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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/27/2026 has been entered.
Status of Claims
Amendment filed on 05/27/2026 is acknowledged.
Claims 4-5, 7-14, 16, 18-33, 36-37, 40, 42-55, 57-58, 60, 62-66, 68, 70-71, 73-74 remain canceled. Claim 56 and 59 are now cancelled.
Claims 1, 34 and 78 are amended.
Claims 79-80 are new.
Claims 1-3, 6, 15, 17, 34-35, 38-39, 41, 61, 67, 69, 72, and 75-80 are pending and being examined on the merits herein.
Priority
The instant application 18038234, filed on 05/23/2023, is a 371 of PCT/US2160815, filed on 11/24/2021, which claims domestic benefit of 63118622, filed on 11/25/2020.
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 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.
Claims 1-3, 6, 15, 17, 34-35, 38-39, 41, 61, 67, 69, 72, and 75-79 are rejected under 35 U.S.C. 103 as being unpatentable over Payne et al. (US20030229335, 12/11/2003, IDS of 08/22/2023), in view of Shalaby (WO2005002471, 01/13/2005, PTO-892).
Payne throughout the reference teaches an intravaginal insert device comprising beneficial cells to a treatment for vaginal infections caused by pathogenic microorganisms (e.g., Abstract).
Regarding instant claims 1 and 2, Payne teaches an intravaginal drug delivery device comprises a scaffold comprising a bacterial source surrounded by an outer cover, generating a chamber containing plurality of cells (e.g., [0022]), wherein the outer cover is a microporous membrane made from cellulose, e.g., plant fibers, as biocompatible materials (e.g., [0023-0024]) (corresponding to instant claim 1(a) and 1(b)). Payne indicates within the outer cover a food source (which reads on the instant claimed nutrient) can be intermixed with inactive freeze-dried the bacteria source (Fig. 1; Claim 24) or can be in solution and contained separate from the bacteria source (Fig. 1; [0034]) (corresponding to instant claim 1(c)). Payne specifies that the outer cover is typically a porous membrane having a pore size relative in size to bacteria source so as to not allow bacteria from the bacteria source to permeate to outer cover, but permeable to metabolic byproducts (e.g., [0008]; [0022]; [0024]; Fig. 1).
Payne teaches that the outer cover can be a microporous membrane, and it can be semipermeable membrane made from cellulose, cellulose acetate, benzolyated cellulose, polyacrylonitrile, and other materials (e.g., [0023]; [0024]), and the outer cover can contain blister packs for storing and activating vaginal insets, hydrating solutions, or desired additives, wherein the blisters are connected by blister channel and a channel seal keeps materials in the two blisters from contacting (e.g, [0035]), corresponding to rib structures between chambers as in instant claim 1(d). Payne mentions that cellulose outer covers generally provide the desired characteristics for the outer covers, and the vaginal insert can use a backbone member that adds additional support for the vaginal insert (not shown in Fig. 1) [0025], the outer cover also can comprise at least one of cellulose, thermoplastic nonwoven webs, thermoplastic films, dialysis membranes, and combinations thereof (Claim 8), suggesting such backbone structure functions as separation barrier and additional support, also corresponding to the rib structure instant claim 1 (d). MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968).
Regarding instant claim 3, Payne teaches that the outer cover is made from a sturdy material that will retain its structural integrity during application, use, and removal from the vaginal tract (Fig. 1; [0025]), indicating the biocompatible material is non-resorbable.
Regarding instant claims 15 and 17, Payne discloses its outer cover allows passage of metabolic byproducts produced by the beneficial bacteria Lactobacilli into the vaginal tract creating an environment hostile to pathogenic microorganisms (Abstract; [0007]).
Regarding instant claims 34, Payne teaches that the plurality of cells is enclosed within an outer cover (e.g., [0022]), wherein the outer cover is a microporous membrane made from biocompatible cellulose including wood pulp fibers, cotton fibers, and other plant fibers, or other nonwoven webs including carded fiber webs (or matrix), air laid webs, and the like; microporous membrane materials and construction generally known in the art (e.g., [0024]).
Regarding instant claim 35, Payne specifies that the bacteria source is inactivated by lyophilization (freeze-drying) or other known methods. The freeze-dried bacteria can be in a powder form within the outer cover or encapsulated in hydrogel microspheres [0008], and microspheres can be formed as a hydrogel (e.g., [0018]).
Regarding instant claim 38-39 and 41, Payne teaches that Lactobacilli generally metabolize sugars such as lactose and produce byproducts including small molecules lactic acid and hydrogen peroxide, and the invention can use any species/strain of Lactobacillus depending on the needs of the user [0017].
Regarding instant claim 61, Payne presents examples of food sources include without limitation fructoogliosaccharides, glycogen, and combinations thereof ([0033]; Claim 25), Payne demonstrates microparticle formation with bacterial suspension in alginate solution, and the resulting microparticles post being flash frozen and lyophilization can be revived in growth media at 37°C [0041]. Payne concludes that encapsulation and freeze-drying of Lactobacilli is a promising technique for hydrogen peroxide production which may be used in vaginal applications [0042]. This demonstration teaches that the enclosed bacterial cells within the outer cover in the intravaginal insert device would be able to grow with the nutrient source, e.g., culture media, intermixed in outer cover and generate beneficial metabolites, e.g., lactic acid and peroxide, corresponding to nutrient supplementation systems comprising nutrients and cell culture media as claimed.
Regarding instant claim 69, Payne teaches using the intravaginal drug delivery device in human body throughout the reference. As it is common knowledge that human body temperature is 37 °C, it is anticipated that the drug delivery device is physically stable at 37 °C, as Payne demonstrates the use of the invention in treatment of vaginal tract infections in the experiment shown at 37 °C [0037-0041], which falls within the range of about 0-50 °C in instant claim 69. MPEP 2131.03.I states that "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). Furthermore, the physical stability does not provide structural limitation to the drug delivery device, and it constitutes inherent property of the drug delivery device that has been taught by prior art.
Regarding instant claim 72, Payne specifies that using Lactobacilli such as Lactobacillus acidophilus to treat vaginal infections is well known method, treating pathogenic microorganism infections of the vaginal tract to introduce and/or promote colonization of the naturally occurring microorganisms [0004], and the vaginal insert is useful in treating infections of the vaginal tract [0022], by inserting the vaginal insert into a vaginal tract (Claim 31). Therefore, Payne teaches the method comprising administering to the subject the drug delivery device as claimed.
Regarding instant claims 76-77, Payne teaches that the outer cover can be a microporous membrane separating the cells and nutrient supplement system as discussed above, and it can be made from polyesters (as an example of resorbable elastomer material), polypropylene, polytetrafluoro-ethylene, and the like; and further, dialysis membranes can be made from cellulose, cellulose acetate, benzolyated cellulose, polyacrylonitrile, and other materials (e.g., [0023]; [0024]).
Regarding instant claim 78, Payne teaches an intravaginal drug delivery device comprises a scaffold comprising a bacterial source surrounded by an outer cover, generating a chamber containing plurality of cells (e.g., [0022]), wherein the outer cover is a microporous membrane (e.g., [0023-0024]) that can include a food source as nutrient supplementation system being contained separate from the bacteria source (Fig. 1; [0034]), therefore generating at least two compartments. Payne specifies that the outer cover is typically a porous membrane having a pore size relative in size to bacteria source so as to not allow bacteria from the bacteria source to permeate to outer cover, but permeable to metabolic byproducts (e.g., [0008]; [0022]; [0024]; Claim 31; Fig. 1), corresponding to semipermeable membrane in instant claim dividing the chambers to hold separately of the nutrients and cells in different compartments.
Regarding instant claim 79, Payne teaches the food source may be in a solution that can be enclosed within a small plastic blister within the outer cover for rehydrating and stimulating metabolic production (e.g., [0033-0034]).
Payne does not teach the rib structure is resorbable as in instant claim 1(d). Payne does teach the biocompatible materials can be silicone, polyurethane, poly(ethylene-co-vinyl acetate) (EVA) or a combination thereof as recited in instant claim 6. Payne does not teach the drug delivery device is an intravaginal ring, and intrauterine device, or a pessary as recited in instant claim 67. Payne does not teach administering the drug delivery device to a subject as a method of contraception as recited in instant claim 75.
Shalaby throughout the reference teaches absorbable / biodegradable (corresponding to resorbable) rings for controlled drug delivery such as one or more bioactive agents at the desired biological sites, which may entail intravaginal (e.g., Abstract; Claims 1, 3-4 and 9) (corresponding to instant claim 67), intraperitoneal, and subcutaneous administration of such agents, in part or totally through the controlled degradation of the absorbable components of the composite system (e.g., Pg. 1, Lines 10-17, Field of Invention).
Shalaby explains drawbacks of non-biodegradable matrix compared to biodegradable matrix, such as pharmaceuticals may have brief activity after solubilization under physiologic conditions in the vagina, and the therapeutic agent being decomposed or inactivated inside the non-biodegradable matrix before it can be released (e.g., Pg. 14, Lines 8-17); in a non-biodegradable matrix, many bio-macromolecules will aggregate and precipitate, clogging the channels necessary for diffusion out of the carrier matrix; The problem is largely alleviated by using an absorbable/biodegradable matrix that allows for degradation-controlled release of the therapeutic agent(e.g., Pg. 14, Lines 18-21). Shalaby indicates that the life of an absorbable/biodegradable polymer in vivo can be modified depending on its chemical structure, molecular weight, and degree of crosslinking, and most highly investigated and/or widely used in drug delivery systems are absorbable/biodegradable polymers an PLA, PGA, copolymers of PLA and PGA (e.g., Pg. 14, Line 25-Pg. 15, Line 10). An advantage of an absorbable/biodegradable material is the elimination of the need for surgical removal after it has fulfilled its mission; the appeal of such a material is more than simply for convenience, from a technical standpoint, a material that absorbs or biodegrades gradually and is excreted over time can offer many unique advantages, including (1) the therapeutic agent release rate is amenable to control through variation of the matrix composition; (2) implantation can be done at sites difficult or impossible for retrieval; and (3) delivery of unstable therapeutic agents is more practical (e.g., Pg. 15, Lines 11-18), corresponding to resorbable material for the drug delivery device, e.g., rib structure, in instant claim 1(d).
Shalaby teaches polyesters, polyamides, polyurethanes, polyorthoesters, and polyanhydrides have bene used for dispersion of drug solutes in a polymer matrix (e.g., Pg. 15, Line 26-Pg. 16, Line 3); the matrix comprising an absorbable/biodegradable polymer comprising urethane linkages (e.g., Claim 6), corresponding to instant claim 6.
Shalaby specifies that one specific aspect of the fiber-reinforced composite ring for the controlled release of at least one bioactive agent comprising a biocompatible matrix reinforced with absorbable/biodegradable fibers capable of providing the mechanical properties needed for inserting and maintaining said ring in a body cavity for the desired period of time, wherein said ring is suited for intravaginal placement for the controlled release of one or more active agent(s) for achieving contraception, selected from the group represented by spermiostatic, spermicidal and hormonal agents and a viscosity modifier of the vaginal mucus; Such an intravaginal ring can be used for the controlled release of one or more bioactive agent(s) selected from the group used for contraception, etc. (e.g., Pg. 21, Lines 9-22; Claims 24-25), corresponding to instant claim 75.
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate Shalaby’s teaching of biodegradable or resorbable material into the drug delivery device taught by Payne to arrive at current invention. Because both references teach in vivo drug delivery devices that using polymeric scaffolds, and Shalaby specifies disadvantages such as macromolecules may aggregate and precipitate clogging the channels necessary for diffusion out of the non-biodegradable matrix, and indicates many advantages of using bioabsorbable materials over non-biodegradable materials, it would have motivated artisans in the field to implement resorbable material to take such advantages for reasonable expectation of success, e.g., smoothly allow nutrient going through the rib structure to allow cell growth, and meanwhile allow bioactive molecules timely diffuse into the patient’s tissue. This renders obviousness as “use of known technique to improve similar
devices (methods, or products) in the same way” or as “applying a known technique to a known device
(method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and
(I)(D). Moreover, It is prima facie obvious to select a known material for incorporation into a
composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair &
Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Claims 1-3, 15, 17, 34-35, 38-39, 41, 61, 67, 69, 72, and 75-80 are rejected under 35 U.S.C. 103 as being unpatentable over Payne et al. (US20030229335, 12/11/2003, IDS of 08/22/2023) in view of Shalaby (WO2005002471, 01/13/2005, PTO-892) as applied to Claims 1-3, 6, 15, 17, 34-35, 38-39, 41, 61, 67, 69, 72, and 75-79 above, further in view of Sostek et al. (WO2011062621 or CA2818514, 05/26/2011, PTO-892).
Payne and Shalaby combined teaches an intravaginal insert device comprising scaffold comprising resorbable materials, e.g., copolymers of PLA and PGA, chambers containing Lactobacilli plurality cells, and blister packs within outer cover, wherein the cell chambers are separated with the nutrient chamber(s) by the semipermeable membrane, and the cells can be activated and produce beneficial metabolites like small molecules lactic acid and peroxide which can treat vaginal tract infections from parasitic microorganisms, as discussed above in great detail regarding claims 1-3, 15, 17, 34-35, 38-39, 41, 61, 69, 72, and 76-79 and incorporated herein.
Payne and Shalaby combined does not teach the one or more second chambers is under greater pressure than the one or more first chambers as recited in instant claim 80.
Sostek throughout the reference teaches articles and methods for growing or analyzing tissues and organs using bioreactors or other devices and components, wherein the bioreactor is configured to provide a growth chamber having one or more inlets, outlets (e.g., Abstract).
Sostek teaches a variety of different scaffolds can be used for seeding, growing, supporting, or maintaining cells (e.g., Pg.20, middle paragraph), and that scaffold can be formed of natural and/or artificial biodegradable materials such as polylactide, polyglycolide, and other alpha-hydroxy acids including PLLA, PGA, PLGA (e.g., Pg. 20, bottom paragraph). Sostek indicates that one or more additives may be provided to the scaffold or support structure prior to cellularization. In some embodiments, one or more additives may be provided in a reservoir ( or a plurality of reservoirs) and released (e.g., using a pump, syringe, any suitable hydrostatic or chemical or osmotic pressure, or any other technique that can be controlled and activated) at a particular time or in response to a particular cue. It should be appreciated that the reservoir(s) may be located (e.g., deposited) within the chamber or in fluid connection with the chamber; Release of material from a reservoir may be controlled using any suitable technique (e.g., Pg. 27, bottom paragraph).
It would have been prima facie obvious for one with ordinary skills in the art prior to filing date to incorporate the teaching of Sostek into the drug delivery device of Payne and Shalaby to arrive at current invention. Because Payne and Shalaby already describe the multicompartment drug delivery structure using semipermeable membranes to divide the nutrient and cells chambers, while artisans in the field would be motivated to combine teaching from Sostek to implement suitable hydrostatic or chemical or osmotic pressure to provide directional release of material, for this instance, higher pressure in the nutrient supplying chambers than the cells’ chamber for forcing the fluid with nutrients and oxygen to the adjacent chamber for maintaining cell growth. This renders obviousness as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D). Moreover, MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968).
Response to Remarks/Arguments
Applicant’s remarks/arguments filed on 05/27/2026 have been fully considered. In light of applicant’s remarks and claim amendment, new ground of rejections has been presented above in this office action.
35 U.S.C. 102 Rejections
Applicant asserts that Payne does not anticipate the instant claims; Payne’s system as described in Fig. 3 wherein the nutrient system is separated from the cells by the “channel seal”. The properties of the channel seal are not described beyond their base function that the channel seal can be broken by a user squeezing the blister. This channel seal is not analogous to the resorbable ribs of the instantly claimed device, which are broken down over time without requiring user input; nor is there any indication that the channel seal of Payne is equivalent to one or more “resorbable ribs” as recited in instant claims.
In light of claim amendment, claim rejections under 35 U.S.C. 102 over Payne have been withdrawn. The new ground rejection has combined Shalaby with Payne to teach the resorbable material as instantly claimed.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., resorbable ribs are broken down over time, not by user input to squeeze the structure) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Payne’s exemplified embodiment does not limit Payne’s teaching of the rib structure as solely the channel seal. Multiple structures in Payne’s device including channel seal can correspond to instantly claimed rib structure, e.g., blister packs, vaginal insert as backbone support, and overcover separating the food supply and cells, based upon their functions as barriers separating food supply and cells. The most relevant paragraphs presented in this office action have been copied below for reference:
Payne teaches that the outer cover can be a microporous membrane, and it can be semipermeable membrane made from cellulose, cellulose acetate, benzolyated cellulose, polyacrylonitrile, and other materials (e.g., [0023]; [0024]), and the outer cover can contain blister packs for storing and activating vaginal insets, hydrating solutions, or desired additives, wherein the blisters are connected by blister channel and a channel seal keeps materials in the two blisters from contacting (e.g, [0035]), corresponding to rib structures between chambers as in instant claim 1(d). Payne mentions that cellulose outer covers generally provide the desired characteristics for the outer covers, and the vaginal insert can use a backbone member that adds additional support for the vaginal insert (not shown in Fig. 1) [0025], the outer cover also can comprise at least one of cellulose, thermoplastic nonwoven webs, thermoplastic films, dialysis membranes, and combinations thereof (Claim 8), suggesting such backbone structure functions as separation barrier and additional support, also corresponding to the rib structure instant claim 1 (d). MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968).
Moreover, MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983), and "A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments." Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), and "Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments." In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). For this instance, based on prior art Payne and Shalaby, Payne’s exemplified embodiments of the scaffold structure do not limit the teaching to one skilled in the art to be expected to draw therefrom to make resorbable rib structures between the food supply chamber and cells chamber.
35 U.S.C. 103 Rejections
Applicant asserts that combined teaching Payne and Moss fail to teach separate chambers separated by resorbable ribs, and instantly claimed devices have unexpected benefits over the devices disclosed in the cited references because instant devices do not require user activation prior to insertion as compared to the device in Payne.
The 35 U.S.C. 103 rejections have been updated to combine Shalaby with Payne, and Sostek with Payne and Shalaby, in light of claim amendment. The benefit of the instant device does not require user activation is not a claimed feature; therefore, the user input in Payne does not disqualify the prior art’s teaching of instantly claimed device structure. Furthermore, Shalaby teaches the resorbable material for the scaffold structure.
Please refer to the entire office action as a complete response to the remarks/arguments.
Conclusion
No claims are allowed.
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/DX.Z./ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616
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