DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
In the April 16, 2024 submission, claims 1-18 were presented for consideration and are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No.12,011,051. The application and patented claims are presented as follows:
*Instant Application 18/445,964
1. A method for the preparation of baby formula comprising,
a) processing active baby formula ingredients in a baby formula powder blending process, whereby the active baby formula ingredients are blended to ensure that a predetermined acceptance criteria is achieved;
b) monitoring data generated by a powder blending device during said baby formula product powder blending process;
c) compiling said data into a historic record of said manufacturing process;
d) analyzing the historic record to provide a comparative analysis against the predetermined acceptance criteria;
e) taking corrective action on said baby formula powder blending process, wherein said corrective action comprises modifying the baby formula powder blending process, whereby the active baby formula ingredients are transformed into a batch.
2. The method of claim 1, wherein the monitoring is continuous.
3. The method of claim 1, wherein the monitoring is semi-continuous.
4. The method of claim 1, wherein the monitoring is part of a quality control protocol.
5. The method of claim 1, wherein the device is a standardization tank.
6. The method of claim 1, wherein the device is a modular cleanroom.
7. The method of claim 1, wherein the device is a clean-in-place system.
8. The method of claim 1, further comprising adding an excipient to the active baby formula ingredients.
9. The method of claim 1, further comprising adding a plurality of excipients to the active baby formula ingredients.
10. The method of claim 8, wherein the excipient is selected from the group consisting of DHA, EPA, or ARA
11. The method of claim 9, wherein the excipient is selected from the group consisting of DHA, EPA, ARA, vitamins, mineral, or carrageenan.
12. The method of claim 1, further comprising a manufacturing execution system (MES) integrated into the powder blending process to monitor the data generated during the powder blending process.
13. The method of claim 12, wherein the MES monitors pH.
14. The method of claim 12, wherein the MES monitors temperature.
15. The method of claim 12, wherein the MES monitors fat concentration.
16. The method of claim 12, wherein the MES monitors additional of the excipient.
17. A non-transitory computer memory having computer executable instructions which when executed in a baby formula powder blending process performs the method of claim 1.
*US Patent No. 12,011,020
1. A method for the preparation of baby formula comprising,
a) processing homogenized active baby formula ingredients in a baby formula standardization process, whereby the standardization process is integrated with a manufacturing execution system (MES) used to monitor and control the data generated during the baby formula standardization process and whereby the homogenized active baby formula ingredients are standardized to ensure that manufacturing parameters from a predetermined acceptance criteria are achieved;
b) monitoring data generated by a standardization device during the baby
formula standardization process;
c) compiling said data into a historic record of the baby formula manufacturing process;
d) analyzing the historic record to provide a comparative analysis against the predetermined acceptance criteria;
e) taking corrective action on the baby formula standardization process, wherein the corrective action comprises modifying the baby formula standardization process, and whereby the homogenized active baby formula ingredients are transformed into a standardized batch.
2. The method of claim 1, wherein the monitoring is continuous.
3. The method of claim 1, wherein the monitoring is semi-continuous.
4. The method of claim 1, wherein the monitoring is part of a quality control protocol.
5. The method of claim 1, wherein the device is a standardization tank.
6. The method of claim 1, wherein the device is a modular cleanroom.
7. The method of claim 1, wherein the device is a powder blender.
8. The method of claim 1, further comprising adding an excipient to the homogenized active baby formula ingredients.
9. The method of claim 8, wherein the excipient is selected from the group consisting of DHA, EPA, or ARA.
10. The method of claim 1, further comprising adding a plurality of excipients to the homogenized active baby formula ingredients.
11. The method of claim 9, wherein the excipient is selected from the group consisting of DHA, EPA, ARA, vitamins, mineral, or carrageenan.
12. The method of claim 1, wherein the MES monitors the addition of the excipient.
13. The method of claim 1, wherein the MES monitors pH.
14. The method of claim 1, wherein the MES monitors temperature.
15. The method of claim 1, wherein the MES monitors fat concentration.
16. A non-transitory computer memory having computer executable instructions which when executed in a baby formula manufacturing environment performs a method for the preparation of baby formula comprising,
a) processing homogenized active baby formula ingredients in a baby formula standardization process, whereby the standardization process is integrated with a manufacturing execution system (MES) used to monitor and control the data generated during the baby formula standardization process and whereby the homogenized active baby formula ingredients are standardized to ensure that manufacturing parameters from a predetermined acceptance criteria are achieved;
b) monitoring data generated by a standardization device during the baby formula standardization process;
c) compiling said data into a historic record of the baby formula manufacturing process;
d) analyzing the historic record to provide a comparative analysis against the predetermined acceptance criteria;
e) taking corrective action on the baby formula standardization process, wherein the corrective action comprises modifying the baby formula standardization process, and whereby the homogenized active baby formula ingredients are transformed into a standardized batch.
* Bolden text denote differences in claim sets
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim set contain all the limitations included in the application claim set. The limitations featured in claim 12 of the application was included in the independent claims of the patent set, wherein the independent claims of the patent further defined manufacturing parameters of the blending process. Regarding the dependent claims, application claims 1-6, 10, 11, 13-15 and 16 are synonymous to dependent claims 1-6, 9, 11, 13-15 and 12, respectively, of the patent claims. Patented dependent claims 7, 8 and 10 were amended to further define characteristics of the blending process, as they relate to application claims 7-9, respectively.
Examiner notes that while several of claim numbers allocated to limitations of the application and patented dependent claims may differ, [limitation] compositions are the same. Numbering of the patented claim set was modified during the patenting process as subject matter was consolidated during the patent process and claim sets were renumbered..
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-18 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kratky et al., US Patent Application Publication No. 2000/0260923 (filed September 9, 2005, hereinafter KRATKY).
As per claim 1, KRATKY teaches of a method for the preparation of baby formula comprising,
processing active baby formula ingredients in a baby formula powder blending standardization process whereby the active baby formula ingredients are blended to ensure that a predetermined acceptance criteria is achieved (see par. 82 and 85: blending powered formula, wherein the mixture is standardized, homogenized and processed through HTST);
monitoring data generated by a powder blending device during said baby formula product powder blending [standardizing] process (see par. 85-86: system monitors both the temperature and pH balance during the blending process via standardized tools, and report results to the manufacturing program to ensure predetermined [standardized] levels are maintained);
compiling said data into a historic record of said manufacturing process (see par. 69: system captures/records processing data, maintain records over time, and subsequently use the data for future processing);
analyzing the historic record to provide a comparative analysis against the predetermined acceptance criteria (see par. 85-86: several parameters are examined and compared during a variety of phases/steps during processing, (e.g., the system monitors temperature and pH levels, compares the captured data to predetermined standardization levels and protocols, and confirm correct levels or adjust operations to ensure conditions are met)); and
taking corrective action on said baby formula powder blending [standardization] process, wherein said corrective action comprises modifying the baby formula powder blending process, whereby the active baby formula ingredients are transformed into a batch (see par. 57, 86, 90: throughout the manufacturing process, processing steps are constantly monitored, compared and adjusted to ensure standards are met, wherein during the transformation in a standard batch, steps are taken to maintain a level of standardization during the transfer of material).
As per claim 2, KRATKY further teaches of the method of claim 1, wherein the monitoring is continuous (see par. 85-86: system ensures continuous monitoring during processing to ensure operations and intermediary steps concur with processing protocols (e.g., temperatures and pH levels are monitored and ensured to remain at standardized levels; components and elements of the system undergo a sterilization process to ensure cleanliness, etc.)).
As per claim 3, KRATKY further teaches of the method of claim 1, wherein the monitoring is semi-continuous (see par. 24, 29 and 34: different steps and processes are examined to ensure predetermined [standardized] levels are met, requiring interim evaluation and processing as a defense against product or process corruption, and provide a safeguard that predetermined standardization levels are maintained).
As per claim 4, KRATKY further teaches of the method of claim 1, wherein the monitoring is part of a quality control protocol (see par. 82, 86: the quality of products used are evaluated and constantly monitored to ensure the end-product meets predetermined nutritional standards (e.g., sterilization of initial equipment and components, acidity of composition, sterility of solutions, etc.)).
As per claim 5, KRATKY further teaches of the method of claim 1, wherein the device is a standardization tank (see par. 24, 29, 85 and 89: mixing based on a sterile equipment and standardized processes).
As per claim 6, KRATKY further teaches of the method of claim 1, wherein the device is a modular cleanroom (see par. par. 24, 29 and 34: in an effort to eradicate bacteria and harmful agents, processing occurs in a clean and sterile environment, wherein the tools and equipment involved in the process undergo a sterilization process).
As per claim 7, KRATKY further teaches of the method of claim 1, wherein the device is a clean-in-place (CIP) system (see par. 69 and 78-80: system uses a CIP system to facilitate formulation blending and homogenization during processing stages to protect the end product from contamination due to the transfer and interchange of equipment during processing.
As per claim 8, KRATKY further teaches of the method of claim 1, further comprising adding an excipient to the active baby formula ingredients (see par. 12 and 79: during processing, the mixture is homogenized based on protocol).
As per claim 9, KRATKY further teaches of the method of claim 1, further comprising adding a plurality of excipients to the active baby formula ingredients (see par. 56: infant formulas are subject to a variety of ingredients to produce a homogenous emulsion).
As per claim 10, KRATKY further teaches of the method of claim 8, wherein the excipient is selected from the group consisting of DHA, EPA, or ARA (see par. 98: containers holding one of the specialty lipids (e.g., DHA, ARA, plurality of oils, etc.) used in product formulations).
As per claim 11, KRATKY further teaches of the method of claim 9, wherein the excipient is selected from the group consisting of DHA, EPA, ARA, vitamins, mineral, or carrageenan (see par. 98: containers holding one of the specialty lipids (e.g., DHA, ARA, various oils, etc.) used in product formulations).
As per claim 12, KRATKY further teaches of the method of claim 1, further comprising a manufacturing execution system (MES) integrated into the powder blending [standardization] process to monitor the data generated during the powder blening process (see par. 2-5: system employs a manufacturing process which prepares, performs multiple blending processes, monitors and optimizes the production of infant formula).
As per claim 13, KRATKY further teaches of the method of claim 12, wherein the MES monitors pH (see par. 86: during processing, the pH levels are monitored, wherein the final composition is adjusted to a required acidity level).
As per claim 14, KRATKY further teaches of the method of claim 12, wherein the MES monitors temperature (see par. 85: during processing, the temperatures are monitored, wherein HIST is brought within a standardized level).
As per claim 15, KRATKY further teaches of the method of claim 12, wherein the MES monitors fat concentration (see par. 79, 82 and 86: fat concentration is monitored respective of mixture and processing product).
As per claim 16, KRATKY further teaches of the method of claim 12, wherein the MES monitors additional of the excipient (see par. 90: a mixture of inactive flavorings and colorings are added to improve likability of an end product (e.g., appeal/improve the taste and look of a product).
As per claim 17, KRATKY further teaches of a non-transitory computer memory having computer executable instructions which when executed in a baby formula manufacturing environment performs the method of claim 1 (see par. 69, 76, 85-86 and 100: computer implemented method for capturing data, performing comparable analysis, controlling and adjusting operations to ensure standardized results and executing the manufacturing of the method noted in claim 1 above).
As per claim 18, KRATKY further teaches of a kit comprising the non-transitory computer memory having computer executable instructions of claim 17 (see par. 76 and 100: computerized instructions used to perform the analysis, control and manufacturing of the computer-implemented method noted in claim 17 above).
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pokorny et al., US Patent Application Publication No. 2003/0150908, Wright et al., US Patent Application Publication No. 2015/0079235 and Mitchell et al, US Patent Application Publication No. 2008/0241339, teach of varying computer-implemented methods and techniques used during the manufacturing processes in producing milk and power-based products, while focusing on maintaining a standard homogenized operational environment.
Conclusion
The applicant is strongly encouraged to contact the examiner if further clarifications are needed with respect to interpretation of currently presented claims and/or cited prior art.
A reference to specific paragraphs, columns, pages, or figures in a cited prior art reference is not limited to preferred embodiments or any specific examples. It is well settled that a prior art reference, in its entirety, must be considered for all that it expressly teaches and fairly suggests to one having ordinary skill in the art. Stated differently, a prior art disclosure reading on a limitation of Applicant's claim cannot be ignored on the ground that other embodiments disclosed were instead cited. Therefore, the Examiner's citation to a specific portion of a single prior art reference is not intended to exclusively dictate, but rather, to demonstrate an exemplary disclosure commensurate with the specific limitations being addressed. In re Heck, 699 F.2d 1331, 1332-33,216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006,1009, 158 USPQ 275, 277 (CCPA 1968)). In re: Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005); In re Fritch, 972 F.2d 1260, 1264, 23 USPQ2d 1780, 1782 (Fed. Cir. 1992); Merck& Co. v. BiocraftLabs., Inc., 874 F.2d 804, 807, 10 USPQ2d 1843, 1846 (Fed. Cir. 1989); In re Fracalossi, 681 F.2d 792,794 n.1,215 USPQ 569, 570 n.1 (CCPA 1982); In re Lamberti, 545 F.2d 747, 750, 192 USPQ 278, 280 (CCPA 1976); In re Bozek, 416 F.2d 1385, 1390, 163 USPQ 545, 549 (CCPA 1969).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELVIN BOOKER whose telephone number is (571)272-7827. The examiner can normally be reached on M-F 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mohammad Ali can be reached on (571) 272-4105. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/Kelvin Booker/
Examiner, Art Unit 2119
/MOHAMMAD ALI/Supervisory Patent Examiner, Art Unit 2119
Prosecution Insights