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 .
Claim Status
Claims 1-14 are currently pending.
Claims 8-14 are withdrawn.
Claims 1-7 are being examined on the merits.
Election/Restriction
Applicant's election without traverse Group I (claims 1-7) in the reply filed on June 04, 2026 is acknowledged.
Claims 8-14 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 04, 2026.
The requirement is still deemed proper and is therefore made FINAL.
Priority
The instant application, filed on May 14, 2024, does not claim benefit to any earlier applications.
Information Disclosure Statement
There is not an Information Disclosure Statement provided.
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 1-7 is 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 1 states “wherein the one or more types of endogenous peptides are bonded to a surface of the microparticle in an amount ranging from about 15% to about 50% coverage of the surface of the microparticle”, it is unclear “the about 15% to about 50%” because there is no unit. Is it by weight, by surface area or by ratio of the molecule? What is the unit?
Claim 3 states “the microparticle has a ratio of poly(glycolic acid) or polyethylene glycol to poly(lactic-co-glycolic acid) of about 15% to about 50% of the microparticle”, it is unclear because is the ratio for one combination or both combinations? What is the unit? Is it by weight, by surface area or by ratio of the molecule?
Claims 2 and 4-7 are dependent on claim1, and do not clarify the issue discussed above, and thus are also rejected.
Claim Rejections - 35 USC § 102
(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 1, 4, and 6 are rejected under 35 U.S.C 102(a)(1)/(a)(2) as being anticipated by Shea et al (US11389517B2; Published on July 19, 2022; filled on June 30, 2021).
Claim 1 is drawn to, a biomimetic drug delivery particles, each particle comprising: a microparticle, wherein the microparticle is a biodegradable copolymer microparticle; one or more types of endogenous peptides, wherein the one or more types of endogenous peptides are bonded to a surface of the microparticle in an amount ranging from about 15% to about 50% coverage of the surface of the microparticle.
Shea et al teaches a peptide-coupled biodegradable poly(lactide-co-glycolide particle.
For claim 1: Shea teaches a surface functionalized biodegradable poly(lactide-co-glycolide) (PLG) (term is used interchangeably with poly(lactic-co-glycolide)) particles (which reads on the copolymer microparticle of the claim) comprising a encapsulated antigen or one or more antigenic epitopes (antigen reads on endogenous peptide of the claim) (claim 1). Reference further discloses that the functionalized surface allows for coupling of peptide molecules to the surface of the particles (abstract). Shea also teaches in some embodiments that an antigen is coupled to a carrier particle (reads on bonded to a surface of the microparticle in the claim) with a negative zeta potential (column 3, second paragraph). Shea further teaches that nanoparticles coupled to an antigen moiety (peptide) can induce tolerance, which is predicted to be useful in disease treatment (column 15, second paragraph). The reference discloses in Figure 1C the coupling efficiency of surface-functionalized poly(lactide-co-glycolide) (term is used interchangeably with poly(lactic-co-glycolide)) particle at 11% (Figure 1C, column 9, first paragraph).
The coupling by the above mentioned would result in a range of peptides covering the surface of the particle. The coverage percentage unit is not defined in the instant specification thus, the claim is interpreted to claim about 15% to 50% of one area of the exterior of the microparticle.
For claim 4: Shea teaches the enhancement tolerance of the associated peptides … for example… the family of thrombospondins (e.g. thrombospondin-1) (paragraph 133), which reads on the claim.
For claims 6: Shea discloses in Figure 1C peptide coverage (reads on endogenous peptides of the claim) of the particle (column 9, paragraph 1), derived from mice antigens, which are mammals and reads on the claim.
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.
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 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 1, 2, 3, 4 and 5, 6, 7 are rejected under 35 U.S.C 103 as being unpatentable over Shea et al (US11389517B2; Published on July 19, 2022; filled on June 30, 2021) in view of Gref et al (Biodegradable Long-Circulating Polymeric Nanospheres: Science, 263(5153), 1600-1603, 1994), and Ritter et al (US20040043075A1; Published on March 04, 2004), and Zhang et al (An Indo-Pacific Humpback Dolphin Genome Reveals Insights into Chromosome Evolution and the Demography of a Vulnerable Species. Iscience,23(10), October 2020).
Shea et al throughout teaches a peptide-coupled biodegradable poly(lactide-co-glycolide particle, as discussed above.
For claim 1: Shea discloses that the functionalized surface allows for coupling of peptide molecules to the surface of the particles (abstract). Shea also teaches in some embodiments that an antigen is coupled to a carrier particle (which reads on endogenous peptides bonded to the surface of the microparticle of the claim) (column 3, second paragraph). The reference discloses in Figure 1C the coupling efficiency of surface-functionalized poly(lactide-co-glycolide (term is used interchangeably with poly(lactic-co-glycolide)) particle at 11% (Figure 1C, column 9, first paragraph).
Alternatively, claim 1 can be interpreted to be 15% to 50% of the entire surface of the particle.
Shea does not explicitly teach the amount ranging from about 15% to about 50% coverage of the surface of the microparticle as recited in claim 1. Reference does not teach the microparticle is a poly(lactic-co-glycolic acid)-poly(glycolic acid) or poly(lactic-co-glycolic acid)-poly(glycolic acid)-polyethylene glycol that has a ratio of about 15% to about 50 % as recited in claims 2 and 3. Shea does not teach that microparticle includes ocular drugs contained within the microparticle, recited in claim 5. Shea reference also does not teach “endogenous peptides are from dolphins as recited in claim 7.
However, Gref et al throughout teaches biodegradable nanospheres developed from amphiphilic copolymers composed of two biocompatible blocks for site-specific drug delivery.
For claim 2: Gref teaches nanospheres (reads on microparticle of the claim) that were prepared from diblock poly(lactic-co-glycolic acid) (PLGA) and polyethylene glycol (PEG) copolymers (Column 1, paragraphs 1 and 2, and figure 1, page 1601).
For claim 3: Gref teaches diblock copolymer of PGLA-PEG, where the PEG-PLGA nanospheres (reads on the microparticle of the claim) molecular weight of PEG is 5kD and PLGA is 45kD (figure 1 description, page 1601).
The molecular weight of the above mentioned would result in 15% to 50% of the microparticle. The percentage unit is not defined in the instant specification thus, the claim is interpreted to claim 15% to 50% by molecular weight of the microparticle.
Ritter et al teaches a microsphere (which reads on the microparticle of the claim) suitable for application of ocular injuries and inflammation and use in the prevention and treatment of ocular injuries and inflammation (abstract).
For claim 5: Ritter et al teaches that the microsphere (reads on microparticle of the claim) known active therapeutic agent selected from the group consisting of… antiviral agents; antifungal agents; … (paragraph 0024).
Zhang et al throughout teaches the evolution of marine mammals such as Cetacea (dolphins).
For claim 7: Zhang discloses that THBS1 (thrombospondin encoding gene) is expressed in Cetacea such as dolphins (Table S26), which reads the claim.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the percentage of peptides bound to the surface of the microparticle because Shea teaches the surface functionalized particle having 11% coupling, which is very close to the claimed 15% and can be optimized to achieve desired percentage of peptides bonded to the microparticle for absorption and effective non-invasive treatment for ocular disorders and diseases.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate PGLA-PEG taught by Gref with the surface functionalized particle taught by Shea because both references teach microparticles for treatment. The motivation of one of ordinary skill in the art would be obvious to modify the microparticle to achieve optimal results by incorporating copolymers PGLA and PEG together to achieve desired treatment effects for ocular diseases and disorders.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate ocular drugs into the microparticle taught by Shea for the treatment of viral, bacterial, and fungal infections taught by Ritter. In addition, because both the Shae and Ritter references teach microparticles for disease treatment, it would have been obvious to one skilled in the art to substitute one type of drug for another. The motivation of one of ordinary skill in the art would be obvious to modify the above mentioned to achieve optimal results for the treatment of ocular diseases and disorders.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute endogenous peptides from mice with those derived from dolphins because both the Shea and Zhang references teach that thrombospondin is present in mammals such as mice and dolphins. The motivation of one of ordinary skill in the art would be obvious to substitute one mammal-derived protein, those derived from dolphins with proteins derived from mice as both mammals express the same protein thrombospondin to achieve optimal results for the treatment of ocular diseases and disorders.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since the Shea, Gref and Ritter references demonstrate peptide bound microparticles for treatment of various disorders and diseases, which are known for effective non-invasive treatment and routinely and known in the art.
Conclusion
None of the claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASMINE A EVANS whose telephone number is (571)272-9796. The examiner can normally be reached Mon-Fri 8:00-5:00EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue 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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/J.A.E./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
