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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/26/2026 has been entered.
Status of the Claims
Receipt of Remarks/Amendments filed on 1/26/2026 is acknowledged. Claims 1-2, 4-14 are currently pending and under examination.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Claim interpretation
Instant claim 1 recites wherein the subject is susceptible to nausea when the concentration of ME in the sample per one million total RBC is less than a mean glutathione-recycling activity + 2X Standard deviation. The examiner interprets that this recitation does not add any structural limitation to the method steps recited in the claims. The method step of quantifying a concentration of beta mercaptoethanol (ME) (which is a method step required in the claim) would provide a certain concentration of ME in the sample. However, the recitation wherein the subject is susceptible to nausea when the concentration of ME in the sample per one million total RBC is less than a mean glutathione-recycling activity + 2X Standard deviation does not add any structure to the method steps because the claim does not require the sample/subject having a particular ME concentration and depending on the concentration that is quantified, it would necessarily make the subject susceptible to nausea when the concentration of ME is less than a mean glutathione recycling activity + 2X Standard deviation.
New/Maintained Claim(s) Rejections/Objections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for 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 recites the concentration of ME in the sample per one million total RBC is less than a mean glutathione-recycling activity + 2X Standard deviation.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). MPEP 2163(II).
The instant specification disclose the mean glutathione recycling capacity (mm ME/106 RBC)+SD was plotted (see page 4). The specification also disclose prescribing an antiemetic drug regimen to the subject when the subject's GSH recycling activity is lower than a cut-off characterized as a mean+2X Standard deviation of about 1.0 (see page 11). Claim 1 recitation wherein the concentration of ME in the sample per one million total RBC is less than a mean glutathione-recycling activity + 2X Standard deviation fails to comply with the written description requirement because neither the claim nor the specification clearly describe what exactly is a mean glutathione-recycling activity + 2X Standard deviation in the context of determining what the concentration of ME is. As mentioned above, the specification disclose that in figure 2, the mean glutathione recycling capacity (mm ME/106 RBC)+SD was plotted, which suggests that the units of the concentration of ME is in mm/10^6 RBC, however, this does not specify what is the exact ME concentration. Also, as mentioned above, the specification disclose that GSH recycling activity is lower than a cut-off characterized as a mean+2X Standard deviation of about 1.0. This again fails to describe and specify what is the concentration of the ME. Is the mean + 2X standard deviation of 1.0 a concentration of ME? And if so, what is the unit of 1.0? The specification fail to describe and specify how exactly the limitation “less than a mean glutathione-recycling activity + 2X Standard deviation” equates to a concentration of ME. Further, there is no description of how the glutathione recycling activity is determined and whether it is based on a certain individual or it is a generally known number in the art. Therefore, the recitation wherein the concentration of ME in the sample per one million total RBC is less than a mean glutathione-recycling activity + 2X Standard deviation fails to comply with the written description requirement.
Claim 4 recites wherein a low GSH recycling capacity is less than 1.0. The specification also fail to provide written description for this recitation in claim 4 because the specification do not describe or specify what is the unit of 1.0 or how this number is determined in the context of GSH recycling capacity. The number 1.0 appears to be arbitrary and neither the specification nor the prior art discloses that this is a known value in the context of GSH recycling capacity. Therefore, claim 4 also fails to comply with the written description requirement.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites wherein the subject is susceptible to nausea when the concentration of ME in the sample per one million total RBC is less than a mean glutathione-recycling activity + 2X Standard deviation. As discussed in the 112(a) rejection above, neither the claim nor the specification clearly describe what exactly is a mean glutathione-recycling activity + 2X Standard deviation in the context of determining what the concentration of ME is. As mentioned above, the specification disclose that in figure 2, the mean glutathione recycling capacity (mm ME/106 RBC)+SD was plotted, which suggests that the units of the concentration of ME is in mm/10^6 RBC, however, this does not specify what is the exact ME concentration. Also, as mentioned above, the specification disclose that GSH recycling activity is lower than a cut-off characterized as a mean+2X Standard deviation of about 1.0. This again fails to specify what is the concentration of the ME. Is the mean + 2X standard deviation of 1.0 a concentration of ME? And if so, what is the unit of 1.0? Neither the specification nor the claims specify how exactly the limitation “less than a mean glutathione-recycling activity + 2X Standard deviation” equates to a concentration of ME, which makes it unclear to the examiner as to what exactly is the concentration of ME and the units of the concentration. Further, it is unclear how the glutathione recycling activity is determined and whether it is based on a certain individual or it is a generally known number in the art. Therefore, the recitation wherein the concentration of ME in the sample per one million total RBC is less than a mean glutathione-recycling activity + 2X Standard deviation renders the claim indefinite.
Claim 4 recites wherein a low GSH recycling capacity is less than 1.0. Neither the claims nor the specification describe or specify what is the unit of 1.0 or how this number is determined in the context of GSH recycling capacity. The number 1.0 appears to be arbitrary and neither the specification nor the prior art discloses that this is a known value in the context of GSH recycling capacity. Thus, it is unclear to the examiner as to what exactly is a GSH recycling capacity of 1.0 and the instant specification also fail to clarify this.
The phrases “moderate to severe nausea”, “low GSH recycling”, “highly or moderately emetogenic”, “low glutathione recycling activity”, “low or moderately emetogenic”, “high GSH recycling activity”, “high glutathione recycling”, “moderately emetogenic or low emetogenic”, and terms “highly”, “moderately”, “moderate”, “severe”, “low” in Claims 7-14 are relative terms which render the claim indefinite. These terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One cannot ascertain what would be low, moderate, high, severe, etc. without a reference to compare the degree to. As such, the metes and bounds of the claims are unclear and these claims are rejected.
Claims 2, 5, 6 are included in the rejection as they depend on a rejected base claim and do not clarify the issues discussed above.
Response to Arguments
With respect to the phrases “low GSH recycling”, “low glutathione recycling activity”, “high GSH recycling activity” and “high glutathione recycling”, applicant argued these phrases would be readily understood by the definitions in the specification. Applicant pointed to page 7-8 of specification for definition of glutathione recycling dependent antioxidant activity.
In response, while the specification disclose what is glutathione recycling dependent antioxidant activity, the specification do not provide a clear definition of what is considered, for example, “low” GSH recycling. As discussed supra, these are relative terms which render the claim indefinite because these terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One cannot ascertain what would be low, moderate, high, severe, etc. without a reference to compare the degree to. As such, the metes and bounds of the claims are unclear and these claims are rejected.
With respect to the phrases “low emetogenic”, “moderately emetogenic”, and “high emetogenic”, applicant argued these phrases are terms of the art that would be readily understood by one skilled in the art to encompass certain classes of agents.
In response, the examiner argues that while applicant assert these are term of the art, the applicant have not provided any evidence/reference which would suggest that these are term of the art and that one can ascertain what would be low, moderate or highly emetogenic. There is also no clear definition in the specification of what is considered, for example, low emetogenic. A drug may be considered a low emetogenic for one individual but may be highly emetogenic for another individual. As such, low, moderate and high emetogenic are relative terms which render the claim indefinite.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 1-2, 4-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kawaguchi (cited in the IDS) in view of Li (Journal of Pharmacological and Toxicological Methods 69 (2014) 39- 48, cited in the IDS), Li et al. (Toxicology in Vitro 27 (2013) 367-377), hereinafter Li2, Kim et al. (Journal of gynecologic oncology 23.2 (2012): 103-109), hereinafter Kim, and Zheng et al. (Journal of Hainan Medical University, 2017, published online July 2016; 23(1): 72-75), hereinafter Zheng, as evidenced by Fleishman et al. (Journal of Oncology Practice, 2012): 136-140), hereinafter Fleishman.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Kawaguchi describes methods and compositions for reducing oxidative stress and/or side effects occurring during cancer chemotherapy (Claims 1 and 12; Example 1). The method includes determining the oxidative stress level in a blood sample ([0018], [0064]-[0065]), and administration of antiemetic drugs to reduce nausea and vomiting ([0032], Fig. 12; Example 1). Kawaguchi recites that a reducing effect on oxidative stress during chemotherapy is confirmed by surveying, for example, the presence or absence of nausea, vomiting, etc. ([0064], Example 1), thereby rendering obvious the limitation of correlating susceptibility to nausea to high level of oxidative stress.
Ascertainment of the difference between the prior art and the claims
Kawaguchi does not expressly teach measuring GSH recycling utilizing the method steps recited in the instant claims and managing a therapeutic regimen. Kawaguchi does not expressly teach administering any of the recited alternate regimens which comprises any emetogenic chemotherapeutic drug with or without antiemetic drug, and predicting delayed nausea as recited in instant claims.
Li is in the same field and understands the role glutathione play in repairing damage induced by cancer drugs, and teaches a method using a bioactive probe of the oxidative pentose phosphate cycle, termed the OxPhos™ test to quantify glutathione recycling dependent antioxidant activity in whole blood and intact human and rodent cells. The test uses hydroxyethyldisulfide (HEDS), which is converted into mercaptoethanol (ME), and is used to measure glutathione-dependent antioxidant activity in breast cancer patient's blood (Abstract; p. 40, 3rd paragraph; Figs. 1-3). Li teaches the calculation of ME concentration in samples with 1 million RBC (Section 3.1; Figs. 1-3). Li2 supports Li by also teaching exposure of the cancer cells to HEDS; quantifying the amount of mercaptoethanol (ME) produced from HEDS by the cells using 5,5-dithiobis 2-nitrobenzoic acid (DTNB) assay, and measuring the optical density (absorbance) at 412 nm (Materials and Methods, Sections 2.1 to 2.11). Li2 teaches HEDS decreases glutathione (GSH) with concomitant increase in oxidized glutathione (GSSG) in glucose-deprived human colon cancer cells independent of p53 status (Fig. 2). The experiment involves culturing 8 x 105 cells. (Section 2.1). Li2 shows the mean for 3-5 independent experiments with SD, and a statistically significant reduction in GSH with concomitant increase in GSSG (Fig. 2). Li observed a concentration-dependent conversion of HEDS to ME of up to 3 mM. (p. 371; Fig. 8).
Neither Kawaguchi, Li, nor Li2 expressly teach the relationship of nausea with GSH recycling activity of RBC.
Kim is in the same field and relays the changes in biologic markers of oxidative stress and plasma endotoxin levels in gynecologic cancer patients (Title). The method includes studying cancer patients treated via pelvic radiotherapy with or without concurrent chemotherapy with cisplatin, paclitaxel, carboplatin, etc. (Table 1). Kim teaches that the GSH/GSSG ratio was reduced dramatically at the initiation of radiotherapy, and the plasma endotoxin level increased. Kim establishes the relationship between the endotoxin level and nausea/vomiting (Abstract; p. 107, Section 4; Fig. 3). Kim contemplates that endotoxin might be correlated closely with intestinal toxicities, and the high incidence of endotoxin in the blood during radiotherapy entering the circulation may be associated with nausea, vomiting, etc. (p. 104, L. Col., 1st paragraph). Kim teaches that no significant changes in the levels of GSH during radiotherapy was observed, however, GSSG level increased and the ratio of GSH/GSSG was reduced under increased oxidative stress conditions (p. 107, Discussion).
Zheng also teaches that persistent nausea and vomiting is a strong source of stress for the body, and recognizes that chemotherapy-induced nausea and vomiting can cause the oxidative stress reaction in the body. Zheng describes the effect of different antiemetic drugs, and how using palonosetron to stop vomiting can reduce the oxidative stress caused by vomiting (p. 74, R. Col., last paragraph). The treatment method involves the use of oxaliplatin (cytostatic chemotherapeutic drug), and palonosetron was administrated during chemotherapy or received tropisetron (2.2 Treatment methods). Palonosetron has better antiemetic effect than first generation antiemetic, tropisetron for gastric cancer patients with chemotherapy, and after chemotherapy, the nutritional status is better and the inflammatory stress level is lighter (Abstract). Furthermore, Zheng teaches that palonosetron is highly selective, has a stronger receptor affinity and longer half-life in the body, and has better treatment effect on acute vomiting and delayed vomiting than tropisetron (p. 72, R. Col.). Thus, Zheng teaches that palonosetron can relieve inflammatory stress caused by chemotherapy-induced vicious vomiting (p. 75, last paragraph). Because oxaliplatin is a moderately emetogenic antineoplastic (cytostatic) drug, as evidenced by Fleishman (Introduction, 1st paragraph). Zheng renders obvious the feature of a highly or moderately emetogenic chemotherapeutic with an antiemetic drug regimen of two or less antiemetic drugs.
Finding of prima facie obviousness Rational and Motivation
(MPEP 2142-2143)
Kawaguchi has taught the method of determining the oxidative stress level in a blood sample from a subject undergoing chemotherapy and the administration of antiemetic drugs to reduce nausea and vomiting; thereby rendering obvious the limitation of correlating susceptibility to nausea to high level of oxidative stress. Li teaches OxPhos™ test to quantify glutathione recycling dependent antioxidant activity in breast cancer patient's blood, converting HEDS to ME. Li2 taught the use of one million cells in assay, and taught the concentration dependent conversion of HEDS to ME. Kim taught that the GSH/GSSG ratio is decreased and was reduced dramatically at the initiation of radiotherapy, and the plasma endotoxin level increased, which correlated to increased nausea/vomiting. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Kawaguchi with that of Li and Kim, and assess the patient’s risk of nausea based on the GSH recycling activity from RBC of patients undergoing chemotherapy, by calculating the concentration of ME by corollary per the teaching of Li and Kim, and arrive at the instant claim. One skilled in the art would have been motivated to apply known techniques, i.e. the techniques of Li and Kim, to a known method, i.e. the method of Kawaguchi, ready for improvement to yield predictable results.
Further, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to look at the corollary of the teachings of the art. Kawaguchi and Li have taught the correlation of oxidative stress and nausea, and quantification of glutathione recycling dependent antioxidant activity; Li2 taught the conversion of HEDS to ME, which correlates to hyperemesis. Kim taught that the GSH/GSSG ratio is decreased and was reduced dramatically at the initiation of radiotherapy, and the plasma endotoxin level increased, which correlated to increased nausea/vomiting. As a corollary, a skilled artisan would know that GSH/GSSG increase would mean the opposite of hyperemesis, i.e. less susceptibility to nausea. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Kawaguchi with that of Li and Kim, and assess the patient’s resistance to nausea based on the GSH/GSSG ratio from RBC of patients undergoing chemotherapy, by calculating the concentration of ME by corollary per the teaching of Li and Kim, and arrive at the instant claim. One skilled in the art would have been motivated to apply known techniques, i.e. the techniques of Li and Kim, to a known method, i.e. the method of Kawaguchi, ready for improvement to yield predictable results.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Zheng with that of Kawaguchi, Kim, and Li, and administer to a subject a therapeutic regimen depending on the level of oxidative stress, as demonstrated by Zheng. For instance, a skilled artisan would use antiemetic palonosetron as disclosed by Zheng with reasonable expectations of success that it would stop nausea and vomiting and reduce the oxidative stress caused by vomiting when the subject treatment involves moderately emetogenic oxaliplatin. Obviousness is established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 1 recitation wherein the subject is susceptible to nausea when the concentration of ME in the sample per one million total RBC is less than a mean glutathione-recycling activity + 2X Standard deviation, as discussed supra, this recitation does not add any structural limitation to the method steps recited in the claims. Moreover, as discussed supra, it is unclear as to what is the concentration of ME which renders the subject being susceptible to nausea.
Regarding claim 4, as discussed supra, neither the claims nor the specification describe or specify what is the unit of 1.0 or how this number is determined in the context of GSH recycling capacity. The number 1.0 appears to be arbitrary and neither the specification nor the prior art discloses that this is a known value in the context of GSH recycling capacity. Thus, it is unclear to the examiner as to what exactly is a GSH recycling capacity of 1.0 and the instant specification also fail to clarify this.
From the combined teaching of the cited references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Argument
Applicant argued that while some of the prior art references may have noted the correlation between oxidative stress and nausea, it is only Applicant that has provided a test with clear blaze marks that provides an actionable method for addressing susceptibility to nausea. One of the recited limitations is that "the subject is susceptible to nausea when the calculation is the mean glutathione-recycling activity + 2X Standard deviation". It was argued that nothing about the cited documents teaches or suggests this blaze mark. Applicant argued that none of the cited documents teaches or suggests the calculation of ME concentration in samples with 1 million RBC.
In response, as discussed supra, the recitation wherein the subject is susceptible to nausea when the concentration of ME in the sample per one million total RBC is less than a mean glutathione-recycling activity + 2X Standard deviation, does not add any structural limitation to the method steps recited in the claims. Moreover, as discussed supra, it is unclear as to what is the concentration of ME which renders the subject being susceptible to nausea. Thus, applicant’s argument regarding the prior art not teaching this is not persuasive to overcome the 103 rejection above.
Applicant argued that while Kim et al observed that "GSSG accumulated and GSH/GSSG was reduced under increased oxidative stress conditions", they stated that "[nausea/vomiting and diarrhea] evidenced no correlation with biologic markers of oxidative stress, including GSH, GSSG, and GSH/GSSG."
In response as discussed supra, Kawaguchi recites that a reducing effect on oxidative stress during chemotherapy is confirmed by surveying, for example, the presence or absence of nausea, vomiting, etc. ([0064], Example 1). The method includes determining the oxidative stress level in a blood sample ([0018], [0064]-[0065]), and administration of antiemetic drugs to reduce nausea and vomiting ([0032], Fig. 12; Example 1). thereby rendering obvious the limitation of correlating susceptibility to nausea to high level of oxidative stress. Further, Kim teaches that the GSH/GSSG ratio was reduced dramatically at the initiation of radiotherapy, and the plasma endotoxin level increased. Kim establishes the relationship between the endotoxin level and nausea/vomiting (Abstract; p. 107, Section 4; Fig. 3). Kim contemplates that endotoxin might be correlated closely with intestinal toxicities, and the high incidence of endotoxin in the blood during radiotherapy entering the circulation may be associated with nausea, vomiting, etc. (p. 104, L. Col., 1st paragraph). Kim teaches that GSSG level increased and the ratio of GSH/GSSG was reduced under increased oxidative stress conditions (p. 107, Discussion). The combination of Kawaguchi and Kim suggest that with reduce GSH/GSSG, the plasma endotoxin level increased, which establishes relationship between endotoxin and nausea/vomiting, as stated by Kim. Kim also teaches the ratio of GSH/GSSG was reduced under increased oxidative stress and as taught by Kawaguchi, oxidative stress correlates with nausea/vomiting. Thus, the combination of Kawaguchi and Kim suggests that a reduced GSH/GSSG can lead to nausea/vomiting due to increased oxidative stress and endotoxin levels.
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 1-2, 4-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11761949.
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘949 patent recites a method for managing emetogenic drug induced nausea in a mammalian subject with cancer, the method comprising: assaying a biological sample containing red blood cells (RBC) obtained from the mammalian subject prior to administration of an emetogenic chemotherapeutic drug, wherein assaying the biological sample comprises measuring glutathione (GSH) recycling dependent antioxidant activity of the RBC as an indicator of oxidative stress, wherein measuring GSH recycling capacity comprises contacting the sample with hydroxyethyldisulfide (HEDS) and quantifying a concentration of β-mercaptoethanol (ME) in the sample as result of the conversion of HEDS to ME; obtaining a calculation that is concentration of ME (mM) in the sample per one million total RBC, and diagnosing the subject as being predisposed to emetogenic drug-induced nausea when the calculation is ≤1.0; and administering to the subject a highly or moderately emetogenic chemotherapeutic with an antiemetic drug regimen of two or less antiemetic drugs; administering to the subject a low emetogenic chemotherapeutic with an antiemetic drug regimen of two or less antiemetic drug; administering to the subject a low emetogenic chemotherapeutic with no antiemetic drug; administering to the subject a full regimen of at least 3 antiemetic drugs with an emetogenic chemotherapeutic drug; predicting delayed nausea for the subject during treatment with a highly or moderately emetogenic cytostatic chemotherapeutic drug; predicting delayed nausea for the subject undergoing surgery requiring an emetogenic general anesthetic agent; optimizing the subject's treatment by treating the subject with an antiemetic drug prior to, during, or after administration of said emetogenic agent; or optimizing the subject's treatment by treating the subject with an antiemetic drug prior to, during, or after administration of a highly or moderately emetogenic chemotherapeutic drug.
While the instant claims are directed to a method for assessing susceptibility to nausea and the reference claims are directed to a method for managing emetogenic drug induced nausea, the method steps recited in the instant claims are the same methods taught by the reference claims. Therefore, the instant claims and the reference claims are obvious variants.
Response to Arguments
Applicant argued that during the prosecution of the '949 Patent, the Examiner has indicated that these two groups of claims are independent or distinct from one another. Accordingly, Applicant submits that these claims are considered patentably distinct from one another and respectfully requests its withdrawal of this rejection.
In response, the examiner argues that the present application is a CON of the ‘949 patent and not a DIV. Therefore, the double patenting rejection is proper.
The third sentence of 35 U.S.C. 121 prohibits the use of a patent issuing on an application in which a requirement for restriction has been made, or on an application filed as a result of such a requirement, as a reference against any divisional application in a nonstatutory double patenting rejection, if the divisional application is filed before the issuance of the patent. The 35 U.S.C. 121 prohibition applies only where the Office has made a requirement for restriction. The prohibition does not apply where the divisional application was voluntarily filed by the applicant and not in response to an Office requirement for restriction. The U.S. Court of Appeals for the Federal Circuit has concluded that the protection of 35 U.S.C. 121 does not extend to all types of continuing applications, stating that "the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications." MPEP 804.01.
Conclusion
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/ALI S SAEED/ Examiner, Art Unit 1616