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 Status
Claims 1-14 are pending.
Claims 1 and 8-9 are currently amended.
Claims 8-14 are withdrawn.
Claims 1-7 are currently under consideration.
Claims 1-7 are rejected.
Acknowledgement of Receipt
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/31/2025 has been entered.
Priority
This application is a 371 of PCT/FR2019/050515 filed 03/07/2019. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. FR1870252, filed on 09/03/2020.
Withdrawn Claim Objections/Rejections
In light of the claim amendments, the objections of claim 1 for claim numbering and word tense(s) are withdrawn.
Upon further consideration, the rejection of claims 1, 4, 6, 8-9 and 13 under 35 U.S.C. § 112(b) as being indefinite is withdrawn.
Upon further consideration, the rejection of claims 1-6 under 35 U.S.C. 103 as being unpatentable over Cuca and Sivert is withdrawn.
Upon further consideration, the rejection of claim 7 under 35 U.S.C. 103 as being unpatentable over Cuca and Sivert further in view of Appel is withdrawn.
New Claim Objections and Rejections
Applicant' s amendments have necessitated the following objections and rejections:
Claims 2-7 are objected to because of the following informalities: lowercase should be used where “Claim” is recited. Typically nouns are capitalized when used for specific names or when they begin a sentence, a quotation, or a title, otherwise you use lowercase for common nouns.
Claim 1 is objected to because of the following informalities: the quotation mark at the end of the claim should be removed.
Claim 1 is objected to because of the following informalities: line 17 of claim 1 recites, “dissolve into water”. Applicants may consider amending to read, “dissolve in water” for brevity.
Claim 1 is objected to because of the following informalities: throughout the claim there are instances where the subject is not in agreement with the verb. For example, the recitation of “wherein the waxy matrix of the solid particles are hydrophobic,” contains the subject, “matrix” which is in singular form while the verb is in a plural form of the infinitive. In the last few lines of the claim, there appears to be verbs or verb phrases missing. Applicants may consider amending to add the verb “is” after the word “principle” and before the word “chosen”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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.
Claim 1 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites, “the waxy matrix comprises hydrophobic compounds that cannot dissolve into water, cannot form emulsions, and cannot react with water.” Applicants point to support for “cannot react with water” as being provided in the description at page 6, lines 15-20 (See Remarks, pg. 7, para.1). However, Applicants have not properly described the newly added limitation, in the application as filed. Applicants describe the waxy matrix of the solid particles consisting of a mixture of water-insoluble hydrophobic compounds which are totally free of water which may be the cause of hydrolysis or oxidation reactions (see Spec., pg. 6, lines 15-18). The specification does not provide support because other than Applicants teaching that water may cause such reactions to occur, there is no proper description of hydrophobic compounds that cannot react with water. A person of ordinary skill in the art, particularly in the context of drug delivery, would expect hydrophobic compounds of the matrix to react in a gastric environment wherein water is a fundamental component. As such, the requirement that the hydrophobic compounds of the waxy matrix not capable of reacting with water consequently raises doubts as to possession of the claimed invention at the time of filing.
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 1, 6 and all dependent claims thereof 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.
Claim 1 recites the limitation "wherein the lipid particles" in line 22 of claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “wherein the lipid particles being suitable for protecting and stabilizing said at least one active principle in a gastric medium and being dispersible in an intestinal medium.” in the last two lines of claim 1. It is unclear whether or not it is the particles or it is the at least one active principle that is dispersible (see Spec., pg. 6, lines 16-18).
Lines 8-9 and line 12 of claim 1 recite, “at least one active principle which is uniformly distributed an embedded into the waxy matrix in a mass proportion of between 0.2% and 85%.” The "active principle" examples in dependent claim 6 include components that are hydrophilic, hydroscopic, water soluble and/or in liquid form. Adjusting ingredients, i.e., active principle, to be within the claimed range further requires a balancing of the formulation by adjusting amounts of the other compounds, i.e., hydrophobic compounds, in order to achieve and maintain the final formulation’s desirable characteristics, e.g., hydrophobic and non-hydroscopic waxy matrix. If the solid particles of the formulation could have a very small amount of active principle embedded in a very large amount of hydrophobic waxy matrix, the particle would be considered hydrophobic. On the other hand, presents a situation where the if the particle is primarily active principle (i.e., at the upper end of the claimed range between 0.2% and 85%), it would be very difficult to envision a situation where the particle would be considered hydrophobic with so little hydrophobic component.
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 6 recites the active principle may be “pharmaceutically active compounds” and also recites it can be for example “anticancer compounds”. Anticancer compounds seem to be encompassed in the broader limitation of pharmaceutically active compounds which is 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. MPEP 2173.05(c)(I) states that a narrower range or preferred embodiment may also be set forth in another independent claim or in a dependent claim. If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made.
The dependent claims must also be rejected as being indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cuca et al. (US 5,494,681, pub. 02/27/1996, cited on IDS) herein referenced Cuca.
Cuca discloses a substantially tasteless pharmaceutical delivery system, which comprises a) an active material; and b) a spatially oriented matrix comprising (i) a wax core material having a melting point within the range of about 50°C and about 200°C; and (ii) a regional hydrophobic polymer material and method for making the same (abstract, col. 2, line 36-53; claim 1) to meet the melting point limitation in line 4 of instant claim 1. Cuca teaches that the hydrophobic materials are those materials that are typically antagonistic to water, i.e., incapable of dissolving in water even though they may have regional areas in the molecule that have some hydrophilic properties (col. 4, lines 67-col. 5, line 2). Cuca teaches a hydrophobic polymer material (col. 4, lines 28 and 65; col. 6, line 7; claim 1). The delivery systems are generally solid or semi-solid (col. 7, lines 37-38).
Cuca teaches that the pharmaceutical delivery system comprises particles obtained are usually between about 10 µm to about 400 µm in size (col. 6, lines 42-45) to meet the particle size limitation in line 3 of instant claim 1.
Regarding lines 8-9 of instant claim 1 and the 0.2% and 85% active principle limitation, Cuca teaches that the active material is uniformly dispersed within the matrix to obtain a smooth suspension and that particles are formed by solidifying the mass (col. 2, lines 56-57). Cuca teaches the use of a therapeutically effective amount of drugs and recognizes that this amount depends on the drug itself being used (col. 4, lines 9-11). Cuca teaches that excipients are present in a way that contributes to the integrity of the matrix (col. 4, line 21). Cuca teaches that amounts of drug from about 5% to about 65% have been easily incorporated into the present matrix and that an amount outside the range limits can lessen bitter masking abilities (col. 4, lines 11-14).
Regarding the exclusionary limitation, the claim language reads as follows: “waxy matrix does not include water, surfactants, emulsifiers, solvents, and/ or (Examiner’s emphasis) any polymeric compounds.” The “or” in the claim means so long as the particle excludes one of water, surfactants, emulsifiers, solvents, or polymeric compounds, it may include the others. That is the broadest reasonable interpretation of the claims. Cuca’s teaching to exclude water, emulsifiers, and solvents; surfactants as optional (see claim 13). Looking to the instant specification, Applicants describe polymeric compounds as aqueous polymeric compound and is a dry formulation (see Spec., pg. 6, line 8). Even though Cuca teaches a polymer compound is not excluded by teaching that the composition may contain a minor amount of hydrophobic polymer material (col. 3, lines 5-6; col. 4, line 52), the prior art of Cuca meets the limitation of the claims.
Regarding the recitation of cannot dissolve into water, cannot form emulsions, and cannot react with water, and considering the 112 issue(s) discussed above, Cuca mentions emulsions once, only to provide background information on the prior art (col. 1, line 20).
Regarding the active principles for pharmaceutical use limitation, Cuca discloses a pharmaceutical delivery system, which comprises an active material (claim 1).
Regarding the last two lines of instant claim 1 (i.e., gastric, intestinal medium), Cuca provides examples of actives for the gastrointestinal medium are provided (col. 3, line 45).
Regarding claim 2, Cuca teaches that portions of the matrix may contain common triglyceride fats and or waxes (col. 5, lines 17-20; col. 8, line 10, see Example 2). Regarding claim 3 (i.e., between 0.5% and 85%), Cuca teaches that long chain fatty hydrocarbons, esters, acids and alcohols are preferred wax materials (col. 4, lines 39-42; claim 4). Cuca teaches that wax material is present in the matrix in amounts of about 10% to about 95% and preferably about 15% to about 85% by weight of the matrix (col. 4, lines 30-32).
Regarding claim 3 (i.e., 0.5% and 85%), as mentioned above, Cuca teaches that amounts of drug from about 5% to about 65% have been easily incorporated into the present matrix and that an amount outside the range limits can lessen bitter masking abilities (col. 4, lines 11-14).
Regarding claim 4 (i.e., 10 µm-2500 µm), Cuca teaches a particle size from about 10 µm to about 400 µm (col. 6, lines 42-45).
Regarding claim 5 (i.e., 25°C and 60°C), Cuca teaches a melting point within the range of about 50°C and about 200°C (col. 6, lines 5-7). MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
Regarding claim 6, Cuca teaches antibiotics as an active principle (col. 3, line 48) to read on the species recited in line 5 of instant claim 6.
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to utilize the delivery system taught by Cuca in with expected results. One would be motivated to do so with a reasonable expectation of success because Cuca provides a system that achieves a good balance between taste masking and control of bioavailability of both water-soluble and insoluble active components (col. 2, lines 28-30) to contribute to the improvement of drug delivery systems absent a clear showing of evidence to the contrary. Cuca teaches that by adjusting the temperature of the melt one skilled in the art may advantageously prevent decomposition of the active ingredient (col. 6, lines 15-16). In addition, Cuca provides a system that is stable and versatile by teaching that the drug release system can accommodate the needs depending on the intended use (col. 3, lines 7-18) and the categories of drugs may vary widely and generally represent any drug combination (col. 3, lines 19-21).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Cuca as applied to claims 1-6 above, further in view of Appel et al. (US 2009/0142401, pub. 06/04/2009), herein referenced Appel.
The teachings of Cuca above are incorporated herein.
Regarding claim 7, while Cuca teaches that modifications may be carried out such as dry powder packaging (e.g., sachet) (col. 5, line 23), a sachet is not explicitly taught.
Appel discloses multiparticulates of low-solubility drugs and carriers that result in rapid release of the drug (abstract, [0009], claim 1). Appel teaches that powders that are incorporated into a suspension are often termed a sachet or an “oral powder for constitution” (OPC) ([0080-0081]).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to use the sachet taught by Appel in the composition of Cuca with expected results. One would be motivated to do so with a reasonable expectation of success because Appel teaches that the sachet that can be formulated into a slurry that can easily be administered orally to advantageously achieve the following: (1) improved dispersal in the gastrointestinal (GI) tract, (2) more uniform GI tract transit time, and (3) reduced inter- and intra-patient variability ([0026]).
Response to Arguments
Applicant's arguments filed 07/31/2025 have been fully considered but they are not persuasive.
35 U.S.C. § 112
Applicants argue that being "embedded" does not signify that waxy matrix "comprises" active principles and point to the description “the waxy matrix melted together with active principles and then solidified into the claim solid particles. Thus, active principles are caught in the mass of the waxy matrix, that is why ‘active principles’ do not belong to the claimed ‘waxy matrix’,” (see Remarks, pg. 7, para. 3).
The Examiner respectfully asserts that the claim limitation of being hydrophobic is limited to only the matrix and the final particle; not the active principle. As mentioned in the rejection above, one can envision a situation wherein a hydrophilic active principle and a waxy matrix can still result in a hydrophobic particle. Further, In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., matrix melted together with active principles) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
35 U.S.C. § 103
Applicants argue that polymers are excluded from the subject matter of claim 1 and Cuca teaches that polymer compounds are essential in the wax core (Remarks, pg. 9, para. 4).
The claim language reads as follows: “said waxy matrix does not include water, surfactants, emulsifiers, solvents, and/ or any polymeric compounds.” The broadest reasonable interpretation here is that the “or” in the claim means that as long as the particle excludes one of water, surfactants, emulsifiers, solvents, or polymeric compounds, it may include the others. Cuca’s teaching to exclude water, emulsifiers, and solvents; surfactants as optional (see claim 13) meets this requirement. While Cuca teaches that the formulation may have a minor amount of hydrophobic polymer material (col. 3, lines 5-6), this is optional. So, given that the prior art teaches a polymer compound is not excluded since the prior art excludes water, surfactants, emulsifiers, and solvents. Cuca does not teach surfactants as being required (claim 13) to read on the formulation free of surfactants.
Regarding Applicants’ argument that “Cuca does not look for protecting active principle against gastric tract,” (Remarks, pg. , para. ), this argument relies on language recited in preamble recitations (e.g., gastro-protected). The recitation of gastro-protected is not limiting because the body of the claim describes a complete invention. The preamble does not provide any distinct definition of any of the claimed invention’s limitations. The preamble of the claim(s) is not considered a limitation and is of no significance to claim construction.
In response to applicant's argument that Cuca has purposes that are different from the instant disclosure (see Remarks, pg. 8, para. 2), a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The prior art may have a different goal or advantage than what Applicant discloses. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. While Applicants may assert that there is a reason to make the claimed invention, for the prior art reference is not required to share the same solution. See MPEP 2154(II).
Applicants state that instant claim 1 do not relate to lipid particles embedded into excipients. Applicants argue that Sivert does not provide motivation to make a hydrophobic waxy matrix for protecting the active principle against gastric environments and releasing it into the intestine (see Remarks, pg. 10, last para.).
Sivert is no longer used.
For these reasons, Applicants’ arguments are found unpersuasive.
Conclusion
Claims 1-7 are rejected; no claims are currently allowable.
The Examiner asks Applicant to provide support for the amendments in the application disclosure by referencing page numbers, paragraphs, figures, etc. for the sake of compact prosecution.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614