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 .
Priority
This application claims priority from provisional application 63/109980 filed 11/05/2020.
Status of Claims
Claims 1, 3-9, 12-13 and 16-24 are pending.
Claims 2, 10, 11, 14 and 15 have been cancelled.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the no more than 5 pluralities of slits oriented at an angle of 1-180 degrees relative to each other (Claim 9 see 112 rejection below for clarification) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 18 and 20 remain objected to for the following typo, “an” should be placed between “and” and “intermediate” in line 2.
Claim Rejections - 35 USC § 112
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 12, 13, 23, and 24 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.
The amendments to claims 12, 13, 23, and 24 are considered to be new matter because the each recite a newly defined larger range of at least 10%. The original disclosure was consistent with the indefinite language previously identified. It provided uncertainty with respect to the scope. However the amendments now kept only the at least and low end of the range to now define a much larger range. This range was not originally disclosed and is therefore considered to be new matter. The applicant is advised to amend each of these claims to positively recite the actual range and delete all recitations of “at least”.
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.
Claim 9 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 9 limits the allograft to having “no more than five pluralities of slits” which renders the claim indefinite. A plurality is simply defined as being more than one. There is no value defined within the original disclosure as a minimum number for the plurality of slits. Therefore pluralities could include 2 slits up to any number. It appears the applicant intended claim 9 to be identifying the pluralities of Figures 4 or 5, but they clearly have well more than 5 identifiable “pluralities”, which meet the orientation requirements. Therefore without limiting the extend of the pluralities, the slits of the applicant’s invention will inherently have an more than 5 pluralities.
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.
Claim(s) 1, 3-7, 9, 12, 13, and 16-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al. (Daniel) US Pub. No. 2018/0085404 A1 in view of Horton et al (Horton) US 2013/0084314 A1.
Regarding claim 1, Daniel discloses a placental tissue allograft (title discloses a placental graft that is capable of being used as an allograft ), wherein said placental tissue allograft is dehydrated (150 Figure 1), meshed (Figure 10), expandable when hydrated (the nature of the placenta graft materials and the mesh shape shown in Figure 10, inherently results in a flexible expandable graft, additionally whether a graft is expandable depends on the initial shape and configuration, in this case if the graft of figure 10 is hydrated but compressed it will inherently be capable of then expanding from that compressed state), and sterile (165 Figure 1).
However, Daniel does not disclose the openings are slits, an insertion method where the slits allow the allograft to expand at least 10%, or that the allograft is lyophilized.
Horton teaches the use of a placental allograft comprising slits (Figure 5) which when implanted expands between 20% and 600% [0010] and the step of lyophilizing the implant (freeze drying is the same as lyophilizing [0020]) in the same field of endeavor for the purpose of providing increased flexibility and moldability to match the needs of each individual patient as well as an implant that can be stored for extended periods.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the circular openings of Daniel with the expandable slits of Horton and to lyophilize the implant as taught by Horton in order to increase flexibility and moldability to match the needs of each individual patient and allowing it to be stored for extended periods.
Regarding claim 3, Daniel discloses the placental tissue allograft of claim 2, wherein the slits are in an engineered pattern (Figure 10) Horton also discloses an engineered pattern (Figure 5).
Regarding claim 4, Daniel discloses the placental tissue allograft of claim 3, wherein all of said slits are parallel to one another (rows of openings are parallel to each other Figure 10) Horton also discloses the arrangement (Figure 5).
Regarding claim 5, Daniel discloses slits which are 0.1-20 mm in length (the diameter of the plurality of holes 1010 are described to be from 0.2 to 2.0 mm which falls within the claimed range, Figure 10; [0058]).
Regarding claim 6, Daniel discloses the distance between two adjacent slits is between 0.1-10 mm (the holes are spaced from 1 mm to 5 mm apart which falls within the claimed range; [0058]).
Regarding claim 7, Daniel discloses wherein a first plurality of said slits are parallel to one another (top row Figure 10 of Daniel and 5 of Horton), a second plurality of said slits are parallel to one another (second row Figure 10 of Daniel and 5 of Horton), and the slits of first plurality and the second plurality are oriented at an angle of 1°-180° relative to each other (Figure 5 of Horton clearly shows all slits arranged at an angle of 180 degrees relative to each other).
Regarding claim 9, as explained in the 112 above pluralities can be identified in any number or grouping. Therefore Daniel as modified by Horton discloses the placental tissue allograft comprising no more than five pluralities of slits (as much as the applicant’s own invention or by identifying all of the slits above the midline as a first plurality and all slits below the midline as a second plurality), wherein each of the two pluralities of slits are oriented at an angle of 1-180° relative to each other (each portions is oriented at 180 degrees from the other portions).
Regarding claim 12, the allograft of Daniel may be expanded by at least 10%along one axis by application of a force that is less than its tensile strength (since the claim fails to define the condition of the allograft prior to being expanded, the implant of Daniel can be folded or rolled up to have of its natural state then unfolded or unrolled thereby expanding it to its original state which would be a 50% expansion, which would inherently take less than its tensile strength because it is just being unfolded and not pulled apart).
Regarding claim 13, the allograft of Daniel may be expanded so as to increase its surface area by at least 10% by application of a force that is less than its tensile strength (as explained above the initial condition is not claimed, therefore a folded up implant would allow for the reduced covered surface area to be expanded by at least 50%).
Regarding claim 16, Daniel discloses a placental tissue allograft comprising amnion [0020].
Regarding claim 17, Daniel discloses a placental tissue allograft comprising chorion ([0045] discloses the Chorion layer can be used in combination with the amnion).
Regarding claim 18, Daniel discloses a placental tissue allograft comprising amnion and an intermediate layer ([0050] Figure 7).
Regarding claim 19, Daniel discloses a placental tissue allograft comprising amnion layered directly on chorion [0050].
Regarding claim 20, Daniel discloses a placental tissue allograft comprising amnion, chorion, and an intermediate layer [0050].
Regarding claims 21 and 22, Daniel discloses a placental tissue allograft capable of being contained within a sealed pouch that is deoxygenated (since the claims are directed at the allograft and not a kit or method of making/using it, the sealed pouch is considered to be language defining how the allograft is used or made and given limited weight, furthermore Daniel discloses it is packaged and sterilized [0027], which inherently requires the package to be sealed or the sterilizing would be ineffective, and this does not prevent it from being deoxygenated in any way).
Regarding claim 23, Daniel as modified by Horton discloses a method of covering a wound [0054] comprising contacting a wound [0054] with a sterile placental tissue allograft (Figure 1 165), wherein said contacting comprises expanding said sterile placental tissue allograft by at least 10%-400% (Horton [0010]) along one axis to cover said wound [0054].
Regarding claim 24, Daniel as modified by Horton discloses a method of treating a subject [0054] in need thereof using the placental tissue allograft of claim 1, said method comprising i) expanding said placental tissue allograft by at least 10%-400% along one axis (Horton [0010]), or expanding said placental tissue allograft so as to increase its surface area by at least 10%-400% (Horton [0010]); and ii) applying the expanded placental tissue allograft to the subject [0054].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel and Horton (Combination 1) as applied to claims 1, 3-7, 9, 12, 13, and 16-24 above, and further in view of Greener et al (Greener) USPN 8,680,360 B2.
Combination 1 discloses the invention substantially as claimed being described above. However, Combination 1 does not disclose .
Greener teaches the use of a flexible sheet comprising multiple pluralities of slits including first and second pluralities arranged 180 degrees to each other and a third plurality of slits arranged 90 degrees/not parallel to the other pluralities (Figures 4-5) in the same field of endeavor for the purpose of providing increased flexibility and expansion in multiple directions.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the concept of orienting some of the slots not parallel to the other slots as taught by Greener in order to provided increased flexibility and expansion in multiple directions.
Response to Arguments
Applicant's arguments filed 09/18/2025 have been fully considered but they are not persuasive.
With respect to the objections to claims 18 and 20 the applicant argues that “intermediate layer” refers specifically to a layer of placental tissue between the amnion and chorion layers not an unspecified layer. This argument does not correct the grammar issue. Currently the claims do not previously identify the intermediate layer or quantify it as any specific layer. Therefore claims 18 and 20 are introducing the two intermediate layer and the proper wording must be included. They need to say “and an intermediate layer” or refer the intermediate layer back to otherwise defined structure.
The applicant argues that Horton does not provide a motivation to lyophilize the tissue grafts. This is simply not true because freeze drying is old and extremely well known method for storing tissue implants. Horton clearly discloses that his implants are stored then freeze dried [0020], which a person of ordinary skill in the art would know allows for longer shelf life.
The applicant cites [0030] to support their argument that the implant of Horton is stored in solution and that Horton discloses steps to solve problems of lyophilization. This is not persuasive because as noted above Horton clearly discloses in [0020] that his implant can be lyophilized. Additionally, the paragraph cited by the applicant clearly outlines the steps taken by Horton (using the backing and the alignment) are done so that he can still lyophilize the implant and not worry about sticking of the layers. If Horton wasn’t still lyophilizing the implant there would be no need to take these steps.
The applicant then cites [0031] that says the graft is stored in solution not dehydrated. This is not persuasive because [0020] clearly supports that it can be dehydrated.
Finally, the applicant then cites [0028] to support the argument that Horton does not “fairly suggest” lyophilizing the implant. As an initial matter it is unclear what the applicant intends by “fairly suggests”. The prior art rejection cites clear teachings and disclosures nothing was identified as suggesting or fairly suggesting. Finally the slit structure addressed in this paragraph has no bearing on the step of lyophilizing. Horton clearly teaches the step of lyophilizing an implant with a pattern of slits. Both Daniel and Horton have the same patterns of openings and slits which means they will be subject to the same need for delicate handling (which Horton solves with a backing, non-contact layout, and freeze drying method). Therefore it would have been obvious to one of ordinary skill in the art to lyophilized the implant in order to provide a longer storage life.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/ Primary Examiner, Art Unit 3774