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 .
Claim Status
Claims 1, 3, 9, 21, 27-30, 32, 37-38, 41, 45, 47, 50, 52, 56-57, and 60-61 were previously pending.
Applicant’s response to the 11 December 2025 Requirement for Restriction/Election Office Action is acknowledged.
In their Response, Applicant has elected a single species of half-life extended (HLE) bispecific antibody of SEQ ID NO: 77. Claims 1, 3, 9, 21, 27-29, 32, 37-38, 41, 45, 47, 50, 52, 56-57, and 60-61 read on the elected species.
Claims 1, 3, 9, 21, 27-30, 32, 37-38, 41, 45, 47, 50, 52, 56-57, and 60-61 remain pending and are currently under examination.
Information Disclosure Statement (IDS)
The IDSs (6) filed on 06 March 2023, 27 February 2025, 10 July 2025, 7 October 2025, 17 November 2025, and 30 March 2026 have been considered by the examiner. Signed copies are enclosed.
Priority
Applicant’s claim for the following priority is acknowledged:
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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 and 41 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 contains the trademark/trade name Triton-X-100®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name because the company can change the formulation at any time and one of ordinary skill (‘POSITA’) could not determine the metes and bounds of the claim. In the present case, the trademark/trade name is used to identify/describe a species of surfactant and, accordingly, the identification/description is indefinite.
Claim 41 recites the limitation “the buffer” in claim 1. The buffer is first introduced in claim 38, not claim 1. Therefore, there is insufficient antecedent basis for this limitation in claim 41, as it is dependent upon claim 1.
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, 32, 37-38, 41, 45, 47, 50, 52, 60, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay (US Pat. No. 8,367,054 B2; date of patent: 05 February 2013) and further in view of Bano (“Primary drying optimization in pharmaceutical freeze-drying: a multivial stochastic modeling framework,” published 24 February 2020).
Bandyopadhyay discloses lyophilized and stabilized formulations of protein PEG-IFN-α conjugates (abstract).
Regarding claim 1, Bandyopadhyay discloses a formulation comprising a protein, lactose, trehalose, and polysorbate 80 that is free of mannitol (col. 9, Table 5). Bandyopadhyay describes a process of lyophilizing this formulation involving:
Loading glass vials containing the formulation into a lyophilizer;
Freezing gradually in a controlled manner at ambient pressure and at a temperature between -40°C to -55°C for a period of 3 to 12 hours;
Subjecting the frozen sample to primary drying cycles at a temperature between -35°C to -45°C, while maintaining a vacuum pressure from 500 mTorr to 50 mTorr; and
Following the primary drying cycles, secondary drying cycles were carried out for at least 6 hours under vacuum pressure between 20 mTorr to 30 mTorr (col. 9, lines 50-67).
Bandyopadhyay discloses another embodiment of a formulation comprising a protein, lactose, and polysorbate 80 (col. 7, Table 1). Bandyopadhyay describes a process of lyophilizing this formulation involving:
Freezing gradually in a controlled manner at ambient pressure and at a temperature between -40°C to -55°C for a period of 3 to 12 hours;
Subjecting the frozen sample to primary drying cycles at temperatures between -45°C to 0°C, while maintaining a vacuum pressure from 500 mTorr to 50 mTorr for a period of at least 16 hours; and
Following the primary drying cycles, secondary drying cycles were carried out for at least 6 hours under vacuum pressure between 20 mTorr to 30 mTorr (col. 7, lines 20-48).
The values disclosed by Bandyopadhyay for temperature, pressure, and time overlap with the instantly claimed ranges. See MPEP 2144.05(I): “in the case where the claimed ranges overlap or lie inside ranges disclosed by prior art, a prima facie case of obviousness exists.”
Regarding claim 32, Bandyopadhyay describes a process of lyophilizing a formulation comprising a protein, lactose, and polysorbate 80 (col. 7, Table 1). The protein is in a concentration of 0.178 mg/mL (col. 7, Table 1), which falls within the claimed range.
Regarding claim 37, Bandyopadhyay discloses a preferred pH range of the formulation is between 4.5 to 7.1, preferably 6.5 to 7.1, and most preferably 6.8 (col. 5, lines 45-55). The range of pH disclosed by Bandyopadhyay as suitable for a formulation undergoing lyophilization encompasses the instantly claimed range.
Regarding claims 38 and 41, Bandyopadhyay discloses buffers are suitable in the formulation for maintaining the pH (col. 5, lines 46-55). The formulation examples provided by Bandyopadhyay comprises sodium succinate as a buffer in a concentration of 10mM (col. 7, Table 1), which falls within the claimed range.
Regarding claim 45, Bandyopadhyay discloses the formulation comprises a cryoprotectant, which provides stability to the protein from freezing-induced stresses (col. 5, lines 55-59). Bandyopadhyay discloses suitable cryoprotectants include polyols such as disaccharide sucrose (col. 5, lines 60-64).
Regarding claims 47 and 60, Bandyopadhyay discloses the cryoprotectant is present in a range from 0.05% to 90%, preferably between 0.05% to 50%, and most preferably between 0.15% to 20% based on the total weight of the solution (col. 6, lines 15-24). The range disclosed by Bandyopadhyay encompasses the instantly claimed range.
Regarding claim 50, Bandyopadhyay discloses polysorbates and polyethylene glycol are exemplary surfactant cryoprotectants to include in the formulation (col 5, lines 55-64). One of the formulation examples provided by Bandyopadhyay include polysorbate 80 at 0.1 mg/mL (col. 7, Table 1).
Regarding claim 52, Bandyopadhyay discloses the cryoprotectant is present in a range from 0.05% to 90%, preferably between 0.05% to 50%, and most preferably between 0.15% to 20% based on the total weight of the solution (col. 6, lines 15-24). The range disclosed by Bandyopadhyay overlaps with the instantly claimed range.
Regarding claim 61, Bandyopadhyay discloses the protein can be present in the formulation from 0.03 mg/mL to 2.0 mg/mL (col. 14, claim 19).
The method of lyophilization disclosed by Bandyopadhyay differs from the instantly claimed invention in that Bandyopadhyay does not expressly disclose the temperature with which the secondary drying cycle occurs. However, the teachings of Bano overcome this deficiency in Bandyopadhyay.
Bano teaches lyophilization to promote long-term stability while avoiding thermal degradation of monoclonal antibody structure (p. 5056). Bano further teaches a conventional method of lyophilization involves three main steps of freezing, primary drying, and secondary drying at the following parameters:
Freezing at a very low temperature (around -50°C) where most of the water solvent is converted to ice;
Primary drying to remove ice from the frozen product at low temperature (around -20°C to -30°C) and low pressure (around 50 mTorr to 100 mTorr);
Secondary drying to desorb the unfrozen water that did not crystallize during freezing and is bound to the product at higher temperatures (around 20°C to 30°C) (p. 5056).
Finally, Bano teaches modification of the claimed variables – time, temperature, and pressure – to meet the constraints of industrial practice (p. 5056-5057).
The claimed secondary drying conditions would have been obvious to a POSITA, before the effective filing date of the claimed invention, because Bandyopadhyay teaches secondary drying for 6 hours under vacuum pressure between 20 mTorr to 30 mTorr, and Bano teaches conventional lyophilization methods involve a secondary drying step at higher temperatures of 20°C to 30°C in order to desorb unfrozen water bound to the protein. Thus, in light of Bandyopadhyay and Bano, the claimed lyophilization parameter of secondary heating to temperatures ranging from 20°C to 30°C, a pressure ranging from 25 mTorr to 100 mTorr for about 5 to 10 hours would have been an obvious selection of conventional secondary drying parameters disclosed by prior art as successful in removing bound water and producing a lyophilized protein formulation.
Claims 3, 9, 21, 27, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay and Bano as applied to claims 1, 32, 37-38, 41, 45, 47, 50, 52, 60, and 61 above, and further in view of Bjelošević (“Aggressive conditions during primary drying as a contemporary approach to optimise freeze-drying cycles of biopharmaceuticals,” published 10 July 2018).
The teachings of Bandyopadhyay and Bano as applied to claims 1, 32, 37-38, 41, 45, 47, 50, 52, 60, and 61 are discussed above. While the combination of Bandyopadhyay and Bano make obvious that which is disclosed in claims 1, 32, 37-38, 41, 45, 47, 50, 52, 60, and 61, neither reference explicitly discloses the limitations of claims 3, 9, 21, 27, and 57. However, these limitations are made obvious in view of Bjelošević.
Bjelošević teaches freeze-drying as the method of choice to dry formulations with biopharmaceutical drugs to enhance protein stability (abstract). Bjelošević teaches discloses a three-step general lyophilization cycle as a method of freeze-drying which involves:
Freezing, where the solution is transformed into ice and freeze-concentrated solution is formed;
Primary drying, where the frozen solvent from the product is removed by sublimation; and
Secondary drying, where the unfrozen water is removed by desorption (p. 292-293).
Regarding claims 3, 9, and 21, Bjelošević teaches a lyophilization procedure whereby samples comprising a monoclonal antibody, sucrose or sucrose/glycine, succinate buffer, and polysorbate 20 were subjected to the following lyophilization steps:
Freezing, ramped to -40°C at 0.5°C/min, and held for 4.5 hours;
Primary drying, heated to -20°C at a rate of 0.25°C, decreased chamber pressure to 0.1 mbar (approx. 75 mTorr), and held for 48 hours;
Secondary drying, heated to 40°C at a rate of 0.1°C/min, and decreased chamber pressure to 0.05 mbar (approx. 37.5 mTorr) (p. 293-295).
The values taught by Bjelošević for temperature, pressure, and time overlap with or approach the instantly claimed ranges. See MPEP 2144.05(I): “in the case where the claimed ranges overlap or lie inside ranges disclosed by prior art, a prima facie case of obviousness exists…Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”
In addition, Bjelošević teaches rate values for each of the three steps of lyophilization which are encompassed by the claimed ranges of instant claims 3, 9, and 21.
Regarding claim 27, Bjelošević teaches the sample subjected to lyophilization contained an IgG monoclonal antibody.
Regarding claim 57, Bjelošević specifically discloses testing the formulations containing a monoclonal antibody, sucrose or sucrose/glycine, succinate buffer, and polysorbate 20 to evaluate storage stability after storage at 40°C for 1 month (p. 294). Bjelošević shows all samples were 99.6% or above in the monomer purity profile, where no significant aggregation or degradation occurred (p. 299). Bjelošević further shows the high molecular weight species was 0.29% or less after 1 storage month at 40°C (p. 300, Table 5). While the limitation claimed in claim 57 is an inherent result that would flow naturally from the method disclosed by the combination of Bandyopadhyay and Bano, Bjelošević further emphasizes the claimed method results in low aggregation as represented by high molecular weight species present at 0.29% or less. Therefore, the result-driven limitation in claim 57 is a natural result of the combination of prior art elements.
Bjelošević provides evidence that, for conventional monoclonal antibody lyophilization, conditions can be selected to avoid protein aggregation and preserve protein activity to enhance long-term storage stability. Specifically, Bjelošević discloses conventional monoclonal antibody lyophilization and temperature cooling or heating rate parameters that make obvious instant claims 3, 9, 21, 27, and 57. The claimed parameters would have been obvious to a POSITA, before the effective filing date of the claimed invention, because Bjelošević teaches these parameters as successful in conventional lyophilization techniques containing a protein, a saccharide, a surfactant, and a buffer. Thus, a POSITA would reasonably predict success in using the parameters taught by Bjelošević in the conventional lyophilization techniques disclosed by the combination of Bandyopadhyay and Bano. The claimed parameters would have been an obvious selection of conventional parameters disclosed by prior art as successful in producing a lyophilized product that is stable and contains no significant aggregates, as evidenced by Bjelošević’s disclosure of a lyophilized formulation that, upon reconstitution, exhibits less than a 0.5% increase in the percentage of high molecular weight species after storage for one month at 40°C.
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay and Bano as applied to claims 1, 32, 37-38, 41, 45, 47, 50, 52, 60, and 61 above, and further in view of Raum (US PGPub. No. 2017/0218078 A1; published: 03 August 2017).
The teachings of Bandyopadhyay and Bano as applied to claims 1, 32, 37-38, 41, 45, 47, 50, 52, 60, and 61 are discussed above. While the combination of Bandyopadhyay and Bano make obvious that which is disclosed in claims 1, 32, 37-38, 41, 45, 47, 50, 52, 60, and 61, neither reference explicitly discloses the limitations of claims 28-30. However, these limitations are made obvious in view of Raum.
Raum discloses bispecific antibody constructs (abstract).
Regarding claims 28-30, Raum discloses the antibody construct of the invention is characterized by having an amino acid sequence of SEQ ID NO: 205 ([0218]). Raum’s SEQ ID NO: 205 is 100% identical to instant SEQ ID NO: 77 as shown below:
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Raum further discloses the antibody construct comprising SEQ ID NO: 205 is a bispecific HLE molecule (p. 105, Table 35).
Raum discloses compositions containing the HLE bispecific antibody construct comprising SEQ ID NO: 77 are capable of lyophilization ([0244], [0284]) with polyols, such as sucrose, and polyethylene glycol (PEG) ([0289]). The polyols, Raum teaches, are useful stabilizing agents in lyophilized formulations to protect proteins from physical and chemical degradation processes ([0289]). Raum teaches sucrose is among the preferred agents to protect against freeze-thaw stresses ([0289]) and PEG is useful to stabilize proteins and also acts as a cryoprotectant ([0289]).
Raum discloses an HLE bispecific antibody construct that is identically to the instantly claimed HLE bispecific antibody. In addition, Raum discloses this antibody is in a pharmaceutical formulation capable of lyophilization with saccharides, a surfactant, and a buffer that make obvious instant claims 28-30. Since Raum discloses the HLE bispecific antibody construct is capable of lyophilization and it is the preferred technique for producing a stable product (see col. 52, lines 13-25), substituting the antibody in Raum with the protein in Bandyopadhyay and Bano would have been obvious to a POSITA. Lyophilization is a well-known technique in the art to stabilize a protein for storage and a POSITA would have a reasonable expectation of success in using the method of Bandyopadhyay and Bano to lyophilize the antibody of Raum. A POSITA would expect success in doing so because Raum not only discloses the antibody is capable of lyophilization, but puts no constraints on the lyophilization method used and discloses similar formulation components as in Bandyopadhyay and Bano (e.g., similar surfactants, saccharides, and buffer).
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay and Bano as applied to claims 1, 32, 37-38, 41, 45, 47, 50, 52, 60, and 61 above, and further in view of Wu (“Advance Understanding of Buffer Behavior during Lyophilization,” published 01 January 2015).
The teachings of Bandyopadhyay and Bano as applied to claims 1, 32, 37-38, 41, 45, 47, 50, 52, 60, and 61 are discussed above. While the combination of Bandyopadhyay and Bano make obvious that which is disclosed in claims 1, 32, 37-38, 41, 45, 47, 50, 52, 60, and 61, neither reference explicitly discloses the limitations of claim 56. However, this limitation is made obvious in view of Wu.
As previously mentioned, Bandyopadhyay teaches a method to lyophilize a formulation containing a protein. Bandyopadhyay’s formulations include the addition of a cryoprotectant sucrose between 0.15% to 20% w/w (col. 5, lines 60-61; col. 6, lines 15-24). Bandyopadhyay’s formulations further disclose the addition of a stabilizer, which can include polysorbate 80, at a preferred concentration of 0.01 to 1 mg/ml (col. 6, lines 5-14). The instantly claimed amount of 0.010% (w/w) polysorbate 80 equals a concentration of 0.10 mg/ml, which falls within the range disclosed by Bandyopadhyay. Bandyopadhyay’s formulations comprise a buffer system to maintain the desired pH of the formulations (col. 5, line 46). Bandyopadhyay discloses the preferred pH range of the formulation is between 4.5 to 7.1, preferably 6.5 to 7.1, and most preferably 6.8 (col. 5, lines 45-55).
Bandyopadhyay’s disclosure differs from instant claim 56 in that Bandyopadhyay does not disclose L-glutamic acid as a buffer. However, this limitation is made obvious in view of Wu. Wu discloses buffering systems in lyophilized products. Wu further discloses most lyophilized products on the market are formulated in the pH range from 4 to 8 (p. 27). Furthermore, Wu discloses common buffers and their pH buffering range, which includes glutamic acid capable of a buffering range of 2 to 5.3 (p. 27).
The claimed parameters of claim 56 would have been obvious to a POSITA, before the effective filing date of the claimed invention, because Bandyopadhyay (in further view of Bano) teaches a method to lyophilize a formulation containing components sucrose and polysorbate 80 in a range or amount that falls within the instantly claimed range and at a pH that approaches the instantly claimed pH. Although Bandyopadhyay does not teach L-glutamic acid as a buffer, Bandyopadhyay does teach the lyophilization in a pH between 4.5 to 7.1 and use of buffers to manipulate the pH. Wu makes obvious the substitution of L-glutamic acid in the genus of buffer disclosed by Bandyopadhyay because Wu discloses suitable buffer systems for lyophilization and teaches glutamic acid is capable of achieving a pH range from 4 to 8 in lyophilization formulations. The claimed concentration of 10mM would be considered routine optimization to achieve the desired pH, as disclosed by Bandyopadhyay. Therefore, a POSITA would have reasonable expectation of success in using L-glutamic acid to achieve a pH between 4 to 8 in lyophilized formulations. Therefore, claim 56 is made obvious by the disclosures of Bandyopadhyay and Bano in further view of Wu.
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.
Co-pending application 18/561,081
Claims 1, 3, 9, 21, 27-30, 32, 37-38, 41, 45, 47, 50, 52, 56-57, and 60-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9, 20, 27-30, 32, 37-38, 41, 44-47, 50, 52, and 56-57 of copending Application No. 18/561,081 (hereinafter ‘081).
Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims of application ‘081 anticipate that of the instant claims.
Claim mapping:
Instant Claim
‘081 Claim
Rationale
1
1, 44, 45, and 50
Both instant claim 1 and ‘081 claim 1 are drawn to a method of preparing a lyophilized formulation the method comprising:
A liquid formulation comprising a protein, a saccharide, and a surfactant at a pH in a range of about 3-7 that does not contain mannitol;
A cooling step, the claimed parameter ranges of ‘081 overlap with the instantly claimed ranges;
A primary drying step, the claimed parameter ranges of ‘081 overlap with the instantly claimed ranges; and
A secondary drying step, the claimed parameter ranges of ‘081 overlap with the instantly claimed ranges;
A lack of an annealing step.
The only difference between ‘081 claim 1 and instant claim 1 is that the primary drying step occurs for a holding time period of about 12 to 24 hours in ‘081 compared to about 45 to 60 hours in instant claim 1. However, the the primary drying step of lyophilization protocols allows for extended primary drying times in order to effectively dry out the sample; and the volume of sample will naturally increase the duration of primary drying time necessary. It is not uncommon to have lyophilization protocols whereby the primary drying cycle lasts 36-72 hours, depending on the volume of the sample.
3
3
The claimed range of the rate at which the cooling step (1(a)) occurs overlaps.
9
9
The claimed range of the rate at which the primary drying step (1(b)) occurs overlaps.
21
20
The claimed range of the rate at which the secondary drying step (1(c)) occurs overlaps.
27
27
Identical limitation.
28
28
Identical limitation.
29
29
Identical limitation.
30
30
‘081 SEQ ID NO: 77 is identical to instant SEQ ID NO: 77:
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32
32
The claimed protein concentration overlaps.
37
37
Identical limitation.
38
38
Identical limitation.
41
41
The claimed range of buffer concentration overlaps.
45
46
Identical limitation.
47
47
The claimed range of saccharide overlaps.
50
50
‘081 surfactants include polysorbate 20 and polysorbate 80.
52
52
The claimed range of surfactant overlaps.
56
56
Identical limitation.
57
57
Identical limitation.
60
47
The claimed range of saccharide overlaps.
61
52
The claimed range of surfactant overlaps.
Therefore, claims 1, 3, 9, 20, 27-30, 32, 37-38, 41, 44-47, 50, 52, and 56-57 of ‘081 anticipate the instantly claimed invention in claims 1, 3, 9, 21, 27-30, 32, 37-38, 41, 45, 47, 50, 52, 56-57, and 60-61.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1, 3, 9, 21, 27-30, 32, 37-38, 41, 45, 47, 50, 52, 56-57, and 60-61 are rejected. No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571)272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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