Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restriction
Applicant elected, with traverse, Group I, and species : 1) a compound of Formula I-E, specifically compound SL07; 2) a neutral lipid, specifically 1,2-distearoyl-sn-glycero-3-phosphocholine
(DSPC); 3) cholesterol (structure lipid) ; 4) a PEG-modified diacylglycerol, specifically PEG-DMG, in the reply filed on 06/25/2026.
The traversal is on the ground that Office has not shown that a serious burden exists to examine the alleged Groups I-IV together.
Applicant’s argument is considered, but NOT persuasive. Please note argument regarding burden is not applicable to 371 application which is based upon whether there is unity of invention or not. Derosa (WO 2020/106903 A1) teaches cationic lipid compounds of Formula I that are similar to instant claimed compounds, and compositions/ nanoparticle thereof for use in the delivery of RNA and encoded protein for treating various diseases, disorders and conditions. As such, the common matter shared by groups of inventions/species is not novel and does not make contribution over the prior art and can therefore not be considered as "special technical features. The requirement is still deemed proper and is therefore made FINAL.
Claims 20-21, 23, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
The elected species, compound SL07, having following structure, is a compound of Formula IE, wherein X is S, L1 and L2 are
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Claims 1-5, 7-14 and 17-19 read on the elected invention and species.
The elected species, compound SL07 (CAS# 2923210-63-1 , entered STN database on May 10, 2023) is found free of anticipatory 102 prior art and rejected under 35 USC 103.
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To practice compact prosecution, the examiner has expanded the search/examination to non-elected species, wherein L1 and L2 are
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, R1 is
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or
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. These non-elected species are rejected under 102 and 103 rejections shown below. Other non-elected species are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species. The absence of other citations of prior art should not be interpreted as an indication that other subgenera within Formula I are free of prior art. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reconsidered. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reconsideration that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
Status of Claims
Claims 1-5, 7-14,17-21, 23 and 25 are pending in the instant application.
Claims 20-21, 23, and 25 are withdrawn.
Claims 1-5, 7-14 and 17-19 are currently under examination.
Priority
This instant application 18/702,909 filed 04/19/2024, is a PCT/IB2022/060125 filed 10/21/2022, which claims benefit of US provisional application 63/270606 filed 10/22/2021. It’s noted compound of Formula IE wherein X is S (including compound SL-7) is not disclosed in US provisional application 63/270606. Thus, the priority date for compound of Formula IE is determined as 10/21/2022, filing date of PCT/IB2022/060125.
Information Disclosure Statement
The information disclosure statement dated 04/19/2024 and 09/12/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the reference listed in IDS are being considered by the Examiner.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 recites acronyms that are not clear definition of PEGylated lipid , e.g. PEG-c- DOMG, PEG-DMG, etc.
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 1-5, 7-14 and 17-19 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 recites compound of Formula I or a prodrug thereof. The phrase “prodrug” is a general term which might refer to vast variety of molecules that have different structures, in different recognized chemical classes and might have different chemical/physical properties, different pharmaceutical /biological activity, etc. Thus, the limitation “prodrug” is not a definite functional group/moiety and comprise indefinite structural limitation. An ordinary skilled in the art would not know what compounds are encompassed by "prodrug", thus, the scope of claim 1 is unascertainable for the patent protection desired.
Claims 2-5, 7-14 and 17-19 are rejected due to dependence on claim 1.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites PEGylated lipid selected from PEG-modified phosphatidylethanolamines or PEG- modified phosphatidic acids which are broad recitation. Claim 12 also recites species, PEG-c- DOMG, PEG-DMG, PEG-DLPE, PEG-DMPE, PEG-DPPC, and PEG-DSPE which are narrower statement of the PEGylated lipid. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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) is incorrect, any correction of the statutory basis 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. §102(a)(1) and (a)(2) as being anticipated by Compounds CAS # 2815266-18-1.
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Compound CAS # 2815266-18-1 reads on instant compound of Formula IE, wherein X is S, L1 and L2 are
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, m=2, n=2, o=p=q=r=2.
Claims 1-4, 8-14 and 17-19 are rejected under 35 U.S.C. §102(a)(1) and (a)(2) as being anticipated by Kugimiya et al. ( WO2022168884A1, Applicant’s IDS dated 09/12/2025, family member of US 2024/0180954 A1).
The teachings of WO2022168884A1 in Japanese are illustrated by teachings of family member US 2024/0180954 A1 ( hereafter “Kugimiya’ 954”).
Kugimiya’ 954 discloses compound of Formula I or pharmaceutical salt thereof as cationic lipids for encapsulation and delivery of nucleic acid medicines, pharmaceutical composition and lipid nanoparticle (LNP) comprising aforementioned cationic lipids (See abstract; [0032]-[0106], Table 1-8; Examples 1-61; claims 1-20).
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It’s noted L1 and L2 in R1 and R2 of Kugimiya’ 954 read on instant L1 and L2; Z is
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reads on instant OC(=O)-R1; X is O or S reads on instant X is O or S.
Kugimiya’ 954 discloses compound species that are encompassed by instant compound of Formula I, e.g. I-5, I-10, etc. (See Example 5, Example 10, [0722], [0768]) .
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Kugimiya’ 954 Compound I-5 read on instant compound of Formula IE , wherein R1 is
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, X is S, L1 and L2 are
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, m=2, n=2, o=p=q=r=2.
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Kugimiya’ 954 Compound I-10 read on instant compound of Formula I, wherein R1 is
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, X is O, L1 and L2 are
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, m=2, n=2, o=p=q=r=2.
Regarding claims 8, 14 and 17, Kugimiya’ 954 discloses lipid nanoparticle (LNP) containing the cationic lipid has excellent properties as a pharmaceutical that the LNP can efficiently encapsulate nucleic acids such as single-stranded or double-stranded polynucleotides, siRNA and mRNA and that the LNP has high stability (See [0032], [0107]).
Regarding claim 9, Kugimiya’ 954 discloses LNP comprising neutral lipid, sterol and polyethylene glycol-modified lipid (See [0575]).
Regarding claim 10, Kugimiya’ 954 discloses neutral lipid, e.g. dioleoyl phosphatidylethanolamine, palmitoyl oleoyl phosphatidylcholine, egg-yolk phosphatidylcholine, dimyristoyl phosphatidylcholine, dipalmitoyl phosphatidylcholine, distearoylphosphatidylcholine, diarachidoyl phosphatidylcholine, dibehenoyl phosphatidylcholine, dilignoceroyl phosphatidylcholine, dioleoyl phosphatidylcholine, sphingomyelin, ceramide, dioleoyl phosphatidylglycerol, dipalmitoyl phosphatidylglycerol, phosphatidylethanolamine, dioleoyl-phosphatidylethanolamine 4-(N-maleimidomethyl)-cyclo hexane-l-carboxylate and the like (See [0579]-[0580]).
Regarding claim 11, Kugimiya’ 954 discloses sterol include cholesterol, dihydrocholesterol, lanosterol, (3-sitosterol, campesterol, stigmasterol, brassicasterol, eigocasterol, fucosterol, 36-[N-(N',
N'-dimethylaminoethyl)carbamoyl]cholesterol (DC-Chol) and the like(See [0583]).
Regarding claim 12, Kugimiya’ 954 discloses polyethylene glycol-modified lipid, e.g. PEG2000-dimyristyl glycerol, PEG2000-di-palmitoyl glycerol, PEG2000-distearoyl glycerol... PEG-diacyl glycerol, PEG-dialkyloxypropyl, PEG-phospholipid, PEG- ceramide and the like (See [0581]).
Regarding claim 13, Kugimiya’ 954 discloses LNP embodiments wherein the cationic lipid is preferably 40 to 70 mol % (See [0576]), neutral lipid is preferably 0 to 30 mol % (See [0580]), polyethylene glycol-modified lipid is preferably 0 to 10 mol % (See [0582]), sterol content is preferably 20 to 50 mol % (See [0584]).
Regarding claim 18, Kugimiya’ 954 discloses the particle size and encapsulation rate of the LNP encapsulating nucleic acid, wherein the diameter ranges from about 69nm to 127nm (See [1108]-[1116], Test Example 1, Table 11-14 ).
Regarding claim 19, Kugimiya’ 954 discloses pharmaceutical composition, comprising the cationic lipid or a pharmaceutically acceptable salt thereof and a carrier/ excipient (See [0611]-[0616]).
Kugimiya’ 954 collectively teaches cationic lipid within the scope of instant claimed compound of Formula I, pharmaceutical composition and lipid nanoparticle (LNP) comprising aforementioned cationic lipids. Thus, Kugimiya’ 954 anticipates instant claimed invention.
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 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 1-5, 7-14 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kugimiya et al. ( WO2022168884A1, Applicant’s IDS dated 09/12/2025, family member of US 2024/0180954 A1).
The teachings of WO2022168884A1 in Japanese are illustrated by teachings of family member US 2024/0180954 A1 ( “Kugimiya’ 954”). The collective teachings of Kugimiya’ 954 is elaborated in preceding 102 rejection and applied as before. Kugimiya’ 954 collectively teaches cationic lipid within the scope of instant claimed compound of Formula I, pharmaceutical composition and lipid nanoparticle (LNP) comprising aforementioned cationic lipids.
Kugimiya’ 954 discloses compound species that are encompassed by or very similar to instant compound of Formula I, e.g. I-5, I-6, I-8, I-10, I-19, I-38, I-40, I-42, I-44, I-61, etc. (See Examples 1-61, Table 1-8),
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Kugimiya’ 954 Compound I-5 is very similar to instant elected species SL07, a compound of Formula IE, wherein X is S, L1 and L2 are
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. The difference between Kugimiya’ 954 compound I-5 and instant claimed compound is the length of alkyl group, i. e, the number of CH2, m, n, o, p, q, r.
According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
In search for more cationic lipid as alternative LPN for delivery of polynucleotide and other active ingredient, it would have been prima facie obvious to one of ordinary skilled in the art to further explore cationic lipid and LPN taught by Kugimiya’ 954, together with optimization based on general knowledge of structure similarity and bioisosteric modification, and arrive at instant claimed invention with reasonable expectation of success.
For example, Kugimiya’ 954 Compound I-5 could have been modified by exploring different length of CH2 in alkyl groups and arrive at instant elected compound SL07.
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As stated in MPEP 2144 .09 III : “Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979) (Claimed and prior art compounds were both directed to heterocyclic carbamoyloximino compounds having pesticidal activity. The only structural difference between the claimed and prior art compounds was that the ring structures of the claimed compounds had two carbon atoms between two sulfur atoms whereas the prior art ring structures had either one or three carbon atoms between two sulfur atoms. The court held that although the prior art compounds were not true homologs or isomers of the claimed compounds, the similarity between the chemical structures and properties is sufficiently close that one of ordinary skill in the art would have been motivated to make the claimed compounds in searching for new pesticides.)”.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of structure similarity and bioisosteric modification of SAR study. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-5, 7-14 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ansell et al. ( US 2015/005363 A1), in view of Patani et al. (Chemical Reviews, 1996, Vol. 96, No. 8, 3147-3176, “Bioisosterism: A Rational Approach in Drug Design”).
Ansell discloses cationic lipid of Formula I, II, III or salt thereof comprising biodegradable groups in lipidic moiety (e.g., a hydrophobic chain), pharmaceutical composition and lipid nanoparticle (LNP) comprising aforementioned cationic lipids for delivering an active agent (e.g. nucleic acid ) (See abstract; [0006]-0036]; [0040]-0053], [0089]- [0090], [0249], Table 1 and 2, Synthesis of compound 1-23; Examples 1-5; claims 1-29).
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It’s noted Ansell compound of Formula III is very similar to instant compound of Formula I , wherein L1 and L2 is
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; R1 is
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or
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X is O or S.
Ansell discloses compound species that are very similar to instant compound of Formula I , e.g. Compound 8, 11, 13, 19, 20, 21, etc. (See [0182]-[0220]),
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Ansell compound 13 and 20 read on instant compound of Formula I , wherein L1 and L2 is
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, except methyl versus ethyl on the nitrogen.
Regarding claims 8, Ansell discloses lipid particle/ nanoparticle (LNP) comprising cationic lipid (See [0040]- [0044], [0116]).
Regarding claims 9-12, Ansell discloses lipid particle comprising a neutral lipid, a lipid capable of reducing aggregation, a cationic lipid, and optionally, a sterol (e.g., cholesterol). Suitable neutral lipids include, but are not limited to, distearoylphosphatidylcholine (DSPC), dipalmitoylphos-
phatidylcholine (DPPC), POPC, DOPE, and SM. Suitable lipids capable of reducing aggregation include, but are not limited to, a PEG lipid, such as PEG-DMA, PEG-DMG, or a combination thereof (See [0041], Example 3; claim 17).
Regarding claim 13, Ansell discloses embodiments wherein the cationic lipid is present in a mole percentage of about 20% and about 60%; the neutral lipid is present in a mole percentage of about 5% to about 25%; the sterol is present in a mole percentage of about 25% to about 55%; and the PEG lipid is PEG-DMA, PEG-DMG, or a combination thereof, and is present in a mole percentage of about 0.5% to about 15% (See claim 17; [0107]-[0114] ).
Regarding claims 14 and 17, Ansell discloses lipid particle/ nanoparticle (LNP) comprising cationic lipid and nucleic acid , e.g., an siRNA or miRNA , polynucleotide (See [0042]- [0043], [0048]-[0049], Example 4).
Regarding claim 18, Ansell discloses the size of the lipid particle wherein the diameter ranges from about 50 nm to about 300 nm, (See [0116] ).
Regarding claim 19, Ansell discloses pharmaceutical composition comprising the cationic lipid or a pharmaceutically acceptable salt thereof and a carrier/ excipient (See [0045], [0125], claim 22).
The difference of Ansell compounds and instant compound of Formula I wherein R1 is
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, is methyl versus ethyl on the nitrogen. The difference of Ansell compounds and instant compound of Formula I wherein R1 is
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, is the length of alkyl group and X is CH2 versus O or S.
Patani et al. discloses bioisosterism for rational modification of lead compounds. Patani teaches classical bioisosteres, e.g. CH2 and O, are a series of replacements defined by Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres (See p. 3148-3149, Table 2). Patani also teaches divalent isosteres wherein CH2, O, S are considered as bioisosteres (See page 3155-3156, Table 19).
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According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
In search for more cationic lipid as alternative lipid particle for delivery of active ingredient, it would have been prima facie obvious to one of ordinary skilled in the art to further explore cationic lipid and LPN taught by Ansell, together with experimentation/optimization based on general knowledge of structure similarity and bioisosteric modification as taught by Patani, and arrive at instant claimed invention with reasonable expectation of success. A skilled artisan would be motivated to explore more cationic lipid and reasonably expect alternative cationic lipid could be used in lipid particle for delivery of active ingredient.
For example, Ansell Compound 13 could have been modified to homolog comprising Et at the nitrogen which reads on instant claimed subgenus wherein L1 and L2 is
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. Ansell Compound 13 could have been modified by introducing O or S as taught by Patani, exploring different length of CH2 in alkyl groups and arrive at instant non-elected species in claim 7.
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One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of structure similarity and bioisosteric modification. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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, 8-14 and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 9- 15, and 18-20 of copending application No. 18/695,909 (reference application). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are drawn to compound formula I with similar core structure wherein L1 and L2 are each independently -(C=O)O- or -O(C=O)- and similar and narrower R1 group, e.g.
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Reference claims 9-15, and 18-20 recite limitation of lipid nanoparticle that are similar to instant claims 8-14 and 17-19.
The difference of instant claims and reference claimed compound are the extra leg of
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which is already taught in reference claims.
According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). It would have been prima facie obvious to one of ordinary skilled in the art to further explore cationic lipid and LPN taught by reference claims , together with optimization based on general knowledge of structure similarity and reasonably expect alternative cationic lipid could be used in lipid particle for delivery of active ingredient,
The instant application shares at least one common inventor /applicant with the reference patent. Furthermore, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists.
Conclusion
NO claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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/L.M./ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
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