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 .
Election/Restrictions
Applicant’s election of the species:
Nanoparticle species: solid-lipid nanoparticles (SLN);
API species: nutraceutical; and
Nutraceutical ligand: caffeine;
in the reply filed on 2/10/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 40 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/10/2026.
Claims Status
Claims 1-27 are cancelled.
Claims 28-47 are pending.
Claim 40 is withdrawn.
Claims 28-39 and 41-47 are presented for examination as they read on the elected subject matter.
Priority
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Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/4/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 28 is objected to because of the following informalities: the preamble recites “an active pharmaceutical ingredient (API)”. Claim 28 also recites in b) “at least one active ingredient”. The issue is whether this “at least one active ingredient” is the same or different from the “active pharmaceutical ingredient” in the preamble. It appears that Applicant left out “pharmaceutical” from b). Appropriate correction is required.
Claim 33 is objected to because of the following informalities: Claim 33 recites “said active pharmaceutical ingredient (API)” but Applicant has already defined API in claim 28. Note claim 37 where Applicant properly has “said API”. Correction is required.
Claim 39 is objected to because of the following informalities: There is a comma between “Paullinia cupana” and “HBK”. That appears improper because guarana is known as Paullinia cupana HBK in one term. Correction is required.
Claim 41 is objected to because of the following informalities: claim 41 recites: “generally recognized as safe (GRAS)”. Applicant has already defined the acronym in claim 37. Correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 28-39 and 41-47 are rejected under 35 U.S.C. 112, first paragraph, because the specification does not reasonably provide enablement for the claimed composition comprising: at least one nanoparticle of a solid lipid nanoparticle; at least one active ingredient nutraceutical; and at least one nutraceutical ligand caffeine configured to specifically bind to said targeted tissue or said targeted cell. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention without an undue amount of experimentation.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: 1) scope or breadth of the claims; 2) nature of the invention; 3) relative level of skill possessed by one of ordinary skill in the art; 4) state of, or the amount of knowledge in, the prior art; 5) level or degree of predictability, or a lack thereof, in the art; 6) amount of guidance or direction provided by the inventor; 7) presence or absence of working examples; and 8) quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure. When the above factors are weighed, it is the Examiner’s position that one skilled in the art could not practice the invention without undue experimentation. While all of the factors have been considered, only those required for a prima facie case are set forth below.
MPEP 2164.01 Test of Enablement states: “Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” The Examiner will show below that the specification is deficient and does not contain sufficient information to make and use the claimed invention.
1) Scope or breadth of the claims
The novel aspects of the invention are directed to a composition for delivering an active pharmaceutical ingredient to a targeted tissue or a targeted cell comprising: a solid lipid nanoparticle; at least one active ingredient nutraceutical; and at least one nutraceutical ligand caffeine configured to specifically bind to said targeted tissue or said targeted cell.
2) Nature of the invention
The nature of the invention is directed to a composition for delivering an active pharmaceutical ingredient to a targeted tissue or a targeted cell.
3) Relative level of skill possessed by one of ordinary skill in the art
The level of skill is high and that of a pharmaceutical drug delivery research scientist. In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II).
4) State of, or the amount of knowledge in, the prior art
The structure of caffeine is fully methylated.
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Sastri et al. (Journal of Applied Pharmaceutical Science Vol. 10(06), pp 126-141, June, 2020) teach that a solid lipid nanoparticle typically has a structure involving several components as shown in Figure 1 (Page 127; see also Table 1, page 136 “Formulation components”):
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Sastri et al. also teach that multi-step synthetic procedures are required to produce the SLNs (Figure 5-9, pages 129-131).
5) Level or degree of predictability, or a lack thereof, in the art
MPEP 2161.01(III) states: “when there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required.”.
6) Amount of guidance or direction provided by the inventor
Applicant was required to provide in the specification additional guidance and direction with respect to how make the claimed subject matter in order for the application to be enabled. In the present case, Applicant was required to provide direction on how to provide a composition comprising a solid lipid nanoparticle with an active ingredient and the nutraceutical ligand caffeine configured to specifically bind to said targeted tissue or said targeted cell. Applicant’s specification states: “the outer surface of the nanoparticle (the shell) is decorated, so as to include at least one targeting compound (a nutraceutical ligand), oriented so as to be available for binding to the target.” (Page 6). But no specific materials or process steps are provided to achieve such decoration. Furthermore, disclosure of a “solid lipid nanoparticle” is not specific but rather generic. The specification did not include any discussion of the specific components or chemistry involved in the solid lipid nanoparticle and thus, failed to apprise one of ordinary skill how to make and use the solid lipid nanoparticle with at least one nutraceutical and caffeine ligand configured to specifically bind to said targeted tissue or said targeted cell. Because the novel aspect of the invention is solid lipid nanoparticles with at least one nutraceutical and caffeine ligand configured to specifically bind to said targeted tissue or said targeted cell, Applicant cannot rely on the knowledge of one skilled in the art to supply the missing information.
7) Presence or absence of working examples
The specification fails to provide scientific data and working embodiments with respect to making a composition as claimed. Example 1 (Page 21) simply states that liposomes are manufactured and “decorated” with targeting nutraceutical. No chemical synthesis is provided in this prophetic example. No prior art is cited or incorporated by reference for guidance on how to prepare a solid lipid nanoparticle. The specification merely teaches: “The decoration is achieved by any type of modification of the shell (chemically bonding to the shell, chemically coordinating with the shell, forming a part of the shell, polymerized into the shell, and so forth) or by modifying a nutraceutical ligand so as to bind to the shell.” (Page 7). However, how such modification is done is not disclosed. The Specification states that: “solid lipid nanoparticles (SLNs)10 decorated by caffein[e]sic ligands 13” (Page 9). However, what lipids were used to make the solid lipid nanoparticles and how these may have been decorated with caffeine as a ligand configured to specifically bind to said targeted tissue or said targeted cell has not been disclosed. Other than caffeine, no starting materials or conditions of the process steps are disclosed. No source of solid lipid nanoparticles is named. This is not omission of minor details. Rather, these critical aspects to make the claimed invention are absent.
8) Quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure
MPEP 2161.01 III states: “(“Although the knowledge of one skilled in the art is indeed relevant, the novel aspect of an invention must be enabled in the patent.”). The Federal Circuit has stated that “‘[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement.’” Auto. Technologies, 501 F.3d at 1283, 84 USPQ2d at 1115 (quoting Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997)). The rule that a specification need not disclose what is well known in the art is “merely a rule of supplementation, not a substitute for a basic enabling disclosure.” Genentech, 108 F.3d at 1366, 42 USPQ2d 1005; see also ALZA Corp., 603 F.3d at 940-41, 94 USPQ2d at 1827. Therefore, the specification must contain the information necessary to enable the novel aspects of the claimed invention. Id. at 941, 94 USPQ2d at 1827; Auto. Technologies, 501 F.3d at 1283-84, 84 USPQ2d at 1115 (“[T]he ‘omission of minor details does not cause a specification to fail to meet the enablement requirement. However, when there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required.’”). In other words, more than a reasonable amount of experimentation is required to make and use the claimed invention. Applicant has an idea or concept or starting point for future investigation for the claimed composition and is leaving it to the ordinary artisan to figure out how to make the claimed composition. MPEP 2103(I)(A): “The purpose of this requirement is to limit patent protection to inventions that possess a certain level of “real world” value, as opposed to subject matter that represents nothing more than an idea or concept, or is simply a starting point for future investigation or research (Brenner v. Manson, 383 U.S. 519, 528-36, 148 USPQ 689, 693-96 (1966); In re Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); In re Ziegler, 992 F.2d 1197, 1200-03, 26 USPQ2d 1600, 1603-06 (Fed. Cir. 1993)).” Moreover, MPEP 2164.03 states: "Thus, the public’s end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.” Applicant has failed to do so and consequently the enablement requirement is not satisfied.
Consequently, in order to actually achieve the claimed invention, it is clear from the discussion above that the skilled artisan could not rely upon Applicant's disclosure as required by 35 U.S.C. 112, first paragraph, and would have no alternative recourse but the impermissible burden of undue experimentation in order to practice the embodiments presently claimed. The Examiner has established on the record a reasonable basis for questioning the adequacy of the disclosure to enable a person of ordinary skill in the art to make and use the claimed invention without resorting to undue experimentation. It is incumbent on the applicant to factually demonstrate that his or her application disclosure is in fact sufficient. See MPEP 2161.01 III.
Claim Rejections - 35 USC § 112
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 38 and 39 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 38 recites the broad recitation “endo” and the claim also recites “(pancreatic)” which is the narrower statement of the range/limitation. Claim 39 recites the broad recitations “(Acacia)” and “chocolate”, and the claim also recites “tryptamine” and “phenethylamine” which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The other terms in parenthesis “(xantheose)” “(Paullinia cupana HBK)” and “PEA” are synonyms for the materials named and do not appear to raise 112 second paragraph issues.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kaur et al. (WO2020109989) teaches solid lipid nanoparticles of curcumin (Title; Abstract; claims 1-26).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
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