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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 January 2026 has been entered.
Claim Status
Applicant’s remarks and amendments, filed 16 January 2026 in response to the final rejection mailed 16 October 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 16 January 2026 replaces all prior versions and listings of the claims.
Claims 1-3, 6, 10, 12, 14, 19-21, 23, 24, 43, 48, and 70 are pending. Claims 48 and 70 remain withdrawn. Claim 1 is amended. Claims 1-3, 6, 10, 12, 14, 19-21, 23, 24, and 43 are being examined on the merits.
Specification
The disclosure is objected to because the phrase “prophetic” should be removed throughout the specification (e.g., tiles of Examples 2-4). This phrase is problematic because the term typically is reserved for hypothetical and untested statements, however what follows in the specification appears to be asserted elsewhere as actually having been performed (uses past tense).
Appropriate correction or clarification is required.
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.
Claims 1-3, 6, 10, 12, 14, 19, 20, 23, 24, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2011/0020443 A1) in view of Bala et al. (J Herb Spice Med Plants, 2009, 203-215).
The instant claims are as of record, drawn to pharmaceutical composition comprising a Hippophae rhamnoides extract having at least 30% polyphenol or proanthocyanidin compounds, Aphanizomenon flos-aquae, Aloe, Fucus vesiculosus, Panax notoginseng, and a pharmaceutically acceptable carrier, wherein the composition is formulated for oral administration and enhances stem cell mobilization in a subject.
Liu et al. teach a magnesium supplement (pharmaceutical composition) which comprises herbal and natural extracts including sea buckthorn (Hippophae rhamnoides; Liu et al., [0114], pg. 16, col. 2), black currant (Ribes spp.; Liu et al., [0114], pg. 14, col. 2), AFA (Aphanizomenon flos-aquae; Liu et al., [0114], pg. 14, col. 2), aloe, Aloe barbadensis, Aloe ferox, Aloe vera, American aloe (Liu et al., [0114], pg. 14, col. 2), bladderwrack (Fucus vesiculosus; Liu et al., [0114], pg. 16, col. 2), Chinese ginseng (Panax notoginseng; Liu et al., [0114], pg. 15, col. 1), beta-glucan (Liu et al., pg. 16, col. 1), and physiologically acceptable carriers (pharmaceutically acceptable carrier; Liu et al., [0088], pg. 10; as required for instant Claims 1-3, 19, 23, and 24). The supplement can be filled into capsules as an oral solid dosage form (formulated for oral administration; single unit dosage), and enteric coatings may also be used (Liu et al., [0084]-[0085], pg. 10; as required for instant Claims 1 and 43).
Liu et al. do not teach wherein the Hippophae rhamnoides extract has at least 30% polyphenols or proanthocyanidin compounds or enhancement of stem cell mobilization in a subject.
Bala et al. teach that a Hippophae rhamnoides leaf extract comprising 24.5% polyphenols and proanthocyanidins results in enhanced proliferation of hematopoietic stem cells (enhancement of stem cell mobilization) in mice (subject; Bala et al., Plant Material, page 204; Table 1, page 205; as required for instant Claim 6).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide the pharmaceutical composition comprising numerous plant extracts as taught by Liu et al. with the specific sea buckthorn extract of Bala et al. in order to obtain a composition which results in enhanced proliferation of hematopoietic stem cells. Additionally, a skilled artisan could incorporate the specific sea buckthorn extract of Bala et al. with a reasonable expectation of success because it is well tolerated by the test animals in a dose of up to 120 mg/kg of body weight (Bala et al., Results, page 207). A skilled artisan could also incorporate the extract of Bala et al. with a reasonable expectation of success because, absent evidence to the contrary, 24.5% proanthocyanidin and polyphenol content is close to 30% and a skilled artisan would therefore expect them to have the same properties (see MPEP § 2144.05).
The references are relied upon for the reasons discussed above, and it would have been obvious to one of skill at the time of the instant invention effective filing to have so provided the amounts. If not expressly taught by the prior art, based upon the overall beneficial teaching provided by these references with respect to inclusion of one or more natural extract provided in oral dosage form and the tolerable amount of sea buckthorn extract administrable to an animal, in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable mass in which to provide the natural extracts in a single dosage form (Claims 10, 12, 14, and 20) and choosing an extract with a particular amount of proanthocyanidins and polyphenols (Claim 1)) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Claims 1-3, 6, 10, 12, 14, , 19-21, 23, 24, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (US 2011/0020443 A1) in view of Bala et al. (J Herb Spice Med Plants, 2009, 203-215) as applied to Claims 1-3, 6, 10, 12, 14, 19, 20, 23, 24, and 43 above, and further in view of Purcell (US 2013/0337096 A1).
The instant claims and teachings of Liu et al. and Drapeau et al. are as of record.
Liu et al. and Bala et al. do not teach wherein the composition comprises 5-100 mg of colostrum (as recited in claim 21).
Purcell teaches a buccal (oral) dosage form for administration of an active ingredient, including pharmaceutically active ingredients (pharmaceutical composition) wherein the active ingredients comprise plant extracts of sea-buckthorn (Hippophae rhamnoides; Purcell, [0095], pg. 6, col. 2), Aloe (Purcell, [0095], pg. 6, col. 1), and/or bladderwrack (Fucus vesiculosus; Purcell, [0095], pg. 6, col. 1), as well as colostrum (Purcell, [0098], pg. 6; as required for instant Claim 21). The active ingredient can comprise up to 80% of a 35 mg microsphere (28 mg; 5-100 mg of colostrum; as required for instant Claim 21).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to include colostrum as taught by Purcell in the composition of Liu et al. and Bala et al. because bovine colostrum (as evidenced by Shing et al., referenced in Purcell at [0098]) modulates immune parameters during and after exercise, reducing incidence of upper respiratory illness in a treatment group (Shing et al., Abstract, page 1113). A skilled artisan could therefore include colostrum in the instantly claimed composition with a reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of 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, 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).
Relevant Prior Art Made of Record
The following prior art is made of record and considered to be relevant to the state of the art at the time of the filing of the instant invention.
Liu et al. (Cell Physiol Biochem, 2013, 814-826) disclose mobilization of endothelial progenitor cells by Panax notoginseng saponins.
Shytle et al. (Med Sci Monit, 2010, BR1-5) disclose extracts of Aphanizomenon flos-aquae that enhance stem cell proliferation.
Boonyagul et al. (Odontol, 2014, 310-317) disclose that acemannan extracted from Aloe vera stimulate bone marrow stromal cell proliferation.
Frenette & Weiss (Blood, 2000, 2460-2468) disclose that fucoidan extracted from Fucus vesiculosus induces mobilization of hematopoietic progenitor cells.
Response to Arguments
Applicant's arguments filed 16 January 2026 have been fully considered but they are not persuasive.
Applicant’s arguments and declaration filed 16 January 2026 with respect to Drapeau et al. 2019 have been considered but are moot because the new ground of rejection does not rely on this reference as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that a person skilled in the art would have to perform undue experimentation to determine the combination of extracts that would result in the highest efficacy, however the claims are not drawn to efficacy for any particular purpose. Additionally, the claims are drawn broadly to a "comprising" composition which may include additional ingredients outside of those listed (e.g., the entire list of 1500 extracts or any combination thereof). See MPEP § 2111.03.
Applicant argues that their results are surprising because the Hippophae rhamnoides extract having at least 30% polyphenol and/or proanthocyanidin compounds can stimulate stem cell release and therefore stimulate repair of distant tissues, however Bala et al. teach that a Hippophae rhamnoides leaf extract comprising 24.5% polyphenols and proanthocyanidins results in enhanced proliferation of hematopoietic stem cells. It is therefore not a surprising result because it was known in the art prior to the effective filing date of the instant application that a Hippophae rhamnoides with at least 24.5% polyphenols and proanthocyanidins stimulate stem cell release.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., congestive heart failure) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, regarding the assertion of synergy between all five compounds in mobilization of stem cells, it is noted that evidence of a greater than expected result may be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately. However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. See MPEP § 716.02(a). In the instant case, as described above in the relevant art and rejections, all five extracts of the composition are known in the art to have a stem cell mobilization effect. Additionally, the instant specification does not provide evidence of synergy for the claimed composition.
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655