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 .
Any rejection from the previous office action, which is not restated here, is withdrawn.
Election/Restrictions
Applicant’s election of Group II (i.e., claims 2-3, 5 and 12-13 drawn to a method of treating Coronavirus infection by administering to a subject in need thereof a therapeutically effective amount of a CXCR4 inhibitor) in the reply filed on August 23, 2022 is acknowledged. Additionally, Applicant’s election of AMD3100 as a single and specific CXCR4 inhibitor in the reply filed on August 23, 2022 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Claims
Claims 1-16 were originally filed on May 30, 2022.
The amendment received on November 9, 2022, canceled claims 1, 4-13, and 15-16; amended claims 2 and 14; and added new claim 17. The amendment received on October 23, 2023, amended claims 2 and 17; and added new claim 18. The amendment received on May 2, 2024, canceled claims 14 and 17-18; amended claims 2.
Claims 2-3 are currently pending and under consideration.
Priority
The present application is a continuation of PCT/IL2021/050273 filed March 11, 2021, and claims priority under 119(e) to U.S. Provisional Application Nos. 62/987,995 filed on March 11, 2020; 63/026,059 filed on May 17, 2020; and 63/106,419 filed on October 28, 2020. 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, or 365(c) is acknowledged.
Maintained Rejections
Claim Rejections - 35 USC § 103
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 pre-AIA 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
103 - KSR Examples of 'Rationales' Supporting a Conclusion of Obviousness(Consistent with the "Functional Approach" of Graham)
Further regarding 35 USC 103(a) rejections, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) (KSR) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Also, a reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Sercundes et al., PLoS Pathog. 12:e1006054 (2016) (cited in the IDS received on July 4, 2022), in view of Liu et al., MedRxiv. available online at https://doi.org/10.1101/2020.02.10.20021584, 14 pages (first available February 12, 2020), alone or as evidenced by, Lai et al., Intl. J. Antimicrobial Agents 55:105924 (2020).
For claims 2, with respect to a method of increasing survival of a subject inflicted by a Coronavirus infection by administering to the subject a therapeutically effective amount of AMD3100 to thereby increase survival of the subject as recited in instant claim 2; and with respect to where the Coronavirus is SARS-CoV-2 as recited in instant claim 3:
Sercundes et al. teaches that when manifesting in the lungs severe malaria causes acute lung injury/acute respiratory distress syndrome (ALI/ARDS) (See Sercundes, abstract; pg. 2, 1st paragraph). Sercundes sought to examine the role of neutrophils in the pathogenesis of malaria-associated ALI-ARDS (See Sercundes, abstract; pg. 2, 4th paragraph). The researchers discuss that the CXCR4/CXCL12 signaling pathway is central to the migration of neutrophils and fibroblasts to the lung tissue in response to lung injuries due to different causes (See Sercundes, pg. 5, last paragraph). As such, Sercundes et al. hypothesized that the CXCR4/CXCL12 axis would be important in malaria-associated ALI/ARDS (See Sercundes, pg. 5, last paragraph). As a control, Sercundes et al. found that mice developing ALI/ARDS showed greater neutrophil accumulation in the lungs compared with mice that did not develop pulmonary complications (See Sercundes, abstract; pg. 3, 2nd to 3rd paragraph). Plus, mice with ALI/ARDS produced more neutrophil-attracting chemokines (See Sercundes, abstract). In fact, post-mortem examinations of the lungs of patients with malaria-associated ALI/ARDS have shown inflammatory infiltrates and accumulated inflammatory cells including neutrophils in the interstitial and alveolar spaces (See Sercundes, pg. 2, 2nd paragraph). However, by administering 5 mg/kg AMD3100 as a CXCR4 antagonist thereby preventing neutrophil accumulation to the malaria infected mice, the development of malaria-associated ALI/ARDS decreased, i.e., reduced neutrophil levels and the respiratory parameters were altered in the lungs of AMD3100 treated mice, and significantly increased mouse survival, i.e., 60% if untreated mice died with signs of ALI/ARDS whereas 90% survived until the end of the experiment in the AMD3100 treated group (See Sercundes, abstract; pg. 5, last paragraph; pg. 6, 1st paragraph; pg. 18, 1st paragraph). Furthermore, Sercundes et al. found that malaria infection induced the formation of neutrophil extracellular traps (NETs) ex vivo, which were associated with inflammation and tissue injury (See Sercundes, abstract; pg. 7, 2nd paragraph). Thus, the teachings of Sercundes et al. demonstrates that neutrophils and NETs contribute in the genesis of experimentally induced malaria-associated ALI/ARDS and proposes a new therapeutic approach to improve the prognosis of severe malaria (See Sercundes, abstract; pg. 9, 2nd paragraph). Therefore, Sercundes et al. satisfies the claim limitation with respect to administering to a subject a therapeutically effective amount of AMD3100 where such amount increased survival of the subject inflicted with an infection by reducing neutrophil levels thereby reducing the likelihood that the subject will develop malaria-associated ALI/ARDS as recited in instant claim 2.
However, Sercundes et al. does not expressly teach where the subject is inflicted by a coronavirus infection and that such a subject would have an increased survival chance when administered AMD3100 as recited in instant claim 2.
Liu et al. teaches that coronavirus is a large virus family, which is known to cause common cold and serious illness such as MERS and SARS (See Liu, pg. 2, 3rd paragraph). In 2019, a novel coronavirus (2019-nCoV) was identified (See Liu, pg. 2, 3rd paragraph), which as evidenced by Lai et al. was later renamed to SARS-CoV-2 (See Lai, abstract). Severe ill patients progressed rapidly to acute respiratory failure, acute respiratory distress syndrome (ARDS), metabolic acidosis, coagulopathy, and septic shock (See Liu, pg. 2, 3rd paragraph). Liu et al. sought to identify useful prognostic risk factors for severe illness that would require appropriate supportive care and prompt access to the ICU (See Liu, pg. 2, 4th to 5th paragraph). The researchers included 61 patients treated at Beijing Ditan Hospital with 2019-nCoV infection in a study and used the LASSO COX regression analyses to select a prognostic factor of severe illness (See Liu, abstract; pg. 2, last paragraph). Of the 61 patients, 44 were diagnosed as mild and 17 as moderate or severe on admission (See Liu, pg. 4, last paragraph; Table 1). Blood neutrophil count in the severe group was significantly higher than that in the mild group, blood lymphocyte count, serum sodium and chlorine levels were significantly lower, and the rate of bacterial infection was significantly increased (See Liu, pg. 4, 1st paragraph; Table 1). Liu’s study found that out of 26 variables included in the LASSO regression, 3 predictive factors were found associated with severe illness incidence; namely, age, neutrophil-to-lymphocyte ratio (NLR) and hypertension (See Liu, pg. 7, 1st paragraph). NLR was the significant factor when the lambda was 1 standard error (See Liu, pg. 7, 1st paragraph). Liu et al. selected NLR as the most useful prognostic factor affecting the prognosis for severe illness incidence by the forward selection procedure (See Liu, pg. 7, 1st paragraph). Patients were divided into two strata according to the cutoff value of NLR (low risk: < 3.13; high risk: ≥ 3.13) and age ( < 50 years; age ≥ 50 years) (See Liu, pg. 11, 1st paragraph). These were then combined to form 4 strata, i.e., strata 1: age < 50 years and NLR < 3.13; strata 2: age < 50 years and NLR ≥ 3.13; strata 3: age ≥ 50 years and NLR < 3.13; and strata 4: age ≥ 50 years and NLR ≥ 3.13) (See Liu, pg. 11, 1st paragraph). There were no severe illness case in the strata 1 and 2, 9.1% case in the strata 3, and 50% cases in the strata 4 (See Liu, pg. 11, 1st paragraph). Liu et al. also followed up the laboratory test results of patients with 2019-nCoV infection and found that 5 patients had a rising neutrophil count and a falling lymphocyte count before their deaths (See Liu, pg. 12, 2nd paragraph). As such, Liu et al. concluded that NLR was the most useful prognostic factor affecting the prognosis for severe illness patients with 2019-nCoV pneumonia where early application of NLR with age was beneficial to patients’ classification management and relief of medical resource shortage (See Liu, pg. 13, 3rd paragraph). Since Liu et al. teaches that it would be beneficial for the NLR to be below 3.13, it would necessarily follow that an agent that reduces neutrophil levels would aid in keeping the NLR below 3.13. Therefore, Liu et al. suggests that lowering the neutrophil levels thereby lowering the NLR would be beneficial to reducing the likelihood of a subject inflicted with SARS-CoV-2 from developing severe illness.
Thus, when combining the teachings of Liu with those of Sercundes, an ordinary skilled artisan would be motivated with a reasonable expectation of success before the effective filing date of the instant application to modify the teachings of Sercundes and administer a therapeutically effective amount of AMD3100 to a subject inflicted with SARS-CoV-2 instead of malaria-associated ALI/ARDS in order to reduce neutrophil levels thereby lowering the NLR where such a result will increase the subject’s chance of survival by reducing the likelihood that the subject develops severe SARS-CoV-2 illness because AMD3100 was shown to prevent neutrophil accumulation in the malaria infected mice, to decrease the development of malaria-associated ALI/ARDS by reducing neutrophil levels and altering the respiratory parameters, and to significantly increase mouse survival, i.e., 60% of untreated mice died with signs of ALI/ARDS whereas 90% survived until the end of the experiment, and because the NLR was shown to be the most useful prognostic factor affecting the prognosis for severe illness in patients with SARS-CoV-2 where lower neutrophil accumulation correlates to a lower NLR and increased likelihood of developing severe SARS-CoV-2.
From the teachings of the references, it is apparent that 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 was prima facie obvious to one of ordinary skill in the art before the effective filing data of the instant application, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicants’ Arguments
Applicants contend that the claimed invention is nonobvious because (1) the Liu reference fails to teach or suggest therapeutic invention to lower neutrophil levels or NLR, but rather, is a clinical prognostic study analyzing blood samples from 61 covid-19 patients, and thus, only teaches that the NLR ratio as an independent prognostic factor for severe illness (See Applicant’s response received on 9/22/25, pg. 2); (2) the Sercundes reference is directed to an entirely different context; namely, AMD3100 administration reduced neutrophil accumulation in the lung tissue, lessened neutrophil extracellular trap formation, and improved survival in a murine malaria model of acute lung injury/ARDS as opposed to a viral animal model, all indicators are in lung histology and function and not in blood (See Applicant’s response received on 9/22/25, pg. 3); (3) the mechanistic effect described in Sercundes contradicts the Examiner’s rationale given that AMD3100 prevents neutrophils from migrating out of the circulation into the lungs, and thus, one would expect blood neutrophil counts in blood to increase, or at least remain elevated, as opposed to decrease (See Applicant’s response received on 9/22/25, pg. 3); and (4) Applicant successfully argued that ARDS caused from coronavirus infection differs markedly from ARDS from other viral causes as asserted in the response received on 12/6/22, and thus, ARDS associated with a parasitic disease cannot be combined with ARDS associated with a coronavirus infection (See Applicant’s response received on 9/22/25, pg. 3).
Response to Arguments
Applicant's arguments filed 9/22/25 for claims 2-3 have been fully considered but they are not persuasive for the following reasons.
As an initial matter, the Examiner would like to point out the interpretation of “increasing survival” as currently claimed. It is noted that the term “increasing survival” is not defined in the instant specification. Pursuant to MPEP 2111, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1).
The specification only refers to a therapeutically effective amount as meaning an amount of active ingredients (CXCR4 antagonist) effective to prevent, alleviate or ameliorate symptoms of a disorder (e.g., Coronavirus infection) or prolong the survival of the subject being treated (See instant, pg. 20, 4th paragraph) (emphasis added). As such, the broadest reasonable interpretation of “increasing survival” of a subject inflicted by a Coronavirus infection encompasses any means, parameter, and/or clinical determination/outcome, e.g., a percentage value that a subject’s survival rate increases such as 1% to 100%, or a clinical parameter such as a biomarker level increase or decrease where the increase or decrease would correlate to the subject’s survival increasing. Thus, the scope of claim 2 does not require any particular percentage, amount, or parameter in order to evaluate whether a subject’s survival has increased. All that is required is for a reference or combination of references to teach and/or suggest any means/rationale for an ordinary skilled artisan to reasonably expect the slightest increase in survival in a subject inflicted by a coronavirus infection.
In response to Applicant’s first argument, i.e., the Liu reference fails to teach or suggest therapeutic invention to lower neutrophil levels or NLR, but rather, is a clinical prognostic study analyzing blood samples from 61 covid-19 patients, and thus, only teaches that the NLR ratio as an independent prognostic factor for severe illness, it is found unpersuasive. It is acknowledged that there is not a single reference that teaches and/or suggests every claim limitation recited in instant claim 2 and the dependent claim. However, Applicants are respectfully reminded that the rejection supra is based on obviousness. Pursuant to MPEP 2142, 35 USC 103 authorizes a rejection where, to meet the claim, it is necessary to modify a single reference or to combine it with one or more other references. Since the rejection is based on obviousness, it is unnecessary for every claim limitation to be taught and/or suggested by a single reference. Additionally, the Examiner recognizes that obviousness may be 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 found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as discussed supra, in the 103 rejection, the combined teachings of Sercundes and Liu are suggestive of the claim limitations as recited in instant claims 2-3. Sercundes et al. expressly teaches administering a therapeutically effective amount of AMD3100 to a subject inflicted with an infection, albeit, a parasitic infection, where such administration significantly increases the survival of the subject by reducing neutrophil levels and the respiratory parameters were altered in the lungs of AMD3100 treated mice. As such, Sercundes already addresses the claim limitation with respect to therapeutic intervention. Therefore, the question is whether an ordinary skilled artisan would be motivated with a reasonable expectation of success to substitute the patient population of Sercundes with a subject inflicted with a coronavirus infection, or posed another way – whether an ordinary skilled artisan would reasonably expect for similar beneficial effects of improved survival in a subject inflicted with a coronavirus as found in a subject inflicted with malaria. The Examiner maintains that the answer to this question is yes in light of the teachings of Liu et al. As discussed supra in the rejection, and as acknowledged by Applicants, Liu et al. expressly found that that the blood NLR ratio in covid-19 patients was an independent prognostic factor for severe illness with patients over 50 years of age, and patients with a NLR above 3.13 were at a significantly higher risk of deterioration. Indeed, Liu et al. concluded that NLR was the most useful prognostic factor affecting the prognosis for severe illness patients with 2019-nCoV pneumonia. As such, Liu provides a nexus between the improved survival of the subjects inflicted with malaria, i.e., reduced neutrophil levels, and a reasonable expectation the same result would occur in subjects inflicted with a coronavirus. Thus, contrary to Applicant’s argument, the Examiner maintains that an ordinary skilled artisan would be motivated to administer a therapeutically effective amount of AMD3100, which Sercundes demonstrates reduces neutrophil levels, with a reasonable expectation that AMD3100 would similarly reduce neutrophil levels in subjects inflicted with a coronavirus infection given that Liu demonstrates that a reduced NLR ratio would be desirable to reduce the severity of 2019-nCoV pneumonia, which in turn, would increase the survival of said subject.
In response to Applicants’ second and third arguments, i.e., the Sercundes reference is directed to an entirely different context; namely, AMD3100 administration reduced neutrophil accumulation in the lung tissue, lessened neutrophil extracellular trap formation, and improved survival in a murine malaria model of acute lung injury/ARDS as opposed to a viral animal model, all indicators are in lung histology and function and not in blood; and the mechanistic effect described in Sercundes contradicts the Examiner’s rationale given that AMD3100 prevents neutrophils from migrating out of the circulation into the lungs, and thus, one would expect blood neutrophil counts in blood to increase, or at least remain elevated, as opposed to decrease, they are found unpersuasive. Regarding the Sercundes reference being focused on an entirely different context, pursuant to MPEP 2141.01(a)(I), in order for a reference to be proper for use in an obviousness rejection under 35 USC 103, the reference must be analogous art to the claimed invention. In re Bigio, 381 F.3d 1320, 1325, 72 USPQ2d 1209, 1212 (Fed. Cir. 2004). A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. The MPEP further notes that “same field of endeavor” and “reasonably pertinent” are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. When determining whether the "relevant field of endeavor" test is met, the examiner should consider "explanations of the invention’s subject matter in the patent application, including the embodiments, function, and structure of the claimed invention." Airbus S.A.S. v. Firepass Corp., 941 F.3d 1374, 1380, 2019 USPQ2d 430083 (Fed. Cir. 2019) (quoting Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212). When determining whether a prior art reference meets the "same field of endeavor" test for the analogous art, the primary focus is on what the reference discloses. Airbus, 41 F.3d at 1380. The examiner must consider the disclosure of each reference "in view of the ‘the reality of the circumstances.’" Airbus, 41 F.3d at 1380 (quoting Bigio, 381 F.3d at 1326, 72 USPQ2d at 1212). These circumstances are to be weighed "from the vantage point of the common sense likely to be exerted by one of ordinary skill in the art in assessing the scope of the endeavor." Airbus, 41 F.3d at 1380. See also Donner Technology, LLC v. Pro Stage Gear, LLC, 979 F.3d 1353, 2020 USPQ2d 11335 (Fed. Cir. 2020). In the instant case, Sercundes administers the same claimed agent to achieve a similar intended result, i.e., increase survival in a subject inflicted with an infection, albeit, a parasitic infection. Although, the infection is of a parasitic nature instead of a coronavirus in Sercundes, the rejection is based on the underlying mechanism of action of the agent and not the infection itself. More specifically, the rejection is based on the fact that AMD3100 significantly increased survival in a subject by reducing neutrophil levels, and this result is desirable in the claimed patient population, e.g., a subject inflicted with a coronavirus. Thus, when considering “the reality of the circumstances” and from the vantage point of the common sense likely to be exerted by one of ordinary skill in the art in assessing the scope of the endeavor, the Examiner maintains that the Sercundes is analogous art as it is in the same field of endeavor as the claimed invention.
Furthermore, regarding Applicant’s assertion that the mechanistic effect described in Sercundes contradicts the Examiner’s rationale given that AMD3100 prevents neutrophils from migrating out of the circulation into the lungs, and thus, one would expect blood neutrophil counts in blood to increase, or at least remain elevated, as opposed to decrease, this argument is merely the argument of counsel and is unsupported by evidence or declarations of those skilled in the art. Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See M.P.E.P. § 2129 and § 2144.03 for a discussion of admissions as prior art. Counsel's arguments cannot take the place of objective evidence. In re Schulze, 145 USPQ 716 (CCPA 1965); In re Cole, 140 USPQ 230 (CCPA 1964); and especially In re Langer, 183 USPQ 288 (CCPA 1974). See M.P.E.P. § 716.01(c) for examples of attorney statements that are not evidence and that must be supported by an appropriate affidavit or declaration. Without evidence to the contrary, the Examiner maintains that the data provided by Sercundes of reducing neutrophil levels in a subject inflicted with an infection would correlate to reducing neutrophil levels, and thus, the NLR ratio in a subject inflicted with a coronavirus infection.
In response to Applicant’s fourth argument, i.e., Applicant successfully argued that ARDS caused from coronavirus infection differs markedly from ARDS from other viral causes as asserted in the response received on 12/6/22, and thus, ARDS associated with a parasitic disease cannot be combined with ARDS associated with a coronavirus infection, it is found unpersuasive. As stated in the Action mailed on 5/23/25, the Examiner of record has changed. A new Examiner is not bound by decisions made by another Examiner and/or at other time points during prosecution. This is especially true since the rejections and the scope of the claims are distinguishable. Although Sercundes teaches a murine malaria model of acute lung injury/ARDS, the rejection supra is not correlating treatment of ARDS in Sercundes with treatment of ARDS in a coronavirus. Rather, the rejection is based on the underlying mechanisms, i.e., neutrophil count, and more specifically, the NLR ratio. Furthermore, the scope of the claims has changed. The scope of the claims in which the previous response was addressing was with respect to treating symptoms of a coronavirus infection whereas the scope of the current claims is to increase survival of a subject inflicted by a coronavirus infection. As discussed supra, “increasing survival” is broadly construed as encompassing any degree of survival; whether the increase in survival is a percentage, e.g., a subject administered AMD3100 survived a week longer when compared a subject not administered AMD3100, whether the increase in survival is based on treatment/symptom management, e.g., a subject administered AMD3100 exhibited less severe symptoms of the coronaviral infection thereby increasing the subject’s chance of survival when compared to a subject not administered AMD3100, or whether the increase in survival is based on a biomarker level being either increased or decreased. In other words, “increased survival” is broadly construed as any amount/level and/or any clinical manifestation that would increase survival in a subject inflicted with a coronavirus infection. Thus, the previous arguments made in 2022 do not per se overcome the pending rejection.
Accordingly, the rejection of claims 2-3 is maintained as Applicants’ arguments are found unpersuasive.
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 2-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 8, 11-13, 15, 18, 20, and 29-30 of copending Application No. 17/910,364 (Stein US Publication No. 2023/0104343 A1). Please note that the rejection has been updated in light of the amendments in the ‘364 application. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘364 claims:
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(See ‘364 claims 1, 4, 8, 15, 18, and 29). As such, the ‘364 claimed invention reads on the instantly claimed method by administering a therapeutically effective amount of AMD3100 to a subject inflicted by a Coronavirus such as SARS-CoV-2 as recited in instant claims 2-3. Moreover, although ‘364 does not expressly claim that the survival of this subject is increased, it would necessarily follow that by treating ARDS associated with a viral infection such as SARS-CoV-2, MERS, or SARS-CoV or by treating a coronavirus infection, the survival of the subject would be increased. Thus, the ‘364 claimed invention anticipates the instantly claimed invention. Therefore, the ‘364 claimed invention is not patentably distinct from the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants’ Arguments
Applicants respectfully request deferring addressing issues of double patenting until indication of allowable subject matter (See Applicant’s Response received on 11/13/14, pg. 24).
Response to Arguments
Applicant’s request to defer addressing the present double-patenting rejection until indication of allowable subject matter is acknowledged. As such, the double-patenting rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached M-F 11:00 to 8:00 pm.
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, Lianko Garyu can be reached at 571-270-7367. 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.
/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
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