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 the Claims
Claims 5, 7, 10, 15, 17, and 21-24 are cancelled. Claim 26 is new. Claims 1-4, 6, 8-9, 11-14, 16, 18-20, and 25-26 are pending. Claims 9, 11-14, 16, 18-20 and 25 are withdrawn. Claims 1-4, 6, 8 and 26 are under examination.
Priority
This application is a national stage entry of PCT/HU2022/050003 filed on 1/24/2022, which claims priority from HUP2100021 filed on 1/22/2021 and HUP2100019 filed on 1/22/2021.
Information Disclosure Statement
The information disclosure statement filed on 07/21/2023 has been considered by the examiner.
Election/Restriction
Applicant's election with traverse of Group I (claims 1-4, 6, 8 and new claim 26) in the reply filed on 2/4/2026 is acknowledged. The traversal is on the ground(s) that the methods cannot be practiced with a materially different product. This is not found persuasive because the prior art of Ibrahim provides for a composition that has pregabalin in a formulation combined with lecithin/phospholipid. Applicant argues that Ibrahim does not provide for dispersed form of phospholipid, however, the nature of the water-in-oil-in-water microemulsion composition being include with hydrophilic substances including water and propylene glycol will provide for lecithin (hydrophobic) being dispersed through these hydrophilic components. Applicant has not shown that Ibrahim’s formulation could not have this micelle contribution scaling factor.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9, 11-14, 16, 18-20 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/4/2026.
Claim Objections
Claim 6 is objected to for missing a comma “,” between recitations of “iso-butanol” and “alcohols having more than one hydroxyl group”.
Claim 6 is objected to for missing a comma “,” between recitations of “vitamin” and “C2-C4 alcohols” in the claim.
Claim 6 is objected to for missing a comma “,” between recitations of “fatty acid ester” and “cetyl palmitate” in the claim.
Claim 6 is objected to for missing commas in the recitation of “chlorhexidine benzyl alcohol benzalkonium chloride,” which should be recited “chlorhexidine, benzyl alcohol, benzalkonium chloride,”
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.
Claim 6 is 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 6 provides for the recitations of “EDTA derivatives” and “mineral oil derivatives” with the specification not describing sufficiently what derivatives of EDTA or mineral oil will encompass. The specification does not define EDTA or mineral oil derivatives in a particular way or provide a sufficient number of species that might encompass all possible derivatives of EDTA or mineral oil with various groups or isomerism that they could have. For the purpose of compact prosecution if the prior art teaches EDTA, mineral oil, or a compound with similar structure to EDTA or oil that is similar to structure or function of mineral oil, it will read on the limitation.
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.
Claim 6 is 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 6 is indefinite for the recitations of “EDTA derivatives” and “mineral oil derivatives” as it is unclear from the specification what derivatives of EDTA or mineral oil will encompass. The specification does not define EDTA or mineral oil derivatives in a particular way or provide a sufficient number of species that might encompass all possible derivatives of EDTA or mineral oil with various groups or isomerism that they could have. For the purpose of compact prosecution if the prior art teaches EDTA, mineral oil, or a compound with similar structures to EDTA or oil that is similar to mineral oil, it will read on the limitation.
Claim 6 is indefinite for the recitation of “base type pH modifier” as it is unclear bye use of “type” if base type means that the pH modifier is a base or if base type relates to some other form/type of a pH modifier related in some structural way to a base. Applicant may amend this limitation to say “basic pH modifier”.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 4, 6, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jablonski WO2019126172A1.
Claim 1 provides for “composition comprising pregabalin, and a phospholipid in dispersed form”, which means the composition has pregabalin and separately a phospholipid that is present in a dispersed form. If applicant means for pregabalin to be present in the composition dispersed in a ground particle or micronized particle form, then applicant should recite this as a limitation in the claim.
Applicant’s recitation of “topical pharmaceutical composition” in the preamble of the claim will be met if the form of the composition would be suitable for a topical use on a subject. Topical does not only apply to skin topicals, but also ophthalmic formulations like eye drops or oral topicals such as mouthwashes or formulations to be applied to the gums.
Jablonski teaches a pregabalin loaded microemulsion composition with 0.6 wt% pregabalin, 6.5 wt% lecithin, 22.2 wt% propylene glycol, and either 1.1 wt% chitosan, 0.4 wt% sodium alginate or 0.15 wt% Carbopol 981 (table 2). Table 2 also has Labrafac, Capryol 90, labrasol, Cremophor EL and water to balance to 100 wt%. Jablonski teaches hydrogel (a gel) (figure 15 and figure 15 description). Jablonski teaches particle size of less than 20 nm in the formulation (table 3). Figure 15 shows the lecithin as dispersed particles in the inner phase found within the external emulsifier where the pregabalin is found within the lecithin vesicles. These images picture micelles (spherical structures formed by amphiphilic molecules). In regards to the micelle contribution scaling factor as in applicant’s claim, Jablonski provides for a formulation with lecithin phospholipid and pregabalin. Thus, it is expected these formulations with have micelle contribution scaling factors as in applicant’s claims (see MPEP 2112 = A composition and its properties are inseparable).
Although applicant appears to indicate the micelle contribution scaling factor range in the claims is representative of reduced micellar formation, there is no evidence on the record with a comparative formulation of Jablonski that Jablonski cannot have such values even though it may contain micelles. Reduced micelles still allows for some amount thereof.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Jablonski WO2019126172A1.
Jablonski teaches the claims as discussed above.
Jablonski does not teach an embodiment with concentrations of pregabalin and lecithin as in applicant’s claims 2-3.
Jablonski does teach lecithin at concentrations of about 1% to about 13 % in a non-limiting example (see claim 37 of Jablonski). Jablonski teaches soybean lecithin in figures 12-14. Jablonski teaches at least 1.2 w/w% of a water-soluble drug of which pregabalin is one (see claims 46-49 of Jablonski and page 15). Jablonski also teaches that pregabalin is used for its intraocular pressure lowering effect (formulation efficacy section and figure 22).
One of ordinary skill in the art before the time of filing would have used amounts of pregabalin above 1.2 wt% (at least 1.2% w/w extends above 1.2 w/w%) as desired for the lowering effect on intraocular pressure in a patient and also used amounts of lecithin within the range taught by Jablonski to provide new formulations for topical treatment of the eye (see MPEP 2144.05 regarding obviousness of overlapping ranges). There would be a reasonable expectation of success in raising amounts of pregabalin for more effectiveness with teachings of Jablonski and adjusting lecithin amounts within the range taught in Jablonski and producing new formulations with concentrations found in applicant’s claims.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jablonski WO2019126172A1 and Schulze-Nahrup US 20100151012.
Jablonski teaches the claims as discussed above. Jablonski does provide for particles sizes less than 20 nm for its formulations.
Jablonski does not teach the particle size of pregabalin as in claim 8.
Schulze teaches pharmaceutical compositions with pregabalin as the active principle (abstract and paragraph 66). Schulze teaches “the composition according to the invention comprises pregabaline with a mean particle size of 0.01 to 50 μm” (10 nm to 50 micron) and refers to it as micronized pregabaline (paragraph 46). Schulze teaches mean particle size of less than 250 microns (paragraph 45). Schulze teaches another embodiment with 50 to 250 micron particles of pregabalin (paragraph 48). Schulze teaches “invention comprises also all combinations of preferred embodiments described, e.g. the combination of the preferred pharmaceutical auxiliary substances with the preferred pregabaline particle size and the preferred form of presentation” (paragraph 88). Examples 13, 13a, and 13b teach a composition for reconstitution with pregabalin and Carbopol. Schulze provides its pregabalin provides stabilization (paragraphs 34 and 39).
One of ordinary skill in the art before the time of filing would have included pregabalin particles with Carbopol of Shulze into formulations of Jablonski also providing for pregabalin with a carbopol/carbomer as these are seen as effective forms of the drug for stabilized compositions. Therefore, there was a reasonable expectation of success in combining the teachings of Jablonski and Schulze and obtaining more stable pharmaceutical formulations of pregabalin for pharmaceutical treatments.
Claims 1-4, 6, 8 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Jablonski WO2019126172A1 and Cetina-Cizmek US 20130065888A1.
Jablonski teaches the claims as discussed above.
It has not been disclosed on the record what micelle contribution scaling factor that Jablonski’s formulation would have to show that it is different than applicant’s formulations, but if applicant provides such evidence, then this rejection is provided to address the use of high pressure homogenization as applicant has used in order to obtain such results.
Cetina teaches an aqueous suspension of an ophthalmic drug (paragraph 15) (an ophthalmic formulation). Cetina teaches “The high pressure homogenization step enables the production of a stable suspension of the drug in the aqueous environment. Further, the high pressure homogenization step enables the drug particles in the suspension to have a more uniform particle size distribution compared to other methods such as ball milling and other high shear methods.” (paragraph 18). Cetina teaches the formulation being free of drug particles having particle size of over 10 microns (claims 34-35 of Cetina and paragraphs 23-24). Cetina teaches drug/active particle sizes of 0.9 to 8 microns (paragraph 85). Cetina also teaches “A further advantage of using high pressure homogenization is that the extent of foaming of the suspension is lower particularly when compared to high shear homogenization.” (paragraphs 20-21).
One of ordinary skill in the prior art before the time of filing would have utilized high pressure homogenization to reduce the drug particle sizes in its formulations. This would lead to reduced size of the drug and provide for a stable suspension of the drug. Thus, there was a reasonable expectation of success in subjecting ophthalmic drug formulations of the prior art such as in Jablonski to high pressure homogenization as taught in Cetina for ophthalmic formulations and obtaining more stable formulations, reduced foaming forms of ophthalmic drugs for administration. As applicant uses high pressure homogenization to provide its formulations with pregabalin and dispersed lecithin, subjecting formulations of Jablonski to this known technique will have a reasonable expectation of success in producing formulations with optimal properties and use of the prior art technique with a formulation having similar ingredients would allow for similar compositional structure.
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 1-4, 6, 8 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 11-19 of U.S. Patent No. 12551458. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for similar amounts of dispersed phospholipid with similar amounts of pregabalin with particle sizes and composition forms of applicant’s claims. Even though ‘458 has process claims, the claims disclose the claimed formulations rendering them anticipated.
Claims 1-4, 6, 8 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-11 of U.S. Patent No.12161613. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for similar amounts of dispersed phospholipid with similar amounts of pregabalin with particle sizes and composition forms of applicant’s claims.
Claim 1-4, 6, 8 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 11-12, 18, 21-22, and 24 of copending Application No. 18/273700 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for similar amounts of dispersed phospholipid with similar amounts of pregabalin with particle sizes and composition forms of applicant’s claims. Although ‘700 does not provide the micelle contribution scaling factor in its claims, but it teaches a composition with similar ingredients made by the same process of high pressure homogenization, and thus, will have such a property/characteristic.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-4, 6, 8 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 10, 11, 16, 18, 19, 21, 24-26 of copending Application No. 18/273575 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each claim set provides for similar amounts of dispersed phospholipid with similar amounts of pregabalin with particle sizes and composition forms of applicant’s claims. Although ‘575 does not provide the micelle contribution scaling factor in its claims, but it teaches a composition with similar ingredients made by the same process of high pressure homogenization, and thus, will have such a property/characteristic.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusions
No claim is 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 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 at (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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK V STEVENS/Primary Examiner, Art Unit 1613
Prosecution Insights