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 .
Status of Claims
Claims 1-20 are pending. This is the first office action on the merits.
Information Disclosure Statement
The IDSs filed 8/16/2024 and 12/16/2024 has been reviewed.
Election/Restrictions
Applicant’s election of Group I (claims 1-10) in the reply dated June 26, 2026 is acknowledged. Applicant’s election of amine groups for the polyethylene glycol polymer functional groups in the reply dated June 26, 2026 is also noted.
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)).
Claim 11-20 are withdrawn as being drawn to a non-elected invention or species, there being no linking or generic claim.
Claims 1-10 are examined on their merits in light of the elected species of amine groups for the polyethylene glycol polymer functional groups.
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 3, 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 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in reciting "wherein the at least one crosslinkiing agent comprises from trilysine acetate, N-(3-dimethylaminopropyl)-N’-ethylcarbodiimide hydrochloride, or N-hydroxysuccinimide." A 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. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See MPEP 2173.05(h).
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in reciting "wherein the first pharmaceutically acceptable buffer solution or the second pharmaceutically acceptable buffer solution comprises a radiopaque material, an antimicrobial agent, or both a radiopaque material and an antimicrobial agent." A 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. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See MPEP 2173.05(h).
Claim 5 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 5 is rejected under 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 applicant regards as the invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in reciting "wherein the instructions combining the dry particulate mixture with the first pharmaceutically acceptable buffer solution to form a slurry, intruding the slurry into a first barrel of the syringe, and introducing the second pharmaceutically acceptable buffer solution into a second barrel of the syringe." This phrase is vague and confusing and it is not clear what the instructions are meant to say.
This phrase is not defined nor explained in the specification and cannot be determined by reference to any other claims. As a result, one of ordinary skill in the art would not be reasonably apprised of how to determine what this phrase means.
Claim Rejections - 35 USC §112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 9 is rejected as being indefinite for failing to further limit in the recitation of “wherein the one or more functional groups comprise succinimide groups.” wherein claim 9 depends from claim 8. Claim 8 recites a Markush group of the one or more functional groups chosen from carboxylic acid groups, ester groups, amine groups, or a combination thereof.” which is a closed list of alternatives as recited.
In contrast, claim 9 recites that the one or more polymers “comprise succinimide groups”, which is open ended and broadens the scope of claim 9 as a dependent claim and therefore fails to further limit claim 8.
This is a failure to further limit the claim from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
It should be noted that amending claim 9 to recite wherein the one or more functional groups is succinimide groups.”, would properly further limit the subject matter of base claim 8.
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 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 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.
Claims 1-6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. US 20030119985 (6/26/2003) in view of Myung et al. WO 2021/222612 (11/4/2021).
Wallace et al. (Wallace) teaches a biocompatible polymer kit device for use in repairing and treating tissues comprising an adhesive composition comprising collagen and a plurality of crosslinkable components having reactive functional groups which are selected so as to enable cross-linking. Examples of non-degradeable linking groups include succinimide. (See [0117]). Wallace teaches a kit that contains a hydrophilic polymer and a crosslinkable component A having nucleophilic groups and a crosslinkable component B having electrophilic groups capable of reaction with the nucleophilic groups when contacted with moisture. (See claims 54-55 and [0021]). Wallace teaches that collagen is a preferred hydrophilic polymer component. (See [0077]). Collagen is called for in instant claim 1. A crosslinking agent is called for in instant claim 2.
Wallace teaches N-hydroxysuccinimide functionalized polyethylene glycol. N-hydroxysuccinimide is called for in instant claim 3. Succinimide groups are called for in claim 9 and succinimide functionalized polyethylene glycol are amine functional groups as called for in instant claim 8.
Wallace teaches that its compositions may also be used for localized delivery of biologically active agents that facilitate healing and regeneration such as antimicrobials as called for in instant claim 10. (See [0161-162]).
Wallace teaches that a way of delivering the adhesive composition of its invention is to prepare the reactive components in inactive form as a powder (or a liquid). The powders can be prepared to be separate dry powders. (See [0072]). A separate dry powdered collagen is called for in instant claim 1. Wallace teaches that the separate powders can be mixed together manually at the site of administration. (See [0065], [0072-73]). Wallace teaches that many devices that are adapted for the delivery of multi-component tissue sealants/hemostatic agents are well known in the art and can also be used in the practice of the present invention. (See [0072]).
These compositions can then be activated after application to the tissue site, or immediately beforehand, by applying an activator. In one embodiment the activator is a buffer solution having a pH that will activate the composition once mixed therewith. (See [0073]). Still another way of delivering the composition is to prepare preformed sheets, and apply the sheets as such to the site of administration. One of skill in the art can easily determine the appropriate administration protocol to use with any particular composition having a known gel strength and gelation time. (See [0073]).
Wallace teaches kits in which the components are provided separately for activation and use at the appropriate time and site of use. (See [0021], [0215-217] and claim 54). A kit is called for in instant claim 1.
Wallace teaches the provision of two buffer solutions, one in which the components are mixed together and kept unreactive to each other by being in a low pH buffer solution. (See [0156]). Thereafter, they can be applied to the targeted tissue site along with a high pH buffer, after which they will rapidly react and form a gel. (See [0156-0157]). Wallace teaches that in general a sulfhydryl-reactive component such as PEG substituted with succinimdyl esters is prepared in water or a dilute buffer with a pH of between around 5 to 6. A buffer with a pH of around 5 to 6 overlaps with the from about 3 to about 5 called for in instant claim 1. Water is a pharmaceutically acceptable buffer solution as called for in instant claim 1.
Wallace then teaches the application of a high pH buffer of pH 9.6 to activate the reaction. (See [0191]). A buffer with a pH of 9.6 falls within the range of about 9 to about 11 called for in instant claim 1.
With respect to claim 4 and 5, the instructions alone do not give rise to patentability because they represent a generic, standard laboratory protocol. See MPEP § 2106.04. A step-by-step method for mixing known ingredients (powders and buffers) from a kit does not give rise to patentability.
Wallace teaches the use of a separate but connected syringe in paragraphs [0187-0188]). This is a double barrelled syringe as called for in instant claim 5.
Wallace does not teach the ratio of the PEG particles to the collagen particles. This deficiency is made up for with the teachings of Myung.
Myung teaches a composition for use as an in-situ forming hydrogel in reconstructing a wounded area in a mammalian subject in need thereof in which a functionalized PEG polymer and collagen are combined to form the hydrogel. (See claims 1-3, Abstract and page 1). Myung teaches that the ratio of collagen to PEG is from about 4% to about 16%. (See Myung claim 20). This overlaps with the from about 8:1 to about 6:1 ratio of PEG particles to collagen particles called for in instant claim 6. Myung teaches that these respective amounts of PEG particles and collagen particles allow for the hydrogel to act as an effective biocompatible scaffold supporting cell alignment, proliferation and tissue regeneration. (See [0016]).
It would been prima facie obvious before the effective filing date of the invention for an ordinarily skilled artisan making the Wallace kit of particulate PEG substituted with succinimdyl esters, particulate collagen and an aqueous buffer solution of pH 5-6 and an aqueous buffer solution of pH 9.6 to use a ratio of collagen to PEG of from about 4% to about 16% as taught by Myung in order to allow for the hydrogel to act as an effective biocompatible scaffold supporting cell alignment, proliferation and tissue regeneration as taught by Myung.
The language of “for treating a fistula” in claim 1 is language of intended use. A recitation of the intended use of the claimed invention, 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, as it is here, then it meets the claim. Note: MPEP 2111.02. In this case, Wallace in view of Myung teach a hydrogel device for use in repairing and treating tissues, so it is capable of being used for this purpose.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. US 20030119985 (6/26/2003) in view of Myung et al. WO 2021/222612 (11/4/2021) as applied to claims 1-6 and 8-10 and further in view of Li WO 96/039159 (12/12/1996)
The teachings of Wallace in view of Myung are described supra. Wallace in view of Myung do not teach the size of the collagen particles. These deficiencies are made up for with the teachings of Li.
Li teaches collagen particles for a collagen-based delivery matrix in which the particles have a diameter between 5 micrometers and 850 micrometers. The collagen particles are dry and have diameters between 5 micrometers and 850 micrometers. (See Abstract, page 1 and claims 14-15). There are three components that can be mixed, the bioactive agent, an aqueous solution and the collagen particles to form a mixed material. (See page 3 and claim 16). Li teaches that delivery of the mixed material can be effected by a syringe or catheter. (See page 3 and claims 19-21). Collagen particles between 5 micrometers and 850 micrometers in diameter overlaps with the about 300 micrometers to about 500 micrometers called for in instant claim 7.
It would been prima facie obvious before the effective filing date of the invention for an ordinarily skilled artisan making the Wallace in view of Myung kit of particulate PEG substituted with succinimdyl esters, 4% to 16% particulate collagen and an aqueous buffer solution of pH 5-6 and an aqueous buffer solution of pH 9.6 to have the particulate collagen have a diameter between 5 micrometers and 850 micrometers as taught by Li in order to allow for the material to be delivered by syringe or catheter as taught by Li.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
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.
SARAH CHICKOS
Examiner
Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
Prosecution Insights