), such that said head stem (116) is inserted into a receiver (head receiver aperture 182, see Fig. 2) in said eyelid care appliance;
d. said head (22, 14, Fig. 1; 122, 14, Fig. 2) having a primary axis through the center of the head face (an axis perpendicular to shaft 16, Fig. 1; 116, Fig. 2. This would extend through the center of the head, and its associated face);
g. accessing the eyelid of said patient (eyelid margin(s) 60, 62, Fig. 5A-5B) with said head (22, 14, Fig. 1; 122, 14, Fig. 2; Figs. 5A-5B) such that the head is applied to said patient's eyelid and meibomian gland orifices (see Figs. 5A-5B, the last sentence of [0006], and the last sentence of [0038]);
h. said eyelid care appliance having a drive system (mechanical drive unit 12 with motor chuck 32, Fig. 1; 112, 132, Fig. 2) that transmits motive force (force from motor 30, Fig. 1) to oscillate said head (the head may be provided with motor-driven reciprocating movement 38a, Fig. 1, “the operable connection of the electric motor 30 transmits a movement 38 through the chuck 32 to the instrument 22” see lines 10-12 of [0025]);
i. contacting said distal surface (the distal surface of the head 22, 14, Fig. 1; 122, 14, Fig. 2 contacts the eyelid margin(s) 60, 62, Figs. 5A-5B) to said eyelid (60, 62, Figs. 5A-5B) to clean said eyelid margins (60, 62) and said meibomian gland orifices (see the last sentence of [0006] and the last sentence of [0038]); and said eyelid care appliance oscillating said head (the head is reciprocated, see reciprocating movement 38a, Fig. 1).
Rynerson is silent regarding said head having a hollow cavity concentric with the primary axis through the center of the head face in an angular sweep motion; said patient applies a topical agent to said head into said hollow cavity; the topical agents applies to the eyelid and meibomian gland orifices; wherein said oscillation comprises repeating circular rotation up to a first angular amount in a first direction around the axis of the head, and circular rotation up to a second angular amount in a second opposite direction around the primary axis of the head such that the head does not make a full revolution.
With respect to the step of the drive system oscillation comprising repeating circular rotation up to a first angular amount in a first direction around the axis of the head, and circular rotation up to a second angular amount in a second opposite direction around the primary axis of the head such that the head does not make a full revolution, it is noted that Applicant has admitted that such oscillating drive system transmissions are “well-known” (see [0336] of the published application). Furthermore, Rynerson specifically contemplates providing “any motion … that creates relative motion to the debris on the eye 15 such that upon contacting the debris with the swab 14, the debris is removed” see lines 12-16 of [0025]).
Schwarz-Hartmann teaches a related handheld scrubbing and cleaning device (Fig. 1) with an attachable head (bristle head 26, selectively attachable by attachment 3, see Fig. 1, see col. 16, lines 20-21) that oscillates (alternating rotary movement 49, Fig. 1), and the head is connected to a stem (the stem may alternatively be considered the brush shaft 23 or the pin 27, Fig. 1). The device has a drive system (see mechanical components inside housing 5, Fig. 1) including a geared joint (pinion 32, spur gear 33 pivotably mounted on shaft 34, Fig. 1, form a geared joint) to produce oscillating movements (49) comprising repeating circular rotation up to a first angular amount in a first direction around the axis of the head, and circular rotation up to a second angular amount in a second opposite direction around the primary axis of the head such that the head does not make a full revolution (see col. 10, lines 47-54, the overall travel range can be about 30 to about 80 degrees). The angular oscillation (49) provides an advantageous cleaning/scrubbing effect as the oscillation movement helps to remove debris (see col. 1, lines 42-45 and col. 5, lines 9-14).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the drive system and cleaning head of Rynerson to include the drive system providing oscillation comprising repeating circular rotation up to a first angular amount in a first direction around the axis of the head, and circular rotation up to a second angular amount in a second opposite direction around the primary axis of the head such that the head does not make a full revolution as taught by Schwarz-Hartmann because this is a simple substitution of one known oscillation drive system for another known oscillation drive system (and Applicant has admitted such oscillating drive systems are well-known) which would provide expected results of driving the cleaning head attachment in an oscillating manner that is particularly advantageous at providing a cleaning/scrubbing effect to remove debris (see col. 1, lines 42-45 and col. 5, lines 9-14 of Schwarz-Hartmann). It is noted that the head of the modified device would perform “an angular sweep motion” based upon the oscillation of Schwarz-Hartmann, and thus the hollow cavity/primary axis would also undergo this angular sweep motion.
The modified Rynerson/Schwarz-Hartmann method is silent regarding said head having a hollow cavity concentric with the primary axis through the center of the head face; said patient applies a topical agent to said head into said hollow cavity; the topical agents applies to the eyelid and meibomian gland orifices.
Hamburg teaches a related eyelid cleaning head (swab 1, Fig. 1) having a hollow cavity (concave depression 8, Fig. 2) concentric with the primary axis through the center of the head face (the concavity 8 extends along the primary axis, which is considered the axis perpendicular to the swab stick 17, Fig. 2), and the head (1) is used to apply topical agents (“antibiotic ointment or other medicant” see col. 2, lines 18-20) to the patient’s eyelid and meibomian gland orifices (see Fig. 3B; and see col. 1, lines 8-12, the swab is applied to the eyelid margin surface(s), “including the meibomian orifices”). The concave head shape “assures adequate treatment of all affected areas and structures of the lid margin” (see col. 2, lines 15-17; col. 1, lines 34-37) to apply the cleansing medicant to the eyelid (col. 2, lines 24-30). Hamburg states that the medicant may be applied to the head after the point of manufacture (col. 4, lines 1-4).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cleaning head of Rynerson/Schwarz-Hartmann to be provided with a hollow cavity concentric with the primary axis through the center of the head face and applying the topical agent to the head as taught by Hamburg because the concavity is particularly suited for applying a cleansing topical agent to the patient’s eyelid and meibomian gland orifices (see Fig. 3B, col. 2, lines 15-17 and col. 1, lines 34-37 of Hamburg).
The modified Rynerson/Schwarz-Hartmann/Hamburg method has a hollow cavity (concavity 8, Fig. 2 of Hamburg) for applying topical agents to the eyelid and meibomian gland orifices (see Fig. 3B and col. 2, lines 24-30 of Hamburg), and states that the topical agent may be applied to the head after the point of manufacture (col. 4, lines 1-4 of Hamburg), but does not specifically state the patient applies the topical agent to the hollow cavity. However, it is well known that topical agents may be applied to an applicator head prior to spreading the topical agent on the skin via the applicator.
For example, La Bianco teaches an oscillating application surface for applying topical agent(s) to the skin (see Figs. 1-2 and lines 1-7 of the Abstract). La Bianco states that the topical agent “may be applied either on the application surface of the applicator or directly on the skin” (see the first sentence of [0006]), and then the applicator is pressed against the skin and the motor is activated (see the second sentence of [0006]). This provides an expected result of applying the topical agent on the skin.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the application of the topical agent(s) of Rynerson/Schwarz-Hartmann/Hamburg to have the patient apply the topical agent to the head as taught by La Bianco because this will provide an expected result of allowing the patient to select which particular topical agent to use, and the selected topical agent is subsequently spread by applying the head to the skin. In the modified method, the patient will be applying the topical agent into the hollow cavity because that forms a majority of the applicator surface.
Regarding claim 2, the modified Rynerson/Schwarz-Hartmann/Hamburg/La Bianco method discloses wherein said head stem (the head stem may be considered to be the pin 27, Fig. 1 of Schwarz-Hartmann) is located on the center of said head and on the opposite side of said head surface (“pin 27 extends through the center of the disk of the bristle head 26” see Fig. 1 and col. 9, lines 46-47 of Schwarz-Hartmann).
Regarding claim 3, the modified Rynerson/Schwarz-Hartmann/Hamburg/La Bianco method discloses wherein said head stem (the head stem may alternatively be considered to be the brush shaft 23, Fig. 1 of Schwarz-Hartmann) is located off center of said head and on the opposite side of said head surface (see Fig. 1 of Schwarz-Hartmann, the brush shaft 23 is offset from the head surface 26, and on the opposite side).
Regarding claim 4, the modified Rynerson/Schwarz-Hartmann/Hamburg/La Bianco method discloses wherein said angular sweep motion is selected from the 90 degrees to 270 degrees if viewed from the face of the head (as best understood, the angular sweep motion is considered the range of angles that the oscillatory motion undergoes. Schwarz-Hartmann discloses the alternating rotary movement 49 can be “up to about 90˚”, see col. 10, lines 50-54. Thus, the disclosed motion falls within the claimed range of 90 to 270 degrees).
Regarding claim 5, the modified Rynerson/Schwarz-Hartmann/Hamburg/La Bianco device method wherein said angular sweep motion speed is selected from 4,000 to15,000 strokes/minute (as best understood the angular sweep motion speed is considered the frequency of the oscillatory motion. “The frequency of the alternating rotary movement (49) of the bristle head (26) can be between about 50 Hz and about 80 Hz” see col. 10, lines 55-57 of Schwarz-Hartmann. 80 Hz is equal to 4,800 strokes per minute and thus falls within the claimed range of 4,000 to 15,000 strokes/minute).
Regarding claim 6, the modified Rynerson/Schwarz-Hartmann/Hamburg/La Bianco method discloses wherein said head is made from materials selected from the group comprising sponge, soft elastomer, thermoplastic elastomer, silicone and a mixture of silicone and thermoplastic elastomer (Rynerson discloses a “sponge” head 14, see para. [0022]; see also the “sponge” material taught by Hamburg, col. 2, lines 54-59).
Regarding claim 9, the modified Rynerson/Schwarz-Hartmann/Hamburg/La Bianco method discloses wherein said topical agent selected from the group comprising of liquids, gels, ointments, cleansers, solvents, gases, powders or other fluid or fluidizable medicaments (“antibiotic ointment or other medicant” see col. 2, lines 18-20 of Hamburg, this would at least be a liquid, ointment, cleanser, “or other fluid or fluidizable medicaments”).
Claim(s) 7-8, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Rynerson et al. (2014/0214062) in view of Schwarz-Hartmann et al. (5,974,615), Hamburg (4,883,454), and La Bianco et al. (2004/0015139) as applied to claim 1 above, and further in view of Parsloe (2012/0165708) and Modak et al. (WO 2017/200818 A1).
Regarding claim 7, the modified Rynerson/Schwarz-Hartmann/Hamburg/La Bianco method is silent regarding wherein said head is made from thermoplastic elastomer and anti- infective agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents.
Parsloe teaches a related eyelid treatment apparatus (Fig. 1) wherein the head (roller in Fig. 3) is made from “rubber, synthetic rubber, silicone rubber or like materials” (see the last sentence of [0038]) which is sufficient to massage the eyelid (see lines 19-20 of [0063]) and the head includes a “pharmacological preparation such as, for example, those containing anti-inflammatories, analgesics, anti-infectives and any other pharmaceutically active compounds which, when applied to the eyelid, may assist in the reduction of symptoms” (see the penultimate sentence of [0063]). An anti-infective coating advantageously provides a sterile head.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the head of Rynerson/Schwarz-Hartmann/Hamburg/La Bianco to be made from a synthetic rubber or like material and include at least an anti-infective and anti-inflammatory coating as taught by Parsloe so eyelid infections and inflammation can be reduced/prevented as the eyelid is massaged. By providing an anti-infective coating, the modified head reads on the broadest reasonable interpretation of the at least one active ingredient providing a sterile head.
The modified Rynerson/Schwarz-Hartmann/Hamburg/La Bianco/Parsloe method states the head may be made from “rubber, synthetic rubber, silicone rubber or like materials” (see the last sentence of [0038] of Parsloe) and one of ordinary skill in the art would understand thermoplastic elastomers to be considered “like materials,” but the modified method does not specifically state thermoplastic elastomer. However, it is noted that it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, and it would have been obvious to select a thermoplastic elastomer as it would be expected to perform similarly as rubber, synthetic rubber, or silicone rubber. In re Leshin, 125 USPQ 416.
The modified Rynerson/Schwarz-Hartmann/Hamburg/La Bianco/Parsloe method is silent regarding the anti-infective agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents.
Modak teaches a related medical device with an anti-infective coating (see the first sentence of the Abstract) that includes curcumin (“[t]he core antimicrobial components of the invention are chlorhexidine (CHX), curcumin (CUR), for example, curcumin C3 complex, and silver (Ag) salt” see para. [0029]). This coating provides anti-inflammatory properties and provides prolonged antibacterial activity as well (see para. [0063]), while being cost-effective and simple to manufacture (see the first sentence of the Abstract).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the anti-infective of Rynerson/Schwarz-Hartmann/Hamburg/La Bianco/Parsloe to include curcumin as taught by Modak because this will provide an expected result of being a suitable material to reduce inflammation and provide prolonged antibacterial activity.
Regarding claim 8, the modified Rynerson/Schwarz-Hartmann/Hamburg/La Bianco method is silent regarding wherein said head is made from silicone and anti-infective agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents.
Parsloe teaches a related eyelid treatment apparatus (Fig. 1) wherein the head (roller in Fig. 3) is made from “rubber, synthetic rubber, silicone rubber or like materials” (see the last sentence of [0038]) which is sufficient to massage the eyelid (see lines 19-20 of [0063]) and the head includes a “pharmacological preparation such as, for example, those containing anti-inflammatories, analgesics, anti-infectives and any other pharmaceutically active compounds which, when applied to the eyelid, may assist in the reduction of symptoms” (see the penultimate sentence of [0063]). An anti-infective coating advantageously provides a sterile head.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the head of Rynerson/Schwarz-Hartmann/Hamburg/La Bianco to be made from a silicone rubber and include at least an anti-infective and anti-inflammatory coating as taught by Parsloe so eyelid infections and inflammation can be reduced/prevented as the eyelid is massaged. By providing an anti-infective coating, the modified head reads on the broadest reasonable interpretation of the at least one active ingredient providing a sterile head.
The modified Rynerson/Schwarz-Hartmann/Hamburg/La Bianco/Parsloe method is silent regarding the anti-infective agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents.
Modak teaches a related medical device with an anti-infective coating (see the first sentence of the Abstract) that includes curcumin (“[t]he core antimicrobial components of the invention are chlorhexidine (CHX), curcumin (CUR), for example, curcumin C3 complex, and silver (Ag) salt” see para. [0029]). This coating provides anti-inflammatory properties and provides prolonged antibacterial activity as well (see para. [0063]), while being cost-effective and simple to manufacture (see the first sentence of the Abstract).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the anti-infective of Rynerson/Schwarz-Hartmann/Hamburg/La Bianco/Parsloe to include curcumin as taught by Modak because this will provide an expected result of being a suitable material to reduce inflammation and provide prolonged antibacterial activity.
Claim(s) 10-12, 14-16, and 19 as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Olkowski et al. (2015/0182415) in view of Choate (2015/0216722).
Regarding claim 10, Olkowski discloses a method of cleaning the eyelid margins and meibomian gland orifices of a patient and said patient having a patient's eye and said patients eye comprised of a lid portion and meibomian gland orifices and said cleaning cleans cellular and sebaceous debris from said meibomian gland orifices (“oscillation of the spongehead cleans the eyelid margins and meibomian gland orifices of cellular and sebaceous debris. Such cleaning prevents, for an ensuing period, gland obstruction and promotes health of the glands in the eyelid” see para. [0147]) comprising of:
k. said head (sponge head 2, Figs. 1a-2c; which may take the form of a concave sponge head 34, Figs. 9a-9c) having a head stem (the central post associated with sponge mount 5, extending from the opposite side of the sponge head 45/34, see Fig. 2a and Fig. 9b; “male mating portion, such as a post[] that mates with a “head receiver” … such as a socket” see lines 6-10 of [0150]) and a head surface (the concave surface of the sponge head 34 as seen in Figs. 9a-9c);
I. said head surface (34, Figs. 9a-9c) is located on the side of said head opposite said stem (the sponge head surface 34 is on the opposite side of the stem, which is the central post extending from the other side as seen in Fig. 9b);
m. attaching said head (“periodic replacement of a disposable spongehead is typically daily in a home use setting” see the last sentence of [0152]) to an eyelid care appliance (housing 1, Figs. 1a-2c; see lines 1-8 of [0164]) such that said head stem (post associated with sponge mount 5, Fig. 2a, Figs. 9a-9c) is inserted into a receiver (head receiver 6, Fig. 3; “male mating portion, such as a post[] that mates with a “head receiver” … such as a socket” see lines 6-10 of [0150]) in said eyelid care appliance;
n. said head having a primary axis through the center of the head face (see the spongehead of Figs. 9a-9c, a primary axis extends through the center of the head);
o. said head having a hollow cavity concentric with the primary axis through the center of the head face (“concave spongehead … which allows for liquids, gels and ointments deposited in the recess of the tip to be applied to the eyelid surface” see Figs. 9a-9c and lines 16-20 of [0164]. The concavity is symmetrical with the primary axis through the center as seen in Fig. 9a-9c) in an angular sweep motion (as best understood, the head will perform a repeating oscillation and thus the head has an angular sweep motion);
p. said patient applies a topical agent to said head into said hollow cavity (“concave spongehead … which allows for liquids, gels and ointments deposited in the recess of the tip to be applied to the eyelid surface” see Figs. 9a-9c and lines 16-20 of [0164] and note that the patient may clean their eyelids without assistance, see the penultimate sentence of [0146]);
q. accessing the eyelid of said patient with said head (“enables a patient to clean his or her eyelids without assistance” see the penultimate sentence of [0146]) such that said topical agents are applied to said patient's eyelid and meibomian gland orifices (see lines 16-20 of [0164]; see also the first sentence of [0050]);
r. said eyelid care appliance having a drive system (motor 7, pinion gear 13, spur gear linkage 14, keyed shaft 15, see Fig. 3 and lines 1-18 of [0166] and see para. [0157]) that transmits motive force to oscillate said head (see the first sentence of [0157]);
s. contacting said distal surface (distal surface of the spongehead in Figs. 9a-9c) to said eyelid to clean said eyelid margins and said meibomian gland orifices (see the last four lines of the Abstract; see lines 11-16 of [0147]. Applying an oscillating spongehead brush to clean the eyelid margins and meibomian gland orifices will clean the eyelash margins); and
t. said eyelid care appliance oscillating said head (2 / 34) wherein said oscillation comprises repeating circular rotation (the head 2 / 34 is circular, see Fig. 9a, and thus rotation is circular) up to a first angular amount in a first direction around the axis of the head (see the last seven lines of [0147], the head oscillates 70 degrees forward), and circular rotation up to a second angular amount in a second opposite direction around the primary axis of the head such that the head does not make a full revolution (see the last seven lines of [0147], the head oscillates 70 degrees backward, and this will not make a full 360 degree revolution. Additionally, note that Applicant has admitted that such oscillating drive system transmissions are “well-known” in para. [0336] of the published application).
Olkowski is silent regarding a piezo electric mechanism that vibrates said head.
Choate teaches a related rotating eye cleaning device for Meibomian gland dysfunction (see Fig. 1, Fig. 3, and lines 1-5 of [0044]) that includes a piezo electric mechanism (piezoelectric member 112, Fig. 1, 112’, Fig. 3) that vibrates the head (tip portion 120’, Fig. 3; “configuration of the piezoelectric cylinder 112' with the electric motor 114 may allow the chuck 104 to transmit motion through the instrument 106' to allow the tip portion 120' to move in an axial oscillation while rotating.” See the last sentence of [0041]). The piezo electric mechanism thus “is capable of treating blepharitis by breaking away the debris on the eyelid with the use of the axial oscillation of the tip 120' while removing the debris with the rotational motion (e.g., forward and/or reverse direction) of the tip 120'. The device 100 may also treat blepharitis with the use of ultrasonic frequencies producing cavitation and/or sonophoresis that may assist in minimizing the over growth of bacteria and the endotoxins that the bacteria produces on the eyelid and eyelashes, as well as decreasing the number of any living organisms that may reside on the eyelid or in the eyelash follicle” (see para. [0044]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Olkowski device to include a piezo electric mechanism to vibrate the head as taught by Choate because these vibrations are stated to be useful for breaking away debris on the eyelid and producing cavitation and/or sonophoresis to treat blepharitis, minimize the growth of bacteria and endotoxins, and decrease the number of other living organisms residing on the eyelid or eyelash follicle.
Regarding claim 11, the modified Olkowski/Choate method discloses wherein said piezo electric mechanism (112, 112’ of Choate) has a piezo electric frequency and said piezo electric frequency creates an ultrasonic motion (“piezo ceramic tube 112 may generate ultrasonic frequencies at the tip 120” see the last sentence of [0034] of Choate; “the ultrasonic eye cleaning device 100 may transmit a range of frequencies (e.g., 20 kHz to 100 MHz) … delivered by the piezoelectric driver” see the first two sentences of [0036]).
Regarding claim 12, the modified Olkowski/Choate method discloses wherein said head stem is located on the center of said head and on the opposite side of said head surface (see Figs. 2a, 9b-9c of Olkowski, the post is on the center of the head, on the opposite side of the surface 34).
Regarding claim 14, the modified Olkowski/Choate method discloses wherein said angular sweep motion is selected from the 90 degrees to 270 degrees if viewed from the face of the head (“angular sweep of the head is nominally 70 degrees (i.e., the head travels 70 degrees forward followed by 70 degrees backwards” see the penultimate sentence of [0147] of Olkowski. This totals 140 degrees of angular sweeping motion, which falls within the claimed range).
Regarding claim 15, the modified Olkowski/Choate method discloses wherein said angular sweep motion speed is selected from 4,000 to15,000 strokes/minute (“Oscillation frequency of the head is nominally 7,000 to 9,000 strokes/minute” see the penultimate sentence of [0147] of Olkowski. This falls within the claimed range).
Regarding claim 16, the modified Olkowski/Choate method discloses wherein said head is made from materials selected from the group comprising sponge, soft elastomer, thermoplastic elastomer, silicone and a mixture of silicone and thermoplastic elastomer (“"Spongehead" means a synthetic sponge” see the second sentence of [0150] of Olkowski).
Regarding claim 19, the modified Olkowski/Choate method discloses wherein said topical agent selected from the group comprising of liquids, gels, ointments, cleansers, solvents, gases, powders or other fluid or fluidizable medicaments (“concave spongehead … allows for liquids, gels and ointments deposited in the recess of the tip to be applied to the eyelid surface” see lines 16-20 of [0164] of Olkowski).
Claim(s) 13 as best understood, is rejected under 35 U.S.C. 103 as being unpatentable over Olkowski et al. (2015/0182415) in view of Choate (2015/0216722) as applied to claim 10 above, and further in view of Reinbold (2013/0180063).
Regarding claim 13, the modified Olkowski/Choate method is silent regarding wherein said head stem is located off center of said head and on the opposite side of said head surface.
Reinbold teaches a related handheld oscillatory cleaning device (Fig. 1) wherein a head stem (eccentric pin 23, Figs. 1-2B) located off center of the head (eccentric pin 23 is off center of the axis R-R of the head 15, see Fig. 1) on the opposite side of the head surface (eccentric pin 23 is located on the opposite side from surface 15A, see Fig. 1). This is an alternative mechanism for producing oscillatory rotary motion (“the eccentric pin 23 swings from side to side, and the spherical pin bearing part 24 bears alternatingly against side surfaces 25A, 25B of the cavity 25, spaced apart circumferentially around the rotation axis R-R. This causes the bristle carrier 15 to correspondingly move in oscillatory rotary motion about its own rotation axis R-R” see para. [0044]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the head stem of Olkowski/Choate to be a head stem located off center of the head and on the opposite side of the head surface as taught by Reinbold because this is shown to be a suitable alternative mechanism for producing oscillatory rotary motion.
Claim(s) 17-18 as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Olkowski et al. (2015/0182415) in view of Choate (2015/0216722) as applied to claim 10 above, and further in view of Parsloe (2012/0165708) and Modak et al. (WO 2017/200818 A1).
Regarding claim 17, the modified Olkowski/Choate method is silent regarding wherein said head is made from thermoplastic elastomer and anti-infective agents selected from the group comprising of Curcumin, Silver,Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents.
Parsloe teaches a related eyelid treatment apparatus (Fig. 1) wherein the head (roller in Fig. 3) is made from “rubber, synthetic rubber, silicone rubber or like materials” (see the last sentence of [0038]) which is sufficient to massage the eyelid (see lines 19-20 of [0063]) and the head includes a “pharmacological preparation such as, for example, those containing anti-inflammatories, analgesics, anti-infectives and any other pharmaceutically active compounds which, when applied to the eyelid, may assist in the reduction of symptoms” (see the penultimate sentence of [0063]). An anti-infective coating advantageously provides a sterile head.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the head of Olkowski/Choate to be made from a synthetic rubber or like material and include at least an anti-infective and anti-inflammatory coating as taught by Parsloe so eyelid infections and inflammation can be reduced/prevented as the eyelid is massaged. By providing an anti-infective coating, the modified head reads on the broadest reasonable interpretation of the at least one active ingredient providing a sterile head.
The modified Olkowski/Choate/Parsloe method states the head may be made from “rubber, synthetic rubber, silicone rubber or like materials” (see the last sentence of [0038] of Parsloe) and one of ordinary skill in the art would understand thermoplastic elastomers to be considered “like materials,” but the modified method does not specifically state thermoplastic elastomer. However, it is noted that it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, and it would have been obvious to select a thermoplastic elastomer as it would be expected to perform similarly as rubber, synthetic rubber, or silicone rubber. In re Leshin, 125 USPQ 416.
The modified Olkowski/Choate/Parsloe method is silent regarding the anti-infective agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents.
Modak teaches a related medical device with an anti-infective coating (see the first sentence of the Abstract) that includes curcumin (“[t]he core antimicrobial components of the invention are chlorhexidine (CHX), curcumin (CUR), for example, curcumin C3 complex, and silver (Ag) salt” see para. [0029]). This coating provides anti-inflammatory properties and provides prolonged antibacterial activity as well (see para. [0063]), while being cost-effective and simple to manufacture (see the first sentence of the Abstract).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the anti-infective of Olkowski/Choate/Parsloe to include curcumin as taught by Modak because this will provide an expected result of being a suitable material to reduce inflammation and provide prolonged antibacterial activity.
Regarding claim 18, the modified Olkowski/Choate method is silent regarding wherein said head is made from silicone and anti-infective 5 agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents.
Parsloe teaches a related eyelid treatment apparatus (Fig. 1) wherein the head (roller in Fig. 3) is made from “rubber, synthetic rubber, silicone rubber or like materials” (see the last sentence of [0038]) which is sufficient to massage the eyelid (see lines 19-20 of [0063]) and the head includes a “pharmacological preparation such as, for example, those containing anti-inflammatories, analgesics, anti-infectives and any other pharmaceutically active compounds which, when applied to the eyelid, may assist in the reduction of symptoms” (see the penultimate sentence of [0063]). An anti-infective coating advantageously provides a sterile head.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the head of Olkowski/Choate to be made from a silicone rubber and include at least an anti-infective and anti-inflammatory coating as taught by Parsloe so eyelid infections and inflammation can be reduced/prevented as the eyelid is massaged. By providing an anti-infective coating, the modified head reads on the broadest reasonable interpretation of the at least one active ingredient providing a sterile head.
The modified Olkowski/Choate/Parsloe method is silent regarding the anti-infective agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents.
Modak teaches a related medical device with an anti-infective coating (see the first sentence of the Abstract) that includes curcumin (“[t]he core antimicrobial components of the invention are chlorhexidine (CHX), curcumin (CUR), for example, curcumin C3 complex, and silver (Ag) salt” see para. [0029]). This coating provides anti-inflammatory properties and provides prolonged antibacterial activity as well (see para. [0063]), while being cost-effective and simple to manufacture (see the first sentence of the Abstract).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the anti-infective of Olkowski/Choate/Parsloe to include curcumin as taught by Modak because this will provide an expected result of being a suitable material to reduce inflammation and provide prolonged antibacterial activity.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-9, as best understood, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,396,884 in view of Rynerson et al. (2014/0214062) in view of Schwarz-Hartmann et al. (5,974,615), Hamburg (4,883,454).
Although the claims at issue are not identical, the claims are not patentably distinct because instant claims 1-9 are merely broader versions of claims 1-14 of U.S. Patent No. 12,396,884. The instant claims include additional limitations such as the head having a stem inserted into a receiver in the eyelid appliance.
However, the prior art Rynerson, Schwarz-Hartmann, and Hamburg teach the missing limitation(s), and it would have been obvious to modify the 12,396,884 claim(S) to include the features taught by Rynerson, Schwarz-Hartmann, and/or Hamburg because the combination would merely provide expected results (see the 103 rejection(s) above).
Claims 10-19, as best understood, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,396,884 in view of Choate (2015/0216722).
Although the claims at issue are not identical, the claims are not patentably distinct because instant claims 10-19 are merely broader versions of claims 1-14 of U.S. Patent No. 12,396,884. The instant claims include additional limitations such as the piezo electric mechanism.
Choate teaches a related rotating eye cleaning device for Meibomian gland dysfunction (see Fig. 1, Fig. 3, and lines 1-5 of [0044]) that includes a piezo electric mechanism (piezoelectric member 112, Fig. 1, 112’, Fig. 3) that vibrates the head (tip portion 120’, Fig. 3; “configuration of the piezoelectric cylinder 112' with the electric motor 114 may allow the chuck 104 to transmit motion through the instrument 106' to allow the tip portion 120' to move in an axial oscillation while rotating.” See the last sentence of [0041]). The piezo electric mechanism thus “is capable of treating blepharitis by breaking away the debris on the eyelid with the use of the axial oscillation of the tip 120' while removing the debris with the rotational motion (e.g., forward and/or reverse direction) of the tip 120'. The device 100 may also treat blepharitis with the use of ultrasonic frequencies producing cavitation and/or sonophoresis that may assist in minimizing the over growth of bacteria and the endotoxins that the bacteria produces on the eyelid and eyelashes, as well as decreasing the number of any living organisms that may reside on the eyelid or in the eyelash follicle” (see para. [0044]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the 12,396,884 claim(s) to include a piezo electric mechanism to vibrate the head as taught by Choate because these vibrations are stated to be useful for breaking away debris on the eyelid and producing cavitation and/or sonophoresis to treat blepharitis, minimize the growth of bacteria and endotoxins, and decrease the number of other living organisms residing on the eyelid or eyelash follicle.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Smith et al. (2012/0065556) discloses a related oscillating massage head for stimulating meibomian glands, using an off center head stem. Gueret (2007/0186951) discloses a related topical agent applicator with a concavity to hold the topical agent. Baschnagel (2011/0160635) discloses a related cotton swab applicator with topical agent(s) held in a cavity. Bujak (9,802,062) discloses a related eye treatment device with piezoelectric mechanism to apply ultrasonic pressure waves to the eyelid. Stredic III (5,738,643) discloses a related spongehead that has a concavity for carrying topical agents.
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/CHRISTOPHER E MILLER/ Examiner, Art Unit 3785
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