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 .
Election/Restrictions
Applicant’s election without traverse of the species of: (A) reduced neutrophil count as the condition; (B) the immunoglobulin Fc region that is a human aglycosylated IgG4 Fc fragment; (C) non-peptidyl polymer that is polyethylene glycol and the group that is propionaldehyde; and, (D) the linkage that is to an N-terminus of a lysine residue, in the reply filed on 2 September 2025 is acknowledged.
Applicant has indicated claims 1, 7-10, 12, 14, 16, 17 and 23-32 read on the elected species and are under examination. Claims 2 and 4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is the national stage entry of PCT/US20/63244 filed on 4 December 2020 band claiming the benefit of US Provisional Application No. 62/943,700 filed on 4 December 2019.
Claims 1, 7-10, 12, 14, 16, 17 and 23-32 have an earliest effective filing date of 4 December 2019.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 24 October 2022 and 2 September 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 7-10, 12, 14, 16, 17 and 23-32 are rejected under 35 U.S.C. 103 as being unpatentable over Vacirca et al., Cancer Medicine, 7(5):1660-1669, published online 23 March 2018 as evidenced by the Drugs.com information pertaining to Eflapegrastim, 9 December 2024, and Barrett et al., Experimental Hematology, 92:51-61, December 2020.
MPEP §2131.01 provides guidance as to 35 U.S.C. 102 rejections over multiple references. Such rejection has been held to be proper when the extra references are cited to: (C) Show that a characteristic not disclosed in the reference is inherent. The MPEP states: “To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749 (Fed. Cir. 1991) (The court went on to explain that “this modest flexibility in the rule that 'anticipation' requires that every element of the claims appear in a single reference accommodates situations in which the common knowledge of technologists is not recorded in the reference; that is, where technological facts are known to those in the field of the invention, albeit not known to judges.” 948 F.2d at 1268, 20 USPQ at 1749-50.). Note that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date. See MPEP §2124.
Regarding claim 1, the Vacirca et al. prior art teaches a method comprising treating breast cancer patients being treated with docetaxel and cyclophosphamide (TC) with Rolontis (eflapegrastim). The prior art teaches “Rolontis™ (Spectrum Pharmaceuticals, Inc., Henderson, NV) (eflapegrastim, SPI-2012, HM10460A) was developed by conjugating the recombinant human G-CSF analog (17th,65th Ser-G-CSF, no additional N-terminal Met) and the human immunoglobulin G4 Fc fragment via a 3.4 kDa Peg linker to produce a longer-acting G-CSF” (pg. 1661, last paragraph of first column). Therefore, the prior art teaches “a protein complex comprising a modified human granulocyte-colony stimulating factor (hG-CSF) covalently linked to an immunoglobulin Fc region via a non-peptidyl polymer, wherein the non-peptidyl polymer is site-specifically linked to an N-terminus of the immunoglobulin Fc region and the modified hG-CSF comprises the polypeptide sequence of SEQ ID NO: 1”. The authors report the primary efficacy endpoint was duration of severe neutropenia (DSN), characterized as compromised white blood cell production. TC was administered on Day 1, followed by 45, 135, or 270 μg/kg Rolontis on Day 2 (Abstract).
Regarding claim 7, the Vacirca et al. teach the condition is “duration of severe neutropenia (DSN) during the first cycle of [TC] treatment” (Abstract).
Regarding claim 8, Vacirca et al. teach treatment of neutropenia during docetaxel and cyclophosphamide (TC) treatment. The Abstract states, “Complete blood counts were monitored daily when the absolute neutrophil count (ANC) fell to <1.5 × 109/L.”
Regarding claim 9, the prior art teaches, “Chemotherapy-induced neutropenia can progress to febrile neutropenia, defined as a single temperature >38.3°C (or ≥38.0°C for >1 h) that presents with concurrent grade 3/4 neutropenia (absolute neutrophil count [ANC] ≤1.0 × 109/L)” (pg. 1661, Introduction, first paragraph). Thus, the prior art teaches treatment of neutropenia before it can progress to febrile neutropenia.
Regarding claim 10, the Vacirca et al. prior art teaches “breast cancer patients being treated with docetaxel and cyclophosphamide (TC)” (Abstract and pg. 1661, Patient Population).
Regarding claim 14, the Vacirca et al. teach, “eligible patients were sequentially assigned to receive SC injections of one of three weight-based doses of Rolontis (45, 135, or 270 μg/kg) or a fixed dose of 6 mg of pegfilgrastim. On Day 1 of each cycle, patients were treated with docetaxel (75 mg/m2) and cyclophosphamide (600 mg/m2) by IV infusion every 3 weeks for up to four cycles. On Day 2 of each cycle (approximately 24 h after TC chemotherapy)” (pg. 1662, Treatment). Therefore, the prior art teaches “a second dose of the protein conjugate”, namely Rolontis, every 3 weeks or 21 days, which is within the “between 15 and 25 days” after the first dose, as required by the claim.
Regarding claim 16, the Vacirca et al. prior art teaches three trial groups receiving three weight-based doses of Rolontis (45, 135, or 270 μg/kg) (see pg. 1662, Treatment and Figure 1). Therefore, the prior art teaches unit dosages within the range of instant claim 16 which includes “about 26 μg/kg, about 50 μg/kg, about 52 μg/kg, about 100 μg/kg, about 88 μg/kg, and about 200 μg/kg”.
Regarding claim 17, while the Vacirca et al. prior art fails to disclose “the therapeutic effective amount is 13.2 mg of the protein conjugate in a 0.6 mL dosage volume” the Drugs.com information for eflapegrastim/Rolontis is relied upon as evidence that eflapegrastim-xnst is formulated as a Pre-Filled Syringe consisting of 13.2 mg/0.6 mL, and “Usual dose: 13.2 mg subcutaneously once per chemotherapy cycle.”
Regarding claim 23, the attached pBLAST search report teaches SEQ ID NO: 2 of the claim is equivalent to the partial immunoglobulin IGHG4 heavy chain that is the human immunoglobulin G4 Fc fragment of Rolontis (pg. 1661, last paragraph of first column).
Regarding claim 24, the prior art teaches Rolontis is formed by conjugating recombinant human G-CSF analog (17th,65th Ser-G-CSF, no additional N-terminal Met) with the human immunoglobulin G4 Fc fragment via a 3.4 kDa Peg linker (pg. 1661, last paragraph of first column). Therefore, the construct utilized in the prior art fulfills the claimed requirements of “the non-peptidyl polymer are respectively linked to the modified human G-CSF and the immunoglobulin Fc region through reactive groups by a covalent bond”.
Regarding claim 25, the Rolontis construct taught by the prior art teaches: the immunoglobulin Fc region consists of a heavy chain. The attached pBLAST confirms that it is equivalent to a partial sequence of an Immunoglobulin heavy chain, specifically IGHG4. Therefore, the prior art teaches the limitation of (b) wherein the immunoglobulin Fc region consists of one to four domains selected from the group consisting of CH1, CH2, CH3, and CH4 domains.
Regarding claim 26, the Vacirca et al. prior art does not teach the Immunoglobulin Fc fragment of Rolontis is a dimer, however, the Barrett et al. reference is relied upon as evidence that, “Eflapegrastim (HM10460A, SPI-2012, Rolontis, Spectrum Pharmaceuticals, Irvine, CA; and Hanmi Pharmaceuticals, Seoul, South Korea) is a novel, long-acting recombinant human (rh) G-CSF analogue currently in late-stage clinical development. Eflapegrastim differs from the currently approved long-acting G-CSF, pegfilgrastim, in the conjugation of G-CSF to human IgG4 Fc fragment [8]. The Fc fragment is expressed as a homodimer, and the conjugate has a molecular weight of approximately 72 kDa, as only one of the two polypeptide chains of the Fc fragment is conjugated to a single molecule of G-CSF analogue (U.S. Adopted Names [USAN] adoption statement)” (emphasis added, pg. 52, second full paragraph). Therefore, the Rolontis of the Vacirca et al. prior art reference fulfills the requirements of part (b) of the instant claims (“the immunoglobulin Fc fragment is a dimer …consisting of singe chain immunoglobulins comprising domains having the same origin”).
Regarding claim 27, the prior art discloses Rolontis is conjugated to the non-peptidyl polyer “Peg” (pg. 1661, last paragraph of first column), which is equivalent to the polyethylene glycol of the instant claim.
Regarding claim 28, the Vacirca et al. prior art fails to disclose the molecular weight of the Peg disclosed as part of the Rolontis construct. However, the Barrett et al. reference is relied upon as evidence that the entire construct of Eflapegrastim “conjugate has a molecular weight of approximately 72 kDa” (pg. 52, second full paragraph). The reference further discloses, “Eflapegrastim consists of two protein components, a G-CSF analogue with a molecular weight of 18.6 kDa and an Fc fragment of human IgG4 with a molecular weight of 49.8 kDa”, which means the final component, Peg, has a molecular weight of about 3.6 kDa [72 kDa – (49.8 kDa + 18.6 kDa)=3.6 kDa].
Regarding claims 29, 30 and 31, given the structure of Polyethylene glycol demonstrates that it has an aldehyde (-OH) reactive groups at both ends (as required by instant claim 29 and part (a) of claim 31) and depending upon the n in the following formula the aldehyde group may be Propionaldehyde (C3H6O) or Butyraldehyde (C4H8O) as required by part (a) of instant claim 30.
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Regarding claim 32, the Vacirca et al. prior art discloses Rolontis “was developed
by conjugating the recombinant human G-CSF analog (17th, 65th Ser-G-CSF, no additional N-terminal Met)” (pg. 1661, first column, last paragraph). Therefore, the prior art teaches the limitation of instant claim 32 wherein the non-peptidyl polymer is linked to the N-terminus of the immunoglobulin Fc region and the N-terminus Serine of a modified G-CSF.
The only limitations that differ between the method of the invention of claims 1 and 12 and the prior art, is timing of the administration. Vacirca et al. teach administration of TC on day 1 and eflapegrastim/Rolontis on Day 2, whereas instant Claim 1: “the protein complex is administered on the same day as the chemotherapeutic regimen”; and instant Claim 12: “wherein the protein complex is administered to the patient within about 6 hours, about 5 hours, about 3 hours, about 2 hours, about 1 hour, about 30 minutes, about 15 minutes, or about 5 minutes of the completion of chemotherapy”. Therefore the method of the claims differs only from the prior art with respect to timing of the co-administration. The courts, however, have stated that, generally, such differences amount to mere optimization and will not support patentability unless there is evidence indicating the claimed feature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421. Thus, the method of instant Claims 1 and 12 is obvious in view of methods disclosed in the prior art and through routine optimization of the disclosed method.
MPEP 2144 sets forth Applicant' s burden for rebuttal of a prima facie case of obviousness based upon routine optimization. Applicant must provide either a showing that the particular amount or range recited within the claims is critical; and/or a showing that the prior art reference teaches away from the claimed method. In the instant case, the specification as filed provides no evidence that the particular amount or range recited within the claims is critical because the specification teaches “the G-CSF will be administered approximately 24 hours after the drug regimen. In another embodiment, the G-CSF will be administered product as the same day as the drug regimen, preferably 30 minutes, 1, hour, 3 hours, 5 hours, 6, hours, 7 hours, 8 hours, or 12 hours after administration of the last drug of the regimen” (pg. 3).
Therefore, the method of the invention is obvious in view of methods that were previously disclosed in the art prior to the filing date of the application, and claims 1, 7-10, 12, 14, 16, 17 and 23-32 are rejected.
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, 7-10, 12, 14, 16, 17 and 23-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,202,871 in view of Vacirca et al. as evidenced by the Drugs.com information pertaining to Eflapegrastim, published online 9 December 2024, and Barrett et al., Experimental Hematology, 92:51-61, December 2020.
The patented (reference) claims are directed to a method for treating or preventing neutropenia in a patient receiving chemotherapy, comprising administering to the patient a therapeutically effective amount of a protein complex comprising a modified human granulocyte-colony stimulating factor (hG-CSF) covalently linked to an N-terminus of an immunoglobulin Fc region via a non-peptidyl polymer, wherein the modified hG-CSF comprises the amino acid sequence of SEQ ID NO: 1.
The reference claims do not teach chemotherapy-induced neutropenia comprising a plurality of cycles of administration of docetaxel and cyclophosphamide (claim 1) and wherein the subject has been diagnosed with breast cancer (claim 10). However, the Vacirca et al. prior art remedies this deficiency by disclosing a method comprising administering to breast cancer subjects receiving docetaxel and cyclophosphamide, a therapeutically effective amount of a protein complex, namely Rolontis, comprising a modified human granulocyte-colony stimulating factor (hG-CSF) covalently linked to an immunoglobulin Fc region via a non-peptidyl polymer, wherein the non-peptidyl polymer is site-specifically linked to an N-terminus of the immunoglobulin Fc region and the modified hG-CSF comprises the polypeptide sequence of SEQ ID NO: 1. While the prior art does not teach “the protein complex is administered on the same day as the chemotherapeutic regimen”, this is deemed mere optimization of a claimed feature that the instant specification does not disclose as critical.
Claims 1, 7-10, 12, 14, 16, 17 and 23-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,171,804 in view of Vacirca et al. as evidenced by the Drugs.com information pertaining to Eflapegrastim, published online 9 December 2024, and Barrett et al., Experimental Hematology, 92:51-61, December 2020.
The patented (reference) claims are directed to preventing or reducing chemotherapy-induced neutropenia in a patient in need thereof. Depending reference claims recite the chemotherapy-induced neutropenia specifically arises from administration of docetaxel and cyclophosphamide (reference claim 4). The reference claims do not explicitly teach “a protein complex comprising a modified human granulocyte-colony stimulating factor (hG-CSF) covalently linked to an immunoglobulin Fc region via a non-peptidyl polymer, wherein the non-peptidyl polymer is site- specifically linked to an N-terminus of the immunoglobulin Fc region and the modified hG-CSF comprises the polypeptide sequence of SEQ ID NO: 1” but the Vacirca et al. prior art and Eflapegrastim drugs.com information and Barrett et al., 2020 reference, however, disclose the Eflapegrastim of the reference claims is equivalent to the protein complex” of the instant claims. While the prior art does not teach “the protein complex is administered on the same day as the chemotherapeutic regimen”, this is deemed mere optimization of a claimed feature which the instant specification does not disclose as a critical feature of the invention.
Claims 1, 7-10, 12, 14, 16, 17 and 23-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,318,430 in view of Vacirca et al. as evidenced by the Drugs.com information pertaining to Eflapegrastim, published online 9 December 2024, and Barrett et al., Experimental Hematology, 92:51-61, December 2020.
The patented (reference) claims are directed to a method comprising administering to the subject a therapeutically effective amount of a chemotherapeutic regimen followed by a therapeutically effective amount of a protein complex comprising a modified human granulocyte-colony stimulating factor (hG-CSF) covalently linked to an immunoglobulin Fc region via a non-peptidyl polymer, wherein the non-peptidyl polymer is site-specifically linked to an N-terminus of the immunoglobulin Fc region and the modified hG-CSF comprises the amino acid sequence of SEQ ID NO: 1. Depending reference claims recite the chemotherapy is a combination of docetaxel and cyclophosphamide (reference claim 5). Depending claims further disclose the protein complex is administered on the same day as a chemotherapeutic regimen (reference claim 2).
While the reference claims are directed to a method of increasing stem cell production in a subject and the instant claims are directed to alleviating or treating a condition in a subject in need thereof, the condition characterized by compromised white blood cell production in the subject, the subjects are not mutually exclusive since the reference claims encompass subjects receiving docetaxel and cyclophosphamide chemotherapy. Further the court in Merck KGaA v. Integra LifeSciences Ltd, 50 USPQ2d 1846 (DC SCalif, 1999) held that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use. Therefore, the invention of the instant claims is obvious in view of the previously patented method.
Claims 1-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,350,315. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to a method for treating or preventing neutropenia in a patient diagnosed with breast cancer comprising administering a chemotherapy regimen of docetaxol and cyclophosphamide and a therapeutically effective amount of a protein complex comprising a modified human granulocyte colony stimulating factor (hG-CSF) covalently linked to an immunoglobulin Fc region via a non-peptidyl polymer, wherein the non-peptidyl polymer is site-specifically linked to an N-terminus of the immunoglobulin Fc region and the modified hG-CSF comprises substitutions in at least one of Cys17 and Pro65, wherein the protein complex is administered on the same day as the chemotherapeutic regimen. The only element that differs from the method of the instant claims is that the instant claims recite a modified hG-CSF, in general, but the patented claims specifically require substitutions in at least one of Cys17 and Pro65.
However, MPEP 2131.03 states, “A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus.” The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989) (Gosteli claimed a genus of 21 specific chemical species of bicyclic thia-aza compounds in Markush claims. The prior art reference applied against the claims disclosed two of the chemical species. The parties agreed that the prior art species would anticipate the claims unless applicant was entitled to his foreign priority date.). Such is the case here, where the patented claims recite a species within the genus of the instant claims.
Therefore, the instant claims are anticipated by the previously patented claims.
Claims 1, 7-10, 12, 14, 16, 17 and 23-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,267,858 in view of Vacirca et al. as evidenced by the Drugs.com information pertaining to Eflapegrastim, published online 9 December 2024, and Barrett et al., Experimental Hematology, 92:51-61, December 2020.
The patented (reference) claims are directed to preventing, alleviating, or treating neutropenia in a patient having compromised white blood cell production comprising administering to the patient a therapeutically effective amount of a protein complex comprising a modified human granulocyte-colony stimulating factor (hG-CSF) covalently linked to an immunoglobulin Fc region via a non-peptidyl polymer, wherein the non-peptidyl polymer is site-specifically linked to an N-terminus of the immunoglobulin Fc region and the modified hG-CSF comprises the amino acid sequence of SEQ ID NO: 1. Depending reference the method further comprising an adjuvant (claim 5) wherein the adjuvant or neoadjuvant chemotherapy is a combination of docetaxel and cyclophosphamide (claim 6). The population of subjects on whom the method is performed includes subjects with “compromised white blood cell production is a result of chemotherapy”. While the prior art does not teach “the protein complex is administered on the same day as the chemotherapeutic regimen” of the instant claims, this is deemed mere optimization of a claimed feature that the instant specification does not disclose as critical.
Therefore, the patented claims render obvious the method of the instant claims.
Claims 1, 7-10, 12, 14, 16, 17 and 23-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,684,655 in view of Vacirca et al. as evidenced by the Drugs.com information pertaining to Eflapegrastim, published online 9 December 2024, and Barrett et al., Experimental Hematology, 92:51-61, December 2020.
The patented (reference) claims are directed to method of treating a condition in a subject in need thereof, the condition characterized by compromised white blood cell production in the subject, the method comprising administering to the subject a therapeutically effective amount of a chemotherapeutic regimen followed by a therapeutically effective amount of a protein complex comprising a modified human granulocyte-colony stimulating factor (hG-CSF) covalently linked to an immunoglobulin Fc region via a non-peptidyl polymer, wherein the non-peptidyl polymer is site-specifically linked to an N-terminus of the immunoglobulin Fc region and the modified hG-CSF comprises the amino acid sequence of SEQ ID NO: 1, wherein the protein complex is administered on the same day as the chemotherapeutic regimen. Depending claims in the patent are directed to the method comprising a neoadjuvant chemotherapy (patented claim 7) wherein the adjuvant or neoadjuvant chemotherapy is a combination of docetaxel and cyclophosphamide (patented claim 8).
Therefore, the patented claims anticipate the claims in the instant application.
Conclusion
No claim is allowed.
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/STACEY N MACFARLANE/Examiner, Art Unit 1675