DETAILED ACTION
Applicant's submission filed on March 3, 2026 has been received and entered into the application file. All arguments have been fully considered. Claims 24-32 are currently pending. Claims 1-23 are cancelled. Claim 32 is new. No claims are amended.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
REJECTION(S) MAINTAINED/UPDATED
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.
Claim 24-31, and new claim 32, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 24 and 32 recite the following methods:
24. A method of producing fibrous tissue and/or chondrocytic tissue in a joint of an individual, comprising the step of delivering fibroblasts to the joint, wherein the fibroblasts have not been exposed to exogenous growth factors, exogenous matrix molecules, exogenous mechanical strain, or a combination thereof, in vitro prior to delivery to the joint, wherein mechanical strain comprises intermittent hydrostatic pressure or shear fluid stress.
32. A method of producing fibrous tissue and/or chondrocytic tissue in a joint
of an individual, comprising the step of delivering fibroblasts to the joint, wherein the fibroblasts have not been exposed to exogenous growth factors, exogenous matrix molecules, exogenous mechanical strain, or a combination thereof, in vitro prior to delivery to the joint, wherein mechanical strain comprises intermittent hydrostatic pressure or shear fluid stress and excludes incidental forces from obtaining, culturing, and/or delivering the fibroblasts.
Regarding claims 24 and 32 and the limitations “…wherein mechanical strain comprises intermittent hydrostatic pressure or shear fluid stress” (claim 24) and “wherein mechanical strain comprises intermittent hydrostatic pressure or shear fluid stress and excludes incidental forces from obtaining, culturing, and/or delivering the fibroblasts” (claim 32), it is noted that a review of Applicant’s specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of a method of producing fibrous tissue and/or chondrocytic tissue in a joint of an individual, comprising the step of delivering fibroblasts to the joint, wherein the fibroblasts have not been exposed to exogenous mechanical strain in vitro prior to delivery to the joint, wherein mechanical strain comprises any type of intermittent hydrostatic pressure or any type of shear fluid stress, and the intermittent hydrostatic pressure or shear fluid stress excludes incidental forces from obtaining, culturing, and/or delivering the fibroblasts.
Applicant’s specification does not provide a specific definition regarding the metes and bounds of the claimed, excluded exogenous intermittent hydrostatic pressure or shear fluid stress, and does not define that the intermittent hydrostatic pressure or shear fluid stress excludes incidental forces from obtaining, culturing, and/or delivering the fibroblasts. Applicant’s specification has only one (1) reference to the term intermittent ([0040]) and does not further define that the excluded intermittent hydrostatic pressure or shear fluid stress would exclude incidental forces from obtaining, culturing, and/or delivering the fibroblasts.
In its broadest reasonable interpretation, this limitation is considered to encompass excluding intermittent hydrostatic pressure that would occur upon conducting intermittent exchanges of liquid culture media when replenishing fresh culture media to the cell culture vessels, for example, and would further exclude in vitro manipulation of the fibroblasts that would cause any type of shear fluid stress at any time during in vitro conditions, such as passaging of the fibroblasts using trituration (i.e., shear fluid stress), with or without enzymatic dissociation, as the fibroblasts are expanded during in vitro culture (as recited in the specification at paragraphs [0022] and [0048]).
However, Applicant’s specification discloses that the claimed method includes standard and routine cell culturing manipulations such as passaging of cells which requires dissociation of cells from the cell culture surface and dissociation of cells from each other, followed by repetitive pipetting (i.e., intermittent shear fluid stress) to resuspend the cells as a cell suspension for seeding to new culture vessels for continued expansion of the cell population ([0022] and [0048]). Applicant’s specification does not further teach passaging without the intermittent application of shear fluid stress to dissociate and resuspend the cells.
In the instant case the only references in the specification to the in vitro conditions of the fibroblasts prior to delivery to the joint include in vitro culturing that includes passaging of the fibroblasts (shear fluid stress) that would include cell culture media changes (intermittent hydrostatic pressure) (Specification at paragraphs [0022] and [0048]). The Specification at [0048] discloses passaging for 5-7 days and passaging of cells for 1-10 times, or more, for example. The specification does not describe in vitro conditions wherein the fibroblasts that are delivered to the joint are not subjected to passaging that excludes any and all types of sheer fluid stress, such as trituration of cells, or that excludes any and all types of intermittent hydrostatic pressure, such as fluid culture media exchanges to remove spent media and replace with fresh culture media.
It is additionally noted that the specification discloses the cells are delivered via injection into the individual using a minimal amount of fluid to suspend the cells ([0041] and [0052]). It is considered the resuspension of the cells for injection would subject the fibroblasts to shear fluid stress prior to delivery to the joint. The specification does not further disclose delivery of the fibroblasts to the joint that exclude such a type of in vitro shear fluid stress.
It is noted that a review of the specification shows that Applicant’s specification does support that the method would exclude subjecting the fibroblasts to in vitro exogenous mechanical strain that promotes chondrogenesis.
A review of the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of the method as currently claimed.
The method as currently claimed excludes exogenous intermittent hydrostatic pressure during in vitro conditions and encompasses excluding intermittent hydrostatic pressure that would occur upon conducting intermittent exchanges of liquid culture media when replenishing fresh culture media to the cell culture vessels, for example.
Accordingly, the claims are considered to lack sufficient written description and are properly rejected under 35 USC 112, first paragraph.
Claims 25-31 are included in the rejection based on their dependence from claim 24.
Response to Remarks:
Applicant has argued that the recited exogenous mechanical strain refers to an intentional conditioning tool related to inducing a biological effect (e.g., inducing chondrogenic differentiation) and is not a generic description of any conceivable force, as discussed at Applicant’s remarks (page 5).
Applicant’s remarks have been fully considered, but are not found persuasive since the recited exogenous mechanical strain is directed to intermittent hydrostatic pressure or shear fluid stress and the specification does not further define that the excluded intermittent hydrostatic pressure or shear fluid stress does not include cell culture manipulations such as cell passaging that includes intermittent shear fluid stress to dissociate cells via repetitive pipetting to form a cell suspension.
Applicant has argued that cell passaging and cell culture media exchanges are not contemplated as the excluded exogenous intermittent mechanical strain, as discussed at Applicant’s remarks (Remarks, page 6, 1st paragraph).
Applicant’s remarks have been fully considered, but are not found persuasive since the specification does not further define/disclose that the excluded intermittent hydrostatic pressure or shear fluid stress would not include standard cell culture manipulations such as cell passaging that includes intermittent shear fluid stress to dissociate cells via repetitive pipetting to form a cell suspension.
Further as to Applicant’s remarks that the specification notes the cells are “minimally manipulated (for example, exposed to serum, antibiotics, etc).” ([0041]) confirming that the inventors drew a clear and deliberate distinction between routine handling and intentional mechanical strain, as discussed at Applicant’s remarks (Remarks, page 6, second and third paragraphs), it is noted that Applicant’s remarks have been fully considered, but are not found persuasive since the specification does not further teach/define the excluded exogenous intermittent would not include incidental forces that occur during cell culture manipulations such as cell passaging that includes intermittent shear fluid stress to dissociate cells via repetitive pipetting to form a cell suspension.
Applicant’s assertion that the term “mechanical strain” only refers to deliberate, controlled application of physical forces, requiring specialized apparatus and thus would not encompass forces that occur during standard laboratory procedures is not found persuasive since Applicant’s specification does not specifically define the claimed mechanical strain would exclude intermittent shear fluid stress such as pipetting for preparing a cell suspension for passaging.
Likewise, Applicants assertion that the claimed exclusion of exogenous mechanical strain comprising intermittent hydrostatic pressure or shear fluid stress would be limited to excluding mechanical strain commonly used to induce a desired biological effect such as differentiation, is not found persuasive (Applicant’s remarks (Remarks, page 7).
In response, it is noted, as discussed above, Applicant’s specification does not specifically define the claimed excluded exogenous mechanical strain would be limited to mechanical strain that promotes differentiation, e.g., bioreactor hydrostatic pressures systems.
Applicant’s specification does not sufficiently disclose and set forth that the claimed intermittent mechanical strain does not exclude shear fluid stresses that are conducted during cell culture manipulations such as passaging of cells.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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, CHRISTOPHER BABIC can be reached at 571-272-8507. 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.
E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
Prosecution Insights