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 .
DETAILED ACTION
2. Applicants’ arguments and amendments filed on 1/22/26, overcomes the rejections of record. However, examiner made and additional 112 second paragraph rejection in order to make strong office action. This 112 second paragraph rejection is not because of the latest amendment of the claims as filed 1/22/2026. Therefore, the following action is made non-final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.
Status of the application
3. Claims 1-6, 8-9, 11-27 are pending in this office action.
Claims 1,4,8,12,13, 15, 17, 18 have been amended.
Claims 7, 10, are cancelled.is cancelled.
Claims 21-27 are new.
Claims 1-6, 8-9, 11-27 have been rejected.
Obviousness Double Patenting (ODP)
4. The non-statutory 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 non-statutory 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); Inre 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 non-statutory 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 AlA.
Effective January 1,1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73 (b). 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 non- statutory 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. SeeMPEP § 804, sub-section |. B.1. Fora reply toa non-final Office action, see 37 CFR1.111(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 e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e-Terminal Disclaimers, refer to www. Uspto.gov /patents/apply/applying -online /e-terminal-disclaimer
Claims 1-2, 4-8, 10-14, 16-20 of current Application Number 18/453969 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 4-6, 10- 12 (claim 12 also recites plant-based collagen), 14-17 of co-pending application 18/453972.
Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
While comparing the co-pending application numbers 18/453972 with the current application number 18/453969, the common feature is that these two applications share the same invention of making a beverage composition comprising water, protein, substantially free of a sweetener, a food acid, a flavoring agent, a de-foaming agent and combinations thereof having a viscosity of about 1 to about 25 milli Pascals and identical range of claimed turbidity (NTU) as claimed in independent claim 1 for both the current and co-pending applications.
Also, as set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art’, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir.1990).
However, it is to be noted that independent claims 1, 7, 13 recite broadly “protein” (i.e. Genus) as claimed in the current Application Number 18/453969 while independent claims 1, 6, and 11 recite “collagen protein” (i.e. species) as claimed in the co-pending Application Number 18/453972. It is to be noted that independent claims 1, 7, 13 in the current Application Number 18/453969 encompasses the claimed “collagen protein” of independent claims 1, 6, and 11 of co-pending Application Number 18/453972. Therefore, it would have been obvious that independent claims 1, 7, 13 of current application Number 18/453969 includes “Collagen protein” and is similar over, the independent claims 1, 6, and 11 of co-pending Application Number 18/453972 in this respect.
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 1-6, 8-9, 11-27 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.
At least independent claims 1, 4, 13, 21 recite the phrase “wherein the
beverage composition is substantially free of a food acid”. The term “food acid” , at least in independent claims 1, 4, 13, 21 is indefinite. It is acknowledged that applicant has listed some examples in the specification (at least in PGPUB in [0068]). But it is unclear what else would be excluded. The reason is , in specification (in PGPUB [0068]) it recites “citrate salt” is food acid. Also, in specification ( in PGPUB [0058]) it recites “citrate salt” is chelating agent. Therefore, It is not properly defined in the applicant’s specification. There is no absolute definition of this term in the art.
Independent claims 1,4,13, 21 have both the chelating agent and composition is “substantially free from food acid”. As such one of ordinary skill in the art would not be made aware of the metes and bounds of the claims 1, 4,13,21. There is no absolute definition of this term in the art.
It is also to be noted that citrate salt is in the list of “food acid” as evidenced by applicant’s specification (in PGPUB [0068]). Citrate salt includes trisodium citrate also. Even if it is claimed as chelating agent as claimed in dependent claims 5,15,28, however, the identical structure would have an inherent property to serve as food acid also. Therefore, it is unclear how claimed ‘trisodium citrate’ as claimed in dependent claims 5,17 ,23 which ultimately depend on respective independent claims 4, 13, 21 which claim “substantially free from food acid”. This renders at least dependent 5, 17, 23 indefinite. However, as independent claims 1, 4,13, 21 are indefinite, therefore all claims 1-6, 8-9, 11-27 are indefinite. This renders 112 second paragraph rejection.
Claim Rejections - 35 USC § 112
5. 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.
6. Claim 20 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. It is to be noted that amended claim 13 recites the claim limitation of “wherein the beverage ……turbidity about 0.0001 to about 25 NTU as measured by ISO 7027-1:2016 test method”. Dependent claim 20 recites identical claim limitation of claim 13 from which it depends on. This makes claim 20 112 fourth paragraph rejection. Applicant may cancel the claim 20, amend the claim 20 to place the claim 20 in proper dependent form, or rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
7. 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.
8. 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.
9. 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.
10. Claim(s) 1, 2, 4, 6, 8, 12, 24- 26 are rejected under 35 U.S.C. 103 as being unpatentable over Bradley et al. (WO 2013/049540).
11. Regarding claims 1, 2, 4, 8, Bradley discloses a beverage composition comprising water, protein etc. and the beverage composition is used for human, animal or other animal consumption (at least in [06]). Bradley et al. also discloses that the protein includes whey protein hydrolysate, whey protein isolate etc., therefore teaching dairy/bovine proteins ([06]-[09], [15], [31], [40] and [41]) which meets claims 1, 2, 4, 8. Bradley et al. also discloses that the protein in the beverage composition can include high concentration of protein (at least in [04]) which can be 4-8% by weight of protein (i.e. 40-80 gm /L) or 2-15% by weight (i.e. 20-150g/L) ([13]). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Bradley et al., however, discloses many range amounts of proteins with varying concentrations and dilutions for daily consumption (At least in [06], [10]). Therefore, Bradley renders obvious the claimed amount of protein. It would also have been well within the skill of one of ordinary skill to have optimized the amount of protein depending on the nutritional profile desired. It is optimizable.
Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of protein in Bradley et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired amount of water to have desired protein in the final product. (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).
Bradley et al. discloses a beverage composition, comprising, providing water ([06]), buffer system including monopotassium phosphate and sodium chloride also (at least in [68]) which can maintain and keep pH within the desired range of up to about 7.5 ([69]) which overlaps claimed range between 4.6 to 10.0 ([69]). It is to be noted that monopotassium phosphate and sodium chloride is not considered as food acid as is also evidenced by applicant’s specification (in PGPUB [0068]). Also, sodium chloride is commonly acknowledged in the food art as a salt and not a food acid. Therefore, the composition may not need any food acid also. This meets the claim limitation of “substantially free of food acid” as claimed in amended claims 1, 4.
Regarding ‘turbidity’, Bradley discloses that the beverage is optically clear and teaches a turbidity of less than 10 nephelometric units ([08]) and it can be 1-3 NTU also [24]). Although Bradley may not specifically teach the turbidity measured as per the claimed test method, one of ordinary skill in the art would have reasonably expected the turbidity to be comparable to the claimed method given that Bradley also teaches the beverage is optically clear which meets claim 1 and also amended independent claim 4.
Regarding the claim limitation of “wherein the beverage composition has a stable shelf life at a temperature of about 20 to about 25 degree C for at least 4 months”, it is to be noted that Bradley et al. discloses that the preservative can be added to the beverage in order to provide stable shelf life (at least in second paragraph under “Detailed Description”). However, Bradley does not specifically disclose the claimed shelf life for at least 4 months at 20 to 25 degree C” as claimed in claims 1, 4.
However, this claimed shelf life as claimed in claim 1 is considered as a physical property of the product. If we consider the disclosure of Bradley et al. as a whole, Bradley discloses that the beverage comprises up to about 99.9% water ([22]) and the beverage composition can be sweetened or unsweetened, flavored or unflavored ([15]), discloses an amount of protein to meet within the claimed ranges as discussed above. Bradley et al. also discloses that the preservative can be added to the beverage in order to provide stable shelf life (at least in second paragraph under “Detailed Description” Examples). Claim 1 is broad and it recites “comprising” open ended transitional phrase. Therefore, one of ordinary skill in the art would have reasonably expected a comparable shelf life to the beverage composition as claimed by including preservative which is optimizable and is within the skill of one of ordinary skill in the art. Bradley also discloses that the pH of the beverage can be in the range of 1 to about 7.5 ([69]), which overlaps with the claimed invention.
It is, therefore, to be noted that as the disclosed amounts of ingredients including an optically clear beverage comprising the claimed protein and water components etc., meet the claimed invention and , therefore, it would be expected, absent any evidence to the contrary, that the composition would meet the claimed limitations of identical claimed property including stable shelf life as claimed in claims 1, 4.
It is also to be noted that the Patent Office is not equipped to manufacture products and then obtain prior art products and make physical comparisons therewith. See In re Brown, 59 CCPA 1036, 459 F.2d 531,173 USPQ 685 (1972) at 59 CCPA 1041.
Furthermore, it has been found that “[T]ne PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same... [footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)). MPEP 2112.V.
12. Regarding claims 6, 12, Bradley et al. discloses that sweeteners can be as low as 2-degree Brix [25], less than 6 -degree Brix (i.e. can be zero also) ([08]), the beverage may be free of lactose ([06]) and it can be unsweetened also ([15], [016]) which reads on substantially free of sweeteners as claimed in claim 12.
13. Regarding claims 24, 26, Bradley et al. also discloses that such a beverage composition can include a coloring agent in order to incorporate desired color to the beverage product (at least in [24]).
14. Regarding claim 25, Bradley et al. discloses that the protein can be from soy i.e. plant protein also ( 36,37,39).
15. Claims 2, 8 and 3, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bradley et al. (WO 2013/049540), as applied to claims 1, 4 and 8 and as evidenced by Segall et al. (KR 20130079408 A).
16. Regarding claims 2, 8, and 3, 9, it is to be noted that claims 2,8 have been rejected as discussed above. However, claims 2, 8 also claims, alternatively, “a plant protein” which is addressed here with claims 3,9 .
Regarding claims 2, 8, and 3, 9, Bradley et al. discloses protein can include a good quality protein as evaluated by PDCAAS percentage core value which includes whey protein, soy protein, Chickpeas etc. (at least in [37]) to meet claims 3, 9 and 15. It is evidenced by Segall et al. that soy protein, Chickpea, pea protein are legume -sourced plant protein (page 2, last three paragraphs; at least paragraphs immediate above and under Description of Embodiment). Therefore, one of ordinary skill in the art would have been motivated with reasonable expectation of success to consider plant protein from legume -sourced protein having an average PDCAAS score of 0.70 which include soy having very high PDCAAS score 0.91 and /or chick pea having high PDCAAS score of 0.78 (in Bradley et al. [37]) and is a source of plant (vegetable) protein suitable for specific vegan population.
17. Claims 5, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Bradley et al. (WO 2013/049540), as applied to claims 1, 4 and further in view of Nayyar et al. (USPN 5,853,785).
18. Regarding claims 5,11 as discussed above, Bradley et al. discloses sodium citrate as the buffer in the beverage composition ([68]), and has been considered in the rejection of claims 4, 10 above.
However, Bradley is silent specifically about trisodium citrate and its amount, as claimed in claims 5, 11.
Nayyar discloses that a slush beverage composition comprising water, other components and a buffer which is trisodium citrate (Column 1, lines 40-55, and Example 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the beverage composition of Bradley to have comprised another sodium citrate buffer, such as a trisodium citrate, in light of the Nayyar’s teaching that trisodium citrate also is used as a buffer in water-based beverage compositions.
One of ordinary skill in the art would have expected a reasonable degree of success in using another type of sodium citrate buffer in the beverage composition of Bradley, in light of the teachings of the prior art. is prima facie obvious to substitute one composition for another that is taught in the prior art to be used for the same purpose, when their equivalency is established or acknowledged by the prior art. See MPEP 2144.06 II.
19. Claim 13, 14, 16, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bradley et al. (WO 2013/049540) and further in view of Theodore et al. AU 2004287493 A1.
20. Regarding method claims 13, 19, 20, it is to be noted that claim 13 has common claim limitations of independent product claim 1. Therefore, the rejection made for claim 1, considering Bradley et al. is applicable here for claim 13 also.
In addition, Bradley et al. teaches a method of making a beverage composition, comprising, providing water, protein in any order ([06]-[09]), buffer system (at least in [68]) which can provide ion to the water containing beverage composition and it helps to maintain and keep pH within the desired range of up to about 7.5 ([69]). Therefore, it overlaps claimed range between 4.6 to 10.0 and the acid also enhances flavor profile ([69]). Therefore, it reads on “providing water with an ion profile” and “adding at least one ionic compound to the water” as claimed in claim 13.
Regarding the claim limitations of claim 13, “substantially free of food acid” , Bradley et al. discloses a beverage composition, comprising, providing water ([06]), buffer system (at least in [68]) which can maintain and keep pH within the desired range of up to about 7.5 ([69]) which overlaps claimed range between 4.6 to 10.0 ([69]). Therefore, the composition may not need any food acid also. This meets the claim limitation of “substantially free of food acid” as claimed in new claim 13.
Regarding ‘turbidity’, Bradley discloses that the beverage is optically clear and teaches a turbidity of less than 10 nephelometric units ([08]) and it can be 1-3 NTU also [24]). Although Bradley may not specifically teach the turbidity measured as per the claimed test method, one of ordinary skill in the art would have reasonably expected the turbidity to be comparable to the claimed method given that Bradley also teaches the beverage is optically clear which meet claims 13, 19, 20.
Regarding the claim limitation of “wherein the beverage composition has a stable shelf life at a temperature of about 20 to about 25 degree C for at least 4 months”, it is to be noted that Bradley et al. discloses that the preservative can be added to the beverage in order to provide stable shelf life (at least in second paragraph under “Detailed Description”). However, Bradley does not specifically disclose the claimed shelf life for at least 4 months at 20 to 25 degree C” as claimed in claims 13, 19.
Bradley is silent about the amended claim limitation of (a) “Pre-heating the beverage composition to a temperature of about 40 to about 120 degree C” (b) steam injection and (c ) cooling at 18-25 -degree C.
Theodore et al. discloses that [0045] such type of beverage product is steam sterilized where it is preheated in a plate heat exchanger to about 80 degree C, then further heated with steam injection to 285- degree F under 50 psi back pressure with a hold period of approximately 5 seconds. The product is then cooled in a plate heat exchanger to 50*F and is ready to aseptically pack (at least paragraph above Claims in Theodore et al.).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Bradley et al. to perform steam sterilization of the beverage product in order to make steam sterilized product ready to aseptically pack the sterile product.
It is to be noted that the disclosed cooling temperature 50-degree F i.e. 10 degree C (C/5=F-32/9). However, claimed cooling temperature is 18-degree C. IT is to be noted that even if the disclosed cooling temperature is not exactly the claimed cooling temperature, however, if we interpret the cooling condition, it is understood that the disclosed cooling temperature provides broadly to pack under cooling condition.
One of ordinary skill in the art would have been motivated to use the teaching of Theodore et al. to cool at around a temperature of 50-degree F (i.e. 10 degree C) with a reasonable expectation of success to maintain the cooling environment even if this temperature increases including a cooling temperature to claimed 18 degree-C , yet during the packaging period of time. Therefore, it can justify the cooling condition of 18 degree C as claimed in claim 13.
21. Regarding claim 14, Bradley discloses the method includes protein from a variety of sources and heavily discusses dairy and whey proteins that can be used, therefore teaching dairy/bovine proteins ([06]-[09], [15], [31], [40] and [41]).
22. Regarding Claim 16, Bradley discloses the composition and method which includes buffers can be used to maintain acidity, preserve color and/or taste and include sodium citrate and teaches amounts starting at 0.001% by weight of the high protein beverage ( [68]), where about 0.001% by weight is equivalent to about 10mg/L of buffer, which is within the claimed range and therefore also meets the limitation for a chelating agent in light of the amount used and it being a sodium citrate.
23. Regarding claim 18, Bradley et al. discloses that sweeteners can be as low as 2-degree Brix [25], less than 6-degree Brix (i.e. can be zero also) ([08]), the beverage may be free of lactose ([06]) and it can be unsweetened also ([15], [016]) which reads on substantially free of sweeteners as claimed in claim 18.
24. Claims 14, 15, are rejected under 35 U.S.C. 103 as being unpatentable over Bradley et al. (WO 2013/049540) in view of Theodore et al. AU 2004287493 as applied to claim 13 and as evidenced by Segall et al. (KR 20130079408 A).
25. It is to be noted that claim 14 has been rejected as discussed above. However, claim 14 also claims, alternatively, “a plant protein”.
Regarding claim 14, Bradley et al. discloses protein can include a good quality protein as evaluated by PDCAAS percentage core value which includes whey protein, soy protein, Chickpeas etc. (at least in [37]) to meet claim 15. It is evidenced by Segall et al. that soy protein, Chickpea, pea protein are legume -sourced plant protein (page 2, last three paragraphs; at least paragraphs immediate above and under Description of Embodiment). Therefore, one of ordinary skill in the art would have been motivated with reasonable expectation of success to consider plant protein from legume -sourced protein having an average PDCAAS score of 0.70 which include soy having very high PDCAAS score 0.91 and /or chick pea having high PDCAAS score of 0.78 (in Bradley et al. [37]) and is a source of plant (vegetable) protein suitable for specific vegan population.
25. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Bradley et al. (WO 2013/049540) and further in view of Theodore et al. AU 2004287493 as applied to claim 13 and further in view of Nayyar et al. (USPN 5,853,785).
26. Regarding claim 17, as discussed above, Bradley et al. discloses sodium citrate as the buffer in the beverage composition ([68]), and has been considered in the rejection of claim 16 above.
However, Bradley is silent specifically about trisodium citrate and its amount, as claimed in claim 17.
Nayyar discloses that a slush beverage composition comprising water, other components and a buffer which is trisodium citrate (Column 1, lines 40-55, and Example 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the beverage composition of Bradley to have comprised another sodium citrate buffer, such as a trisodium citrate, in light of the Nayyar’s teaching that trisodium citrate also is used as a buffer in water-based beverage compositions.
One of ordinary skill in the art would have expected a reasonable degree of success in using another type of sodium citrate buffer in the beverage composition of Bradley, in light of the teachings of the prior art. is prima facie obvious to substitute one composition for another that is taught in the prior art to be used for the same purpose, when their equivalency is established or acknowledged by the prior art. See MPEP 2144.06 II.
27. Claim 21, 27 are rejected under 35 U.S.C. 103 as being unpatentable over Bradley et al. (WO 2013/049540) and further in view of Theodore et al. AU 2004287493 A1.
28. Regarding claim 21, it is to be noted that claim 13 has common claim limitations of independent product claim 1. Therefore, the rejection made for claim 1, considering Bradley et al. is applicable here for claim 21 also.
In addition, Bradley et al. teaches a method of making a beverage composition, comprising, providing water, protein in any order ([06]-[09]), buffer system (at least in [68]) which can provide ion to the water containing beverage composition and it helps to maintain and keep pH within the desired range of up to about 7.5 ([69]). Therefore, it overlaps claimed range between 4.6 to 10.0 and the acid also enhances flavor profile ([69]).
Regarding the claim limitations of “substantially free of food acid” as claimed in claim 21, Bradley et al. discloses a beverage composition, comprising, providing water ([06]), buffer system (at least in [68]) which can maintain and keep pH within the desired range of up to about 7.5 ([69]) which overlaps claimed range between 4.6 to 10.0 ([69]). Therefore, the composition may not need any food acid also. This meets the claim limitation of “substantially free of food acid” as claimed in new claim 21.
Regarding ‘turbidity’, Bradley discloses that the beverage is optically clear and teaches a turbidity of less than 10 nephelometric units ([08]) and it can be 1-3 NTU also [24]). Although Bradley may not specifically teach the turbidity measured as per the claimed test method, one of ordinary skill in the art would have reasonably expected the turbidity to be comparable to the claimed method given that Bradley also teaches the beverage is optically clear which meet claim 21.
Regarding the claim limitation of “wherein the beverage composition has a stable shelf life at a temperature of about 20 to about 25 degree C for at least 4 months”, it is to be noted that Bradley et al. discloses that the preservative can be added to the beverage in order to provide stable shelf life (at least in second paragraph under “Detailed Description”). However, Bradley does not specifically disclose the claimed shelf life for at least 4 months at 20 to 25 degree C” as claimed in claim 21.
Bradley is silent about the amended claim limitation of (a) “Pre-heating the beverage composition to a temperature of about 40 to about 120 degree C” (b) steam injection and (c ) cooling at 18-25 -degree C.
Theodore et al. discloses that [0045] such type of beverage product is steam sterilizated where it is preheated in a plate heat exchanger to about 80 degree C, then further heated with steam injection to 285- degree F under 50 psi back pressure with a hold period of approximately 5 seconds. The product is then cooled in a plate heat exchanger to 50*F and is ready to aseptically pack (at least paragraph above Claims in Theodore et al.).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Bradley et al. to perform steam sterilisation of the beverage product in order to make steam sterilized product ready to aseptically pack the sterile product.
It is to be noted that the disclosed cooling temperature 50-degree F i.e. 10 degree C (C/5=F-32/9). However, claimed cooling temperature is 18-degree C. IT is to be noted that even if the disclosed cooling temperature is not exactly the claimed cooling temperature, however, if we interpret the cooling condition, it is understood that the disclosed cooling temperature provides broadly to pack under cooling condition.
One of ordinary skill in the art would have been motivated to use the teaching of Theodore et al. to cool at around a temperature of 50-degree F (i.e. 10 degree C) with a reasonable expectation of success to maintain the cooling environment even if this temperature increases including a cooling temperature to claimed 18 degree-C , yet during the packaging period of time. Therefore, it can justify the cooling condition of 18 degree C as claimed in claim 21.
The Examiner notes that claim 21 is product-by-process claims.
Therefore, it is to be noted that, in this case, the courts have held that when the prior art factor appears to differ from the claimed factor only in the method of obtaining the factor, the burden of persuasion was on applicant to show that the claimed product exhibited unexpected properties compared with that of the prior art. The courts further noted that “no objective evidence has been provided establishing that no method was known to those skilled in this field whereby the claimed material might have been synthesized.” 10 USPQ2d at 1926.
The courts also held that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on 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) (citations omitted).
Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See MPEP §2113.
Lastly the courts have held that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). The examiner further notes that “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP §2113.
29. Regarding claim 27, Bradley et al. discloses that the protein can be from soy i.e. plant protein also ( 36,37,39).
30. Claims 22, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Bradley et al. (WO 2013/049540) in view of Theodore et al. AU 2004287493 as applied to claim 21 and further in view of Nayyar et al. (USPN 5,853,785).
31. Regarding claims 22, 23, Bradley et al. discloses sodium citrate as the buffer in the beverage composition ([68]), and has been considered in the rejection of claims 4, 10 and 16 above.
However, Bradley is silent specifically about trisodium citrate and its amount, as claimed in claims 22, 23.
Nayyar discloses that a slush beverage composition comprising water, other components and a buffer which is trisodium citrate (Column 1, lines 40-55, and Example 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the beverage composition of Bradley to have comprised another sodium citrate buffer, such as a trisodium citrate, in light of the Nayyar’s teaching that trisodium citrate also is used as a buffer in water-based beverage compositions.
One of ordinary skill in the art would have expected a reasonable degree of success in using another type of sodium citrate buffer in the beverage composition of Bradley, in light of the teachings of the prior art. is prima facie obvious to substitute one composition for another that is taught in the prior art to be used for the same purpose, when their equivalency is established or acknowledged by the prior art. See MPEP 2144.06 II.
Response to arguments
32. Applicant’s arguments and amendments have been considered. However, they are not persuasive.
33. Regarding ODP rejection, it is to be noted that the alleged claim limitation “wherein the beverage composition has a stable shelf life at a temperature of about 20 to about 25 degree C for at least 4 months” is included in the latest filed independent claims 1, 11 of application number 18/453972 as filed 1/22/2026. The ODP rejection is maintained.
34. It is to be noted that applicant’s presentation of declaration by the inventor is not filed under this application. It is filed under 18/453972 on 1/22/2026. However, because ODP rejection has been made with this application 18/453972, therefore, the declaration is considered to respond in this section. Applicants are advised to submit affidavit under this application also.
35. Applicant’s amendments can still be addressed with the combinations of prior arts of record as used in the prior office action and discussed below. However, examiner used one new secondary prior art by Theodore et al. AU 2004287493 A1 to address some additional claim limitations as claimed in the amended claim 13, and new claim 21.
36. Applicants primarily argued that “Applicants respectfully disagree and respectfully asserts that the office action has misconstrued a beverage with a buffer system as a beverage product substantially free of a food acid” (in Remarks, page 3, second paragraph).
In response, it is to be noted that
(i) in the examples do say this is an example of a citrate salt so for this example trisodium citrate” as “buffer has ‘acid part’ and therefore, it cannot be added as a “buffer” to modify primary prior art by Bradley with the teaching of Nayyar et al. because Nayyar et al. does not teach its use as “chelating agent”. However, trisodium citrate” is controversial from the standpoint of applicant’ s specification (in PGPUB [0068], [0058]) and discussed in detail above.
(ii) It is also to be understood that the motivation is to be used from secondary prior art. However, if the ingredient has identical structure and is used to same food composition of the claimed invention, then the disclosed composition will have identical property including the property of serving as chelating agent. It is also to be noted that if we consider the arguments that trisodium citrate has ionic part which is food acid, will still exist when added to similar beverage product. Therefore, if we consider this applicants argument, that trisodium citrate, as buffer, contributes ionic part which is food acid, then if trisodium citrate chelating agent is considered to be added, then applicant contradicts claimed invention of “no food acid” composition. However, examiner does not think so. The reason is, buffer is not "a food acid". Buffer's function is to maintain stable ph. A food acid lowers ph. Therefore, any buffer composition (e.g. trisodium citrate buffer) made with acid (i.e. citric acid) cannot have necessarily the property of the respective acid part having "A food acid" property to lower pH with desired acidity. On the contrary, buffer prevents drastic ph. shift. Buffer neutralizes added acid ( H+) or basic ions (OH--) depending on the type of buffer used.
(a) applicant’s dependent claim claims “chelating agent” trisodium citrate is added to the product of independent claim which recites “free of food acid” from which the dependent claim depends. This is understood. However, as discussed clearly under 112 second paragraph rejection that in specification (in PGPUB [0068]) it recites “citrate salt” is food acid. Also, in specification ( in PGPUB [0058]) it recites “citrate salt” is chelating agent. Therefore, It is not properly defined in the applicant’s specification. There is no absolute definition of this term in the art. The detailed discussion as discussed under 112 second paragraph rejection is applicable here as response for the above arguments too.
It is also mentioned under item #11 that Bradley et al. discloses a beverage composition, comprising buffer system including monopotassium phosphate and sodium chloride also (at least in [68]) which can maintain and keep pH within the desired range of up to about 7.5 ([69]). Monopotassium phosphate and sodium chloride are not considered as food acid as is also evidenced by applicant’s specification (in PGPUB [0068]). Also, sodium chloride is commonly acknowledged in the food art as a salt and not a food acid.
37. Unexpected Result (Fourth and fifth page, in remarks ):
(a) It is to be noted that applicant’s did submit declaration on 1/22/2026 for the application 18/453972 but not for this application 18453969. As because this 18/453972 has been considered for ODP rejection, examiner is considering the affidavit to respond for this application too. However, applicant’s are requested to kindly submit this declaration under this application 18/453972 also. Examiner is addressing and responding considering the arguments and a declaration together based on the arguments and declaration under 37 CFR 1.132 ( at least paragraphs paragraphs 12-28).
(b) Applicant’s arguments including the arguments made under affidavit, have been considered and responded below.
In response, Examiner also does not agree with the arguments including declaration (paragraphs 12-19) that Bradley cannot be modified by Nayyar et al. [Unexpected Result]:
The reasons are :
(i) Applicant’s arguments based on unexpected result is considered. However, as discussed above, chelating agent like “trisodium citrate” is controversial from the standpoint of applicant’ s specification (in PGPUB [0068], [0058]). The reasons explained under 112 second paragraph rejection and is applicable here too. Therefore, if it also serves as a food acid, it does not commensurate with the scope of the independent claims 1, 4, 13 and 26 when the surprising result with respect to shelf stability of the claimed product at a temperature 20-25 degree C for at least 4 months is achieved for at least 4 months after being hot-filled, with a chelating agent trisodium citrate as argued by the applicants on (On fifth page, lower mid-section, in remarks). The reason is, and as discussed above, even if it is claimed trisodium citrate is a chelating agent, however, the identical structure would have an inherent property to serve as food acid also. This is also evidenced by applicants’ specification that citrate salt has both the properties (in PGPUB [0058], [0068]) Therefore, the unexpected result as established using “trisodium citrate” is not clear and not acceptable.
It is also to be noted that and as mentioned in the office action above that claimed shelf life is considered as a physical property of the product. Therefore, it would be expected, absent any evidence to the contrary, that the composition would meet the claimed limitations of identical claimed property including stable shelf life as claimed in claims 1, 4, 13, 21.
It is also to be noted that the Patent Office is not equipped to manufacture products and then obtain prior art products and make physical comparisons therewith. See In re Brown, 59 CCPA 1036, 459 F.2d 531,173 USPQ 685 (1972) at 59 CCPA 1041.
Furthermore, it has been found that “[T]ne PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same... [footnote omitted].” The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977)). MPEP 2112.V.
The rejection is made as non- final.
Conclusion
38. Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792