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 4/14/26 with the following:
Amended claims
1, 11, 13, 16
Newly canceled claims
10, 12, 15
Newly added claims
Previously canceled claims
Previously withdrawn claims
Claims under instant examination
1-9, 11, 13-14, 16-22
Withdrawn Claim Rejections
All rejections pertaining to claims 10, 12 an d15 are moot because the claims were cancelled in view of the amendments filed on 4/14/26.
The rejections of:
claims 1-3, 5, 8, 10, 13-14 and 17 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);
claims 1-8, 10, 13-14 and 17 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); and
claim 11 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).
are hereby withdrawn in view of the claim amendments filed on 4/14/26; specifically with regards to incorporating limitations of previous claims 10, 12 and 15 into the independent claim 1.
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 1-9, 13-14 and 16-22 remain rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 112353803; published: 2/12/21; of record), in view of Begum (Is Soy Lecithin Healthy or Harmful for Your Body?; 8/20/24; of record) and Hemmila et al. (US 2017/0100335; published: 4/13/17; of record).
The English language machine translation of CN 1123535803 were previously submitted. 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)
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 5-6), 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?].
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 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.
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)
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.
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.
Claim 11 is newly rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 112353803; published: 2/12/21; of record), Begum (Is Soy Lecithin Healthy or Harmful for Your Body?; 8/20/24; of record) and Hemmila et al. (US 2017/0100335; published: 4/13/17; of record; of record) as applied to claims 1-9, 13-14 and 16-22 above, and further in view of Peng et al. (CN 106924176; published: 8/11/20; of record).
The English language machine translations of CN 1123535803 and CN 106924176 were previously submitted. 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)
Liu, Begum and Hemmila teach the limitations of instant claims 1-9, 13-14 and 16-22 (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-soluble 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.
Response to Arguments
Applicants’ arguments have been fully considered, but are not found persuasive.
Applicants argue that there is no reasonable expectation that the combination of the nano-preparations from Liu, Peng and Hemmila would produce a composition with known or expected properties (Remarks: p. 5). More specifically, neither reference teaches or suggests using a cationic species to promote dispersion of lipid-based nanoparticles within a viscous cellulose-containing base (Remarks: p. 7). Applicants also argue that the Examiner’s proposed combination amounts to hindsight reconstruction of Applicant’s composition, not a predictable combination supported by the prior art.
This is not found persuasive. Although the 103 references are silent about the cationic species promoting dispersion of lipid-based nanoparticles within a viscous cellulose-containing base, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method.
Furthermore, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
THIS ACTION IS MADE FINAL. 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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