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 application has been transferred and is now under examination by Valarie Bertoglio, AU 1632.
Election/Restrictions
Applicant's election with traverse of Group II, claims 12-19 in the reply filed on 09/24/2025 is acknowledged. The traversal is on the ground(s) that Applicant disagrees with the Examiner’s assertion that the groups are related as process of making and product made. Applicant argues that the groups are related as composition (Group II) and method of using the composition (Group I). This is not found persuasive because regardless of whether Group I is a method of making or a method of using the product, the two can be shown to be distinct if there are alternative methods (of either making or using the composition).
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the egg yolk powder can be used in cell culture as a media supplement or can be used in vivo as a food supplement to be consumed.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/24/2025.
Specification
The use of the term Fortetropin, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 14 is objected to because of the following informalities: Claim 14 appears to have typographical/grammatical errors. Line 2 appears as though it should read “…powder is included at an amount…”. Appropriate correction is required.
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 15 and 19 are 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.
Dependent claim 15 is unclear as to whether “egg yolk derived product” is required to be a powder or even egg yolk powder, as recited in independent claim 12. The term “derived” is not clear. If claim 15 is interpreted within the metes and bounds of claim 12, it must still be a powdered egg yolk. However, egg yolk derived product could also be anything that is from egg yolk such as purified follistatin protein. As well, the claim should read “yolk-derived”.
Claims 19 contains the trademark/trade name Fortetropin. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an egg yolk powder and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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) s 12-16 and 19 are rejected under 35 U.S.C. 102a1 as being anticipated by Joglekar (Regenerative Engineering and Translational Medicine (2020) 6:125–137).
Joglekar taught DMEM+10% FBS+1%P/S supplemented with fertilized chicken (avian, claim 16) egg yolk stock solution. The stock solution was made from frozen egg yolk, pulverized at -80◦C into a powder (referred to as Fortetropin®, see page 126, col. 2, claim 19), which was then dissolved in PBS. Thus, Joglekar meets the limitations of claims 12 and 15, Cell culture media (DMEM) comprising a composition (PBS) comprising egg yolk powder.
With regard to claim 13, requiring the powder be “optimized” for solubility in culture media, what constitutes “optimization” is not clearly set forth. However, Joglekar teaches that the powder was dissolved to a concentration of 50 mg/ml in PBS because of the ease of getting the yolk into solution prior to adding to the media. The egg yolk was added to the media to reach varying concentrations of 500mg/ml, 1 mg/ml, and 10 mg/ml. (see page 126, last two paragraphs). Claim 14 requires the yolk be added at an amount sufficient to promote growth. Figure 1 supports that the number of viable cells increased over 7 days in the presence of 500mg/ml yolk in culture medium.
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.
Claims 12 and 17-18 is/are rejected under 35 U.S.C. 103 as being obvious over Joglekar (Regenerative Engineering and Translational Medicine (2020) 6:125–137) in view of US 12,251,405 (Dariani), US 8,815,320 (Buxmann) and Rannou (Journal of Food Engineering 154 (2015) 58–68).
Joglekar meets the limitations of claim 12 as set forth above. Joglekar does not teach high pressure pasteurization prior to freeze drying. However, Dariani teaches multiple means for preservation of powdered egg yolk. Dariani states, “In one nonlimiting embodiment, the preservation step comprises subjecting the biological source for follistatin … to a pressure of at least 4000 bar, for at least 1 minute, preferably to 5500-6500 bar, more preferably to 6000 bar for at least 1 minute…” see col 2, lines 63-66. Dariani teaches that freeze drying (claim 17) maintains active follistatin, a protein that benefits muscle growth. Dariani also teaches that contrary to previous findings, the egg yolk can be spray/heat dried while preserving follistatin activity (col. 2, lines 4-8).
Buxmann teaches,
It was found that the high pressure treatment and/or the pulsed electric field treatment of liquid whole egg, liquid egg white, preferably of liquid egg yolk effectively reduces the bacterial contamination by a factor of at least 10, preferably by a factor of at least 100, more preferably of at least 1000. For example, for high pressure treatment, a reduction of the bacterial contamination to about 50 CFU/g, corresponding to a reduction by a factor of 3000 was found when starting from raw liquid egg yolk having a natural bacterial content of 1.5.times.10.sup.5 CFU/g. For pulsed electric field treatment, a reduction by a factor of 10 to a factor of 1000 was found. The reduction of the natural microbiological contamination by the high pressure treatment and/or the pulsed electric field treatment is sufficient for preserving the egg white, whole egg or egg yolk. Column 2
Rannou also teaches pasteurization followed by spray-drying under multiple conditions (see section 2.1). Rannou teaches how different preservation techniques can alter the properties of the final preserved egg yolk product (see discussion). For example, heat can decrease protein solubility, which could be damaging or beneficial, depending on desired purpose of the product.
It would have been obvious at the time of filing to preserve egg yolk powder through numerous combinations of methods including high pressure pasteurization as taught by Buxmann and freeze drying (to avoid application of heat) as taught by Dariani or through spray drying, as taught by Rannou to arrive at the invention as claimed. One would have been motivated to vary to conditions based on desired output characteristics as supported by Rannou. One would have had a reasonable expectation of success in carrying out the claimed combination because the various treatments and their effects on the resulting powder had been revealed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALARIE BERTOGLIO whose telephone number is (571)272-0725. The examiner can normally be reached M-F 6AM-2:30PM.
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/ Primary Examiner, Art Unit 1632