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 .
Election/Restrictions
Applicant’s election of the pharmaceutical composition of Claims 6-8, 13-15, and 17-21 in the reply filed on 23 December 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of the Claims
Claims 1-15 and 17-21 are pending.
Claims 1-5 and 9-12 are withdrawn from consideration as directed to non-elected inventions.
Claims 6-8, 13-15, and 17-21 are presented for examination.
Priority
The instant application is a Continuation of International application PCT/EP2021/085026 filed 9 December 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 pertaining to European applications 20306555.2 filed 11 December 2020, and 21199651.7 filed 29 September 2021.
Claim Interpretation
Applicants Claims are directed to “pharmaceutical compositions” comprising a poly(e-caprolactone) and polydopamine graft copolymer (PCL-g-PDA) which “is a carrier for sustained release of an active pharmaceutical ingredient.” From this language it is unclear whether it is necessary that the composition actually contains an active pharmaceutical ingredient, or whether this language simply represents a recitation of a possible intended use of the graft copolymer. As the broadest reasonable interpretation of the actual language presented would incorporate as few limitations as possible, the examiner has determined the language represents an intended use of the composition actually set forth by the claims. See Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005)(indicating that during patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification”); see also Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003)(a recitation of an intended use will not limit the scope of the claim because it merely defines a context in which the invention may operate). Claim 7 indicates the composition “is an intravitreal implant,” which again appears to recite an intended use of the polymer composition rather than an affirmative recitation of structural elements of the composition. Claim 8 indicates that the active is a small molecule present in a defined concentration range. Claim 13 defines a “pharmaceutical compositions” containing a specific (PCL-g-PDA) recited in Claim 12, with Claim 14 indicating that the composition is one which forms a sustained release pharmaceutical gel depot in situ when injected into the eye and Claim 15 indicating the drug is an antibody. As set forth above concerning the actual language presented, it is unclear whether the pharmaceutical active is actually required, or merely represents a manner in which the composition may be used. Claim 17 defines a composition containing the (PCL-g-PDA) polymer recited in Claim 7, also containing a defined concentration of a small molecule active agent. Claim 18 defines a “pharmaceutical compositions” containing a specific (PCL-g-PDA) recited in Claim 10, with Claim 19 indicating that the composition is one which forms a sustained release pharmaceutical gel depot in situ when injected into the eye and Claim 20 indicating the drug is an antibody. As set forth above concerning the actual language presented, it is unclear whether the pharmaceutical active is actually required, or merely represents a manner in which the composition may be used.
Claim Rejections - 35 USC § 112(b)
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, 7, 13-15, and 18-20 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 6, 7, 13-15, and 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. As set forth in greater detail above, each of Claims 6, 7, 13-15, and 18-20 present language making it unclear whether the compositions claimed actually include a pharmaceutical active agent along with each of the (PCL-g-PDA) copolymers which are affirmatively identified as required components. Applicants are advised to not only explicitly incorporate language and structures specifically identifying the particular polymers to be incorporated into these pharmaceutical compositions, but also to incorporate language making it clear that a pharmaceutical active agent is present in the composition.
Claim Rejections - 35 USC § 102
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 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 6 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiong (Shuqiang Xiong, et al, Poly(e-Caprolactone)-Grafted Polydopamine Particles for Biocomposites with Near-Infrared Light Triggered Self-Healing Ability, 84 Polymer 328 (2016)).
Xiong describes PCL-g-PDA copolymeric particles useful in the construction of biocompatible composites. 330, 335.
Claim Objections
Claims 8 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Allowable Subject Matter
No claims are currently in condition for allowance. However, the Examiner contacted attorney Bill Tian to discuss a series of Examiner’s Amendments to place the application in condition for allowance, but applicants attorney was unable to consult with their client within the Examiner’s timeframe. Nevertheless, the Examiner has searched the art and determined that, except as set forth above, Applicants particular PCL-g-PDA graft copolymer having a polycaprolactone backbone possessing grafted pendant polydopamine in combination with a generic pharmaceutical active agent, appears free of the art. As set forth above, the Examiner suggests explicitly reciting the inclusion of an active pharmaceutical agent in combination with each of a particular PCL-g-PDA graft copolymer possessing a PCL backbone for Claim 6, an explicit recitation of an active pharmaceutical agent in combination with the copolymer of Claim 12 in Claim 13, and an explicit recitation of an active pharmaceutical agent in combination with the specific copolymer of Claim 10 in Claim 18. If so amended, the Examiner would then consider rejoinder of method claims depending from and incorporating all limitations of an allowed pharmaceutical composition claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 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, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614