DETAILED ACTION
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 the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 03/11/2026 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims: (1) the 35 U.S.C. §103 rejections of claims 25-29 over Beetz have been withdrawn; (2) the 35 U.S.C. §103 rejection of claim 3 over Schlipf and Pazos has been withdrawn; and (3) the 35 U.S.C. §103 rejection of claim 6 over Schlipf and Bagwe has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-2, 4-5, 7, 9-14, 18, 22-24, 30-36
Withdrawn claims: 10-14, 18, 22
Previously cancelled claims: 8, 15-17, 19-21
Newly cancelled claims: 3, 6, 25-29 (*Applicant should delete the canceled claims.)
Amended claims: 1, 4
New claims: 30-36
Claims currently under consideration: 1-2, 4-5, 7, 9, 23-24, 30-36
Currently rejected claims: 1-2, 4-5, 7, 9, 23-24, 30-36
Allowed claims: None
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.
Claims 1-2, 4-5, 7, 9, 23-24, 30, and 32-35 are rejected under 35 U.S.C. 112(b) 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 that the surface composition of the agglomerated particles contain less fat when compared to particles of a powdered a powdered milk product prepared from the same milk source using traditional high heat spray drying. However, it is unclear as to whether the particles of the traditional spray drying method are agglomerated particles or standard (i.e., non-agglomerated) particles. Therefore, the claim is indefinite.
For the purpose of the examination, the particles of the traditional spray drying method are considered to also be agglomerated particles.
Claims 2, 4-5, 7, 9, 23-24, and 30 are rejected by reason of dependency from claim 1.
Claim 32 recites that the process produces agglomerated particles during spray drying. However, it is unclear as to whether the term “the process” refers to the electrostatic spray drying process or the traditional high heat spray drying process. Therefore, the claim is indefinite.
For the purpose of this examination, “the process” will be considered to refer to both electrostatic spray drying process and the traditional high heat spray drying process.
Claims 33, 34, and 35 are rejected by reason of dependency from claim 32.
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.
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.
Claims 1-2, 4-5, 9, 23, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Beetz (US 2019/0329201; previously cited), hereinafter referred to as “Schlipf”, in view of Murrieta-Pazos (Murrieta-Pazos et al., “Composition gradient from surface to core in dairy powders: Agglomeration effect”, 2012, Food Hydrocolloids, 26(1), page 149-158; PDF page numbers used for citations; previously cited), hereinafter referred to as “Pazos”.
Regarding claim 1, Schlipf teaches an electrostatic spray dried [0034] powdered milk product [0020], [0023], wherein the product was produced by an electrostatic spray drying process which uses an air inlet temperature of less than 100°C, such as 60°C [0024], which falls within the claimed air inlet temperature of the process of the present inventive product. It is presumable that the temperature of the exhaust outlet is less than the temperature of the air inlet, so that an air inlet of 60°C would produce an exhaust outlet of less than 60°C, which falls within the claimed exhaust outlet temperature of the process of the presently inventive product. Schlipf also teaches that the temperatures of the process of the present inventive product are lower than the temperatures of a traditional high heat spray drying process [0024] which uses air inlet temperatures of 180-200°C [0003], which falls within the range of temperatures for a traditional high heat spray drying process recited in claim 1.
Schlipf also teaches that the spray dried powdered milk product may be further treated by a downstream treatment process to develop performance characteristics such as solubility and processibility and for sizing or morphological processing [0039], [0043].
Schlipf does not teach that the powdered milk product is agglomerated; or that the agglomerated particles have the claimed surface composition.
However, Pazos teaches that agglomerated milk powders were developed in order to improve functional properties such as handling and reconstitution properties (page 2, column 2, 2nd paragraph). Pazos discloses that agglomerated milk powders are formed by a process performed downstream from the spray drying process (page 2, column 2, 2nd paragraph).
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the present invention to have modified the spray dried milk product of Schlipf to be an agglomerated spray dried milk product as taught by Pazos. Since Schlipf teaches that its spray dried powdered milk product may be further treated by a downstream treatment process to develop performance characteristics such as solubility and processibility and for sizing or morphological processing [0039], [0043], but does not disclose such a downstream process, a skilled practitioner would have been motivated to consult an additional reference such as Pazos in order to determine a suitable downstream process which would enhance solubility and processibility of the product and provide sizing/morphological processing. Therefore, the claimed agglomerated powdered milk product is rendered obvious.
In regards to the claimed reduced fat in the surface composition of the agglomerated particles, the combination of Schlipf and Pazos discloses the electrostatic spray drying process disclosed in present claim 1. Therefore, the combination of Schlipf and Pazos is considered to disclose embodiments of the product which comprise the claimed surface composition, thereby rendering the claimed surface composition obvious.
It is noted that claim 1 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP §2113.I. Furthermore, the Office does not have laboratory facilities to test claim limitations drawn toward results of producing the product as claimed. Accordingly, such the claimed reduction in surface fat concentration does not serve to distinguish the product as claimed from the prior art and the claimed product is thus considered obvious to one having ordinary skill in the art.
Regarding claim 2, modified Schlipf teaches the invention as described above in claim 1, including that during the spray drying process, milk components such as lipids, proteins, lactose, and minerals are redistributed throughout the droplet resulting in heterogeneity between the surface and the core of the particle (Pazos, page 2, column 1). Pazos discloses spray dried skim milk powder as having 30.9% and 16.9% of the surface composition comprising a carbohydrate (corresponding to lactose) (page 8, Table 7, column corresponding to lactose content for SSMP as measured by XPS and EDX) and discloses spray dried whole milk powder as having 13.9% of the surface composition comprising a carbohydrate (page 9, Table 8, column corresponding to lactose content in SWMP as measured by EDX). These values fall within the claimed concentration, thereby rendering the concentrations obvious.
Regarding claim 4, modified Schlipf teaches the invention as described above in claim 1, including the agglomerated size is 674.6 and 439.4 µm (corresponding to D(v,0.90) for AWMP and ASMP, respectively) (Pazos page 7, column 2, Table 4), which fall within the claimed range. Schlipf teaches that droplets from the atomizer may be within a range of 10-300 µm [0044]. This range is considered to encompass the claimed size of the primary particles since Pazos discloses that droplets produced by the atomizer could collide with fines and stick together to form the agglomerates (page 2, column 2, 2nd paragraph). The selection of a value within the encompassing range renders the claimed primary particle size obvious. MPEP 2144.05.I.
Regarding claim 5, Schlipf teaches the invention as described above in claim 1, including the milk product comprises a source milk comprising milk, whey protein [0020], and/or nutritional formulation (corresponding to food and beverage materials) [0019].
Regarding claim 9, Schlipf teaches the invention as described above in claim 1, including the applied voltage is 0.25-80 kV [0034], which falls within the claimed voltage range. Although Schlipf teaches the claimed applied voltage, it is noted that claim 9 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon the product itself. MPEP §2113.I.
Regarding claim 23, Schlipf teaches the invention as described above in claim 1, including the spray drying occurs at temperatures below the denaturation temperatures of milk proteins such as 20°C and 22°C [0025]. Therefore, it is presumable that the milk product of Schlipf retains amounts of milk protein which fall within the claimed retention range when compared with a milk product exposed to spray drying temperatures greater than the less than 100°C used in the invention of Schlipf. Therefore, the claimed retention is rendered obvious.
Regarding claim 30, modified Schlipf teaches the invention as described above in claim 1, including the agglomerated particles comprised of spherical particles pasted to other spherical particles (Pazos, page 6, Fig. 4, picture 2A, 2B, 4A, and 4B; page 7, column 1, paragraph under section 3.2.1). The description and appearance of these agglomerated particles are the same as the description and appearance of the agglomerated powders shown in Figs. 11A and 11B and [0121] of the present specification. Therefore, the agglomerated milk product of the prior art is considered to have a spherical particle morphology as presently claimed.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schlipf (US 2019/0329201; previously cited) and Pazos (Murrieta-Pazos et al., “Composition gradient from surface to core in dairy powders: Agglomeration effect”, 2012, Food Hydrocolloids, 26(1), page 149-158; PDF page numbers used for citations; previously cited) as applied to claim 1 above, as evidenced by Wagoner (Wagoner, R., “Fat in whole milk misunderstood; new labels may help”, 2020, Farm and Dairy, https://www.farmanddairy.com/news/fat-in-whole-milk-misunderstood-new-labels-may-help/601308.html; previously cited).
Regarding claim 7, Schlipf teaches the invention as described above in claim 1, including the source milk comprises whole milk [0020], which contains 3.25-18% fat as evidenced by Wagoner (page 2, 4th paragraph under “Rebranding opportunity”), such as 3.25% (Wagoner, page 2, 2nd paragraph), which falls within the claimed concentration.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Schlipf (US 2019/0329201; previously cited) and Pazos (Murrieta-Pazos et al., “Composition gradient from surface to core in dairy powders: Agglomeration effect”, 2012, Food Hydrocolloids, 26(1), page 149-158; PDF page numbers used for citations; previously cited) as applied to claim 1 above, and further in view of Kumar (Kumar et al., “Yoghurt Powder – A Review of Process Technology, Storage and Utilization”, 2004, Food and Bioproducts Processing, 82(C2), pages 133-142).
Regarding claim 24, modified Schlipf teaches the invention as described above in claim 1, including that the source material of the spray dried powdered milk product may comprise milk and probiotics [0019]-[0021].
The prior art does not teach that the product comprises yogurt powder containing viable Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus.
However, Kumar teaches a spray dried milk product comprising yogurt powder (page 137, column 1, paragraph under “Spray-drying of Yoghurt”) and viable L. delbrueckii subsp. bulgaricus and S. thermophilus (page 137, column 2, 1st-2nd paragraphs). Kumar teaches that yogurt is a highly nutritious product which appeals to consumers and has many applications in the food industry (page 133, column 1, 1st paragraph; page 141, column 1, 1st paragraph).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the present invention to have modified the source of the product of Schlipf to be yogurt as taught by Kumar. Since Schlipf discloses that its source material may comprise milk and probiotics [0019]-[0021], but does not disclose a material comprising such ingredients, a skilled practitioner would have been motivated to consult an additional reference such as Kumar in order to determine a suitable source material comprising milk and probiotics for spray drying. In using the yogurt of Kumar as a source material for the spray dried product of Schlipf, the resulting spray dried product would comprise yogurt powder containing viable L. delbrueckii subsp. bulgaricus and S. thermophilus as presently claimed, thereby rendering the claim obvious.
Claims 31-36 are rejected under 35 U.S.C. 103 as being unpatentable over Schlipf (US 2019/0329201; previously cited) in view of Kumar (Kumar et al., “Yoghurt Powder – A Review of Process Technology, Storage and Utilization”, 2004, Food and Bioproducts Processing, 82(C2), pages 133-142).
Regarding claim 31, Schlipf teaches an electrostatic spray dried [0034] powdered dairy (corresponding to milk) product [0020], [0023], wherein the product was produced by an electrostatic spray drying process which uses an air inlet temperature of less than 100°C, such as 60°C [0024], which falls within the claimed air inlet temperature of the process of the present inventive product. It is presumable that the temperature of the exhaust outlet is less than the temperature of the air inlet, so that an air inlet of 60°C would produce an exhaust outlet of less than 60°C, which falls within the claimed exhaust outlet temperature of the process of the presently inventive product. Schlipf also teaches that the temperatures of the process of the present inventive product are lower than the temperatures of a traditional high heat spray drying process [0024] which uses air inlet temperatures of 180-200°C [0003], which falls within the range of temperatures for a traditional high heat spray drying process recited in claim 31. Schlipf teaches that the source material of the spray dried powdered milk product may comprise milk and probiotics [0019]-[0021].
Schlipf does not teach that the product comprises live microorganisms, wherein the viability of the live microorganisms in the product after electrostatic spray drying is superior to the viability of live microorganisms in a dairy product prepared from the same dairy source material using tradition high heat spray drying operating at inlet temperatures of 160-200°C.
However, Kumar teaches a spray dried milk product comprising yogurt powder (page 137, column 1, paragraph under “Spray-drying of Yoghurt”) and viable L. delbrueckii subsp. bulgaricus and S. thermophilus (page 137, column 2, 1st-2nd paragraphs). Kumar teaches that yogurt is a highly nutritious product which appeals to consumers and has many applications in the food industry (page 133, column 1, 1st paragraph; page 141, column 1, 1st paragraph). Kumar teaches that viability of the live microorganisms (corresponding to yogurt bacteria) is dependent partly upon inlet and outlet temperatures used in the spray drying process; and that microorganism viability decreases with increasing inlet or outlet temperatures (page 137, column 2, 1st paragraph). Kumar teaches a viability of live organisms in the spray dried dairy product of 51.6-54.7% (page 137, column 2, 2nd paragraph).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the present invention to have modified the source of the product of Schlipf to be yogurt as taught by Kumar. Since Schlipf discloses that its source material may comprise milk and probiotics [0019]-[0021], but does not disclose a material comprising such ingredients, a skilled practitioner would have been motivated to consult an additional reference such as Kumar in order to determine a suitable source material comprising milk and probiotics for spray drying. In using the yogurt of Kumar as a source material for the spray dried product of Schlipf, the resulting spray dried product would comprise an electrostatic spray dried dairy product containing viable microorganisms, thereby rendering the claim obvious.
Regarding claim 32, modified Schlipf teaches the invention as described above in claim 31, including the process may produce agglomerated particles during spray drying (Kumar, page 138, column 1, paragraph under “Instant Yoghurt Powder” – page 138, column 2, 1st paragraph). Although the prior discloses the claimed feature, it is noted that claim 32 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon the product itself. MPEP §2113.I.
Regarding claim 33, modified Schlipf teaches the invention as described above in claim 32, including that viability of the live microorganisms is dependent upon inlet and outlet temperatures, type of atomization, and direction of airflow in the spray drier used in the spray drying process; and that microorganism viability decreases with increasing inlet or outlet temperatures (Kumar, page 137, column 2, 1st paragraph). Kumar teaches a viability of live organisms in the spray dried dairy product of 51.6-54.7% after applying an outlet temperature of 70-75°C (page 137, column 2, 2nd paragraph).
As the viability of the live microorganisms is a variable that can be modified, among others, by adjusting inlet and outlet temperatures, type of atomization, and direction of airflow in the spray drier, the viability of the live microorganisms would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed viability of the live microorganisms cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, inlet and outlet temperatures, type of atomization, and direction of airflow in the spray drier in the method of Schlipf to obtain the desired viability by using a viability of 51.6-54.7% after applying an outlet temperature of 70-75°C as a guide as taught by Kumar (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 34, modified Schlipf teaches the invention as described above in claim 32, including the live microorganisms have a viability of more than 106 CFU/g (Kumar, abstract), which falls within the claimed range.
Regarding claim 35, Schlipf teaches the invention as described above in claim 34, including spray drying occurring at inlet temperatures below 100°C, such as 60°C [0024]. Therefore, the combination of Schlipf and Kumar is considered to disclose embodiments of the product which comprise the claimed surface composition, thereby rendering the claimed surface composition obvious. Kumar teaches that the product may comprise agglomerated particles comprising primary particles (page 138, column 1, paragraph under “Instant Yoghurt Powder” – page 138, column 2, 1st paragraph).
Schlipf also teaches that droplets from the atomizer may be within a range of 10-300 µm [0044]. This range is considered to encompass the claimed size of the primary particles since Kumar discloses that droplets produced by the atomizer (corresponding to the claimed primary particles) are dried and then agglomerated (page 138, column 2, 1st paragraph). The selection of a value within the encompassing range renders the claimed primary particle size obvious. MPEP 2144.05.I.
Regarding claim 36, Schlipf teaches the invention as described above in claim 31, including that the system for producing the spray dried product has a unit which may be employed to modulate equipment at desired operational conditions [0064]. This disclosure at least suggests that the method may comprises applying modulating voltage between at least two different voltage levels during spray drying.
However, it is noted that claim 36 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon the product itself. MPEP §2113.I.
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 1, 5, 9, and 25-29 over Beetz; claim 24 over Beetz as evidenced by Lempert: Applicant’s arguments with respect to claim(s) 1, 5, 9, and 24-29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; and because Applicant canceled claims 25-29.
Claim Rejections – 35 U.S.C. §103 of claims 1, 5, 9, and 23 over Schlipf; claims 2-4 over Schlipf and Pazos; claim 6 over Schlipf and Bagwe; claim 7 over Schlipf and Wagoner; claim 24 over Beetz as evidenced by Lempert: Applicant’s amendments and arguments have been fully considered and the amendments are considered to overcome the rejections as set forth in the previous Office Action. However, upon further consideration, a new ground(s) of rejection is made in view of Schlipf and Pazos.
Applicant amended claim 1 to recite that the spray dried milk product comprised agglomerated particles. Due to such amendment, Applicant argued that Schlipf does not disclose agglomerated particles produced during the spray drying process as Schlipf discloses agglomeration resistance as being a desirable characteristic of its spray dried product. Applicant argued that Pazos discloses a post-drying mechanical process to produce its agglomerated particles which goes against the requirement that the agglomerated particles are produced during the spray drying process as recited in amended claim 1. Applicant argued that neither Schlipf nor Pazos discloses a primary particle size of 10-25 µm as now recited by amended claim 4 (Applicant’s Remarks, page 11, 1st paragraph under section “B” – page 12, 5th paragraph; page 13, 2nd paragraph; page 14, 5th-6th paragraphs).
However, the Examiner points out that Schlipf discloses that its finished product “may” have agglomeration resistance in [0043], not that its finished product “must” have agglomeration resistance. Therefore, agglomeration resistance is not necessarily present in the finished product. The Examiner also points out that Schlipf discloses this desired feature in regard to the finished product (e.g., an agglomerated product), not in regard to the materials which are being spray dried to form the finished product.
In regard to Applicant’s assertion that Pazos discloses a post-drying mechanical process to produce its agglomerated particles which goes against the requirement that the agglomerated particles are produced during the spray drying process as recited in amended claim 1, claim 1 does not recite such a feature. Therefore, Applicant’s argument is moot.
In regard to Applicant’s assertion that neither Schlipf nor Pazos discloses a primary particle size of 10-25 µm as now recited by amended claim 4, Schlipf teaches that droplets from the atomizer may be within a range of 10-300 µm [0044]. This range is considered to encompass the claimed size of the primary particles since Pazos discloses that droplets produced by the atomizer could collide with fines and stick together to form the agglomerates (page 2, column 2, 2nd paragraph). The selection of a value within the encompassing range renders the claimed primary particle size obvious. MPEP 2144.05.I.
Applicant then argued that Pazos’ findings demonstrate that the agglomerated particles recited in present claim 1 are structurally distinct from conventionally agglomerated dairy powders in Pazos as the claimed agglomerated particles have reduced surface fat while conventional agglomerated dairy powders have a surface fat composition that is unchanged by agglomeration. Applicant stated that Pazos discloses in the abstract that no difference between standard and agglomerated powders was observed in the gradient composition and fat fractions properties, thereby suggesting that agglomeration process does not change the particle surface properties. Applicant argued that these disclosures confirm that the surface fat reduction recited in present claim 1 is not an inherent result of the agglomeration itself, but a consequence of the electrostatic spray drying process (Applicant’s Remarks, page 13, 1st and 3rd paragraphs; page 14, 2nd paragraph).
However, the Examiner points out that claim 1 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP §2113.I.
As described above in the rejection of amended claim 1, the combination of Schlipf and Pazos discloses electrostatic spray drying, agglomeration, and inlet and outlet temperatures as recited in present claim 1. Therefore, the combination of prior art is considered to render the process steps recited in present claim 1 and any characteristics resulting from those process steps obvious, especially wherein Schlipf discloses or suggests electrostatic spray drying and inlet and outlet temperatures which fall within the claimed temperature range; and wherein the present specification discloses that electrostatic spray drying produces highly agglomerated, granular-like powders as agglomeration is induced by electrostatic charge [0025], [0094].
Furthermore, as noted in the 35 U.S.C. §103 rejection of claim 1 written above, the particles of the electrostatic spray drying process and the particles of the traditional spray drying process are both considered to be agglomerated particles. Pazos compares the surface composition of standard (i.e., non-agglomerated) particles with the surface composition of agglomerated particles. The present claims compare the surface composition of agglomerated particles from electrostatic spray drying with the surface composition of agglomerated particles from traditional high heat spray drying. Therefore, the comparison in Pazos is not the same comparison recited in the present claims.
Applicant then argued that the surface composition recited in present claim 1 is not an inherent result of low-temperature spray drying, but linked to the electrostatic charge that induces agglomeration during drying. Applicant argued that there is no basis to presume that Schlipf’s non-agglomerated product produced without or with electrostatic charging would possess the claimed surface composition. Due to this reason, Applicant argued that the Office has not met the burden of establishing inherency with evidence (Applicant’s Remarks, page 13, 4th paragraph- page 14, 1st paragraph).
However, the Examiner again points out that Schlipf discloses or suggests electrostatic spray drying and inlet and outlet temperatures which fall within the temperature range recited in present claim 1; and that the present specification discloses that electrostatic spray drying produces highly agglomerated, granular-like powders as agglomeration is induced by electrostatic charge [0025], [0094]. This disclosure in the present specification is repeated by the Applicant in the 4th paragraph on page 13 of Applicant’s Remarks. Therefore, if the prior art discloses electrostatic spray drying and the Applicant states that electrostatic spray drying causes the formation of the claimed surface composition, it would be obvious for embodiments of the product of the prior art to comprise the claimed surface composition, especially wherein the Applicant has not provided evidence to the contrary; and wherein the present claims are directed to a product, not a method. For at least these reasons, the cited prior art is considered to render the claimed surface composition obvious.
Applicant canceled claim 6, thereby mooting its rejection. Applicant argued that Bagwe does not cure the aforementioned deficiencies of Schlipf (Applicant’s Remarks, page 14, 3rd-4th paragraphs).
The features of amended claim 1 are shown to be rendered obvious by the combination of Schlipf and Pazos as described in the prior art rejections and in the responses written above. Bagwe is continued to be relied on as an evidentiary reference regarding the additional features of claim 7.
Applicant then argued that none of the cited references disclose the milk protein bioactivity recited in present claim 23 (Applicant’s Remarks, page 15, 1st-2nd paragraphs).
However, as described above in the rejection of present claim 23, Schlipf teaches that the spray drying occurs at temperatures below the denaturation temperatures of milk proteins such as 20°C and 22°C [0025]. Therefore, it is presumable that the milk product of Schlipf retains amounts of milk protein which fall within the claimed retention range when compared with a milk product exposed to spray drying temperatures greater than the less than 100°C used in the invention of Schlipf. Therefore, the claimed retention is rendered obvious, especially wherein Applicant has not provided evidence to the contrary.
Applicant’s arguments have been shown to be unpersuasive. Therefore, the claims stand rejected over new combinations of prior art. The rejections of claims 3, 6, and 25-29 are moot due to the cancellation of these claims.
New Claims 30-36: Applicant’s argued that none of Beetz, Schlipf, and Pazos disclose agglomerated particles have spherical morphology as recited by new claim 30 (Applicant’s Remarks, page 15, 1st paragraph under section C).
However, as recited above in the rejection of new claim 30, Pazos teaches that the agglomerated particles comprise of spherical particles pasted to other spherical particles (page 6, Fig. 4, picture 2A, 2B, 4A, and 4B; page 7, column 1, paragraph under section 3.2.1). The description and appearance of these agglomerated particles are the same as the description and appearance of the agglomerated powders shown in Figs. 11A and 11B and [0121] of the present specification. Therefore, the agglomerated milk product of the prior art is considered to have a spherical particle morphology as presently claimed.
Applicant argued that Beetz does not disclose the superior cell viability recited in new claim 31. Applicant argued that Schlipf provide any examples involving live microorganisms, viability measurements, and no comparison to traditional spray drying. Applicant argued that claims 32-36 are patentable by reason of dependency from claim 31 (Applicant’s Remarks, page 15, 2nd paragraph under section C- page 16, 3rd paragraph).
However, new claim 31 and its dependents are rendered obvious by the combination of Schlipf and Kumar as described in their rejections written above.
Conclusion
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 Kelly Kershaw whose telephone number is (571)272-2847. The examiner can normally be reached Monday - Thursday 9:00 am - 4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at (571) 270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KELLY P KERSHAW/Examiner, Art Unit 1791
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