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 claims
Claims 1-6 and 9-11 are original. Claims 7-8 and 12-15 are currently amended. Claims 1-15 are pending and under examination.
Priority
This application is a 371 of PCT/US2023/066373, filed on 04/28/2023. It claims the priority benefit of U.S. Provisional Patent Application Serial No. 63/335,847, filed on April 28, 2022.
Information Disclosure Statement
The two information disclosure statements (IDS) submitted on 12/09/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 8 and 14 are objected to because of the following informalities:
Claim 8 States “phthalate esters (diethyl phthalate,”. This phrase is missing a parenthesis. Proper syntax is “phthalate esters (diethyl phthalate),”.
Claim 14 states “additional residues selected from the following residues: leucine, isoleucine, and/or valine”. This is improper Markush language. Proper syntax is “additional residues selected from the group consisting of: leucine, isoleucine, and/or valine”
Appropriate correction is required.
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 3-6, 8, 11 and 15 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 3 recites the limitation "wherein said rehydrated peptide-based colloidal particles". There is insufficient antecedent basis for this limitation in the claim. Claim 3 initially recites “rehydrate said lyophilized or spray-dried peptide-based colloidal particles”, which is narrower term than "said rehydrated peptide-based colloidal particles", as the latter may include peptide-based colloidal particles that are not necessarily lyophilized or spray-dried. A suggested amendment is to alter the language to “wherein the rehydrated lyophilized or spray-dried peptide-based colloidal particles”.
Claim 3 recites the limitation "said rehydrating step". There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites “excipient, optionally along with one or more hydrophobic and/or… hydrophobic segment and a C-terminal hydrophilic segment;”. It is unclear whether only the components recited after “optionally” and before the “;” is not required, or whether all of the components following “optionally” are not required. For the purpose of compact prosecution, the latter shall be read.
Claim 4 twice recites “said extruded colloidal particles”. There is insufficient antecedent basis for this limitation in the claim, as the claim initially states “extruding said suspension of colloidal particles”, which is narrower. A suggested amendment is to alter the claim language to "said extruded suspension of colloidal particles".
Claims 5 and 6 are also indefinite for being dependent to indefinite claim 4.
Claim 5 recites “said extruding step”. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites parentheses such as “(pentane, hexane, heptane, and n-Decane)”, “(cyclohexane)”, “(benzene, toluene, and xylene)”, and “(diethyl phthalate)”. However, it is unclear whether these compounds are mere exemplary or whether these are necessary components of the Markush list. The former will be assumed (exemplary). Applicant may delete parentheticals. It is acceptable to have broad options and narrow options as optional members of the group if they are not in parenthetical form.
Claim 11 twice recites “said liquid state lipid, fat, grease, wax, or oil”. There is insufficient antecedent basis for this limitation in the claim. A suggested amendment is to alter the claim language to “said lipid, fat, grease, wax, or oil transitioned to a liquid state”.
Claim 11 states “said amphipathic peptides”. There is insufficient antecedent basis for this limitation in the claim, as claim 9 states “amphipathic linear peptides”, which is narrower. A suggested amendment is to alter the language to “said amphipathic linear peptides”.
Claim 11 recites “said peptide monolayer encapsulating solidified lipid, fat, grease, wax, or oil”. There is insufficient antecedent basis for this limitation in the claim. Its independent claim 9 recites a “a peptide monolayer encapsulating a room temperature solid lipid, fat, grease, wax, or oil”, which is a narrower form. A suggested amendment is to alter the claim language to “said peptide monolayer encapsulating a room temperature solid lipid, fat, grease, wax, or oil”.
Claim 11 recites “to a liquid state; optionally dissolving… liquid state lipid, fat, grease, wax, or oil;”. It is unclear whether only the components recited after “optionally” and before the “;” is not required, or whether all of the components following “optionally” are not required. For the purpose of compact prosecution, the latter shall be assumed.
Claim 15 is indefinite for the recitation of “preferably lysine” as it is unclear if this is meant to be a necessary part of the claimed invention or if it is just an optional preferable feature. Applicant may delete “, preferably lysine” of if applicant desires lysine to be part of the claim change “, preferably lysine” to “wherein the amino acid residues are lysine.”
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.
Claims 4-6 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tomich et al. (WO2020198020A1 {published on 10/1/2020}; in-text citations used from its U.S pre-grant publication family US20220183277A1 {priority date of 03/22/2019}).
Tomich et al. discloses linear peptides for creation of colloidal particles and micelles for delivery of active agents [¶abstract].
Regarding Claim 4-6: Tomich et al. teaches that the inventive concept is a suspension of peptide-based colloidal particles comprising an amphipathic linear-peptide monolayer encapsulating a non-polar lipid or core, optionally containing a hydrophobic or poorly water-soluble active agent [¶¶24-31]. In a single embodiment, Tomich et al. teaches initial particle populations having first mean diameters of approximately 408.6 nm and 236.8 nm [¶47]. Tomich et al. teaches extruding those particle suspensions through 100-nm polycarbonate filters, whose pore dimension is smaller than each disclosed first mean particle diameter [¶49]. Tomich et al. teaches that extrusion reduced the approximately 408.6 nm particle’s (i.e., h5F-L) to approximately 80 nm and the approximately 240 nm particles to approximately 90 nm (h5V-L) [¶49]. The post-extrusion populations were obtained or collected to measure the second average diameters, thereby inherently teaching the collection step.
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 1, 3-8, 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Tomich et al. (WO2020198020A1 {published on 10/1/2020}; in-text citations used from its related U.S pre-grant publication family US20220183277A1 {priority date of 03/22/2019}) In view of Adami et al. (US20170020819A1).
Tomich et al. discloses linear peptides for creation of colloidal particles and micelles for delivery of active agents [¶abstract].
Regarding Claim 1:
Tomich et al. teaches a composition comprising a plurality of colloidal particles suspended in an aqueous carrier, where each particle comprises a peptide matrix having a hydrophobic core and hydrophilic surface that sequesters (or encapsulates) a non-polar excipient, including a lipid oil, or a non-polar solvent, optionally together with one or more hydrophobic or poorly water-soluble active agents dispersed or distributed therein [¶¶5-7, 25-26].
Tomich et al. teaches that the particles are formed from a plurality of linear, unbranched amphipathic peptides, each comprising an N-terminal hydrophobic segment connected to a C-terminal hydrophilic segment [¶¶25-28].
Tomich et al. teaches that the amphiphilic peptides form a monolayer at the oil-water interface, with the hydrophilic portion oriented outward toward the aqueous environment and the hydrophobic portions oriented toward and interacting with the non-polar excipient droplet [¶¶25, 29].
However, Tomich et al. does not teach the composition in lyophilized form.
Adami et al. discloses compositions for making a solid lyophile of one or more nucleic acid active agents, which can be reconstituted as a drug product [¶abstract].
Regarding Claim 1:
Adami et al. teaches aqueous suspensions of lipid nanoparticles containing encapsulated active agents, lyophilizing the suspensions to form stable solid lyophile products, and subsequently reconstituting them into aqueous suspensions of lipid nanoparticles [¶¶4-7, 85-89, 92-95].
Regarding Claim 3: Refer to a.i.-a.iii. and b.i. above. In addition, Adami et al. teaches that the reconstituted suspension may contain stable nanoparticles comparable to those present before lyophilization and that the average particle size may remain within 5% to 10% of the original size [¶¶95-101]. Adami et al. further teaches embodiments with only minor changes (<10%) in particle size and retention of at least approximately 85% encapsulation efficiency following lyophilization and reconstitution, with a uniform particle size (measured by PDI, <0.200) [¶101, ¶297-301, table 2]. Tomich et al. also teaches that its colloidal particles remained stable, as discrete colloidal particles, in an aqueous solution for extended periods of time, without agglomeration, coalescing, or falling apart [¶29].
Regarding Claim 4: Tomich et al. teaches a suspension of peptide-based colloidal particles comprising an amphipathic linear-peptide monolayer encapsulating a non-polar lipid or core, optionally containing a hydrophobic or poorly water-soluble active agent [¶¶24-31]. Tomich et al. teaches initial particle populations having first mean diameters of approximately 408.6 nm and 236.8 nm [¶47]. Tomich et al. teaches extruding those particle suspensions through 100-nm polycarbonate filters, whose pore dimension is smaller than each disclosed first mean particle diameter [¶49]. Tomich et al. teaches that extrusion reduced the approximately 408.6 nm particle’s (i.e., h5F-L) to approximately 80 nm and the approximately 240 nm particles to approximately 90 nm (h5V-L) [¶49]. The post-extrusion populations were obtained or collected to measure the second average diameters, thereby inherently teaching the collection step.
Regarding Claim 5: Tomich et al. teaches resizing the peptide-based colloidal particles by extruding the particle suspensions through a 100 nm polycarbonate filter [¶49].
Regarding Claim 6: Tomich et al. teaches that extrusion through said filter reduced the approximately 408.6 nm particles (i.e., h5F-L) to a secondary size of approximately 80 nm and the approximately 240 nm particles to a secondary size of approximately 90 nm (i.e., h5V-L) [¶49].
Regarding Claim 7: Tomich et al. teaches that the non-polar excipient encapsulated by the peptide matrix may be a lipid or oil [¶¶24-25, 30].
Regarding Claim 8: Tomich et al. teaches that preferred non-polar excipients (e.g., solvents) may include cyclohexane, benzene, n-decane, piperonyl butoxide, diethyl phthalate and the like, or combinations thereof [¶30].
Regarding Claim 12: Refer to a. ii. above. Tomich et al. also teaches that amphiphilic linear peptides have an overall chain length of 20 amino acid residues or fewer, preferably 5-20 residues [¶26].
Regarding Claim 13: Refer to a. ii. above. Tomich et al. also teaches that the N-terminal hydrophobic segments are preferably each from about 3 residues to about 11 amino acid residues in length, and more preferably from about 4 to about 10 residues in length, and even more preferably from about 5 to about 9 residues in length [¶26].
Regarding Claim 14: Refer to a. ii. above. Tomich et al. also teaches FLIVI as a preferred hydrophobic segment and FLIVIKKKKK as a preferred complete peptide sequence [¶¶27]. The FLIVI segment contains one phenylalanine residue, one leucine residue, two isoleucine residues, and one valine residue.
Regarding Claim 15: Refer to a. ii. above. Tomich et al. also teaches that the hydrophilic (polar) lysine (“K”) tail sequences are preferably from about 1 to about 7 lysine residues in length, more preferably from about 1 to about 6 lysine residues, and even more preferably from about 1 to about 5 lysine residues, and lists KKKKK as a preferred five-residue hydrophilic segment while specifying amphiphilic peptides to have sequences such as FLIVIKKKKK and VLIVIKKKKK [¶¶26-27].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to lyophilize Tomich et al.’s aqueous suspension of peptide-based colloidal particles according to Adami et al. in order to improve storage stability, simplify handling and transportation, and permit convenient aqueous reconstitution before use. Adami et al. teaches those aqueous suspensions of lipid nanoparticles containing encapsulated active agents may be converted into stable solid lyophile products and subsequently reconstituted while substantially retaining their original particle size, uniformity, and encapsulation efficiency. Because Tomich et al. likewise concerns stable colloidal delivery particles having a hydrophobic interior that encapsulates non-polar excipients and optional active ingredients, A person of ordinary skill in the art would have recognized Adami et al.’s lyophilization technique as applicable to Tomich et al.’s particles for the same established purpose. Moreover, Tomich et al. teaches that its peptide-coated particles remain as discrete colloidal particles in aqueous solutions without agglomerating, coalescing, or falling apart, while Adami et al. demonstrates preservation of nanoparticles structure and encapsulated contents after drying and reconstitution. Accordingly, a person of ordinary skill in the art would have had a reasonable expectation of success that lyophilizing Tomich et al.’s particles according to Adami et al. would predictably yield the claimed dried composition wile substantially preserving particle integrity and encapsulation upon rehydration.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Tomich et al. (WO2020198020A1 {published on 10/1/2020}; in-text citations used from its U.S pre-grant publication of US20220183277A1 {priority date of 03/22/2019}) In view of Adami et al. (US20170020819A1) in further view of Bhambhani et al. (US20120121580A1).
Tomich et al. and Adami et al. collectively teach all required limitations of claims 1, 3-8, 12-15.
However, Tomich et al. and Adami et al. fail to collectively teach all required limitations of claim 2.
Bhambhani et al. discloses methods of producing lyophilized pharmaceutical compositions comprising a high concentration of therapeutic protein or antibody prior to lyophilization, wherein the lyophilized formulation can be reconstituted with a diluent in about 15 minutes or less [¶abstract].
Regarding Claim 2: Bhambhani et al. teaches that a lyophilized pharmaceutical formulation may contain a unit dose of active pharmaceutical ingredient for administration to one patient or animal [¶23]. Bhambhani et al. teaches a kit comprising a container holding a lyophilized formulation and instructions for reconstituting the lyophilized formulation with a diluent, optionally together with a second container holding the diluent [¶130]. Bhambhani et al. teaches that the container may be a vial, syringe, pen device, or autoinjector, and describes fill volumes [¶¶132-133]. Bhambhani et al. identifies sterile water for injection (“SWFI”) and bacteriostatic water for injection (“BWFI”) as suitable aqueous reconstitution diluents [¶135].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to package the dried peptide-based composition of Tomich et al., as modified by Adami et al., in the kit format taught by Bhambhani et al. One would have been motivated to provide the dried composition in a unit dose container together with reconstitution instructions and an aqueous diluent in order to facilitate storage, transportation, accurate dosing, and convenient point-of-use preparation for administration. Bhambhani et al. expressly teaches kits comprising a container holding a lyophilized formulation, instructions for reconstitution, and suitable aqueous diluents, such as sterile water for injection. Furthermore, because Adami et al. already teaches a lyophilized formulation intended for reconstitution and Bhambhani et al. teaches packaging analogous lyophilized formulations in such kits for the same purpose, a person of ordinary skill in the art would have had a reasonable expectation of success incorporating Tomich et al. and Adami et al.’s dried composition into Bhambhani et al.’s convenient kit configuration.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Tomich et al. (WO2020198020A1 {published on 10/1/2020}; in-text citations used from its U.S pre-grant publication family US20220183277A1 {priority date of 03/22/2019}) In view of Shastri et al. (US20060083781A1).
Tomich et al. discloses linear peptides for creation of colloidal particles and micelles for delivery of active agents [¶abstract].
Regarding Claim 9: Tomich et al. teaches a suspension of peptide-based colloidal particles comprising an amphipathic linear-peptide monolayer encapsulating a non-polar lipid or oil droplet, optionally containing a hydrophobic or poorly water-soluble active agent [¶¶24-31].
However, Tomich et al. fails to teach the encapsulated oil being a room temperature solid lipid, fat, grease, wax, or oil.
Shastri et al. discloses functionalized solid lipid nanoparticles comprising a neutral lipid and a first functionalized polymer, wherein at least a portion of the first functionalized polymer is at the exterior of the solid lipid nanoparticle; [¶abstract].
Regarding Claim 9: Shastri et al. teaches that the particle interior is a lipid core having a generally spherical or droplet shape and that the functionalized polymer may be located at the surface or embedded partially within the lipid [¶82]. Shastri et al. teaches the solid lipid core may be surface-functionalized with peptides [¶268]. Shastri et al. teaches a layered structure in which the polymer substantially surrounds the lipid exterior [¶113]. Shastri et al. teaches that at least a portion of the solid lipid nanoparticles of the invention are solid at room temperature and atmospheric pressure [¶90].
Regarding Claim 10: Shastri et al. teaches lipids related to fatty acid esters, fatty alcohols, sterols, waxes, monoglycerides, diglycerides, and triglycerides [¶¶89, 91-92, 94]. Shastri et al. specifically teaches triglycerides comprising palmitic acid, oleic acid, and stearic acid [¶95].
Regarding Claim 11: Tomich et al. teaches that conventional solid lipid nanoparticles are prepared by melting the lipid, dispersing the molten lipid in water, and cooling the dispersion to solidify the lipid particles [¶2].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Tomich et al.’s peptide-based colloidal particles by employing the room-temperature-solid lipid materials and conventional solid lipid nanoparticle preparation techniques taught by Shastri et al. A person of ordinary skill in the art would have been motivated to do so because Shastri et al. teaches that room-temperature solid lipids, including triglycerides, partial glycerides, and waxes may be used to form stable solid lipid nanoparticles while retaining a lipid core suitable for carrying active agents. Because Tomich et al. already teaches peptide monolayers encapsulating hydrophobic lipid or oil cores and Shastri et al. teaches that such solid lipid cores are conventionally prepared by melting the lipid, dispersing the molten lipid in an aqueous phase, and cooling the dispersion to solidify the lipid particles, one of ordinary skill in the art would have had a reasonable expectation of success in knowing that substituting Shastri et al.’s room-temperature solid lipid core preparational technique into Tomich et al.’s peptide-based colloidal system would predictably yield peptide-encapsulated colloidal particles having a room-temperature solid lipid core while preserving the particle architecture and encapsulating properties taught by Tomich et al.
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 non-statutory 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, 7, and 12-15 are rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of granted U.S. Patent No. 12677828- 17/441,916 (referred to as patent ‘828): 1, 4, 6, 8 (for present claim 1, 7, 15); 4, 6, 8 (for present claim 12); 4, 8 (for present claim 13); 4 (for present claim 14)– in view of Adami et al. (US20170020819A1).
Note that patent ‘828 is the patent of USPGPub 20220183277A1.
Each of the above claims (or claim groups) of patent ‘828 teach all limitations of their corresponding claim(s) listed in the present application, except for the following difference: patent ‘828 does not teach the lyophilization of such compositions in accordance with present claim 1. Adami et al. remedies this deficiency by teaching that such compositions comprising nanoparticles having a hydrophobic core may be lyophilized per its teachings recited in the U.S.C 103 rejections made above. Lyophilization of such compositions is a matter of routine optimization of a formulation for the purpose of enhancing stability, obvious to a person of ordinary skill in the art and made with a reasonable expectation of success. Accordingly, the present claims differ from the claims of patent ‘916 only by an obvious variation that does not impart a patentable distinction.
Conclusions
No claim is found allowable.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/ Primary Examiner, Art Unit 1613
Prosecution Insights