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 .
Status of the Claims
Claims 2 and 3 are pending.
Claims 2 and 3 are newly amended.
Claims 2 and 3 have been examined on their merits.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The rejection of claims 2 and 3 under 35 U.S.C. 103 as being unpatentable over Takagi et al. (US20050019910A1, 2005) in view of Pernes et al. (Bulletin UASVN Animal Sciences and Biotechnologies, 2016) and Liu et al. (US20160348065A1, 2016) as evidenced by Gradinaru et al. (Life, 2025) and Millipore Sigma (Iscove’s Modified Dulbecco’s Media (IMDM) formulation, retrieved from internet 01/30/2026) is withdrawn to address the claims as amended.
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.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Takagi et al. (US20050019910A1, 2005) in view of Fathi et al. (Theriogenology, 2017) and Liu et al. (US20160348065A1, 2016).
In regards to claim 2, Takagi teaches a medium for growing human cells, including cells included in a process of differentiation of fertilized human eggs (which would include an oocyte) (claim 1).
In regards to the use of the preamble, “A composition for improving a quality of in vitro maturation of mammalian oocytes and a pregnancy rate of recipient mammalians after in vitro fertilization of the in vitro matured oocytes and embryo transfer”, this is an intended use of the composition.
According to MPEP 2111.02, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See also, See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation").
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, because the composition of Takagi is explicitly for cells included in a process of differentiation of fertilized human eggs (claim 2), which would include oocytes, and is at least capable of performing this intended use.
Continuing, Takagi teaches that medium comprises thrombopoietin (THPO) (claim 6).
Takagi does not explicitly teach that the medium comprises L-carnitine.
However, a person of ordinary skill in the art would have been motivated to supplement the media with L-carnitine because as taught by Fathi, oocytes supplemented with 0.5 mg/mL L-carnitine demonstrate higher developmental rates of to morula and blastula stages, and therefore, recommends it use as a supplement for these cells/structures (Abstract, p18). Furthermore, because Fathi demonstrates that media for culturing oocytes can be supplemented with L-carnitine (In vitro oocytes maturation and staining, p19), a person of ordinary skill in the art could have supplemented the medium with L-carnitine with predictable results and a reasonable expectation of success.
In regards to the weight ratios as in claim 2 (it is noted that word weight has been interpreted as being synonymous with mass), in regards to the weight ratio THPO and L-carnitine, Takagi is silent as to this amount.
However, in regards to the concentration of THPO, Liu teaches that THPO can be added to media for culturing stem cell types with 1-10 µg/L (claim 3). A person of ordinary skill in the art would have been motivated to use a concentration between the range of 1-10 µg/L because Liu indicates that this concentration is suitable for culturing stem cells (claim 3; paragraph [0017]). Furthermore, because both Takagi and Liu teaches that cell culture media can comprise THPO, it could have been done with predictable results and a reasonable expectation of success.
In regards to the concentration of L-carnitine, as above, Fathi teaches that cells were supplanted with 0.5 mg/mL (500 µg/L) (Abstract, p18).
Together, this results in a weight (mass) ratio of 500 µg L-carnitine to 1 µg THPO, which is 500:1 and overlaps with the claimed range (see MPEP 2144.05, 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 re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
In regards to claim 3, as above, Takagi teaches a medium for growing human cells, including cells included in a process of differentiation of fertilized human eggs (which would include an oocyte) (claim 1).
In regards to the use of the preamble, “A composition for improving a quality of in vitro maturation of mammalian oocytes and a pregnancy rate of recipient mammalians after in vitro fertilization of the in vitro matured oocytes and embryo transfer”, this is an intended use of the composition.
According to MPEP 2111.02, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See also, See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation").
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, because the composition of Takagi is explicitly for cells included in a process of differentiation of fertilized human eggs (claim 2), which would include oocytes, and is at least capable of performing this intended use.
Continuing, Takagi teaches that medium comprises thrombopoietin (THPO) (claim 6).
Takagi does not explicitly teach that the medium comprises L-carnitine.
However, a person of ordinary skill in the art would have been motivated to supplement the media with L-carnitine because as taught by Fathi, oocytes supplemented with 0.5 mg/mL L-carnitine demonstrate higher developmental rates to morula and blastula stages, and therefore, recommends it use as a supplement for these cells/structures (Abstract, p18). Furthermore, because Fathi demonstrates that media for culturing oocytes can be supplemented with L-carnitine (In vitro oocytes maturation and staining, p19), a person of ordinary skill in the art could have supplemented the medium with L-carnitine with predictable results and a reasonable expectation of success.
In regards to the concentrations, the claim only requires that the various regents “are able” to make working concentrations “during in vitro culture.”
Therefore, the claim suggests that the composition can have different concentrations when at times other than during in vitro culture. This could read on a kit comprising THPO (at any concentration) and L-carnitine wherein the THPO and L-carnitine are mixed to create a working solution.
However, in as much claim 3 could be interpreted as requiring specific concentrations of THPO and L-carnitine,
In regards to THPO, as above, Liu teaches that THPO can be added to media for culturing stem cell types with 1-10 µg/L (claim 3; which is 0.001 to 0.01 µg/mL), which overlaps with the range of 0.001-5 µg/L as in claim 3.
As above, a person of ordinary skill in the art would have been motivated to use a concentration between the range of 1-10 µg/L because Liu indicates that this concentration is suitable for culturing stem cells (claim 3; paragraph [0017]). Furthermore, because both Takagi and Liu teaches that cell culture media can comprise THPO, it could have been done with predictable results and a reasonable expectation of success.
Additionally, as above, Fathi teaches that cells were supplanted with 0.5 mg/mL (500 µg/L) (Abstract, p18), which also overlaps with the claimed range.
Therefore, the combined teachings of Takagi, Liu, and Fathi renders the invention unpatentable as claimed.
Response to Arguments
Applicant argues that the Takagi et al. (US20050019910A1, 2005) in view of Pernes et al. (Bulletin UASVN Animal Sciences and Biotechnologies, 2016) and Liu et al. (US20160348065A1, 2016) as evidenced by Gradinaru et al. (Life, 2025) and Millipore Sigma (Iscove’s Modified Dulbecco’s Media (IMDM) formulation, retrieved from internet 01/30/2026) fails to show a composition that comprises L-carnitine and THPO or L-carnitine, THPO, and Vitamin C or its precursor in the claimed weight ratios or concentrations as in claims 2 and 3 (Remarks, p4-5).
Applicant’s arguments filed 04/22/2026 have been fully considered, but are not persuasive.
Takagi teaches a medium for growing human cells, including cells included in a process of differentiation of fertilized human eggs (which would include an oocyte) (claim 1).
As discussed above, in regards to the use of the preamble, “A composition for improving a quality of in vitro maturation of mammalian oocytes and a pregnancy rate of recipient mammalians after in vitro fertilization of the in vitro matured oocytes and embryo transfer”, this is an intended use of the composition.
According to MPEP 2111.02, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See also, See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation").
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, because the composition of Takagi is explicitly for cells included in a process of differentiation of fertilized human eggs (claim 2), which would include oocytes, and is at least capable of performing this intended use.
Continuing, Takagi teaches that medium comprises thrombopoietin (THPO) (claim 6).
Takagi does not explicitly teach that the medium comprises L-carnitine.
However, a person of ordinary skill in the art would have been motivated to supplement the media with L-carnitine because as taught by Fathi, oocytes supplemented with 0.5 mg/mL L-carnitine demonstrate higher developmental rates to morula and blastula stages, and therefore, recommends it use as a supplement for these cells/structures (Abstract, p18). Furthermore, because Fathi demonstrates that media for culturing oocytes can be supplemented with L-carnitine (In vitro oocytes maturation and staining, p19), a person of ordinary skill in the art could have supplemented the medium with L-carnitine with predictable results and a reasonable expectation of success.
In regards to the weight ratios as in claim 2 (it is noted that word weight has been interpreted as being synonymous with mass), in regards to the weight ratio THPO and L-carnitine, Takagi is silent as to this amount.
However, in regards to the concentration of THPO, Liu teaches that THPO can be added to media for culturing stem cell types with 1-10 µg/L (claim 3). A person of ordinary skill in the art would have been motivated to use a concentration between the range of 1-10 µg/L because Liu indicates that this concentration is suitable for culturing stem cells (claim 3; paragraph [0017]). Furthermore, because both Takagi and Liu teaches that cell culture media can comprise THPO, it could have been done with predictable results and a reasonable expectation of success.
In regards to the concentration of L-carnitine, as above, Fathi teaches that cells were supplanted with 0.5 mg/mL (500 µg/L) (Abstract, p18).
Together, this results in a weight (mass) ratio of 500 µg L-carnitine to 1 µg THPO, which is 500:1 and overlaps with the claimed range (see MPEP 2144.05, 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 re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
In regards to the concentrations in clam 3, as above, the claim only requires that the various regents “are able” to make working concentrations “during in vitro culture.”
Therefore, the claim suggests that the composition can have different concentrations when at times other than during in vitro culture. This could read on a kit comprising THPO (at any concentration) and L-carnitine wherein the THPO and L-carnitine are mixed to create a working solution.
However, in as much claim 3 could be interpreted as requiring specific concentrations of THPO and L-carnitine,
In regards to THPO, as above, Liu teaches that THPO can be added to media for culturing stem cell types with 1-10 µg/L (claim 3; which is 0.001 to 0.01 µg/mL), which overlaps with the range of 0.001-5 µg/L as in claim 3.
As above, a person of ordinary skill in the art would have been motivated to use a concentration between the range of 1-10 µg/L because Liu indicates that this concentration is suitable for culturing stem cells (claim 3; paragraph [0017]). Furthermore, because both Takagi and Liu teaches that cell culture media can comprise THPO, it could have been done with predictable results and a reasonable expectation of success.
Additionally, as above, Fathi teaches that cells were supplanted with 0.5 mg/mL (500 µg/L) (Abstract, p18), which also overlaps with the claimed range.
Therefore, the combined teachings of Takagi, Liu, and Fathi renders the invention unpatentable as claimed.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
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