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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-12 in the reply filed on 03/11/2026 is acknowledged. The traversal is on the ground(s) that there is no serious burden in searching all three groups. This is not found persuasive because claims 1-12 are a simple solution. At claim 13, applicants adds exosomes and vesicles, so that the method of preserving is not commensurate in scope with Group I, but instead with the “Mixed solution”, which is more of a suspension as in Group III. Applicant is adding elements in Groups II-lll which do not require search in Group I. Aside from the differing classification, applicant would place the burden on searching not only a simple solution, but the method and suspension of Groups II and lll. Applicant can not claim these elements together because of the burden on this office as set out above.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/11/2026.
Information Disclosure Statement
An information disclosure statement was filed on 12/10/2025.
Specification
The disclosure is objected to because of the following informalities: The specification is missing a Brief Description of the Drawings. It is suggested this be placed at the top of page 3.
Appropriate correction is required.
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.
Claims 4, 6, 8, 10-12 are 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.
Applicant claims the following:
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Note that the claims lists Markush Groups for both the carrier and the stabilizer. Selection is limited to the members of Markush Group, but does not include combinations thereof. Claims 4, 6, 8, 10-12 select multiple members of the Markush Group, which is not supported by claim 1. 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.
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, 3-12 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claims 4, 6, 8-12, Applicant sets out claims which appear to include a combination of the members of the Markush Group listed for the carrier and the stabilizer of claim 1. This combination is not supported by the original specification (see specification at bottom of page 3 to top of page 4). Correction is requested.
Claims 1, 3-12 are unclear in setting out “salt” as one of the stabilizers because the term is so broad, that it has no specific meaning. Further, it overlaps with amino acid salts making the metes and bounds of Markush Group unclear. Clarification is requested.
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.
Claims 1, 3-12 are 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.
The claims are indefinite in the use of the term “salt” as one of the stabilizers because the term is so broad that it does not particularly point out which salts are part of the composition. The metes and bounds of the claim are also indefinite since “salt” overlaps with “amino acid salt”. Clarification is requested.
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.
Claim(s) 1, 2, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over FDA Highlights of the use of PEG 3350, electrolytes (which include salts such as NaCl and sodium bicarbonate (2023) )in view of Gerard et al ( High Dose Polyethylene Glycol 3350 and Gatorade solutions for Patients with Previous Inadequate Bowel Preparations for Colonoscopy Are Safe and Effective (BMC Gastroenterol. 2023 May 11;23:146.
The article by FDA shows the combination of PEG 3350 and electrolytes . These electrolytes include salt which include NaCl and sodium bicarbonate, and further teaches addition of clear fluids. The article by Gerard et al indicates that PEG 3350 and Gatorade ™. One of the components of Gatorade ™ is sucrose. Therefore , it would have been well within the skill of the ordinary practitioner to claims PEG 3350, with sats and sucrose as in claim 1, and additionally include sodium chloride as set out in claim 2. Those of ordinary skills would have the skill to modify the percentage of PEG 3350 and sucrose in this well known solution in order to obtain the therapeutic result sought by applicant (see Description for components of the FDA compositions , and Table 1 of the Gerard et al article )as set out in claims 9 and 10 . It would have been well within the skill of the ordinary practitioner to claim PEG 3350, salts and Sucrose as taught by FDA and Gerard et al.
Conclusion
No claims are allowed.
Judicial notice is given in regards the composition of Gatorade™ as shown here:
Sucrose Content in Gatorade
Gatorade contains sucrose (table sugar) as one of its primary carbohydrate sources, along with dextrose (glucose) and sometimes fructose, depending on the flavor summerstirs.com+1.
Per serving (12 fl oz / 355 mL)
Total carbohydrates: ~14–21 g
Sugars: ~13–20 g, mostly from sucrose and dextrose p.globalsources.com
Added sugars: ~21 g in a 12 fl oz serving, which is about 41% of the daily recommended limit for added sugars nutritionandingredients.com
Per 20 fl oz (591 mL)
Added sugars: ~34 g (about 69% of the daily recommended limit) nutritionandingredients.com
Sucrose vs. glucose in Gatorade
Sucrose is a disaccharide made of glucose and fructose. In Gatorade, it contributes to both sweetness and a quick energy boost summerstirs.com.
Glucose (dextrose) is also present and is absorbed rapidly into the bloodstream, providing immediate energy summerstirs.com.
Fructose may be present in some variants, offering a slower, more sustained energy release summerstirs.com.
Example (Lemon-Lime Gatorade)
Ingredients list: Water, sugar (sucrose), dextrose, citric acid, salt, sodium citrate, monopotassium phosphate, gum arabic, glycerol ester of rosin, natural flavor, yellow #5 VCU Blogs+1.
The “sugar” listed is sucrose, and dextrose is the second ingredient, making both significant carbohydrate sources.
SummaryA standard 12 fl oz bottle of Gatorade contains roughly 21 g of added sugars, with sucrose being a major component alongside dextrose. This means sucrose makes up a large portion of the drink’s total carbohydrate content and contributes to its high glycemic load, especially in orange-flavored variants nutritionandingredients.com+2.
US Patent No. 10,933,096 is cited as a patent of interest in its disclosure of a preserving solution.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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