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 .
Election/Restrictions
Applicant’s election of Group I, Species A3 in the reply filed on 11/18/2025 is acknowledged. 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Claim(s) 8-20 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/ species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/18/2025.
PLEASE NOTE: Examiner is withdrawing the species election requirement for Species B1-B4.
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.
Claim(s) 1-7 is/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.
Within claim 1, lines 1-2: Applicant claims, “a pyloric occlusion system comprising a silk-based volumizing agent injected into a pyloric tissue”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the invention – the scope of the claim is determined by the preamble (which is to the pyloric occlusion system alone); however, the aforementioned claim requirement is claiming the method of use (the silk-based volumizing agent injected into a pyloric tissue). As such, it is unclear, whether Applicant is trying to claim the pyloric occlusion system alone or the method us implanting/ using the pyloric occlusion system. Claim(s) 2-7, which depend from claim 1, inherit all the problems associated with claim 1.
Within claim 3, lines 3-5: Applicant claims, “wherein the first bulking agent component is fibrinogen, the second bulking agent component is thrombin, or both”; it is unclear, and therefore indefinite, what is being referred to by the “or both” – does the “or both” refer to the second bulking agent potentially comprising fibrinogen or thrombin OR is the “or both” referring to either the first or second bulking agent comprising both the fibrinogen and thrombin? Claim(s) 4-6, which depend from claim 3, inherit all the problems associated with claim 3.
Claim 5 recites the limitation "the in-situ implant" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the in-situ implant" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the pyloric sphincter" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Hoang et al. (US 2018/0272033 A1).
With respect to claim 1:
Hoang et al. discloses a pyloric occlusion system (injectable composition) comprising a silk-based tissue volumizing agent (injectable composition comprising silk fibroin) configured to be injected into a pyloric tissue, wherein the silk-based tissue volumizing agent (injectable composition comprising silk fibroin) is configured to degrade at approximately a same rate as a growth rate of the pyloric tissue (will degrade to allow soft tissue regeneration) (paragraph [0006, 0047, 0131]). (PLEASE NOTE: With respect to claim 1: Applicant claims: “a silk-based tissue volumizing agent configured to be injected into a pyloric tissue”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering injectable composition, as disclosed by Hoang et al., as capable of being injected into a pyloric tissue. Additionally, Applicant claims, “the silk-based tissue volumizing agent is configured to degrade at approximately a same rate as a growth rate of the pyloric tissue”, this is functional language. “While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did no defeat the Board's finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); In Re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F. 2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). “[A]pparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).” See MPEP 2114. Examiner is considering the injectable composition (if positioned differently, such as within the pyloric tissue), as disclosed by Hoang et al., as capable of degrading at approximately the same rate as growth of pyloric tissue (as the silk used in forming the injectable composition, as disclosed by Hoang et al., is made from the same material, as disclosed by Applicant and will therefore have the same/ similar degradation characteristic when positioned in the same tissue.))
With respect to claim 2:
Wherein the silk-based tissue volumizing agent (injectable composition) is configured to partially occlude a pylorus. (PLEASE NOTE: With respect to claim 2: Applicant claims: “the silk-based tissue volumizing agent configured to partially occlude a pylorus”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering injectable composition, as disclosed by Hoang et al., as capable of being injected into a pyloric tissue and partially occluding a pylorus.)
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by CLINE et al. (US 2016/0199630 A1).
With respect to claim 1:
CLINE et al. discloses a pyloric occlusion system (occlusive element in the form of a pre-formed device/ cervical canal barrier implant) (paragraphs [0084]) comprising a silk-based tissue volumizing agent (silk) (paragraph [0087]) configured to be injected into a pyloric tissue, wherein the silk-based tissue volumizing agent (silk) is configured to degrade at approximately a same rate as a growth rate of the pyloric tissue. (PLEASE NOTE: With respect to claim 1: Applicant claims: “a silk-based tissue volumizing agent configured to be injected into a pyloric tissue”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering occlusive element formed of silk, as disclosed by CLINE et al., as capable of being injected into a pyloric tissue. Additionally, Applicant claims, “the silk-based tissue volumizing agent is configured to degrade at approximately a same rate as a growth rate of the pyloric tissue”, this is functional language. “While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did no defeat the Board's finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); In Re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F. 2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). “[A]pparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).” See MPEP 2114. Examiner is considering the occlusive element formed of silk/ cervical canal barrier implant (if positioned differently, such as within the pyloric tissue), as disclosed by CLINE et al., as capable of degrading at approximately the same rate as growth of pyloric tissue (as the silk used to create the occlusive element/ cervical canal barrier implant, as disclosed by CLINE et al., is made from the same material, as disclosed by Applicant and will therefore have the same/ similar degradation characteristic when positioned in the same tissue.) )
With respect to claim 2:
Wherein the silk-based tissue volumizing agent (occlusive element formed of silk/ cervical canal barrier implant) is configured to partially occlude a pylorus. (PLEASE NOTE: With respect to claim 2: Applicant claims: “the silk-based tissue volumizing agent configured to partially occlude a pylorus”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering occlusive element formed of silk/ cervical canal barrier implant, as disclosed by CLINE et al., as capable of being injected into a pyloric tissue and partially occluding a pylorus.)
With respect to claim 3:
Further comprising a first bulking agent component (fibrinogen of ectocervical microbial barrier) and a second bulking agent component (thrombin of ectocervical microbial barrier) configured to polymerize (increase in viscosity due to a chemical reaction) when placed in contact in-situ with the first bulking agent component (fibrinogen of ectocervical microbial barrier) on a surface of the pyloric tissue, wherein the first bulking agent component is fibrinogen (fibrinogen of ectocervical microbial barrier), the second bulking agent component is thrombin (thrombin of ectocervical microbial barrier), or both (paragraphs [0089, 0123, 0175, 0177, 0186, 0199]). (PLEASE NOTE: With respect to claim 3: Applicant claims: “configured to polymerize when placed in contact in-situ with the first bulking agent component on a surface of the pyloric tissue”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering ectocervical microbial barrier of fibrinogen and thrombin, as disclosed by CLINE et al., as capable of positioned on a surface of pyloric tissue.)
With respect to claim 4:
Wherein the first bulking agent (fibrinogen of ectocervical microbial barrier) component and the second bulking agent component (thrombin of ectocervical microbial barrier) are configured to polymerize (increase in viscosity due to a chemical reaction) to form an in-situ implant (ectocervical microbial barrier) (paragraphs [0089, 0123, 0175, 0177, 0186, 0199]).
Within respect to claim 5:
Wherein the in-situ implant (ectocervical microbial barrier) is configured to completely occlude the pylorus. (PLEASE NOTE: With respect to claim 1: Applicant claims: “the in-situ implant is configured to completely occlude the pylorus”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering the ectocervical microbial barrier, as disclosed by CLINE et al., as capable of being positioned such that it can completely occlude a pylorus.)
With respect to claim 6:
Wherein the in-situ implant (ectocervical microbial barrier) is configured anchor to at least one side of the pyloric sphincter. (PLEASE NOTE: With respect to claim 1: Applicant claims: “in-situ implant is configured anchor to at least one side of the pyloric sphincter”; this is intended use language. A recitation of the intended use of the claimed invention/ structure must result in a structural difference between the claimed invention/ structure and the prior art in order to patentably distinguish the claimed invention/ structure from the prior art. If the prior art structure is capable of performing the intend use, then it meets the claim. Examiner is considering the ectocervical microbial barrier, as disclosed by CLINE et al., as capable of being positioned such that it can anchor to at least one side of the pyloric sphincter.)
With respect to claim 7:
Wherein the silk-based volumizing agent (occlusive element formed of silk/ cervical canal barrier implant) is imageable via ultrasound (contains a visualization feature visible via transcutaneous ultrasound) (paragraphs [0110, 0114]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA S PRESTON/ Examiner, Art Unit 3774