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
Change of Examiner
The examiner assigned to the instant application has changed. The new examiner is Bong-Sook Baek. Contact information is provided at the end of this Office Action.
Status of Claims
Claims 1-29 are pending.
Election/Restrictions
Applicants’ election of Group I and the following species: synthetic biomaterial and a compound of formula (I-aa) wherein L1 is C2-C14 alkylene and L2 is C2-14 alkylene, in the reply filed on 4/13/2026 is acknowledged. The election was made without traverse.
Applicant stated that claims 1, 4-6, and 10-21 encompass the elected species. However, it is noted that claims 7-9 also encompass the elected compound of formula (I-aa).
Accordingly, claims 2-3 and 22-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim.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 1 and 4-21 are under examination in the instant office action.
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.
Claims 10-12 are 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. All the dependent claims are included.
Claim 10 recites “the rhamnolipid of formula (I)” in lines 1-2. There is insufficient antecedent basis for this limitation because the claims from the claim 10 depends does not recite said “rhamnolipid of formula (I)”.
For the examination purpose, it is treated as if it depends from claim 7.
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 1, 4-12, and 14-21 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200179437 (hereafter, Chakroff) in view of US 20070155678 (hereafter, Piljac).
Chakroff teaches a scaffold comprising an electrospun polymer fiber for treating a chronic wound wherein the electrospun fiber may comprise a polymer selected from the group consisting of polyglycolic acid, poly(lactide-co-caprolactone), polylactic acid, polycaprolactone, copolymers thereof, and combinations thereof (electrospun support comprising a synthetic biomaterial) (abstract and [0038]-[0040]).
Chakroff further teaches that the polymer solution or the resulting electrospun polymer fibers may comprise an agent that comprises a compound for affecting cellular changes in a tissue and the agent may be an anti-proliferative compound, a vasodilator, a vasoconstrictor, an analgesic, or any combination thereof or the agent may be selected from miRNA, a gene vector, a peptide, a stem cell, a protein, a ligand, a lipid, or any combination thereof ([0049]).
Chakroff further teaches that chronic skin wounds frequently have an alkaline pH in the range of about 7.0 to about 9.0 while healthy skin, on the other hand, typically has a slightly acidic pH in the range of about 4.0 to about 6.0 ([0064]). Chakroff further teaches that the pH of a typical wound gradually decreases as the wound heals and reducing the pH of a wound or damaged tissue improve and/or accelerate the healing of a wound ([0064]).
Chakroff does not specifically teach a rhamnolipid impregnated within the electrospun polymer scaffold (electrospun support).
Piljac teaches the use of a composition comprising one or more rhamnolipids as an active ingredient for wound healing (abstract). Piljac teaches that the rhamnolipid has the following formula 1:
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wherein R1 is hydrogen or unsubstituted alpha-L-rhamnopyranosyl, or alpha-L-rhamnopyranosyl substituted at the 2 position, R2 is -CHR4-CH2-COOR6, R3 is –(CH2)x-CH3, x is 4-19 and R6 is -CH3 (0025)-[0030]). The compound of formula I encompasses the claimed formula of (I-aa).
Piljac specifically discloses the following compound as preferred rhamnolipid:
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(di-rhamnolipid) ([0032]).
The compound is the species of claimed formula I-aa wherein Rx is
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, RY is
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96
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, and L1 and L2 are C6 alkylene.
Piljac further discloses said one or more rhamnolipids are present in said composition in an amount of from 0.001 to 5% by weight or 0.01 to 1% by weight based on total weight of the composition ([0041] and claim 8). Since the MW of the above di-rhamnolipid is about 650.8 g/mol, 0.001% w/w di-rhamnolipid is about 15.4 µM, 0.01% w/w di-rhamnolipid is about 154 µM, and 1% w/w di-rhamnolipid is about 15400 µM. The concentration range overlaps those recited in claims 16-18.
Also, Piljac teaches that the rhamnolipids of the present invention can be prepared by conventional methods, preferably by fermentation, isolation and purification ([0031]). This means that the rhamnolipids are synthetically prepared or naturally occurring rhamnolipids as recited in claims 14-15.
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 use the electrospun scaffold of Chakroff in combination with the rhamnolipid of Piljac in the treatment of wounds because of the following reasons. Chakroff already teaches that the polymer solution or the resulting electrospun polymer fibers can comprise an agent that comprises a compound for affecting cellular changes in a tissue including an analgesic and a lipid. Also, the rhamnolipid was taught to be an active agent effective for wound healing as evidenced by Piljac. Thus, one of ordinary skill in the art would have been motivated combine both in a therapeutic composition for treating a wound on the reasonable expectation they would provide combined effects while the electrospun polymer scaffold would also work as a carrier for delivering the active agent such as rhamnolipid.
As to the concentration of the rhamnolipid, Piljac teaches and suggest the effective concentration range of the same rhamnolipid in a composition, which overlaps those claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Those of ordinary skill in the art would have readily optimized the concentration of the same rhamnolipid in a therapeutic composition for treating a wound based on the concentration range of Piljac for maximizing therapeutic outcome. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). See MPEP 2144.05 IIA.
As to pH range recited in claim 19-20, Chakroff already teaches that chronic skin wounds frequently have an alkaline pH in the range of about 7.0 to about 9.0 while healthy skin typically has a slightly acidic pH in the range of about 4.0 to about 6.0, thus reducing the pH of a wound or damaged tissue may improve and/or accelerate the healing of a wound. Accordingly, 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 adjust the pH of a therapeutic composition to the range which is favorable for improving the healing of a wound as taught by Chakroff.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200179437 (hereafter, Chakroff) in view of US 20070155678 (hereafter, Piljac) in further view of Hogan et al. (Journal of Hazardous Materials, 364: 600-607, 2019).
Chakroff and Piljac as applied supra are herein applied for the same teachings in their entirety.
Piljac does not specifically disclose enantiomeric purity of the rhamnolipid recited in claim 13. However, it was known in the art that chemical synthesis produces four diastereomers of rhamnolipid, (R, R), (R,S), (S,S) and (S,R) and each diastereomer can be separated to have enantiomeric purity in excess of 90.0% as evidenced by Hogan et al. (p601, col 1, praa 4, Fig. 1, p602, col 1, 2.1.2, and Table 1). Hogan et al. further teach that novel rhamnolipids with altered stereochemistry or congener makeup may have different properties and that such differences resulted in measurable changes in biodegradation, zebrafish toxicity, and human lung cell toxicity (p606, col 1, para 3).
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 use a rhamnolipid having enantiomeric purity because enantiomerically pure rhamnolipids could be prepared and different enantiomers may have different biological specificity and toxicity as evidenced by Hogan et al. The skilled artisan would have been motivated to do so on the reasonable expectation that enantiomerically pure rhamnolipids would provide consistent activity in the biological systems where the chirality is important.
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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