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 10/22/2025, have been fully considered but are not persuasive. Therefore, the following action is final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.
Status of the application
3. Claims 1-15 are pending in this office action.
Claims 2, 6,7, 8 have been amended.
Claims 1-15 have been rejected.
Claim Rejections - 35 USC § 103
4. 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.
5. 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.
6. 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 non -obviousness.
7. Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Geremia et al. et al. WO 2020/097458 in view of Brunner et al. WO 2018/149756 A1.
8. Regarding claims 1-4, 9, Geremia et al. discloses (Example 22) a powdered synthetic oligosaccharide formulation having (i) a DP 1 to DPn (n being 4-100) (at least in claims 1, 2 of Geremia et al. (ii) the resulting powder comprises about 35 wt.% absorbed oligosaccharide having 50% by weight of the powder exhibit below 511 micrometer, 90% by weight of the powder exhibit below 886 micrometer particle size (at least Ex 23), (iii) density 1.3063 g/ml ([00352]), (iv) Geremia et al. also discloses that it can be powder formulation which can be without water (i.e. 0 wt.%) (at least in Ex 23) and also it can contain moisture (water) 5-10 wt.% for such formulation ([00353], claim 112,113 of Geremia et al.). Geremia et al. also discloses that feed grade silica is used in the powdered formulation to yield a stable, flowable powder containing at least 50% by weight of oligosaccharide with respect to the total powder having density 1.5562 g/ml (at least in Ex 23, [00356]). Geremia et al. also discloses that oligosaccharide preparation comprises less than 80% etc. (At least in claim 121 of Geremia et al.)., and 80%-1% etc. (At least in claim 122 of Geremia et al.) anhydro-subunit containing oligosaccharides by relative abundance (At least in claims 121, 122 of Geremia et al.).
It is to be noted that Gerecia et al. discloses “the carrier loading formulation was repeated using feed-grade silica to yield a stable, flowable powder with a loading of at least 50 wt.% oligosaccharide preparation (dry solids basis) with respect to the final powder (at least in [00356], Ex 22). Therefore, it would have been obvious that silica is powdered form and is amorphous.
Geremia et al. also discloses that feed grade silica is used in the powdered formulation to yield a stable, flowable powder having density 1.5562 g/ml (at least in Ex 23, [00356]).
However, Geremia et al. is specifically silent about “storage-stable” (i.e. storage stability-“stability during and/or after storage”) powdered formulation as claimed in claim 1 and specific claim limitation of “silica-based adsorbate is amorphous precipitated silica” as claimed in claim 4.
Brunner et al. discloses that ‘storage-stable’ (e.g. “Storage-stable i.e. exhibit a retention” at least, third paragraph from bottom of page 2), composition can be made using specific amorphous precipitated silica as carrier material and this silica is, for example, available as Ibersil D-250 from IQE Group, Sipernat 2200 from Evonik or Tixosil 68 from Solvay, Zeofree 5170 from J.M. Huber Cooperation or Newsil C50 from Quechen Silicon Chemical Co Ltd. (at least page 3, paragraph 6, Under WO 2012/084629). It is evidenced from applicant’s specification that this disclosed silica is identical to the specific amorphous precipitated silica from identical company (at least in specification, PGPUB [0016]). Therefore, it will have identical property of the claimed composition including identical “storage-stability” of the product to meet independent claim 1 and is identical amorphous precipitated silica as carrier material as claimed in claim 4.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Geremia et al. with the teaching of discloses that storage-stable (i.e. “exhibit a retention” at least, third paragraph from bottom of page 2), composition can be made using specific amorphous precipitated silica as carrier material and this silica is , for example, available as Ibersil D-250 from IQE Group, Sipernat 2200 from Evonik or Tixosil 68 from Solvay, Zeofree 5170 from J.M. Huber Cooperation or Newsil C50 from Quechen Silicon Chemical Co Ltd.(at least page 3, paragraph 6, Under WO 2012/084629)).
9. Regarding claims 5, 6, 7, Geremia et al. discloses that diatomaceous earth was added combined with the oligosaccharide preparation to make a stable, flowable powder having particle size of less than 511 micron and having 35 wt.% adsorbed oligosaccharides in the formulation (Example 23, [00355]).
10. Regarding claim 8, Geremia et al. discloses that the relative abundance of oligosaccharides in each of the n (4-10) fractions decreases monotonically with its degree of polymerization. In some embodiments, the relative abundance of oligosaccharides in each of the n fractions decreases monotonically with its degree of polymerization (at least in [0005]).
11. Regarding claims 10, 11, Geremia et al. discloses that each fraction of said
oligosaccharide preparation comprises less than 80%, 70%, 60%, 50%, 40%, 30%, 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, or 2% anhydro-subunit containing oligosaccharides by relative abundance At least in claim 121 of Germia et al.).
12. Regarding claim 12, Geremia et al. discloses that at least one fraction of said oligosaccharide comprises greater than 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 30%, 40%, 50%, 60%, 70%, or 80% anhydro-subunit containing oligosaccharides by relative abundance. The method of any preceding claim, wherein said oligosaccharide preparation comprises greater than 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 30%, 40%, 50%, 60%, 70%, or 80% anhydro-subunit containing oligosaccharides by relative abundance (at least in [0008], claim 129 of Germia et al.).
13. Regarding claims 13, 14, Geremia et al. discloses the oligosaccharide preparation has a weight average molecular weight of from about 300 to about 2500 g/mol as determined by HPLC (at least in claims 52,53 of Geremia et al.).
14. Regarding claim 15, Geremia et al. discloses the oligosaccharide preparation has a number average molecular weight of from about 500 to about 2000 g/mol as determined by HPLC. (at least in [0008], claims 57,58, 61 of Geremia et al.)
Response to arguments
15. Applicant’s arguments and amendments overcome 112 second paragraph of rejection. Applicant’s arguments and amendments do not overcome 103 obviousness rejections of record. Examiner is addressing below.
16. Argument : Applicants argued in Remarks (last two lines of first page -second page) that “all pending claims are patentably unobvious over Geremia et al and Brunner et al. “Brunner et al. embraces 3-nitrooxvpropanol (3-NOP) and structurally similar molecules. Therefore, Brunner et al merely explicitly teaches a storage-stable formulation for 3-NOP and structurally similar molecules. In striking contrast to Brunner et al, the presently claimed subject matter does not relate to 3-NOP or similar molecules, but to a formulation of an oligosaccharide preparation”.
Response: In response , it is to be noted that and as discussed in the office action above (item #8 above) that primary prior art by Geremia et al. discloses the resulting flowable powder comprises about 35 wt.% absorbed oligosaccharide having 50% by weight of the powder exhibit below 511 micrometer, 90% by weight of the powder exhibit below 886 micrometer particle size (at least Ex 23) which is less than claimed less than or equal to 3000 micron size. Geremia et al. discloses feed grade silica can also be used to make flowable powder which comprises absorbed oligosaccharide ([00356]). It is to be noted that the disclosed silica have identical structure with particle size of claimed silica. Therefore, the disclosed composition would have identical claimed storage stability property to protect and provide storage stability. Therefore, the storage stable property of silica is inherent.
Therefore, it is understood that silica has the inherent property to enhance storage stability and retains the compound in the powdered formulation made with silica which is identical to claimed silica of claim 1 and also is identical to applicant’s silica (in applicant’s specification, PGPUB [0016]).
It is to be noted that Brunner et al. is secondary prior art used additionally to emphasize that discloses “storage- stable” composition can be made using specific amorphous precipitated silica as carrier material.
17. Argument: Applicants argued in Remarks (Fifth paragraph of second page) that “ A person having ordinary skill in the art would not have any motivation to consider any teaching of Brunner et al's 3-NOP formulation as being reasonably transferable to a formulation of an oligosaccharide preparation”.
Response: In response, the response made in item # 16 above is applicable here also. In addition, it is to be noted that secondary prior art by Brunner et al. uses 3-NOP formulation as an example to establish that silica is used to provide storage stability to make storage- stable” composition. Brunner et al. does not mention that the method using silica is not compatible to provide storage stability of any specific group of compound(s).
18. Argument: Applicants argued in Remarks (last paragraph of second page-third page) that “ When assessing unobviousness under 35 USC §103, it is submitted to be impermissible to merely cherry-pick and recombine individual features from separate documents of the prior art in hindsight of Applicant's disclosure. As the Supreme Court observed in KSR Int'!. Co. v. Teleflex Inc. et al, 550 U.S. 398, 418-419 (2007) (hereinafter "KSR", emphasis supplied): In the present case, the Examiner isolated a feature from a formulation of a small molecule (3-NOP) and then transferred such an isolated feature to a formulation of a mixture of considerably larger molecules (oligosaccharides). A person ordinarily skilled in the art would have had no reasonable expectation that a feature relating to a formulation of one class of molecules could be successfully transferable to a formulation of an entirely different class of molecules”.
Response: “ In response to applicant's arguments regarding the arguments based on the allegations that ‘picking and choosing various elements from the several combinations of references”, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986)”.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Therefore, the rejection is maintained and made final.
Conclusion
19. 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 extension fee 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 date of this final action.
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
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792