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 .
Priority
The present application is a National Stage entry of International application PCT/US2023/011978 filed 01/31/2023, which claims the benefit of Provisional US application 63305922 filed 02/02/2022.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 07/29/2024, in the matter of Application N° 18/834,006. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1-15 and 17-24 are pending.
Claims 1-15 and 17-24 are presented for examination and rejected as set forth below.
Drawings
The drawings are objected to because instant Figures 5a-6b are low resolution and/or have small text size (i.e., as compared to instant Figures 3-4). 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 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 1-15 and 17-24 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, 18-20 and 24 recites a “Boswellia derived compound”, whereby the claims and the Specification (see whole document, particularly [0005-0006]) do not describe what constitutes a “Boswellia derived compound” but only that “Boswellia extract or Boswellia compound” are non-limiting examples of this category. The term “Boswellia derived compound” is therefore indefinite because it is unclear how far one can deviate from the listed parent compounds (i.e., the term “derivative” itself does not provide structure, and a PHOSITA could understand this term to mean chemical derivatization) and yet still remain within the metes and bounds of the invention claimed. “A Boswellic acid compound” of claim 2 appears to represent a finite grouping of boswellic acids in the literature, and is therefore not considered problematic.
Because claim 1 is rejection, all claims that depend from claim 1 are additionally rejected.
Claims 4, 6, 8, 15, and 18-19 recite the term “about” to describe numerical values, whereby “about” is not defined in an indefinite way by Applicant’s Specification [0024]. Thus, Applicant defines “the terms "about," "approximately," or "generally," can simultaneously represent, for example, “the value can be raised or lowered by 10%, such as, such as 7.5%, 5%, such as 4%, such as 3%, such as 2%, such as 1%”, which is indefinite, and additionally, represents broad and narrow ranges (See MPEP § 2173.05(c)). The examiner will interpret the numerical limits of the claims without the term “about” and suggests removal of the term “about” throughout the claim set.
Claim Rejections - 35 USC § 103
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.
Claims 1-4, 6-8, 10, 17-21, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Hingorani (US20170333362A1).
Applicant’s claims are directed to “an extended release composition comprising: lipid multiparticulate particles, and an active agent, the lipid multiparticulate particles comprising a lipid matrix, and wherein the active agent is dispersed within the lipid matrix, the active agent comprising a Boswellia derived compound, wherein the active agent is released from the lipid multiparticulate particles over a period of time.”
Note, the Examiner considers the BRI of “lipid matrix” to be a matrix of components that comprises lipid materials (e.g., non-limiting materials are described by Applicant’s Specification at [0054]). Furthermore, when Applicant claims “over a period of time” (instant claim 1) and/or claims 0.5-24 h is a sufficient time period for an “extended release” composition (instant claim 19), then a teaching of any of these time periods is sufficient to teach the limitation of “extended release.” For “nutraceutical,” as found in claim 21, Applicant defines “nutraceutical” as any compound added to a dietary source (e.g., a food, beverage, or a dietary supplement) that provides health or medical benefits in addition to its basic nutritional value (see Specification at [0028]).
Hingorani teaches an active agent delivery system (abstract), that demonstrates variable release profiles (see Figures 8-9). Hingorani’s formulations benefit from improved stability, solubility, and permeability of biological active compounds in the gut after oral consumption (abstract).
Regarding claims 1-4, 18-20 and 23-24: Hingorani teaches an active agent delivery system, comprising a carrier granule, wherein the carrier granule comprises an agglomeration of solid lipid particles for oral dosing (Hingorani – claim 1). The solid lipid particles (that are agglomerated) comprise a specific ratio of long-chain lipids [0031] (reads on “lipid multiparticulate particles comprising a lipid matrix” of instant claim 1) and a biologically active compound (i.e., different from employing nanoparticles, micelles, liposomes, which are unstable in the gut [0016], which is similar to Applicant’s particular embodiment as described by Applicant’s Specification at [0053]), whereby the solid lipid particles solves the liposome problem by stabilizing the formulation in the gut and allowing for lymphatic transport [0085-0086]. Furthermore, Hingorani teaches useful example lipids for the solid lipid particles [0035].
Hingorani teaches a method of administering acetyl-11-keto-β-boswellic acid (AKBA) (reads on the instant active agent of claims 1-3 and 18-20), as the active agent [0183], and demonstrates clinical efficacy (in contrast to failed formulations [0087-0088] in knee osteoarthritis (i.e., an inflammatory condition, and therefore reading on “a mammal in need of reduction in inflammation” of instant claim 23) (Example 5, [0182-0189]). The protocol relies on a dose of 100 mg of 40% Boswellic acids (reads on instant amount range of 1-1000 mg in claim 18). Hingorani teaches the disclosed active agent delivery system to enhance bioavailability (reads on instant claim 24) (Hingorani – claim 1).
Although Hingorani does not explicitly state extended release (or sustained/controlled release, but instead discusses drug exposure in terms of enhanced bioavailability [0032]), Hingorani demonstrates that the formulations demonstrate 480 mins (or 8 h) sustained release (i.e., reads on claim 19) in a phosphatidylcholine phospholipid example of formulation F2 [0105, 0159-0163], within an oral dosage format ([0032], Hingorani – claim 1) (reads on release time period of instant claims 4 and 19).
With regard to the active agent being “dispersed” (instant claim 1), Hingorani teaches the solid lipid microparticles containing an active ingredient “embedded” in the carrier granule [0051] and/or having a “core of an active ingredient”, as in figure 1 [0051] (reads on “dispersed” of claim 1). This is further clarified in the method of making, where the active ingredient is mixed with phosphatidylcholine and ascorbyl palmitate via homogenization to make the solid lipid particle prior to further processing to the carrier granule (Hingorani – claim 27). Furthermore, Hingorani describes the term “dispersed” merely to mean an individual molecule within a medium [0014].
Regarding claim 6: Hingorani teaches 15-40 wt% active compound within the delivery system (reads on 1-80 wt%) (Hingorani – claim 22).
Regarding claim 7: Hingorani teaches capsules, tablets, powders, etc. [0089].
Regarding claim 8: Hingorani teaches the carrier granule (i.e., as an agglomeration of solid lipid particles, this corresponds to the instant lipid multiparticulate particle) to have a particle size of 150-840 microns (reads on the instant range of 40-3000 microns of claim 8).
Regarding claim 10: Hingorani teaches stearic acid in the solid lipid particles [0035].
Regarding claim 17 and 21: Hingorani teaches ascorbyl palmitate as an antioxidant [0035], but also the composition can comprise lipophilic vitamins (i.e., vitamin E is a known antioxidant), other known antioxidants, etc. [0036-0037]. As discussed previously for the term “nutraceutical” (in terms of Applicant’s definition in the Specification [0028]), vitamins would be considered a nutraceutical ingredient because they are recognized to add health/medical benefits in addition to nutritional value, as discussed for vitamins (reads on the instant second nutraceutical ingredient of claim 21) [0037]. Furthermore, a number of other compounds optionally included compounds (e.g., omega fatty acids, etc.) would be considered nutraceutical ingredients [0035-0037].
Thus, Hingorani teaches the elements and motivations for the instant claims under this rejection as obvious.
Claims 1-15 and 17-24 are rejected under 35 U.S.C. 103 as being unpatentable over Hingorani (US20170333362A1), as applied to claims 1-4, 6-8, 10, 17-21, and 23-24 above, and in further view of Williams (US20180125863A1) and Lugo (Journal of the International Society of Sports Nutrition, 2013).
As discussed above, Hingorani teaches an AKBA delivery system, comprising carrier granules made of agglomerated solid lipid particles with embedded active. However, Hingorani does not teach “encapsulation” of the active (instant claim 5) (whereby dispersed and encapsulated are different, according to Applicant’s Specification at [0044], so the Examiner considers encapsulated to mean that the active is within a shell of different material), the concept of the lipid matrix comprising at least one low flow point excipient and on high flow point excipient in certain amounts (instant claims 9 and 15) (whereby Applicant defines “flow point” as related to viscosity of an ingredient in the Specification [0033]), the lipid matrix to comprise the specified wax, fatty alcohol, and a fatty acid (instant claim 11-12), the lipid matrix to comprise a surfactant or a cross-linked carboxymethyl cellulose salt (instant claims 13-14), and the undenatured collagen (instant claim 22).
Williams teaches a lipid multiparticulate (LMP) formulation [0002, 0011]. The multiparticulate comprises particles of active agent encapsulated in a solid solution of excipient and the dissolved active agent [0026] (reads on “encapsulated” in instant claim 5), improving bioavailability of the drug [0026, 0063-0064, 0087, 0120]. Furthermore, The LMP solid particles comprising a lipid matrix [0061-0063] that have a specific ratio of excipients such as at least one low flow point excipient comprises at least 10 wt % of the composition, the at least one high flow point excipient comprises at least 5 wt % of the composition (thus, reading on instant claims 9 and 15). With regard to the numerical range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Furthermore, the optimization of the low flow to high flow excipient amounts is to promote solidification of the lipid particles, while maintaining processability, as it’s taught that high flow point excipient is not appreciably digested in the GI tract [0036]. Also, Williams teaches the lipid multiparticulates comprise waxes (e.g., candelilla wax [0035]), fatty alcohols (e.g., stearyl alcohol [0033]), fatty acids (e.g., stearic acid [0034]), etc. [0027] (reads on instant claims 11-12), and they would improve the performance and chemical stability of the formulations [0037-0040]. Finally, Williams teaches incorporation of surfactants such as polysorbates (Williams – claim 11) (reads on instant claims 13-14) to improve performance and stability [0037, 0045].
Lugo teaches oral undenatured collagen (reads on instant claim 22) (abstract) is a useful treatment for patients experiencing osteoarthritis (pg 10, paragraph 2; abstract; pg 8, ‘discussion’).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hingorani’s AKBA delivery system, comprising carrier granules made of solid lipid particles with the encapsulated variant of the active within the lipid particle, and alternatively with the additional components for the lipid matrix (e.g., low flow point excipient, high point excipient, candelilla wax, stearyl alcohol, stearic acid, polysorbate surfactant, etc.), as taught by Williams, because Williams teaches various motivations:
Williams teaches the encapsulation of the crystalline active agent within a solid solution of excipient within a lipid multiparticulate (LMP) formulation, improves bioavailability of the drug [0026, 0063-0064, 0087, 0120].
Williams teaches the optimization of the low flow to high flow excipient amounts is to ensure softening of the formulation [0030], while also to promote solidification of the lipid particles, maintain processability, and improve formulation stability [0036].
Williams teaches candelilla wax, stearyl alcohol, stearic acid are preferred components in these types of formulations [0027, 0034-0035]; and would improve the performance and chemical stability of the formulations [0037-0040].
Williams teaches surfactants such as polysorbates (Williams – claim 11) would improve the performance and chemical stability of the formulations [0037].
With regard to the rationale and benefits of points (a-d), Hingorani is interested in solidification of lipid particles (abstract) and improving bioavailability of the active agent (Hingorani – claim 1), including AKBA for the treatment of osteoarthritis (Example 5, [0182-0189]), and Hingorani teaches a highly similar active agent delivery system, comprising a carrier granule, wherein the carrier granule comprises an agglomeration of solid lipid particles for oral dosing (Hingorani – claim 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hingorani’s AKBA delivery system, comprising carrier granules made of solid lipid particles, by adding undenatured collagen, because Lugo teaches oral undenatured collagen (abstract) is a useful oral treatment for patients experiencing osteoarthritis (pg 10, paragraph 2, abstract, pg 8, ‘discussion’), and Hingorani teaches AKBA for the treatment of osteoarthritis (Example 5, [0182-0189]). It is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose (see MPEP 2144.06(I)). The idea for combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, the combination of AKBA and undenatured collagen (i.e., defined as a nutraceutical in Applicant’s Specification at [0020]) would provide an additive improvement effect in osteoarthritic patients in oral formulations.
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 1-15 and 17-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Hingorani (US20170333362A1), Williams (US20180125863A1), and Lugo (Journal of the International Society of Sports Nutrition, 2013):
claims 1-10, 14-22, and 25-28 of copending Application No. 18/833,977 (reference application)
claims 1-25 of copending Application No. 18/833,990 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because all claim sets teach lipid multiparticulate particles comprising an anti-inflammatory active agent for joint health. The copending applications differ only significantly by not specifying the acetyl-11-keto-β-boswellic acid (AKBA) of the instant claims and reciting other active agents.
This is remedied by Hingorani, who teaches AKBA as suitable active agent for lipid solid particle formulations, based on carrier granules (i.e., similarly to “lipid multiparticulate particle formulations”) to improve the bioavailability of the active agent (Hingorani – claim 1; Example 5, [0182-0189]). One of ordinary skill in the art would have been motivated to modify the teachings of the copending Applications, because Hingorani teaches that AKBA is a suitable active agent for enhanced bioavailability in lipid multiparticulate particle formulations that can treat inflammation in osteoarthritis (Example 5, [0182-0189]). Furthermore, the copending Applications are directed to treatment of joint inflammation. Finally, Williams and Lugo provide additional elements and motivations that combine with the copending claim set and Hingorani to read on the remaining details of the instant claims (see 103 analysis above for general rationale).
This is a provisional nonstatutory double patenting rejection.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 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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/R.P./Examiner, Art Unit 1614 6/1/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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