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 with traverse of Invention I (claims 1-11) and Species III (Figure 5) in the reply filed on August 4, 2026 is acknowledged. The traversal is on the ground(s) that: Although the Requirement asserts that the process as claimed can be used to make another and materially different product, such as a bottle having a bottle cap and a bottle body, Applicant respectfully contends that this example characterizes the process at an overly broad level of generality. The process claims are directed to manufacturing the disclosed two-part stopper, not merely to the general formation of separate polymer components. The Specification describes the two-part stopper as including a stopper cap and a stopper body configured for use as a stopper in a syringe. Accordingly, the alleged bottle example does not adequately show that the process as claimed can be used to make another materially different product. The Requirement further asserts that the product as claimed can be made by another and materially different process, such as cutting two polymer material pieces and gluing the two polymer material pieces together, Applicant respectfully contends that this example does not adequately show that the resulting structure would provide the product as claimed. The claimed product is not merely two polymer materials joined together, but a two-part stopper configured for use with a syringe. The Specification describes the stopper as having sealing ribs and being formed from materials selected and arranged for the stopper's intended use. Merely cutting two polymer material pieces and gluing them together does not establish that the resulting structure would provide a stopper having the claimed structure and functionality, including sealing engagement suitable for use in a syringe. Therefore, Applicant respectfully contends that the Requirement does not adequately establish that Invention I and Invention II are distinct in view of MPEP § 806.05(f). The Requirement further asserts that a serious search and/or examination burden exists because Inventions I and II have acquired a separate status in the art in view of their different classification, recognized divergent subject matter, or different field of search. Applicant respectfully disagrees. According to MPEP § 803, "[Ilf the search and examination of all the claims in an application can be made without serious burden, the examiner must examine them on the merits, even though they include claims to independent or distinct inventions." (emphasis added). Although the Requirement asserts that Inventions I and II have separate classification, separate status in the art, and/or require a different field of search, the Requirement does not establish how examination of the product and method claims directed to the same disclosed two- part stopper would result in a serious burden being imposed. Applicant respectfully contends that, when searching for a two-part stopper configured for use with a syringe, one would reasonably be expected to find methods of manufacturing two-part stoppers, including co-injection molding or sequential injection molding, similar to that of invention II. Likewise, when searching for a method of making the disclosed two- part stopper, one would inevitably find two-part stoppers and syringes incorporating the two-part stopper, similar to that of invention I. The product and process claims are directed to closely related aspects of the same disclosed two-part stopper and its manufacture. Accordingly, searching for the elected invention would reasonably involve consideration of the method of making a similar disclosed two-part stopper. With respect to the species restriction, Applicant respectfully contends that the Requirement does not adequately establish that the identified species would impose a serious search and/or examination burden. The identified species are directed to alternative configurations of the same two-part stopper. The differences identified in the Requirement relate to the extent of lamination of the stopper cap and/or stopper body and the number or location of sealing ribs. The mere identification of different lamination arrangements or different sealing-rib configurations does not, by itself, demonstrate that the claims would require materially different searches or examinations. Applicant respectfully contends that, when searching for the two-part stopper of elected Species III, one would inevitably find two-part stoppers similar to that of Species I and Species II. Specifically, when searching for a two-part stopper having a laminated stopper cap and a stopper body having two sealing ribs associated with Species III, one would inevitably find two- part stoppers having a laminated cap or laminated stopper body, similar to Species I and Species II, and two-part stoppers having 2 or more of sealing ribs on the stopper body, similar to Species I or Species II. The identified species merely describe different or alternative arrangements configurations of a two-part stopper used with a syringe, including variations in the lamination of the stopper cap and/or stopper body and the number of sealing ribs, while the two-part stopper remains configured for attachment to a plunger so as to act as a seal for the syringe barrel (Remarks, pages 3-5).
This is not found persuasive because: First, the process of making only makes a cap and a body out of polymer materials. And the process of making does not claim the stopper cap and the stopper body “configured for use as a stopper in a syringe”, as argued by Applicant. Second, the product can be made by cutting two polymer material pieces and gluing the two polymer material pieces together. And the product does not claim the stopper being formed from materials selected “and arranged for the stopper's intended use”, as argued by Applicant. Third, the serious search and/or examination burden is because the inventions have acquired a separate status in the art in view of their different classification, recognized divergent subject matter, and different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries). Fourth, the different species have mutually exclusive characteristics for each identified species requiring a search of recognized divergent subject matter, different classes/subclasses or electronic resources, and different search strategies or search queries.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 4, 2026.
Specification
The abstract of the disclosure is objected to because:
In line 3, “the stopper” should be changed to “a stopper”
In line 3, “the remainder” should be changed to “a remainder”
In line 4, “same” should be changed to “the stopper”
In line 5, “such stoppers” should be changed to “the stopper”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 3-5, and 8-11 are objected to because of the following informalities:
In regards to claim 1, lines 2-3, “formed from a first polymer material formed from a first polymer material” should be changed to “formed from a first polymer material”.
In regards to claim 3, line 1, “first polymer material” should be changed to “the first polymer material”.
In regards to claim 3, line 2, “the range” should be changed to “a range”.
In regards to claim 3, lines 2-3, “the range” should be changed to “a range”.
In regards to claim 4, lines 5-6, “at least one brominated isobutylene paramethyl-styrene terpolymers (BIMSM) rubber” should be changed to “at least one brominated isobutylene paramethyl-styrene terpolymer (BIMSM) rubber”.
In regards to claim 4, line 6, “the backbone” should be changed to “a backbone”.
In regards to claim 4, line 6, “the polymer” should be changed to “the at least one brominated isobutylene paramethyl-styrene terpolymer (BIMSM) rubber”.
In regards to claim 5, line 4, “thereof” should be changed to “of the one or more additives, the one or more fillers, the one or more processing aids, the one or more oils, or the one or more dyes or colorants”.
In regards to claim 8, line 2, “thereon” should be changed to “on the at least one of the stopper cap and/or the stopper body”.
In regards to claim 9, line 2, “thereon” should be changed to “on the stopper cap”.
In regards to claim 10, line 2, “thereon” should be changed to “on the stopper body”.
In regards to claim 11, lines 4-5, “formed from a first polymer material formed from a first polymer material” should be changed to “formed from a first polymer material”.
In regards to claim 11, line 8, “so as act” should be changed to “so as to act”.
Appropriate correction is required.
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 2, 4, and 9-10 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.
In regards to claim 2, lines 3-4 recite “a platen temperature between about 90°C and about 130°C”. Claim 2 depends upon claim 1. Claim 1, line 3 recites “a low temperature of less than 130°C”. It is unclear whether the two temperatures are the same or different.
In regards to claim 4, lines 3-4, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation “the one or more styrene terpolymers are selected from one or more crosslinked backbone unsaturated styrene terpolymers” following the phrase is part of the claimed invention.
In regards to claim 4, lines 4-6, the phrase "further optionally" renders the claim indefinite because it is unclear whether the limitation “the one or more styrene terpolymers are selected from at least one brominated isobutylene paramethyl-styrene terpolymers (BIMSM) rubber with no unsaturation on the backbone of the polymer” following the phrase is part of the claimed invention.
In regards to claim 9, line 1 recites “a sealing rib”. Claim 9 depends upon claim 8. Claim 8, line 2 recites “at least one sealing rib”. It is unclear whether the two recitations are the same element or different elements. Claim 10 is rejected by virtue of being dependent upon claim 9.
In regards to claim 10, lines 1-2 recite “at least two sealing ribs”. Claim 10 depends upon claim 9. Claim 9, line 1 recites “a sealing rib”. Claim 9 depends upon claim 8. Claim 8, line 2 recites “at least one sealing rib”. It is unclear whether the three recitations are the same element or different elements.
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 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fournier et al (US 2017/0368264).
In regards to claim 1, Fournier et al a two-part stopper (Figure 2) comprising:
a stopper cap (513) formed from a first polymer material formed from a first polymer material (paragraph [0060])
a stopper body (511) formed from a second polymer material (paragraph [0060])
Fournier et al is silent about whether the first polymer material “can be processed at a low temperature of less than 130°C” and whether the second polymer material “can be processed at a higher temperature of more than 150°C”. But the limitations “can be processed at a low temperature of less than 130°C” and “can be processed at a higher temperature of more than 150°C” are held as process terms in a product-by-process claim, and thus the patentability of a product does not depend on its method of production. Structurally, Fournier et al teaches the same structure claimed of a two-part stopper comprising a stopper cap and a stopper body.
In regards to claim 2, Fournier et al is silent about wherein the processing of the first polymer material is defined as an increase in ultimate torque response as measured by cure rheometer (ASTM 05289) of at least 400 percent within 10 minutes of isothermal conditioning at a platen temperature between about 90°C and about 130°C. But the limitation “wherein the processing of the first polymer material is defined as an increase in ultimate torque response as measured by cure rheometer (ASTM 05289) of at least 400 percent within 10 minutes of isothermal conditioning at a platen temperature between about 90°C and about 130°C” is held as a process term in a product-by-process claim, and thus the patentability of a product does not depend on its method of production. Structurally, Fournier et al teaches the same structure claimed of a two-part stopper comprising a stopper cap and a stopper body.
In regards to claim 3, Fournier et al teaches wherein first polymer material has a Young’s modulus in the range of about 7.5 MPa to about 12.5 MPa and a Shore A hardness in the range of about 40 to about 120 (paragraph [0060]: EPDM (ethylene propylene diene terpolymer)).
In regards to claim 4, Fournier et al teaches wherein the first polymer material is one or more propylene-containing polymers (paragraph [0060]: EPDM (ethylene propylene diene terpolymer)).
In regards to claim 5, Fournier et al teaches wherein either one, or both, of the first polymer material and/or the second polymer material further comprises one or more fillers (paragraph [0060]).
In regards to claim 6, Fournier et al teaches wherein at least one of the stopper cap and/or the stopper body is at least partially laminated (635).
In regards to claim 7, Fournier et al teaches wherein the stopper cap is laminated (635).
In regards to claim 8, Fournier et al teaches wherein at least one of the stopper cap and/or the stopper body further comprises at least one sealing rib (630/610) formed thereon.
In regards to claim 9, Fournier et al teaches wherein the stopper cap has a sealing rib (630) formed thereon.
In regards to claim 10, Fournier et al teaches wherein the stopper body has at least two sealing ribs formed thereon (paragraph [0051]: both secondary sealing profiles 610 could be formed on said hollow cylindrical body 511).
In regards to claim 11, Fournier et al teaches a syringe (paragraph [0054]: syringe)(Figure 2) comprising:
a syringe barrel (paragraph [0054]: syringe body)
a plunger (claim 11: actuator member), wherein the plunger is designed to fit within the syringe barrel (paragraph [0002])
a two-part stopper (Figure 2) having a stopper cap (513) formed from a first polymer material formed from a first polymer material (paragraph [0060]), and a stopper body (511) formed from a second polymer material (paragraph [0060]), wherein the stopper is adapted for attachment to one end of the plunger so as act as a seal for the syringe barrel (claim 11)(paragraph [0054])
Fournier et al is silent about whether the first polymer material “can be processed at a low temperature of less than 130°C” and whether the second polymer material “can be processed at a higher temperature of more than 150°C”. But the limitations “can be processed at a low temperature of less than 130°C” and “can be processed at a higher temperature of more than 150°C” are held as process terms in a product-by-process claim, and thus the patentability of a product does not depend on its method of production. Structurally, Fournier et al teaches the same structure claimed of a syringe comprising a syringe barrel, a plunger, and a two-part stopper having a stopper cap and a stopper body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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, Kevin C Sirmons can be reached at (571) 272-4965. 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.
/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
Prosecution Insights