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 1-17 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.’s 18/628,935, 16/852,829, 16/431,631, 16/402,143, 14/588,392, 63/505,710, 62/835,868, 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 being formed from silicone, carvacrol and oregano oil” (claim 1, claim 9).
Accordingly, claims 1-17 are not entitled to the benefit of these prior application(s).
The earliest potential priority for claims 1-17 appears to be based upon the instant application 18/761,526 filed July 2, 2024.
Drawings
The drawings are objected to because the details of Figure 28 (filed August 6, 2024), are illegible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The disclosure is objected to because of the following informalities:
Paragraph [0173] of the printed publication states “cleanse eyelids associated eye” which appears to have omitted the word --with--.
Paragraph [0271] of the printed publication states “which is associated eye 450” which appears to have omitted the word --with--.
Appropriate correction is required.
Claim Objections
Claims 1-17 are objected to because of the following informalities:
Claim 1, line 6 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 1, line 10 recites “an eyelid care appliance” and the Examiner suggests --the eyelid care appliance-- because this has already been recited in lines 3-4.
Claim 1, line 23 recites “comprises of an angular sweep motion” and the Examiner suggests deleting the word “of.”
Claim 1, line 23 recites “an angular sweep motion” and the Examiner suggests --the angular sweep motion-- because it has already been recited in line 15.
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 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 7, line 3 recites “Carvacrol Curcumin” and it appears there should be a comma separating these words.
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, line 2 recites “patients eye” and the Examiner suggests --patient’s eye--.
Claim 9, line 6 recites “comprising of:” and the Examiner suggests --, the method comprising the steps of:-- to clarify.
Claim 9 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 9, line 9 recites “the side of said head” and the Examiner suggests --a side of said head--.
Claim 9, line 10 recites “an eyelid care appliance” and the Examiner suggests --the eyelid care appliance-- because this has already been recited in lines 3-4.
Claim 9, line 24 recites “an angular sweep motion” and the Examiner suggests --the angular sweep motion-- because it has already been recited in line 15.
Claim 10, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 9.
Claim 11, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 9.
Claim 12, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 9.
Claim 13, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 9.
Claim 13, lines 2-3 recite “the 90 degrees” and the Examiner suggests deleting “the”.
Claim 14, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 9.
Claim 15, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 9.
Claim 16, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 9.
Claim 17, lines 1-2 recite “a patient” and the Examiner suggests --the patient-- because a patient has already been recited in claim 9.
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 1-17 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, lines 14-15 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 18-19 recite “eyelid care appliance having a drive system that transmits motive force to oscillate said head” which is confusing because lines 3-4 recite “an eyelid care appliance comprising an electrical mechanical oscillator.” It is unclear what the distinction is between the “drive system” and the “electrical mechanical oscillator.” The specification does not provide any explanation of which particular structure(s) would be considered the “electrical mechanical oscillator.” As best understood, the “drive system” and “electrical mechanical oscillator” appear to be referring to the same disclosed structure(s).
Claim 1, line 25 recites “the axis of the head” which lacks antecedent basis. It is unclear if this is referring to the same axis as the “primary axis.”
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 6, lines 2-4 recite “said head is selected from materials selected from the group comprising sponge, soft elastomer, thermoplastic elastomer, silicone and a mixture of silicone and thermoplastic elastomer” which is confusing because claim 1 already recites the head is formed from silicone. It is unclear whether claim 6 is attempting to re-define the head material.
Claim 7, lines 2-3 recite “said head is made from thermoplastic elastomer and anti-infective agents selected from the group comprising of Carvacrol…” which is confusing because claim 1 already recites the head is formed from “silicone, carvacrol and oregano oil.” It is unclear if claim 7 is intending to recite the head is a mixture of silicone and thermoplastic elastomer or if claim 7 is attempting to re-define whether the head is made of silicone. Furthermore, it is unclear if claim 7 is attempting to re-define whether carvacrol is part of the head.
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, lines 2-3 recite “said head is made from silicone and anti-infective agents selected from the group comprising of Carvacrol…” which is confusing because claim 1 already recites the head is formed from “silicone, carvacrol and oregano oil.” The Examiner suggests --said head comprising anti-infective agents selected from…--. Additionally, it is unclear if claim 8 is attempting to re-define whether carvacrol is part of the head.
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, lines 14-15 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 9, lines 18-19 recite “eyelid care appliance having a drive system that transmits motive force to oscillate said head” which is confusing because lines 3-4 recite “an eyelid care appliance comprising an electrical mechanical oscillator.” It is unclear what the distinction is between the “drive system” and the “electrical mechanical oscillator.” The specification does not provide any explanation of which particular structure(s) would be considered the “electrical mechanical oscillator.” As best understood, the “drive system” and “electrical mechanical oscillator” appear to be referring to the same disclosed structure(s).
Claim 9, lines 25-26 recite “the axis of the head” which lacks antecedent basis. It is unclear if this is referring to the same axis as the “primary axis.”
Claim 13, 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 15, 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 15, lines 2-4 recite “said head is selected from materials selected from the group comprising sponge, soft elastomer, thermoplastic elastomer, silicone and a mixture of silicone and thermoplastic elastomer” which is confusing because claim 9 already recites the head is formed from silicone. It is unclear whether claim 15 is attempting to re-define the head material.
Claim 16, lines 2-3 recite “said head is made from thermoplastic elastomer and anti-infective agents selected from the group comprising of Carvacrol…” which is confusing because claim 9 already recites the head is formed from “silicone, carvacrol and oregano oil.” It is unclear if claim 16 is intending to recite the head is a mixture of silicone and thermoplastic elastomer, and it is unclear if claim 16 is attempting to re-define whether carvacrol is part of the head.
Claim 16, 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 17, lines 2-3 recite “said head is made from silicone and anti-infective agents selected from the group comprising of …” which is confusing because claim 9 already recites the head is formed from “silicone, carvacrol and oregano oil.” The Examiner suggests --said head comprising anti-infective agents selected from the group…--.
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--.
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) 1-2, 4-11, and 13-17, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Foster et al. (2020/0330270) in view of Nostro et al. (“Effects of Oregano, carvacrol and thymol on Staphylococcus aureus and Staphylococcus epidermidis biofilms.” Journal of Medical Microbiology, vol. 56, no. 4, 1 Apr. 2007, pp. 519-523).
Regarding claim 1, Foster discloses a method of cleaning eyelid margins and meibomian gland orifices of a patient (the eyelid is scrubbed as in Figure 23, using a bristlebrush 200 or soft-tip 201 of Figs. 20-21, Figs. 26-27; “to massage and cleanse eyelid and eyelash margins 400 and 410 which is associated eye 450” see para. [0145]) and said patient having a patient’s eye and said patient’s eye comprised of a lid portion having an eyelid surface and meibomian gland orifices (see eye 450, Fig. 23) and an eyelid care appliance (i.e., integral eyelid care appliance of Figs. 1a-7b) comprising an electrical mechanical oscillator (“drive system that transmits motive force from the motor to oscillate a head receiver” see the first sentence of [0027]. The drive system includes an electrical mechanical oscillator such as receiver linkage 17, keyed shaft 15, and motor 7, Fig. 3) and a head (sponge mount 5 or soft-tip 200 or 201 fitted to head receiver 6, see Fig. 2a and the first sentence of [0209]) and said head cleans cellular and sebaceous debris from said meibomian gland orifices by massaging the eyelid surface (“applies the oscillating head to an eyelid, oscillation of the head cleans, massages, and stimulates the eyelash margins, eyelid margins and meibomian gland orifices of cellular and sebaceous debris” see para. [0146]) comprising of:
a. said head being formed from silicone (“bristlebrush or Soft-Tip 200 is preferably made of a soft elastomer or silicone” see para. [0218]) and anti-infective or anti-microbial agents (the silicone can be mixed with anti-infective agents such as aminoglycosides, curcumin, flax seed, or tea tree oil, see para. [0179]-[0185]. Foster additionally states “any antimicrobial substance which can be integrated into the silicon or soft plastic material, that forms the bristlebrush or Soft-Tip 200, would be appropriate” see para. [0222]),
b. said head having a head stem (“a mount having a polygonal post configured to removably couple with a corresponding socket of the head receiver” see para. [0026], see Figs. 20-21, and Figs. 26-27), a head center (center of head as seen in the top figure of Fig. 20) and a head face (the upper surface of the head as seen in Figs. 20-21);
c. said head face is located on a side of said head opposite said stem (see Figures 20-21 and Fig. 26, the upper side of the head is on a distal side, opposite the stem);
d. attaching said head to an eyelid care appliance (i.e., integral eyelid care appliance of Figs. 1a-7b) such that said head stem is inserted into a receiver (head receiver 6, Fig. 2a) in said eyelid care appliance (“the bristlehead or Soft-Tip comprising a mount having a polygonal post configured to removably couple with a corresponding socket of the head receiver, the post and the socket oriented along the second axis, wherein friction between the post and the socket is configured to keep the bristlehead or Soft-Tip coupled to the head receiver during use” see para. [0026]);
e. said head having a primary axis through the center of said head and said center of said head is the center of the head face (a primary axis extends through the stem, and the center of the head in the center of the head face as seen in Figs. 20-21, Figs. 26-27);
f. said head having a hollow cavity (hollow cavity 202, Fig. 27) concentric with the primary axis of the head face (“The hollow cavity 202 is located concentric with the primary axis through the center of the head face of the bristlebrush or Soft-Tip 200” see para. [0205]) in an angular sweep motion (the head will perform an angular sweeping motion, such as 70 degrees forward/backward, see para. [0146]);
g. accessing the eyelid of said patient with said head face (see Fig. 23) to scrub said patient's eyelid and meibomian gland orifices (“to massage and cleanse eyelid and eyelash margins 400 and 410 which is associated eye 450” see para. [0145]; “applies the oscillating head to an eyelid, oscillation of the head cleans, massages, and stimulates the eyelash margins, eyelid margins and meibomian gland orifices of cellular and sebaceous debris.” See para. [0146]);
h. said eyelid care appliance having a drive system that transmits motive force to oscillate said head (“drive system that transmits motive force from the motor to oscillate a head receiver” see the first sentence of [0027], see Fig. 3);
i. contacting said head face to said eyelid surface (see Fig. 23) to clean said eyelid margins and said meibomian gland orifices (“applies the oscillating head to an eyelid, oscillation of the head cleans, massages, and stimulates the eyelash margins, eyelid margins and meibomian gland orifices of cellular and sebaceous debris.” See para. [0146]); and
j. said eyelid care appliance oscillating said head (see the first sentence of [0027]) wherein said oscillation comprises of an angular sweep motion (“ angular sweep of the head is nominally 70 degrees (i.e. the head travels 70 degrees forward followed by 70 degrees backwards)” see para. [0146]) comprising of repeating a 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 page 19, claim 11).
Foster is silent regarding the silicone head being also formed with carvacrol and oregano oil. However, it is reiterated that Foster suggests a variety of anti-infective or antimicrobial substances could be formed with the silicone head (the silicone can be mixed with anti-infective agents such as aminoglycosides, curcumin, flax seed, or tea tree oil, see para. [0179]-[0185]. Foster additionally states “any antimicrobial substance which can be integrated into the silicon or soft plastic material, that forms the bristlebrush or Soft-Tip 200, would be appropriate” see para. [0222]).
Nostro teaches that oregano, carvacrol, and thymol are “essential oils that have been shown to be potential agents in the treatment of infections, and are safe in terms of human and animal health … known for their wide spectrum of antimicrobial activity… possess[ing] multiple biological properties such as anti-inflammatory, anti-leishmanial, antioxidant, hepato-protective and anti-tumoral activities” (see paragraph two of the Introduction on page 519). The study found oregano, carvacrol, and thymol to be effective in inhibiting staphylococcal biofilms (see generally the Results and Discussion section on pages 520-522; “a general attenuated level of biofilm formation in the presence of subinhibitory concentrations of oregano, carvacrol and thymol was observed…” “carvacrol and thymol, alone or in oregano oil, could diffuse through the polysaccharide matrix of the biofilm and destabilize it due to their strong intrinsic antimicrobial properties” … “The findings of the present study highlight the promising role of oregano, carvacrol and thymol as new lead structures in the search for novel antibacterial agents”).
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 formation of the head of Foster to utilize silicone combined with antimicrobial substances such as oregano, carvacrol, and thymol as taught by Nostro because these are safe substances that provide strong antimicrobial properties and have demonstrated an ability to inhibit the growth of staphylococcus biofilms.
Regarding claim 2, the modified Foster/Nostro method discloses wherein said head stem is located on the center of said head and on the opposite side of said head face (see insert 402, Fig. 26 of Foster).
Regarding claim 4, the modified Foster/Nostro method discloses wherein said angular sweep motion is selected from 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. Foster discloses the angular sweep motion can be 70 degrees forward, 70 degrees backward, totaling 140 degrees of motion. Thus, the disclosed motion falls within the claimed range of 90 to 270 degrees).
Regarding claim 5, the modified Foster/Nostro method discloses wherein said angular sweep motion speed is selected from 4,000 to 15,000 strokes/minute (as best understood the angular sweep motion speed is considered the frequency of the oscillatory motion. Foster states the oscillation frequency is 7,000 to 9,000 strokes/minute, see para. [0146]. Thus, the disclosed frequency falls within the claimed range).
Regarding claim 6, the modified Foster/Nostro 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 (“bristlebrush or Soft-Tip 200 is preferably made of a soft elastomer or silicone” see para. [0218] of Foster).
Regarding claim 7, the modified Foster/Nostro method discloses wherein said head is made from thermoplastic elastomer and anti-infective agents selected from the group comprising of Carvacrol Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents (“the bristlebrush or Soft-Tip 200 … is fabricated from a soft polymer such as silicone, a soft elastomer, thermoplastic elastomer … any antimicrobial substance which can be integrated into the silicon or soft plastic material … such as silver, coper, and curcumin” see para. [0222] of Foster).
Regarding claim 8, the modified Foster/Nostro method discloses wherein said head is made from silicone and anti-infective agents selected from the group comprising of Carvacrol, Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents (“bristlebrush or Soft-Tip 200 is preferably made of a soft elastomer or silicone” see para. [0218] of Foster. Additionally, the silicone can be mixed with anti-infective agents such as aminoglycosides, curcumin, see para. [0179]-[0185] of Foster. Additionally, Foster has been modified by Nostro to include carvacrol).
Regarding claim 9, Foster discloses a method of cleaning eyelid margins and meibomian gland orifices of a patient (the eyelid is scrubbed as in Figure 23, using a bristlebrush 200 or soft-tip 201 of Figs. 20-21, Figs. 26-27; “to massage and cleanse eyelid and eyelash margins 400 and 410 which is associated eye 450” see para. [0145]) and said patient having a patient’s eye and said patient’s eye comprised of a lid portion having an eyelid surface and meibomian gland orifices (see eye 450, Fig. 23) and an eyelid care appliance (i.e., integral eyelid care appliance of Figs. 1a-7b) comprising an electrical mechanical oscillator (“drive system that transmits motive force from the motor to oscillate a head receiver” see the first sentence of [0027]. The drive system includes an electrical mechanical oscillator such as receiver linkage 17, keyed shaft 15, and motor 7, Fig. 3) and a head (sponge mount 5 or soft-tip 200 or 201 fitted to head receiver 6, see Fig. 2a and the first sentence of [0209]) and said head cleans cellular and sebaceous debris from said meibomian gland orifices by massaging the eyelid surface (“applies the oscillating head to an eyelid, oscillation of the head cleans, massages, and stimulates the eyelash margins, eyelid margins and meibomian gland orifices of cellular and sebaceous debris” see para. [0146]) comprising of:
a. said head being formed from silicone (“bristlebrush or Soft-Tip 200 is preferably made of a soft elastomer or silicone” see para. [0218]) and anti-infective or anti-microbial agents (the silicone can be mixed with anti-infective agents such as aminoglycosides, curcumin, flax seed, or tea tree oil, see para. [0179]-[0185]. Foster additionally states “any antimicrobial substance which can be integrated into the silicon or soft plastic material, that forms the bristlebrush or Soft-Tip 200, would be appropriate” see para. [0222]),
b. said head having a head stem (“a mount having a polygonal post configured to removably couple with a corresponding socket of the head receiver” see para. [0026], see Figs. 20-21, and Figs. 26-27), a head center (center of head as seen in the top figure of Fig. 20) and a head face (the upper surface of the head as seen in Figs. 20-21);
c. said head face is located on the side of said head opposite said stem (see Figures 20-21 and Fig. 26, the upper side of the head is on a distal side, opposite the stem);
d. attaching said head to an eyelid care appliance (i.e., integral eyelid care appliance of Figs. 1a-7b) such that said head stem is inserted into a receiver (head receiver 6, Fig. 2a) in said eyelid care appliance (“the bristlehead or Soft-Tip comprising a mount having a polygonal post configured to removably couple with a corresponding socket of the head receiver, the post and the socket oriented along the second axis, wherein friction between the post and the socket is configured to keep the bristlehead or Soft-Tip coupled to the head receiver during use” see para. [0026]);
e. said head having a primary axis through the center of said head and said center of said head is the center of the head face (a primary axis extends through the stem, and the center of the head in the center of the head face as seen in Figs. 20-21, Figs. 26-27);
f. said head having a hollow cavity (hollow cavity 202, Fig. 27) concentric with the primary axis of the head face (“The hollow cavity 202 is located concentric with the primary axis through the center of the head face of the bristlebrush or Soft-Tip 200” see para. [0205]) in an angular sweep motion (the head will perform an angular sweeping motion, such as 70 degrees forward/backward, see para. [0146]);
g. accessing the eyelid of said patient with said head (see Fig. 23) to scrub said patient's eyelid and meibomian gland orifices (“to massage and cleanse eyelid and eyelash margins 400 and 410 which is associated eye 450” see para. [0145]; “applies the oscillating head to an eyelid, oscillation of the head cleans, massages, and stimulates the eyelash margins, eyelid margins and meibomian gland orifices of cellular and sebaceous debris.” See para. [0146]);
h. said eyelid care appliance having a drive system that transmits motive force to oscillate said head (“drive system that transmits motive force from the motor to oscillate a head receiver” see the first sentence of [0027], see Fig. 3) and a piezo electric mechanism that vibrates said head (“piezo electric mechanism to create the therapeutic effect … soundwaves generated by the piezo electric mechanism and delivered by the disposable tip, penetrate the eyelids vibrating the Meibomian glands…” see para. [0150]-[0151] of Foster);
i. contacting said head face to said eyelid surface (see Fig. 23) to clean said eyelid margins and said meibomian gland orifices (“applies the oscillating head to an eyelid, oscillation of the head cleans, massages, and stimulates the eyelash margins, eyelid margins and meibomian gland orifices of cellular and sebaceous debris.” See para. [0146]); and
j. said eyelid care appliance oscillating said head (see the first sentence of [0027]) wherein said oscillation comprises an angular sweep motion (“ angular sweep of the head is nominally 70 degrees (i.e. the head travels 70 degrees forward followed by 70 degrees backwards)” see para. [0146]) comprising of repeating a 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 page 19, claim 11) thereby minimizing splatter (the Foster method performs the same oscillating rotation, and thus would minimize splatter).
Foster is silent regarding the silicone head being also formed with carvacrol and oregano oil. However, it is reiterated that Foster suggests a variety of anti-infective or antimicrobial substances could be formed with the silicone head (the silicone can be mixed with anti-infective agents such as aminoglycosides, curcumin, flax seed, or tea tree oil, see para. [0179]-[0185]. Foster additionally states “any antimicrobial substance which can be integrated into the silicon or soft plastic material, that forms the bristlebrush or Soft-Tip 200, would be appropriate” see para. [0222]).
Nostro teaches that oregano, carvacrol, and thymol are “essential oils that have been shown to be potential agents in the treatment of infections, and are safe in terms of human and animal health … known for their wide spectrum of antimicrobial activity… possess[ing] multiple biological properties such as anti-inflammatory, anti-leishmanial, antioxidant, hepato-protective and anti-tumoral activities” (see paragraph two of the Introduction on page 519). The study found oregano, carvacrol, and thymol to be effective in inhibiting staphylococcal biofilms (see generally the Results and Discussion section on pages 520-522; “a general attenuated level of biofilm formation in the presence of subinhibitory concentrations of oregano, carvacrol and thymol was observed…” “carvacrol and thymol, alone or in oregano oil, could diffuse through the polysaccharide matrix of the biofilm and destabilize it due to their strong intrinsic antimicrobial properties” … “The findings of the present study highlight the promising role of oregano, carvacrol and thymol as new lead structures in the search for novel antibacterial agents”).
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 formation of the head of Foster to utilize silicone combined with antimicrobial substances such as oregano, carvacrol, and thymol as taught by Nostro because these are safe substances that provide strong antimicrobial properties and have demonstrated an ability to inhibit the growth of staphylococcus biofilms.
Regarding claim 10, the modified Foster/Nostro method discloses wherein said piezo electric mechanism has a piezo electric frequency and said piezo electric frequency creates an ultrasonic motion (“The frequency of the piezo electric mechanism adds an ultrasonic dimension to the treatment effect” see para. [0150]-[0151] of Foster).
Regarding claim 11, the modified Foster/Nostro method discloses wherein said head stem is located on the center of said head and on the opposite side of said head face (see insert 402, Fig. 26 of Foster).
Regarding claim 13, the modified Foster/Nostro 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. Foster discloses the angular sweep motion can be 70 degrees forward, 70 degrees backward, totaling 140 degrees of motion. Thus, the disclosed motion falls within the claimed range of 90 to 270 degrees).
Regarding claim 14, the modified Foster/Nostro method discloses wherein said angular sweep motion speed is selected from 4,000 to 15,000 strokes/minute (as best understood the angular sweep motion speed is considered the frequency of the oscillatory motion. Foster states the oscillation frequency is 7,000 to 9,000 strokes/minute, see para. [0146]. Thus, the disclosed frequency falls within the claimed range).
Regarding claim 15, the modified Foster/Nostro 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 (“bristlebrush or Soft-Tip 200 is preferably made of a soft elastomer or silicone” see para. [0218] of Foster).
Regarding claim 16, the modified Foster/Nostro method discloses wherein said head is made from thermoplastic elastomer and anti-infective agents selected from the group comprising of Carvacrol, Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents (“the bristlebrush or Soft-Tip 200 … is fabricated from a soft polymer such as silicone, a soft elastomer, thermoplastic elastomer … any antimicrobial substance which can be integrated into the silicon or soft plastic material … such as silver, coper, and curcumin” see para. [0222] of Foster).
Regarding claim 17, the modified Foster/Nostro method discloses 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 (“bristlebrush or Soft-Tip 200 is preferably made of a soft elastomer or silicone” see para. [0218] of Foster. Additionally, the silicone can be mixed with anti-infective agents such as aminoglycosides, curcumin, see para. [0179]-[0185] of Foster).
Claim(s) 3 and 12, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Foster et al. (2020/0330270) in view of Nostro et al. (“Effects of Oregano, carvacrol and thymol on Staphylococcus aureus and Staphylococcus epidermidis biofilms.” Journal of Medical Microbiology, vol. 56, no. 4, 1 Apr. 2007, pp. 519-523) as applied to claims 1 and 9 above, and further in view of Guyuron et al. (2006/0168746).
Regarding claim 3, the modified Foster/Nostro method discloses wherein said head stem (“a mount having a polygonal post configured to removably couple with a corresponding socket of the head receiver” see para. [0026], see Figs. 20-21, and Figs. 26-27 of Foster) is located on the opposite side of said head face (see Figs. 20-21, Figs. 26-27), but is silent regarding the head stem being off center of said head.
Guyuron teaches a related rotating/oscillating cleaning head (Fig. 1, Fig. 10) wherein the head stem is located off center of the head (lower outside connection 184 and eccentric bore 185 form a receiver/stem connection and are located off center of head 186, see Fig. 10; see para. [0087]. It is noted that one of ordinary skill in the art would recognize that the bore/connection could be reversed such that the head 186 has a post and the drive shaft 182 has the bore. See MPEP 2144.04(VI)(A)). Guyuron states “upon rotation of the drive shaft 182, the head 186 will rotate in an extended circular motion on an offset axis generally perpendicular to the longitudinal axis of the device” (see para. [0087]). Thus, the offset location provides an expected result of extending the circular motion of the 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 stem of Foster/Nostro to be located off center of the head as generally taught by Guyuron because this provides an expected result of extending the circular motion of the head, thus providing a larger area of contact.
Regarding claim 12, the modified Foster/Nostro method discloses wherein said head stem (“a mount having a polygonal post configured to removably couple with a corresponding socket of the head receiver” see para. [0026], see Figs. 20-21, and Figs. 26-27 of Foster) is located on the opposite side of said head face (see Figs. 20-21, Figs. 26-27), but is silent regarding the head stem being off center of said head.
Guyuron teaches a related rotating/oscillating cleaning head (Fig. 1, Fig. 10) wherein the head stem is located off center of the head (lower outside connection 184 and eccentric bore 185 form a receiver/stem connection and are located off center of head 186, see Fig. 10; see para. [0087]. It is noted that one of ordinary skill in the art would recognize that the bore/connection could be reversed such that the head 186 has a post and the drive shaft 182 has the bore. See MPEP 2144.04(VI)(A)). Guyuron states “upon rotation of the drive shaft 182, the head 186 will rotate in an extended circular motion on an offset axis generally perpendicular to the longitudinal axis of the device” (see para. [0087]). Thus, the offset location provides an expected result of extending the circular motion of the 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 stem of Foster/Nostro to be located off center of the head as generally taught by Guyuron because this provides an expected result of extending the circular motion of the head, thus providing a larger area of contact.
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 1-17, 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 Foster et al. (2020/0330270) in view of Nostro et al. (“Effects of Oregano, carvacrol and thymol on Staphylococcus aureus and Staphylococcus epidermidis biofilms.” Journal of Medical Microbiology, vol. 56, no. 4, 1 Apr. 2007, pp. 519-523) and Guyuron et al. (2006/0168746).
Although the claims at issue are not identical, the claims are not patentably distinct because instant claims 1-17 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 Foster, Nostro, and Guyuron 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 Foster, Nostro, and Guyuron because the combination would merely provide expected results (see the 103 rejection(s) above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Parsloe (2012/0165708) discloses a related eyelid massaging device made of silicone rubber or like materials, coated with an anti-inflammatory or anti-infective agent to assist in the reduction of symptoms. 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. La Bianco et al. (2004/0015139) discloses a related skin treatment applicator that applies lotion to the applicator or to the skin. Choate (2015/0216722) discloses a related oscillating eye cleaner. Rynerson et al. (2014/0214062) discloses a related oscillating eyelid cleaner. Baschnagel (2011/0160635) discloses a related cotton swab applicator with topical agent(s) held in a cavity. Olkowski et al. (2015/0182415) discloses a related oscillating eyelid care appliance. Schwarz-Hartmann et al. (5,974,615) discloses a related oscillating cleaning brush head. 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. Hamburg (4,883,454) discloses a related eyelid treatment spongehead with antibiotics. Modak et al. (WO 2017/200818 A1) discloses a related coating for infection-resistant medical devices, including curcumin and silver.
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/CHRISTOPHER E MILLER/ Examiner, Art Unit 3785
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