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 .
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.
Priority
Claims 3 and 6 have a priority date of 9/27/24 as the parent applications filed 3/29/22 and 3/28/23 do not have support for the overnight culture being specifically at 37°C.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “infection prevention or mitigation mechanism” in claim 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: While the specification discloses that the material of the non-porous, non-organic polymer of the sealing layer prevents any bacteria from transferring from the tissue-facing surface to the opposing surface of the textile layer after the tissue-facing surface is submerged in 10 mL of growth media containing 1,000 CFU/mL overnight culture of Staph. aureus for 24 hours, the specification fails to disclose that this process is conducted specifically at 37°C.
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 3, 6 and 8 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.
Claims 3, 6 are indefinite due to lack of description in the specification for the limitation “at 37°C”, therefore rendering the scope of the claim unclear.
Claim 8 recites the limitation "the material comprises silicone foam rubber", but claim 1, upon which claim 8 depends, recites “a non-porous, non-organic polymer”. Silicone foam is inherently porous. Therefore, the limitation of claim 8 is being interpreted as reciting "the material comprises silicone rubber".
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.
Claim(s) 1-15 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stevenson (20200330213).
With regards to claim 1, Stevenson discloses a tubular or non-tubular implant or prosthetic (10)comprising: a textile layer ([0379], “the conduit 10 is a woven, fibrous polymer conduit 10”) comprising a plurality of interstices and/or pores (10e, [0098], [0379]), and defining an interfacing surface (10a) and an opposing surface (10b); and a sealing layer (14) comprising a non-porous, non-organic polymer ([0467], silicone rubber) adhered to the interfacing surface and defining a tissue-facing surface (FIG 1c), wherein the non-porous, non-organic polymer is configured to at least partially penetrate through at least some of the plurality of interstices and/or pores at the interfacing surface of the textile layer ([0646], “two mechanisms by which silicone penetrated into the inner surface of the fabric were observed, i.e., either through the yarn bundle fibers or by passing between the gaps in the yarn bundles.”), wherein the non-porous, non-organic polymer is formed of a material configured to prevent transmission or migration of bacteria through the sealing layer ([0467], silicone rubber is chemically inert and hydrophobic, preventing bacteria from adhering. Therefore, the prior art is capable of preventing transmission or migration of bacteria through the sealing layer. The examiner also notes that term “configured to prevent” is given the broadest reasonable interpretation to encompass any degree of prevention).
With regards to claim 2, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 1, wherein the material of the non-porous, non-organic polymer of the sealing layer (14) prevents transmission or migration of bacteria from the tissue-facing surface to the opposing surface of the textile layer ([0467], silicone rubber is chemically inert and hydrophobic, preventing bacteria from adhering. Therefore, the prior art is capable of preventing transmission or migration of bacteria through the sealing layer. The examiner also notes that term “configured to prevent” is given the broadest reasonable interpretation to encompass any degree of prevention).
With regards to claim 3, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 2, wherein the material of the non-porous, non-organic polymer of the sealing layer (14) prevents any bacteria from transferring from the tissue-facing surface to the opposing surface of the textile layer after the tissue-facing surface is submerged in 10 mL of growth media containing 1,000 CFU/mL overnight culture of Staph. aureus for 24 hours at 37°C ([0467], silicone rubber is chemically inert and hydrophobic, preventing bacteria from adhering). The phrase “prevents any bacteria from transferring from the tissue-facing surface to the opposing surface of the textile layer after the tissue-facing surface is submerged in 10 mL of growth media containing 1,000 CFU/mL overnight culture of Staph. aureus for 24 hours at 37°C” is treated as functional language that is not given full patentable weight. The prior art is not required to disclose that the sealing layer prevents bacteria from transferring under the given conditions, but merely have the capability of the performing the function, in order to meet the claim requirement. The sealing layer of Stevenson is capable of performing this function.
With regards to claim 4, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 1, wherein the material of the non-porous, non-organic polymer of the sealing layer prevents transmission or migration of bacteria from the opposing surface of the textile layer to the tissue-facing surface ([0467], silicone rubber is chemically inert and hydrophobic, preventing bacteria from adhering. Therefore, the prior art is capable of preventing transmission or migration of bacteria through the sealing layer. The examiner also notes that term “configured to prevent” is given the broadest reasonable interpretation to encompass any degree of prevention).
With regards to claim 5, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 1, wherein the material of the non-porous, non-organic polymer of the sealing layer mitigates buildup of bacteria on the tissue-facing surface compared to a similar implant or prosthetic with a sealing layer formed of an organic polymer ([0467], silicone rubber is chemically inert and hydrophobic, preventing bacteria from adhering. Therefore, the prior art is capable of preventing transmission or migration of bacteria through the sealing layer. The examiner also notes that term “configured to prevent” is given the broadest reasonable interpretation to encompass any degree of prevention).
With regards to claim 6, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 5, wherein the tissue-facing surface of the non-porous, non-organic polymer of the sealing layer measures at least 50% less bacteria than a tissue-facing surface from the similar implant or prosthetic with the sealing layer formed of the organic polymer after both tissue-facing surfaces are submerged in 10 mL of growth media containing 1,000 CFU/mL overnight culture of Staph. aureus for 24 hours at 37°C ([0467], silicone rubber is chemically inert and hydrophobic, preventing bacteria from adhering). The phrase “prevents any bacteria from transferring from the tissue-facing surface to the opposing surface of the textile layer after the tissue-facing surface is submerged in 10 mL of growth media containing 1,000 CFU/mL overnight culture of Staph. aureus for 24 hours at 37°C” is treated as functional language that is not given full patentable weight. The prior art is not required to disclose that the sealing layer prevents bacteria from transferring under the given conditions, but merely have the capability of the performing the function, in order to meet the claim requirement. The sealing layer of Stevenson is capable of performing this function.
With regards to claim 7, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 1, wherein the material comprises silicone ([0467], silicone rubber).
With regards to claim 8, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 1, wherein the material comprises silicone rubber ([0467], silicone rubber).
With regards to claim 9, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 1 comprising a cross-section formed of at least a first zone, a second zone, and a third zone (FIG 17), wherein the first zone is within the textile layer and is bounded on a first side by the opposing surface of the textile layer (FIG 17) and wherein the plurality of interstices and/or pores within the first zone do not comprise any of the non-porous, non-organic polymer of the sealing layer ([0699], “The fiber bundles 58 at the inner textile surface 54 were free from silicone sealant 56”), wherein the second zone is within the textile layer and located adjacent to and bounded on a first side by the first zone and on an opposing side by the interfacing surface (FIG 17), wherein the plurality of interstices and/or pores within the second zone comprise at least some of the non-porous, non-organic polymer ([0699], “the silicone sealant 56 penetrated and encapsulated the textile fiber bundles 58 at the outer textile surface”), wherein the third zone is within the sealing layer and is located adjacent to and bounded on a first side by the interfacing surface of the textile layer and on an opposing side by the tissue-facing surface of the sealing layer (FIG 17), and wherein the material of the non-porous, non-organic polymer is configured to prevent transmission or migration of the bacteria from the tissue-facing surface to at least the first zone ([0467], silicone rubber is chemically inert and hydrophobic, and capable of preventing bacteria from migrating. Therefore, the prior art is capable of preventing transmission or migration of bacteria through the sealing layer. The examiner also notes that term “configured to prevent” is given the broadest reasonable interpretation to encompass any degree of prevention).
With regards to claim 10, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 9, wherein the material of the non-porous, non-organic polymer is configured to prevent transmission or migration of the bacteria from the tissue-facing surface to at least the first zone and the second zone ([0467], silicone rubber is chemically inert and hydrophobic, and capable of preventing bacteria from migrating. Therefore, the prior art is capable of preventing transmission or migration of bacteria through the sealing layer. The examiner also notes that term “configured to prevent” is given the broadest reasonable interpretation to encompass any degree of prevention).
With regards to claim 11, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 1, wherein the non-porous, non-organic polymer of the sealing layer does not penetrate to the opposing surface of the textile layer (FIG 14, [0688], “Individual textile bundles 58 were general free of silicone sealant penetration”).
With regards to claim 12, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 1, wherein at least some of the non-porous, non-organic polymer of the sealing layer penetrates to the opposing surface of the textile layer (FIG 12, [0677], “Fiber bundles 58A were fully encapsulated by the silicone sealant 56”).
With regards to claim 13, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 1, wherein the material of the non-porous, non-organic polymer is configured to prevent bacteria from adhering to the tissue-facing surface ([0467], silicone rubber is chemically inert and hydrophobic, and capable of preventing bacteria from adhering. Therefore, the prior art is capable of preventing transmission or migration of bacteria through the sealing layer. The examiner also notes that term “configured to prevent” is given the broadest reasonable interpretation to encompass any degree of prevention).
With regards to claim 14, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 1, wherein the material of the non-porous, non-organic polymer is configured to prevent seromas from forming on the tissue-facing surface ([0467], silicone rubber is chemically inert and hydrophobic, and capable of preventing seromas from forming).
With regards to claim 15, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 1, wherein the material of the non-porous, non-organic polymer is configured to prevent infection from forming on the tissue-facing surface ([0467], silicone rubber is chemically inert and hydrophobic, and capable of preventing bacteria from adhering, and therefore infection from forming. The examiner also notes that term “configured to prevent” is given the broadest reasonable interpretation to encompass any degree of prevention).
With regards to claim 17, Stevenson discloses a tubular or non-tubular implant or prosthetic comprising: a textile layer ([0379], “the conduit 10 is a woven, fibrous polymer conduit 10”) comprising a plurality of interstices and/or pores (10e, [0098], [0379]), and defining an interfacing surface (10a) and an opposing surface (10b); and a sealing layer (14) comprising a non-porous, non-organic polymer ([0467], silicone rubber) attached to the interfacing surface and defining a tissue-facing surface (FIG 1c), wherein the non-porous, non-organic polymer is configured to at least partially penetrate through at least some of the plurality of interstices and/or pores at the interfacing surface of the textile layer ([0646], “two mechanisms by which silicone penetrated into the inner surface of the fabric were observed, i.e., either through the yarn bundle fibers or by passing between the gaps in the yarn bundles.”), wherein the non-porous, non-organic polymer is formed of a material configured to prevent or mitigate transmission or migration of bacteria through the sealing layer ([0467], silicone rubber is chemically inert and hydrophobic, and capable of preventing bacteria from migrating. The examiner also notes that term “configured to prevent” is given the broadest reasonable interpretation to encompass any degree of prevention).
With regard to claim 18, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 17, wherein the material of the non-porous, non-organic polymer of the sealing layer prevents or mitigates transmission or migration of bacteria from a body cavity adjacent the tissue-facing surface through the implant or prosthetic ([0467], silicone rubber is chemically inert and hydrophobic, and capable of preventing bacteria from migrating. The examiner also notes that term “configured to prevent” is given the broadest reasonable interpretation to encompass any degree of prevention).
With regards to claim 19, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 17, wherein the material of the non-porous, non-organic polymer of the sealing layer prevents or mitigates transmission or migration of bacteria from a blood stream adjacent the opposing surface of the textile layer through the implant or prosthetic ([0467], silicone rubber is chemically inert and hydrophobic, and capable of preventing bacteria from migrating. The examiner also notes that term “configured to prevent” is given the broadest reasonable interpretation to encompass any degree of prevention).
With regards to claim 20, Stevenson discloses a tubular or non-tubular implant or prosthetic (10) configured to prevent or mitigate infection when implanted into a living body, comprising: ([0379], “the conduit 10 is a woven, fibrous polymer conduit 10”) comprising a plurality of interstices and/or pores (10e, [0098], [0379]), and defining an interfacing surface (10a) and an opposing surface (10b); and a sealing layer (14) of a non-porous, non-organic polymer and/or co-polymer ([0467], silicone rubber) adhered to the interfacing surface and defining a tissue-facing surface (FIG 1c), wherein the non-porous, non-organic polymer and/or co-polymer is configured to at least partially penetrate through at least some of the plurality of interstices and/or pores at the interfacing surface of the textile layer ([0646], “two mechanisms by which silicone penetrated into the inner surface of the fabric were observed, i.e., either through the yarn bundle fibers or by passing between the gaps in the yarn bundles.”), wherein the sealing layer mitigates infections by preventing transmission or migration of bacteria through the sealing layer ([0467], silicone rubber is chemically inert and hydrophobic, and capable of preventing bacteria from migrating. Therefore, the prior art is capable of preventing transmission or migration of bacteria through the sealing layer. The examiner also notes that term “configured to prevent” is given the broadest reasonable interpretation to encompass any degree of prevention).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Stevenson (20200330213) in view of Song (20120328683).
With regards to claim 16, Stevenson discloses the tubular or non-tubular implant or prosthetic of claim 1, but fails to disclose that it further comprises at least one infection prevention or mitigation mechanism embedded within the sealing layer or disposed on the tissue-facing surface of the sealing layer.
Song discloses an infection prevention mechanism ([0002], oligomeric antimicrobial compounds) and a silicone rubber ([0002]). Song teaches disposing the infection prevention mechanism on the silicone rubber ([0002]; this element is interpreted under 112(f) as being an antibiotic, see paragraph [0082] of the instant application, and equivalents thereof). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Stevenson’s implant to include at least one infection prevention or mitigation mechanism embedded within the sealing layer or disposed on the tissue-facing surface of the sealing layer, as taught by Song, in order to impart antimicrobial activity on the implant ([0002]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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, Melanie Tyson can be reached at (571) 272-9062. 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.
/R.F.N./Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
Prosecution Insights