DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 22, 24, 26, 32, and 34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Claims 22, 24, 32, and 34 recite processes.
Step 2A, Prong 1: The claims recite “determining the age of the patient,” which is a mental process that can be performed entirely in the human mind, or by a human using a physical aid such as a pen and paper. Thus, the claims are directed to an abstract idea judicial exception.
Step 2A, Prong 2: The claims recite mentally analyzing information to identify if a patient has an age recited in the claim. The claims also recite "administering a composition comprising recombinant follicle stimulating hormone (FSH) to the patient, wherein the recombinant FSH includes a2,3- and a2,6-sialylation." This administration step is part of controlled ovarian stimulation (COS) protocol known in the art for all patients of any age in need of infertility treatment (see e.g. Cottingham WO 2019/211153 A1, p. 3, line 19 - p. 4, line 9; p. 8, lines 2-38; p. 9, lines 1-16; p. 12, lines 18-34; p. 14, line 36 - p. 15, line 10; Examples 1-2). Therefore, this administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.
Step 2B: The claims recite mentally analyzing information to identify if a patient has an age recited in the claim. The claims also recite "administering a composition comprising recombinant follicle stimulating hormone (FSH) to the patient, wherein the recombinant FSH includes a2,3- and a2,6-sialylation." This administration step is part of controlled ovarian stimulation (COS) protocol known in the art for all patients of any age in need of infertility treatment (see e.g. Cottingham WO 2019/211153 A1, p. 3, line 19 - p. 4, line 9; p. 8, lines 2-38; p. 9, lines 1-16; p. 12, lines 18-34; p. 14, line 36 - p. 15, line 10; Examples 1-2). Therefore, this administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way. Thus, the claims do not amount to significantly more than the judicial exception.
Therefore, claims 22, 24, 32, and 34 are patent ineligible.
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.
Claims 21-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cottingham (WO 2019/211153 A1, published 7 November 2019; IDS 9/8/2023).
Cottingham teaches a method of treating infertility comprising administering a composition comprising recombinant follicle stimulating hormone (FSH) to the patient, wherein the recombinant FSH includes a2,3- and a2,6-sialylation (p. 3, line 19 - p. 4, line 9; p. 8, lines 2-38; p. 9, lines 1-16; p. 12, lines 18-34; p. 14, line 36 - p. 15, line 10; Examples 1-2). Cottingham teaches that preferably 5% to 20% of the total sialylation is a2,6-sialylation and preferably 80% to 95% of the total sialylation is a2,6-sialylation (p. 12, lines 10-18). Cottingham teaches that the FSH is expressed in a human cell line (p. 3, lines 19-32).
Cottingham teaches that the method comprises determining the serum AMH level of the patient prior to administering the recombinant FSH having a2,3- and a2,6-sialylation (p. 10, lines 19-27). For patients with a serum AMH level < 15 pmol/L, the dose is 11 to 13 ug per day (p. 9, lines 24-28), in particular 12 ug per day (p. 5, lines 17-18; Table A). For patients with a serum AMH level > 15 pmol/L, the dose is 0.09 to 0.19 ug per kg bodyweight of the patient per day (p. 5, lines 20-21; Table A; p. 10, lines 28-32). See also Table B, p. 34.
Cottingham teaches that the composition may be used to treat infertility and for controlled ovarian stimulation (COS) in a female subject aged 30 years or over, for example 37 years or over (p. 12, lines 35-36). Cottingham reduce to practice treatment of patients aged 30 to 42 years in a phase 2 clinical trial (p. 28, lines 16-24). Cottingham teaches that the trial includes patients 37 years and under (i.e. age 30 to 37 years) (p. 30, line 10).
Cottingham teaches a step of determining the age of the patient prior to administering (see Inclusion criteria number 4, p. 29, lines 15-17).
Anticipation analysis will begin with claim 35 because it is the broadest independent claim in the claim listing.
Regarding independent claim 35, Cottingham teaches a method of treating infertility by controlled ovarian stimulation, comprising administering a composition comprising recombinant follicle stimulating hormone (FSH) to the patient, wherein the recombinant FSH includes a2,3- and a2,6-sialylation (p. 3, line 19 - p. 4, line 9; p. 8, lines 2-38; p. 9, lines 1-16; p. 12, lines 18-34; p. 14, line 36 - p. 15, line 10; Examples 1-2). Therefore, Cottingham teaches all of the active method steps of the instant claim. The prior art is silent regarding the result of the claimed method as expressed in the preamble of the claim, reducing the likelihood of early pregnancy loss. Because the prior art teaches all of the same active method steps as the claim, that is administering the same exact structure, to the same patients, in the same manner, the claimed effect of reducing likelihood of early pregnancy loss is inherent to the prior art method. The inventors have found a new property of a recombinant FSH that includes a2,3- and a2,6-sialylation and such a discovery does not constitute a new use. Therefore, Cottingham anticipates claim 35.
Regarding independent claim 36, Cottingham teaches a method of treating infertility by controlled ovarian stimulation, comprising administering a composition comprising recombinant follicle stimulating hormone (FSH) to the patient, wherein the recombinant FSH includes a2,3- and a2,6-sialylation (p. 3, line 19 - p. 4, line 9; p. 8, lines 2-38; p. 9, lines 1-16; p. 12, lines 18-34; p. 14, line 36 - p. 15, line 10; Examples 1-2). Cottingham teaches that the method comprises determining the serum AMH level of the patient prior to administering the recombinant FSH having a2,3- and a2,6-sialylation (p. 10, lines 19-27). For patients with a serum AMH level > 15 pmol/L, the dose is 0.09 to 0.19 ug per kg bodyweight of the patient per day (p. 5, lines 20-21; Table A; p. 10, lines 28-32). See also Table B, p. 34. Therefore, Cottingham teaches all of the active method steps of the instant claim. The prior art is silent regarding the result of the claimed method as expressed in the preamble of the claim, increasing the probability of live birth. Because the prior art teaches all of the same active method steps as the claim, that is administering the same exact structure, to the same patients, in the same manner, the claimed effect of increasing the probability of live birth is inherent to the prior art method. The inventors have found a new property of a recombinant FSH that includes a2,3- and a2,6-sialylation and such a discovery does not constitute a new use. Therefore, Cottingham anticipates claim 36.
Regarding independent claim 21, Cottingham teaches a method of treating infertility comprising administering a composition comprising recombinant follicle stimulating hormone (FSH) to the patient, wherein the recombinant FSH includes a2,3- and a2,6-sialylation (p. 3, line 19 - p. 4, line 9; p. 8, lines 2-38; p. 9, lines 1-16; p. 12, lines 18-34; p. 14, line 36 - p. 15, line 10; Examples 1-2). Cottingham teaches that the composition may be used to treat infertility and for controlled ovarian stimulation (COS) in a female subject aged 30 years or over, for example 37 years or over (p. 12, lines 35-36). Cottingham reduce to practice treatment of patients aged 30 to 42 years in a phase 2 clinical trial (p. 28, lines 16-24). Cottingham teaches that the trial includes patients 37 years and under (i.e. age 30 to 37 years) (p. 30, line 10).
The teaching in Cottingham that the clinical trial includes female patients age 30 to 37 years is a range that falls within the claimed range 30 to 40 years. Therefore, the claimed range is anticipated by the prior art range in the reduction to practice, 30 to 37 years.
In addition, MPEP § 2131.03(II) states: When the prior art discloses a range which touches or overlaps the claimed range, but no specific examples falling within the claimed range are disclosed, the claimed subject matter must be disclosed in the reference with "sufficient specificity to constitute an anticipation under the statute." In Clear Value, the claim at issue was directed to a process of clarifying water with alkalinity below 50 ppm, whereas the prior art taught that the same process works for systems with alkalinity of 150 ppm or less. In holding the claim anticipated, the court observed that "there is no allegation of criticality or any evidence demonstrating any difference across the range." Clear Value Inc. v. Pearl River Polymers Inc., 668 F.3d 1340, 101 USPQ2d 1773 (Fed. Cir. 2012) at 1345, 101 USPQ2d at 1777.
In the instant case, the general prior art range 30 years or over, for example 37 years or over (p. 12, lines 35-36) and the reduction to practice range patients aged 30 to 42 years (p. 28, lines 16-24), touch or overlap the claimed range 30 to 40 years. There is no allegation of criticality or any evidence demonstrating any difference across the range. The instant specification suggests an improvement in live birth rate is greater in the higher age strata but does not provide any evidence that 30 to 40 years as claimed is critical versus 30 to 42 years in the prior art. Therefore, the claimed range is anticipated by the prior art species.
Therefore, Cottingham teaches all of the active method steps of the instant claim. The prior art is silent regarding the result of the claimed method as expressed in the preamble of the claim, increasing the probability of live birth. Because the prior art teaches all of the same active method steps as the claim, that is administering the same exact structure, to the same patients, in the same manner, the claimed effect of increasing the probability of live birth is inherent to the prior art method. The inventors have found a new property of a recombinant FSH that includes a2,3- and a2,6-sialylation and such a discovery does not constitute a new use. Therefore, Cottingham anticipates claim 21.
The following analysis addresses claims 22-34 and 37-39 which depend from claim 21.
Regarding claim 22, Cottingham teaches a step of determining the age of the patient prior to administering (see Inclusion criteria number 4, p. 29, lines 15-17).
Regarding claim 23, the teaching in Cottingham that the clinical trial includes female patients age 30 to 37 years (p. 30, line 10) is the same as the claimed range 30 to 37 years.
Regarding claim 24, Cottingham teaches a step of determining the age of the patient prior to administering (see Inclusion criteria number 4, p. 29, lines 15-17).
Regarding claim 25, the general prior art range 30 years or over, for example 37 years or over (p. 12, lines 35-36) and the reduction to practice range patients aged 30 to 42 years (p. 28, lines 16-24), touch or overlap the claimed range 36 to 40 years. There is no allegation of criticality or any evidence demonstrating any difference across the range. The instant specification suggests an improvement in live birth rate is greater in the higher age strata but does not provide any evidence that 36 to 40 years as claimed is critical versus 30 to 42 years in the prior art. Therefore, the claimed range is anticipated by the prior art species.
Regarding claim 26, Cottingham teaches a step of determining the age of the patient prior to administering (see Inclusion criteria number 4, p. 29, lines 15-17).
Regarding claim 27, Cottingham teaches that for patients with a serum AMH level < 15 pmol/L, the dose is 11 to 13 ug per day (p. 9, lines 24-28), in particular 12 ug per day (p. 5, lines 17-18; Table A).
Regarding claim 28, Cottingham teaches that the method comprises determining the serum AMH level of the patient prior to administering the recombinant FSH having a2,3- and a2,6-sialylation (p. 10, lines 19-27).
Regarding claim 29, Cottingham teaches for patients with a serum AMH level > 15 pmol/L, the dose is 0.09 to 0.19 ug per kg bodyweight of the patient per day (p. 5, lines 20-21; Table A; p. 10, lines 28-32). See also Table B, p. 34.
Regarding claim 30, Cottingham teaches that the method comprises determining the serum AMH level of the patient prior to administering the recombinant FSH having a2,3- and a2,6-sialylation (p. 10, lines 19-27).
Regarding claim 31, Cottingham teaches that for patients with a serum AMH level < 15 pmol/L, the dose is 11 to 13 ug per day (p. 9, lines 24-28), in particular 12 ug per day (p. 5, lines 17-18; Table A). For patients with a serum AMH level > 15 pmol/L, the dose is 0.09 to 0.19 ug per kg bodyweight of the patient per day (p. 5, lines 20-21; Table A; p. 10, lines 28-32). See also Table B, p. 34.
The general prior art range 30 years or over, for example 37 years or over (p. 12, lines 35-36) and the reduction to practice range patients aged 30 to 42 years (p. 28, lines 16-24), touch or overlap the claimed range 35 to 40 years. There is no allegation of criticality or any evidence demonstrating any difference across the range. The instant specification suggests an improvement in live birth rate is greater in the higher age strata but does not provide any evidence that 35 to 40 years as claimed is critical versus 30 to 42 years in the prior art. Therefore, the claimed range is anticipated by the prior art species.
Regarding claim 32, Cottingham teaches a step of determining the age of the patient prior to administering (see Inclusion criteria number 4, p. 29, lines 15-17). The general prior art range 30 years or over, for example 37 years or over (p. 12, lines 35-36) and the reduction to practice range patients aged 30 to 42 years (p. 28, lines 16-24), touch or overlap the claimed range 35 to 40 years. There is no allegation of criticality or any evidence demonstrating any difference across the range. The instant specification suggests an improvement in live birth rate is greater in the higher age strata but does not provide any evidence that 35 to 40 years as claimed is critical versus 30 to 42 years in the prior art. Therefore, the claimed range is anticipated by the prior art species.
Cottingham teaches that the method comprises determining the serum AMH level of the patient prior to administering the recombinant FSH having a2,3- and a2,6-sialylation (p. 10, lines 19-27). For patients with a serum AMH level < 15 pmol/L, the dose is 11 to 13 ug per day (p. 9, lines 24-28), in particular 12 ug per day (p. 5, lines 17-18; Table A). For patients with a serum AMH level > 15 pmol/L, the dose is 0.09 to 0.19 ug per kg bodyweight of the patient per day (p. 5, lines 20-21; Table A; p. 10, lines 28-32). See also Table B, p. 34.
Regarding claim 33, Cottingham teaches clinical trials conducted in Japan (p. 4, lines 10-27).
Regarding claim 34, Cottingham teaches a step of determining the age of the patient prior to administering (see Inclusion criteria number 4, p. 29, lines 15-17). The general prior art range 30 years or over, for example 37 years or over (p. 12, lines 35-36) and the reduction to practice range patients aged 30 to 42 years (p. 28, lines 16-24), touch or overlap the claimed range 35 to 40 years. There is no allegation of criticality or any evidence demonstrating any difference across the range. The instant specification suggests an improvement in live birth rate is greater in the higher age strata but does not provide any evidence that 35 to 40 years as claimed is critical versus 30 to 42 years in the prior art. Therefore, the claimed range is anticipated by the prior art species.
Regarding claims 37-38, Cottingham teaches that preferably 5% to 20% of the total sialylation is a2,6-sialylation and preferably 80% to 95% of the total sialylation is a2,6-sialylation (p. 12, lines 10-18).
Regarding claim 39, Cottingham teaches that the FSH is expressed in a human cell line (p. 3, lines 19-32).
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.
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.
Claims 21-34 and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Cottingham (WO 2019/211153 A1, published 07 November 2019; IDS 9/8/2023).
Cottingham teaches a method of treating infertility comprising administering a composition comprising recombinant follicle stimulating hormone (FSH) to the patient, wherein the recombinant FSH includes a2,3- and a2,6-sialylation (p. 3, line 19 - p. 4, line 9; p. 8, lines 2-38; p. 9, lines 1-16; p. 12, lines 18-34; p. 14, line 36 - p. 15, line 10; Examples 1-2). Cottingham teaches that preferably 5% to 20% of the total sialylation is a2,6-sialylation and preferably 80% to 95% of the total sialylation is a2,6-sialylation (p. 12, lines 10-18). Cottingham teaches that the FSH is expressed in a human cell line (p. 3, lines 19-32).
Cottingham teaches that the method comprises determining the serum AMH level of the patient prior to administering the recombinant FSH having a2,3- and a2,6-sialylation (p. 10, lines 19-27). For patients with a serum AMH level < 15 pmol/L, the dose is 11 to 13 ug per day (p. 9, lines 24-28), in particular 12 ug per day (p. 5, lines 17-18; Table A). For patients with a serum AMH level > 15 pmol/L, the dose is 0.09 to 0.19 ug per kg bodyweight of the patient per day (p. 5, lines 20-21; Table A; p. 10, lines 28-32). See also Table B, p. 34.
Cottingham teaches that the composition may be used to treat infertility and for controlled ovarian stimulation (COS) in a female subject aged 30 years or over, for example 37 years or over (p. 12, lines 35-36). Cottingham reduce to practice treatment of patients aged 30 to 42 years in a phase 2 clinical trial (p. 28, lines 16-24). Cottingham teaches that the trial includes patients 37 years and under (i.e. age 30 to 37 years) (p. 30, line 10).
Cottingham teaches a step of determining the age of the patient prior to administering (see Inclusion criteria number 4, p. 29, lines 15-17).
Regarding independent claim 21, Cottingham teaches a method of treating infertility comprising administering a composition comprising recombinant follicle stimulating hormone (FSH) to the patient, wherein the recombinant FSH includes a2,3- and a2,6-sialylation (p. 3, line 19 - p. 4, line 9; p. 8, lines 2-38; p. 9, lines 1-16; p. 12, lines 18-34; p. 14, line 36 - p. 15, line 10; Examples 1-2). Cottingham teaches that the composition may be used to treat infertility and for controlled ovarian stimulation (COS) in a female subject aged 30 years or over, for example 37 years or over (p. 12, lines 35-36). Cottingham reduce to practice treatment of patients aged 30 to 42 years in a phase 2 clinical trial (p. 28, lines 16-24). Cottingham teaches that the trial includes patients 37 years and under (i.e. age 30 to 37 years) (p. 30, line 10).
MPEP § 2144.05(I) states: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In the instant case, the claimed range 30 to 40 years overlaps or lies inside the prior art range 30 years or over, for example 37 years or over (p. 12, lines 35-36) and the reduction to practice range patients aged 30 to 42 years (p. 28, lines 16-24). Therefore, the claimed age range is prima facie obvious over the prior art.
The reference is silent with respect to the effect of increasing the probability of live birth. The fact that the inventor 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. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the instant case, the effect of increasing the probability of live birth flows from the cited reference which teaches administering the same compounds, to the same subjects, in the same manner as the instant claims.
Regarding claim 22, Cottingham teaches a step of determining the age of the patient prior to administering (see Inclusion criteria number 4, p. 29, lines 15-17).
Regarding claim 23, the claimed range 30 to 37 years overlaps or lies inside the prior art range 30 years or over, for example 37 years or over (p. 12, lines 35-36) and the reduction to practice range patients aged 30 to 42 years (p. 28, lines 16-24). Therefore, the claimed age range is prima facie obvious over the prior art.
Regarding claim 24, Cottingham teaches a step of determining the age of the patient prior to administering (see Inclusion criteria number 4, p. 29, lines 15-17).
Regarding claim 25, the claimed range 36 to 40 years overlaps or lies inside the prior art range 30 years or over, for example 37 years or over (p. 12, lines 35-36) and the reduction to practice range patients aged 30 to 42 years (p. 28, lines 16-24). Therefore, the claimed age range is prima facie obvious over the prior art.
Regarding claim 26, Cottingham teaches a step of determining the age of the patient prior to administering (see Inclusion criteria number 4, p. 29, lines 15-17).
Regarding claim 27, Cottingham teaches that for patients with a serum AMH level < 15 pmol/L, the dose is 11 to 13 ug per day (p. 9, lines 24-28), in particular 12 ug per day (p. 5, lines 17-18; Table A).
Regarding claim 28, Cottingham teaches that the method comprises determining the serum AMH level of the patient prior to administering the recombinant FSH having a2,3- and a2,6-sialylation (p. 10, lines 19-27).
Regarding claim 29, Cottingham teaches for patients with a serum AMH level > 15 pmol/L, the dose is 0.09 to 0.19 ug per kg bodyweight of the patient per day (p. 5, lines 20-21; Table A; p. 10, lines 28-32). See also Table B, p. 34.
Regarding claim 30, Cottingham teaches that the method comprises determining the serum AMH level of the patient prior to administering the recombinant FSH having a2,3- and a2,6-sialylation (p. 10, lines 19-27).
Regarding claim 31, Cottingham teaches that for patients with a serum AMH level < 15 pmol/L, the dose is 11 to 13 ug per day (p. 9, lines 24-28), in particular 12 ug per day (p. 5, lines 17-18; Table A). For patients with a serum AMH level > 15 pmol/L, the dose is 0.09 to 0.19 ug per kg bodyweight of the patient per day (p. 5, lines 20-21; Table A; p. 10, lines 28-32). See also Table B, p. 34.
The claimed range 35 to 40 years overlaps or lies inside the prior art range 30 years or over, for example 37 years or over (p. 12, lines 35-36) and the reduction to practice range patients aged 30 to 42 years (p. 28, lines 16-24). Therefore, the claimed age range is prima facie obvious over the prior art.
Regarding claim 32, Cottingham teaches a step of determining the age of the patient prior to administering (see Inclusion criteria number 4, p. 29, lines 15-17). The claimed range 35 to 40 years overlaps or lies inside the prior art range 30 years or over, for example 37 years or over (p. 12, lines 35-36) and the reduction to practice range patients aged 30 to 42 years (p. 28, lines 16-24). Therefore, the claimed age range is prima facie obvious over the prior art.
Cottingham teaches that the method comprises determining the serum AMH level of the patient prior to administering the recombinant FSH having a2,3- and a2,6-sialylation (p. 10, lines 19-27). For patients with a serum AMH level < 15 pmol/L, the dose is 11 to 13 ug per day (p. 9, lines 24-28), in particular 12 ug per day (p. 5, lines 17-18; Table A). For patients with a serum AMH level > 15 pmol/L, the dose is 0.09 to 0.19 ug per kg bodyweight of the patient per day (p. 5, lines 20-21; Table A; p. 10, lines 28-32). See also Table B, p. 34.
Regarding claim 33, Cottingham teaches clinical trials conducted in Japan (p. 4, lines 10-27).
Regarding claim 34, Cottingham teaches a step of determining the age of the patient prior to administering (see Inclusion criteria number 4, p. 29, lines 15-17). The claimed range 35 to 40 years overlaps or lies inside the prior art range 30 years or over, for example 37 years or over (p. 12, lines 35-36) and the reduction to practice range patients aged 30 to 42 years (p. 28, lines 16-24). Therefore, the claimed age range is prima facie obvious over the prior art.
Regarding claims 37-38, Cottingham teaches that preferably 5% to 20% of the total sialylation is a2,6-sialylation and preferably 80% to 95% of the total sialylation is a2,6-sialylation (p. 12, lines 10-18).
Regarding claim 39, Cottingham teaches that the FSH is expressed in a human cell line (p. 3, lines 19-32).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 7 am - 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA BRADLEY/Primary Examiner, Art Unit 1654