DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-23 are pending.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statements filed 9/28/2023 and 3/18/2024 are acknowledged.
Claim Rejections- 35 USC § 112
3. 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 8 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 8 recites “triazolium-based ionic liquid” and the term based renders the metes and bounds of the claim unclear because it is not clear what needs to be included such that it is based on triazolium. It is suggested to remove tazed.
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 9 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 9 does not further limit the structure of claim 1 and therefore is not considered further limiting. 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.
Claim Rejections- 35 USC § 102
4. 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.
Claims 1-3, 9 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rogers et al. (US 20070093462).
Rogers et al. (US 20070093462) (hereinafter Rogers et al.) disclose a composition comprising a cation and anion and is an ionic liquid where both actives are pharmaceutical agents where the pharmaceutical includes ibuprofen (claims 31 and 62). The compositions comprise water (para 0093).
Claim Rejections- 35 USC § 103
5. 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.
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 and 4-8, 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (20070093462).
Rogers et al. has been discussed supra in the 102 rejection. Rogers et al. disclose that examples of pharmaceutical actives that are ionic or can be made ionic and combined with other ions to form the ionic liquid compositions include those such as acetaminophen (para 0157 and 0205). With regards to claim 7, the balance can be zero if 100 % can be the ionic salt. The ionic liquids have a cationic to anionic ratio 1:1 or 2:1 (para 0366). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Rogers et al. disclose that some other specific examples of the disclosed ionic liquids include, but are not limited to, ionic liquids where any of the cations in the ionic liquid are aliphatic benzylalkyl ammonium cations (e.g., benzalkonium), dialiphatic dialkyl ammonium cations (e.g., didecyldimethylammonium), and aliphatic heteroaryl cations (e.g., hexadecylpyridinium) are combined with any of the anions of sulfacetamide,ibuprofen, and saccharinate (para 0370-0373). Rogers et al. disclose water is present in an amount from less than about 10 % (para 0093). Rogers et al. disclose that the formulations may contain polyethylene glycol (PEG) (para 0423). The compositions can be administered orally (para 0422).
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have selected various combinations of the various disclosed active pharmaceutical agents such as ibuprofen and acetaminophen of Rogers to arrive at compositions yielding no more than one would expect from such an arrangement.
6. Claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (20070093462) as applied to claims 1 and 4-8, 18 and 21 above, and further in view of Mitragotri et al. (WO 2021102084) and Caparica et al. “Choline-Amino Acid Ionic Liquids as Green Functional Excipients to Enhance Drug Solubility”.
Rogers et al. has been discussed supra and does not disclose the ionic liquid is choline. Mitragotri et al. (WO 2021102084) (hereinafter Mitragotri et al.) disclose choline and derivatives have been shown to be well suited as IL cations for the types of anions (para 0081). Caparica et al. “Choline-Amino Acid Ionic Liquids as Green Functional Excipients to Enhance Drug Solubility” disclose that choline based ionic liquids are known solubility enhancers for drug delivery systems (abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include choline in the ionic liquids of Rogers et al. One would have been motivate to do so to enhance the solubility of the drug delivery systems.
7. Claims 1 and 10-17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (20070093462) as applied to claims 1 and 4-8, 18 and 21 above, and further in view of Chantereau et al. “Design of Nonsteroidal Anti-Inflammatory Drug-Based ionic Liquids with Improved Water Solubility and Drug Delivery”.
Rogers et al. has been discussed supra and does not disclose the ionic salt is choliate salts of drugs such as ibuprofen and naproxen.
Chantereau et al. “Design of Nonsteroidal Anti-Inflammatory Drug-Based ionic Liquids with Improved Water Solubility and Drug Delivery” (hereinafter Chantereau et al.) disclose NSAID-based ionic liquids such as cholinium ibuprofenate and cholinium naproxenate aim to improve water solubility of these drugs (Last paragraph of introduction).
Cholinium bicarbonate, 80 % in water, racemic ibuprofen are disclosed (Experimental section-materials). 12.93/10 g gives a ratio where slightly more NSAID. Ibuprofen and naproxen are disclosed. The reference teaches that the conversion of NSAID into cholinium-based ILs allows for an increase in their solubility in PBS aqueous solutions by 2 orders of magnitude which is beneficial onto improve bioavailability. One of ordinary skill in the art would adjust the ratio to arrive at the desired solubility of the drug. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to adjust he amount of naproxen present in the composition as a cholinate salt because it increases the bioavailability of the drug.
8. Claims 1, 19 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (20070093462) as applied to claims 1 and 4-8, 18 and 21 above, and further in view of Guo et al. (US 20180263916) and Gullapalli et al. “Soft gelatin capsules (softgels)”,
Rogers et al. has been discussed supra and does not disclose softgel capsule or PEG 200-1500 however, Guo et al. (US 20180263916) disclose soft gelatin capsules containing excipient PEG where molecular weight can be from 200-800 (para 0039-40). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the PEG of molecular weight of Guo as this is a known suitable solvent system. Gullapalli et al. “Soft gelatin capsules (softgels)” discloses that softgel dosage form offers several advantages over other dosage forms, such delivering a liquid matrix designed to solubilize and improve the oral bioavailability of a poorly soluble compound as a unit dose solid dosage form, delivering low and ultra-low doses of a compound, delivering a low melting compound, and minimizing potential generation of dust during manufacturing and thereby improving the safety of production personnel. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the dosage form in Rogers et al. be a softgel. One would have been motivated to do so because it improves the oral bioavailability of poorly soluble compounds.
DOUBLE PATENING
9. 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.
Claim 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18552975. Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to liquid formulations the differences being the instant claims recite ionic liquid however, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to include the same drugs in ionic liquid formulations. One would have been motivated to do so because incorporation into ionic liquid formulations helps enhance drug solubility as discussed supra.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
CORRESPONDENCE
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/Primary Examiner, Art Unit 1615