DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-25 are pending and examined on the merits.
Claims 3-13, 15-17, and 19-22 are currently amended.
Information Disclosure Statement
The three information disclosure statements (IDS’s) submitted on 08/23/2023, 07/24/2024, and 01/20/2026 were filed before the mailing date of the First Office Action on the merits. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7 and 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Claypool (U.S. Patent No. 2,961,679 A).
Regarding claim 1, Claypool teaches:
An applicator head (see head 12 at least in Figs. 2-3) for administration of a topical formulation (col. 1, lines 15-20 teach a cream that is applied to the surface of a human body), comprising a dosing aid (see friction members or treads 13 at least in Figs. 2-3) for application of a predefined dose of the topical formulation (col. 2, lines 65-67 teach that the treads 13 are raised portions which allow for cream to be contained directly adjacent the location of the treads 13),
wherein the applicator head (12) comprises an applicator surface (see Fig. 3 for example; Examiner is treating the applicator surface to include the concentric rings 13; this interpretation is consistent with Applicant’s disclosure at page 12, lines 27-28 and page 13, lines 18-19 indicating that Fig. 3 shows an applicator surface includes the dose markings 60’ and 62’) adapted to apply the topical formulation to a user's skin (see at least col. 1, lines 15-20),
wherein the applicator surface comprises an outlet opening (see opening 11 at least in Figs. 2-3),
wherein the dosing aid comprises a dose marking on the applicator surface (see treads 13, which are visible to a user),
wherein the dose marking circumscribes an inner dosing compartment that serves to measure the predefined dose of the topical formulation (col. 2, lines 65-67 teach that the treads 13 are raised portions which allow for cream to be contained directly adjacent the location of the treads 13 so that the cream is located in the grooves 14, which are considered as inner dosing compartments; see also Fig. 6), and
wherein the outlet opening is disposed inside the inner dosing compartment (see for example Fig. 3).
Regarding claims 2 and 5, Claypool teaches the invention as discussed above in claim 1. Additionally, Claypool teaches: wherein the dose marking has an outline that is at least partially circular (see for example Fig. 3), the circular part of the outline having a diameter D (see for example Fig. 3; as applied to claim 2), and wherein the outlet opening is disposed centrally of the circular part of the outline of the dose marking (see for example Fig. 3; as applied to claim 5).
Regarding claims 3 and 5, Claypool teaches the invention as discussed above in claim 2. Additionally, Claypool teaches: wherein the dose marking has a completely circular outline (see for example Fig. 3; as applied to claim 3), and wherein the outlet opening is disposed centrally of the circular part of the outline of the dose marking (see for example Fig. 3; as applied to claim 5).
Regarding claims 4 and 5, Claypool teaches the invention as discussed above in claim 2. Additionally, Claypool teaches: wherein the dose marking is partially circular and partially ellipsoid (Examiner notes that every circle is an ellipse; see page 4 of attachment titled “Ellipses” and page 1 of attachment titled “How is an Ellipse Different from a Circle?”; therefore, Fig. 3 of Claypool teaches a partially circular and a partially ellipsoid dose marking; as applied to claim 4), and wherein the outlet opening is disposed centrally of the circular part of the outline of the dose marking (see for example Fig. 3; as applied to claim 5).
Regarding claim 6, Claypool teaches the invention as discussed above in claim 1. Additionally, Claypool teaches: wherein the diameter D is selected such that, when the topical formulation is ejected from the outlet opening, the amount of topical formulation that spreads from the outlet opening and over the inner dosing compartment until it reaches the dose marking, corresponds to the predefined dose (col. 2, lines 65-67 teach that the treads 13 are raised portions which allow for cream to be contained directly adjacent the location of the treads 13 so that the cream is located in the grooves 14, which are considered as inner dosing compartments; therefore, the amount of topical formulation that spreads from the outlet opening and over the inner dosing compartment 14 corresponds to the treads 13; see also Fig. 6).
Regarding claim 7, Claypool teaches the invention as discussed above in claim 1. Additionally, Claypool teaches: wherein the dose marking is a visual dose marking (see treads 13, which are visible to a user).
Regarding claim 8, Claypool teaches the invention as discussed above in claim 1. However, Claypool is silent as to the process of forming the dose marking on the applicator surface.
The claimed language “wherein the dose marking is realized on the applicator surface by surface treatment of the applicator surface, application of color markings on the applicator surface, by producing the applicator surface from several materials, wherein a border between two distinct materials serves as the dose marking, or by moulding-in of the dose marking into the applicator surface” is being treated as a product by process limitation, that is, that the applicator head with the dose marking is formed by surface treatment, by application of color, by producing several materials, or by moulding. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. Therefore, Claypool anticipates the claim because Claypool teaches each and every limitation of the product produced by the process of claim 8. Here, Claypool teaches a dose marking (see treads 13 at least in Figs. 3 and 6) on the applicator surface (see Fig. 3 for example; see also claim 1 above) being formed by moulding-in of the dose marking into the applicator surface (col. 2, lines 62-63, for example, teach that the treads 13 are formed integral with the head 12).
Thus, even though Claypool is silent as to the process used to form the dose marking on the applicator surface, the product of Claypool is the same or similar as that claimed, especially since both Applicant’s device and the prior art device are both adapted to topically apply a measured dose of a cream-type fluid onto a skin (see claim 1 above).
Regarding claim 10, Claypool teaches the invention as discussed above in claim 1. Additionally, Claypool teaches: wherein the dose marking flushes with the applicator surface (as described in claim 1, since the surface includes the wavy concentric rings 13 texturing, the markings are flush with that surface; as broadly claimed, the surface is not required to be a flat surface).
Regarding claim 11, Claypool teaches the invention as discussed above in claim 1. Additionally, Claypool teaches: wherein the dosing aid is adapted for dosing of two predefined doses of topical formulation (as see in Figs. 2-3, the applicator 12 comprises multiple treads 13 and grooves 14; therefore, the applicator head 12 is adapted for dosing two predefined doses).
Regarding claim 12, Claypool teaches the invention as discussed above in claim 1. Additionally, Claypool teaches: wherein there is more than one dose marking on the applicator surface (see at least Fig. 3), and wherein the dose markings are arranged on the applicator surface concentrically around the outlet opening (see at least Fig. 3).
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Regarding claim 13, Claypool, with reference to Image 1 above, teaches the invention as discussed above in claim 12. Additionally, Claypool teaches: wherein there are a first and a second dose marking on the applicator surface (see Image 1), wherein the first dose marking is arranged between the outlet opening and the second dose marking (Id.), and wherein the first and second dose marking between them circumscribe a ring dosing compartment (see at least Image 1), and wherein the ring dosing compartment has a ring width W that is the distance between the first and the second dose marking (see at least Image 1).
Regarding claim 14, Claypool, with reference to Image 1 above, teaches the invention as discussed above in claim 13. Additionally, Claypool teaches: wherein the ring width W is selected such that when the topical formulation is ejected from the outlet opening, the amount of topical formulation that spreads from the outlet opening and over the inner dosing compartment and further over the ring dosing compartment, until it reaches the second dose marking, corresponds to a second predefined dose (see Image 1 above; due to the existence of a second dose marking, any solution that is ejected from the opening will advance until the first dose marking, creating a dosing compartment, the solution will then continue advancing as the solution continues to be ejected from the opening until it reaches the second dose marking, creating a second dose compartment having a second predefined dose).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 18-19, 21-23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Claypool (U.S. Patent No. 2,961,679 A).
Regarding claim 18, Claypool teaches:
An applicator head (see head 12 at least in Figs. 2-3) for administration of a topical formulation (col. 1, lines 15-20 teach a cream that is applied to the surface of a human body), comprising a dosing aid (see friction members or treads 13 at least in Figs. 2-3) for application of a predefined dose of the topical formulation (col. 2, lines 65-67 teach that the treads 13 are raised portions which allow for cream to be contained directly adjacent the location of the treads 13),
wherein the applicator head (12) comprises an applicator surface (see Fig. 3 for example) adapted to apply the topical formulation to a user's skin (see at least col. 1, lines 15-20),
wherein the applicator surface comprises an outlet opening (see opening 11 at least in Figs. 2-3), and wherein the dosing aid comprises a dose marking on the applicator surface (treads 13 are visible to a user),
wherein the dose marking has an outline that is at least partially circular (see at least Figs. 2-3), the circular part of the outline having a diameter D (see for example Fig. 3),
and wherein the outlet openings are disposed on the applicator surface point symmetrical to a center of the circular outline (see for example Fig. 3), and
wherein the dose marking circumscribes an inner dosing compartment that serves to measure the predefined dose of the topical formulation (col. 2, lines 65-67 teach that the treads 13 are raised portions which allow for cream to be contained directly adjacent the location of the treads 13 so that the cream is located in the grooves 14, which are considered as inner dosing compartments; see also Fig. 6).
However, while Claypool does not explicitly teach multiple outlet openings, as required by the claim, Applicant has not disclosed that having multiple outlet openings serves any advantage or particular purpose or solves a stated problem. Furthermore, one of ordinary skill in the art would expect that the opening of Claypool and the claimed multiple outlet openings to have similar functionality. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the opening of Claypool to obtain the claimed invention because such a modification would have been considered a mere design consideration. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (see MPEP 2144.04(IV)(B)).
Regarding claim 19, Claypool teaches the invention as discussed above in claim 18. Additionally, Claypool teaches: wherein the dose markings have an outline and a diameter D (see for example Fig. 3) which are adapted to a predefined dose of topical formulation, to be measured with the dosing aid (as broadly recited, the dose markings 13 have an outline and diameter D that correspond to a predefined dose of the topical formulation).
Regarding claim 21, Claypool teaches the invention as discussed above in claim 18. Additionally, Claypool teaches: wherein the dose markings further comprise a dose indicator or dose indicators (see treads 13 in Fig. 2).
Regarding claim 22, Claypool teaches the invention as discussed above in claim 18. Additionally, Claypool teaches: A packaging for a topical formulation comprising an applicator head according to claim 18 (see for example Fig. 1 showing the invention contained within a container 10 and covered by a cap 20).
Regarding claim 23, Claypool teaches the invention as discussed above in claim 22. Additionally, Claypool teaches: a product comprising a packaging according to claim 22 containing a topical formulation (col. 1, lines 15-20 teach a cream that is applied to the surface of a human body).
Regarding claim 25, Claypool teaches the invention as discussed above in claim 22. Additionally, Claypool teaches: A method of dosing the topical formulation according to claim 19 comprising the steps of:
urging the topical formulation from the packaging and out of the outlet opening on the applicator surface (see at least col. 2, lines 54-56),
letting the topical formulation spread over the applicator surface until it covers the inner dosing compartment (the inner dosing compartment is considered to be defined by the opening 11 and the tread 13 immediately adjacent the opening 11; upon urging the topical formulation out of the outlet opening, the topical formulation will pile up about the opening and cover the inner dosing compartment because the inner most tread 13 will stop the advancement of the topical formulation; see also Fig. 6).
While Claypool does not explicitly teach the step of stopping urging of the topical formulation as soon as the topical formulation covers the inner dosing compartment, as required by the claim, one of ordinary skill in the art would have reasonably recognized that the dose markings 13 serve as an effective means for determining the amount of topical formulation that can be applied to a human skin. Therefore, in order to achieve such amount of topical formulation, one of ordinary skill would have reasonably concluded that stopping the urging of the topical formulation as soon as the topical formulation covers the inner dosing compartment will allow for a predetermined amount of the topical formulation to be contained on the applicator surface.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Claypool (U.S. Patent No. 2,961,679 A) in view of Fuisz (U.S. Pre Grant Pub. No. 2015/0282981 A1).
Regarding claim 9, Claypool teaches the invention as discussed above in claim 8. While, Claypool does not explicitly teach that the dose marking has a color that is different from the color of a rest of the applicator surface, as required by the claim, such a configuration is well known in the art and one of ordinary skill in the art would have been motivated to choose a color for the dose marking that is different from the color of the rest of the applicator surface at least in order for a user to better see the dose marking in order for a user to be able to ascertain how much topical solution needs to be urged out of the container in order to not waste too much topical solution. Such a modification is reasonably within the capacity of one of ordinary skill in the art.
Additionally, prior art references exist which teach markings having a different color than the rest of the dispenser. For example, Fuisz teaches an analogous dispensing tip (see Abstract) comprising markings 16 having a color different than the color of other portions of the dispensing tip assembly (see para. [0017]).
Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Claypool by making the dose marking have a color that is different from the color of the rest of the applicator surface at least in order for the dose marking to be easily distinguished from the rest of the applicator surface, as taught by Fuisz (see para. [0017]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Claypool (U.S. Patent No. 2,961,679 A) in view of Bougamont (U.S. Pre Grant Pub. No. 2006/0071034 A1).
Regarding claim 15, Claypool teaches the invention as discussed below in claim 13. However, Claypool is silent as to the process of manufacturing the applicator surface.
The claimed language “wherein the applicator surface is manufactured by bi-injection moulding” is being treated as a product by process limitation, that is, that the applicator surface is made by bi-injection moulding. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. Therefore, Claypool anticipates the claim because Claypool teaches each and every limitation of the product produced by the process of claim 15.
Thus, even though Claypool is silent as to the process of manufacturing the applicator surface, it appears that the product of Claypool would be the same or similar as that claimed, especially since both Applicant’s device and the prior art device are both adapted to topically apply a measured dose of a cream-type fluid onto a skin (see Abstract). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have formed the device of Claypool using bi-injection moulding at least because such a process is a conventional means for forming medical devices, such as the applicator head with the applicator surface of Claypool, that is well known in the art.
Additionally, prior art references exist which teach bi-injection moulding procedures. For example, Bougamont teaches an analogous cosmetic product dispenser (see Abstract) that can be manufactured by means of bi-injection moulding procedure (see para. [0067]).
Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have manufactured the device of Claypool by bi-injection moulding at least in order to reduce production time, labor, and assembly costs.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Claypool (U.S. Patent No. 2,961,679 A), as applied to claim 13 above, and further in view of Gueret (U.S. Pre Grant Pub. No. 2002/0048481 A1).
Regarding claims 16-17, Claypool teaches the invention as discussed above in claim 13. However, Claypool is silent as to the diameters of the dose markings, as required by the claim.
Gueret teaches an analogous device for applying a substance to a human skin (see Abstract) comprising an at least one applicator element comprising a plurality of grooves arranged concentrically (see for example Fig. 11, [0008], [0116]) and a plurality of bosses (see para. [0013]). Gueret further teaches that the one applicator element may have a diameter of at least 20mm while another applicator element may have a diameter of at least 30mm-40mm (see para. [0014]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Claypool to incorporate the teachings of Gueret by spacing the dose markings away from a circumferential center of the applicator head such that the diameter D of the first dose marking is about 19mm to about 21mm (as applied to claim 16) and the diameter D of the second dose marking is about 25mm to about 27mm and the ring width W is from about 0.8mm to about 3mm (as applied to claim 17) at least such a modification would have involved a mere change in the size of the diameters of the dose markings. A size change is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955) (see MPEP 2144.04(IV)(B). Additionally, one of ordinary skill in the art would have been motivated to change the diameters of the dose markings as necessary to produce different effects or desired characteristics of the device for packaging and applying a substance, as taught by Gueret (see para. [0152]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Claypool (U.S. Patent No. 2,961,679 A), as applied to claim 23 above, and further in view of Carrara (US Pre-Grant Pub. No. 2014/0221943 A1).
Regarding claim 24, Claypool teaches the invention as discussed above in claim 23. However, Claypool does not explicitly teach that the topical formulation has a viscosity in the range of 1 Pa.s to 4 Pa.s, as required by the claim.
Carrara teaches an analogous applicator system for applying viscous liquid to the human skin (Abstract). Carrara further teaches that the dispenser contains a viscous liquid having a viscosity of at least 3000 centipoise, or 3 Pa.s (see para. [0018]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Claypool to incorporate the teachings of Carrara by having the topical formulation have a viscosity of between 1 Pa.s and 4 Pa.s at least in order for the viscous liquid to adhere to the application surface, as taught by Carrara (see para. [0018] of Carrara). In addition, one of ordinary skill in the art would have been motivated to choose a topical solution with a viscosity of between 1 Pa.s and 4 Pa.s, such as the one taught in Carrara, to use with the device of Claypool at least because Claypool teaches that the device is adapted for use with “form retaining fluid”, such as shaving cream or cosmetic creams which retain their shape, unsupported in relatively small quantities (see col. 1, lines 48-57), and one of ordinary skill in the art would have found it reasonably obvious to adapt the device to be used with other similar viscous solutions.
Double Patenting
Claim 20 of this application is patentably indistinct from claim 1 of Application No. 17/411,277. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 20 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of copending Application No. 17/411,277 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Greiner-Perth (U.S. Pre Grant Pub. No. 2023/0200514 A1) – Massage Applicator
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781