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
Response to Election/Restriction filed on December 23, 2025 is acknowledged. Claims 1-20 are pending in the instant application.
Election/Restrictions
Applicant elected without traverse LH from Group I and patient with ovarian reserve reduced defined as lower than 2 ng/mL AMH and an AFC lower than 10 (which reads on claims 6-7, 18-19) in the reply filed December 23, 2025.
The restriction is deemed proper and is made FINAL in this office action. Claims 4-5 and 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-3, 6-15, 18-20 are examined on the merits of this office action.
Claim Objections
Claim 1 is objected to for the following informality: the limitation of “administering to said individual said LH or with molecule having..” (line 6) should be replaced with - “administering to said individual said LH or
Claims 8, 11-15 are objected to for the following informality: the limitation of “wherein LH” should be replaced with -wherein the LH”.
Claim 9 is objected to for the following informality: the limitation of “wherein CG” should be replaced with -wherein the CG”.
Claim Rejections - 35 USC § 112, First Paragraph
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, 6-7, 11-15, 18-19 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
Scope of the claims
The claims are directed to methods of inducing activation and/or maturation or development of primordial and/or primary ovarian follicles in an individual by administering LH, a molecule having LH-like activity or a composition comprising such molecules, wherein the molecule having LH-like activity is selected from G or an LH agonist. Accordingly, the claims encompass a broad functional genus of molecules defined solely by their ability to exhibit LH-like activity including structurally diverse non peptide LH agonists, irrespective of differences in receptor binding mode, signaling bias, potency, or downstream pathway activation, provided that the claimed follicular effects are achieved.
Therefore, to meet the written description requirement of 35 U.S.C. § 112, first paragraph, the specification must disclose a representative number of species that meet both the structural and functional limitations of the genus or the specification and/or the prior art must identify the structural elements that correlate to the claimed function in a manner that demonstrates to one of ordinary skill in the art that Applicant was in possession of the claimed genus at the time the application was filed.
Actual Reduction to Practice
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The specification demonstrates actual reduction to practice for methods using exogenous LH, as evidenced by a prospective human clinical study (see paragraph 0101, PGPUB) involving 30 patients, defined LH dosing regiments, statistically significant increases in ovarian reserve markers (AFC and AMH), and improved IVF related outcomes following treatment. These data reasonably establish possession of methods using LH itself to influence follicular development. However, the specification does not demonstrate actual reduction to practice for CG or LH agonist other than LH itself. No experimental examples, in vivo studies, in vitro assays or comparative data are provided for any non-LH LH-like molecules including LH agonists.
Sufficient relevant identifying characteristic
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination thereof.
For use of LH, the specification identifies the hormone, its receptor and downstream biological effects supported by experimental data. For CG, the specification merely identifies the molecule as an alternative with LH like activity without disclosure of specific formulations, dosing or experimental confirmation in the claimed contexts. For LH agonists, the specification provides only generalized function descriptions, such as “drug like low molecular weight ligands”, thienopyrimidines and pharmacological chaperones interacting allosterically with LH/CG receptor” (see paragraph 0043). The specification does not identify any specific LH agonist compound, any representative species or any defining structural features common to the claimed LH agonist genus. Accordingly, the specification lacks sufficient relevant identifying characteristics to demonstrate possession of the full scope of LH agonists encompassed by the claims.
Physical and Chemical Properties
The physical and chemical properties of LH are well established and implicitly relied upon in the specification. In contrast, for the claimed genus of LH agonists, the specification does not disclose chemical structure, molecular weight ranges, receptor binding, signaling potency, pharmacokinetic properties or formulation characteristics. The absence is particularly significant given that LH agonists may be peptides, small molecules or even allosteric modulators, each class having markedly different physical and chemical properties that affect their activity.
Functional characteristics when coupled with a known or disclosed correlation between function and structure:
The specification describes functional outcomes including activation of the PI3K pathway, FOXO3 a nuclear to cytoplasmic translocation, upregulation of CCN family proteins, and increases in AFC and AMH. These functional effects are experimentally supported only for LH administration. Importantly, LH agonists are known in the art to be pharmacologically heterogenous. Different LH agonists can act as full or partial agonists, binding different and affect different downstream signaling pathways. As a result, two molecules characterized as “LH agonists” may produce materially different intracellular signaling profiles and biological outcomes. In the context of primordial follicle activation, which depends precise and pathway specific signaling thresholds, the mere designation of a compound and an LH agonist does not predict its ability to induce the claimed effects. The specification does not disclose any correlation between specific structural features of LH agonists and particular downstream signaling events required for primordial or primary follicle activation, no does it demonstrate that structurally diverse LH agonists would predictably reproduce the effects observed with LH itself. The functional description without representative structure or structure/function correlation, does not establish possession of the claimed genus.
Method of Making
The specification does not describe methods for synthesizing LH agonists, methods for identifying or screening compounds for LH like activity relevant to primordial follicle activation, or methods for selecting among pharmacologically diverse LH agonists. The absence of disclosure regarding how LH agonists are obtained or selected further indicates that he inventors did not possess such compounds for use in the claimed methods at the time of filing.
Conclusion
Accordingly, the specification does not reasonably convey to one of ordinary skill in the art that the inventors were in possession of the claimed methods which encompass LH agonists. In conclusion, only use of LH or CG satisfies the written description requirements of 35 U.S.C. 112, first paragraph.
Claim Rejections - 35 USC § 112
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, 6-15, 18-20 is 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 claims “A method of inducing activation, and/or maturation or development of primordial and/or primary follicles in an individual with luteinising hormone (LH) or with a molecule having LH-like activity or with a composition comprising it, said method comprising administering to said individual said LH or with molecule having LH-like activity or said composition comprising it, wherein the molecule having LH-like activity is selected from the group consisting of chorionic gonadotropin (CG) or an LH-agonist.” The phrase “a composition comprising it” lacks clear antecedent basis as it is unclear whether “it” refers to LH, the molecule having LH-like activity or both. As a result the scope of what is being administered is ambiguous, and the claim fails to particularly point out and distinctly claim the subject matter regarded as the invention.
A suggested amendment is as follows “A method of inducing activation, and/or maturation or development of primordial and/or primary follicles in an individual with luteinising hormone (LH) or with a molecule having LH-like activity or with a composition comprising said LH or molecule having LH-like activity, said method comprising administering to said individual said LH or said composition comprising said LH or molecule having LH-like activity, wherein the molecule having LH-like activity is selected from the group consisting of chorionic gonadotropin (CG) or an LH-agonist.” Furthermore, the limitation of “inducing activation, and/or maturation or development of.. …”is confusing because of the “and/or” followed by the “or”. For example, is the ”or” prior to development directed to the entire group. For example is it “activation, maturation or development” (any one) or is activation and one of (maturation or development) or is it activation and maturation as a group OR development (requiring activation and maturation and not development or just the development). Applicant should clarify this point of confusion and particularly point out their invention. The “and/or” combined with the “or” creates multiple possible interpretations, and the boundaries of the claim cannot be determined with reasonable certainty. A suggested amendment to overcome this issue would be “inducing at least one of activation, maturation, or development of primordial and/or primary follicles…”
Claims 2-3, 6-15, 18-20 are also rejected due to their dependence on claim 1 and not further clarifying this point of confusion.
Claims 6-7 and 18-19 claim treating patients having a serum concentration of AMH an AFC levels lower than 2/1.5 ng/ml AMH or 10/8 for AFC. However, claim 3, from which they depend on claims “wherein the activation….is associated with an increase in AFC and AMH”. Claims 6-7, 18-19 do not specify when the recited AMH level or AFC level is measured, such as prior to treatment, during treatment, or after treatment. Because AMH levels an AFC can vary over time and in response to treatment, the scope of claims is unclear. As a result, a person of ordinary skill in the art would not be able to determine, with reasonable certainty, which patients fall within the scope of claims 6-7 and 18-19. A suggested amendment would including the limitation “prior to administration of said LH or molecule having LH-like activity…”
Claim 13 claims “The method according to claim1, wherein LH or the molecule having LH-like activity is taken in association or in combination with an infertility treatment in an individual.” The claim recites that LH or a molecule having LH-like activity is take “in association or in combination with an infertility treatment”. The term “association” is broad and undefined, and the claim (nor spec) does not specify that nature, timing or manner of such association or combination. Association can mean almost anything including temporal proximity (before during after), a loose clinical relationship, inclusion in the overall treatment plan or even correlation rather that co-use. The specification does not define association nor contrast in with combination. As a result, the metes and bounds of the claim are unclear.
Claim 14 is dependent on claim 1 and claims “wherein LH or the molecule having LH like activity is taken before the infertility treatment”. There is lack of antecedent basis for the limitation “the infertility treatment” given claim 1 does not introduce the phrase “a fertility treatment” and thus the metes and bounds (the scope) of claim 14 are unclear.
Claim 15 claims “The method according to claim1, wherein LH or the molecule having LH-like activity is taken neither in association nor in combination with FSH.” The claim recites that LH or a molecule having LH-like activity is take “neither in association nor in combination with FSH”. The term “association” is broad and undefined, and the claim (nor spec) does not specify that nature, timing or manner of such association or combination. Association can mean almost anything including temporal proximity (before during after), a loose clinical relationship, inclusion in the overall treatment plan or even correlation rather that co-use. The specification does not define association nor contrast in with combination. As a result, the metes and bounds of the claim are unclear.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-3, 8-15, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nordkild (WO2013010840 A2).
Regarding claim 1, Nordkild teaches “A method for inducing folliculogenesis and supporting subsequent embryo plantation in a female human comprising: starting stimulation by administering FSH on cycle day 1 -3 of a menstrual cycle, administering a GnRH antagonist from day 4-7 of the stimulation until ovulation, administering an LH agonist by administering at least one dosage of hCG in the period from day 1-9, said at least one dosage of hCG being sufficient to stimulate follicle development until ovulation, discontinuing administration of FSH when at least one follicle has a mean diameter of 12-14 mm, and providing luteal support by administering one or more dosages of an LH agonist sufficient to provide a serum progesterone concentration of at least 20 nmol/L 7-10 days after ovulation” (see claims 119, 123, also figure 3c which shows hCG as the LH agonist but Nordkild also teaches LH can be the agonist (see Figure 3C description) ). Nordkild teaches “A method for providing luteal support to females undergoing assisted reproductive therapy, said method comprising administering an LH agonist during the luteal phase at least until 2 weeks after ovulation” (claim 95). Nordkild teaches wherein the LH agonist is LH itself (see claim 98). Regarding claims 11-12, Nordkild further teaches “wherein the LH agonist can be administered until at least 3 weeks after ovulation, such as 4 weeks, for example 5 weeks, such as 6 weeks, such as 7 weeks, for example 8 weeks, such as 9 weeks, for example 10 weeks after ovulation (claim 96). Regarding claims 8-9, Nordkild teaches human LH and human CG (see claim 119, 123 and also figure 3C and description thereof). Regarding claims 10 and 20, Nordkild teaches A preferred dosage range of recombinant or urinary LH includes daily dosages of 100-600 IU LH per day, preferably 150-450 IU LH per day (see page 74, lines 7-10, and also claim 101, preferred dose of 250-350 IU/day, which falls within the range of 170-350 IU a day). Regarding hCG, Nordkild teaches doses of 175-225 IU daily (see Figure 2C description).
Regarding claims 1-3, the recited functional limitations describe biological effects and physiological results (e.g. development/maturation of primordial follicles and primary follicles along with AFC and AMH) that are a result of administration of the LH in the prior art. Nordkild teaches administering LH or LH agonist in a manner sufficient to activate follicles and support luteal function (at the same dosing). According, the claimed functional limitations do not patentably distinguish the claims from the prior art, as they merely recite the intended result or inherent property of the disclosed method (see MPEP 2112).
Regarding claim 13, Nordkild also teaches administering additional infertility treatment (see claim 119, administering FSH, along with GnRH antagonist, LH agonist such as hCG).
Regarding claim 14, because there is no infertility treatment defined in claim 1, the broadest reasonable interpretation is that the LH or LH agonist is given before any infertility treatment. Thus, Figure 3C of Nordkild shows that the LH agonist (either hCG or LH, see figure description of Figure 3C) is given prior to a GnRH agonist thus meeting limitations of be given before an infertility treatment.
Regarding claim 15, there is some confusion regarding the limitation of “neither in association nor in combination with FSH” as there are no timing requirements of the claims or a description of what is meant by “association” and how it is different from “combination” (see 112 b rejection above). Given the broadest reasonable interpretation, the LH agonist (hCG or LH) was administered days 7-10 and 12-28 independent of FSH). Thus, Figure 3C of Nordkild shows that the LH agonist (either hCG or LH, see figure description of Figure 3C) is given without being combined with FSH meeting limitations claim 15.
Claim(s)1-3, 6-7, 10, 13-14, 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Renzini (J Assist Reprod Genet, 2017,34:1645-1651, cited in Applicant’s IDS).
Regarding claim 1, Renzini teaches a method of administering to an individual LH for ovarian stimulation (see abstract).
Regarding claims 1-3, the recited functional limitations describe biological effects and physiological results (e.g. development/maturation of primordial follicles and primary follicles along with AFC and AMH) that are a result of administration of the LH in the prior art. Renzini teaches administering LH for the purpose of ovarian stimulation at the same claimed doses. Accordingly, the claimed functional limitations do not patentably distinguish the claims from the prior art, as they merely recite the intended result or inherent property of the disclosed method (see MPEP 2112). Regarding claims 6-7 and 18-19, Renzini teaches an AFC less than 10 and 8 (see table 2, AFC around 4.9) and an AMH of less than 1.5 ng/ml (see Table 3, page 1643, right column, first paragraph). Regarding claim 10, Renzini teaches a daily dose of rLH at 150 IU thus falling within the range of claim 10.
Regarding claim 13, Renzini also teaches administering additional infertility treatment (see page 1646, right column, last two paragraphs, see table 1).
Regarding claim 14, because there is no infertility treatment defined in claim 1, the broadest reasonable interpretation is that the LH or LH agonist is given before any infertility treatment. Renzini teaches administering r-HCG after LH thus meeting the limitations of being administered prior to an infertility treatment.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 6-15, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nordkild (WO2013010840 A2) in view of Goksedef (J Turkish-German Gynecol Assoc 2010; 11: 212-5) in view of Renzini (J Assist Reprod Genet, 2017,34:1645-1651).
Regarding claim 1, Nordkild teaches “A method for inducing folliculogenesis and supporting subsequent embryo plantation in a female human comprising: starting stimulation by administering FSH on cycle day 1 -3 of a menstrual cycle, administering a GnRH antagonist from day 4-7 of the stimulation until ovulation, administering an LH agonist by administering at least one dosage of hCG in the period from day 1 -9, said at least one dosage of hCH being sufficient to stimulate follicle development until ovulation, discontinuing administration of FSH when at least one follicle has a mean diameter of 12-14 mm, and providing luteal support by administering one or more dosages of an LH agonist sufficient to provide a serum progesterone concentration of at least 20 nmol/L 7-10 days after ovulation” (see claims 119, 123, also figure 3c which shows hCG as the LH agonist but Nordkild also teaches LH can be the agonist (see Figure 3C description) ). Nordkild teaches “A method for providing luteal support to females undergoing assisted reproductive therapy, said method comprising administering an LH agonist during the luteal phase at least until 2 weeks after ovulation” (claim 95). Nordkild teaches wherein the LH agonist is LH itself (see claim 98). Regarding claims 11-12, Nordkild further teaches “wherein the LH agonist can be administered until at least 3 weeks after ovulation, such as 4 weeks, for example 5 weeks, such as 6 weeks, such as 7 weeks, for example 8 weeks, such as 9 weeks, for example 10 weeks after ovulation (claim 96). Regarding claims 8-9, Nordkild teaches human LH and human CG (see claim 119, 123 and also figure 3C and description thereof and X). Regarding claims 10 and 20, Nordkild teaches A preferred dosage range of recombinant or urinary LH includes daily dosages of 100-600 IU LH per day, preferably 150-450 IU LH per day (see page 74, lines 7-10, and also claim 101, preferred dose of 250-350 IU/day, which falls within the range of 170-350 IU a day). Regarding hCG, Nordkild teaches doses of 175-225 IU daily (see Figure 2C description).
Regarding claims 1-3, the recited functional limitations describe biological effects and physiological results (e.g. development/maturation of primordial follicles and primary follicles along with AFC and AMH) that are a result of administration of the LH in the prior art. Nordkild teaches administering LH or LH agonist in a manner sufficient to activate follicles and support luteal function (at the same dosing). According, the claimed functional limitations do not patentably distinguish the claims from the prior art, as they merely recite the intended result or inherent property of the disclosed method (see MPEP 2112).
Regarding claim 13, Nordkild also teaches administering additional infertility treatment (see claim 119, administering FSH, along with GnRH antagonist, LH agonist such as hCG).
Regarding claim 14, because there is not infertility treatment defined in claim 1, the broadest reasonable interpretation is that the LH or LH agonist is given before any infertility treatment. Thus, Figure 3C of Nordkild shows that the LH agonist (either hCG or LH, see figure description of Figure 3C) is given prior to a GnRH agonist thus meeting limitations of be given before an infertility treatment.
Regarding claim 15, there is some confusion regarding the limitation of “neither in association nor in combination with FSH” as there are no timing requirements of the claims or a description of what is meant by “association” and how it is different from “combination” (see 112 b rejection above). Given the broadest reasonable interpretation, the LH agonist (hCG or LH) was administered days 7-10 and 12-28 independent of FSH). Thus, Figure 3C of Nordkild shows that the LH agonist (either hCG or LH, see figure description of Figure 3C) is given without being combined with FSH meeting limitations claim 15.
Nordkild is silent to the patients having serum levels of lower than 10/8 for AFC and lower than 2/1.5 ng/ml (instant claims 6-7, 18-19).
Goksedef teaches Serum anti AMH levels and AFC are correlated markers of ovarian reserve (Abstract, tables 1-2). Goksedef teaches low AMH and low AFC values identify women with diminished ovarian reserve, who are referred for fertility treatment and are recognized as poor responders (introduction, discussion). Goksedef teaches AMH and AFC measurements are used prior to fertility treatment to stratify patients and guide assisted reproduction strategies (introduction, Discussion). Goksedef teaches AMH levels below 2 (see Table 1, 2.23 +/-1.9) and AFC levels below 8 (see Table 1, 8.35 +/-2.83). Goksedef therefore teaches the clinical significance and identification of the specific patient subpopulation recited in claims 6-7 and 18-19.
Renzini teaches subject with reduced ovarian reserve as defined as less than 11 AFC and less than 1.1 ng/mL AMH. Renzini teaches treatment with LH (150IU/day, see methods, ovulation stimulation) containing compositions which appeared to be beneficial for the treatment of women with extremely poor ovarian reserve (see Abstract).
It would have been obvious before the effective filing date of the claimed invention apply the LH or LH agonist treatment regiment taught by Nordkild to the subset of infertility patients identified by Goksedef and Renzini as having low AMH and or low AFC (reduced ovarian reserve) because Goksedef establishes that patients with low AMH and AFC are infertility patients requiring assisted reproductive therapy including IVF, Renzini establishes use of an LH treatment in patients with values less than 11 for AFC and 1.1 ng/ml for AMH and Nordkild teaches administering LH or LH agonists to improve follicular development and ovarian response in assisted reproduction. One of ordinary skill in the art would have been motivated to apply known ovarian stimulation regimes (including LH administration) to poor reserve patients, as these patients are recognized as having impaired ovarian response and therefor a greater clinical need for optimized stimulation. This combination applies a known treatment to a known and clinically relevant patient population, which is routine and predictable variation under KSR Int’l Co. v. Teleflex Inc., 550 US 398 (2007).
There is a reasonable expectation of success in administering LH or an LH agonist to patients with low AMH and/or AFC (very poor ovarian reserve) because Goksedef confirms that AMH and AFC are predictors of ovarian response, not contraindications to treatment, Renzini teaches that LH containing compositions are effective in these populations and Norkild teaches that LH administration promotes follicular development during assisted reproduction.
Conclusion
NO claims are allowed.
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/ERINNE R DABKOWSKI/Examiner, Art Unit 1654