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
The Amendments filed on 7/28/2026 has been received and entered.
Claims 1 and 3-21 are pending. Claims 1, 3, and 7 are examined on the merits.
Claims 4-6 and 8-21 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1 and 2-7), ginger, in the reply filed on 7/28/2026 is acknowledged.
Claims 4-6 and 8-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/28/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/12/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, and 7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Limited amount of guidance and limited number of working examples in the specification
While the Specification recited cardiovascular disease attributed to endothelial dysfunction, such as atherosclerosis and coronary heart disease are affected by NO, there are no other cardiovascular diseases mentioned (page 5, paragraph 1).
Nature of the invention
There are many types of cardiovascular diseases.
Congenital heart disease is associated with one having defect occurs when the heart or blood vessels near the heart don't develop normally before birth. Congenital cardiovascular defects are present in about 1 percent of live births. They're the most common congenital malformations in newborns. In most cases scientists don't know why they occur (see 2026, Congenital Heart Disease | American Heart Association). Thus it would be impossible to prevent someone from getting cardiovascular disease through genetic disposition.
State of the prior art
There are many risk factors associated with cardiovascular disease. As stated above, different cardiovascular disease has different causes or its causes are not known. Therefore, it would be impossible to prevent all types of cardiovascular disease.
Relative skill level of those in the art
Those in the art would have a difficult time to treat all types of cardiovascular disease because of the many causes of cardiovascular disease. Therefore, the relative skill level required would be high.
Predictability or unpredictability in the art
Because of the many causes of cardiovascular disease, the unpredictability in the art would be high.
The breadth of the claims
The breadth of the claims is broad, particularly for cardiovascular disease, and alleviate the occurrence or negative effects of cardiovascular disease in general. Nutritional supplement is not going to alleviate or fix a deformed heart for baby with congenital hear disease.
Applicant’s claims are broadly drawn to a composition that is able to prevent cardiovascular disease. In order to be enabled for prevention of a condition, applicant must demonstrate that the invention is able to prevent the condition each and every instance of that condition. Applicant’s specification does not set forth any evidence that the claimed product is able to prevent cardiovascular disease for all potential causes of cardiovascular disease. In addition, the art teaches cardiovascular disease prevention is not accepted as possible because many risk factors such as family history cannot be controlled (see http://www.americanheart.org/presenter.jhtml?identifier=4565). Because applicant’s specification does not show prevention of all cardiovascular disease and the art acknowledges that prevention is not currently possible, a person of ordinary skill in the art would be forced to experiment unduly in order to determine if applicant’s invention actually functions as claimed. Therefore, the claims are not considered enabled for the prevention of cardiovascular disease.
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) 1, 3, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rajfer (US 20120121740 A1).
Rajfer teaches a method of treating or preventing erectile dysfunction or age related erectile dysfunction, comprising the steps of administering to a patient having or at risk of having the dysfunction ginger or a ginger derivative and an additional compound selected from the group consisting of L-arginine, L-citrulline, and mixtures of L-arginine and L-citrulline, said administration step comprising administering of from about 250 mg up to 2 g of ginger or ginger derivative and from about 500 mg to 3 g of the additional compound on substantially a daily basis over a period of at least one month for treatment of erectile dysfunction or age related erectile dysfunction (Claim 13). The same ingredient in the same dosage when used will lead to preventing onset of endothelial dysfunction and subsequent cardiovascular disease.
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 and 3-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10973866 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because not the same disease is claimed.
US 10973866 B2 teaches:
1. A method for treatment of erectile dysfunction or age related erectile dysfunction, comprising: administering a pharmaceutically effective amount of a composition over a sufficient period of time that results in an increase in erectile function, wherein the composition consists essentially of 10 mg to 2 g ginger or a ginger derivative, an effective amount of Muira puama, an effective amount of Paullinia cupana, and an effective amount of at least one of the group consisting of L-arginine and L-citrulline that stimulates the production of iNOS resulting in slowing, stopping or reversing smooth muscle cell deterioration, wherein smooth muscle deterioration is associated with erectile dysfunction and age related erectile dysfunction.
2. The method according to claim 1, wherein the amount of L-arginine, L-citrulline, or a mixture of L-arginine and L-citrulline in the composition is 10 mg to 3 g.
3. The method according to claim 1, wherein the amount of Muira puama in the composition is 500 mg to 1.5 g.
4. The method according to claim 1, wherein the amount of Paullinia cupana in the composition is 500 mg.
5. The method according to claim 1, wherein the composition consists essentially of 500 mg of ginger or ginger derivative, 1,600 g of L-arginine, L-citrulline, or mixture of L-arginine and L-citrulline, 500 mg to 1.5 g of Muira puama, and 500 mg of Paullinia cupana.
The same ingredient in the same dosage when used will lead to preventing onset of endothelial dysfunction and subsequent cardiovascular disease.
Claims 1 and 3-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10792324 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because not the same disease is claimed.
US 10792324 B2 teaches:
1. A method for treatment of bone fractures, loss of bone mineral content or bone density, comprising: administering a pharmaceutically effective amount of a composition comprising ginger or a ginger derivative, Muira puama, Paullinia cupana, and at least one of the group consisting of L-arginine and L-citrulline that stimulates osteoblasts to increases production of NOS, nitric oxide production and cGMP resulting in bone formation.
2. The method according to claim 1, wherein the composition comprises 250 mg to 2 g ginger or ginger derivative.
3. The method according to claim 1, including 10 mg to 3 g of L-arginine, L-citrulline, or a mixture of L-arginine and L-citrulline.
4. The method according to claim 1, including 10 mg to 2 g of L-arginine, L-citrulline, or a mixture of L-arginine and L-citrulline.
5. The method according to claim 1, including 100 mg to 3 g of Muira puama.
6. The method according to claim 1, including 500 mg to 1.5 g of Muira puama.
7. The method according to claim 1, including at least 250 mg of Paullinia cupana.
8. The method according to claim 1, including 500 mg of Paullinia cupana.
9. The method according to claim 1, including 250 mg to 2 g of ginger or ginger derivative, 250 mg to 2 g of L-arginine, L-citrulline, or mixture of L-arginine and L-citrulline, 500 mg to 1.5 g of Muira puama, and 500 mg of Paullinia cupana.
10. The method according to claim 1, wherein administration of the pharmaceutically effective amount of the composition over the sufficient period of time will increase the rate of bone fracture healing.
11. The method according to claim 1, wherein administration of the pharmaceutically effective amount of the composition over the sufficient period of time is effective in treatment of osteoporosis.
The same ingredient in the same dosage when used will lead to preventing onset of endothelial dysfunction and subsequent cardiovascular disease.
Claim 1 and 3-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 20240180995 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because not the same disease is claimed.
US 20240180995 A1 teaches:
1. A method for protecting human arterial endothelial cells from endothelial cell dysfunction, comprising: administering a pharmaceutically effective amount of a composition over a sufficient period of time to stimulate NOS and protecting human arterial endothelial cells from endothelial cell dysfunction.
2. The method according to claim 1, wherein the composition comprises ginger or a ginger derivative, Muira puama, Paullinia cupana, and L-arginine and/or L-citrulline.
3. The method according to claim 2, wherein the composition comprises 250 mg to 2 g ginger or ginger derivative.
4. The method according to claim 2, wherein the composition comprises 10 mg to 3 g of L-arginine, L-citrulline, or a mixture of L-arginine and L-citrulline.
5. The method according to claim 2, wherein the composition comprises 10 mg to 2 g of L-arginine, L-citrulline, or a mixture of L-arginine and L-citrulline.
6. The method according to claim 2, wherein the composition comprises 100 mg to 3 g of Muira puama.
7. The method according to claim 2, wherein the composition comprises 500 mg to 1.5 g of Muira puama.
8. The method according to claim 2, wherein the composition comprises at least 250 mg of Paullinia cupana.
9. The method according to claim 2, wherein the composition comprises 500 mg of Paullinia cupana.
10. The method according to claim 2, wherein the composition comprises 250 mg to 2 g of ginger or ginger derivative, 250 mg to 2 g of L-arginine, L-citrulline, or mixture of L-arginine and L-citrulline, 500 mg to 1.5 g of Muira puama, and 500 mg of Paullinia cupana.
The same ingredient in the same dosage when used will lead to preventing onset of endothelial dysfunction and subsequent cardiovascular disease.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice .
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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