DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-20 are currently pending.
Election/Restrictions
3. Applicant’s election of virus for the species in the reply filed on October 1, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
4. Claims 1-20 are examined on the merits.
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.
5. Claims 11 and 12 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inhibiting a viral infection, does not reasonably provide enablement for prevention of viral infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s claims are broadly drawn to a method that is able to prevent viral infection by administering a polysaccharide which provides support for the immune system. In order to be enabled for prevention of a condition, applicant must demonstrate that the invention is able to prevent the condition in each and every instance of that condition. Applicant’s specification does not set forth any evidence that the claimed polysaccharides are able to prevent viral infection for all potential types of viral infection. In addition, an artisan of ordinary skill would recognize that even known preventative vaccines are not able to provide complete prevention from infection in all instances in all patients. Furthermore, the art teaches that there are at least 219 different types of viruses that are known to infection humans (see Woolhouse (Phil. Trans. R. Soc. B (2012), vol. 367, pp. 2864-2871)). Thus, the artisan would be forced to test all different types of polysaccharides against all types of viruses to determine if the support of the immune system provided by a polysaccharide is also able to provide a preventative action against viral infection. Thus, since applicant’s specification does not show prevention of viral infection and the art acknowledges that prevention is not necessarily predictable, a person of ordinary skill in the art would be forced to experiment unduly in order to determine if applicant’s invention actually function as claimed. Therefore, the claims are not considered enabled for the prevention of viral infection.
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.
6. Claim 15 is 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.
Claim 15, at line 4, is indefinite because it is unclear what is meant by a “sol” formulation.
Claim Rejections - 35 USC § 102
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.
7. Claim(s) 1 and 8-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Konowalchuk (US 2010/0221281).
This reference teaches a method for stimulating the immune system to provide a protective effect (considered to read on a type of “support”) by administering a composition comprising a polysaccharide. The reference teaches that the administration is useful for treating or inhibiting viral infection in humans (see paragraphs 201-205, 253-255). Treating the viral infection would lead to the treatment of the symptoms as claimed by applicant in claim 10. The reference teaches that the composition can be administering orally, systemically, or topically in the form of a tablet, capsule, lozenge, ointment, cream, gel, spray, patch, or injection. The composition can contain excipients which can be artificial or food, nutritional or beverage ingredients. In addition, the reference teaches that the polysaccharide is administered at a dosage of 100, 200, 250, or 300 mg/kg body weight (see paragraphs 74, 76, 194, 208, 210, and 228).
8. Claim(s) 1, 2, 8-15 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (US 4,886,666).
This reference teaches a method for increasing immune function (considered to read on a type of “support”) and for treating and inhibiting viral infection in a human by administering a composition comprising a polysaccharide. Treating the viral infection would lead to the treatment of the symptoms as claimed by applicant in claim 10. The reference teaches that the composition can contain over 50% of the polysaccharide. In addition, the reference teaches that the composition is formulated for oral (systemic) administration in the form of a tablet, capsule, syrup, or beverage using excipients. The reference teaches the use of excipients such as dicalcium phosphate and magnesium stearate (see abstract, column 4, and claims). These ingredients can be synthesized (i.e. “artificial”).
9. Claim(s) 1, 3-5, 13-15, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Milijkovic (US 2006/0263508).
This reference teaches a method for modulating and stimulating the immune system by administering a composition comprising polysaccharides. The reference teaches that the polysaccharides are from a coffee cherry (fruit) extract. The reference teaches that the fruit extract contains the pulp and is from Coffea arabica. In addition, the reference teaches that a plurality of polysaccharides are present in the extract. The reference teaches that the composition is administered orally (systemic) as a food, beverage, or nutritional product. In addition, the reference teaches that synthetic ingredients can be added (see paragraphs 18-20, 25, 29, 45, 49-51).
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.
10. Claim(s) 1, 3, 6, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milijkovic (US 2006/0263508).
The teachings of this reference are discussed above. The reference does not teach that the extract contains at least 50% of the polysaccharide. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the polysaccharide produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
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.
11. Claims 1, 2, and 8-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/060,659 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method for supporting the immune system by administering a composition comprising a polysaccharide. The reference application also teaches that the subject is infected with a pathogen and that the administration treats the symptoms of infection. In addition, the reference applicant teaches that the composition can be administered orally, topically, or systemically in formulations that overlap with those claimed by applicant. The reference does not teach that the composition contains the same concentrations or dosages of the polysaccharides claimed; however, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 3:30pm.
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, Terry McKelvey can be reached at 571-272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655