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 2-4 and 8-19 are currently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 8-16, in the reply filed on Nov. 15, 2025 is acknowledged. Claims 2-4 and 17-19 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 8-16 have been considered on the merits.
Claim Objections
Claims 8, 10-11 and 16 are objected to because of the following informalities:
Claim 8 recites the term “NAD+”, which appears to symbolize nicotinamide adenine dinucleotide having a positive charge using the abbreviation “NAD.” If this is an abbreviation, then the abbreviation needs to be spelled out at least once. Appropriate correction is required.
Claims 8, 10-11 and 16 show an inconsistent use of capitalization, such as in the terms “Urolithin,” “Reduced Nicotinamide riboside”, “Nicotinic acid mononucleotide,” and Nicotinic acid riboside.” Appropriate correction is required.
Claim Interpretation
In claim 8, the term “pharmaceutical composition” is interpreted under a broadest reasonable claim interpretation as implicitly requiring the composition comprising the combination also comprises at least one additional “pharmaceutical” component to those recited the claim, e.g., water, saline, or other pharmaceutical composition components known in the prior art such as carrier, diluents, excipients, and serum albumins.
Claim Rejections - 35 USC § 112(a), Written Description
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 8-16 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.
Subject in Need (claims 8-14 and 16)
When claim 8 is analyzed in light of the specification, the instant invention is directed to a method comprising administering a composition comprising (1) a urolithin, (2) NAD+ precursor and (3) vitamin B12 to a subject in need. Claim 13 or 14 limits the subject to one having or at risk of having either subnormal amounts of haemopoietic cells or anemia, leukopenia and thrombocytopenia. Thus, claim 8 at least encompasses such subjects.
M.P.E.P. §2163 states “To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.”
In the instant case, claim 8 broadly comprises a genus of subjects merely at risk of having (1) subnormal amounts of haemopoietic cells or (2) anemia, leukopenia and thrombocytopenia. Moreover, the term “subject” or subject at risk as recited in claims 13-14 is not defined in the claims or instant specification.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described.
In the instant case, the specification describes “subjects at risk” of developing subnormal amounts of haematopoietic cells may include ones with blood cancers (e.g., leukaemia, lymphoma and myeloma), blood disorders (e.g. inherited anaemia, inborn errors of metabolism, aplastic anaemia, beta-thalassaemia, Blackfan-Diamond syndrome, globoid cell leukodystrophy, sickle cell anaemia, severe combined immunodeficiency, X-linked lymphoproliferative syndrome, Wiskott-Aldrich syndrome, Hunter's syndrome, Hurler's syndrome, Lesch Nyhan syndrome, osteopetrosis); subjects undergoing chemotherapy rescue of the immune system, and subjects with, e.g., autoimmune diseases, diabetes, rheumatoid arthritis, systemic lupus erythromatosis; subjects presenting a severe neutropenia and/or severe thrombocytopenia and/or severe anaemia, such as post-transplanted subjects or subjects undergoing ablative chemotherapy for solid tumours, patients suffering toxic, drug-induced or infectious haematopoietic failure (i.e. benzene-derivatives, chloramphenicol, B19 parvovirus, etc.) as well as patients suffering from myelodysplastic syndromes, from severe immunological disorders, or from congenital haematological disorders (pg. 24, lines 3-18). However, it is not clear if any of the aforementioned subjects are representatives as one or all of these may instead may be exclusive examples of subjects having subnormal amounts of haemopoietic cells.
Claim 8 encompasses a single subject at risk of developing all three of anemia, leukopenia and thrombocytopenia as indicated by claim 14. This means the subject has not yet developed any of the three aforementioned conditions. However the instant specification is silent as to any representative of this type of subject. Instead there is description of patients generally suffering from myelodysplastic syndromes, undergoing chemotherapy, bone marrow transplant, radiation therapy or other interventions without any indication of how these are related to the risk of developing anemia, leukopenia and thrombocytopenia (pg. 23, line 21, to pg. 24, line 2). Thus, the instant application fails to provide any representative species of a subject at risk of developing all three of anemia, leukopenia and thrombocytopenia.
As to “subjects at risk of developing subnormal amounts of haematopoietic cells”, the instant application may provide some representative species at pg. 24, lines 3-18, but the skilled artisan cannot envision the entire genus from this description, which may include subjects not suffering from any condition, not yet diagnosed with any disorder or not presenting with a sign described at [0208], such as due to a congenital inheritance which forecasts such a risk.
Thus, the skilled artisan cannot envision how to identify which subjects are at risk across the full genus of the subjects of either claim 13 or 14, and thus, by definition encompassed by claim 8. Critically, the specification fails to describe enough representative structures as well as any assay to determine the requisite risk level or any structural feature having sufficient nexus to the functionally defined genus (“at risk”), such as a specific type of mutation or sequence variation.
Thus, there is a lack of evidence in the instant specification as filed that the inventors were in possession of a method for use in treatment or prevention in the genus of subjects encompassed by claim 8 over the entire scope.
Combined Preparation for use with a TPO receptor analogue
When claim 16 is analyzed in light of the specification, the instant invention is directed to a method comprising administering to a subject in need a composition preparation comprising (1) a urolithin, (2) NAD+ precursor and (3) vitamin B12 wherein the preparation is for use with the agent(s) selected from a G-CSF analogue and TPO receptor analogue. Thus, claim 8 at least encompasses such preparations for use with a TPO receptor analogue.
The instant specification is silent as to any representative species of a “TPO receptor analogue.” Moreover, there is no evidence the prior art provides any example of a TPO receptor analogue, however applicant is invited to furnish evidence to the contrary. Thus, the skilled artisan cannot envision the scope of TPO receptor analogues referred to in claim 16 or whether such agent even exists, and thus, by definition encompassed by claim 8. Therefore, there is a lack of evidence in the instant specification as filed that the inventors were in possession of a method for use in treatment or prevention encompassed by claim 8 over the entire scope of preparations formulated for use with a TPO receptor analogue.
35 USC § 112(a), Scope of Enablement
Claims 8-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not enable any person, skilled in the art to which it pertains or with which it is most nearly connected to, to make/use the method of claim 8 over its entire scope. However the specification in view of the prior art does enable methods for treating leukopenia and/or thrombocytopenia, by administering to a subject a composition comprising NR and/or NMN, regardless of the presence of a urolithin or Vitamin B12 component. Similarly, methods of administering to subject Vitamin B12 along with another therapy(s) are enabled treatments for synergistically treating some types of infection, but this is regardless of the presence of a NAD precursor or Vitamin B12 in the method.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). The court in Wands states that "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue.' Not 'experimentation;" (Wands, 8 USPQ2d 104). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighting many factual considerations." (Wands, 8 USPQ2d 1404).
The factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation required is “undue” include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Furthermore, the USPTO does not have laboratory facilities to test if an invention will function as claimed when working examples are not disclosed in the specification. Therefore, enablement issues are raised and discussed based on the state of knowledge pertinent to an art at the time of the invention. And thus, skepticism raised in the enablement rejections are those raised in the art by artisans of expertise.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Breadth of the claims:
The claims are broadly directed to methods of preventing (a) anemia, leukopenia and/or thrombocytopenia; (b) infection; and/or (c) cancer. It is noted that the claims encompass preventing in a subject all five of anemia, leukopenia thrombocytopenia, infection, and cancer. It is also noted that under a broadest reasonable interpretation, the term “preventing” encompassing completely delaying or precluding the (a) anemia, leukopenia and/or thrombocytopenia; (b) infection; and/or (c) cancer in the subject. Thus, the claims are broadly directed to methods for use in “preventing” the recited conditions in a subject that has not yet experienced any of these conditions, the skilled artisan cannot envision from the application shows possession of the claimed methods alone predictably could be used in completely preventing the recited condition(s) in a subject.
The state of the art:
The prior art teaches a NAD+-boosting strategy comprising orally administering (feeding) a NAD+ precursor (vitamin B3 analog, e.g., NMN) to a subject improves HSC function/proliferation in vivo after transplantation thereby increasing populations of white blood cells, monocytes, granulocytes, platelets and neutrophils, especially the NAD+ precursor nicotinamide riboside (NR) in Niagen® (Abstract, Fig. 1, 3, 7; pg. 406, right col., last para., to pg. 407, left col., last para.; pg. 414, left col., last para., to right col.). The art teaches administering to a subject urolithin A can produce an anti-inflammatory effects in vivo and other promising anticancer-related effects in vitro or in combination of with chemotherapeutic agents preclinical animals models, however urolithins have not yet realized its full potential and to treat an infection or cancer on their own, especially in a human subject (see e.g., Karumuru et al., pg. 123, left col., last para., to pg. 134, left col., last para.; Table I). The prior art teaches vitamin B12 supplementation can help treat some viral infections in certain subjects in combination with other agents. The prior art also teaches treatments for (a) anemia, leukopenia, thrombocytopenia; (b) infections; and (c) cancers; however it is difficult to predict a priori the subjects before they develop the disorder or quantify the amount of risk of such over the full scope of the claims. Furthermore, when intervening to prevent a disorder before it appears, it is often difficult to say for a single subject with any certainty that the future failure of the disorder to appear is due to the intervention, chance or even inaccurate risk assessment. Thus, across the breadth of any anemia, leukopenia, thrombocytopenia, infection or cancer, there are not sufficient predictive capabilities in the prior art nor ways to validate a complete prevention for many of these disorders in most situations.
Thus, these aspects of complete prevention over the scope of the entire genus of disorders recited in claim 8 must be shown to a reasonable extent so that one of the ordinary skills in the art would be able to practice the invention without any undue burden being on such an artisan.
Furthermore, the prior art is silent as to a single administration that prevents all five of anemia, leukopenia, thrombocytopenia, infection and cancer by a single method. Thus, this aspect of concurrent treatment or prevention of 5 disorders via a single method according to claim 8 must be shown to a reasonable extent so that one of the ordinary skills in the art would be able to practice the invention without any undue burden being on such an artisan, such as using only a nutritional composition.
The amount of direction and guidance and working examples provided by Applicant:
Nowhere does the specification provide any working embodiment of administering any composition to a subject nor accomplishing treatment or prevention of any condition in a subject. Instead, the only empirical data shown is in vitro data showing the effect of contacting mouse hematopoietic stem cells (HSC) with a composition comprising urolithin A, nicotinamide riboside and vitamin B12 (Example 1; FIG. 1), which is neither predictive or even instructive of what would happen if the same was administered in vivo to a subject, including a mouse. Similarly, nowhere does the specification provide any example of a method of preventing any type of anemia, leukopenia, thrombocytopenia, infection, or cancer, not to mention preventing combinations thereof in a single subject or completely preventing any of the aforementioned in a subject, and the in vitro data regarding HSC mitochondria provides no prediction regarding in vivo blood cell levels or effects on infections or cancers.
Instead, the specification merely demonstrates the combination urolithin A, nicotinamide riboside and vitamin B12 (with additional repeated contactings with nicotinamide riboside) lowers the mitochondrial membrane potential of mouse bone marrow-derived.
The instant specification provides no direction, guidance or working examples for determining a suitable subject, a suitable route of administration, or a suitable amount to administer to effectuate either a treatment or prevention.
Thus, there is no evidence in the instant application or the prior art that the scope of modified cytokines encompassed by the claims could predictably provide a cryopreservation function and extensive experimentation would be required to determine which modified cytokines fit the definition recited over the scope of possible cytokines and modifications thereof.
In summary, the claims are rejected under 35 U.S.C. 112(a) because the specification does not reasonably provide enablement to a person skilled in the art to which it pertains or with which it is most nearly connected to completely prevent (a) anemia, leukopenia and/or thrombocytopenia; (b) infection; and/or (c) cancer, especially in a single subject. Given the lack of working examples, the limited guidance provided in the specification, the lack of guidance in the prior art, and the broad scope of the claims, undue and/or unreasonable experimentation would have been required for one skilled in the art to produce the desired effect over the full scope of the claims.
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 8-16 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 pre-AIA the applicant regards as the invention.
The claims are interpreted as provided in a previous section.
Claim 8 recites the term “NAD+ precursor”, which is neither defined in the claim nor the specification (see pg. 15), and thus, a person of ordinary skill in the art would not understand the metes and bounds of the entire genus NAD+ precursors in the claim. For example, the instant application explains the term “NAD+ precursor” encompasses a food extract enriched in NAD. But as ordinarily used in the art, a precursor to a biosynthesized molecule (e.g., NAD) means just the direct upstream compounds utilized in the entire biosynthesis pathway(s) (e.g., NAD salvage pathway) producing said molecule, e.g., vitamin B3, tryptophan, nicotinic acid mononucleotide, nicotinamide mononucleotide, and dihydronicotinamide mononucleotide (Canto, Metabolites 12: 630 (2022) at Fig. 1). If the applicant acts as her own lexicographer to redefine a term of a claim contrary to its ordinary meaning, the written description must clearly define the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). In the instant case, there is no such clear redefinition, and, thus, the term “NAD+ precursor” as used in the claims is indefinite. Claims 9 and 12-16 are included in this rejection for depending from indefinite claim 8.
Claim 8 recites the phrase a “subject in need of same,” which is ambiguous and unclear as to what the pronoun “same” refers to from amongst a need for the treatment or prevention of a recited condition(s) or the composition or one or more of urolithin, NAD+ precursor, and/or Vitamin B12. Claims 9-16 are included in this rejection for depending from indefinite claim 8.
Claim 12 recites the term “nutritional” composition, which is incoherent and unclear as any composition comprising Vitamin B12 and intended for administration to a subject may be considered nutritional for that subject as its intended use, including a pharmaceutical composition.
Claims 13-15 each recites the term “a subject”; however, claim 8 has already introduced a subject and thus claims 13-15 are ambiguous and unclear as to whether “a subject” refers to “the subject” of claim 8 or another subject lacking an antecedent.
Claim 13 recites a subject “is at risk of having subnormal amounts of haematopietic cells,” which is according to the instant specification encompasses subnormal amounts of erythrocytes, leukocytes and/or platelets (pg. 4, lines 3-4; pg. 23, lines 7-8). As this definition is contrary to the ordinary meaning of hematopoietic stem cell, which does not include differentiating or mature blood cells, the applicant has misused this term’s meaning without any attempt to clear redefine it. If the applicant acts as her own lexicographer to redefine a term of a claim contrary to its ordinary meaning, the written description must clearly define the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. In the instant case, there is no such clear redefinition, and, thus, the term “at risk of having subnormal amounts of haematopietic cells” is indefinite.
Claim 16 recites the composition comprising the combination is prepared for “separate use” or “sequential use” with specifically recited agent(s). The specification defines “separate” and “sequential” in an overlapping manner, with “sequential” meaning one after another and “separate” meaning independently with a time interval permitting a multi-drug effect (pg. 22, lines 13-18); however, the instant application is silent as to how this pertains specifically for use with G-CSF analogue and/or TPO receptor analogue. Thus, a person of ordinary skill in the art would not understand the metes and bounds of a preparation for separate or sequential use with the agent(s) selected from a G-CSF analogue, TPO receptor analogue or combinations thereof. For purposes of examination herein, any composition of claim 8 is considered to satisfy at least a subset of the alternative options of claim 16. Furthermore it is noted that as the specification defines “separate” and “sequential” in an overlapping manner, with “sequential” meaning one after another (i.e., independently) and “separate” meaning independently with a time interval permitting a multi-drug effect means that all “sequential” administrations are separate but not all “separate” administrations are sequential regarding the instant claims.
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.
Claim 16 is 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.
Claim 16 further recites only functional language regarding the nature of the combination composition of claim 8 as being a preparation for simultaneous, separate, or sequential use with a recited agent(s); however, this functional language fails to imply any limitation to claim 8 except regarding an intended use “for simultaneous, separate or sequential” use with an additional agent that need not be administered to the subject. Intended use language in a method claim is not limiting if failing to provide or imply any additional active method step or narrowing of a step of the claimed method of the claim from which it depends. Here, while the claim 16 language attempts to narrow the composition comprising urolithin, NAD+ precursor and Vitamin B12 by an intended use, there is no structure or active method step implied by “for simultaneous, separate, or sequential use”. Thus, claim 16 fails to further limit the subject matter of a claim 8.
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 § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 8-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andreux (WO2017109195A1).
Regarding claim 8, Andreux discloses administering to a subject a composition comprising nicotinamide riboside (NR), a urolithin, and vitamin B12 (pg. 10, lines 26-31; pg. 4, line 15, to pg. 5, line 16; pg. 4, line 10), such as (1) a subject with cancer in order to treat the cancer (pg. 20, line 28, to pg. 21, line 15) or (2) a subject desiring an improvement in muscle performance/endurance just for personal preference or to improve mitochondrial function and/or wellbeing (pg. 17, lines 10, to pg. 19, line 9; such as in an aging subject (pg. 20, lines 24-25).
For purposes of applying prior art, an intended use of a claimed product only limits the claimed method if there is an active method step or implied structure/feature not recited in the claim (see Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999) as “it is important not to import into a claim limitations that are not part of the claim.” See MPEP 2111.01.02. The preamble phrase “for use in the treatment or prevention” is not considered limiting and the “in need of same” limits the subject to in need of the composition comprising a combination of a urolithin, NAD+ precursor and vitamin B12 but not necessarily In need of treatment or prevention of any specific condition.
Regarding claim 9, Andreux discloses wherein the urolithin is urolithin A (pg. 5, lines 13-14).
Regarding claims 10-11, Andreux discloses wherein the NAD+ precursor is nicotinamide riboside (NR) (pg. 9, line 21-25; pg. 10, lines 26-31).
Regarding claim 12, Andreux discloses wherein the composition is in the form of a pharmaceutical composition or nutritional composition (pg. 7, line 23).
Regarding claims 13, Andreux discloses wherein the subject has diabetes (pg. 20, line 27, to pg. 21, line 3), which is encompassed by a subject at risk of having subnormal amounts of hematopoietic stem cells according to instant specification at pg. 26, lines 3-10.
Regarding claim 14, Andreux discloses wherein the composition is used to increase the number of hematopoietic stem cells and their progeny (e.g., by stimulating mitophagy and autophagy therein) (pg. 22, lines 6-8). Furthermore, the limitation to a subject at risk of having leukopenia encompass many subjects, as there is a non-zero risk of contracting an HIV infection.
Regarding claim 15, Andreux discloses administering the composition to a subject after surgery (orthopedic surgery) (pg. 20, lines 10-20).
Regarding claim 16, as it is unclear what limitation, if any, on the method comes from the language of “combined for separate or sequential use with a G-CSF analogue and/or TPO analogue, claim 16 is anticipated by Andreux by virtue of anticipation of claim 1 as set forth above.
Thus, Andreux anticipates the claimed invention.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 8-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 18, 22-23, and 26 of the “reference application” US 17/442,217.
Claim 2 of the reference application is directed to a method of treating an infection or cancer in a subject by administering an effective amount of a composition comprising c) the NAD+ precursor nicotinamide riboside (NR), a urolithin, and a Vitamin B12; and claim 18 teaches wherein the composition comprises a pharmaceutical carrier, diluent or excipient.
Regarding instant claim 9, reference claim 22 teaches wherein the urolithin is Urolithin A. Regarding instant claims 10-11, reference claim 2 teaches the NAD+ precursor is NR. Regarding instant claim 12, reference claim 23 teaches wherein the composition is a pharmaceutical or nutritional composition. Regarding instant claims 13-14, reference claim 2 teaches wherein the subject has lymphoma, multiple myeloma or leukemia, each of which provides a risk of having subnormal amounts of hematopoietic stem cells as instantly defined (see instant pg. 24, lines 3-4) as well as having or at risk of having anemia, leukopenia and/or thrombocytopenia as well as myelodysplastic syndrome for multiple myeloma. Regarding instant claim 15, reference claim 26 teaches wherein the subject has undergone surgery, radiotherapy, and/or chemotherapy. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 8-12 and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-6, 10, 13, and 16-17 of the “reference application” US 18/836,884.
Claim 16 of the reference application is directed to a method of treating cancer or tumor formation in a subject having already received a cancer therapy and in remission phase, the method comprising administering a therapeutically effective amount of a composition comprising a urolithin, a NAD+ precursor, and a Vitamin B12, wherein the NAD+ precursor is Nicotinic Acid, Nicotinamide, Nicotinamide Riboside (NR), Reduced Nicotinamide riboside (NRH), Nicotinamide Mononucleotide (NMN), Nicotinic acid mononucleotide, Nicotinic acid riboside, or a mixture thereof.
Instant claims 8 and 10-11 differ from the reference claims in that the subject need not have received any cancer therapy nor be in remission, but in view of claim 15, claim 8 encompasses subjects in need of cancer treatment that have undergone chemotherapy, radiotherapy, and/or surgery, including ones in remission phase.
Regarding instant claim 9, reference claim 6 teaches wherein the urolithin is Urolithin A. Regarding instant claim 12, reference claim 13 teaches wherein the composition is a pharmaceutical or nutritional composition. Regarding instant claim 15, reference claim 10 teaches wherein the preceding cancer therapy comprises surgery, radiation, or chemotherapy.
Regarding instant claim 16, as it is unclear what limitation, if any, on the method comes from the language of “combined for separate or sequential use with a G-CSF analogue and/or TPO analogue, claim 16 is rendered obvious for the same reasons set forth above for claim 8.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 8 and 10-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 10, and 12-16 of the “reference application” US 18/246,710.
Claim 8 of the reference application is directed to a method of preventing anemia, leukopenia, thrombocytopenia, infection or cancer in a subject using the combination of a NAD+ precursor, and Vitamin B12; and dependent claim 12 teaches wherein urolithin is included.
Regarding instant claims 10-11, reference claim 10 teaches wherein the NAD+ precursor is Nicotinic Acid, Nicotinamide Riboside (NR), Reduced Nicotinamide riboside (NRH), Nicotinamide Mononucleotide (NMN), Nicotinic acid mononucleotide, Nicotinic acid riboside, or a mixture thereof. Regarding instant claim 12, reference claim 12 teaches using a urolithin composition in the form of a pharmaceutical or nutritional composition. Regarding instant claim 13, reference claim 13 teaches wherein the subject has or is at risk of having subnormal amounts of hematopoietic cells. Regarding instant claim 14, reference claim 14 teaches wherein the subject has anemia, leukopenia and thrombocytopenia. Regarding instant claim 15, reference claim 15 teaches wherein the subject has undergone haemopoietic stem cell transplant, bone marrow transplant, myeloablative condition, chemotherapy, radiotherapy or surgery. Regarding instant claim 16, reference claim 16 teaches wherein a combination preparation for simultaneous, separate or sequential use with the agent selected from a G-CSF analogue, TPO receptor analogue or combinations thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 8-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 10, and 12-16 of the “reference application” US 18/246,710 as applied above, and further in view of Gonzalez (González et al., Crit Rev Food Sci Nutr 57(16): 3373-83 (2017)).
The instant claims differ from the reference claims in that no individual type of urolithin is specified. However urolithin A is the most studied of the urolithins, and in view of Gonzalez teaching urolithin A exhibits equivalent or stronger anticancer functions than other urolithins (pg. 3378, left col., 2nd para.; pg. 3379, left col., 2nd para. and right col., para. 1-2), it would be obvious to one of ordinary skill in the art to select the specific urolithin that is urolithin A for use in the method of the reference claims when the goal is to treat a subject having cancer.
Conclusion
No claim is allowed.
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/ERIC J ROGERS/Examiner, Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638