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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
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 and 3-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yanagisawa et al. (WO 2018/181538; published: 10/4/18; in IDS dated 2/28/24).
The English machine language translation of WO 2018/181538 is attached herein. The passages cited below which indicate the teachings of the ‘538 publication are based on its English translation.
Yanagisawa et al. is directed to a nanodisk which can be produced easily and makes it possible to disperse a hydrophobic compound in water satisfactorily, wherein the nanodisk is characterized by containing a lipid bilayer and a lipopeptide biosurfactant [Abstract].
With regards to instant claim 1, Yanagisawa et al. teach a method for producing a nanodisk including a step of mixing a lipid and a lipopeptide biosurfactant in an aqueous solvent [0015]. Yanagisawa et al. teach wherein the nanodisk further comprises a hydrophilic compound [0013]. Yanagisawa et al. teach that the abovementioned nanodisk composition has high permeability to skin tissue (i.e., has improved skin penetration property of a hydrophilic compound) [0065].
With regards to instant claim 3, Yanagisawa et al. teach wherein the lipopeptide biosurfactant is surfactin represented by formula (I) or a salt thereof; represented by chemical formula I:
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, wherein X represents an amino acid residue selected from leucine, isoleucine and valine; R represents a C9-1 8 alkyl group [0010].
With regards to instant claim 4, Yanagisawa et al. teach wherein a glycerophospholipid represented by the following formula (II) is used as the lipid; represented by chemical formula II:
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, wherein R and R independently represent a C10-24 alkyl group or a C10-2 4 alkenyl group [0018].
With regards to instant claim 5, Yanagisawa et al. teach a cosmetic comprising the abovementioned nanodisk [0021] and [0065].
With regards to instant claim 6, Yanagisawa et al. teach a cosmetic comprising the abovementioned nanodisk [0021] and [0065] and furthermore, wherein the hydrophobic compound (of the nanodisk composition) has high permeability to skin tissues (i.e., is topically applied in order to permeate the skin) [0065].
Therefore, by teaching all the limitations of claims 1 and 3-6, Yanagisawa et al. anticipate the instant invention as claimed.
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 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.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yanagisawa et al. (WO 2018/181538; published: 10/4/18; in IDS dated 2/28/24).
The English machine language translation of WO 2018/181538 is attached herein. The passages cited below which indicate the teachings of the ‘538 publication are based on its English translation.
As noted in the anticipation rejection above Yanagisawa et al. anticipates claims 1 and 3-6 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103(a) over Yanagisawa et al. for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Yanagisawa et al. is directed to a nanodisk which can be produced easily and makes it possible to disperse a hydrophobic compound in water satisfactorily, wherein the nanodisk is characterized by containing a lipid bilayer and a lipopeptide biosurfactant [Abstract].
With regards to instant claim 1, Yanagisawa et al. teach a method for producing a nanodisk including a step of mixing a lipid and a lipopeptide biosurfactant in an aqueous solvent [0015]. Yanagisawa et al. teach wherein the nanodisk further comprises a hydrophilic compound [0013]. Yanagisawa et al. teach that the abovementioned nanodisk composition has high permeability to skin tissue (i.e., has improved skin penetration property of a hydrophilic compound) [0065].
With regards to instant claim 3, Yanagisawa et al. teach wherein the lipopeptide biosurfactant is surfactin represented by formula (I) or a salt thereof; represented by chemical formula I:
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, wherein X represents an amino acid residue selected from leucine, isoleucine and valine; R represents a C9-1 8 alkyl group [0010].
With regards to instant claim 4, Yanagisawa et al. teach wherein a glycerophospholipid represented by the following formula (II) is used as the lipid; represented by chemical formula II:
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, wherein R and R independently represent a C10-24 alkyl group or a C10-2 4 alkenyl group [0018].
With regards to instant claim 5, Yanagisawa et al. teach a cosmetic comprising the abovementioned nanodisk [0021] and [0065].
With regards to instant claim 6, Yanagisawa et al. teach a cosmetic comprising the abovementioned nanodisk [0021] and [0065] and furthermore, wherein the hydrophobic compound (of the nanodisk composition) has high permeability to skin tissues (i.e., is topically applied in order to permeate the skin) [0065].
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
With regards to instant claim 2, Yanagisawa et al. teach that the amount of the lipopeptide biosurfactant to the phospholipid can be 0.4 times or more and 1.2 times or less. When the amount is 0.4 times or more, the nanodisk is more reliably formed, and if the amount is 1.2 times or less by mole, the amount of the lipopeptide biosurfactant not involved in the formation of the nanodisk is not so excessive, and is economical. Although Yanagisawa et al. teach a molar ratio desired in its compositions, it does not specifically teach wherein a mass ratio of the lipopeptide biosurfactant to the phospholipid is 0.5 times or more and 3 times or less, as required by instant claim 2.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The ratio (e.g., mass) of the claimed lipopeptide biosurfactant (e.g., surfactin) and the phospholipid is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each lipopeptide biosurfactant and the phospholipid in order to best achieve the desired results as such would provide advantageous biological effect. 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 engage in routine experimentation to determine optimal or workable ranges that produce expected results. 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). In the instant case, Yanagisawa et al. teach that the amount of the lipopeptide biosurfactant to the phospholipid can be 0.4 times or more and 1.2 times or less. When the amount is 0.4 times or more, the nanodisk is more reliably formed, and if the amount is 1.2 times or less by mole, the amount of the lipopeptide biosurfactant not involved in the formation of the nanodisk is not so excessive, and is economical. The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amounts of each lipopeptide biosurfactant and the phospholipid would impact its ability to form the nanodisc taught by Yanagisawa et al. and therefore be an optimizable variable.
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 would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617