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 .
DETAILED ACTION
Claims 2, and 9-14 are canceled. Claims 18-20 are new. Claims 1, 3-8 and 15-20 are pending and under consideration in this action.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The certified copy of EP20382019.6 was received in English on 08/03/2026. Thus, the effective filing date is 01/15/2020.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “and / or” in line 1, which should be replaced with “and/or” because the additional spaces are unnecessary.
Claim 1 recites “LDL” in the last line, which should be replaced with “low-density lipoprotein (LDL)” because LDL is an acronym.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-8 and 15-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amendment filed on 08/03/2026 has introduced new matter into the claims.
Claim 1, as filed on 08/03/2026, recites a method for the treatment and / or reduction of oxidative stress in a subject comprising: administering a composition to the subject in need thereof, the composition comprising the bacteria Lactobacillus rhamnosus, Lactobacillus casei and Bifidobacterium longum, together with one or more food-based and/or pharmaceutically acceptable vehicles and/or excipients, wherein L. rhamnosus is the strain BPL0015 deposited in the Spanish Type Culture Collection under deposit number CECT8361, L. casei is the strain BPL0004 deposited in the Spanish Type Culture Collection under deposit number CECT9104 and B. longum is the strain IATA-ES 1 deposited in the Spanish Type Culture Collection under deposit number CECT7347; and wherein the oxidative stress is associated with molecular damage to lipids or DNA and the composition is configured to reduce at least one of a malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2'-deoxiguanosin level of the subject.
Applicant directs attention to the specification and the figures as originally filed for support, and Applicant asserts that no new matter has been added. See the remarks p. 11 para. 2. However, the specification as filed and the original claims do not provide sufficient written description of the above underlined limitations.
Claim 1 and dependent claims contain new matter because of the limitation requiring the composition to be configured to reduce at least one of a malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2'-deoxiguanosin level of the subject.
The specification as filed and the original claims do not provide support for reducing at least one of a malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2'-deoxiguanosin level of the subject, as recited in amended claim 1. The specification states that the intake by humans of the composition of the invention, preferably daily and for six weeks, decreases the oxidative damage to lipids and DNA resulting from high-intensity and long-duration physical exercise. In particular, levels of serum malondialdehyde and oxidized LDL (indicative of oxidative lipid damage) and urinary 8-oxo 2-deoxyguanosine (indicative of oxidative DNA damage) increased less in subjects that consumed the composition of the invention. See p. 3 lines 22-27. The specification teaches test 1 in which subjects perform 90 minutes of high-intensity physical activity. See p. 17 lines 23-24. After test 1, subjects in the probiotic group begin a 6-week period of probiotic consumption. See p. 17 lines 32-33. Test 2 consists of the same high intensity physical activity performed after the 6-week product consumption. See p. 18 lines 1-3. Figure 2 shows that the increase in serum malondialdehyde during physical exercise is reduced in the probiotic group. See p. 14 lines 29-30. Figure 4 shows that the increase in serum oxidized-LDL during physical exercise for the probiotic group is reduced. See p. 15 lines 1-2. Figure 6 shows that the increase in 8-oxo 2’-deoxiguanosin in urine for 24 hrs during physical activity is reduced for the probiotic group. See p. 15 lines 8-10. In other words, Figs. 2, 4 and 6 do not show that the probiotic reduces levels of serum malondialdehyde, serum oxidized-LDL and -oxo 2’-deoxiguanosin in urine. Rather, Figs. 2, 4 and 6 show that the levels increase, but the amount that the levels increase are reduced as a result of probiotic consumption. Moreover, the specification discloses that that the intake of probiotic decreases the increase in serum malondialdehyde, serum oxidized chol-LDL and 8-oxo 2′-deoxiguanosin in 24-hour urine. See p. 25 lines 9-11. Thus, the specification and the original claims do not provide support for reducing the recited levels.
Such limitations recited in the instant claim 1 and required by the instant claims, which did not appear in the specification or original claims, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in the instant claim. Applicant can remove the new matter limitations from the claims to obviate this rejection.
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 1, 3-8 and 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, as amended, recites that the composition is configured to reduce at least one of a malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2'-deoxiguanosin level of the subject, which is indefinite because it is unclear how the limitation structurally limits the composition. The specification does not describe structural configurations of the claimed composition that reduces a malondialdehyde level, a serum oxidized LDL level, or an 8-oxo 2'-deoxiguanosin level of a subject. MPEP 2181(II)(A) indicates that if there is no disclosure of structure, material or acts for performing the recited function, the claim fails to satisfy the requirements of 35 U.S.C. 112(b)
Claims 3-8 and 15-20 depend from claim 1 and are rejected for the reason set forth above.
Claims 18-20 are indefinite because the claims recite a function without reciting a particular structure, material or step associated with the function. See MPEP 2173.05(g). Claim 18 recites the composition is configured to reduce an overall increase in the malondialdehyde level during the physical activity. Claim 19 recites the composition is configured to reduce an overall increase in the serum oxidised LDL level during the physical activity. Claim 20 recites the composition is configured to reduce an overall increase in the 8-oxo 2’-deoxiguanosin level during the physical activity. It is unclear how the compositions recited in claims 18-20 are required to be structurally configured. The instant specification discloses a 6-week dosing regimen of a composition that consists of a mixture of L. rhamnosus BPL0015 (CECT8361) (45%), L. casei BPL0004 (CECT9104) (45%), and B. longum IATA-ES1 (CECT7347) (10%) where the final product contains 109 CFU/capsule. See p. 16 lines 20-26. The specification indicates that the 6-week dosing regimen of the composition reduces the overall increases in serum malondialdehyde, serum oxidized chol-LDL and 8-oxo 2′-deoxiguanosin levels. See p. 25 lines 9-11. However, it is unclear whether claims 18-20 intend to limit the composition configuration to this embodiment described in the specification. As such, one of ordinary skill in the art cannot ascertain the metes and bounds of the required composition configurations of claims 18-20.
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 18-20 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.
Claims 18-20 fail to include all the limitations of the claim upon which they depend. Claims 18-20 separately depend from claim 15, which in turn depends from claim 1. Claim 1 requires the composition to be configured to reduce at least one of a malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2’-deoxiguanosin level of the subject. Claim 18 recites the composition is configured to reduce an overall increase in the malondialdehyde level during the physical activity. Claim 19 recites the composition is configured to reduce an overall increase in the serum oxidised LDL level during the physical activity. Claim 20 recites the composition is configured to reduce an overall increase in the 8-oxo 2’-deoxiguanosin level during the physical activity. Claims 18-20 encompass embodiments in which there is an overall increase in a malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2’-deoxiguanosin level, respectively. Therefore, claims 18-20 are of improper dependent form for failing to further limit the subject matter of the claim upon which they depend.
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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-8 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lopéz (EP 3 222 282 A1 published 09/27/2017; hereafter Lopéz (2017)) in view of Lopéz (EP 3 272 396 A1 published 01/24/2018; hereafter Lopéz (2018)), Zhou (Free Radical Biology and Medicine, 2009, 47(7), 891-905), Ji (Oxidative Medicine and Cellular Longevity, 2016, 2721469, 8 pages), and Román (Francisco Clinicaltrials.gov, NIH, 10 Jan. 2019).
Regarding claim 1, Lopéz (2017) teaches a probiotic composition comprising Bifidobacterium longum CECT7347 and Lactobacillus rhamnosus CECT8361. See claims 1-2 of Lopéz (2017). The composition comprises a pharmaceutically acceptable carrier. See claim 5 of Lopéz (2017). Examples of pharmaceutically acceptable carriers include gelatin. See [0027]. The probiotic composition further comprises a microorganism selected from a group that includes Lactobacillus. See claim 11 of Lopéz (2017). Lopéz (2017) teaches an embodiment in which the Lactobacillus is L. casei. See [0040]. Lopéz (2017) teaches administering a single daily tablet of the probiotic composition to plaque psoriasis patients. See example 2 paragraphs [0085]-[0092].
Lopéz (2017) does not teach L. casei CECT9104.
Lopéz (2018) teaches a probiotic composition that comprises L. casei CECT 9104 and B. longum CECT 7347. See claims 1-2, and 15 and paragraphs [0030-0032]. The composition comprises a pharmaceutically acceptable carrier. See claim 4 of Lopéz (2018). Examples of pharmaceutically acceptable carriers include gelatin. See [0042]. Lopéz (2018) teaches a composition that further comprises a microorganism selected from a group that includes Lactobacillus. See claim 10 of Lopéz (2018). Lopéz (2018) teaches an embodiment in which the Lactobacillus is L. rhamnosus. See [0055]. Lopéz (2018) teaches dosing atopic dermatitis patients with one capsule of the probiotic composition per day. See example 2 [0088]-[0096].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine the L. casei CECT 9104 of Lopéz (2018) with the probiotic composition of Lopéz (2017). One would be motivated to do so because Lopéz (2017) teaches an embodiment in which the probiotic composition further comprises L. casei. There would be a reasonable expectation of success because Lopéz (2018) teaches an L. casei strain (CECT 9104) that can be used in combination with B. longum CECT 7347 (i.e. the same B. longum strain as Lopéz (2017)) and L. rhamnosus.
Lopéz (2017) and Lopéz (2018) do not teach administering the composition to a subject in need of treatment and/or reduction of oxidative stress, wherein the oxidative stress is associated with molecular damage to lipids or DNA.
Zhou discloses that reactive oxygen species (ROS) play a role in the pathogenesis of psoriasis; and that skin is a major target of oxidative stress due to ROS. See the abstract and the last paragraph on page 900 of Zhou. Zhou discloses that ROS-mediated oxidative stress is involved in a vast number of biological responses causing DNA modification and lipid peroxidation (i.e. lipid damage). See p. 892 left column para. 4. Therefore, Zhou suggests that psoriasis (i.e. the same disease taught by Lopéz (2017)) is associated with ROS, and that oxidative stress is associated with molecular damage to lipids or DNA.
Ji teaches that oxidative stress is a factor in the pathogenesis of atopic dermatitis. See lines 1-2 of the conclusion section on page 6. Ji states that oxidative stress can directly cause damage to epidermal keratinocytes by DNA damage, damage of cellular enzymes, or damage to cell membrane structures through lipid oxidation. See p. 4 left column last passage. Therefore, Ji suggests that atopic dermatitis (i.e. the same disease taught by Lopéz (2018)) is associated with oxidative stress, and oxidative stress is associated with molecular damage to lipids or DNA.
Román teaches evaluating the antioxidant efficacy of a product probiotic and determining the efficacy of the investigational product versus placebo in reducing oxidative stress during the performance of a physical exercise of a certain intensity and duration. See the title on page 1 and the brief summary section on page 4. Román teaches a dietary supplement consisting of Lactobacillus rhamnosus, Lactobacillus casei, and Bifidobacterium longum. See the intervention/ treatment section on page 2. Román discloses that the dietary supplement is formulated into a capsule. See the left column on page 6. Furthermore, Román teaches analyzing 8-oxo 2'-deoxyguanosine in 24-hour urine at the beginning and at six weeks of consumption of the product. Román teaches analyzing malondialdehyde in plasma at the beginning and at six weeks of consumption of the product. Román teaches a blood analysis of oxidized LDL at the beginning and at six weeks of consumption of the product. See numbers 1, 3 and 5-6 of the secondary outcome measures section spanning pgs. 6-7.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to substitute the L. rhamnosus CECT 8361 Lopéz (2017), the L. casei CECT 9104 of Lopéz (2018), and the B. longum CECT 7347 taught by Lopéz (2017) and Lopéz (2018) for Roman’s L. rhamnosus, L. casei and B. longum used in Román’s method of reducing oxidative stress. One would be motivated to use the specific strains of Lopéz (2017) and Lopéz (2018), because Zhou and Ji suggest using the strains of Lopéz (2017) and Lopéz (2018) for treating diseases associated with oxidative stress. There would be a reasonable expectation of success because Román teaches formulating a composition comprising L. rhamnosus, L. casei and B. longum. Thus, one would reasonably expect the L. rhamnosus CECT 8361, L. casei CECT 9104 and B. longum CECT 7347 to serve the same function in the composition of Román in the same field of reducing oxidative stress.
Lopéz (2017), Lopéz (2018), Zhou, Ji, and Román do not teach the composition is configured to reduce at least one of a malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2’-deoxiguanosin level of the subject. However, Román teaches measuring oxidative damage to DNA by analyzing 8-oxo 2'-deoxyguanosine, measuring oxidative damage to lipids by analyzing malondialdehyde in plasma, and measuring oxidized LDL.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention that the composition of Lopéz (2017) and Lopéz (2018) is configured to reduce at least one of a malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2’-deoxiguanosin level of the subject. MPEP 2112.01(II) states that "products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 3, Lopéz (2017) teaches a L. rhamnosus concentration that is at least 30%. See [0046] and [0057].
Lopéz (2018) teaches a B. longum CECT7347 concentration of 10% and a L. casei CECT 9104 concentration of 45%. See [0060].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to optimize the concentrations of the L. rhamnosus CECT8361, B. longum CECT7347 and L. casei CECT 9104 strains in the composition of Lopéz (2017) and Lopéz (2018). One would be motivated to do so because Lopéz (2017) and Lopéz (2018) suggests that the probiotics should be present in a therapeutically effective amount so that they can exert their effect. See [0042] of Lopéz (2017) and [0057] of Lopéz (2018). There would be a reasonable expectation of success because both references provide starting concentrations from which one could reasonably optimize. MPEP 2144.05(II) indicates that differences in concentration generally amount to “routine optimization” and will not support patentability unless there is evidence indicating the claimed feature is critical. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, Lopéz (2017) teaches a microorganism concentration in the composition between 103 and 1012 cfu, preferably 109 cfu. See [0044] and [0059].
Lopéz (2018) teaches a total concentration of microorganisms of microorganisms of L. casei CECT 9104 and/or B. longum CECT7347 in the composition between 103 and 1012 cfu, preferably 109 cfu. See [0059].
Regarding claim 5, Lopéz (2017) teaches a probiotic composition formulated as a nutritional composition, said nutritional composition may be a food. See [0034]. Lopéz (2017) teaches pharmaceutically acceptable carriers including gelatin. See [0027].
Lopéz (2018) teaches pharmaceutically acceptable carriers including gelatine. See [0042]. The probiotic composition may be formulated for pharmaceutical administration, i.e., forming part of pharmaceutical products to be administered to the subject orally and/or for food administration. See [0036].
Although Lopéz (2017), Lopéz (2018), Zhou, Ji, and Román do not explicitly state “food gels”, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention that the probiotic formulations taught by Lopéz (2017) and Lopéz (2018) can be formulated into food gels, because Lopéz (2017) and Lopéz (2018) teach probiotic food formulations and suggest that the probiotic can be combined with a gelatin carrier.
Regarding claim 6, Lopéz (2017) teaches a probiotic composition to be administered to a subject orally. See [0021], [0032] and [0096].
Lopéz (2018) teaches a probiotic composition to be administered to a subject orally. See [0036], [0047] and [0091]-[0093].
Regarding claim 7, Lopéz (2017) teaches a composition formulated in solid form. See claim 6 of Lopéz (2017).
Lopéz (2018) teaches a composition formulated in solid form. See claim 5 of Lopéz (2018).
Regarding claim 8, Lopéz (2017) teaches a solid formulation selected from a group that includes capsules See claim 7 of Lopéz (2017).
Lopéz (2018) teaches a solid formulation selected from a group that includes capsules See claim 6 of Lopéz (2018).
Regarding claim 15, Román teaches a study for determining the efficacy of the investigational product (i.e. the dietary supplement) in reducing oxidative stress during the performance of a physical exercise. See the brief summary section. The primary purpose of the study plan is for treatment. See page 5. Román teaches a study population comprised of subjects that perform physical exercise (e.g. subjects in need thereof). See the inclusion criteria section.
Regarding claim 16-17, Román teaches a study design that includes the consumption of one dietary supplement capsule at breakfast for six weeks. See the left column on page 6.
Regarding claim 18, Román teaches reducing oxidative stress during the performance of a physical exercise. See p. 4 the brief summary section. Román teaches analyzing malondialdehyde in plasma at the beginning and at six weeks of consumption of the product. See number 3 of the secondary outcome measures section spanning pgs. 6-7.
Lopéz (2017), Lopéz (2018), Zhou, Ji, and Román do not explicitly teach a composition configured to reduce an overall increase in malondialdehyde level during activity.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention that the composition of Lopéz (2017) and Lopéz (2018) is configured to reduce an overall increase in malondialdehyde level during activity. MPEP 2112.01(II) states that "products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 19, Román teaches reducing oxidative stress during the performance of a physical exercise. See p. 4 the brief summary section. Román teaches a blood analysis of oxidized LDL at the beginning and at six weeks of consumption of the product. See number 6 of the secondary outcome measures section on p. 7.
Lopéz (2017), Lopéz (2018), Zhou, Ji, and Román do not explicitly teach a composition configured to reduce an overall increase in serum oxidized LDL level during activity.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention that the composition of Lopéz (2017) and Lopéz (2018) is configured to reduce an overall increase in serum oxidized LDL level during activity. MPEP 2112.01(II) states that "products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 20, Román teaches reducing oxidative stress during the performance of a physical exercise. See p. 4 the brief summary section. Román teaches analyzing 8-oxo 2'-deoxyguanosine in 24-hour urine at the beginning and at six weeks of consumption of the product. See number 1 of the secondary outcome measures section on p. 6.
Lopéz (2017), Lopéz (2018), Zhou, Ji, and Román do not explicitly teach a composition configured to reduce an overall increase in 8-oxo 2'-deoxyguanosine level during activity.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention that the composition of Lopéz (2017) and Lopéz (2018) is configured to reduce an overall increase in 8-oxo 2'-deoxyguanosine level during activity. MPEP 2112.01(II) states that "products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Response to Arguments
Applicant's arguments filed 08/03/2026 have been fully considered to the extent that they might apply to the new grounds of rejection set forth above, but they are unpersuasive.
Applicant argues that Lopéz (2017) and Lopéz (2018) fail to disclose the claim limitations. Zhou, Ji, and Román fail to address the shortcomings of Lopéz (2017) and Lopéz (2018). Even though Román discusses measuring malondialdehyde, oxidized LDL and 8-oxo 2’-deoxiguanosin, there is no speculation on the future results or that those biomarkers would be reduced during the trial. As such, Román cannot reasonably be interpreted as disclosing “the composition is configured to reduce at least one of malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2’-deoxiguanosin level of the subject”. See the remarks, the paragraph spanning pgs. 8-9.
This argument is not persuasive because the fact that applicant has recognized another advantage 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. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Lopéz (2017), Lopéz (2018), Zhou, Ji and Román teach every required structural element recited in claim 1. Applicant argues that the prior art references do not teach a composition configured to reduce at least one of malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2’-deoxiguanosin level of the subject. However, Applicant has not pointed to a claimed structural element associated with such level reductions. MPEP 2112.01(II) states that "products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the composition of Lopéz (2017) and Lopéz (2018), which is structurally indistinguishable from the claimed composition, is capable of reducing the required levels when administered in accordance with the active method steps taught by Román.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-8 and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,434,127 B2 to Rodríguez (hereafter Rodríguez ‘127) in view of Lopéz (EP 3 272 396 A1, published 01/24/2018, hereafter Lopéz 2018) and Román (Francisco Clinicaltrials.gov, NIH, 10 Jan. 2019).
Claim 1 of Rodríguez ‘127 recites a formulation comprising the strains Lactobacillus rhamnosus CECT 8361 and Bifidobacterium longum CECT 7347, the combination of which is able to improve semen quality, and a carrier and/or an excipient.
Claim 2 of Rodríguez ‘127 recites the formulation according to claim 1, wherein the Lactobacillus rhamnosus CECT 8361: Bifidobacterium longum CECT 7347 ratio is 50:50.
Claim 3 of Rodríguez ‘127 recites the formulation according to claim 1, wherein the formulation is a pharmaceutical formulation or a functional nutritional formulation.
Claim 4 of Rodríguez ‘127 recites the formulation according to claim 3, wherein the pharmaceutical formulation comprises a pharmaceutically acceptable carrier and/or excipient.
Claim 5 of Rodríguez ‘127 recites the formulation according to claim 3, wherein the pharmaceutical formulation is suitable for oral administration.
Claim 6 of Rodríguez ‘127 recites the formulation according to claim 3, wherein the nutritional formulation is a functional food or a nutritional supplement.
Claim 7 of Rodríguez ‘127 recites the formulation according to claim 6, wherein the food is selected from the group consisting of a dairy product, a meat product, a vegetable product, an animal feed and a beverage.
Claim 8 of Rodríguez ‘127 recites the formulation according to claim 1, wherein the total concentration of microorganisms of the strains Lactobacillus rhamnosus CECT 8361 and Bifidobacterium longum CECT 7347 in the formulation is between 106 and 1012 cfu.
Claim 9 of Rodríguez ‘127 recites the formulation according to claim 1, wherein the strains Lactobacillus rhamnosus CECT 8361 shows greater antioxidant activity than other strains of Lactobacillus, wherein greater antioxidant activity means that Lactobacillus rhamnosus CECT 8361 affords cells greater protection against oxidative stress than other strains of Lactobacillus.
Claim 10 of Rodríguez ‘127 recites the formulation of claim 8, wherein the total concentration of microorganisms of the strains Lactobacillus rhamnosus CECT 8361 and Bifidobacterium longum CECT 7347 in the formulation is 109 cfu.
Claim 11 of Rodríguez ‘127 recites the method for improving semen quality in a subject comprising administering to a subject a formulation comprising a Lactobacillus rhamnosus strain CECT 8361 in combination with a Bifidobacterium longum strain CECT 7347 and a carrier and/or excipient.
Claim 12 of Rodríguez ‘127 recites the method according to claim 11, wherein the Lactobacillus rhamnosus: Bifidobacterium longum ratio is 50:50.
Claim 13 of Rodríguez ‘127 recites the method according to claim 11, wherein the formulation is a pharmaceutical formulation or a functional nutritional formulation.
Claim 14 of Rodríguez ‘127 recites the method according to claim 13, wherein the pharmaceutical formulation comprises a pharmaceutically acceptable carrier and/or excipient.
Claim 15 of Rodríguez ‘127 recites the method according to claim 13, wherein the pharmaceutical formulation is developed for oral administration.
Claim 16 of Rodríguez ‘127 recites the method according to claim 13, wherein the functional nutritional formulation is a food or a nutritional supplement.
Claim 17 of Rodríguez ‘127 recites the method according to claim 16, wherein the food is selected from the group consisting of a dairy product, a meat product, a vegetable product, an animal feed and a beverage.
Claim 18 of Rodríguez ‘127 recites the method according to claim 11, wherein the subject is a fish or a mammal.
Claim 19 of Rodríguez ‘127 recites the method according to claim 11, wherein the microorganisms of the strains Lactobacillus rhamnosus and Bifidobacterium longum in the formulation are administered at a dose of between 106 and 1012 cfu/day.
Claim 20 of Rodríguez ‘127 recites the method according to claim 19, wherein the microorganisms of the strains Lactobacillus rhamnosus and Bifidobacterium longum in the formulation are administered at a dose of 109 cfu/day.
Claim 21 of Rodríguez ‘127 recites the method according to claim 11, wherein the dosage of the formulation is at least once a day.
The instant claims differ from the patent claims of Rodríguez ‘127 in that the patent claims of Rodríguez ‘127 lack: a method for the treatment and/or reduction of oxidative stress in a subject comprising: administering a composition to the subject in need thereof; the composition comprising Lactobacillus casei deposit number CECT9104; and wherein the oxidative stress is associated with molecular damage to lipids or DNA and the composition is configured to reduce at least one malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2’-deoxiguanosin level of the subject (relevant to instant claim 1); L. rhamnosus at a concentration of 45%, L. casei at a concentration of 45% and B. longum at a concentration of 10% (relevant to instant claim 3); wherein the one or more food-based acceptable vehicles are smoothies or food gels (relevant to instant claim 5); a solid form (relevant to instant claim 7); and a composition presented in capsule form (relevant to instant claim 8). The patent claims of Rodríguez ‘127 lack: oxidative stress caused by physical activity (relevant to instant claim 15); and a composition that is administered for 6 weeks (relevant to instant claim 17). The patent claims of Rodríguez ‘127 lack a composition configured to reduce an overall increase in the: malondialdehyde level during the physical activity (relevant to instant claim 18); serum oxidized LDL level during the physical activity (relevant to instant claim 19); and the 8-oxo 2’-deoxiguanosin level during physical activity (relevant to instant claim 20).
However, Lopéz 2018 teaches a probiotic composition comprising L. casei CECT 9104 and further comprising a pharmaceutically acceptable carrier. See claims 1-2 of Lopéz 2018. Román teaches administering a composition comprising B. longum, L. casei, and L. rhamnosus for the purpose of treating oxidative stress. See the brief summary section. Román teaches analyzing 8-oxo 2'-deoxyguanosine, malondialdehyde in plasma and oxidized LDL. See the secondary outcome measures section spanning pgs. 6-7 (relevant to instant claims 1 and 18-20). Lopéz 2018 teaches a L. casei strain CECT 9104 concentration of 45%, and B. longum CECT 7347 concentration of 10% [0060] (relevant to instant claim 3). Lopéz 2018 teaches examples of carriers including gelatin [0042] (relevant to instant claim 5). Lopéz 2018 teaches solid formulations selected from a group that includes capsules. See claim 6 of Lopéz 2018 (relevant to instant claims 7-8). Román teaches treating oxidative stress during the performance of a physical exercise. See the brief summary section and pages 5-6 (relevant to instant claim 15). Román teaches a study design that includes the consumption of one dietary supplement capsule at breakfast for six weeks. See the left column on page 6 (relevant to instant claim 17).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the formulation recited in the patent claims of Rodríguez ‘127 by adding the L. casei CECT 9104 and gelatin of Lopéz 2018, and by further administering that formulation for 6 weeks, as taught by Román, for the purpose of treating oxidative stress caused by physical activity.
Claims 1, 3-8 and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,912,802 B2 to Lopéz (hereafter Lopéz ‘802) in view of Lopéz (EP 3 272 396 A1, published 01/24/2018, hereafter Lopéz 2018) and Román (Francisco Clinicaltrials.gov, NIH, 10 Jan. 2019).
Claim 1 of Lopéz ‘802 recites a probiotic composition comprising microorganisms of Bifidobacterium animalis subs. lactis (B. lactis), Bifidobacterium longum and Lactobacillus rhamnosus, wherein the concentration of B. longum with respect to the total concentration of microorganisms present in the composition is at least 30%, wherein B. lactis is B. lactis CECT 8145, B. longum is B. longum ES1 CECT 7347 and L. rhamnosus is L. rhamnosus CECT 8361.
Claim 2 of Lopéz ‘802 recites a method for the treatment or prevention of psoriasis outbreaks or psoriasis comprising administering to a subject in need thereof an effective amount of a probiotic composition comprising Bifidobacterium animalis subsp. lactis (B. lactis), Bifidobacterium longum and Lactobacillus rhamnosus, wherein B. lactis is B. lactis CECT 8145 is, B. longum is B. longum ES1 CECT 7347 and/or L. rhamnosus is L. rhamnosus CECT 8361.
Claim 4 of Lopéz ‘802 recites the method according to claim 2, wherein the probiotic composition is a pharmaceutical composition or a nutritional composition.
Claim 5 of Lopéz ‘802 recites the method according to claim 4, wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier and/or an excipient.
Claim 6 of Lopéz ‘802 recites the method according to claim 4, wherein the pharmaceutical composition is formulated for administration in liquid form or in solid form.
Claim 7 of Lopéz ‘802 recites the method according to claim 6, wherein the solid formulation is selected from the group consisting of tablets, lozenges, sweets, chewable tablets, chewing gum, capsules, sachets, powders, granules, coated particles or coated tablets, tablets and gastro-resistant tablets and capsules and dispersible strips and films.
Claim 9 of Lopéz ‘802 recites the method according to claim 4, wherein the nutritional composition is a food or a nutritional supplement.
Claim 10 of Lopéz ‘802 recites the method according to claim 9, wherein the food is selected from the group consisting of fruit or vegetable juices, ice cream, infant formula, milk, yogurt, cheese, fermented milk, milk powder, cereals, baked goods, milk-based products, meat products and beverages.
Claim 11 of Lopéz ‘802 recites the method according to claim 2, wherein the composition further comprises a microorganism selected from the group consisting of Lactobacillus sp., Streptococcus sp., Bifidobacterium sp., Saccharomyces sp., Kluyveromyces sp. and combinations thereof.
Claim 12 of Lopéz ‘802 recites the method according to claim 2, wherein the total concentration of microorganisms of the strains B. lactis, L. rhamnosus and B. longum in the composition is between 103 and 1012 cfu.
Claim 13 of Lopéz ‘802 recites the method according to claim 2, wherein the concentration of B. longum with respect to the total concentration of microorganisms present in the composition is at least 30%.
The instant claims differ from the patent claims of Lopéz ‘802 in that Lopéz ‘802 lacks: a method for the treatment and/or reduction of oxidative stress in a subject comprising: administering a composition to the subject in need thereof; the composition comprising Lactobacillus casei deposit number CECT9104; and wherein the oxidative stress is associated with molecular damage to lipids or DNA and the composition is configured to reduce at least one malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2’-deoxiguanosin level of the subject (relevant to instant claim 1); the L. rhamnosus at a concentration of 45%, the L. casei at a concentration of 45% and the B. longum at a concentration of 10% (relevant to instant claim 3); and wherein the one or more food-based acceptable vehicles are smoothies or food gels (relevant to instant claim 5). The patent claims of Lopéz ‘802 lack: oxidative stress caused by physical activity (relevant to instant claim 15); and a composition that is administered for 6 weeks (relevant to instant claim 17). The patent claims of Lopéz ‘802 lack a composition configured to reduce an overall increase in the: malondialdehyde level during the physical activity (relevant to instant claim 18); serum oxidized LDL level during the physical activity (relevant to instant claim 19); and the 8-oxo 2’-deoxiguanosin level during physical activity (relevant to instant claim 20).
However, Lopéz 2018 teaches a probiotic composition comprising L. casei CECT 9104 and further comprising a pharmaceutically acceptable carrier. See claims 1-2 and of Lopéz (2018). Román teaches administering a composition comprising B. longum, L. casei, and L. rhamnosus for the purpose of treating oxidative stress. See the brief summary section. Román teaches analyzing 8-oxo 2'-deoxyguanosine, malondialdehyde in plasma and oxidized LDL. See the secondary outcome measures section spanning pgs. 6-7 (relevant to instant claims 1 and 18-20). Lopéz 2018 teaches that the concentration of L. casei strain CECT 9104 at a concentration of 45%, and B. longum CECT 7347 at a concentration of 10% [0060] (relevant to instant claim 3). Lopéz 2018 teaches examples of carriers including gelatin [0042] (relevant to instant claim 5). Román teaches treating oxidative stress during the performance of a physical exercise. See the brief summary section and pages 5-6 (relevant to instant claims 15). Román teaches a study design includes the consumption of one dietary supplement capsule at breakfast for six weeks. See the left column on page 6 (relevant to instant claim 17).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the formulation recited in the patent claims of Lopéz ‘802 by adding the L. casei CECT 9104 and gelatin of Lopéz 2018, and by further administering that formulation for 6 weeks, as taught by Román, for the purpose of treating oxidative stress caused by physical activity.
Claims 1, 3-8 and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,576,116 B2 to Lopéz (hereafter Lopéz ‘802) in view of Lopéz (EP 3 272 396 A1, published 01/24/2018, hereafter Lopéz 2018) and Román, Francisco Clinicaltrials.gov, NIH, 10 Jan. 2019. This rejection is no longer provisional because application no. 16/318,684, previously referred to as Lopéz ‘684, became U.S. Patent No. 12,576,116 on 03/17/2026.
Patent claim 1 recites a probiotic composition comprising Bifidobacterium animalis subsp. lactis (B. lactis), Bifidobacterium longum and Lactobacillus casei, wherein B. lactis is B. lactis CECT 8145, B. longum is B. longum CECT 7347 and L. casei is L. casei CECT 9104, wherein B. longum concentration is 35% with respect to the total concentration of microorganisms present in the composition; B. lactis concentration is 35% with respect to the total concentration of microorganisms, and L. casei concentration is 30% with respect to the total concentration of microorganisms; the total concentration of microorganisms of the strains B. lactis, L. casei and B. longum in the composition is from 107 cfu to 108 cfu, and the probiotic composition is a food selected from the group consisting of fruit or vegetable juices and infant formula.
The instant claims differ from the patent claims in that the patent claims lack: a method for the treatment and/or reduction of oxidative stress in a subject comprising: administering a composition to the subject in need thereof; the composition comprising Lactobacillus rhamnosus CECT 8361, and wherein the oxidative stress is associated with molecular damage to lipids or DNA and the composition is configured to reduce at least one malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2’-deoxiguanosin level of the subject (relevant to instant claim 1); L. rhamnosus at a concentration of 45%, L. casei at a concentration of 45% and B. longum at a concentration of 10% (relevant to instant claim 3); wherein the one or more food-based acceptable vehicles are smoothies or food gels (relevant to instant claim 5); and the composition in capsule form (relevant to instant claim 8). The patent claims lack: oxidative stress caused by physical activity (relevant to instant claim 15); and a composition that is administered for 6 weeks (relevant to instant claim 17). The patent claims lack a composition configured to reduce an overall increase in the: malondialdehyde level during the physical activity (relevant to instant claim 18); serum oxidized LDL level during the physical activity (relevant to instant claim 19); and the 8-oxo 2’-deoxiguanosin level during physical activity (relevant to instant claim 20).
However, Lopéz 2018 teaches a probiotic composition comprising L. rhamnosus CECT 8361 and further comprising a pharmaceutically acceptable carrier. See claims 1-2 and 5 of Lopéz 2018. Román teaches administering a composition comprising B. longum, L. casei, and L. rhamnosus for the purpose of treating oxidative stress. See the brief summary section. Román teaches analyzing 8-oxo 2'-deoxyguanosine, malondialdehyde in plasma and oxidized LDL. See the secondary outcome measures section spanning pgs. 6-7 (relevant to instant claims 1 and 18-20). Lopéz 2018 teaches L. rhamnosus at a concentration of at least 30%. See [0044] (relevant to instant claim 3). Lopéz 2018 teaches a total concentration of 109 cfu. See paragraphs [0044], [0059] (relevant to instant claim 4). Lopéz 2018 teaches gelatine as an example of a carrier [0027] (relevant to instant claim 5). Lopéz 2018 teaches solid formulations selected from a group that includes capsules. See claim 7 of Lopéz 2018 (relevant to instant claim 7-8). Román teaches treating oxidative stress during the performance of a physical exercise. See the brief summary section and pages 5-6 (relevant to instant claims 15). Román teaches a study design includes the consumption of one dietary supplement capsule at breakfast for six weeks. See the left column on page 6 (relevant to instant claim 17).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the probiotic composition recited in patent claim 1 by adding the L. rhamnosus CECT 8361 and gelatine of Lopéz (2017), by further optimizing the percentage of each strain and by further administering that formulation for 6 weeks, as taught by Román, for the purpose of treating oxidative stress caused by physical activity.
Claims 1, 3-8 and 15-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-11 and 16 of copending Application No. 17/888,317 (hereafter Lopéz ‘317; effective filing date of 07/18/2016) in view of Lopéz (EP 3 222 282 A1, published 09/27/2017, hereafter Lopéz 2017) and Román, Francisco Clinicaltrials.gov, NIH, 10 Jan. 2019.
This is a provisional nonstatutory double patenting rejection.
Claim 1 of Lopéz ‘317 recites a method for the treatment and/or prevention of atopic dermatitis comprising administering to a subject in need thereof an effective amount of a probiotic composition comprising a therapeutically effective amount of Bifidobacterium animalis subsp. lactis (B. lactis), Bifidobacterium longum and Lactobacillus casei, wherein B. lactis is B. lactis CECT 8145, B. longum is B. longum CECT 7347 and L. casei is L. casei CECT 91042 wherein B. longum concentration is 35% with respect to the total concentration of microorganisms present in the composition; B. lactis concentration is 35% with respect to the total concentration of microorganisms; and L. casei concentration is at 30% with respect to the total concentration of microorganisms; and wherein the total concentration of microorganisms of the strains B. lactis, L. casei and B.longum in the composition is from 107 to 108 cfu/mL.
Claim 2 of Lopéz ‘317 recites the method according to claim 1 wherein the probiotic composition is a pharmaceutical composition or a nutritional composition.
Claim 3 of Lopéz ‘317 recites the method according to claim 2 wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier and/or an excipient.
Claim 4 of Lopéz ‘317 recites the method according to claim 2, wherein the pharmaceutical composition is formulated for administration in liquid form or in solid form.
Claim 5 of Lopéz ‘317 recites the method according to claim 4, wherein the solid form is selected from the group consisting of tablets, lozenges, sweets, chewable tablets, chewing gum, capsules, sachets, powders, granules, coated particles or coated tablets, tablets and gastro-resistant tablets and capsules and dispersible strips and/or films.
Claim 6 of Lopéz ‘317 recites the method according to claim 4, wherein the liquid form is selected from the group consisting of oral solutions, suspensions, emulsions and syrups.
Claim 7 of Lopéz ‘317 recites the method according to claim 2, wherein the nutritional composition is a food or a nutritional supplement.
Claim 8 of Lopéz ‘317 recites the method according to claim 7, wherein the food is selected from the group consisting of fruit or vegetable juices, ice cream, infant formula, milk, yogurt, cheese, fermented milk, milk powder, cereals, baked goods, milk-based products, meat products and beverages.
The instant claims differ from the copending claims of Lopéz ‘317 in that the copending claims of Lopéz ‘317 lack: a method for the treatment and/or reduction of oxidative stress in a subject comprising: administering a composition to the subject in need thereof; the composition comprising Lactobacillus rhamnosus CECT 8361 and wherein the oxidative stress is associated with molecular damage to lipids or DNA and the composition is configured to reduce at least one malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2’-deoxiguanosin level of the subject (relevant to instant claim 1); L. rhamnosus at a concentration of 45%, L. casei at a concentration of 45% and B. longum at a concentration of 45% (relevant to instant claim 3); 109 CFU total amount of bacteria (relevant to instant claim 4); and wherein the one or more food-based acceptable vehicles are smoothies or food gels (relevant to instant claim 5). The copending claims of Lopéz ‘317 lack: oxidative stress caused by physical activity (relevant to instant claim 15); and a composition that is administered for 6 weeks (relevant to instant claim 17). The copending claims of Lopéz ‘317 lack a composition configured to reduce an overall increase in the: malondialdehyde level during the physical activity (relevant to instant claim 18); serum oxidized LDL level during the physical activity (relevant to instant claim 19); and the 8-oxo 2’-deoxiguanosin level during physical activity (relevant to instant claim 20).
However, Lopéz 2017 teaches a probiotic composition comprising L. rhamnosus CECT 8361 and further comprising a pharmaceutically acceptable carrier. See claims 1-2 and 5 of Lopéz 2017. Román teaches administering a composition comprising B. longum, L. casei, and L. rhamnosus for the purpose of treating oxidative stress. See the brief summary section. Román teaches analyzing 8-oxo 2'-deoxyguanosine, malondialdehyde in plasma and oxidized LDL. See the secondary outcome measures section spanning pgs. 6-7 (relevant to instant claims 1 and 18-20). Lopéz 2017 teaches L. rhamnosus in a concentration of at least 30%. See [0044] (relevant to instant claim 3). Lopéz 2017 teaches a total concentration of 109 cfu. See paragraphs [0044], [0059] (relevant to instant claim 4). Lopéz 2017 teaches gelatine as an example of a carrier [0027] (relevant to instant claim 5). Román teaches treating oxidative stress during the performance of a physical exercise. See the brief summary section and pages 5-6 (relevant to instant claims 15). Román teaches a study design includes the consumption of one dietary supplement capsule at breakfast for six weeks. See the left column on page 6 (relevant to instant claim 17).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the pharmaceutical composition or a nutritional composition recited in the copending claims of Lopéz ‘317 by adding the L. rhamnosus CECT 8361 and gelatine of Lopéz 2017, by further optimizing the percentage of each strain and total bacterial concentration and by further administering that formulation for 6 weeks, as taught by Román, for the purpose of treating oxidative stress caused by physical activity.
Response to Arguments
Applicant's arguments filed 08/03/2026 have been fully considered but they are not persuasive.
Non-statutory Double Patenting
Applicant asserts that the amendment overcomes the following non-statutory double patenting rejections, because claim 1 now recites “[a] method for the treatment and / or reduction of oxidative stress in a subject” and “wherein the oxidative stress is associated with molecular damage to lipids or DNA and the composition is configured to reduce at least one of a malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2’-deoxiguanosin level of the subject”. See the remarks p. 10 para. 5.
This argument is not persuasive. With respect to limitation of amended claim 1 that requires the oxidative stress to be associated with molecular damage to lipids or DNA, the instant specification discloses that “[o]xidative stress occurs when ROS collapse the antioxidant cell defense system…[t]his reaction damages nucleic acids, proteins, and lipids”. See p. 1 lines 14-17. Therefore, all oxidative stress is understood to be associated with DNA and lipid damage. With respect to the limitation of amended claim 1 that requires the composition to be configured to reduce at least one of a malondialdehyde level, a serum oxidized LDL level, and an 8-oxo 2’-deoxiguanosin level of the subject, Román teaches administering a composition comprising B. longum, L. casei, and L. rhamnosus (brief summary section) and analyzing 8-oxo 2'-deoxyguanosine, malondialdehyde in plasma and oxidized LDL (secondary outcome measures section). Since all of the non-statutory double patenting rejections are obvious-type rejections that rely on the teachings of Román, this newly added limitation is met. As such, the non-statutory double patenting rejections are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657
