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 .
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 a 371 of PCT/CN2020/103613 filed July 22, 2020.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed on January 21, 2022. Foreign priority is claimed through China 2019 10660749.1 filed on July 22, 2019. All claims have been given an effective filing date of July 22, 2019.
Election/Restriction
Applicant’s election with traverse of species A) An interferon, with the further election of interferon α2b; B) A cancer, with the further election of liver cancer; and C) An anticancer agent, with the further election of a chemotherapeutic agent, specifically gemcitabine in the reply filed on 05/19/2025 is acknowledged. The traversal is on the grounds that no undue burden exists to examine the totality of the claims. This is not found persuasive because a search burden is not considered in the restriction of a 371 international application. An international application should relate to only one invention or, if there is more than one invention, the inclusion of those inventions in one international application is only permitted if all inventions are so linked as to form a single general inventive concept (PCT Rule 13.1). The species of the instant application do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same property or activity, and differ in either structure, class of chemical compound, or disease etiology. Therefore, a search burden is not considered in the restriction requirement for an international application and the argument is not found persuasive.
Claims 6-8, 19, and 27-30 are withdrawn from further consideration pursuant
to 37 CFR 1.142(b), as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 05/19/2025.
Claim Status
Claim listing filed on May 19, 2025 is pending. Claims 6-8, 19, and 27-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species. Claims 1-5, 9-18, 20-26, and 31-32 are examined upon their merits.
Information Disclosure Statement
No information disclosure statement has been filed. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Specifically, there is a hyperlink in the first paragraph on page 11 in the specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 15, 25, and 32 are objected to because of the following informalities:
Claim 15 recites “2 week” in lines 2 and 3 which should be corrected to “2 weeks.”
Claim 25 recites “administered during and between plurality of consecutive treatment courses” and should recite “administered during and between the plurality of consecutive treatment courses.”
Claim 32 repeats “an alkylating agent” twice in line 2 wherein it should only be stated once. Similarly, “vindesine” is repeated twice in line 10 wherein it should only be stated once. “Icotinib” is repeated twice in lines 21 and 22 wherein it should only be stated once, and the “icotinib” in line 22 has an improper space after it. Examiner urges applicant to review Claim 32 for other improper duplicates.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1, 3, 5, 9-18, 20-26, and 31-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3, 9, 11, 13, 20, and 32 recite the phrases "such as", “for example”, and “preferably” which render the claims indefinite because it is unclear whether the limitations following these phrases are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of compact prosecution, the limitations following the phrases "such as", “for example”, and “preferably” are interpreted as optional limitations.
Claims 9-15 recite the relative terms “about” and “approximately.” Because there is no definition of the terms “about” and “approximately” in the specification, the metes and bounds of Claims 9-15 cannot be readily determined (MPEP § 2173.05(b)III.A). For the purpose of compact prosecution, the terms “about” and “approximately” will not be considered. For example, Claim 11 recites “from about 1 week to about 24 weeks” and will be interpreted as “from 1 week to 24 weeks.”
Claims 9 and 17-18 recite the relative term “substantially.” Because there is no definition of the term “substantially” in the specification, the metes and bounds of Claims 9 and 17-18 cannot be readily determined (MPEP § 2173.05(b)III.D). It is unclear what boundaries are defined by “substantially the entire course” in Claim 9 or “substantially the same” in Claims 17-18. For the purpose of compact prosecution, the term “substantially” will not be considered. Claim 9 will be interpreted as “the entire course,” and Claims 17-18 will be interpreted as “the same.”
Claims 3 and 5 recite the limitation "the interferon" in line 1. There is insufficient antecedent basis for this limitation in the claims. An interferon-based therapeutic agent (Claim 1) is not necessarily an interferon. Note, “the duration” and “the interval” in Claims 10-15 and 17-18 are not indefinite for lack of antecedent basis because it is clear that the duration is the length of time of each consecutive treatment course of Claim 1, and the interval is the length of time between each consecutive treatment course of Claim 1. Further, the specification defines that the duration is the time period from the first administration to the last administration, plus 5 in vivo half-lives of the therapeutic agent (page 8, paragraph 6).
Claim 9 is directed to a method of administration such that during the entire course, the concentration of neopterin in the subject is higher than the concentration of neopterin before the first administration. Claim 9 uses functional language because the feature (the administration) is defined by what it does (increases concentration of neopterin for the entire course) rather than by what it is (MPEP § 2173.05(g)). To determine if functional language is ambiguous, the following factors are considered: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim. These factors are examples of points to be considered when determining whether language is ambiguous and are not intended to be all inclusive or limiting (MPEP § 2173.05(g)). Claim 9 recites a result obtained (maintained elevated concentration of neopterin) without reciting any administration steps that cause this function. It is unclear what administration steps (ie when to administer, how to administer, how frequently to administer, what quantity to administer) cause the required function of maintained elevated neopterin concentration, and Claim 9 is rejected for indefinite functional language.
Claims 1, 5, 9-18, 20-26, and 31-32 are directed to “an interferon-based therapeutic agent.” The specification defines the “interferon-based therapeutic agent” as a therapeutic agent capable of generating at least part of the effects of a natural interferon (page 5, paragraph 1). This definition uses functional language because the feature (the interferon-based therapeutic agent) is defined by what it does (capable of generating at least part of the effects of a natural interferon) rather than by what it is (MPEP § 2173.05(g)). The definition states a result obtained without any required structure. The metes and bounds of “an interferon-based therapeutic agent” cannot be readily determined, and Claims 1, 5, 9-18, 20-26, and 31-32 are rejected.
Claim 26 recites “wherein the additional agent is administered according to its conventional scheme.” “Conventional scheme” is not defined in the specification. In the art, a “conventional scheme” can vary by agent, disease, and patient. Therefore, the metes and bounds of Claim 26 cannot be readily determined. For the purpose of compact prosecution, “conventional scheme” will be interpreted with the broadest reasonable interpretation as any dosing scheme known in the art prior to the time of filing.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 9-18, 20-26, and 31-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is directed to a method of treating any disease by administering any interferon-based therapeutic agent. “Treating” is not defined in the specification and is interpreted as alleviating the symptoms or complications of an established disease, delaying the progression of an established disease, and/or curing or eliminating an established disease. The specification defines the “interferon-based therapeutic agent” as a therapeutic agent capable of generating at least part of the effects of a natural interferon (page 5, paragraph 1). Claim 4 specifically defines the interferon-based therapeutic agent as IFN-α2b, but Claim 4 is still directed to treating any disease. Similarly, Claim 20 defines wherein the disease is a cancer, but Claim 20 is still directed to any interferon-based therapeutic agent. Therefore, the claims are directed to treating a genus of diseases by administering a genus of agents.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. In order to provide adequate written description and evidence of possession of a method of treating a genus of diseases by administering a genus of agents, the specification must provide sufficient distinguishing identifying characteristics of the genera. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed agent, methods of using the claimed treatment, or any combination thereof.
Example 2 teaches treating patients with chronic hepatitis B by intermittently administering Pegberon (specification page 14). Examples 6-14 teach treating liver, lung, colorectal, and melanoma cancers in mice by intermittently administering PEG-mIFN-α4 (specification pages 20-31). However, using two different agents in the treatment of five different disease models does not provide sufficient written description for the treatment of any disease by administering any agent capable of generating at least part of the effects of a natural interferon.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (MPEP § 2163.05.Ib). In the absence of sufficient recitation of distinguishing identifying characteristics or structure-to-function attributes for the entire genus of agents, the specification does not provide adequate written description of the claimed genus of agents. Similarly, in the absence of sufficient recitation of treating a representative number of disease types, the specification does not provide adequate written description of the claimed genus of diseases. In view of the case law directed to an appropriate number of representative species, claims 1-5, 9-18, 20-26, and 31-32 are rejected for insufficient written description.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see page 1115).
Claims 1-5, 9-18, 20-26, and 31-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating diseases by administering interferon-based agents that are outlined in the specification and known in the art prior to filing, does not reasonably provide enablement for the broad scope of treating any disease by administering any interferon-based therapeutic agent. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
MPEP § 2164.01(a) states that there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure
does not satisfy the enablement requirement and whether any necessary experimentation is
“undue”. These factors include, but are not limited to:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims and nature of the invention:
The nature of the invention is complex, encompassing the treatment of any disease by administering any interferon-based therapeutic agent (Claim 1). When analyzing the scope of enablement, the claims are analyzed with respect to the teachings of the specification and are to be "given their broadest reasonable interpretation consistent with the specification." See MPEP 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
The state of the prior art and level of predictability in the art:
The level of predictability in the art depends, most importantly, on whether the claimed invention can be practiced by one of ordinary skill in the art. The art does not teach a single therapeutic agent that is capable of treating all diseases that vary widely in etiologies and symptoms. The genus comprises influenza, tuberculosis, Lyme disease, heart disease, stroke, cancer, diabetes, asthma, Alzheimer’s disease, Parkinson’s disease, depression, anxiety, bipolar disease, arthritis, cystic fibrosis, etc. The art also fails to enable the structures and functions for the genus of interferon-based therapeutic agents that encompasses any therapeutic agent capable of generating at least part of the effects of a natural interferon (specification page 5, paragraph 1).
There is not support in the art or in the Applicant’s disclosure leading one of ordinary skill to overcome the lack of predictability in treating any disease by administering any interferon-based therapeutic agent.
Level of skill in the art:
The level of skill would be high encompassing oncology, immunology, neurology, virology, protein science, functional assays, etc.
Amount of direction provided by inventor and the existence of working examples:
The specification teaches treating patients with chronic hepatitis B by intermittently administering Pegberon (Example 2, page 14). Examples 6-14 teach treating liver, lung, colorectal, and melanoma cancers in mice by intermittently administering PEG-mIFN-α4 (specification pages 20-31). However, using two different agents in the treatment of five different disease models does not provide enablement to make any agent capable of generating at least part of the effects of a natural interferon and use the agents in the treatment of any disease.
A person having ordinary skill in the art would have to make a substantial inventive contribution in order to treat any disease with any interferon-based agent, since there is no guidance within the disclosure as filed pertaining to this embodiment.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
Given that the nature of the claims is in vivo treatment, a person having ordinary skill in the art would have to perform multiple further experiments with a representative number of interferon-based agents, in human clinical trials or in animal models, that are predictive of treatment in a representative number of disease types in order to demonstrate the invention could be used with a reasonable expectation of success. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to practice the invention commensurate with the scope of the claims.
The instant specification does not enable the invention to treat any disease by administering any interferon-based therapeutic agent (Claim 1).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 10-14, 16-18, 20-21, 24, 26, and 31-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stefan et al. Anti-Cancer Drugs 2002 as evidenced by Radwanski et al. J Clin Pharmacol. 1987.
The instant claims recite a method for treating a disease in a subject comprising intermittently administering an interferon-based therapeutic agent for a plurality of consecutive treatment courses (Claim 1). Dependent claims recite: wherein the interferon-based therapeutic agent is an interferon (Claim 2) specifically interferon-α2b (Claims 3-4); the duration of the consecutive treatment course is the time period from the first administration to the last administration, plus 5 in vivo half-lives of the agent (Claim 10); the duration of the treatment course is from 1 to 24 weeks (Claim 11); the duration of the treatment course and the interval is from 1 to 12 weeks (Claim 12); the interval is from 1 to 24 weeks (Claim 13); the duration of the treatment course and the interval is from 1 to 8 weeks (Claim 14); the interferon-based therapeutic agent is administered for 2-25 or more courses (Claim 16); the durations of the courses and intervals are the same (Claims 17-18); the disease is cancer (Claim 20); the method further comprises administering an additional agent (Claim 21); the administration of the interferon-based agent overlaps with the administration of the additional agent (Claim 24); the additional agent is administered according to its conventional scheme (Claim 26); the additional agent is an anticancer agent (Claim 31) specifically gemcitabine (Claim 32).
Note, intermittently administering consecutive treatment courses is interpreted as administering the agent on and off in cycles wherein the “off” interval between “on” treatment courses is at least 1 week (page 8, paragraph 8). “Plurality” in Claim 1 is interpreted as two or more courses. “Overlap” in administration is interpreted to mean the “on” treatment courses of both agents occur completely or partially at the same time. This interpretation is based on specification page 12, paragraph 2, that defines “complete overlap” as when the additional agent is administered during the entire interferon-based agent treatment course.
Stefan teaches a phase I clinical trial in patients with non-small cell lung, ovarian, pancreatic, or renal cancer (title). Gemcitabine was administered once weekly and IFN-α2b was administered three times weekly for 3 consecutive weeks followed by one week of rest (abstract). The 28-day treatment regimen was repeated cyclically (abstract). Therefore, Stefan teaches a 3-week consecutive treatment course with a 1-week rest interval. Stefan also teaches overlapping the administration of IFN-α2b with gemcitabine. Radwanski teaches that the elimination half-life of IFN-α2b IV infusion is 1.7 hours, intramuscular injection is 2.2 hours, and subcutaneous injection is 2.9 hours (abstract). Based on the definition of duration (Claim 10 and specification page 8, paragraph 6), the IFN-α2b would be cleared 8.5 to 14.5 hours after the last administration.
Therefore, Claims 1-4, 10-14, 16-18, 20-21, 24, 26, and 31-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stefan as evidenced by Radwanski.
Claims 1-2, 11-18, 20-23, 26, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wada et al. Br J Haematol. 2000 as evidenced by Shudo et al. Expert Opin Drug Metab Toxicol. 2009.
Claims 1-2, 11-14, 16-18, 20-21, 24, 26, and 31 are recited in the rejection above. Claim 15 recites wherein the duration of each course and interval is 2 weeks to 6 weeks. Claim 22 recites wherein the administration of the interferon-based agent does not overlap with the administration of the additional agent. Claim 23 recites wherein the additional agent is administered between the plurality of consecutive treatment courses.
Wada teaches a pilot study evaluating treatments for patients with multiple myeloma (abstract). Patients received combination chemotherapy (ranimustine, vincristine, melphalan, dexamethasone) over the first 3 weeks of a 6-week cycle (Table 1). Patients then received IFN-α2a subcutaneously three times weekly over the last 3 weeks of a 6-week cycle (Table 1). The 6-week cycle was repeated for three cycles (Table 1). At the conclusion of the treatment cycles, the responders were randomized into two groups that received or did not receive IFN-α as maintenance therapy (abstract). Therefore, Wada teaches a 3-week consecutive treatment course with a 3-week rest interval. During the rest interval, the patients were treated with chemotherapy that did not overlap with the administration of the IFN-α2a. Shudo teaches that the half-life of IFN-α2a after injection is 5.1 hours (page 2, paragraph 2). Based on the definition of duration (Claim 10 and specification page 8, paragraph 6), the IFN-α2a would be cleared 25.5 hours after the last administration.
Therefore, Claims 1-2, 11-18, 20-23, 26, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wada as evidenced by Shudo.
Claims 1-5, 10-13, 16-18, 21, and 24-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goujard et al. AIDS. 2012 as evidenced by Palumbo et al. Ther Adv Chronic Dis. 2011.
Claims 1-4, 10-13, 16-18, 21, 24, and 26 are recited in the rejections above. Claim 5 recites wherein the interferon is PEGylated. Claim 25 recites wherein the additional agent is administered during and between the plurality of consecutive treatment courses.
Goujard teaches a clinical trial evaluating treatments for HIV (abstract). Patients in the “ART-STI-IFN” group were administered continuous antiviral medications comprising nucleoside reverse transcriptase inhibitors, protease inhibitors, and/or nonnucleoside reverse transcriptase inhibitors from weeks 0-36, 40-48, 52-60, and 64-72 (Figure 1 and page 1896, paragraph 7). The patients were also administered pegylated IFN-α2b (PEG-IFN-α2b) (abstract) subcutaneously once a week from weeks 0-14, 38-40, 50-52, and 62-64 (Figure 1 and page 1896, paragraphs 6-7). Therefore, Goujard teaches PEGylated IFN administered during and between additional antiviral agents. Palumbo teaches that the half-life of PEG-IFN-α2b is 40 hours (page 40, paragraph 1). Based on the definition of duration (Claim 10 and specification page 8, paragraph 6), the PEG-IFN-α2b would be cleared 8 days after the last administration. Because the PEG-IFN-α2b was administered once weekly, the regimen after week 36 comprises a 2-week consecutive treatment course with a 10-week rest interval that is repeated for 3 cycles.
Therefore, Claims 1-5, 10-13, 16-18, 21, and 24-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goujard as evidenced by Palumbo.
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.
1. Claims 1-5, 9-18, 20-21, and 31-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-10, 14-22, and 24-25 of copending U.S. App. No. 18/273,321. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims recite a method for treating a disease in a subject comprising intermittently administering an interferon-based therapeutic agent for a plurality of consecutive treatment courses (Claim 1). Dependent claims recite: wherein the interferon-based therapeutic agent is an interferon (Claim 2) specifically interferon-α2b (Claims 3-4); the interferon is PEGylated (Claim 5); the interferon-based agent is administered such that neopterin concentration is higher during the entire course as compared to the concentration before the first administration (Claim 9); the duration of the consecutive treatment course is the time period from the first administration to the last administration, plus 5 in vivo half-lives of the agent (Claim 10); the duration of the treatment course is from 1 to 24 weeks (Claim 11); the duration of the treatment course and the interval is from 1 to 12 weeks (Claim 12); the interval is from 1 to 24 weeks (Claim 13); the duration of the treatment course and the interval is from 1 to 8 weeks (Claim 14); the duration of the treatment course and the interval is from 2 to 6 weeks (Claim 15); the interferon-based therapeutic agent is administered for 2-25 or more courses (Claim 16); the durations of the courses and intervals are the same (Claims 17-18); the disease is cancer (Claim 20); the method further comprises administering an additional agent (Claim 21); the additional agent is an anticancer agent (Claim 31) specifically gemcitabine (Claim 32).
The copending claims recite: a method for preventing cancer recurrence comprising administering an interferon-based therapeutic agent and optionally an additional anticancer agent (Claim 1); administering at least 1 consecutive course of the interferon-based therapeutic agent (Claim 2); comprising intermittently administering a plurality of consecutive courses of the interferon-based therapeutic agent (Claim 3); wherein the interferon-based therapeutic agent is an interferon (Claim 7) specifically interferon-α2b (Claims 8-9); the interferon is PEGylated (Claim 10); the interferon-based agent is administered such that neopterin concentration is higher during the entire course as compared to the concentration before the first administration (Claim 14); the duration of the consecutive treatment course is the time period from the first administration to the last administration, plus 5 in vivo half-lives of the agent (Claim 15); the duration of the treatment course is from 1 to 24 weeks (Claim 16); the interval is from 1 to 24 weeks (Claim 17); the duration of the treatment course and the interval is from 1 to 8 weeks (Claim 18); the duration of the treatment course and the interval is from 2 to 6 weeks (Claim 19); the interferon-based therapeutic agent is administered for 2-25 or more courses (Claim 20); the durations of the courses and intervals are the same (Claims 21-22); the additional anticancer agent is gemcitabine (Claim 24); the cancer is selected from cancer types that overlap with copending Claim 20 (Claim 25).
The copending claims teach a method of preventing cancer recurrence. The instant claims teach a method of treating a disease wherein the disease is cancer. The copending specification does not define “preventing” and the instant specification does not define “treating.” Without definitions, the broadest reasonable interpretation of “treating” encompasses delaying the progression of an established disease which is equivalent to preventing the recurrence of an established cancer. Thus, the method of the instant claims is either anticipated and/or rendered obvious by the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 1-5, 9-18, 20-24, and 31-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-12, 14-19, and 23-24 of copending U.S. App. No. 18/273,323. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1-5, 9-18, 20-21, and 31-32 are set forth above. Claim 22 recites wherein the administration of the interferon-based agent does not overlap with the administration of the additional agent. Claim 23 recites wherein the additional agent is administered between the plurality of consecutive treatment courses. Claim 24 recites wherein the administration of the interferon-based agent overlaps with the administration of the additional agent.
The copending claims recite: a method for treating cancer in a subject comprising intermittently administering an interferon-based therapeutic agent for a plurality of consecutive cancer treatment courses and administering an additional anticancer agent (Claim 1); the interferon-based agent is administered such that neopterin concentration is higher during the entire course as compared to the concentration before the first administration (Claim 3); the duration of the consecutive treatment course is the time period from the first administration to the last administration, plus 5 in vivo half-lives of the agent (Claim 4); the duration of the treatment course is from 1 to 24 weeks (Claim 5); the duration of the treatment course and the interval is from 1 to 12 weeks (Claim 6); the interval is from 1 to 24 weeks (Claim 7); the duration of the treatment course and the interval is from 1 to 8 weeks (Claim 8); the duration of the treatment course and the interval is from 2 to 6 weeks (Claim 9); the interferon-based therapeutic agent is administered for 2-25 or more courses (Claim 10); the durations of the courses and intervals are the same (Claims 11-12); the additional anticancer agent is administered during each consecutive treatment course (Claim 14); the additional anticancer agent is administered after each consecutive treatment course and not during each treatment course (Claim 15); wherein the interferon-based therapeutic agent is an interferon (Claim 16) specifically interferon-α2b (Claims 17-18); the interferon is PEGylated (Claim 19); the cancer is selected from cancer types that overlap with copending Claim 20 (Claim 23); the anticancer agent is gemcitabine (Claim 24).
Because the copending claims recite the same elements of the instant claims, the method of the instant claims is either anticipated and/or rendered obvious by the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3. Claims 1-5, 9-18, 20-26, and 31-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 9-25 of copending U.S. App. No. 18/099,664. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 1-5, 9-18, 20-24, and 31-32 are set forth above. Claim 25 recites wherein the additional agent is administered during and between the plurality of consecutive treatment courses. Claim 26 recites wherein the additional agent is administered according to its conventional scheme.
The copending claims recite: a method for treating cancer in a subject comprising intermittently administering an interferon-based therapeutic agent for a plurality of consecutive cancer treatment courses and administering an additional anticancer agent (Claim 1); wherein the interferon-based therapeutic agent is an interferon (Claim 2) specifically interferon-α2b (Claims 3-4); the interferon is PEGylated (Claim 5); the interferon-based agent is administered such that neopterin concentration is higher during the entire course as compared to the concentration before the first administration (Claim 9); the duration of the consecutive treatment course is the time period from the first administration to the last administration, plus 5 in vivo half-lives of the agent (Claim 10); the duration of the treatment course is from 1 to 24 weeks (Claim 11); the duration of the treatment course and the interval is from 1 to 12 weeks (Claim 12); the interval is from 1 to 24 weeks (Claim 13); the duration of the treatment course and the interval is from 1 to 8 weeks (Claim 14); the duration of the treatment course and the interval is from 2 to 6 weeks (Claim 15); the interferon-based therapeutic agent is administered for 2-25 or more courses (Claim 16); the durations of the courses and intervals are the same (Claims 17-18); the cancer is selected from cancer types that overlap with copending Claim 20 (Claim 19); the administration of the interferon-based agent does not overlap with the administration of the additional anticancer agent (Claim 20); the anticancer agent is administered between the plurality of consecutive treatment courses (Claim 21); the administration of the interferon-based agent overlaps with the administration of the additional anticancer agent (Claim 22); the additional anticancer agent is administered during and between the plurality of consecutive treatment courses (Claim 23); the additional anticancer agent is administered according to its conventional scheme (Claim 24); the anticancer agent is gemcitabine (Claim 25).
Because the copending claims recite the same elements of the instant claims, the method of the instant claims is either anticipated and/or rendered obvious by the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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, Jeffrey Stucker can be reached at (571) 272-0911. 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.
/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/STACEY N MACFARLANE/Examiner, Art Unit 1675
Prosecution Insights