DETAILED ACTION
Claims 1-2, 5, 10-14, 18, 29-30, 33, 35, 38, 40-45 are currently pending. Claims 1-2, 5, 10-11, 29-30, 33, 35, 38, 40-41 are currently under examination.
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 without traverse of Group III (claims 29-30, 33, 35, 38 and 40-41) in the reply filed on 09/16/2025 is acknowledged.
Upon further consideration Groups I and III are rejoined into the same group. Claims 12-14, 18 and 42-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/16/2025.
Species Election:
Applicant's election with traverse of steroid as the drug and polyinylpyrrolidone (PVP) for the water-soluble material in the reply filed on 09/16/2025 is acknowledged. The traversal is on the ground(s) that the claims are generic and because all the claims cover these variations there is no search burden. This is not found persuasive because the restriction requirement/species election not based on search burden. The instant case is a national stage entry thus the species election is based on unity of invention, wherein unity of invention was broken over the ‘285 patent.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-2, 5, 10-11, 29-30, 33, 35, 38 and 40-41 are under consideration to the extent of the elected species, the drug is a steroid and the water-soluble material is PVP.
Priority
The instant application is a national stage entry of PCT/CN2021/127458, filed 10/29/2021, which claims priority to PCTCN2020125319, filed 10/30/2020 and CN202111255791.9, filed 10/27/2021.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 04/27/2023 and 11/24/2025 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
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) 1-2, 5, 10-11, 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).
Regarding claims 1 and 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 claim 2, the limitation of wherein the unfolding member comprises at least one elastic portion configured such that the unfolding member is in the contracted shape proximal to the pharmaceutical unit under the action of the contract force and returns to the unfolding shape distal to the pharmaceutical unit when the constraint force is withdrawn, wherein the retaining member at least partially encase the pharmaceutical unit and the at least one unfolding member such that the at least conflicting member is contracted in shape is met by the ‘285 patent teaching 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 claim 5, the limitation of a plurality of unfolding members, wherein the retaining member is connected to at least two unfolding members, such that the at least two unfolding members are in the contracted shape, wherein the unfolding member has a strip, petal or rod shape is met by the ‘285 publication teaching (figures 4-5) hemi-cylinders which are connected by two hydrophilic/hydrophobic strips and are secured by gelatin tape (column 7, line 60 to column 8 line 5).
Regarding claim 10, the limitation of wherein the pharmaceutical unit comprises a hollow compartment is met by the ‘285 publication teaching a hollow half cylinder (column 5, lines 1-10).
Regarding claim 11, the limitation of wherein the pharmaceutical unit comprises an outer shell and a drug inner core, wherein the outer shell comprises the same host material as the unfolding material is met by the ‘285 patent teaching a container portion which may be formed of nylon and contain a tablet and a strip which may include nylon (column 3, lines 55-65, column 4 line 55 to column 5, line 6).
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 form 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.
Conclusion
No claims are allowed.
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