DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9-14, 16-23, 25-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 9, 13, and 22 recite “no more than 1.4% by weight of the least one synthetic emulsifier”. However, there is no support for the range created by “no more than”.
Claims 10-12, 14, 16-21 and 23-28 are rejected as they rely on independent claims 9, 13 and 22, respectively.
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 9-21 are 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.
Regarding claim 9, the animal feed supplement is formed AFTER the composition is added to the animal feed. If the composition comprises synthetic emulsifier at 0.25 to 25 g/ton of feed, it is unclear how the supplement (i.e., which is the composition added to the feed) can have 1.4% of the synthetic emulsifier?
Regarding claim 13, it is unclear how the animal feed composition can comprise both synthetic emulsifier at 0.25 to 25 g/ton of feed and the animal feed composition at the same time comprises no more than 1.4% by weight of the synthetic emulsifier.
Claims 10-12 and 14-21 are rejected as they rely on independent claims 9 and 13 and include all the limitations of their respective independent claim.
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 9-13, 15-22 and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over CN104839508. Applicants have provided a translation of CN104839508 (see IDS of 7/11/2024) and this is relied upon in the rejection.
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CN104839508 teaches a composite emulsifier composition that can be added to animal feed. At the bottom of page 1 of the translation, it is taught that the composition improves absorption and utilization of feeds to meet special energy and fatty acid needs.
The composite emulsifier comprises 2-15% of monoglycerides, 5-15% lysolecithin, and 2-20% of a synthetic emulsifier such as Span-80 (i.e., sorbitan monolaurate) (pg. 3, fourth paragraph of translation). Given sorbitan monooleate and sorbitan monolaurate are both surfactants derived from sorbitol and ethylene oxide, it would have been obvious to use sorbitan monolaurate in CN104839508.
As to the amount of each ingredient, it would have been obvious to vary the amount of each ingredient based on the dietary needs of the subject in which the feed is administered. As noted above, CN104839508 teaches that the claimed ingredients can be used to form a composition that more easily digested and results in an absorption and utilization of fat to meet special energy and fatty acid needs (pg. 1, first paragraph of translation).
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As to claim 10, Example 6 shows administering in batches over a 4 week period (see page 10, Example 6).
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As to claim 11, CN104839508 teaches the product can be a powder (pg. 3, fourth paragraph of translation) or in emulsion form in the fourth paragraph on page 4. Given the emulsion form, it would have bene obvious that the product can also be liquid. Thus, CN104839508 teaches that the composition can be administered in a liquid form.
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As to claim 12, Example 1 provides a dry powder formulation (see page 7, Example 1).
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CN104839508 teaches a composite emulsifier composition that can be added to animal feed. At the bottom of page 1 of the translation, it is taught that the composition improves absorption and utilization of feeds to meet special energy and fatty acid needs.
The composite emulsifier comprises 2-15% of monoglycerides, 5-15% lysolecithin, and 2-20% of a synthetic emulsifier such as Span-80 (i.e., sorbitan monooleate) (pg. 3, fourth paragraph of translation). Given sorbitan monooleate and sorbitan monolaurate are both surfactants derived from sorbitol and ethylene oxide, it would have been obvious to use sorbitan monolaurate in CN104839508.
As to the amount of each ingredient, it would have been obvious to vary the amount of each ingredient based on the dietary needs of the subject in which the feed is administered. As noted above, CN104839508 teaches that the claimed ingredients can be used to form a composition that more easily digested and results in an absorption and utilization of fat to meet special energy and fatty acid needs (pg. 1, first paragraph of translation).
The administration of the composite emulsifier would naturally increase absorption and utilization of feeds as compared with animal fat alone or animal fat with only lysolecithin.
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At the bottom of page 1 of the translation, it is taught that the composition improves absorption and utilization of feeds to meet special energy and fatty acid needs. CN104839508 teaches that the composite emulsifier comprises 2-15% of monoglycerides, 5-15% lysolecithin, and 2-20% of a synthetic emulsifier such as Span-80 (i.e., sorbitan monooleate) (pg. 3, fourth paragraph of translation). However, it would have been obvious to vary the amount of ingredients based on the level of absorption needed and utilization rate of feeds met.
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As to claims 16-17, CN104839508 teaches a composite emulsifier composition that can be added to animal feed. At the bottom of page 1 of the translation, it is taught that the composition improves absorption and utilization of feeds to meet special energy and fatty acid needs. However, given the same ingredients are administered, the administration of the composite emulsifier would naturally increase as compared with animal fat alone or animal fat with only lysolecithin and replace the energy deficiency, as claimed.
Applicant has chosen to use parameters that cannot be measured by the Office, for the purpose of prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facia case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
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As to claims 18-20, Examples 5 and 6 show that the composition is in the form or powder preparation (i.e., premix) and applied as dry mix. However, in Examples 5 and 6 (starting at the bottom of page 9 of the translation), the composition is added to the overall feed. It would have been obvious to prepare the composition in liquid or dry powder form depending on the type of feed the composition is added.
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The composite emulsifier comprises a synthetic emulsifier such as Span-80 (i.e., sorbitan monooleate) (pg. 3, fourth paragraph of translation). Given sorbitan monooleate and sorbitan monolaurate are both surfactants derived from sorbitol and ethylene oxide, it would have been obvious to use sorbitan monolaurate in CN104839508.
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CN104839508 teaches a composite emulsifier composition that can be added to animal feed. At the bottom of page 1 of the translation, it is taught that the composition improves absorption and utilization of feeds to meet special energy and fatty acid needs.
The composite emulsifier comprises 2-15% of monoglycerides, 5-15% lysolecithin, and 2-20% of a synthetic emulsifier such as Span-80 (i.e., sorbitan monooleate) (pg. 3, fourth paragraph of translation). Given sorbitan monooleate and sorbitan monolaurate are both surfactants derived from sorbitol and ethylene oxide, it would have been obvious to use sorbitan monooleate in CN104839508.
As to the amount of each ingredient, it would have been obvious to vary the amount of each ingredient based on the dietary needs of the subject in which the feed is administered. As noted above, CN104839508 teaches that the claimed ingredients can be used to form a composition that more easily digested and results in an absorption and utilization of fat to meet special energy and fatty acid needs (pg. 1, first paragraph of translation).
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At the bottom of page 1 of the translation, it is taught that the composition improves absorption and utilization of feeds to meet special energy and fatty acid needs. CN104839508 teaches that the composite emulsifier comprises 2-15% of monoglycerides, 5-15% lysolecithin, and 2-20% of a synthetic emulsifier such as Span-80 (i.e., sorbitan monooleate) (pg. 3, fourth paragraph of translation). However, it would have been obvious to vary the amount of ingredients based on the level of absorption needed and utilization rate of feeds met.
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As to claims 25-26, CN104839508 teaches a composite emulsifier composition that can be added to animal feed. At the bottom of page 1 of the translation, it is taught that the composition improves absorption and utilization of feeds to meet special energy and fatty acid needs. However, the given the same ingredients are administered, the administration of the composite emulsifier would naturally increase as compared with animal fat alone or animal fat with only lysolecithin and replace the energy deficiency, as claimed.
Applicant has chosen to use parameters that cannot be measured by the Office, for the purpose of prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facia case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
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CN104839508 teaches a composite emulsifier composition that can be added to animal feed.
In a test group of broilers, the composite emulsifier is added at an amount of 300g/ton.
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The composite emulsifier comprises 2-15% of monoglycerides, 5-15% lysolecithin, and 2-20% of a synthetic emulsifier such as Span-80 (i.e., sorbitan monooleate) (pg. 3, fourth paragraph of translation). Given sorbitan monooleate and sorbitan monolaurate are both surfactants derived from sorbitol and ethylene oxide, it would have been obvious to use sorbitan monolaurate in CN104839508.
Claims 14 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over CN104839508 as applied to claims 13 or 22 above, and further in view of Bregniet al., Some Considerations about the hydrophilic-lipophilic balance system, International Journal of Pharmaceutics 356 (2008) 44—51 (BREGNI) (See IDS of 7/11/2014).
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CN104839508 teaches a composite emulsifier composition that can be added to animal feed. At the bottom of page 1 of the translation, it is taught that the composition improves absorption and utilization of feeds to meet special energy and fatty acid needs.
CN104839508 does not teach the use of monoglyceride selected from glycerol monooleate or glycerol monostearate.
However, BREGNI teaches that the HLB value of Span-80 falls somewhere between 4.3 and 6.8 (see Table 5 on page 49). BREGNI explains that the HLB system is a surfactant classification system (abstract). BREGNI also teaches that glycerol monostearate also functions as an emulsifier and has an HLB of 4.15 (see pg. 47, tight column, last paragraph).
It would have been obvious to modify CN104839508 to include glyceryl monostearate, as BREGNI teaches that glycerol monostearate is an emulsifier with similar properties to the SPAN -80 emulsifier of CN10439508 (i.e., low HLB, a lower HLB values indicate a more lipophilic emulsifier, whereas higher values indicate a more hydrophilic emulsifier).
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive.
The applicant argues that compared to the references, CN508 does not teach a composite emulsifier. It teaches a fat composition that is applied to piglet feed, of which the composite emulsifier may be a component. It is allegedly unclear whether the beneficial effects of the CN508 composition are due to lysolecithin, monoglycerides, and synthetic emulsifiers within the composite emulsifier, which itself includes a number of additional ingredients. Moreover, it is alleged that according to CN508, the improved absorption/utilization is at least partly due to the fat powder's similarity to pig mother's milk. The applicant argues that one of ordinary skill in the art would not be able to determine that lysolecithin, monoglycerides, and synthetic emulsifiers would have an unexpectedly beneficial effect from looking at the fat composition provided by CN508. It is also argued that CN508 does not teach an inclusion rate for Span 80 with the feed in which the fat composition is added to, and the Span 80 seems to have a similar weight range within the composite emulsifier as the other ingredients.
However, CN104839508 teaches that the claimed ingredients can be used to form a composition that more easily digested and results in an absorption and utilization of fat to meet special energy and fatty acid needs (pg. 1, first paragraph of translation). In this regard, the lysolecithin, monoglycerides, and synthetic emulsifiers are result effective variables and it would have been obvious to vary the amount of ingredients based on the desired absorption and utilization. Moreover, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
With respect to at least claim 17, the applicant also argues that CN508 does not teach that its composite emulsifier replaces an energy deficiency of 60 kcal/kg of animal feed.
However, claim 17 recites that the animal feed supplement replaces at least 60 kcal/kg of animal feed. CN104839508 teaches a composite emulsifier composition that can be added to animal feed. At the bottom of page 1 of the translation, it is taught that the composition improves absorption and utilization of feeds to meet special energy and fatty acid needs. Thus, given the supplement increase absorption and utilization, it would have been obvious to include the supplement in an animal feed to replace an energy deficiency of an animal
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 PHILIP A DUBOIS whose telephone number is (571)272-6107. The examiner can normally be reached M-F, 9:30-6:00p.
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.
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/PHILIP A DUBOIS/Examiner, Art Unit 1791 /Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
