DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of the Claims
Claims 1, 2, 8, 9, 15, 16, 23-29, 32-45, 49-52, 54, 55, 58-63, 65, and 68-73 are pending. Claims 3-7, 10-14, 17-22, 30, 31, 46-48, 53, 56, 57, 64, and 67 are cancelled. Claims 35-41 are withdrawn. Claims 1, 2, 8, 9, 15, 16, 23-29, 32-34, 42-45, 49-52, 54, 55, 58-63, 65, and 68-73 are under consideration in this action.
Change in Examiner
The examiner for your application in the USPTO has changed. Examiner Monica Shin can be reached at 571-272-7138.
Election/Restrictions
Applicant’s election of the following species in the reply filed on June 13, 2025 is acknowledged:
Large agent: botulinum toxin
Cosmetic or therapeutic agent: fillers
Device: stamp
Administration site: skin surface overlying a muscle or muscle group
Disease: hyperfunctional facial lines
It is noted that the search has been expanded to also include the species wrinkles.
Formulation: lotion
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 35-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 13, 2025.
Examiner’s Observations
With regards to Claim 71, it is noted that the examination set forth below is directed to the elected species, hyperfunctional facial lines and wrinkles. However, for the purposes of compact prosecution, it is noted that several unelected species of diseases, disorders, and conditions may be subject to a rejection under 35 U.S.C. 112(a), scope of enablement when search and consideration is expanded to include such species with regards to treatment and/or prevention of several diseases, disorders, or conditions listed in claim 71, in particular for prevention of those with no known cause, e.g., Alzheimer’s Disease, Parkinson’s Disease, Crohn’s disease, etc.
Further regarding Claim 71, it is noted that certain conditions are listed more than once in the Markush group (e.g., headache, skin cancer).
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 71 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.
Regarding claim 71, the phrases "e.g." and “such as” in lines 2, 3, 5-7, 10, and 19 render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further regarding Claim 71, “etc.” in line 5 renders the claim indefinite because it is unclear what other diseases, disorders, or conditions are encompassed by the term.
Further regarding Claim 71, the phrases “certain ophthalmologic conditions” and “certain urologic conditions” render the claim indefinite because it is unclear what about the conditions would render it encompassed by the claim or not. It is unclear what “certain” ophthalmologic conditions and what “certain” urologic conditions are and are not encompassed by the claim.
Further regarding Claim 71, the claim is indefinite as it contains parentheses which raises the question as to which term is required by the claim because the subject matter in the parentheses is not identical in scope. Essentially, the claims use both narrow and broad limitations. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
It is further noted that the parentheses starting in lines 6 and 7 do not have close parentheses.
With regards to Claims 70 and 71, “unsightly facial expression” and “unwanted sweating” render the claims indefinite because “unsightly” and “unwanted” are subjective. What is “unsightly” or “unwanted” to one person is not necessarily “unsightly” or “unwanted” to another. Thus, it is ultimately unclear what specific facial expression and sweat are and are not encompassed by the claims.
Claim Rejections - 35 USC § 103
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.
Claims 1, 2, 8, 9, 15, 16, 23, 29, 32-34, 42, 43, 45, 49-52, 54, 58-62, 65, and 68-72 are rejected under 35 U.S.C. 103 as being unpatentable over David et al. (David) (US 2010/0196445 A1; published Aug. 5, 2010) and Alam et al. (Alam) (J Am Acad Dermatol; published Sept. 2018).
With regards to Claims 1, 23, 29, 32, and 68-71, David discloses a method for treating a skin region having wrinkles comprising (a) applying a microneedle device to the skin region to perforate the skin region; (b) applying to the skin region a penetration enhancer; and (c) applying to the skin region a botulinum neurotoxin (para.0004, 0019, 0021, 0031, 0032, 0058; David claims 5-7, 10). Steps (a), (b), and/or (c) may be repeated at least 2 or 3 times (David claims 18-19). The aforementioned repetition may be per year (David claim 20).
The molecular weight of the botulinum neurotoxin protein molecule, for all seven of the known botulinum neurotoxin serotypes, is about 150 kD (para.0036).
With regards to Claims 42 and 43, David discloses the use of a microneedle device to deliver the neurotoxin or neurotoxin formulation. Microneedle delivery technologies can facilitate drug delivery to various skin depths using arrays of short needle(s). The microneedle device comprises one or more porous microneedles or one or more non-porous microneedles (para.0011, 0021). The microneedles can be used as an array of more than one microneedle (para.0025).
With regards to Claim 45, David discloses performing the method discussed above for treating a skin region having wrinkles (David claim 5). In an embodiment, the skin region is the forehead or nasolabial folds (reading on a skin surface overlying a muscle or muscle group) (David claim 24).
With regards to Claims 49 and 50, the microneedles are sufficiently long to penetrate through the stratum corneum skin layer and into the epidermal/dermal layer, but sufficiently short to not result in substantial pain due to activation of nerve endings. Due to the small size of microneedles, application is virtually pain-free, with minimal (if any) bleeding or application site reaction (para.0021).
With regards to Claims 51 and 52, in an embodiment, the microneedles are made of a metal, such as titanium (a biocompatible material) (para.0028).
With regards to Claim 54, in an embodiment, a microneedle array comprising 10-25 needles is used (para.0025). The microneedles penetrate skin up to a depth approximately in between the bottom of the stratum corneum and the top of the dermal layer (reading on microneedles making an impression in a period of continuous contact between the site and a device that comprises one or more microneedles) (para.0025-0026).
With regards to Claims 58-61, in an embodiment, an array of microneedles comprises a 10x10 matrix (reading on a plurality of microneedles arranged in a geometrical pattern). In another embodiment, an array of microneedles comprises a 20x20 matrix. In some embodiments, the distance between each microneedle in an array is from approximately 100-400 microns. In an embodiment, the particular dimensions of the array can be chosen depending on the desired enhancement of skin permeability (para.0025). David further discloses that steps (a), (b), and/or (c) of their method may be repeated at least 2 times (David claims 18-19).
With regards to Claim 65, steps (a), (b), or (c) is applied for at least 20 seconds, 25 seconds, 30 seconds, or 60 seconds (David claim 12).
With regards to Claim 72, the dosage form of botulinum neurotoxin for administration to human patients include lotions (para.0060).
David does not appear to explicitly disclose (i) a dosing regimen in which at least two successive doses are separated from one another by a time period of at least one month, or (ii) wherein the step of administering is further in combination with a cosmetic or therapeutic agent. Alam is relied upon for this disclosure.
Alam discloses that injectable fillers and neuromodulators are used for a range of indications pertaining to the correction of facial aging and disfigurement. Fillers can correct soft tissue loss, depressed scars, and atrophy or asymmetry induced by systemic of local disease. Neuromodulators correct muscle-mediated skin creases, reshape the face, and address right-left functional asymmetry. Among the prepackaged injectable fillers approved by the U.S. FDA are hyaluronic acid derivatives, calcium hydroxylapatite, and poly-L-lactic acid; neuromodulators include three types of botulinum toxin type A and one type of type B. Filler and toxin injections are part of a complete treatment plan. Reinjection is typically required to maintain the clinical effect (abstract).
Examples of common locations on the face and neck where fillers are injected and locations on the face and neck where neuromodulator injections are safely placed are shown on Figures 1 and 2, and include, for example, the forehead (p.424-425).
Neuromodular injections are repeated every 3 months in novice patients, and as infrequently as every 4 to 6 months in experienced patients. When a patient receives toxin for facial rhytids (wrinkles) repeatedly, the duration of action is enhanced. The effect, which starts by lasting about 3 months, can eventually remain for 4, 5, or even 6 months. Some patients may choose to receive injections several times a year to maintain the aesthetic effect (p.431, col.2, Frequency of Injection).
Fillers and toxins can be used in combination. Fillers and toxins are safely and effectively used in combination. On the face, toxins reduce dynamic creases (reading on hyperfunctional facial lines) while fillers correct static creases at rest. The concurrent use of fillers and toxins at the same site, if indicated, is common practice (p.432, col.1, Combination Treatments).
With regards to the timing of the dosing regimen as recited in the instant Claims 1, 2, 8, 9, 15, 16, and 68-70, as discussed above, David discloses that their method for treating a skin region having wrinkles, which includes applying to the skin region a botulinum neurotoxin, may be repeated at least 2 or 3 times per year. In light of Alam’s disclosure that repeated administration of neuromodular injections (e.g., botulinum toxin) enhances the duration of action, and it is known for patients to repeat the injection every 3 months or every 4-6 months, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date to combine the teachings of David and Alam and repeat administration of the botulinum toxin every 3 months or every 4-6 months when performing David’s method discussed above to treat wrinkles (David) and hyperfunctional facial lines (Alam). One of ordinary skill in the art would have been motivated to do so in order to enhance the duration of action of the botulinum toxin and to maintain the aesthetic effect of the treatment. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as David discloses that the botulinum toxin in their method for treating wrinkles may be repeated throughout the year, and Alam discloses that such treatment is known to be repeated every 3 months or every 4-6 months depending on the experience of the patient and is known to treat wrinkles and hyperfunctional facial lines.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. In the present case, in light of Alam’s disclosure of known frequency of administration of neuromodular injections for facial aging, e.g., wrinkles and hyperfunctional facial lines, one of ordinary skill in the art would have found it prima facie obvious and would have been motivated to engage in routine experimentation to determine the optimal or workable frequency of administration of doses of botulinum toxin when treating wrinkles and hyperfunctional facial lines based on Alam’s disclosed art recognized frequency and adjusting based on art recognized and conventional parameters, such as the depth or severity of the wrinkles and/or hyperfunctional facial lines and whether the patient is a novice or experienced patient. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955).
Further, with regards to the area and number of impressions as recited in the instant Claims 59-62, as discussed above, David discloses that their method for treating a skin region having wrinkles, which includes applying a microneedle device to the skin region to perforate the skin region, may be repeated (e.g., at least 2 or 3 times). Because the purpose of the microneedle application to the skin is to perforate the skin and facilitate drug delivery to various skin depths, and in light of Alam’s disclosure of common areas known to administer botulinum toxin, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date to combine the teachings of David and Alam and optimize the number of microneedle impressions and the location of the microneedle impressions based on art recognized factors, such the area where the wrinkles are to be treated, the depth or severity of the wrinkles to be treated, and whether the patient is a novice or experienced patient. One of ordinary skill in the art would have been motivated to do so in order to optimize the delivery of the botulinum toxin, thus optimizing the effect of the botulinum toxin in treating the wrinkles and/or hyperfunctional facial lines, and to be able to efficiently and effectively cover the desired area for treatment. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as David discloses that the application of the microneedle device may be repeated when performing the method, and Alam discloses the various known areas on the face for treatment (e.g., of wrinkles and hyperfunctional facial lines) with botulinum toxin.
Further, with regards to the further administration of a cosmetic or therapeutic agent as recited in Claims 33 and 34, as discussed above, Alam discloses that fillers and toxins are known to be used together when correcting facial aging and disfigurement. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of David and Alam and further administer a filler when performing the method of the combined teachings of David and Alam as discussed above. One of ordinary skill in the art would have been motivated to do so in order to address the issues in multiple ways. For example, Alam discloses that toxin reduce dynamic creases (hyperfunctional facial lines) while fillers correct static creases at rest. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Alam discloses that fillers and toxins are known to safely and effectively be used in combination.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over David et al. (David) (US 2010/0196445 A1; published Aug. 5, 2010) and Alam et al. (Alam) (J Am Acad Dermatol; published Sept. 2018) as applied to Claims 1, 2, 8, 9, 15, 16, 23, 29, 32-34, 42, 43, 45, 49-52, 54, 58-62, 65, and 68-72 set forth above, further in view of Ruegg et al. (Ruegg) (US 2010/0168023 A1; published Jul. 1, 2010).
The teachings of David and Alam and the motivation for their combination as they apply to Claims 1, 2, 8, 9, 15, 16, 23, 29, 32-34, 42, 43, 45, 49-52, 54, 58-62, 65, and 68-72 are set forth above and incorporated herein.
The combined teachings of David and Alam do not appear to explicitly disclose the administration of a non-irritating penetration enhancing agent (Claims 26-28). Ruegg is relied upon for this disclosure. The teachings of Ruegg are set forth herein below.
Ruegg discloses injectable compositions comprising botulinum toxin that may be administered to a subject for various therapeutic aesthetic and/or cosmetic purposes (abstract). Ruegg discloses that an aspect of the invention is the recognition that certain non-native molecules can be added to botulinum toxin to improve toxin diffusion through tissues. The non-native molecules act as penetration enhancers that improve the ability of the toxin to reach target structures after injection. Furthermore, the non-native molecules may increase the stability of the toxin prior to and after injection. The penetration enhancers may be positively charged carriers, such as cationic peptides (para.0017).
In an embodiment, the non-native molecules are cationic peptides. It is believed that the peptides enhance tissue penetration of molecules associated in complex after injection, while enhancing stabilization of the botulinum toxin in skin. It is believed that the enhanced tissue penetration afforded by these peptides in particular affords reduced antigenicity, a better safety profile, enhanced potency, faster onset of clinical efficacy or longer during of clinical efficacy compared to conventional commercial botulinum toxin complexes that are bound to exogenous albumin (para.0042).
With regards to Claims 26-28, as discussed above, David discloses the administration of a penetration enhancing agent in the method. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date to further combine the teachings of David and Alam with the teachings of Ruegg and use Ruegg’s cationic peptides as the penetration enhancer in the method of the combined teachings of David and Alam discussed above. One ordinary skill in the art would have been motivated to do so to obtain the benefit such as enhancing tissue penetration of the botulinum toxin, reducing antigenicity, providing a better safety profile, enhancing potency, and providing a longer clinic efficacy when administering the botulinum toxin in the method of the combined teachings of David and Alam discussed above. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as David explicitly discloses the administration of a penetration enhancer, and Ruegg discloses that cationic peptides are known to as penetration enhancers used with botulinum toxin.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Claims 44, 55, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over David et al. (David) (US 2010/0196445 A1; published Aug. 5, 2010) and Alam et al. (Alam) (J Am Acad Dermatol; published Sept. 2018) as applied to Claims 1, 2, 8, 9, 15, 16, 23, 29, 32-34, 42, 43, 45, 49-52, 54, 58-62, 65, and 68-72 set forth above, further in view of Lee et al. (Lee) (US 2010/0262081 A1; published Oct. 14, 2010).
The teachings of David and Alam and the motivation for their combination as they apply to Claims 1, 2, 8, 9, 15, 16, 23, 29, 32-34, 42, 43, 45, 49-52, 54, 58-62, 65, and 68-72 are set forth above and incorporated herein.
The combined teachings of David and Alam do not appear to explicitly disclose wherein the device is a stamp (Claims 44, 55, and 63). Lee is relied upon for this disclosure. The teachings of Lee are set forth herein below.
Lee discloses a microneedle-replaceable stamp comprising a main body having a handle portion and a microneedle plate or sheet that is detachably mounted to the main body. According to the microneedle stamps, when the microneedles are damaged or contaminated, they can be replaced easily and sanitarily, which provides user convenience (abstract; para.0002, 0008, 0010, 0011, 0024-0026; Figs. 12-14).
The microneedle plate includes a plurality of microneedles formed protrudingly downwardly from the bottom surface thereof and an adhesive layer coated on the top surface thereof so as to be detachably mounted on the bottom of the microneedle-attaching portion of the main body (para.0072). If the microneedles are damaged or contaminated, the microneedle plate is removed and a new microneedle plate can be attached on the microneedle-attaching portion of the main body. A protective film may be attached on the microneedle plate so as to protect the adhesive layer, and is removed and attached when in use (para.0073).
Lee discloses that in general, transdermal delivery of a cosmetic agent or drug is disadvantageous in that since the stratum corneum makes it difficult for the agent and drug to penetrate therethrough, percutaneous or transcutaneous absorption of active ingredients thereof is extremely low. Particularly, if the active ingredients have a large molecular weight, the absorption becomes further lower (par.0003).
One proposed technique to solve this problem was using microneedles. According to the technique, a fluid channel passing through a part or the whole of the epidermis is formed in a human skin by using microneedles through which drug is delivered into the epidermal layer of the skin or a lower layer. In addition, when a microneedle penetrates and stimulates the dermal layer, a burn or a scar can be naturally healed. Also, the skin is induced to produce collagen, so that the effect of improving skin tone and preventing skin aging can be maximized (para.0004).
With regards to Claims 44, 55, and 63, as discussed above, David discloses the use of a microneedle device to perforate the skin region to be treated. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date to further combine the teachings of David and Alam with the teachings of Lee and use Lee’s microneedle stamp as the microneedle device to perform the method of the combined teachings of David and Alam discussed above. One of ordinary skill in the art would have been motivated to do so as Lee’s microneedle stamp provides a device that can easily replace the microneedles when damaged or contaminated, thus being more sanitary and more convenient for the user. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as David discloses the use of a microneedle device to perform the method of the combined teachings of David and Alam, and Lee’s microneedle stamp is known to be used on the skin, in particular to penetrate and stimulate the dermal level, thus allowing better penetration and absorption of the cosmetic or drug agent being applied.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Claims 24, 25, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over David et al. (David) (US 2010/0196445 A1; published Aug. 5, 2010) and Alam et al. (Alam) (J Am Acad Dermatol; published Sept. 2018) as applied to Claims 1, 2, 8, 9, 15, 16, 23, 29, 32-34, 42, 43, 45, 49-52, 54, 58-62, 65, and 68-72 set forth above, further in view of Edelson et al. (Edelson) (US 2011/0212157 A1; published Sept. 1, 2011).
The teachings of David and Alam and the motivation for their combination as they apply to Claims 1, 2, 8, 9, 15, 16, 23, 29, 32-34, 42, 43, 45, 49-52, 54, 58-62, 65, and 68-72 are set forth above and incorporated herein.
The combined teachings of David and Alam do not appear to explicitly disclose (i) wherein the composition comprises a nanoemulsion (Claim 24), or (ii) wherein the composition comprises a macroemulsion (Claim 25). Edelson is relied upon for this disclosure. The teachings of Edelson are set forth herein below.
Edelson discloses methods of treating conditions or disorders associated with dermal structures. Specifically, Edelson demonstrates that nanoparticle compositions (e.g., nanoemulsions) can deliver active agents efficiently and specifically to the dermis (para.0003-0004). In an embodiment, the nanoparticle compositions (e.g., nanoemulsions) contain botulinum toxin) (para.0006, 0009).
The compositions can be incorporated into a cream that is applied to the skin for transdermal delivery of the toxin, achieving biological results, e.g., reduction of wrinkles (para.0172).
In some embodiments, a nanoparticle composition comprising one or more therapeutic agents (e.g., botulinum toxin) is incorporated within a microemulsion or nanoemulsion (para.0012).
Edelson’s Fig. 1 shows that the botulinum nanoemulsion had two particle size peaks having an average particle size of about 95 nm (para.0461; Table 2).
With regards to Claim 25, as discussed above, David discloses topical application of a botulinum toxin composition in the method. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the teachings of David and Alam with the teachings of Edelson and try formulating the botulinum toxin composition as a microemulsion as disclosed by Edelson as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). One of ordinary skill in the art would have been motivated with a reasonable expectation of success in doing so Edelson discloses that topical formulations of botulinum toxin used for treating conditions of structures, e.g., reduction of wrinkles, are known to be in the form of microemulsions.
Edelson’s Fig. 2 shows that the microemulsion had a single particle size peak with particle sizes ranging from about 1.1-1.5 micron (Table 1). It is noted that the instant Specification defines “macroemulsion” as an emulsion in which at least some droplets have diameters in the several hundred nanometers to micrometers size range, and as will be understood by those of ordinary skill in the art, a macroemulsion is characterized by droplets greater than 300 nm in diameter (P.G. Pub., Spec., para.0040). Because Edelson’s microemulsion has particle sizes ranging from about 1100-1500 nm, the microemulsion reads on a macroemulsion as defined by the instant Specification.
With regards to Claim 24, as discussed above, David discloses topical application of a botulinum toxin composition in the method. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the teachings of David and Alam with the teachings of Edelson and try formulating the botulinum toxin composition as a nanoemulsion as disclosed by Edelson as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). One of ordinary skill in the art would have been motivated with a reasonable expectation of success in doing so Edelson discloses that topical formulations of botulinum toxin used for treating conditions of structures, e.g., reduction of wrinkles, are known to be in the form of nanoemulsions.
Further, regarding Claim 73, the limitation “a dosing regimen that achieves a peak effect of the large agent no sooner than about 1 month after the administering” appears to be due to the combination of the topical botulinum treatment (e.g., nanoemulsion formulation) with microneedle skin conditioning (MSC) (P.G. Pub., Spec., para.0121-0122). Because the combined teachings of David, Alam, and Edelson discussed above is directed to performing MSC with topical application of a nanoemulsion composition of botulinum toxin, and repeating every 3 months or every 4-6 months, absent evidence to the contrary, the method of the combined teachings of David, Alam, and Edelson as discussed above will also achieve a peak effect of the botulinum toxin no sooner than about 1 month after administration.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
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, 2, 8, 9, 15, 16, 23-25, 29, 32-34, 42-45, 49-52, 54, 55, 58-63, 65, and 68-73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, 12-19, 22-60, 76, 89, 101, and 157 of copending Application No. 17/297,493 (Copending 493) in view of Alam et al. (Alam) (J Am Acad Dermatol; published Sept. 2018).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims claim substantial similar and overlapping methods comprising administering a composition that delivers botulinum toxin to a site on skin of a subject in need of treatment, in combination with microneedle skin conditioning (MSC).
The primary difference between the instant claims and the claims of Copending 493 is the instant claims requires administration of a plurality of doses of the composition and MSC according to a dosing regimen in which at least two successive doses are separated from one another by a time period of at least one month. Alam is relied upon for this disclosure. The teachings of Alam are set forth above and incorporated herein.
With regards to the timing of the dosing regimen as recited in the instant Claims 1, 2, 8, 9, 15, 16, and 68-70, as discussed above, Copending 493 claims treating a skin region having wrinkles, which includes applying to the skin region a botulinum neurotoxin, and claims that more than one dose may be administered. In light of Alam’s disclosure that repeated administration of neuromodular injections (e.g., botulinum toxin) enhances the duration of action, and it is known for patients to repeat the injection every 3 months or every 4-6 months, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date to combine the claims of Copending 493 and teachings of Alam and repeat administration of the botulinum toxin every 3 months or every 4-6 months when performing Copending 493’s claimed method. One of ordinary skill in the art would have been motivated to do so in order to enhance the duration of action of the botulinum toxin and to maintain the aesthetic effect of the treatment. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Copending 493 claims that the botulinum toxin in their method for treating wrinkles may be repeated, and Alam discloses that such treatment is known to be repeated every 3 months or every 4-6 months depending on the experience of the patient.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. In the present case, in light of Alam’s disclosure of known frequency of administration of neuromodular injections for facial aging, e.g., wrinkles, one of ordinary skill in the art would have found it prima facie obvious and would have been motivated to engage in routine experimentation to determine the optimal or workable frequency of administration of doses of botulinum toxin when treating wrinkles based on Alam’s disclosed art recognized frequency and adjusting based on art recognized and conventional parameters, such as the depth or severity of the wrinkles and whether the patient is a novice or experienced patient. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955).
Further, with regards to the area and number of impressions as recited in the instant Claims 59-62, as discussed above, Copending 493 claims a method for treating a skin region having wrinkles, which includes MSC. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date to combine the teachings of David and Alam and optimize the number of microneedle impressions and location of the microneedle impressions based on art recognized factors, such the area where the wrinkles are to be treated, the depth or severity of the wrinkles to be treated, and whether the patient is a novice or experienced patient. One of ordinary skill in the art would have been motivated to do so in order to optimize the delivery of the botulinum toxin, thus optimizing the effect of the botulinum toxin in treating the wrinkles, and to be able to efficiently and effectively cover the desired area for treatment. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Copending 493 claims that the application of the microneedle device may be repeated when performing the method, and Alam discloses the various known areas on the face for treatment (e.g., of wrinkles) with botulinum toxin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 2, 8, 9, 15, 16, 23-29, 32-34, 42-45, 49-52, 54, 55, 58-63, 65, and 68-73 are rejected. No claims are allowed.
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/MONICA A SHIN/Primary Examiner, Art Unit 1616