DETAILED ACTION
Claims 12-14, 18, 29-30, 33, 35, 38 and 40-45 are currently pending. Claims 29-30, 33, 35, 38, 40-41 are currently under examination.
This office action replaces the office action dated 5/21/2026, wherein the detailed action data was not included due to technical error.
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 .
Examiner’s Note
Applicant's amendments and arguments filed 04/03/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 04/03/2026, it is noted that claims 29 is amended and no new matter or claims have been added.
Modified Rejection:
The following rejections are modified based on Applicant’s claim amendments.
Claim Objections
Claim 30 is objected to because of the following informalities: Claims 30 contains “portion).”. The parenthesis appears to be added as a typographical error and is not identified as a claim amendment, however is newly added.
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 inventio n 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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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) 29-30, 33, 35, 38 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 3,844,285 (Applicant provided) as evidenced by Merriam-Webster (Merriam-Webster, Spring, accessed 05/11/2026).
Regarding claims 29, the limitation of a pharmaceutical dosage form, comprising a pharmaceutical unit comprising a drug, at least one unfolding member connected to the pharmaceutical unit and configured to have contracted proximal shape and an unfolding shape distal to the pharmaceutical unit and retaining member connected to at least one unfolding member and applying a constraining force from the unfolding member when the water-soluble material is dissolved such that the unfolding member can change from the contracted shape to the unfolding shape is met by the ‘285 patent teaching a therapeutic substance administered in at least one body portion having a first configuration or being adapted to be arranged in a first configure whereby it is adapted to be adjusted so as to pass into the rumen and being adapted to change in the rumen into a second configuration which will prevent or at least hinder regurgitation of the device (abstract). A restraining means may be or comprise any material which is dissolved, destroyed, ruptured or broken in the rumen environment and include gelatin (column 4, lines 25-30). The device may be retained in the configuration under tension as a result of gelatin tape and the device opens (column 7, lines 30-40). Two hemi-cylinders are joined by an elastic hinge member made out of nylon. Gelatin tape is positioned to secure the device configuration (Figures 7, column 8, lines 10-25). The gelatin tape (33) reads on the retaining member, the nylon rope reads on the unfolding membrane (32) and the hemispherical unit reads on the pharmaceutical unit comprising the drug (31) (Figure 7).
Regarding the limitation of “wherein at least a portion of the unfolding member is in a bent or folded shape, selected from the group consisting of a spring shape, a continuous S-shaped bending, a Z-shaped bending or an 8-shaped shape is met by the ‘285 patent teaches elastic hinge member (Figures 7, column 8, lines 10-25). Merriam-Webster teaches the definition of Spring is an elastic body or device that recovers its original shape when released after being distorted (page 3). Therefore, the elastic hinge taught by the ‘285 patent meets the definition of a spring and has a shape, therefore spring shaped. The instant specification does not provide a definition of “spring-shape”.
Regarding claims 30 and 33, the limitation of wherein the retaining member comprises a first portion and a second portion, the unfolding member is connected to the first portion, the second portion comprises a water soluble material and the retaining member removed the constraint force from the unfolding member when the water-soluble material of the second portion is dissolved thereby allowing the unfolding member to at least partially unfold is met by the ‘285 patent teaching Two hemi-cylinders are joined by an elastic hinge member made out of nylon. Gelatin tape is positioned to secure the device configuration (Figures 7, column 8, lines 10-25). The gelatin tape (33) reads on the retaining member, the nylon rope reads on the unfolding membrane (32) and the hemispherical unit reads on the pharmaceutical unit comprising the drug (31) (Figure 7). It is noted that the gelatin tape fully contains the entire structure (figure 7), wherein the instant claims nor specification do not define portion or provide a distinction between the first and second portion, the inside and outside of the gelatin tape layer may be used as the first and second portion, both formed of gelatin to dissolve and release the unfolding mechanism. The first portion of the unfolding member (nylon) has a dissolution rate in gastric juice less than the second portion of the retaining member in gastric juice (gelatin tape).
Regarding claim 35, 38, the limitation of wherein the unfolding member further comprises a third portion, wherein the first portion of the unfolding member is connected to the second portion of the unfolding member by the third portion of the unfolding member and the first portion of the unfolding member is disconnected from the second portion when the third portion is dissolved is met by the ‘285 patent teaching a first and second drug core containing portions (first and second portion) connected by a hydrophobic/hydrophilic strip (Figures 4-5, column 7 line 50 to column 8 line 5) wherein suitable materials include treated gelatins and polydextrans (column 4, lines 5-15) wherein the desire for the connecting means to dissolve after drug is release to detach the semicylinders so the animals my regurgitate the individual semicylinders is taught (column 7, lines 35-50).
Regarding claim 40 the limitation of wherein the pharmaceutical dosage form has a length greater than or equal to 16 mm at least one direction when the water-soluble material of the retaining member is at least partially dissolved is met by the ‘285 patent teaching 150 mm capsules and 30 mm diameter (Example 1).
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v.Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under
35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected
various combinations of disclosed ingredients (for example, the first and second portions connected with an elastic or hydrophilic/hydrophobic band and a gelatin tape coating) from within the prior art disclosure of the ‘285 patent, to arrive at the instantly claimed pharmaceutical dosage form “yielding no more than one would have expected from such an arrangement”.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a connecting means which is degraded after release of the active agent and before degradation of the semicylinders as the ‘285 patent teaches the desire for the connecting means to degrade to enable the animal to regurgitate intact semicylinders.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 3,844,285 as applied to claims 1-2, 5, 10-11, 29-30, 33, 35, 38 and 40 above, and further in view of US 4,268,497 (Applicant provided).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-2, 5, 10-11, 29-30, 33, 35, 38 and 40 are taught by the combination of the ‘285 patent.
The ‘285 patent does not specifically teach wherein the unfolding member is configured to fully unfold within at least 10 min after entering gastric juice.
The ‘497 patent teaches oral administration to ruminant animal include veterinary medicament. The sheet is taught as rolled up and stuck together with adhesive backed aper strips for administration and unrolls in the ruminant animal (abstract). The constraining means is chosen so that it is quickly removed in the rumen environment to allow the sheet to unfold once it is in the rumen in the manner of the invention. It is taught as readily dissolved, and includes gelatin (column 3, line 60 to column 4, line 5).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have the restraining means as taught by the ‘285 patent dissolve immediate upon reaching the gastric juice as the ‘497 patent teaches the it was known to have constraining means quickly remove in the rumen environment, wherein the ‘285 patent teaches the desire for unfolding of the dosage form to prevent regurgitation. One of ordinary of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘285 patent and the ‘497 patent are both directed to gelati containing means which are used for delivery of pharmaceutical composition to rumen animal which are unfolded.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues nylon rope (32) does not read on the claimed unfolding member. The ‘285 patent discloses the nylon rope connecting the two hemi-cylinders, which the Examiner analogizes to the unfolding member, primarily functions as a hinge or connector. The ‘285 patent does not specifically elucidate the mechanical properties of this nylon rope component nor does it explain the specific force conditions under which the device deforms form the state shown in figure 7 to figure 6. Based on Figures 6-7 the device’s openings process likely relied more on the rotation or relative displacement of its components rather than shape recovery.
In response, the ‘285 patent teaches elastic material such as rubber and nylon (column 3, lines 55-65) for a hinge with biassing means (column 3, lines 40-50) wherein hinges are taught to be elastic (column 8, lines 10-20) wherein the cylinders are folded together under tension (column 7, lines 30-35). Thus the elastic hinge is taught to be under tension, thus teaching the elastic portion in a contracted shape under action of constrain force.
Applicant argues the unfolding member of the present application is explicitly designed to comprise at least one elastic part and configured into a shape involving continuous folds in a plane, wherein the folding shape is “wherein at least a portion of the unfolding member is in a bent or folded shape, selected form the group consisting of a spring shape, a continuous S-shaped bending, a Z-shaped bending or an 8-shaped shape”. This design ensures that the unfolding member has a contracted shape storing sufficient elastic potential energy to deploy the device with a small volume in this state. Unlike springs or other three-dimensional elastic configures, this configure extending substantially in a plain particularly suitable for 3D printing.
In response, the limitation of wherein the folding shape is “wherein at least a portion of the unfolding member is in a bent or folded shape, selected from the group consisting of a spring shape, a continuous S-shaped bending, a Z-shaped bending or an 8-shaped shape” is met by the ‘285 patent teaches elastic hinge member (Figures 7, column 8, lines 10-25). Merriam-Webster teaches the definition of Spring is an elastic body or device that recovers its original shape when released after being distorted (page 3). Therefore, the elastic hinge taught by the ‘285 patent meets the definition of a spring and has a shape, therefore spring shaped. The instant specification does not provide a definition of “spring-shape”. It appears Applicant is stating the claims are unlike springs, however instant claims springs.
Applicant argues gelatin shape does not read on retaining member as the ‘285 patent does not specifically elucidate the mechanical properties of the nylon rope thus the gelatin strap primary functions to bind and secure two ridged components that are already specific relative positions, wherein the object of constraint is these two components rather than the nylon rope.
In response, the ‘285 patent teaches elastic material such as rubber and nylon (column 3, lines 55-65) for a hinge with biassing means (column 3, lines 40-50) wherein hinges are taught to be elastic (column 8, lines 10-20) wherein the cylinders are folded together under tension (column 7, lines 30-35). Thus the elastic hinge is taught to be under tension, thus teaching the elastic portion in a contracted shape under action of constrain force. The gelatin tape provides restraint during administration (column 7, lines 30-40).
Applicant argues the present application is directed toward animal or human patients to solve the problem of shot effective retention time of drugs in the stomach which necessitates frequent dosing. The ‘285 patent is directed toward ruminants and aims to solve the problem of dosage form being regurgitated. The device is directed to anti-regurgitation and not active gastric retention.
In response, the instant claims are directed to product claims. The structure of the claimed device is taught by the ‘285 patent as discussed above. In response to applicant's argument that the device has active gastric retention, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues the gelatin strap in the ‘285 patent is a single function constraint that dissolves and disappears. There is no design for a first part that remains as a functional structure after deployment. The Examiner’s interpretation of the inner and outer layers of the gelatin strap as corresponding to these two parts constitutes an over interpretation.
In response, the instant claims do not require that a portion of the restraining element remains as a functional structure after deployment and further does not define “portion”. The ‘285 patent teaching Two hemi-cylinders are joined by an elastic hinge member made out of nylon. Gelatin tape is positioned to secure the device configuration (Figures 7, column 8, lines 10-25). The gelatin tape (33) reads on the retaining member, the nylon rope reads on the unfolding membrane (32) and the hemispherical unit reads on the pharmaceutical unit comprising the drug (31) (Figure 7). It is noted that the gelatin tape fully contains the entire structure (figure 7), wherein the instant claims nor specification do not define portion or provide a distinction between the first and second portion, the inside and outside of the gelatin tape layer may be used as the first and second portion, both formed of gelatin to dissolve and release the unfolding mechanism.
Applicant argues the ‘285 patent strips connecting the drug core are dissolvable however their purpose is to allow separation of the two parts after drug release. This is entirely different form the purpose of this part of the unfolding member in the present application. The technical purpose is opposite.
In response to applicant's argument that the third part unfolding is for gastric retention not safe expulsion, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues the ‘150 mm capsule size in the ‘285 patent is the administration size not a minimum retention dimension to be achieve upon deployment in the rumen. There is no teaching or suggestion that its device needs to deploy to a size greater than or require to a specific threshold for retention purposes.
In response, the ‘285 patent teaches the claimed size range and thus would meet the instant claim limitations. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.
See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues the combination with the ’497 patent lack as a reasonable motivation and would not achieve the specific technical effects of the present invention. Applicant argues the ‘285 patent contains no teaching for deployment time and speed. The ‘497 patent is directed toward ruminants and its rapid removal of constraint is intended to allow a rolled sheet to unfold quickly. This is different from the present invention which precisely controls deployment kinetics for human gastric retention. 9999Applicant argues the ‘285 patent seeks morphological change for anti-regurgitation, while the ‘497 patent seeks rapid deployment. Applicant points to the instant specification for the size time curve to demonstrate the desired deployment kinetics achieve through specific folding parameter.
In response, the ‘297 patent teaches the desire for unfolding of the dosage form to prevent regurgitation and the ‘497 patent teaches it was known to have containing means quickly remove in the rumen environment so the device would fold (abstract, column 3, lines 60- column 4, line 5). One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘285 patent and the ‘497 patent are both directed to gelatin containing means which are used for delivery of pharmaceutical compristion to a rumen animal which are unfolded. Regarding the size-time curve, the tested example is to a specific structure (figure 36) containing a specific configuration and size, wherein the instant claims are more broad in structure, such as no size claimed and elastic portion shape and connection, and therefore are not commensurate in scope.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/
Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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