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 .
DETAILED ACTION
Response to Amendment
As a result of the amendments to the claim, the objection over the specification have been withdrawn.
Also, the objections over Claims 31 and 33 have been withdrawn.
All rejection not repeated in this Office Action have been withdrawn.
Claims 1,20-21, 23-35, 37-39, 57-61 are currently pending in this Office Action. Claim 1 has been withdrawn due to being drawn to the non-elected invention.
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 20-21, 23-35, 37-39 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.
Regarding Claim 20, the term “effective amount” in line 3 is a relative term which renders the claim indefinite. The term “effective” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. See response to arguments below.
Claims 21, 23-35, 37-39 are rejected based on their dependency on a rejected claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 20-21, 23-27, 34-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fernandez (CA 3011848 A1).
Regarding Claims 20, 21, and 23, Fernandez discloses a nutritional supplement composition for peroral administration (orally dissolvable compositions, abstract), comprising an amount of a dietary metal (iron, as required by Claim 21, see abstract) through direct chemical binding (paragraph 202) and a coordinating ligand comprising a water insoluble polysaccharide (cellulose, as required by Claim 23), wherein the coordinating ligand directly binds to the dietary metal (the iron may be encapsulated in cellulose, paragraph 182, with an ion exchange resin in solution, paragraph 202).
Regarding Claim 24-26, 34, 35, the claims are rejected over Fernandez since the dietary metal anionic complex and the dietary metal cationic complex are not required.
Regarding Claim 27, Fernandez further teaches wherein PS is cellulose (paragraph 182).
Regarding Claim 33, Fernandez further teaches wherein the composition comprises a morphology selected from the group consisting of a powder (paragraph 75).
Claim Rejections - 35 USC § 103
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, 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 factual inquiries 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.
Claim(s) 37-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez (CA 3011848 A1).
Regarding Claim 37-39, the claims are directed to an intended use of the structures of Claim 20. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, since Fernandez is also directed to a nutritional supplement (see abstract), the prior art is also capable of the intended use of Claims 37-39.
Allowable Subject Matter
Claims 28-32 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art is silent to the composition comprising [M(OH2)x(PS)][ZnCl4] wherein M is a dietary metal or a combination of dietary metals, wherein PS is a polysaccharide, and wherein x ranges from 0 to 18, optionally 0 to 6. Since there is no teaching or suggestion of the claimed composition that is administered to a subject in need of a dietary metal as recited in Claim 28, there is no reason to arrive to the claimed invention as recited in Claim 28 as a whole.
Claims 57-61 are allowable for reasons similarly discussed above with respect to Claim 28.
Response to Arguments
Applicant’s arguments in the remarks filed 26 May 2026 has been considered, but is found not persuasive to overcome all of the rejections set in the previous Office Action.
As to the rejection under 35 U.S.C. 112(b) over claim 20, Applicant argues that one of ordinary skill in the art would understand what is claimed in light of the specification which indicates that “[a]n effective amount” of an agent is that amount of agent which is sufficient to provide a beneficial effect to the subject to which the agent is administered”. However, the argument is not persuasive because the claims are directed to a composition and is not further limited by a method of use or an intended use. Therefore, Applicant’s basis of a beneficial effect to the subject to which the agent is administered cannot be relied on to define “an effective amount” because administering the composition to a subject is not required by the claim. Furthermore, “a beneficial effect” is not clearly defined and it is not clear what or how a benefit can be measured such that one of ordinary skill in the art can determine “an effective amount” of dietary metal and a coordinating ligand. For these reasons, the rejection under 35 U.S.C. 112(b) is maintained.
As to the rejection under 35 U.S.C. 102 over Claim 20, Applicant argues that Fernandez does not teach every limitation required by the claim. Specifically, Applicant argues that Fernandez does not teach an encapsulation that comprises unmodified cellulose because Fernandez requires a water-soluble film whereas the claim requires a water-insoluble polysaccharide. The argument is not persuasive because even if Fernandez requires a modified cellulose such as ethyl cellulose, ethyl cellulose still constitutes as a water-insoluble polysaccharide and therefore meets the limitation of Claim 20. Furthermore, since Fernandez interchangeably refers to ethyl cellulose as a cellulose (“encapsulated in cellulose, such as a modified cellulose or an ethyl cellulose”, emphasis added, paragraph 182), ethyl cellulose is construed to meet the limitations of Claim 23 absent further limitation requiring cellulose to be a native or unmodified cellulose.
As to the rejections under 35 U.S.C. 103, the rejections have been maintained in view of the response above with respect to Claim 20. In response to Applicant’s recitation of the specification to bring context to the claim, it is noted that Claims 37-39 are dependent to Claim 20 which does not require Zinc in the composition. Therefore, the argument is not sufficient to overcome the rejection regarding intended use.
Conclusion
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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/T.H.N/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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