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 .
Detailed Action
This application is a national stage application of PCT/CA2022/051254, filed August 18, 2022, which claims benefit of provisional applications 63/354322, filed June 22, 2022, and 63/235316, filed August 20, 2021. Claims 1-21, 24, 27, 32, 35, 37, 39, 42-53, 63, and 64 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted September 18, 2024, is acknowledged wherein claims 6-21, 24, 27, 32, 35, 37, 39, 42, 43, 46-53, 63, and 64 are amended and claims 22, 23, 25, 26, 28-31, 33, 34, 36, 38, 40, 41, 54-62, and 65-73 are canceled.
Claim interpretation
Claim 1 is directed to a method of treating a fibrous capsule formation in a patient comprising treating the fibrous capsule formation with a medically acceptable fucan composition. Claims 2-4 are similarly directed to methods of treating a foreign body response, capsular contracture, and biofilm infection, respectively. According to p. 3 paragraph 7 of the specification as originally filed, treatment can include inhibition, prevention, removal, or reduction. Therefore applying the fucan to an implant would be reasonably considered to infringe the claims if it were to prevent or inhibit the named conditions from occurring, whether or not said conditions are present at the time of application.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. This claim, which depends from claim 1, requires that the implant is composed of a non-synthetic, biologic, naturally derived, or synthetic material. Since all materials must be either synthetic or not synthetic, any embodiment of claim 1 would infringe this claim. Therefore claim 7 fails to further limit the scope of claim 1. 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.
Claim Rejections - 35 USC § 102
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 1-10, 14, 17-20, 32, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mohan et al. (Reference included with PTO-892)
Independent claims 1-4 are directed to methods of treating a fibrous capsule formation, foreign body response, capsular contracture, or biofilm infection in a patient comprising treating the conditions with a therapeutically acceptable amount of medically acceptable fucan. As discussed under the heading “Claim interpretation,” “treating” as recited in the claims is interpreted to include preventing or inhibiting, meaning that the claims can be infringed by a treatment of an implant wherein no such condition currently exists, so long as the future occurrence of such a condition is inhibited or prevented. Furthermore As described by Jacombs et al., (Reference included with PTO-892) infection with bacterial biofilms can be a source of capsular contracture. Therefore claims 1 and 3 would also be considered to potentially be infringed by a treatment wherein biofilm formation is inhibited. Claim 8 further describes the implant as being selected from a list including a catheter.
Mohan et al. discloses that implants composed of polydimethylsiloxane, (PDMS) such as urinary catheters, are easily prone to foreign body reaction and biofilm formation. (p. 5825 left column) Mohan et al. further describes coating these materials with natural polysaccharides. (p. 5825 right column) One of the polysaccharides used was sulfated fucoidan, which is reasonably considered to be a medically acceptable fucan. (p. 5826 left column) Surface modification with this polysaccharide was seen to inhibit both protein fouling, which is a cause of foreign body reaction, (p. 5829 left column last paragraph) and formation of biofilms. (p. 5830 left column last paragraph – right column first paragraph) Therefore implanting a catheter coated with this material in a subject would be expected to inhibit or prevent both foreign body response and biofilm formation. Regarding claims 1 and 3, as discussed above, this would be expected to inhibit capsule formation and contracture as well. Regarding claim 32, a catheter coated with this fucoidan material would infringe claim 32. While the experimental section of Mohan et al. (p. 5930 right column third paragraph – p. 5831 left column third paragraph) does not specifically describe coating a urinary catheter with fucoidan, the reference describes using the disclosed fucoidan coatings for this purpose, (See background on p. 5826 and conclusion on p. 5840) and furthermore provides a method by which such a goal could be accomplished. This is sufficient to provide written description under 35 USC 112(a) for a catheter coated with fucoidan and a process of implanting this catheter into a patient for the purpose of inhibiting or preventing foreign body response and biofilm infection, for example, thereby anticipating the present claims.
Regarding claim 5, as discussed above, coating a catheter with fucoidan would be expected to inhibit the recited conditions. Regarding claim 6, a catheter is a medical device. Regarding claim 7, as discussed under 35 USC 112(d) above this claim fails to further limit the base claims. Regarding claims 8 and 35, this claim allows for the implant to be a catheter. Regarding claim 9, this claim allows for the implant to be made out of silicone, which includes PDMS as a species. Regarding claim 10, as discussed above, Mohan describes coating the surface of the catheter with fucoidan. Regarding claims 14 and 17, implanting a catheter coated with fucoidan in a subject would reasonably comprise coadministering the catheter and the fucoidan and administering the fucoidan at the site of the implant. Regarding claim 18, since foreign body reactions are a characteristic of animals, and non-animal subjects would not be implanted with urinary catheters, describing the implantation of said catheters in a subject would necessarily refer to an animal subject. Regarding claim 19, the fucoidan coating can reasonably be considered to be a film, for example. Regarding claim 20, the process of coating the catheter comprises delivering the fucoidan in either water for injection USP or sodium chloride. (p. 5830 right column third paragraph)
Claims 44-46, 51, and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alkhatib et al. (Reference included with PTO-1449)
Independent claims 44 and 45 claim a method for treating or inhibiting a transplant condition comprising treatment of the patient with a medically acceptable fucan composition. Alkhatib et al. discloses a process whereby experimental animals undergo cardiac transplantation, followed by intramuscular administration of fucan. (p. 16 section 2.2) The treatment was seen to inhibit the formation of coronary lesions in allografted subjects. (p. 17 section 3.1.1) Therefore this method of treatment is seen to anticipate present claims 44 and 45. Regarding claim 46, this claim includes heart transplants. Regarding claims 51 and 53, these claims are seen to be anticipated by the method described by Alkhatib, which involves first administering the fucan at the time of the transplantation and then continuing to administer it on subsequent days.
For these reasons Alkhatib et al. is seen to anticipate the present claims.
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.
Claims 1-10, 14, 17-20, 32, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Mohan et al. (Reference included with PTO-892)
The disclosure of Mohan et al. is discussed above. While as discussed above, Mohan et al. is seen to describe the concept of implanting a urinary catheter coated with fucoidan in such a way as to provide written description for such a process and directly anticipate the claimed invention, even assuming for the sake of argument that Mohran’s disclosure is judged to not directly anticipate such a process of medical device, it would still have been obvious to one of ordinary skill in the art at the time of the invention to produce such a device and implant it into a subject. One of ordinary skill in the art would have seen the description of the coating and evaluation processes described by Mohran et al. as specifically suggesting that coating a urinary catheter with fucoidan would be useful and would have provided a reasonable expectation of success in achieving the desired therapeutic benefit by implanting such a device in a patient.
Claims 1-21, 24, 27, 32, 35, 37, 39, 42, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (Reference included with PTO-892) in view of Springate et al. (PCT international publication WO2020/019077, Reference included with PTO-892)
Independent claims 1-4 are directed to methods of treating a fibrous capsule formation, foreign body response, capsular contracture, or biofilm infection in a patient comprising treating the conditions with a therapeutically acceptable amount of medically acceptable fucan. As discussed under the heading “Claim interpretation,” “treating” as recited in the claims is interpreted to include preventing or inhibiting, meaning that the claims can be infringed by a treatment of an implant wherein no such condition currently exists, so long as the future occurrence of such a condition is inhibited or prevented.
Shin et al. discloses that silicone breast implants are commonly used, but are also often accompanied by capsular contracture, a foreign body response which involves the formation of a fibrotic capsule. (p. 1 left column, p. 2 left column second and third paragraphs) Among possible preventative methods for this condition, anti-adhesion membranes are found to be effective. (p. 4 left column third paragraph) Inhibition of biofilms (p. 5 left column second and third paragraphs) and surface modification using antifibrosis drugs (p. 6 left column fourth paragraph – p. 7 left column first paragraph) Shin et al. does not specifically describe treating, inhibiting, or preventing capsular contracture using a fucan.
Springate et al. describes high molecular weight fucans. (p. 2 paragraph 6) These fucans can be used to treat medical conditions including fibrous adhesions, for example administering to the site of a fibrous adhesion. (p. 5 paragraphs 12-14) The fucans can be formulated for example as medical devices or liquid pharmaceutical compositions. (p. 5 paragraph 15) One possible trigger for fibrous adhesions is the presence of foreign material. (p. 53 paragraph 170) Adhesions due to a wide variety of surgical procedures can be treated. (pp. 56-57 paragraph 178)
Springate et al. discloses fucan compositions having low amounts of endotoxin, including as low as 0.0005 EU per mg. (p. 3 paragraphs 6-8) These fucans can be used to treat medical conditions including fibrous adhesions, for example administering to the site of a fibrous adhesion in an animal. (p. 5 paragraphs 13 and 16) The fucans can be formulated for example as medical devices or liquid pharmaceutical compositions. (p. 6 paragraph 16) One possible trigger for fibrous adhesions is the presence of foreign material. (p. 37 paragraph 133) Adhesions due to a wide variety of surgical procedures can be treated. (pp. 40-41 paragraph 141)
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer a fucan as described by Springate et al. to prevent, inhibit, or treat capsular contracture in a patient having a breast implant, rendering claims 1-3. Regarding claim 4, while the references do not specifically mention that fucans treat bacterial biofilms, the scope of the present claims includes methods of treating bacterial biofilms in a subject not currently suffering from a biofilm. Therefore since as described by Shin, bacterial biofilms can form on silicone breast implants, administering the same claimed compound to a subject having such an implant would reasonably be considered to be a method of preventing or inhibiting the future formation of a biofilm. One of ordinary skill in the art would have seen the disclosure of Shin et al. as suggesting the use of anti-adhesion and antifibrosis drugs, such as the fucans described by Springate, to treat or prevent capsular contracture, as evidenced by the variety of different drugs of this type described by the reference.
Regarding claim 6, as discussed above Springate describes administering the fucan as a medical device or pharmaceutical composition. Regarding claim 7, as discussed under 35 USC 112(d) this claim does not further limit the base claim. Regarding claim 8, this claim includes breast implants within its scope. Regarding claim 9, this claim includes silicone within its scope.
Regarding claims 10 and 12, Springate et al. discloses that the medical composition can be administered at various times, including after the opening of a surgical wound, during surgery, or after closing the surgical wound. (p. 6 paragraph 18) The discussion of using meshes or coating of therapeutic agents by Shin and the discussion of administering the fucan during surgery by Springate would suggest administering the fucan as a coating or embedded therapeutic agent in the implant. Regarding claims 11 and 13, Springate describes administering the liquid medical device to a specific location susceptible to fibrous adhesions. (p. 40 paragraph 140) This would suggest that the fucan could be applied to the implant after implantation into the patient. Regarding claims 14 and 15, the aforementioned methods of administering the fucan with the implant of after implantation would infringe these claims as well. Regarding claim 17, both references clearly describe administering the therapeutic agent to the site of the implant. Regarding claim 18, breast implants would necessarily be administered only to an animal. Regarding claim 19, the mention of a liquid medical device would infringe the embodiment of a liquid in this claims. Regarding claim 20, p. 72 paragraph 238 of Springate suggests adding a applying the fucan in a solution of lactated Ringer’s injection USP.
Regarding claims 32 and 35, a breast implant coated with fucan as an antifibrosis agent would infringe these claims.
For these reasons the invention taken as a whole is prima facie obvious.
Claims 63 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Alkhatib et al. as applied to claims 44-46, 51, and 53 above, and further in view of Springate et al. (PCT international publication WO2020/019077, Reference included with PTO-892)
The disclosure of Alkhatib et al. is discussed above. While Alkhatib et al. does not specifically describe the endotoxin content of the fucan, as discussed above, Springate et al. discloses a method for producing very low endotoxin content fucan for use as a medical device or pharmaceutical composition. It would have been obvious to one of ordinary skill in the art at the time of the invention to use a low endotoxin fucan composition as described by Springate in the process described by Alkhatib in order to administer a safe composition having endotoxin levels within the amounts recited in claims 63-64. Based on Springate’s teachings, one of ordinary skill in the art would have recognized that minimizing the amount of endotoxin in fucan being administered to a surgical site would be necessary and beneficial.
For these reasons the invention taken as a whole is prima facie obvious.
Claims 44-53, 63 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Maurette et al. (Reference included with PTO-892) in view of Springate et al. (PCT international publication WO2020/019077, Reference included with PTO-892)
Independent claims 44 and 45 claim a method for treating or inhibiting a transplant condition comprising treatment of the patient with a medically acceptable fucan composition.
Maurette et al. discloses a study of laproscopic procedures performed in patients who had undergone liver transplants. (p. 2499 left column second paragraph – right column second paragraph) In many cases adhesions were found to be present in the peritoneal cavity due to the earlier transplant. (p. 2501 right column seventh paragraph, p. 2502 right column first paragraph)
The disclosure of Springate et al. is as discussed previously.
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer a low endotoxin fucan composition as described by Springate et al. to a patient undergoing liver transplantation, in order to prevent future complications from tissue adhesions. One of ordinary skill in the art would have found this to be obvious because Springate et al. discloses treating adhesions resulting from a wide variety of surgical procedures, which would lead one of ordinary skill in the art at the time of the invention to expect that it would be effective at inhibiting adhesions due to liver transplantation as well.
Regarding claim 46, this claim includes liver transplants. Regarding claims 47-53, Springate et al. discloses that the medical composition can be administered at various times, including after the opening of a surgical wound, during surgery, or after closing the surgical wound. (p. 6 paragraph 18) The discussion of administering the fucan during surgery by Springate would suggest administering the fucan as a coating or embedded therapeutic agent in the transplant. Furthermore, Springate describes administering the liquid medical device to a specific location susceptible to fibrous adhesions. (p. 40 paragraph 140) This would suggest that the fucan could be applied to the transplant after implantation into the patient. Regarding claims 52 and 53, the aforementioned methods of administering the fucan with the implant of after implantation would infringe these claims as well.
Regarding claims 63 and 64, It would have been obvious to one of ordinary skill in the art at the time of the invention to use a low endotoxin fucan composition as described by Springate in the process described by Alkhatib in order to administer a safe composition having endotoxin levels within the amounts recited in claims 63-64. Based on Springate’s teachings, one of ordinary skill in the art would have recognized that minimizing the amount of endotoxin in fucan being administered to a surgical site would be necessary and beneficial.
For these reasons the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 6/2/2026
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