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 1-6 are pending and currently under consideration for patentability under 37 CFR 1.104.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
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. 14/588,392, 16/431,631, 16/402,143, 61/922,791, 62/011,591, 62/835,868 fail(s) 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:
“a thermoplastic elastomer having at least one active ingredient imbibed in the thermoplastic elastomer and the at least one active ingredient is selected from the group consisting of an aminoglycoside and an anti-infective agent” (claim 1); and
“elastomer having an active ingredient imbibed in the thermoplastic elastomer … the active ingredient is selected from the group consisting of an aminoglycoside and an anti-infective agent” (claim 6).
The earliest potential priority for claims 1-6 appears to be based upon app. 62/835,868, filed April 18, 2019.
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, the abstract recites “The invention relates generally to the field of medical devices and, more specifically, to” which is language that can be implied, and should be deleted.
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 Objections
Claims 1-2 and 4 are objected to because of the following informalities:
Claim 1, line 2 recites “debris comprising, the steps of:” and the Examiner suggests relocating the comma: --debris, comprising the steps of:--.
Claim 2, lines 2-3 recite “a fluidizable medicaments” and the Examiner suggests either –fluidizable medicaments—or –a fluidizable medicament--.
Claim 4, line 1 recites “an anti-infective agent” and the Examiner suggests –the anti-infective agent—to clarify the antecedent basis from claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is 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 6, line 16 recites “the axis of the head” which lacks antecedent basis. The claim previously recites a “primary axis” of the head, and it is unclear whether this is referring to the same axis.
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) 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Olkowski et al. (2015/0182415) in view of Parsloe (2012/0165708) and Abadilla (2019/0133296).
Regarding claim 1, Olkowski discloses a method of massaging an eyelid (“the spongehead (oscillating or inactive) can be used to massage blockage areas” see the penultimate sentence of [0164]. Additionally, an oscillating sponge head applied to the eyelids reads on a massage) and cleaning a margin of the eyelid and a meibomian gland orifice of a patient's eye of cellular and sebaceous debris (“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, the steps of:
attaching (“periodic replacement of a disposable spongehead is typically daily in a home use setting” see the last sentence of [0152]) a head (sponge head 2, Figs. 1a-2c; which may take the form of a concave sponge head 34, Figs. 9a-9c) to an eyelid care appliance (housing 1, Figs. 1a-2c; see lines 1-8 of [0164]), the head having a primary axis through a center of a head face (see the spongehead of Figs. 9a-9c, a primary axis extends through the center of the head), and the head for cleaning the eyelid (see lines 6-8 of [0147]);
the 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);
pivoting the head in a frame with one or more detents to orient the head at an angle ranging from about 20˚ to about 80˚ (“head receiver pivots in a frame that either has detents at given head angles (e.g., 30 degrees, 45 degrees, 60 degrees, etc.) or has a locking mechanism that holds the head at a user selectable head angle. The spongehead can also be locked in place at each detent position. The preferable head angle is typically in the range from 20 degrees to 80 degrees” see para. [0160]);
applying a topical agent to the hollow cavity of the head (“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]), the hollow cavity forms a reservoir (see Fig. 9c and lines 15-20 of [0164], the cavity “allows for liquids, gels and ointments deposited in the recess of the tip” and thus forms a reservoir) to capture the topical agent during use (see lines 15-20 of [0164]);
transmitting, via 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]), a force to oscillate the head (see the first sentence of [0157]), the drive system comprising:
a power supply (“a power supply (typically a replaceable and/or rechargeable battery) powers a DC motor” see the first sentence of [0156]); and
a motor (motor 7, Fig. 3) electrically connected to the power supply (see the first sentence of [0156]);
a driveshaft having a first end (adjacent spur gear linkage 14, Fig. 3) connected to the motor (7, Fig. 3) and a second end connected to the head (“the oscillating driveshaft causes the head receiver to oscillate, which causes the spongehead mounted in the head receiver to oscillate” see para. [0156], thus the drive shaft is at least operably connected to the head);
applying, via the head, the topical agent to the eyelid and the meibomian gland orifice (“a head in which the sponge has a recessed tip (called a “concave spongehead”, shown in FIGS. 9a-9c, with a concave sponge <34>), which 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]; “a user grips the proximal portion of the appliance … and applies the oscillating head on the distal end of the appliance, together with a solvent or cleanser, to the eyelid margin to scrub the eyelid margin” see also the first sentence of [0050]);
oscillating the head (see the first sentence of [0050]) wherein the oscillating comprising:
repeating a first 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 primary axis of the head (see the last seven lines of [0147], the head oscillates 70 degrees forward), and a second 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. [0369] of the published application);
massaging (note, any of the oscillation forces being applied to the eyelid read on a massage), via the head face (surface of the head), the eyelid (“the spongehead (oscillating or inactive) can be used to massage blockage areas” see the penultimate sentence of [0164]);
cleaning, via the head face, the margin of the eyelid and the meibomian gland orifice (“a user grips the proximal portion of the appliance … and applies the oscillating head on the distal end of the appliance, together with a solvent or cleanser, to the eyelid margin to scrub the eyelid margin” see the first sentence of [0050]); and
massaging (note, any of the oscillation forces being applied to the eyelid read on a massage), via the head face (surface of the head), along an entirety of a longitudinal axis of the meibomian gland orifice through the eyelid (the orifices of the meibomian glands are massaged with the oscillating spongehead, see lines 11-14 of [0147]. The meibomian gland orifices are located at the distal end of the meibomian gland, and the longitudinal axis of one of these orifices is relatively short. Furthermore, the method involves moving the sponge head “along the eyelid margin”, see lines 18-21 of [0163] and thus massaging more than one meibomian gland and its associated longitudinal axis of the gland orifice. The combination of moving the device along the eyelid margin plus the size of the spongehead relative to the meibomian gland orifice as seen in Fig. 18C would massage an entirety of a longitudinal axis of at least one meibomian gland orifice) such that the reservoir (the space provided by the hollow concave surface, see Figs. 9a-9c, lines 16-20 of [0164]) capturing the topical agent which would otherwise escape during the massaging of the eyelid and the cleaning of the margins of the eyelid and the meibomian gland orifice (the hollow concave surface of the spongehead, Fig. 9c, is configured to capture at least some amount of topical agent during use, at least relative to if a non-concave surface is used).
Olkowski is silent regarding the head comprising a thermoplastic elastomer having at least one active ingredient imbibed in the thermoplastic elastomer and the at least one active ingredient is selected from the group consisting of an aminoglycoside and an anti-infective agent, the at least one active ingredient providing a sterile head.
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 is imbibed with at least one active ingredient (“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]. Merriam-Webster defines “imbibed” as to take in or up; to assimilate or take into solution; soak, steep. Thus, being coated with the pharmacological preparation reads on the broadest reasonable interpretation of “imbibed” as the coating is taken in or assimilated as part of the surface). An anti-infective coating provides a relatively 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 to be made from a silicone rubber or like material imbibed with at least an anti-infective 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/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 the at least one active ingredient being imbibed in the 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. See MPEP 2144.07.
Abadilla teaches a related applicator device for applying cream to tissue (Fig. 1) where the applicator head (spreader 8, Fig. 1) is made of a soft but resilient plastic such as thermoplastic elastomer (“soft but resilient plastic … made from thermoplastic elastomer (TPE)” see lines 1-4 of [0075]). The applicator head may include at least one active ingredient such as an anti-infective imbibed in the thermoplastic elastomer (“To enable hygienic use, the TPE material that the flexible material is made from is formulated with an antimicrobial additive during the manufacturing process… actively challenges harmful bacteria… germ and mold-fighting properties are effective on the surface and within the material itself” see para. [0078]. An antimicrobial additive reads on anti-infective because antimicrobial agents challenge harmful bacteria thus preventing bacterial infections).
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 material of the synthetic rubber head of Olkowski/Parsloe to comprise a thermoplastic elastomer with the at least one active ingredient such as an anti-infective imbibed in the thermoplastic elastomer as taught by Abadilla because a soft but resilient thermoplastic elastomer material would be expected to perform substantially the same as the synthetic rubber(s) of Parsloe, and because the at least one active ingredient may fight bacteria/infection both at the surface and within the material itself. Thus, the active ingredient(s) would help reduce bacterial growth in the eyelid applicator and at the treatment area.
Regarding claim 2, the modified Olkowski/Parsloe/Abadilla method discloses wherein the topical agent is selected from the group consisting of a liquid, a gel, an ointment, a cleanser, a solvent, a gas, a powder, and a 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).
Regarding claim 3, it is noted that claim 1 only recites aminoglycoside in the alternative (“the at least one active ingredient is selected from the group consisting of an aminoglycoside and an anti-infective agent”). Claim 3 does not positively require that the at least one active ingredient be an aminoglycide. Thus, the modified Olkowski/Parsloe/Abadilla method satisfies the limitations of claim 3 because the “aminoglycoside” is not positively required.
Regarding claim 4, the modified Olkowski/Parsloe/Abadilla method discloses wherein the head comprises an anti-infective agent (as taught by Parsloe and Abadilla) and silicone (Parsloe discloses the head may comprise “rubber, synthetic rubber, silicone rubber or like materials” (see the last sentence of [0038]. Furthermore, it is reiterated 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. See MPEP 2144.07. Selecting a head material to comprise silicone would be expected to be suitable based upon Parsloe’s eyelid massager).
Regarding claim 6, Olkowski discloses a method of massaging an eyelid (“the spongehead (oscillating or inactive) can be used to massage blockage areas” see the penultimate sentence of [0164]. Additionally, an oscillating sponge head applied to the eyelids reads on a massage) and cleaning a margin of the eyelid and a meibomian gland orifice of a patient's eye of cellular and sebaceous debris (“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 the steps of:
attaching (“periodic replacement of a disposable spongehead is typically daily in a home use setting” see the last sentence of [0152]) a head (sponge head 2, Figs. 1a-2c; which may take the form of a concave sponge head 34, Figs. 9a-9c) to an eyelid care appliance (housing 1, Figs. 1a-2c; see lines 1-8 of [0164]),
the head having a primary axis through a center of a head face (see the spongehead of Figs. 9a-9c, a primary axis extends through the center of the head), and the head for cleaning the margin of the eyelid (see lines 6-16 of [0147]);
the 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);
applying a topical agent to be retained (“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]) in a reservoir of the hollow cavity of the head (see Fig. 9c and lines 15-20 of [0164], the cavity “allows for liquids, gels and ointments deposited in the recess of the tip” and thus forms a reservoir);
transmitting, via 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]), a force to oscillate the head (see the first sentence of [0157]);
applying, via the head, the topical agent to the eyelid and the meibomian gland orifice (“a head in which the sponge has a recessed tip (called a “concave spongehead”, shown in FIGS. 9a-9c, with a concave sponge <34>), which 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]; “a user grips the proximal portion of the appliance … and applies the oscillating head on the distal end of the appliance, together with a solvent or cleanser, to the eyelid margin to scrub the eyelid margin” see also the first sentence of [0050]);
oscillating the head (see the first sentence of [0050]) wherein the oscillating comprising:
repeating a first 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 a second 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. [0369] of the published application); and
contacting the head face to the eyelid to massage the eyelid and to clean the margin of the eyelid and the meibomian gland orifice (a user grips the proximal portion of the appliance … and applies the oscillating head on the distal end of the appliance, together with a solvent or cleanser, to the eyelid margin to scrub the eyelid margin” see also the first sentence of [0050]).
Olkowski is silent regarding the head is made from a thermoplastic elastomer having an active ingredient imbibed in the thermoplastic elastomer; the active ingredient is selected from the group consisting of an aminoglycoside and an anti-infective agent, the active ingredient providing a sterile head
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 is imbibed with at least one active ingredient (“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]. Merriam-Webster defines “imbibed” as to take in or up; to assimilate or take into solution; soak, steep. Thus, being coated with the pharmacological preparation reads on the broadest reasonable interpretation of “imbibed” as the coating is taken in or assimilated as part of the surface). An anti-infective coating provides a relatively 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 to be made from a silicone rubber or like material imbibed with at least an anti-infective 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/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 the at least one active ingredient being imbibed in the 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. See MPEP 2144.07.
Abadilla teaches a related applicator device for applying cream to tissue (Fig. 1) where the applicator head (spreader 8, Fig. 1) is made of a soft but resilient plastic such as thermoplastic elastomer (“soft but resilient plastic … made from thermoplastic elastomer (TPE)” see lines 1-4 of [0075]). The applicator head may include at least one active ingredient such as an anti-infective imbibed in the thermoplastic elastomer (“To enable hygienic use, the TPE material that the flexible material is made from is formulated with an antimicrobial additive during the manufacturing process… actively challenges harmful bacteria… germ and mold-fighting properties are effective on the surface and within the material itself” see para. [0078]. An antimicrobial additive reads on anti-infective because antimicrobial agents challenge harmful bacteria thus preventing bacterial infections).
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 material of the synthetic rubber head of Olkowski/Parsloe to comprise a thermoplastic elastomer with the at least one active ingredient such as an anti-infective imbibed in the thermoplastic elastomer as taught by Abadilla because a soft but resilient thermoplastic elastomer material would be expected to perform substantially the same as the synthetic rubber(s) of Parsloe, and because the at least one active ingredient may fight bacteria/infection both at the surface and within the material itself. Thus, the active ingredient(s) would help reduce bacterial growth in the eyelid applicator and at the treatment area.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Olkowski et al. (2015/0182415) in view of Parsloe (2012/0165708) and Abadilla (2019/0133296) as applied to claim 4 above, and further in view of Modak et al. (WO 2017/200818 A1).
Regarding claim 5, the modified Olkowski/Parsloe/Abadilla method is silent regarding wherein the anti-infective is selected from the group consisting of curcumin, silver, copper, amebicides, 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/Parsloe/Abadilla 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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 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 Olkowski et al. (2015/0182415), Parsloe (2012/0165708), Abadilla (2019/0133296), and Modak et al. (WO 2017/200818 A1).
Although the claims are not identical, the instant claims 1-6 are broader versions of the patented claims. For example, instant claim 1 omits various limitations from patented claim 1, such as “a main body with a housing having a longitudinal axis, a control, an instrumentation package”, “the primary axis is inclined to the longitudinal axis of the body by an angle of between 20 degrees and 90 degrees”, “an oscillation frequency of 7,000 to 9,000 strokes/minute”, etc. Furthermore, to any extent that instant claims 1-6 recite limitations not disclosed by patented claims 1-14, Olkowski, Parsloe, Abadilla, and/or Modak disclose the missing limitation(s) and would merely provide expected results (see the 35 USC 103 rejection(s) above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER E MILLER whose telephone number is (571)270-1473. The examiner can normally be reached Mon-Fri 9:00-5:30 (Eastern).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTOPHER E MILLER/ Examiner, Art Unit 3785
Prosecution Insights