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 .
In view of the amendment, previous 112(b) rejection on claim 73 is hereby withdrawn.
Claim Objections
Claim 72 is objected to because of the following informalities: on the last line, applicant need to change “(a) to (c)” to --- (i) to (iii) ---. Appropriate correction is required.
Claim 78 is objected to because of the following informalities: on line 2, applicant need to change “pain and muscle” to --- pain or muscle ---. Appropriate correction is required.
Claim 80 is objected to because of the following informalities: on line 3, applicant need to change “any one of said (a) and (b) or (c)” to --- any one of said (a) or said (b) or (c) --- (so as to make the meaning of the claim clear). Also, on line 5, applicant need to change “at least one of said (a) and (b) or (c);” to --- at least one of said (a) or said (b) or (c); ---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 79 is 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.
Instant claim 61, from which claim 79 depends, recites “b) a filler being inulin in the amount of 55-80% by weight”. Yet, claim 79 recites “(ii) a filler being inulin in an amount of 60-85%, by weight;”. Thus, instant claim 79 fails to further limit the subject matter of claim 61. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 61-68 and 70-80 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.
In claim 61, applicant recite “[a] composition comprising: a) a microalgae powder . . .; and b) a filler being inulin in the amount of 55-80% by weight or (c) . . . , wherein said composition is characterized by increased stability, . . ., compared to a control, and wherein said increased stability is maintained for a period of at least 6 months.” However, instant composition comprising 55-80 wt.% of inulin being characterized by increased stability and maintaining such increased stability for a period of at least 6 months is not described in present specification in such a way as to reasonably convey to one skilled in the art that inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention for the following reasons: as shown in present specification, applicant’s inventive Formulation 4 contains 40 wt.% of inulin; Formulation 5 contains 60 wt.% of inulin; Formulation 6 contains 80 wt.% of inulin; Formulations 7 and 8 contains 37 wt.% of inulin; and Formulation 9 contains 76.6 wt.% of inulin. However, for the inventive Formulations 5, 6 and 9 that contain inulin in the amounts that fall within the claimed range of 55-80 wt.%, there was no showing of maintenance in the increased stability for at least 6 months as instantly claimed: for the formulations 5 and 6, at 35 days, the percentages for the astaxanthin remaining already went below 95% and below 97%, respectively (see Tables 12 and 13); and for the formulation 9, at 90 days, the percentage for the astaxanthin remaining went below 95% (in vacuum condition) – see Table 18 (and the same formulation 9, at 13 days, the percentage went below 85% under aerated condition – see Table 19). Thus, one can conclude that for Formulations 5, 6 and 9, which represent present invention, the stability would certainly not be maintained for a period of at least 6 months. On the contrary, applicant’s best result (in terms of astaxanthin stability) was in fact obtained for their Formulation 8 containing inulin in the amount of 37%, which clearly falls outside of the claimed range – see Table 16, which shows 100% astaxanthin remaining at 90 days (under vacuum condition). Formulation 7 containing inulin the amount of 37% also showed 100% astaxanthin remaining at 30 days (under vacuum condition). Therefore, for the reason explained above, it is the Examiner’s position that instant composition comprising 55-80 wt.% of inulin being characterized by increased stability and maintaining such increased stability for a period of at least 6 months is not described in present specification in such a way as to reasonably convey to one skilled in the art that inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 61, 63-67, 70-72, 74-77, 79 and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (CN 106473114 A and its English translation) in view of Long et al (CN 106913589 A and its English translation) (with (i) Ware (“Why is grapefruit good for you?” MedicalNewsToday, an internet article updated on June 23, 2023 and obtained from the website: https://www.medicalnewstoday.com/articles/280882), which is cited here merely to support the Examiner’s assertion that grapefruit is a rich source of antioxidants; (ii) Mularczyk et al (“Astaxanthin and other Nutrients from Haematococcus pluvialis-Multifunctional Applications”, Mar Drugs, vol.18(9) (Sep.7, 2020), pg.1-22), which is being cited here merely to support the Examiner’s assertion that Haematococcus pluvialis has been shown to accumulate up to 5% dry weight of astaxanthin; (iii) an internet article on nutrition facts on grapefruit as obtained from the website: https://www.urmc.rochester.edu/encyclopedia/content.aspx?contenttypeid=76&contentid=09111-2, which is being cited here merely to support the Examiner’s assertion that grapefruit contains alpha-tocopherol) .
In its Example 1 (see [0040]-[0045]); see also [0009]-[0010]) , Wu teaches an anti-aging composition comprising 20% of rose petals, 32% of whole grape fruit powder, 36% of inulin and 12% of Haematococcus pluvialis (the percentages are by weight – see [0010]). The Haematococcus pluvialis teaches instant microalgae of claim 76.
With respect to instant “microalgae powder”, Wu does not explicitly state that the Haematococcus pluvialis is in a powder form. However, as evidenced by Long et al (see [0006]), Haematococcus pluvialis powder has been approved by the FDA and has been used in the health care product market as a dietary ingredient. It would have been obvious to one skilled in the art to use Haematococcus pluvialis in a powder form in Wu’s anti-aging composition with a reasonable expectation of success. Thus, Wu in view of Long teaches instant microalgae powder.
With respect to instant range (5-30 wt.%) for the amount of the microalgae powder, as stated above, Wu’s anti-aging composition of Embodiment 1 contains 12 wt.% Haematococcus pluvialis (instant microalgae powder). Since such value falls within instant range, Wu teaches instant range for the amount of the microalgae powder. As stated in In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), “the disclosure in the prior art of any value within a claimed ranges is an anticipation of that range.”
With respect to instant range (55-80 wt.%) for the amount of the filler, which is inulin, as shown above, Wu’s anti-aging composition of Example 1 contains 36 wt.% inulin. Such value does not teach instant range 55-80 wt.%. However, Wu teaches ([0010]) that its composition can contain inulin in the amount of 20-50 wt.%. Although such range does not overlap with instant range 55-80 wt.% for the amount of the filler (inulin), it is the Examiner’s position that 50 wt.% (the higher end of Wu’s range) and 55 wt.% (the lower end of instant range) are close to each other that one skilled in the art would have expected them to have the same properties and thus, Wu’s range 20-50 wt.% for the amount of inulin would render instant range prima facie obvious. Where the claimed ranges and prior art do not overlap but are close enough that one skilled in the art would have expected them to have the same properties, a prima facie case of obviousness would also exist which may also be overcome by a showing of unexpected results, In re Titanium Metals Corporation of America v. Banner, 227 USPQ 773 (Fed. Cir. 1985): in instant case, applicant have not shown unexpected results of instant range (55-80 wt.%) for the amount of the filler (inulin) by comparing a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. See MPEP 716.02(d)(II). In fact, applicant’s best result (in terms of astaxanthin stability) was obtained for their formulation 8, which contains inulin in the amount of 37 wt.%, which clearly lies outside of the claimed range. Besides, 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. See MPEP 2144.05 (II)(A).
Thus, Wu in view of Long renders obvious instant claims 61, 63, 76 and 80 (since Wu in view of Long teaches instant composition of claim 61, such composition would accordingly show increased stability, processability, or both, when compared to a control (as described in claim 80) and maintain the increased stability for a period of at least 6 months as recited in claim 61 or for 6-12 months as recited in claim 63).
With respect to instant claims 64, 70 and 71, as shown above, Wu’s anti-aging composition also comprises whole grape fruit powder, and as evidenced by Ware’s internet article “Why is grapefruit good for you?” (see the 3rd page, under “Cancer”), grapefruit is a rich source of antioxidants, such as vitamin C. Besides, Wu also teaches ([0015]-[0016]) that the main functional substance of the whole grape fruit powder is red wine polyphenol, which contains a variety of powerful antioxidants. Thus, Wu in view of Long renders obvious instant claims 64, 70 and 71 (instant claims 70 and 71 do not require the presence of the wax material in instant composition of claim 64. It only requires that if the composition of claim 64 further comprises a wax material, then the wax material has to be selected from those listed in claim 70 and that the wax material has to be carnauba wax and the amount for the carnauba wax has to be 1-10 wt.% as recited in claim 71). With respect to instant claim 72, as discussed above, Wu’s anti-aging composition contains whole grapefruit powder, and according to nutrition facts on grapefruit (obtained from the website: https://www.urmc.rochester.edu/encyclopedia/content.aspx?contenttypeid=76&contentid=09111-2 ), grapefruit contains vitamin E (alpha-tocopherol) (instant antioxidant of claim 72 (ii)). Thus, Wu in view of Long renders obvious instant claim 72.
With respect to instant claims 65 and 66, Wu teaches ([0044]) that the main active ingredient of Haematococcus pluvialis is astaxanthin (instant carotenoid of claims 65-66). Thus, Wu in view of Long renders obvious instant claims 65 and 66.
With respect to instant claim 67, Wu teaches ([0010]) that its anti-aging composition may contain Haematococcus pluvialis in the amount of 1-15 wt.%. Furthermore, as evidenced by Mularczyk et al (see pg.7, lines 6-7), Haematococcus pluvialis has been shown to accumulate up to 5% dry weight of astaxanthin. Assuming about 5% dry weight of astaxanthin, this gives the amount for the astaxanthin present in Wu’s anti-aging composition (containing 1-15 wt.% of Haematococcus pluvialis) to be in a range of about 0.05-0.75 wt.%. Although such range does not overlap instant range 1-8 wt.% for the amount of astaxanthin, it is the Examiner’s position that the higher end (0.75 wt.%) of such range and the lower end (1 wt.%) of instant range are so close to each other that a prima facie case of obviousness would exist: where the claimed ranges and prior art do not overlap but are close enough that one skilled in the art would have expected them to have the same properties, a prima facie case of obviousness would also exist which may also be overcome by a showing of unexpected results, In re Titanium Metals Corporation of America v. Banner, supra. Besides, 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. See MPEP 2144.05 (II)(A). Thus, Wu in view of Long renders obvious instant claim 67.
With respect to instant claim 74, as discussed above, Wu’s Example 1 composition contains 12 wt.% of Haematococcus pluvialis. Such value falls within instant range 8-24 wt.% for the amount of the microalgae powder, and thus teaches instant range. In re Wertheim supra. Thus, Wu in view of Long renders obvious instant claim 74.
With respect to instant claim 75, instant claim recites claim limitations for the magnesium recited in (c) of claim 61. However, instant claim language of claim 75 does not require the presence of instant component (c) (i.e., a filler being the combination of inulin and magnesium) in instant composition of claim 61. It only requires that if the filler of claim 61 were the combination of inulin and magnesium, then the magnesium has to satisfy the limitation of claim 75. Thus, Wu in view of Long still renders obvious instant claim 75.
With respect to instant claim 77, as already discussed above, Wu’s anti-aging composition comprises whole grape fruit powder, which is a rich source of antioxidants, such as vitamin C (instant component (iii) (one or more additives) of claim 77). Thus, Wu in view of Long renders obvious instant claim 77.
With respect to instant claim 79, based on the teachings of Wu in view of Long as discussed above, it would be obvious to one skilled in the art to prepare Wu’s anti-aging composition by mixing 12 wt.% of Haematococcus pluvialis (microalgae) in powder form and 20-50 wt.% of inulin (along with 20 wt.% of rose petals and 32 wt.% of whole grape fruit powder). Although Wu’s 20-50 wt.% of inulin is not the same as instant 60-85 wt.% of inulin, 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. See MPEP 2144.05 (II)(A). As already discussed above (see also Paragraph 16 below), in instant case, applicant have not shown the criticality of instant range 60-85 wt.% for the amount of inulin (also, as indicated above and below in Paragraph 16, applicant’s data in present specification actually indicate that the best result (in the astaxanthin stability) was obtained when the inulin concentration was 37 wt.% (which falls within Wu’s range). Under these circumstances, it is the Examiner’s position that Wu in view of Long would still render obvious instant claim 79.
Claim(s) 62 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (CN 106473114 A and its English translation) in view of Long et al (CN 106913589 A and its English translation) as applied to claim 61 above, and further in view of Giampapa (US 2004/0001817 A1) and Liang et al (CN 106261445 A and its English translation).
With respect to instant claim 62, Wu teaches ([0002]) that its invention relates to the field of nutritional health products, in particular to an anti-aging composition, but does not explicitly teach that its anti-aging composition is in the form of a tablet. As evidenced by Giampapa (see [0061]), it is already known in the art that an anti-aging nutritional supplement composition can be in the form of a tablet, capsule or caplet. Furthermore, as evidenced by Liang et al (see [0006] and [0009]) (and as also evidenced by Long et al ([0075])), Haematococcus pluvialis-containing composition has been made into an anti-aging Haematococcus pluvialis tablet. It would have been obvious to one skilled in the art to have Wu’s anti-aging composition containing Haematococcus pluvialis powder in the form of a tablet according to the well-known practice in the art (and also for convenience reasons) with a reasonable expectation of success. Thus, Wu in view of Long, and further in view of Giampapa and Liang renders obvious instant claim 62.
Claim(s) 68 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (CN 106473114 A and its English translation) in view of Long et al (CN 106913589 A and its English translation) as applied to claim 61 above, and further in view of Boursier et al (US 2011/0311599 A1).
As discussed above, Wu’s anti-aging composition comprises rose petals, whole grape fruit powder, inulin and Haematococcus pluvialis.
Wu’s composition does not contain instant maltodextrin or gum acacia. Wu teaches ([0025]) that inulin is a soluble dietary fiber. As evidenced by Boursier ([0098]-[0101]), it is known in the art that branched maltodextrin (another well-known soluble dietary fiber) is beneficial to the metabolism and to the intestinal equilibrium. It would have been obvious to one skilled in the art to further incorporate branched maltodextrin (in addition to the inulin) as another soluble dietary fiber in Wu’s anti-aging composition so as to bring benefits to the metabolism and intestinal equilibrium as taught by Boursier. Thus, Wu in view of Long, and further in view of Boursier renders obvious instant claim 68.
Claim(s) 73 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (CN 106473114 A and its English translation) in view of Long et al (CN 106913589 A and its English translation), as applied to claim 61 above, and further in view of Boursier et al (US 2011/0311599 A1), Liang et al (CN 106261445 A and its English translation), Hall (US 2017/0015603 A1) and Leslie (WO 2009/143020 A1).
First of all, with respect to instant limitation “wherein said filler further comprising a dietary fiber being present in said composition”, as evidenced by Boursier ([0098]-[0101]), it is known in the art that branched maltodextrin (which teaches instant dietary fiber of claim 73) is beneficial to the metabolism and to the intestinal equilibrium. It would have been obvious to one skilled in the art to further incorporate branched maltodextrin (in addition to the inulin) in Wu’s anti-aging composition so as to bring benefits to the metabolism and intestinal equilibrium as taught by Boursier. Secondly, Wu’s anti-aging composition of Example 1 does not contain a wax material which is required to be present in the composition of claim 73. However, as evidenced by Liang et al (see [0006] and [0009]) (and as also evidenced by Long et al ([0075])), Haematococcus pluvialis-containing composition has been made into an anti-aging Haematococcus pluvialis tablet. It would have been obvious to one skilled in the art to have Wu’s anti-aging composition containing Haematococcus pluvialis powder in the form of a tablet (according to the well-known practice in the art and also for convenience reasons) with a reasonable expectation of success. Furthermore, as evidenced by Hall ([0047] and [0012]) and Leslie ([0063]), it is well known in the art that carnauba wax (instant wax material of claim 73) is often used as a binding agent for a tablet composition. It would have been obvious to one skilled in the art to use carnauba wax in Wu’s anti-aging composition as a binding agent with a reasonable expectation of aiding the tablet-formation of Wu’s anti-aging composition. Leslie teaches ([0063]) that such a binding agent (carnauba wax) can be used in the amount of 0.5-30 wt.%. With respect to instant range for the weight ratio of the further added dietary fiber to the wax material being 80:1 to 2:1, although Wu in view of Long and Boursier does not teach the amount for the branched maltodextrin (the dietary fiber of claim 73), Wu teaches ([0035]) that too little dietary fiber brings modern civilization diseases, such as obesity, diabetes, colon cancer, constipation, etc.. Based on Wu’s such teaching, and based on Leslie’s teaching that carnauba wax can be used in the amount of 0.5-30 wt.%, it would be within a realm of one of ordinary skill in the art to determine the optimum weight ratio range for the dietary fiber to the wax material. That is, instant range for the weight ratio of the dietary fiber to the wax material would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a 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 233.
Thus, Wu in view of Long and Boursier, and further in view of Liang, Hall and Leslie renders obvious instant claim 73.
Claim(s) 78 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (CN 106473114 A and its English translation) in view of Long et al (CN 106913589 A and its English translation) as applied to claim 61 above, and further in view of Qiu et al (CN 109043537 A and it English translation).
Although Wu does not teach that its anti-aging composition is used in ameliorating or reducing muscle pain or muscle cramps, Qiu et al (see [0039] of English translation) teaches that natural astaxanthin in Haematococcus pluvialis can reduce muscle pain, reduce muscle damage and shorten recovery time. It would have been obvious to one skilled in the art to administer Wu’s anti-aging composition comprising Haematococcus pluvialis (a source of astaxanthin) to a patient having muscle pain or muscle damage so as to reduce the muscle pain and muscle damage and to shorten recovery time. Thus, Wu in view of Long and further in view of Qiu renders obvious instant claim 78.
Response to Arguments
With respect to instant 103 rejections over Wu in view of Long, applicant first argue that present specification provides clear evidence of unexpected results for compositions containing 55-80 wt.% inulin: applicant argue that as shown in Table 3 and Figure 1, compositions with inulin concentrations within the claimed range (e.g., 55%, 65%, 75%) exhibited significantly improved stability over a 6-month period compared to compositions with lower inulin concentrations (e.g., 37%, 45%), and that this unexpected improvement in long-term stability is not taught or suggested by Wu or Long. However, applicant’s such argument of unexpected results is not found to be persuasive for the following reasons: (i) Table 3 (as referred by applicant) shows Formulations I-VIII (also, Table 4 shows Formulations IX-XIII and Table 5 shows Formulations XIV-XVI), and applicant clearly state (see [0138] of present specification) that “Formulations I to XVI failed to meet the requirements of structural integrity needed for the tableting process. These formulations were characterized as having: no flow in the processing conveyer, low mechanical stability, low table weight, or a combination thereof.” Thus, Table 3 referred by applicant actually represents comparative formulations, not their inventive formulations; (ii) Figure 1, also referred by applicant, does not exhibit significantly improved stability over a 6-month period of their inventive composition compared to compositions with lower inulin concentrations (e.g., 37% or 45%) as argued by applicant. Figure 1 shows the percent of subjects that have reported pain per treatment week (1-8), which was calculated for the two treatment groups, and applicant state (see [0178] of present specification) that while the “Max treatment” group showed a substantial reduction in the number of subjects reporting pain, the placebo group showed only a mild reduction. However, the “Max” treatment composition (as shown in Table 26 of present specification) actually refers to applicant’s composition containing inulin in the amount of 37.41 wt.%, which is clearly outside of the claimed range; (iii) Furthermore, as already discussed above, applicant have not shown unexpected results of instant range (55-80 wt.%) for the amount of the filler (inulin) by comparing a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. See MPEP 716.02(d)(II). The only data points shown by applicant are 40 wt.% (Formulation 4), 60 wt.% (Formulation 5), 80 wt.% (Formulation 6), 37 wt.% (Formulations 7 and 8) and 76.6 wt.% (Formulation 9) (see Tables 2, 5, 6 and 7), and applicant’s best result (in terms of astaxanthin stability) was actually obtained for their Formulation 8 - compare the results as shown in Tables 11-19 – Table 16 shows that applicant’s Formulation 8 containing only 37 wt.% of inulin shows 100% of astaxanthin remaining at 90 days). Besides, there is no data that shows instant composition of claim 61 maintaining increased stability “for a period of at least 6 months” (180 days). For these reasons, applicant have not shown unexpected results of using 55-80 wt.% of inulin.
Applicant next argue that Wu explicitly teaches that its composition contains inulin in the amount of 20-50 wt.% and thus effectively teaches away from using higher concentrations of inulin. Applicant argue that one skilled in the art, following Wu’s teachings, would not have been motivated to increase the inulin concentration beyond 50 wt.%, let alone to the claimed range of 55-80 wt.%. Applicant argue that 50% and 55% are not essentially equivalent, as 55% marks a 10% increase over 50%, the application of which can be regarded as neither obvious nor conventional in dosing/formulating, let alone with a reasonable success. However, as already discussed above, although Wu’s range (20-50 wt.%) does not overlap with instant range 55-80 wt.% for the amount of the filler (inulin), it is the Examiner’s position that 50 wt.% (the higher end of Wu’s range) and 55 wt.% (the lower end of instant range) are close enough to each other that one skilled in the art would have expected them to have the same or similar properties and thus, Wu’s range would render instant range prima facie obvious. Where the claimed ranges and prior art do not overlap but are close enough that one skilled in the art would have expected them to have the same properties, a prima facie case of obviousness would also exist which may also be overcome by a showing of unexpected results, In re Titanium Metals Corporation of America v. Banner, supra: as explained above in this paragraph, in instant case, applicant have not shown unexpected results of using inulin in the amount of instant range (55-80 wt.%). Not only that, applicant actually show that their best result is obtained for their Formulation 8 containing only 37 wt.% of inulin (please note that in Wu’s Example 1 composition contains 36 wt.% of inulin) Besides, 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. See MPEP 2144.05 (II)(A).
Applicant next argue that the data presented in the specification demonstrates the criticality of the claimed range of 55-80 wt.% inulin. Applicant argue that as shown in Figure 1, there is a marked improvement in stability when the inulin concentration exceeds 55 wt.%, which continues through 80 wt.%. However, as already addressed above, applicant have not compared a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. See MPEP 716.02(d)(II). The only data points shown by applicant are 40 wt.% (Formulation 4), 60 wt.% (Formulation 5), 80 wt.% (Formulation 6), 37 wt.% (Formulations 7 and 8) and 76.6 wt.% (Formulation 9): there are no data points at 50 wt.%, 55 wt.% and no data points above 80 wt.%. Besides, applicant’s best result (in terms of astaxanthin stability) was actually obtained for their Formulation 8 containing inulin in the amount of 37%, which clearly lies outside of the claimed range. Applicant’s argument as to Figure 1 was already addressed above by the Examiner.
Applicant lastly argue that amended claim 61 specifies that the increased stability is maintained for at least 6 months (or 6-12 months as in claim 63) and argue that neither Wu nor Long teaches or suggests this long-term stability benefit associated with the claimed inulin concentration range. However, as discussed above, since Wu in view of Long teaches instant composition of claim 61, it is the Examiner’s position that such composition would accordingly maintain increased stability for a period of at least 6 months as recited in claim 61 (or for 6-12 months as recited in claim 63) unless shown otherwise by applicant. Besides, as already pointed out in Paragraph 9 above, applicant themselves have not shown that instant composition comprising 55-80 wt.% inulin maintains the increased stability for at least 6 months.
For the reasons discussed above, instant 103 rejections over Wu in view of Long still stand.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
October 30, 2025
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