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 .
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 07/17/2026 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claims Status
Applicant’s election without traverse of Group I, claims 1-10 and the species of: Polyhydroxyalkanoate PHA based amphiphilic block copolymer (e.g. PHA as the hydrophobic block and PEG/Dextran as a hydrophilic block and liquid form in the reply filed on 07/20/2026 is acknowledged. Examiner notes that the species elections to hydrophilic block is withdrawn.
Claims 11-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 07/20/2026.
Claims 1-10 are under current examination.
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 5 and 10 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 5 recites that the hydrophilic block includes at least one selected from. It is unclear if the “includes at least one selected from” is selected from the group comprising or from the group consisting of for the Markush grouping of the hydrophilic block. Thus, it is unclear what other alternatives may be encompassed by the claim in view of the interpretation to selection from the group comprising. Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. It is suggested that Applicants can recite at least one selected from the group consisting of.
Claim 10 recites (w/v) wherein the units are in parenthesis. It is unclear whether the units are required by the claim in view of the parenthesis. It is suggested that Applicants can remove the parenthesis.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chul et al. (KR101156094).
Chul et al. teach amphiphilic PHA-mPEG block copolymers forming core shell nanoparticles with emulsification and enhance stability for dispersion in water, therefore surfactant properties are suggested, see abstract, pages 2, 3, 5, 6-8. The PHA includes poly 3-hydroxybutyrate co-4-hydroxybutrate, see claim 1 at page 12 and pages 5-6 . The particles have a hydrophilic mPEG surface and core of PHA inner surface, see page 3. Paragraph [0002] of the instant specification discloses that through the dispersing function, the surfactant helps maintain stability by evenly distributing. As Chul maintains stability for dispersion it can be considered an amphiphilic surfactant polymer.
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.
Claim(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Biggs et al. (United States Patent 20090162407) in view of Pan et al. (Alternative block polyurethanes based on poly(3-hydroxybutryate-co-4-hydroxybutrate) and poly (ethylene glycol)).
Biggs et al. teach compositions comprising excipients such as polyhydroxyalkanoates hydrophobic block and a hydrophilic block having PEG and/or polysaccharides wherein the hydrophobic block comprises 500-2,000, 000 Daltons, see paragraph [0120]. Since the hydrophobic and hydrophilic blocks form a copolymer together the copolymer would be considered amphiphilic. The hydrophilic block comprises 100-100,00 daltons (equivalent to g/mol), see paragraph [0120]. The PHA can comprise hydroxybutyrate, see claim 9 and paragraphs [0120]-[123]. In one embodiment the hydrophilic component can comprise 40% by weight with the hydrophobic PHA component at 60% by weight meeting a ratio of 1 to 1.5, see paragraph [0213] and [0248], [0250]. Such copolymers can comprise polymer excipient, see paragraph [0114]-[0117], [0248] and entire document. As the polymer comprised of hydrophobic and hydrophilic blocks can make up an excipient it is capable of being a surfactant composition. The recitation of the intended use as a surfactant of the claimed polymer composition must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The hydrophobic polymers can comprise 10-99% hydrophobic polymer with 1-90% hydrophilic polymer, see paragraph [0255]. The composition can comprise o/w or w/o emulsions thus comprises a liquid, see abstract. Together the polymer excipient makes up at minimum 11% to 100% of the excipient, see paragraph [0250]. The polymers which make up the microparticle of Biggs allow for the delivery of active agents and are biocompatible, see paragraph [0004]. Thus, it would have been obvious to adjust the amount of the amphiphilic polymers in Biggs to obtain sufficient delivery of active agents. Regarding claim 6, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Here, the prior art teaches products comprising PHA and a hydrophilic block component.
Biggs does not expressly teach that the 4-hdyroxybutryate comprises 0.1-60% by weight of the polyhydroxyalkanoate.
However, Pan et al. teach the synthesis of P3/4HB-alt-PEG block copolymers (3-hydroxybutryate/4-hydroxybutryate copolymer)which possess excellent hemocompatibility and are nontoxic, see conclusion. The 4-hydorxybutarate (4HB) is 20% and the 3HB (3-hydroxybutyrate) is 80%, see 2.1 materials. In another embodiment, the 4HB comprises 40%, see section 2.1.
It would have been prima facie obvious to provide the copolymer of Biggs as a poly(3-hydroxybutyrate-co-4-hydroxybutyrate) with a PEG block wherein the portion of the 4HB (4-hydroxybutryate) is about 20% by weight or 40% by weight. These amounts disclosed in Pan of 4HB overlap and render obvious the claimed range of 0.1-60% by weight with respect to the PHA.
One of ordinary skill in the art would have been motivated to do so to provide good hemocompatibility to the microparticles created by such polymers in Biggs.
There would have been a reasonable expectation of success because Biggs teaches a composition having hydroxybutyrate hydrophobic blocks with hydrophilic blocks including PEG or polysaccharide.
Claim(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chul et al. (KR101156094) in view of Pan et al. (Alternative block polyurethanes based on poly(3-hydroxybutryate-co-4-hydroxybutrate) and poly (ethylene glycol)).
Chul et al. teach amphiphilic PHA-mPEG block copolymers forming core shell nanoparticles with emulsification and enhance stability for dispersion in water, therefore surfactant properties are suggested, see pages 2, 3, 5, 6-8. The PHA includes poly 3-hydroxybutyrate co-4-hydroxybutrate, see claim 1. The particles have a hydrophilic mPEG surface and core of PHA inner surface. Paragraph [0002] of the specification discloses that through the dispersing function, the surfactant helps maintain stability by evenly distributing. As Chul maintains stability for dispersion it can be considered an amphiphilic surfactant polymer.
The polymer composition can be present at 0.05w/v percent as 500 micrograms/mL is 0.5mg/mL which per 100mL is 50mg/100mL thus 0.05% w/v, see figures 6-8. The nanoparticle dispersion can also comprise 100500microgram/mL (10.05% w/v as 1% w/v is 1,000,000 mcg/100mL=10,000 mg/mL thus 10500mcg/ml/10,000mcg.per mL per 1%w/v is about 10.05% w/v, see pages 10-11. One of ordinary skill in the art would have been motivated to adjust the concentration of such polymeric nanoparticles to increase the stability of the dispersion in aqueous medium as PHA-mPEG amphiphilic particles are taught to stabilize the dispersion. Chul teaches a mw of the PEG portion (hydrophilic portion) at 2000g/mol, see Example 1.
Chul however does not teach the mW of the PHA hydrophobic portion wherein the 4-hydroxybutyrate is from 0.1-60% by weight.
Pan et al. teach the synthesis of P3/4HB-alt-PEG block copolymers which possess excellent hemocompatibility and are nontoxic, see conclusion. The 4-hydorxybutarate (4HB) is 20% and the 3HB (3-hydroxybutyrate) is 80%, see 2.1 materials. In another embodiment, the 4HB comprises 40%, see section 2.1. The molecular weight of the PEG is 3400g/mol and the molecular weight of the PHA is 3600g/ml, see section 3.1. This meets a ratio of about 1 to 1.05.
It would have been prima facie obvious to provide the copolymer of Chul as a poly(3-hydroxybutyrate-co-4-hydroxybutyrate) with a PEG block wherein the portion of the 4HB (4-hdroxybutyrate) is about 20% by weight or 40% by weight. These amounts disclosed in Pan of 4HB overlap and render obvious the claimed range of 0.1-60% by weight with respect to the PHA.
One of ordinary skill in the art would have been motivated to do so to provide good hemocompatibility for the particles of Chul et al.
There would have been reasonable expectation of success because Chul teaches copolymers of poly(3-hydroxybutyrate-co-4-hydroxybutyrate) with a PEG just not the amounts of the 4-HB or the molecular weight of the PHA portion.
Conclusion
Claims 1-10 are rejected and no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm 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.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
