DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-20 are currently pending and under consideration.
Priority
The present application is a continuation of US application no. 17/315,509 (now US Patent no. 11,903,965) filed on 05/10/2021, which was a continuation of US application no. 17/021,883 (now US Patent no. 11,033,582) filed on 09/15/2020, which was a continuation of US application no. 16/225,210 (now US Patent no. 10,821,133) filed on 12/19/2018. Acknowledgment is made of applicant’s claim for benefit under 35 U.S.C. 119(e) of Provisional application No. 62/611,098, filed on 12/28/2017. The present application and all claims are being examined with an effective filing date of December 28, 2017. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 1-2, 4-12 and 14-20 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, in part, “testing a portion of the batch of the delipidated plasma to characterize the pre-beta high density lipoprotein in order to, at least in part, determine a first characteristic of the pre-beta high density lipoprotein” and further recites “testing a portion of the prepared delipidated plasma…determining a second characteristic of the pre-beta high density lipoprotein from the prepared preserved delipidated plasma”, wherein the first and second characteristics are compared “to determine an extent of degradation” and to determine whether the prepared preserved delipidated plasma is suitable for administration. Similarly, claim 11 recites determining a first characteristic and a second characteristic of modified high density lipoprotein, comparing the characteristics to determine an extent of degradation, and determining suitability for administration.
The recitations of a “first characteristic” and a “second characteristic” are indefinite because it is unclear what specific characteristic is being measured and compared. The instant specification at paragraph 0146 teaches that the plasma may be assessed for numerous parameters, including but not limited to concentration and size of pre-beta and alpha HDL particles, total cholesterol, HDL, LDL, ApoA-I, ApoB, triglycerides, CBC parameters, electrolytes, coagulation parameters, cholesterol content, cholesterol efflux capacity, and other parameters. Thus, the specification describes numerous potential “characteristics” that may be measured. However, the claims do not identify which characteristic is being measured before preservation and after preservation, whether the same characteristic is being measured at both time points, or which characteristic is used to determine the recited “extent of degradation” and suitability for administration. As a result, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the claimed invention.
Although claim 2 specifies that the first characteristic is a first concentration of the pre-beta high density lipoprotein and claim 12 specifies that the first characteristic is a first concentration of the modified high density lipoprotein, the second characteristic remains undefined in claims 2 and 12. Accordingly, the indefiniteness identified above remains.
Claims 3 and 13 are not subject to this rejection because both the first characteristic and the second characteristic are expressly defined as concentrations.
Additionally, claims 12-13 recite the limitation “wherein the first characteristic of the pre-beta high density lipoprotein is a first concentration of the pre-beta high density lipoprotein” and “wherein the second characteristic of the pre-beta high density lipoprotein is a second concentration of the pre-beta high density lipoprotein from the prepared preserved delipidated plasma”. However, claim 11, from which claims 12 and 13 depend, does not recite pre-beta high density lipoprotein. Claim 11 is drawn to a method for preserving modified high density lipoproteins and recites, in part, “determine a first characteristic of the modified density lipoprotein” and “determining a second characteristic of the modified high density lipoprotein from the prepared preserved delipidated plasma”. Therefore, there is insufficient antecedent basis for “the pre-beta high density lipoprotein” in the claims.
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.
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 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Bellotti et al. (US20060172939, cited in the IDS).
Bellotti et al. discloses methods for removing lipids from HDL particles while leaving LDL particles substantially intact, via the extracorporeal treatment of blood plasma using either a single solvent or multiple solvents (Specification, para 0002). Specifically, Bellotti et al. teaches obtaining plasma containing HDL particles from a patient, selectively delipidating the HDL particles within the plasma, removing residual solvent, and collecting the modified HDL-containing plasma for administration to the patient. It is noted that with respect to obtaining plasma, Bellotti et al. expressly teaches withdrawing blood from a patient and separating the blood into plasma and red blood cells (para 0152-0153). Bellotti et al. further teaches characterizing HDL particles and HDL subspecies using analytical techniques including native PAGE, immunoblotting, and image analysis. In particular, Bellotti et al. teaches analysis of ApoA-1-containing HDL subspecies including pre-beta-1 HDL and pre-beta-2 HDL particles before and after solvent treatment. Bellotti et al. teaches that solvent treatment increases the levels of pre-beta-1 HDL and pre-beta-2 HDL particles and decreases alpha HDL subspecies, thereby comparing HDL characteristics before and after processing (Fig. 1-2 and 17; and Examples 7-8, para 0182-0185). Because Bellotti et al. expressly teaches characterization and comparison of pre-beta HDL subspecies before and after treatment, Bellotti teaches testing a portion of the batch of the delipidated plasma to characterize the modified high density lipoproteins of claim 11 and the pre-beta high density lipoprotein of claim 1 in order to determine characteristics thereof.
Bellotti et al. further teaches maintaining the processed plasma following treatment and prior to administration to a patient (see Figs. 1-2; Example 8). The term “preserving” is broadly recited and is not limited to any particular preservation technique. Therefore, under the broadest reasonable interpretation, preserving encompasses retaining, storing, or otherwise maintaining the treated plasma for subsequent administration. Bellotti therefore teaches preserving the batch of delipidated plasma.
Bellotti et al. further teaches preparing the treated plasma for administration and administering the treated plasma to a patient (see Example 8). The phrase “after a period of time” is broadly recited and does not require any minimum duration. Therefore, any non-zero interval between preservation and administration reasonably satisfies the limitation. Bellotti inherently requires the passage of time between processing, characterization, handling, and administration of the plasma product.
Bellotti et al. further teaches testing and characterizing HDL particles following treatment. Example 7 of Bellotti et al. expressly compares HDL subspecies present before treatment with HDL subspecies present after treatment and evaluates changes resulting from the processing steps. Thus, Bellotti et al. teaches determining a first characteristic and a second characteristic of HDL particles and comparing those characteristics before and after processing.
Bellotti et al. does not expressly describe determining an “extent of degradation” or determining suitability for administration based upon the comparison. However, before the effective filing date of the claimed invention, Bellotti taught characterization and comparison of HDL particle properties before and after processing and taught administration of the processed HDL product to a patient. Given Bellotti’s teaching that HDL and pre-beta HDL particles may be characterized according to measurable properties including relative levels of HDL subspecies, charge, molecular mass, size, shape, and chemical composition, it would have been obvious to a person of ordinary skill in the art to compare characteristics of the particles before and after processing in order to evaluate changes resulting from the processing and determine whether the plasma product remained suitable for administration to a patient. One of ordinary skill in the art would have had a reasonable expectation of success because Bellotti et al. expressly teaches analytical methods capable of characterizing HDL particles and demonstrates successful comparison of HDL subspecies before and after treatment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine whether changes observed in the HDL particles following processing indicated degradation of the particles and whether the processed plasma remained suitable for administration. Accordingly, the invention as a whole would have been prima facie obvious over Bellotti et al.
Thus, claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Bellotti et al.
Claims 2-8, 10, 12-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bellotti et al., as applied to claims 1 and 11 above, and further in view of Sacks et al. (Selective delipidation of plasma HDL enhances reverse cholesterol transport in vivo. J Lipid Res. 2009 May;50(5):894-907, cited in PTO-892).
The teachings of Bellotti et al., as they apply to claims 1 and 11, have already been discussed above. Bellotti et al. does not expressly teach wherein the first and second characteristic of the pre-beta high density lipoprotein is the concentration of the lipoprotein, modifying the pre-beta high density lipoprotein to a concentration in a range of 1 mg/dl to 400 mg/dl”, freezing the batch at a temperature of less than -30°C and for less than 20 minutes, thawing the preserved delipidated plasma in a temperature range of 2°C to 26°C, storing the thawed delipidated plasma at a temperature in a range of 1°C to 6°C for no more than 5 days, nor wherein the period of time between preserving and preparing the delipidated plasma is one week to three years.
Regarding claims 2 and 12, Sacks et al. teaches measuring concentrations of HDL species before and after selective delipidation. Specifically, Sacks et al. teaches that lipids and apolipoproteins were measured in plasma before and after delipidation (p. 895, left column). Sacks et al. further teaches measuring HDL cholesterol, total apoA-I, preβ-1, other preβ, and α-HDL particles at various time points following infusion (pp. 897-900). Therefore, Sacks et al. teaches measuring concentrations of preβ HDL species before and after treatment.
Regarding claims 3-4 and 13-14, Sacks et al. teaches that selective delipidation alters HDL concentrations and that HDL concentrations were measured and monitored before and after treatment. Specifically, Sacks et al. teaches that HDL cholesterol concentration was reduced from 42 mg/dL to 10 mg/dL following selective delipidation (p. 898, Table 1) and that concentrations of preβ-like HDL and α-HDL particles were measured following infusion (pp. 897-900). It would have been obvious to one of ordinary skill in the art to adjust the amount of preβ HDL and monitor concentration levels to achieve a desired therapeutic concentration because concentration represents a result-effective variable affecting administration and efficacy of HDL preparations. Optimization of such concentrations would have been obtainable through routine experimentation. See MPEP §2144.05.
Regarding claims 5 and 15, Sacks et al. teaches freezing plasma samples during processing and analysis. Specifically, Sacks et al. teaches that samples for two-dimensional gel analysis were frozen at -70°C prior to analysis (p. 895). Therefore, Sacks et al. teaches preserving plasma samples by freezing at a temperature less than -30°C.
Regarding claims 6 and 16, Sacks et al. teaches thawing preserved plasma prior to use. Specifically, Sacks et al. teaches that donor vervet plasma was thawed in a refrigerator overnight prior to further processing (p. 896). Therefore, Sacks et al. teaches thawing preserved plasma prior to administration.
Regarding claims 7 and 17, Sacks et al. teaches freezing and thawing plasma samples as part of preparation and administration procedures (pp. 895-896). Although Sacks et al. does not expressly disclose subjecting a volume of delipidated plasma in a range from 1 milliliter to 2 liters to a temperature less than -30°C for less than 20 minutes, it would have been obvious to one of ordinary skill in the art to optimize freezing conditions, including sample volume, temperature, and duration, because such parameters represent result-effective variables affecting preservation and handling of plasma products. Determination of workable values would have involved only routine experimentation. See MPEP §2144.05.
Regarding claims 8 and 18, Sacks et al. teaches storing donor plasma prior to thawing, processing, and administration. Specifically, Sacks et al. teaches that donor plasma was stored at -20°C since collection and subsequently thawed for use (p. 896). Although Sacks et al. does not expressly disclose a storage period of one week to three years, the duration of storage represents a result-effective variable that would have been selected according to clinical, manufacturing, and logistical requirements. Determination of an appropriate storage duration would have involved only routine optimization of known preservation procedures. See MPEP §2144.05.
Regarding claims 10 and 20, Sacks et al. teaches storing plasma, thawing plasma, and subsequently utilizing the thawed plasma in a therapeutic administration procedure. Specifically, Sacks et al. teaches that donor plasma was stored at -20°C since collection, thawed in a refrigerator overnight, and subsequently processed and administered (p. 896). Therefore, Sacks et al. teaches storing and subsequently using thawed plasma following preservation.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine the prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, the teachings of Bellotti et al., that pre-beta HDL-containing and modified HDL-containing delipidated plasma may be prepared, characterized, preserved, evaluated, and administered to a patient, and the teachings of Sacks et al. that HDL and pre-beta HDL species may be measured before and after delipidation, that plasma samples may be frozen, stored, and thawed during processing, and that HDL concentrations may be monitored during preparation and administration, would have led a person of ordinary skill in the art to measure concentrations of pre-beta HDL species, preserve delipidated plasma by freezing and thawing, and determine appropriate concentration, temperature, volume, storage, and processing conditions for preparation of HDL products intended for therapeutic administration. Given that Bellotti et al. demonstrates successful preparation, characterization, and administration of modified HDL-containing plasma products, and Sacks et al. demonstrates successful measurement, storage, freezing, thawing, and analysis of HDL-containing plasma products, a person of ordinary skill in the art would have had a reasonable expectation of success in applying the teachings of Sacks et al. to the methods of Bellotti et al. In particular, a skilled artisan would have readily predicted that employing known concentration measurement, freezing, thawing, storage, and processing procedures in the Bellotti methods would successfully result in preserved pre-beta HDL-containing and modified HDL-containing plasma products suitable for administration to a patient. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Thus, claims 2-8, 10, 12-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bellotti et al., in view of Sacks et al.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Bellotti et al., as applied to claims 1 and 11 above, and further in view of Shanbrom et al. (U.S. Patent No. 4,086,218, cited in PTO-892).
The teachings of Bellotti et al., as they apply to claims 1 and 11, have already been discussed above. Bellotti et al. does not expressly teach adding a preservative to the delipidated plasma prior to preservation.
Regarding claims 9 and 19, Bellotti and Saks do not expressly teach adding a preservative prior to the preserving step.
Shanbrom et al. teaches adding a preservative solution comprising heparin and polyethylene glycol to plasma prior to freezing and preservation, wherein the preservative preserves blood factors and other protein constituents of the plasma and improves stability and recovery following freezing and thawing. Specifically, Shanbrom et al. teaches combining heparin and a polyol such as polyethylene glycol with plasma before freezing such that blood factors are preserved and increased stability may be obtained (col. 2, lines 54-66). Shanbrom et al. further teaches that AHF and other protein constituents of plasma are preserved by adding a preservative solution to plasma and that the preservative solution may be mixed with plasma soon after collection to preserve protein constituents during subsequent freezing and thawing operations (col. 3, lines 28-48).
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine the prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, the teachings of Bellotti et al. that delipidated plasma containing pre-beta HDL particles may be prepared and preserved for therapeutic administration, and the teachings of Shanbrom et al. that preservatives may be added to plasma prior to preservation in order to preserve blood factors and other protein constituents of the plasma during freezing, storage, and thawing, would have led a person of ordinary skill in the art to add a preservative to the delipidated plasma of Bellotti et al. prior to the preserving step. Given that Shanbrom et al. demonstrates that the addition of preservatives such as heparin and polyethylene glycol preserves plasma protein constituents and improves stability during preservation and subsequent thawing, a person of ordinary skill in the art would have readily predicted that the combination of these teachings would successfully result in a method for preserving pre-beta high-density lipoprotein-containing plasma and modified high-density lipoprotein-containing plasma for administration to a patient. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Thus, claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Bellotti et al., in view of Shanbrom 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 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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,821,133. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious over the invention of US ‘133, as explained below.
The invention of US ‘133 is drawn to “[a] method for preserving pre-beta high density lipoprotein for administration to a patient, comprising:
obtaining a batch of delipidated plasma comprising the pre-beta high density lipoprotein;
testing a portion of the batch of the delipidated plasma to characterize the pre-beta high density lipoprotein in order to, at least in part, determine a first concentration of the pre-beta high density lipoprotein;
preserving the batch of the delipidated plasma;
after a period of time, preparing the preserved delipidated plasma for administration to the patient;
testing a portion of the prepared preserved delipidated plasma by acquiring the first concentration of the pre-beta high density lipoprotein, determining a second concentration of the pre-beta high density lipoprotein from the prepared preserved delipidated plasma, comparing the second concentration of the pre-beta high density lipoprotein to the first concentration of the pre-beta high density lipoprotein to determine an extent of degradation, and determining if the prepared preserved delipidated plasma is suitable for administration based on the second concentration of the pre-beta high density lipoprotein; and
administering the prepared preserved delipidated plasma comprising the second concentration of the pre-beta high density lipoprotein to the patient”.
Dependent claims include “[t]he method of claim 1, further comprising, prior to said preserving, modifying an amount of the pre-beta high density lipoprotein to ensure a concentration of the pre-beta high density lipoprotein is in a range of 1 mg/dl to 400 mg/dl”; “the method of claim 1, wherein said preserving comprises freezing the batch at a temperature less than −30° C”; “the method of claim 1, wherein said preparing comprises thawing the preserved delipidated plasma in a temperature range of 2° C. to 26° C”; “the method of claim 1, wherein said preserving comprises subjecting a volume of the delipidated plasma in a range from 1 milliliter to 2 liters to a temperature of less than −30° C. for less than 20 minutes”; “[t]he method of claim 1, wherein the period of time ranges from one week to three years”; “[t}he method of claim 1, further comprising, prior to said preservation, adding a preservative to the delipidated plasma”; “[t]he method of claim 1, wherein said preparing comprises thawing the preserved delipidated plasma and further comprising storing the thawed delipidated plasma at a temperature in a range of 1° C. to 6° C. for no more than 5 days.”
Another independent claim is drawn to “[a] method for preserving modified high density lipoproteins for administration to a patient, comprising:
obtaining a batch of delipidated plasma comprising the modified high density lipoproteins by connecting at least one person to a device for withdrawing blood, withdrawing blood containing blood cells from the at least one person, separating the blood cells from the blood to yield a blood plasma fraction containing high density lipoproteins and low density lipoproteins, delipidating the high density lipoproteins using a solvent, separating out the low density lipoproteins, and collecting the delipidated plasma with the modified high density lipoproteins;
testing a portion of the batch of the delipidated plasma to characterize the modified high density lipoproteins in order to, at least in part, determine a first concentration of the modified density lipoprotein;
preserving the batch of the delipidated plasma;
after a period of time, preparing the preserved delipidated plasma for administration to the patient;
testing a portion of the prepared preserved delipidated plasma by acquiring the first concentration of the modified high density lipoprotein, determining a second concentration of the modified high density lipoprotein from the prepared preserved delipidated plasma, comparing the second concentration of the modified high density lipoprotein to the first concentration of the modified high density lipoprotein to determine an extent of degradation, and determining if the prepared preserved delipidated plasma is suitable for administration based on the second concentration of the modified high density lipoprotein; and
administering the prepared preserved delipidated plasma comprising the second concentration of modified high density lipoproteins to the patient.”
Dependent limitations include: “[t]he method of claim 9, further comprising, prior to said preserving, modifying an amount of the modified high density lipoproteins to ensure a concentration of the modified high density lipoproteins is in a range of 1 mg/dl to 400 mg/dl”; “[t]he method of claim 9, wherein said preserving comprises freezing the batch at a temperature less than −30° C”; “[t]he method of claim 9, wherein said preparing comprises thawing the preserved delipidated plasma in a temperature range of 2° C. to 26° C”; “[t]he method of claim 9, wherein said preserving comprises subjecting a volume of the delipidated plasma in a range from 1 milliliter to 2 liters to a temperature less than −30° C. for less than 20 minutes”; “[t]he method of claim 9, wherein the period of time ranges from one week to three years”; “[t]he method of claim 9, further comprising, prior to said preservation, adding a preservative to the delipidated plasma”; “[t]he method of claim 9, wherein said preparing comprises thawing the preserved delipidated plasma and further comprising storing the thawed delipidated plasma at a temperature in a range of 1° C to 6° C for no more than 5 days”.
Therefore the US’133 claimed invention anticipates the instantly claimed invention.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,033,582. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious over the invention of US ‘582, as explained below.
The invention of US ‘582 is drawn to a method for preserving pre-beta high density lipoprotein for administration to a patient, comprising:
obtaining a batch of delipidated plasma comprising the pre-beta high density lipoprotein;
testing a portion of the batch of the delipidated plasma to characterize the pre-beta high density lipoprotein in order to, at least in part, determine a first characteristic of the pre-beta high density lipoprotein, wherein the first characteristic comprises a first concentration of the pre-beta high density lipoprotein in the delipidated plasma;
preserving the batch of the delipidated plasma;
after a period of time, preparing the preserved delipidated plasma for administration to the patient, wherein the period of time ranges from one week to three years;
testing a portion of the prepared preserved delipidated plasma by acquiring a first amount of the pre-beta high density lipoprotein, determining a second characteristic of the pre-beta high density lipoprotein from the prepared preserved delipidated plasma, wherein the second characteristic comprises a second concentration of the pre-beta high density lipoprotein in the prepared preserved delipidated plasma, comparing the second characteristic of the pre-beta high density lipoprotein to the first characteristic of the pre-beta high density lipoprotein to determine an extent of degradation, and determining if the prepared preserved delipidated plasma is suitable for administration based on the second characteristic of the pre-beta high density lipoprotein; and
administering the prepared preserved delipidated plasma to the patient.
Dependent claims include: “the method of claim 1, further comprising, prior to said preserving, modifying an amount of the pre-beta high density lipoprotein to ensure a concentration of the pre-beta high density lipoprotein is in a range of 1 mg/dl to 400 mg/dl”; “[t]he method of claim 1, wherein said preserving comprises freezing the batch at a temperature less than −30° C”; “[t]he method of claim 1, wherein said preparing comprises thawing the preserved delipidated plasma in a temperature range of 2° C. to 26° C”; “[t]he method of claim 1, wherein said preserving comprises subjecting a volume of the delipidated plasma in a range from 1 milliliter to 2 liters to a temperature of less than −30° C. for less than 20 minutes”; “[t]he method of claim 1, further comprising, prior to said preservation, adding a preservative to the delipidated plasma”; “[t]he method of claim 1, wherein said preparing comprises thawing the preserved delipidated plasma and further comprising storing the thawed delipidated plasma at a temperature in a range of 1° C to 6° C for no more than 5 days.”
Another independent claim is drawn to “[a] method for preserving modified high density lipoproteins for administration to a patient, comprising:
obtaining a batch of delipidated plasma comprising the modified high density lipoproteins by connecting at least one person to a device for withdrawing blood, withdrawing blood containing blood cells from the at least one person, separating the blood cells from the blood to yield a blood plasma fraction containing high density lipoproteins and low density lipoproteins, delipidating the high density lipoproteins using a solvent, separating out the low density lipoproteins, and collecting the delipidated plasma with the modified high density lipoproteins;
testing a portion of the batch of the delipidated plasma to characterize the modified high density lipoproteins in order to, at least in part, determine a first characteristic of the modified density lipoprotein, wherein the first characteristic comprises a first concentration of the modified density lipoprotein in the delipidated plasma;
preserving the batch of the delipidated plasma;
after a period of time, preparing the preserved delipidated plasma for administration to the patient, wherein the period of time ranges from one week to three years;
testing a portion of the prepared preserved delipidated plasma by acquiring a first amount of the modified high density lipoprotein, determining a second characteristic of the modified high density lipoprotein from the prepared preserved delipidated plasma, wherein the second characteristic comprises a second concentration of the pre-beta high density lipoprotein in the prepared preserved delipidated plasma, comparing the second characteristic of the modified high density lipoprotein to the first characteristic of the modified high density lipoprotein to determine an extent of degradation, and determining if the prepared preserved delipidated plasma is suitable for administration based on the second characteristic of the modified high density lipoprotein; and
administering the prepared preserved delipidated plasma to the patient.
Dependent limitation include “[t]he method of claim 8, further comprising, prior to said preserving, modifying an amount of the modified high density lipoproteins to ensure a concentration of the modified high density lipoproteins is in a range of 1 mg/dl to 400 mg/dl”; “[t]he method of claim 8, wherein said preserving comprises freezing the batch at a temperature less than −30° C”; “[t]he method of claim 8, wherein said preparing comprises thawing the preserved delipidated plasma in a temperature range of 2° C. to 26° C”; “[t]he method of claim 8, wherein said preserving comprises subjecting a volume of the delipidated plasma in a range from 1 milliliter to 2 liters to a temperature less than −30° C. for less than 20 minutes”; “[t]he method of claim 8, further comprising, prior to said preservation, adding a preservative to the delipidated plasma”; “[t]he method of claim 8, wherein said preparing comprises thawing the preserved delipidated plasma and further comprising storing the thawed delipidated plasma at a temperature in a range of 1° C. to 6° C. for no more than 5 days”.
Therefore, the US’582 claimed invention anticipates the instantly claimed invention.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,903,965. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious over the invention of US ‘965, as explained below.
The invention of US ‘965 is drawn to a method for preserving pre-beta high density lipoprotein for administration to a patient, comprising:
obtaining a batch of delipidated plasma comprising the pre-beta high density lipoprotein;
testing a portion of the batch of the delipidated plasma to characterize the pre-beta high density lipoprotein in order to, at least in part, determine a first characteristic of the pre-beta high density lipoprotein, wherein the first characteristic comprises a first concentration of the pre-beta high density lipoprotein in the delipidated plasma;
preserving the batch of the delipidated plasma;
after a period of time, preparing the preserved delipidated plasma for administration to the patient, wherein the period of time ranges from one week to three years;
testing a portion of the prepared preserved delipidated plasma by acquiring a first amount of the pre-beta high density lipoprotein, determining a second characteristic of the pre-beta high density lipoprotein from the prepared preserved delipidated plasma, wherein the second characteristic comprises a second concentration of the pre-beta high density lipoprotein in the prepared preserved delipidated plasma, comparing the second characteristic of the pre-beta high density lipoprotein to the first characteristic of the pre-beta high density lipoprotein to determine an extent of degradation, and determining if the prepared preserved delipidated plasma is suitable for administration based on the second characteristic of the pre-beta high density lipoprotein; and
administering the prepared preserved delipidated plasma to the patient.
Dependent claims include: “the method of claim 1, further comprising, prior to said preserving, modifying an amount of the pre-beta high density lipoprotein to ensure a concentration of the pre-beta high density lipoprotein is in a range of 1 mg/dl to 400 mg/dl”; “[t]he method of claim 1, wherein said preserving comprises freezing the batch at a temperature less than −30° C”; “[t]he method of claim 1, wherein said preparing comprises thawing the preserved delipidated plasma in a temperature range of 2° C. to 26° C”; “[t]he method of claim 1, wherein said preserving comprises subjecting a volume of the delipidated plasma in a range from 1 milliliter to 2 liters to a temperature of less than −30° C. for less than 20 minutes”; “[t]he method of claim 1, further comprising, prior to said preservation, adding a preservative to the delipidated plasma”; “[t]he method of claim 1, wherein said preparing comprises thawing the preserved delipidated plasma and further comprising storing the thawed delipidated plasma at a temperature in a range of 1° C to 6° C for no more than 5 days.”
Another independent claim is drawn to “[a] method for preserving modified high density lipoproteins for administration to a patient, comprising:
obtaining a batch of delipidated plasma comprising the modified high density lipoproteins by connecting at least one person to a device for withdrawing blood, withdrawing blood containing blood cells from the at least one person, separating the blood cells from the blood to yield a blood plasma fraction containing high density lipoproteins and low density lipoproteins, delipidating the high density lipoproteins using a solvent, separating out the low density lipoproteins, and collecting the delipidated plasma with the modified high density lipoproteins;
testing a portion of the batch of the delipidated plasma to characterize the modified high density lipoproteins in order to, at least in part, determine a first characteristic of the modified density lipoprotein, wherein the first characteristic comprises a first concentration of the modified density lipoprotein in the delipidated plasma;
preserving the batch of the delipidated plasma;
after a period of time, preparing the preserved delipidated plasma for administration to the patient, wherein the period of time ranges from one week to three years;
testing a portion of the prepared preserved delipidated plasma by acquiring a first amount of the modified high density lipoprotein, determining a second characteristic of the modified high density lipoprotein from the prepared preserved delipidated plasma, wherein the second characteristic comprises a second concentration of the pre-beta high density lipoprotein in the prepared preserved delipidated plasma, comparing the second characteristic of the modified high density lipoprotein to the first characteristic of the modified high density lipoprotein to determine an extent of degradation, and determining if the prepared preserved delipidated plasma is suitable for administration based on the second characteristic of the modified high density lipoprotein; and
administering the prepared preserved delipidated plasma to the patient.
Dependent limitation include “[t]he method of claim 8, further comprising, prior to said preserving, modifying an amount of the modified high density lipoproteins to ensure a concentration of the modified high density lipoproteins is in a range of 1 mg/dl to 400 mg/dl”; “[t]he method of claim 8, wherein said preserving comprises freezing the batch at a temperature less than −30° C”; “[t]he method of claim 8, wherein said preparing comprises thawing the preserved delipidated plasma in a temperature range of 2° C. to 26° C”; “[t]he method of claim 8, wherein said preserving comprises subjecting a volume of the delipidated plasma in a range from 1 milliliter to 2 liters to a temperature less than −30° C. for less than 20 minutes”; “[t]he method of claim 8, further comprising, prior to said preservation, adding a preservative to the delipidated plasma”; “[t]he method of claim 8, wherein said preparing comprises thawing the preserved delipidated plasma and further comprising storing the thawed delipidated plasma at a temperature in a range of 1° C. to 6° C. for no more than 5 days”.
Therefore, the US’965 claimed invention anticipates the instantly claimed invention.
Conclusion
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAGHMEH NINA MOAZZAMI whose telephone number is (703)756-4770. The examiner can normally be reached Monday-Friday, 9:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached at 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NAGHMEH NINA MOAZZAMI/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
Prosecution Insights