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 .
Claims 1-4 and 8-21 are pending and are currently under consideration.
Claims 1-4 and 8-13 are currently amended.
Claims 14-21 are newly added.
Newly submitted claim 14-21 and amended claims 10-13 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: methods of treating, methods of making, and the species of chemotherapeutics and probiotics were not previously presented and would have been properly restricted had they been earlier presented.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 10-21 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Amendments
The amendment filed 12/04/2025 did not follow the required procedures for making amendments. Applicant is requested to review MPEP 1.121 “Manner of making amendments in applications” as this section provides guidance as to how to properly underline and strikethrough amendments. There are numerous, significant failures to follow the required guidelines, including, but not limited to claim 4, wherein numerous limitations that were previously present are simply omitted, and claim 8 where limitations are added without any proper marking.
Should further responses have such errors, they will not be entered or considered since such errors results in obfuscation of the record.
Claim Interpretation
It is noted that Applicant defines “vegetable material” as being fruits of 7-year-old pomegranate shrubs of the “Wonderful” variety, and specifically those grown in an orchard located near Marsala (see Instant Specification, page 20, lines 18-22).
Withdrawn Rejections
The rejection of claims 10, 11, and 13 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn in view of Applicant’s amendments to said claims removing the “use” limitations.
The rejection of claims 5-7 and 12 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn in view of Applicant’s cancellation of claims 5-7 and Applicant’s amendment to claim 12, shifting the invention to a method claim that has been withdrawn.
The rejection of claims 10, 11, and 13 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 is withdrawn in view of Applicant’s amendments to said claims removing the “use” limitations.
Claim(s) 5-7 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nuncio-Jáuregui et al (Journal of Functional Foods, 2015) is withdrawn in view of Applicant’s cancellation of claims 5-7 and Applicant’s amendment to claim 12, shifting the invention to a method claim that has been withdrawn.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites that the immature pomegranate is between 35-60 dates from fruit set, yet claim 1 from which it depends recites that the immature pomegranate is harvested 30 to 40 dates after and appearance of the fruit or parts thereof. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Rejections Maintained and Made Again in view of Applicant’s Amendments
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 1-4, 8, and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims, as written, do not sufficiently distinguish over compositions comprising extracts such as ellagic acid, punicalagin α and β, gallotannins, and granatins as they exist naturally because the claims do not particularly point out any non-naturally occurring differences between the claimed composition and the naturally occurring compositions. The claimed composition reads upon naturally occurring pomegranates, which comprises ellagic acid, punicalagin α and β, gallotannins, and granatins.
In the absence of the hand of man, naturally occurring compositions (e.g. red clover) are considered non-statutory subject matter (Diamond v. Chakrabarty, 206 U.S.P.Q. 193 (1980)). It should be noted that the mere purity of a naturally occurring product does not necessarily impart patentability (Ex parte Siddiqui, 156 U.S.P.Q. 426 (1996)). However, when purification results in a new utility, patentability is considered (Merck Co. v. Chase Chemical Co., 273 F. Supp 68 (1967), 155 U.S.P.Q. 139, (District Court, New Jersey, 1967)). The examiner suggests narrowing the scope of claim 1 to include non-naturally occurring elements to indicate the hand of the inventor. See MPEP 2105.
Response to Arguments
Applicant argues in the Remarks filed 12/04/2025 that the claimed product is made by a process that concentrated the extract and does not extract certain ingredients from the starting pomegranate product, and therefore, results in a product that has therapeutic value that pomegranates do not. Applicant’s argument is not found persuasive. First, the instant claims are directed to a product “comprising,” wherein the instant claims are inclusive to the presence of additional components, including the other components present in pomegranates. This is further evidenced by claim 9 which indicates that other extracts and/or vegetable components can be present. Second, the instant claims do not require any particular purity or concentration, wherein the process recited could result in the same purity and concentration that exists naturally in pomegranates. Applicant has not provided evidence to the contrary.
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 (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 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.
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.
Claim(s) 1-4, 8, and 9 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Nuncio-Jáuregui et al (Journal of Functional Foods, 2015).
It is noted that the instant claims are directed to a product, not a method, wherein Applicant has not established any specific structural differences by utilizing the instantly claimed method steps in the product claims.
Nuncio-Jáuregui teaches that known components of pomegranates include punicalagin, gallotannins, ellagic acid, and granatin α and β (See entire document for instance, page 357, left column and Table 1). It is noted that Nuncio-Jáuregui articulates that methanol extracts are known (see entire document, for instance, page 356, paragraph 2.3.1). Nuncio-Jáuregui teaches that the antioxidant potential of pomegranate can be affected by many factors, including maturity stage, fruit cultivar, the different natures of the materials (solid: thinning fruits or liquid: pomegranate juice), extraction procedure and the specific method for their determination (see entire document, for instance, page 361, paragraph bridging the left and right columns). Nuncio-Jáuregui teaches that the components were ground into powders (see entire document, for instance, page 355, fourth paragraph).
Nuncio-Jáuregui, while teaching all of the instantly claimed components, does not expressly indicate the number of days at which the extract is extracted as instantly claimed.
It would have been obvious to one or ordinary skill in the art, before the effective filing date of the instantly claimed invention to optimize when the extract is extracted. Nuncio-Jáuregui teaches that the antioxidant potential of pomegranate can be affected by many factors, including maturity stage, fruit cultivar, the different natures of the materials. As such, one of ordinary skill in the art would have been motivated to optimize when the extract is extracted in order to achieve the desired antioxidant potential of the material.
Applicant is reminded that the intended use of a product claim carries no patentable weight unless it imparts a structural limitation. See MPEP 2111.02. Therefore, since the intended use of the composition as a treating composition is merely identifying that the composition can be used to treat conditions such as tumors, and not imparting a structural limitation, it is the Examiner's position that the composition is capable of performing the intended use.
Response to Arguments
Applicant argues in the Remarks filed 12/04/2025 that the claimed product is made by a process that concentrated the extract and does not extract certain ingredients from the starting pomegranate product, and therefore, results in a product that has therapeutic value that the prior art does not. Applicant’s argument is not found persuasive. First, the instant claims are directed to a product “comprising,” wherein the instant claims are inclusive to the presence of additional components, including the other components present in pomegranates. This is further evidenced by claim 9 which indicates that other extracts and/or vegetable components can be present. Second, the instant claims do not require any particular purity or concentration, wherein the process recited could result in the same purity and concentration that exists naturally in pomegranates and the extracts of Nuncio-Jáuregui. Applicant asserts that the use of formic acid results in a different product, however, Applicant has not provided evidence in support of said assertion.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611