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
A new claim set was filed on 4/13/26 with the following:
Amended claims
1
Newly canceled claims
2
Newly added claims
Previously canceled claims
Previously withdrawn claims
Claims under instant examination
1 and 3-6
Withdrawn Claim Rejections
All rejections pertaining to claim 2 are moot because the claims were cancelled in view of the amendments filed on 4/13/26.
The rejections of:
claims 1 and 3-6 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); and
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)
are hereby withdrawn in view of the claim amendments filed on 4/13/26.
Oath/Declaration
Declaration filed under 37 C.F.R. 1.132 on 4/13/26 has been fully considered but is not found persuasive to overcome the obviousness conclusion of this case (See Response to Arguments below for details).
Examiner’s Note
Appendix A and B present non-patent literature that was addressed in the Declaration filed on 4/13/26. However, no IDS was submitted for such references and therefore, the Examiner did not consider such. An IDS should be submitted in response to the instant Office action in order to properly make the references of record.
New 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.
Claims 1 and 3-6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites the limitation "…a total mass ratio of the lipopeptide biosurfactant and the phospholipid to a hydrophilic compound…" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Claim 1, line 1 recites “a hydrophilic compound”, therefore, it is unclear if the “a hydrophilic compound” in lines 6-7 refers to this same one recited in line 1 or a different hydrophilic compound. Therefore, it is unclear what this limitation refers to and how to interpret the claim.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefinite concerns outlined above.
New Claim Rejections - 35 USC § 103
Applicant' s claim amendments have necessitated the following new grounds of rejection.
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 and 3-6 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), as evidenced by Vaseem et al. (Adv Pharm Bull., 2023 Oct 14, 14(1), 67-85).
The English machine language translation of WO 2018/181538 is of record. The passages cited below which indicate the teachings of the ‘538 publication are based on its English translation.
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]. Furthermore, Yanagisawa et al. teach that the nanodisk may significantly improve the transdermal properties of hydrophilic compounds [0030]. As evidenced by Vaseem et al., there are three main regions of the skin: epidermis and dermis (i.e., the dermal tissue), and subcutaneous tissue [Fig. 1] and the dermis comprises blood vessels [p. 68, 2nd column, 1st para.]. Also as evidenced by Vaseem et al., a transdermal drug delivery system (e.g., that of Yanagisawa – [0030]) must penetrate all three layers of the skin for medication delivery to the systemic circulation [p. 68, 2nd column, 1st para.]. That is, one of ordinary skill in the art would understand that the teaching of Yanagisawa et al. of improved skin penetration property of hydrophilic compounds and improved transdermal properties of hydrophilic compounds reads on the claim 1 limitation “the hydrophilic compound is delivered to a dermal tissue” because the epidermis (skin layer) is part of the dermal tissue and transdermal deliver penetrate all three layers including the dermis which contains the blood vessels.
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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114
488
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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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136
404
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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 1, 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 1.
With regards to the total mass ratio of the lipopeptide biosurfactant and the phospholipid to the hydrophilic compound limitation of claim 1, Yanagisawa et al. teach that the amount of hydrophilic compound is preferably 0.1-100 parts by mass of the lipid, respectively. However, they do not specifically wherein the total mass ratio of the lipopeptide biosurfactant and the phospholipid to the hydrophilic compound is 1 time or more and 100 times or less, as required by instant claim 1.
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, as well as the total mass ratio of the lipopeptide biosurfactant and the phospholipid to the hydrophilic compound, 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 nanodisk 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.
Response to Arguments
Applicants’ arguments have been fully considered, but are not found persuasive.
Applicants argue that Yanagisawa does not teach or suggest the total mass of the lipopeptide biosurfactant and the phospholipid to a hydrophilic compound as claimed (Remarks: p. 6).
This is not found persuasive. In response, and as indicated in the instant 103 rejection, the concentration/mass ratio of ingredients is a result effective parameter that would be routinely optimized. Furthermore, it is noted that the Applicants do not present unexpected results commensurate in scope with the claims.
Applicants argue that Yanagisawa does not teach a composition that delivers a hydrophilic compound to the dermal tissue (Remarks: p. 6). Furthermore, Applicants submit a Declaration on 4/13/26 to show that the hydrophilic compound being delivered past the epidermis and into the dermal tissue is unexpected in view of Yanagisawa (Remarks: p. 6). More specifically, Applicant asserts that the inventors did not contemplate to what extent a hydrophilic compound could be made to penetrate by means of the combination of surfactin and a phospholipid at the time of Yanagisawa and its was wholly unexpected that the hydrophilic compound could be delivered past the epidermis and into the dermal tissue (Remarks: p. 6; Declaration: p. 1-2).
This is not found persuasive. In response, and as indicated in the instant 103 rejection:
“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]. Furthermore, Yanagisawa et al. teach that the nanodisk may significantly improve the transdermal properties of hydrophilic compounds [0030]. As evidenced by Vaseem et al., there are three main regions of the skin: epidermis and dermis (i.e., the dermal tissue), and subcutaneous tissue [Fig. 1] and the dermis comprises blood vessels [p. 68, 2nd column, 1st para.]. Also as evidenced by Vaseem et al., a transdermal drug delivery system (e.g., that of Yanagisawa – [0030]) must penetrate all three layers of the skin for medication delivery to the systemic circulation [p. 68, 2nd column, 1st para.]. That is, one of ordinary skill in the art would understand that the teaching of Yanagisawa et al. of improved skin penetration property of hydrophilic compounds and improved transdermal properties of hydrophilic compounds reads on the claim 1 limitation “the hydrophilic compound is delivered to a dermal tissue” because the epidermis (skin layer) is part of the dermal tissue and transdermal deliver penetrate all three layers including the dermis which contains the blood vessels.”
This is not found persuasive.
Based on Yanagisawa’s teachings it is expected that the hydrophilic compound would be delivered past the epidermis into the dermal tissue and therefore, the Declaration has been considered but is not found persuasive to overcome the 103 rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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