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 .
Status of the Application
Claims 1-14 are pending, of which Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 11-14 are under current examination.
Amendment necessitated new claim rejection as set forth below.
New Claim Rejections - 35 USC § 103
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 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.
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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 11-14 and elected species are rejected under 35 U.S.C. 103 as being unpatentable over Rademacher (US 5164374) and M’Rabet (US 8754064 B2) in combination.
Determining the scope and contents of the prior art
Rademacher teaches a method of treating arthritis with example of rheumatoid arthritis (RA), a chronic inflammation and an auto-inflammatory disorder, by suppressing immune response (and inflammation) comprising exposing serum or synovial fluid of human of any age (includes humans of 5 years or older) with example of treating human patient using 3’-sialylactose and/or 6’-sialylactose alone (thus, isolated or purified from original source of bovine or human) or in combination (6’ SL in combination is a food grade only ingredients) as an active ingredient in a pharmaceutical composition or a pharmaceutically acceptable aqueous solution in an effective amount (also provides comparison between untreated and treated subject) (Entire patent, especially abstract, figures, Col 3-10 and claims). The cited prior art further discloses that 3’-sialylactose and/or 6’-sialylactose are orally absorbed intact (Entire patent, especially col 8).
With regard to limitation “attenuating macrophage inflammation related arthritis”-Since the cited prior art teaches treating same arthritis as in the instant claims, the treatment of the cited prior art is expected to attenuate macrophage inflammation” whether or not realized by the cited prior art.
Ascertaining the differences between the prior art and the claims at issue
Rademacher teaches a method of treating arthritis with example of rheumatoid arthritis (RA), a chronic inflammation and an auto-inflammatory disorder, by suppressing immune response (and inflammation) comprising exposing serum or synovial fluid of human of any age (includes humans of 5 years or older) with example of treating human patient using 3’-sialylactose and/or 6’-sialylactose alone (thus, isolated or purified from original source of bovine or human) or in combination (6’ SL in combination is a food grade only ingredients) as an active ingredient in a pharmaceutical composition or a pharmaceutically acceptable aqueous solution in an effective amount. However, the cited prior art doesn’t give working example of oral administration of the composition; and food grade agent in the composition.
Resolving the level of ordinary skill in the pertinent art
With regard to the above difference of a working example of oral administration of the composition - The cited prior art teaches that the composition may be administered therapeutically and is primarily dependent upon the physical characteristics of the recipients and the severity of the arthritic condition. The cited prior art further discloses that 3’-sialylactose and/or 6’-sialylactose are orally absorbed intact.
With regard to the above difference of food grade agent from the list - Rademacher teaches a method of treating arthritis with example of rheumatoid arthritis (RA), a chronic inflammation and an auto-inflammatory disorder, by suppressing immune response using 3’-sialylactose and/or 6’-sialylactose alone (thus, isolated or purified from original source of bovine or human) or in combination (6’ SL in combination is a food grade only ingredients) as an active ingredient in a pharmaceutical composition or a pharmaceutically acceptable aqueous solution in an effective amount. The deficiency of ingredient that may be given with 3’SL, or 3’SL and 6’SL combination is cured by M’Rabet (US 8754064 B2).
In the same field of endeavor, M’Rabet teaches a method of treating inflammatory disorders by stimulating immune response with example of treating rheumatoid arthritis in humans with example of elderly patients (includes patients above the age of 18 years) comprising administering 3’-sialylactose and/or 6’-sialylactose (purified or isolated) along with soy protein, cow’s milk protein (thus, 3’SL + a food grade agent) orally as clinical food (thus the ingredients are food grade and orally administered) (entire application, especially, abstract, Col 2-4, 6-8 and Claims).
Thus, with the guidance provided by the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that the 3’SL, or 3’SL and 6’SL may be administered along with soy protein, cow’s milk protein through an oral route. Thus, the cited prior art meets limitation of the instant claims.
Based on the above established facts, it appears that the above cited prior art read applicants’ process.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Rademacher teaches a method of treating arthritis with example of rheumatoid arthritis (RA), a chronic inflammation and an auto-inflammatory disorder, by suppressing immune response (and inflammation) comprising exposing serum or synovial fluid of human of any age (includes humans of 5 years or older) with example of treating human patient using 3’-sialylactose and/or 6’-sialylactose alone (thus, isolated or purified from original source of bovine or human) or in combination (6’ SL in combination is a food grade only ingredients) as an active ingredient in a pharmaceutical composition (thus food grade only ingredients) in an effective amount. M’Rabet teaches a method of treating inflammatory disorders by stimulating immune response with example of treating rheumatoid arthritis in humans with example of elderly patients (includes patients above the age of 18 years) comprising administering 3’-sialylactose and/or 6’-sialylactose (purified or isolated) along with soy protein, cow’s milk protein orally as clinical food.
Thus, the combination reads applicant’s process.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that 3’SL may be administered orally with cow milk or soy protein for treating rheumatoid arthritis, and can be made by the teaching of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed process with a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 11-14 in the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over the claims 1-7 and 10-11 of co-pending US application 18100204. Although the conflicting claims are not identical, they are not patentably distinct from each other because of the following reasons:
The claims of instant application are drawn to a method of treating arthritis comprising HMO, elected species 3’SL and co-pending applications are drawn to a process of treating arthritis comprising HMO, elected species 3’SL with a difference in wording.
The difference of wording, however, does not constitute a patentable distinction, because the claims in the present invention simply fall within the scope of co-pending application. For the foregoing reasons, the instantly claimed process is made obvious.
This is provisional obviousness-type double patenting rejection because the conflicting claims have not been patented yet.
Response to Arguments
Applicants’ remarks and amendment, filed on 11/17/2025, have been fully considered but not found persuasive.
Applicant argument is moot in view of new rejection as set forth above.
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.
Conclusion
No Claim is allowed.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623