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 .
2. Applicant’s amendment filed on 01/20/2026 is acknowledged.
3. Claims 1-7, 9-12, 15-17, 19, 24, 26, 29-31, 35 and 37 are pending. Claim 1 is the independent claim.
4. Applicant’s election without traverse of Group I, and the species of “a vaccine comprising DSPE as the lipid, PEG2x as the linker, and MD39 trimer as the immunogen, wherein the linker is positioned between the lipid and the immunogen” in the reply filed on 01/20/2026 is acknowledged.
5. Claims 29-31, 35 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group and claims 15-17 and 19 are withdrawn as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/20/2026.
6. Claims 1-7, 9-12, 24 and 26 are under consideration as they read on “a vaccine comprising DSPE as the lipid, PEG2x as the linker, and MD39 trimer as the immunogen, wherein the linker is positioned between the lipid and the immunogen.”
7. Applicant’s IDS document filed on 09/15/2023, 01/23/2026 and 01/23/2026 have been considered.
Claim Rejections - 35 USC § 112
8. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
9. Claims 1-7, 9-12, 24 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not reasonably provide enablement for: a vaccine comprising an amphiphilic conjugate, wherein the amphiphilic conjugate comprises an immunogen operably linked to an albumin-binding lipid, and wherein the vaccine is suitable for transmucosal administration to induce a humoral immune response of claim 1; wherein the transmucosal administration is intranasal administration of claim 2; wherein the immunogen is a protein antigen having a molecular weight between about 10 kDa and about 500 kDa of claim 3; wherein the immunogen comprises a protein antigen selected from the group consisting of a human immunodeficiency virus (HIV) antigen, a SARS-CoV-2 antigen, an influenza antigen, a rotavirus antigen, a cytomegalovirus (CMV) antigen, an Epstein-Barr virus (EBV) antigen, a respiratory syncytial virus (RSV) antigen, and a cholera antigen of claim 4; wherein the immunogen comprises a monomer antigen or trimer antigen of claim 5; wherein the immunogen comprises an antigenic peptide of claim 6; wherein the albumin-binding lipid is selected from the group consisting of a cholesterol, a monoacyl lipid, and a diacyl lipid of claim 7;
wherein the albumin-binding lipid is 1 ,2-distearoyl-sn-glycero-3 phosphoethanolamine (DSPE) of claim 9; wherein the immunogen is operably linked to the albumin-binding lipid via a first linker of claim 10; wherein the first linker is selected from the group consisting of a hydrophilic polymer, a string of hydrophilic amino acids, polysaccharides, oligonucleotides, or a combination thereof of claim 11; wherein the first linker comprises a polyethylene glycol (PEG) linker of claim 12; further comprising an adjuvant of claim 24; and wherein transmucosal administration of the vaccine elicits or enhances production of antibodies that bind to the immunogen of claim 26.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and or use the invention commensurate in scope with the claims. The specification disclosure does not enable one skilled in the art to practice the invention without an undue amount of experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
At issue is whether or not the claimed compositions could be used as vaccines. Vaccines are used to prevent specific diseases caused by a specific agent. The claims do not recite any disease to be prevented by the use of the claimed vaccines. At a minimum, claims directed to using vaccines must be directed to specifically preventing a particular disease. A “vaccine” to treat an unspecified disease is not enabled as the vaccine composition would be unsuccessfully used to treat any other disease or disorder than the one that it is formulated to prevent. One of ordinary skill in the art would be required to perform undue experimentation to make and use a vaccine formulated for preventing disorder X to prevent disorder Y.
Futhermore, the specification does not provide sufficient guidance on how to sufficiently any disease (vaccination) by administering the claimed compounds. The first criterion in judging a vaccine is the level of antibody (humoral immune response) before and after immunization. The success of the vaccination is judged by the extent of increase in the level of antigen - specific antibody. The second criterion for a vaccine is its ability to stimulate memory T lymphocytes (cell-mediated immune response) (See Kuby; PTO-892; Reference U). As such one of ordinary skill in the art would be required to perform undue experimentation to make and use the genus of vaccines encompassed for pharmaceutical use in preventing disease.
The specification fails to provide guidance as to how to prevent (100% prevention) any disease using any of the recited agents. The art is highly unpredictable as to what will be a therapy for HIV for example, so it would require an undue amount of experimentation for one of ordinary skill in the art to practice the claimed invention commensurate in the scope with the claims. The invention may encompass pharmaceutical compositions which treat HIV for example, but the specification does not disclose how to totally prevent HIV for example using a “vaccine” composition.
As evidenced by the HIVinfo.NIH.gov website on 04/04/2026, no FDA-approved preventive HIV vaccines currently exist (PTO-892; Reference V). As such, the specification is not enabled for any HIV vaccine of any kind.
The specification is not enabled for any vaccine which comprises “an immunogen” of claim 1; an immunogen “which is a protein wherein the immunogen is a protein antigen having a molecular weight between about 10 kDa and about 500 kDa” of claim 3; an immunogen which “comprises a protein antigen selected from the group consisting of a human immunodeficiency virus (HIV) antigen, a SARS-CoV-2 antigen, an influenza antigen, a rotavirus antigen, a cytomegalovirus (CMV) antigen, an Epstein-Barr virus (EBV) antigen, a respiratory syncytial virus (RSV) antigen, and a cholera antigen” of claim 4; “wherein the immunogen comprises a monomer antigen or trimer antigen” of claim 5; and“wherein the immunogen comprises an antigenic peptide” of claim 6. The specification is not enabled any of these immunogens “wherein transmucosal administration of the vaccine elicits or enhances production of antibodies that bind to the immunogen” of claim 26. One of ordinary skill in the art would be required to perform undue experimentation to make and use the invention commensurate in scope with the claims.
Since no in vivo studies were used as model system to prevent any disorder it is not clear that reliance on the in vitro data accurately reflects the relative animal efficacy of the claimed therapeutic strategy. The specification does not adequately teach how to effectively treat any disorders or reach any therapeutic endpoint in animals by administrating the vaccine, much less any disorder as encompassed by the instant claims. The specification does not teach how to extrapolate data obtained from the in vitro studies to the development of effective in vivo animal therapeutic treatment, commensurate in scope with the claimed invention. There must be a rigorous correlation of biological activity between the disclosed in vitro activity and an in vivo effectiveness to establish a method of preventing disease using a “vaccine”.
Although, the specification describes in vitro experiments, there is no correlation on this record between the in vitro studies and the preventing HIV for example in currently available form for humans or animals. It is not enough to rely on in vitro studies where, as here, a person having ordinary skill in the art has no basis for perceiving those studies as constituting recognized screening procedures with clear relevance to efficacy in humans or animals (emphasis added). Ex parte Maas, 9 USPQ2d 1746
In view of the absence of a specific and detailed description in Applicant's specification of how to effectively use the genus of “vaccine” compositions claimed, absence of working examples providing evidence which is reasonably predictive that the genus of claimed agents are effective for in vivo use for prevention of disease, and the lack of predictability in the art at the time the invention was made, an undue amount of experimentation would be required to practice the claimed vaccine compositions with a reasonable expectation of success.
Substantiating evidence may be in the form of animal tests, which constitute recognizedscreening procedures with clear relevance to efficacy in humans. See Ex parte Krepelka, 231USPQ 746 (Board of Patent Appeals and Interferences 1986) and cases cited therein. Ex parteMaas, 9 USPQ2d 1746.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
10. Claims 1-7, 9-12, 24 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is not in possession of: a vaccine comprising an amphiphilic conjugate, wherein the amphiphilic conjugate comprises an immunogen operably linked to an albumin-binding lipid, and wherein the vaccine is suitable for transmucosal administration to induce a humoral immune response of claim 1; wherein the transmucosal administration is intranasal administration of claim 2; wherein the immunogen is a protein antigen having a molecular weight between about 10 kDa and about 500 kDa of claim 3; wherein the immunogen comprises a protein antigen selected from the group consisting of a human immunodeficiency virus (HIV) antigen, a SARS-CoV-2 antigen, an influenza antigen, a rotavirus antigen, a cytomegalovirus (CMV) antigen, an Epstein-Barr virus (EBV) antigen, a respiratory syncytial virus (RSV) antigen, and a cholera antigen of claim 4; wherein the immunogen comprises a monomer antigen or trimer antigen of claim 5; wherein the immunogen comprises an antigenic peptide of claim 6; wherein the albumin-binding lipid is selected from the group consisting of a cholesterol, a monoacyl lipid, and a diacyl lipid of claim 7; wherein the albumin-binding lipid is 1 ,2-distearoyl-sn-glycero-3 phosphoethanolamine (DSPE) of claim 9; wherein the immunogen is operably linked to the albumin-binding lipid via a first linker of claim 10; wherein the first linker is selected from the group consisting of a hydrophilic polymer, a string of hydrophilic amino acids, polysaccharides, oligonucleotides, or a combination thereof of claim 11; wherein the first linker comprises a polyethylene glycol (PEG) linker of claim 12; further comprising an adjuvant of claim 24; and wherein transmucosal administration of the vaccine elicits or enhances production of antibodies that bind to the immunogen of claim 26.
The specification has not adequately described any the structure of “an immunogen” of claim 1; an immunogen “which is a protein wherein the immunogen is a protein antigen having a molecular weight between about 10 kDa and about 500 kDa” of claim 3; an immunogen which “comprises a protein antigen selected from the group consisting of a human immunodeficiency virus (HIV) antigen, a SARS-CoV-2 antigen, an influenza antigen, a rotavirus antigen, a cytomegalovirus (CMV) antigen, an Epstein-Barr virus (EBV) antigen, a respiratory syncytial virus (RSV) antigen, and a cholera antigen” of claim 4; “wherein the immunogen comprises a monomer antigen or trimer antigen” of claim 5; and “wherein the immunogen comprises an antigenic peptide” of claim 6; and the function of being a vaccine of claim 1 and “wherein transmucosal administration of the vaccine elicits or enhances production of antibodies that bind to the immunogen” of claim 26.
Conception cannot be achieved until a representative description of the structural and functional properties of the claimed invention has occurred, regardless of the complexity or simplicity of the method.
The specification has neither demonstrated a structure function relationship nor provided a representative number of species of immunogens with the recited functions.
The specification must set forth the structural features that allow one of ordinary skill in the art to identify and produce the recited immunogens. In the instant case, definition by function does not suffice to define the genus because it is only an indication of what the immunogens do, rather than what they are.. "Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features" Ex parte Kubin (83 U.S.P.Q.2d 1410 (BPAI 2007)), at page 16. In this instant case, Applicants have not provided the requisite identifying structural features of the immunogens encompassed. "Without a correlation between structure and function, the claim does little more than define the claimed invention by function" supra, at page 17.
The specification does not provide adequate written description of the claimed invention.
The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 U.S.P.Q.2d 1111
(Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the applicant had possession at the time of invention of the claimed invention.
Adequate written description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it. In the instant application, the amino acid sequence itself or isolated protein is required. See Fiers v. Revel, 25 USPQ 2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts., 18 USPQ2d 1016. In view of the aforementioned problems regarding description of the claimed invention, the specification does not provide an adequate written description of the invention claimed herein.
See The Regents of the University of California v. Eli Lilly and Company, 43 USPQ2d 1398,
1404-7 (Fed. Cir. 1997). In University of California v. Eli Lilly and Co., 39 U.S.P.Q.2d 1225
(Fed. Cir. 1995) the inventors claimed a genus of DNA species encoding insulin in different vertebrates or mammals, but had only described a single species of cDNA which encoded rat insulin. The court held that only the nucleic acids species described in the specification (i.e. nucleic acids encoding rat insulin) met the description requirement and that the inventors were not entitled to a claim encompassing a genus of nucleic acids encoding insulin from other vertebrates, mammals or humans, id. at 1240. The Federal Circuit has held that if an inventor is "unable to envision the detailed constitution of a gene so as to distinguish it from other materials.
. .conception has not been achieved until reduction to practice has occurred", Amgen, Inc. v.
Chugai Pharmaceutical Co, Ltd., 18 U.S.P.Q.2d 016 (Fed. Cir. 1991). Attention is also directed to the decision of The Regents of the University of California v. Eli Lilly and Company (CAFC,
July 1997) wherein is stated: "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 222 USPQ 369, 372-373 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.").
Accordingly, naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material. Thus, as we have previously held, a cDNA is not defined or described by the mere name "cDNA," even if accompanied by the name of the protein that it encodes, but requires a kind of specificity usually achieved by means of the recitation of the sequence of nucleotides that make up the cDNA." See
Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606.
As such, there is insufficient written description of the required kind of structure identifying information about the corresponding makeup of the claimed vaccine compositions comprising immunogens to demonstrate possession.
11. 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.
12. 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.
Claim 1: A vaccine comprising an amphiphilic conjugate, wherein the amphiphilic conjugate comprises an immunogen operably linked to an albumin-binding lipid, and wherein the vaccine is suitable for transmucosal administration to induce a humoral immune response.
13. Claims 1-7, 10-11, 24 and 26 are rejected under 35 U.S.C. 102(1)(1) as being anticipated by Tokatlian et al. (PTO-892; Reference W)
Tokatlian et al. teaches covalently anchoring a stabilized HIV envelope gp140 trimer, BG505 MD39, on the surfaces of synthetic liposomes to study the effects of trimer density and vesicle stability on vaccine-elicited humoral responses in mice. (In particular, abstract).
MD39-conjugated liposomes were prepared by unilamellar liposomes comprised of phospholipid:cholesterol:DGS-NTA(Ni):MPB lipids in a 61.5:28.5:5:5 mole ratio were synthesized by lipid film rehydration and membrane extrusion using a 100 nm membrane at T > Tm(phospholipid) (DMPC = 37 °C, DPPC = 50 °C, DSPC = 60 °C), followed by post-synthesis binding of 6xHis-Cys C-terminal-modified trimer (MD39-HHHHHHC) for 1 hour at 37 °C in PBS (final concentrations 2.1 µM MD39, 3.53 mM liposomes) followed by 16–18 hr incubation at 4 °C with rotation. Non-covalent liposomes were prepared similarly without MPB lipid (phospholipid:cholesterol:DGS-NTA(Ni) lipids in a 66.5:28.5:5 mole ratio). Increasingly stabilized liposomes were prepared with 15 mole% MPB lipid and with sphingomyelin in place of cholesterol (phospholipid:sphingomyelin:DGS-NTA(Ni):MPB lipids in a 51.5:28.5:5:15 mole ratio) (In particular, page 9, whole document).
Female balb/c mice (6–10 weeks old, Jackson Laboratories) were immunized with 1 µg MD39 trimer conjugated to liposomes mixed with 0.2 U ISCOMATRIX adjuvant (CSL Ltd.) or 5 µg in-house saponin adjuvant.
Claim 2 is included in this rejection because absent evidence to the contrary the claimed MD39 liposome formulation is not incompatible with intranasal administration.
The reference teachings anticipate the claimed invention.
14. 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.
15. Claims 1-7, 9-12, 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Tokatlian et al. (PTO-892; Reference W) in view of Wang et al. (PTO-892; Reference X).
Tokatlian et al. teaches covalently anchoring a stabilized HIV envelope gp140 trimer, BG505 MD39, on the surfaces of synthetic liposomes to study the effects of trimer density and vesicle stability on vaccine-elicited humoral responses in mice. (In particular, abstract).
MD39-conjugated liposomes were prepared by unilamellar liposomes comprised of phospholipid:cholesterol:DGS-NTA(Ni):MPB lipids in a 61.5:28.5:5:5 mole ratio were synthesized by lipid film rehydration and membrane extrusion using a 100 nm membrane at T > Tm(phospholipid) (DMPC = 37 °C, DPPC = 50 °C, DSPC = 60 °C), followed by post-synthesis binding of 6xHis-Cys C-terminal-modified trimer (MD39-HHHHHHC) for 1 hour at 37 °C in PBS (final concentrations 2.1 µM MD39, 3.53 mM liposomes) followed by 16–18 hr incubation at 4 °C with rotation. Non-covalent liposomes were prepared similarly without MPB lipid (phospholipid:cholesterol:DGS-NTA(Ni) lipids in a 66.5:28.5:5 mole ratio). Increasingly stabilized liposomes were prepared with 15 mole% MPB lipid and with sphingomyelin in place of cholesterol (phospholipid:sphingomyelin:DGS-NTA(Ni):MPB lipids in a 51.5:28.5:5:15 mole ratio) (In particular, page 9, whole document).
Female balb/c mice (6–10 weeks old, Jackson Laboratories) were immunized with 1 µg MD39 trimer conjugated to liposomes mixed with 0.2 U ISCOMATRIX adjuvant (CSL Ltd.) or 5 µg in-house saponin adjuvant.
Claim 2 is included in this rejection because absent evidence to the contrary the claimed MD39 liposome formulation is not incompatible with intranasal administration.
The claimed invention differs from the prior art in the recitation of wherein the albumin binding lipid is DSPE of claim 9 and wherein the linker is PEG of claim 12.
Wang et al. teaches Poly(ethylene glycol)–distearoylphosphatidylethanolamine (PEG-DSPE) block copolymers are biocompatible and amphiphilic polymers that can be widely utilized in the preparation of liposomes, polymeric nanoparticles, polymer hybrid nanoparticles, solid lipid nanoparticles, lipid–polymer hybrid nanoparticles, and microemulsions. Particularly, the terminal groups of PEG can be activated and linked to various targeting ligands, which can prolong the circulation time, improve the drug bioavailability, reduce undesirable side effects, and especially target specific cells, tissues, and even the intracellular localization in organelles. (In particular, abstract, whole document).
Wang teaches that conventional liposomes have low bioavailability and short blood-circulation time, and are easily absorbed by the RES.77,78 Strategies have been developed to overcome these difficulties by coating the surface of the liposomes with hydrophilic polymers or a glycolipid, such as PEG or monosialoganglioside (GMI).79,80 PEG possesses high flexibility, favorable hydrophilicity, antiphagocytosis against macrophages, resistance to immunological recognition, non combination with proteins, and biocompatibility,81–84 which enable the extensive application in developing the PEGylated liposomes for delivering various drugs PEGylated liposomes have attracted considerable attention as the passive targeting administration carriers for the therapy of cancer and infectious diseases. They outweigh other carriers in increasing the systemic circulation time of drugs, delivering active molecules to the site of action and preventing damage of healthy tissue from toxic effects. During the preparation, the key step of developing long circulating liposomes was accompanied by the inclusion of the synthetic polymer PEG in the liposome composition, such as PEG-DSPE. The incorporation of PEG-DSPE in the lipid-based carriers substantially prolongs the circulation lifetime of the liposomes. Dos Santos et al2 demonstrated that merely 0.5 mol% of PEG2000-DSPE would significantly increase the plasma circulation longevity of the liposomes from 1,2-distearoyl-sn-glycero-3-phosphatidylcholine (DSPC). The aggregation of DSPC-based liposomes was completely precluded with 2 mol% PEG2000-DSPE, suggesting that PEG2000-DSPE reduced the in vivo clearance of cholesterol free liposomal formulations and the adsorption of plasma proteins primarily by inhibiting surface interactions and particularly by liposome-liposome aggregation. The pharmacokinetics, biodistribution, and therapeutic efficacy of the PEGylated liposomes containing cisplatin and nonliposomal cisplatin were compared by Newman et al.87 They found that PEGylated liposomes had superior antitumor activity, lower kidney toxicity, and a prolonged circulation time, and also showed a 55-fold higher distribution volume, threefold higher peak plasma levels, and 60-fold larger plasma under the plasma concentration time curve (AUC) compared to those of cisplatin. Moreover, PEGylated liposome–treated animals displayed a 28-fold higher tumor AUC than for cisplatin. (In particular pages 4189-4190, whole document).
It would have been obvious to one of ordinary skill in the art at the time of invention to have modified the MD39-conjugated liposomes of Tokatilian et al. to use DSPE and PEG or PEG-2000 (PEG2k) because Wang et al. teaches that the key step of developing long circulating liposomes was accompanied by the inclusion of the synthetic polymer PEG in the liposome composition, such as PEG-DSPE and PEG2000-DSPE. Furthermore, it would have been obvious to have used PEG2000-DSPE because the aggregation of DSPC-based liposomes was completely precluded with 2 mol% PEG2000-DSPE. Wang et al. also teaches that PEGylated liposomes had superior antitumor activity, lower kidney toxicity, and a prolonged circulation time, and also showed a 55-fold higher distribution volume, threefold higher peak plasma levels, and 60-fold larger plasma under the plasma concentration time curve (AUC).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
16. No claim is allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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April 4, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641