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 without traverse of the species of R1, R2, FG, and R3 in the reply filed on March 2, 2026 is acknowledged. In view of the relevant prior art listed below (Dankers, Mes), the species election requirement is hereby withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: a comma is necessary after formula (I). Appropriate correction is required.
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 1-20 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.
Claim 1 recites “a polyethylene glycol polymer C of formula HO-P-OH, wherein; …. P is a polymeric group having a number average molecular weight (Mn) of 250 to 50,000 Da”. However polyethylene glycol is H−(O−CH2−CH2)n−OH. Therefore “polyethylene glycol polymer C of formula HO-P-OH”, wherein P is defined as in claim 1 is either incorrect or vague as it implies somehow modifying polyethylene glycol with additional hydroxyl group(s). The disclosure does not resolve this issue. It states “HO-P-OH preferably represents a polyether, more preferably polyethylene glycol (PEG)” (Specification para.[0045]), which does not clarify the “polyethylene glycol polymer C of formula HO-P-OH” in claim 1.
Claim 1 lacks an “and” or an “or” after the penultimate clause “R3 is a C2-C16 alkyl or a C4-C16 alkenyl,”. Therefore it is ambiguous whether all or less than all of the limitations in the “wherein” clause are required.
None of the dependent claims resolves these issues and therefore each is also rejected on these grounds.
For the purposes of examination now “a polyethylene glycol polymer C of formula HO-P-OH” is construed as polyethylene glycol wherein n is 250-50,000 Da.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a peritoneal disease, does not reasonably provide enablement for preventing the same.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. Claims 1-20 encompass methods of “preventing” or treating a peritoneal disease. While the Applicant’s disclosure may be enabling for methods of ameliorating or treating a peritoneal disease, it does not enable prevention or inhibition of a peritoneal disease via administration of the hydrogel composition of claim 1.
In re Wands, 858 F.2d 731, 736-40, 8 USPQ2d 1400, 1403-07 (Fed. Cir. 1988), set forth eight factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." (MPEP § 2164.01)
a. The breadth of the claim: The rejected claims are drawn to methods of preventing or inhibiting a peritoneal disease in a patient. The claim term "preventing" implies that any peritoneal disease is completely absent in patients treated according to the methods claimed.
b. Nature of the invention: The nature of the invention is methods of preventing or inhibiting, or treating any peritoneal disease in patients via administration of the hydrogel composition of claim 1. The hydrogel need not comprise any pharmaceutical active agent except in claims 8-10.
c. The state of the prior art: Dankers (Dankers, P.Y.W., et al., Convenient formulation and application of a supramolecular ureido-pyrimidinone modified poly(ethylene glycol) carrier for intrarenal growth factor delivery, European Polymer Journal 72 (2015) 484–493) teaches applying a “supramolecular hydrogel carrier based on ureido-pyrimidinone (UPy) modified poly(ethylene glycol)” (UPy-PEG) to “deliver anti-inflammatory and anti-fibrotic growth factor protein BMP7 to the kidney” (abstract; see title; pp.488-92). The supramolecular hydrogel carrier is made using the UPy-PEG polymer (Fig.1 and accompanying text). The hydrogel carrier is injected (p.486 2.1, 2.3). Dankers does not specifically teach a UPy-PEG polymer obtained from reacting compounds A, B, and C in claim 1. Prevention of a peritoneal disease as the term would be generally understood as absence of a peritoneal disease, however, was not attained or reported in these studies.
d. Level of one of ordinary skill in the art: the level of ordinary skill is high as trained physicians would practice peritoneal disease prevention by administering the hydrogel composition of claim 1.
e. Level of predictability in the art: the level of predictability in preventing a peritoneal disease low as the term encompasses any condition occurring within the abdominopelvic cavity at large including the liver, intestines, bladder, etc. The term “disease” also encompasses a wide range of conditions including inflammation, infection, cancer, etc.
f. Amount of direction provided by the inventor: Applicant does not appear to disclose guidance or methods of how to specifically prevent or inhibit a peritoneal disease apart from simply administering the hydrogel composition of claim 1.
g. Existence of working examples: The disclosure does not include any animal models or in vitro data tending to support any clinical attainment of prevention or inhibition of a peritoneal disease.
h. Quantity or experimentation needed to make or use the invention based on the content of the disclosure: considering the state of the art as discussed by the references above, particularly regarding the unpredictability of preventing any and all peritoneal disease, wide variability among individuals, and the lack of guidance provided in the specification, the person of ordinary skill would have to engage in significant amount experimentation and ingenuity to practice the invention commensurate in the scope of the claims.
In conclusion, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with claims 1-20.
Citation of Relevant Prior Art
Dankers (Dankers, P.Y.W., et al., Convenient formulation and application of a supramolecular ureido-pyrimidinone modified poly(ethylene glycol) carrier for intrarenal growth factor delivery, European Polymer Journal 72 (2015) 484–493). Dankers teaches applying a “supramolecular hydrogel carrier based on ureido-pyrimidinone (UPy) modified poly(ethylene glycol)” (UPy-PEG) to “deliver anti-inflammatory and anti-fibrotic growth factor protein BMP7 to the kidney” (abstract; see title; pp.488-92). The supramolecular hydrogel carrier is made using the UPy-PEG polymer (Fig.1 and accompanying text). The hydrogel carrier is injected (p.486 2.1, 2.3). Dankers does not specifically teach a UPy-PEG polymer obtained from reacting compounds A, B, and C in claim 1.
Mes (WO 2014/185779 Al; see IDS). Mes teaches a “supramolecular biodegradable polymer comprising a quadruple hydrogen bonding unit (abbreviated herein as "4H-unit"), a biodegradable backbone and hard blocks” (abstract). Mes specifically teaches compound A of instant claim 1 as “compound F’” Formula (7) (pp.6, 17) wherein R1 and FG are defined identically as here (p.8, 19). Mes further teaches hydroxy-terminated poly(ethylene glycol), i.e., compound C here. However R2 in compound A here or compound F of Mes, and R3 in compound B (compound C’ in Mes) are distinct. Mes’s “supramolecular polymer is specifically suitable for biodegradable articles such as biomedical implants that need high strength and/or elasticity, e.g. medical implants in the cardio-vascular field” (abstract).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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.
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.
/H. SARAH PARK/Primary Examiner, Art Unit 1614