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 .
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 1-3, 5, 8, 10, 13-14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (CN 112353803; published: 2/12/21), as evidenced by Begum (Is Soy Lecithin Healthy or Harmful for Your Body?; 8/20/24).
The English language machine translation of CN 1123535803 is attached herein. The passages cited below which indicate the teachings of the ‘803 publication are based on its English translation.
Liu is directed to lidocaine nanoliposome gels (Title). Liu teaches the following embodiment: a lidocaine nanoliposome gel (i.e., the claimed plurality of lipid-based positively charged nanoparticles in claims 1 and 17), comprising the following raw materials in parts by weight: 5-40 parts of lidocaine hydrochloride (i.e., the claimed amide-based anesthetic agent in claims 1 and 5), 5-40 parts of tetracaine hydrochloride (i.e., the claimed ester-based anesthetic agent in claims 1-3), 1-20 parts of tetracaine base (i.e., the claimed ester-based anesthetic agent in claims 1-2), lidocaine Alkali 1-20 parts(i.e., the claimed amide-based anesthetic agent in claims 1 and 5), dyclonine hydrochloride 1-20 parts, procaine hydrochloride 1-15 parts (i.e., the claimed ester-based anesthetic agent in claims 1-2), soy phospholipids 10~200 parts (i.e., the claimed soybean lecithin in claims 13-14), cholesterol 5-100 parts, xanthan gum 1-10 parts, carbomer 1-10 parts, 1-10 parts of sodium carboxymethyl cellulose (i.e., the claimed viscous base in claims 1 and 10).
With regards to instant claim 8, Liu teaches wherein soy phospholipids are included in the abovementioned composition, and as evidenced by Begum, such behaves as a preservative [See Section: Is soy lecithin a preservative?].
Therefore, by teaching all the limitations of claims 1-3, 5, 8, 10, 13-14 and 17, Liu anticipates 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 1-8, 10, 13-14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 112353803; published: 2/12/21) and Begum (Is Soy Lecithin Healthy or Harmful for Your Body?; 8/20/24).
The English language machine translation of CN 1123535803 is attached herein. The passages cited below which indicate the teachings of the ‘803 publication are based on its English translation.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
As noted in the anticipation rejection above Liu anticipates claims 1-3, 5, 8, 10, 13-14 and 17 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over Liu 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))).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Liu teaches a composition comprising 5-40 parts of lidocaine hydrochloride and 5-40 parts of tetracaine hydrochloride, Liu does not teach wherein tetracaine HCl is present in a concentration ranging from about 0.01-4.0% w/w and lidocaine is present in a concentration ranging from 0.05-6.0% w/w, as required by instant claims 4 and 7.
Noted the composition of Liu comprises lidocaine HCl (limitations of instant claim 6).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding the concentration of tetracaine HCl and lidocaine HCl as specified in claims 4 and 7, MPEP 2144.05 states:
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).
Furthermore, Liu teaches that lidocaine HCl and tetracaine HCl achieve good anesthetic effect and furthermore, the combination of lidocaine HCl and tetracaine HCl provide a synergistic [last 2 ¶s of Disclosure of Invention Section]. The Applicants' specification provides no evidence that the selected concentration range in claims 4 and 7 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to numerous physical/chemical/biological properties of various chemicals (e.g., desired anesthetic effect, disease state of patient being administered the composition), it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine these teachings and alter the concentration. One of ordinary skill in the art would have been motivated to change the concentration as this could be expected to be advantageous for providing the optimal therapeutic effect.
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 112353803; published: 2/12/21) and Begum (Is Soy Lecithin Healthy or Harmful for Your Body?; 8/20/24) as applied to claims 1-8, 10, 13-14 and 17 above, and further in view of Peng et al. (CN 106924176; published: 8/11/20).
The English language machine translations of CN 1123535803 and CN 106924176 are attached herein. The passages cited below which indicate the teachings of the ‘803 and ‘176 publications are based on its English translation.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
As noted in the anticipation rejection above Liu anticipates claims 1-3, 5, 8, 10, 13-14 and 17 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over Liu 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))).
Furthermore, Liu teaches the limitations of instant claims 4 and 6-7 (see rejection above for details).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Liu teaches a nanoliposome gel comprising a sodium carboxymethyl cellulose base, Liu does not teach wherein the cellulose base is, for example, methyl cellulose, as required by instant claim 11. However, such deficiency is cured by Peng.
Peng is directed to nanoliposome gel comprising drugs [Title]. Peng teaches a water-soluble gel matrix comprising cellulose derivative selected from methyl cellulose and sodium carboxymethyl cellulose.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on these teachings, 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 substitute one water-solubel gel matrix for another, each of which is taught by the prior art to be useful for the same purpose (sodium carboxymethyl cellulose for methyl cellulose for the purpose of forming a nanoliposome gel), in order to form a third composition to be used for the very same purpose (See MPEP 2144.06).
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.
Claims 9, 12, 15-16 and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 112353803; published: 2/12/21) and Begum (Is Soy Lecithin Healthy or Harmful for Your Body?; 8/20/24) as applied to claims 1-8, 10, 13-14 and 17 above, and further in view of Hemmila et al. (US 2017/0100335; published: 4/13/17).
The English language machine translation of CN 1123535803 is attached herein. The passages cited below which indicate the teachings of the ‘803 publication are based on its English translation.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
As noted in the anticipation rejection above Liu anticipates claims 1-3, 5, 8, 10, 13-14 and 17 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over Liu 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))).
Furthermore, Liu teaches the limitations of instant claims 4 and 6-7 (see rejection above for details).
With regards to instant claims 18 and 20, Liu teaches lecithin.
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Liu teaches a preservative, Liu does not teach wherein the preservative is benzalkonium chloride, as required by instant claim 9. However, such deficiency is cured by Hemmila.
Liu does not teach wherein the nanoparticles/nanoemulsion comprise mineral oil, a nonionic surfactant (e.g., polysorbate 80) and a cation such as cetylpyridinium chloride and sterile water, as required by instant claims 12, 15-16 and 18-21. However, such deficiencies are cured by Hemmila.
Liu is silent with regards to the pH. Liu does not teach wherein the pH of the composition is about 4.5-6.5, as required by instant claim 22. However, such deficiency is cured by Hemmila.
Hemmila is directed to topical nanoemulsion compositions to be used as therapy for wounds [Title, Abstract]. Hemmila teaches that its nanoemulsion comprise particles of nano-size and can be in the form of a gel (i.e., the same as the Liu) [0012, 0182]. Hemmila teaches a nanoemulsion comprising a suitable preservative such as benzalkonium chloride [0169]. Hemmila also teaches that benzalkonium chloride is a cationic surfactant and has multiple functions: emulsifying agent, preservative and active [Tables 4A and 5].
Hemmila teaches wherein the nano-sized particles are part of a nanoemulsion, similar to the liposome gel of Liu. Hemmila teaches wherein the oil phase can comprise any type of oil, for example, mineral oil [0019, 0146] and also teaches that mineral oil behaves as a palliative agent [0178]. And specifically, when sterile water is used as the aqueous phase, mineral oil may be employed as the oil phase [0213]. With regards to the surfactants, Hemmila teaches a combination of nonionic and cationic surfactants [0135-0136, 0166]. Hemmila teaches that the cationic surfactant is preferably cetylpyridinium chloride (CPC) [Table 1] and the nonionic surfactant is Tween 80 (i.e., polysorbate 80) [0135-0136, Table 4A and 4B]. With regards to the pH, Hemmila teaches wherein the nanoemulsions can comprise a pH adjuster (e.g., iethyanolamine, lactic acid, monoethanolamine, triethylanolamine, sodium hydroxide, sodium phosphate, semi-synthetic derivatives thereof) and/or a buffer [0168, 0170] and in a particular embodiment, Hemmila teaches a stable and compatible, CPC-comprising compositions wherein the pH ranges from 4.82-4.89 [Table 12].
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on these teachings, 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 substitute one preservative for another, each of which is taught by the prior art to be useful for the same purpose (preservative of Liu for benzalkonium chloride taught by Hemmila for the purpose of preventing microbial growth and increase shelf life of the topical composition), in order to form a third composition to be used for the very same purpose (See MPEP 2144.06). Furthermore, Liu and Hemmila et al. are both directed to topical compositions comprising nanosized particles with active agents. Based on these teachings, 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 modify the composition of Liu by further incorporating the preservative benzalkonium chloride to achieve the predictable result of obtaining a composition suitable for topical application. One of ordinary skill in the art would have been motivated to do so because Hemmila teaches that benzalkonium chloride is a known preservative but also advantageously behaves as an emulsifying agent and active agent.
Liu and Hemmila et al. are both directed to topical compositions comprising nanosized particles with active agents. Based on these teachings, 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 modify the nanoliposome gel of Liu by further incorporating sterile water, mineral oil, cetylpyridinium chloride and polysorbate 80 and adjusting the pH to 4.82-4.89 to achieve the predictable result of obtaining a composition suitable for topical application. One of ordinary skill in the art would have been motivated to do so because Hemmila teaches that such is advantageous for the following reasons: (1) to provide a palliative effect upon administration (mineral oil), (2) to providing emulsifying preservative and active effects and a stable composition via a combination of nonionic and cationic surfactants (e.g., cetylpyridinium chloride and tween 80) [Tables 4A, 4B] and (3) providing a stable and compatible composition (pH 4.82-4.89).
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
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617