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 .
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.
Election/Restrictions
Applicant's election with traverse in the reply filed on 3 August 2026, is acknowledged. The traversal is on the ground(s) that the examination of the full claimed scope of genus formula I from both instant claims 1 and 11 would not present an undue search or examination burden.
This is not found persuasive because there is ample evidence that the search would be “unduly burdensome” on Examiner. Since the Election of Species Requirement is correctly written under 35 USC 371 format, the determining factor is “whether or not the alternative species of genus formula I do (or don’t) share a common structure and whether the alternative species do (or don’t) all belong to a recognized class of chemical compounds”. Here, Examiner showed proof that the alternative species of genus formula I do not all share a common structure AND do not all belong to a recognized class of chemical compounds. See discussion within pages 5-6 of the Election of Species Requirement mailed 5 May 2026. Additionally, it is noted on the record that the variability introduced at variables “X”, R1, and R6 in both instant claims 1 and 11 assure that the various alternative species thereof don’t share a common structure and hence don’t belong to a recognized class of chemical compounds.
The requirement is still deemed proper and is therefore made FINAL.
Applicants provided a compliant species election of the compound from Example 11:
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from page 52 of the Specification, wherein: R5 is methyl; R6 is C16alkyl; R2 is methyl; R4 is methyl; R3 is methyl; L1 is -C(=O)-C5alkene-C(=O)-R1, wherein X is C5alkene; R1 is -OPEG.
Applicants’ elected species is free of the prior art.
The Examiner extended the Markush search to the compound “Tocopherol glutarate polyethylene glycol”:
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, wherein: R5 is methyl; R6 is C16alkyl; R2 is methyl; R4 is methyl; R3 is methyl; L1 is -C(=O)-C3alkene-C(=O)-R1, wherein X is C3alkene; R1 is -OPEG (which is “poly(C2alkylene glycol)”).
This search has prior art against the compound only (claims 11-12) and not as a composition with the buffer (claim 1).
Therefore, per Markush search practice, the Markush search will not be extended unnecessarily to additional species in this Office Action.
The Markush search reads on claims 1-8 and 11-14.
Current Status of 18/696,753
This Office Action is responsive to the amended claims of 3 August 2026.
Claims 1-8 and 11-14 have been examined on the merits. Claims 1, 11, and 14 are currently amended. Claims 2, 4, and 12 are original. Claims 3, 5-8, and 13 are previously presented.
Priority
The effective filing date is 4 October 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 20 August 2024, are 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 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 6 and 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.
Claim 6 recites the limitations: 1) "a poly(alkylene glycol)" and 2) “the surfactant molecule”. There is insufficient antecedent basis for these two limitations in the claim.
As drafted, the limitations 1) "a poly(alkylene glycol)" and 2) “the surfactant molecule” each render the metes and bounds of claim 6 undefined (hence rendering claim 6 indefinite under 35 USC 112(b)). The artisan does not know where antecedent basis can be found for a hydrophilic “poly(alkylene glycol)” within parent claim 1 (unless Applicants intend it to have antecedent basis to variable R1?). Also, the artisan does not know where antecedent basis can be found for “the surfactant molecule” within parent claim 1, drawn to an “amphiphilic surfactant” (is parent claim 1’s “amphiphilic surfactant” the same thing as “the surfactant molecule” of claim 6?)
Recommended revisions to render moot this rejection: indicate in claim 6 which variable from parent claim 1 the “poly(alkylene glycol)” belongs (its antecedent basis to claim 1) AND 2) revise claim 6 to: -- amphiphilic surfactant [[molecule]] -- .
Claim 12 recites the limitation "the amphiphilic surfactant". There is insufficient antecedent basis for this limitation in the claim.
As drafted, the limitation "the amphiphilic surfactant" renders the metes and bounds of the claim 12 undefined (hence rendering claim 12 indefinite under 35 USC 112(b)). The artisan is not certain where antecedent basis for the limitation "the amphiphilic surfactant" can be found within claims 11 or 12. Deleting “amphiphilic” within claim 12 will render moot this rejection.
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 12 and 14 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.
Dependent claim 12, drawn to “the amphiphilic surfactant” of claim 12, improperly changes the scope of the “surfactant” of claim 11. Hence, claim 12 is rejected under 35 USC 112(d): dependent claim 12’s “amphiphilic surfactant” is not the same scope as “surfactant” from parent claim 11. Deleting “amphiphilic” within claim 12 will render moot this rejection.
Dependent claim 14 fails to properly further limit parent claims 1 and 13 (hence claim 14 is rejected under 35 USC 112(d)) since claim 14 does not narrow the scope of the “protein defined within claim 1”. Claim 1 does not define the protein. Rather, claim 1 defines the composition as “a protein-containing formulation” but is otherwise silent as to the protein. Thus, the scope of “protein” has not changed between claim 1 and claims 13-14. (As an example of a “protein” that is properly further defined, look to claims 3-4).
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.
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.
Claims 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
ACS (American Chemical Society. Chemical Abstract Service. RN 1187923-72-3. Entered into STN: 13 October 2009).
The prior art reference ACS teaches the compound “Tocopherol glutarate polyethylene glycol”:
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(see enclosed ACS reference), which is a species of genus formula I, wherein: R5 is methyl; R6 is C16alkyl; R2 is methyl; R4 is methyl; R3 is methyl; L1 is -C(=O)-C3alkene-C(=O)-R1, wherein X is C3alkene; R1 is -OPEG (which is “poly(C2alkylene glycol)”), which PEG group terminates in hydroxyl. This anticipates instant claim 12.
The limitation “surfactant” and/or “amphiphilic surfactant” are interpreted as inherent properties/functions of claims 11-12. See MPEP 2112.01(I) and (II). This anticipates instant claims 11-12.
This prior art reference represents the best prior art for the scope of Markush search extension for genus formula I performed within this Office Action following Markush search practice. Any other reference the Examiner considered either did not immediately envisage the above compound or did not teach the specific compound, above.
Conclusion
Claims 6, 11-12, and 14 are not presently allowable as written.
Claims 1-5, 7-8, and 13 are presently (emphasis) allowed. Additional Markush searching in the next (Final) Office Action could retrieve new prior art on additional Markush species of genus formula I.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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