Prosecution Insights
Last updated: October 25, 2026
Application No. 19/119,188

Gamma stable composite elastomeric and thermoplastic material for pump tubing and other polymer geometries

Non-Final OA §103
Filed
Apr 08, 2025
Priority
Nov 22, 2022 — provisional 63/427,249 +1 more
Examiner
LEE, GEOFFREY S
Art Unit
3746
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Synth-Bio LLC
OA Round
1 (Non-Final)
61%
Grant Probability
Moderate
1-2
OA Rounds
1y 6m
Est. Remaining
81%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allowance Rate
212 granted / 350 resolved
-9.4% vs TC avg
Strong +20% interview lift
Without
With
+20.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
31 currently pending
Career history
402
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
49.4%
+9.4% vs TC avg
§102
26.3%
-13.7% vs TC avg
§112
23.3%
-16.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 350 resolved cases

Office Action

§103
DETAILED ACTION Claims 1-3, 6, 8-10, and 12-24 are pending. Claim Interpretation Applicant uses the term “micropore.” The term micropore is conventionally used to refer to materials that allow the free exchange of gases or the filtering of material. Applicant does not claim any filtering or gas exchange properties of the material. Instead, the micropore is only disclosed as containing the elastomeric material (applicant’s par 0011, 0034). Furthermore, no exchange of fluid is implied because the material is disclosed as a peristaltic pump tube, valve seat, valve liner, and gasket (Applicant’s spec, par 0002, 0036), which are all structures with fluid impermeability. In light of applicant’s disclosure, a person of ordinary skill in the art would interpret “micropore” as referring to the diameter of pores within the material with no implication of a filtering or gas exchange function, and that said micropore be capable of accepting some elastomeric material (applicant’s par 0011, 0034). Claim Objections Claims 1, 3, and 15 are objected to because of the following informalities: Claim 1 line 1, change ”an membrane” to “a membrane” because the word “an” should precede a word beginning with a consonant. Claim 3 recites “consisting of a polypropylene”. Delete the “a,” applicant is claiming the details of material composition and is not reciting a new structural element that necessitates the indefinite article “a.” Claim 15 recites “consisting of a polypropylene”. Delete the “a,” applicant is claiming the details of material composition and is not reciting a new structural element that necessitates the indefinite article “a.” Appropriate correction is required. 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. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 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. Claims 1-3, 6, 8-10, 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Golub (US2018/0274528) in view of Zhou (CN 102131568, citations to included translation). Claim 1, Golub discloses an article (flexible tubing, par 0006) comprising: a membrane (tube wall made of the continuous phase polypropylene and the cross-linked rubber phase, par 0007-0008) comprised of an elastomeric material (cross-linked rubber phase, par 0004) and having a membrane outer surface (continuous polypropylene phase, par 0004; liner layer, par 0036); and a substrate (polypropylene phase, par 0004) comprised of a microporous thermoplastic material (polypropylene, par 0008, See applicant’s claim 3) comprising a plurality of micropores (continuous phase of polypropylene has a cross-linked rubber phase discontinuously dispersed in the continuous phase, par 0008; the continuous phase provides space / pores that are occupied by the elastomeric material; this interpretation is in accord with applicant’s disclosure which extends elastomeric material into the micropores, applicant’s par 0011, 0034), said substrate attached to at least a portion of the membrane outer surface (the two materials are joined to make the tube, par 0004, 0036) …and wherein a volume ratio of the elastomeric material to the microporous thermoplastic material is in a range of between 1:1 and 100:1 (material volume ratio of the first polymeric material to the liner layer, 90-99%, par 0037; 90%-99% is equivalent to 9:1 – 99:1 which are between 1:1 and 100:1). Golub is silent on a membrane outer surface “having a thickness in a range of between 0.5 µm and 12 µm.” Zhou discloses a method of forming an asymmetric membrane, where a coating on a porous substrate of 0.5 microns to 10 microns in order to polymerize / cure the coating with ultraviolet radiation (par 0099); where the coating is a polymerized material retained within the porous substrate (abstract, par 0011, 0017-0019, 0020, 0024, 0029), where polypropylene is the polymerizable composition (par 0101, 0126), that is retained in the porous substrate via curing by the ultraviolet radiation (par 0017). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to select a thickness of the membrane outer surface of Golub in the range of 0.5 microns to 10 microns as taught by Zhou in order to effectively polymerize / cure the layer with ultraviolet light during the manufacturing process and assist in retaining the coating layer in the pores of the substrate (Zhou, par 0017). Claim 2, Golub in view of Zhou teaches the article of claim 1, wherein the elastomeric material is selected from the group consisting of …, fluorinated silicone (Golub, silicone rubber, par 0044), ethylene propylene diene monomer rubber (EPDM)(Golub, EPDM rubber, par 0043), and fluorocarbon-based Fluoroelastomers (rubber with a fluoropolymer liner layer, par 0036). Claim 3, Golub in view of Zhou teaches the article of claim 1, wherein the microporous thermoplastic material is selected from the group consisting of a polypropylene (Golub, par 0039, 0058) … Claim 6, Golub in view of Zhou teaches the article of claim 1. Golub is silent wherein the plurality of micropores have an average pore size in a range of between 0.1 µm and 15 µm. Zhou further teaches the plurality of micropores have an average pore size in a range of between 0.1 µm and 15 µm (Zhou, pore diameter less than 10 microns/ µm to less than 1 micron/ µm, par 0026; examiner notes that µm is the micron unit). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention select a micropore diameter size of Golub in view of Zhou that would allow effective polymerization of the coating as taught by Zhou, thereby ensuring a bond between the substrate and coating. Claim 8, Golub in view of Zhou teaches the article of claim 6, wherein a portion of the elastomeric material extends into at least a portion of the micropores (Golub, the polypropylene continuous phase and the cross-linked discontinuous phase dispersed within the continuous phase, par 0020). Claim 9, Golub in view of Zhou teaches the article of claim 1, wherein the article is in the form of a hollow tube (Golub, tube, par 0006). Claim 10, Golub in view of Zhou teaches the article of claim 9, wherein the hollow tube has an inside diameter in the range of between 0.5 mm and 300 mm (Golub, diameter 0.5mm to 40mm, par 0035). Claim 15, Golub in view of Zhou teaches the article of claim 2, wherein the microporous thermoplastic material is selected from the group consisting of a polypropylene (Golub, par 0039, 0058) … Claim 16, Golub in view of Zhou teaches the article of claim 2. Golub is silent wherein the plurality of micropores have an average pore size in a range of between 0.1 µm and 15 µm. Zhou further teaches the plurality of micropores have an average pore size in a range of between 0.1 µm and 15 µm (Zhou, pore diameter less than 10 microns/ µm to less than 1 micron/ µm, par 0026; examiner notes that µm is the micron unit). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention select a micropore diameter size of Golub in view of Zhou that would allow effective polymerization of the coating as taught by Zhou, thereby ensuring a bond between the substrate and coating. Claim 17, Golub in view of Zhou teaches the article of claim 3. Golub is silent wherein the plurality of micropores have an average pore size in a range of between 0.1 µm and 15 µm. Zhou further teaches the plurality of micropores have an average pore size in a range of between 0.1 µm and 15 µm (Zhou, pore diameter less than 10 microns/ µm to less than 1 micron/ µm, par 0026; examiner notes that µm is the micron unit). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention select a micropore diameter size of Golub in view of Zhou that would allow effective polymerization of the coating as taught by Zhou, thereby ensuring a bond between the substrate and coating. Claim 18, Golub in view of Zhou teaches the article of claim 16, wherein a portion of the elastomeric material extends into at least a portion of the micropores (Golub, the polypropylene continuous phase and the cross-linked discontinuous phase dispersed within the continuous phase, par 0020). Claim 19, Golub in view of Zhou teaches the article of claim 17, wherein a portion of the elastomeric material extends into at least a portion of the micropores (Golub, the polypropylene continuous phase and the cross-linked discontinuous phase dispersed within the continuous phase, par 0020). Claim 20, Golub in view of Zhou teaches the article of claim 19, wherein the article is in the form of a hollow tube (Golub, tube, par 0006). Claim 21, Golub in view of Zhou teaches the article of claim 20, wherein the hollow tube has an inside diameter in the range of between 0.5 mm and 300 mm (Golub, diameter 0.5mm to 40mm, par 0035). Claims 12-14 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Golub in view of Zhou in view of Gill (WO 9116562). PNG media_image1.png 168 324 media_image1.png Greyscale Gill fig 20 Claim 12, Golub in view of Zhou teaches the article of claim 1. Golub is silent on wherein the article is in the form of a gasket (12). Nevertheless, Golub teaches the use of the claimed elastomer material in peristaltic pumps (par 0003), where that elastomer material is in contact with the fluid within the pump (par 0036). A person of ordinary skill in the art would recognize that lining one portion of the pumping system suggests lining other fluid touching portions of the pumping system, such as the valves or sealing portions, for the same benefit as lining the tubing. Gill teaches a valve (fig 20, 360, pg 25 ln 28-35) made of elastomeric material (361) with flanges (362) which are in place of the gasket (335) and a bottom (362) which is sized to fit sealingly against the partition plate (325). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to manufacture the elastomeric material of Golub in view of Zhou as a gasket (362) as taught in Gill in order to provide the expected result of sealing on a valve surface in a pump system. Claim 13, Golub in view of Zhou teaches the article of claim 1. Golub is silent on wherein the article is in the form of a valve liner (13). Nevertheless, Golub teaches the use of the claimed elastomer material in peristaltic pumps (par 0003), where that elastomer material is in contact with the fluid within the pump (par 0036). A person of ordinary skill in the art would recognize that lining one portion of the pumping system suggests lining other fluid touching portions of the pumping system, such as the valves or sealing portions, for the same benefit as lining the tubing. Gill teaches a valve (fig 20, 360, pg 25 ln 28-35) made of elastomeric material (361), inert into the outlet chamber of the valve (329) with flanges (362) which are in place of the gasket (335) and a bottom (362) which is sized to fit sealingly against the partition plate (325). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to manufacture the elastomeric material of Golub in view of Zhou as a valve liner (360 is insert into the valve chamber 329) as taught in Gill in order to provide the expected result of sealing on a valve surface in a pump system. Claim 14, Golub in view of Zhou teaches the article of claim 1. Golub is silent on wherein the article is in the form of a valve seat (14). Nevertheless, Golub teaches the use of the claimed elastomer material in peristaltic pumps (par 0003), where that elastomer material is in contact with the fluid within the pump (par 0036). A person of ordinary skill in the art would recognize that lining one portion of the pumping system suggests lining other fluid touching portions of the pumping system, such as the valves or sealing portions, for the same benefit as lining the tubing. Gill teaches a valve (fig 20, 360, pg 25 ln 28-35) made of elastomeric material (361), inert into the outlet chamber of the valve (329) with flanges (362) which are in place of the gasket (335) and a bottom (362) which is sized to fit sealingly against the partition plate (325). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to manufacture the elastomeric material of Golub in view of Zhou as a bottom (362) sealing and sitting against partition plate (325) as taught in Gill in order to provide the expected result of sealing a valve seat on a valve surface in a pump system. Claim 22, Golub in view of Zhou teaches the article of claim 19. Golub is silent on wherein the article is in the form of a gasket (12). Nevertheless, Golub teaches the use of the claimed elastomer material in peristaltic pumps (par 0003), where that elastomer material is in contact with the fluid within the pump (par 0036). A person of ordinary skill in the art would recognize that lining one portion of the pumping system suggests lining other fluid touching portions of the pumping system, such as the valves or sealing portions, for the same benefit as lining the tubing. Gill teaches a valve (fig 20, 360, pg 25 ln 28-35) made of elastomeric material (361) with flanges (362) which are in place of the gasket (335) and a bottom (362) which is sized to fit sealingly against the partition plate (325). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to manufacture the elastomeric material of Golub in view of Zhou as a gasket (362) as taught in Gill in order to provide the expected result of sealing on a valve surface in a pump system. Claim 23, Golub in view of Zhou teaches the article of claim 19. Golub is silent on wherein the article is in the form of a valve liner (13). Nevertheless, Golub teaches the use of the claimed elastomer material in peristaltic pumps (par 0003), where that elastomer material is in contact with the fluid within the pump (par 0036). A person of ordinary skill in the art would recognize that lining one portion of the pumping system suggests lining other fluid touching portions of the pumping system, such as the valves or sealing portions, for the same benefit as lining the tubing. Gill teaches a valve (fig 20, 360, pg 25 ln 28-35) made of elastomeric material (361), inert into the outlet chamber of the valve (329) with flanges (362) which are in place of the gasket (335) and a bottom (362) which is sized to fit sealingly against the partition plate (325). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to manufacture the elastomeric material of Golub in view of Zhou as a valve liner (360 is insert into the valve chamber 329) as taught in Gill in order to provide the expected result of sealing on a valve surface in a pump system. Claim 24, Golub in view of Zhou teaches the article of claim 19. Golub is silent on wherein the article is in the form of a valve seat (14). Nevertheless, Golub teaches the use of the claimed elastomer material in peristaltic pumps (par 0003), where that elastomer material is in contact with the fluid within the pump (par 0036). A person of ordinary skill in the art would recognize that lining one portion of the pumping system suggests lining other fluid touching portions of the pumping system, such as the valves or sealing portions, for the same benefit as lining the tubing. Gill teaches a valve (fig 20, 360, pg 25 ln 28-35) made of elastomeric material (361), inert into the outlet chamber of the valve (329) with flanges (362) which are in place of the gasket (335) and a bottom (362) which is sized to fit sealingly against the partition plate (325). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to manufacture the elastomeric material of Golub in view of Zhou as a bottom (362) sealing and sitting against partition plate (325) as taught in Gill in order to provide the expected result of sealing a valve seat on a valve surface in a pump system. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Charkoudian (US 7,919,178) discusses manufacturing of an analogous porous membrane. Smith (US 7,338,692) discusses manufacturing of an analogous porous membrane. Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEOFFREY S LEE whose telephone number is (571)272-5354. The examiner can normally be reached Mon-Fri 0900-1800. 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, Essama Omgba can be reached at (469) 295-9278. 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. /GEOFFREY S LEE/Examiner, Art Unit 3746
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Prosecution Timeline

Apr 08, 2025
Application Filed
Sep 15, 2026
Non-Final Rejection mailed — §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
61%
Grant Probability
81%
With Interview (+20.4%)
3y 1m (~1y 6m remaining)
Median Time to Grant
Low
PTA Risk
Based on 350 resolved cases by this examiner. Grant probability derived from career allowance rate.

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