Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Allowability Withdrawn
The indication of allowability of claims 31, 32, 46, and 50 set forth in the previous action is withdrawn and prosecution is reopened in view of the following new grounds of rejection.
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35
U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Claim Status
Original patent claims 1-20 and new claims 31, 32, 35, 46-48, and 50 are pending after entry of the amendment filed 18 November 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 46-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 46 recites a nutrition bar comprising “whey protein comprising insoluble whey protein particles having a volume weighted mean particle size D(4.3) of less than 10 micron” and “a hardness from 400 to 100 g…” While Figure 10 and the description thereof (col.27, lines 62-63) does indeed support a whey protein produced by the reactor comprising insoluble whey protein particles having a volume weighted mean particle size D(4,3) of less than 10 micron, it is clear that this is the particle size prior to drying. After drying, the particles sizes are disclosed to be much larger, as shown in Figure 3. Thus, the disclosure does not support a nutrition bar having a particle size, as dried, of less than 10 micron. Accordingly, it is suggested to amend line 4 of claim 46 to include the phrase “prior to drying” after “less than 10 micron.”
Additionally, Figures 4 and 5 do not illustrate a hardness as low as 400 g nor does the description describe such. However, the Figures do show a hardness as low as about 500 g ranging beyond and including about 1100 g. The Examiner suggests amending the hardness range to read “about 500 to about 1100g.”
Claims 47 and 48 are likewise rejected as being dependent on claim 46 and including all the limitations thereof.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 31, 32, 35, and 50 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2011/0046048 to Minor et al. (hereinafter Minor) in view of WO 2006/058538 to Oldrup (hereinafter Oldrup).
With respect to claim 31, Minor teaches a high protein drinking yogurt. For example, para [0136] discloses “[y]oghurt like products with a pH less than pH 4.2” produced from the ingredients of composition A1 were heat treated using different methods and temperatures to produce various compositions. See para [0136]. The products are shown in Table 2 as Experimental Examples 1 and 2. It is noted that the instant patent under reissue (US 10,888,100) describes yoghurt as “an acidic or fermented food or beverage product prepared from a dairy resource, and either viable micro-organisms or chemical acidulants or both. For the purposes of this invention yoghurt also refers to yoghurt-like products that may include non-dairy derived lipids, flavourings and food-approved stabilisers, acids and texturizers.” See col.8, line 66 to col.9, line 5. Thus, the yoghurt-like drink composition of Minor is a drinking yoghurt according to the instant invention.
Further, as described in Table 1 and Example 1 of Minor (paras [0130-0131]), the composition of A1 contains 12g/100 ml of whey (WPC) protein (12% w/v protein) and the protein has a D(4,3) particle size of less than 10 micron. Minor discloses that the process of heat treatment of the whey denatures the protein (para [0039]) but does not teach the percentage of denaturable proteins that are denatured.
Oldrup also discloses a high (whey) protein composition produced by heat treatment and suggests the degree of denaturing should be optimized to be above 70% by weight where a high temperature treatment such as UHT follows the denaturing step, in order to avoid further denaturing caused by the high temperature treatment. Oldrup further recognizes that the degree of denaturing is dependent upon the heating temperature and heating time. See page 6, line 31 to page 7, line 7. It would have been obvious to optimize the heating time and temperature in the process of Minor in order to achieve a degree of denaturing of at least 70% as Minor discloses that it is necessary to pasteurize or sterilize the compositions, using a method such as UHT, as a final step. See para [0107]. Such a high degree of denaturing would have prevented further denaturing by the UHT sterilizing process.
As to claims 32 and 50, Minor teaches “a sufficiently low viscosity to allow the composition to be easily consumed orally or be administered by tube.” See para [0021]. Suggested viscosities are those lower than 500 mPa·s at a shear rate of 100 s-1, with viscosities below 50 mPa·s being preferred. Minor does not measure the viscosity at a shear rate of 50 s-1 but does disclose that the recited viscosity “is ideal for orally administering the liquid enteral nutritional composition” (emphasis added; para [0100]). As the compositions of both Minor and the instant claims are orally administered or drinkable, the viscosity of Minor when measured at 50 s-1 would have necessarily been within the claimed range of less than 600 mPa·s.
With respect to claims 35 and 50, Minor discloses that whey proteins comprise “at least 85 weight%...of the total protein present in the liquid nutritional composition.” See para [0083].
Allowable Subject Matter
Claims 1-20 are allowed for the reasons set forth in the previous office action.
Protest
A protest against issuance of a patent based upon this reissue application has been filed under 37 CFR 1.291(a) on 17 September 2025, and a copy has been served on Patent Owner. Patent Owner stated in the Response filed 18 November 2025 (see page 9) that “for the record that it disagrees with the positions espoused in the Protest, including that any pending claims lack support in the originally filed specification and that any combination of documents cited therein render any pending claims obvious.”
All references submitted in the Protest have been fully considered.
On pages 5-7, Protester argues that the original disclosure fails to support the recitation of a volume weighted mean particle size D(4,3) of less than 10 micron, as set forth in claims 1 and 21. However, Figure 4 discloses a denatured whey particle prior to drying as produced by the method of the invention, wherein the D(4,3) particle sizes are less than 10 micron. See col.12, lines 35-47. Further, Figure 10 illustrates particles having a D(4,3) particle size of less than 10 micron produced by the reactor of the invention. See col.27, lines 60-63. Figure 10 specifically shows D(4,3) particle sizes ranging from near 0 to 40 micron, with the bulk of the particles falling below about 6 micron. The claims are directed to the compositions described by Figures 4 and 10 and containing particles having a D(4,3) diameter of less than 10 micron. Thus, the disclosure (Figures 4 and 10) discloses a broader range than that which is claimed, and specific values within the broader range. These facts mirror those in In re Wertheim, 541 F.2d 257, 262 (CCPA 1976) where the rejected patent application claims recited a range (solids content of “between 35% and 60%”) while the specification disclosed a broader range (“concentrated … until a concentration of 25 to 60% solid matter is reached”), along with specific embodiments (solids content of 36% and 50%). In concluding that Wertheim’s specification supported the claimed range, even though the precise range was not repeated verbatim in the specification, the CCPA opined that “persons skilled in the art would consider processes employing a 35–60% solids content range to be part of [Wertheim’s] invention and would be led by the [specification’s] disclosure so to conclude.” Id at 265.
Further, the specification need not expressly recite the claimed range for support. Written description of claimed subject matter may be found in figures as well the written disclosure. “An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997).
On page 8 of the Protest, it is argued that the disclosure fails to provide support for claims 27 and 46. Claim 27 has been canceled by the amendment of 18 November 2025 and claim 46 has been rejected under 35 USC 112(a).
As to the argument presented on page 8 of the Protest regarding claim 47, this claim has been previously amended such that limitation argued is no longer present.
On page 9 of the Protest, Protester states that claims 22-47 should be rejected under 35 USC §103 over prior art to Minor, Rowney, and Merrill. Specifically, Protester argues that claims 21-23 and 26-40 are obvious over Minor; claims 24 and 25 are obvious over Minor in view of Rowney; and claims 41-45 are obvious over Merrill in view of Minor. Protestor did not present any art or proposed rejection of claims 46 and 47. See pages 23-24 of the Protest.
Of the above listed claims, claims 21-30, 33, 34, 36-45, and 49 were canceled by the amendment of 18 November 2025, leaving claims 31, 32, 35, 46-48, and 50 pending. The Examiner has rejected claims 31, 32, 35, and 50 under 35 USC §103 over Minor in view of Oldrup.
Conclusion
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 10,888,100 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Any inquiry concerning this communication or earlier communications from the
Examiner should be directed to ELIZABETH MCKANE whose telephone number is
(571) 272-1275. The examiner can normally be reached on Mon-Thurs; 6:30 am -
4:30 pm.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's
supervisor Patricia Engle can be reached on 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELIZABETH L MCKANE/Specialist, Art Unit 3991
Conferees:
/LEE E SANDERSON/ /Patricia L Engle/Reexamination Specialist, Art Unit 3991 SPRS, Art Unit 3991