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 .
Election/Restrictions
Applicant’s election without traverse of Group III (Claims 21-24, 28, 30, 32, 37, 39, 40, 42, 44, 46, 47, 54, 56, 57, 66, 67, and 68) in the reply filed on 20 October 2025 is acknowledged.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 39 and 40 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this case, Claim 21 states provided that the cultured milk product may comprise a human mammary epithelial cell (hMEC) or a plasma cell (PC)(emphasis added). Wherein Claim 39 states one or more human mammary epithelial cells (hMECs) or plasma cells (PCs). In this case the use of “..or more” this raises an issue because claim 21 is limited to a hMEC or a PC, meaning a single one, and not a plurality or mixture.
Claim 40 is rejected due to its dependence on rejected claim 39.
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.
Claim 21-22, 28, 30, 32, 37, 39, 42, 44, 46, 47, 54, 56-57, and 66-68 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (herein referred to as Yang, CN 101953403 A) in view of Wang et al. (herein referred to as Wang, US 6034130 A), Plaza-Diaz et al. (herein referred to as Plaza-Diaz, “Human Milk Oligosaccharides and Immune System Development”), Pandya et al. (herein referred to as Pandya, CN 107205409 A), Gaull et al. (herein referred to as Gaull, US 20020192296 A1), and Conti et al. (herein referred to as Conti, US 8673849 B2)
With regard to Claims 21 and 46, Yang teaches a milk product wherein the product contains secretory IgA (sIgA) ([0001]), Lactoferrin ([0006]) and lactose ([0006]). Yang teaches the milk product does not comprise or is substantially free of persistent organic pollutants (POPs), heavy metals, prescription pharmaceutical drugs, recreational drugs, allergens, cells, hormones, or virus (whole document).
However, Yang is silent to the product containing fatty acids.
Wang teaches lipid composition in which the content and the distribution of the fatty acids are similar to those of human milk fat (abstract). Wang teaches the composition comprises lauric acid (Col 2 line 26), myristic acid (col 2 line 27), and palmitic acid (col 2 line 25). Wang teaches the content and the distribution of the fatty acids which mimic those of human milk fat (col 2 lines 19-20).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Yang to include fatty acids such as lauric acid, myristic acid, and palmitic acid as taught by Wang to mimic human milk fat.
Continuing, Yang is silent to 3’-sialyllactose and 6’-sialyllactose.
Plaza-Diaz teaches maternal milk contains compounds that may affect newborn immunity. Among these are a group of oligosaccharides that are synthesized in the mammary gland from lactose; these oligosaccharides have been termed human milk oligosaccharides (abstract). Plaza-Diaz teaches humans lack the enzymes (sialidases, fucosidases) that break down HMOs; therefore, these compounds reach the colon intact, where they are digested by bacteria within the intestinal microbiota. In this sense, HMOs are prebiotics and they promote the growth of a favorable microbiota (4. Beneficial Effects of HMOs). Plaza-Diaz teaches 3’-sialyllactose and 6’-sialyllactose are human milk oligosaccharides (figure 1).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Yang to include 3’-sialyllactose and 6’-sialyllactose as described by Plaza-Diaz to promote the growth of a favorable microbiota.
Yang is silent to the composition comprising alpha-lactalbumin, beta-casein, kappa-casein, Alpha-S1-casein, and glucose.
Pandya teaches compositions comprising casein (abstract) wherein the composition includes dairy products ([0038], [0270]). Pandya teaches the composition comprises beta-casein ([0020], [0058]), kappa-casein ([0020], [0058]), alpha-S1-casein ([0022], [0058]) alpha-lactalbumin ([0021], [0288]), and glucose ([0018]). Pandya teaches the glucose is a sweetener ([0022]). Pandya teaches the resulting milk substitute products exhibit characteristics that resemble natural milk in appearance, function, taste, smell, and feel ([0288]).
It would have been obvious to one with ordinary skill in the art to modify Yang to include the teaches of Pandya so the resulting milk product exhibit characteristics that resemble natural milk in appearance, function, taste, smell, and feel.
Yang is silent to the composition comprising lysozyme.
Gaull teaches compositions containing human milk proteins (abstract). Gaull teaches the composition comprises lysozyme ([0016]). Gaull teaches lysozyme protects the infant from bacterial infection ([0016]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Yang to include Lysozyme as taught by Gaull to protects the consumer (such as an infant) from bacterial infection.
Lastly, Yang is silent to the composition comprising lactadherin.
Conti teaches monomeric and multimeric peptidic compounds which have antiviral activity (abstract). Conti teaches lactaherin is a glycoprotein present in membranes of milk fat globules (col 1 lines 59-60). The proteins associated with the membranes of the milk fat globules fulfil functions that are important for newborns and infants (col 1 lines 36-39). Conti teaches lactaherin has anti-viral activity (col 3 lines 17-18).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Yang in view of Conti to include lactadherin because of its anti-viral activity and milk fat globules fulfil functions that are important for newborns and infants.
With regard to Claim 22, Yang teaches the product contains docosahexaenoic acid (DHA) ([0006]).
With regard to Claim 28, Yang teaches the product does not comprise or is substantially free of polychlorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs), polychlorinated biphenyls (PCBs), and pesticides (whole document)
With regard to Claim 30, Yang teaches the product does not comprise or is substantially free of heavy metals (whole document).
With regard to Claim 32, Yang teaches the product does not comprise or is substantially free of pharmaceutical or recreational drugs (whole document),
With regard to Claim 37, Yang teaches the product does not comprise or is substantially free of allergens (whole document).
With regard to claim 39, Yang teaches the product does not comprise or is substantially free of human stem cells, human immune cells, or bacterial cells (whole document).
With regard to claim 42, Yang teaches the product does not comprise or is substantially free of virus (whole document)
With regard to claim 44, Yang teaches the product does not comprise or is substantially free of hormones (whole document).
With regard to Claim 47, Yang teaches the composition comprises lecithin ([0006]).
With regard to Claim 54, Yang teaches the composition is food consumed by infants ([0004]). Therefore one with ordinary skill in the art would recognize the composition would inherently be food-grade.
With regard to Claims 56-57, Yang teaches administering the milk product to a human subject wherein the human subject is an infant ([0004]).
With regard to Claim 66-68, Yang teaches administering the subject the milk product ([0006]). Because the prior art teaches substantially the same composition as what is instantly claimed, administering the product would inherently prevent infection in the subject. See MPEP 2112.1(II) "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Claims 23- 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (CN 101953403 A) in view of Wang (US 6034130 A), Plaza-Diaz ( “Human Milk Oligosaccharides and Immune System Development”), Pandya (CN 107205409 A), Gaull (US 20020192296 A1), Conti (US 8673849 B2) and Fride et al. (herein referred to as Fride, US 20110172305 A1).
With regard to Claims 23-24, Yang is silent to the composition comprising at least one endocannabinoid.
Fride teaches a method for promoting infant feeding, growth or development comprising administering to an infant a formula or a pharmaceutical composition comprising an endocannabinoid (abstract). Fride teaches compositions comprising an endocannabinoid promote infant, child, or adolescent feeding, growth or development ([0012]). Fride teaches examples of endocannabinoid include anandamide and 2-arachidonoyl glycerol (2AG) ([0014]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Yang to include endocannabinoids such as anandamide and 2-arachidonoyl glycerol as taught by Fride to promote infant, child, or adolescent feeding, growth or development.
Claims 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (CN 101953403 A) in view of Wang (US 6034130 A), Plaza-Diaz ( “Human Milk Oligosaccharides and Immune System Development”), Pandya (CN 107205409 A), Gaull (US 20020192296 A1), Conti (US 8673849 B2) and Witkowska-Zimny et al. (herein referred to as WZ, “Cells of Human breast milk”)
With regard to Claims 39-40, Yang teaches the product does not comprise or is substantially free of human stem cells, human immune cells, or bacterial cells (whole document). And more specifically does not comprise or is substantially free of a myoepithelial cells, myeloid precursor cells, neutrophils, granulocytes, T cells, Staphylococcus, Acinetobacter, Streptococcus, Pseudomonas, Lactococcus, Enterococcus, or Lactobacillus (whole document).
However, Yang is silent to the product comprising one or more human mammary epithelial cells (hMECs) or plasma cells (PCs).
WZ teaches human milk is a complex fluid that has developed to satisfy the nutritional requirements of infants. In addition to proteins, lipids, carbohydrates and other biologically active components, breast milk contains a diverse microbiome that is presumed to colonize the infant gastrointestinal tract and a heterogeneous population of cells (abstract). WZ teaches part of this diverse microbiome includes mammary epithelial cells (background). WZ teaches epithelial cells, specifically lactocytes, are responsible for the synthesis and secretion of milk into the alveolar lumen. These alveolar cells express cytokeratin 18 (CK18) and synthesize milk proteins such as α-lactalbumin and ß-casein (Non-immune cells and stem/progenitor human breast milk cells). As discussed above, α-lactalbumin and ß-casein contribute to a milk product having characteristics that resemble natural milk in appearance, function, taste, smell, and feel (Pandya [0020]-[0021]). WZ teaches that epithelial cells isolated from fresh breast milk are adherent cells that form colonies of various morphologies that can be maintained through multiple in vitro culture passages (Non-immune cells and stem/progenitor human breast milk cells).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Yang to utilize isolated mammary epithelial cells, specifically lactocytes, as taught by WZ because the cells synthesized α-lactalbumin and ß-casein which contribute to milk products that resemble natural milk in appearance, function, taste, smell, and feel.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARLA I DIVIESTI whose telephone number is (571)270-0787. The examiner can normally be reached Monday-Friday 7am-3pm (MST).
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, Erik Kashnikow can be reached at (571) 270-3475. 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.
/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792