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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/03/2026 has been entered.
Status of the Application
Claims 28, 30, 31, 33-40, 43, 46-48, 50-58 are pending, of which claims 28, 30, 31, 33-39 and 51-57 stand withdrawn.
Claims 40, 43, 46-48, 50 and 58 are under current examination.
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 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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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 40, 43, 46-48, 50, 58 and elected species are rejected under 35 U.S.C. 103 as being unpatentable over Chertok (ACS Nano, Vol 10, No. 8, pages 7267-7278, 2016; as provided by the applicant on IDS dated 09/05/2024).
Determining the scope and contents of the prior art
Chertok teaches a PEG-lipid comprising fragmented heparin (same as in claim 46) of Mw 5-10 kDa (same as claim 47 and 48) wherein fragmented heparin is conjugated to the PEG-lipid through a covalent Carbon-nitrogen bond between carbonyl carbon of aldehyde group of heparin and a nitrogen in the N-terminal amino group in a link with sulfhydryl moiety -S (CH2)2 CONH-NH of a PEG-lipid comprising such link (Entire article, especially Figures 1 and 2):
PNG
media_image1.png
695
1455
media_image1.png
Greyscale
PNG
media_image2.png
714
927
media_image2.png
Greyscale
With regards to process limitations of the instant claims, “PEG-lipid has affinity ---and Factor H”- Since the cited prior art teaches same PEG-lipid as in the instant claims, the PEG-lipid of the cited prior art is also capable of having same affinity “PEG-lipid has affinity ---and Factor H”, whether or not recognized by the cited prior art. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000).
Ascertaining the differences between the prior art and the claims at issue
Chertok teaches a PEG-lipid comprising fragmented heparin (same as in claim 46) of Mw 5-10 kDa (same as claim 47 and 48) wherein fragmented heparin is conjugated to the PEG-lipid through a covalent Carbon-nitrogen bond between carbonyl carbon of aldehyde group of heparin and a nitrogen in the N-terminal amino group in a link with sulfhydryl moiety -S (CH2)2 CONH-NH of a PEG-lipid comprising such link, but differs with respect to link with sulfhydryl moiety -S (CH2)2 CONH-NH vs instant claims cysteine -S-CH2-CH(COOH)(NH).
Resolving the level of ordinary skill in the pertinent art
With regards to the above difference link with sulfhydryl moiety -S (CH2)2 CONH-NH vs instant claims cysteine -S-CH2-CH(COOH)(NH)-The link -S (CH2)2 CONH-NH is closely structurally similar to the instant claims cysteine -S-CH2-CH(COOH)(NH) link. Thus, with the guidance provided by the cited prior art, it would have been prima facie obvious to a person of ordinary sill in the art with a reasonable expectation of success that a link similar to -S (CH2)2 CONH-NH, such as cysteine may be useful in making PEG-lipid of the instant claims.
Based on the above established facts, it appears that teachings of above cited prior art read applicants’ PEG-lipid.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have modified the elements as claimed by known methods with no change in their respective functions, and the modification would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Chertok teaches a PEG-lipid comprising fragmented heparin (same as in claim 46) of Mw 5-10 kDa (same as claim 47 and 48) wherein fragmented heparin is conjugated to the PEG-lipid through a covalent Carbon-nitrogen bond between carbonyl carbon of aldehyde group of heparin and a nitrogen in the N-terminal amino group in a link with sulfhydryl moiety -S (CH2)2 CONH-NH of a PEG-lipid comprising such link.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that an amino acid linker, such as cysteine similar to the linker of the cited prior art may be used to make PEG-lipid and can be made by teachings of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed PEG-lipid with a reasonable expectation of success.
Response to Arguments
Applicant’s remarks and amendment, as filed on 02/18/2026 and 04/03/2026, have been fully considered but not found persuasive.
Applicant’s argument is moot in view of new rejection as set forth above.
Conclusion
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PANCHAM BAKSHI whose telephone number is (571)270-3463. The examiner can normally be reached M-Thu 7-4.30 EST.
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, Milligan Adam can be reached at 571-2707674. 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.
/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
Prosecution Insights