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 .
Claim Status
Claims 1-38 are pending.
Claims 1-38 are examined on the merits herein.
Priority
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 30-Jul-2025 and 17-Oct-2025 has been considered by the examiner.
Specification
The use of the term “BioSphincter”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The use of the term “ThermoFisher”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The use of the term “Invitrogen”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The use of the term “VitaCyte”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 9 and 26 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. Claims 9 and 26 recite that the “anorectum tissue cell biopsy weighs at least about 50 mg, preferably about 200 mg”. the word “preferably” creates uncertainty regarding whether the 200 mg is a claim limitation.
Claims 14 and 31 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. Claims 14 and 31 recite that the “intestinal tissue cell biopsy weighs at least about 50 mg, preferably about 200 mg”. the word “preferably” creates uncertainty regarding whether the 200 mg is a claim limitation.
Claims 2-5 and 19-22 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. Claims 2-5 and 19-22 recite that the NPCs and SMCs or laminin and collagen are in a ratio of. Neither the claims nor the specification define these ratios as the ratio between NPCs: SMCs versus SMCs: NPCs or laminin: collagen versus collagen: laminin, and creates uncertainty and ambiguity in the claim limitation.
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.
Claims 7 and 24 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. Claims 7 and 24, which depend from claims 1 and 18, respectively, recites “…further comprising obtaining the anorectum tissue cell biopsy from the subject” when claims 1 and 18 already required “isolating smooth muscle cells (SMCs) from an anorectum tissue cell biopsy from a subject”. To isolate cells from a biopsy, the biopsy must have been already performed, and thus, claims 7 and 24 do not further limit the parent claim. 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.
Claims 11 and 28 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. Claims 11 and 28, which depend from claims 1 and 18, respectively, recites “…further comprising obtaining the intestinal tissue cell biopsy from the subject” when claims 1 and 18 already required “isolating neural progenitor cells (NPCs) from an intestinal tissue cell biopsy obtained from the subject”. To isolate cells from a biopsy, the biopsy must have been already performed, and thus, claims 11 and 28 do not further limit the parent claim. 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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-8, 10-12, and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bitar (US9993505B2, Patent: 12-Jun-2018).
In regards to Claim 1, Bitar teaches:
The smooth muscle tissue is isolated from the internal anal sphincter of New Zealand white rabbit (Col 6, line 56-57) and Example 2 smooth muscle cells were isolated from rabbit sigmoid colon (Col 18, line 36-38).
Example 2 Neuronal progenitor cells were isolated from rabbit jejunum (Col 18, line 47-48).
The neuronal cells also can be grown in a fibrin gel, or in a collagen or a collagen/laminin matrix. After mixture with the matrix material, the neuronal cell population can be cultured to form a layer of neuronal cells. The neuronal cell population may be cultured to coat a cylindrical ring (Col 10, line 19-24) and in another embodiment, the smooth muscle cell population and the neuronal cell population are mixed together with the matrix material and cultured simultaneously to produce a transient three-dimensional matrix (Col 10, line 36-40).
Furthermore, Example 2, the enteric neuronal progenitor cells were resuspended in a 0.4 mg/ml collagen (type I rat tail) and laminin (5 ug/ml) solution. The solution was pipetted onto Sylgard coated 35 mm dishes around a central post. When placed in the 37C incubator, solution gelled in 15-30 minutes (Col 18, line 1-5).
1 ml of Neuronal Differentiation Medium (Neurobasal A+B27) was added and the plates were returned to the 37 C/7% CO2 incubator for differentiation (Example 2, Col 18, line 11-13)
The methods can include the steps of obtaining a population of smooth muscle cells and neuronal progenitor cells and seeding the cells together onto a matrix material, followed by culturing the seeded cells to form an innervated smooth muscle cell construct of directionally oriented smooth muscle cells (Col 3, line 15-20)
In regards to Claim 2-4, 6, and 10, Bitar teaches a method for generating an innervated IAS construct from both NPCs and SMCs within a collagen/laminin matric around a central post, exposed to neural differentiation media as discussed above. Bitar further teaches in Example 2, that the smooth muscle cells were trypsinized and neurospheres were accutased. 500k smooth muscle cells and 200k enteric neuronal progenitor cells were centrifuged to form a cell pellet (Col 17, 64-66), translating to a ratio of 200,000:500,000 or 1:2.5.
In regards to Claim 5, Bitar teaches a Type 1 rat tail collagen and laminin solution of 0.4 mg/mL collagen and 5 µg/mL of laminin (Example 2, Col 18, line 1-3), which is a ratio of 5 µg/mL: 400 µg/mL or 1:80.
In regards to Claim 7, Bitar teaches that the smooth muscle cells can be obtained from the patient who will be the recipient of the tissue engineering structure. Such autologous cells can be obtained from a surgical excision or a biopsy and can be isolated, cultured, expanded or enriched according to various techniques known in the art (Col 6, line 22-27).
In regards to Claim 8, Bitar teaches that the smooth muscle cells can be isolated from the internal anal sphincter (IAS) of New Zealand White rabbits (Col 6, line 55-56).
In regards to Claim 11-12, Bitar teaches that the neuronal progenitor cells were isolated from rabbit jejunum. Briefly, a biopsy of rabbit jejunum was cleaned of any material using HBSS. The tissue was minced and digested in a collagenase/dispase mixture. The cell suspension was then filtered through a 40 μm mesh and plated on petri dishes (Example 2, Col 18, line 47-52).
In regards to Claim 15, Bitar teaches that at day 4, the innervated smooth muscle tissue constructs were placed next to the non-innervated smooth muscle constructs around the same tubular composite chitosan scaffold (Example 2, Col 19, line 15-18) and microscopic evaluation of the innervated construct at day 4 showed that the enteric neural progenitor cells were arranged towards the periphery of the construct. Initial differentiation and axonal projections were observed in the construct (Example 2, Col 20, line 20-24).
In regards to Claim 16, Bitar teaches the collagen was type I rat tail (Example 2, Col 18, line 2).
In regards to Claim 35, Bitar teaches that the treatment methods are directed to a subject who has a condition or disorder or a predisposition towards fecal incontinence (Col 5, line 19-27).
Claim(s) 18-25, and 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raghavan et al. (Perianal implantation of bioengineered human internal anal sphincter constructs intrinsically innervated with human neural progenitor cells, Published: 2014).
In regards to Claim 18, Raghavan teaches:
An innervated IAS constructs that use dual layered collagen/laminin hydrogels have been described previously. Two cell types were used in the bioengineering process (1) circular smooth muscle isolated from the human IAS and (2) enteric neuronal progenitor cells isolated from the human colorectum. A custom-made, 35-mm culture dish was used with a central polydimethylsiloxane post defining luminal space. (Page 669-670).
A total of 200,000 neuronal progenitor cells were resuspended in a 0.8 mg/mL Collagen gel containing 10 mg/mL of laminin (Page 670).
Rats were anesthetized by the use of isoflurane and given a 0.05–0.1 mg/kg buprenorphine injection subcutaneously. The rat perineum was prepped with chlorhexidine, and a circumferential incision was made approximately 3 mm away from the anal verge; then, approximately 5 mm of the rat’s distal rectum was dissected. The IAS construct was gently slipped onto the distal-most rectum over the native IAS and rested in place (Page 670).
In regards to Claims 19-21, 23, and 27, Raghavan teaches a method for IAS construct creation using human cells comprising 500,000 circular smooth muscle cells isolated from the human IAS was suspended in 0.8 mg/mL Collagen I solution, and a total of 200,000 neuronal progenitor cells were resuspended in a 0.8 mg/mL Collagen gel containing 10 µg/mL of laminin (Page 670). 500k circular smooth muscle cells and 200k neuronal progenitor cells, translating to a ratio of 200,000:500,000 or 1:2.5.
In regards to Claim 22, Raghavan teaches a 0.8 mg/mL collagen solution with laminin at 10 µg/mL (Page 670), which is a ratio of 10 µg/mL of laminin: 800 µg/mL of collagen or 1:80.
In regards to Claim 24-25, Raghavan teaches that Human IAS circular smooth muscle was isolated as described before from human IAS obtained after surgery from National Development and Research Institute (Page 669).
In regards to Claim 28, Raghavan teaches enteric neuronal progenitor cells were isolated from samples of human colorectum by the use of a protocol adapted from Raghavan et al for rabbit intestines. Briefly, a 4-cm2 piece of colorectum was cleaned extensively and washed in ice-cold Hank’s balanced salt solution. The tissue was minced finely and digested in a mixture containing collagenase II, dispase, and DNAse I. After the digestion, cells were screened serially through 70-mm and 40-mm meshes and plated in neuronal growth medium (Page 669).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1, 9, 13-14, 17, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bitar as applied to claim 1 above, and further in view of Raghavan.
Bitar teaches the innervated internal anal sphincter construct methodology comprising of isolating smooth muscle cell from an anorectum tissue cell biopsy, isolating neural progenitor cells, forming a hydrogel matrix with neural differentiation media, and maturing the hydrogel to form an innervated internal anal sphincter construct as applied to claim 1 discussed above.
In regards to Claims 9 and 14, Bitar teaches a biopsy of the IAS tissue and jejunal tissue for SMC and NPC isolation (Col 6, line 50-57 and Col 18, line 47-52), and further teaches that these isolated cells are used to make the innervated construct.
In regards to Claim 13, Bitar teaches that smooth muscle cell can be obtained through surgical excision or a biopsy (Col 6, line 24-26), and that the rabbit neural progenitor cells were obtained through biopsy (Example 2, Col 18, line 47-50).
In regards to Claim 17, Bitar teaches that the neuronal progenitor cell solution was pipetted onto Sylgard coated plate with a central post (Example 2, Col 19, line 1-2).
In regards to Claim 36, Bitar teaches that the subject refers to any living organism such as humans (Col 5, line 10-11).
However, Bitar does not teach the minimum biopsy mass of anorectum or intestinal tissue of at least 50 mg of claims 9 and 14. Bitar does not teach that the intestinal tissue cell was obtained through laparoscopically of claim 13. Bitar does not teach that the resultant innervated internal anal sphincter with an open lumen has a diameter of 20-25 mm of claim 17. For this reason, Raghavan is added.
Raghavan teaches specific intestinal tissue dimensions excised to yield workable NPC quantities for an identical IAS construct comprising of a 4 cm2 piece of colorectum (Page 669). Raghavan teaches the clinical context for the obtaining the biopsies that the enteric neuronal progenitor cells were isolated from samples of human colorectum (Page 669), and that the construct is designed for clinical translation as a novel treatment in humans (Page 673). Raghavan teaches that a custom made 35 mm culture dish was used with a central post that ultimately defines the luminal space (Page 669-670).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bitar with the teachings of Raghavan. A person having ordinary skill in the art would have been motivated to do so since both references are directed to the same invention with similar methodology and matrix materials with the express goal of IAS construct creation for the treatment of fecal incontinence. One would have been motivated to obtain a biopsy of sufficient mass of at least 50 mg, preferably 200 mg in order to yield the 500,000 SMCs and 200,000 NPCs as the working sample quantities in Raghavan.
Further, one would have obtained the jejunal biopsy through laparoscopy as the standard minimally invasive approach for intestinal tissue procurement in human patients, and the size of the construct central lumen of approximately 20-25 mm to anatomically fit a human and enable the subsequent implantation technique represents routine experimental optimization of a known result-effective variable. For the foregoing reasons, Claims 1, 9, 13-14, 17, and 36 are rendered obvious by the teachings of the prior art.
Claim(s) 18, 26, 29-34, and 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raghavan as applied to claim 18 above, and further in view of Bitar and Silverman et al. (US007318801B2, Patent: 15-Jan-2008, Filed: 15-Jul-2003).
Raghavan teaches the innervated IAS constructs that use dual layered collagen/laminin hydrogels methodology comprising of a neuronal progenitor cells, intestinal tissue cell biopsy, smooth muscle cell isolation, forming a hydrogel matrix, and implantation of the construct as applied to claim 18 discussed above.
In regards to Claim 26 and 31, Raghavan teaches specific intestinal tissue dimensions excised to yield workable NPC quantities for an identical IAS construct comprising of a 4 cm2 piece of colorectum (Page 669).
In regards to Claim 29 and 30, Raghavan teaches a treatment method including obtaining intestinal tissue biopsy (Page 669).
In regards to Claim 32, Raghavan teaches that concentric alignment was complete in 2-3 days and that by day 10, a fibrous neuronal network was associated with the concentric smooth muscle for the construct.
In regards to Claim 33 and 34, Raghavan teaches the process of implanting an innervated IAS construct into a subject via circumferential dissection around the anorectum.
In regards to Claim 37 and 38, Raghavan teaches that the construct is directed towards a regenerative tissue engineered solution for remedying fecal incontinence (Page 669) and that the intended use is in humans through clinical translation.
However, Raghavan does not teach the minimum biopsy mass of anorectum or intestinal tissue of at least 50 mg of claims 26 and 31. Raghavan does not teach that the intestinal tissue biopsy is obtained from jejunal small intestine or obtained laparoscopically of claims 29 and 30. Raghavan does not explicitly teach that the construct matured in about 3-12 days of claim 33. Raghavan does not teach that four or multiple innervated IAS constructs are generated and implanted into the subject of claims 33 and 34. Raghavan does not explicitly teach the specific clinical qualification or symptoms required for fecal incontinence diagnosis of claim 37 and 38. For this reason, Bitar is added.
Bitar teaches in Example 2 that the neuronal progenitor cells were isolated from rabbit jejunum (Example 2, Col 18, line 47-52) and Bitar further teaches that the biopsy can be sourced from multiple intestinal sites (Col 6, line 50-54). Bitar teaches that at day 4, the innervated smooth muscle construct was placed next to the non-innervated smooth muscle construct (Example 2, Col 19, like 15-18), with differentiation observed by day 5 (Example 2, Col 20, line 33-37). Bitar teaches that the subject refers to any living organism such as humans (Col 5, line 10-11), and teaches that the treatment methods are directed to a subject who has a condition or disorder or a predisposition towards fecal incontinence (Col 5, line 19-27).
Silverman teaches the implantation of a plurality of implants with four or more implants being preferable (Col 10, line 11-18), noting that each quadrant of the internal sphincter is thereby enlisted to participate equally in augmenting sphincter competency (Col 10, line 18-20).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Raghavan, Bitar, and Silverman. A person having ordinary skill in the art would have been motivated to do so since both Raghavan and Biter are directed towards the IAS construct creation to treat human fecal incontinence. One would have been motivated to obtain a biopsy of sufficient mass of at least 50 mg, preferably 200 mg in order to yield the 500,000 SMCs and 200,000 NPCs as the working sample quantities in Raghavan.
Furthermore, one would have also been motivated to substitutes the jejunal tissue for colorectal tissue as the NPC source since Bitar demonstrates that using jejunum results functional NPCs by applying the identical protocol with a reasonable expectation of success, conduct the biopsy using a laparoscope as the standard for minimally invasive approach, mature the construct 3-12 days, encompassing the day 4 and 5 functional constructs of Bitar’s example 2, implant four constructs as per Silverman, and apply the methodology to human subjects with fecal incontinence. Each of these limitations constitutes either a routine optimization of a result-effective variable, a simple substitution of a known art element, or an application of a known standard clinical technique. For the foregoing reasons, Claims 26, 29-34, and 37-38 are rendered obvious by the teachings of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WENHAN LI whose telephone number is (571)272-9143. The examiner can normally be reached Monday-Friday 7:30 am-5 pm EST.
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/W.L./Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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