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 Claims
Claims 1-8 were originally filed August 2nd, 2021. The preliminary amendment filed the same day has been entered. Claims 2 and 4-8 are currently pending.
Withdrawn Claim Objections
In view of Applicant’s amendments to claims 4 and 6-8 and canceling of claim 3 the claim objections to said claims are hereby withdrawn.
Claim Interpretation
For the purposes of applying prior art, the claim scope has been interpreted as set forth below
per the guidance set forth in MPEP § 2111.
Claim 2 recites the open language “comprising,” in relation to a composition which does not exclude additional unrecited elements while also reciting the closed language “consisting of” in relation to a pharmaceutical composition, which does not allow for additional unrecited elements (see MPEP § 2111.03(I) and (II)). Claim 2 is interpreted as a composition comprising a pharmaceutical combination and allows for additional components. Therefore, while the pharmaceutical combination is limited to i. at least one TNF inhibitor and ii. riboflavin the overall composition is not limited to these two elements.
Withdrawn Claim Rejections
In view of Applicant’s amendments as follows:
canceling claims 1 and 3,
claim 2 to be drawn to a single composition,
claim 4 to remove the clause “the formulation” and “the sole active ingredients” (in part),
claim 5 to clarify “a formulation use” as “a formulation comprising the…”,
claim 8 to remove the clause within the parenthetical,
the 35 U.S.C. 112(b) rejections regarding these matters are hereby withdrawn. It is noted claims 4 and 6 have 35 U.S.C. 112(b) rejections regarding other matters of indefiniteness that are maintained (see below).
In view of Applicant amending claim 6 to recite an active step of administering the 35 U.S.C. 101 rejection of claim 6 is hereby withdrawn.
In view of Applicant amending claim 2 to recite specific TNF inhibitors the 35 U.S.C. 102(a)(1) rejection over Carpenter (as cited on the IDS dated 08/02/2021) is hereby withdrawn.
Maintained Claim Rejections - 35 USC § 112(b)
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.
It is noted the following rejection is maintained from the Non-final dated 26 November 2024 however in light of Applicant’s amendments the claim
Claims 2 and 4-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Applicant's arguments filed 23 May 2025 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Regarding claims 2 and 4, Applicant has argued “active ingredient” is a term that is well understood by those skilled in the art and for whom the metes and bounds are clear (see Remarks pg. 6 lines 16-18).
The FDA defines “active” ingredient as “any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals” (see Drugs@FDA pg. 1, accessed online 17 July 2025). Therefore, a person of ordinary skill in the art would understand the definition of an “active” versus “non-active” ingredient can change depending on the particular context of the formulation. For example, US Patent Application Publication No. 2018/0055856 A1 (referred to herein as DeLuca) discloses alcohol can be either an active or inactive ingredient depending on the product formulation (see DeLuca pg. 8, 1st col. para [0060]). Thus, it is unclear how a generic composition can comprise active ingredients given “active ingredient” is determined from variables attributed to the administration of the compositions.
Regarding claim 6, Applicant has argued the claim has been amended to recite an administration step (see Remarks pg. 6 last line).
While claim 6 has been amended to recite the step of administering the composition, the scope of claim 6 remains unclear. For example, is claim 6 drawn to an intended use of the product as “Use of the composition” suggests, or alternatively, drawn to a method of treating or lessening the symptoms as “comprising administering to a person in need thereof” suggests.
Therefore the 35 U.S.C. 112(b) rejection of claims 2 and 4-8 are hereby maintained.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 2 and 4-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matsumoto (see U.S. Patent Publication 2006/0292148 A1 Published December 28th, 2006, as cited on the IDS dated 08/02/2021).
Applicant's arguments filed 23 May 2025 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues the newly amended claim 2 is drawn to a composition consisting of (i.e., closed language) at least one TNF inhibitor and riboflavin while the prior art is drawn to Elental® which comprises additional components (see Remarks pg. 7 last para). As set forth in the Claim Interpretation above claim 2 is drawn to a “composition comprising” which allows for additional elements while the pharmaceutical combination consists of (i.e., closed language) is limited to only active ingredients. Therefore, the presence of the addition elements of Elental® are permissible in the composition.
Therefore the 35 U.S.C. 102(a)(1) rejection of claims 2, 4, 5, 7, and 8 is hereby maintained.
Regarding amended claim 6, in so far as the claim is intended to encompass a method of treatment Matsumoto discloses the infliximab and Elental® were administered to a 31 year old male with Crohn’s Disease (see Matsumoto pg. 6, 2nd col. para [0060 and 0061]).
The following objections and rejections are necessitated by amendment.
Claim Objections
Applicant is advised that should claim 5 be found allowable, claim 7 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
New Claim Rejections
Claim Rejections - 35 USC § 112(b)
Claims 2 and 4-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 is drawn to i. a composition comprising, ii. a pharmaceutical combination consisting of active ingredients, iii. at least one TNF inhibitor and riboflavin. The scope of the composition is unclear. For example, does the composition comprise i. a pharmaceutical combination consisting of active ingredients and ii. at least one TNF inhibitor and riboflavin, or alternatively does the composition comprise a pharmaceutical combination consisting of active ingredients wherein the active ingredients the active ingredients are at least one TNF inhibitor and riboflavin.
Claims 4-8 depend from canceled claim 1. Therefore, the scope of claims 4-8 are unclear.
In so far as claim 5 is intended to be dependent from claim 2, claim 5 is drawn to a composition or a formulation which suggests alternative embodiments; however, it is unclear what the difference in scope of a composition versus formulation is. Specifically, the composition of claim 2 comprises (i.e., open language) a pharmaceutical combination consisting of (i.e., closed language), yet the formulation comprises (i.e., open language) the pharmaceutical combination of claim 1 which consists of (i.e., closed language).
In so far as claim 6 is intended to be dependent from claim 2, it is unclear if the step of administering to a person in need thereof the composition of claim 2 is required. The language of claim 6 is drawn to a use of the composition; therefore, is the step of administering dependent upon the “use” of the composition, or alternatively, does claim 6 require the step of administering.
Conclusion
No claim allowed.
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.
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/H.A.P./Examiner, Art Unit 1644
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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