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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 6/12/2026 wherein claims 1-26 and 51-54 were canceled; claims 27, 29, 30, 32, and 47-50 were amended; and claim 59 and 60 were added.
Note(s): Claims 27-50 and 55-60 are pending.
Priority
This application is a 371 of PCT/CN2022/117091 filed 9/5/2022 and claims benefit to PCT/CN2021/116681 filed 9/6/2021.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 USC 119 (a) – (d). The certified copy has been filed 3/5/2024 in the pending application. While a certified copy was submitted, it is not in English. However, an English translation was filed on 6/12/2026.
Note(s): The earliest effective filing date is 9/6/2021 because the pending invention is fully disclosed in the PCT/CN2021/116681.
Claim Interpretation
Pending claim 27 is directed to a liposome nanocarrier delivery system comprising a liposome carrier and a substance wherein the liposome carrier comprises a phospholipid and cholesterol; the liposome carrier is a nanocarrier delivery system is modified with a targeting ligand which is hyaluronic acid and DSPE-PEG2000-NH2 coupled through an amide bond; and the final concentration of the targeting ligand is 10 – 100 µg/ml.
Note(s): It is unclear whether or not the substance is present as one of the final components of the delivery system or if the substance is what is modified in the delivery system to become the targeting ligand.
Pending claim 32 is directed to a liposome nanocarrier delivery system wherein the liposome nanocarrier delivery system comprises a liposome carrier and a substance; the liposome carrier comprises phospholipid and cholesterol and the liposome nanocarrier contains a targeting ligand which is hyaluronic acid and DSPE-PEG2000-NH2 through an amide bond; and the targeting ligand is 100 ± 24 µg/ml.
Note(s): It is unclear whether or not the substance is present as one of the final components of the delivery system or if the substance is what is modified in the delivery system to become the targeting ligand.
Applicant’s Election
Once again, Applicant's election with traverse of Group I (pending claims 27-33, 45, 59, and 60) filed 1/16/2026 is acknowledged. The restriction requirement was deemed proper and is made FINAL.
Once again, the Examiner acknowledges receipt of Applicant’s election of the species wherein the phospholipid is distearoylphosphatidylcholine (DSPC) and DSPE-PEG2000; the liposome carrier is DSPC, cholesterol, and DSPE-PEG2000; the solvent is water; HPD and rosuvastatin calcium are also present in the liposome nanocarrier system; and the targeting ligand is hyaluronic acid and DSPE-PEG2000. Claims 27-33, 45, 59, and 60 read on the elected species.
Initially, Applicant’s elected species was searched. No prior art was found which could be used to reject the claims. Thus, the search was extended to that in the cited prior art below. The search was not further extended because prior art was found which could be used to reject the claims.
Withdrawn Claims
Claims 34-44, 46-50, and 55-58 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The information disclosure statement filed 6/12/2026 was considered.
Response to Applicant’s Arguments and/or Amendment
The Applicant's arguments and/or amendment filed 6/12/2026 to the rejection of claims 27-33 and 45 made by the Examiner under 35 USC 103 and/or 112 have been fully considered and deemed persuasive-in-part for the reasons set forth below.
Written Description Rejection
The 112 first paragraph (written description) rejection is WITHDRAWN because Applicant amended the claims to overcome the rejection.
112 Second Paragraph Rejections
All outstanding 112 second paragraph rejections are WITHDRAWN because Applicant amended the claims to overcome the rejections. However, the newly amended claims are still vague and indefinite as indicated by the new grounds of rejections below.
103 Rejection
Note(s): The 103 rejection is maintained for reasons of record and those set forth below. The rejection was modified to address the amended claims and arguments in Applicant’s response filed 6/12/2026,
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.
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 27-33, 45, 59, and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (Langmuir, 2010, Vol. 26, No. 13, pages 11140-11144) in view of Gorzelanny et al (Biomacromolecules, 2007, Vol. 8, pages 3035-3040).
Pending claim 27 is directed to a liposome nanocarrier delivery system comprising a liposome carrier and a substance wherein the liposome carrier comprises a phospholipid and cholesterol; the liposome nanocarrier delivery system contains a targeting ligand which is independently or collectively hyaluronic acid and DSPE-PEG2000-NH2 coupled through an amide bond; and the final concentration of the targeting ligand is 10 – 100 µg/ml.
Note(s): The substance is selected from one or more of statins, fibrates, antiplatelet drugs, PCSK9 inhibitors, anticoagulant drugs, angiotensin converting enzyme inhibitors, calcium ion antagonists, MMPs inhibitors, beta-receptor blockers, and glucocorticoid.
Claim 28 is directed to various phospholipids therein which include distearoyl phosphatidyl ethanolamine.
Claim 30 is directed to the substance as being one of the many listed therein.
Claim 31 disclose that the average molecular weight of the hyaluronic acid is 12,000 to 16,000.
Claim 32 contains all the limitations of independent claim 27 with the exception that the final concentration of the target ligand is 100 µg/ml ± 24 µg/ml instead of 10 – 100 µg/ml.
Claim 33 is directed to small, large, and multilamellar liposomes.
Claim 45 is directed to a medicine comprising the nanocarrier delivery system and a pharmaceutically acceptable carrier.
Claim 59 is directed to the delivery system of claim 27 wherein the atherosclerosis related disease is a disease selected from acute coronary syndrome, asymptomatic myocardial ischemia, latent coronary heart disease, angina pectoris, myocardial infarction, ischemic heart disease, sudden death, in-stent restenosis, cerebral ischemic stroke, hemorrhagic apoplexy, carotid atherosclerosis, vertebral atherosclerosis, subclavian atherosclerosis, occlusive peripheral atherosclerosis, retinal atherosclerosis, renal atherosclerosis, lower extremity atherosclerosis, upper extremity atherosclerosis, mesenteric atherosclerosis and atherosclerotic impotence, aortic dissection, hemangioma, thromboembolism, heart failure, and cardiogenic shock.
Claim 60 is directed to the delivery system of claim 32 wherein the atherosclerosis related disease is a disease selected from acute coronary syndrome, asymptomatic myocardial ischemia, latent coronary heart disease, angina pectoris, myocardial infarction, ischemic heart disease, sudden death, in-stent restenosis, cerebral ischemic stroke, hemorrhagic apoplexy, carotid atherosclerosis, vertebral atherosclerosis, subclavian atherosclerosis, occlusive peripheral atherosclerosis, retinal atherosclerosis, renal atherosclerosis, lower extremity atherosclerosis, upper extremity atherosclerosis, mesenteric atherosclerosis and atherosclerotic impotence, aortic dissection, hemangioma, thromboembolism, heart failure, and cardiogenic shock.
Zhang et al is directed to polyethylene glycolated phospholipid substances. Specifically, small unilamellar nanocarrier vesicles were generate from 1,2-dimyristoylphosphatidylcholine (DMPC) with varying molar amounts of 1,2-distearoyl-sn-glycero-3-phosphoetholamine-N-[methoxy(poly(ethylene glycol))-2000 (DSPE-PEG2000) and fused into (modified with) membranes on different polymer-modified silicon dioxide surfaces including chitosan, poly-lysine, and hyaluronic acid. Glutaraldehyde is used as a crosslinker for coupling chitosan onto the animated silicon dioxide surface. The thickness of PEGylated lipid membrane varied as the molar fraction of PEG increased. Cholesterol was incorporated into the mixture to improve the structural stability of the lipid membrane. Different amounts of cholesterol alter the thickness and surface morphology of the membrane. The liposome preparation is extruded using a filter with an average pore size of 50 nanometers to generate a phospholipid containing liposome nanocarrier delivery system (see entire document, especially, abstract; page 11140, right column, second complete paragraph; pages 11140-11141, bridging paragraph; page 11141, left column, first and second complete paragraphs; page 11141, Figures 3-5).
On page 11141, the liposome preparation process is disclosed. Briefly, the DSPE-PEG2000 and cholesterol are mixed with SMPC in chloroform. The solvent is evaporated and the thin film remaining is rehydrated with PBS solution to a concentration of 1 mM DMPC. Next, the solution clarified with and extruded through a filter having an average pore size of 50 nanometers.
Zhang et al disclose that one can vary the amount of DSPE-PEG2000 (the other component being optimized in the ratio) from 1.5-5 mole percent (page 11143, left and right columns, bridging paragraph). The targeting ligand comprises hyaluronic acid and DSPE-PEG2000. It would be obvious to a skilled artisan to optimize the amount because the Zhang et al disclose various way of optimizing the liposome components, desired property of interest (e.g., thickness and surface morphology of the membrane). Still, Zhang et al disclose that one can vary the amount of DSPE-PEG2000 (the other component being optimized in the ratio) from 1.5-5 mole percent (page 11143, left and right columns, bridging paragraph; page 11144, Figure 9). According to MPEP 2144.05, generally differences in things such as concentration wherein the prior art discloses evidence indicating that such factor is critical and may be optimized, determining optimum workable ranges by routine experimentation is expected.
Zhang et al disclose that the hyaluronic acid has a molecular weight of 60,000 (page 11141, left column, second complete paragraph). However, it is disclosed substrate surface modification occurred such that the concentration of hyaluronic acid ended up being 1 mM (page 11141, left column, first complete paragraph). In addition, the abstract discloses that one can vary various components to optimize various desired properties of the vesicles as discussed supra. According to MPEP 2144.05, generally differences in things such as concentration wherein the prior art discloses evidence indicating that such factor is critical and may be optimized, determining optimum workable ranges by routine experimentation is expected. Thus, it would be obvious to the skilled artisan to alter the molecular weight of hyaluronic acid depending upon the modifications that thereof. For example, in the abstract, it is disclosed that different polymer modifications of silicon dioxide surfaces including those to hyaluronic acid may be made. Hence, the skilled artisan would recognize that that the molecular weight will vary.
For the reasons above, the limitations of claims 27, 28, 30-33, and 45 are met.
Regarding claims 59 and 60, it is duly noted that the claims are directed to use of the liposome delivery system which do not further limit the components (liposome carrier, substance, and targeting ligand) of the delivery system. Applicant is respectfully requested to review 2173.05(p) regarding claims directed to both a product and process. Both claims 59 and 60 were examined as product claims because they depend from independent claims 27 and 32, of which both claims are initially directed to products. As a result of claims 59 and 60 not further incorporating any product limitations, those claims are encompassed by the cited prior art which renders obvious the product. In addition, Applicant’s attention is directed to MPEP 2112.01.II which discloses that product of identical chemical composition cannot have mutually exclusive properties. Thus, since the product is rendered obvious by the cited prior art, then like the pending invention, the product of the prior art would be capable of being a delivery system for the diseases disclosed in claims 59 and 60.
In regards to Applicant incorporating the various substances (statins, fibrates, antiplatelet drugs, PCSK9 inhibitors, anticoagulant drugs, angiotensin converting enzyme inhibitors, calcium ion antagonists, MMPs inhibitors, beta-receptor blockers, and glucocorticoid) into independent claims 27 and 32), Gorzelanny et al (Biomacromolecules, 2007, Vol. 8, pages 3035-3040) is made of record to illustrate that in the art, chitosan is recognized as a substance that suppresses MMP2 expression in melanoma cells (see entire document, especially; abstract; page 3035, left column, first paragraph; page 3035, left and right columns, bridging paragraph; page 3037, left column, first paragraph). Thus, chitosan is encompassed by the general group of “MMPs inhibitors” as one possible group of substances compatible with those of the pending invention. Hence, the substance of Zhang et al used for coupling to the surface is encompassed by the pending invention.
Claim 29 is directed to a mass ratio of the substance to the liposome carrier as set forth therein.
While Zhang et al does not give all the amounts of the ratio of substance to liposome carrier, the document discloses that substances such as different polymer-modified silicon dioxide surfaces including chitosan, polylysine and hyaluronic acid may be incorporated into the nanostructures (page 11140, abstract). In addition, it would be obvious to a skilled artisan to optimize the ratio of substance to liposome carrier because the Zhang et al disclose various way of optimizing the components, desired property of interest (e.g., thickness and surface morphology of the membrane). Still, Zhang et al disclose that one can vary the amount of DSPE-PEG2000 (the other component being optimized in the ratio) from 1.5-5 mole percent (page 11143, left and right columns, bridging paragraph). According to MPEP 2144.05, generally differences in things such as concentration (ratios) wherein the prior art discloses evidence indicating that such factor is critical and may be optimized, determining optimum workable ranges by routine experimentation is expected. Thus, it the limitations of claim 29 are rendered obvious.
For the reasons set forth supra, the pending invention (claims 27-33, 45, 59, and 60) is rendered obvious by Zhang et al in view of Gorzelanny et al (Biomacromolecules, 2007, Vol. 8, pages 3035-3040).
APPLICANT’S ASSERTIONS
In summary, it is asserted that (1) the pending invention is directed to a delivery system, comprising a liposome carrier and a targeting ligand, which is inserted into the liposome carrier in combination with a substance that is used for treating atherosclerosis or an atherosclerosis related disease. (2) In addition, it is cited that the role of hyaluronic acid in Zhang et al is different from that of the pending invention. (3) Still, it is asserted that Zhang et al does not involve any therapeutic agent or drug delivery and that the claims are directed to a substance used for treating atherosclerosis or an atherosclerosis related disease actively encapsulated by the liposome carrier which is a therapeutic agent. (4) It is asserted that the concentration of the target are not taught or suggested by Zhang et al. (5) It is asserted that the pending invention has superior plaque regression, high encapsulation rate and stability, and unexpected technical effects. It is asserted that Example 4 disclose the excellent therapeutic effect of the liposome nanocarrier delivery system.
EXAMINER’S RESPONSE
Applicant’s arguments were considered and deemed non-persuasive for reasons of record and those set forth below.
First, Applicant is respectfully requested to thoroughly review the claims and MPEP 2173.05(p). The pending claims set forth a product as well as a process and as such the pending claims are indefinite. Secondly, the claims are examined as a product and the components disclosed in the cited prior art overlap with those of the pending invention. As a result, MPEP 2112.01 sets forth that products of identical chemical composition cannot have mutually exclusive properties as a chemical substance/composition and its properties are inseparable. Hence, the hyaluronic acid in the prior art possesses the same properties of the hyaluronic acid in the pending invention. Thus, in both instances, hyaluronic acid would be capable of performing the same functions. Likewise, the product of Zhang et al would be capable of treating atherosclerosis or an atherosclerosis related disease like Applicant’s invention.
It is not necessary for Zhang et al to use a substance that is used for treating atherosclerosis or an atherosclerosis related disease as Applicant is claiming a product (initially), not a method of using a product. The claims were examined as if they were product claims.
In regards to the amounts, as indicated in the rejections, it would have been obvious to a skilled artisan to optimize the values. Thus, it is not necessary that Zhang et al teach the specific amounts as Applicant if one is optimizing based on MPEP 2144.05 discussed in the rejection supra.
In regards to assertion (5) above, it is duly noted that the claims were examined as product claims, not method claims. While it is asserted that the assay of Example 4 demonstrates the excellent therapeutic effect of the liposome delivery system, the pending claims are not directed to a method of obtaining a therapeutic effect (e.g., treatment) by administering the product (delivery system).
For the reasons set forth herein, the rejection is still deemed proper. Applicant is once again requested to thoroughly review the claims for clarity of the claimed invention. Also, review MPEP 2173.05(p).II which is directed to claims having both product and method steps. The pending claims are still ambiguous.
NEW GROUNDS OF REJECTIONS
Double Patenting Rejection
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 USPQM 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 27-33, 45, 59, and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-12, and 16-19 of U.S. Patent No. 12,642,875. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to liposome nanocarrier delivery systems that comprise (1) a liposome carrier comprising phospholipid and cholesterol, (2) a hyaluronic acid targeting ligand, and (3) a substance which includes statins (patented invention is specifically stated to rosuvastatin). Thus, the inventions disclose overlapping subject matter.
112 Second Paragraph Rejections
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 27-33, 45, 59, and 60 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.
Claims 27-33, 45, 59, and 60: Independent claims 27 and 32 are vague and indefinite for the following reasons. (1) It is confusing as to whether Applicant intended to set forth a product or method claim. The claims appear to be product claims, but the product claims contain active steps that are generally reserved for method/process claims. For example, the claims (for example, see independent claims 27 and 32) initially focuses on the product, but then discloses the purpose of the liposome delivery system (for treating atherosclerosis or an atherosclerosis related disease) and how the delivery system is modified with a targeting ligand that is inserted into the liposome carrier. Thus, the claims contain both a product and method/process steps.
Accord to MPEP 2173.05(p), a single claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product, the claim limitation is not directed to the product, but rather to actions involving the product which creates confusion as to when direct infringement occurs. Specifically, it is unclear whether infringement occurs when one has the actual product comprising a liposome carrier (phospholipid and cholesterol) and a substance (selected from statins, fibrates, antiplatelet drugs, PCSK9 inhibitors, anticoagulant drugs, angiotensin converting enzyme inhibitors, calcium ion antagonists, MMPs inhibitors, beta receptor blockers, and glucocorticoid) or when (a) the phospholipid and cholesterol are encapsulated by the liposome carrier; (b) the delivery system is modified with a targeting ligand; and (c) the delivery system is modified with the targeting ligand and is inserted into the liposome carrier. Since claims 28-31, 33, 45, 59, and 60 depend upon independent claims 27 or 32 for clarification, those claims are also vague and indefinite.
Note(s): If Applicant is claiming a product, it is respectfully suggested that the claims may be amended as or in a format that clearly sets forth the claimed product:
“A liposome nanocarrier delivery system comprising a targeting ligand, a liposome carrier and a substance; wherein the liposome carrier comprises phospholipid and cholesterol;
wherein the substance is selected from one or more of statins, fibrates, antiplatelet drugs, PCSK9 inhibitors, anticoagulant drugs, angiotensin converting enzyme inhibitors, calcium ion antagonists, MMPs inhibitors, β-receptor blockers, glucocorticoid, and pharmaceutically acceptable salts thereof’; and wherein the targeting ligand is hyaluronic acid and DSPE-PEG2000-NH2 and said targeting ligand has a final concentration of 10-100 µg/ml”.
Claims 27-29, 31-33, 45, 59, and 60: Independent claims 27 and 32 are ambiguous for the following reasons: according to MPEP 2173.05(h), while a Markush grouping may include a large number of alternatives, and not necessarily be indefinite under, in certain circumstances, a Markush group may be so expansive that a skilled artisan cannot determine the metes and bounds of the claimed invention. In the pending claims, the substance is directed to any statin, any fibrate, any antiplatelet drugs, any PCSK9 inhibitor, any anticoagulant drug, any angiotensin converting enzyme inhibitor, any calcium ion antagonist, any MMPs inhibitor, any β-receptor blockers, and any glucocorticoids. Thus, the claim encompasses a substance defined by a Markush group that encompasses a massive number of distinct alternative members such that one skilled in the art cannot determine the metes and bounds of the claim. As a result, due to an inability to envision the compounds defined by the Markush groups, the claim is deemed to be vague and indefinite. Since claims 28-31, 33, 45, 59, and 60 depend upon independent claims 27 or 32 for clarification, those claims are also vague and indefinite.
Claims 27-33, 45, 59, and 60: Independent claims 27 and 32 (lines 15-16 and 15, respectively) are ambiguous because of the phrase targeting ligand...“is hyaluronic acid and DSPE-PEG2000-NH2”. Specifically, it is unclear if one is indicating that the targeting ligand is a Markush grouping wherein one may select from hyaluronic acid and DSPE-PEG2000-NH2 (see MPEP 803.02) or if both hyaluronic acid and DSPE-PEG2000NH2 are required for the targeting ligand component. Please clarify the pending invention.
112 Fourth Paragraph Rejections
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.
Claims 59 and 60 are 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. In particular, claims 59 and 60 depend from independent claims 27 and 32 respectively, which are product claims comprising a liposome carrier (comprising a phospholipid and cholesterol), a substance (selected from statins, fibrates, antiplatelet drugs, PCSK9 inhibitors, anticoagulant drugs, angiotensin converting enzyme inhibitors, calcium ion antagonists, MMP inhibitors, beta receptor blockers, and glucocorticoids), and a targeting ligand (the targeting ligand is hyaluronic acid and DSPE-PEG2000-NH2). However, claims 27 and 32 do not further limit claims 27 and 32 because they are directed to uses (treatment) of the product. As a result, one is attempting to limit the product claim by its intended use, not by incorporating additional product components into the product claims. 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.
Comments/Notes
Applicant is respectfully requested to thoroughly review MPEP 608.01(i) and 608.01(m) regarding the format of claims.
Conclusion
Claims 27-33, 45, 59, and 60 are rejected and claims 34-44, 46-50, and 55-58 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
June 29, 2026
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