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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/2025 has been entered.
Status of the Application
Claims 1-3, 6, 7 and 10-11 are pending.
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 1-3, 6, 7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Rademacher (US 5164374) as evidenced by CDC (Childhood Arthritis, www.cdc.gov/arthritis/types/childhood.htm#print, 08/09/2023).
Determining the scope and contents of the prior art
Rademacher teaches a method of treating arthritis (encompass juvenile arthritis (as evidenced from CDC, arthritis in children is called as juvenile arthritis), 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) comprising treating human patient using 3’-sialylactose and/or 6’-sialylactose alone or as an active ingredient in a pharmaceutical composition through routes such as orally or direct injection into the synovial fluid (includes intrasynovially) 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 provides examples only with sialyl lactose (with only two choices 3’SL and 6’SL). The cited prior art further provides that SL for use in the process is available commercially as well as in the mixture form with traces of lactosamaine and gives Table 1 of such commercial mixture of SL. (entire patent, especially, abstract, col 3-10).
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Since the cited prior art teaches only 2 SL in treating arthritis, 3’SL and 6’SL (genus contains a small number of members) along with example of using SL (and also claims to SL), a person of skill in the art, reading the reference, would ‘at once envisage’ each member” of the genus or combination, which is 3’SL, 6’SL and combination of 3’SL and 6’SL.
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). In Kennametal, the challenged claim was to a cutting tool requiring a ruthenium binding agent with a physical vapor deposition (PVD) coating. The reference described all the elements of the claimed coated cutting tool but did not explicitly disclose the specific combination of ruthenium binding agent with a PVD coating. However, the reference disclosed that ruthenium was one of five specified binding agents and PVD was one of three suitable coating techniques. The Federal Circuit stated that the reference’s "express ‘contemplat[ion]’ of PVD coatings provided sufficient evidence that a reasonable mind could find that a person of skill in the art… would immediately envisage applying a PVD coating. Thus, substantial evidence supports the Board's conclusion that [the reference] effectively teaches 15 combinations, of which one anticipates pending claim 1. Though it is true that there is no evidence in [the reference] of ‘actual performance’ of combining the ruthenium binder and PVD coatings, this is not required." Kennametal, 780 F.3d at 1383, 114 USPQ2d at 1255 (citations omitted). See also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1274, 122 USPQ2d 1116, 1120 (Fed. Cir. 2017) ("Kennametal does not stand for the proposition that a reference missing a limitation can anticipate a claim if a skilled artisan viewing the reference would "at once envisage" the missing limitation. Rather, Kennametal addresses whether the disclosure of a limited number of combination possibilities discloses one of the possible combinations.").
If one of ordinary skill in the art is able to "at once envisage" the specific compound within the generic chemical formula, the compound is anticipated. One of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds included in the generic formula before any of the compounds can be "at once envisaged." One may look to the preferred embodiments to determine which compounds can be anticipated. In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962).
In In re Petering, the prior art disclosed a generic chemical formula "wherein X, Y, Z, P, and R'- represent either hydrogen or alkyl radicals, R a side chain containing an OH group." The court held that this formula, without more, could not anticipate a claim to 7-methyl-9-[d, l'-ribityl]-isoalloxazine because the generic formula encompassed a vast number and perhaps even an infinite number of compounds. However, the reference also disclosed preferred substituents for X, Y, Z, P, R, and R' as follows: where X, P, and R' are hydrogen, where Y and Z may be hydrogen or methyl, and where R is one of eight specific isoalloxazines. The court determined that this more limited generic class consisted of about 20 compounds. The limited number of compounds covered by the preferred formula in combination with the fact that the number of substituents was low at each site, the ring positions were limited, and there was a large unchanging structural nucleus, resulted in a finding that the reference sufficiently described "each of the various permutations here involved as fully as if he had drawn each structural formula or had written each name." The claimed compound was 1 of these 20 compounds. Therefore, the reference "described" the claimed compound and the reference anticipated the claims.
In In re Schauman, 572 F.2d 312, 197 USPQ 5 (CCPA 1978), claims to a specific compound were anticipated because the prior art taught a generic formula embracing a limited number of compounds closely related to each other in structure and the properties possessed by the compound class of the prior art was that disclosed for the claimed compound. The broad generic formula seemed to describe an infinite number of compounds but claim 1 was limited to a structure with only one variable substituent R. This substituent was limited to low alkyl radicals. One of ordinary skill in the art would at once envisage the subject matter within claim 1 of the reference.
Ascertaining the differences between the prior art and the claims at issue
Rademacher teaches a method of treating arthritis (encompass juvenile arthritis (as evidenced from CDC, arthritis in children is called as juvenile arthritis), 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 or as an active ingredient in a pharmaceutical composition through routes such as orally or direct injection into the synovial fluid (includes intrasynovially) in an effective amount. However, the cited prior art is silent about reciting the treatment as first line of treatment and doesn’t provide effect on IL-1 and IL-6.
Resolving the level of ordinary skill in the pertinent art
With regard to limitation “first line of therapy”- Although the cited prior art is silent about reciting particular terminology of the limitation, the cited prior discloses treatment with only 3’SL or 3’SL and 6’SL and thus is a first line therapy. Thus, the cited prior art meets limitations of the instant claims.
With regard to not providing effect on IL-1 and IL-6- The cited prior art teaches treating rheumatoid arthritis by suppressing a pro-inflammatory immune response in humans using 3’-sialylactose or 3’SL and 6’SL. Since the cited prior art teaches treating same disease using same compound, the result of such treatment, such as reduction of IL-1 and IL-6 is also expected whether or not realized by the cited prior art. Additionally, “wherein” clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.
Further, Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014), the court found that an "adapted to" clause limited a machine claim where "the written description makes clear that 'adapted to,' as used in the [patent] application, has a narrower meaning, viz., that the claimed machine is designed or constructed to be used as a rowing machine whereby a pulling force is exerted on the handles." In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
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 (encompass juvenile arthritis (as evidenced from CDC, arthritis in children is called as juvenile arthritis), 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 or as an active ingredient in a pharmaceutical composition through routes such as orally or direct injection into the synovial fluid (includes intrasynovially) in an effective amount.
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 useful in treating juvenile arthritis, 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.
Response to arguments
Applicant’s amendment and remarks filed on 12/22/2025 have been fully considered but not found persuasive.
Applicant argued over rejection under 103 that Juvenile arthritis (JA) and rheumatoid arthritis (RA) are different in several criteria and presented new art Prahalad. Applicant argued that Prahalad in Table 1 provides RA has an IGM-RF component, which is missing in JA and Examiner’s cited prior art teaches use of bovine colostrum mixture to disrupt IgG-RF complex:
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This is not found persuasive and the instant claims are anticipated and/or obvious over the cited prior art. This is because (1) the office never mentioned that JA and RA are same. However, the office did mean that arthritis in children is called juvenile arthritis and presented evidence of CDC definition of juvenile arthritis, 2023 (more recent than 2002 ref cited by the applicant), which is the subject of the instant claims. The cited prior art teaches treating arthritis in humans of any age and as evidenced by CDC, arthritis in children is called juvenile arthritis. Rademacher not only teaches treating arthritis in human of any age but also subtype of arthritis, RA, which in children is juvenile RA, which is not subject of the instant claims; (2) applicant presented prior art, Prahalad and is arguing over RA vs juvenile RA. As mentioned earlier juvenile RA is not a limitation of the instant claims. Thus, applicant is arguing over a limitation of juvenile RA, which is not limitation of the instant claims. Thus, the prior art on which applicant is basing their argument is irrelevant to the instant claims and/or the rejection; (3) Contrary to applicant’s argument, Table 1 of Prahalad has nothing about IgG-RF; (4) Applicant is conveniently equating IgM-RF as IgG-RF with no evidence; (5) Contrary to applicant’s argument and contrary to paragraph of Rademacher cited by the applicant, Rademacher never mention IgG-RF and binding to IgG-RF complex.
Applicant argued that Rademacher teaches a mixture as sialyllactose/ lactosamine vs the instant claims that requires consisting of 3SL or 3SL and 6SL:
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This is not found persuasive and the instant claims are anticipated and/or obvious over the cited prior art. This is because contrary to applicant’s argument the cited art discloses only two sialyl lactose isomers 3’SL, 6’SL, mixture of 3’SL and 6’SL, mixture of sialyllactosamine with 3’SL and 6’SL in treating arthritis. The cited prior art further provides preferably using SL for treating arthritis. The cited prior art provides examples only with sialyl lactose (only two choices 3’SL and 6’SL; also see claims). The cited prior art further provides that SL for use in the process is available commercially as well as in the mixture form with traces of lactosamaine and gives Table 1 of such commercial mixture of SL. Extra teaching of the cited prior art about availability and suggestion of using commercially available SL and different forms doesn’t preclude that the cited prior art teaches process of the instant claims. (entire patent, especially, abstract, col 3-10).
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Since the cited prior art teaches only 2 SL in treating arthritis, 3’SL and 6’SL (genus contains a small number of members) along with example of using SL(and also claims to SL), a person of skill in the art, reading the reference, would ‘at once envisage’ each member” of the genus or combination, which is 3’SL, 6’SL and combination of 3’SL and 6’SL.
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). In Kennametal, the challenged claim was to a cutting tool requiring a ruthenium binding agent with a physical vapor deposition (PVD) coating. The reference described all the elements of the claimed coated cutting tool but did not explicitly disclose the specific combination of ruthenium binding agent with a PVD coating. However, the reference disclosed that ruthenium was one of five specified binding agents and PVD was one of three suitable coating techniques. The Federal Circuit stated that the reference’s "express ‘contemplat[ion]’ of PVD coatings provided sufficient evidence that a reasonable mind could find that a person of skill in the art… would immediately envisage applying a PVD coating. Thus, substantial evidence supports the Board's conclusion that [the reference] effectively teaches 15 combinations, of which one anticipates pending claim 1. Though it is true that there is no evidence in [the reference] of ‘actual performance’ of combining the ruthenium binder and PVD coatings, this is not required." Kennametal, 780 F.3d at 1383, 114 USPQ2d at 1255 (citations omitted). See also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1274, 122 USPQ2d 1116, 1120 (Fed. Cir. 2017) ("Kennametal does not stand for the proposition that a reference missing a limitation can anticipate a claim if a skilled artisan viewing the reference would "at once envisage" the missing limitation. Rather, Kennametal addresses whether the disclosure of a limited number of combination possibilities discloses one of the possible combinations.").
If one of ordinary skill in the art is able to "at once envisage" the specific compound within the generic chemical formula, the compound is anticipated. One of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds included in the generic formula before any of the compounds can be "at once envisaged." One may look to the preferred embodiments to determine which compounds can be anticipated. In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962).
In In re Petering, the prior art disclosed a generic chemical formula "wherein X, Y, Z, P, and R'- represent either hydrogen or alkyl radicals, R a side chain containing an OH group." The court held that this formula, without more, could not anticipate a claim to 7-methyl-9-[d, l'-ribityl]-isoalloxazine because the generic formula encompassed a vast number and perhaps even an infinite number of compounds. However, the reference also disclosed preferred substituents for X, Y, Z, P, R, and R' as follows: where X, P, and R' are hydrogen, where Y and Z may be hydrogen or methyl, and where R is one of eight specific isoalloxazines. The court determined that this more limited generic class consisted of about 20 compounds. The limited number of compounds covered by the preferred formula in combination with the fact that the number of substituents was low at each site, the ring positions were limited, and there was a large unchanging structural nucleus, resulted in a finding that the reference sufficiently described "each of the various permutations here involved as fully as if he had drawn each structural formula or had written each name." The claimed compound was 1 of these 20 compounds. Therefore, the reference "described" the claimed compound and the reference anticipated the claims.
In In re Schauman, 572 F.2d 312, 197 USPQ 5 (CCPA 1978), claims to a specific compound were anticipated because the prior art taught a generic formula embracing a limited number of compounds closely related to each other in structure and the properties possessed by the compound class of the prior art was that disclosed for the claimed compound. The broad generic formula seemed to describe an infinite number of compounds but claim 1 was limited to a structure with only one variable substituent R. This substituent was limited to low alkyl radicals. One of ordinary skill in the art would at once envisage the subject matter within claim 1 of the reference.
Conclusion
No Claim is allowed.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
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