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 .
Summary
Claims 1-3 and 53-64 are pending in this office action. Claims 53-64 are new. Claims 9-52 are cancelled. Claims 4-8 are withdrawn from consideration. Applicant is encouraged to amend withdrawn claims 4-8 to be within the scope of the pending claims in order to expedite prosecution upon allowance. All pending claims are under examination in this application.
Priority
The current application filed on February 21, 2023 is a 371 of PCT/US2021/047203 filed August 23, 2021, which in turn claims domestic priority to provisional patent application 63/068,944 filed on August 21, 2020.
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 2-3 and 53-64 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.
Claims 2-3 and 53-64 fail to define R2. Therefore, the structures are unclear and indefinite.
Claim Rejections - 35 USC § 103
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 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Perrissoud et al. (US2007/0167408A1) in view of Kollbe et al. (WO2017/059057A1).
[The Examiner is going to introduce each reference and then combine them in the rejection of the instant claims.]
1. Perrissoud et al.
Perrissoud et al. is considered to be the prior art closest to the present application and teaches novel alkyl phospholipid derivatives with reduced cytotoxicity and uses thereof (see title). In addition, Perrissoud et al. disclose that the present invention provides novel alkyl phospholipid derivatives with reduced cytotoxicity that are useful for treating various diseases and/or pathophysiological conditions in mammals, preferably humans, that are caused by microorganisms, in particular bacteria, fungi, protozoa and/or viruses. Such alkyl phospholipids can be employed as single drugs or in the course of combination therapies and can also be used for the treatment of tumors (see abstract).
2. Kollbe et al.
Kollbe et al. teach nano-adhesive and surface primer compound and use thereof
(see title). Also, Kollbe et al. disclose a compound for self-assembly onto a mineral and/or metal oxides substrate, the compound comprising a catechol group attached to an end group through a spacer group (see abstract).
Combination of Perrissoud et al. and Kollbe et al.
Regarding instant claim 1, Perrissoud et al. and Kollbe et al. teach a synthetic ionizable phospholipid. The necessary citations within Perrissoud et al. and Kolbe et al. that correspond to instant claim 1 are compiled within Table I.
Table I
Instant Claim 1
Perrissoud et al. and Kollbe et al. Citations
PNG
media_image1.png
200
400
media_image1.png
Greyscale
Perrissoud et al. disclose that the present invention provides novel alkyl phospholipid derivatives with reduced cytotoxicity that are useful for treating various diseases and/or pathophysiological conditions in mammals, preferably humans, that are caused by microorganisms, in particular bacteria, fungi, protozoa and/or viruses. Such alkyl phospholipids can be employed as single drugs or in the course of combination therapies and can also be used for the treatment of tumors (see abstract within Perrissoud et al.).
PNG
media_image2.png
200
400
media_image2.png
Greyscale
Perrissoud et al. disclose the phospholipid within Figure I (see page 19, compound 149 within Perrissoud et al.).
Figure I
PNG
media_image3.png
200
364
media_image3.png
Greyscale
R8 = C15 unsubstituted alkyl; R-4-R7 = H; R2 = C1 unsubstituted alkyl; R3 = C2 unsubstituted alkyl; R1 = C1 unsubstituted alkyl; wherein n = 1.
Additionally, Perrissoud et al. disclose the phospholipid within Figure II (see page 10, compound 57 within Perrissoud et al.).
Figure II
PNG
media_image4.png
200
400
media_image4.png
Greyscale
Furthermore, Kollbe et al. teach R1 substituents on a phospholipid (see paragraph [0008] within Kollbe et al.) that meet the instant claim limitation off the ammonium nitrogen (see claim 5 within Kolbe et al.).
Figure III
PNG
media_image5.png
617
1813
media_image5.png
Greyscale
Moreover, please see the discussion within Perrissoud et al. (specification) covering all disclosed analogues for the additional instant claim variations (see paragraphs [0029-0076] within Perrissoud et al.).
Therefore, a skilled artisan (POSITA; person of ordinary skill in the art) would under routine experimentation synthetically “blend” the above structures to construct the phospholipid of instant claim 1 using the Perrissoud et al. and Kolbe et al. references.
Motivation to combine: Both references offer synthetic variations on the phospholipid of instant claim 1 that a skilled artisan (POSITA) would consult in reaching the target compound.
[Perrissoud et al. and Kollbe et al. disclose all the elements of instant claim 1 within the remaining instant claims of this 35 U.S.C. 103 section.]
Regarding instant claim 2, Perrissoud et al. and Kollbe et al. teach wherein the desired phospholipid is obtained with the following substituents.
R1 is selected from a group consisting of C2-C16 unsubstituted alkyl; or C2-C16 substituted alkyl, or C4-C12 substituted cycloalkyl;
R2 is H; R3 is selected from C2-C18 unsubstituted alkyl;
R4, R5, R6, and R7 are independently selected from a group consisting of H, C1-C4 unsubstituted alkyl, or C1-C4 substituted alkyl;
R8 is selected from C3-C18 unsubstituted alkyl; and n is an integer from 1 to 3.
Please see the discussion and citations within instant claim 1 for the necessary rejection text. Additionally, please see the discussion within Perrissoud et al. (specification) covering all disclosed analogues for the additional instant claim variations (see paragraphs [0029-0076] within Perrissoud et al.).
Regarding instant claim 3, Perrissoud et al. and Kollbe et al. teach wherein the desired phospholipid is obtained with the following substituents.
R1 is selected from a group consisting of C2-C15 unsubstituted alkyl;
R2 is H; R3 is selected from C2-C16 unsubstituted alkyl;
R4, R5, R6, and R7 are independently selected from a group consisting of H, methyl, or ethyl;
R8 is selected from C4-C16 unsubstituted alkyl; and n is an integer from 1 to 2.
Please see the discussion and citations within instant claim 1 for the necessary rejection text for R1-R8, and n. In addition, please see the discussion within Perrissoud et al. (specification) covering all disclosed analogues for the additional instant claim variations (see paragraphs [0029-0076] within Perrissoud et al.).
Regarding instant claims 53-64, Perrissoud et al. and Kollbe et al. teach wherein the desired phospholipid is obtained with the listed substituents. Please see the discussion and citations within instant claim 1 for the necessary rejection text for R1-R8, and n. Furthermore, please see the discussion within Perrissoud et al. (specification) covering all disclosed analogues for the additional instant claim variations (see paragraphs [0029-0076] within Perrissoud et al.).
Analogous Art
The Perrissoud et al. and Kollbe et al. references are applicable to the endeavor of the instant application. Therefore, these teachings make the references relevant to instant claims 1-3 and 53-64.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the phospholipid disclosed by Perrissoud et al. using the teachings of Kollbe et al. to incorporate the necessary claim limitations.
The motivation to combine the Perrissoud et al. and Kollbe et al. references relies on the fact that each citation discloses text regarding the synthetic modifications of ionizable phospholipids. This overlap “links” the two references making them analogous art.
Starting with Perrissoud et al., the skilled person only had to try the necessary claim limitations disclosed by Kollbe et al. The combination of Perrissoud et al. and Kollbe et al. would allow one to arrive at the present application without employing inventive skill. This combination of the phospholipid taught by Perrissoud et al. along with the use of the necessary claim limitations taught by Kollbe et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the phospholipid disclosed by Perrissoud et al. with the use of the necessary claim limitations taught by Kollbe et al. This combined modification would have led to an enhanced ionizable phospholipid that would be beneficial for patients.
Response to Arguments
Applicant's arguments filed March 5, 2026 have been fully considered but they are not persuasive.
The instant claim amendments were sufficient to address the claim objection. Therefore, the claim objection is withdrawn from the Non-Final office action dated December 5, 2025.
The amendments did not necessitate a new ground of rejection.
Applicant Argument: The Applicant argues that the instant claim amendments make the claims allowable over the art of record.
Examiner’s Rebuttal: The Examiner respectfully disagrees. Perrissoud et al. disclose compound 57 (see Figure II) which suggests an analogue with a -NH- moiety. This functional group is common within synthetic organic chemistry. A skilled artisan (POSITA) would be familiar with this amine or ammonium salt. Synthetically “blending” the derivatives within the prior art of record makes the structures of the present invention obvious to the skilled artisan (POSITA).
Applicant Argument: The Applicant argues that the deficiencies of Perrissoud et al. cannot be cured by the teachings of Kollbe et al.
Examiner’s Rebuttal: The Examiner respectfully disagrees. The teachings of Perrissoud et al. and Kollbe et al. offer all of the synthetic variations from the present application. A skilled artisan (POSITA) would consult both the references to compile all the analogues synthesized disclosed within the instant claims. Despite the fact that a suitable derivative is not listed within Perrissoud et al. comprising all the substituents, the specification does disclose a vast majority of the analogues taught within the instant application (see paragraphs [0029-0076] within Perrissoud et al.). The circumstance that the Kollbe et al. reference is for a different area than that described within Perrissoud et al. is non-applicable here. A skilled artisan (POSITA) would search for references which describe close analogues of the claimed phospholipid and would come across the Kollbe et al. citation. The Kollbe et al. reference has a synthetic match for one side of the phosphate. Truncating the catechol functionality and substituting in the desired lipid is within the scope of the skilled artisan (POSITA).
[Examiner’s Comment: It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).]
Thus, the 35 U.S.C. §103 rejection for instant claims 1-3 and 53-64 is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN W LIPPERT III whose telephone number is (571)270-0862. The examiner can normally be reached Monday - Thursday 9:00 AM - 5:00 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, Robert A Wax can be reached on 571-272-0623. 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.
/JOHN W LIPPERT III/Examiner, Art Unit 1615 /Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights