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 .
Response to Arguments
Applicants' arguments, filed July 29, 2025, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Applicant’s arguments with respect to the pending claim(s) have been considered but are moot because the new grounds of rejection set forth below. While some of the same references as previously applied are used in the new grounds of rejection below, the failure of the previous combination to teach all features of amended claim 1 is remedied by the new reference Abd-Elazeem et al. as set forth in greater detail below.
Applicants’ failure to argue the rejection on the grounds of non-statutory double patenting over US Patent Nos. 9,040,514 and 9,339,506 by requesting that the rejection be held in abeyance is noncompliant with the regulations under 37 C.F.R. 1.111. The instant rejection is not a provisional rejection as the claims of US Patent Nos. 9,040,514 and 9,339,506 have been issued. In the interest of compact prosecution, the Examiner has examined the instant application. However, in order for the response to the instant Office Action to be fully responsive and in compliance with the regulations under 37 C.F.R. 1.111, the Applicant should either file a terminal disclosure or traverse the rejection based on US Patent Nos. 9,040,514 and 9,339,506. Because applicant did not distinctly and specifically point out the supposed errors in the instant non-statutory double patenting rejection based on US Patent Nos. 9,040,514 and 9,339,506 and no Terminal Disclaimers have been filed, the rejections are is maintained for the reasons set forth below.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3 – 6, 14, 15, 30, 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Kerrigan et al. (US 9,339,506) in view of Abd-Elazeem et al. (Egyptian Rheumatologist, 2018).
Kerrigan et al. discloses methods of manufacturing an anhydrous copper complex of formula C12H10ClCuN2O4 and treating neuromuscular and other diseases such as rheumatoid arthritis that is preferably administered in a pharmaceutical and/or dietary supplement composition (whole document, e.g., abstract). As shown at the top of col 4, this formula is a cuprous nicotinic acid complex. Such compositions will comprise at least one pharmaceutically acceptable additive and dietary supplements are orally administered. The disease to be treated is preferably a neuromuscular disease such as rheumatoid arthritis or pain (col 4, ln 9 – 20), which reads on chronic pain. Most preferably the animal being treated is a human (col 6, ln 36 – 37). The frequency of dosing may be dependent on the purity of the compounds and particular disease or physical ailment being treated but a dosage regime providing a total of 10 mg/day is disclosed (col 6, ln 45 onward). As will be understood by one skilled in the art the optimal dosage level for a particular subject will vary depending on a plurality of factors including the potency and activity of the pharmacologically active ingredient along with the age, body weight, general health, sex, diet, time of administration, route of administration and rate of excretion, drug combination (if any) and the severity of the particular disease or physical ailment undergoing therapy (col 6, ln 49 – 57). Column 7, ln 36 provides additional discussion of suitable oral dosage formulations.
Administration to a human subject suffering from a chronic pain such as a subject with rheumatoid arthritis is not explicitly disclosed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare and administer an oral dosage form containing the cuprous nicotinic acid complex of Kerrigan et al. to a human subject such as to treat rheumatoid arthritis. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Kerrigan et al. discloses that the disclosed cuprous nicotinic acid complexes can be orally administered to treat conditions such as rheumatoid arthritis and pain. While the claims are not limited to such subjects, given the patient populations disclosed by Kerrigan et al. and that a subject suffering from rheumatoid arthritis will experience chronic pain given the characteristic symptoms of rheumatoid arthritis, one of ordinary skill in the art would reasonably expect the complex of Kerrigan et al. to treat neuromuscular conditions including those causing chronic pain. The amount of the therapeutic ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results based on factors such as those explicitly disclosed by Kerrigan et al. and that are also known to one of ordinary skill in the art. There is no evidence of record as to the criticality of the claimed dosage such as those recited in claims 30 and 32.
The collection of a blood sample after administration of the copper nicotinic acid that includes the number of both neutrophils and lymphocytes or their ratio, such as by a complete blood count (CBC) test, is not disclosed.
Abd-Elazeem et al. discloses that the assessment of inflammation in RA patients with a trusted marker is important to detect [sic] long-term outcome but some inflammatory markers reflect short term inflammation and low discrimination with other superimposed inflammatory conditions (p 227, col 1, ¶ 2). Systemic inflammation is associated with changes in circulating blood cell quantity and composition (p 227, col 2, ¶ 1). Increased neutrophil count and low lymphocyte count are independent predictors of mortality and neutrophils are ready in active RA patients and have a role to increase disease by secreting proteases, prostaglandins, reactive oxygen intermediates to the synovial space and active other cells by secreting various mediators (p 228, col 1, ¶ 2). The neutrophil-lymphocyte (NLR) is the proportion of absolute neutrophil to lymphocyte counts retrieved from the CBC test (p 228, col 1, ¶ 2). NLR is widely agreed to be useful for the development of activity in chronic inflammatory conditions such as ulcerative colitis and familial Mediterranean fever (p 228, col 1, ¶ 2). While CBC is routinely carried out in RA patients for monitoring drug side effects and possible disease related changes, the relationship between NLR and chronic inflammatory arthritides was barely investigated so additional assessments of NLR in RA patients according to disease activity was carried out (p 228, col 1, ¶¶ 2 and 3). NLR and PLR (platelet lymphocyte ratio) were significantly increased in the active RA patients compared to the control with NLR being significantly higher in the active patients with positive-compared to negative-RF patients (p 229, col 2, ¶ 2). Studies discussed at p 229, col 2, ¶ 4 suggest NLR and PLR as inflammatory markers which must be used to assess disease activity in RA patients with the NLR increased across worsening DAS28 activity groups suggesting that lower NLRs indicated improvement in the RA or the RA being in a less active state.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to collect a blood sample for the common blood test CBC and to look at the absolute neutrophil and lymphocyte numbers and/or their ratio given the disclosure of Abd-Elazeem et al. as to the relationship of those numbers and ratios to the disease activity in RA using a blood test that is already routinely carried out in RA patients. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because such information is available from the routinely carried out CBC blood test used in RA patients to monitor for drug side effects and can also be used to assess the state of the RA in that subject. The time between administration of a drug to treat RA and performing the CBC blood test to check for side effects from the drugs being used to treat RA and/or to check on the status of the RA is a results effect parameter that one of ordinary skill in the art would routinely optimize. Time should be given for the drug(s) such as cuprous nicotinic acid to begin to have a therapeutic effect but no so long that the initial onset of undesirable side effects is missed and to provide the opportunity to change the treatment regimen if necessary. There is no evidence of record as to the criticality of the claimed time frame.
While modulation of the immune response is not disclosed verbatim, when reading the preamble in the context of the entire claim, the recitation “modulating an immune response in a human subject” is not limiting beyond requiring a human subject because the body of the claim otherwise describes a complete invention. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). The active step recited in the body of the claim is disclosed by Kerrigan et al. with administration to a human subject and therefore the recitation in the preamble does not patentably distinguish the claims over the prior art.
Claim(s) 1, 3 – 6, 14, 15, 30, 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over El-Saadani (J Exp Ther Oncol, 2004) in view of Riley et al. (US 6,214,817) and Abd-Elazeem et al. (Egyptian Rheumatologist, 2018).
El-Saadani discloses that the copper(I)-nicotinate complex [CuCl(HNA)2] has shown anti-inflammatory effects, cytoprotective effects, prevented gastric congestion and capillary damage in experimental animals, shown SOD [superoxide dismutase] mimic activity and acted as a immunopotentiator (p 20, col 1, ¶ 2). A potent curative effect on fatty liver syndrome in hens was seen with a three week treatment protocol and 8 mg/kg/day with CuCl(HNA)2 (p 20, col 1, ¶ 2). Oral doses of Cu(I)-nicotinic acid complex (0.8 mg/kg/day) suspended in 25% TWEEN®-80 in saline with 0.5 L-ascorbic acid, reading on pharmaceutically acceptably additives, were administered to 24 male patients with HCC (hepatocellular carcinoma) that were also receiving 5-fluorourail (5-FU; ¶ bridging cols 1 and 2 on p 20). The copper complex was suspended and not dissolved and there is no evidence of record that the suspended material was not in the anhydrous state. Blood samples were collected immediately before the dose was given, at 20 days and 40 days after treatment (p 20, col 2, ¶ 2). As shown in table 2, various hematological parameters in a blood sample from patients improved for those treated with both 5-FU and CuCl(HNA)2 (p 22, col 1). Table 3 shows that the combination treatment with CuCl(HNA)2 significantly compensated for the decreased serum levels of SOD and ceruloplasmin, which has SOD-like activity, compared to those that only received 5-FU (p 22, col 2, ¶ 2). CuCl(HNA)2 treatment strengthens the cellular defense mechanism against free radicals- lipid peroxidation and increased SOD (p 23, col 1, ¶ 2).
Administration to a subject suffering from chronic pain is not disclosed.
Riley et al. discloses manganese or iron metal complexes that are effective as catalysts for dismutating superoxide (col 1, ln 13 - 16) and the SOD mimics of the present invention are useful as therapeutic agents for inflammatory states and diseases in which superoxide anions are implicated (col 2, ln 66 - col 3, ln 10). Such disease states and disorders include rheumatoid arthritis and severe chronic pain (col 38, ln 1 – 9) which read on neuromuscular conditions. Various solid or liquid dosage forms including those for oral administration such as capsules, tablets, solutions and suspensions are disclosed (col 39, ln 19 – 34). The compositions may also comprise adjuvants, which read on pharmaceutically acceptable additives (col 39, ln 19 – 34). The dose of therapeutic agent to be administered can be provided in dosage unit compositions that may contain sub-multiples to make up the daily dose or combined into a single dose (col 38, ln 24 – 35). The dosage regimen for treating a disease or condition with the compounds and/or compositions of this invention are selected in accordance with a variety of factors, including the type, age, weight, sex, diet and medical condition of the patient, the severity of the disease, the route of administration, pharmacological considerations including the activity, efficacy, pharmacokinetic and toxicology profiles of the particular compound employed, whether a drug delivery system is utilized and whether the compound is administered as part of a combination and those of ordinary skill in the art can readily determine appropriate dosage for any subject based on the teachings of the specification and routine analysis of the subject (col 38, ln 39 – 54).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer the CuCl(HNA)2 of El-Saadani et al. that has SOD mimicking activity and increases SOD levels to a subject with chronic pain to treat the chronic pain. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the compounds of Riley et al. that mimic SOD activity are taught as useful for the treatment of conditions including rheumatoid arthritis and chronic pain. While the exact metal complexes are not the same, the compounds in El-Saadani and Riley et al. mimic SOD and for CuCl(HNA)2, increase SOD when orally administered. Therefore one of ordinary skill in the art would reasonably expect that the CuCl(HNA)2 complex of El-Saadani would also be useful in the treatment of chronic pain. One of ordinary skill in the art would also select an appropriate dosage form for administration of the therapeutic ingredient and optimize the dose of the therapeutic agent. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of providing the desired therapeutic effect in a subject using their knowledge and criteria for determining the dose that are explicitly disclosed by Riley et al. As no water is mentioned in El-Saadani when discussing the complex, the complex is presumed to be anhydrous and when formulated in a solid oral dosage form or a suspension form where not fully dissolved to form a solution, would remain in that state.
The collection of a blood sample after administration that includes the number of both neutrophils and lymphocytes, such as by a complete blood count (CBC) test, is not disclosed.
Abd-Elazeem et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to perform a CBC test on the collected blood samples in El-Saadani et al. and look at the absolute neutrophil and lymphocyte numbers and/or their ratio given the disclosure of Abd-Elazeem et al. as to the relationship of those numbers and ratios to marker for systemic inflammation given the anti-inflammatory effects of the copper nicotinic acid complex taught by El-Saadani and other conditions such as chronic pain and RA. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because such information is available from the routinely carried out CBC blood test used in RA patients to monitor for drug side effects and can also be used to assess the state of the RA in that subject and the subjects in El-Saadani et al. were already have blood samples collected and various hematological parameters and indices. The time between administration of a drug and performing a CBC blood test, to check for side effects from the drugs and/or to check on the status of the condition being treated is a results effect parameter that one of ordinary skill in the art would routinely optimize. Time should be given for the drug(s) such as cuprous nicotinic acid to begin to have a therapeutic effect but no so long that the initial onset of undesirable side effects is missed and to provide the opportunity to change the treatment regimen if necessary. There is no evidence of record as to the criticality of the claimed time frame and El-Saadani et al. discloses blood tests on days 0, 20 and 40, a range which overlaps with the range of claim 34 of least 28 days.
While modulation of the immune response is not disclosed verbatim, when reading the preamble in the context of the entire claim, the recitation “modulating an immune response in a human subject” is not limiting beyond requiring a human subject because the body of the claim otherwise describes a complete invention. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). The active step recited in the body of the claim is disclosed by El-Saadani with administration to a human subject and therefore the recitation in the preamble does not patentably distinguish the claims over the prior art.
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, 3 – 6, 14, 15, 30, 32 and 34 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 4 of U.S. Patent No. 9,040,514 in view of El-Saadani (J Exp Ther Oncol, 2004), Riley et al. (US 6,214,817) and Abd-Elazeem et al. (Egyptian Rheumatologist, 2018).
The claims of US’514 recite the administration of the anhydrous copper (I) nicotinic acid complex as shown in claim 1 to an animal such as a human for the treatment of Lyme disease (claims 1 and 2).
Administration to a human subject to treat a condition such as chronic pain is not claimed.
El-Saadani, Riley et al. and Abd-Elazeem et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer the CuCl(HNA)2 of US’514 to subject with chronic pain to treat the chronic pain. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because El-Saadani discloses that such compounds mimic SOD activity. The compounds of Riley et al. that also mimic SOD activity are taught as useful for the treatment of conditions including rheumatoid arthritis and chronic pain. While the exact metal complexes are not the same, the compounds in US’514/El-Saadani and Riley et al. mimic SOD and for CuCl(HNA)2, to increase SOD when orally administered. Therefore one of ordinary skill in the art would reasonably expect that the CuCl(HNA)2 complex of US’514 would also be useful in the treatment of chronic pain. One of ordinary skill in the art would also select an appropriate dosage form for administration of the therapeutic ingredient and optimize the dose of the therapeutic agent. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of providing the desired therapeutic effect in a subject using their knowledge and criteria for determining the dose that are explicitly disclosed by Riley et al. As no water is mentioned in El-Saadani when discussing the complex, the complex is presumed to be anhydrous and when formulated in a solid oral dosage form or a suspension form where not fully dissolved to form a solution, would remain in that state.
It also would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to collect a blood sample for a common test such as CBC and to look at the absolute neutrophil and lymphocyte numbers and/or their ratio given the disclosure of Abd-Elazeem et al. as to the relationship of those numbers and ratio to the disease activity in RA using a blood test that is already routinely carried out in RA patients. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because such information is available from the routinely carried out CBC blood test. The time between administration of a drug to treat RA and performing the CBC blood test, to check for side effects from the drugs being used to treat RA and/or to check on the status of the RA is a results effect parameter that one of ordinary skill in the art would routinely optimize. Time should be given for the drug(s) such as cuprous nicotinic acid to begin to have a therapeutic effect but no so long that the initial onset of undesirable side effects is missed and to provide the opportunity to change the treatment regimen if necessary. There is no evidence of record as to the criticality of the claimed time frame.
While modulation of the immune response is not disclosed verbatim, when reading the preamble in the context of the entire claim, the recitation “modulating an immune response in a human subject” is not limiting beyond requiring a human subject because the body of the claim otherwise describes a complete invention. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). The active step recited in the body of the claim is disclosed by El-Saadani with administration to a human subject and therefore the recitation in the preamble does not patentably distinguish the claims over the prior art.
Claims 1, 3 – 6, 14, 15, 30, 32 and 34 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 7 of U.S. Patent No. 9,339,506 in view of El-Saadani (J Exp Ther Oncol, 2004), Riley et al. (US 6,214,817) and Abd-Elazeem et al. (Egyptian Rheumatologist, 2018).
The claims of US’506 recite a pharmaceutical and/or dietary supplement comprising an effective amount of an anhydrous copper(I)-nicotinic acid complex as shown in claim 1 and a carrier (claim 1). Effective amounts can be 1 – 20 mg (claim 4). Additional ingredients such as an inert diluent, reading on a pharmaceutically acceptable additive can be present (claims 2 and 3).
Administration of the claimed pharmaceutical and/or dietary supplement to a human subject such as to treat a condition such as chronic pain is not disclosed.
El-Saadani, Riley et al. and Abd-Elazeem et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer the CuCl(HNA)2 of US’506 to subject with chronic pain to treat the chronic pain. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because El-Saadani discloses that such compounds mimic SOD activity. The compounds of Riley et al. that also mimic SOD activity are taught as useful for the treatment of conditions including rheumatoid arthritis and chronic pain. While the exact metal complexes are not the same, the compounds in US’506/El-Saadani and Riley et al. mimic SOD and for CuCl(HNA)2, to increase SOD when orally administered. Therefore one of ordinary skill in the art would reasonably expect that the CuCl(HNA)2 complex of US’506 would also be useful in the treatment of chronic pain. One of ordinary skill in the art would also select an appropriate dosage form for administration of the therapeutic ingredient and optimize the dose of the therapeutic agent. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results of providing the desired therapeutic effect in a subject using their knowledge and criteria for determining the dose that are explicitly disclosed by Riley et al. As no water is mentioned in El-Saadani when discussing the complex, the complex is presumed to be anhydrous and when formulated in a solid oral dosage form or a suspension form where not fully dissolved to form a solution, would remain in that state.
It also would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to collect a blood sample for a common test such as CBC and to look at the absolute neutrophil and lymphocyte numbers and/or their ratio given the disclosure of Abd-Elazeem et al. as to the relationship of those numbers and ratio to the disease activity in RA using a blood test that is already routinely carried out in RA patients. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because such information is available from the routinely carried out CBC blood test. The time between administration of a drug to treat RA and performing the CBC blood test, to check for side effects from the drugs being used to treat RA and/or to check on the status of the RA is a results effect parameter that one of ordinary skill in the art would routinely optimize. Time should be given for the drug(s) such as cuprous nicotinic acid to begin to have a therapeutic effect but no so long that the initial onset of undesirable side effects is missed and to provide the opportunity to change the treatment regimen if necessary. There is no evidence of record as to the criticality of the claimed time frame.
While modulation of the immune response is not disclosed verbatim, when reading the preamble in the context of the entire claim, the recitation “modulating an immune response in a human subject” is not limiting beyond requiring a human subject because the body of the claim otherwise describes a complete invention. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). The active step recited in the body of the claim is disclosed by El-Saadani with administration to a human subject and therefore the recitation in the preamble does not patentably distinguish the claims over the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 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, Michael Hartley can be reached at 571-272-0616. 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.
/Nissa M Westerberg/Primary Examiner, Art Unit 1618