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 .
This action is responsive to papers filed 12/29/2025.
Claims 7-8, 10-12, 14, 26-29, 32-34, 39, 41, and 43 have been amended.
No claims have been newly canceled and claims 47-57 have been newly added.
Claims 7-8, 10-12,14 ,18-19, 23, 26-29, 32-39, 41, 43, and 45-57 are currently pending.
Claims 18-19, 23, 26-29, 32-39, 41, 43, 45-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/18/2025.
Claims 7-8, 10-12, 14, and 47-57 have been examined on their merits.
Claim Interpretation
Applicant has defined the term “consisting essentially of” as “including the components specified but excluding other components except for materials present as impurities, unavoidable materials present as a result of processes used to provide the components, and components added for a purpose other than achieving the technical effect of the invention” (page 10 of the Specification).
The transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s) of the claimed invention. A “consisting essentially of” claim occupies a middle ground between closed claims that are written in a consisting of format and fully open claims that are drafted in a comprising format. For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” See MPEP 2111.03 and 2163.
Regarding claim 8, the limitation of “free yolk granules” is interpreted as the addition of separated (free) egg yolk granules that are not already present in the egg yolk extract.
Regarding claims 53-57, the reference to cell culture medium in these claims refers to the intended use of the egg yolk extract of claim 7 with a cell culture medium. They do not impart any structure to the egg yolk extract. 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 7, 10-12, 14 and 47-57 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Roder (US 4,454,227-from IDS filed 02/17/2023) as evidenced by Offen (US 2019/0029236).
Regarding claims 7, 10-12, 47, Roder disclose an egg yolk extract that supports cell proliferation and survival at least equivalent to FBS when used at the same concentration in a cell culture medium (column 1 line 55- column 2 line 55). The egg yolk must not necessarily be separated from the egg white and thus whisked eggs are suitable (lysed yolk sphere and homogenized egg yolk and egg white, includes egg white proteins) (column 1 line 68 to column 2 line 2). Since whisked eggs will include a mixture of egg yolk and egg white, the proteins found in egg whites will inherently be present and include ovalbumin, ovotransferrin, lysozyme and ovoinhibitor as evidenced by Offen (US 2019/0029236, page 16 para 200). A commercial egg yolk emulsion is also described (lysed yolk spheres and homogenized egg yolk) (column 2 lines 2-3).
Regarding claims 14, 48-51, Roder disclose wherein the egg yolk extract is extracted preferably from a hen’s egg, but also from duck or goose eggs (column 2 lines 4-7).
Regarding claim 52, the egg yolk extract is used in a liquid solution so it is deemed to be in liquid form (column 2 lines 51-55).
Regarding claims 53-57, The egg yolk extract is disclosed as suitable for use in a culture medium. The limitations with regard to the cell culture medium are all deemed to be intended use limitations for the egg yolk extract and do not directly relate to the structure or function of the egg yolk extract. Roder discloses that their egg yolk extract is suitable for use at various concentrations, specifically 1%, and can be used instead of FCS and does not require DMSO (column 1-2, Table 1).
Therefore, the teaching of Roder anticipates Applicant’s invention as claimed.
Claim(s) 1, 8, 14, 48-57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elhassan et al (Animal Reproduction Sciences, 1999).
Regarding claim 1, Elhassan disclose an egg yolk extract product that supports cell proliferation and/or survival at least equivalent to FBS when used at the same concentration in a cell culture medium wherein the egg yolk extract comprises lysed egg yolk spheres (abstract, page 155- section 2.1-preparation of EY, yolk granules and yolk plasma, page 158-section 3 -results, page 159, Table 3). The egg yolk extract is shown to be comparable (at least equivalent to) FCS (aka FBS) when used at the same concentration in a cell culture medium (page 158-159, Table 2).
Regarding claim 8, Elhassan disclose an egg yolk extract product (YP) that further comprises free yolk granules (YG) (page 159, experiment 3, Table 3, YP + YG).
Regarding claims 14, 48-51, Elhassan disclose wherein the egg yolk is obtain from the egg of a chicken (avian) (page 155-section 2.1).
Regarding claim 52, Elhassan disclose wherein the egg yolk extract is part of a liquid (solution) (Title, abstract, page 156, section 2.4, page 157-section 2.5.1.3, section 2.5.2.1, section 2.5.2.2 for example).
Regarding claims 53-57, The egg yolk extract is disclosed as suitable for use in a culture medium. The limitations with regard to the cell culture medium are all deemed to be intended use limitations for the egg yolk extract and do not directly relate to the structure or function of the egg yolk extract. Elhassan discloses that their egg yolk extract is suitable for use at various concentrations, specifically 2.5% or 5%, and can be used instead of FCS and does not require DMSO (abstract, pages 158-159, section 3-results).
Therefore, the teaching of Elhassan et al anticipate Applicant’s invention as claimed.
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) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Roder (US 4,454,227-from IDS filed 02/17/2023) as evidenced by Offen (US 2019/0029236) and in view of Huang et al (Journal of Food Science 2019-from IDS filed 12/29/2025).
Regarding claim 8, Roder teach an egg yolk extract as described above, but do not specifically teach further comprising free yolk granules in their egg yolk extract composition. The limitation of “free yolk granules” is interpreted as the addition of separated (free) egg yolk granules not already present in the egg yolk extract.
Huang teach that the egg yolk granule fraction has proteins, lipids, low cholesterol content, good emulsifying properties and heat resistance and can be used to develop a food product with high emulsion stabilizing property (page 206, column 1). Huang specifically indicate that the egg yolk or whole egg products can be used to prevent or cure specific diseases in animal production and aquaculture (pages 205 206, end of column 2 to beginning of column 1).
One of ordinary skill in the art would have been motivated to further include free yolk granules in the egg yolk extract of Roder because Huang teach that the egg yolk granule fraction has proteins, lipids, low cholesterol content, good emulsifying properties and heat resistance and can be used to develop a food product with high emulsion stabilizing property. One of ordinary skill in the art would have had a reasonable expectation of success because Huang specifically indicate that the egg yolk or whole egg products can be used to prevent or cure specific diseases in animal production and aquaculture and Roder is drawn to an egg yolk product intended to provide nutrition to cells.
Therefore, the combined teachings of Roder and Huang et al render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive. Applicants’ arguments have been addressed in so far as they relate to the rejections above.
Applicant argues that Roder does not teach the limitation of an egg yolk extract that comprises lysed yolk spheres.
This is not found persuasive. Roder disclose multiple embodiments for their egg yolk extract composition including “the egg yolk must not necessarily be separated from the egg white, suitable are therefore also whisked eggs, for example” (column 1 line 68- column 2 line 2). The whisking of eggs is a mixing of the egg yolk and the egg white such that they are blended together into a mixture. Whisking eggs breaks down the viscous, distinct structures of whites and yolks (breaking down yolks lyses them), blending them into a uniform, homogenous liquid. In addition, Roder disclose wherein one embodiment of their egg yolk product includes a commercial egg yolk emulsion (column 2 lines 2-3). An egg yolk emulsion is a product wherein the egg yolk has been broken down and mixed into an emulsified composition. The emulsification process breaks the yolk and thus causes lysis of the egg yolk.
Applicant argues that Roder is limited to fetal calf serum (FCS) and that this is not the same as fetal bovine serum (FBS). Applicant asserts that FBS is limited to use with mammalian cells and that FCS is limited to cultivation of insect cells. Applicant asserts that Roder fails to teach the use of an FBS alternative and fails to teach the cultivating of any other cell type (e.g. mammalian cells).
This is not found persuasive. First, the claims are drawn to a product and not a method of use. The recitation of FBS in the claims has to do with a property of the claimed egg yolk extract in comparison to a property of FBS and does not require the presence of FBS in the claimed composition. Second, FBS and FCS are known in the art of cell culture as synonyms for the same serum product obtain from the fetus of a cow (bovine) as evidenced by Hernandez et al (US 2010/0227819). Hernandez state that “culture media usually contained up to about 10% of animal serum, such as fetal bovine serum (FBS), also called fetal calf serum (FCS)” (page 1 para 5). Third, intended use limitations are only given patentable weight in that they require that the claimed product is in a format suitable for such intended use. As long as the reference product is in a form suitable for such intended use then the claimed intended use limitations are deemed to be met.
Applicant argues that there is no teaching in Roder of FBS or use of the egg yolk for supporting cell proliferation and/or survival at least equivalent to FBS when used at the same concentration in a cell culture medium as claimed. Applicant again asserts that fetal bovine serum and fetal calf serum are not the same thing.
This is not found persuasive. Roder specifically state “for preparing a nutrient medium suitable for cell culture, only about 5 to 20% of the FCS amount of egg yolk is required” (column 1 lines 65-68). The fact that less concentration of egg yolk as compared to FCS is needed for cell culture means that the reference egg yolk product is supporting cell proliferation and/or survival at least equivalent (and better than) the same concentration of FCS (FBS). In addition, as stated above, it is well known in the art of cell culture that FBS and FCS are used interchangeably to refer to the same serum product that is obtained from fetal cows (bovine) as evidenced by Hernandez et al (US 2010/0227819).
Hernandez state that “culture media usually contained up to about 10% of animal serum, such as fetal bovine serum (FBS), also called fetal calf serum (FCS)” (page 1 para 5).
Applicant argues that because Roder indicate a preference for commercial egg yolk emulsion in their disclosure that Roder does not teach the claimed invention. Applicant asserts that commercial egg yolk emulsion is not the lysed yolk spheres and homogenized egg yolk as alleged in the last Office Action. Applicant argues that the commercial egg yolk emulsion embodiment of Roder is limited to use for the culture of bacteria and microorganisms.
This is not found persuasive. First, Roder disclose multiple embodiments for their egg yolk extract composition including “the egg yolk must not necessarily be separated from the egg white, suitable are therefore also whisked eggs, for example” (column 1 line 68- column 2 line 2). The whisking of eggs is a mixing of the egg yolk and the egg white such that they are blended together into a mixture. Whisking eggs breaks down the viscous, distinct structures of whites and yolks (breaking down yolks lyses them), blending them into a uniform, homogenous liquid. Second, the indication in a reference of the preference for one embodiment does not negate the teaching of additional embodiments within that reference.
Applicant argues that their specification as filed describes processes to lyse the egg yolk spheres and points to examples recited in the specification at page 4 lines 24-25. Applicant asserts that the whisked eggs taught by Roder would not result in lysis of the egg yolk spheres as claimed. Applicant argues that Roder does not teach lysing egg yolk spheres in their disclosure and that Roder is silent with regard to lysis in general. Applicant asserts that based on the teachings of Roder that one of ordinary skill in the art is not led to the isolation of egg yolk spheres or the lysis thereof for inclusion in a cell culture medium as presently claimed.
This is not found persuasive. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In the current case, the claims do not require a specific degree of lysing of the egg yolks and thus any manner of breaking the egg yolk apart that allows for the product to be used in a cell culture method is deemed to meet the limitation of lysed egg yolk spheres. The whisking of eggs is a mixing of the egg yolk and the egg white such that they are blended together into a mixture. Whisking eggs breaks down the viscous, distinct structures of whites and yolks (breaking down yolks lyses them), blending them into a uniform, homogenous liquid.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of non-anticipation and nonobviousness fails to outweigh the evidence of anticipation and obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hernandez et al., “Serum-free Cell Culture Medium for Mammalian Cells”, US 2010/0227819, see page 1 para 5.
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 LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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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.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631