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 .
Claim Status
Claims 11, 13, 15, 17, and 19-24 are pending. Claims 1-3, 5-7, 12, 14, 16, and 18 were canceled; claims 19-24 were added; and claims 11, 13, 15, and 17 were amended in the Reply filed 8/27/2025.
Election/Restrictions
An election/restriction requirement has not been set forth on record at this time. However, the originally presented and examined invention is understood to be the methods as set forth in the claims filed 8/18/2023, which comprised the steps of administering to an individual via any route, a composition comprising glycine and N-acetylcysteine, at a therapeutically effective amount, for prophylactic or therapeutic benefits set forth as statements of intended and expected use.
However, Applicant is directed to MPEP §§ 818, 818.02(a), 819, and 821.
Priority
The priority claim to US Provisional Application 62/167,433 (filed 5/28/20215) is acknowledged.
Information Disclosure Statement
No IDS was filed in the Response submitted 8/27/2025.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Following the cancellation of claims 1 and 5, amended claim 11 is representative of the pending claim scope and each presently recites:
Claim 1 (currently amended) A method of achieving an effect in an individual who is at least 50 years old, the method comprising orally administering a total dosage between 1 and 30 mg/kg of body weight per dav of a composition comprising glycine and N- acetylcysteine to the individual who is at least 50 years old, during and/or before and/or after exercise which is aerobic and/or weight training, the effect is enhanced muscle performance and/or recovery independent of the composition’s effects on glutathione, wherein the composition is 5% to 75% by weight of the glycine and N-acetyl-cysteine and a weight ratio of glycine and N-acetyl-cysteine in the composition is from 1:1 to 1:10000.
The applicable claim interpretation is set forth below.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
Reason for treatment: Claim 11 and 15 recite the same method of administering the same composition via the same route of administration to the same patient populations at the same concentration, and only differ by the recitation of an intended or expected result set forth in the preamble of each claim (i.e., claim 11 recites “of achieving an effect in an individual”, and claim 15 recites “of preventing or delaying onset of a condition or state of in an individual”). However, per MPEP § 2111.02, “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”. Here, exact same active method steps are performed using the same compounds in the same patient populations using the same route of administration and concentrations. Therefore, the recitation of intended and expected use in the preambles is not limiting, and are deemed fully satisfied by prior art that satisfies the steps and structures recited in the body of the claim (see also MPEP § 2111.04(I), noting that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”)1.
Timing of treatment: Amended claims 11 and 15 recite the durations of either “during and/or before and/or after exercise”. No actual amount of specific time in years, months, weeks, days, hours, minutes or seconds is actually specified in the claims or in the originally filed disclosure. Accordingly, it is unclear if the durations may be taken simply as weekly supplements in individuals exercising once or twice a week, or if the claim more specifically requires administration during or within ten minutes of exercise. In the absence of guidance, the phrases are given the broadest reasonable interpretation and understood to correspond to unbounded ranges of time including at least days, hours, minutes, or seconds before or after exercise.
Route of administration: The claimed invention is understood to be limited to a route of oral administration (see, e.g., instant claims 11 and 15).
Exercise: The term “exercise” is undefined on record, and therefore the term is given the broadest reasonable interpretation to include any exercise of any kind, including any usage of any muscle that would prevent or delay atrophy from non-use, including breathing exercises (see, e.g., US200902754432 at ¶[0001]), walking (see, e.g., US200900826773 at ¶[0019]), and any calorie expending body movement. In the Reply filed 8/27/2025, Applicant has more specifically required that the exercise is “aerobic and/or weight training”, but such terms are not specifically defined on record. Any exercise involving walking is reasonably understood to constitute “aerobic” exercise. Any exercise involving lifting any amount of weight (i.e., resistance) is reasonably understood to constitute “weight training”, including routine daily or household activities (i.e., lifting objects).
Dosage frequency: Claims 11 and 15 require oral administration on a “per day” basis.
Dosage: The amended claims require “a total dosage between 1 and 30 mg/kg of body weight per dav of a composition comprising glycine and N- acetylcysteine”, wherein the administered composition is 5% to 75% by weight of a combination of glycine and N-acetyl-cysteine. This means that 0.05 mg to 22 mg/kg of glycine and NAC are actually administered to patients, wherein the remainder is presumably suitable pharmaceutical excipients (see, e.g., Spec. filed 8/18/2023 at ¶[0063]).
Applicable patient population: The applicable patient population is understood to be any patient “at least 50 years old” (see, e.g., instant claims 11 and 15), who has exercised for an unspecified amount of time, at some time (i.e., months, weeks, days, hours, minutes) “during, before, or after” taking the composition, wherein the exercise must be “aerobic” (i.e., walking, gardening, etc.) or “weight training” (i.e., lifting something). Critically, this patient population is broad and reasonably includes any 50-year olds that are remotely active (e.g., playing with grandkids, carrying groceries, walking, golfing, lifting household items, etc.). The patient population need not be “in need thereof” of any effect or condition recited in the preamble.
“Athlete”: Claims 20 and 23 recite the “wherein” clause “wherein the individual is an athlete”. The term “athlete” is not defined on record, and it is unclear what does or does not constitute an individual “who is at least 50 years old” and is also an “athlete”. The term “athlete” is used in the originally filed disclosure four times (see, e.g., Spec. filed 8/18/2023 at ¶¶[0091] referring to “elite athletes” and “older athletes”, [0016] stating that “In specific embodiments, the individual is an athlete although the individual may not be an athlete. The individual may engage in exercise for recreational and/or health purposes”). Accordingly, the term “athlete” appears to be utilized as a subjective term that does not materially differentiate individuals that are included or excluded by the scope of claims 20 and 23.
Additional claim interpretations are set forth below.
Claim Objections
Applicant is advised that should claims 11, 13, and 19-21 are found allowable, claims 15, 17, and 22-24, respectively, will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Here, claims 11 and 15 are representative, and are directed to the same active method steps of treating the same patient population using the same compounds administered via the same routes at the same dosage and dosage frequency; claims 11 and 15 only differ with respect to an intended or expected result, but performing the exact same steps with the exact same compounds would necessarily yield the same exact results, and therefore the difference in intended and expected outcomes does not meaningfully distinguish the pending claim sets (i.e., claims 11, 13, and 19-21 relative to claims 15, 17, and 22-24; see also MPEP § 2111.04(I), noting that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”)4.
Withdrawn Claim Rejections
The rejection of claims 1-3, 5-7, and 11-18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of the cancellation of claims 1-3, 5-7, 12, 14, 16, and 18; and in view of the amendments to claims 11, 13, 15, and 17. However, the revised claims have necessitated revised rejections, which are set forth below.
The rejection of claims 2-3, 6-7, 12-14, and 16-18 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of the cancellation of claims 1-3, 5-7, 12, 14, 16, and 18; and in view of the amendments to claims 11, 13, 15, and 17. However, the amendments have necessitated a revised rejection, which is set forth on record below.
The rejection of claims 1-3, 5-7, and 11-18 under 35 U.S.C. 103 as being unpatentable over US 2013/0245121 A1 (Sept. 19, 2013), is withdrawn in view of the cancellation of claims 1-3, 5-7, 12, 14, 16, and 18; and in view of the amendments to claims 11, 13, 15, 17 as filed 8/27/2025. However, the amendments have necessitated a revised rejection, which is set forth on record below.
The rejection of claims 1-3, 5-7, and 11-18 under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 8362080 (Jan. 29, 2013), is withdrawn in view of the cancellation of claims 1-3, 5-7, 12, 14, 16, and 18; and in view of the amendments to claims 11, 13, 15, 17 as filed 8/27/2025. However, the amendments have necessitated a revised rejection, which is set forth on record below.
The rejection of claims 1-3, 5-7, and 11-18 under 35 U.S.C. 103 as being unpatentable over US 7,754,700 (Jul. 13, 2010) is withdrawn in view of the cancellation of claims 1-3, 5-7, 12, 14, 16, and 18; and in view of the amendments to claims 11, 13, 15, 17 as filed 8/27/2025.
The rejection of claims 1-3, 5-7, and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004/112511 A2 (Dec. 29, 2004) is withdrawn in view of the cancellation of claims 1-3, 5-7, 12, 14, 16, and 18; and in view of the amendments to claims 11, 13, 15, 17 as filed 8/27/2025. However, the amendments have necessitated a revised rejection, which is set forth on record below.
The rejections of claims 1-3, 5-7, and 11-18 under 35 U.S.C. 103 as being unpatentable over US 8,809,311 B2 (Aug. 19, 2014; filed Aug. 10, 2009) is withdrawn in view of the cancellation of claims 1-3, 5-7, 12, 14, 16, and 18; and in view of the amendments to claims 11, 13, 15, 17 as filed 8/27/2025.
The rejection of claims 1-3, 5-7, and 11-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 8802730 (Aug. 12, 2014), is withdrawn in view of the cancellation of claims 1-3, 5-7, 12, 14, 16, and 18; and in view of the amendments to claims 11, 13, 15, 17 as filed 8/27/2025. However, the amendments have necessitated a revised rejection, which is set forth on record below.
The rejection of claims 1-3, 5-7, and 11-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 8362080 (Jan. 29, 2013), is withdrawn in view of the cancellation of claims 1-3, 5-7, 12, 14, 16, and 18; and in view of the amendments to claims 11, 13, 15, 17 as filed 8/27/2025. However, the amendments have necessitated a revised rejection, which is set forth on record below.
The rejection of claims 1-3, 5-7, and 11-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9084760 (Jul. 21, 2015), is withdrawn in view of the cancellation of claims 1-3, 5-7, 12, 14, 16, and 18; and in view of the amendments to claims 11, 13, 15, 17 as filed 8/27/2025. However, the amendments have necessitated a revised rejection, which is set forth on record below.
The rejection of claims 1-3, 5-7, and 11-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,730,711 (Aug. 22, 2023), is withdrawn in view of the cancellation of claims 1-3, 5-7, 12, 14, 16, and 18; and in view of the amendments to claims 11, 13, 15, 17 as filed 8/27/2025. However, the amendments have necessitated a revised rejection, which is set forth on record below.
The rejections of claims 1-3, 5-7, and 11-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,186,292 (Jan. 7, 2025), is withdrawn in view of the cancellation of claims 1-3, 5-7, 12, 14, 16, and 18; and in view of the amendments to claims 11, 13, 15, 17 as filed 8/27/2025. However, the amendments have necessitated a revised rejection, which is set forth on record below.
New or Revised Claim Rejections as Necessitated by Applicant Amendment
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11, 13, 15, 17, and 19-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Amended claims 11 and 15 recite the subjective duration of “during and/or before and/or after exercise”, which implies an indefinite duration, which renders the claim scope indefinite. The literal interpretation of “during and/or before and/or after exercise” yields an unreasonable result because literally running or lifting weights 40 years prior to oral administration of Glycine and NAC literally occurs “before” administration, and any future activity, even occurring decades after administration, literally occurs “after” administration; accordingly, a literal interpretation (i.e., the broadest possible interpretation) is deemed unreasonable. However, this is problematic because although a literal interpretation including years and decades is clearly understood to be an unreasonable timescale, it is unknown what the metes and bounds of a reasonable time scale for “before” and “after” might be (i.e., 720 hours? 240 hours? 36 hours? 12 hours? 5 hours? 2 hours? 0.5 hours? 0.25 hours?). Rather, it is reasonably understood that the duration is meant to capture a much smaller time range, perhaps on the order of weeks, days, hours, or minutes, but zero guidance is provided permitting an artisan to do more than make a subjective guess regarding the intended duration. Accordingly, the claim scope is indefinite because although the implied duration is clearly less than the literal meaning, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Accordingly, an artisan would not know how to avoid infringement of the claimed invention, and close prior art exists (see, e.g., Rejections of Record under 35 USC 102 and 103, including those set forth below, wherein such discussions are incorporated into the instant rejection). For purposes of applying prior art, the broadest reasonable interpretation is understood to include exercise within 720 hours of administration.
Amended claims 13 and 17 now recite “wherein the glycine and the N-acetylcysteine are comprised in a dipeptide”, which renders the claim scope indefinite because glycine (i.e.,
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), as recited at instant claims 11 and 15 are recited as two separate, distinct, and exact chemical components within a single composition. Neither glycine nor N-acetylcysteine is a dipeptide; dipeptides differ in molecular weight, chemical structure, and chemical properties (polarity, osmolality, etc.). Accordingly, it is unclear how the composition of claim 11 or 15 may “comprise glycine and N-acetylcysteine” (i.e., two, distinct and exact chemical components), that are “comprised in” a chemically distinct and singular component that is not chemically identical to either glycine or N-acetylcysteine. Accordingly, Applicant appears to be using a specialized definition of “dipeptide” that includes non-dipeptide chemical compositions, however, the term “dipeptide” is used in the art to refer to compounds that materially differ from glycine (i.e.,
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), but the Applicant’s specialized definition for “dipeptide” is not set forth on record. Further examination of amended claims 13 and 17 in view of the prior art is precluded. Applicant is advised that a dipeptide structure could be recited in an independent claim as an alternative to two distinct components. However, examination to date has been limited to methods of administering a composition comprising two separate components, namely glycine (i.e.,
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). Claims directed to compositions comprising a single dipeptide have not been examined and have not been previously set forth on record in the claim; accordingly, claims properly directed to dipeptides would be considered a separate and distinct invention (see MPEP §§ 818, 818.02(a), 819, and 821).
Newly added claims 20 and 23 further limits the scope of the patient population of patients that are “at least 50 years old” by reciting the phrase “wherein the individual is an athlete”, which renders the claim scope indefinite. The term “athlete” in claims 20 and 23 is a relative term which renders the claim indefinite. The term “athlete” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “athlete” is defined as
A person trained or gifted in exercises or contests involving physical agility, stamina, or strength; a participant in a sport, exercise, or game requiring physical skill5.
Although it is undisputed that an active marathoner, competitive tennis player, pro golfer, etc. are “athletes”, the metes and bounds of who is or is not an athlete is largely subjective, and therefore it is unclear how the term should be meaningfully construed as a limitation in the instant claims such that artisans are aware of what does or does not constitute infringement of the claims. More specifically, the meaning of “athlete” is subjective because it is unclear who is or is not “gifted” per se. In addition, the meaning of “athlete” is not limited to physical fitness, but includes “training” for various “exercises or contests”; and more broadly includes any “participant in a sport, exercise, or game requiring physical skill”, which presumably includes darts, golfing, ballroom dancing, fishing, turkey hunting, swimming, hiking, biking, walking, pickleball, singing, etc. Accordingly, the term “athlete” is subjective in nature, and does not meaningfully imply any particular limitation regarding a patient’s physical fitness, age, endurance, stamina, gender, muscle mass, BMI, etc., etc. Accordingly, claims 20 and 23 are rejected as indefinite because the metes and bounds of the term “athlete” are unknown, “athlete” is a subjective term, an artisan would not know how to avoid infringement of the limitation, and close prior art exists (see, e.g., Rejections of Record under 35 USC 102 and 103, including those set forth below, wherein such discussions are incorporated into the instant rejection). For purposes of examination, “athlete” is given its broadest reasonable interpretation in view of the definition provided above, and includes any “participant in a sport, exercise, or gam requiring physical skill”, wherein the person may be a participant in an exercise, such as aerobic exercise or weight training. Accordingly, claims 20 and 23 are rejected for reasons applicable to claims 11 and 15.
Claims 13, 17, and 19-24 depend directly or indirectly from an indefinite base claim and fail to clarify the indefiniteness of the base claim. Accordingly, these claims are rejected as indefinite for the reasons applied to each independent claim, respectively.
Accordingly, claims 11, 13, 15, 17, and 19-24 are rejected.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13, 17, 20 and 23 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Amended claims 13 and 17 depend from amended claims 11 and 15, respectively, and each recite “wherein the glycine and the N-acetyl-cysteine are comprised in a dipeptide”. This violates 35 U.S.C. 112(d) because claims 11 and 15 are limited to methods of administering a composition comprising two separate, exact components, namely glycine (i.e.,
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), which are chemically distinct from dipeptides. Accordingly, claims 13 and 17 are rejected as being of improper dependent form for failing to include all the limitations of the claim upon which it depends, namely a composition comprising two separate, exact components, namely glycine and N-acetylcysteine.
Newly added claims 20 and 23 depend, respectively, from claims 11 and 15, and ostensibly only further limit the scope of amended claims 11 and 15 by reciting “wherein the individual is an athlete”. However, the term “athlete” is not defined on record. In the art, the term “athlete” is defined as
A person trained or gifted in exercises or contests involving physical agility, stamina, or strength; a participant in a sport, exercise, or game requiring physical skill6.
Notably, this means that any “participant in a[n] …exercise…requiring physical skill” is an “athlete”. Notably, claims 11 and 15 require that the patient is a person who takes the composition “during and/or before and/or after exercise which is aerobic and/or weight training” (see, e.g., amended claims 11 and 15). Accordingly, claims 11 and 15 already ostensibly limit the claim scope to athletes, namely people who are “participant[s] in a[n] …exercise…requiring physical skill”, namely “aerobic” exercises and/or “weight training”. Accordingly, claims 20 and 23 are rejected as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Accordingly, claims 13, 17, 20 and 23 are rejected.
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.
[Obviousness Rejection 01]
Claims 11, 15, and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0245121 A1 (Sept. 19, 2013) in view of Flack7, as evidenced by Dictionary8.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejection and in a separate section above, and those discussions and interpretations are incorporated into the instant rejection. Examination of claims 13 and 17 in view of the prior art has been precluded as explained above. Additional claim interpretations are set forth below.
Regarding instant claims 11, 15, 19-24, and the administration of a composition comprising glycine and N-acetylcysteine (“NAC”) to a patient over 50 years of age, US’121 teaches, suggests, and claims methods of administering “an effective amount” of glycine and NAC to an individual that is “at least sixty years of age” in order to increase GSH levels or otherwise prevent or treat diabetes (see, e.g., US’121 at claims 4-11; see esp. US’121 at claim 9; see also US’121 at ¶¶[0003], [0009]-[0010], [0077], [0079]). Regarding instant claims 11, 15, 19, 22, and the administration of a composition comprising “between 1 and 30 mg/kg of body weight per day of a composition comprising 1-99% of glycine and NAC in a ratio of 1:1 to 1:10000, US’121 claims and teaches methods of administering “an effective amount” of glycine and NAC to individuals over 60 years old (see, e.g., US’121 at claim 9). The term “effective amount” is explicitly defined as including administration of a total dosage of between about 1 and about 30 mg/kg per day of a composition comprising glycine and NAC, wherein glycine and NAC may be in a ratio of 1:1 to 1:10,000, and wherein each component may independently comprise 1-99% of the composition (see, e.g., US’121 at ¶¶[0092]-[0094]; see also MPEP 2144.05(I), noting that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”). Regarding instant claims 11, 15, and oral administration, US’121 claims and directs artisans to administer glycine and NAC in oral formulations (see, e.g., US’121 at claim 6, ¶¶[0083], [0085], [0133). Regarding instant claims 11, 15, and the administration of a single composition, US’121 claims and directs artisans to administer glycine and NAC in the same composition (see, e.g., US’121 at claim 5).
The prior art of US’121 differs from the instant claims as follows: First, the instant claims recite a different intended use with a different intended and expected result; and second, instant claims 11, 15, and 20-24 recite and require an “aerobic” or “weight training” “exercise” to have been performed within an indefinite time span before, during, or after administration, wherein newly added claims 20 and 23 require the patient to be an “athlete”.
Regarding claims 11, 15, and the recitations of intended or expected results in the preamble and “wherein” clauses, per MPEP § 2111.04(I), “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”. Here, the issued claims teach the same active method steps as instantly claimed (i.e., oral administration of the same compound to the same or overlapping patient population at the same or overlapping concentration), and therefore would necessarily and inherently result in the same effects as instantly claimed if enabled. The instant claims are presumed fully enabled at this time. Similarly, as explained at MPEP § 2111.02(II), a preamble reciting a purpose or intended use, corresponding only to prior art structures and steps, would be expected to necessarily and inherently yield the same results because the same compounds are administered in the same manner and dosage to the same patient population. Accordingly, although additional advantages of performing a prior art method may be later discovered, additional advantages which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding the difference at claims 11, 15, 20-21, and 23-24 and the requirement for an unspecified aerobic or weight training “exercise” before, during, or after an unspecified amount of time relative to administration, the claimed and described methods set forth in US’121 encompass all possible patients over the age of 60, without limitation regarding exercise (see, e.g., US’121 at claim 9). Accordingly, the prior art population of US’121 fully encompasses all patient populations over the age of 60, including patients that perform aerobic exercises or weight training (i.e., resistance training); or patients that either will perform such exercises or otherwise have done such activities at some point prior in their life (note claims 11 and 15 include past, present, and future activities). Accordingly, regardless of such limitations on patient populations, it would remain obvious in view of the prior art to treat all such patients by orally administering to them about 1-30 mg/kg/day of a composition comprising glycine and NAC (wherein each component may independently comprise 1-99% of the composition, and wherein each component may be in a ratio of 1:1 to 1:10,000), because such patients would predictably and expectedly benefit from such treatment by preventing or treating diabetes exactly as taught and suggested by US’121 (see, e.g., US’121 at claims 4-11; see esp. US’121 at claim 9; see also US’121 at ¶¶[0003], [0009]-[0010], [0077], [0079]). However, US’121 does not explicitly teach the treatment of “athletes”, or the past, concurrent, or future performance of aerobic exercise or weight training as presently required.
Regarding specific treatment of patients over 50 years of age that perform (or “performed”, or “will perform”) “aerobic exercise”, “weight training”, or treatment of “athletes” generally, Flack pertains to diabetes prevention and intervention in older adults, including those over 60 and 65 years of age (see, e.g., Flack at title, abs, 1 at col I at 1st ¶ and col I-II at bridging ¶, 2 at §§ 2.2). Flack identifies that resistance training (i.e., “weight-training”) is recommended for “older or diabetic individuals” (see, e.g., Flack at 5 at col II at § 5; p. 6 at Fig. 1), and for “sedentary older diabetic or prediabetic individuals” (see, e.g., Flack at 6 at col II at final ¶, citation 29). Flack additionally identifies that aerobic exercise is recommended to prevent diabetes, and that aerobic exercise improves glucose control and insulin sensitivity (see, e.g., Flack at 3 at col II at § 4, citation 29). Accordingly, an individual over 60 years of age would be motivated to improve, prevent, or treat diabetes by performing aerobic and/or resistance training to predictably improve glycemic control and fitness. Such individuals would be “athletes” as required by instant claims 20 and 23, because an “athlete” is understood to be
A person trained or gifted in exercises or contests involving physical agility, stamina, or strength; a participant in a sport, exercise, or game requiring physical skill9.
Notably, this means that any “participant in a[n] …exercise…requiring physical skill” is an “athlete”; accordingly, individuals participating in aerobic or resistance training are reasonably inferred to be “athletes” in the absence of any additional guidance on record. Accordingly, individuals exercising as suggested by Flack would necessarily fall within the definition of “athlete”. In sum, in view of Flack, an artisan would readily appreciate that aerobic exercise and/or resistance exercises in individuals over 60 would be predicted and expected to desirably improve, prevent, or treat diabetes and desirably improve overall fitness.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reasons: The invention is the combination of prior art elements (i.e., compositions comprising glycine and NAC, known aerobic and/or resistance exercises) according to known methods (i.e., oral administration of a composition comprising about 1-30 mg/kg/day of a composition comprising glycine and NAC as taught by the primary reference) of treating the same or overlapping patient population (i.e., patients over 60 years old, including those that have recently breathed, eaten, or walked), to yield predictable results (i.e., treatment or prevention of diabetes, increase of GHS levels, etc.) exactly as taught and suggested by the primary reference in view of Flack (see, e.g., MPEP § 2143(I)(A), (C), (D), (F), and (G); see also MPEP § 2144.05(I); see also MPEP § 2144.06(I), noting that the treatment disclosed by the primary reference and the treatments of Flack are both art-recognized treatments of diabetes, and would therefore be obvious to combine to form a combined treatment also predicted and expected to treat diabetes). Furthermore, each element merely performs its art-recognized function in combination as it does separately.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the skill in the art to administer a known composition at a known concentration to a known patient population via a known route of administration to achieve known and expected results. Furthermore, it is well within the ordinary skill in the art to combine such known treatments with other known treatments for the treatment and prevention of diabetes, such as those disclosed by Flack.
Zero unexpected results commensurate in scope with the requirements set forth at MPEP § 716, § 716.01, and § 716.02 have been placed on record at this time showing criticality of range or unexpected results dependent upon timing of exercise relative to administration.
Claims 11, 15, and 19-24 are rejected are rejected.
[Obviousness Rejection 02]
Claims 11, 15, and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 8362080 (Jan. 29, 2013) in view of Flack10, as evidenced by Dictionary11.
Claim interpretation: The applicable claim interpretation has been set forth in preceding rejections and also in a separate section above, and those discussions and interpretations are incorporated into the instant rejection. Examination of claims 13 and 17 in view of the prior art has been precluded as explained above. Additional claim interpretations are set forth below.
Regarding instant claims 11, 15, 18-24, and methods of administering glycine and NAC to patients, US’080 claims methods of administering to “an individual” an “effective amount” of “glycine and n-acetylcysteine” (see, e.g., US’080 at claims 1-4). Regarding instant claims 11, 15, 18-24, and oral administration, the primary reference explicitly claims a method that includes oral administration (see, e.g., US’080 at claims 1-2 and 4; see esp. id. at claim 4). Regarding instant claims 11, 15, and the treatment of patients that are ≥50 years old, US’080 claims the treatment of “an individual” (see, e.g., US’080 at claim 1-2 and 4), wherein an “individual” would be readily understood to include elderly patients that were at least 60 years of age or older (see, e.g., US’080 at col. 2 at lines 34-40, stating “individuals, for example elderly humans; see also id. at col 6 at lines 55-56, noting that “elderly” refers to 60+ year olds). Regarding instant claims 11, 15, 19, 22, and the administration of 1-30 mg/kg of a composition comprising 5%-75% of glycine and N-acetylcysteine, wherein glycein and NAC are in a 1:1 1:10,000 ratio, the primary reference recites the administration of an “effective amount” (see, e.g., US’080 at claim 1-2 and 4), which is not defined by the instant claim, but would be readily understood to include at least “0.1 to 100 mg/kg of body weight per day”, wherein glycine and N-acetylcysteine may be in a ratio of 1:1 to 1:10,000, and wherein glycine and N-acetylcysteine may independently comprise 1-99% of the administered amount of the compound (see, e.g., US’080 at col. 9 at lines 20-61; see also MPEP 2144.05(I), noting that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”).
The prior art of US’080 differs from the instant claims as follows: First, the instant claims recite a different intended use with a different intended and expected result; and second, instant claims 11, 15, 20-21, and 23-24 recite and require an unspecified “exercise” to have been performed within an indefinite time span before, during, or after administration.
Regarding claims 11, 15, and the recitations of intended or expected results in the preamble and “wherein” clauses, per MPEP § 2111.04(I), “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”. Here, the issued claims teach the same active method steps as instantly claimed (i.e., oral administration of the same compound to the same or overlapping patient population at the same or overlapping concentration), and therefore would necessarily and inherently result in the same effects as instantly claimed if enabled. The instant claims are presumed fully enabled at this time. Similarly, as explained at MPEP § 2111.02(II), a preamble reciting a purpose or intended use, corresponding only to prior art structures and steps, would be expected to necessarily and inherently yield the same results because the same compounds are administered in the same manner and dosage to the same patient population. Accordingly, although additional advantages of performing a prior art method may be later discovered, additional advantages which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding the difference at claims 11, 15, and 20-24 and the requirement for an unspecified aerobic or weight training “exercise” before, during, or after an unspecified amount of time relative to administration, accordingly, the prior art population treated by the claimed methods of the primary reference fully encompasses all patient populations over the age of 60, which would necessarily include patients that perform aerobic exercises or weight training (i.e., resistance training); or patients that either will perform such exercises or otherwise have done such activities at some point prior in their life (note claims 11 and 15 include past, present, and future activities). Accordingly, regardless of such limitations on patient populations, it would remain obvious in view of the prior art to treat all such patients by orally administering to them the same composition (i.e., glycine and NAC) at an overlapping dosage and dosage frequency, to predictably and expectedly obtain the benefits taught and suggested by the primary reference. Specifically, US’080 identifies that such treatment would desirably treat one or more medical conditions, including diabetes-related conditions (see, e.g., US’080 at claims 1(a), (d), (f), etc.). However, the primary reference does not explicitly teach the treatment of “athletes”, or otherwise explicitly teach the treatment of the subgenus of individuals that perform (or performed, or will perform) aerobic exercise or weight training as presently required.
Regarding specific treatment of patients over 50 years of age that perform (or “performed”, or “will perform”) “aerobic exercise”, “weight training”, or treatment of “athletes” generally, Flack pertains to diabetes prevention and intervention in older adults, including those over 60 and 65 years of age (see, e.g., Flack at title, abs, 1 at col I at 1st ¶ and col I-II at bridging ¶, 2 at §§ 2.2). Flack identifies that resistance training (i.e., “weight-training”) is recommended for “older or diabetic individuals” (see, e.g., Flack at 5 at col II at § 5; p. 6 at Fig. 1), and for “sedentary older diabetic or prediabetic individuals” (see, e.g., Flack at 6 at col II at final ¶, citation 29). Flack additionally identifies that aerobic exercise is recommended to prevent diabetes, and that aerobic exercise improves glucose control and insulin sensitivity (see, e.g., Flack at 3 at col II at § 4, citation 29). Accordingly, an individual over 60 years of age would be motivated to improve, prevent, or treat diabetes by performing aerobic and/or resistance training to predictably improve glycemic control and fitness. Such individuals would be “athletes” as required by instant claims 20 and 23, because an “athlete”12 is understood to be
A person trained or gifted in exercises or contests involving physical agility, stamina, or strength; a participant in a sport, exercise, or game requiring physical skill13.
Notably, this means that any “participant in a[n] …exercise…requiring physical skill” is an “athlete”; accordingly, individuals participating in aerobic or resistance training are reasonably inferred to be “athletes” in the absence of any additional guidance on record. Accordingly, individuals exercising as suggested by Flack would necessarily fall within the definition of “athlete”. In sum, in view of Flack, an artisan would readily appreciate that aerobic exercise and/or resistance exercises in individuals over 60 would be predicted and expected to desirably improve, prevent, or treat diabetes and desirably improve overall fitness.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reasons: The invention is the combination of prior art elements (i.e., compositions comprising glycine and NAC; known aerobic and/or resistance exercises) according to known methods (i.e., oral administration of a known composition comprising known amounts of known components; known methods of exercising to treat or prevent diabetes) of the same or overlapping patient population (i.e., patients over 60 years old, including those that have recently exercised), to yield predictable results (i.e., treatment of conditions recited at claim 1 of the primary reference) exactly as taught and suggested by the primary reference (see, e.g., MPEP § 2143(I)(A), (C), (D), (F), and (G); see also MPEP § 2144.05(I); see also MPEP § 2144.06(I), noting that the treatment disclosed by the primary reference and the treatments of Flack are both art-recognized treatments of diabetes, and would therefore be obvious to combine to form a combined treatment also predicted and expected to treat diabetes). Furthermore, each element merely performs its art-recognized function in combination as it does separately.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the skill in the art to administer a known composition at a known concentration to a known patient population via a known route of administration to achieve known and expected results. Furthermore, it is well within the ordinary skill in the art to combine such known treatments with other known treatments for the treatment and prevention of diabetes, such as those disclosed by Flack, to predictably and expectably obtain the results of both treatments (i.e., the treatment or prevention of diabetes).
Zero unexpected results commensurate in scope with the requirements set forth at MPEP § 716, § 716.01, and § 716.02 have been placed on record at this time showing criticality of range or unexpected results dependent upon timing of exercise relative to administration.
Claims 11, 15, and 19-24 are rejected are rejected.
[Obviousness Rejection 03]
Claims 11, 15, and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004/112511 A2 (Dec. 29, 2004) in view of Elsawy et al.14, as evidenced by Dictionary15.
Claim interpretation: The applicable claim interpretation has been set forth in preceding rejections and also in a separate section above, and those discussions and interpretations are incorporated into the instant rejection. Examination of claims 13 and 17 in view of the prior art has been precluded as explained above. Additional claim interpretations are set forth below.
Regarding instant claims 11, 15, and the oral administration of 1 mg/kg to 30 mg/kg daily of a composition comprising glycine and NAC, WO’511 teaches and discloses a dietary supplement, taken orally, that comprises glycine and N-acetyl-cysteine (see, e.g., WO’511 at title, abs, p. 6 at 1st ¶, claims 19-21, 25-27, passim), wherein a daily oral capsule or tablet dosage composition may comprise 860mg total to 7000 mg total (see, e.g., WO’511 at 16 at 2nd full ¶ to end of page). Typical adult humans are understood to weigh between 50-100 kg, which would correspond to a daily dosage range of at least 8.6 mg/kg to at least 70 mg/kg per day (see id., see also MPEP § 2144.05 (explaining that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists). Regarding instant claims 11, 15, and administration to patients over 50 years of age, WO’511 informs artisans that the treatment restores growth hormone levels and provides numerous benefits (see, e.g., WO’511 at title, abs, 3 at 1st ¶, 3 at penultimate ¶, at 4 at 2nd full ¶) and explains that such benefits are applicable to patients over 60 (see, e.g., WO’511 at 2 at final ¶, referring to men between 61-81 and adults 50 years old; see also id. at 4 at 2nd full ¶, referring to 60 year olds). Accordingly, an artisan would readily appreciate that the method of oral administration of the compositions of WO’511 could be desirably, beneficially, and predictably administered to patients of any age in need of such benefits, including the explicitly identified patient populations over 60 years of age. Regarding instant claims 11, 15, 19, 22, and compositions comprising 5-75% by weight of glycine and NAC, and a weight ratio of glycine:NAC of 1:1 to 1:10,000, WO’511 explicitly directs artisans to embodiments wherein glycine and NAC constitute >9% wt/wt of the composition and have a gly:NAC ratio of 1:5 (see, e.g., WO’511 at 17 at 1st paragraph describing a “preferred embodiment”; showing 300mg/3100mg total). Regarding claim 19 and other ratios, WO’511 informs artisans that the amounts of glycine and NAC may be varied within limited ranges, including 1:1 ratios (see, e.g., WO’511 at 8-9 at bridging ¶ discussing (a)-(h), claims 1, 19, 25, 31; see also MPEP § 2144.05, explaining that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists). Accordingly, such prior art compositions fully satisfy the claimed limitations pertaining to the administered composition.
The primary reference differs from the instant claims as follows: Although the primary reference teaches the same or overlapping compositions administered via the same administration route at the same dosage and dosage frequency to the same or overlapping patient population instantly claimed, the primary reference (i) recites a different rationale for administering the treatment; and (ii) does not recite nor require the past, concurrent, or future performance of aerobic exercise or weight training (i.e., resistance training). Accordingly, the relevant issue is whether or not a difference in rationale combined with a requirement to exercise is sufficient to render the claimed invention non-obvious in view of the prior art.
Predicted and expected benefits: WO’511 informs artisans that the treatment restores growth hormone levels and provides numerous benefits (see, e.g., WO’511 at title, abs, 3 at 1st ¶, 3 at penultimate ¶, at 4 at 2nd full ¶) and explains that such benefits are applicable to patients over 60 (see, e.g., WO’511 at 2 at final ¶, referring to men between 61-81 and adults 50 years old; see also id. at 4 at 2nd full ¶, referring to 60 year olds). Among the expected and predicted benefits of treatment include stimulating growth, cell repair and regeneration of skin, bone, heart, lungs, liver and kidneys “to their former youthful cell levels”, benefiting the immune system, reducing risk factors for heart attack and stroke, improvement of emphysema, improvement of bone density, reduction of wrinkles, improvement in presbyopia, restoration of hair color and growth, reduction of fat, increased muscle mass, increased and improved sexual potency and frequency of sexual relations, and improved healing capacity (see, e.g., WO’511 at 3 at 1st ¶ to final ¶).
Regarding the difference in recitation of a different purpose and different intended or expected results at the instant claims, per MPEP § 2111.04(I), “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”. Here, the issued claims teach the same active method steps as instantly claimed (i.e., oral administration of the same compound to the same or overlapping patient population at the same or overlapping concentration), and therefore would necessarily and inherently result in the same effects as instantly claimed if enabled. The instant claims are presumed fully enabled at this time. Similarly, as explained at MPEP § 2111.02(II), a preamble reciting a purpose or intended use, corresponding only to prior art structures and steps, would be expected to necessarily and inherently yield the same results because the same compounds are administered in the same manner and dosage to the same patient population. Accordingly, although additional advantages of performing a prior art method may be later discovered, additional advantages which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Accordingly, the recitations of intended and expected use in the preambles are understood to be fully satisfied by any prior art reference that teaches the same steps upon the same patient population.
Regarding instant claims 11, 15, 20-21, 23-24, and limitations pertaining to aerobic or weight-based exercise, exercising is a generic recommendation for virtually all patients and has numerous known and expected advantages, well-understood by artisans. Specifically, Elsawy is cited herein to establish that exercise is recommended to elderly patients, including those 65 and over, in order to desirably reduce the incidence of heart disease, stroke, diabetes mellitus, lung disease, Alzheimer disease, hypertension, and cancer (see, e.g., Elsawy at title, abs, Table 1 on 56, passim). Elsawy identifies that both aerobic exercise (see, e.g., Elsawy at abs) and resistance training (see, e.g., Elsawy at abs, 55 at col II at § “Maintaining Function”, 56 at “Sort: Key Recommendations for Practice”, noting that “strength-training” is reasonably synonymous with “resistance training” or “weight training”) are recommended to older adults, wherein the expected benefits are numerous and include at least the benefits enumerated at Table 1 (see, e.g., Elsawy at Table 1 on 56, noting that decreased risk of heat disease, stroke, diabetes type 2, colon cancer, breast cancer, lung cancer, endometrial cancer are reported, as well as improved cardiorespiratory and muscular fitness, reduced depression, improved cognitive function, increased bone density, improved sleep quality, fall prevention, etc., etc. are all art-recognized benefits of exercise). Accordingly, limitations pertaining to exercise appear to simply mirror known and existing art-recommendations for older adults, wherein such limitations have numerous art-recognized benefits. Notably, combining routine and recommended physical exercise as taught and suggested by Elsawy with the therapeutic supplement method taught by the primary reference would be readily understood to desirably and beneficially improve health in such patients, because combining such prior art methods would be predicted and expected to yield the combined benefits of each prior art methodology (i.e., the benefits of both exercise as well as the benefits of glycine/NAC supplements as taught by the primary reference).
Regarding instant claims 20, 23, and the requirement for the patient to be an “athlete”, the term “athlete” is not specifically defined on record, and therefore an “athlete”16 is understood to be
A person trained or gifted in exercises or contests involving physical agility, stamina, or strength; a participant in a sport, exercise, or game requiring physical skill17.
Notably, this means that any “participant in a[n] …exercise…requiring physical skill” is an “athlete” (see Dictionary at 1). Accordingly, in the absence of any objective, definite definition supported by the originally filed disclosure providing guidance to the contrary, all individuals participating in aerobic or resistance training as taught by Elsawy are reasonably inferred to be “athletes” in the absence of any additional guidance on record because such patients are “participants in a …exercise…. requiring physical skill” (see Dictionary at 1). Accordingly, individuals exercising as suggested by Elsawy would necessarily fall within the definition of “athlete”.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reasons: The invention is the use or application of the known techniques of exercise as taught by Elsawy to improve the known methods of improving hormone levels as taught by the primary reference, in order to predictably improve the methods of the primary reference in a known and predictable manner, namely by improving the primary reference’s methods predicted to reduce risk factors for heart attack and stroke, improve bone density, reduce fat, and increase muscle mass18 by combining it with exercise regimens as taught by Elsawy that predictably also improve reduce the incidence of heart disease and stroke, improve bone density, reduce fat, increase muscle mass, and additionally improve cognitive function, improve sleep quality, and reduce incidence of cancers, diabetes, and depression, exactly as taught and suggested by the secondary reference (see, e.g., MPEP § 2143(I)(A), (C), (D), (F), and (G); see also MPEP § 2144.05(I); see also MPEP § 2144.06(I), noting that the treatment disclosed by the primary reference and the treatments of Elsawy are both art-recognized means of improving the health of older adults over the age of 50, and would therefore be obvious to combine to form a combined treatment also predicted and expected to improve the health of older adults over 50). Furthermore, each prior art element or method would merely be expected to perform its art-recognized function in combination as it does separately.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the skill in the art to administer a known composition at a known concentration to a known patient population via a known route of administration to achieve known and expected results. Furthermore, it is well within the ordinary skill in the art to combine known treatments of improving the health of older adults to obtain a combined methodology the predictably and expectedly yields the benefits of both prior art methodologies.
Zero unexpected results commensurate in scope with the requirements set forth at MPEP § 716, § 716.01, and § 716.02 have been placed on record at this time showing any criticality of range or unexpected results dependent upon timing of exercise relative to administration.
Claims 11, 15, and 19-24 are rejected are rejected.
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.
[NSDP Rejection 01]
Claims 11, 15, and 19-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 8802730 (Aug. 12, 2014) in view of in view of Elsawy et al.19, as evidenced by Dictionary20.
Although the claims at issue are not identical, they are not patentably distinct from each other as discussed below.
Claim interpretation: The applicable claim interpretation has been set forth in preceding rejections and also in a separate section above, and those discussions and interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
The pending claims are understood to be directed to methods of orally administering a composition comprising less than 30 mg/kg, combined, of glycine and N- acetylcysteine to any patient over 50 years of age (see, e.g., instant claims 11, 15), wherein for independent claims 11 and 15, administration must be within an indefinite time frame before, during, and/or after an unspecified amount of aerobic “exercise” or weight training (i.e., resistance training). The completion of such methods are understood to necessarily or inherently result in the intended and expected result, as set forth in the claims.
Regarding instant claims 11, 15, and 19-24, US’730 claims methods of administering to an individual that is “at least sixty years of age” an “effective amount” of “glycine and n-acetylcysteine” (see, e.g., US’730 at claim 9). Regarding claims 11, 15, 19-24, and oral administration, the method is understood to broadly encompass all forms of administration (see, e.g., US’730 at claim 9), which would necessarily include oral administration (see, e.g., US’730 at claims 4-6 and 9). Regarding instant claims 11, 15, 19, 22, and 5-75% by weight of glycine and N-acetylcysteine, wherein the ratio of glycine:NAC is 1:1 to 1:10,000, US’730 recites the administration of an “effective amount” (see, e.g., US’730 at claim 9), which is not defined by the instant claim. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Here, “effective amount” would readily be understood to mean “0.1 to 100 mg/kg of body weight per day”, wherein glycine and N-acetylcysteine may be in a ratio of 1:1 to 1:10,000, and wherein glycine and N-acetylcysteine may comprise 1-99% of the administered amount of the compound (see, e.g., US;730 at col. 9 at lines 34-61).
The issued method of claims US’730 differs from the instant claims as follows: The issued claims of the primary reference (i) do not recite the same intended or expected result as instantly claimed, and (ii) the issued claims do not recite nor require aerobic or weight training exercises to have been performed within an indefinite time span before, during, or after treatment.
Regarding the difference in recitation of intended or expected results at the instant claims, per MPEP § 2111.04(I), “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”. Here, the issued claims teach the same active method steps as instantly claimed (i.e., oral administration of the same compound to the same or overlapping patient population at the same or overlapping concentration), and therefore would necessarily and inherently result in the same effects as instantly claimed21 if enabled. The instant claims are presumed fully enabled at this time.
Regarding the difference at claims 11, 15, 20-21, 23-24, and the requirement for an unspecified exercise before, during, or after an unspecified amount of time relative to administration, the issued claims encompass all possible patients over the age of 60, without limitation (see, e.g., US’730 at claim 9). Accordingly, such patients include all patients that would benefit from treatment of medical conditions, diabetes, or reducing body weight or lowing cholesterol (see, e.g., US730 at claims 2-4, 9-11), without limitation excluding athletes (i.e., the issued claim scope includes athletes and patients that routinely exercise). Accordingly, the instant claims fail to materially or substantially differentiate the pending claim scope relative to the patient population the issued claims, since they materially and substantially overlap in scope.
If claims 11, 15, 20-21, and 23-24 are interpreted to require a past or concurrent exercise regime as a required method limitation rather than as a description of a patient population, this would not patentably distinguish the instant claims in view of the issued claims and prior art as follows: exercising is a generic recommendation for virtually all patients and has numerous known and expected advantages, well-understood by artisans. Specifically, Elsawy is cited herein to establish that exercise is recommended to elderly patients, including those 65 and over, in order to desirably reduce the incidence of heart disease, stroke, diabetes mellitus, lung disease, Alzheimer disease, hypertension, and cancer (see, e.g., Elsawy at title, abs, Table 1 on 56, passim). Elsawy identifies that both aerobic exercise (see, e.g., Elsawy at abs) and resistance training (see, e.g., Elsawy at abs, 55 at col II at § “Maintaining Function”, 56 at “Sort: Key Recommendations for Practice”, noting that “strength-training” is reasonably synonymous with “resistance training” or “weight training”) are recommended to older adults, wherein the expected benefits are numerous and include at least the benefits enumerated at Table 1 (see, e.g., Elsawy at Table 1 on 56, noting that decreased risk of heat disease, stroke, diabetes type 2, colon cancer, breast cancer, lung cancer, endometrial cancer are reported, as well as improved cardiorespiratory and muscular fitness, reduced depression, improved cognitive function, increased bone density, improved sleep quality, fall prevention, etc., etc. are all art-recognized benefits of exercise). Accordingly, limitations pertaining to exercise appear to simply mirror known and existing art-recommendations for older adults, wherein such limitations have numerous art-recognized benefits. Notably, combining routine and recommended physical exercise as taught and suggested by Elsawy with the therapeutic supplement method taught by the primary reference would be readily understood to desirably and beneficially improve health in such patients, because combining such prior art methods would be predicted and expected to yield the combined benefits of each prior art methodology (i.e., the benefits of both exercise as well as the benefits of glycine/NAC supplements as taught by the primary reference). Regarding instant claims 20, 23, and the requirement for the patient to be an “athlete”, the term “athlete” is not specifically defined on record, and therefore an “athlete”22 is understood to be
A person trained or gifted in exercises or contests involving physical agility, stamina, or strength; a participant in a sport, exercise, or game requiring physical skill23.
Notably, this means that any “participant in a[n] …exercise…requiring physical skill” is an “athlete” (see Dictionary at 1). Accordingly, in the absence of any objective, definite definition supported by the originally filed disclosure providing guidance to the contrary, all individuals participating in aerobic or resistance training as taught by Elsawy are reasonably inferred to be “athletes” in the absence of any additional guidance on record because such patients are “participants in a …exercise…. requiring physical skill” (see Dictionary at 1). Accordingly, individuals exercising as suggested by Elsawy would necessarily fall within the definition of “athlete”.
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)). Here the differences are minimal because the active method steps involving the “hand of man” appear to be identical (or otherwise substantially overlapping) in both claim sets, or otherwise only differ by a requirement for exercise (i.e., a known prior art activity having known benefits) and therefore administering the same compounds to the same (or overlapping patient population) via the same administration route at the same (or overlapping) dosage would be expected and predicted to achieve the same predicted and expected outcomes set forth in the issued claims (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are directed to obvious variants of the representative claims because it is well-within the ordinary skill in the art to perform a known method on a known patient population using a known drug via a known route of administration at a known concentration (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A), (C), (G)). In addition or alternatively, the claimed invention is the use or application of the known techniques of exercise as taught by Elsawy to improve the known and issued method of the primary reference in a known and predictable manner, namely by augmenting the methods of the issued claims with exercise regimens as taught by Elsawy, the issued claims would simply yield the predicted and expected results enumerated at claims 2-11 and additionally provide the benefits attributable to exercise (e.g., reduced incidence of heart disease and stroke, improve bone density, reduce fat, increase muscle mass, and additionally improve cognitive function, improve sleep quality, and reduce incidence of cancers, diabetes, and depression), exactly as taught and suggested by the secondary reference (see, e.g., MPEP § 2143(I)(C), (D), (F), and (G), § 2144.05(I), § 2144.06(I)). In sum, the minor differences cannot be said to patentably distinguish the instant claims relative to the issued claims.
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to overlapping methods of administering the same compounds via the same administration route to the same patient population at the same concentration ranges as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 11, 15, and 19-24 are rejected.
[NSDP Rejection 02]
Claims 11, 15, and 19-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 8362080 (Jan. 29, 2013) in view of in view of Elsawy et al.24, as evidenced by Dictionary25. Although the claims at issue are not identical, they are not patentably distinct from each other as discussed below.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejections and also in a separate section above, and those discussions and interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below
The pending claims are understood to be directed to methods of orally administering a composition comprising less than 30 mg/kg, combined, of glycine and N- acetylcysteine to any patient over 50 years of age (see, e.g., instant claims 11, 15), wherein for independent claims 11 and 15, administration must be within an indefinite time frame before, during, and/or after an unspecified amount of aerobic “exercise” or weight training (i.e., resistance training). The completion of such methods are understood to necessarily or inherently result in the intended and expected result, as set forth in the claims.
Regarding instant claims 11, 15, and 19-24, US’080 claims methods of administering to “an individual” an “effective amount” of “glycine and n-acetylcysteine” to desirably treat one or more medical conditions selected from enumerated diseases or conditions (a)-(k) (see, e.g., US’080 at claims 1-4). Regarding claims 11, 15, 19-24, and oral administration, the primary reference explicitly claims a method that includes oral administration (see, e.g., US’080 at claims 1-2 and 4). Regarding instant claims 11, 15, and the treatment of patients that are ≥50 years old, US’080 claims the treatment of “an individual” (see, e.g., US’080 at claim 1-2 and 4), which is not defined by the instant claim. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Critically, “an individual” would be readily understood to be defined in a manner including elderly patients that were at least 60 years of age or older (see, e.g., US’080 at col. 2 at lines 34-40, stating “individuals, for example elderly humans; see also id. at col 6 at lines 55-56, noting that “elderly” refers to 60+ year olds). Regarding instant claims 11, 15, 19, 22, and 5-75% by weight of glycine and N-acetylcysteine, wherein the ratio of glycine:NAC is 1:1 to 1:10,000, the primary reference recites the administration of an “effective amount” (see, e.g., US’080 at claim 1-2 and 4), which is not defined by the instant claim. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Here, “effective amount” would readily be understood to mean “0.1 to 100 mg/kg of body weight per day”, wherein glycine and N-acetylcysteine may be in a ratio of 1:1 to 1:10,000, and wherein glycine and N-acetylcysteine may independently comprise 1-99% of the administered amount of the compound (see, e.g., US’080 at col. 9 at lines 20-61).
The issued method of claims US’080 differs from the instant claims as follows: The issued claims of the primary reference (i) do not recite the same intended or expected result as instantly claimed, and (ii) the issued claims do not recite nor require aerobic or weight training exercises to have been performed within an indefinite time span before, during, or after treatment.
Regarding the difference in recitation of a different purpose and different intended or expected results at the instant claims, per MPEP § 2111.04(I), “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”. Here, the issued claims teach the same active method steps as instantly claimed (i.e., oral administration of the same compound to the same or overlapping patient population at the same or overlapping concentration), and therefore would necessarily and inherently result in the same effects as instantly claimed if enabled. The instant claims are presumed fully enabled at this time. Similarly, as explained at MPEP § 2111.02(II), a preamble reciting a purpose or intended use, corresponding only to prior art structures and steps, would be expected to necessarily and inherently yield the same results because the same compounds are administered in the same manner and dosage to the same patient population. Accordingly, although additional advantages of performing a prior art method may be later discovered, additional advantages which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding the difference at claims 11, 15, 21-21, 23-24 and the requirement for an unspecified amount of aerobic or weight-training exercise before, during, or after an unspecified amount of time relative to administration, the issued claims encompass all possible patients over the age of 60, without limitation (without limitation excluding athletes (i.e., the issued claim scope includes athletes and patients that routinely exercise). Accordingly, the instant claims fail to materially or substantially differentiate the pending claim scope relative to the patient population the issued claims, since they materially and substantially overlap in scope.
If claims 11, 15, 20-21, and 23-24 are interpreted to require a past or concurrent exercise regime as a required method limitation rather than as a description of a patient population, this would not patentably distinguish the instant claims in view of the issued claims and prior art as follows: exercising is a generic recommendation for virtually all patients and has numerous known and expected advantages, well-understood by artisans. Specifically, Elsawy is cited herein to establish that exercise is recommended to elderly patients, including those 65 and over, in order to desirably reduce the incidence of heart disease, stroke, diabetes mellitus, lung disease, Alzheimer disease, hypertension, and cancer (see, e.g., Elsawy at title, abs, Table 1 on 56, passim). Elsawy identifies that both aerobic exercise (see, e.g., Elsawy at abs) and resistance training (see, e.g., Elsawy at abs, 55 at col II at § “Maintaining Function”, 56 at “Sort: Key Recommendations for Practice”, noting that “strength-training” is reasonably synonymous with “resistance training” or “weight training”) are recommended to older adults, wherein the expected benefits are numerous and include at least the benefits enumerated at Table 1 (see, e.g., Elsawy at Table 1 on 56, noting that decreased risk of heat disease, stroke, diabetes type 2, colon cancer, breast cancer, lung cancer, endometrial cancer are reported, as well as improved cardiorespiratory and muscular fitness, reduced depression, improved cognitive function, increased bone density, improved sleep quality, fall prevention, etc., etc. are all art-recognized benefits of exercise). Accordingly, limitations pertaining to exercise appear to simply mirror known and existing art-recommendations for older adults, wherein such limitations have numerous art-recognized benefits. Notably, combining routine and recommended physical exercise as taught and suggested by Elsawy with the therapeutic supplement method taught by the primary reference would be readily understood to desirably and beneficially improve health in such patients, because combining such prior art methods would be predicted and expected to yield the combined benefits of each prior art methodology (i.e., the benefits of both exercise as well as the benefits of glycine/NAC supplements as taught by the primary reference). Regarding instant claims 20, 23, and the requirement for the patient to be an “athlete”, the term “athlete” is not specifically defined on record, and therefore an “athlete”26 is understood to be
A person trained or gifted in exercises or contests involving physical agility, stamina, or strength; a participant in a sport, exercise, or game requiring physical skill27.
Notably, this means that any “participant in a[n] …exercise…requiring physical skill” is an “athlete” (see Dictionary at 1). Accordingly, in the absence of any objective, definite definition supported by the originally filed disclosure providing guidance to the contrary, all individuals participating in aerobic or resistance training as taught by Elsawy are reasonably inferred to be “athletes” in the absence of any additional guidance on record because such patients are “participants in a …exercise…. requiring physical skill” (see Dictionary at 1). Accordingly, individuals exercising as suggested by Elsawy would necessarily fall within the definition of “athlete”.
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)). Here the differences are minimal because the active method steps involving the “hand of man” appear to be identical (or otherwise substantially overlapping) in both claim sets, or otherwise only differ by a requirement for exercise (i.e., a known prior art activity having known benefits) and therefore administering the same compounds to the same (or overlapping patient population) via the same administration route at the same (or overlapping) dosage would be expected and predicted to achieve the same predicted and expected outcomes set forth in the issued claims (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are directed to obvious variants of the representative claims because it is well-within the ordinary skill in the art to perform a known method on a known patient population using a known drug via a known route of administration at a known concentration (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A), (C), (G)). In addition or alternatively, the claimed invention is the use or application of the known techniques of exercise as taught by Elsawy to improve the known and issued method of the primary reference in a known and predictable manner, namely by augmenting the methods of the issued claims with exercise regimens as taught by Elsawy, the issued claims would simply yield the predicted and expected results enumerated at claims 2-11 and additionally provide the benefits attributable to exercise (e.g., reduced incidence of heart disease and stroke, improve bone density, reduce fat, increase muscle mass, and additionally improve cognitive function, improve sleep quality, and reduce incidence of cancers, diabetes, and depression), exactly as taught and suggested by the secondary reference (see, e.g., MPEP § 2143(I)(C), (D), (F), and (G), § 2144.05(I), § 2144.06(I)). In sum, the minor differences cannot be said to patentably distinguish the instant claims relative to the issued claims.
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to overlapping methods of administering the same compounds via the same administration route to the same patient population at the same concentration ranges as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 11, 15, and 19-24 are rejected.
[NSDP Rejection 03]
Claims 11, 15, and 19-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9084760 (Jul. 21, 2015) in view of in view of Elsawy et al.28, as evidenced by Dictionary29. Although the claims at issue are not identical, they are not patentably distinct from each other as discussed below.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejections and also in a separate section above, and those discussions and interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below
The pending claims are understood to be directed to methods of orally administering a composition comprising less than 30 mg/kg, combined, of glycine and N- acetylcysteine to any patient over 50 years of age (see, e.g., instant claims 11, 15), wherein for independent claims 11 and 15, administration must be within an indefinite time frame before, during, and/or after an unspecified amount of aerobic “exercise” or weight training (i.e., resistance training). The completion of such methods are understood to necessarily or inherently result in the intended and expected result, as set forth in the claims.
Regarding instant claims 11, 15, and 19-24, US’760 claims methods of administering to “an individual” an “effective amount” of “glycine and n-acetylcysteine” (see, e.g., US’760 at claims 1-6). Regarding claims 11, 15, and oral administration, the claims of the primary reference broadly include all forms of administration (see, e.g., US’760 at claims 1, 4, and 6), and oral administration is explicitly recited (see, e.g., US’760 at claim 3). Regarding instant claims 11, 15, and the treatment of patients that are ≥50 years old, the primary reference claims the treatment of “an individual” (see, e.g., US’760 at claims 1, 3-4-6), which is not defined by the claims. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Critically, “an individual” would be readily understood to be defined in a manner including elderly patients that were at least 60 years of age or older (see, e.g., US’760 at col. 2 at lines 34-40, stating “individuals, for example elderly humans; see also id. at col 6 at lines 50-63, noting that “elderly” refers to 60+ year olds). In addition, claim 5 explicitly recites and directs artisans to the treatment of patients 60+ years old (see, e.g., US’760 at claim 5). Regarding instant claims 11, 15, 19, 22, and administration of 1-30 mg/kg/day of 5-75% by weight of glycine and N-acetylcysteine, wherein the ratio of glycine:NAC is 1:1 to 1:10,000, the primary reference recites the administration of an “effective amount” (see, e.g., US’760 at claims 1-6), which is not defined by the instant claim. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Here, “effective amount” would readily be understood to mean “between about 1 mg/kg and about 30 mg/kg of body weight per day”, wherein glycine and N-acetylcysteine may be in a ratio of 1:1 to 1:10,000, and wherein glycine and N-acetylcysteine may independently comprise 1-99% of the administered amount of the compound (see, e.g., US’760 at col. 9 at lines 20-61).
The issued method of claims US’080 differs from the instant claims as follows: The issued claims of the primary reference (i) do not recite the same intended or expected result as instantly claimed, and (ii) the issued claims do not recite nor require aerobic or weight training exercises to have been performed within an indefinite time span before, during, or after treatment.
Regarding the difference in recitation of a different purpose and different intended or expected results at the instant claims, per MPEP § 2111.04(I), “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”. Here, the issued claims teach the same active method steps as instantly claimed (i.e., oral administration of the same compound to the same or overlapping patient population at the same or overlapping concentration), and therefore would necessarily and inherently result in the same effects as instantly claimed if enabled. The instant claims are presumed fully enabled at this time. Similarly, as explained at MPEP § 2111.02(II), a preamble reciting a purpose or intended use, corresponding only to prior art structures and steps, would be expected to necessarily and inherently yield the same results because the same compounds are administered in the same manner and dosage to the same patient population. Accordingly, although additional advantages of performing a prior art method may be later discovered, additional advantages which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding the difference at claims 11, 15, 21-21, 23-24 and the requirement for an unspecified amount of aerobic or weight-training exercise before, during, or after an unspecified amount of time relative to administration, the issued claims encompass all possible patients over the age of 60, without limitation (without limitation excluding athletes (i.e., the issued claim scope includes athletes and patients that routinely exercise). Accordingly, the instant claims fail to materially or substantially differentiate the pending claim scope relative to the patient population the issued claims, since they materially and substantially overlap in scope.
If claims 11, 15, 20-21, and 23-24 are interpreted to require a past or concurrent exercise regime as a required method limitation rather than as a description of a patient population, this would not patentably distinguish the instant claims in view of the issued claims and prior art as follows: exercising is a generic recommendation for virtually all patients and has numerous known and expected advantages, well-understood by artisans. Specifically, Elsawy is cited herein to establish that exercise is recommended to elderly patients, including those 65 and over, in order to desirably reduce the incidence of heart disease, stroke, diabetes mellitus, lung disease, Alzheimer disease, hypertension, and cancer (see, e.g., Elsawy at title, abs, Table 1 on 56, passim). Elsawy identifies that both aerobic exercise (see, e.g., Elsawy at abs) and resistance training (see, e.g., Elsawy at abs, 55 at col II at § “Maintaining Function”, 56 at “Sort: Key Recommendations for Practice”, noting that “strength-training” is reasonably synonymous with “resistance training” or “weight training”) are recommended to older adults, wherein the expected benefits are numerous and include at least the benefits enumerated at Table 1 (see, e.g., Elsawy at Table 1 on 56, noting that decreased risk of heat disease, stroke, diabetes type 2, colon cancer, breast cancer, lung cancer, endometrial cancer are reported, as well as improved cardiorespiratory and muscular fitness, reduced depression, improved cognitive function, increased bone density, improved sleep quality, fall prevention, etc., etc. are all art-recognized benefits of exercise). Accordingly, limitations pertaining to exercise appear to simply mirror known and existing art-recommendations for older adults, wherein such limitations have numerous art-recognized benefits. Notably, combining routine and recommended physical exercise as taught and suggested by Elsawy with the therapeutic supplement method taught by the primary reference would be readily understood to desirably and beneficially improve health in such patients, because combining such prior art methods would be predicted and expected to yield the combined benefits of each prior art methodology (i.e., the benefits of both exercise as well as the benefits of glycine/NAC supplements as taught by the primary reference). Regarding instant claims 20, 23, and the requirement for the patient to be an “athlete”, the term “athlete” is not specifically defined on record, and therefore an “athlete”30 is understood to be
A person trained or gifted in exercises or contests involving physical agility, stamina, or strength; a participant in a sport, exercise, or game requiring physical skill31.
Notably, this means that any “participant in a[n] …exercise…requiring physical skill” is an “athlete” (see Dictionary at 1). Accordingly, in the absence of any objective, definite definition supported by the originally filed disclosure providing guidance to the contrary, all individuals participating in aerobic or resistance training as taught by Elsawy are reasonably inferred to be “athletes” in the absence of any additional guidance on record because such patients are “participants in a …exercise…. requiring physical skill” (see Dictionary at 1). Accordingly, individuals exercising as suggested by Elsawy would necessarily fall within the definition of “athlete”.
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)). Here the differences are minimal because the active method steps involving the “hand of man” appear to be identical (or otherwise substantially overlapping) in both claim sets, or otherwise only differ by a requirement for exercise (i.e., a known prior art activity having known benefits) and therefore administering the same compounds to the same (or overlapping patient population) via the same administration route at the same (or overlapping) dosage would be expected and predicted to achieve the same predicted and expected outcomes set forth in the issued claims (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are directed to obvious variants of the representative claims because it is well-within the ordinary skill in the art to perform a known method on a known patient population using a known drug via a known route of administration at a known concentration (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A), (C), (G)). In addition or alternatively, the claimed invention is the use or application of the known techniques of exercise as taught by Elsawy to improve the known and issued method of the primary reference in a known and predictable manner, namely by augmenting the methods of the issued claims with exercise regimens as taught by Elsawy, the issued claims would simply yield the predicted and expected results enumerated at claims 2-11 and additionally provide the benefits attributable to exercise (e.g., reduced incidence of heart disease and stroke, improve bone density, reduce fat, increase muscle mass, and additionally improve cognitive function, improve sleep quality, and reduce incidence of cancers, diabetes, and depression), exactly as taught and suggested by the secondary reference (see, e.g., MPEP § 2143(I)(C), (D), (F), and (G), § 2144.05(I), § 2144.06(I)). In sum, the minor differences cannot be said to patentably distinguish the instant claims relative to the issued claims.
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to overlapping methods of administering the same compounds via the same administration route to the same patient population at the same concentration ranges as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 11, 15, and 19-24 are rejected.
[NSDP Rejection 04]
Claims 11, 15, and 19-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,730,711 (Aug. 22, 2023) in view of in view of Elsawy et al.32, as evidenced by Dictionary33. Although the claims at issue are not identical, they are not patentably distinct from each other as discussed below.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejections and also in a separate section above, and those discussions and interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below
The pending claims are understood to be directed to methods of orally administering a composition comprising less than 30 mg/kg, combined, of glycine and N- acetylcysteine to any patient over 50 years of age (see, e.g., instant claims 11, 15), wherein for independent claims 11 and 15, administration must be within an indefinite time frame before, during, and/or after an unspecified amount of aerobic “exercise” or weight training (i.e., resistance training). The completion of such methods are understood to necessarily or inherently result in the intended and expected result, as set forth in the claims.
Regarding instant claims 11, 15, and 19-24, US’711 claims methods of administering to “an individual” an “effective amount” of “glycine and n-acetylcysteine” (see, e.g., US’711 at claims 1-4). Regarding 11, 15, and oral administration, the claims of the primary reference broadly include all forms of administration (see, e.g., US’711 at claims 1-4), and oral administration is explicitly recited (see, e.g., US’711 at claim 4). Regarding instant claims 11, 15, and 19-24, and the treatment of patients that are ≥50 years old, the primary reference claims the treatment of “an individual” (see, e.g., US’711 at claims 1-4), which is not defined by the claims. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Critically, “an individual” would be readily understood to be defined in a manner including elderly patients that were at least 60 years of age or older (see, e.g., US’711 at col. 5 at lines 45-50, stating “individuals, for example elderly humans; see also id. at col 10 at lines 10-18, noting that “elderly” refers to 60+ year olds). Regarding instant claims 11, 15, 19, 22, and administration of 1-30 mg/kg/day of 5-75% by weight of glycine and N-acetylcysteine, wherein the ratio of glycine:NAC is 1:1 to 1:10,000, the primary reference recites the administration of an “effective amount” (see, e.g., US’711 at claims 1-4), which is not defined by the instant claim. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Here, “effective amount” would readily be understood to mean “between about 1 mg/kg and about 30 mg/kg of body weight per day”, wherein glycine and N-acetylcysteine may be in a ratio of 1:1 to 1:10,000, and wherein glycine and N-acetylcysteine may independently comprise 1-99% of the administered amount of the compound (see, e.g., US’711 at col. 13 at line 34 to col. 14 at line 5).
The issued method of claims US’080 differs from the instant claims as follows: The issued claims of the primary reference (i) do not recite the same intended or expected result as instantly claimed, and (ii) the issued claims do not recite nor require aerobic or weight training exercises to have been performed within an indefinite time span before, during, or after treatment.
Regarding the difference in recitation of a different purpose and different intended or expected results at the instant claims, per MPEP § 2111.04(I), “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”. Here, the issued claims teach the same active method steps as instantly claimed (i.e., oral administration of the same compound to the same or overlapping patient population at the same or overlapping concentration), and therefore would necessarily and inherently result in the same effects as instantly claimed if enabled. The instant claims are presumed fully enabled at this time. Similarly, as explained at MPEP § 2111.02(II), a preamble reciting a purpose or intended use, corresponding only to prior art structures and steps, would be expected to necessarily and inherently yield the same results because the same compounds are administered in the same manner and dosage to the same patient population. Accordingly, although additional advantages of performing a prior art method may be later discovered, additional advantages which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding the difference at claims 11, 15, 21-21, 23-24 and the requirement for an unspecified amount of aerobic or weight-training exercise before, during, or after an unspecified amount of time relative to administration, the issued claims encompass all possible patients over the age of 60, without limitation (without limitation excluding athletes (i.e., the issued claim scope includes athletes and patients that routinely exercise). Accordingly, the instant claims fail to materially or substantially differentiate the pending claim scope relative to the patient population the issued claims, since they materially and substantially overlap in scope.
If claims 11, 15, 20-21, and 23-24 are interpreted to require a past or concurrent exercise regime as a required method limitation rather than as a description of a patient population, this would not patentably distinguish the instant claims in view of the issued claims and prior art as follows: exercising is a generic recommendation for virtually all patients and has numerous known and expected advantages, well-understood by artisans. Specifically, Elsawy is cited herein to establish that exercise is recommended to elderly patients, including those 65 and over, in order to desirably reduce the incidence of heart disease, stroke, diabetes mellitus, lung disease, Alzheimer disease, hypertension, and cancer (see, e.g., Elsawy at title, abs, Table 1 on 56, passim). Elsawy identifies that both aerobic exercise (see, e.g., Elsawy at abs) and resistance training (see, e.g., Elsawy at abs, 55 at col II at § “Maintaining Function”, 56 at “Sort: Key Recommendations for Practice”, noting that “strength-training” is reasonably synonymous with “resistance training” or “weight training”) are recommended to older adults, wherein the expected benefits are numerous and include at least the benefits enumerated at Table 1 (see, e.g., Elsawy at Table 1 on 56, noting that decreased risk of heat disease, stroke, diabetes type 2, colon cancer, breast cancer, lung cancer, endometrial cancer are reported, as well as improved cardiorespiratory and muscular fitness, reduced depression, improved cognitive function, increased bone density, improved sleep quality, fall prevention, etc., etc. are all art-recognized benefits of exercise). Accordingly, limitations pertaining to exercise appear to simply mirror known and existing art-recommendations for older adults, wherein such limitations have numerous art-recognized benefits. Notably, combining routine and recommended physical exercise as taught and suggested by Elsawy with the therapeutic supplement method taught by the primary reference would be readily understood to desirably and beneficially improve health in such patients, because combining such prior art methods would be predicted and expected to yield the combined benefits of each prior art methodology (i.e., the benefits of both exercise as well as the benefits of glycine/NAC supplements as taught by the primary reference). Regarding instant claims 20, 23, and the requirement for the patient to be an “athlete”, the term “athlete” is not specifically defined on record, and therefore an “athlete”34 is understood to be
A person trained or gifted in exercises or contests involving physical agility, stamina, or strength; a participant in a sport, exercise, or game requiring physical skill35.
Notably, this means that any “participant in a[n] …exercise…requiring physical skill” is an “athlete” (see Dictionary at 1). Accordingly, in the absence of any objective, definite definition supported by the originally filed disclosure providing guidance to the contrary, all individuals participating in aerobic or resistance training as taught by Elsawy are reasonably inferred to be “athletes” in the absence of any additional guidance on record because such patients are “participants in a …exercise…. requiring physical skill” (see Dictionary at 1). Accordingly, individuals exercising as suggested by Elsawy would necessarily fall within the definition of “athlete”.
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)). Here the differences are minimal because the active method steps involving the “hand of man” appear to be identical (or otherwise substantially overlapping) in both claim sets, or otherwise only differ by a requirement for exercise (i.e., a known prior art activity having known benefits) and therefore administering the same compounds to the same (or overlapping patient population) via the same administration route at the same (or overlapping) dosage would be expected and predicted to achieve the same predicted and expected outcomes set forth in the issued claims (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are directed to obvious variants of the representative claims because it is well-within the ordinary skill in the art to perform a known method on a known patient population using a known drug via a known route of administration at a known concentration (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A), (C), (G)). In addition or alternatively, the claimed invention is the use or application of the known techniques of exercise as taught by Elsawy to improve the known and issued method of the primary reference in a known and predictable manner, namely by augmenting the methods of the issued claims with exercise regimens as taught by Elsawy, the issued claims would simply yield the predicted and expected results enumerated at claims 2-11 and additionally provide the benefits attributable to exercise (e.g., reduced incidence of heart disease and stroke, improve bone density, reduce fat, increase muscle mass, and additionally improve cognitive function, improve sleep quality, and reduce incidence of cancers, diabetes, and depression), exactly as taught and suggested by the secondary reference (see, e.g., MPEP § 2143(I)(C), (D), (F), and (G), § 2144.05(I), § 2144.06(I)). In sum, the minor differences cannot be said to patentably distinguish the instant claims relative to the issued claims.
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to overlapping methods of administering the same compounds via the same administration route to the same patient population at the same concentration ranges as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 11, 15, and 19-24 are rejected.
[NSDP Rejection 05]
Claims 11, 15, and 19-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,186,292 (Jan. 7, 2025) in view of in view of Elsawy et al.36, as evidenced by Dictionary37. Although the claims at issue are not identical, they are not patentably distinct from each other as discussed below.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejections and also in a separate section above, and those discussions and interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
The pending claims are understood to be directed to methods of orally administering a composition comprising less than 30 mg/kg, combined, of glycine and N- acetylcysteine to any patient over 50 years of age (see, e.g., instant claims 1, 5, 11, 15), wherein for independent claims 11 and 15, administration must be within an indefinite time frame before, during, and/or after an unspecified amount of aerobic “exercise” or weight training (i.e., resistance training). The completion of such methods are understood to necessarily or inherently result in the intended and expected result, as set forth in the claims.
Issued claims 1-7 of US’292, are understood to be directed to the treatment of patients with “mitochondrial dysfunction” Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Accordingly, “mitochondrial dysfunction” is understood to include diabetes or otherwise patients in need of treatment with metformin (see, e.g., US’292 at claims 1, 6-7; see also US’292 col. 16 at line 55 to col. 60). Regarding instant claims 11, 15, and 19-24, US’292 claims methods of administering to “an individual” an “effective amount” of “glycine and n-acetylcysteine” (see, e.g., US’292 at claims 1-7). Regarding 11, 15, and oral administration, the claims of the primary reference broadly include all forms of administration (see, e.g., US’292 at claims 1-7), and oral administration is explicitly recited (see, e.g., US’292 at claim 4). Regarding instant claims 11, 15, and the treatment of patients that are ≥50 years old, the primary reference claims the treatment of “an individual” (see, e.g., US’292 at claims 1-7), which is not defined by the claims. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Critically, “an individual” would be readily understood to be defined in a manner including elderly patients that were at least 60 years of age or older (see, e.g., US’292 at col. 5 at lines 50-55, stating “individuals, for example elderly humans; see also id. at col 10 at lines 15-21, noting that “elderly” refers to 60+ year olds). Regarding instant claims 11, 15, 19, 22, and administration of 1-30 mg/kg/day of 5-75% by weight of glycine and N-acetylcysteine, wherein the ratio of glycine:NAC is 1:1 to 1:10,000, the primary reference recites the administration of an “effective amount” (see, e.g., US’292 at claims 1-7), which is not defined by the instant claim. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)). Here, “effective amount” would readily be understood to mean “between about 1 mg/kg and about 30 mg/kg of body weight per day”, wherein glycine and N-acetylcysteine may be in a ratio of 1:1 to 1:10,000, and wherein glycine and N-acetylcysteine may independently comprise 1-99% of the administered amount of the compound (see, e.g., US’292 at col. 13 at lines 44 to col. 14 at line 10).
The issued claims of the primary reference differs from the instant claims as follows: The issued claims of the primary reference (i) do not recite the same intended or expected result as instantly claimed, and (ii) the issued claims do not recite nor require aerobic or weight training exercises to have been performed within an indefinite time span before, during, or after treatment.
Regarding the difference in recitation of a different purpose and different intended or expected results at the instant claims, per MPEP § 2111.04(I), “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”. Here, the issued claims teach the same active method steps as instantly claimed (i.e., oral administration of the same compound to the same or overlapping patient population at the same or overlapping concentration), and therefore would necessarily and inherently result in the same effects as instantly claimed if enabled. The instant claims are presumed fully enabled at this time. Similarly, as explained at MPEP § 2111.02(II), a preamble reciting a purpose or intended use, corresponding only to prior art structures and steps, would be expected to necessarily and inherently yield the same results because the same compounds are administered in the same manner and dosage to the same patient population. Accordingly, although additional advantages of performing a prior art method may be later discovered, additional advantages which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Accordingly, such recitations do not patentably or materially distinguish the instant claims relative to the issued claims. Here, both the inventions of the instant claim set and the issued claim set of US’292 would be obvious to apply and administer to diabetic patients taking metformin.
Regarding the difference at claims 11, 15, 21-21, 23-24 and the requirement for an unspecified amount of aerobic or weight-training exercise before, during, or after an unspecified amount of time relative to administration, the issued claims encompass all possible patients over the age of 60, without limitation (without limitation excluding athletes (i.e., the issued claim scope includes athletes and patients that routinely exercise). Accordingly, the instant claims fail to materially or substantially differentiate the pending claim scope relative to the patient population the issued claims, since they materially and substantially overlap in scope.
If claims 11, 15, 20-21, and 23-24 are interpreted to require a past or concurrent exercise regime as a required method limitation rather than as a description of a patient population, this would not patentably distinguish the instant claims in view of the issued claims and prior art as follows: exercising is a generic recommendation for virtually all patients and has numerous known and expected advantages, well-understood by artisans. Specifically, Elsawy is cited herein to establish that exercise is recommended to elderly patients, including those 65 and over, in order to desirably reduce the incidence of heart disease, stroke, diabetes mellitus, lung disease, Alzheimer disease, hypertension, and cancer (see, e.g., Elsawy at title, abs, Table 1 on 56, passim). Elsawy identifies that both aerobic exercise (see, e.g., Elsawy at abs) and resistance training (see, e.g., Elsawy at abs, 55 at col II at § “Maintaining Function”, 56 at “Sort: Key Recommendations for Practice”, noting that “strength-training” is reasonably synonymous with “resistance training” or “weight training”) are recommended to older adults, wherein the expected benefits are numerous and include at least the benefits enumerated at Table 1 (see, e.g., Elsawy at Table 1 on 56, noting that decreased risk of heat disease, stroke, diabetes type 2, colon cancer, breast cancer, lung cancer, endometrial cancer are reported, as well as improved cardiorespiratory and muscular fitness, reduced depression, improved cognitive function, increased bone density, improved sleep quality, fall prevention, etc., etc. are all art-recognized benefits of exercise). Accordingly, limitations pertaining to exercise appear to simply mirror known and existing art-recommendations for older adults, wherein such limitations have numerous art-recognized benefits. Notably, combining routine and recommended physical exercise as taught and suggested by Elsawy with the therapeutic supplement method taught by the primary reference would be readily understood to desirably and beneficially improve health in such patients, because combining such prior art methods would be predicted and expected to yield the combined benefits of each prior art methodology (i.e., the benefits of both exercise as well as the benefits of glycine/NAC supplements as taught by the primary reference). Regarding instant claims 20, 23, and the requirement for the patient to be an “athlete”, the term “athlete” is not specifically defined on record, and therefore an “athlete”38 is understood to be
A person trained or gifted in exercises or contests involving physical agility, stamina, or strength; a participant in a sport, exercise, or game requiring physical skill39.
Notably, this means that any “participant in a[n] …exercise…requiring physical skill” is an “athlete” (see Dictionary at 1). Accordingly, in the absence of any objective, definite definition supported by the originally filed disclosure providing guidance to the contrary, all individuals participating in aerobic or resistance training as taught by Elsawy are reasonably inferred to be “athletes” in the absence of any additional guidance on record because such patients are “participants in a …exercise…. requiring physical skill” (see Dictionary at 1). Accordingly, individuals exercising as suggested by Elsawy would necessarily fall within the definition of “athlete”.
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)). Here the differences are minimal because the active method steps involving the “hand of man” appear to be identical (or otherwise substantially overlapping) in both claim sets, both claim sets apply to diabetics taking metformin, and otherwise only differ by a requirement for exercise (i.e., a known prior art activity having known benefits) and therefore administering the same compounds to the same (or overlapping patient population) via the same administration route at the same (or overlapping) dosage would be expected and predicted to achieve the same predicted and expected outcomes set forth in the issued claims (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are directed to obvious variants of the representative claims because it is well-within the ordinary skill in the art to perform a known method on a known patient population using a known drug via a known route of administration at a known concentration (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A), (C), (G)). In addition or alternatively, the claimed invention is the use or application of the known techniques of exercise as taught by Elsawy to improve the known and issued method of the primary reference in a known and predictable manner, namely by augmenting the methods of the issued claims with exercise regimens as taught by Elsawy, the issued claims would simply yield the predicted and expected results enumerated at claims 2-11 and additionally provide the benefits attributable to exercise (e.g., reduced incidence of heart disease and stroke, improve bone density, reduce fat, increase muscle mass, and additionally improve cognitive function, improve sleep quality, and reduce incidence of cancers, diabetes, and depression), exactly as taught and suggested by the secondary reference (see, e.g., MPEP § 2143(I)(C), (D), (F), and (G), § 2144.05(I), § 2144.06(I)). In sum, the minor differences cannot be said to patentably distinguish the instant claims relative to the issued claims.
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to overlapping methods of administering the same compounds via the same administration route to the same patient population at the same concentration ranges as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 11, 15, and 19-24 are rejected.
Response to Arguments
Applicant's arguments filed 8/27/2025 have been fully considered but they are not persuasive. Examiner notes that all prior rejections have been withdrawn; all rejections relying upon art previously applied under 35 USC 112 or 103 have been withdrawn and replaced with revised rejections that depend upon one or more references not addressed by the Applicant; the new or revised rejections therefore render the majority of arguments moot. All revisions were necessitated by Applicant’s amendments. Remaining applicable arguments are addressed below.
Regarding arguments pertaining to double-patenting rejections, it is the Examiner’s understanding that Applicant fails to raise specific arguments, but instead asserts that it is premature to file terminal disclaimers (see, e.g., Reply filed 8/27/2025 at 7-8 at bridging ¶, 8 at 1st full ¶). Accordingly, the rejections are maintained as revised above, and all revisions were necessitated by Applicant’s amendments.
It is the Examiner’s understanding that Applicant has addressed all rejections under 35 USC 103 collectively (see, e.g., Reply filed 8/27/2025 at 5 at penultimate ¶ to 7 at 4th ¶), and therefore the arguments are addressed collectively.
It is the Examiner’s understanding that Applicant’s position is that exercise requirements render the claimed invention non-obvious relative to the prior art (see, e.g., Reply filed 8/27/2025 at 5 at final ¶). This is not persuasive because Elsawy et al.40 establishes that exercise was well-known in the prior art and had well-known and expected benefits. Accordingly, the null hypothesis is that combining exercise with prior art glycine/NAC compositions would simply and predictably lead to the combination of art-recognized benefits associated with exercise and also the benefits associated with administration of glycine/NAC compositions. Zero unexpected results commensurate in scope with the requirements set forth at MPEP § 716, § 716.01, and § 716.02 have been placed on record at this time showing any criticality of range or unexpected results dependent upon timing of exercise relative to administration.
It is the Examiner’s understanding that Applicant argues the teachings of the primary references piecemeal and in the absence of consideration of the secondary reference (see, e.g., Reply filed 8/27/2025 at 6 at 1st ¶). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Arguments with respect to US’311 (“McCord”) are moot in view of the withdrawal of the rejection (see, e.g., Reply filed 8/27/2025 at 6 at 2nd to 4th ¶¶).
Allegations suggesting improper or impermissible hindsight: It is the Examiner’s understanding that Applicant is suggesting that the Examiner’s position relies upon improper or impermissible hindsight (see, e.g., Reply filed 8/27/2025 at 7 at 1st ¶). If Applicant means to suggest that the Examiner arrived at the instantly claimed invention via the use of improper hindsight, this is not persuasive because any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Here, Applicant fails to identify a single aspect of the claimed invention that was not taught, disclosed, or suggested by the prior art relied upon by the Examiner. Accordingly, such arguments are not persuasive.
Allegations suggesting the references “teach away”: It is the Examiner’s understanding that Applicant is suggesting that the references “teach away” from the claimed invention in view of the statements alleging that the primary references provide “no reason whatsoever that would have motivated the skilled artisan to modify” the primary references to include exercise requirements (see, e.g., Reply filed 8/27/2025 at 7 at 2nd and 3rd ¶¶). Examiner notes that this argument is not persuasive because none of prior art references at issue “teach away” from the claimed invention since they do not actually “criticize, discredit, or otherwise discourage the solution claimed” (see, e.g., MPEP § 2141.02(VI)). Applicant has not identified any disclosure that “criticizes, discredits, or otherwise discourages the solution claimed”. Accordingly, no “teaching away” has been identified on record.
Allegations suggesting “skepticism of experts”: It is the Examiner’s understanding that Applicant’s statements amount to a suggestion that the Examiner’s position would be met with skepticism of experts (see, e.g., Reply filed 8/27/2025 at 7 at 2nd and 3rd ¶¶, alleging that the primary references provide “no reason whatsoever that would have motivated the skilled artisan to modify” the primary references to include exercise requirements). If Applicant means to suggest the existence of skepticism of experts, such evidence should be filed per MPEP § 716.05 as evidence is required to establish skepticism of experts. In the absence of such evidence, such statements are understood to be unsupported conjecture of counsel. The prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)), and no objective evidence rebutting this presumption has been placed on record to date.
Applicant has a different rationale for arriving at the instant invention: It is the Examiner’s understanding that Applicant identifies that their rationale for arriving at the claimed invention differs from the rationale relied upon by the Examiner to establish obviousness (see, e.g., Reply filed 8/27/2025 at 7 at 2nd and 3rd ¶¶, alleging that the primary references provide “no reason whatsoever that would have motivated the skilled artisan to modify” the primary references to include exercise requirements). Examiner notes that this is not persuasive because an examiner may support a determination of obviousness by relying upon a rationale that differs from the Applicant’s rationale (see, e.g., MPEP § 2144(IV)). Here, the Examiner’s rationales are explicitly identified in the rejection (i.e., MPEP § 2143(I)(A), (C), (D), (F), (G), etc.), but Applicant fails to address or specifically dispute these rationales supporting a determination of obviousness.
Allegations suggesting “lack of predictability” or “lack of reasonable expectation of success”: It is the Examiner’s understanding that Applicant is alleging a lack of predictability or otherwise a lack of reasonable expectation of success (see, e.g., Reply filed 8/27/2025 at 7 at 2nd and 3rd ¶¶). This is not persuasive because the Applicant’s assertions do not reflect the proper legal standards for evaluating predictability. MPEP § 2143.02(II) explains that “[o]bviousness does not require absolute predictability”, but instead clarifies that only “at least some degree of predictability is required” (see, e.g., MPEP § 2143.02(II)). Here, the rejection explicitly addresses predictability and reasonable expectation of success, but Applicant fails to address the explicitly identified predicted and expected results set forth in the rejection. Here, the Examiner’s basis for “predictability” is merely based upon the presumption that the prior art is fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). As explained at MPEP § 2143.02, predictability and reasonable expectation of success are satisfied when “all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art”. Here zero evidence of unexpected results commensurate in scope with the requirements of MPEP 716.02 have been set forth on record, all elements of the claimed invention were known in the prior art, one of ordinary skill was fully enabled to combined each component using routine methods in the biochemical arts per the guidance of the primary reference, and the elements would have merely performed their art-recognized, respective functions (see Rejection, above). Accordingly, such arguments are not persuasive.
Accordingly, all applicable arguments have been fully considered but not found persuasive for reasons set forth above. Therefore, the claims remain rejected in view of the new or revised rejections set forth above, wherein all new or revised rejections were necessitated by Applicants amendments.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10952982 B2 (cited in previous action) claims related materials but has not been applied in a non-statutory double patenting rejection at this time. US’982 at claims 5-6 teaches a substantially similar method, but wherein the dipeptide of N-acetylcysteinylglycine is administered rather than two separate amino acids of NAC and glycine (see, e.g., US’982 at claims 5-6). The instant claims recite two separate elements (i.e., NAC and separately glycine), rather than one element, and therefore the instant claims are understood to not read upon dipeptide formulations at this time.
US20050261367A1 (cited in previous action) tests and discloses patient case studies wherein compositions comprising glycine and NAC are administered to patients over 50 years of age (see, e.g., US’367 at ¶¶[0204]-[0211], [0216]-[0224]).
US8747894 (cited in previous action) pertains to effervescent compositions comprising N-acetylcysteine and sodium glycine carbonate (see, e.g., US’894 at title, abs, claims 1, 15).
WO 99/61038 (Dec. 2, 1999; cited in previous action) teaches and discloses orally administered nutritional supplements comprising N-acetylcysteine and glycine, wherein such compounds are identified to be “Glutathione equivalents” in the art, taught for use at daily amounts of 1,042-4,820 mg and 101-1,288 mg, respectively per day, and identified as useful for the beneficial treatment of depression, libido, liver damage, alcohol desire, etc. (see, e.g., WO’038 at title, abs, claims, p. 15 at Table A).
WO02/087593A1 (Nov. 7, 2002; cited in previous action) discloses a treatment of functional vitamin B12 deficiency, which involves the administration of the glutathione pre-cursor of NAC to a patient over 50 years of age, at 600 mg per day (see, e.g., WO’593 at title, abs, Example 2 at pages 20-29 at patients 1-4). WO’593 identifies glycine and NAC as glutathione precursors (see, e.g., WO’592 at claims 1, 5-6, 18, 26).
US 2011/0077303 A1 (cited in previous action) has a disclosure similar to US 2013/0245121 A1 (Sept. 19, 2013), as applied under 35 USC 103 above, and has been deemed redundant in view of that reference.
US 2011/0034519 A1 (cited in previous action) is understood to be redundant in view of the disclosure of US 8,809,311 B2, discussed below.
US2004/0120983 (Jun. 24, 2004; cited in previous action) discloses nutritional supplements comprising NAC and glycine (see, e.g., id. at title, abs, claims, passim).
US2006/0116334 (Jun. 1, 2006; cited in previous action) discloses nutritional supplements comprising NAC and glycine (see, e.g., id. at title, abs, ¶¶[0046]-[0048]).
US20020136763 (Sep. 26, 2002; cited in previous action) discloses methods of increasing glutathione levels in mammals via oral administration of formulations comprising glutathione (see, e.g., id. at title, abs, claims, passim).
US20130266545 (Oct. 10, 2013; cited in previous action) discloses methods of wound closure utilizing formulations NAC (see, e.g., id. at title, abs, claims, passim).
Elsawy et al. (Physical Activity Guidelines for Older Adults, Am Fam Physician. 2010;81(1):55-59; hereafter “Elsawy”; cited in previous action) is cited herein to establish that exercise is recommended to elderly patients, including those 65 and over, in order to desirably reduce the incidence of heart disease, stroke, diabetes mellitus, lung disease, Alzheimer disease, hypertension, and cancer (see, e.g., Elsawy at title, abs, passim). Accordingly, combining routine and recommended physical exercise with medical regimens would be readily understood to desirably and beneficially improve health in such patients, wherein such exercise would be daily and therefore necessarily within hours or minutes of taking additional medications that the patient may require or need.
US 7,754,700 (Jul. 13, 2010) was previously applied under 35 USC 103 in the Action mailed 5/27/2025 and that disclosure is incorporated herein. In brief, US’700 discloses daily dosage compositions comprising N-acetylcysteine and glycine containing capsules (see, e.g., US’700 at col 9 at lines 1-65; see also id. at col. 8 at lines 30-35), having a total dosage amount of 1,185.685 mg, which may be administered once to three times daily (see id), which would range from a total of 1,185.685 mg to 3,557.055 mg per day (one to three doses). Typical adult humans are understood to weigh between 50-100 kg, which would correspond to a daily dosage range of ~23.7 mg/kg to ~35.57 mg/kg per day (see id., see also MPEP § 2144.05 (explaining that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists). Regarding amended claims 11, 15, 19, 22, and the administration of glycine and NAC in a 1:1 to 1:10,000 weight ratio, US’700 identifies that glycine may be present within the range of 50-750 mg (see, e.g., US’700 at col. 5 at lines 1-5) and that NAC may be present within the range of 100-500 mg (see, e.g., US’700 at col. 4 at lines 5-10). Accordingly, the disclosed range of glycine to NAC includes at least 1:0.5 to 1:10 (i.e., 50:100 mg and 50:500 mg), which overlaps in scope with the instantly claimed range of weight ratios (see also MPEP § 2144.05 (explaining that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists). Accordingly, such limitations do not weigh in favor of non-obviousness in view of the prior art. Regarding amended claims 11, 15, and the administration of glycine and NAC in a composition wherein glycine and NAC constitute 5-75% by weight of the composition, US’700 identifies that all components may vary over ranges (see, e.g., US’700 at col. 3 at line 19 to col. 8 at line 25), and additionally exemplifies the embodiment of Example 1, which comprises both NAC and glycine (see, e.g., US’700 at col 9 at lines 1-65). Notably, Example 1 illustrates an example comprising a total weight of 1,185.685 mg that comprises 150 mg of NAC and 75 mg of glycine (i.e., 225 mg total of NAC+glycine), which constitutes ~19% by weight of the exemplified composition (see, e.g., US’700 at col 9 at lines 1-65), wherein glycine may range from 50-750 mg (see, e.g., US’700 at col. 5 at lines 1-5) and that NAC may range form 100-500 mg (see, e.g., US’700 at col. 4 at lines 5-10). Accordingly, an artisan would readily appreciate that the prior art teaches and exemplifies embodiments comprising over 5% by weight a combination of NAC and glycine. Accordingly, such limitations do not distinguish the claims relative to the prior art. However, US’700 differs from the instant claims because it is directed to the treatment of tinnitus and does not recite nor require performance of an aerobic exercise and/or weight training (i.e., resistance training).
US 8,809,311 B2 (Aug. 19, 2014; filed Aug. 10, 2009; cited in previous action) was previously applied under 35 USC 103 in the Action mailed 5/27/2025 and that disclosure is incorporated herein. US’311 discloses methods of administering a composition comprising NAC and glycine to patients over 50 years of age (see, e.g., US’311 at Example 1 and 2 at col. 11 at line 61 to col. 14 at line 33; see esp. id. at col 12 at lines 32-35 and col. 13 at lines 50-55). US’311 reduces to practice two case-studies involving a 59 year old and a 56 year old (see, e.g., US’311 at Example 1 and 2 at col. 11 at line 61 to col. 14 at line 33; see esp. id. at col 12 at lines 32-35 and col. 13 at lines 50-55), wherein the patients were given four capsules by mouth daily of a formulation comprising NAC and glycine (see id. at col 12 at lines 50-60 and col. 14 at lines 1-10), wherein each patient performed exercise consisting of walking, hiking, raking a lawn, stair climbing, or other exercise before, during, or after taking the capsules on a regular, daily basis (see id. at col 12 at lines 45-51 and 59-66, col. 14 at lines 8-25).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new or revised 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 RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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 G. 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.
/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 See also, MPEP § 2111.04(I), noting that “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”
2 Cited in previous action.
3 Cited in previous action.
4 See also, MPEP § 2111.04(I), noting that “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”
5 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025).
6 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025).
7 Flack et al., Aging, resistance training, and diabetes prevention. J Aging Res. 2010 Dec 15;2011:127315. doi: 10.4061/2011/127315. PMID: 21197110; PMCID: PMC3010636; hereafter “Flack”.
8 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025); hereafter “Dictionary”.
9 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025).
10 Flack et al., Aging, resistance training, and diabetes prevention. J Aging Res. 2010 Dec 15;2011:127315. doi: 10.4061/2011/127315. PMID: 21197110; PMCID: PMC3010636; hereafter “Flack”.
11 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025); hereafter “Dictionary”.
12 The term “athlete” has been rejected as a subjective term under 35 USC 112(b), and is not specifically defined in a manner that meaningfully distinguishes “athletes” from the genus of the prior art as explained in the instant rejection.
13 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025).
14 Elsawy et al. , Physical Activity Guidelines for Older Adults, Am Fam Physician. 2010;81(1):55-59; hereafter “Elsawy”; cited in previous action; hereafter “Elsawy”.
15 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025); hereafter “Dictionary”.
16 The term “athlete” has been rejected as a subjective term under 35 USC 112(b), and is not specifically defined in a manner that meaningfully distinguishes “athletes” from the genus of the prior art as explained in the instant rejection.
17 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025).
18 see, e.g., WO’511 at 3 at 1st ¶ to final ¶.
19 Elsawy et al. , Physical Activity Guidelines for Older Adults, Am Fam Physician. 2010;81(1):55-59; hereafter “Elsawy”; cited in previous action; hereafter “Elsawy”.
20 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025); hereafter “Dictionary”.
21 Additional advantages which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
22 The term “athlete” has been rejected as a subjective term under 35 USC 112(b), and is not specifically defined in a manner that meaningfully distinguishes “athletes” from the genus of the prior art as explained in the instant rejection.
23 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025).
24 Elsawy et al. , Physical Activity Guidelines for Older Adults, Am Fam Physician. 2010;81(1):55-59; hereafter “Elsawy”; cited in previous action; hereafter “Elsawy”.
25 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025); hereafter “Dictionary”.
26 The term “athlete” has been rejected as a subjective term under 35 USC 112(b), and is not specifically defined in a manner that meaningfully distinguishes “athletes” from the genus of the prior art as explained in the instant rejection.
27 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025).
28 Elsawy et al. , Physical Activity Guidelines for Older Adults, Am Fam Physician. 2010;81(1):55-59; hereafter “Elsawy”; cited in previous action; hereafter “Elsawy”.
29 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025); hereafter “Dictionary”.
30 The term “athlete” has been rejected as a subjective term under 35 USC 112(b), and is not specifically defined in a manner that meaningfully distinguishes “athletes” from the genus of the prior art as explained in the instant rejection.
31 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025).
32 Elsawy et al. , Physical Activity Guidelines for Older Adults, Am Fam Physician. 2010;81(1):55-59; hereafter “Elsawy”; cited in previous action; hereafter “Elsawy”.
33 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025); hereafter “Dictionary”.
34 The term “athlete” has been rejected as a subjective term under 35 USC 112(b), and is not specifically defined in a manner that meaningfully distinguishes “athletes” from the genus of the prior art as explained in the instant rejection.
35 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025).
36 Elsawy et al. , Physical Activity Guidelines for Older Adults, Am Fam Physician. 2010;81(1):55-59; hereafter “Elsawy”; cited in previous action; hereafter “Elsawy”.
37 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025); hereafter “Dictionary”.
38 The term “athlete” has been rejected as a subjective term under 35 USC 112(b), and is not specifically defined in a manner that meaningfully distinguishes “athletes” from the genus of the prior art as explained in the instant rejection.
39 “Athlete”, Dictionary.com, 5 pages, also available at https://www.dictionary.com/browse/athlete (last visited 9/26/2025).
40 Elsawy et al. , Physical Activity Guidelines for Older Adults, Am Fam Physician. 2010;81(1):55-59; hereafter “Elsawy”; cited in previous action; hereafter “Elsawy”.
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