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
Formal Matters
Claims 1-20 are new. Claims 21-40 are new, pending and under examination.
Priority
The instant application is a continuation of 17/841,924 filed on 6/16/2022, which is a continuation of 17/702,608 filed on 3/23/2022, which is a continuation of PCT/CA20/51275 filed on 9/23/2020, which claims priority from US provisional applications 62/904,584 filed on 9/23/2019 and 62/904,606 filed on 9/23/2019.
Information Disclosure Statement
The information disclosure statements filed on 6/5/2024, 11/26/2024 and 9/29/2025 have been considered by the examiner.
Drawing Objection
The drawings are objected to because Figures 1B and 2 are difficult to discern effects as they appear to be mainly dark boxes. Applicant needs to provide a clearer image of these figures. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 26, 27, 28, is objected to for the double use of “and” for the group and for this structure “selected from…. or combinations thereof” is more appropriate since applicant is not using “selected from the group consisting of ….and….” Markush structure.
Claim 29 is objected to for “theobromine theophylline” that is missing a comma, which should be “theobromine, theophylline”.
Claim 32 is objected to for “one or more surfactants or more surfactants” which is more appropriately “one or more surfactants” after deletion of “or more surfactants” that appears after the first “surfactants” in this recitation.
Claim 36 is objected to for being a redundant claim as it provides for the same limitation as claim 35 reworded in a different manner. Claim 36 allows for all the same options of entrapped one or more compounds as claim 35 does. Applicant should delete claim 36 or amend it to provide for a different limitation.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) – Written Description
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.
Claims 26, 27, 29, 30 and 31 are 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 26 provides for “salicylate derivatives” without providing a definition of what derivatives is or without a significant number of species that would provide for all the items that salicylate derivatives would encompass. As derivatives would not only cover salts and isomers, but also compounds with various added or deleted groups, this provides for potentially many compounds with diverse structures and functions. Paragraph 87 of the specification provides that “one or more salicylate derivatives is selected from ethyl salicylate, salicylic acid, acetylsalicylic acid and trolamine salicylate. In an embodiment, the salicylate derivative is methyl salicylate.” This provides for only 5 species of compounds. Thus, applicant has written description for these species that are listed as in paragraph 87 (or claim 28), but does not have adequate written description for all the compounds that salicylate derivatives could encompass either through a particular definition of the important structural features for “derivatives” or an adequate number of representative species that would allow full ownership of the large group of “salicylate derivatives”.
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 26-27, 29-32, 34 and 38 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 26 is vague and indefinite for the recitation of “salicylate derivatives”. The metes and bounds of what salicylate derivatives is not provided by a definition in the applicant’s specification or a representative number of species that might . There is no guidance to indicate what would or would not be considered a salicylate derivative. If the prior art provides for a compound that can be reasonably interpreted as a salicylate derivative, it will read on the claim.
Claims 27, 29, 30 and 31 are rejected as being dependent on an indefinite claim without repairing the issue.
Claims 30 and 31 recite the limitation "the polycationic surfactants" in dependence to claim 26 where the recitation is “one or more terpenes, alkaloids, polycationic surfactants, or any combination thereof” which describes each listed item with “one or more”. Without “one or more’ in front of polycationic surfactants, it is unclear which of “the polycationic surfactants” are being referred to by the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 is indefinite for “stabilized by one or more surfactants” since it is unclear if this is referring to “stabilized by a surfactant” in claim 21, on which claim 32 depends, or if the “one or more surfactants” represents additional new surfactant(s) in addition to “a surfactant” as provided in claim 21. Applicant may amend claim 32 to say “stabilized by the surfactant”.
Claim 34 is indefinite for the use of “comprises” in trying to limit the group of items preceding “comprises” as “comprises” opens the group to other elements and it would be unclear if additional items would have to fall into group of items preceding “comprises”. Applicant may amend the claim to use “selected from the group consisting of…and…” or “is….or…” Markush language rather than “comprises”.
Claim 38 is indefinite for “short peptides” as “short” is a relative term. There is no indication what length short would refer to. For the purpose of compact prosecution, if the prior art provided peptides, it would meet the limitation.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 23 is not further limiting because it provides for “entrapped in the lipid bilayer and the oil-in-water emulsion” while claim 21, on which it depends, indicates “entrapped in the lipid bilayer or the oil-in-water emulsion” which presents and either/or situation. There is no option in claim 21 for “entrapped in both of lipid bilayer and oil-in-water emulsion”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-25, 33, 35, 36, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 24, 34-36 and 40 of copending Application No.18/431490 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each is a biphasic lipid vesicle composition with oil-in-water emulsion stabilized by surfactants. ‘490 provides for diethylene glycol monooleyl ether, sorbitan monopalmitate, or polyoxyethylene (4) dilaurate as penetration enhancing agents, penetration enhancing agents and vesicle forming lipids. ‘490 provides for small molecule, peptide, carbohydrate and nucleic acids.
Claims 26, 28, 31, 34 and 38 in addition to Claims 21-25, 33, 35, 36, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 24, 34-36 and 40 of copending Application No.18/431490 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each is to a biphasic lipid vesicle composition with oil-in-water emulsion stabilized by surfactants.
‘490 does not teach the limitations of claims 26, 28, 31, 34 and 38.
Foldvari teaches a suspension of biphasic lipid vesicles obtainable by (i) preparing an oil-in-water emulsion, said oil-in-water emulsion stabilized by a surfactant and (ii) mixing said oil-in-water emulsion with vesicle-forming lipids, said lipid vesicles composed of a lipid-bilayer membrane enclosing a central core compartment containing the surfactant-stabilized oil-in-water emulsion, and entrapped in the biphasic lipid vesicles (claim 1 of Foldvari and figure 1, also other claims of Foldvari). This biphasic vesicle has a plurality of lipid bilayers (see section II. A. Biphasic lipid, series of lipid bilayers). Foldvari teaches the penetration enhancer can be included in the oil-in-water emulsion or in the lipid bilayer (column 8, lines 33-38). Foldvari teaches surfactants to form the oil-in-water emulsions and provides for nonionic surfactants including polyethylene glycol-60 almond glycerides, avocado oil diethanolamine, ethoxylated jojoba oil (polyethylene glycol - 40 jojoba acid and polyethyleneglycol-40 jojoba alcohol); polyoxyethylene derivatives, Such as polyoxyethylene-20 Sorbitan monooleate and polyoxythethylene-20 Sorbitan monoStear ate; lanolin derivatives, such as polychol 20 (LANETH 20) and polychol 40 (LANETH 40); and neutral phosphate esters, Such as polypropyleneglycol-cetyl ether phosphate and diethanolamine oleth-3 phosphate. (column 6 and column 7). Example 1 provides for glyceryl monostearate (a nonionic surfactant) when making the oil-in-water emulsion component (column 14). The HLB of glyceryl monostearate is 4.2. Foldvari teaches monolauroyllysine (HLB 8-10) (has two amine groups that can become cationic, thus, polycationic), dipalmitoyllysine (has two amine groups that can become cationic), methyl salicylate among the penetration enhancers that can be included in the vesicles (column 8, lines 25-30). These compounds have lysine that is an amino acid. Methyl salicylate is salicylic acid with a methyl group and is related to ethyl salicylate Foldvari provides for immunogen being a protein, peptide, nucleic acid or plant fraction. Foldvari teaches phospholipids for making biphasic lipid bilayers (section III). Ceramides glycolipids and others are taught in section III. Foldvari provides for a primary lipid component of hydrogenated phosphatidyl choline and cholesterol in example 1 and table 1. Foldvari teaches “There are a variety of synthetic vesicle-forming lipids and naturally-occurring vesicle-forming lipids suitable for use, such as phospholipids, which include phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol, phosphatidic acid, and sphingomyelin”. Foldvari provides for antimicrobial agents in the oil-in-water emulsion.
One of ordinary skill in the art would have provided components including salicylate derivatives or polycationic surfactants, antimicrobial agents and vesicle forming lipids such as phosphatydiylserine, sphingomyelin and phosphatidylethanolamine into biophasic lipid vesicle as these agents were known for making functional biphasic lipid vesicles. There was a reasonable expectation of success that these items would be included to make biphasic lipid vesicles that would allow for delivery of agents/compounds.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, and 5-16 of US Patent 11,801,221. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for biphasic lipid vesicles with oil-and-water emulsion with penetration enhancers that comprise non-ionic surfactants with HLB of about 10 or less. Claim 1 of ‘221 provides for one or more nonionic surfactants with an HLB of about 10 or less and a one or more second surfactants comprising polyoxyethylene (10) cetyl ether and polysorbate 80. ‘221 claim 1 provides for the first surfactants of applicant’s claims.
Claims 21-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 81-83, 85-86, 88, 90-95, 97, 99, 101 and 102 of copending Application No.17/702,608 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each is a lipid vesicle composition with oil-in-water emulsion stabilized by surfactants. ‘608 also provides for nonionic surfactant penetration enhancers with specifying HLB less than 10 and species as in applicant’s claims. Claims of ‘608 provide for polyoxyetheylene (10) cetyl ether and polysorbate 80. Thus, three or more surfactants is provided by claims of ‘608.
Advisory Notice and Closest Prior Art
The closest prior art is Foldvari US 5993852 or US 20100196453 which disclose a suspension of biphasic lipid vesicles obtainable by (i) preparing an oil-in-water emulsion, said oil-in-water emulsion stabilized by a surfactant and (ii) mixing said oil-in-water emulsion with vesicle-forming lipids, said lipid vesicles composed of a lipid-bilayer membrane enclosing a central core compartment containing the surfactant-stabilized oil-in-water emulsion, and entrapped in the biphasic lipid vesicles (claim 1 of Foldvari and figure 1, also other claims of Foldvari). However, Foldvari or ‘453 does not provide for use of the 3 listed surfactants (diethylene glycol monooleyl ether, sorbitan monopalmitate or polyoxyethylene(4) dilaurate (PEG(4)dilaurate) as penetration enhancers for the biphasic lipid vesicles. These surfactants were found to enhance delivery of compounds from such biphasic lipid vesicles into the viable epidermis better than other surfactants (see examples and tables of applicant’s specification, paragraph 305 particularly).
If applicant addresses the objections and 112 issues while filing the appropriate terminal disclaimers, applicant may have allowable claims barring any issues added due to claim amendments/corrections.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached on (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK V STEVENS/Primary Examiner, Art Unit 1613