App. No. 19/341,677

Strategy check: re-ranked from #3 — An examiner concession that the exemplified value falls outside the claimed range, coupled with a fallback passage absent from the record, is a more targeted and potentially dispositive gap for claim 7 than the generic, evidence-dependent enzyme-survival theory ranked #1.

a weight ratio of the sucrose to the glucose is within a range of 0.15 to 0.55

The office action concedes that Wan's Example 4 value (0.76) falls outside the claimed 0.15–0.55 range and rests the rejection solely on Wan ¶[0179], which the examiner characterizes as a syrup:sugar ratio of 1:10 to 10:1. The Wan text in the record does not contain that syrup:sugar range; instead the supplied excerpt discloses bonding-blend monosaccharide:disaccharide molar ratios of 'about 1:3 to about 3:1' and 'about 1:1.5 to about 1.5:1,' which are molar (not weight) ratios and are framed differently than the examiner's citation. Counsel may argue that, on the record as supplied, the examiner's ¶[0179] basis for reaching the claimed weight-ratio range is not supported and that the passages that are present would not translate to the claimed 0.15–0.55 weight ratio. Because Wan is graded fully grounded but these specific passages were not in the supplied copy, counsel should retrieve Wan ¶[0179] and Example 4 to confirm exactly what is recited before relying on this distinction.

• —Wan (supplied excerpt): 'the monosaccharide and the disaccharide have a molar ratio from about 1:3 to about 3:1 ... from about 1:1.5 to about 1.5:1.'
• —Wan (supplied excerpt): 'the bonding blend comprises a glucose syrup and sucrose.'
• —Office action (claim 7): concedes Example 4 ratio 'to be 0.76, which does not teach instant range of 0.15 to 0.55'

Risk The examiner may produce Wan ¶[0179] verbatim, and if it does recite a 1:10 to 10:1 syrup:sugar range that overlaps the claimed range, this argument collapses. Verify the passage before asserting the reference was mischaracterized.

Strategy check: re-ranked from #6 — The engineered multi-reference range is the specific, record-grounded weak link for this ratio claim, more targeted than the #1 enzyme-survival theory; note the §112(d) defect cannot be argued away and requires amendment.

weight ratio of the pectin to the water ... 0.05 to 1.2; weight ratio of the citric acid to the pectin ... 0.005 to 0.80; sucrose ... 8 wt% to 35 wt%; weight ratio of the glucoraphanin to the pectin ... 0.001 to 0.2

The examiner's calculations that each claimed ratio/percentage is met derive from Wan Example 4's specific ingredient amounts (e.g., 146.3 g pectin, 507.5 g water, 310 g sucrose, 1437.5 g batch weight) and from Wan ¶[0096]'s 2–8 g per-gummy weight used to back out per-gummy glucoraphanin:pectin ratios. These specific Example 4 amounts and ¶[0096] are not present in the Wan text supplied in the record, so counsel cannot presently confirm the arithmetic on which the overlapping-range findings depend. Counsel should retrieve Wan Example 4 and ¶[0096] and independently check each computed ratio before conceding the numeric limitations are taught; if the amounts differ, the In re Wertheim overlapping-range rationale may not hold. Note the general pectin range the examiner cites for claim 3 (0.01–10 wt%) does appear in the supplied Wan text, so that particular basis is verifiable, whereas the Example 4-based ratios are not.

• —OA3 finding: 'the specific "Example 4" formulation and several paragraph-numbered passages the examiner relies on are not present in the text supplied.'
• —Wan (supplied excerpt, verifiable for claim 3): 'Pectin may be present in the gummy composition dosage in an amount of from about 0.01% by weight to about 10% by weight.'

Risk The examiner may simply reproduce Example 4 and ¶[0096], confirming the calculations; because Wan is graded fully grounded this passage gap is likely a supplied-copy limitation rather than a true absence, so this is a verify-first posture, not an established gap.

Strategy check: re-ranked from #8 — The top-ranked enzyme-survival theory is directed to loss of catalytic activity, but the claim recites only presence/immobilization of the myrosinase — so it may not map to any claim limitation and, per MPEP § 2145, needs a § 1.132 declaration; the inherency-necessity attack targets an actual limitation using the examiner's own language and requires no evidence.

a matrix formed by interconnected molecules of the pectin, defining a plurality of pores therebetween, wherein the sulforaphane, the glucoraphanin, and the myrosinase are disposed within the pores and immobilized therein

The only reference supplying the pore-network and 'immobilized therein' teaching is Lofgren, an NPL article whose text was never retrieved into the record (graded unverifiable). Because that text has not been seen, counsel cannot presently establish that this limitation is absent, and the grounding discipline bars treating this as an established prima-facie gap. Separately, and independent of Lofgren's exact content, the examiner's rationale is stated in probabilistic terms — the actives 'would naturally be disposed within the pores ... and immobilized therein' — which counsel may test against the inherency standard of MPEP § 2112 requiring that an inherent result be necessarily, not merely probably or possibly, present. Counsel should obtain Lofgren, verify the ~500 nm pore teaching, and evaluate whether homogeneous mixing into a gummy batter necessarily yields actives 'immobilized' in pores as opposed to dissolved or dispersed, before relying on this as a distinction.

• —OA3 finding: 'The sole reference supplying the pore/immobilization teaching is Lofgren et al, an NPL article whose text is NOT in the record (UNVERIFIABLE).'
• —Office action inherency language: the actives 'would naturally be disposed within the pores of the pectin gel and immobilized therein.'

Risk This is a verify-first posture toward an unverifiable reference and must not be treated as dispositive; if Lofgren in fact discloses the pore structure and the examiner's 'naturally disposed' theory holds, the inherency finding may stand. Do not conclude the limitation is missing until Lofgren is retrieved.

an active ingredient consisting of sulforaphane, glucoraphanin, and myrosinase ... wherein the sulforaphane, the glucoraphanin, and the myrosinase are disposed within the pores and immobilized therein

Claim 1 requires myrosinase — an enzyme — as a mandatory active that is disposed within and immobilized in the pectin matrix. Larsen itself describes myrosinase as an enzyme, 'a member of the glycoside hydrolase family' with 'Enzyme Commission number ... EC 3.2.1.147,' whose utility is to catalyze conversion of glucoraphanin to sulforaphane. The Wan disclosure that the examiner relies on for the gummy manufacturing process teaches heating the gelling blend to elevated temperatures (Wan: 'the gelling blend may be heated to from about 140 F to about 240 F'), and the office action itself characterizes Wan's Example 4 as using '409.1 g of boiling glucose syrup.' Counsel may argue that a PHOSITA in gummy/enzyme formulation (per the OA4 skill definition, aware of 'enzyme thermal stability') would not have had a reasonable expectation that a functional myrosinase enzyme would survive those processing conditions and remain active while immobilized, so the combination the examiner proposes is directed to a result the art gives no reasonable expectation of achieving.

• —Larsen: 'Myrosinase ... is a member of the glycoside hydrolase family and can catalyse the hydrolysis of glucosinolates, including glucoraphanin. The Enzyme Commission number of myrosinase is EC 3.2.1.147.'
• —Wan: 'Before the combining step, the gelling blend may be heated to from about 140 F to about 240 F. In one embodiment, the gelling blend may be heated to from about 180 F to about 210 F.'
• —Office action characterization of Wan Example 4: '409.1 g of boiling glucose syrup'

⚠ Risk The examiner may respond that Wan adds the 'active blend' after heating/cooling and that the claim requires only that myrosinase be present, not demonstrably active; the examiner may also point to Mastaloudis for myrosinase-activity units. Prosecution-history-estoppel caution: characterizing myrosinase as heat-labile or arguing a particular activity threshold could narrow claim scope and create estoppel about processing conditions or enzyme-activity limits not currently in the claims.

an active ingredient consisting of sulforaphane, glucoraphanin, and myrosinase

Claim 1 uses closed 'consisting of' language limiting the active ingredient to exactly the three named components. Larsen, however, teaches administration of a composition 'comprising sulforaphane, and/or glucoraphanin and/or myrosinase' and repeatedly frames its preferred embodiments as broccoli sprouts or broccoli sprout juice (optionally with mustard seeds), which the reference itself treats as complex botanical materials rather than an isolated three-component active. Counsel may argue that reading Larsen to teach the closed three-active combination requires selecting the 'and/or' permutation containing all three and the isolated/purified forms (Larsen recites 'purified or isolated myrosinase') while disregarding Larsen's preferred broccoli-sprout embodiments — a reading counsel can test against MPEP § 2141.02's requirement to consider the reference as a whole. This is a claim-scope point counsel should weigh: whether the examiner's mapping accounts for the exclusionary effect of 'consisting of.'

• —Larsen claim 2: 'a composition comprising sulforaphane, and/or glucoraphanin and/or myrosinase.'
• —Larsen: 'In another particularly preferred use or method of the invention, the human subject is administered a composition comprising Broccoli sprouts (such as Broccoli sprout juice).'
• —Larsen claim 6: '... or purified or isolated myrosinase.'

⚠ Risk The examiner will likely respond that Larsen expressly lists all three actives and purified/isolated myrosinase, so the closed group is met, and that 'and/or' encompasses the all-three option. Prosecution-history-estoppel caution: arguing that 'consisting of' excludes broccoli-sprout matrix components could later be used to limit the claim to isolated actives and bar equivalents that include incidental botanical carriers.

further comprising a white mustard seed powder comprising the myrosinase

The examiner finds claim 20 ambiguous as to whether it adds a second myrosinase source or specifies the form of the claim-1 myrosinase, and points to specification ¶[0034] as supporting the latter reading. Counsel may argue that, read in light of ¶[0034], the scope is reasonably certain under the examination standard, so the § 112(b) basis is contestable on claim construction. As a practical matter, however, this is a defect the examiner has already offered a straightforward path to resolve, and counsel should weigh whether adopting the examiner's suggested formulation (specifying that the myrosinase is provided in the form of white mustard seed powder) is the cleaner route than arguing definiteness. This should be framed under In re Packard / MPEP § 2173.02, not the litigation 'reasonable certainty' standard.

• —Office action: the examiner 'assumed that applicant meant the latter' based on 'the reading of present specification ([0034]).'

Risk The examiner may maintain that on its face the claim is amenable to more than one plausible construction under BRI (the Ex parte Miyazaki prong) regardless of the specification. Prosecution-history caution: an amendment adopting 'in the form of white mustard seed powder' will define the myrosinase source on the record and may limit equivalents; do not argue that a simultaneous § 112(b) and § 103 rejection is improper, which is a losing position under compact prosecution.

a matrix formed by interconnected molecules of the pectin, defining a plurality of pores therebetween, wherein the sulforaphane, the glucoraphanin, and the myrosinase are disposed within the pores and immobilized therein

The rejection assembles Larsen (a method reference), Rinsch and Wan (general gummy popularity), Lofgren (pore structure), and Mastaloudis (myrosinase units) and rests the motivation on generic statements that gummies are 'popular' and appeal to those who dislike swallowing tablets. Counsel may argue the office action articulates no reason specific to Larsen's three-active, myrosinase-containing composition for selecting Wan's particular Example 4 formulation and arriving at each claimed numeric ratio and the pore-immobilization architecture. Under KSR and MPEP § 2143.01, the reasoning must have a rational underpinning rather than a conclusion that the combination 'would have been obvious'; where the only apparent roadmap to the specific claimed matrix/pore/immobilization arrangement is the applicant's own disclosure, that is improper hindsight. Counsel should press that a generic preference for gummy dosage forms does not supply a reason to converge on this specific pectin/sugar/citric-acid architecture with the actives immobilized in pores.

• —Rinsch: 'Recently, gummy products have been supplemented with vitamins, minerals, essential oils and other nutritional supplements to provide a nutritional supplement that appeals to children and adults that do not like to swallow or have difficulty swallowing tablets or capsules.'
• —OA2 finding on Larsen: 'It is a method reference directed to what is administered and its physiological effect, not to a specific solid dosage-form architecture.'

Risk The examiner will likely respond that the § 2143(A)/(F) rationale (combining known elements / market forces) and the express Rinsch/Wan teachings supply an articulated reason, and that KSR does not require a teaching-suggestion-motivation in the references. Framing the architecture as non-obvious should avoid statements that concede the individual ingredients or ranges are conventional beyond what is necessary.

based on a total weight of the gummy formulation

The examiner rejects claim 1 (and dependents 2–5) for lack of antecedent basis because the preamble introduces a 'supplement formulation' while later limitations reference 'the gummy formulation.' Counsel may argue that a PHOSITA reading the claim as a whole would understand the two terms to refer to the same composition, so the scope is reasonably certain under In re Packard. That said, this is a facial informality the examiner has flagged squarely, and counsel should weigh whether conforming the terminology by amendment is the cleaner resolution than contesting definiteness. The same reasoning applies to the examiner's 'the pores' / 'the plurality of pores' point, which is a straightforward antecedent conformity item.

• —Office action: 'Claim 1 recites the limitation "the gummy formulation" ... There is insufficient antecedent basis for this limitation in the claim.'
• —Office action: 'Applicant needs to change "the pores" to --- the plurality of pores --- to provide a proper antecedent basis.'

Risk The examiner is likely to maintain the antecedent-basis objection because 'supplement formulation' and 'gummy formulation' are literally different terms; a definiteness argument here is fragile and amendment is the ordinary path. Any conforming amendment should be checked for unintended scope changes.