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 .
An amendment was filed on 08/04/2026.
Claim Status
Claims 1-22 are pending. Claims 1-12 were selected as the elected invention. Claims 13-22 were withdrawn.
Withdrawn Objection and Rejection
The objection to the Specification and the rejection of claims 1, 6, 8, 10-12 under 35 USC 112(d) for improper dependent form are withdrawn in view of the amendment filed 08/04/2026. . The rejection of claims 4, 6, 8-12 under 35 USC 112, first paragraph, for written description of combinations, is also withdrawn in view of the same amendment.
Maintained Rejection(s)
The rejection of claims 1, 3-12 under 35 USC 112, first and second paragraph is maintained with regard to “non-amino acid salts”. The rejection of claims 1, 2, 9 and 10 under 35 USC 103 over FDA Highlights in view of Gerard is also maintained.
The full citation of these rejections is cited from the previous office action:
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.
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.
Response to Arguments
Applicant's arguments filed 08/04/2026 have been fully considered but they are not persuasive.
With regard to the rejection under 35 USC 112, first paragraph, to applicant’s amendment and arguments regarding “non-amino acid salts”, the term is not defined by the specification . Further under 35 USC 112, second paragraph, the term in the claims fails to identify what these “non-amino acid salts” encompass and are therefore indefinite as to the metes and bounds of the term. It is suggested that applicant amend the term to set out the only two salts set out in the specification at page 1, lines 19-21 as a Markush Group in claim 1. Alternatively, Applicant could also amend the specification to also set out “non-amino acid salts” to encompass a Markush Group of these two specific salts. This second suggestion has the advantage that the term would be defined in the specification (overcoming the rejection under 35 USC 112, first paragraph) , could remain as is, and claim 2 would not need to be incorporated into claim 1. Claim 2 should however set out the Markush Group consisting of the two salts to further satisfy the requirements under 35 USC 112, second paragraph. The rejections under 35 USC 112, first and second paragraphs for “non-amino acid salts” is maintained.
Regarding the response to the rejection under 35 USC 103 over FDA Highlights in view of Gerard, applicant frames arguments direction to the composition’s intended use, without differentiation the composition. Applicant is reminded that a composition is a composition, no matter its intended use. And since the composition appears to be obvious, the heretofore unknown use of that composition for cell preservation does not change the determination under patent law. Instead, it is applicant’s burden to show that the composition put forth by the teachings of the references would not function as claimed and show unexpected/unusual results which would rebut prima facie obviousness.
Applicant’s amended claim 1 to include:
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This language is considered an intended use of the composition and its functional language does nothing to alter the determination of obviousness under 35 USC 103 for the composition. Applicant is again urged to show in declaration form that the composition as taught by the references would not function as a cell preservation function as claimed in order to overcome the rejection under 35 USC 103 over FDA Highlights in view of Gerard. The rejection under 35 USC 103 over FDA Highlights and in view of Gerard is therefore maintained in this action.
New Rejection
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) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022261716 (Patrick et al).
Patrick et al disclose Aqueous Formulations for Preservation of Extracellular Vesicles. The formulation comprising a polyol, a sugar or combination thereof in an amount of about 5% (w/v) to about 15(w/v) and a buffering agent having a buffering capacity at a pH equal to or less than 7.0, with a pH of the aqueous formulation of equal to or less than about 7.0 (claim 1). The formulation is used on an extracellular vesicle (claim 2). The formulation is frozen [0003]. Sucrose is set out as one of the polyol or sugars in claim 3 and [0018]. A buffering agent may also include histidine (an amino acid) in claims 4 and 5. The concentration of amino acid is about 10nM to about 30mM as set out in [0015] – [0016]. The composition may also contain a surfactant such as Polysorbate 80 (claims 8-9). Freezing of the formulations can occur for greater than 4 weeks as set out in [0017] – [0019] and [0049]. Patrick et al differs in that it does no explicitly set out a residual cell concentration of 80%. However, given that Patrick et al disclose a formulation with the same components, at comparable concentrations, at the same temperatures at a duration of greater than 4 weeks, those of ordinary skill would expect similar residual concentrations of preserved extracellular vesicles . There are no unexpected or unusual results which would rebut prima facie obviousness. Therefore the instantly claimed formulation would have been obvious to one of ordinary skill in the art at the time of filing given the teachings of Patrick et al.
Conclusion
No claims are allowed.
Correspondence
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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