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 Claims
Due to communications filed 12/13/24, the following is a non-final first office action. Due to a preliminary amendment filed 12/13/24, claims 1-15 are amended. Claims 1-15 are pending in this application and are rejected as follows. The previous rejection has been modified to reflect claim amendments.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “means of an access opening” in lines 5-6 of claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objection
Claim 1 is objected to because of the following informalities: The limitation “each individual case” in line 17 of claim 1 should read as “each individual case of said plurality of cases”. 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.
Claim 15 is 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.
With regard to claim 15, this claim is rejected as being indefinite. Claim 15 recites, “A kit for the distribution of food products according to claim 1.” There is insufficient antecedent basis for the limitation “the distribution of food products”. For examination purposes the examiner will interpret the claim to recite, “A kit, said kit comprising said box of claim 1, a jug, and a mixer.
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)(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) 1-9, 11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by (DE 202004011103 U1).
As per claim 1, (DE 202004011103 U1) discloses:
A box for supplying food products for dysphagic users, (See Fig. 1);
said box comprising:
- a plurality of cases organized in layers, each case of said plurality of cases containing at least one food product to be supplied to a dysphagic user and which can be picked up by means of an access opening, (See Fig. 1, [1-3]);
- a container which defines at least one housing compartment of said plurality of cases and a pickup opening, (See Fig. 1, [4]);
Wherein - said plurality of cases of first set are distributed in a respective first layer;- said plurality of cases of a second set are distributed in a respective second layer, (See Fig. 1, [3] (shows multiple layers));
and
- said first layer is positioned between said pickup opening and said second layer, (According to the embodiment in 1 is a first dosing carrier ( 1 ) for holding preparation elements ( 2 ) designed as a blister pack. On the first dosing carrier ( 1 ) is a daily ration of preparation elements ( 2 ) arranged with day phases. Seven first dosing carriers ( 1 ) are in the area of a second dosing carrier ( 3 ) positionable);
each individual case is picked up at a first time range and a case adjacent thereto is picked up at a second time range, subsequently to the first time range, (The Blister packs are typically packaged in a cardboard box realized outer packaging transported and stored. at many preparations it is necessary depending on the time a predetermined dosage - e.g. in the morning, at noon, in the evening; task of the present invention is an introductory device mentioned type in such a way that removal of the preparation elements is supported according to a predefinable chronological order.).
For purposes of this rejection, Examiner interprets that the limitations of this claim are no more than non-functional descriptive material. Claiming the term “dysphagic” is non-functional descriptive data, and therefore is given little patentable weight.
As per claim 2, (DE 202004011103 U1) discloses:
wherein said first set of cases picked up at a first time range, and said second set of cases picked up at a second time range, subsequently to said first time range, (The Blister packs are typically packaged in a cardboard box realized outer packaging transported and stored. at many preparations it is necessary depending on the time a predetermined dosage - e.g. in the morning, at noon, in the evening; task of the present invention is an introductory device mentioned type in such a way that removal of the preparation elements is supported according to a predefinable chronological order.).
As per claim 3, (DE 202004011103 U1) discloses:
at least one package leaflet associated with one of said sets of cases and positioned between one of said sets of cases and said pickup opening , said package leaflet bearing at least one piece of information instruction concerning the-products contained in said relevant set of cases, (The first dosing carrier ( 1 ) is of dividing lines ( 5 ) divided into three sections. Through the dividing lines ( 5 ) a delayed intake of the preparation elements can be supported. For example, taking a first group of preparation elements ( 2 ) in the morning, a second group at noon and a third group in the evening. The delayed intake can also be supported by suitable imprints).
As per claim 4, (DE 202004011103 U1) discloses:
at least a first package leaflet associated with said first set of cases and a second package leaflet associated with said second set of cases , (The first dosing carrier ( 1 ) is of dividing lines ( 5 ) divided into three sections. Through the dividing lines ( 5 ) a delayed intake of the preparation elements can be supported. For example, taking a first group of preparation elements ( 2 ) in the morning, a second group at noon and a third group in the evening. The delayed intake can also be supported by suitable imprints);
said first package leaflet being positioned between said pickup opening and said first layer said second package leaflet being positioned between said first layer and said second layer, (According to the embodiment in 1 is a first dosing carrier ( 1 ) for holding preparation elements ( 2 ) designed as a blister pack. On the first dosing carrier ( 1 ) is a daily ration of preparation elements ( 2 ) arranged with day phases. Seven first dosing carriers ( 1 ) are in the area of a second dosing carrier ( 3 ) positionable);
As per claim 5, (DE 202004011103 U1) discloses:
characterized by the fact that wherein each of said sets of cases comprises at least a first case intended to be opened at a first time period, and a second case intended to be opened at a second time period, subsequently to said first time period, ((The first dosing carrier ( 1 ) is of dividing lines ( 5 ) divided into three sections. Through the dividing lines ( 5 ) a delayed intake of the preparation elements can be supported. For example, taking a first group of preparation elements ( 2 ) in the morning, a second group at noon and a third group in the evening. The delayed intake can also be supported by suitable imprints);; at many preparations it is necessary depending on the time a predetermined dosage - e.g. in the morning, at noon, in the evening);
and said first case and said second case being arranged side by side to
make said relevant layer, (See Fig. 1, [3]).
As per claim 6, (DE 202004011103 U1) discloses:
wherein said plurality of cases comprises:- a third set of cases intended to be picked up at a third time range, subsequently to said second time range, and- a fourth set of cases intended to be picked up at a fourth time range, subsequently to said third time range, (See Fig 1, [3]).
As per claim 7, although (DE 202004011103 U1) doesn’t specifically disclose wherein each set of cases comprises seven cases, it would have been obvious to one having ordinary skill in the art at the time the invention was made to repeat the steps of the invention at a subsequent predetermined time, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
As per claim 8, (DE 202004011103 U1) discloses:
wherein said first time range or said second time range lasts one week and said first time
period or said second time period lasts one day, (It is particularly possible in the area of the first Dosierträgers all preparation elements to position that to take on a given day as well are scheduled at a certain time of day. With an arrangement of the first seven dosing carriers in the area of a second dosage carrier there are weekly rations provided.).
As per claim 9, (DE 202004011103 U1) discloses:
wherein at least one of said cases has an identifying element adapted to identify said case and/or the a time period when said case has to be opened, (See Fig. 1).
As per claim 11, although (DE 202004011103 U1) don’t specifically disclose wherein each of said cases contains seven sachets or multiples thereof, it would have been obvious to one having ordinary skill in the art at the time the invention was made to repeat the steps of the invention at a subsequent predetermined time, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim Rejections - 35 USC § 103
3. 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.
4. 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.
Claim(s) 10, 12, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over (DE 202004011103 U1), and further in view of (JP 3798913 B2).
As per claim 10, (DE 202004011103 U1) does not disclose:
wherein each of said cases contains at least one sachet containing a different food product in the a form of powdered food composition.
However, (JP 3798913 B2) discloses in: ([0031] Furthermore, the thickening additive solution obtained according to the present invention is preferably used for the purpose of adding to a food for persons with difficulty in chewing / swallowing to prevent aspiration. For such applications, the thickening additive solution is preferably subdivided into either a portion container or a sachet).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to include the above limitations as taught by (JP 3798913 B2) into the teachings of (DE 202004011103 U1) since the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 12, (DE 202004011103 U1) does not disclose:
wherein said powdered food composition is dissolvable in a reconstitution liquid to obtain a dish having a degree of viscosity between 0 and 4 on the IDDSI scale,
However, this limitation is obvious with [0010] of JP 3798913 B2 since this reference discloses: “further, the additive solution for thickening according to the present invention can be supplementarily added to foods of persons with difficulty in chewing / swallowing to obtain nursing foods and training foods that express the desired viscosity and gel properties in a short time”, which is consistent with the IDDSI’s 0-4 viscosity (levels 0 through 4 represents a fluid-focused food).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to include the above limitations as taught by (JP 3798913 B2) into the teachings of (DE 202004011103 U1) since the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 14, (DE 202004011103 U1) discloses:
- having a plurality of cases contained in a container, (See Fig. 1);
wherein each of said cases comprises:
at least one identifying element adapted to identify said case, and/or the time period in which said case has to be opened, (See Fig. 1);
wherein said plurality of cases comprise a first set of cases and a second set of cases, (Fig. 1, [multiple cases are seen stacked inside of the container);
and wherein said cases of said first set are distributed in a respective first layer and said cases of said second set are distributed in a respective second layer, (See Fig. 1, [3] (shows multiple layers of cases));
and
- picking at least one case according to a predetermined order defined by said identifying element,( task of the present invention is an introductory device mentioned type in such a way that removal of the preparation elements is supported according to a predefinable chronological order.);
(DE 202004011103 U1) doesn’t specifically disclose the following limitations, however (JP 3798913 B2) discloses:
and at least one sachet containing a different food product in the a form of powdered food composition to be supplied to a dysphagic user, ((JP 3798913 B2), [0031] Furthermore, the thickening additive solution obtained according to the present invention is preferably used for the purpose of adding to a food for persons with difficulty in chewing / swallowing to prevent aspiration. For such applications, the thickening additive solution is preferably subdivided into either a portion container or a sachet);
- opening said at least one case to pick up at least said sachet; - opening said sachet and dissolving the content thereof in a reconstitution liquid, ((JP 3798913 B2): [0013]: A specific example is shown. A liquid paste was prepared by dissolving 10 parts by weight of sodium alginate in 100 parts by weight of a mixed solvent of water and ethyl alcohol (weight ratio 1: 1). The viscosity of this liquid paste was measured with a B-type viscometer (Vistometron manufactured by Shibaura System Co., Ltd .: rotation speed 60 rpm, rotor No. 1, measurement temperature 25 ° C.) and found to be 15.5 cP.; [0030]
The reason why it is preferable to add the thickening additive according to the present invention in an equal amount or less with respect to the object containing water is to prevent other functions of the object from being impaired, for example, in the case of food. This is to prevent the original taste from fading. In this sense, it is better to use as little as possible. However, it is not preferable that the viscosity of the liquid paste is increased and the fluidity is deteriorated in order to add viscosity or gelation to the target product in a small amount. In addition, it is preferable that the material easily disperses and dissolves and develops viscosity and gelation in a short time, and the liquid volume ratio to the object is preferably selected in consideration of these; [0031]: Furthermore, the thickening additive solution obtained according to the present invention is preferably used for the purpose of adding to a food for persons with difficulty in chewing / swallowing to prevent aspiration. For such applications, the thickening additive solution is preferably subdivided into either a portion container or a sachet).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to include the above limitations as taught by (JP 3798913 B2) into the teachings of (DE 202004011103 U1) since the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over (DE 202004011103 U1), and further in view of AMANO et al (US 20130342676 A1).
As per claim 13, (DE 202004011103 U1) doesn’t specifically disclose:
wherein each sachet comprises at least one distinctive mark adapted to distinguish the different sachets from each other.
However, AMANO et al (US 20130342676 A1) discloses in: [0093] Here, when processing a large number of prescriptions together, the case of packaging a medicine in the form of so-called continuous prescriptions etc., the medicines are also packed wherein a medicine is packaged as a series of former-dose sachets and sachets of latter-dose sachets. Further, when packaging a medicine in such a packaging form, empty sachets in which the medicine is not packaged may be provided in the middle section of the continuous body of sachets. Furthermore, when an empty sachet is formed, distinguishing mark such as bar code may also be attached on an empty sachet.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to include the above limitations as taught by AMANO et al into the teachings of (DE 202004011103 U1) since the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over (DE 202004011103 U1), and further in view of GILIS et al (BR 9708585 A).
As per claim 15, (DE 202004011103 U1) does not disclose: said kit comprising said box a jug and a mixer.
However, GILIS et al (BR 9708585 A) discloses: (“The resulting mixture is added to a mixture the remainder of excipients and mixture in one planetary mixer that up is obtained a homogeneous mixture. This powder is fully inserted in the capsule using-if one equipment of filling capsules (automatic) known. One advantage of that present form the oral solid dosage is which. When the same form of oral solid dosage of according with the present invention is still not completely dissolved in acid environment stomach and for the last bowel by, where the environment is nearly neutral, that is, very less acid, then the tartrate of cisapride is also capable of dissolving quickly,"This form of dosage cannot be taken; unto with food" or "This form of dosage can be administered once only of the patient have been in fasting" or similar. The container may have any format or conventional form known in the prior art and which is made of one material pharmaceutically acceptable, by example a box of paper or cardboard. A bottle or jug of glass or plastic, one bag resselável, or cartela with a blister pack with individual dosages to be taken of cartela of according with one therapeutic program; The patient can take the medicine when the symptoms appear. Experimental Example 1 part: to The Tablet the following ingredients were intimately mixed on one planetary mixer”).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to include the above limitations as taught by GILIS et al into the teachings of (DE 202004011103 U1) since the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Akiba Robinson whose telephone number is 571-272-6734 and email is Akiba.Robinsonboyce@USPTO.gov. The examiner can normally be reached on Monday-Thursday 6:30am-4:30pm.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Resha Desai can be reached on 571-270-7792. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the receptionist whose telephone number is (703) 305-3900.
January 28, 2026
/AKIBA K ROBINSON/Primary Examiner, Art Unit 3628