DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application, filed June 3, 2022, claims the benefit of U.S. provisional application 63/196425, filed June 3, 2021.
Election/Restrictions
Applicant previously elected without traverse of the invention of Group I, drawn to a method of increasing nitrogen retention in a subject, encompassed by claims 1-9, in the reply filed May 3, 2024.
Status of the Application
Applicant’s communication, received October 29, 2025, is acknowledged.
Claims 1-4 and 6-22 are pending in this application.
Claims 10-20 were withdrawn as directed to a non-elected invention in the Office action mailed June 4, 2024.
Claims 1-4, 6-9, and 21-22 are examined on the merits herein.
The following grounds of rejection are maintained from the previous office action, mailed May 29, 2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35
U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-7, 9, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Muniyappa (Muniyappa, R.; et al. Diabetes 2006, vol. 55, pp. 3142-3150; of record) in view of Coulson (Coulson, S.; et al. Inflammapharmacology 2013, vol. 21, pp. 79-90; cited in IDS received July 21, 2023)
Claim 1 is directed to a method of increasing nitrogen retention in a subject comprising administering to the subject a therapeutically effective amount of a composition comprising glucosamine for a period of up to 21 days. Claim 2 depends from claim 1 and requires the subject is administered a total daily dose of between about 3000 mg and about 5000 mg of the glucosamine, claim 3 requires the composition is administered one or more times per day, and claim 4 requires the composition is administered up to three times per day. Claim 6 requires the administering of the composition reduces amino acid excretion via stools of the subject, claim 7 requires the administering of the composition reduces a rating of stomach bloating by the subject according to Gastrointestinal Symptom Rating Scale 7 (GSRS), and claim 9 requires the composition is not co-administered with chondroitin or green lipped muscle extract to the subject.
Claim 21 depends from claim 1 and requires the glucosamine is glucosamine hydrochloride, and claim 22 depends from claim 21 and requires the administering of the composition reduces a rating of stomach bloating by the subject according to Gastrointestinal Symptom Rating Scale 7 (GSRS).
Muniyappa teaches a clinical trial where lean and obese subjects were administered 500 mg of glucosamine hydrochloride orally three times each day for a period of six weeks (p. 3142, Abstract, lines 6-10). Muniyappa teaches that the glucosamine administered to patients was glucosamine hydrochloride (p. 3143, Glucosamine and placebo preparations section, line 1). Muniyappa teaches that the clinical trial was conducted under an investigational new drug application approved by the FDA, and that the glucosamine was tested for purity, potency, and quality. Muniyappa states that certificates of analysis were obtained for the glucosamine, and drug master files were kept on file with the FDA (p. 3143, Glucosamine and placebo preparations section, lines 2-10). Muniyappa further teaches that their source of glucosamine was the same as the glucosamine used in a related trial wherein subjects were administered the combination of glucosamine and chondroitin (p. 3148, Glucosamine preparation and pharmacokinetics section, lines 5-10). In this instance, the absence of an express teaching from Muniyappa that chondroitin is included in the preparation of glucosamine is interpreted to mean that glucosamine hydrochloride was administered without chondroitin. Similarly, Muniyappa is silent regarding green-lipped muscle extract. In this instance, the absence of an express teaching from Muniyappa of green-lipped muscle extract being administered with glucosamine is interpreted to mean that glucosamine hydrochloride was administered without green-lipped muscle extract.
Muniyappa does not teach wherein the composition is administered to the subject for a period of up to 21 days and wherein administering glucosamine increases nitrogen retention in a subject, as recited in claim 1. In addition, Muniyappa does not teach administration of a daily dose between about 3000 mg and about 5000 mg of the glucosamine, as required by claim 2, wherein administering glucosamine reduces amino acid excretion via stools of the subject as recited in claim 6, or wherein administering of the composition reduces a rating of stomach bloating by the subject according to Gastrointestinal Symptom Rating Scale 7 (GSRS) as required by claims 7 and 22.
Coulson teaches a clinical trial in which 38 patients received 3,000 mg/day of glucosamine sulfate for 12 weeks (p. 79, Abstract, lines 7-11). Coulson specifically teaches the gastrointestinal complaints in terms of number of patients and range of severity according to the GSRS 7-point Likert scale (p. 86, Table 4 caption), listing bloating as one example. Coulson teaches that seven patients reported mild-severe bloating at the beginning of the clinical trial (baseline), which was reduced to 3 patients reporting mild bloating at the end of 12 weeks administered glucosamine sulfate (p. 86, Table 4). In addition, Coulson measures the daily pain score during the 12 weeks of their study (p. 86, Figure 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to administer a dose of 3000 mg of glucosamine, such as the glucosamine hydrochloride taught by Muniyappa, for the purposes of reducing stomach bloating. One of ordinary skill in the art would have been motivated to administer a dose of 3000 mg of glucosamine for the purposes of reducing stomach bloating because Coulson teaches that the number of patients experiencing stomach bloating and the severity of the stomach bloating decreased while being administered 3000 mg of glucosamine sulfate. Therefore, in view of Muniyappa teaching that the bioavailability of glucosamine from sulfate and hydrochloride salts is similar and that it is unlikely clinical outcomes would not be affected by the use of glucosamine sulfate, it would have been obvious to one of ordinary skill in the art to administer a dose of 3000 mg of glucosamine, such as the glucosamine hydrochloride taught by Muniyappa, because such a dose may be a more effective treatment for reducing stomach bloating than the lower dose taught by Muniyappa.
Regarding the increase in nitrogen retention and the reduction in amino acid excretion required by claims 1 and 6, an increase in nitrogen retention and a reduction in amino acid excretion is believed to be necessarily present when glucosamine is administered to a subject in the dosage taught by Muniyappa and Coulson. Based on evidence in the instant specification, administration of 3000 mg/day of glucosamine hydrochloride for 21 days (p. 11, paragraph 0064, lines 2-4) increases nitrogen retention in a subject as revealed by a reduction in amino acid excretion in the stools of subjects administered glucosamine compared with subjects administered placebo. The specification states that glucosamine supplementation significantly reduced fecal glutamate, isoleucine, leucine and valine content, as well as total branched-chain amino acids and total amino acids (p. 21, paragraph 0086, lines 1-4; p. 21-22, Table 4). The reduction in total amino acids is interpreted as evidence of increased nitrogen retention and a reduction in amino acid excretion in the stools of the subject, as recited in claims 1 and 6.
Regarding the dose of glucosamine administered to the subject, although the dose of glucosamine administered (3000 mg/day) in the specification is higher than the dose administered by Muniyappa (1500 mg/day), because Coulson teaches administration of a dose of 3000 mg/day, one of ordinary skill in the art would have recognized that the higher dose of glucosamine hydrochloride, obvious over Muniyappa in view of Coulson, would have the effect of necessarily increasing nitrogen retention, and decreasing excretion of amino acids in the stool, as evidenced by the instant specification.
Regarding the requirement that the composition is administered to the subject for a period of up to 21 days, although both Muniyappa and Coulson teach administration of glucosamine for longer than 21 days, one of ordinary skill in the art would have recognized dosing time as a result-effective variable. Coulson measures a daily pain score during the 12 weeks of their study (p. 86, Figure 2), demonstrating that symptoms may be evaluated during their trial. Therefore, in view of Coulson, one of ordinary skill in the art would have been motivated to monitor bloating while glucosamine is being administered, not just at the end of a 12 week period, and would have adjusted the dosing schedule in accordance with one’s bloating symptoms.
MPEP 2144.05 (II) at A states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In this instance, one of ordinary skill in the art would have recognized that a dosing schedule may be adjusted based on patient condition and symptoms to reduce bloating.
Regarding the administration of glucosamine hydrochloride for increasing nitrogen retention and reducing amino acid excretion in stools, MPEP 2112.01 (especially at I) citing In re Best, 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe necessarily includes functions or characteristics that are newly recited or is identical to a product or method as instantly claimed. In such a situation the burden is shifted to the applicants to show the products or methods of the applicant and the prior art are not the same or that the prior art products or methods do not necessarily possess the characteristics of those instantly claimed.
In this instance, as stated above, the administration of glucosamine hydrochloride to a human subject is believed to necessarily have the effect of increasing nitrogen retention and reducing amino acid excretion in stools, as evidenced by the instant specification. Therefore, the method obvious over Muniyappa in view of Coulson, wherein glucosamine hydrochloride is administered to human subjects in the claimed dosages and claimed frequencies, is believed to necessarily to have the effect of increasing nitrogen retention and reducing amino acid excretion via stools.
The MPEP 2112 at I states: “[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).” Furthermore, MPEP 2112 at II states: “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency).”
Therefore, the previously unappreciated properties of glucosamine administration increasing nitrogen retention and reducing amino acid excretion in stools does not render patentable the method of glucosamine administration previously disclosed in the prior art.
Therefore the invention taken as a whole is prima facie obvious.
Response to Applicant’s arguments: Regarding the rejection of claims 1-4, 6-7, 9, and 21-22 as unpatentable over Muniyappa in view of Coulson, Applicant argues that Muniyappa is non-analogous art to the claimed invention. Applicant argues that Muniyappa describes a long-term study ( 6 weeks) to determine if standard doses of oral glucosamine cause or worsen insulin resistance or endothelial dysfunction for patients who take glucosamine long-term for conditions such as osteoarthritis (see Muniyappa, abstract), whereas the current claims are methods of administering glucosamine for up to 21 days to increase nitrogen retention. Applicant argues that the problem to be solved is to provide immediate relief (21 days or less, not 6 weeks) through increased nitrogen retention in a subject suffering from bloating (not osteoarthritis), and because Muniyappa is not from the same field of endeavor as the claimed invention, nor is Muniyappa reasonably pertinent to the problem faced by the inventor, Applicant submits that Muniyappa is non-analogous art with reference to the claimed invention. Applicant argues that because Muniyappa is non-analogous, it should not be cited alone or combined with other art in a rejection of the pending claims.
Applicant further argues that Coulson is also non-analogous art. That is, Coulson also
fails to teach, suggest, or provide any reason for short-term administration (i.e., less than 21
days) to increase nitrogen retention because Coulson is not from the same field of endeavor or
reasonably pertinent to the problem faced by the inventor. Instead, Coulson discloses a 12-week
administration (see abstract) for osteoarthritis patients. Thus, Applicant submits that Coulson is
non-analogous art with reference to the claimed invention.
Applicant’s arguments have been fully considered but they are not found persuasive. Each of Muniyappa and Coulson are considered analogous art because each teach studies in which the glucosamine is administered to a subject. Moreover, both Muniyappa and Coulson acknowledges that glucosamine is administered for the purposes of treating osteoarthritis, and Coulson further teaches administration of glucosamine in patients with knee osteoarthritis and further teaches its effect on gastrointestinal microbiota profiles (Coulson, p. 79, title). Accordingly, because each are relevant to the treatment of osteoarthritis, one of ordinary skill in the art would have reasonably combined the teachings of Muniyappa and Coulson. Furthermore, because Coulson teaches the gastrointestinal benefits of glucosamine administration, one of ordinary skill in the art would have contemplated these benefits when administering glucosamine to a subject. Therefore, both Muniyappa and Coulson are reasonably considered as analogous art to the claimed invention, because each teaches glucosamine administration, and Coulson further teaches the gastrointestinal benefits of glucosamine administration.
Regarding the administration of glucosamine for a period of up to 21 days, although both Muniyappa and Coulson teach administration of glucosamine for longer than 21 days, one of ordinary skill in the art would have recognized dosing time as a result-effective variable. Coulson measures daily pain score during the 12 weeks of their study (p. 86, Figure 2), demonstrating that patient symptoms may be evaluated during their trial. Therefore, in view of Coulson, one of ordinary skill in the art would have been motivated to monitor symptoms, including bloating, during the course of glucosamine administration, not just at the end of a 12 week period, and adjust the dosing schedule in accordance with a patient’s symptoms, such as a patient’s bloating symptoms. See MPEP 2144.05 (II).
Accordingly, the present rejection of claims 1-4, 6-7, 9, and 21-22 as unpatentable over Muniyappa in view of Coulson is maintained.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Muniyappa in view of Coulson and Fosdick (U.S. pre-grant publication no. US 20040077055 A1; of record).
Claim 8 requires the glucosamine is not derived from shellfish.
Muniyappa and Coulson teach as described in the above rejection under 35 U.S.C. 103.
Muniyappa and Coulson do not teach wherein the glucosamine is not derived from shellfish, as required by claim 8.
Fosdick teaches that glucosamine is primarily derived from harvested shellfish and other aquatic organisms (p. 1, paragraph 0004, lines 1-5). Fosdick teaches that a significant portion of the human population have shellfish allergies and are unable to use products that contain ingredients derived from shellfish (p. 1, paragraph 0005, lines 1-4). Moreover, Fosdick teaches that it is not economically practical, if even possible, to ensure glucosamine products from shellfish sources are completely free of shellfish allergens, and thus hyper allergenic individuals who must avoid all shellfish products cannot ingest materials from shellfish, such as glucosamine (p. 1, paragraph 0005, lines 7-13).
In addition, Fosdick teaches methods of producing glucosamine derived from fungal biomass containing chitin (cover page, Abstract, lines 2-3), and Fosdick claims a glucosamine composition comprising glucosamine and the absence of shellfish allergens (p. 11, claim 28).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the shellfish-derived glucosamine administered in the method obvious over Muniyappa in view of Coulson for glucosamine derived from a non-shellfish source, as taught by Fosdick. One of ordinary skill in the art would have been motivated to substitute the shellfish-derived glucosamine in the method obvious over Muniyappa in view of Coulson for a shellfish-free glucosamine to expand the number of subjects that could be administered glucosamine as a therapy for bloating. For example, by sourcing glucosamine that was not derived from shellfish, subjects with a shellfish allergy could be administered glucosamine. One of ordinary skill in the art would have had a reasonable expectation of success administering glucosamine from a source other than shellfish because the glucosamine hydrochloride is expected to have the same chemical structure, and thus the same biological effect, regardless of the source of the glucosamine.
Therefore the invention taken as a whole is prima facie obvious.
Response to Applicant’s arguments: Regarding the rejection of claim 8 as unpatentable over Muniyappa in view of Coulson and Fosdick, Applicant argues that Fosdick fails to remedy the deficiencies of Muniyappa and Coulson.
Applicant’s arguments have been fully considered but they are not found persuasive. As described in the above rejection and in the above examiner’s response to arguments, although both Muniyappa and Coulson teach administration of glucosamine for longer than 21 days, one of ordinary skill in the art would have recognized dosing time as a result-effective variable and would have adjusted the dosing schedule in accordance with a patient’s symptoms. See MPEP 2144.05 (II).
Accordingly, the present rejection of claim 8 as unpatentable over Muniyappa in view of Coulson and Fosdick is maintained.
Claims 1-4, 6-7, 9, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Braham (Braham, R.; et al. British Journal of Sports Medicine 2003, vol. 37, pp. 45-49; of record) in view of Coulson.
Braham teaches a study to examine the effects of oral glucosamine supplementation on the functional ability and degree of pain felt by individuals who had regular knee pain due to previous articular cartilage damage and osteoarthritis (p. 45, Abstract, Objective section, lines 1-3).
Braham teaches that 50 volunteers (p. 45, Methods section, line 1) were instructed to ingest 2000 mg of glucosamine hydrochloride or placebo in the morning over a three month period (p. 46, second full paragraph, lines 4-8). Braham teaches that one subject from the group administered glucosamine experienced bloating (p. 47, Table 2). Braham is silent regarding administration of chondroitin or green-lipped muscle extract with the glucosamine hydrochloride. In this instance, the absence of an explicit teaching from Braham that chondroitin or green-lipped muscle extract was included in the preparation of glucosamine is interpreted to mean that glucosamine hydrochloride was administered without chondroitin or green-lipped muscle extract.
Braham further teaches that glucosamine in the form of glucosamine sulfate or hydrochloride has been shown to regenerate cartilage and to exhibit some anti-inflammatory effects (p. 45, left column, fourth paragraph, lines 9-12). In addition, Braham teaches scores for the Knee Pain Scale for were measured at 0, 4, 8, and 12 weeks of their study (p. 47, Table 3).
Braham does not teach wherein the composition is administered to the subject for a period of up to 21 days and wherein administering glucosamine increases nitrogen retention in a subject, as recited in claim 1. In addition, Braham does not teach administration of a daily dose between about 3000 mg and about 5000 mg of the glucosamine, as required by claim 2, wherein administering glucosamine reduces amino acid excretion via stools of the subject as recited in claim 6, or wherein administering of the composition reduces a rating of stomach bloating by the subject according to Gastrointestinal Symptom Rating Scale 7 (GSRS) as required by claims 7 and 22.
Coulson teaches as described in the above rejections under 35 U.S.C. 103.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to administer a dose of 3000 mg of glucosamine hydrochloride for the purposes of reducing stomach bloating. One of ordinary skill in the art would have been motivated to administer a dose of 3000 mg of glucosamine hydrochloride for the purposes of reducing stomach bloating because Coulson teaches that the number of patients experiencing stomach bloating and the severity of the stomach bloating decreased while administered 3000 mg of glucosamine sulfate, and because Braham teaches that both glucosamine sulfate and glucosamine hydrochloride have been shown to regenerate cartilage and to exhibit some anti-inflammatory effects. Therefore, one of ordinary skill in the art would have recognized glucosamine sulfate and glucosamine hydrochloride as equivalent forms of glucosamine that are each likely to possess some anti-inflammatory effects, and would have contemplated administering a dose of 3000 mg of glucosamine hydrochloride for the purposes of reducing stomach bloating.
Regarding the increase in nitrogen retention and reduction in amino acid excretion recited in claims 1 and 6, an increase in nitrogen retention a reduction and a reduction in amino acid excretion via stools of the subject are believed to be necessarily present when glucosamine is administered to a subject. Based on evidence in the instant specification, administration of 3000 mg/day of glucosamine hydrochloride for 21 days (p. 11, paragraph 0064, lines 2-4) increases nitrogen retention in a subject as revealed by a reduction in amino acid excretion in the stools of subjects administered glucosamine compared with subjects administered placebo. The specification states that glucosamine supplementation significantly reduced fecal glutamate, isoleucine, leucine and valine content, as well as total branched-chain amino acids and total amino acids (p. 21, paragraph 0086, lines 1-4; p. 21-22, Table 4). The reduction in total amino acids is interpreted as evidence of increased nitrogen retention and a reduction in amino acid excretion in the stools of the subject, as recited in claims 1 and 6.
Regarding the dose of glucosamine administered to the subject, although the dose of glucosamine administered (3000 mg/day) in the specification is higher than the dose administered by Braham (2000 mg/day), because Coulson teaches administration of a dose of 3000 mg/day, one of ordinary skill in the art would have recognized that the higher dose of glucosamine hydrochloride, obvious over Braham in view of Coulson, would have the effect of necessarily increasing nitrogen retention, and decreasing excretion of amino acids in the stool, as evidenced by the instant specification.
Regarding the requirement that the composition is administered to the subject for a period of up to 21 days, although both Braham and Coulson teach administration of glucosamine for longer than 21 days, one of ordinary skill in the art would have recognized dosing time as a result-effective variable. Braham measures scores for the Knee Pain Scale at 0, 4, 8, and 12 weeks of their study (p. 47, Table 3), and Coulson measures daily pain score during the 12 weeks of their study (p. 86, Figure 2), demonstrating that symptoms may be evaluated during the trial period. Therefore, in view of both Braham and Coulson, one of ordinary skill in the art would have been motivated to monitor bloating while glucosamine is being administered, not just at the end of a 12 week period, and would have adjusted the dosing schedule of glucosamine in accordance with one’s bloating symptoms.
MPEP 2144.05 (II) at A states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In this instance, one of ordinary skill in the art would have recognized that a dosing schedule may be adjusted based on patient condition and symptoms to reduce bloating.
Regarding wherein administration of glucosamine hydrochloride to a human subject for increasing nitrogen retention and reducing amino acid excretion in stools, MPEP 2112.01 (especially at I) citing In re Best, 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe necessarily includes functions or characteristics that are newly recited or is identical to a product or method as instantly claimed. In such a situation the burden is shifted to the applicants to show the products or methods of the applicant and the prior art are not the same or that the prior art products or methods do not necessarily possess the characteristics of those instantly claimed.
In this instance, the administration of glucosamine hydrochloride to a human subject is believed to necessarily have the effect of increasing nitrogen retention and reducing amino acid excretion in stools, as evidenced by the instant specification. Therefore, the method obvious over Braham in view of Coulson, wherein glucosamine hydrochloride is administered to human subjects in the claimed dosages and claimed frequencies, is expected to have the effect of increasing nitrogen retention and reducing amino acid excretion via stools.
Therefore the previously unappreciated properties of glucosamine administration increasing nitrogen retention and reducing amino acid excretion in stools does not render patentable the method of glucosamine administration previously disclosed in the prior art.
Therefore the invention taken as a whole is prima facie obvious.
Response to Applicant’s arguments: Regarding the rejection of claims 1-4, 6-7, 9, and 21-22 as unpatentable over Braham in view of Coulson, Applicant argues that Braham is also non-analogous art and fails to teach, suggest, or provide any reason for administering glucosamine to increase nitrogen retention in a subject for up to 21 days as claimed. Applicant argues that the teachings of Braham are directed to the administration of glucosamine to relieve knee pain. As noted in the Office Action, Braham references bloating in Table 2, but the teachings therein are irrelevant or even teach away from the claimed methods. Table 2 lists side effects reported by patients who received glucosamine and patients who received the placebo. Each patient set had one patient each that reported bloating, and the glucosamine patient reported bloating issues for 28 days. Because Braham is neither from the same field of endeavor as the claimed invention nor reasonably pertinent to the problem faced by the inventor, Applicant submits that Braham is non-analogous art with reference to the claimed invention and should not be cited alone or combined with other art in a rejection of the pending claims.
Applicant further argues that Coulson is also non-analogous art. That is, Coulson also
fails to teach, suggest, or provide any reason for short-term administration (i.e., less than 21
days) to increase nitrogen retention because Coulson is not from the same field of endeavor or
reasonably pertinent to the problem faced by the inventor. Instead, Coulson discloses a 12-week
administration (see abstract) for osteoarthritis patients. Thus, Applicant submits that Coulson is
non-analogous art with reference to the claimed invention.
Applicant’s arguments have been fully considered but they are not found persuasive. Each of Braham and Coulson are considered analogous art because each teach studies in which the glucosamine is administered to a subject. Moreover, both Braham and Coulson acknowledge that glucosamine is administered for the purposes of treating osteoarthritis, and Coulson further teaches administration of glucosamine in patients with osteoarthritis and its effect on gastrointestinal microbiota profiles (Coulson, p. 79, title). Accordingly, because each are relevant to the treatment of osteoarthritis, one of ordinary skill in the art would have reasonably combined the teachings of Braham and Coulson. Furthermore, because Coulson teaches the gastrointestinal benefits of glucosamine administration, one of ordinary skill in the art would have contemplated these benefits when administering glucosamine to a subject. Therefore, both Braham and Coulson are reasonably considered as analogous art to the claimed invention, because each teaches glucosamine administration, and Coulson further teaches the gastrointestinal benefits of glucosamine administration.
Regarding Applicant’s argument that Braham’s teachings in Table 2 are irrelevant or even teach away from the claimed methods, the examiner agrees that the teachings of Braham regarding bloating are not relevant to the present rejection because the study of Braham is not powered to evaluate an effect on bloating. Nonetheless, the examiner maintains that because Braham and Coulson acknowledge that glucosamine is administered for the purposes of treating osteoarthritis, and Coulson teaches administration of glucosamine in patients with osteoarthritis and further teaches its effect on gastrointestinal microbiota profiles (Coulson, p. 79, title). Accordingly, one of ordinary skill in the art would have reasonably combined the teachings of Braham and Coulson.
Regarding the administration of glucosamine for a period of up to 21 days, although both Braham and Coulson teach administration of glucosamine for longer than 21 days, one of ordinary skill in the art would have recognized dosing time as a result-effective variable. Braham measures scores for the Knee Pain Scale at 0, 4, 8, and 12 weeks of their study (p. 47, Table 3), and Coulson measures daily pain score during the 12 weeks of their study (p. 86, Figure 2), demonstrating that symptoms may be evaluated during their trial. Therefore, in view of Braham and Coulson, one of ordinary skill in the art would have been motivated to monitor a patient’s symptoms, including bloating, during the course of glucosamine administration, not just at the end of a 12 week period, and would have adjusted the dosing schedule in accordance with the patient’s symptoms, such as the patient’s bloating symptoms. See MPEP 2144.05 (II).
Accordingly, the present rejection of claims 1-4, 6-7, 9, and 21-22 as unpatentable over Braham in view of Coulson is maintained.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Braham in view of Coulson and Fosdick.
Braham and Coulson teach as described in the above rejections under 35 U.S.C. 103.
Braham and Coulson do not teach wherein the glucosamine is not derived from shellfish, as required by claim 8.
Fosdick teaches as described in the above rejection under 35 U.S.C. 103.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the shellfish-derived glucosamine administered in the method obvious over Braham in view of Coulson for glucosamine derived from a non-shellfish source, as taught by Fosdick. One of ordinary skill in the art would have been motivated to substitute the shellfish-derived glucosamine in the method obvious over Braham in view of Coulson for shellfish-free glucosamine to expand the number of subjects that could be administered glucosamine as a therapy for bloating. By sourcing glucosamine that was not derived from shellfish, subjects with a shellfish allergy could be administered glucosamine. One of ordinary skill in the art would have had a reasonable expectation of success administering glucosamine from a source other than shellfish because the glucosamine hydrochloride is expected to have the same chemical structure, and thus the same biological effect, regardless of the source of the glucosamine.
Therefore the invention taken as a whole is prima facie obvious.
Response to Applicant’s arguments: With regards to the rejection of claim 8 as unpatentable over Braham in view of Coulson and Fosdick, Applicant argues that Braham and Coulson fail to disclose administration of the composition for a period of up to 21 days, and Fosdick fails to cure this deficiency.
Applicant’s arguments have been fully considered but they are not found persuasive. As described in the above rejection and in the above examiner’s response to arguments, although both Braham and Coulson teach administration of glucosamine for longer than 21 days, one of ordinary skill in the art would have recognized dosing time as a result-effective variable and would have adjusted the dosing schedule in accordance with a patient’s symptoms. See MPEP 2144.05 (II).
Accordingly, the present rejection of claim 8 as unpatentable over Braham in view of Coulson and Fosdick is maintained.
Conclusion
No claims are allowed.
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/B.M.B./ Examiner, Art Unit 1693
/ERIC OLSON/ Primary Examiner, Art Unit 1693