Prosecution Insights
Last updated: April 19, 2026
Application No. 18/107,936

IMMUNOMODULATORY OLIGOSACCHARIDES

Final Rejection §101§102§112§DP
Filed
Feb 09, 2023
Examiner
BAKSHI, PANCHAM
Art Unit
1623
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Regents of the University of California
OA Round
4 (Final)
77%
Grant Probability
Favorable
5-6
OA Rounds
2y 5m
To Grant
99%
With Interview

Examiner Intelligence

Grants 77% — above average
77%
Career Allow Rate
873 granted / 1132 resolved
+17.1% vs TC avg
Strong +30% interview lift
Without
With
+30.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
77 currently pending
Career history
1209
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
32.0%
-8.0% vs TC avg
§102
23.0%
-17.0% vs TC avg
§112
27.0%
-13.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1132 resolved cases

Office Action

§101 §102 §112 §DP
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 Status of the Application Claims 1, 5, 7-11 and 14-16 are pending, of which claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1, 5, 7, 11 and 14-16 are under current examination. Amendment necessitated new claim rejection as set forth below. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1, 5, 7, 11 and 14-16 and elected species are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a composition “formulated for consumption (may contain any ingredient natural) and/or to be consumed by humans ---contains human milk oligosaccharides consisting of 3’SL or 3’SL and 6’SL and/or one or more food agents including milk protein etc. Since 3’SL or 3’SL and 6’SL exist naturally with human milk oligosaccharide (HMO) in human milk as well as in animal milk (as several HMOs are common among human and animal milk), the composition is naturally occurring and is a natural product. The Examiner further provides evidence that 3’SL or 3’SL and 6’SL exists in nature, in bovine milk and in human milk along with other edible components, such as HMOs, milk proteins to both humans and non-human subject, Rademacher (US5164374) (entire patent, especially, col 3, 4 and 8): PNG media_image1.png 143 620 media_image1.png Greyscale PNG media_image2.png 484 589 media_image2.png Greyscale PNG media_image3.png 734 573 media_image3.png Greyscale The limitations- “nutritional composition; formulated for consumption; non-human subjects---dog, cat---etc.”; does not indicate any structural or manipulative difference. Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification and the plain meaning of the other terms, the broadest reasonable interpretation of claim 1 and claim 11 is a product contains human milk oligosaccharides or may contain HMO along with 3’SL or 3’SL and 6’SL and/or one or more food agents including milk protein etc.. Since 3’SL or 3’SL and 6’SL exist naturally with human milk oligosaccharide (HMO) in human milk as well as in animal milk (as several HMOs are common among human and animal milk) and milk protein, the composition is naturally occurring and is a natural product. The language “nutritional composition; formulated for consumption; non-human subjects---dog, cat---etc.”; does not indicate any structural or manipulative difference in the invention recited in the body of the claim, and instead merely conveys intended uses. Importantly, the claims are drawn to a product, which occurs naturally and the limitations “nutritional composition; formulated for consumption; non-human subjects---dog, cat etc.; effective to attenuate macrophage inflammation in non-human or human—cat, dog etc.,” provides no patentable distinction from a naturally occurring composition as it is not structurally different compared to its naturally existing form. Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Here, the claim recites a composition, which is a statutory category of invention. As explained in the MPEP, it is not necessary to identify a single category into which a claim falls, so long as it is clear that the claim falls into at least one category. MPEP 2106.03(I). Here, because the composition is a composition of matter, the claim is to at least one statutory category of invention (Step 1: YES). Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Because claim 1 recites a nature-based product, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). Although claims recite intended uses limitations “nutritional composition; formulated for consumption; non-human subjects---dog, cat etc.; effective to attenuate macrophage inflammation in non-human or human; or dietary supplement”, the markedly different characteristics analysis should be applied only to the nature-based product limitation. MPEP 2106.04(c)(I)(A). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). As evidenced by Rademacher (US5164374) (entire patent, especially, col 3, 4 and 8): PNG media_image1.png 143 620 media_image1.png Greyscale PNG media_image2.png 484 589 media_image2.png Greyscale : PNG media_image3.png 734 573 media_image3.png Greyscale , the composition of the instant claims with 3’SL or 3’SL and 6’SL along with other HMOs, naturally occurs and milk proteins naturally occurs in bovine and human. Therefore, the claimed composition is a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two. Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55. Instant Claims, recites limitations “nutritional composition; formulated for consumption; non-human subjects,---cat, dog etc.; effective to attenuate macrophage inflammation in non-human; dietary supplement”. These limitations do not provide any information as to how the claimed composition is different from its naturally occurring form, thus fails to meaningfully limit the claim because it is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, the limitations “nutritional composition; formulated for consumption; non-human subjects,---cat, dog etc.; effective to attenuate macrophage inflammation in non-human--dietary supplement” does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception (Step 2A: YES). Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As discussed with respect to Step 2A Prong Two, the claims recite limitations “nutritional composition; formulated for consumption; non-human subjects,---cat, dog etc.; effective to attenuate macrophage inflammation in non-human ;dietary supplement” which is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept (Step 2B: NO). The claim is not eligible. 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 1, 5, 7, 11 and 14-16, are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. Claims 1, 5 and 7, are indefinite as (a) claim1 recites “formulated for consumption or oral administration ----consists of milk oligosaccharides ---6’SL and one or more food agents ---selected from the group consisting of --- ". This is because applicant first recites broad limitation of “formulated for consumption”, i.e., open to any ingredient and then recites “consists of milk oligosaccharides ---6’SL and one or more food agents ---selected from the group consisting of ---”, such recitation reflects use of both narrow and broad limitations within the same claim. Thus, the scope of the claim is unclear. It is unclear what composition may have. If applicants intend to have 3’SL or 3’ and 6’SL along with the food agent recited in the claim, applicant is suggested to delete “formulated for consumption or oral administration”. For compact prosecution, the claim has been interpreted as open ended with any oligosaccharide, food agents or any other component for making formulation. Since dependent claims 5 and 7 doesn’t cure above deficiency, these claims are also indefinite. Claims 11 and 14-16, are indefinite as claim 11 recites “formulated to be consumed by humans---contains human milk oligosaccharides consisting of 3’-sialyllactose ---6’SL ". This is because applicant first recites broad composition “formulated to be consumed by humans” (i.e., may contain any ingredient) “contains human milk oligosaccharides” (again broad that it may contain any HMO) followed by “consisting of 3’-sialyllactose ---6’SL”, a narrow limitation. Such recitation of broad and narrow limitations within the same claim makes scope of claim unclear. If applicants intend to have 3’SL or 3’ and 6’SL only in the composition, applicant is suggested to delete “formulated to be consumed” and “contains human milk oligosaccharides. For compact prosecution, the claim has been interpreted as open ended with any oligosaccharide, food agents or any other component for making formulation. Since dependent claims 14-16 doesn’t cure above deficiency, these claims are also indefinite. Appropriate correction required. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1, 5, 7, 11, 14-16 and elected species are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by M’Rabet (US 8754064 B2). M’Rabet discloses a nutritional composition comprising 3’SL or 3’SL and 6’SL (6’SL is also an HMO) along with soy protein, milk protein and nucleotide (entire application, especially abstract, col 2, 3, 4 6 and claims). With regards to limitations “formulated for consumption; non-human subjects—dog, cat etc.; effective to attenuate macrophage inflammation in non-human; formulated for consumption--human subjects at least 5 years or older; dietary supplement”-Since the cited prior art teaches same composition comprising same components as in the instant claims, the composition of the instant claims is also capable of “formulated for consumption; non-human subjects—dog, cat etc.; effective to attenuate macrophage inflammation in non-human; formulated for consumption--human subjects at least 5 years or older; dietary supplement”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims 1, 5, 7, 11 and 14-16. Since the cited prior art reads on all the limitations of the instant claims 1, 5, 7, 11 and 14-16, these claims are anticipated. Claims 11, 14-16 and elected species are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Rademacher (US5164374). Rademacher discloses a nutritional composition comprising naturally occurring in human milk and bovine colostrum (isolated from human and bovine) isolated 3’SL or 3’SL and 6’SL or 3’SL, 6’SL and lactosamine (entire application, especially abstract, col 3-8, claims and figures). Further, as evidenced by the cited prior art, such composition is sold commercially by Sigma: PNG media_image1.png 143 620 media_image1.png Greyscale PNG media_image2.png 484 589 media_image2.png Greyscale : PNG media_image3.png 734 573 media_image3.png Greyscale The cited prior art 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). 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 lactosamine 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 composition of the instant claims. (entire patent, especially, abstract, col 3-10). PNG media_image4.png 254 599 media_image4.png Greyscale PNG media_image5.png 380 614 media_image5.png Greyscale PNG media_image6.png 467 738 media_image6.png Greyscale PNG media_image7.png 702 580 media_image7.png Greyscale 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. With regards to limitations “formulated for consumption--human subjects at least 5 years or older; dietary supplement”-Since the cited prior art teaches same composition comprising same components as in the instant claims, the composition of the instant claims is also capable of “formulated for consumption--human subjects at least 5 years or older; dietary supplement”. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000). Thus, the cited prior art reads on all limitations of the instant claims 11 and 14-16. Since the cited prior art reads on all the limitations of the instant claims 11 and 14-16, these claims are anticipated. 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 1, 5, 7, 11 and 14-16 in the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over the claims 1-14 of co-pending US application 18111103; and Claims 11 and 14-16 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 composition comprising HMO, elected species 3’SL and claims 1-14 of co-pending US application 18111103 are drawn to a composition and/or a process (process discloses composition) of using composition comprising HMO, elected species 3’SL with a difference in wording. Further, claims 11 and 14-16 of instant application are drawn to a composition consisting of 3’SL or 3’SL and 6’SL and claims 1-7 and 10-11 of co-pending US application 18100204 are drawn to a composition and/or a process (process discloses composition) of using composition consisting of 3’SL or 3’SL and 6’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 composition 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. Applicants’ argument is moot over rejection under 101 in view of new rejection as set forth above. Applicants’ argument is moot over rejection under 112b in view of new rejection as set forth above. Applicant argued over rejection under 102, over M’Rabet (US 8754064 B2), that the cited prior art teaches 4 components in the composition Vs the instant claim composition: PNG media_image8.png 388 912 media_image8.png Greyscale Applicant further argued about teaching of the cited prior art on immune response, DTH response etc., that can be detrimental to arthritic condition or would not reduce inflammation. This is not found persuasive and the instant claims stand rejected under 102. This is because (1) The instant claims are also open ended and may have any additional ingredient, please see the claim interpretation and rejection under 112b; (2) M’Rabet discloses a nutritional composition comprising 3’SL or 3’SL and 6’SL with soy protein, milk protein and nucleotide: PNG media_image9.png 312 635 media_image9.png Greyscale . (b) the instant claims are open ended for making formulation and therefore includes any additional ingredient; (3) the instant claims are drawn to a composition and not to any process; (4) applicant is arguing over process limitation not recited in the instant claims; (4) applicant is arguing without providing any evidence on inflammation effect. Applicant argued over rejection under 102, over Rademacher, that the cited prior art teaches not just 3’SL or 3’SL and 6’SL as in the instant claim composition. This is not found persuasive and the instant claims stand rejected under 102. This is because (1) The instant claims are also open ended and may have any additional ingredient, please see the claim interpretation and rejection under 112b; (2) Further, contrary to applicant’s argument the cited prior art discloses two sialyl lactose isomers 3’SL, 6’SL, mixture of 3’SL and 6’SL, mixture of sialyllactosamine with 3’SL and 6’SL. The cited prior art 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). 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 lactosamine 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 composition of the instant claims. (entire patent, especially, abstract, col 3-10). PNG media_image4.png 254 599 media_image4.png Greyscale PNG media_image5.png 380 614 media_image5.png Greyscale PNG media_image6.png 467 738 media_image6.png Greyscale PNG media_image7.png 702 580 media_image7.png Greyscale 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. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PANCHAM BAKSHI whose telephone number is (571)270-3463. The examiner can normally be reached M-Thu 7-4.30 EST. 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, Milligan Adam can be reached on 571-2707674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
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Prosecution Timeline

Feb 09, 2023
Application Filed
May 23, 2024
Non-Final Rejection — §101, §102, §112
Oct 24, 2024
Response Filed
Jan 21, 2025
Final Rejection — §101, §102, §112
Apr 22, 2025
Response after Non-Final Action
May 21, 2025
Request for Continued Examination
May 25, 2025
Response after Non-Final Action
Aug 14, 2025
Non-Final Rejection — §101, §102, §112
Nov 17, 2025
Response Filed
Feb 11, 2026
Final Rejection — §101, §102, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

5-6
Expected OA Rounds
77%
Grant Probability
99%
With Interview (+30.4%)
2y 5m
Median Time to Grant
High
PTA Risk
Based on 1132 resolved cases by this examiner. Grant probability derived from career allow rate.

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