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 .
Claim Status
Claims 1-5 are pending and being examined on the merits.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Link (HealthLine, 2020, 13 pages) as evidenced by Beijer et al. (Immunology, 2014, 39-45).
MPEP § 2112 provides guidance as to the Examiner' s burden of proof for a rejection of claims under 35 U.S.C. 102 or 103 based upon the express, implicit, and inherent disclosures of a prior art reference. The case law clearly states that something which is old does not become patentable upon the discovery of a new property.
The instant claims are as of record, drawn to methods of activating dendritic cells, natural killer cells, helper T cells, killer T cells, B cells, or macrophages comprising causing a human to ingest young barley leaves.
Link, however, anticipates the claims by teaching that barley grass (young barley leaves) is a common ingredient at juice shops and health stores (causing a human to ingest; Link, page 1; as required for instant Claims 1, 3, and 5). When consumed by humans (causing a human to ingest), barley grass affects heart health, helps maintain health blood sugar levels, and is rich in nutrients such as fiber (barley-leaf derived dietary fiber; Link, page 3; as required for instant Claim 3), Vitamin A, Vitamin C, Vitamin K, polyphenols, and flavonoids. Vitamin A regulates immune function (immune function is maintained; Link, page 3; as required for instant Claims 2 and 4).
Although Link teaches each of the active steps in the claimed method, they are
silent regarding the intended use of the method recited in the preamble i.e. activating dendritic cells or activating natural killer cells, helper T cells, killer T cells, B cells, or macrophages. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the barley grass of the prior art is structurally different from the young barley leaves of the instant application. The single-step method of causing a human to ingest young barley leaves is the same, and thus the properties of activating dendritic cells or activating natural killer cells, helper T cells, killer T cells, B cells, or macrophages are inherent, especially in the absence of evidence to the contrary. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the young barley leaves of the instant application and the barley grass of the prior art is either identical or sufficiently similar to the claimed method that whatever differences exist, they are not patentably significant.
The cited reference discloses ingestion of barley grass and the health benefits thereof, which appears to be identical to the presently claimed method since it is formulated and/or obtained from the same component materials and is administered/administrable to a subject. Additionally, Link discloses that barley grass comprises Vitamin A (Link, page 3), and Beijer et al. disclose that several key features of the immune system are dependent on the presence of Vitamin A and that the development of conventional dendritic cells is influenced by Vitamin A levels (Beijer et al., Introduction, page 39). Conventional dendritic cells, in turn, stimulate T-cell responses (Beijer et al., Overview of conventional DC development, page 40) and induce B-cell mucosal homing receptors (Beijer et al., Summary, page 39). Consequently, the claimed process (and compositions provided therein) appears to be anticipated by the reference.
In the alternative, even if the process (and compositions therein (with respect to an intended therapeutic effect against activating dendritic cells or activating natural killer cells, helper T cells, killer T cells, B cells, or macrophages) is not identical to the referenced process, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of in the claimed process, particularly in view of the similar characteristics which they have been shown to share (e.g. the similar component materials/formulations and the same broad administration). Thus, the claimed process (and administered-composition effects intrinsic thereto) would have at least been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within the processes thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-2 of copending Application No. 18/893,925 (reference application).
Although the claims at issue are not identical and differ in the intended effect (e.g., activating dendritic cells and activating natural killer cells, helper T cells, killer T cells, B cells, or macrophages of instant Claims 1-5 versus improving sleep quality and relieving psychological stress of Claims 1-2 of the reference application), they are not patentably distinct from each other because both methods comprise causing a human to ingest young barley leaves. Since the administration method and composition to be ingested are the same, the intended effects are inherent and thus not patentably distinct from one another.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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