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 responsive to communications on 01/15/2026 are pending.
Claims 2 and 3 have been 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Withdrawn Objections & Rejections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 Any objections or rejections not specifically reiterated are hereby withdrawn.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 prior rejection of the claims under 35 UCS 103 as being unpatentable over Malcuit et al. (US20110274662A1, 2011) is withdrawn upon reconsideration of the claims and in order to incorporate Takagi et al. (US20050019910A1, 2005), Pernes et al. (Bulletin UASVN Animal Sciences and Biotechnologies, 2016), and Liu et al. (US20160348065A1, 2016) as discussed below.
The objection to claims 2 and 3 is withdrawn upon reconsideration of the claims and in order to incorporate Takagi et al. (US20050019910A1, 2005), Pernes et al. (Bulletin UASVN Animal Sciences and Biotechnologies, 2016), and Liu et al. (US20160348065A1, 2016) as discussed below.
Because the previous Final Rejection on 10/15/2025 has been withdrawn, the instant office action is non-final.
Response to Arguments
Applicant argues that claims 2 and 3 have been rewritten in independent form, contain all of the limitations, of the previously objected to claim, and therefore, should be allowed (Remarks, p4).
Applicant’s arguments with respect to claims 2 and 3 have been considered but are moot because, as discussed above, upon reconsideration of the claims and in order to incorporate Takagi et al. (US20050019910A1, 2005), Pernes et al. (Bulletin UASVN Animal Sciences and Biotechnologies, 2016), and Liu et al. (US20160348065A1, 2016) (as discussed in depth below), the objections to claims 2 and 3 have been withdrawn.
Applicant traverses the rejection of the claims under 35 UCS 103 over Malcuit et al. (US20110274662 A1) (Remarks, p4).
Applicant’s arguments with respect to claims 2 and 3 have been considered but are moot because, as discussed above, upon reconsideration of the claims and in order to incorporate Takagi et al. (US20050019910A1, 2005), Pernes et al. (Bulletin UASVN Animal Sciences and Biotechnologies, 2016), and Liu et al. (US20160348065A1, 2016) (as discussed in depth below), the rejection of the claim under 35 UCS 103 over Malcuit et al. (US20110274662 A1) have been withdrawn.
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 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).
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).
In regards to Vitamin C or precursor thereof, as evidenced by Gradinaru, glucose is a Vitamin C (L-ascorbate) precursor (Fig. 6, p13).
A person of ordinary skill in the art would have recognized that mammalian cells require glucose in culture, and indeed, Takagi teaches the medium comprises nutrients for supporting cell growth and maintenance (paragraph [0011]), which again, a person of ordinary skill in the art would have recognized suggests glucose. Indeed, Takagi also gives Iscove media as an example (paragraph [0012]), which as evidenced by Millipore Sigma comprises glucose (third page).
In regards to Vitamin C (also commonly referred to as ascorbate or ascorbic acid), while Takagi teaches that it is well known in the art that culture media is supplemented with vitamins (paragraph [0002]), Takagi is silent on whether the media comprises Vitamin C specifically.
However, a person of ordinary skill in the art would have been motivated to include Vitamin C specifically because Pernes teaches that Vitamin C supplementation increases meiosis resumption and maturation rates of oocytes (Abstract, p230; Results and Discussion, p232-233; Table 1, p232).
Additionally, because Pernes teaches that oocyte media can be supplemented with Vitamin C at varying concentrations (Table 1, p232) and because as above, Takagi teaches that it is known in the art that media can be supplemented with vitamins (and indeed, teaches that media can be supplemented with at least L-ascorbic acid phosphate ester (paragraph [0032]), which is a known Vitamin C derivative), it could have been done 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 of vitamin C or its precursor to the THPO, Takagi is silent as to weight ratios of THPO and vitamins or nutrients.
However, in regards to the concentrations of the Vitamin C, Pernes teaches that oocytes can be supplemented with Vitamin C at concentrations ranging from at least 50 to 750 µM (Table 1, p232). When converted to µg/L, 50 µM Vitamin C has a concentration 8806 µg/L (Vitamin C has a molar mass of 176.12 g/mol, concentration (C) = 50 µM = 50 µmol/L; C = 50 µmol/L x (1 mol /106 µmol) = 5 x 10-5 mol/L; Mass Concentration = C x mass; thus, 5 x 10-5 mol/L x 176.12 g/mol = 0.008806 g/L, which is 8806 µg/L).
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.
Concentrations of 8806 µg/L Vitamin C and 10 µg/L THPO would results in a Vitamin C to THPO weight ratio of 880:1, which overlaps with the range as in claim 1 (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).
In regards to Vitamin C or precursor thereof, as evidenced by Gradinaru, glucose is a Vitamin C (L-ascorbate) precursor (Fig. 6, p13).
A person of ordinary skill in the art would have recognized that mammalian cells require glucose in culture, and indeed, Takagi teaches the medium comprises nutrients for supporting cell growth and maintenance (paragraph [0011]), which again, a person of ordinary skill in the art would have recognized suggests glucose. Indeed, Takagi also gives Iscove media as an example (paragraph [0012]), which as evidenced by Millipore Sigma comprises glucose (third page).
In regards to Vitamin C (also commonly referred to as ascorbate or ascorbic acid), while Takagi teaches that it is well known in the art that culture media is supplemented with vitamins (paragraph [0002]), Takagi is silent on whether the media comprises Vitamin C specifically.
However, a person of ordinary skill in the art would have been motivated to include Vitamin C specifically because Pernes teaches that Vitamin C supplementation increases meiosis resumption and maturation rates of oocytes (Abstract, p230; Results and Discussion, p232-233; Table 1, p232).
Additionally, because Pernes teaches that oocyte media can be supplemented with Vitamin C at varying concentrations (Table 1, p232) and because as above, Takagi teaches that it is known in the art that media can be supplemented with vitamins (and indeed, teaches that media can be supplemented with at least L-ascorbic acid phosphate ester (paragraph [0032]), which is a known Vitamin C derivative), it could have been done with predictable results and a reasonable expectation of success.
In regards to the limitation wherein “an amount of Vitamin C or its precursor is able to make a working concentration of vitamin C reach 0.5-500 µg/mL, etc.”, it is noted that claim 3 is a composition, not a method, and the claim does not require method steps of culturing. Furthermore, 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 Vitamin C or a precursor thereof and THPO (at any concentration) wherein the Vitamin C or a precursor thereof and THPO are mixed to create a working solution.
However, in as much claim 3 could be interpreted as requiring specific concentrations of Vitamin C or a precursor thereof and THPO, in regards to Vitamin C, as above, C, Pernes teaches that oocytes can be supplemented with Vitamin C at concentrations ranging from at least 50 to 750 µM (Table 1, p232). As above, when converted µg/L, 50 µM Vitamin C has a concentration 8806 µg/L (or 8.806 µg/mL), which overlaps with the range of 0.5 to 500 µg/mL as in claim 3.
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.
Therefore, the combined teachings of Takagi, Pernes, and Liu renders the invention unpatentable as claimed.
Conclusion
No claims are allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH PAUL MIANO/Examiner, Art Unit 1631