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 .
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 1-5 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.
Claim 1 recites “providing liquid human milk into a spray drying machine at a rate of about 2 milliliters per millisecond.”
A flow rate of 2 milliliters per millisecond appears much too high in the context of the claimed process.
From the prosecution of parent Application 17/835,901, Examiner understands that Applicant intended to recite a flow rate of --about 2 milliliters per minute--.
To overcome this rejection, Applicant should replace “about 2 milliliters per millisecond” with --about 2 milliliters per minute--. Such an amendment will not be held to introduce new matter into the claim.
Claims 2-5 are rejected due to their dependency on indefinite claim 1.
Claim 4 recites “a significant amount of immunoglobulin content”. It is unclear what amount of immunoglobulin is necessary for said amount to qualify as “significant”.
Claim Rejections - 35 USC § 102/35 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 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.
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.
Claim(s) 1, 2, 4, and 5 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Aguilar Uscanga et al. (“Assessment of the Accelerated Shelf Life of Human Milk Dehydrated by Aspersion and Treated by UV, High Pressures, and Pasteurization”), or, in the alternative, under 35 U.S.C. 103 as obvious over Aguilar Uscanga in view of Buchi (“B-290 Mini Spray Dryer Operation Manual”).
With regard to claims 1 and 2: Aguilar Uscanga teaches a method of processing human milk (abstract, section 2.1), the method comprising:
Providing liquid human milk into a spray drying machine at a rate of about 2 milliliters per minute (section 2.1, especially final paragraph thereof).
Operating the spray drying machine at a temperature (air inlet temperature) of 165 degrees C (section 2.1, especially final paragraph thereof).
Spray drying the liquid human milk in the spray drying machine to transform the liquid human milk into a powderized human milk product (section 2.1, especially final paragraph thereof).
Aguilar Uscanga does not explicitly teach: i) transferring the powderized human milk product from the spray drying machine to a receptacle coupled to the spray drying machine, wherein the receptacle is formed from one or more nonreactive materials; or ii) receiving the powderized human milk product into a container removably coupled to the receptacle, wherein the container is formed from one or more nonreactive materials and is configured to transport the powderized human milk product away from the receptacle.
However, Aguilar Uscanga teaches that the spray drying machine is a “BÜCHI Mini Spray Dryer, B-29” (section 2.1, especially final paragraph thereof). Examiner has found no evidence supporting the existence of any device by that specific designation. In other words, the available evidence, or rather the lack thereof, indicates that there is no device by the specific designation “BÜCHI Mini Spray Dryer, B-29”, in existence. However, there is ample evidence for the existence of a Buchi device called the “Mini Spray Dryer B-290” (see for example, the Buchi reference cited in this rejection). In view of the forgoing, all available evidence points to the citation of a “BÜCHI Mini Spray Dryer, B-29” in Aguilar Uscanga as being the result of a minor error, wherein Aguilar Uscanga had intended to cite a --Buchi Mini Spray Dryer B-290--. Thus, it is understood that the “BÜCHI Mini Spray Dryer, B-29” cited in Aguilar Uscanga is actually a --Buchi Mini Spray Dryer B-290--.
Accordingly, it is understood that the spray drying process of Aguilar Uscanga is carried out in a Buchi Mini Spray Dryer B-290. In the alternative, the combined disclosures of Aguilar Uscanga and Buchi at least suggest that the spray drying process is carried a Buchi Mini Spray Dryer B-290.
Buchi, which is the operation manual for the Buchi B-290, teaches that the B-290 comprises a receptacle (cyclone) 5 coupled to the spray drying machine and a container (product collection vessel) 6 removably coupled to the receptacle 5 and configured to transport powderized solids away from receptacle 5 (Page 22, Figure 4.1, Section 4.1). This teaching indicates that, in operation of the B-290 spray dryer, powderized product will be transferred to the receptacle (cyclone) 5 and subsequently received by the container (product collection vessel) 6.
Buchi teaches that the receptacle (cyclone) 5 is formed from a non-reactive material, i.e. glass (pages 30-31, Figure 5.2 and section 5.4; Pages 70-71, Figures and section 10.2 [see part 004189 on table 10-8 in particular]). Note: The glass is specifically 3.3 borosilicate glass (page 21, section 3.3).
Buchi also teaches that the container (product collection vessel) 6 is formed from a non-reactive material, i.e. glass (pages 30-31, Figure 5.2 and section 5.4; Pages 70-71, Figures and section 10.2 [see part 044678 on table 10-8 in particular]). Note: The glass is specifically 3.3 borosilicate glass (page 21, section 3.3).
As discussed above, it is understood that the method of Aguilar Uscanga involves using the Buchi B-290 as the spray drying machine for spray drying the human milk. Accordingly, in view of the teachings by Buchi on the B-290 and the operation thereof, it is understood that the method of Aguilar Uscanga implicitly comprises steps of: i) transferring the powderized human milk product from the spray drying machine to a receptacle coupled to the spray drying machine, wherein the receptacle is formed from one or more nonreactive materials; and ii) receiving the powderized human milk product into a container removably coupled to the receptacle, wherein the container is formed from one or more nonreactive materials and is configured to transport the powderized human milk product away from the receptacle.
In the alternative, the combined disclosures of Aguilar Uscanga and Buchi at least suggest that the use of the Buchi B-290 as the spray drying machine for spray drying the human milk. Accordingly, the combined disclosures of Aguilar Uscanga and Buchi at least suggest incorporating such steps of transferring and receiving into the spray drying method of Aguilar Uscanga.
If it is not implicit in the method of Aguilar Uscanga, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Aguilar Uscanga in view of Buchi by adding steps of: i) transferring the powderized human milk product from the spray drying machine to a receptacle coupled to the spray drying machine, wherein the receptacle is formed from one or more nonreactive materials, and ii) receiving the powderized human milk product into a container removably coupled to the receptacle, wherein the container is formed from one or more nonreactive materials and is configured to transport the powderized human milk product away from the receptacle, in order to obtain a predictably functional spray drying process which is congruent with the teachings and suggestions of Aguilar Uscanga.
With regard to claim 4: The shelf life of the powderized human milk product is over 180 days (Aguilar Uscanga: section 3.4).
While it is not expressly taught that the powderized human milk product is additive and preservative-free, Aguilar Uscanga does not teach or suggest adding any additives or preservatives during the method of spray drying the human milk (See the description of the method in section 2.1). Accordingly, it is understood that the powderized human milk product is free of additives and preservatives.
In the alternative, a person having ordinary skill in the art would recognize that the process of Aguilar Uscanga should, or at least could, involve the production of an additive and preservative free powderized human milk product.
It is not implicit in Aguilar Uscanga it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Aguilar Uscanga by carrying out the spray drying method without the addition of additives or preservatives, so as to yield a powderized human milk product that is additive and preservative free, in order to obtain a predictably functional human milk spray drying process that is congruent with the teachings and suggestions of Aguilar Uscanga.
Aguilar Uscanga does not explicitly teach that the powderized human milk product comprises a significant amount of immunoglobulin content.
However, the conditions of the spray drying in Aguilar Uscanga are identical to those of the claimed spray drying (section 2.1, especially final paragraph thereof). Accordingly, the powderized human milk obtained from the spray drying in Aguilar Uscanga will necessarily have the same properties as the powderized human milk obtained from spray drying in the claimed method. Thus, the powderized human milk product in Aguilar Uscanga necessarily comprises a significant amount of immunoglobulin content.
With regard to claim 5: Aguilar Uscanga further comprises steps of:
Pasteurizing and/or providing a high hydrostatic pressure to the liquid human milk prior to providing the liquid human milk into the spray drying machine (section 2.1, especially final paragraph thereof; Figure 1).
Heating, during the pasteurizing and the heigh hydrostatic pressure treatment, the liquid human milk prior to providing the liquid human milk into the spray drying machine (section 2.1, especially final paragraph thereof; Figure 1).
And moving the powderized human milk product from the container into one or more transportable units (trilaminated bags) formed from several nonreactive materials (PET, aluminum, OPA, and CPP) that safely contain the powderized human milk product, wherein the one or more transportable units are configured to readily transport the contained human milk product to one or more end consumers (section 2.2; Figure 1).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aguilar Uscanga in view of Buchi as applied to claims 1 and 2 above, and further view of Jones ("What Is the Difference Between Glass and Crystal?”; https://www.webstaurantstore.com/blog/3476/crystal-vs-glass.html) and Abate et al. (US 2012/0167410), hereafter referred to as Abate.
With regard to claim 3: Aguilar Uscanga either anticipates or, in combination with Buchi, renders obvious all of the limitations of claims 1 and 2 as described in the 102/103 rejections above.
Aguilar Uscanga is silent to the one or more nonreactive materials from which the receptacle is formed comprising a crystal material, i.e. crystal glass.
However, as discussed in the rejection of claims 1-3 above, the receptacle (cyclone) is formed from a non-reactive material, the non-reactive material being glass (Buchi: pages 30-31, Figure 5.2 and section 5.4; Pages 70-71, Figures and section 10.2 [see part 004189 on table 10-8 in particular]).
Crystal glass is understood to be a special type of glass which is strengthened compared to normal glass by the inclusion of strengthening minerals. For example, Jones teaches that crystal is a type of glass that contains strengthening minerals which make the material more durable (see section titled “Crystal vs Glass”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Aguilar Uscanga in view of Jones by constructing the receptacle (cyclone) from a non-reactive material in the form of crystal glass (as opposed to a non-reactive material in the form of normal glass), in order to obtain a receptacle (cyclone) which is more durable in comparison to a receptacle formed from normal glass.
Modified Aguilar Uscanga is silent to the to the one or more nonreactive materials from which the container is formed comprising aluminum.
However, it is known in the art to form containers for spray drying systems, equivalent to the container, from aluminum. For example, Abate teaches a spray drying system having an aluminum container (aluminum box) for collecting spray dried material (paragraph [0173]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to further modify Aguilar Uscanga in view of Abate by constructing the container from a nonreactive material in the form of aluminum, in order to obtain a spray drying system having a predictably functional container for collecting spray dried material.
Conclusion
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/JONATHAN LUKE PILCHER/ Examiner, Art Unit 1772