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 .
DETAILED ACTION
Status of Claims
Claims 1-19 are pending.
Election/Restrictions
Applicants’ election of Group II and the following species: cyanoacrylate for polymer film forming agent, mequinol for stabilizer, and drops for application, in the reply filed on 5/13/2026 is acknowledged. 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 § 818.03(a))
Accordingly, claims 1 and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim. Claims 2-15 are under examination in the instant office action.
Claim Objections
Claims 4-8 are objected to because of the following informalities: typographical errors
In claim 4, “S02”, in line 2, appears to be typographical errors for --SO2--. Appropriate correction is required. In addition, the same typographical error is noted in the specification and should be corrected accordingly.
Also, claims 5-8 recite “The method of claim 9, of claim 9, further comprising” in line 1. It should be corrected to recite: “The method of claim 9, wherein the topical polymer film-forming solution further comprises.
Claim Rejections - 35 USC § 112 (b)
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 4 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 pre-AIA the applicant regards as the invention.
Claim 4 recites “the stabilizer is selected from the group consisting of: <1% hydroquinone, Mequinol, S02, Butylated hydroxyanisole, and combinations thereof.”
First, it is unclear whether the percentage range (<1%) only applies for hydroquinone or the other stabilizers. Second, it is unclear whether the percentage (%) in the claim refers to mass fraction (% w/w), mass concentration (% w/v) or volume concentration (% v/v). As such, it renders the claim indefinite. For examination purpose, it is interpreted to be limited to “hydroquinone”.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 2-8 are improperly dependent on succeeding claim 9 as claim 9 is not a claim that is previously set forth (see MPEP 608.01(n), iii. Test for proper dependency).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 2-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 6274127 (hereafter, SCHRAER) in view of US 2002/0068266 (hereafter, ASKILL).
SCHRAER teaches a method of using non-adhesive antiperspirant compositions comprising a water or sweat-reactive monomer as the antiperspirant active, an anhydrous carrier, and a polymerization inhibitor, wherein the compositions are applied topically to the underarm or other suitable area of the skin to inhibit or prevent perspiration and the polymer-containing active is derived from water-reactive monomers that reacts with sweat at the opening of the sweat ducts after application, to thereby polymerize and form the polymer-containing antiperspirant active over and within the affected sweat ducts (abstract, col 2, lines 26-33, and claim 3).
SCHRAER further teaches that the water-reactive monomer is preferably cyanoacrylate esters such as octyl 2-cyanoacrylate, n-butyl 2-cyanoacrylate and combinations thereof (col 3, line 64-col 4, line 43 and claim 19).
SCHRAER further teaches that the anhydrous carrier suitable for use in the composition is preferably in liquid form (solution) and a suitable example of the anhydrous carrier includes cyclopentasiloxane (column 4, lines 45-54 and col5, lines 17-24).
SCHRAER discloses that the polymerization inhibitor provides polymerization stability in the package and to control the rate of polymerization after the composition has been applied topically to the skin and includes hydroquinone, p-methoxy phenol (mesquinol), and butylated hydroxy anisole (col 6, lines 10-14 and 33-44). Concentration of the polymerization inhibitor typically ranges from more typically from about 10 ppm to about 1% by weight of the composition (<1%) (col 6, lines 23-32).
The prior art specifically discloses exemplary solutions comprising octyl 2-cyanoacrylate or n-butyl 2-cyanoacrylate, a polymerization inhibitor (stabilizer) and anhydrous carrier such as cyclopentasiloxane, which is a liquid (Table 1).
SCHRAER also discloses that the antiperspirant compositions in Table 1 are applied topically to the underarm (axillary) or other suitable area of the skin and form on the applied surface discontinuous polymer-containing films in contact topically positioned over sweat ducts in the skin, wherein the polymer-containing films are derived from water-reactive monomers reacting with sweat at the opening of the sweat ducts after application to the skin, to thereby polymerize and form the polymer-containing films over the sweat ducts and/or polymeric plugs within the sweat ducts and the applied compositions are non-adhesive and help to inhibit or prevent perspiration at the applied area of the skin (col 2, lines 15-23, Table 1, and col 14, lines 10-21). SCHRAER teaches that the compositions adhere to the applied surface of the skin but do not result in cosmetically noticeable adhesion of adjacent skin surfaces or clothing to the applied surface of the skin and these non-adhesive compositions are also preferably non-sticky after application (col 3, lines 1-9).
SCHRAER further teaches that the composition is preferably applied in an amount ranging from about 0.1 gram to about 20 grams, more preferably from about 0.1 gram to about 10 grams, even more preferably from about 0.1 gram to about 1 gram, to each underarm or other desired area of the skin (col 13, lines 7-11). If it is converted to the unit of microliter (μl), 0.1 g of the solution is about 100 μl based on the density of cyclopentasiloxane (0.95g/ml), which falls within the claimed range.
In addition, SCHRAER teaches the antiperspirant compositions may further comprise other optional materials known for use in antiperspirant, deodorant or other personal care product, or which are otherwise suitable for topical application to skin (non-toxic) and such other optional materials include dyes or colorants, emulsifiers, distributing agents, pharmaceuticals or other topical actives (medicaments), preservatives, surfactants, processing aides such as viscosity modifiers, wash-off aids (col 12, lines 15-23). SCHRAER further teaches the non-adhesive composition further comprises an odor-controlling active selected from the group consisting of deodorant active, antiperspirant active, deodorant perfume, fragrance and combinations thereof (claim 13).
The prior art is silent about “the compound curing into a film less than 20 μm thick in about 10-15 seconds with manual friction applied or in about 20-30 seconds by air drying.
However, SCHRAER teaches and suggests applying to the skin such as the underarm (axillary) or other suitable area of the skin the same polymer film-forming compound comprising the same polymer film-forming agent (e.g., octyl 2-cyanoacrylate or n-butyl 2-cyanoacrylate) and the same polymerization stabilizer (e.g., p-methoxy phenol (mesquinol), which forms a thin film over the sweat ducts and/or polymeric plugs within the sweat ducts as claimed. When a liquid composition is topically applied to the skin, manual friction or air-drying while applying the liquid composition naturally occurs. It is common sense to allow air-dry once a liquid medicine is applied to the skin. Also, the prior art teaches applying the same composition in the amount which overlaps or are close to those claimed, the same polymer film forming composition would form a film having the same or similar thickness within similar time upon applying in the absence of evidence to the contrary. Also, as to intended results recited in claims 11-12, the method of the prior art inherently performs the functions as recited in claims when the same polymer film-forming solution is topically applied to the target skin area for inhibiting perspiration as taught by the prior art. It is noted that products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable. “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103). When the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Applicants are advised that In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) states: "Where, as here, the claimed and prior art product is identical or substantially identical, or is produced by an identical or substantially identical process, the PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product ........ Whether the rejection is based on 'inherency' under 35 USC 102, on 'prima facie obviousness' under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products [footnote omitted]."
In the alternative, it was well known that the size and thickness of the polymeric film formed onto the site can be readily controlled by the amount and viscosity of cyanoacrylate composition packaged in a single dose product or by use of a multiple use dispenser which governs the amount of material applied onto a unit area of surface skin as evidenced by ASKILL ([0077]). ASKILL teaches application of a cyanoacrylate prepolymer composition onto the cadaver skin followed by in situ polymerization of the prepolymer to form a polymeric film, wherein the cyanoacrylate compositions preferably include a polymerization inhibitor in an effective amount to inhibit premature polymerization of the composition during storage ([0029] and [0089]). ASKILL further teaches that application is conducted under conditions wherein the polymeric film has a thickness of from about 2 to about 500 microns and still more preferably from about 20 to about 100 microns and if thinner polymeric films are desired, then the polymeric film should have a thickness of from about 2 to about 50 microns and preferably from 10 to 40 microns ([0076]). The range overlaps the claimed range. ASKILL also teaches that the amount of cyanoacrylate composition applied to a unit area to obtain such thicknesses is well within the skill of the art ([0076]). In addition, ASKILL teaches that polymerization occurs at ambient conditions for a sufficient period of time to allow polymerization to proceed and generally, the particular length of time required for polymerization will vary depending on factors such as the amount of adhesive composition applied, the temperature of the site, the moisture content of the site, the extent surface area of the site, and the like ([0071]). ASKILL further teaches that in a preferred embodiment, polymerization is generally complete within about 10 to about 60 seconds while the site is maintained at or below ambient conditions ([0071]).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the thickness of the film by adjusting the amount of the polymer film-forming solution depending on desired purposes. The skilled artisan would have readily determined the amount of the polymer film-forming solution comprising polymerizable cyanoacrylates for obtaining suitable thickness via routine experimentation because the amount of cyanoacrylate composition applied to a unit area to obtain intended thicknesses is well within the skill of the art as evidenced by ASKILL. Also, the skilled artisan would have readily arrived at the particular length of manual friction or air-drying time required for intended polymerization reaction with sweat through routine experimentation. In addition, ASKILL teaches the ranges overlapping those claimed. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). It is the position of the Examiner that it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to determine suitable thickness and sufficient time of manual friction or air-drying through routine or manipulative experimentation to obtain desired film over the skin for intended purpose, as these are variable parameters attainable within the art as evidenced by ASKILL.
As to claim 15, ASKILL teaches that the cyanoacrylate film forming composition can be applied using a dispenser which dispenses it in a controlled dropwise manner ([0077]). Thus, it would have been obvious to use a suitable dispenser such as dropper for applying the intended amount of the liquid composition to the skin in a controlled dropwise manner. The skilled artisan would have been motivated to do so because the topical solution could be applied in drops which could be easily spread over the target skin area.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the forgoing discussion, it is concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the reference, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONG-SOOK BAEK whose telephone number is 571-270-5863. The examiner can normally be reached 9:00AM-6:00PM Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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